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Sample records for developed patient-reported outcome

  1. Development of a patient-reported outcome

    DEFF Research Database (Denmark)

    Juul, Tina; Søgaard, Karen; Roos, Ewa M.

    2015-01-01

    removed from the original 69. A multidimensional questionnaire, divided into five subscales, was developed from the remaining 34 items: mobility; symptoms; sleep disturbance; everyday activity and pain; and participation in everyday life. Exploratory factor analysis supported a 5-subscale structure......OBJECTIVE: To develop a patient-reported outcome evaluating the impact of neck pain. The results of item generation and reduction and subscale structure in support of the content and construct validity of the measure are reported. METHODS: Items were generated from the literature and through focus...

  2. Improving a newly developed patient-reported outcome for thyroid patients, using cognitive interviewing

    DEFF Research Database (Denmark)

    Watt, Torquil; Rasmussen, Ase Krogh; Groenvold, Mogens

    2008-01-01

    Objective To improve a newly developed patient-reported outcome measure for thyroid patients using cognitive interviewing. Methods Thirty-one interviews using immediate retrospective and expansive probing were conducted among patients with non-toxic goiter (n = 4), nodular toxic goiter (n = 5) Gr...

  3. Development of a patient-reported outcome instrument for patients with lumbar radicular pain

    OpenAIRE

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Handberg, Charlotte; Nielsen, Claus Vinther; Hørder, Mogens; Maribo, Thomas

    2017-01-01

    Background Low back pain (LBP) is the leading cause to years lived with disability. 10–20% of patients with LBP experience radicular pain (lumbar radiculopathy). Patient-reported outcomes (PROs) play an important role in advancing patient-centered health care. Although patient involvement is essential to develop valid patient-centred PRO instruments patients are not always involved. The International Classification of Functioning, Disability and Health (ICF) are proposed to facilitate consist...

  4. Development of a patient-reported outcome instrument for patients with lumbar radicular pain

    DEFF Research Database (Denmark)

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Handberg, Charlotte

    and ICF Rehabilitation Set. Items in the ICF-PRO are developed within methods and terminology of The Patient-Reported Outcomes Measurement Information System (PROMIS®). The development process contains five phases (figure 1). Results This poster presents preliminary results from phase 1-3. 89...... the focus group identified three themes: 'Simplicity', 'Application' and 'Individuality' representing elements of most importance for the patients toward a patient centered consultation (figure 2). Conclusions We found that ‘Simplicity’, ‘Application’ and ‘Individuality’ was essential to patients to lead...

  5. Proceedings of Patient Reported Outcome Measure’s (PROMs Conference Sheffield 2016: advances in patient reported outcomes research

    Directory of Open Access Journals (Sweden)

    Tim Croudace

    2016-10-01

    Full Text Available Table of contents S1 Using computerized adaptive testing Tim Croudace S2 Well-being: what is it, how does it compare to health and what are the implications of using it to inform health policy John Brazier O1 “Am I going to get better?”—Using PROMs to inform patients about the likely benefit of surgery Nils Gutacker, Andrew Street O2 Identifying Patient Reported Outcome Measures for an electronic Personal Health Record Dan Robotham, Samantha Waterman, Diana Rose, Safarina Satkunanathan, Til Wykes O3 Examining the change process over time qualitatively: transformative learning and response shift Nasrin Nasr, Pamela Enderby O4 Developing a PROM to evaluate self-management in diabetes (HASMID: giving patients a voice Jill Carlton, Donna Rowen, Jackie Elliott, John Brazier, Katherine Stevens, Hasan Basarir, Alex Labeit O5 Development of the Primary Care Outcomes Questionnaire (PCOQ Mairead Murphy, Sandra Hollinghurst, Chris Salisbury O6 Developing the PKEX score- a multimodal assessment tool for patients with shoulder problems Dominic Marley, James Wilson, Amy Barrat, Bibhas Roy O7 Applying multiple imputation to multi-item patient reported outcome measures: advantages and disadvantages of imputing at the item, sub-scale or score level Ines Rombach, Órlaith Burke, Crispin Jenkinson, Alastair Gray, Oliver Rivero-Arias O8 Integrating Patient Reported Outcome Measures (PROMs into routine primary care for patients with multimorbidity: a feasibility study Ian Porter, Jaheeda Gangannagaripalli, Charlotte Bramwell, Jose M. Valderas O9 eRAPID: electronic self-report and management of adverse-events for pelvic radiotherapy (RT patients Patricia Holch, Susan Davidson, Jacki Routledge, Ann Henry, Kevin Franks, Alex Gilbert, Kate Absolom & Galina Velikova O10 Patient reported outcomes (PROMs based recommendation in clinical guidance for the management of chronic conditions in the United Kingdom Ian Porter, Jose M.Valderas O11 Cross-sectional and

  6. Development of a patient-reported outcome instrument for patients with lumbar radicular pain

    DEFF Research Database (Denmark)

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Nielsen, Claus Vinther

    Background: Low back pain (LBP) is the leading contributor to years lived with disability. It is a complex biopsychosocial phenomenon where complete differential diagnosis and assessment is difficult and needs to be comprehensive. Therefore a biopsychosocial approach is recommended. Substantial...... pain. Methods: The development of the PRO will be based on ICF Comprehensive Core Set for Low Back Pain and Rehabilitation Set and existing items from the The Patient-Reported Outcomes Measurement Information System (PROMIS®). The development process will be divided into five steps: 1. Linking PROMIS....... Conclusion(s) : A PRO instrument is developed to systematise and qualify the description on functioning among patients with lumbar radicular pain. The development process is in progress and next step is to engage patients and clinicians in the development process.  Implications : With development of this PRO...

  7. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO

    DEFF Research Database (Denmark)

    Watt, Torquil; Bjorner, Jakob Bue; Groenvold, Mogens

    2015-01-01

    BACKGROUND: Thyroid diseases affect quality of life (QoL). The Thyroid-Related Patient-Reported Outcome (ThyPRO) is an international comprehensive well-validated patient-reported outcome, measuring thyroid-related QoL. The current version is rather long-85 items. The purpose of the present study...... was to develop an abbreviated version of the ThyPRO, with conserved good measurement properties. METHODS: A cross-sectional (N = 907) and a longitudinal sample (N = 435) of thyroid patients were analyzed. A graded item response theory (IRT) model was fitted to the cross-sectional data. Short-form scales.......89-0.98), and the mean scale levels were similar. CONCLUSIONS: A 39-item version of the ThyPRO, with good measurement properties, was developed and is recommended for clinical use....

  8. Development and validation of a patient-reported outcome measure for stroke patients.

    Science.gov (United States)

    Luo, Yanhong; Yang, Jie; Zhang, Yanbo

    2015-05-08

    Family support and patient satisfaction with treatment are crucial for aiding in the recovery from stroke. However, current validated stroke-specific questionnaires may not adequately capture the impact of these two variables on patients undergoing clinical trials of new drugs. Therefore, the aim of this study was to develop and evaluate a new stroke patient-reported outcome measure (Stroke-PROM) instrument for capturing more comprehensive effects of stroke on patients participating in clinical trials of new drugs. A conceptual framework and a pool of items for the preliminary Stroke-PROM were generated by consulting the relevant literature and other questionnaires created in China and other countries, and interviewing 20 patients and 4 experts to ensure that all germane parameters were included. During the first item-selection phase, classical test theory and item response theory were applied to an initial scale completed by 133 patients with stroke. During the item-revaluation phase, classical test theory and item response theory were used again, this time with 475 patients with stroke and 104 healthy participants. During the scale assessment phase, confirmatory factor analysis was applied to the final scale of the Stroke-PROM using the same study population as in the second item-selection phase. Reliability, validity, responsiveness and feasibility of the final scale were tested. The final scale of Stroke-PROM contained 46 items describing four domains (physiology, psychology, society and treatment). These four domains were subdivided into 10 subdomains. Cronbach's α coefficients for the four domains ranged from 0.861 to 0.908. Confirmatory factor analysis supported the validity of the final scale, and the model fit index satisfied the criterion. Differences in the Stroke-PROM mean scores were significant between patients with stroke and healthy participants in nine subdomains (P < 0.001), indicating that the scale showed good responsiveness. The Stroke

  9. Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

    Science.gov (United States)

    Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

    Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

  10. A systematic review of patient-reported outcome measures in paediatric otolaryngology.

    Science.gov (United States)

    Powell, J; Powell, S; Robson, A

    2018-01-01

    Recently, there has been increased emphasis on the development and application of patient-reported outcome measures. This drive to assess the impact of illness or interventions, from the patient's perspective, has resulted in a greater number of available questionnaires. The importance of selecting an appropriate patient-reported outcome measure is specifically emphasised in the paediatric population. The literature on patient-reported outcome measures used in paediatric otolaryngology was reviewed. A comprehensive literature search was conducted using the databases Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, and PsycInfo, using the terms: 'health assessment questionnaire', 'structured questionnaire', 'questionnaire', 'patient reported outcome measures', 'PROM', 'quality of life' or 'survey', and 'children' or 'otolaryngology'. The search was limited to English-language articles published between 1996 and 2016. The search yielded 656 articles, of which 63 were considered relevant. This included general paediatric patient-reported outcome measures applied to otolaryngology, and paediatric otolaryngology disease-specific patient-reported outcome measures. A large collection of patient-reported outcome measures are described in the paediatric otolaryngology literature. Greater standardisation of the patient-reported outcome measures used in paediatric otolaryngology would assist in pooling of data and increase the validation of tools used.

  11. Patient reported outcomes: looking beyond the label claim

    Directory of Open Access Journals (Sweden)

    Doward Lynda C

    2010-08-01

    Full Text Available Abstract The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to ameliorate symptoms, facilitate functioning or, ultimately, to improve quality of life. In such cases, patient reported evidence is increasingly viewed as an essential complement to traditional clinical evidence for establishing a product's competitive advantage in the marketplace. In a commercial setting, the value of patient reported outcomes is viewed largely in terms of their potential for securing a labelling claim in the USA or inclusion in the summary of product characteristics in Europe. Although, the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements, the value of these outcomes goes beyond satisfying requirements for a label claim. The European regulatory authorities, payers both in the US and Europe, clinicians and patients all play a part in determining both the availability and the pricing of medicinal products and all have an interest in patient-reported data that go beyond just symptoms. The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups.

  12. PATIENT-REPORTED OUTCOMES (PROs): PUTTING THE PATIENT PERSPECTIVE IN PATIENT-CENTERED OUTCOMES RESEARCH

    Science.gov (United States)

    Snyder, Claire F.; Jensen, Roxanne E.; Segal, Jodi B.; Wu, Albert W.

    2013-01-01

    Patient-centered outcomes research (PCOR) aims to improve care quality and patient outcomes by providing information that patients, clinicians, and family members need regarding treatment alternatives, and emphasizing patient input to inform the research process. PCOR capitalizes on available data sources and generates new evidence to provide timely and relevant information and can be conducted using prospective data collection, disease registries, electronic medical records, aggregated results from prior research, and administrative claims. Given PCOR’s emphasis on the patient perspective, methods to incorporate patient-reported outcomes (PROs) are critical. PROs are defined by the U.S. Food & Drug Administration as “Any report coming directly from patients… about a health condition and its treatment.” However, PROs have not routinely been collected in a way that facilitates their use in PCOR. Electronic medical records, disease registries, and administrative data have only rarely collected, or been linked to, PROs. Recent technological developments facilitate the electronic collection of PROs and linkage of PRO data, offering new opportunities for putting the patient perspective in PCOR. This paper describes the importance of and methods for using PROs for PCOR. We (1) define PROs; (2) identify how PROs can be used in PCOR, and the critical role of electronic data methods for facilitating the use of PRO data in PCOR; (3) outline the challenges and key unanswered questions that need to be addressed for the routine use of PROs in PCOR; and (4) discuss policy and research interventions to accelerate the integration of PROs with clinical data. PMID:23774513

  13. Patient-reported outcomes in insomnia: development of a conceptual framework and endpoint model.

    Science.gov (United States)

    Kleinman, Leah; Buysse, Daniel J; Harding, Gale; Lichstein, Kenneth; Kalsekar, Anupama; Roth, Thomas

    2013-01-01

    This article describes qualitative research conducted with patients with clinical diagnoses of insomnia and focuses on the development of a conceptual framework and endpoint model that identifies a hierarchy and interrelationships of potential outcomes in insomnia research. Focus groups were convened to discuss how patients experience insomnia and to generate items for patient-reported questionnaires on insomnia and associated daytime consequences. Results for the focus group produced two conceptual frameworks: one for sleep and one for daytime impairment. Each conceptual framework consists of hypothesized domains and items in each domain based on patient language taken from the focus group. These item pools may ultimately serve as a basis to develop new questionnaires to assess insomnia.

  14. Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process

    Science.gov (United States)

    Robson, Joanna C.; Milman, Nataliya; Tomasson, Gunnar; Dawson, Jill; Cronholm, Peter F.; Kellom, Katherine; Shea, Judy; Ashdown, Susan; Boers, Maarten; Boonen, Annelies; Casey, George C.; Farrar, John T.; Gebhart, Don; Krischer, Jeffrey; Lanier, Georgia; McAlear, Carol A.; Peck, Jacqueline; Sreih, Antoine G.; Tugwell, Peter; Luqmani, Raashid A.; Merkel, Peter A.

    2016-01-01

    Objective Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. Methods Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. Results The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. Conclusion The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. (First Release September 1 2015; J Rheumatol 2015;42:2204–9; doi:10.3899/jrheum.141143) PMID:26329344

  15. Patient perspective workshop: moving towards OMERACT guidelines for choosing or developing instruments to measure patient-reported outcomes.

    Science.gov (United States)

    Kirwan, John R; Fries, James F; Hewlett, Sarah E; Osborne, Richard H; Newman, Stanton; Ciciriello, Sabina; van de Laar, Mart A; Dures, Emma; Minnock, Patricia; Heiberg, Turid; Sanderson, Tessa C; Flurey, Caroline A; Leong, Amy L; Montie, Pamela; Richards, Pam

    2011-08-01

    The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced "Truth" statement in the OMERACT Filter.

  16. Instrument development and evaluation for patient-related outcomes assessments

    Directory of Open Access Journals (Sweden)

    Farnik M

    2012-03-01

    Full Text Available Małgorzata Farnik, Władysław PierzchałaDepartment of Pneumonology, Silesian University of Medicine, Katowice, PolandAbstract: Patient-related outcomes measures could provide important information for the current state of the art in medical care and even have an impact on macrodecisions in the health care system. Patient-related outcomes were initially defined as subjective health indicators that allow disability and illness to be assessed, based on patient, caregiver, or physician self-reports. As illness involves psychological and behavioral complex processes of care, a multidisciplinary approach in measuring patient-reported outcomes should be recommended, such as quality of life questionnaires. Patient-related outcomes measures should correspond to specific clinical situations and bring opportunities to improve quality of care. Objective measurements enable quantitative data to be collected and analyzed. Depending on the aim of the research, investigators can use existing methods or develop new tools. This publication presents a methodology for developing patient-related outcomes measures, based on a multistage procedure. The proper definition of specific study objectives and the methodology of instrument development are crucial for successfully transferring the study concept. The model of instrument development is the process of starting from the preliminary phase and includes questionnaire design and scaling, pilot testing (cognitive debriefing, revision of the preliminary version, evaluation of the new tool, and implementation. Validation of the new instrument includes reliability, reproducibility, internal consistency, and responsiveness. The process of designing the new tool should involve a panel of experts, including clinicians, psychologists (preliminary phase, and statisticians (scale development and scoring, and patients (cognitive debriefing. Implementation of a new tool should be followed by evaluation study – assessment of

  17. AMCP Partnership Forum: Improving Quality, Value, and Outcomes with Patient-Reported Outcomes.

    Science.gov (United States)

    2018-03-01

    Patient-reported outcomes (PROs), which provide a direct measure of a patient's health status or treatment preferences, represent a key component of the shift toward patient-centered health care. PROs can measure the state of a patient's disease-specific and overall health throughout the care continuum, enabling them to have a variety of uses for key health care stakeholders. Currently, PROs are used in drug development, aligning patient and clinician goals in care, quality-of-care measures, and coverage and reimbursement decisions. While there have been significant strides by key health care stakeholders to further the development and use of PROs, there are a number of challenges limiting more widespread use. In light of these current challenges and the potential for PROs to improve health care quality and value, on October 19, 2017, the Academy of Managed Care Pharmacy convened a forum of key stakeholders representing patients, payers, providers, government, and pharmaceutical companies to discuss and identify solutions to the current challenges and barriers to further use of PROs. These discussions informed the development of participants' ideal future state in which PROs maximize the goals of all health care stakeholders and the actionable steps required to make the future state a reality. While stakeholders shared unique perspectives throughout the forum, they had consensus on 2 overarching issues: the importance of PROs in defining value, improving patient care, and implementing value-based payment models and the need for strong organizational and operational systems to achieve optimal adoption and use. Participants identified several key challenges in PRO use and adoption: achieving a representative patient population, inclusion of PRO data in medication labels, the necessity for both standardized and customizable PROs, and operational and organizational barriers to collecting and analyzing PROs. To overcome these challenges, participants recommended that

  18. Integrating patient reported outcomes with clinical cancer registry data: a feasibility study of the electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) system.

    Science.gov (United States)

    Ashley, Laura; Jones, Helen; Thomas, James; Newsham, Alex; Downing, Amy; Morris, Eva; Brown, Julia; Velikova, Galina; Forman, David; Wright, Penny

    2013-10-25

    Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both Pplanning and for targeting service provision.

  19. Provincial development of a patient-reported outcome initiative to guide patient care, quality improvement, and research.

    Science.gov (United States)

    Olson, Robert A; Howard, Fuchsia; Lapointe, Vincent; Schellenberg, Devin; Nichol, Alan; Bowering, Gale; Curtis, Susan; Walter, Allison; Brown, Steven; Thompson, Corinne; Bergin, Jackie; Lomas, Sheri; French, John; Halperin, Ross; Tyldesley, Scott; Beckham, Wayne

    2018-01-01

    The BC Cancer Agency Radiotherapy (RT) program started the Prospective Outcomes and Support Initiative (POSI) at all six centres to utilize patient-reported outcomes for immediate clinical care, quality improvement, and research. Patient-reported outcomes were collected at time of computed tomography simulation via tablet and 2 to 4 weeks post-RT via either tablet or over the phone by a registered nurse. From 2013 to 2016, patients were approached on 20,150 attempts by POSI for patients treated with RT for bone metastases (52%), brain metastases (11%), lung cancer (17%), gynecological cancer (16%), head and neck cancer (2%), and other pilots (2%). The accrual rate for all encounters was 85% (n = 17,101), with the accrual rate varying between the lowest and the highest accruing centre from 78% to 89% ( P < .001) and varying by tumour site ( P < .001). Using the POSI database, we have performed research and quality improvement initiatives that have changed practice.

  20. Patient experiences with oily skin: The qualitative development of content for two new patient reported outcome questionnaires

    OpenAIRE

    Arbuckle, Robert; Atkinson, Mark J; Clark, Marci; Abetz, Linda; Lohs, Jan; Kuhagen, Ilka; Harness, Jane; Draelos, Zoe; Thiboutot, Diane; Blume-Peytavi, Ulrike; Copley-Merriman, Kati

    2008-01-01

    Abstract Objective To develop the content for two new patient reported outcome (PRO) measures to: a) assess the severity of symptoms; and b) the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. Methods Using input from initial treatment satisfaction focus groups (n = 42), a review of relevant literature and expert clinicians (n = 3), a discussion guide was developed to guide qualitative inquiry usi...

  1. A systematic review and development of a classification framework for factors associated with missing patient-reported outcome data.

    Science.gov (United States)

    Palmer, Michael J; Mercieca-Bebber, Rebecca; King, Madeleine; Calvert, Melanie; Richardson, Harriet; Brundage, Michael

    2018-02-01

    Missing patient-reported outcome data can lead to biased results, to loss of power to detect between-treatment differences, and to research waste. Awareness of factors may help researchers reduce missing patient-reported outcome data through study design and trial processes. The aim was to construct a Classification Framework of factors associated with missing patient-reported outcome data in the context of comparative studies. The first step in this process was informed by a systematic review. Two databases (MEDLINE and CINAHL) were searched from inception to March 2015 for English articles. Inclusion criteria were (a) relevant to patient-reported outcomes, (b) discussed missing data or compliance in prospective medical studies, and (c) examined predictors or causes of missing data, including reasons identified in actual trial datasets and reported on cover sheets. Two reviewers independently screened titles and abstracts. Discrepancies were discussed with the research team prior to finalizing the list of eligible papers. In completing the systematic review, four particular challenges to synthesizing the extracted information were identified. To address these challenges, operational principles were established by consensus to guide the development of the Classification Framework. A total of 6027 records were screened. In all, 100 papers were eligible and included in the review. Of these, 57% focused on cancer, 23% did not specify disease, and 20% reported for patients with a variety of non-cancer conditions. In total, 40% of the papers offered a descriptive analysis of possible factors associated with missing data, but some papers used other methods. In total, 663 excerpts of text (units), each describing a factor associated with missing patient-reported outcome data, were extracted verbatim. Redundant units were identified and sequestered. Similar units were grouped, and an iterative process of consensus among the investigators was used to reduce these units to a

  2. Patient-reported outcomes in borderline personality disorder

    Science.gov (United States)

    Hasler, Gregor; Hopwood, Christopher J.; Jacob, Gitta A.; Brändle, Laura S.; Schulte-Vels, Thomas

    2014-01-01

    Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes. PMID:25152662

  3. Overcoming barriers to implementing patient-reported outcomes in an electronic health record: a case report.

    Science.gov (United States)

    Harle, Christopher A; Listhaus, Alyson; Covarrubias, Constanza M; Schmidt, Siegfried Of; Mackey, Sean; Carek, Peter J; Fillingim, Roger B; Hurley, Robert W

    2016-01-01

    In this case report, the authors describe the implementation of a system for collecting patient-reported outcomes and integrating results in an electronic health record. The objective was to identify lessons learned in overcoming barriers to collecting and integrating patient-reported outcomes in an electronic health record. The authors analyzed qualitative data in 42 documents collected from system development meetings, written feedback from users, and clinical observations with practice staff, providers, and patients. Guided by the Unified Theory on the Adoption and Use of Information Technology, 5 emergent themes were identified. Two barriers emerged: (i) uncertain clinical benefit and (ii) time, work flow, and effort constraints. Three facilitators emerged: (iii) process automation, (iv) usable system interfaces, and (v) collecting patient-reported outcomes for the right patient at the right time. For electronic health record-integrated patient-reported outcomes to succeed as useful clinical tools, system designers must ensure the clinical relevance of the information being collected while minimizing provider, staff, and patient burden. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Development and implementation of a patient reported outcome intervention (QLIC-ON PROfile) in clinical paediatric oncology practice.

    NARCIS (Netherlands)

    Engelen, V.; Haverman, L.; Koopman, H.; Schouten-van Meeteren, N.; Meijer, E.M.M.; Vrijmoet-Wiersma, J.; Dijk, E.M. van; Last, B.; Detmar, S.; Grootenhuis, M.

    2010-01-01

    OBJECTIVE: The use of patient reported outcomes (PRO) in routine clinical practice is becoming increasingly common, but there is limited knowledge about the development and implementation of PRO. The objective of the current paper is to provide a thorough description of the development and

  5. Development and implementation of a patient reported outcome intervention (QLIC-ON PROfile) in clinical paediatric oncology practice

    NARCIS (Netherlands)

    Engelen, V.; Haverman, L.; Koopman, H.; Schouten-van Meeteren, A.Y.N.; Meijer-van den Bergh, E.; Vrijmoet-Wiersma, J.; van Dijk, E.M.; Last, B.F.; Detmar, S.; Grootenhuis, M.

    2010-01-01

    Objective: The use of patient reported outcomes (PRO) in routine clinical practice is becoming increasingly common, but there is limited knowledge about the development and implementation of PRO. The objective of the current paper is to provide a thorough description of the development and

  6. A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten Bogh; Lund, Hans; Guyatt, GH

    2010-01-01

    Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta-analyses ......Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta...... composite disability scores. Conclusions As choosing the most favorable PROs from individual trials can overestimate the effect compared to a systematic approach, using a prioritized list as presented in this study is recommended to reduce reviewer's likelihood of biased selection of PROs in meta-analyses....

  7. Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.

    Science.gov (United States)

    Voineskos, Sophocles H; Nelson, Jonas A; Klassen, Anne F; Pusic, Andrea L

    2018-01-29

    Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.

  8. Patient empowerment: The need to consider it as a measurable patient-reported outcome for chronic conditions

    Science.gov (United States)

    2012-01-01

    Background Health policy in the UK and elsewhere is prioritising patient empowerment and patient evaluations of healthcare. Patient reported outcome measures now take centre-stage in implementing strategies to increase patient empowerment. This article argues for consideration of patient empowerment itself as a directly measurable patient reported outcome for chronic conditions, highlights some issues in adopting this approach, and outlines a research agenda to enable healthcare evaluation on the basis of patient empowerment. Discussion Patient empowerment is not a well-defined construct. A range of condition-specific and generic patient empowerment questionnaires have been developed; each captures a different construct e.g. personal control, self-efficacy/self-mastery, and each is informed by a different implicit or explicit theoretical framework. This makes it currently problematic to conduct comparative evaluations of healthcare services on the basis of patient empowerment. A case study (clinical genetics) is used to (1) illustrate that patient empowerment can be a valued healthcare outcome, even if patients do not obtain health status benefits, (2) provide a rationale for conducting work necessary to tighten up the patient empowerment construct (3) provide an exemplar to inform design of interventions to increase patient empowerment in chronic disease. Such initiatives could be evaluated on the basis of measurable changes in patient empowerment, if the construct were properly operationalised as a patient reported outcome measure. To facilitate this, research is needed to develop an appropriate and widely applicable generic theoretical framework of patient empowerment to inform (re)development of a generic measure. This research should include developing consensus between patients, clinicians and policymakers about the content and boundaries of the construct before operationalisation. This article also considers a number of issues for society and for healthcare

  9. Pre-validation methods for developing a patient reported outcome instrument

    Directory of Open Access Journals (Sweden)

    Castillo Mayret M

    2011-08-01

    Full Text Available Abstract Background Measures that reflect patients' assessment of their health are of increasing importance as outcome measures in randomised controlled trials. The methodological approach used in the pre-validation development of new instruments (item generation, item reduction and question formatting should be robust and transparent. The totality of the content of existing PRO instruments for a specific condition provides a valuable resource (pool of items that can be utilised to develop new instruments. Such 'top down' approaches are common, but the explicit pre-validation methods are often poorly reported. This paper presents a systematic and generalisable 5-step pre-validation PRO instrument methodology. Methods The method is illustrated using the example of the Aberdeen Glaucoma Questionnaire (AGQ. The five steps are: 1 Generation of a pool of items; 2 Item de-duplication (three phases; 3 Item reduction (two phases; 4 Assessment of the remaining items' content coverage against a pre-existing theoretical framework appropriate to the objectives of the instrument and the target population (e.g. ICF; and 5 qualitative exploration of the target populations' views of the new instrument and the items it contains. Results The AGQ 'item pool' contained 725 items. Three de-duplication phases resulted in reduction of 91, 225 and 48 items respectively. The item reduction phases discarded 70 items and 208 items respectively. The draft AGQ contained 83 items with good content coverage. The qualitative exploration ('think aloud' study resulted in removal of a further 15 items and refinement to the wording of others. The resultant draft AGQ contained 68 items. Conclusions This study presents a novel methodology for developing a PRO instrument, based on three sources: literature reporting what is important to patient; theoretically coherent framework; and patients' experience of completing the instrument. By systematically accounting for all items dropped

  10. Development of the AOSpine Patient Reported Outcome Spine Trauma (AOSpine PROST) : A universal disease-specific outcome instrument for individuals with traumatic spinal column injury

    NARCIS (Netherlands)

    Sadiqi, Said; Lehr, A. Mechteld; Post, Marcel W.; Dvorak, Marcel F.; Kandziora, Frank; Rajasekaran, S.; Schnake, Klaus J.; Vaccaro, Alexander R.; Oner, F. Cumhur

    To report on the multi-phase process used in developing the AOSpine Patient Reported Outcome Spine Trauma (AOSpine PROST), as well as the results of its application in a pilot study. The International Classification of Functioning, Disability and Health (ICF) methodology was used as the basis for

  11. Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials

    DEFF Research Database (Denmark)

    Petkovic, Jennifer; Barton, Jennifer L; Flurey, Caroline

    2017-01-01

    , and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking...

  12. Development of an online library of patient-reported outcome measures in gastroenterology: The GI-PRO database

    OpenAIRE

    Khanna, P; Agarwal, N; Khanna, D; Hays, RD; Chang, L; Bolus, R; Melmed, G; Whitman, CB; Kaplan, RM; Ogawa, R; Snyder, B; Spiegel, BM

    2014-01-01

    OBJECTIVES:Because gastrointestinal (GI) illnesses can cause physical, emotional, and social distress, patient-reported outcomes (PROs) are used to guide clinical decision making, conduct research, and seek drug approval. It is important to develop a mechanism for identifying, categorizing, and evaluating the over 100 GI PROs that exist. Here we describe a new, National Institutes of Health (NIH)-supported, online PRO clearinghouse-the GI-PRO database.METHODS: Using a protocol developed by th...

  13. Patient-reported allergies cause inferior outcomes after total knee arthroplasty.

    Science.gov (United States)

    Hinarejos, Pedro; Ferrer, Tulia; Leal, Joan; Torres-Claramunt, Raul; Sánchez-Soler, Juan; Monllau, Joan Carles

    2016-10-01

    The main objective of this study was to analyse the outcomes after total knee arthroplasty (TKA) of a group of patients with at least one self-reported allergy and a group of patients without reported allergies. We hypothesized there is a significant negative influence on clinical outcome scores after TKA in patients with self-reported allergies. Four-hundred and seventy-five patients who had undergone TKA were analysed preoperatively and 1 year after surgery. The WOMAC, KSS and SF-36 scores were obtained. The patients' Yesavage depression questionnaire score was also recorded. The scores of the 330 (69.5 %) patients without self-reported allergies were compared to the scores of the 145 (30.5 %) patients with at least one self-reported allergy in the medical record. Preoperative scores were similar in both groups. The WOMAC post-operative scores (23.6 vs 20.4; p = 0.037) and the KSS-Knee score (91.1 vs 87.6; p = 0.027) were worse in the group of patients with self-reported allergies than in the group without allergies. The scores from the Yesavage depression questionnaire and in the SF-36 were similar in both groups. Patients with at least one self-reported allergy have worse post-operative outcomes in terms of the WOMAC and KSS-Knee scores after TKA than patients without allergies. These poor outcomes do not seem to be related to depression. Therefore, more research is needed to explain them. Reported allergies could be considered a prognostic factor and used when counselling TKA patients. I.

  14. Using patient-reported outcomes in schizophrenia: the Scottish Schizophrenia Outcomes Study.

    Science.gov (United States)

    Hunter, Robert; Cameron, Rosie; Norrie, John

    2009-02-01

    The primary aim of the Scottish Schizophrenia Outcomes Study (SSOS) was to assess the feasibility and utility of routinely collecting outcome data in everyday clinical settings. Data were collected over three years in the Scottish National Health Service (NHS). There were two secondary aims of SSOS: first, to compare data from patient-rated, objective, and clinician-rated outcomes, and second, to describe trends in outcome data and service use across Scotland over the three years of the study (2002-2005). This study used a naturalistic, longitudinal, observational cohort design. A representative sample of 1,015 persons with ICD-10 F20-F29 diagnoses (schizophrenia, schizotypal disorders, or delusional disorders) was assessed annually using the clinician-rated measure, the Health of the Nation Outcome Scale (HoNOS), and the patient-reported assessment, the Avon Mental Health Measure (Avon). Objective outcomes data and information on services and interventions were collected. Data were analyzed with regression modeling. Of the 1,015 persons recruited, 78% of the cohort (N=789) completed the study. Over the study period, significant decreases were seen in the number of hospitalizations, incidence of attempted suicide and self-harm, and civil detentions. Avon scores indicated significant improvement on all subscales (behavior, social, access, and mental health) and on the total score. However, HoNOS scores on the behavior and symptom subscales did not change, scores on the impairment subscale increased significantly (indicating increased levels of impairment), and scores on the social subscale decreased significantly (indicating improved social functioning). This study has demonstrated that it is feasible within the Scottish NHS to routinely collect meaningful outcomes data in schizophrenia. Patient-reported assessments were also successfully collected and used in care plans. This model shows that it is possible to incorporate patient-reported assessments into routine

  15. Psychometric properties of patient-reported outcome measures for hip arthroscopic surgery

    DEFF Research Database (Denmark)

    Kemp, Joanne L; Collins, Natalie J; Roos, Ewa M.

    2013-01-01

    Patient-reported outcomes (PROs) are considered the gold standard when evaluating outcomes in a surgical population. While the psychometric properties of some PROs have been tested, the properties of newer PROs in patients undergoing hip arthroscopic surgery remain somewhat unknown.......Patient-reported outcomes (PROs) are considered the gold standard when evaluating outcomes in a surgical population. While the psychometric properties of some PROs have been tested, the properties of newer PROs in patients undergoing hip arthroscopic surgery remain somewhat unknown....

  16. Patient-reported Outcomes in Cystic Fibrosis

    OpenAIRE

    Goss, Christopher H.; Quittner, Alexandra L.

    2007-01-01

    Over the past 20 years, there has been tremendous progress in the area of patient-reported outcomes (PROs). A PRO instrument is defined as any measure of a patient's health status that is elicited directly from the patient and assesses how the patient “feels or functions with respect to his or her health condition.” The advances seen in clinical research regarding PROs has been mirrored in research in cystic fibrosis (CF). A large number of instruments have been used for both therapeutic and ...

  17. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 6: creating national initiatives to support development and use-the PROMIS example.

    Science.gov (United States)

    Bartlett, Susan J; Witter, James; Cella, David; Ahmed, Sara

    2017-09-01

    Patient-reported outcome (PRO) data are beneficial to a range of stakeholders including patients, clinicians, researchers, national funding and regulatory agencies, health system administrators, and policymakers. Because stakeholders represent diverse groups and needs, it is challenging to reach consensus on how to advance PRO development and harmonize data across settings to enable use for multiple secondary purposes. Collaborative national networks can facilitate the sharing of expertise, resources, and necessary infrastructure; create development, use, and reporting standards; optimize formats to efficiently store and transfer data; and disseminate tools and information for widespread uptake. In the United States, the National Institutes of Health's Patient-Reported Outcomes Measurement Information System offers an example of how collaborators can work across distances to form essential partnerships, create a common vision, and leverage technology to accelerate the development and testing of universal PROs that are broadly applicable across health conditions and settings. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Patient-reported outcomes, patient-reported information: from randomized controlled trials to the social web and beyond.

    Science.gov (United States)

    Baldwin, Mike; Spong, Andrew; Doward, Lynda; Gnanasakthy, Ari

    2011-01-01

    Internet communication is developing. Social networking sites enable patients to publish and receive communications very easily. Many stakeholders, including patients, are using these media to find new ways to make sense of diseases, to find and discuss treatments, and to give support to patients and their caregivers. We argue for a new definition of patient-reported information (PRI), which differs from the usual patient-reported outcomes (PRO). These new emergent data from the social web have important implications for decision making, at both an individual and a population level. We discuss new emergent technologies that will help aggregate this information and discuss how this will be assessed alongside the use of PROs in randomized controlled trials and how these new emergent data will be one facet of changing the relationship between the various stakeholders in achieving better co-created health.

  19. Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Oxford 2017: Advances in Patient Reported Outcomes Research

    NARCIS (Netherlands)

    Velikova, Galina; Valderas, Jose M.; Potter, Caroline; Batchelder, Laurie; A’Court, Christine; Baker, Matthew; Bostock, Jennifer; Coulter, Angela; Fitzpatrick, Ray; Forder, Julien; Fox, Diane; Geneen, Louise; Gibbons, Elizabeth; Jenkinson, Crispin; Jones, Karen; Kelly, Laura; Peters, Michele; Mulhern, Brendan; Labeit, Alexander; Rowen, Donna; Meadows, Keith; Elliott, Jackie; Brazier, John E.; Knowles, Emma; Keetharuth, Anju; Brazier, John E.; Connell, Janice; Carlton, Jill; Buck, Lizzie Taylor; Ricketts, Thomas; Barkham, Michael; Goswami, Pushpendra; Salek, Sam; Ionova, Tatyana; Oliva, Esther; Fielding, Adele K.; Karakantza, Marina; Al-Ismail, Saad; Collins, Graham P.; McConnell, Stewart; Langton, Catherine; Jennings, Daniel M.; Else, Roger; Kell, Jonathan; Ward, Helen; Day, Sophie; Lumley, Elizabeth; Phillips, Patrick; Duncan, Rosie; Buckley-Woods, Helen; Aber, Ahmed; Jones, Gerogina; Michaels, Jonathan; Porter, Ian; Gangannagaripalli, Jaheeda; Davey, Antoinette; Ricci-Cabello, Ignacio; Haywood, Kirstie; Hansen, Stine Thestrup; Valderas, Jose; Roberts, Deb; Gumber, Anil; Podmore, Bélène; Hutchings, Andrew; van der Meulen, Jan; Aggarwal, Ajay; Konan, Sujith; Price, Andrew; Jackson, William; Bottomley, Nick; Philiips, Michael; Knightley-Day, Toby; Beard, David; Gibbons, Elizabeth; Fitzpatrick, Ray; Greenhalgh, Joanne; Gooding, Kate; Gibbons, Elizabeth; Valderas, Chema; Wright, Judy; Dalkin, Sonia; Meads, David; Black, Nick; Fawkes, Carol; Froud, Robert; Carnes, Dawn; Price, Andrew; Cook, Jonathan; Dakin, Helen; Smith, James; Kang, Sujin; Beard, David; Griffiths, Catrin; Guest, Ella; Harcourt, Diana; Murphy, Mairead; Hollinghurst, Sandra; Salisbury, Chris; Carlton, Jill; Elliott, Jackie; Rowen, Donna; Gao, Anqi; Price, Andrew; Beard, David; Lemanska, Agnieszka; Chen, Tao; Dearnaley, David P.; Jena, Rajesh; Sydes, Matthew; Faithfull, Sara; Ades, A. E.; Kounali, Daphne; Lu, Guobing; Rombach, Ines; Gray, Alastair; Jenkinson, Crispin; Rivero-Arias, Oliver; Holch, Patricia; Holmes, Marie; Rodgers, Zoe; Dickinson, Sarah; Clayton, Beverly; Davidson, Susan; Routledge, Jacqui; Glennon, Julia; Henry, Ann M.; Franks, Kevin; Velikova, Galina; Maguire, Roma; McCann, Lisa; Young, Teresa; Armes, Jo; Harris, Jenny; Miaskowski, Christine; Kotronoulas, Grigorios; Miller, Morven; Ream, Emma; Patiraki, Elizabeth; Geiger, Alexander; Berg, Geir V.; Flowerday, Adrian; Donnan, Peter; McCrone, Paul; Apostolidis, Kathi; Fox, Patricia; Furlong, Eileen; Kearney, Nora; Gibbons, Chris; Fischer, Felix; Gibbons, Chris; Coste, Joel; Martinez, Jose Valderas; Rose, Matthias; Leplege, Alain; Shingler, Sarah; Aldhouse, Natalie; Al-Zubeidi, Tamara; Trigg, Andrew; Kitchen, Helen; Davey, Antoinette; Porter, Ian; Green, Colin; Valderas, Jose M.; Coast, Joanna; Smith, Sarah; Hendriks, Jolijn; Black, Nick; Shah, Koonal; Rivero-Arias, Oliver; Ramos-Goni, Juan-Manuel; Kreimeier, Simone; Herdman, Mike; Devlin, Nancy; Finch, Aureliano Paolo; Brazier, John E.; Mukuria, Clara; Zamora, Bernarda; Parkin, David; Feng, Yan; Bateman, Andrew; Herdman, Mike; Devlin, Nancy; Patton, Thomas; Gutacker, Nils; Shah, Koonal

    2017-01-01

    The proceedings contain 36 papers. The topics discussed include: using patient reported outcome measures (PROMs) in cancer care; validation of the long-term conditions questionnaire (LTCQ) in a diverse sample of health and social care users in England; the national institutes of health

  20. Patient-Reported Outcomes and Fatigue in Patients with Chronic Hepatitis C Infection.

    Science.gov (United States)

    Golabi, Pegah; Sayiner, Mehmet; Bush, Haley; Gerber, Lynn H; Younossi, Zobair M

    2017-08-01

    Fatigue is a common symptom. Diagnosis is difficult. Fatigue is often a complex symptom. In the recent years, fatigue has gained considerable amount of attention. It has 2 major types, central and peripheral, which may occur together or alone. Although fatigue has many strong relations with depression and sleep disorders, it is a separate entity. For the diagnosis of fatigue, self-reports and patient-reported outcomes are highly valuable tools because these methods can reflect patients' perceptions. Treating the underlying disease with newly developed direct-acting antivirals often improves the perceived fatigue. Healthy lifestyle changes are the cornerstone of the treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Inter-provider comparison of patient-reported outcomes: developing an adjustment to account for differences in patient case mix.

    Science.gov (United States)

    Nuttall, David; Parkin, David; Devlin, Nancy

    2015-01-01

    This paper describes the development of a methodology for the case-mix adjustment of patient-reported outcome measures (PROMs) data permitting the comparison of outcomes between providers on a like-for-like basis. Statistical models that take account of provider-specific effects form the basis of the proposed case-mix adjustment methodology. Indirect standardisation provides a transparent means of case mix adjusting the PROMs data, which are updated on a monthly basis. Recently published PROMs data for patients undergoing unilateral knee replacement are used to estimate empirical models and to demonstrate the application of the proposed case-mix adjustment methodology in practice. The results are illustrative and are used to highlight a number of theoretical and empirical issues that warrant further exploration. For example, because of differences between PROMs instruments, case-mix adjustment methodologies may require instrument-specific approaches. A number of key assumptions are made in estimating the empirical models, which could be open to challenge. The covariates of post-operative health status could be expanded, and alternative econometric methods could be employed. © 2013 Crown copyright.

  2. Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients’ experience

    Science.gov (United States)

    2014-01-01

    Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients’ experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative research interview is given as well as information about the form and content of qualitative interviews required for developing PRO measures. Particular attention is paid to the description of interviewing approaches (e.g., semi-structured and in-depth interviews, individual vs. focus group interviews). Information about how to get prepared for a qualitative interview is provided with the description of how to develop discussion guides for exploratory or cognitive interviews. Interviewing patients to obtain knowledge regarding their illness experience requires interpersonal and communication skills to facilitate patients’ expression. Those skills are described in details, as well as the skills needed to facilitate focus groups and to interview children, adolescents and the elderly. Special attention is also given to quality assurance and interview training. The paper ends on ethical considerations since interviewing for the development of PROs is performed in a context of illness and vulnerability. Therefore, it is all the more important that, in addition to soliciting informed consent, respectful interactions be ensured throughout the interview process. PMID:24499454

  3. Setting the vision: applied patient-reported outcomes and smart, connected digital healthcare systems to improve patient-centered outcomes prediction in critical illness.

    Science.gov (United States)

    Wysham, Nicholas G; Abernethy, Amy P; Cox, Christopher E

    2014-10-01

    Prediction models in critical illness are generally limited to short-term mortality and uncommonly include patient-centered outcomes. Current outcome prediction tools are also insensitive to individual context or evolution in healthcare practice, potentially limiting their value over time. Improved prognostication of patient-centered outcomes in critical illness could enhance decision-making quality in the ICU. Patient-reported outcomes have emerged as precise methodological measures of patient-centered variables and have been successfully employed using diverse platforms and technologies, enhancing the value of research in critical illness survivorship and in direct patient care. The learning health system is an emerging ideal characterized by integration of multiple data sources into a smart and interconnected health information technology infrastructure with the goal of rapidly optimizing patient care. We propose a vision of a smart, interconnected learning health system with integrated electronic patient-reported outcomes to optimize patient-centered care, including critical care outcome prediction. A learning health system infrastructure integrating electronic patient-reported outcomes may aid in the management of critical illness-associated conditions and yield tools to improve prognostication of patient-centered outcomes in critical illness.

  4. Development and content validity testing of a patient-reported outcomes questionnaire for the assessment of hereditary angioedema in observational studies.

    Science.gov (United States)

    Bonner, Nicola; Abetz-Webb, Linda; Renault, Lydie; Caballero, Teresa; Longhurst, Hilary; Maurer, Marcus; Christiansen, Sandra; Zuraw, Bruce

    2015-07-01

    Hereditary Angioedema (HAE), a rare genetic disease, manifests as intermittent, painful attacks of angioedema. Attacks vary in frequency and severity and include skin, abdominal and life-threatening laryngeal swellings. This study aimed to develop a patient reported outcome (PRO) tool for the assessment of HAE attacks, including their management and impact on patients' lives, for use in clinical studies, or by physicians in general practice. The results of open-ended face to face concept elicitation interviews with HAE patients in Argentina (n = 10) and the US (n = 33) were used to develop the first draft questionnaire of the HAE patient reported outcomes questionnaire (HAE PRO). Subsequently, in-depth cognitive debriefing interviews were performed with HAE patients in the UK (n = 10), Brazil (n = 10), Germany (n = 11) and France (n = 12). Following input from eight multinational clinical experts further cognitive interviews were conducted in the US (n = 12) and Germany (n = 12). Patients who experienced abdominal, cutaneous or laryngeal attacks of varying severity levels were included in all rounds of interviews. Across the rounds of interviews patients discussed their HAE attack symptoms, impacts and treatments. Cognitive debriefing interviews explored patient understanding and relevance of questionnaire items. All interviews were conducted face to face following a pre-defined semi-structured interview guide in the patient's native language. Patients reported a variety of HAE symptoms, attack triggers, warning signs, attack impacts and treatment options which were used to develop the HAE PRO. The HAE PRO was revised and refined following input from patients and clinical experts. The final 18-item HAE PRO provides an assessment of the HAE attack experience including symptoms, impacts, treatment requirements, healthcare resource use and loss of productivity caused by HAE attacks. Patient and expert input has contributed to the

  5. Patient-reported outcome measures in arthroplasty registries

    DEFF Research Database (Denmark)

    Rolfson, Ola; Bohm, Eric; Franklin, Patricia

    2016-01-01

    The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use...... are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain...... should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before...

  6. Using Patient Reported Outcomes Measures to Promote Integrated Care

    Directory of Open Access Journals (Sweden)

    Marcel G. M. Olde Rikkert

    2018-04-01

    Full Text Available Introduction: Patient reported outcome measures (PROMs have been introduced as standardised outcomes, but have not been implemented widely for disease targeted pathways of care, nor for geriatric patients who prefer functional performance and quality of life. Discussion: We describe innovative multipurpose implementation of PROMs as evidenced by two best practices of PROMs application in geriatric and physiotherapy practice. We show that PROMs can show meaningful outcomes in older subjects’ patient journeys, which can at the same time serve individuals and groups of both patients and professionals. Key lesson: PROMs can deliver generic outcomes relevant for older patients, may improve patient-physician relationship, quality of care and prediction of future outcomes in geriatric care, if they are valid, reliable and responsive, but still short and simple. A precondition to make the hard tip from research to practice is that PROMs are carefully positioned in the clinical encounters and in electronic health records.

  7. Patient reported outcome measures (PROMs)

    DEFF Research Database (Denmark)

    Bech, Per; Austin, Stephen Fitzgerald; Lau, Marianne Engelbrecht

    2018-01-01

    INTRODUCTION: Patient-reported outcome measures (PROMs) for anxiety and depressive disorders are an important aspect of measurement-based care. AIM: The aim of the study was to perform a clinimetric analysis of two PROMs scales in patents with depression and anxiety. METHODS: Patients completed...... recruited from two Danish mental health centers with anxiety or depression. The standardization of the SCL-10 and WHO-5 by T-scores indicated that a T-score of 65 corresponding to being moderately in need of treatment and a T-score of 75 to be severely in need of treatment. The coefficient of alpha...... with anxiety or depression undergoing psychotherapy treatment....

  8. The patient-physician partnership in asthma: real-world observations associated with clinical and patient-reported outcomes.

    Science.gov (United States)

    Small, M; Vickers, A; Anderson, P; Kay, S

    2010-09-01

    It is hypothesized that a good partnership between asthma patients and their physicians has a direct and positive influence on the patients' clinical and patient-reported outcomes. Conversely, poor partnership has a detrimental effect on clinical and patient-reported outcomes. This paper uses data from a real-world observational study to define partnership through matched physician and patient data and correlate the quality of partnership with observed clinical and patient-reported outcomes. Data were drawn from Adelphi's Respiratory Disease Specific Programme, a cross-sectional study of consulting patients in five European countries undertaken between June and September 2009. A range of clinical and patient-reported outcomes were observed allowing analysis of the partnership between 2251 asthma patients and their physicians. Analysis demonstrates that the better the partnership between patient and physician, the more likely the patient is to have their asthma condition controlled (PPartnership is also associated with lower impact on lifestyle (Ppartnership is a contributory factor in the improvement of asthma treatment, and patient education may lead to improvement in a patient's ability to contribute to this. Device satisfaction is one of the markers of good partnership.

  9. Proceedings of Patient Reported Outcome Measure?s (PROMs) Conference Sheffield 2016: advances in patient reported outcomes research

    OpenAIRE

    Croudace, Tim; Brazier, John; Gutacker, Nils; Street, Andrew; Robotham, Dan; Waterman, Samantha; Rose, Diana; Satkunanathan, Safarina; Wykes, Til; Nasr, Nasrin; Enderby, Pamela; Carlton, Jill; Rowen, Donna; Elliott, Jackie; Brazier, John

    2016-01-01

    Table of contents S1 Using computerized adaptive testing Tim Croudace S2 Well-being: what is it, how does it compare to health and what are the implications of using it to inform health policy John Brazier O1 “Am I going to get better?”—Using PROMs to inform patients about the likely benefit of surgery Nils Gutacker, Andrew Street O2 Identifying Patient Reported Outcome Measures for an electronic Personal Health Record Dan Robotham, Samantha Waterman, Diana Rose, Safarina Satkunanathan, Til W...

  10. Patient-Reported Outcomes in Weight Loss and Body Contouring Surgery

    DEFF Research Database (Denmark)

    Poulsen, Lotte; Klassen, Anne; Rose, Michael

    2017-01-01

    BACKGROUND: Health-related quality of life and satisfaction with appearance are important outcomes in bariatric and body contouring surgery. To investigate these outcomes, scientifically sound and clinically meaningful patient-reported outcome instruments are needed. The authors measured health-r...

  11. All together now: findings from a PCORI workshop to align patient-reported outcomes in the electronic health record.

    Science.gov (United States)

    Jensen, Roxanne E; Snyder, Claire F; Basch, Ethan; Frank, Lori; Wu, Albert W

    2016-11-01

    In recent years, patient-reported outcomes have become increasingly collected and integrated into electronic health records. However, there are few cross-cutting recommendations and limited guidance available in this rapidly developing research area. Our goal is to report key findings from a 2013 Patient-Centered Outcomes Research Institute workshop on this topic and a summary of actions that followed from the workshop, and present resulting recommendations that address patient, clinical and research/quality improvement barriers to regular use. These findings provide actionable guidance across research and practice settings to promote and sustain widespread adoption of patient-reported outcomes across patient populations, healthcare settings and electronic health record systems.

  12. Patient-Reported Outcomes in Patients with Chronic Kidney Disease and Kidney Transplant—Part 1

    Directory of Open Access Journals (Sweden)

    Evan Tang

    2018-01-01

    Full Text Available Chronic kidney disease (CKD is a complex medical condition that is associated with several comorbidities and requires comprehensive medical management. Given the chronic nature of the condition, its frequent association with psychosocial distress, and its very significant symptom burden, the subjective patient experience is key toward understanding the true impact of CKD on the patients’ life. Patient-reported outcome measures are important tools that can be used to support patient-centered care and patient engagement during the complex management of patients with CKD. The routine collection and use of patient-reported outcomes (PROs in clinical practice may improve quality of care and outcomes, and may provide useful data to understand the disease from both an individual and a population perspective. Many tools used to measure PROs focus on assessing health-related quality of life, which is significantly impaired among patients with CKD. Health-related quality of life, in addition to being an important outcome itself, is associated with clinical outcomes such as health care use and mortality. In Part 1 of this review, we provide an overview of PROs and implications of their use in the context of CKD. In Part 2, we will review the selection of appropriate measures and the relevant domains of interest for patients with CKD.

  13. Discrepancies between patient-reported outcome measures when assessing urinary incontinence or pelvic-prolapse surgery

    DEFF Research Database (Denmark)

    Larsen, Michael Due; Lose, Gunnar; Guldberg, Rikke

    2016-01-01

    INTRODUCTION AND HYPOTHESIS: In order to assess the outcome following surgery for urinary incontinence (UI) and pelvic organ prolapse (POP) the importance of patient-reported outcome measures, in addition to the clinical objective measures, has been recognised. The International Consultation...... on Incontinence has initiated the development and evaluation of disease-specific questionnaires (ICIQ) to compare the patient's degree of improvement. Alternatively, the Patient's Global Impression of Improvement (PGI-I score) with an inherent before-after assessment has been widely accepted in recent studies...

  14. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    Science.gov (United States)

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  15. Development and content validity of a patient reported outcomes measure to assess symptoms of major depressive disorder

    Directory of Open Access Journals (Sweden)

    Lasch Kathryn

    2012-04-01

    Full Text Available Abstract Background Although many symptoms of Major Depressive Disorder (MDD are assessed through patient-report, there are currently no patient-reported outcome (PRO instruments that incorporate documented evidence of patient input in PRO instrument development. A review of existing PROs used in MDD suggested the need to conduct qualitative research with patients with MDD to better understand their experience of MDD and develop an evaluative instrument with content validity. The aim of this study was to develop a disease-specific questionnaire to assess symptoms important and relevant to adult MDD patients. Methods The questionnaire development involved qualitative interviews for concept elicitation, instrument development, and cognitive interviews to support content validity. For concept elicitation, ten MDD severity-specific focus group interviews with thirty-eight patients having clinician-confirmed diagnoses of MDD were conducted in January 2009. A semi-structured discussion guide was used to elicit patients' spontaneous descriptions of MDD symptoms. Verbatim transcripts of focus groups were coded and analyzed to develop a conceptual framework to describe MDD. A PRO instrument was developed by operationalizing concepts elicited in the conceptual framework. Cognitive interviews were carried out in patients (n = 20 to refine and test the content validity of the instrument in terms of item relevance and comprehension, instructions, recall period, and response categories. Results Concept elicitation focus groups identified thirty-five unique concepts falling into several domains: i emotional, ii cognitive, iii motivation, iv work, v sleep, vi appetite, vii social, viii activities of daily living, ix tired/fatigue, x body pain, and xi suicidality. Concept saturation, the point at which no new relevant information emerges in later interviews, was achieved for each of the concepts. Based on the qualitative findings, the PRO instrument developed

  16. Use of patient-reported outcomes in outpatient settings as a means of patient involvement and self-management support

    DEFF Research Database (Denmark)

    Mejdahl, Caroline; Nielsen, Berit Kjærside; Hjøllund, Niels Henrik Ingvar

    2016-01-01

    Rationale, aims and objectives: Patient-reported outcomes (PROs) are being implemented in clinical practice across different healthcare settings with varying purposes. Involving patients in reporting outcomes may increase their attention to symptoms and thereby support their self-management. The ...... to strengthen patient involvement and securing benefit from PROs.......Rationale, aims and objectives: Patient-reported outcomes (PROs) are being implemented in clinical practice across different healthcare settings with varying purposes. Involving patients in reporting outcomes may increase their attention to symptoms and thereby support their self......-management. The aim of the present study was to describe patients’ experiences with a web-based PRO system where patients complete a PRO questionnaire at home or in the outpatient clinic prior to a consultation. Moreover, the study aimed to explore how PROs influenced the interaction between patients and clinicians...

  17. A new internet-based tool for reporting and analysing patient-reported outcomes and the feasibility of repeated data collection from patients with myeloproliferative neoplasms

    DEFF Research Database (Denmark)

    Brochmann, Nana; Zwisler, Ann-Dorthe; Kjerholt, Mette

    2016-01-01

    PURPOSE: An Internet-based tool for reporting and analysing patient-reported outcomes (PROs) has been developed. The tool enables merging PROs with blood test results and allows for computation of treatment responses. Data may be visualized by graphical analysis and may be exported for downstream...

  18. A hierarchy of patient-reported outcomes for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten; Lund, Hans; Roos, Ewa M

    2012-01-01

    Objectives. To develop a prioritised list based on responsiveness for extracting patient-reported outcomes (PROs) measuring pain and disability for performing meta-analyses in knee osteoarthritis (OA). Methods. A systematic search was conducted in 20 highest impact factor general and rheumatology...

  19. Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study.

    Science.gov (United States)

    Hung, Man; Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D

    2015-01-01

    Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties.

  20. The development of PubMed search strategies for patient preferences for treatment outcomes.

    Science.gov (United States)

    van Hoorn, Ralph; Kievit, Wietske; Booth, Andrew; Mozygemba, Kati; Lysdahl, Kristin Bakke; Refolo, Pietro; Sacchini, Dario; Gerhardus, Ansgar; van der Wilt, Gert Jan; Tummers, Marcia

    2016-07-29

    The importance of respecting patients' preferences when making treatment decisions is increasingly recognized. Efficiently retrieving papers from the scientific literature reporting on the presence and nature of such preferences can help to achieve this goal. The objective of this study was to create a search filter for PubMed to help retrieve evidence on patient preferences for treatment outcomes. A total of 27 journals were hand-searched for articles on patient preferences for treatment outcomes published in 2011. Selected articles served as a reference set. To develop optimal search strategies to retrieve this set, all articles in the reference set were randomly split into a development and a validation set. MeSH-terms and keywords retrieved using PubReMiner were tested individually and as combinations in PubMed and evaluated for retrieval performance (e.g. sensitivity (Se) and specificity (Sp)). Of 8238 articles, 22 were considered to report empirical evidence on patient preferences for specific treatment outcomes. The best search filters reached Se of 100 % [95 % CI 100-100] with Sp of 95 % [94-95 %] and Sp of 97 % [97-98 %] with 75 % Se [74-76 %]. In the validation set these queries reached values of Se of 90 % [89-91 %] with Sp 94 % [93-95 %] and Se of 80 % [79-81 %] with Sp of 97 % [96-96 %], respectively. Narrow and broad search queries were developed which can help in retrieving literature on patient preferences for treatment outcomes. Identifying such evidence may in turn enhance the incorporation of patient preferences in clinical decision making and health technology assessment.

  1. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    Science.gov (United States)

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  2. Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study

    Science.gov (United States)

    Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D

    2015-01-01

    Background Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. Objective The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Methods Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. Results The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. Conclusions We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties. PMID:27227131

  3. Patient experiences with oily skin: the qualitative development of content for two new patient reported outcome questionnaires.

    Science.gov (United States)

    Arbuckle, Robert; Atkinson, Mark J; Clark, Marci; Abetz, Linda; Lohs, Jan; Kuhagen, Ilka; Harness, Jane; Draelos, Zoe; Thiboutot, Diane; Blume-Peytavi, Ulrike; Copley-Merriman, Kati

    2008-10-16

    To develop the content for two new patient reported outcome (PRO) measures to: a) assess the severity of symptoms; and b) the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. Using input from initial treatment satisfaction focus groups (n = 42), a review of relevant literature and expert clinicians (n = 3), a discussion guide was developed to guide qualitative inquiry using Internet focus groups (IFGs). IFGs were conducted with German (n = 26) and US (n = 28) sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3) years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40) reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face) methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, self-consciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale) and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale). Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of these measures reported elsewhere.

  4. Patient-reported outcome measures in burning mouth syndrome - a review of the literature.

    Science.gov (United States)

    Ni Riordain, R; McCreary, C

    2013-04-01

    Oral Diseases (2013) 19, 230-235 This review aims to investigate the patient-reported outcomes currently used in the burning mouth syndrome literature and to explore whether any standardisation of such measures has taken place. Electronic databases were searched for all types of burning mouth syndrome studies using patient-reported outcome measures. Studies were selected by predefined inclusion criteria. Copies of the papers obtained were thoroughly reviewed. A study-specific data extraction form was used, allowing papers to be reviewed in a standardised manner. The initial literature search yielded a total of 173 citations, 43 of which were deemed suitable for inclusion in this study. Symptom severity and symptomatic relief were reported as a patient-reported outcome measure in 40 of the studies and quantified most commonly using a visual analogue scale. Quality of life was reported in 13 studies included in this review. Depression and/or anxiety was reported in 14 of the studies. As is evident from the variety of questionnaires and instruments used in the evaluation of the impact of burning mouth syndrome on patients' lives, no standardisation of patient outcomes has yet been achieved. © 2012 John Wiley & Sons A/S.

  5. Social inequalities in patient-reported outcomes among older multimorbid patients--results of the MultiCare cohort study.

    Science.gov (United States)

    von dem Knesebeck, Olaf; Bickel, Horst; Fuchs, Angela; Gensichen, Jochen; Höfels, Susanne; Riedel-Heller, Steffi G; König, Hans-Helmut; Mergenthal, Karola; Schön, Gerhard; Wegscheider, Karl; Weyerer, Siegfried; Wiese, Birgitt; Scherer, Martin; van den Bussche, Hendrik; Schäfer, Ingmar

    2015-02-07

    In this article three research questions are addressed: (1) Is there an association between socioeconomic status (SES) and patient-reported outcomes in a cohort of multimorbid patients? (2) Does the association vary according to SES indicator used (income, education, occupational position)? (3) Can the association between SES and patient-reported outcomes (self-rated health, health-related quality of life and functional status) be (partly) explained by burden of disease? Analyses are based on the MultiCare Cohort Study, a German multicentre, prospective, observational cohort study of multimorbid patients from general practice. We analysed baseline data and data from the first follow-up after 15 months (N = 2,729). To assess burden of disease we used the patients' morbidity data from standardized general practitioner (GP) interviews based on a list of 46 groups of chronic conditions including the GP's severity rating of each chronic condition ranging from marginal to very severe. In the cross-sectional analyses SES was significantly associated with the patient-reported outcomes at baseline. Associations with income were more consistent and stronger than with education and occupational position. Associations were partly explained (17% to 44%) by burden of disease. In the longitudinal analyses only income (but not education and occupational position) was significantly related to the patient-reported outcomes at follow-up. Associations between income and the outcomes were reduced by 18% to 27% after adjustment for burden of disease. Results indicate social inequalities in self-rated health, functional status and health related quality of life among older multimorbid patients. As associations with education and occupational position were inconsistent, these inequalities were mainly due to income. Inequalities were partly explained by burden of disease. However, even among patients with a similar disease burden, those with a low income were worse off in terms of the

  6. Patient- and clinician- reported outcome in eating disorders

    DEFF Research Database (Denmark)

    Winkler, Laura Vad; Frølich, Jacob Stampe; Gudex, Claire

    2017-01-01

    Patient-reported outcome is increasingly applied in health sciences. Patients with eating disorders (EDs) characteristically have a different opinion of their needs to that of the health professionals, which can lead to ambivalence towards treatment and immense compliance difficulties. This cross....... This association was not observed in bulimia nervosa (BN). We did not find a correlation between SF-36 scores and BMI in any of the diagnostic groups....

  7. Methods for interpreting change over time in patient-reported outcome measures.

    Science.gov (United States)

    Wyrwich, K W; Norquist, J M; Lenderking, W R; Acaster, S

    2013-04-01

    Interpretation guidelines are needed for patient-reported outcome (PRO) measures' change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy. This article reviews the evolution of the methods and the terminology used to describe and aid in the communication of meaningful PRO change score thresholds. Anchor- and distribution-based methods have played important roles, and the FDA has recently stressed the importance of cross-sectional patient global assessments of concept as anchor-based methods for estimation of the responder definition, which describes an individual-level treatment benefit. The final FDA PRO Guidance proposes the cumulative distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population. While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO's relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.

  8. Patient- and clinician- reported outcome in eating disorders.

    Science.gov (United States)

    Winkler, Laura Al-Dakhiel; Frølich, Jacob Stampe; Gudex, Claire; Hørder, Kirsten; Bilenberg, Niels; Støving, René Klinkby

    2017-01-01

    Patient-reported outcome is increasingly applied in health sciences. Patients with eating disorders (EDs) characteristically have a different opinion of their needs to that of the health professionals, which can lead to ambivalence towards treatment and immense compliance difficulties. This cross-sectional study compared data assessed by the clinician to patient-reported measures in patients with a history of EDs. We included data from a cohort of patients with EDs (n=544) referred to a specialized ED unit in Denmark. Patient-reported measures included the Eating Disorder Inventory-2 (EDI-2) and the Short Form 36 (SF-36), and clinical data included remission status and body mass index (BMI). We found a positive association between BMI and EDI-2 scores for anorexia nervosa (AN) and eating disorder not otherwise specified (EDNOS), reflecting increasing ED symptomatology with increasing BMI. This association was not observed in bulimia nervosa (BN). We did not find a correlation between SF-36 scores and BMI in any of the diagnostic groups. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. An introduction to patient-reported outcome measures (PROMs) in physiotherapy

    NARCIS (Netherlands)

    Kyte, D.G.; Calvert, M.; Wees, P.J. van der; Hove, R. Ten; Tolan, S.; Hill, J.C.

    2015-01-01

    The use of patient-reported outcome measures (PROMs) is set to rise in physiotherapy. PROMs provide additional 'patient-centred' data which is unique in capturing the patient's own opinion on the impact of their disease or disorder, and its treatment, on their life. Thus, PROMs are increasingly used

  10. Patient-reported outcome measures for chronic obstructive pulmonary disease : the exclusion of people with low literacy skills and learning disabilities

    NARCIS (Netherlands)

    Jahagirdar, D.; Kroll, T.; Ritchie, K.; Wyke, S.

    2013-01-01

    BACKGROUND: Patient-reported outcome measures (PROMs) are intended to reflect outcomes relevant to patients. They are increasingly used for healthcare quality improvement. To produce valid measures, patients should be involved in the development process but it is unclear whether this usually

  11. Added value of qualitative studies in the development of health related patient reported outcomes such as the pain coping and cognition list in patients with sub-acute neck pain

    NARCIS (Netherlands)

    Pool, J.J.M.; Hiralal, S.; Ostelo, R.W.J.G.; van der Veer, K.; de Vet, H.C.W.

    2010-01-01

    Psychometric analyses, such as factor analysis, internal consistency and construct validity analysis, are well known and frequently applied methods in the development of health related patient reported outcomes. These statistical indexes shed very little light on how respondents interpret individual

  12. The development of PubMed search strategies for patient preferences for treatment outcomes

    Directory of Open Access Journals (Sweden)

    Ralph van Hoorn

    2016-07-01

    Full Text Available Abstract Background The importance of respecting patients’ preferences when making treatment decisions is increasingly recognized. Efficiently retrieving papers from the scientific literature reporting on the presence and nature of such preferences can help to achieve this goal. The objective of this study was to create a search filter for PubMed to help retrieve evidence on patient preferences for treatment outcomes. Methods A total of 27 journals were hand-searched for articles on patient preferences for treatment outcomes published in 2011. Selected articles served as a reference set. To develop optimal search strategies to retrieve this set, all articles in the reference set were randomly split into a development and a validation set. MeSH-terms and keywords retrieved using PubReMiner were tested individually and as combinations in PubMed and evaluated for retrieval performance (e.g. sensitivity (Se and specificity (Sp. Results Of 8238 articles, 22 were considered to report empirical evidence on patient preferences for specific treatment outcomes. The best search filters reached Se of 100 % [95 % CI 100-100] with Sp of 95 % [94–95 %] and Sp of 97 % [97–98 %] with 75 % Se [74–76 %]. In the validation set these queries reached values of Se of 90 % [89–91 %] with Sp 94 % [93–95 %] and Se of 80 % [79–81 %] with Sp of 97 % [96–96 %], respectively. Conclusions Narrow and broad search queries were developed which can help in retrieving literature on patient preferences for treatment outcomes. Identifying such evidence may in turn enhance the incorporation of patient preferences in clinical decision making and health technology assessment.

  13. Patient Compliance With Electronic Patient Reported Outcomes Following Shoulder Arthroscopy.

    Science.gov (United States)

    Makhni, Eric C; Higgins, John D; Hamamoto, Jason T; Cole, Brian J; Romeo, Anthony A; Verma, Nikhil N

    2017-11-01

    To determine the patient compliance in completing electronically administered patient-reported outcome (PRO) scores following shoulder arthroscopy, and to determine if dedicated research assistants improve patient compliance. Patients undergoing arthroscopic shoulder surgery from January 1, 2014, to December 31, 2014, were prospectively enrolled into an electronic data collection system with retrospective review of compliance data. A total of 143 patients were included in this study; 406 patients were excluded (for any or all of the following reasons, such as incomplete follow-up, inaccessibility to the order sets, and inability to complete the order sets). All patients were assigned an order set of PROs through an electronic reporting system, with order sets to be completed prior to surgery, as well as 6 and 12 months postoperatively. Compliance rates of form completion were documented. Patients who underwent arthroscopic anterior and/or posterior stabilization were excluded. The average age of the patients was 53.1 years, ranging from 20 to 83. Compliance of form completion was highest preoperatively (76%), and then dropped subsequently at 6 months postoperatively (57%) and 12 months postoperatively (45%). Use of research assistants improved compliance by approximately 20% at each time point. No differences were found according to patient gender and age group. Of those completing forms, a majority completed forms at home or elsewhere prior to returning to the office for the clinic visit. Electronic administration of PRO may decrease the amount of time required in the office setting for PRO completion by patients. This may be mutually beneficial to providers and patients. It is unclear if an electronic system improves patient compliance in voluntary completion PRO. Compliance rates at final follow-up remain a concern if data are to be used for establishing quality or outcome metrics. Level IV, case series. Copyright © 2017 Arthroscopy Association of North

  14. Training clinicians in how to use patient-reported outcome measures in routine clinical practice

    NARCIS (Netherlands)

    Santana, Maria J.; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

    2015-01-01

    Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs

  15. Patient-reported allergies predict postoperative outcomes and psychosomatic markers following spine surgery.

    Science.gov (United States)

    Xiong, David D; Ye, Wenda; Xiao, Roy; Miller, Jacob A; Mroz, Thomas E; Steinmetz, Michael P; Nagel, Sean J; Machado, Andre G

    2018-05-22

    Prior studies have shown that patient-reported allergies can be prognostic of poorer postoperative outcomes. To investigate the correlation between self-reported allergies and outcomes after cervical or lumbar spine surgery. Retrospective cohort study at a single tertiary-care institution. All patients undergoing cervical or lumbar spine surgery from 2009-2014. The primary outcome measure was change in the EuroQol-5 Dimensions (EQ-5D) following surgery. Secondary outcomes included change in the Pain Disability Questionnaire (PDQ) and Patient Health Questionnaire-9 (PHQ-9), achieving the minimal clinically important difference (MCID) in these measures, as well as cost of admission. Prior to and following surgery, EQ-5D, PDQ, and PHQ-9 were recorded for patients with available data. Paired student's t-tests were used to compare change in these measures following surgery. Multivariable linear and logistic regression were used to assess the relationship between the log transformation of the total number of allergies and outcomes. 592 cervical patients and 4,465 lumbar patients were included. The median number of reported allergies was two. The EQ-5D index increased from 0.539 to 0.703 for cervical patients and from 0.530 to 0.676 for lumbar patients (pallergies predicted significantly higher odds of achieving the PDQ MCID (OR = 2.09, 95% CI 1.05-4.15, p=0.02 for cervical patients; OR = 1.30, 95% CI 1.03-1.68, p=0.03 for lumbar patients). However, this relationship was not durable for patients with follow-up exceeding 1 year. The log transformation of number of allergies for lumbar patients predicted significantly increased cost of admission (β=$3,597, pallergies correlate with subjective improvement in pain and disability following spine surgery and may serve as a marker of postoperative outcomes. The relationship between allergies and PDQ improvement may be secondary to the short-term expectation-actuality discrepancy, as this relationship was not durable beyond 1

  16. Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

    Science.gov (United States)

    Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

    2018-05-09

    We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other

  17. Utilization of patient-reported outcomes as a step towards collaborative medicine.

    Science.gov (United States)

    Blackwell, Laura S; Marciel, Kristen K; Quittner, Alexandra L

    2013-09-01

    Patient-reported outcomes (PROs) have been successfully developed for a variety of chronic respiratory diseases, such as asthma and cystic fibrosis (CF). They have recently been used to evaluate the efficacy of new medications and assess current patient functioning. Although regulatory bodies have favored PROs that measures symptoms, other domains of functioning, such as treatment burden, should be considered. This review examines current guidelines for the development and application of PROs in clinical trials, describes methods for selecting appropriate measures for paediatric populations, and presents a model incorporating PROs into clinical practice. Guidance on interpretation of these measures and graphic presentation of results are illustrated. PROs can serve as the link between the health care provider and patient to foster collaborative and personalized medicine. This model promotes greater patient responsibility, facilitates communication with providers, encourages shared decision-making, and enhances adherence. Published by Elsevier Ltd.

  18. A review of patient and carer participation and the use of qualitative research in the development of core outcome sets.

    Science.gov (United States)

    Jones, Janet E; Jones, Laura L; Keeley, Thomas J H; Calvert, Melanie J; Mathers, Jonathan

    2017-01-01

    To be meaningful, a core outcome set (COS) should be relevant to all stakeholders including patients and carers. This review aimed to explore the methods by which patients and carers have been included as participants in COS development exercises and, in particular, the use and reporting of qualitative methods. In August 2015, a search of the Core Outcomes Measures in Effectiveness Trials (COMET) database was undertaken to identify papers involving patients and carers in COS development. Data were extracted to identify the data collection methods used in COS development, the number of health professionals, patients and carers participating in these, and the reported details of qualitative research undertaken. Fifty-nine papers reporting patient and carer participation were included in the review, ten of which reported using qualitative methods. Although patients and carers participated in outcome elicitation for inclusion in COS processes, health professionals tended to dominate the prioritisation exercises. Of the ten qualitative papers, only three were reported as a clear pre-designed part of a COS process. Qualitative data were collected using interviews, focus groups or a combination of these. None of the qualitative papers reported an underpinning methodological framework and details regarding data saturation, reflexivity and resource use associated with data collection were often poorly reported. Five papers reported difficulty in achieving a diverse sample of participants and two reported that a large and varied range of outcomes were often identified by participants making subsequent rating and ranking difficult. Consideration of the best way to include patients and carers throughout the COS development process is needed. Additionally, further work is required to assess the potential role of qualitative methods in COS, to explore the knowledge produced by different qualitative data collection methods, and to evaluate the time and resources required to

  19. A Novel Patient-Derived Conceptual Model of the Impact of Celiac Disease in Adults: Implications for Patient-Reported Outcome and Health-Related Quality-of-Life Instrument Development.

    Science.gov (United States)

    Leffler, Daniel A; Acaster, Sarah; Gallop, Katy; Dennis, Melinda; Kelly, Ciarán P; Adelman, Daniel C

    2017-04-01

    Celiac disease is a chronic inflammatory condition with wide ranging effects on individual's lives caused by a combination of symptoms and the burden of adhering to a gluten-free diet (GFD). To further understand patients' experience of celiac disease, the impact it has on health-related quality of life (HRQOL), and to develop a conceptual model describing this impact. Adults with celiac disease on a GFD reporting symptoms within the previous 3 months were included; patients with refractory celiac disease and confounding medical conditions were excluded. A semistructured discussion guide was developed exploring celiac disease symptoms and impact on patients' HRQOL. An experienced interviewer conducted in-depth interviews. The data set was coded and analyzed using thematic analysis to identify concepts, themes, and the inter-relationships between them. Data saturation was monitored and concepts identified formed the basis of the conceptual model. Twenty-one participants were recruited, and 32 distinct gluten-related symptoms were reported and data saturation was reached. Analysis identified several themes impacting patients' HRQOL: fears and anxiety, day-to-day management of celiac disease, physical functioning, sleep, daily activities, social activities, emotional functioning, and relationships. The conceptual model highlights the main areas of impact and the relationships between concepts. Both symptoms and maintaining a GFD have a substantial impact on patient functioning and HRQOL in adults with celiac disease. The conceptual model derived from these data may help to design future patient-reported outcomes as well as interventions to improve the quality of life in an individual with celiac disease. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  20. Early patient-reported outcomes versus objective function after total hip and knee arthroplasty

    DEFF Research Database (Denmark)

    Luna, I E; Kehlet, H; Peterson, B

    2017-01-01

    AIMS: The purpose of this study was to assess early physical function after total hip or knee arthroplasty (THA/TKA), and the correlation between patient-reported outcome measures, physical performance and actual physical activity (measured by actigraphy). PATIENTS AND METHODS: A total of 80...... patients aged 55 to 80 years undergoing THA or TKA for osteoarthritis were included in this prospective cohort study. The main outcome measure was change in patient reported hip or knee injury and osteoarthritis outcome score (HOOS/KOOS) from pre-operatively until post-operative day 13 (THA) or 20 (TKA...

  1. Patient experiences with oily skin: The qualitative development of content for two new patient reported outcome questionnaires

    Directory of Open Access Journals (Sweden)

    Draelos Zoe

    2008-10-01

    Full Text Available Abstract Objective To develop the content for two new patient reported outcome (PRO measures to: a assess the severity of symptoms; and b the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. Methods Using input from initial treatment satisfaction focus groups (n = 42, a review of relevant literature and expert clinicians (n = 3, a discussion guide was developed to guide qualitative inquiry using Internet focus groups (IFGs. IFGs were conducted with German (n = 26 and US (n = 28 sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. Results There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3 years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40 reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, self-consciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale. Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. Conclusion The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of

  2. Relationship of patient-reported outcomes with MRI measures in rheumatoid arthritis

    DEFF Research Database (Denmark)

    Baker, Joshua F; Conaghan, Philip G.; Emery, Paul

    2017-01-01

    PURPOSE: We assessed whether MRI measures of synovitis, osteitis and bone erosion were associated with patient-reported outcomes (PROs) in a longitudinal clinical trial setting among patients with rheumatoid arthritis (RA). METHODS: This longitudinal cohort of 291 patients with RA was derived from...

  3. mHealth and big data will bring meaning and value to patient-reported outcomes.

    Science.gov (United States)

    Weiler, Anne

    2016-01-01

    The intersection of widespread mobile adoption, cloud computing and healthcare will enable patient-reported outcomes to be used to personalize care, draw insights and shorten the cycle from research to clinical implementation. Today, patient-reported outcomes are largely collected as part of a regulatory shift to value-based or bundled care. When patients are able to record their experiences in real-time and combine them with passive data collection from sensors and mobile devices, this information can inform better care for each patient and contribute to the growing body of health data that can be used to draw insights for all patients. This paper explores the current limitations of patient reported outcomes and how mobile health and big data analysis unlocks their potential as a valuable tool to deliver care.

  4. Beyond FEV1 in COPD: a review of patient-reported outcomes and their measurement

    Directory of Open Access Journals (Sweden)

    Jones P

    2012-10-01

    Full Text Available Paul Jones,1 Marc Miravitlles,2 Thys van der Molen,3 Karoly Kulich41Division of Clinical Science, University of London, London, UK; 2Institut d'Investigacions Biomèdiques August Pi i Sunyer, Hospital Clínic, Ciber de Enfermedades Respiratorias, Barcelona, Spain; 3Department of Primary Care, University Medical Centre Groningen, Groningen, The Netherlands; 4Novartis Pharma AG, Basel, SwitzerlandAbstract: Patients with chronic obstructive pulmonary disease (COPD present with a variety of symptoms and pathological consequences. Although primarily viewed as a respiratory disease, COPD has both pulmonary and extrapulmonary effects, which have an impact on many aspects of physical, emotional, and mental well-being. Traditional assessment of COPD relies heavily on measuring lung function, specifically forced expiratory volume in 1 second (FEV1. However, the evidence suggests that FEV1 is a relatively poor correlate of symptoms such as breathlessness and the impact of COPD on daily life. Furthermore, many consequences of the disease, including anxiety and depression and the ability to perform daily activities, can only be described and reported reliably by the patient. Thus, in order to provide a comprehensive view of the effects of interventions in clinical trials, it is essential that spirometry is accompanied by assessments using patient-reported outcome (PRO instruments. We provide an overview of patient-reported outcome concepts in COPD, such as breathlessness, physical functioning, and health status, and evaluate the tools used for measuring these concepts. Particular attention is given to the newly developed instruments emerging in response to recent regulatory guidelines for the development and use of PROs in clinical trials. We conclude that although data from the development and validation of these new PRO instruments are emerging, to build the body of evidence that supports the use of a new instrument takes many years. Furthermore, new

  5. Patient-reported outcomes (PROs) in chronic urticaria

    DEFF Research Database (Denmark)

    Moestrup, Kristian; Ghazanfar, Misbah N.; Thomsen, Simon F.

    2017-01-01

    Chronic urticaria is an itching skin disease which persists for more than 6 weeks. Chronic urticaria has great impact on the daily life of the patient, and the fluctuating nature of the symptoms complicates the monitoring and treatment of the disease. Currently, there are no reliable biomarkers...... to identify and measure disease activity in chronic spontaneous urticaria. Consequently, use of patient-reported outcomes (PROs) is crucial when evaluating and monitoring different aspects of chronic urticaria such as disease activity/severity, disease control, and quality of life. We present an overview...... of seven different PROs used in chronic urticaria and highlight their strengths, limitations, and use in clinical practice and research....

  6. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 3: patient-reported outcomes can facilitate shared decision-making and guide self-management.

    Science.gov (United States)

    Noonan, Vanessa K; Lyddiatt, Anne; Ware, Patrick; Jaglal, Susan B; Riopelle, Richard J; Bingham, Clifton O; Figueiredo, Sabrina; Sawatzky, Richard; Santana, Maria; Bartlett, Susan J; Ahmed, Sara

    2017-09-01

    There is a shift toward making health care patient centered, whereby patients are part of medical decision-making and take responsibility for managing their health. Patient-reported outcomes (PROs) capture the patient voice and can be used to engage patients in medical decision-making. The objective of this paper is to present important factors from patients', clinicians', researchers', and decision-makers' perspectives that influence successful adoption of PROs in clinical practice. Factors recommended in this paper were informed by a patient partner. Based on themes arising from the Montreal Accord proceedings, we describe factors that influence the adoption of PROs and how PROs can have a positive effect by enhancing communication and providing opportunities to engage patients, carers, and clinicians in care. Consideration of patient factors (e.g., health literacy), family support and networks (e.g., peer-support networks), technology (e.g., e-health), and health care system factors (e.g., resources to implement PROs) is necessary to ensure PROs are successfully adopted. PRO evaluation plans most likely to succeed over the long term are those incorporating PROs identified by patients as necessary for self-management and that coincide with providers' needs for collaboratively developing treatment plans with patients and families. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Financial Hardship and Patient-Reported Outcomes after Hematopoietic Cell Transplantation.

    Science.gov (United States)

    Abel, Gregory A; Albelda, Randy; Khera, Nandita; Hahn, Theresa; Salas Coronado, Diana Y; Odejide, Oreofe O; Bona, Kira; Tucker-Seeley, Reginald; Soiffer, Robert

    2016-08-01

    Although hematopoietic cell transplantation (HCT) is the only curative therapy for many advanced hematologic cancers, little is known about the financial hardship experienced by HCT patients nor the association of hardship with patient-reported outcomes. We mailed a 43-item survey to adult patients approximately 180 days after their first autologous or allogeneic HCT at 3 high-volume centers. We assessed decreases in household income; difficulty with HCT-related costs, such as need to relocate or travel; and 2 types of hardship: hardship_1 (reporting 1 or 2 of the following: dissatisfaction with present finances, difficulty meeting monthly bill payments, or not having enough money at the end of the month) and "hardship_2" (reporting all 3). Patient-reported stress was measured with the Perceived Stress Scale-4, and 7-point scales were provided for perceptions of overall quality of life (QOL) and health. In total, 325 of 499 surveys (65.1%) were received. The median days since HCT was 173; 47% underwent an allogeneic HCT, 60% were male, 51% were > 60 years old, and 92% were white. Overall, 46% reported income decline after HCT, 56% reported hardship_1, and 15% reported hardship_2. In multivariable models controlling for income, those reporting difficulty paying for HCT-related costs were more likely to report financial hardship (odds ratio, 6.9; 95% confidence interval, 3.8 to 12.3). Hardship_1 was associated with QOL below the median (odds ratio, 2.9; 95% confidence interval, 1.7 to 4.9), health status below the median (odds ratio, 2.2; 95% confidence interval, 1.3 to 3.6), and stress above the median (odds ratio, 2.1; 95% confidence interval, 1.3 to 3.5). In this sizable cohort of HCT patients, financial hardship was prevalent and associated with worse QOL and higher levels of perceived stress. Interventions to address patient financial hardship-especially those that ameliorate HCT-specific costs-are likely to improve patient-reported outcomes. Copyright © 2016

  8. Financial Hardship and Patient-Reported Outcomes after Hematopoietic Cell Transplantation

    Science.gov (United States)

    Abel, Gregory A.; Albelda, Randy; Khera, Nandita; Hahn, Theresa; Salas Coronado, Diana Y.; Odejide, Oreofe O.; Bona, Kira; Tucker-Seeley, Reginald; Soiffer, Robert

    2016-01-01

    Although hematopoietic cell transplantation (HCT) is the only curative therapy for many advanced hematologic cancers, little is known about the financial hardship experienced by HCT patients, nor the association of hardship with patient-reported outcomes. We mailed a 43-item survey to adult patients approximately 180 days post first autologous or allogeneic HCT at three high-volume centers. We assessed decreases in household income, difficulty with HCT-related costs such as need to relocate or travel, and two types of hardship: “hardship_1” (reporting one or two of the following: dissatisfaction with present finances, difficulty meeting monthly bill payments, or not having enough money at the end of the month), and “hardship_2” (reporting all three). Patient-reported stress was measured with the Perceived Stress Scale (PSS-4), and seven-point scales were provided for perceptions of overall quality of life (QOL) and health. 325 of 499 surveys (65.1%) were received. The median days since HCT was 173; 47% underwent an allogeneic HCT, 60% were male, 51% were > 60 years old, and 92% were white. Overall, 46% reported income decline post-HCT, 56% reported “hardship_1” and 15% “hardship 2.” In multivariable models controlling for income, those reporting difficulty paying for HCT-related costs were more likely to report financial hardship (OR 6.9 [3.8, 12.3]). “Hardship_1” was associated with QOL below the median (OR 2.9 [1.7, 4.9]), health status below the median (OR 2.2 [1.3, 3.6]), and stress above the median (OR 2.1 [1.3, 3.5]). In this sizable cohort of HCT patients, financial hardship was prevalent, and associated with worse QOL and higher levels of perceived stress. Interventions to address patient financial hardship—especially those that ameliorate HCT-specific costs—are likely to improve patient-reported outcomes. PMID:27184627

  9. Perspectives of patients and professionals on the use of patient reported outcome measures in primary care

    DEFF Research Database (Denmark)

    Porter, Ian; Gangannagaripalli, Jaheeda; Davey, Antoinette

    2017-01-01

    /or healthcare professional’s perspectives on the clinical utility of using PROMs in clinical practice. Results: 19 studies met the inclusion criteria (4 after 2012), 11 of which were conducted in the UK, reporting on the views of professionals (8), patients (5), and both (7). The majority of studies (12...... communication it was also noted that they undermined the human element of consultations, along with professional intuition and judgement. Burden on GP time was also noted. Conclusions: Patients and professionals highlighted a number of benefits of using PROMs in clinical practice, particularly in terms......A71 Perspectives of patients and professionals on the use of patient-reported outcome measures in primary care: a systematic review of qualitative studies Background: Although the use of patient-reported outcome measures (PROMs) in healthcare settings has increased substantially over recent years...

  10. Development of a proxy-reported pulmonary outcome scale for preterm infants with bronchopulmonary dysplasia

    Directory of Open Access Journals (Sweden)

    Laughon Matthew M

    2011-07-01

    Full Text Available Abstract Background To develop an accurate, proxy-reported bedside measurement tool for assessment of the severity of bronchopulmonary dysplasia (also called chronic lung disease in preterm infants to supplement providers' current biometric measurements of the disease. Methods We adapted Patient-Reported Outcomes Measurement Information System (PROMIS methodology to develop the Proxy-Reported Pulmonary Outcomes Scale (PRPOS. A multidisciplinary group of registered nurses, nurse practitioners, neonatologists, developmental specialists, and feeding specialists at five academic medical centers participated in the PRPOS development, which included five phases: (1 identification of domains, items, and responses; (2 item classification and selection using a modified Delphi process; (3 focus group exploration of items and response options; (4 cognitive interviews on a preliminary scale; and (5 final revision before field testing. Results Each phase of the process helped us to identify, classify, review, and revise possible domains, questions, and response options. The final items for field testing include 26 questions or observations that a nurse assesses before, during, and after routine care time and feeding. Conclusions We successfully created a prototype scale using modified PROMIS methodology. This process can serve as a model for the development of proxy-reported outcomes scales in other pediatric populations.

  11. Six Sessions of Anterior-to-Posterior Ankle Joint Mobilizations Improve Patient-Reported Outcomes in Chronic Ankle Instability Patients: A Critically Appraised Topic.

    Science.gov (United States)

    Wikstrom, Erik A; Bagherian, Sajad; Cordero, Nicole B; Song, Kyeongtak

    2018-01-24

    Clinical Scenario: Chronic ankle instability (CAI) is a complex musculoskeletal condition that results in sensorimotor and mechanical alterations. Manual therapies, such as ankle joint mobilizations are known to improve clinician-oriented outcomes like dorsiflexion range of motion but their impact of patient-reported outcomes remains less clear. Focused Clinical Question: Do anterior-to-posterior ankle joint mobilizations improve patient reported outcomes in patients with CAI? Summary of Key Findings: Three studies (2 RCT, 1 Prospective cohort) quantified the effect of at least 2-weeks of anterior-to-posterior ankle joint mobilizations on improving patient reported outcomes immediately after the intervention and at a follow-up assessment. All three studies demonstrated significant improvements in at least one patient-reported outcome immediately after the intervention and at the follow-up assessment. Clinical Bottom Line: At least 2-weeks of ankle joint mobilization improves patient-reported outcomes in patients with CAI and these benefits are retained for at least a week following the termination of the intervention. Strength of Recommendation: Strength of recommendation is an A due to consistent good-quality patient-oriented evidence.

  12. Rationale for Using Social Media to Collect Patient-Reported Outcomes in Patients with Celiac Disease.

    Science.gov (United States)

    Park, Kt; Harris, Merissa; Khavari, Nasim; Khosla, Chaitan

    2014-02-01

    Patients with celiac disease (CD) are increasingly interconnected through social media, exchanging patient experiences and health-tracking information between individuals through various web-based platforms. Social media represents potentially unique communication interface between gastroenterologists and active social media users - especially young adults and adolescents with celiac disease-regarding adherence to the strict gluten-free diet, gastrointestinal symptoms, and meaningful discussion about disease management. Yet, various social media platforms may be underutilized for research purposes to collect patient-reported outcomes data. In this commentary, we summarize the scientific rationale and potential for future growth of social media in patient-reported outcomes research, focusing on college freshmen with celiac disease as a case study and provide overview of the methodological approach. Finally, we discuss how social media may impact patient care in the future through increasing mobile technology use.

  13. [Development of patient-reported outcome scale for myasthenia gravis: a psychometric test].

    Science.gov (United States)

    Chen, Xin-lin; Liu, Feng-bin; Guo, Li; Liu, Xiao-bin

    2010-02-01

    To investigate the scientificity of patient-reported outcome (PRO) scale for myasthenia gravis (MG), which was used to evaluate the clinical effects of traditional Chinese and Western medicine treatment on MG patients. Psychometric performance of the MG-PRO scale was also expected to be evaluated in this study. A total of 100 MG patients and 100 healthy people were face-to-face interviewed by well-trained investigators, and the data of MG-PRO scale were collected. The classical theory test (CTT) and item response theory (IRT) methods were used to analyze the psychometric performance such as validity, reliability, person separation index (PSI) and differential item functioning (DIF) in the MG-PRO scale. The results of CTT analysis showed that the split-half reliabilities of the MG-PRO scale and each dimension were greater than 0.7. In the analysis of internal consistency of each dimension, the Cronbach's alpha was greater than 0.8. Each facet had greater correlation with its dimension than the other dimensions. Four principal components were extracted by exploratory factor analysis, which represented all dimensions of the scale, and the cumulative variance was 55.54%. The scores of each of the 8 facets between MG patients and healthy people were different (Pdefinition and connotation of quality of life and contains special issues of MG patients as well, and shows good reliability (split-half reliability, Cronbach's alpha), validity (content validity, construct validity, discriminate validity) from the results of CTT, and good psychometric performance from the results of IRT.

  14. Education attainment is associated with patient-reported outcomes: findings from the Swedish Hip Arthroplasty Register.

    Science.gov (United States)

    Greene, Meridith E; Rolfson, Ola; Nemes, Szilard; Gordon, Max; Malchau, Henrik; Garellick, Göran

    2014-06-01

    Age, sex, and medical comorbidities may be associated with differences in patient-reported outcome scores after THA. Highest level of education may be a surrogate for socioeconomic status, but the degree to which this is associated with patient-reported outcomes after THA is not known. We investigated the national Swedish Hip Arthroplasty Register for the association of education attainment on patient-reported outcomes 1 year after THA; specifically, we evaluated level of education attainment against health-related quality of life (HRQoL), pain reduction, and satisfaction with treatment 1 year after THA. All THAs for osteoarthritis performed from 2005 through 2007 with complete patient-reported outcome measures (representing 49% of the THAs performed for this diagnosis) were selected from the Swedish Hip Arthroplasty Register. These cases were merged with national databases containing education attainment, marital status, and comorbidities (n = 11,464; mean age of patients, 64 years). The patient-reported outcome measure protocol included the HRQoL measure EuroQol five-dimension scale (EQ-5D), a VAS for pain, the Charnley classification survey, and a VAS addressing THA satisfaction. Linear regression analyses determined the association of preoperative patient factors with patient-reported outcomes. High education attainment was associated with higher HRQoL (EQ-5D index ß(high) = 0.03 ± 0.01; EQ VAS ß(high) = 2.6 ± 0.5) after THA, whereas those with low and medium education were at risk for lower HRQoL. High education was associated with less pain after treatment (ß(high) = -3.3 ± 0.05). Individuals with low or medium education were at risk for less satisfaction with THA (p education to a greater extent. Identification of patients who will benefit most from THA and educating those at risk for poorer outcomes, like patients with low and medium education, ultimately may improve patient satisfaction, HRQoL, pain, and the cost utility of THA. Level III

  15. Patient-reported outcomes in adult survivors with single-ventricle physiology

    DEFF Research Database (Denmark)

    Overgaard, Dorthe; Schrader, Anne-Marie; Lisby, Karen H

    2011-01-01

    Objectives: Data on patient-reported outcomes (PROs) in patients with single-ventricle physiology (SVP) are scarce. We sought (1) to describe the perceived health status, quality of life, symptoms of anxiety and depression, and sense of coherence in adult survivors with SVP, (2) to compare PROs a...... of perceived health and quality of life. For patients in Ability Index class II and III, PROs were poorer. Conclusions: PROs in patients with SVP are generally good....

  16. Patient-reported outcomes in Danish implantable cardioverter defibrillator patients with a Sprint Fidelis lead advisory notification

    DEFF Research Database (Denmark)

    Pedersen, Susanne S; Versteeg, Henneke; Nielsen, Jens Cosedis

    2011-01-01

    Few studies have investigated the association between implantable cardioverter defibrillators (ICDs) and lead advisory notifications and patient-reported outcomes (PROs). We examined (i) whether the mode used to inform patients about a device advisory is associated with PROs, and (ii) whether...... patients with a lead subject to a device advisory report poorer PROs than non-advisory controls....

  17. Development of a patient-reported outcome measure of recovery after abdominal surgery: a hypothesized conceptual framework.

    Science.gov (United States)

    Alam, Roshni; Figueiredo, Sabrina M; Balvardi, Saba; Nauche, Bénédicte; Landry, Tara; Lee, Lawrence; Mayo, Nancy E; Feldman, Liane S; Fiore, Julio F

    2018-05-17

    We initiated a research program to develop a novel patient-reported outcome measure (PROM) to assess postoperative recovery from the perspective of abdominal surgery patients. In light of FDA recommendations, the first stage of our program aimed to, based on previous literature and expert input, develop a hypothesized conceptual framework portraying the health domains that are potentially relevant to the process of recovery after abdominal surgery. This study was conducted in three phases: (1) systematic review to identify PROMs with measurement properties appraised in the context of recovery after abdominal surgery, (2) content analysis to categorize the health domains covered by the PROMs according to the ICF, and (3) two-round Delphi study to gain expert input regarding which of these health domains are relevant to the process of recovery. Participants were experts in perioperative care identified through two major surgical societies (35 invited). The systematic review identified 19 PROMs covering 66 ICF domains. 23 experts (66%) participated in the Delphi process. After Round 2, experts agreed that 22 health domains (8 body functions, 14 activities and participation) are potentially relevant to the process of recovery after abdominal surgery. These domains were organized into a diagram, representing our hypothesized conceptual framework. This hypothesized conceptual framework is an important first step in our research program and will be further refined based on in-depth qualitative interviews with patients. The sound methodological approach used to derive this framework may be valuable for studies aimed to develop PROMs according to FDA standards.

  18. [Outcome Quality in Medical Rehabilitation: Relationship Between "Patient-Reported Outcomes" (PROs) and Social Security Contributions].

    Science.gov (United States)

    Nübling, R; Kaluscha, R; Krischak, G; Kriz, D; Martin, H; Müller, G; Renzland, J; Reuss-Borst, M; Schmidt, J; Kaiser, U; Toepler, E

    2017-02-01

    Aim of the Study The outcome quality of medical rehabilitation is evaluated often by "Patient Reported Outcomes" (PROs). It is examined to what extent these PROs are corresponding with "hard" or "objective" outcomes such as payments of contributions to social insurance. Methods The "rehabilitation QM outcome study" includes self-reports of patients as well as data from the Rehabilitation Statistics Database (RSD) of the German pension insurance Baden-Wurttemberg. The sample for the question posed includes N=2 947 insured who were treated in 2011 in 21 clinics of the "health quality network" and who were either employed or unemployed at the time of the rehabilitation application (e. g. the workforce or labour force group, response rate: 55%). The sample turned out widely representative for the population of the insured persons. Results PROs and payment of contributions to pension insurance clearly correspond. In the year after the rehabilitation improved vs. not improved rehabilitees differed clearly with regard to their payments of contributions. Conclusions The results support the validity of PROs. For a comprehensive depiction of the outcome quality of rehabilitation PROs and payments of contributions should be considered supplementary. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

  20. What is the optimal time point to assess patient-reported recovery after hip and knee replacement? A systematic review and analysis of routinely reported outcome data from the English patient-reported outcome measures programme.

    Science.gov (United States)

    Browne, John Patrick; Bastaki, Hamad; Dawson, Jill

    2013-07-30

    It is unclear if there is a clinically important improvement in the six to 12-month recovery period after hip and knee replacement. This is an obvious gap in the evidence required by patients undergoing these procedures. It is also an issue for the English PROMs (Patient-Reported Outcome Measures) Programme which uses 6-month outcome data to compare the results of hospitals that perform hip and knee replacements. A systematic review of studies reporting the Oxford Hip Score (OHS) or Oxford Knee Score (OKS) at 12 months after surgery was performed. This was compared with six-month outcome data collected for 60, 160 patients within the English PROMs programme. A minimally important difference of one standard error of the measurement, equivalent to 2.7 for the OHS and 2.1 for the OKS, was adopted. Six studies reported OHS data for 10 different groups containing 8,308 patients in total. In eight groups the change scores reported were at least 2.7 points higher than the six-month change observed in the PROMs programme (20.2 points). Nine studies reported OKS data for 13 different groups containing 4,369 patients in total. In eight groups the change scores reported were at least 2.1 points higher than the six-month change observed in the PROMs programme (15.0 points). There is some evidence from this systematic review that clinically important improvement in the Oxford hip and knee scores occurs in the six to 12 month recovery period. This trend is more apparent for hip than knee replacement. Therefore we recommend that the English Department of Health study the impact on hospital comparisons of using 12- rather than six-month outcome data.

  1. An Introduction to Item Response Theory for Patient-Reported Outcome Measurement

    Science.gov (United States)

    Nguyen, Tam H.; Han, Hae-Ra; Kim, Miyong T.

    2015-01-01

    The growing emphasis on patient-centered care has accelerated the demand for high-quality data from patient-reported outcome (PRO) measures. Traditionally, the development and validation of these measures has been guided by classical test theory. However, item response theory (IRT), an alternate measurement framework, offers promise for addressing practical measurement problems found in health-related research that have been difficult to solve through classical methods. This paper introduces foundational concepts in IRT, as well as commonly used models and their assumptions. Existing data on a combined sample (n = 636) of Korean American and Vietnamese American adults who responded to the High Blood Pressure Health Literacy Scale and the Patient Health Questionnaire-9 are used to exemplify typical applications of IRT. These examples illustrate how IRT can be used to improve the development, refinement, and evaluation of PRO measures. Greater use of methods based on this framework can increase the accuracy and efficiency with which PROs are measured. PMID:24403095

  2. Collecting Patient Reported Outcomes in the Wild: Opportunities and Challenges.

    Science.gov (United States)

    Cabitza, Federico; Dui, Linda Greta

    2018-01-01

    Collecting Patient Reported Outcomes (PROs) is generally seen as an effective way to assess the efficacy and appropriateness of medical interventions, from the patients' perspective. In 2016 the Galeazzi Orthopaedic Institute established a digitized program of PROs collection from spine, hip and knee surgery patients. In this work, we re-port the findings from the data analysis of the responses collected so far about the complementarity of PROs with respect to the data reported by the clinicians, and about the main biases that can undermine their validity and reliability. Although PROs collection is recognized as being far more complex than just asking the patients "how they feel" on a regular basis and it entails costs and devoted electronic platforms, we advocate their further diffusion for the assessment of health technology and clinical procedures.

  3. Patient-Reported Disease Activity and Adverse Pregnancy Outcomes in Systemic Lupus Erythematosus and Rheumatoid Arthritis.

    Science.gov (United States)

    Harris, Nathaniel; Eudy, Amanda; Clowse, Megan

    2018-06-15

    While increased rheumatic disease activity during pregnancy has been associated with adverse pregnancy outcomes, this activity is typically assessed by the physician. Little is known, however, about the association between patient-reported measures of disease activity and pregnancy outcomes. Univariate and multivariable regression models were used to assess the relationship between patient and physician-reported measures of disease activity and adverse pregnancy outcomes in 225 patients with lupus or rheumatoid arthritis (RA) enrolled in a prospective registry at a single academic center from 2008-2016. In women with RA, patient-reported disease activity is associated with preterm birth (OR 5.9 (1.5-23.9)), and gestational age (beta -1.5 weeks (-2.6, -0.4 weeks)). The physician assessment of disease activity also predicted preterm (OR 2.1 (1.2-3.5)), small for gestational age births (OR 1.8 (1.03-3.1), and gestational age in weeks (beta -0.6 weeks (-0.9, -0.02 weeks)). On the other hand, SLE patient-reported disease activity measures, including the HAQ, pain or global health measures, are not associated with adverse pregnancy outcomes. However, physician measures of SLE disease activity are associated with preterm birth (OR 2.9 (1.-6.3)), cesarean delivery (OR 2.3 (1.0-5.3)), and preeclampsia (OR 2.8 (1.3-6.3)). The results do not appear to be driven by lupus nephritis or antiphospholipid syndrome. For women with RA, patient-reported measures of disease activity may be useful adjuncts to physician-reported measures in identifying pregnancies at greater risk. In contrast, in SLE, no patient-reported measures were associated with adverse outcomes while physician measures of disease activity helped predict several adverse pregnancy outcomes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  4. Agreement between touch-screen and paper-based patient-reported outcomes for patients with fibromyalgia

    DEFF Research Database (Denmark)

    Wæhrens, Eva Elisabet Ejlersen; Amris, Kirstine; Bartels, Else Marie

    2015-01-01

    OBJECTIVES: To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience......) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM. METHOD: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory...

  5. The PU-PROM: A patient-reported outcome measure for peptic ulcer disease.

    Science.gov (United States)

    Liu, Na; Lv, Jing; Liu, Jinchun; Zhang, Yanbo

    2017-12-01

    Patient-reported outcome measure (PROM) conceived to enable description of treatment-related effects, from the patient perspective, bring the potential to improve in clinical research, and to provide patients with accurate information. Therefore, the aim of this study was to develop a patient-centred peptic ulcer patient-reported outcome measure (PU-PROM) and evaluate its reliability, validity, differential item functioning (DIF) and feasibility. To develop a conceptual framework and item pool for the PU-PROM, we performed a literature review and consulted other measures created in China and other countries. Beyond that, we interviewed 10 patients with peptic ulcers, and consulted six key experts to ensure that all germane parameters were included. In the first item selection phase, classical test theory and item response theory were used to select and adjust items to shape the preliminary measure completed by 130 patients and 50 controls. In the next phase, the measure was evaluated used the same methods with 492 patients and 124 controls. Finally, we used the same population in the second item reselection to assess the reliability, validity, DIF and feasibility of the final measure. The final peptic ulcer PRO measure comprised four domains (physiology, psychology, society and treatment), with 11 subdomains, and 54 items. The Cronbach's α coefficient of each subdomain for the measure was >0.800. Confirmatory factory analysis indicated that the construct validity fulfilled expectations. Model fit indices, such as RMR, RMSEA, NFI, NNFI, CFI and IFI, showed acceptable fit. The measure showed a good response rate. The peptic ulcer PRO measure had good reliability, validity, DIF and feasibility, and can be used as a clinical research evaluation instrument with patients with peptic ulcers to assess their condition focus on treatment. This measure may also be applied in other health areas, especially in clinical trials of new drugs, and may be helpful in clinical

  6. How do aggregated patient-reported outcome measures data stimulate health care improvement? A realist synthesis

    Science.gov (United States)

    Dalkin, Sonia; Gibbons, Elizabeth; Wright, Judy; Valderas, Jose Maria; Meads, David; Black, Nick

    2017-01-01

    Objectives Internationally, there has been considerable debate about the role of data in supporting quality improvement in health care. Our objective was to understand how, why and in what circumstances the feedback of aggregated patient-reported outcome measures data improved patient care. Methods We conducted a realist synthesis. We identified three main programme theories underlying the use of patient-reported outcome measures as a quality improvement strategy and expressed them as nine ‘if then’ propositions. We identified international evidence to test these propositions through searches of electronic databases and citation tracking, and supplemented our synthesis with evidence from similar forms of performance data. We synthesized this evidence through comparing the mechanisms and impact of patient-reported outcome measures and other performance data on quality improvement in different contexts. Results Three programme theories were identified: supporting patient choice, improving accountability and enabling providers to compare their performance with others. Relevant contextual factors were extent of public disclosure, use of financial incentives, perceived credibility of the data and the practicality of the results. Available evidence suggests that patients or their agents rarely use any published performance data when selecting a provider. The perceived motivation behind public reporting is an important determinant of how providers respond. When clinicians perceived that performance indicators were not credible but were incentivized to collect them, gaming or manipulation of data occurred. Outcome data do not provide information on the cause of poor care: providers needed to integrate and interpret patient-reported outcome measures and other outcome data in the context of other data. Lack of timeliness of performance data constrains their impact. Conclusions Although there is only limited research evidence to support some widely held theories of how

  7. Development and validation of the impact of dry eye on everyday life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on patients.

    Science.gov (United States)

    Abetz, Linda; Rajagopalan, Krithika; Mertzanis, Polyxane; Begley, Carolyn; Barnes, Rod; Chalmers, Robin

    2011-12-08

    To develop and validate a comprehensive patient-reported outcomes instrument focusing on the impact of dry eye on everyday life (IDEEL). Development and validation of the IDEEL occurred in four phases: 1) focus groups with 45 dry eye patients to develop a draft instrument, 2) item generation, 3) pilot study to assess content validity in 16 patients and 4) psychometric validation in 210 subjects: 130 with non-Sjögren's keratoconjunctivitis sicca, 32 with Sjögren's syndrome and 48 controls, and subsequent item reduction. Focus groups identified symptoms and the associated bother, the impact of dry eye on daily life and the patients' satisfaction with their treatment as the central concepts in patients' experience of dry eye. Qualitative analysis indicated that saturation was achieved for these concepts and yielded an initial 112-item draft instrument. Patients understood the questionnaire and found the items to be relevant indicating content validity. Patient input, item descriptive statistics and factor analysis identified 55 items that could be deleted. The final 57-item IDEEL assesses dry eye impact constituting 3 modules: dry eye symptom-bother, dry eye impact on daily life comprising impact on daily activities, emotional impact, impact on work, and dry eye treatment satisfaction comprising satisfaction with treatment effectiveness and treatment-related bother/inconvenience. The psychometric analysis results indicated that the IDEEL met the criteria for item discriminant validity, internal consistency reliability, test-retest reliability and floor/ceiling effects. As expected, the correlations between IDEEL and the Dry Eye Questionnaire (a habitual symptom questionnaire) were higher than between IDEEL and Short-Form-36 and EuroQoL-5D, indicating concurrent validity. The IDEEL is a reliable, valid and comprehensive questionnaire relevant to issues that are specific to dry eye patients, and meets current FDA patient-reported outcomes guidelines. The use of this

  8. Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

    Directory of Open Access Journals (Sweden)

    S. Nicole Culos-Reed

    2012-01-01

    Full Text Available Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.

  9. Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices.

    Science.gov (United States)

    Eremenco, Sonya; Pease, Sheryl; Mann, Sarah; Berry, Pamela

    2017-01-01

    This paper describes the rationale and goals of the Patient-Reported Outcome (PRO) Consortium's instrument translation process. The PRO Consortium has developed a number of novel PRO measures which are in the process of qualification by the U.S. Food and Drug Administration (FDA) for use in clinical trials where endpoints based on these measures would support product labeling claims. Given the importance of FDA qualification of these measures, the PRO Consortium's Process Subcommittee determined that a detailed linguistic validation (LV) process was necessary to ensure that all translations of Consortium-developed PRO measures are performed using a standardized approach with the rigor required to meet regulatory and pharmaceutical industry expectations, as well as having a clearly defined instrument translation process that the translation industry can support. The consensus process involved gathering information about current best practices from 13 translation companies with expertise in LV, consolidating the findings to generate a proposed process, and obtaining iterative feedback from the translation companies and PRO Consortium member firms on the proposed process in two rounds of review in order to update existing principles of good practice in LV and to provide sufficient detail for the translation process to ensure consistency across PRO Consortium measures, sponsors, and translation companies. The consensus development resulted in a 12-step process that outlines universal and country-specific new translation approaches, as well as country-specific adaptations of existing translations. The PRO Consortium translation process will play an important role in maintaining the validity of the data generated through these measures by ensuring that they are translated by qualified linguists following a standardized and rigorous process that reflects best practice.

  10. Psychometric validation of patient-reported outcome measures assessing chronic constipation

    Directory of Open Access Journals (Sweden)

    Nelson LM

    2014-09-01

    Full Text Available Lauren M Nelson,1 Valerie SL Williams,1 Sheri E Fehnel,1 Robyn T Carson,2 James MacDougall,3 Mollie J Baird,3 Stavros Tourkodimitris,2 Caroline B Kurtz,3 Jeffrey M Johnston31RTI Health Solutions, Durham, NC, USA; 2Forest Research Institute, Jersey City, NJ, USA; 3Ironwood Pharmaceuticals, Cambridge, MA, USABackground: Measures assessing treatment outcomes in previous CC clinical trials have not met the requirements described in the US Food and Drug Administration's guidance on patient-reported outcomes.Aim: Psychometric analyses using data from one Phase IIb study and two Phase III trials of linaclotide for the treatment of chronic constipation (CC were conducted to document the measurement properties of patient-reported CC Symptom Severity Measures.Study methods: Each study had a multicenter, randomized, double-blind, placebo-controlled, parallel-group design, comparing placebo to four doses of oral linaclotide taken once daily for 4 weeks in the Phase IIb dose-ranging study (n=307 and to two doses of linaclotide taken once daily for 12 weeks in the Phase III trials (n=1,272. The CC Symptom Severity Measures addressing bowel function (Bowel Movement Frequency, Stool Consistency, Straining and abdominal symptoms (Bloating, Abdominal Discomfort, Abdominal Pain were administered daily using interactive voice-response system technology. Intraclass correlations, Pearson correlations, factor analyses, F-tests, and effect sizes were computed.Results: The CC Symptom Severity Measures demonstrated satisfactory test–retest reliability and construct validity. Factor analyses indicated one factor for abdominal symptoms and another for bowel symptoms. Known-groups F-tests substantiated the discriminating ability of the CC Symptom Severity Measures. Responsiveness statistics were moderate to strong, indicating that these measures are capable of detecting change.Conclusion: In large studies of CC patients, linaclotide significantly improved abdominal and

  11. Postoperative weight bearing and patient reported outcomes at one year following tibial plateau fractures.

    Science.gov (United States)

    Thewlis, Dominic; Fraysse, Francois; Callary, Stuart A; Verghese, Viju Daniel; Jones, Claire F; Findlay, David M; Atkins, Gerald J; Rickman, Mark; Solomon, Lucian B

    2017-07-01

    Tibial plateau fractures are complex and the current evidence for postoperative rehabilitation is weak, especially related to the recommended postoperative weight bearing. The primary aim of this study was to investigate if loading in the first 12 weeks of recovery is associated with patient reported outcome measures at 26 and 52 weeks postoperative. We hypothesized that there would be no association between loading and patient reported outcome measures. Seventeen patients, with a minimum of 52-week follow-up following fragment-specific open reduction and internal fixation for tibial plateau fracture, were selected for this retrospective analysis. Postoperatively, patients were advised to load their limb to a maximum of 20kg during the first 6 weeks. Loading data were collected during walking using force platforms. A ratio of limb loading (affected to unaffected) was calculated at 2, 6 and 12 weeks postoperative. Knee Injury and Osteoarthritis Scores were collected at 6, 12, 26 and 52 weeks postoperative. The association between loading ratios and patient reported outcomes were investigated. Compliance with weight bearing recommendations and changes in the patient reported outcome measures are described. Fracture reduction and migration were assessed on plain radiographs. No fractures demonstrated any measurable postoperative migration at 52 weeks. Significant improvements were seen in all patient reported outcome measures over the first 52 weeks, despite poor adherence to postoperative weight bearing restrictions. There were no associations between weight bearing ratio and patient reported outcomes at 52 weeks postoperative. Significant associations were identified between the loading ratio at 2 weeks and knee-related quality of life at six months (R 2 =0.392), and between the loading ratio at 6 weeks combined with injury severity and knee-related quality of life at 26 weeks (R 2 =0.441). In summary, weight bearing as tolerated does not negatively affect the

  12. Patients' Experience of Myositis and Further Validation of a Myositis-specific Patient Reported Outcome Measure - Establishing Core Domains and Expanding Patient Input on Clinical Assessment in Myositis. Report from OMERACT 12.

    Science.gov (United States)

    Regardt, Malin; Basharat, Pari; Christopher-Stine, Lisa; Sarver, Catherine; Björn, Anita; Lundberg, Ingrid E; Wook Song, Yeong; Bingham, Clifton O; Alexanderson, Helene

    2015-12-01

    The Outcome Measures in Rheumatology (OMERACT) myositis working group was established to examine patient-reported outcomes (PRO) as well as to validate patient-reported outcome measures (PROM) in myositis. Qualitative studies using focus group interviews and cognitive debriefing of the myositis-specific Myositis Activities Profile (MAP) were used to explore the experience of adults living with polymyositis (PM) and dermatomyositis (DM). Preliminary results underscore the importance of patient input in the development of PROM to ensure content validity. Results from multicenter focus groups indicate the range of symptoms experienced including pain, fatigue, and impaired cognitive function, which are not currently assessed in myositis. Preliminary cognitive debriefing of the MAP indicated that while content was deemed relevant and important, several activities were not included; and that questionnaire construction and wording may benefit from revision. A research agenda was developed to continue work toward optimizing PRO assessment in myositis with 2 work streams. The first would continue to conduct and analyze focus groups until saturation in the thematic analysis was achieved to develop a framework that encompassed the patient-relevant aspects of myositis. The second would continue cognitive debriefing of the MAP to identify potential areas for revision. There was agreement that further work would be needed for inclusion body myositis and juvenile dermatomyositis, and that the inclusion of additional contributors such as caregivers and individuals from the pharmaceutical/regulatory spheres would be desirable. The currently used PROM do not assess symptoms or the effects of disease that are most important to patients; this emphasizes the necessity of patient involvement. Our work provides concrete examples for PRO identification.

  13. Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers.

    Science.gov (United States)

    Antunes, Bárbara; Harding, Richard; Higginson, Irene J

    2014-02-01

    Many patient-reported outcome measures have been developed in the past two decades, playing an increasingly important role in palliative care. However, their routine use in practice has been slow and difficult to implement. To systematically identify facilitators and barriers to the implementation of patient-reported outcome measures in different palliative care settings for routine practice, and to generate evidence-based recommendations, to inform the implementation process in clinical practice. Systematic literature review and narrative synthesis. Medline, PsycInfo, Cumulative Index to Nursing and Allied Health Literature, Embase and British Nursing Index were systematically searched from 1985. Hand searching of reference lists for all included articles and relevant review articles was performed. A total of 3863 articles were screened. Of these, 31 articles met the inclusion criteria. First, data were integrated in the main themes: facilitators, barriers and lessons learned. Second, each main theme was grouped into either five or six categories. Finally, recommendations for implementation on outcome measures at management, health-care professional and patient levels were generated for three different points in time: preparation, implementation and assessment/improvement. Successful implementation of patient-reported outcome measures should be tailored by identifying and addressing potential barriers according to setting. Having a coordinator throughout the implementation process seems to be key. Ongoing cognitive and emotional processes of each individual should be taken into consideration during changes. The educational component prior to the implementation is crucial. This could promote ownership and correct use of the measure by clinicians, potentially improving practice and the quality of care provided through patient-reported outcome measure data use in clinical decision-making.

  14. Technical report: an ePRO patient reported outcome program for the evaluation of patients with irritable bowel syndrome.

    Science.gov (United States)

    Gerson, C D; Gerson, M-J

    2014-02-01

    Patient reported outcome (PRO) is an important healthcare concept that describes patient's participation in their care by self-evaluation, usually in the form of questionnaires. This report describes an unique computerized technique, electronic PRO (ePRO), for following the progress of patients with irritable bowel syndrome (IBS). Patients first completed a series of questionnaires, including questions about their illness history, symptom severity, and, in this application, psychological and relationship issues. The symptom severity and psychological questionnaires were then completed at intervals by the patients on their own computers. The ePRO was constructed to allow scores to be automatically summed and placed on a time-line graph for review at the time of the next office visit. Of the 32 patients who completed the initial set of questionnaires, 20 maintained participation in the program for a 6-month period. Of those 20 patients, median number of submissions was 7.0; median interval between questionnaire submissions was 3.0 weeks, whereas median interval between office visits was 5.9 weeks. On average, questionnaire completion took less than 5 min and was positively experienced by the patients. The ePRO program proved to be technically feasible, clinically useful, and positively experienced by the patients. It provides a focus on a collaborative conversation between physician and patient. It has significant potential as a technique for evaluating outcome in response to various therapies. © 2013 John Wiley & Sons Ltd.

  15. An introduction to patient-reported outcome measures (PROMs) in physiotherapy.

    Science.gov (United States)

    Kyte, D G; Calvert, M; van der Wees, P J; ten Hove, R; Tolan, S; Hill, J C

    2015-06-01

    The use of patient-reported outcome measures (PROMs) is set to rise in physiotherapy. PROMs provide additional 'patient-centred' data which is unique in capturing the patient's own opinion on the impact of their disease or disorder, and its treatment, on their life. Thus, PROMs are increasingly used by clinicians to guide routine patient care, or for the purposes of audit, and are already firmly embedded in clinical research. This article seeks to summarise the key aspects of PROM use for physiotherapists, both in routine clinical practice and in the research setting, and highlights recent developments in the field. Generic and condition-specific PROMs are defined and examples of commonly used measures are provided. The selection of appropriate PROMs, and their effective use in the clinical and research settings is discussed. Finally, existing barriers to PROM use in practice are identified and recent physiotherapy PROM initiatives, led by the Royal Dutch Society for Physical Therapy are explored. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Racial and ethnic variations in one-year clinical and patient-reported outcomes following breast reconstruction.

    Science.gov (United States)

    Berlin, Nicholas L; Momoh, Adeyiza O; Qi, Ji; Hamill, Jennifer B; Kim, Hyungjin M; Pusic, Andrea L; Wilkins, Edwin G

    2017-08-01

    Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Patient-Reported Outcome Measures in Dysphagia: A Systematic Review of Instrument Development and Validation

    Science.gov (United States)

    Patel, Dhyanesh A.; Sharda, Rohit; Hovis, Kristen L.; Nichols, Erin E.; Sathe, Nila; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.; Vaezi, Michael F.; Francis, David O.

    2017-01-01

    Objective Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to 1) identify all currently available measures and 2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Results Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987 – 2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson’s disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: 1) direct patient involvement in content development, 2) empirically justified dimensionality, 3) demonstrable responsiveness to change, 4) plan for interpreting missing responses, and 5) literacy level assessment. Conclusion This is the first comprehensive systematic review assessing developmental properties of all available dysphagia

  18. Cognitive interviewing methodology in the development of a pediatric item bank: a patient reported outcomes measurement information system (PROMIS study

    Directory of Open Access Journals (Sweden)

    DeWalt Darren A

    2009-01-01

    Full Text Available Abstract Background The evaluation of patient-reported outcomes (PROs in health care has seen greater use in recent years, and methods to improve the reliability and validity of PRO instruments are advancing. This paper discusses the cognitive interviewing procedures employed by the Patient Reported Outcomes Measurement Information System (PROMIS pediatrics group for the purpose of developing a dynamic, electronic item bank for field testing with children and adolescents using novel computer technology. The primary objective of this study was to conduct cognitive interviews with children and adolescents to gain feedback on items measuring physical functioning, emotional health, social health, fatigue, pain, and asthma-specific symptoms. Methods A total of 88 cognitive interviews were conducted with 77 children and adolescents across two sites on 318 items. From this initial item bank, 25 items were deleted and 35 were revised and underwent a second round of cognitive interviews. A total of 293 items were retained for field testing. Results Children as young as 8 years of age were able to comprehend the majority of items, response options, directions, recall period, and identify problems with language that was difficult for them to understand. Cognitive interviews indicated issues with item comprehension on several items which led to alternative wording for these items. Conclusion Children ages 8–17 years were able to comprehend most item stems and response options in the present study. Field testing with the resulting items and response options is presently being conducted as part of the PROMIS Pediatric Item Bank development process.

  19. Measuring quality of life in cleft lip and palate patients: currently available patient-reported outcomes measures.

    Science.gov (United States)

    Eckstein, Donna A; Wu, Rebecca L; Akinbiyi, Takintope; Silver, Lester; Taub, Peter J

    2011-11-01

    Patient-reported outcomes in cleft lip and palate treatment are critical for patient care. Traditional surgical outcomes focused on objective measures, such as photographs, anatomic measurements, morbidity, and mortality. Although these remain important, they leave many questions unanswered. Surveys that include aesthetics, speech, functionality, self-image, and quality of life provide more thorough outcomes assessment. It is vital that reliable, valid, and comprehensive questionnaires are available to craniofacial surgeons. The authors performed a literature review to identify questionnaires validated in cleft lip and palate patients. Qualifying instruments were assessed for adherence to guidelines for development and validation by the scientific advisory committee and for content. The authors identified 44 measures used in cleft lip and palate studies. After 15 ad hoc questionnaires, eight generic instruments, 11 psychiatric instruments, and one non-English language questionnaire were excluded, nine measures remained. Of these, four were never validated in the cleft population. Analysis revealed one craniofacial-specific measure (Youth Quality of Life-Facial Differences), two voice-related measures (Patient Voice-Related Quality of Life and Cleft Audit Protocol for Speech-Augmented), and two oral health-related measures (Child Oral Health Impact Profile and Child Oral Health Quality of Life). The Youth Quality of Life-Facial Differences, Child Oral Health Impact Profile, and Child Oral Health Quality of Life questionnaires were sufficiently validated. None was created specifically for clefts, resulting in content limitations. There is a lack of comprehensive, valid, and reliable questionnaires for cleft lip and palate surgery. For thorough assessment of satisfaction, further research to develop and validate cleft lip and palate surgery-specific instruments is needed.

  20. Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO

    NARCIS (Netherlands)

    Watt, T.; Barbesino, G.; Bjorner, J.B.; Bonnema, S.J.; Bukvic, B.; Drummond, R.; Groenvold, M.; Hegedus, L.; Kantzer, V.; Lasch, K.E.; Marcocci, C.; Mishra, A.; Netea-Maier, R.T.; Ekker, M.; Paunovic, I.; Quinn, T.J.; Rasmussen, A.K.; Russell, A.; Sabaretnam, M.; Smit, J.W.; Torring, O.; Zivaljevic, V.; Feldt-Rasmussen, U.

    2015-01-01

    BACKGROUND AND PURPOSE: Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed

  1. Self-efficacy as a predictor of patient-reported outcomes in adults with congenital heart disease.

    Science.gov (United States)

    Thomet, Corina; Moons, Philip; Schwerzmann, Markus; Apers, Silke; Luyckx, Koen; Oechslin, Erwin N; Kovacs, Adrienne H

    2018-04-01

    Self-efficacy is a known predictor of patient-reported outcomes in individuals with acquired diseases. With an overall objective of better understanding patient-reported outcomes in adults with congenital heart disease, this study aimed to: (i) assess self-efficacy in adults with congenital heart disease, (ii) explore potential demographic and medical correlates of self-efficacy and (iii) determine whether self-efficacy explains additional variance in patient-reported outcomes above and beyond known predictors. As part of a large cross-sectional international multi-site study (APPROACH-IS), we enrolled 454 adults (median age 32 years, range: 18-81) with congenital heart disease in two tertiary care centres in Canada and Switzerland. Self-efficacy was measured using the General Self-Efficacy (GSE) scale, which produces a total score ranging from 10 to 40. Variance in the following patient-reported outcomes was assessed: perceived health status, psychological functioning, health behaviours and quality of life. Hierarchical multivariable linear regression analysis was performed. Patients' mean GSE score was 30.1 ± 3.3 (range: 10-40). Lower GSE was associated with female sex ( p = 0.025), not having a job ( p = 0.001) and poorer functional class ( p = 0.048). GSE positively predicted health status and quality of life, and negatively predicted symptoms of anxiety and depression, with an additional explained variance up to 13.6%. No associations between self-efficacy and health behaviours were found. GSE adds considerably to our understanding of patient-reported outcomes in adults with congenital heart disease. Given that self-efficacy is a modifiable psychosocial factor, it may be an important focus for interventions targeting congenital heart disease patients' well-being.

  2. Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears

    DEFF Research Database (Denmark)

    Thorlund, Jonas Bloch; Englund, Martin; Christensen, Robin

    2017-01-01

    orthopaedic departments in the Region of Southern Denmark. Participants were recruited between 1 February 2013 and 31 January 2014, and at one of the original four hospitals from 1 February 2014 to 31 January 2015. PARTICIPANTS: Individuals selected from Knee Arthroscopy Cohort Southern Denmark, aged 18...... on knee pathology. Patient reported outcomes were recorded via online questionnaires. MAIN OUTCOME MEASURES: Primary outcome was the average between-group difference in change on four of five subscales of the knee injury and osteoarthritis outcome score (KOOS). The four subscales covered pain, symptoms...

  3. Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format

    Directory of Open Access Journals (Sweden)

    Ritenbaugh Cheryl

    2011-12-01

    Full Text Available Abstract Background Patients receiving complementary and alternative medicine (CAM therapies often report shifts in well-being that go beyond resolution of the original presenting symptoms. We undertook a research program to develop and evaluate a patient-centered outcome measure to assess the multidimensional impacts of CAM therapies, utilizing a novel mixed methods approach that relied upon techniques from the fields of anthropology and psychometrics. This tool would have broad applicability, both for CAM practitioners to measure shifts in patients' states following treatments, and conventional clinical trial researchers needing validated outcome measures. The US Food and Drug Administration has highlighted the importance of valid and reliable measurement of patient-reported outcomes in the evaluation of conventional medical products. Here we describe Phase I of our research program, the iterative process of content identification, item development and refinement, and response format selection. Cognitive interviews and psychometric evaluation are reported separately. Methods From a database of patient interviews (n = 177 from six diverse CAM studies, 150 interviews were identified for secondary analysis in which individuals spontaneously discussed unexpected changes associated with CAM. Using ATLAS.ti, we identified common themes and language to inform questionnaire item content and wording. Respondents' language was often richly textured, but item development required a stripping down of language to extract essential meaning and minimize potential comprehension barriers across populations. Through an evocative card sort interview process, we identified those items most widely applicable and covering standard psychometric domains. We developed, pilot-tested, and refined the format, yielding a questionnaire for cognitive interviews and psychometric evaluation. Results The resulting questionnaire contained 18 items, in visual analog scale format

  4. Patient Satisfaction with Collection of Patient-Reported Outcome Measures in Routine Care.

    Science.gov (United States)

    Recinos, Pablo F; Dunphy, Cheryl J; Thompson, Nicolas; Schuschu, Jesse; Urchek, John L; Katzan, Irene L

    2017-02-01

    Systematic collection of patient-reported outcome measures (PROMs) during ambulatory clinic visits can enhance communication between patient and provider, and provide the ability to evaluate outcomes of care. Little is known about patient satisfaction of PROM data collection in routine clinical care. To evaluate patient reaction to the routine collection of PROMs in the ambulatory setting. Before all ambulatory clinic visits at our neurological institute, patients electronically complete health status questionnaires. We administered an 8-question patient satisfaction survey to a sample of patients seen across the institute after their clinical visit. Of 343 patients approached, 323 agreed to participate. The majority responded that the questionnaire system was easy to use, was an appropriate length, and benefited their care overall (strongly agree or agree = 92.3%, 87.6%, and 77.3%, respectively). Provider review of the PROMs with the patient during the clinic visit was associated with significantly higher positive responses to all questions, even those regarding logistical aspects of the collection process. There were significant age and race differences in response to perceived benefit: those in the Black/other race category had a markedly lower probability of viewing the process favorably with increasing age. Systematic collection of PROMs via an electronic questionnaire appears to be well accepted by patients. A minority of patients did not feel the questionnaire content applied to their appointment or that the system was a beneficial feature of the clinical practice. The provider can significantly improve the patient's perception of PROM collection and the patient-physician encounter by reviewing the questionnaire results with the patient.

  5. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

    Science.gov (United States)

    Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of

  6. Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO

    DEFF Research Database (Denmark)

    Watt, Torquil; Barbesino, Giuseppe; Bjørner, Jakob

    2015-01-01

    BACKGROUND AND PURPOSE: Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid......-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version. METHODS: The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social...... scale scores, most of which could be explained by sample differences not controlled for. CONCLUSION: The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in international multicenter studies....

  7. Pectus patient information website has improved access to care and patient reported outcomes.

    Science.gov (United States)

    Tikka, Theofano; Webb, Joanne; Agostini, Paula; Kerr, Amy; Mannion, Glenn; Steyn, Richard S; Bishay, Ehab; Kalkat, Maninder S; Rajesh, Pala B; Naidu, Babu

    2016-04-26

    Pectus is the most common congenital disorder. Awareness amongst primary care physicians and the general public is poor. NHS commissioning bodies plan to withdraw funding for this surgery because they deem a lack of sufficient evidence of benefit. The purpose of this study is to assess the effects of introducing a patient information website on referral and activity patterns and on patients reported outcomes. We produced an innovative information website, www.pectus.co.uk , accessible to the general public, providing information about pectus deformities; management options and advice about surgery. Referral patterns and number of cases where studied before and after the introduction of the website in 2010. Patients' satisfaction post-op was assessed using the Brompton's single step questionnaire (SSQ). The website had considerable traffic with 2179 hits in 2012, 4983 in 2013 and 7416 in 2014. This has led to 1421 contacts and 372 email enquiries. These emails have resulted in an increased number of patients who have been assessed and go on to have surgery. We asked 59 pectus excavatum patients who were operated from 2008 to 2014 to complete the SSQ. We received 32 replies. Eighty-four percent (16/19) of patients who visited the website and then underwent surgery, found the website useful. All patients scored satisfactorily in SSQ. Even though those who visited the website tended to be more satisfied with the surgical outcomes this did not reach statistical significance. This group of patients said that would have the operation again given the option compared to 76.9 % of the group who did not visit the website before surgery (p=0.031). Despite the fact that patients who visited the website experienced more post-operative complications were equally or more satisfied with post-operative outcomes. The overall SSQ obtainable score was not different for the two subgroups, being more widespread in the group that did not visit the website. The introduction of a pectus

  8. Mining telemonitored physiological data and patient-reported outcomes of congestive heart failure patients.

    Science.gov (United States)

    Mlakar, Miha; Puddu, Paolo Emilio; Somrak, Maja; Bonfiglio, Silvio; Luštrek, Mitja

    2018-01-01

    This paper addresses patient-reported outcomes (PROs) and telemonitoring in congestive heart failure (CHF), both increasingly important topics. The interest in CHF trials is shifting from hard end-points such as hospitalization and mortality, to softer end-points such health-related quality of life. However, the relation of these softer end-points to objective parameters is not well studied. Telemonitoring is suitable for collecting both patient-reported outcomes and objective parameters. Most telemonitoring studies, however, do not take full advantage of the available sensor technology and intelligent data analysis. The Chiron clinical observational study was performed among 24 CHF patients (17 men and 7 women, age 62.9 ± 9.4 years, 15 NYHA class II and 9 class III, 10 of ishaemic, aetiology, 6 dilated, 2 valvular, and 6 of multiple aetiologies or cardiomyopathy) in Italy and UK. A large number of physiological and ambient parameters were collected by wearable and other devices, together with PROs describing how well the patients felt, over 1,086 days of observation. The resulting data were mined for relations between the objective parameters and the PROs. The objective parameters (humidity, ambient temperature, blood pressure, SpO2, and sweeting intensity) could predict the PROs with accuracies up to 86% and AUC up to 0.83, making this the first report providing evidence for ambient and physiological parameters to be objectively related to PROs in CHF patients. We also analyzed the relations in the predictive models, gaining some insights into what affects the feeling of health, which was also generally not attempted in previous investigations. The paper strongly points to the possibility of using PROs as primary end-points in future trials.

  9. Teleophthalmology: improving patient outcomes?

    Directory of Open Access Journals (Sweden)

    Sreelatha OK

    2016-02-01

    Full Text Available Omana Kesary Sreelatha,1 Sathyamangalam VenkataSubbu Ramesh2 1Ophthalmology Department, Sultan Qaboos University Hospital, Muscat, Oman; 2Department of Optometry, School of Allied Health Sciences, Manipal University, Manipal, India Abstract: Teleophthalmology is gaining importance as an effective eye care delivery modality worldwide. In many developing countries, teleophthalmology is being utilized to provide quality eye care to the underserved urban population and the unserved remote rural population. Over the years, technological innovations have led to improvement in evidence and teleophthalmology has evolved from a research tool to a clinical tool. The majority of the current teleophthalmology services concentrate on patient screening and appropriate referral to experts. Specialty care using teleophthalmology services for the pediatric group includes screening as well as providing timely care for retinopathy of prematurity (ROP. Among geriatric eye diseases, specialty teleophthalmology care is focused toward screening and referral for diabetic retinopathy (DR, glaucoma, age-related macular degeneration (ARMD, and other sight-threatening conditions. Comprehensive vision screening and refractive error services are generally covered as part of most of the teleophthalmology methods. Over the past decades, outcome assessment of health care system includes patients’ assessments on their health, care, and services they receive. Outcomes, by and large, remain the ultimate validators of the effectiveness and quality of medical care. Teleophthalmology produces the same desired clinical outcome as the traditional system. Remote portals allow specialists to provide care over a larger region, thereby improving health outcomes and increasing accessibility of specialty care to a larger population. A high satisfaction level and acceptance is reported in the majority of the studies because of increased accessibility and reduced traveling cost and time

  10. Electronic Patient Reported Outcomes in Paediatric Oncology - Applying Mobile and Near Field Communication Technology.

    Science.gov (United States)

    Duregger, Katharina; Hayn, Dieter; Nitzlnader, Michael; Kropf, Martin; Falgenhauer, Markus; Ladenstein, Ruth; Schreier, Günter

    2016-01-01

    Electronic Patient Reported Outcomes (ePRO) gathered using telemonitoring solutions might be a valuable source of information in rare cancer research. The objective of this paper was to develop a concept and implement a prototype for introducing ePRO into the existing neuroblastoma research network by applying Near Field Communication and mobile technology. For physicians, an application was developed for registering patients within the research network and providing patients with an ID card and a PIN for authentication when transmitting telemonitoring data to the Electronic Data Capture system OpenClinica. For patients, a previously developed telemonitoring system was extended by a Simple Object Access Protocol (SOAP) interface for transmitting nine different health parameters and toxicities. The concept was fully implemented on the front-end side. The developed application for physicians was prototypically implemented and the mobile application of the telemonitoring system was successfully connected to OpenClinica. Future work will focus on the implementation of the back-end features.

  11. Risk profile of patients developing nonunion of the clavicle and outcome of treatment

    DEFF Research Database (Denmark)

    Ban, Ilija; Troelsen, Anders

    2016-01-01

    PURPOSE: The most common complication following treatment of a clavicle fracture is nonunion. Most nonunions are symptomatic and treatment is mostly operative. The aim of this study was to describe risk profiles of patients developing nonunion and what outcome is observed following operative...... of functionality and patient reported satisfaction and remission of symptoms was done a minimum of six months post-operatively by mail. Response rate was 60%. RESULTS: The overall nonunion rate was 7.5%. Nine nonunions were initially treated operatively. Risk factors associated with nonunion of our series...

  12. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument.

    Science.gov (United States)

    Patrick, Donald L; Burke, Laurie B; Gwaltney, Chad J; Leidy, Nancy Kline; Martin, Mona L; Molsen, Elizabeth; Ring, Lena

    2011-12-01

    The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR

  13. Patient-reported outcomes and adult patients' disease experience in the idiopathic inflammatory myopathies. report from the OMERACT 11 Myositis Special Interest Group.

    Science.gov (United States)

    Alexanderson, Helene; Del Grande, Maria; Bingham, Clifton O; Orbai, Ana-Maria; Sarver, Catherine; Clegg-Smith, Katherine; Lundberg, Ingrid E; Song, Yeong Wook; Christopher-Stine, Lisa

    2014-03-01

    The newly formed Outcome Measures in Rheumatology (OMERACT) Myositis Special Interest Group (SIG) was established to examine patient-reported outcome measures (PROM) in myositis. At OMERACT 11, a literature review of PROM used in the idiopathic inflammatory myopathies (IIM) and other neuromuscular conditions was presented. The group examined in more detail 2 PROM more extensively evaluated in patients with IIM, the Myositis Activities Profile, and the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire, through the OMERACT filter of truth, discrimination, and feasibility. Preliminary results from a qualitative study of patients with myositis regarding their symptoms were discussed that emphasized the range of symptoms experienced: pain, physical tightness/stiffness, fatigue, disease effect on emotional life and relationships, and treatment-related side effects. Following discussion of these results and following additional discussions since OMERACT 11, a research agenda was developed. The next step in evaluating PROM in IIM will require additional focus groups with a spectrum of patients with different myositis disease phenotypes and manifestations across a range of disease activity, and from multiple international settings. The group will initially focus on dermatomyositis and polymyositis in adults. Qualitative analysis will facilitate the identification of commonalities and divergent patient-relevant aspects of disease, insights that are critical given the heterogeneous manifestations of these diseases. Based on these qualitative studies, existing myositis PROM can be examined to more thoroughly assess content validity, and will be important to identify gaps in domain measurement that will be required to develop a preliminary core set of patient-relevant domains for IIM.

  14. Patient-reported outcomes in European spondyloarthritis patients: a systematic review of the literature

    Directory of Open Access Journals (Sweden)

    Torre-Alonso JC

    2018-05-01

    Full Text Available Juan Carlos Torre-Alonso,1 Rubén Queiro,2 Marta Comellas,3 Luís Lizán,3,4 Carles Blanch5 1Rheumatology Department, Faculty of Medicine and Health Sciences, University of Oviedo, Hospital Monte Naranco, Oviedo, Spain; 2Rheumatology Division, Hospital Universitario Central de Asturias (HUCA, Oviedo, Spain; 3Outcomes 10, Castellón de la Plana, Spain; 4Medicine Department, Jaime I University, Castellón de la Plana, Spain; 5Health Economics & Market Access, Novartis Pharmaceuticals, Barcelona, Spain Objective: This review aims to summarize the current literature on patient-reported outcomes (PROs in spondyloarthritis (SpA. Patients and methods: We performed a systematic literature review to identify studies (original articles and narrative and systematic reviews regarding PROs (health-related quality of life [HRQoL], satisfaction, preferences, adherence/compliance, and persistence in SpA patients published in the European Union through December 2016. International databases (Medline/PubMed, Cochrane Library, ISI Web of Knowledge, Scopus were searched using keywords in English. The methodological quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine criteria. Results: A total of 26 publications met the inclusion criteria. Generally, studies indicated that SpA has a negative impact on patients’ HRQoL. In patients with ankylosing spondylitis, physical domains were more affected than emotional ones, whereas for psoriatic arthritis, both physical and psychological factors were strongly affected by the disease. Data indicated that biological agents (BAs greatly contributed to improvement in HRQoL in both ankylosing spondylitis and psoriatic arthritis patients. Findings on compliance with BAs were heterogeneous. However, persistence rates exceeded 50% irrespective of the BA administered. Results on preferences indicated that most SpA patients prefer being involved in decisions regarding their treatment and that

  15. Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review.

    Science.gov (United States)

    de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J

    2018-05-01

    Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to

  16. The Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (PROM) in Septorhinoplasty.

    Science.gov (United States)

    Spiekermann, Christoph; Amler, Susanne; Rudack, Claudia; Stenner, Markus

    2018-06-01

    The patient's satisfaction with the esthetic result is a major criterion of success in septorhinoplasty. However, the idea of esthetic perfection varies greatly and primarily depends on subjective perception. Hence, patient-reported instruments are important and necessary to assess the outcome in septorhinoplasty. To analyze the potential of the visual analog scale (VAS) as a patient-reported outcome measure in septorhinoplasty, the perception of the nasal appearance was assessed by a VAS pre- and postoperatively in 213 patients undergoing septorhinoplasty. Furthermore, in this prospective study, the patients' satisfaction concerning the procedure's result was analyzed using a five-point Likert scale. Females had lower preoperative VAS scores but a higher increase compared to males. Patients with lower initial VAS scores showed a higher improvement in the VAS score postoperatively compared to patients with higher initial VAS scores. Satisfaction with the result depends on the increase in the VAS score value. The VAS scale is a short and comprehensible tool to assess patients' perception of nasal appearance preoperatively and represents an appropriate instrument to assess the esthetic patient-reported outcome in septorhinoplasty.Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  17. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 8: patient-reported outcomes in electronic health records can inform clinical and policy decisions.

    Science.gov (United States)

    Ahmed, Sara; Ware, Patrick; Gardner, William; Witter, James; Bingham, Clifton O; Kairy, Dahlia; Bartlett, Susan J

    2017-09-01

    Given that the goal of health care systems is to improve and maintain the health of the populations they serve, the indicators of performance must include outcomes that are meaningful to patients. The growth of health technologies provides an unprecedented opportunity to integrate the patient voice into clinical care by linking electronic health records (EHRs) to patient-reported outcome (PRO) data collection. However, PRO data must be relevant, meaningful, and actionable for those who will have to invest the time and effort to collect it. In this study, we highlight opportunities to integrate PRO data collection into EHRs. We consider how stakeholder perspectives should influence the selection of PROs and ways to enhance engagement in and commitment to PRO implementation. We propose a research and policy agenda to address unanswered questions and facilitate the widespread adoption of PRO data collection into EHRs. Building a learning health care system that gathers PRO data in ways that can inform individual patient care, quality improvement, and comparative effectiveness research has the potential to accelerate the application of new evidence and knowledge to patient care. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Does CPAP Affect Patient-Reported Voice Outcomes?

    Science.gov (United States)

    Hartke, Vance; Gillespie, Amanda; Smith, Libby J; Soose, Ryan J

    2018-04-01

    Upper aerodigestive tract symptoms are common in patients with obstructive sleep apnea (OSA). It remains unclear whether continuous positive airway pressure (CPAP) improves or worsens these otolaryngology symptoms. As therapy-related side effects limit CPAP adherence, this study aimed to determine if CPAP negatively affects voice, sinonasal, and reflux symptoms of the upper airway. Case series with planned data collection was performed at an academic otolaryngology sleep center. Newly diagnosed patients with OSA were evaluated before and 6 months after initiating CPAP therapy. Data collected included CPAP data download, Reflux Symptom Index (RSI), Epworth Sleepiness Scale (ESS), Voice Handicap Index 10 (VHI-10), Sino-Nasal Questionnaire (SNQ), and oral dryness visual analog scale (VAS). For the 11 CPAP-adherent participants, the RSI significantly improved with CPAP (mean RSI, 22.0-9.5; P = .002); however, the VAS, VHI-10, and SNQ did not change after 6 months of CPAP therapy. In a small sample size, patient-reported voice outcomes (VHI-10) and other upper aerodigestive tract symptoms did not worsen with CPAP; rather, CPAP therapy was associated with a reduction in reflux symptoms.

  19. Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 9: anonymization and ethics considerations for capturing and sharing patient reported outcomes.

    Science.gov (United States)

    Arbuckle, Luk; Moher, Ester; Bartlett, Susan J; Ahmed, Sara; El Emam, Khaled

    2017-09-01

    Patient-reported outcomes (PROs) are collected with consent for care; however, using the data for any other purpose requires consent for that additional purpose, or the anonymization of the data. Collecting explicit consent to use this data for secondary purposes, before the patient completes a PRO, can also bias the responses. We consider the ethical and security issues related to the collection of data at the point of care or in the population and the aggregation and integration of PRO data with administrative databases to facilitate decision making and comparative effectiveness research. In this article, we describe risk-based anonymization, taking the context of the data release into account, so that we may consider the degree by which the release is considered anonymized. We also consider the ethical use of anonymized data, the anonymization of free-form text, and the secure linking data sets without sharing any personal information. Many good standards and best practices exist for the sharing of health data and could be used as a baseline in the development of a national PRO initiative. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Feasibility test of a UK-scalable electronic system for regular collection of patient-reported outcome measures and linkage with clinical cancer registry data: The electronic Patient-reported Outcomes from Cancer Survivors (ePOCS system

    Directory of Open Access Journals (Sweden)

    Velikova Galina

    2011-10-01

    Full Text Available Abstract Background Cancer survivors can face significant physical and psychosocial challenges; there is a need to identify and predict which survivors experience what sorts of difficulties. As highlighted in the UK National Cancer Survivorship Initiative, routine post-diagnostic collection of patient reported outcome measures (PROMs is required; to be most informative, PROMs must be linked and analysed with patients' diagnostic and treatment information. We have designed and built a potentially cost-efficient UK-scalable electronic system for collecting PROMs via the internet, at regular post-diagnostic time-points, for linking these data with patients' clinical data in cancer registries, and for electronically managing the associated patient monitoring and communications; the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS system. This study aims to test the feasibility of the ePOCS system, by running it for 2 years in two Yorkshire NHS Trusts, and using the Northern and Yorkshire Cancer Registry and Information Service. Methods/Design Non-metastatic breast, colorectal and prostate cancer patients (largest survivor groups, within 6 months post-diagnosis, will be recruited from hospitals in the Yorkshire Cancer Network. Participants will be asked to complete PROMS, assessing a range of health-related quality-of-life outcomes, at three time-points up to 15 months post-diagnosis, and subsequently to provide opinion on the ePOCS system via a feedback questionnaire. Feasibility will be examined primarily in terms of patient recruitment and retention rates, the representativeness of participating patients, the quantity and quality of collected PROMs data, patients' feedback, the success and reliability of the underpinning informatics, and the system running costs. If sufficient data are generated during system testing, these will be analysed to assess the health-related quality-of-life outcomes reported by patients, and to explore

  1. A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis

    DEFF Research Database (Denmark)

    Højgaard, Pil; Klokker, Louise; Orbai, Ana Maria

    2018-01-01

    Background: An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. Objectives: To synthesize the evidence on measurement properties of patient reported outcome measures...... (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. Methods: A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing...... the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Results: Fifty-five studies were included in the systematic...

  2. Patient-reported outcomes instruments: bridging the gap between international copyright laws and common practice for developers and users--a case example.

    Science.gov (United States)

    Anfray, Caroline

    2009-12-01

    Copyright laws are intended to protect the rights of authors in their literary, scientific, and artistic works. The recent controversy about the standardized version of the Asthma Quality of Life Questionnaire between Elizabeth Juniper and Eirini Grammatopoulou et al. is an example of the difficulties inherent to copyright faced by developers and users of patient-reported outcome (PRO) instruments. This brief communication presents the basics of international copyright laws (i.e., the Berne Convention), the facts behind the controversy, and our analysis of the case based on our experience as a distributing center of PRO instruments. We conclude that better communication between developers and users would prevent most unfortunate complications and misunderstandings.

  3. Process- and patient-reported outcomes of a multifaceted medication adherence intervention for hypertensive patients in secondary care

    DEFF Research Database (Denmark)

    Hedegaard, Ulla; Hallas, Jesper; Ravn-Nielsen, Lene Vestergaard

    2016-01-01

    BACKGROUND: Adherence to antihypertensive medications is suboptimal. Hospital pharmacist interventions including motivational interviewing (MI) might assist in improving adherence in patients with hypertension. For an intervention to be useful, it is important to have tools that can easily identify...... potential adherence problems. OBJECTIVES: To evaluate process outcomes and patient- and pharmacist-reported outcomes of a pharmacist adherence intervention for hypertensive patients treated in hospital outpatient clinics. Secondly, to determine the agreement between two different adherence metrics......-39% reported increased knowledge, confidence and skills in relation to their medication as well as better quality of life. The pharmacists found that the intervention elements were meaningful pharmacist tasks, and that the DRAW tool was easy to use and helped them focus on addressing reasons for non...

  4. The Role of Patient-Reported Outcome Measures in Value-Based Payment Reform.

    Science.gov (United States)

    Squitieri, Lee; Bozic, Kevin J; Pusic, Andrea L

    2017-06-01

    The U.S. health care system is currently experiencing profound change. Pressure to improve the quality of patient care and control costs have caused a rapid shift from traditional volume-driven fee-for-service reimbursement to value-based payment models. Under the 2015 Medicare Access and Children's Health Insurance Program Reauthorization Act, providers will be evaluated on the basis of quality and cost efficiency and ultimately receive adjusted reimbursement as per their performance. Although current performance metrics do not incorporate patient-reported outcome measures (PROMs), many wonder whether and how PROMs will eventually fit into value-based payment reform. On November 17, 2016, the second annual Patient-Reported Outcomes in Healthcare Conference brought together international stakeholders across all health care disciplines to discuss the potential role of PROs in value-based health care reform. The purpose of this article was to summarize the findings from this conference in the context of recent literature and guidelines to inform implementation of PROs in value-based payment models. Recommendations for evaluating key perspectives and measurement goals are made to facilitate appropriate use of PROMs to best benefit and amplify the voice of our patients. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  5. Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease

    Science.gov (United States)

    Kocks, Jan Willem H; van den Berg, Jan Willem K; Kerstjens, Huib AM; Uil, Steven M; Vonk, Judith M; de Jong, Ynze P; Tsiligianni, Ioanna G; van der Molen, Thys

    2013-01-01

    Background Exacerbations of chronic obstructive pulmonary disease (COPD) are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients) were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ), and the St George’s Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found to be less impaired than in hospitalized patients, while the rate and pattern of recovery was remarkably similar. Conclusion Daily health status measurements were found to predict treatment failure, which could help decision-making for patients hospitalized due to an exacerbation of COPD. PMID:23766644

  6. Cognitive reserve and patient-reported outcomes in multiple sclerosis.

    Science.gov (United States)

    Schwartz, Carolyn E; Snook, Erin; Quaranto, Brian; Benedict, Ralph H B; Vollmer, Timothy

    2013-01-01

    Adaptation and compensation in the face of changing pathology may be better understood by considering the concept of cognitive reserve, which may protect against disability in multiple sclerosis (MS). The present work investigates the relationship between cognitive reserve and demographic characteristics, health behaviors, and patient-reported outcomes (PROs). Cross-sectional data (n=1142) were drawn from the North American Research Committee on MS (NARCOMS) Registry, from whom additional survey data were collected. Cognitive reserve was measured using the Stern and Sole-Padulles measures, the O*NET occupational classification system, and the Godin Leisure-Time Exercise Questionnaire. PROs were assessed using generic (SF -12v2, Perceived Deficits Questionnaire, Ryff Psychological Well-Being, Diener Satisfaction with Life Scale) and disease-specific (Patient-Determined Disease Steps, Performance Scales) measures. Psychometric analysis created unidimensional cognitive reserve subscales. Regression models examined relationships between cognitive reserve, demographic characteristics, and PROs. The cognitive reserve measures assessed distinct but related constructs. Individuals with high cognitive reserve were more likely to report lower levels of perceived disability and perceived cognitive deficits, and higher levels of physical health, mental health, and well-being. Both active and passive reserve are associated with better outcomes, independent of demographic factors, and these associations apply to both generic and disease-specific outcomes. This expanded measurement of cognitive reserve captures both the passive and active aspects of the construct, and there is a consistent and substantial relationship with PROs. Individuals with high passive and/or active reserve are healthier and experience higher levels of well-being.

  7. Is patient responsibility for managing musculoskeletal disorders related to self-reported better outcome of physiotherapy treatment?

    Science.gov (United States)

    Larsson, Maria E H; Kreuter, Margareta; Nordholm, Lena

    2010-07-01

    Musculoskeletal disorders are prevalent and a major burden on individuals and society. Information on relationships of patient involvement and responsibility to outcome is limited. This study aimed to explore relationships between self-reported outcome of physiotherapy treatment and attitudes toward responsibility for musculoskeletal disorders. A cross-sectional postal survey design was used. Patients (n=615) from an outpatient physiotherapy clinic, who had finished their physiotherapy treatment within the last 6 months were sent a questionnaire that included the Attitudes regarding Responsibility for Musculoskeletal disorders instrument (ARM), self-reported outcome of treatment and sociodemographic data. A total of 279 (45%) completed forms were returned. Multiple logistic regression analysis was used. The patients' scores on the four dimensions of ARM ("responsibility self active," "responsibility out of my hands," "responsibility employer," and "responsibility medical professionals"), controlled for age, sex, education, and physical activity as well as for number of treatments, main treatment, and physiotherapist, were associated with the patients' self-reported treatment outcome. Patients who attributed responsibility more to themselves were more likely (OR 2.37 and over) to report considerable improvement as the outcome of physiotherapy treatment. Because this study was conducted at only one physiotherapy outpatient clinic and had a cross-sectional design, the results should be replicated in other settings. Because patients' attitudes regarding responsibility for musculoskeletal disorders can possibly affect the outcome of physiotherapy treatment, it might be useful to decide whether to systematically try to influence the person's attitude toward responsibility for the management of the disorder or to match treatment to attitude.

  8. Patient-reported outcome measures in dysphagia: a systematic review of instrument development and validation.

    Science.gov (United States)

    Patel, D A; Sharda, R; Hovis, K L; Nichols, E E; Sathe, N; Penson, D F; Feurer, I D; McPheeters, M L; Vaezi, M F; Francis, David O

    2017-05-01

    Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We

  9. The importance of patient-reported outcome measures in reconstructive urology.

    Science.gov (United States)

    Jackson, Matthew J; N'Dow, James; Pickard, Rob

    2010-11-01

    Patient-reported outcome measures (PROMs) are now recognised as the most appropriate instruments to assess the effectiveness of healthcare interventions from the patient's perspective. The purpose of this review was to identify recent publications describing the use of PROMs following reconstructive urological surgery. A wide systematic search identified only three original articles published in the last 2 years that prospectively assessed effectiveness using a patient-completed condition-specific or generic health-related quality of life (HRQoL) instrument. These publications illustrate the need to administer PROMs at a postoperative interval relevant to the anticipated recovery phase of individual procedures. They also highlight the difference in responsiveness of generic HRQoL instruments to symptomatic improvement between straightforward conditions such as pelviureteric junction obstruction and complex multidimensional conditions such as meningomyelocele. PROMs uptake and awareness is increasing in reconstructive urology but more work is required to demonstrate the effectiveness of surgical procedures for patients and healthcare funders alike. Healthcare policy-makers now rely on these measures to determine whether specific treatments are worth financing and to compare outcomes between institutions.

  10. Patient reported outcome measures in male incontinence surgery.

    Science.gov (United States)

    Tran, M G B; Yip, J; Uveili, K; Biers, S M; Thiruchelvam, N

    2014-10-01

    Patient reported outcome measures (PROMs) were used to evaluate outcomes of the artificial urinary sphincter (AUS) and the AdVance™ (American Medical Systems, Minnetonka, MN, US) male sling system (AVMS) for the symptomatic management of male stress urinary incontinence. All male patients with stress urinary incontinence referred to our specialist clinic over a two-year period completed the ICIQ-UI SF (International Consultation on Incontinence Questionnaire on Urinary Incontinence Short Form) and the ICIQ-MLUTS LF (International Consultation on Incontinence Questionnaire on Male Lower Urinary Tract Symptoms Long Form) at consultation as well as at subsequent follow-up appointments. The Wilcoxon signed-rank test for non-parametric paired data was used for pre and postoperative comparisons. The chi-squared test was used for categorical variables. Thirty-seven patients (forty surgical cases) completed a preoperative and at least one follow-up questionnaire. There was a statistically significant improvement in PROMs postoperatively, regardless of mode of surgery (p25) had greater improvement with an AUS than with the AVMS (p<0.01). This prospective study shows that completion and collection of PROMs as part of routine clinical practice is achievable and useful in the assessment of male stress incontinence surgery. PROMs are important instruments to assess effectiveness of healthcare intervention and they are useful adjuncts in surgical studies.

  11. Patient-Reported Allergies Predict Worse Outcomes After Hip and Knee Arthroplasty: Results From a Prospective Cohort Study.

    Science.gov (United States)

    Otero, Jesse E; Graves, Christopher M; Gao, Yubo; Olson, Tyler S; Dickinson, Christopher C; Chalus, Rhonda J; Vittetoe, David A; Goetz, Devon D; Callaghan, John J

    2016-12-01

    Retrospective analyses have demonstrated correlation between patient-reported allergies and negative outcomes after total joint arthroplasty. We sought to validate these observations in a prospective cohort. One hundred forty-four patients undergoing total hip arthroplasty and 302 patients undergoing total knee arthroplasty were prospectively enrolled. Preoperatively, patients listed their allergies and completed the Medical Outcomes Study Short Form 36 (SF-36) and the Charlson Comorbidity Index (CCI) Questionnaire. At a mean of 17 months (range 12-25 months) postoperatively, SF-36, CCI, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were obtained by telephone survey. Regression analysis was used to determine the strength of correlation between patient age, comorbidity burden, and number of allergies and outcome measurements. In 446 patients, 273 reported at least 1 allergy. The number of allergies reported ranged from 0 to 33. Penicillin or its derivative was the most frequently reported allergy followed by sulfa, environmental allergen, and narcotic pain medication. Patients reporting at least 1 allergy had a significantly lower postoperative SF-36 Physical Component Score compared to those reporting no allergies (51.3 vs 49.4, P = .01). The SF-36 postoperative Mental Component Score was no different between groups. Multivariate regression analysis showed that age and patient reported allergies, but not comorbidities, were independently associated with worse postoperative SF-36 Physical Component Summary (PCS) and WOMAC score. Patients with allergies experienced the same improvement in SF-36 PCS as those without an allergy. Comorbidities did not correlate with patient-reported function postoperatively. Patients who report allergies have lower postoperative outcome scores but may experience the same increment in improvement after total joint arthroplasty. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Patient perspective: choosing or developing instruments.

    Science.gov (United States)

    Kirwan, John R; Fries, James F; Hewlett, Sarah; Osborne, Richard H

    2011-08-01

    Previous Outcome Measures in Rheumatology (OMERACT) meetings recognized that patients view outcomes of intervention from a different perspective. This preconference position paper briefly sets out 2 patient-reported outcome (PRO) instrument approaches, the PROMISE computer adaptive testing (CAT) system and development of a rheumatoid arthritis-specific questionnaire to measure fatigue; a tentative proposal for a PRO instrument development pathway is also made.

  13. Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome.

    Science.gov (United States)

    Marquis, P; Lasch, K E; Delgado-Herrera, L; Kothari, S; Lembo, A; Lademacher, C; Spears, G; Nishida, A; Tesler, Waldman L; Piault, E; Rosa, K; Zeiher, B

    2014-06-26

    Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or

  14. Qualitative Development of a Patient-Reported Outcome Symptom Measure in Diarrhea-Predominant Irritable Bowel Syndrome

    Science.gov (United States)

    Marquis, P; Lasch, K E; Delgado-Herrera, L; Kothari, S; Lembo, A; Lademacher, C; Spears, G; Nishida, A; Tesler, Waldman L; Piault, E; Rosa, K; Zeiher, B

    2014-01-01

    OBJECTIVES: Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). METHODS: Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. RESULTS: Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items

  15. Effects of patient health literacy, patient engagement and a system-level health literacy attribute on patient-reported outcomes: a representative statewide survey.

    Science.gov (United States)

    Kaphingst, Kimberly A; Weaver, Nancy L; Wray, Ricardo J; Brown, Melissa L R; Buskirk, Trent; Kreuter, Matthew W

    2014-10-07

    The effects of health literacy are thought to be based on interactions between patients' skill levels and health care system demands. Little health literacy research has focused on attributes of health care organizations. We examined whether the attribute of individuals' experiences with front desk staff, patient engagement through bringing questions to a doctor visit, and health literacy skills were related to two patient-reported outcomes. We administered a telephone survey with two sampling frames (i.e., household landline, cell phone numbers) to a randomly selected statewide sample of 3358 English-speaking adult residents of Missouri. We examined two patient-reported outcomes - whether or not respondents reported knowing more about their health and made better choices about their health following their last doctor visit. Multivariable logistic regression models were used to examine the independent contributions of predictor variables (i.e., front desk staff, bringing questions to a doctor visit, health literacy skills). Controlling for self-reported health, having a personal doctor, time since last visit, number of chronic conditions, health insurance, and sociodemographic characteristics, respondents who had a good front desk experience were 2.65 times as likely (95% confidence interval [CI]: 2.13, 3.30) and those who brought questions were 1.73 times as likely (95% CI: 1.32, 2.27) to report knowing more about their health after seeing a doctor. In a second model, respondents who had a good front desk experience were 1.57 times as likely (95% CI: 1.26, 1.95) and those who brought questions were 1.66 times as likely (95% CI: 1.29, 2.14) to report making better choices about their health after seeing a doctor. Patients' health literacy skills were not associated with either outcome. Results from this representative statewide survey may indicate that one attribute of a health care organization (i.e., having a respectful workforce) and patient engagement through

  16. Development and validation of a primary sclerosing cholangitis-specific patient-reported outcomes instrument: The PSC PRO.

    Science.gov (United States)

    Younossi, Zobair M; Afendy, Arian; Stepanova, Maria; Racila, Andrei; Nader, Fatema; Gomel, Rachel; Safer, Ricky; Lenderking, William R; Skalicky, Anne; Kleinman, Leah; Myers, Robert P; Subramanian, G Mani; McHutchison, John G; Levy, Cynthia; Bowlus, Christopher L; Kowdley, Kris; Muir, Andrew J

    2017-11-20

    Primary sclerosing cholangitis (PSC) is a chronic liver disease associated with inflammation and biliary fibrosis that leads to cholangitis, cirrhosis, and impaired quality of life. Our objective was to develop and validate a PSC-specific patient-reported outcome (PRO) instrument. We developed a 42-item PSC PRO instrument that contains two modules (Symptoms and Impact of Symptoms) and conducted an external validation. Reliability and validity were evaluated using clinical data and a battery of other validated instruments. Test-retest reliability was assessed in a subgroup of patients who repeated the PSC PRO after the first administration. One hundred two PSC subjects (44 ± 13 years; 32% male, 74% employed, 39% with cirrhosis, 14% with a history of decompensated cirrhosis, 38% history of depression, and 68% with inflammatory bowel disease [IBD]) completed PSC PRO and other PRO instruments (Short Form 36 V2 [SF-36], Chronic Liver Disease Questionnaire [CLDQ], Primary Biliary Cholangitis - 40 [PBC-40], and five dimensions [5-D Itch]). PSC PRO demonstrated excellent internal consistency (Cronbach alphas, 0.84-0.94) and discriminant validity (41 of 42 items had the highest correlations with their own domains). There were good correlations between PSC PRO domains and relevant domains of SF-36, CLDQ, and PBC-40 (R = 0.69-0.90; all P 0.05). Test-retest reliability was assessed in 53 subjects who repeated PSC PRO within a median (interquartile range) of 37 (27-47) days. There was excellent reliability for most domains with intraclass correlations (0.71-0.88; all P < 0.001). PSC PRO is a self-administered disease-specific instrument developed according to U.S. Food and Drug Administration guidelines. This preliminary validation study suggests good psychometric properties. Further validation of the instrument in a larger and more diverse sample of PSC patients is needed. (Hepatology 2017). © 2017 by the American Association for the Study of Liver Diseases.

  17. Patient reported outcomes in chronic skin diseases: eHealth applications for clinical practice

    NARCIS (Netherlands)

    van Cranenburgh, O.D.

    2016-01-01

    The overall aim of this thesis was to examine and integrate patient reported outcomes (PROs) in dermatological care. In part I, we specifically examined health-related quality of life (HRQoL), treatment satisfaction, and experiences with care in patients with chronic skin diseases. Our results

  18. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries

    DEFF Research Database (Denmark)

    Reaney, Matthew; Mathieu, Chantal; Ostenson, Claes-Göran

    2013-01-01

    who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both cohorts compared with those for clinical outcomes. CONCLUSIONS: These data from a clinical practice study support those from clinical...... clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study. METHODS: CHOICE was a 24-month, prospective observational study conducted in six European......BACKGROUND: Improvements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient's perspective in routine...

  19. Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    DEFF Research Database (Denmark)

    Bæksted, Christina; Nissen, Aase; Pappot, Helle

    2016-01-01

    CONTEXT: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) to i......CONTEXT: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO...

  20. Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

    Science.gov (United States)

    Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

    2012-10-01

    Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

  1. A comprehensive systematic review of the development process of 104 patient-reported outcomes (PROs for physical activity in chronically ill and elderly people

    Directory of Open Access Journals (Sweden)

    Frei Anja

    2011-12-01

    Full Text Available Abstract Background Capturing dimensions of physical activity relevant to patients may provide a unique perspective for clinical studies of chronically ill patients. However, the quality of the development of existing instruments is uncertain. The aim of this systematic review was to assess the development process of patient-reported outcome (PRO instruments including their initial validation to measure physical activity in chronically ill or elderly patient populations. Methods We conducted a systematic literature search of electronic databases (Medline, Embase, Psychinfo, Cinahl and hand searches. We included studies describing the original development of fully structured instruments measuring dimensions of physical activity or related constructs in chronically ills or elderly. We broadened the population to elderly because they are likely to share physical activity limitations. At least two reviewers independently conducted title and abstract screening and full text assessment. We evaluated instruments in terms of their aim, items identification and selection, domain development, test-retest reliability, internal consistency, validity and responsiveness. Results Of the 2542 references from the database search and 89 from the hand search, 103 full texts which covered 104 instruments met our inclusion criteria. For almost half of the instruments the authors clearly described the aim of the instruments before the scales were developed. For item identification, patient input was used in 38% of the instruments and in 32% adaptation of existing scales and/or unsystematic literature searches were the only sources for the generation of items. For item reduction, in 56% of the instruments patient input was used and in 33% the item reduction process was not clearly described. Test-retest reliability was assessed for 61%, validity for 85% and responsiveness to change for 19% of the instruments. Conclusions Many PRO instruments exist to measure

  2. Electronic capture of patient-reported and clinician-reported outcome measures in an elective orthopaedic setting: a retrospective cohort analysis.

    Science.gov (United States)

    Malhotra, Karan; Buraimoh, Olatunbosun; Thornton, James; Cullen, Nicholas; Singh, Dishan; Goldberg, Andrew J

    2016-06-20

    To determine whether an entirely electronic system can be used to capture both patient-reported outcomes (electronic Patient-Reported Outcome Measures, ePROMs) as well as clinician-validated diagnostic and complexity data in an elective surgical orthopaedic outpatient setting. To examine patients' experience of this system and factors impacting their experience. Retrospective analysis of prospectively collected data. Single centre series. Outpatient clinics at an elective foot and ankle unit in the UK. All new adult patients attending elective orthopaedic outpatient clinics over a 32-month period. All patients were invited to complete ePROMs prior to attending their outpatient appointment. At their appointment, those patients who had not completed ePROMs were offered the opportunity to complete it on a tablet device with technical support. Matched diagnostic and complexity data were captured by the treating consultant during the appointment. Capture rates of patient-reported and clinician-reported data. All information and technology (IT) failures, language and disability barriers were captured. Patients were asked to rate their experience of using ePROMs. The scoring systems used included EQ-5D-5L, the Manchester-Oxford Foot Questionnaire (MOxFQ) and the Visual Analogue Scale (VAS) pain score. Out of 2534 new patients, 2176 (85.9%) completed ePROMs, of whom 1090 (50.09%) completed ePROMs at home/work prior to their appointment. 31.5% used a mobile (smartphone/tablet) device. Clinician-reported data were captured on 2491 patients (98.3%). The mean patient experience score of using Patient-Reported Outcome Measures (PROMs) was 8.55±1.85 out of 10 and 666 patients (30.61%) left comments. Of patients leaving comments, 214 (32.13%) felt ePROMs did not adequately capture their symptoms and these patients had significantly lower patient experience scores (ptechnology into a service improvement programme. Excellent capture rates of ePROMs and clinician

  3. Home healthcare nurse retention and patient outcome model: discussion and model development.

    Science.gov (United States)

    Ellenbecker, Carol Hall; Cushman, Margaret

    2012-08-01

    This paper discusses additions to an empirically tested model of home healthcare nurse retention. An argument is made that the variables of shared decision-making and organizational commitment be added to the model based on the authors' previous research and additional evidence from the literature. Previous research testing the home healthcare nurse retention model established empirical relationships between nurse, agency, and area characteristics to nurse job satisfaction, intent to stay, and retention. Unexplained model variance prompted a new literature search to augment understanding of nurse retention and patient and agency outcomes. Data come from the authors' previous research, and a literature search from 1990 to 2011 on the topics organizational commitment, shared decision-making, nurse retention, patient outcomes and agency performance. The literature provides a rationale for the additional variables of shared decision-making and affective and continuous organizational commitment, linking these variables to nurse job satisfaction, nurse intent to stay, nurse retention and patient outcomes and agency performance. Implications for nursing.  The new variables in the model suggest that all agencies, even those not struggling to retain nurses, should develop interventions to enhance nurse job satisfaction to assure quality patient outcomes. The new nurse retention and patient outcome model increases our understanding of nurse retention. An understanding of the relationship among these variables will guide future research and the development of interventions to create and maintain nursing work environments that contribute to nurse affective agency commitment, nurse retention and quality of patient outcomes. © 2011 Blackwell Publishing Ltd.

  4. Patient reported outcomes in pediatric oncology practice: suggestions for future usage by parents and pediatric oncologists

    NARCIS (Netherlands)

    Schepers, S. A.; Engelen, V. E.; Haverman, L.; Caron, H. N.; Hoogerbrugge, P. M.; Kaspers, G. J. L.; Egeler, R. M.; Grootenhuis, M. A.

    2014-01-01

    Several studies in adults have shown patient reported outcomes (PROs) to be effective in enhancing patient-physician communication and discussion of Health Related Quality of Life outcomes. Although less studied, positive results have been demonstrated in children. A PRO-intervention needs to be

  5. Development and initial psychometric evaluation of patient-reported outcome questionnaires to evaluate the symptoms and impact of hidradenitis suppurativa.

    Science.gov (United States)

    Kimball, Alexa B; Sundaram, Murali; Banderas, Benjamin; Foley, Catherine; Shields, Alan L

    2018-03-01

    Two patient-reported outcome (PRO) questionnaires, the Hidradenitis Suppurativa Symptom Assessment (HSSA) and Hidradenitis Suppurativa Impact Assessment (HSIA), were developed to measure signs, symptoms and impacts of HS in treatment efficacy studies. In accordance with FDA guidelines and published best practices, four stages of research were conducted to create the questionnaires: concept elicitation, questionnaire construction, content evaluation and psychometric evaluation. Subjects (N = 20) who participated in the concept elicitation stage reported 15 unique HS-related signs and symptoms and 51 impacts. Following this, eight sign and symptom concepts and 21 impacts were selected for construction of the HSSA and HSIA, respectively. During content evaluation, cognitive debriefing interviews with HS subjects (N = 20) confirmed subjects could read, comprehend and meaningfully respond to both questionnaires. Modifications made after this stage of work resulted in a nine-item HSSA and a 17-item HSIA. The HSSA and HSIA were subsequently entered into a US-based observational study (N = 40), and the scores produced by each were found to be reliable, construct valid, and able to distinguish among clinically distinct groups. The HSSA and HSIA are content-valid, HS-specific, PRO questionnaires with demonstrated ability to generate reliable, valid scores when administered to patients with HS in a research setting.

  6. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

    Science.gov (United States)

    Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

    2016-05-01

    Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. Published by Elsevier Inc.

  7. Patient-reported outcome and risk of revision after shoulder replacement for osteoarthritis

    DEFF Research Database (Denmark)

    Rasmussen, Jeppe V; Polk, Anne; Brorson, Stig

    2014-01-01

    PURPOSE: We used patient-reported outcome and risk of revision to compare hemiarthroplasty (HA) with total shoulder arthroplasty (TSA) and stemmed hemiarthroplasty (SHA) with resurfacing hemiarthroplasty (RHA) in patients with glenohumeral osteoarthritis. PATIENTS AND METHODS: We included all...... of presentation, the raw scores were converted to a percentage of the maximum score. Revision rates were calculated by checking reported revisions to the DSR until December 2011. WOOS and risk of revision were adjusted for age, sex, previous surgery, and type of osteoarthritis. RESULTS: There were 113 TSAs...... and 1096 HAs (837 RHAs and 259 SHAs). Patients treated with TSA generally had a better WOOS, exceeding the predefined minimal clinically important difference, at 1 year (mean difference 10, p

  8. Patient anxiety and concern as predictors for the perceived quality of treatment and patient reported outcome (PRO) in orthopaedic surgery

    DEFF Research Database (Denmark)

    Bilberg, Randi; Nørgaard, Birgitte; Overgaard, Søren

    2012-01-01

    ABSTRACT: BACKGROUND: Previous studies have shown that patients' anxiety and dissatisfaction are predictors for increased postoperative pain and reduced efficacy of pain treatment. However, it remains to be shown whether patient anxiety and concern are predictors for the perceived quality...... of treatment and patient reported outcome (PRO).The aim of this study is to investigate whether there is a correlation between preoperative anxiety and concern, and the perceived quality of postoperative treatment and outcome. The hypothesis is that anxious and concerned patients are less satisfied...... with treatment and have a poorer outcome.Methods/designThis study is designed as a prospective follow-up study and has the aim of investigating the correlation between patient anxiety and concern, patients[ACUTE ACCENT] perceived quality of treatment and outcome. This correlation will be detected using five...

  9. Analyzing differences between patient and proxy on Patient Reported Outcomes in multiple sclerosis.

    Science.gov (United States)

    Sonder, Judith M; Holman, Rebecca; Knol, Dirk L; Bosma, Libertje V A E; Polman, Chris H; Uitdehaag, Bernard M J

    2013-11-15

    Proxy respondents, partners of multiple sclerosis (MS) patients, can provide valuable information on the MS patients' disease. In an earlier publication we found relatively good agreement on patient reported outcomes (PROs) measuring physical impact and functioning, but we found large differences on (neuro)psychological scales. We aim to identify patient and proxy related variables explaining differences between patients' and proxies' ratings on five PROs. We report on data from 175 MS patients and proxy respondents. Regression analyses were performed, using as dependent variable the mean differences on five scales: Physical and Psychological scale of the Multiple Sclerosis Impact Scale (MSIS-29), the Multiple Sclerosis Walking Scale (MSWS), Guy's Neurological Disability Scale (GNDS) and the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ). The independent variables were patient, proxy and disease related variables. Caregiver strain was significantly related to differences between patient and proxy scores for all five PROs. A higher level of patient anxiety on the HADS was linked to larger differences on all PROs except the GNDS. In addition, cognitive functioning, proxy depression, walking ability, proxy gender and MS related disability were contributing to the discrepancies. We found several patient and proxy factors that may contribute to discrepancies between patient and proxy scores on MS PROs. The most important factor is caregiver burden. © 2013 Elsevier B.V. All rights reserved.

  10. The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms: The Genital Psoriasis Symptoms Scale (GPSS).

    Science.gov (United States)

    Gottlieb, Alice B; Kirby, Brian; Ryan, Caitriona; Naegeli, April N; Burge, Russel; Potts Bleakman, Alison; Anatchkova, Milena D; Yosipovitch, Gil

    2018-03-01

    Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs. Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS. The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs. Eli Lilly & Company. Plain language summary available for this article.

  11. Comparative effectiveness studies examining patient-reported outcomes among children with cleft lip and/or palate: a systematic review.

    Science.gov (United States)

    Ranganathan, Kavitha; Vercler, Christian J; Warschausky, Seth A; MacEachern, Mark P; Buchman, Steven R; Waljee, Jennifer F

    2015-01-01

    Health care policy makers are increasingly encouraging comparative effectiveness research. Little is known regarding comparative studies among children with cleft lip and/or palate. Cleft lip and/or palate profoundly influences self-perception and social functioning, and patient-reported outcomes provide a unique perspective on the success of reconstruction. The purpose of this study was to systematically review the literature regarding patient-reported outcomes among patients with cleft lip and/or palate. The authors reviewed articles from MEDLINE, Embase, and PsycInfo that examined the use of patient-reported outcome instruments for cleft lip and/or palate. Studies of patients with cleft lip and/or palate across any age that described the use of patient-completed measures in patient and control populations were included. A research librarian confirmed the search, and two independent, blinded reviewers performed full-text review. The authors identified 1979 articles and selected 30 for inclusion. Forty-two different assessment tools were used to analyze factors such as self-esteem, behavior, and social support. The Strengths and Difficulties Questionnaire was most commonly used (n = 7), followed by the Childhood Experience Questionnaire (n = 5), and the Satisfaction with Appearance survey (n = 4). Barriers to analysis included lack of standardization of survey administration, effect of publication bias, and variations in patient populations between individual studies. Comparative studies of patient-reported outcomes among patients with cleft lip and/or palate are infrequent. Many instruments exist to measure patient-reported outcomes in this population, but no specific standard exists. Identifying efficient and targeted forms of instrument selection and administration will enhance comparative studies among children with cleft lip and/or palate. Diagnostic, III.

  12. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials.

    Science.gov (United States)

    Kotronoulas, Grigorios; Kearney, Nora; Maguire, Roma; Harrow, Alison; Di Domenico, David; Croy, Suzanne; MacGillivray, Stephen

    2014-05-10

    The systematic use of patient-reported outcome measures (PROMs) has been advocated as an effective way to standardize cancer practice. Yet, the question of whether PROMs can lead to actual improvements in the quality of patient care remains under debate. This review examined whether inclusion of PROM in routine clinical practice is associated with improvements in patient outcomes, processes of care, and health service outcomes during active anticancer treatment. A systematic review of five electronic databases (Medline, EMBASE, CINAHL [Cumulative Index to Nursing and Allied Health Literature], PsycINFO, and Psychology and Behavioral Sciences Collection [PBSC]) was conducted from database inception to May 2012 to locate randomized and nonrandomized controlled trials of patients receiving active anticancer treatment or supportive care irrespective of type of cancer. Based on prespecified eligibility criteria, we included 26 articles that reported on 24 unique controlled trials. Wide variability in the design and use of interventions delivered, outcomes evaluated, and cancer- and modality-specific context was apparent. Health service outcomes were only scarcely included as end points. Overall, the number of statistically significant findings were limited and PROMs' intervention effect sizes were predominantly small-to-moderate. The routine use of PROMs increases the frequency of discussion of patient outcomes during consultations. In some studies, PROMs are associated with improved symptom control, increased supportive care measures, and patient satisfaction. Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health services usage.

  13. Do patient-reported outcomes (PROs have a role in the management of patients with cystic fibrosis?

    Directory of Open Access Journals (Sweden)

    Sam eSalek

    2012-03-01

    Full Text Available Background: Health-related quality of life (HRQoL is a rapidly growing area of expertise and the most commonly used patient-reported outcome (PRO. The impact of CF on HRQoL is liable to be great, making CF patients ideal candidates for the application of HRQoL instruments. The aims of this study were to assess the affect of CF on HRQoL, to ascertain the reliability and validity of the UKSIP and the CFQoL in the adult CF population, and to examine their role in the management of patients. Methods: Seventy participants were recruited from the All Wales Adult Cystic Fibrosis Centre at Llandough Hospital, UK. There were two stages to the study; self-report of the UKSIP and CFQoL in the first stage, and completion of the same two questionnaires seven to ten days later for the second stage. Results: The areas of HRQoL most impaired by CF were employment and concerns regarding the future. The UKSIP and CFQoL showed high internal consistency (rα=0.89-0.93 and test-retest reliability (rs=0.57-0.94, p<0.005 in the CF population. Validity was variable; with the UKSIP showing discrimination across socio-demographic factors, whilst the CFQoL showed increased sensitivity to clinical variables. Many parameters influenced patient-reported HRQoL, with the greatest correlations seen with the Borg score (p<0.005. The use of a HRQoL instrument in CF annual reviews is recommended to provide holistic patient care. The results of this study underpin the value of HRQoL as a patient-reported outcome measure in the management of adult CF.

  14. Patient-Reported Outcome questionnaires for hip arthroscopy: a systematic review of the psychometric evidence

    Science.gov (United States)

    2011-01-01

    Background Hip arthroscopies are often used in the treatment of intra-articular hip injuries. Patient-reported outcomes (PRO) are an important parameter in evaluating treatment. It is unclear which PRO questionnaires are specifically available for hip arthroscopy patients. The aim of this systematic review was to investigate which PRO questionnaires are valid and reliable in the evaluation of patients undergoing hip arthroscopy. Methods A search was conducted in Pubmed, Medline, CINAHL, the Cochrane Library, Pedro, EMBASE and Web of Science from 1931 to October 2010. Studies assessing the quality of PRO questionnaires in the evaluation of patients undergoing hip arthroscopy were included. The quality of the questionnaires was evaluated by the psychometric properties of the outcome measures. The quality of the articles investigating the questionnaires was assessed by the COSMIN list. Results Five articles identified three questionnaires; the Modified Harris Hip Score (MHHS), the Nonarthritic Hip Score (NAHS) and the Hip Outcome Score (HOS). The NAHS scored best on the content validity, whereas the HOS scored best on agreement, internal consistency, reliability and responsiveness. The quality of the articles describing the HOS scored highest. The NAHS is the best quality questionnaire. The articles describing the HOS are the best quality articles. Conclusions This systematic review shows that there is no conclusive evidence for the use of a single patient-reported outcome questionnaire in the evaluation of patients undergoing hip arthroscopy. Based on available psychometric evidence we recommend using a combination of the NAHS and the HOS for patients undergoing hip arthroscopy. PMID:21619610

  15. The development and validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the Acute Respiratory Tract Infection Questionnaire: ARTIQ

    DEFF Research Database (Denmark)

    Aabenhus, R.; Thorsen, H.; Siersma, V.

    2013-01-01

    OBJECTIVE: Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. METHODS: Qualitative...... interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model......, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care....

  16. Validation of Patient-Reported Outcomes Measurement Information System Computerized Adaptive Tests Against the Foot and Ankle Outcome Score for 6 Common Foot and Ankle Pathologies.

    Science.gov (United States)

    Koltsov, Jayme C B; Greenfield, Stephen T; Soukup, Dylan; Do, Huong T; Ellis, Scott J

    2017-08-01

    The field of foot and ankle surgery lacks a widely accepted gold-standard patient-reported outcome instrument. With the changing infrastructure of the medical profession, more efficient patient-reported outcome tools are needed to reduce respondent burden and increase participation while providing consistent and reliable measurement across multiple pathologies and disciplines. The primary purpose of the present study was to validate 3 Patient-Reported Outcomes Measurement Information System computer adaptive tests (CATs) most relevant to the foot and ankle discipline against the Foot and Ankle Outcome Score (FAOS) and the Short Form 12 general health status survey in patients with 6 common foot and ankle pathologies. Patients (n = 240) indicated for operative treatment for 1 of 6 common foot and ankle pathologies completed the CATs, FAOS, and Short Form 12 at their preoperative surgical visits, 1 week subsequently (before surgery), and at 6 months postoperatively. The psychometric properties of the instruments were assessed and compared. The Patient-Reported Outcomes Measurement Information System CATs each took less than 1 minute to complete, whereas the FAOS took 6.5 minutes, and the Short Form 12 took 3 minutes. CAT scores were more normally distributed and had fewer floor and ceiling effects than those on the FAOS, which reached as high as 24%. The CATs were more precise than the FAOS and had similar responsiveness and test-retest reliability. The physical function and mobility CATs correlated strongly with the activities subscale of the FAOS, and the pain interference CAT correlated strongly with the pain subscale of the FAOS. The CATs and FAOS were responsive to changes with operative treatment for 6 common foot and ankle pathologies. The CATs performed as well as or better than the FAOS in all aspects of psychometric validity. The Patient-Reported Outcomes Measurement Information System CATs show tremendous potential for improving the study of patient

  17. Outcomes important to burns patients during scar management and how they compare to the concepts captured in burn-specific patient reported outcome measures.

    Science.gov (United States)

    Jones, Laura L; Calvert, Melanie; Moiemen, Naiem; Deeks, Jonathan J; Bishop, Jonathan; Kinghorn, Philip; Mathers, Jonathan

    2017-12-01

    Pressure garment therapy (PGT) is an established treatment for the prevention and treatment of hypertrophic scarring; however, there is limited evidence for its effectiveness. Burn survivors often experience multiple issues many of which are not adequately captured in current PGT trial measures. To assess the effectiveness of PGT it is important to understand what outcomes matter to patients and to consider whether patient-reported outcome measures (PROMs) can be used to ascertain the effect of treatments on patients' health-related quality of life. This study aimed to (a) understand the priorities and perspectives of adult burns patients and the parents of burns patients who have experienced PGT via in-depth qualitative data, and (b) compare these with the concepts captured within burn-specific PROMs. We undertook 40 semi-structured interviews with adults and parents of paediatric and adolescent burns patients who had experienced PGT to explore their priorities and perspectives on scar management. Interviews were audio-recorded, transcribed and thematically analysed. The outcomes interpreted within the interview data were then mapped against the concepts captured within burn-specific PROMs currently in the literature. Eight core outcome domains were identified as important to adult patients and parents: (1) scar characteristics and appearance, (2) movement and function, (3) scar sensation, (4) psychological distress, adjustments and a sense of normality, (5) body image and confidence, (6) engagement in activities, (7) impact on relationships, and (8) treatment burden. The outcome domains presented reflect a complex holistic patient experience of scar management and treatments such as PGT. Some currently available PROMs do capture the concepts described here, although none assess psychological adjustments and attainment of a sense of normality following burn injury. The routine use of PROMs that represent patient experience and their relative contribution to trial

  18. Patient-reported outcome measures versus inertial performance-based outcome measures: A prospective study in patients undergoing primary total knee arthroplasty.

    Science.gov (United States)

    Bolink, S A A N; Grimm, B; Heyligers, I C

    2015-12-01

    Outcome assessment of total knee arthroplasty (TKA) by subjective patient reported outcome measures (PROMs) may not fully capture the functional (dis-)abilities of relevance. Objective performance-based outcome measures could provide distinct information. An ambulant inertial measurement unit (IMU) allows kinematic assessment of physical performance and could potentially be used for routine follow-up. To investigate the responsiveness of IMU measures in patients following TKA and compare outcomes with conventional PROMs. Patients with end stage knee OA (n=20, m/f=7/13; age=67.4 standard deviation 7.7 years) were measured preoperatively and one year postoperatively. IMU measures were derived during gait, sit-stand transfers and block step-up transfers. PROMs were assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Society Score (KSS). Responsiveness was calculated by the effect size, correlations were calculated with Spearman's rho correlation coefficient. One year after TKA, patients performed significantly better at gait, sit-to-stand transfers and block step-up transfers. Measures of time and kinematic IMU measures demonstrated significant improvements postoperatively for each performance-based test. The largest improvement was found in block step-up transfers (effect size=0.56-1.20). WOMAC function score and KSS function score demonstrated moderate correlations (Spearman's rho=0.45-0.74) with some of the physical performance-based measures pre- and postoperatively. To characterize the changes in physical function after TKA, PROMs could be supplemented by performance-based measures, assessing function during different activities and allowing kinematic characterization with an ambulant IMU. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. A content analysis of peripheral arterial disease patient-reported outcome measures using the International Classification of Functioning, Disability and Health.

    Science.gov (United States)

    Osborne, Candice Lee; Kauvar, David Seth

    2017-10-17

    The purpose of this study was to link, classify and describe the content of peripheral arterial disease (PAD)-specific patient-reported outcome measures using the International Classification of Functioning. The results were then analyzed to determine if these assessments provide clinicians and researchers with a comprehensive understanding of the lived experience of patients with PAD. Each meaningful concept in identified PAD assessments was linked to the International Classification of Functioning, Disability and Health to determine included and excluded content areas. An overall perspective was assigned to each assessment item. Inter-rater reliability was established using a kappa statistic. The body functions component is most frequently addressed overall followed by the activities and participation component. International Classification of Functioning chapter and category distribution vary greatly between assessments and no assessment comprehensively examines community participation and relationships. The majority of the assessment items are of the health status-disability and quality of life perspectives. The results of this study suggest the need for the development of a comprehensive PAD assessment that includes a more even distribution of International Classification of Functioning topics and subtopics. A more comprehensive assessment would better capture the lived experience of this patient population. Implications for Rehabilitation A better understanding of the data collected using the current peripheral arterial disease-specific patient-reported outcome measures may contribute to the development of more comprehensive assessment tools that will ultimately lead to improved patient care. This study contributes to the preliminary foundation for the development of a peripheral arterial disease International Classification of Functioning, Disability and Health Core Set. Clinicians and researchers interested in using peripheral arterial disease

  20. How patient outcomes are reported in drug advertisements.

    Science.gov (United States)

    Lexchin, J

    1999-05-01

    To examine how changes in outcomes are reported in drug advertisements in medical journals. Advertisements from a convenience sample of 38 issues of Canadian Family Physician, Canadian Journal of Anaesthesia, Canadian Journal of Psychiatry, Canadian Medical Association Journal, and the New England Journal of Medicine. Method of reporting changes in clinical outcomes (relative risk reduction [RRR], absolute risk reduction [ARR], number needed to treat [NNT]), name of product, and company marketing product were sought. In the 22 advertisements included in the analysis, 11 reported results as RRRs; two reported results as RRRs, but readers could calculate ARRs or NNTs from figures given in the advertisement; and nine gave no measure of results, but readers could calculate RRRs, ARRs, or NNTs from figures given. Most companies report changes in outcomes as RRRs, and this bias could influence the way physicians prescribe. Changes to the rules governing journal advertising and increased emphasis on critical appraisal skills would help mitigate this bias.

  1. Feasibility of 4 patient-reported outcome measures in a registry setting

    DEFF Research Database (Denmark)

    Paulsen, Aksel; Pedersen, Alma Becic; Overgaard, Søren

    2012-01-01

    Background and purpose Feasibility is an important parameter when choosing which patient-reported outcomes (PRO) to use in a study. We assessed the feasibility of PROs in a hip registry setting. Methods Primary total hip arthroplasty (THA) patients (n = 5,747) who had been operated on 1-2, 5.......1% to 46%, respectively. Missing items ranged from 1.2% to 3.4%, and 0.8-4.3% required manual validation (p analysis, depending on descriptive factor and choice of PRO. Interpretation All 4 PROs fulfilled...

  2. Are patient-reported outcomes predictive of patient satisfaction 5 years after anterior cervical spine surgery?

    Science.gov (United States)

    Schroeder, Gregory D; Coric, Dom; Kim, Han Jo; Albert, Todd J; Radcliff, Kris E

    2017-07-01

    Patient satisfaction is becoming an increasing common proxy for surgical quality; however, the correlation between patient satisfaction and surgical outcomes 2 and 5 years after anterior cervical surgery has not been evaluated. The study aimed to determine if patient satisfaction is predicted by improvement in patient-reported outcomes (PRO) 2 and 5 years after anterior cervical spine surgery. This is a retrospective analysis of prospectively collected data. The sample included patients enrolled in the Food and Drug Administration investigational device exemption clinical trial comparing total disc replacement with Mobi-C cervical artificial disc and anterior cervical discectomy and fusion. The outcome measures were visual analog scale (VAS) neck pain score, Neck Disability Index (NDI), and Short-Form 12-Item scores, as well as patient satisfaction. Receiver operating characteristic curves were used to determine if improvement in different PRO metrics can accurately identify patient satisfaction. Additionally, a logistic regression analysis was performed on the results at 24 months and 60 months to identify independent predictors of patient satisfaction. This research was supported by LDR (Zimmer Biomet) 13785 Research Boulevard - Suite 200 Austin, TX 78750. Data were available for 512 patients at 60 months. At 24 months postoperatively, NDI score improvement (area under the curve [AUC]=0.806), absolute NDI score (AUC=0.823), and absolute VAS neck pain score (AUC=0.808) were all excellent predictors of patient satisfaction. At 60 months postoperatively, NDI score improvement (AUC=0.815), absolute NDI score (AUC=0.839), VAS neck pain score improvement (AUC=0.803), and absolute VAS neck pain score (AUC=0.861) were all excellent predictors of patient satisfaction. In patients undergoing one- and two-level anterior cervical spine surgery, between 2 and 5 years postoperatively, patient satisfaction is significantly predicted by PROs, including the VAS neck score and the

  3. Case-mix & patients' reports of outcome in Independent Sector Treatment Centres: Comparison with NHS providers.

    Science.gov (United States)

    Browne, John; Jamieson, Liz; Lewsey, Jim; van der Meulen, Jan; Copley, Lynn; Black, Nick

    2008-04-09

    There has been considerable concern expressed about the outcomes achieved in Independent Sector Treatment Centres (ISTCs) introduced in England since 2003. Our aim was to compare the case-mix and patients' reported outcomes of surgery in ISTCs and in NHS providers. Prospective cohort study of 769 patients treated in six ISTCs and 1895 treated in 20 NHS providers (acute hospitals and treatment centres) in England during 2006-07. Participants underwent one of three day surgery procedures (inguinal hernia repair, varicose vein surgery, cataract extraction) or hip or knee replacement. Change in patient-reported health status and health related quality of life (measured using a disease-specific and a generic (EQ-5D) instrument) was assessed either 3-months (day surgery) or 6-months (hip/knee) after surgery. In addition patient-reported post-operative complications and an overall assessment of success of surgery were collected. Outcome measures were adjusted (using multivariable regression) for patient characteristics (disease severity, duration of symptoms, age, sex, socioeconomic status, general health, previous similar surgery, comorbidity). Post-operative response rates varied by procedure (73%-88%) and were similar for those treated in ISTCs and NHS facilities. Patients treated in ISTCs were healthier, were less likely to have any comorbidity and, for those undergoing cataract surgery or joint replacement, their primary condition was less severe. Those undergoing hernia repair or joint replacement were less likely to have had similar surgery before. When adjustment was made for pre-operative characteristics, patients undergoing cataract surgery or hip replacement in ISTCs achieved a slightly greater improvement in functional status and quality of life than those treated in NHS facilities, while the opposite was true of patients undergoing hernia repair. No significant differences were found for the two other procedures. Patients treated in ISTCs were less likely to

  4. Patient satisfaction and positive patient outcomes in ambulatory anesthesia

    Directory of Open Access Journals (Sweden)

    Shah U

    2015-04-01

    Full Text Available Ushma Shah, David T Wong, Jean Wong Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, ON, Canada Abstract: Most surgeries in North America are performed on an ambulatory basis, reducing health care costs and increasing patient comfort. Patient satisfaction is an important outcome indicator of the quality of health care services incorporated by the American Society of Anesthesiologists (ASA. Patient satisfaction is a complex concept that is influenced by multiple factors. A patient's viewpoint and knowledge plays an influential role in patient satisfaction with ambulatory surgery. Medical optimization and psychological preparation of the patient plays a pivotal role in the success of ambulatory surgery. Postoperative pain, nausea, and vomiting are the most important symptoms for the patient and can be addressed by multimodal drug regimens. Shared decision making, patient–provider relationship, communication, and continuity of care form the main pillars of patient satisfaction. Various psychometrically developed instruments are available to measure patient satisfaction, such as the Iowa Satisfaction with Anesthesia Scale and Evaluation du Vecu de I'Anesthesie Generale, but none have been developed specifically for ambulatory surgery. The ASA has made recommendations for data collection for patient satisfaction surveys and emphasized the importance of reporting the data to the Anesthesia Quality Institute. Future research is warranted to develop a validated tool to measure patient satisfaction in ambulatory surgery. Keywords: patient, satisfaction, anesthesia, outcomes, questionnaire, perspectives

  5. Relationship between patient-reported outcomes and clinical outcomes in metastatic castration-resistant prostate cancer: post hoc analysis of COU-AA-301 and COU-AA-302.

    Science.gov (United States)

    Cella, D; Traina, S; Li, T; Johnson, K; Ho, K F; Molina, A; Shore, N D

    2018-02-01

    Patient-reported outcomes (PROs) are used to assess benefit-risk in drug development. The relationship between PROs and clinical outcomes is not well understood. We aim to elucidate the relationships between changes in PRO measures and clinical outcomes in metastatic castration-resistant prostate cancer (mCRPC). We investigated relationships between changes in self-reported fatigue, pain, functional well-being (FWB), physical well-being (PWB) and prostate cancer-specific symptoms with overall survival (OS) and radiographic progression-free survival (rPFS) after 6 and 12 months of treatment in COU-AA-301 (N = 1195) or COU-AA-302 (N = 1088). Eligible COU-AA-301 patients had progressed after docetaxel and had Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2. Eligible COU-AA-302 patients had no prior chemotherapy and ECOG PS 0 or 1. Patients were treated with abiraterone acetate (1000 mg/day) plus prednisone (10 mg/day) or prednisone alone daily. Association between self-reported fatigue, pain and functional status, and OS and/or rPFS, using pooled data regardless of treatment, was assessed. Cox proportional hazard regression modeled time to death or radiographic progression. In COU-AA-301 patients, PRO improvements were associated with longer OS and longer time to radiographic progression versus worsening or stable PROs (P AA-302 patients, worsening PROs were associated with higher likelihood of radiographic progression (P ≤ 0.025) compared with improved or stable PROs. In multivariate models, worsening PWB remained associated with worse rPFS. The 12-month analysis confirmed the 6-month results. PROs are significantly associated with clinically relevant time-to-event efficacy outcomes in clinical trials and may complement and help predict traditional clinical practice methods for monitoring patients for disease progression. © The Author 2017. Published by Oxford University Press on behalf of the European Society for

  6. Evaluating test-retest reliability in patient-reported outcome measures for older people: A systematic review.

    Science.gov (United States)

    Park, Myung Sook; Kang, Kyung Ja; Jang, Sun Joo; Lee, Joo Yun; Chang, Sun Ju

    2018-03-01

    This study aimed to evaluate the components of test-retest reliability including time interval, sample size, and statistical methods used in patient-reported outcome measures in older people and to provide suggestions on the methodology for calculating test-retest reliability for patient-reported outcomes in older people. This was a systematic literature review. MEDLINE, Embase, CINAHL, and PsycINFO were searched from January 1, 2000 to August 10, 2017 by an information specialist. This systematic review was guided by both the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and the guideline for systematic review published by the National Evidence-based Healthcare Collaborating Agency in Korea. The methodological quality was assessed by the Consensus-based Standards for the selection of health Measurement Instruments checklist box B. Ninety-five out of 12,641 studies were selected for the analysis. The median time interval for test-retest reliability was 14days, and the ratio of sample size for test-retest reliability to the number of items in each measure ranged from 1:1 to 1:4. The most frequently used statistical methods for continuous scores was intraclass correlation coefficients (ICCs). Among the 63 studies that used ICCs, 21 studies presented models for ICC calculations and 30 studies reported 95% confidence intervals of the ICCs. Additional analyses using 17 studies that reported a strong ICC (>0.09) showed that the mean time interval was 12.88days and the mean ratio of the number of items to sample size was 1:5.37. When researchers plan to assess the test-retest reliability of patient-reported outcome measures for older people, they need to consider an adequate time interval of approximately 13days and the sample size of about 5 times the number of items. Particularly, statistical methods should not only be selected based on the types of scores of the patient-reported outcome measures, but should also be described clearly in

  7. Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

    Science.gov (United States)

    Santana, Maria J; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

    2015-07-01

    Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. Adult learning programs teaching clinicians

  8. The colostomy impact score: development and validation of a patient reported outcome measure for rectal cancer patients with a permanent colostomy. A population-based study.

    Science.gov (United States)

    Thyø, A; Emmertsen, K J; Pinkney, T D; Christensen, P; Laurberg, S

    2017-01-01

    The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment. In this population-based study, 610 patients with a permanent colostomy after previous rectal cancer treatment during the period 2001-2007 completed two questionnaires: (i) the basic stoma questionnaire consisting of 22 items about stoma function with one anchor question addressing the overall stoma impact on QOL and (ii) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Answers from half of the cohort were used to develop the score and subsequently validated on the remaining half. Logistic regression analyses identified and selected items for the score and multivariate analysis established the score value allocated to each item. The colostomy impact score includes seven items with a total range from 0 to 38 points. A score of ≥ 10 indicates major colostomy impact (Major CI). The score has a sensitivity of 85.7% for detecting patients with significant stoma impact on QOL. Using the EORTC QLQ scales, patients with Major CI experienced significant impairment in their QOL compared to the Minor CI group. This new scoring system appears valid for the assessment of the impact on QOL from having a permanent colostomy in a Danish rectal cancer population. It requires validation in non-Danish populations prior to its acceptance as a valuable patient-reported outcome measure for patients internationally. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

  9. Combining Clinical Information and Patient Reported Outcome Measures in Orthopaedic Surgery and Sports Medicine

    NARCIS (Netherlands)

    Kampen, D.A. van

    2013-01-01

    In this thesis we investigated the use of clinical information and Patient Reported Outcome Measures (PROMs) for patient evaluation in orthopaedic surgery and sports medicine. In the first part, we showed that the Dutch version of the Simple Shoulder Test (SST) is a valid and reliable

  10. Worse patient-reported outcome after lateral approach than after anterior and posterolateral approach in primary hip arthroplasty

    Science.gov (United States)

    Havelin, Leif I; Furnes, Ove; Baste, Valborg; Nordsletten, Lars; Hovik, Oystein; Dimmen, Sigbjorn

    2014-01-01

    Background The surgical approach in total hip arthroplasty (THA) is often based on surgeon preference and local traditions. The anterior muscle-sparing approach has recently gained popularity in Europe. We tested the hypothesis that patient satisfaction, pain, function, and health-related quality of life (HRQoL) after THA is not related to the surgical approach. Patients 1,476 patients identified through the Norwegian Arthroplasty Register were sent questionnaires 1–3 years after undergoing THA in the period from January 2008 to June 2010. Patient-reported outcome measures (PROMs) included the hip disability osteoarthritis outcome score (HOOS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), health-related quality of life (EQ-5D-3L), visual analog scales (VAS) addressing pain and satisfaction, and questions about complications. 1,273 patients completed the questionnaires and were included in the analysis. Results Adjusted HOOS scores for pain, other symptoms, activities of daily living (ADL), sport/recreation, and quality of life were significantly worse (p < 0.001 to p = 0.03) for the lateral approach than for the anterior approach and the posterolateral approach (mean differences: 3.2–5.0). These results were related to more patient-reported limping with the lateral approach than with the anterior and posterolateral approaches (25% vs. 12% and 13%, respectively; p < 0.001). Interpretation Patients operated with the lateral approach reported worse outcomes 1–3 years after THA surgery. Self-reported limping occurred twice as often in patients who underwent THA with a lateral approach than in those who underwent THA with an anterior or posterolateral approach. There were no significant differences in patient-reported outcomes after THA between those who underwent THA with a posterolateral approach and those who underwent THA with an anterior approach. PMID:24954494

  11. Life after endometrial cancer: A systematic review of patient-reported outcomes.

    Science.gov (United States)

    Shisler, Robert; Sinnott, Jennifer A; Wang, Vivian; Hebert, Courtney; Salani, Ritu; Felix, Ashley S

    2018-02-01

    Women with endometrial cancer (EC) are the second largest population of female cancer survivors in the United States. However, the outcomes of EC survivors, from the patient perspective, are not well-understood. Therefore, we conducted a systematic review of patient-reported outcomes (PROs) following an EC diagnosis. We searched MEDLINE, EMBASE, Scopus, CINAHL, and reference lists to identify published observational studies that examined PROs among women with EC. Reviewers independently reviewed eligible full-text study articles and conducted data extraction. We qualitatively summarized included articles according to exposures [e.g. body mass index (BMI), treatment, etc.] or specific PROs (e.g. sexual function). Of 1722 unique studies, 102 full-text articles were reviewed, of which a total of 27 studies fulfilled the inclusion criteria. The most commonly used PRO questionnaires were the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (n=9), Short Form 36 Questionnaire (SF-36, n=8), the Functional Assessment of Cancer Therapy-General (FACT-G, n=5), and the Female Sexual Function Index (FSFI, n=4). Obesity was associated with lower quality of life (QOL) and physical functioning. Treatment type affected several outcomes. Laparoscopy generally resulted in better QOL outcomes than laparotomy. Likewise, vaginal brachytherapy was associated with better outcomes compared to external beam radiation. Sexual function outcomes were dependent on age, time since diagnosis, and having consulted a physician before engaging in sexual activities. In addition, a physical activity intervention was associated with improved sexual interest but not sexual function. Our review provides insight into the experience of EC survivors from the patient perspective. Factors that contribute to QOL, such as pain, fatigue, emotional and social functioning, should be monitored following an EC diagnosis. Copyright © 2017 Elsevier Inc

  12. Systematic Review of Radiation Therapy Toxicity Reporting in Randomized Controlled Trials of Rectal Cancer: A Comparison of Patient-Reported Outcomes and Clinician Toxicity Reporting

    Energy Technology Data Exchange (ETDEWEB)

    Gilbert, Alexandra, E-mail: a.gilbert@leeds.ac.uk [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom); Ziegler, Lucy; Martland, Maisie [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom); Davidson, Susan [The Christie Hospital, Manchester (United Kingdom); Efficace, Fabio [Italian Group for Adult Hematologic Diseases, Rome (Italy); Sebag-Montefiore, David; Velikova, Galina [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom)

    2015-07-01

    The use of multimodal treatments for rectal cancer has improved cancer-related outcomes but makes monitoring toxicity challenging. Optimizing future radiation therapy regimens requires collection and publication of detailed toxicity data. This review evaluated the quality of toxicity information provided in randomized controlled trials (RCTs) of radiation therapy in rectal cancer and focused on the difference between clinician-reported and patient-reported toxicity. Medline, EMBASE, and the Cochrane Library were searched (January 1995-July 2013) for RCTs reporting late toxicity in patients treated with regimens including preoperative (chemo)radiation therapy. Data on toxicity measures and information on toxicity reported were extracted using Quantitative Analyses of Normal Tissue Effects in the Clinic recommendations. International Society for Quality of Life Research standards on patient-reported outcomes (PROs) were used to evaluate the quality of patient-reported toxicity. Twenty-one RCT publications met inclusion criteria out of 4144 articles screened. All PRO studies reported higher rates of toxicity symptoms than clinician-reported studies and reported on a wider range and milder symptoms. No clinician-reported study published data on sexual dysfunction. Of the clinician-reported studies, 55% grouped toxicity data related to an organ system together (eg “Bowel”), and 45% presented data only on more-severe (grade ≥3) toxicity. In comparison, all toxicity grades were reported in 79% of PRO publications, and all studies (100%) presented individual symptom toxicity data (eg bowel urgency). However, PRO reporting quality was variable. Only 43% of PRO studies presented baseline data, 28% did not use any psychometrically validated instruments, and only 29% of studies described statistical methods for managing missing data. Analysis of these trials highlights the lack of reporting standards for adverse events and reveals the differences between clinician and

  13. The early development phases of a European Organisation for Research and Treatment of Cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction.

    Science.gov (United States)

    Thomson, H J; Winters, Z E; Brandberg, Y; Didier, F; Blazeby, J M; Mills, J

    2013-03-01

    A comprehensive evaluation of breast reconstruction (BRR) surgery includes measurement of patient reported outcomes (PROs). There is, however, a lack of validated BRR-specific PRO measures (PROMs) that adequately assess relevant issues. This study is developing a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire/module specific for PROs in BRR to supplement the cancer-core and breast cancer EORTC questionnaires, respectively: the QLQ-C30 and QLQ-BR23. Phases I and II of questionnaire development followed EORTC guidelines including a systematic literature review to identify all potential 'issues' (concepts relevant to PROs) and semi-structured interviews with 89 patients and 9 European multi-disciplinary health care professionals (HCPs) (Sweden, Italy and the United Kingdom [UK]). Interviewers asked participants the 'relevance' of outcomes identified in the literature and captured additional 'issues' of importance. The literature search and interviews of patients and HCPs yielded 69 issues relating to BRR operationalised into 31 provisional items (single questions) for the module, which was conceptualised to contain five scales: treatment/surgery related symptoms (affecting the shoulder, arm and reconstructed breast), body image, sexuality, cosmetic outcomes (pertaining to three areas: breast, donor site and nipple) and overall satisfaction. The provisional development of the EORTC BRR module has 31 items addressing issues of importance to patients as well as HCPs. Further international testing is underway as a UK National Cancer Research Network trial to ensure that this PROM will be psychometrically and clinically robust and applicable for use in clinical trials, cohort studies, national audit and clinical practice. Copyright © 2012 Elsevier Ltd. All rights reserved.

  14. The usefulness of a mobile device-based system for patient-reported outcomes in a spine outpatient clinic.

    Science.gov (United States)

    Kim, Chi Heon; Chung, Chun Kee; Choi, Yunhee; Shin, HyunJeong; Woo, Ji Won; Kim, Sung-Mi; Lee, Hyuk-Joon

    2016-07-01

    Patient-reported outcomes (PROs) are typically collected using a paper form, but this format is cumbersome to incorporate into outpatient clinic visits as well as in research. Therefore, we developed a mobile device-based system (mobile system) for spinal PRO. We hypothesized that this system may improve the quality of care in an outpatient clinic. This study aimed to analyze the patient-reported efficacy of a mobile system through a survey of patients' responses compared with a paper system. A prospective observational study was carried out. Surveys were conducted for 103 patients who had experience using both the paper and electronic systems in the outpatient clinic. Patient-reported positive response score (PRS) was the outcome measure. The survey included the characteristics of the patients (sex, age, use of smartphone, familiarity with smartphone applications, proficiency of typing with mobile device, site of pain, and education level) and eight questions in four domains: (1) efficacy in the waiting room, (2) efficacy during the clinic visit, (3) overall satisfaction, and (4) opinion about the use of this system. The response to each question was scored from 1 to 5 (1, negative; 5, positive response). The patient-reported PRS was calculated by adding the scores of the 8 questions and converting the total range to 0-100 (60, neutral). The mean PRS of the 8 questions was 79.8 (95% CI, 76.7-83.9). The mean PRS was 78.9 (75.6-82.2) at the waiting room and was 80.5 (77.1-83.9) during the clinic. The PRS for overall satisfaction and use of this system were 83.3 (79.6-87.0) and 77.1 (71.9-82.3), respectively. The use of smartphones and the proficiency of typing were independently significant predictors of PRS with an R(2) value of 0.325. The mobile device-based system improved the patient-reported efficacy in spine outpatient clinics. However, various factors such as the use of smartphones need to be considered when developing and applying mobile systems. Copyright

  15. Laparoscopic Heller Myotomy vs Per Oral Endoscopic Myotomy: Patient-Reported Outcomes at a Single Institution.

    Science.gov (United States)

    Hanna, Andrew N; Datta, Jashodeep; Ginzberg, Sara; Dasher, Kevin; Ginsberg, Gregory G; Dempsey, Daniel T

    2018-04-01

    Although laparoscopic Heller myotomy (LHM) has been the standard of care for achalasia, per oral endoscopic myotomy (POEM) has gained popularity as a viable alternative. This retrospective study aimed to compare patient-reported outcomes between LHM and POEM in a consecutive series of achalasia patients with more than 1 year of follow-up. We reviewed demographic and procedure-related data for patients who underwent either LHM or POEM for achalasia between January 2011 and May 2016. Phone interviews were conducted assessing post-procedure achalasia symptoms via the Eckardt score and achalasia severity questionnaire (ASQ). Demographics, disease factors, and survey results were compared between LHM and POEM patients using univariate analysis. Significant predictors of procedure failure were analyzed using univariate and multivariate analysis. There were no serious complications in 110 consecutive patients who underwent LHM or POEM during the study period, and 96 (87%) patients completed phone surveys. There was a nonsignificant trend toward better patient-reported outcomes with POEM. There were significant differences in patient characteristics including sex, achalasia type, mean residual lower esophageal pressure (rLESP), and follow-up time. The only univariate predictors of an unsatisfactory Eckardt score or ASQ were longer follow-up and lower rLESP, with follow-up length being the only predictor on multivariate analysis. There were significant demographic and clinical differences in patient selection for POEM vs LHM in our group. Although the 2 procedures have similar patient-reported effectiveness, subjective outcomes seem to decline as a result of time rather than procedure type. Copyright © 2018 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  16. Patient-reported outcome 2 years after lung transplantation: does the underlying diagnosis matter?

    Directory of Open Access Journals (Sweden)

    Ghosh S

    2012-11-01

    moderate disability, while pulmonary fibrosis and pulmonary arterial hypertension patients displayed severe disability. Patients with chronic obstructive pulmonary disease had the worst pain level, whereas patients with pulmonary fibrosis had the worst emotion and cognition levels. A random-effect model confirmed that development of broncholitis obliterans syndrome was the most important determinant of health status (P = 0.03 compared to other variables, such as cytomegalovirus infections and underlying diagnoses.Conclusion: Descriptions of patients’ HRQL among different diagnosis groups could be used by clinicians to assist individualized patient care.Keywords: patient-reported outcomes, health-related quality of life measures, underlying diagnoses in lung transplant recipients, health utilities index

  17. Development, content validity, and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome.

    Science.gov (United States)

    Vork, L; Keszthelyi, D; Mujagic, Z; Kruimel, J W; Leue, C; Pontén, I; Törnblom, H; Simrén, M; Albu-Soda, A; Aziz, Q; Corsetti, M; Holvoet, L; Tack, J; Rao, S S; van Os, J; Quetglas, E G; Drossman, D A; Masclee, A A M

    2018-03-01

    End-of-day questionnaires, which are considered the gold standard for assessing abdominal pain and other gastrointestinal (GI) symptoms in irritable bowel syndrome (IBS), are influenced by recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments in the natural state and environment of a subject, and herewith overcomes these limitations. This report describes the development of a patient-reported outcome measure (PROM) based on the ESM principle, taking into account content validity and cross-cultural adaptation. Focus group interviews with IBS patients and expert meetings with international experts in the fields of neurogastroenterology & motility and pain were performed in order to select the items for the PROM. Forward-and-back translation and cognitive interviews were performed to adapt the instrument for the use in different countries and to assure on patients' understanding with the final items. Focus group interviews revealed 42 items, categorized into five domains: physical status, defecation, mood and psychological factors, context and environment, and nutrition and drug use. Experts reduced the number of items to 32 and cognitive interviewing after translation resulted in a few slight adjustments regarding linguistic issues, but not regarding content of the items. An ESM-based PROM, suitable for momentary assessment of IBS symptom patterns was developed, taking into account content validity and cross-cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow. © 2017 John Wiley & Sons Ltd.

  18. Reported outcomes of 453 pregnancies in patients with Gaucher disease: An analysis from the Gaucher outcome survey.

    Science.gov (United States)

    Lau, Heather; Belmatoug, Nadia; Deegan, Patrick; Goker-Alpan, Ozlem; Schwartz, Ida Vanessa D; Shankar, Suma P; Panahloo, Zoya; Zimran, Ari

    2018-02-01

    Gaucher disease (GD) may worsen during pregnancy, leading to the discussion of continuing treatment during pregnancy. We examined fetal outcomes of pregnancies reported in the Gaucher Outcome Survey, an international GD-specific registry established in 2010. A total of 453 pregnancies were reported. Most pregnancies (336/453, 74.2%) were in women who did not receive GD-specific treatment during pregnancy, while enzyme replacement therapy (ERT) was received during 117/453 (25.8%) pregnancies. No pregnancies exposed to substrate reduction therapy were reported. The percentage of normal outcomes (live birth delivered at term with no congenital abnormalities) was similar in untreated and treated pregnancies (92.9% vs. 91.4%). The percentage of spontaneous abortions in untreated pregnancies was 3.6% (95% CI, 1.9%- 6.2%) compared with 6.9% (95% CI, 3.0%-13.1%) in treated pregnancies (p=0.1866). In women who received velaglucerase alfa <1month prior to conception and/or during pregnancy, 34/36 (94.4%) pregnancies had normal outcomes and 2 (5.6%) ended in spontaneous abortion. Normal outcomes were observed in the 20 pregnancies with velaglucerase alfa exposure starting <1month prior to conception and continuing through all trimesters. These observations, in addition to information in the literature, suggest that continuation of ERT during pregnancy may be appropriate for GD patients. Copyright © 2016 Shire Human Genetic Therapies, Inc. Published by Elsevier Inc. All rights reserved.

  19. Case-mix & patients' reports of outcome in Independent Sector Treatment Centres: Comparison with NHS providers

    Directory of Open Access Journals (Sweden)

    van der Meulen Jan

    2008-04-01

    Full Text Available Abstract Background There has been considerable concern expressed about the outcomes achieved in Independent Sector Treatment Centres (ISTCs introduced in England since 2003. Our aim was to compare the case-mix and patients' reported outcomes of surgery in ISTCs and in NHS providers. Methods Prospective cohort study of 769 patients treated in six ISTCs and 1895 treated in 20 NHS providers (acute hospitals and treatment centres in England during 2006–07. Participants underwent one of three day surgery procedures (inguinal hernia repair, varicose vein surgery, cataract extraction or hip or knee replacement. Change in patient-reported health status and health related quality of life (measured using a disease-specific and a generic (EQ-5D instrument was assessed either 3-months (day surgery or 6-months (hip/knee after surgery. In addition patient-reported post-operative complications and an overall assessment of success of surgery were collected. Outcome measures were adjusted (using multivariable regression for patient characteristics (disease severity, duration of symptoms, age, sex, socioeconomic status, general health, previous similar surgery, comorbidity. Results Post-operative response rates varied by procedure (73%–88% and were similar for those treated in ISTCs and NHS facilities. Patients treated in ISTCs were healthier, were less likely to have any comorbidity and, for those undergoing cataract surgery or joint replacement, their primary condition was less severe. Those undergoing hernia repair or joint replacement were less likely to have had similar surgery before. When adjustment was made for pre-operative characteristics, patients undergoing cataract surgery or hip replacement in ISTCs achieved a slightly greater improvement in functional status and quality of life than those treated in NHS facilities, while the opposite was true of patients undergoing hernia repair. No significant differences were found for the two other

  20. The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative

    NARCIS (Netherlands)

    J. Alonso (Jordi); S.J. Bartlett (Susan); M. Rose (Matthias); N.K. Aaronson (Neil); J.E. Chaplin (John); F. Efficace (Fabio); A. Leplège (Alain); A. LU (Aiping); D.S. Tulsky (David); H. Raat (Hein); U. Ravens-Sieberer (Ulrike); D. Revicki (Dennis); C.B. Terwee (Caroline); J.M. Valderas (Jose); D. Cella (David); C.B. Forrest (Christopher)

    2013-01-01

    textabstractPatient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often

  1. Phelan-McDermid syndrome data network: Integrating patient reported outcomes with clinical notes and curated genetic reports.

    Science.gov (United States)

    Kothari, Cartik; Wack, Maxime; Hassen-Khodja, Claire; Finan, Sean; Savova, Guergana; O'Boyle, Megan; Bliss, Geraldine; Cornell, Andria; Horn, Elizabeth J; Davis, Rebecca; Jacobs, Jacquelyn; Kohane, Isaac; Avillach, Paul

    2017-09-01

    The heterogeneity of patient phenotype data are an impediment to the research into the origins and progression of neuropsychiatric disorders. This difficulty is compounded in the case of rare disorders such as Phelan-McDermid Syndrome (PMS) by the paucity of patient clinical data. PMS is a rare syndromic genetic cause of autism and intellectual deficiency. In this paper, we describe the Phelan-McDermid Syndrome Data Network (PMS_DN), a platform that facilitates research into phenotype-genotype correlation and progression of PMS by: a) integrating knowledge of patient phenotypes extracted from Patient Reported Outcomes (PRO) data and clinical notes-two heterogeneous, underutilized sources of knowledge about patient phenotypes-with curated genetic information from the same patient cohort and b) making this integrated knowledge, along with a suite of statistical tools, available free of charge to authorized investigators on a Web portal https://pmsdn.hms.harvard.edu. PMS_DN is a Patient Centric Outcomes Research Initiative (PCORI) where patients and their families are involved in all aspects of the management of patient data in driving research into PMS. To foster collaborative research, PMS_DN also makes patient aggregates from this knowledge available to authorized investigators using distributed research networks such as the PCORnet PopMedNet. PMS_DN is hosted on a scalable cloud based environment and complies with all patient data privacy regulations. As of October 31, 2016, PMS_DN integrates high-quality knowledge extracted from the clinical notes of 112 patients and curated genetic reports of 176 patients with preprocessed PRO data from 415 patients. © 2017 The Authors. American Journal of Medical Genetics Part B: Neuropsychiatric Genetics Published by Wiley Periodicals, Inc.

  2. Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review.

    Science.gov (United States)

    Gaudry, Stéphane; Messika, Jonathan; Ricard, Jean-Damien; Guillo, Sylvie; Pasquet, Blandine; Dubief, Emeline; Boukertouta, Tanissia; Dreyfuss, Didier; Tubach, Florence

    2017-12-01

    Intensivists' clinical decision making pursues two main goals for patients: to decrease mortality and to improve quality of life and functional status in survivors. Patient-important outcomes are gaining wide acceptance in most fields of clinical research. We sought to systematically review how well patient-important outcomes are reported in published randomized controlled trials (RCTs) in critically ill patients. Literature search was conducted to identify eligible trials indexed from January to December 2013. Articles were eligible if they reported an RCT involving critically ill adult patients. We excluded phase II, pilot and physiological crossover studies. We assessed study characteristics. All primary and secondary outcomes were collected, described and classified using six categories of outcomes including patient-important outcomes (involving mortality at any time on the one hand and quality of life, functional/cognitive/neurological outcomes assessed after ICU discharge on the other). Of the 716 articles retrieved in 2013, 112 RCTs met the inclusion criteria. Most common topics were mechanical ventilation (27%), sepsis (19%) and nutrition (17%). Among the 112 primary outcomes, 27 (24%) were patient-important outcomes (mainly mortality, 21/27) but only six (5%) were patient-important outcomes besides mortality assessed after ICU discharge (functional disability = 4; quality of life = 2). Among the 598 secondary outcomes, 133 (22%) were patient-important outcomes (mainly mortality, 92/133) but only 41 (7%) were patient-important outcomes besides mortality assessed after ICU discharge (quality of life = 20, functional disability = 14; neurological/cognitive performance = 5; handicap = 1; post-traumatic stress = 1). Seventy-three RCTs (65%) reported at least one patient-important outcome but only 11 (10%) reported at least one patient-important outcome besides mortality assessed after ICU discharge. Patient-important outcomes are rarely primary

  3. Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Kocks JWH

    2013-06-01

    Full Text Available Jan Willem H Kocks,1,2 Jan Willem K van den Berg,3 Huib AM Kerstjens,2,4 Steven M Uil,3 Judith M Vonk,2,5 Ynze P de Jong,3 Ioanna G Tsiligianni,1,2 Thys van der Molen1,2 1Department of General Practice, 2Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Center Groningen, Groningen, 3Department of Pulmonary Diseases, Isala Klinieken, Zwolle, 4Department of Pulmonary Diseases and Tuberculosis, 5Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands Background: Exacerbations of chronic obstructive pulmonary disease (COPD are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods: Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ, and the St George's Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results: All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found

  4. Feasibility of the collection of patient-reported outcomes in an ambulatory neurology clinic.

    Science.gov (United States)

    Moura, Lidia M V R; Schwamm, Eli; Moura Junior, Valdery; Seitz, Michael P; Hsu, John; Cole, Andrew J; Schwamm, Lee H

    2016-12-06

    To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p Neurology.

  5. A Systematic Review of Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Knee Arthroplasty.

    Science.gov (United States)

    Gagnier, Joel J; Mullins, Megan; Huang, Hsiaomin; Marinac-Dabic, Danica; Ghambaryan, Anna; Eloff, Benjamin; Mirza, Faisal; Bayona, Manuel

    2017-05-01

    While clinical research on total knee arthroplasty (TKA) outcomes is prevalent in the literature, studies often have poor methodological and reporting quality. A high-quality patient-reported outcome instrument is reliable, valid, and responsive. Many studies evaluate these properties, but none have done so with a systematic and accepted method. The objectives of this study were to identify patient-reported outcome measures (PROMs) for TKA, and to critically appraise, compare, and summarize their psychometric properties using accepted methods. MEDLINE, EMBASE, SCOPUS, Web of Science, PsycINFO, and SPORTDiscus were systematically searched for articles with the following inclusion criteria: publication before December 2014, English language, non-generic PRO, and evaluation in the TKA population. Methodological quality and evidence of psychometric properties were assessed with the COnsensus-based standards for the selection of health Status Measurement INstruments (COSMIN) checklist and criteria for psychometric evidence proposed by the COSMIN group and Terwee et al. One-hundred fifteen studies on 32 PROMs were included in this review. Only the Work, Osteoarthritis or joint-Replacement Questionnaire, the Oxford Knee Score, and the Western Ontario and McMaster Universities Arthritis Index had 4 or more properties with positive evidence. Most TKA PROMs have limited evidence for their psychometric properties. Although not all the properties were studied, the Work, Osteoarthritis or joint-Replacement Questionnaire, with the highest overall ratings, could be a useful PROM for evaluating patients undergoing TKA. The methods and reporting of this literature can improve by following accepted guidelines. Published by Elsevier Inc.

  6. Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting

    Directory of Open Access Journals (Sweden)

    Armitage Gerry

    2011-05-01

    Full Text Available Abstract Background Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS, and a patient incident reporting tool (PIRT - to help the NHS prevent patient safety incidents by learning more about when and why they occur. Methods To develop the PMOS 1 literature will be reviewed to identify similar measures and key contributory factors to error; 2 four patient focus groups will ascertain practicality and feasibility; 3 25 patient interviews will elicit approximately 60 items across 10 domains; 4 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis. To develop the PIRT 1 individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2 nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50 will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their

  7. The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative

    NARCIS (Netherlands)

    Alonso, J.; Bartlett, S.J.; Rose, M.; Aaronson, N.K.; Chaplin, J.; Efficace, F.; Leplège, A.; Aiping, L.U.; Tulsky, D.S.; Raat, H.; Ravens-Sieberer, U.; Revicki, D.; Terwee, C.B.; Valderas, J.M.; Cella, D.; Forrest, C.B.

    2013-01-01

    Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in

  8. Data collection of patient outcomes: one institution's experience.

    Science.gov (United States)

    Whitaker, Thomas J; Mayo, Charles S; Ma, Daniel J; Haddock, Michael G; Miller, Robert C; Corbin, Kimberly S; Neben-Wittich, Michelle; Leenstra, James L; Laack, Nadia N; Fatyga, Mirek; Schild, Steven E; Vargas, Carlos E; Tzou, Katherine S; Hadley, Austin R; Buskirk, Steven J; Foote, Robert L

    2018-03-01

    Patient- and provider-reported outcomes are recognized as important in evaluating quality of care, guiding health care policy, comparative effectiveness research, and decision-making in radiation oncology. Combining patient and provider outcome data with a detailed description of disease and therapy is the basis for these analyses. We report on the combination of technical solutions and clinical process changes at our institution that were used in the collection and dissemination of this data. This initiative has resulted in the collection of treatment data for 23 541 patients, 20 465 patients with provider-based adverse event records, and patient-reported outcome surveys submitted by 5622 patients. All of the data is made accessible using a self-service web-based tool.

  9. Development of a functional, internet-accessible department of surgery outcomes database.

    Science.gov (United States)

    Newcomb, William L; Lincourt, Amy E; Gersin, Keith; Kercher, Kent; Iannitti, David; Kuwada, Tim; Lyons, Cynthia; Sing, Ronald F; Hadzikadic, Mirsad; Heniford, B Todd; Rucho, Susan

    2008-06-01

    The need for surgical outcomes data is increasing due to pressure from insurance companies, patients, and the need for surgeons to keep their own "report card". Current data management systems are limited by inability to stratify outcomes based on patients, surgeons, and differences in surgical technique. Surgeons along with research and informatics personnel from an academic, hospital-based Department of Surgery and a state university's Department of Information Technology formed a partnership to develop a dynamic, internet-based, clinical data warehouse. A five-component model was used: data dictionary development, web application creation, participating center education and management, statistics applications, and data interpretation. A data dictionary was developed from a list of data elements to address needs of research, quality assurance, industry, and centers of excellence. A user-friendly web interface was developed with menu-driven check boxes, multiple electronic data entry points, direct downloads from hospital billing information, and web-based patient portals. Data were collected on a Health Insurance Portability and Accountability Act-compliant server with a secure firewall. Protected health information was de-identified. Data management strategies included automated auditing, on-site training, a trouble-shooting hotline, and Institutional Review Board oversight. Real-time, daily, monthly, and quarterly data reports were generated. Fifty-eight publications and 109 abstracts have been generated from the database during its development and implementation. Seven national academic departments now use the database to track patient outcomes. The development of a robust surgical outcomes database requires a combination of clinical, informatics, and research expertise. Benefits of surgeon involvement in outcomes research include: tracking individual performance, patient safety, surgical research, legal defense, and the ability to provide accurate information

  10. If patient-reported outcome measures are considered key health-care quality indicators, who is excluded from participation?

    Science.gov (United States)

    Kroll, Thilo; Wyke, Sally; Jahagirdar, Deepa; Ritchie, Karen

    2014-10-01

    Patient-reported outcome measures have received increasing attention with regard to ensuring quality improvement across the health service. However, there is a risk that people with disabilities and low literacy are systematically excluded from the development of these measures as well as their application in clinical practice. This editorial highlights some of these risks and the potential consequences of exclusion for these groups. © 2012 John Wiley & Sons Ltd.

  11. Clinical and patient reported outcomes of bleaching effectiveness.

    Science.gov (United States)

    Klaric Sever, Eva; Budimir, Zrinka; Cerovac, Matea; Stambuk, Mario; Par, Matej; Negovetic Vranic, Dubravka; Tarle, Zrinka

    2018-01-01

    The objective of this study is to evaluate clinical and patient reported outcomes of different bleaching products. Thirty participants were randomly divided into three bleaching groups (n = 10). Bleaching was performed with high concentrations of hydrogen peroxide (HP) - Boost (40%) and Dash (30%), and with prefabricated splints Bite&White (6% HP). Tooth colour was measured before, immediately after, and 1 and 6 months after the bleaching by using classical shade guide and spectrophotometer. Tooth hypersensitivity was self-rated by patients on the Wong-Baker's face scale. Patient satisfaction was evaluated on a 7-point Likert-type scales that measured perceived performance and importance of different characteristics of bleaching treatment. All products were effective in teeth colour change (ΔE > 3.3), which was significantly higher for Boost (p = .016) and Dash (p = .024) than Bite&White treatment. Perception of hypersensitivity was the highest in Boost group, followed by Dash and Bite&White treatment. Most of the patients were satisfied with final tooth colour, length and comfort during treatment, but were dissatisfied with the stability of bleached tooth colour. Materials with the higher concentrations of bleaching agent demonstrated greater bleaching effectiveness than at-home bleaching product, but also a greater hypersensitivity. Lengthening the treatment process, but achieving a more stable tooth colour may improve the perceived value of a bleaching service.

  12. Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) questionnaire: a new patient-reported outcome instrument for PAH.

    Science.gov (United States)

    McCollister, Deborah; Shaffer, Shannon; Badesch, David B; Filusch, Arthur; Hunsche, Elke; Schüler, René; Wiklund, Ingela; Peacock, Andrew

    2016-06-14

    Regulators and clinical experts increasingly recognize the importance of incorporating patient-reported outcomes (PROs) in clinical studies of therapies for pulmonary arterial hypertension (PAH). No PAH-specific instruments have been developed to date in accordance with the 2009 FDA guidance for the development of PROs as endpoints in clinical trials. A qualitative research study was conducted to develop a new instrument assessing PAH symptoms and their impacts following the FDA PRO guidance. A cross-sectional study was conducted at 5 centers in the US in symptomatic PAH patients aged 18-80 years. Concept elicitation was based on 5 focus group discussions, after which saturation of emergent concepts was reached. A PRO instrument for PAH symptoms and their impacts was drafted. To assess the appropriateness of items, instructions, response options, and recall periods, 2 rounds of one-on-one cognitive interviews were conducted, with instrument revisions following each round. Additional interviews tested the usability of an electronic version (ePRO). PRO development considered input from an international Steering Committee, and translatability and lexibility assessments. Focus groups comprised 25 patients (5 per group); 20 additional patients participated in cognitive interviews (10 per round); and 10 participated in usability interviews. Participants had a mean ± SD age of 53.1 ± 15.8 years, were predominantly female (93 %), and were diverse in race/ethnicity, WHO functional class (FC I/II: 56 %, III/IV: 44 %), and PAH etiology (idiopathic: 56 %, familial: 2 %, associated: 42 %). The draft PRO instrument (PAH-SYMPACT®) was found to be clear, comprehensive, and relevant to PAH patients in cognitive interviews. Items were organized in a draft conceptual framework with 16 symptom items in 4 domains (respiratory symptoms, tiredness, cardiovascular symptoms, other symptoms) and 25 impact items in 5 domains (physical activities, daily activities, social

  13. Overview of Classical Test Theory and Item Response Theory for Quantitative Assessment of Items in Developing Patient-Reported Outcome Measures

    Science.gov (United States)

    Cappelleri, Joseph C.; Lundy, J. Jason; Hays, Ron D.

    2014-01-01

    Introduction The U.S. Food and Drug Administration’s patient-reported outcome (PRO) guidance document defines content validity as “the extent to which the instrument measures the concept of interest” (FDA, 2009, p. 12). “Construct validity is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity” (Strauss & Smith, 2009, p. 7). Hence both qualitative and quantitative information are essential in evaluating the validity of measures. Methods We review classical test theory and item response theory approaches to evaluating PRO measures including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized “difficulty” (severity) order of items is represented by observed responses. Conclusion Classical test theory and item response theory can be useful in providing a quantitative assessment of items and scales during the content validity phase of patient-reported outcome measures. Depending on the particular type of measure and the specific circumstances, either one or both approaches should be considered to help maximize the content validity of PRO measures. PMID:24811753

  14. Barriers to antiretroviral therapy adherence in developed countries: a qualitative synthesis to develop a conceptual framework for a new patient-reported outcome measure.

    Science.gov (United States)

    Engler, Kim; Lènàrt, Andras; Lessard, David; Toupin, Isabelle; Lebouché, Bertrand

    2018-05-02

    Suboptimal adherence to antiretroviral therapy (ART) remains common. Patient-centered tools are needed to comprehensively assess adherence barriers in HIV clinical practice. Thus, we conducted a research synthesis to produce a conceptual framework for a new patient-reported outcome measure (PRO) for use in routine HIV care in Canada and France. A PRO's conceptual framework graphically represents the concepts to be measured and the potential relationships between them. Towards ensuring the framework's relevance to the target populations' concerns, qualitative studies with HIV-positive adults on barriers to ART adherence in developed countries were synthesized with thematic analysis, attending to the cross-study prevalence and interrelationships of barrier themes. In March 2016, searches within Medline, PsychINFO, and Embase produced 5,284 records. Two reviewers determined the final sample (n = 41). Analysis generated three levels of ART adherence barrier themes. Twenty Level 2 themes and their component subthemes (Level 3) were organized into 6 higher-order themes (Level 1): Cognitive and emotional aspects (100% of studies contributing content -prevalence), Lifestyle factors (95%), Social and material context (95%), Characteristics of ART (90%), Health experience and state (73%), and Healthcare services and system (66%). As to interrelationships, study authors articulated relationships between all higher-order themes (Level 3). Linkages between Level 2 barrier themes showed great variability, from 21% to 95%. Overall, this synthesis contributes an exceptionally detailed conceptual framework and report of ART adherence barriers, applicable to a wide range of PLHIV. It suggests that a key to understanding many barriers is through their interconnections. It also identifies gaps in barrier research. Concerning the new PRO's development, comprehensiveness will need to be weighed against other concerns (e.g., respondent burden) and the provision of barrier

  15. Patient-reported Outcomes after ADM-assisted Implant-based Breast Reconstruction: A Cross-sectional Study

    Directory of Open Access Journals (Sweden)

    Vera L. Negenborn, MD

    2018-02-01

    Conclusion:. There is an increased demand for patient-reported outcome measures in a changing practice to which the opinion of the patient assumes a larger role. With high satisfaction rates, ADM-assisted IBBR is a valuable reconstruction method, provided that complication rates remain low. Hence, it should only be performed in a selected group of women.

  16. PRISM, a Patient-Reported Outcome Instrument, Accurately Measures Symptom Change in Refractory Gastroesophageal Reflux Disease.

    Science.gov (United States)

    Fuller, Garth; Bolus, Roger; Whitman, Cynthia; Talley, Jennifer; Erder, M Haim; Joseph, Alain; Silberg, Debra G; Spiegel, Brennan

    2017-03-01

    Most patients with gastroesophageal reflux disease (GERD) experience relief following treatment with proton pump inhibitors (PPIs) (Vakil et al. in Am J Gastroenterol 101:1900-1920, 2006; Everhart and Ruhl in Gastroenterology 136:376-386, 2009). As many as 17-44% of patients, however, exhibit only partial response to therapy. Most extant GERD patient-reported outcome (PRO) instruments fail to meet development best practices as described by the FDA (Talley and Wiklund in Qual Life Res 14:21-33, 2005; Van Pinxteren et al. in Cochrane Database Syst Rev 18:CD002095, 2004; El-Serag et al. in Aliment Pharmacol Ther 32:720-737, 2010). To develop and validate a PRO instrument for clinical trials involving patients with GERD who are PPI partial responders. We prepared a systematic literature review, held patient focus groups, convened an expert panel, and conducted cognitive interviews to establish content validity. Eligible participants took PPI therapy for at least 8 weeks, had undergone an upper endoscopy, and scored at least 8 points on the GerdQ [6]. Qualitative data guided development of 26 draft items. Items were reviewed by expert panels and debriefed with patients. The resulting 21-item instrument underwent psychometric evaluation during a Phase IIB trial. During the trial, confirmatory factor analysis (n = 220) resulted in a four-factor model displaying the highest goodness of fit. All domains had a high inter-item correlation (Cronbach's α > 0.8). Test-retest reliability and convergent validity were strong, with highly significant (p < 0.01) correlations between average weekly PRISM scores and severity anchors and significant (p < 0.05) correlations with anchor subscales. Cumulative distribution functions revealed significant differences between responders and non-responders. Analysis in a clinical trial setting demonstrated strong psychometric properties suggesting validity of PRISM. Developed in line with FDA guidance on PROs, PRISM represents an

  17. Measurement properties of patient-reported outcome measures (PROMS) in Patellofemoral Pain Syndrome: a systematic review.

    Science.gov (United States)

    Green, Andrew; Liles, Clive; Rushton, Alison; Kyte, Derek G

    2014-12-01

    This systematic review investigated the measurement properties of disease-specific patient-reported outcome measures used in Patellofemoral Pain Syndrome. Two independent reviewers conducted a systematic search of key databases (MEDLINE, EMBASE, AMED, CINHAL+ and the Cochrane Library from inception to August 2013) to identify relevant studies. A third reviewer mediated in the event of disagreement. Methodological quality was evaluated using the validated COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) tool. Data synthesis across studies determined the level of evidence for each patient-reported outcome measure. The search strategy returned 2177 citations. Following the eligibility review phase, seven studies, evaluating twelve different patient-reported outcome measures, met inclusion criteria. A 'moderate' level of evidence supported the structural validity of several measures: the Flandry Questionnaire, Anterior Knee Pain Scale, Functional Index Questionnaire, Eng and Pierrynowski Questionnaire and Visual Analogue Scales for 'usual' and 'worst' pain. In addition, there was a 'Limited' level of evidence supporting the test-retest reliability and validity (cross-cultural, hypothesis testing) of the Persian version of the Anterior Knee Pain Scale. Other measurement properties were evaluated with poor methodological quality, and many properties were not evaluated in any of the included papers. Current disease-specific outcome measures for Patellofemoral Pain Syndrome require further investigation. Future studies should evaluate all important measurement properties, utilising an appropriate framework such as COSMIN to guide study design, to facilitate optimal methodological quality. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. Patient-reported outcome measures for patients with meniscal tears: a systematic review of measurement properties and evaluation with the COSMIN checklist

    Science.gov (United States)

    Middleton, Robert; Beard, David J; Price, Andrew J; Hopewell, Sally

    2017-01-01

    Objective Meniscal tears occur frequently in the population and the most common surgical treatment, arthroscopic partial meniscectomy, is performed in approximately two million cases worldwide each year. The purpose of this systematic review is to summarise and critically appraise the evidence for the use of patient-reported outcome measures (PROMs) in patients with meniscal tears. Design A systematic review was undertaken. Data on reported measurement properties were extracted and the quality of the studies appraised according to Consensus-based Standards for the Selection of Health Measurement Instruments. Data sources A search of MEDLINE, Embase, AMED and PsycINFO, unlimited by language or publication date (last search 20 February 2017). Eligibility criteria for selecting studies Development and validation studies reporting the measurement properties of PROMs in patients with meniscal tears were included. Results 11 studies and 10 PROMs were included. The overall quality of studies was poor. For measurement of symptoms and functional status, there is only very limited evidence supporting the selection of either the Lysholm Knee Scale, International Knee Documentation Committee Subjective Knee Form or the Dutch version of the Knee injury and Osteoarthritis Outcome Score. For measuring health-related quality of life, only limited evidence supports the selection of the Western Ontario Meniscal Evaluation Tool (WOMET). Of all the PROMs evaluated, WOMET has the strongest evidence for content validity. Conclusion For patients with meniscal tears, there is poor quality and incomplete evidence regarding the validity of the currently available PROMs. Further research is required to ensure these PROMs truly reflect the symptoms, function and quality of life of patients with meniscal tears. PROSPERO registration number CRD42017056847. PMID:29030413

  19. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation.

    Science.gov (United States)

    Williams, Valerie J; Piva, Sara R; Irrgang, James J; Crossley, Chad; Fitzgerald, G Kelley

    2012-08-01

    Secondary analysis, pretreatment-posttreatment observational study. To compare the reliability and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Outcome Survey activities of daily living subscale (KOS-ADL), and the Lower Extremity Functional Scale (LEFS) in individuals with knee osteoarthritis (OA). The WOMAC is the current standard in patient-reported measures of function in patients with knee OA. The KOS-ADL and LEFS were designed for potential use in patients with knee OA. If the KOS-ADL and LEFS are to be considered viable alternatives to the WOMAC for measuring patient-reported function in individuals with knee OA, they should have measurement properties comparable to the WOMAC. It would also be important to determine whether either of these instruments may be superior to the WOMAC in terms of reliability or responsiveness in this population. Data from 168 subjects with knee OA, who participated in a rehabilitation program, were used in the analyses. Reliability and responsiveness of each outcome measure were estimated at follow-ups of 2, 6, and 12 months. Reliability was estimated by calculating the intraclass correlation coefficient (ICC2,1) for subjects who were unchanged in status from baseline at each follow-up time, based on a global rating of change score. To examine responsiveness, the standard error of the measurement, minimal detectable change, minimal clinically important difference, and the Guyatt responsiveness index were calculated for each outcome measure at each follow-up time. All 3 outcome measures demonstrated reasonable reliability and responsiveness to change. Reliability and responsiveness tended to decrease somewhat with increasing follow-up time. There were no substantial differences between outcome measures for reliability or any of the 3 measures of responsiveness at any follow-up time. The results do not indicate that one outcome measure is more reliable or responsive than

  20. Importance ratings on patient-reported outcome items for survivorship care: comparison between pediatric cancer survivors, parents, and clinicians.

    Science.gov (United States)

    Jones, Conor M; Baker, Justin N; Keesey, Rachel M; Eliason, Ruth J; Lanctot, Jennifer Q; Clegg, Jennifer L; Mandrell, Belinda N; Ness, Kirsten K; Krull, Kevin R; Srivastava, Deokumar; Forrest, Christopher B; Hudson, Melissa M; Robison, Leslie L; Huang, I-Chan

    2018-04-18

    To compare importance ratings of patient-reported outcomes (PROs) items from the viewpoints of childhood cancer survivors, parents, and clinicians for further developing short-forms to use in survivorship care. 101 cancer survivors, 101 their parents, and 36 clinicians were recruited from St. Jude Children's Research Hospital. Participants were asked to select eight items that they deemed useful for clinical decision making from each of the four Patient-Reported Outcomes Measurement Information System Pediatric item banks. These item banks were pain interference (20 items), fatigue (23 items), psychological stress (19 items), and positive affect (37 items). Compared to survivors, clinicians rated more items across four domains that were statistically different than did parents (23 vs. 13 items). Clinicians rated five items in pain interference domain (ORs 2.33-6.01; p's important but rated three items in psychological stress domain (ORs 0.14-0.42; p's important than did survivors. In contrast, parents rated seven items in positive affect domain (ORs 0.25-0.47; p's important than did survivors. Survivors, parents, and clinicians viewed importance of PRO items for survivorship care differently. These perspectives should be used to assist the development of PROs tools.

  1. OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody–associated Vasculitis

    Science.gov (United States)

    Robson, Joanna C.; Tomasson, Gunnar; Milman, Nataliya; Ashdown, Sue; Boonen, Annelies; Casey, George C.; Cronholm, Peter F.; Cuthbertson, David; Dawson, Jill; Direskeneli, Haner; Easley, Ebony; Kermani, Tanaz A.; Farrar, John T.; Gebhart, Don; Lanier, Georgia; Luqmani, Raashid A.; Mahr, Alfred; McAlear, Carol A.; Peck, Jacqueline; Shea, Beverley; Shea, Judy A.; Sreih, Antoine G.; Tugwell, Peter S.; Merkel, Peter A.

    2018-01-01

    Objective The antineutrophil cytoplasmic antibody–associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016. Methods A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented. Results OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement). Conclusion The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial. PMID:28864650

  2. Development and validation of a patient-reported questionnaire assessing systemic therapy induced diarrhea in oncology patients.

    Science.gov (United States)

    Lui, Michelle; Gallo-Hershberg, Daniela; DeAngelis, Carlo

    2017-12-22

    Systemic therapy-induced diarrhea (STID) is a common side effect experienced by more than half of cancer patients. Despite STID-associated complications and poorer quality of life (QoL), no validated assessment tools exist to accurately assess STID occurrence and severity to guide clinical management. Therefore, we developed and validated a patient-reported questionnaire (STIDAT). The STIDAT was developed using the FDA iterative process for patient-reported outcomes. A literature search uncovered potential items and questions for questionnaire construction used by oncology clinicians to develop questions for the preliminary instrument. The instrument was evaluated on its face validity and content validity by patient interviews. Repetitive, similar and different themes uncovered from patient interviews were implemented to revise the instrument to the version used for validation. Patients starting high-risk STID treatments were monitored using the STIDAT, bowel diaries and EORTC QLQ-C30. The STIDAT was evaluated for construct validity using exploratory factor analysis (EFA) using minimal residual method with Promax rotation, reliability and consistency. A weighted scoring system was developed and a receiver-operating characteristic (ROC) curve evaluated the tool's ability to detect STID occurrence. Median scores and variability were analysed to determine how well it differentiates between diarrhea severities. A post-hoc analysis determined how diarrhea severity impacted QoL of cancer patients. Patients defined diarrhea based on presence of watery stool. The STIDAT assessed patient's perception of having diarrhea, daily number of bowel movements, daily number of diarrhea episodes, antidiarrheal medication use, the presence of urgency, abdominal pain, abdominal spasms or fecal incontinence, patient's perception of diarrhea severity, and QoL. These dimensions were sorted into four clusters using EFA - patient's perception of diarrhea, frequency of diarrhea, fecal

  3. The Gait Deviation Index Is Associated with Hip Muscle Strength and Patient-Reported Outcome in Patients with Severe Hip Osteoarthritis

    DEFF Research Database (Denmark)

    Rosenlund, Signe; Holsgaard-Larsen, Anders; Overgaard, Søren

    2016-01-01

    ) and with severe primary hip osteoarthritis underwent 3-dimensional gait analysis. Mean Gait Deviation Index, pain after walking and maximal isometric hip muscle strength (flexor, extensor, and abductor) were recorded. All patients completed the 'Physical Function Short-form of the Hip disability...... was to investigate associations between Gait Deviation Index as a measure of gait 'quality' and hip muscle strength and between Gait Deviation Index and patient-reported outcomes in patients with primary hip osteoarthritis. METHOD: Forty-seven patients (34 males), aged 61.1 ± 6.7 years, with BMI 27.3 ± 3.4 (kg/m2...... and Osteoarthritis Outcome Score (HOOS-Physical Function) and the Hip disability and Osteoarthritis Outcome Score subscales for pain (HOOS-Pain) and quality-of-life (HOOS-QOL). RESULTS: Mean Gait Deviation Index was positively associated with hip abduction strength (pstrength (p = 0...

  4. Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID: Frequently asked questions

    Directory of Open Access Journals (Sweden)

    Perrier Laure-Lou

    2005-03-01

    Full Text Available Abstract The exponential development of Patient-Reported Outcomes (PRO measures in clinical research has led to the creation of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID to facilitate the selection process of PRO measures in clinical research. The project was initiated by Mapi Research Trust in Lyon, France. Initially called QOLID (Quality of Life Instruments Database, the project's purpose was to provide all those involved in health care evaluation with a comprehensive and unique source of information on PRO and HRQOL measures available through the Internet. PROQOLID currently describes more than 470 PRO instruments in a structured format. It is available in two levels, non-subscribers and subscribers, at http://www.proqolid.org. The first level is free of charge and contains 14 categories of basic useful information on the instruments (e.g. author, objective, original language, list of existing translations, etc.. The second level provides significantly more information about the instruments. It includes review copies of over 350 original instruments, 120 user manuals and 350 translations. Most are available in PDF format. This level is only accessible to annual subscribers. PROQOLID is updated in close collaboration with the instruments' authors on a regular basis. Fifty or more new instruments are added to the database annually. Today, all of the major pharmaceutical companies, prestigious institutions (such as the FDA, the NIH's National Cancer Institute, the U.S. Veterans Administration, dozens of universities, public institutions and researchers subscribe to PROQOLID on a yearly basis. More than 800 users per day routinely visit the database.

  5. Patient-reported outcomes in adults with congenital heart disease: Inter-country variation, standard of living and healthcare system factors.

    Science.gov (United States)

    Moons, Philip; Kovacs, Adrienne H; Luyckx, Koen; Thomet, Corina; Budts, Werner; Enomoto, Junko; Sluman, Maayke A; Yang, Hsiao-Ling; Jackson, Jamie L; Khairy, Paul; Cook, Stephen C; Subramanyan, Raghavan; Alday, Luis; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Mackie, Andrew S; Menahem, Samuel; Caruana, Maryanne; Veldtman, Gruschen; Soufi, Alexandra; Fernandes, Susan M; White, Kamila; Callus, Edward; Kutty, Shelby; Van Bulck, Liesbet; Apers, Silke

    2018-01-15

    Geographical differences in patient-reported outcomes (PROs) of adults with congenital heart disease (ConHD) have been observed, but are poorly understood. We aimed to: (1) investigate inter-country variation in PROs in adults with ConHD; (2) identify patient-related predictors of PROs; and (3) explore standard of living and healthcare system characteristics as predictors of PROs. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS) was a cross-sectional, observational study, in which 4028 patients from 15 countries in 5 continents were enrolled. Self-report questionnaires were administered: patient-reported health (12-item Short Form Health Survey; EuroQOL-5D Visual Analog Scale); psychological functioning (Hospital Anxiety and Depression Scale); health behaviors (Health Behavior Scale-Congenital Heart Disease) and quality of life (Linear Analog Scale for quality of life; Satisfaction With Life Scale). A composite PRO score was calculated. Standard of living was expressed as Gross Domestic Product per capita and Human Development Index. Healthcare systems were operationalized as the total health expenditure per capita and the overall health system performance. Substantial inter-country variation in PROs was observed, with Switzerland having the highest composite PRO score (81.0) and India the lowest (71.3). Functional class, age, and unemployment status were patient-related factors that independently and consistently predicted PROs. Standard of living and healthcare system characteristics predicted PROs above and beyond patient characteristics. This international collaboration allowed us to determine that PROs in ConHD vary as a function of patient-related factors as well as the countries in which patients live. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Measuring outcomes that matter to face-lift patients: development and validation of FACE-Q appearance appraisal scales and adverse effects checklist for the lower face and neck.

    Science.gov (United States)

    Klassen, Anne F; Cano, Stefan J; Scott, Amie M; Pusic, Andrea L

    2014-01-01

    The FACE-Q is a new patient-reported outcome instrument to evaluate a range of outcomes for patients undergoing any type of facial cosmetic operation, minimally invasive cosmetic procedure, or facial injectable. This article describes the development and validation of FACE-Q scales relevant to face-lift patients. The FACE-Q was developed by following international guidelines for patient-reported outcome instrument development. For outcomes following a face lift, the authors developed five appearance appraisal scales (i.e., Satisfaction with Cheeks, Satisfaction with Lower Face and Jawline, Appraisal of Nasolabial Folds, Appraisal of Area Under the Chin, and Appraisal of the Neck) and an adverse effects checklist. A field test of these scales was performed in a sample of 225 face-lift patients, and were evaluated using both modern and traditional psychometric methods. The five FACE-Q appearance appraisal scales were found to be clinically meaningful, reliable, valid, and responsive to clinical change. These findings were supported by Rasch measurement theory analysis (e.g., overall chi-square values of p ≥ 0.18; Person Separation Index ≥ 0.88). Responsiveness analyses showed that patient scores for facial appearance improved significantly after treatment (p < 0.001); changes in scores were associated with moderate effect sizes (range effect size, 0.40 to 0.79; range standardized response mean, 0.37 to 0.69). Traditional psychometric statistics provided further support (e.g., Cronbach's alpha values ≥ 0.94) CONCLUSIONS:: The FACE-Q appearance appraisal scales are scientifically sound and clinically meaningful and can be used with the adverse effects checklist to measure patient-reported outcomes following a face lift.

  7. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms

    Directory of Open Access Journals (Sweden)

    Ramakrishnan K

    2013-12-01

    Full Text Available Karthik Ramakrishnan,1 T Christopher Bond,1 Ami Claxton,1 Vipan C Sood,2 Maria Kootsikas,2 Wendy Agnese,2 Scott Sibbel11DaVita Clinical Research, Minneapolis, MN, USA; 2Mitsubishi Tanabe Pharma Corporation, Jersey City, NJ, USAAbstract: One of the most common conditions affecting end-stage renal disease (ESRD patients undergoing hemodialysis (HD is pruritus. Studies report that itchy and dry skin, symptoms of pruritus, affect 40%–90% of ESRD patients. Yet, in clinical practice the condition is often underdiagnosed resulting in inadequate management and an underappreciated impact on patient outcomes. Two retrospective analyses were conducted: a preliminary analysis of ESRD patients with pruritus symptoms (n=73,124 undergoing HD or peritoneal dialysis at a large dialysis provider and a subsequent detailed analysis of a homogenous subset of patients undergoing in-center HD (n=38,315. The goal was to better understand the clinical burden of pruritus as it relates to patient characteristics, quality of life, medication use, and HD compliance. This population is commonly burdened by multiple comorbidities and related polypharmaceutical management; identifying the relationship of pruritus to these ailments can help guide future research and resource allocation. The detailed analysis confirmed trends observed in the preliminary analysis: 30% reported being "moderately" to "extremely bothered" by itchiness. The HD patient population with the highest severity of self-reported pruritus also had a consistent trend in overall increased resource utilization – higher monthly doses of erythropoietin-stimulating agents (53,397.1 to 63,405.4 units and intravenous (IV iron (237.2 to 247.6 units and higher use of IV antibiotics (14.1% to 20.7%, as well as poorer quality-of-life measures (25-point reductions in Burden of Disease Score and Effects on Daily Life subscales of the Kidney Disease Quality of Life-36 survey. These results highlight the need to better

  8. The Cervical Dystonia Impact Profile (CDIP-58: Can a Rasch developed patient reported outcome measure satisfy traditional psychometric criteria?

    Directory of Open Access Journals (Sweden)

    Bhatia Kailash P

    2008-08-01

    Full Text Available Abstract Background The United States Food and Drug Administration (FDA are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58, a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1 provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2 enable researchers and clinicians to compare it with existing dystonia PROMs; and 3 help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. Methods We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. Results A total of 391 people returned completed questionnaires (corrected response rate 87%. Analyses showed: 1 data quality was high (low missing data ≤ 4%, subscale scores could be computed for > 96% of the sample; 2 item groupings passed tests for scaling assumptions; 3 good targeting (except for the Sleep subscale, ceiling effect = 27%; 4 good reliability (Cronbach's alpha ≥ 0.92, test-retest intraclass correlations ≥ 0.83; and 5 validity was supported. Conclusion This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis.

  9. Integrating Patient-Reported Outcomes into Spine Surgical Care through Visual Dashboards: Lessons Learned from Human-Centered Design.

    Science.gov (United States)

    Hartzler, Andrea L; Chaudhuri, Shomir; Fey, Brett C; Flum, David R; Lavallee, Danielle

    2015-01-01

    The collection of patient-reported outcomes (PROs) draws attention to issues of importance to patients-physical function and quality of life. The integration of PRO data into clinical decisions and discussions with patients requires thoughtful design of user-friendly interfaces that consider user experience and present data in personalized ways to enhance patient care. Whereas most prior work on PROs focuses on capturing data from patients, little research details how to design effective user interfaces that facilitate use of this data in clinical practice. We share lessons learned from engaging health care professionals to inform design of visual dashboards, an emerging type of health information technology (HIT). We employed human-centered design (HCD) methods to create visual displays of PROs to support patient care and quality improvement. HCD aims to optimize the design of interactive systems through iterative input from representative users who are likely to use the system in the future. Through three major steps, we engaged health care professionals in targeted, iterative design activities to inform the development of a PRO Dashboard that visually displays patient-reported pain and disability outcomes following spine surgery. Design activities to engage health care administrators, providers, and staff guided our work from design concept to specifications for dashboard implementation. Stakeholder feedback from these health care professionals shaped user interface design features, including predefined overviews that illustrate at-a-glance trends and quarterly snapshots, granular data filters that enable users to dive into detailed PRO analytics, and user-defined views to share and reuse. Feedback also revealed important considerations for quality indicators and privacy-preserving sharing and use of PROs. Our work illustrates a range of engagement methods guided by human-centered principles and design recommendations for optimizing PRO Dashboards for patient

  10. On-demand Modafinil Improves Ejaculation Time and Patient-reported Outcomes in Men With Lifelong Premature Ejaculation.

    Science.gov (United States)

    Tuken, Murat; Kiremit, Murat Can; Serefoglu, Ege Can

    2016-08-01

    To evaluate the effects of modafinil on the intravaginal ejaculatory latency time (IELT) and patient-reported outcomes in patients with lifelong premature ejaculation (PE). Treatment-naïve lifelong PE patients were included in this proof-of-concept study. Self-estimated IELTs of the patients were recorded and the Premature Ejaculation Profile (PEP) questionnaire was administered before the initiation of on-demand modafinil 100 mg treatment. At the end of 1 month of treatment, self-estimated IELTs were recorded again, along with posttreatment PEP outcomes. Overall, 55 lifelong PE patients with a mean age of 35.07 ± 7.80 (range: 22-58) years were enrolled. Modafinil treatment modestly increased the mean IELT at the end of 1 month (24.82 ± 16.10 seconds vs 49.82 ± 31.46 seconds, P = .0001). Moreover, at the end of 1 month, patients reported in the PEP questionnaire better control over ejaculation (0.75 ± 0.67 vs 1.35 ± 0.91, P = .0001), improved satisfaction with sexual intercourse (0.98 ± 0.78 vs 1.40 ± 0.85, P = .0001), lesser personal distress (0.42 ± 0.69 vs 0.89 ± 1.01, P = .0001), and reduced interpersonal difficulty (1.69 ± 1.48 vs 1.95 ± 1.47, P = .0001). In an uncontrolled proof-of-concept study of men with treatment-naïve lifelong PE where IELT was self-reported without a stopwatch, modest improvements of both IELT and patient-reported outcome measures were observed. Future controlled clinical trials are necessary to confirm these findings. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Patient Reported Outcome Measure of Spiritual Care as Delivered by Chaplains.

    Science.gov (United States)

    Snowden, Austyn; Telfer, Iain

    2017-01-01

    Chaplains are employed by health organizations around the world to support patients in recognizing and addressing their spiritual needs. There is currently no generalizable measure of the impact of these interventions and so the clinical and strategic worth of chaplaincy is difficult to articulate. This article introduces the Scottish PROM, an original five-item patient reported outcome measure constructed specifically to address this gap. It describes the validation process from its conceptual grounding in the spiritual care literature through face and content validity cycles. It shows that the Scottish PROM is internally consistent and unidimensional. Responses to the Scottish PROM show strong convergent validity with responses to the Warwick and Edinburgh Mental Well-Being Scale, a generic well-being scale often used as a proxy for spiritual well-being. In summary, the Scottish PROM is fit for purpose. It measures the outcomes of spiritual care as delivered by chaplains in this study. This novel project introduces an essential and original breakthrough; the possibility of generalizable international chaplaincy research.

  12. Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury.

    Science.gov (United States)

    Patel, Darshan P; Lenherr, Sara M; Stoffel, John T; Elliott, Sean P; Welk, Blayne; Presson, Angela P; Jha, Amitabh; Rosenbluth, Jeffrey; Myers, Jeremy B

    2017-10-10

    The majority of spinal cord injury (SCI) patients have urinary issues, such as incontinence, retention, and frequency. These problems place a significant burden on patients' physical health and quality of life (QoL). There are a wide variety of bladder management strategies available to patients with no clear guidelines on appropriate selection. Inappropriate bladder management can cause hospitalizations and serious complications, such as urosepsis and renal failure. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder-management strategy but little is known about patient's QoL with different bladder managements. Our study's aim is to assess patient reported QoL measures with various bladder managements after SCI. This manuscript describes the approach, study design and common data elements for our central study. This is a multi-institutional prospective cohort study comparing three different bladder-management strategies (clean intermittent catheterization, indwelling catheters, and surgery). Information collected from participants includes demographics, past medical and surgical history, injury characteristics, current and past bladder management, and SCI /bladder-related complications. Patient reported outcomes and QoL questionnaires were administered at enrollment and every 3 months for 1 year. Aims of this study protocol are: (1) to assess baseline QoL differences between the three different bladder-management strategies; (2) determine QoL impact when those using either form of catheter management undergo a surgery over the 1 year of follow-up among patients eligible for surgery; (3) assess the effects of changes in bladder management and complications on QoL over a 1-year longitudinal follow-up. By providing information about patient-reported outcomes associated with different bladder management strategies after SCI, and the impact of bladder management

  13. Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes.

    Science.gov (United States)

    Lang, Niklaus P; Zitzmann, Nicola U

    2012-02-01

    The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.

  14. Integrating Patient-Reported Outcomes into Spine Surgical Care through Visual Dashboards: Lessons Learned from Human-Centered Design

    Science.gov (United States)

    Hartzler, Andrea L.; Chaudhuri, Shomir; Fey, Brett C.; Flum, David R.; Lavallee, Danielle

    2015-01-01

    Introduction: The collection of patient-reported outcomes (PROs) draws attention to issues of importance to patients—physical function and quality of life. The integration of PRO data into clinical decisions and discussions with patients requires thoughtful design of user-friendly interfaces that consider user experience and present data in personalized ways to enhance patient care. Whereas most prior work on PROs focuses on capturing data from patients, little research details how to design effective user interfaces that facilitate use of this data in clinical practice. We share lessons learned from engaging health care professionals to inform design of visual dashboards, an emerging type of health information technology (HIT). Methods: We employed human-centered design (HCD) methods to create visual displays of PROs to support patient care and quality improvement. HCD aims to optimize the design of interactive systems through iterative input from representative users who are likely to use the system in the future. Through three major steps, we engaged health care professionals in targeted, iterative design activities to inform the development of a PRO Dashboard that visually displays patient-reported pain and disability outcomes following spine surgery. Findings: Design activities to engage health care administrators, providers, and staff guided our work from design concept to specifications for dashboard implementation. Stakeholder feedback from these health care professionals shaped user interface design features, including predefined overviews that illustrate at-a-glance trends and quarterly snapshots, granular data filters that enable users to dive into detailed PRO analytics, and user-defined views to share and reuse. Feedback also revealed important considerations for quality indicators and privacy-preserving sharing and use of PROs. Conclusion: Our work illustrates a range of engagement methods guided by human-centered principles and design

  15. Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza.

    Science.gov (United States)

    Powers, John H; Guerrero, M Lourdes; Leidy, Nancy Kline; Fairchok, Mary P; Rosenberg, Alice; Hernández, Andrés; Stringer, Sonja; Schofield, Christina; Rodríguez-Zulueta, Patricia; Kim, Katherine; Danaher, Patrick J; Ortega-Gallegos, Hilda; Bacci, Elizabeth Dansie; Stepp, Nathaniel; Galindo-Fraga, Arturo; St Clair, Kristina; Rajnik, Michael; McDonough, Erin A; Ridoré, Michelande; Arnold, John C; Millar, Eugene V; Ruiz-Palacios, Guillermo M

    2016-01-05

    To develop content validity of a comprehensive patient-reported outcome (PRO) measure following current best scientific methodology to standardize assessment of influenza (flu) symptoms in clinical research. Stage I (Concept Elicitation): 1:1 telephone interviews with influenza-positive adults (≥18 years) in the US and Mexico within 7 days of diagnosis. Participants described symptom type, character, severity, and duration. Content analysis identified themes and developed the draft Flu-PRO instrument. Stage II (Cognitive Interviewing): The Flu-PRO was administered to a unique set of influenza-positive adults within 14 days of diagnosis; telephone interviews addressed completeness, respondent interpretation of items and ease of use. Samples: Stage I: N = 46 adults (16 US, 30 Mexico); mean (SD) age: 38 (19), 39 (14) years; % female: 56%, 73%; race: 69% White, 97% Mestizo. Stage II: N = 34 adults (12 US, 22 Mexico); age: 37 (14), 39 (11) years; % female: 50%, 50%; race: 58% White, 100% Mestizo. Symptoms identified by >50%: coughing, weak or tired, throat symptoms, congestion, headache, weakness, sweating, chills, general discomfort, runny nose, chest (trouble breathing), difficulty sleeping, and body aches or pains. No new content was uncovered during Stage II; participants easily understood the instrument. Results show the 37-item Flu-PRO is a content valid measure of influenza symptoms in adults with a confirmed diagnosis of influenza. Research is underway to evaluate the suitability of the instrument for children and adolescents. This work can form the basis for future quantitative tests of reliability, validity, and responsiveness to evaluate the measurement properties of Flu-PRO for use in clinical trials and epidemiology studies.

  16. Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) diary in patients with influenza-like illness (ILI)

    Science.gov (United States)

    Bacci, Elizabeth D.; Leidy, Nancy K.; Poon, Jiat-Ling; Stringer, Sonja; Memoli, Matthew J.; Han, Alison; Fairchok, Mary P.; Coles, Christian; Owens, Jackie; Chen, Wei-Ju; Arnold, John C.; Danaher, Patrick J.; Lalani, Tahaniyat; Burgess, Timothy H.; Millar, Eugene V.; Ridore, Michelande; Hernández, Andrés; Rodríguez-Zulueta, Patricia; Ortega-Gallegos, Hilda; Galindo-Fraga, Arturo; Ruiz-Palacios, Guillermo M.; Pett, Sarah; Fischer, William; Gillor, Daniel; Moreno Macias, Laura; DuVal, Anna; Rothman, Richard; Dugas, Andrea; Guerrero, M. Lourdes

    2018-01-01

    Background The inFLUenza Patient Reported Outcome (FLU-PRO) measure is a daily diary assessing signs/symptoms of influenza across six body systems: Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, Body/Systemic, developed and tested in adults with influenza. Objectives This study tested the reliability, validity, and responsiveness of FLU-PRO scores in adults with influenza-like illness (ILI). Methods Data from the prospective, observational study used to develop and test the FLU-PRO in influenza virus positive patients were analyzed. Adults (≥18 years) presenting with influenza symptoms in outpatient settings in the US, UK, Mexico, and South America were enrolled, tested for influenza virus, and asked to complete the 37-item draft FLU-PRO daily for up to 14-days. Analyses were performed on data from patients testing negative. Reliability of the final, 32-item FLU-PRO was estimated using Cronbach’s alpha (α; Day 1) and intraclass correlation coefficients (ICC; 2-day reproducibility). Convergent and known-groups validity were assessed using patient global assessments of influenza severity (PGA). Patient report of return to usual health was used to assess responsiveness (Day 1–7). Results The analytical sample included 220 ILI patients (mean age = 39.3, 64.1% female, 88.6% white). Sixty-one (28%) were hospitalized at some point in their illness. Internal consistency reliability (α) of FLU-PRO Total score was 0.90 and ranged from 0.72–0.86 for domain scores. Reproducibility (Day 1–2) was 0.64 for Total, ranging from 0.46–0.78 for domain scores. Day 1 FLU-PRO scores correlated (≥0.30) with the PGA (except Gastrointestinal) and were significantly different across PGA severity groups (Total: F = 81.7, pFLU-PRO scores are reliable, valid, and responsive in adults with influenza-like illness. PMID:29566007

  17. Development of the outcome expectancy scale for self-care among periodontal disease patients.

    Science.gov (United States)

    Kakudate, Naoki; Morita, Manabu; Fukuhara, Shunichi; Sugai, Makoto; Nagayama, Masato; Isogai, Emiko; Kawanami, Masamitsu; Chiba, Itsuo

    2011-12-01

    The theory of self-efficacy states that specific efficacy expectations affect behaviour. Two types of efficacy expectations are described within the theory. Self-efficacy expectations are the beliefs in the capacity to perform a specific behaviour. Outcome expectations are the beliefs that carrying out a specific behaviour will lead to a desired outcome. To develop and examine the reliability and validity of an outcome expectancy scale for self-care (OESS) among periodontal disease patients. A 34-item scale was tested on 101 patients at a dental clinic. Accuracy was improved by item analysis, and internal consistency and test-retest stability were investigated. Concurrent validity was tested by examining associations of the OESS score with the self-efficacy scale for self-care (SESS) score and plaque index score. Construct validity was examined by comparing OESS scores between periodontal patients at initial visit (group 1) and those continuing maintenance care (group 2). Item analysis identified 13 items for the OESS. Factor analysis extracted three factors: social-, oral- and self-evaluative outcome expectancy. Cronbach's alpha coefficient for the OESS was 0.90. A significant association was observed between test and retest scores, and between the OESS and SESS and plaque index scores. Further, group 2 had a significantly higher mean OESS score than group 1. We developed a 13-item OESS with high reliability and validity which may be used to assess outcome expectancy for self-care. A patient's psychological condition with regard to behaviour and affective status can be accurately evaluated using the OESS with SESS. © 2011 Blackwell Publishing Ltd.

  18. Development of a core outcome set for studies involving patients undergoing major lower limb amputation for peripheral arterial disease: study protocol for a systematic review and identification of a core outcome set using a Delphi survey.

    Science.gov (United States)

    Ambler, Graeme K; Bosanquet, David C; Brookes-Howell, Lucy; Thomas-Jones, Emma; Waldron, Cherry-Ann; Edwards, Adrian G K; Twine, Christopher P

    2017-12-28

    The development of a standardised reporting set is important to ensure that research is directed towards the most important outcomes and that data is comparable. To ensure validity, the set must be agreed by a consensus of stakeholders including patients, healthcare professionals and lay representatives. There is currently no agreed core outcome set for patients undergoing major lower limb amputation for peripheral arterial disease (PAD) for either short- or medium-term research outcomes. By developing these sets we aim to rationalise future trial outcomes, facilitate meta-analysis and improve the quality and applicability of amputation research. We will undertake a comprehensive systematic review of studies of patients undergoing major lower limb amputation for PAD. Data regarding all primary and secondary outcomes reported in relevant studies will be extracted and summarised as outcome domains. We will then undertake focus groups with key stakeholders (patients, carers, health and social care workers) to collect qualitative data to identify the main short- and medium-term research outcomes for patients undergoing major lower limb amputation. Results of the systematic review and focus groups will be combined to create a comprehensive list of potential key outcomes. Stakeholders (patients, researchers and health and social care workers) will then be polled to determine which of the outcomes are considered to be important in a general context using a three-phase Delphi process. After preliminary analysis, results will be presented at a face-to-face meeting of key stakeholders for discussion and voting on the final set of core outcomes. This project is being run in parallel with a feasibility trial assessing perineural catheters in patients undergoing lower limb amputation (the PLACEMENT trial). Full ethical approval has been granted for the study (Wales REC 3 reference number 16/WA/0353). Core outcome sets will be developed for short- and medium-term outcomes of

  19. The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative.

    Science.gov (United States)

    Alonso, Jordi; Bartlett, Susan J; Rose, Matthias; Aaronson, Neil K; Chaplin, John E; Efficace, Fabio; Leplège, Alain; Lu, Aiping; Tulsky, David S; Raat, Hein; Ravens-Sieberer, Ulrike; Revicki, Dennis; Terwee, Caroline B; Valderas, Jose M; Cella, David; Forrest, Christopher B

    2013-12-20

    Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item

  20. Use of the Derriford Appearance Scale 59 to assess patient-reported outcomes in secondary cleft surgery.

    Science.gov (United States)

    Ricketts, Sophie; Regev, Eran; Antonyshyn, Oleh M; Kiss, Alex; Fialkov, Jeffrey A

    2016-01-01

    Secondary rhinoplasty, one of the final procedures in addressing the stigma of the cleft lip and palate (CLP), has both functional and aesthetic objectives. The way in which physicians evaluate outcomes in surgery concerning aesthetics is changing. Well-designed patient-reported outcome measures to assess health-related quality of life improvements attributable to surgery are increasingly being used. The Derriford Appearance Scale 59 (DAS-59) is currently the only available validated patient-reported outcome measure that assesses concern about physical appearance. Twenty patients with CLP presenting between May 2009 and May 2013 for secondary rhinoplasty to Sunnybrook Health Sciences Centre (Toronto, Ontario) were recruited. DAS-59 measures were administered both preoperatively and at least six months after surgery. Pre- and postoperative measures were scored and compared. Item-by-item analysis of the measure was also performed. Total scores for this CLP group indicated greater concern about appearance than the general population. Across all subscales of the measure, there was a reduction in scores after secondary rhinoplasty suggesting less patient concern with appearance and a positive effect of surgery on patient quality of life. Item-by-item analysis suggested relatively few items in the measure were driving overall change in total scores. Comparison of pre- and postoperative scores with the DAS-59 in secondary cleft rhinoplasty suggests there is less concern with appearance after surgery. However, a small number of items within this generic scale contributing to this difference may suggest the need for a more patient specific measure for assessment of surgical outcomes in the cleft population.

  1. Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: the VALENCE study

    NARCIS (Netherlands)

    Younossi, Zobair M.; Stepanova, Maria; Zeuzem, Stefan; Dusheiko, Geoffrey; Esteban, Rafael; Hezode, Christophe; Reesink, Hendrik W.; Weiland, Ola; Nader, Fatema; Hunt, Sharon L.

    2014-01-01

    Interferon (IFN) negatively impacts patients' well-being and patient-reported outcomes (PROs). Our aim was to assess PROs during treatment with an IFN-free regimen [sofosbuvir (SOF)+ribavirin (RBV)]. Four PRO questionnaires [Short Form-36 (SF-36), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV),

  2. Patient-reported outcome measures in arthroplasty registries

    DEFF Research Database (Denmark)

    Rolfson, Ola; Eresian Chenok, Kate; Bohm, Eric

    2016-01-01

    survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario...... of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions...... all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health...

  3. Impact of rituximab on patient-reported outcomes in patients with rheumatoid arthritis from the US Corrona Registry.

    Science.gov (United States)

    Harrold, Leslie R; John, Ani; Best, Jennie; Zlotnick, Steve; Karki, Chitra; Li, YouFu; Greenberg, Jeffrey D; Kremer, Joel M

    2017-09-01

    To evaluate the impact of rituximab on patient-reported outcomes (PROs) in a US-based observational cohort of patients with rheumatoid arthritis (RA). Patients with active RA, prior exposure to ≥1 tumor necrosis factor inhibitor (TNFi) and who newly initiated rituximab were identified. Changes in PROs were assessed 1 year after rituximab initiation. PRO measures included Clinical Disease Activity Index (CDAI); patient global disease activity, pain and fatigue (visual analog score; 0-100); morning stiffness (hours); modified Health Assessment Questionnaire (mHAQ; 0-3); and EuroQoL EQ-5D. Of the 667 patients who newly initiated rituximab, baseline PRO and clinical measures indicated that patients were substantially impacted by their RA disease and quality of life; 54% of patients had high disease activity. One year after rituximab initiation, 49.0, 47.1, 49.8, and 23.2% of patients reported clinically meaningful improvements in patient global, pain, fatigue, and mHAQ, respectively. Morning stiffness and EuroQol EQ-5D domains improved in 48 and 19-32% of patients, respectively. These real-world registry data demonstrated that patients with long-standing, refractory RA experienced improvements in PROs 1 year after initiating rituximab.

  4. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis

    NARCIS (Netherlands)

    Strand, Vibeke; van Vollenhoven, Ronald F.; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H.; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie; Wallenstein, Gene

    2016-01-01

    To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to

  5. Development of a patient-reported outcome

    DEFF Research Database (Denmark)

    Sørensen, Tina Juul; Søgaard, Karen; Roos, Ewa M

    2015-01-01

    removed from the original 69. A multidimensional questionnaire, divided into five subscales, was developed from the remaining 34 items: mobility; symptoms; sleep disturbance; everyday activity and pain; and participation in everyday life. Exploratory factor analysis supported a 5-subscale structure...

  6. The Computer-based Health Evaluation Software (CHES: a software for electronic patient-reported outcome monitoring

    Directory of Open Access Journals (Sweden)

    Holzner Bernhard

    2012-11-01

    Full Text Available Abstract Background Patient-reported Outcomes (PROs capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Electronic PRO data capture (ePRO with software packages to administer questionnaires, storing data, and presenting results has facilitated PRO assessment in hospital settings. Compared to conventional paper-pencil versions of PRO instruments, ePRO is more economical with regard to staff resources and time, and allows immediate presentation of results to the medical staff. The objective of our project was to develop software (CHES – Computer-based Health Evaluation System for ePRO in hospital settings and at home with a special focus on the presentation of individual patient’s results. Methods Following the Extreme Programming development approach architecture was not fixed up-front, but was done in close, continuous collaboration with software end users (medical staff, researchers and patients to meet their specific demands. Developed features include sophisticated, longitudinal charts linking patients’ PRO data to clinical characteristics and to PRO scores from reference populations, a web-interface for questionnaire administration, and a tool for convenient creating and editing of questionnaires. Results By 2012 CHES has been implemented at various institutions in Austria, Germany, Switzerland, and the UK and about 5000 patients participated in ePRO (with around 15000 assessments in total. Data entry is done by the patients themselves via tablet PCs with a study nurse or an intern approaching patients and supervising questionnaire completion. Discussion During the last decade several software packages for ePRO have emerged for different purposes. Whereas commercial products are available primarily for ePRO in clinical trials, academic projects have focused on data collection and presentation in daily

  7. Added Value of Patient-Reported Outcome Measures in Stroke Clinical Practice.

    Science.gov (United States)

    Katzan, Irene L; Thompson, Nicolas R; Lapin, Brittany; Uchino, Ken

    2017-07-21

    There is uncertainty regarding the clinical utility of the data obtained from patient-reported outcome measures (PROMs) for patient care. We evaluated the incremental information obtained by PROMs compared to the clinician-reported modified Rankin Scale (mRS). This was an observational study of 3283 ischemic stroke patients seen in a cerebrovascular clinic from September 14, 2012 to June 16, 2015 who completed the routinely collected PROMs: Stroke Impact Scale-16 (SIS-16), EQ-5D, Patient Health Questionnaire-9, PROMIS Physical Function, and PROMIS fatigue. The amount of variation in the PROMs explained by mRS was determined using r 2 after adjustment for age and level of stroke impairment. The proportion with meaningful change was calculated for patients with ≥2 visits. Concordance with change in the other scales and the ability to discriminate changes in health state as measured by c-statistic was evaluated for mRS versus SIS-16. Correlation between PROMs and mRS was highest for SIS-16 ( r =-0.64, P measures. PROMs provide additional valuable information compared to the mRS alone in stroke patients seen in the ambulatory setting. SIS-16 may have a better ability to identify change than mRS in health status of relevance to the patient. PROMs may be a useful addition to mRS in the assessment of health status in clinical practice. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  8. Raising the profile of pilot and feasibility studies in relation to the development, evaluation and implementation of patient-reported outcome measures.

    OpenAIRE

    Jones, GL

    2017-01-01

    This editorial introduces a new special series on the pilot and feasibility testing of patient-reported outcome measures (PROMs) in the on-line open access journal Pilot and Feasibility Studies. Pilot and feasibility studies are typically implemented to address issues of uncertainty before undertaking a larger definitive study such as a randomised controlled trial or large scale survey. This editorial considers the role that such pilot and feasibility testing plays in relation to the developm...

  9. A systematic review of patient reported outcome measures (PROMs) used in child and adolescent burn research.

    Science.gov (United States)

    Griffiths, C; Armstrong-James, L; White, P; Rumsey, N; Pleat, J; Harcourt, D

    2015-03-01

    Patient reported outcome measures (PROMs) can identify important information about patient needs and therapeutic progress. The aim of this review was to identify the PROMs that are being used in child and adolescent burn care and to determine the quality of such scales. Computerised and manual bibliographic searches of Medline, Social Sciences Index, Cinahl, Psychinfo, Psycharticles, AMED, and HAPI, were used to identify English-language articles using English-language PROMs from January 2001 to March 2013. The psychometric quality of the PROMs was assessed. 23 studies met the entry criteria and identified 32 different PROMs (31 generic, 1 burns-specific). Overall, the psychometric quality of the PROMs was low; only two generic scales (the Perceived Stigmatisation Questionnaire and the Social Comfort Scale) and only one burns-specific scale (the Children Burn Outcomes Questionnaire for children aged 5-18) had psychometric evidence relevant to this population. The majority of PROMs did not have psychometric evidence for their use with child or adolescent burn patients. To appropriately identify the needs and treatment progress of child and adolescent burn patients, new burns-specific PROMs need to be developed and validated to reflect issues that are of importance to this population. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  10. Assessing Patient-Reported Outcomes Following Orthognathic Surgery and Osseous Genioplasty.

    Science.gov (United States)

    Schwitzer, Jonathan A; Albino, Frank P; Mathis, Ryan K; Scott, Amie M; Gamble, Laurie; Baker, Stephen B

    2015-11-01

    Primary outcomes for orthognathic surgery and genioplasty patients include satisfaction with appearance, improved motor function, and enhanced quality of life. The goal of this study was to assess outcomes among patients undergoing these procedures, and to highlight the potential use of FACE-Q instrument for use in patients with dentofacial deformities. A total of 56 patients presenting for orthognathic surgery and/or osseous genioplasty completed the FACE-Q during preoperative and/or at postoperative visits. FACE-Q scores increased following surgery in satisfaction with facial appearance overall (+24.5, P jawline (+40.7, P < 0.01), and in all satisfaction with chin items (profile, prominence, shape, and overall). Patients also demonstrated increased social confidence (+8.9, P = 0.29). There was no improvement in psychologic well-being (-0.8, P = 0.92). All 3 surgical groups of patients experienced gains in satisfaction with appearance following surgery. Patients who underwent orthognathic surgery either alone or in combination with genioplasty demonstrated statistically significant improvements in satisfaction with facial appearance overall (P < 0.01 for both groups), whereas patients who underwent genioplasty alone did not (P = 0.13). In addition, patients who underwent orthognathic surgery combined with genioplasty demonstrated greater improvement in satisfaction with chin than patients who underwent genioplasty alone. In conclusion, patients who underwent orthognathic surgery and/or genioplasty demonstrated improvement in appearance and social confidence. The use of this model supports the successful outcomes possible for patients undergoing these procedures.

  11. Feasibility of using a handheld electronic device for the collection of patient reported outcomes data from children.

    Science.gov (United States)

    Vinney, Lisa A; Grade, John D; Connor, Nadine P

    2012-01-01

    The manner in which a communication disorder affects health-related quality of life (QOL) in children is not known. Unfortunately, collection of quality of life data via traditional paper measures is labor intensive and has several other limitations, which hinder the investigation of pediatric quality of life in children. Currently, there is not sufficient research regarding the use of electronic devices to collect pediatric patient reported outcomes in order to address such limitations. Thus, we used a cross-over design to compare responses to a pediatric health quality of life instrument (PedsQL 4.0) delivered using a handheld electronic device to those from a traditional paper form. Respondents were children with (n=9) and without (n=10) a speech or voice disorder. For paper versus the electronic format, we examined time to completion, number of incomplete or inaccurate question responses, intra-rater reliability, ease of use, and child and parent preference. There were no significant differences between children's scores, time to complete the measure, or ratings related to ease of answering questions. The percentage of children who made answering errors or omissions with paper and pencil was significantly greater than the percentage of children who made such errors using the device. This preliminary study demonstrated that use of an electronic device to collect QOL or patient-reported outcomes (PRO) data from children is more efficient than and just as feasible, reliable, and acceptable as using paper forms. The development of hardware and software applications for the collection of QOL and/or PRO data in children with speech disorders is likely warranted. The reader will be able to understand: (1) The potential benefits of using electronic data capture via handheld devices for collecting pediatric patient reported outcomes; (2) The Pediatric Quality of Life Inventory 4.0 is a measure of the perception of general health quality that has distinguished between

  12. Data collection of patient outcomes: one institution’s experience

    Science.gov (United States)

    Whitaker, Thomas J; Mayo, Charles S; Ma, Daniel J; Haddock, Michael G; Miller, Robert C; Corbin, Kimberly S; Neben-Wittich, Michelle; Leenstra, James L; Laack, Nadia N; Fatyga, Mirek; Schild, Steven E; Vargas, Carlos E; Tzou, Katherine S; Hadley, Austin R; Buskirk, Steven J; Foote, Robert L

    2018-01-01

    Abstract Patient- and provider-reported outcomes are recognized as important in evaluating quality of care, guiding health care policy, comparative effectiveness research, and decision-making in radiation oncology. Combining patient and provider outcome data with a detailed description of disease and therapy is the basis for these analyses. We report on the combination of technical solutions and clinical process changes at our institution that were used in the collection and dissemination of this data. This initiative has resulted in the collection of treatment data for 23 541 patients, 20 465 patients with provider-based adverse event records, and patient-reported outcome surveys submitted by 5622 patients. All of the data is made accessible using a self-service web-based tool. PMID:29538757

  13. Identifying thresholds for relationships between impacts of rationing of nursing care and nurse- and patient-reported outcomes in Swiss hospitals: a correlational study.

    Science.gov (United States)

    Schubert, Maria; Clarke, Sean P; Glass, Tracy R; Schaffert-Witvliet, Bianca; De Geest, Sabina

    2009-07-01

    In the Rationing of Nursing Care in Switzerland Study, implicit rationing of care was the only factor consistently significantly associated with all six studied patient outcomes. These results highlight the importance of rationing as a new system factor regarding patient safety and quality of care. Since at least some rationing of care appears inevitable, it is important to identify the thresholds of its influences in order to minimize its negative effects on patient outcomes. To describe the levels of implicit rationing of nursing care in a sample of Swiss acute care hospitals and to identify clinically meaningful thresholds of rationing. Descriptive cross-sectional multi-center study. Five Swiss-German and three Swiss-French acute care hospitals. 1338 nurses and 779 patients. Implicit rationing of nursing care was measured using the newly developed Basel Extent of Rationing of Nursing Care (BERNCA) instrument. Other variables were measured using survey items from the International Hospital Outcomes Study battery. Data were summarized using appropriate descriptive measures, and logistic regression models were used to define a clinically meaningful rationing threshold level. For the studied patient outcomes, identified rationing threshold levels varied from 0.5 (i.e., between 0 ('never') and 1 ('rarely') to 2 ('sometimes')). Three of the identified patient outcomes (nosocomial infections, pressure ulcers, and patient satisfaction) were particularly sensitive to rationing, showing negative consequences anywhere it was consistently reported (i.e., average BERNCA scores of 0.5 or above). In other cases, increases in negative outcomes were first observed from the level of 1 (average ratings of rarely). Rationing scores generated using the BERNCA instrument provide a clinically meaningful method for tracking the correlates of low resources or difficulties in resource allocation on patient outcomes. Thresholds identified here provide parameters for administrators to

  14. A new internet-based tool for reporting and analysing patient-reported outcomes and the feasibility of repeated data collection from patients with myeloproliferative neoplasms.

    Science.gov (United States)

    Brochmann, Nana; Zwisler, Ann-Dorthe; Kjerholt, Mette; Flachs, Esben Meulengracht; Hasselbalch, Hans Carl; Andersen, Christen Lykkegaard

    2016-04-01

    An Internet-based tool for reporting and analysing patient-reported outcomes (PROs) has been developed. The tool enables merging PROs with blood test results and allows for computation of treatment responses. Data may be visualized by graphical analysis and may be exported for downstream statistical processing. The aim of this study was to investigate, whether patients with myeloproliferative neoplasms (MPNs) were willing and able to use the tool and fill out questionnaires regularly. Participants were recruited from the outpatient clinic at the Department of Haematology, Roskilde University Hospital, Denmark. Validated questionnaires that were used were European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, Myeloproliferative Neoplasm Symptom Assessment Form, Brief Fatigue Inventory and Short Form 36 Health Survey. Questionnaires were filled out ≥ 6 months online or on paper according to participant preference. Regularity of questionnaire submission was investigated, and participant acceptance was evaluated by focus-group interviews. Of 135 invited patients, 118 (87 %) accepted participation. One hundred and seven participants (91 %) preferred to use the Internet-based tool. Of the 118 enrolled participants, 104 (88 %) submitted PROs regularly ≥ 6 months. The focus-group interviews revealed that the Internet-based tool was well accepted. The Internet-based approach and regular collection of PROs are well accepted with a high participation rate, persistency and adherence in a population of MPN patients. The plasticity of the platform allows for adaptation to patients with other medical conditions.

  15. The relationship between pain severity and patient-reported outcomes among patients with chronic low back pain in Japan

    Directory of Open Access Journals (Sweden)

    Montgomery W

    2016-06-01

    Full Text Available William Montgomery,1 Jeffrey Vietri,2 Jing Shi,3 Kei Ogawa,4 Sawako Kariyasu,4 Levent Alev,4 Masaya Nakamura5 1Eli Lilly Australia Pty Ltd., Sydney, NSW, Australia; 2Health Outcomes Practice, Kantar Health, Horsham, PA, 3Health Outcomes Practice, Kantar Health, Princeton, NJ, USA; 4Eli Lilly Japan K.K., Kobe, Japan; 5Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan Objective: The aim of this study was to quantify the impact of pain severity on patient-reported outcomes among individuals diagnosed with chronic low back pain in Japan. Methods: Data were provided by the 2012 Japan National Health and Wellness Survey (N=29,997, a web-based survey of individuals in Japan aged ≥18 years. This analysis included respondents diagnosed with low back pain of ≥3-month duration. Measures included the revised Medical Outcomes Study 36-Item Short-Form Survey Instrument, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the Work Productivity and Activity Impairment: General Health questionnaire, and self-reported all-cause health care visits (6 months. Generalized linear models were used to assess the relationship between outcomes and severity of pain in the past week as reported on a numeric rating scale ranging from 0 (no pain to 10 (pain as bad as you can imagine, controlling for length of diagnosis, sociodemographics, and general health characteristics. Results: A total of 290 respondents were included in the analysis; mean age was 56 years, 41% were females, and 56% were employed. Pain severity was 3/10 for the first quartile, 5/10 for the median, and 7/10 for the third quartile of this sample. Increasing severity was associated with lower scores for mental and physical component summaries and Short-Form 6D health utility, higher depression (Patient Health Questionnaire-9 and anxiety (Generalized Anxiety Disorder-7 scores, greater absenteeism and presenteeism, greater activity impairment

  16. Development of Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT-QoL): A novel instrument for medication management.

    Science.gov (United States)

    Sakthong, Phantipa; Suksanga, Phattrapa; Sakulbumrungsil, Rungpetch; Winit-Watjana, Win

    2015-01-01

    Medicines can affect a patient's health-related quality of life (HRQoL), but there exists no standardized HRQoL measure for medication management. To develop the new HRQoL instrument "Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life" (PROMPT-QoL), and to evaluate its content validity and preliminary psychometrics using a Rasch model. The PROMPT-QoL questionnaire was developed through the concept review, item generation, cognitive interviews, and initial psychometric evaluation. Its first draft was initially tested by Round-1 interviews of 120 adult outpatients taking their medicines at least three months continuously. The final draft with 43 items was then constructed and checked by 10 physicians and 5 pharmacists for the questionnaire importance and content validity. Round-2 interviews in six patient groups with 10 patients of each were conducted to elicit patients' understanding of the questionnaire and assess preliminary psychometrics using the Rasch analysis, including fit statistics, person and item reliabilities. The 43-item PROMPT-QoL comprised 10 domains: General Attitude toward Medication Use, Medicine Information, Disease Information, Medicine Effectiveness, Impacts of Medicines and Side-effects, Psychological Impacts of Medication Use, Convenience, Availability and Accessibility, Therapeutic Relationship with Healthcare Providers, and Overall QoL. Based on the patient interviews and expert review, the questionnaire was considered important, useful, and comprehensive. All items and domains yielded content validity indexes above the acceptable values of 0.80 and 0.90, respectively. In Round 2, thirty-nine problems identified in Group 1 were reduced to two issues in Group 6 after amendments. The Rasch analysis revealed eight items were misfit and two domains were reliable for both personal and item aspects (Medicine Information and Psychological Impacts of Medication Use). The newly developed PROMPT-QoL has favorable content

  17. Using R and WinBUGS to fit a generalized partial credit model for developing and evaluating patient-reported outcomes assessments.

    Science.gov (United States)

    Li, Yuelin; Baser, Ray

    2012-08-15

    The US Food and Drug Administration recently announced the final guidelines on the development and validation of patient-reported outcomes (PROs) assessments in drug labeling and clinical trials. This guidance paper may boost the demand for new PRO survey questionnaires. Henceforth, biostatisticians may encounter psychometric methods more frequently, particularly item response theory (IRT) models to guide the shortening of a PRO assessment instrument. This article aims to provide an introduction on the theory and practical analytic skills in fitting a generalized partial credit model (GPCM) in IRT. GPCM theory is explained first, with special attention to a clearer exposition of the formal mathematics than what is typically available in the psychometric literature. Then, a worked example is presented, using self-reported responses taken from the international personality item pool. The worked example contains step-by-step guides on using the statistical languages r and WinBUGS in fitting the GPCM. Finally, the Fisher information function of the GPCM model is derived and used to evaluate, as an illustrative example, the usefulness of assessment items by their information contents. This article aims to encourage biostatisticians to apply IRT models in the re-analysis of existing data and in future research. Copyright © 2012 John Wiley & Sons, Ltd.

  18. The development, implementation and evaluation of a transitional care programme to improve outcomes of frail older patients after hospitalisation

    DEFF Research Database (Denmark)

    Heim, Noor; Rolden, Herbert; van Fenema, Esther M

    2016-01-01

    samples. CONCLUSIONS: by involving stakeholders in designing and developing the transitional care programme, commitment of healthcare providers was secured. Feasible innovations in integrated transitional care for frail older patients after hospitalisation were sustainably implemented from within......BACKGROUND: fragmented healthcare systems are poorly suited to treat the increasing number of older patients with multimorbidity. OBJECTIVE: to report on the development, implementation and evaluation of a regional transitional care programme, aimed at improving the recovery rate of frail...... hospitalised older patients. METHODS: the programme was drafted in co-creation with organisations representing older adults, care providers and knowledge institutes. Conducting an action research project, the incidence of adverse outcomes within 3 months after hospital admission, and long-term care expenses...

  19. Treatment with budesonide/formoterol pressurized metered-dose inhaler in patients with asthma: a focus on patient-reported outcomes

    Directory of Open Access Journals (Sweden)

    Richard D O'Connor

    2011-01-01

    Full Text Available Richard D O'ConnorSharp Rees-Stealy Medical Group, San Diego, CA, USAAbstract: In the United States, budesonide/formoterol pressurized metered-dose inhaler (pMDI is approved for treatment of asthma in patients aged ≥12 years whose asthma is not adequately controlled with an inhaled corticosteroid (ICS or whose disease severity clearly warrants treatment with an ICS and a long-acting β2-adrenergic agonist. This article reviews studies of budesonide/formoterol pMDI in patients with persistent asthma, with a particular focus on patient-reported outcomes (eg, perceived onset of effect, patient satisfaction with treatment, health-related quality of life [HRQL], global assessments, sleep quality and quantity, as these measures reflect patient perceptions of asthma control and disease burden. A search of PubMed and respiratory meetings was performed to identify relevant studies. In two pivotal budesonide/formoterol pMDI studies in adolescents and adults, greater efficacy and similar tolerability were shown with budesonide/formoterol pMDI 160/9 µg and 320/9 µg twice daily versus its monocomponents or placebo. In those studies, improvements in HRQL, patient satisfaction, global assessments of asthma control, and quality of sleep also favored budesonide/formoterol pMDI compared with one or both of its monocomponents or placebo. Budesonide/formoterol pMDI has a rapid onset of effect (within 15 minutes that patients can feel, an attribute that may have benefits for treatment adherence. In summary, budesonide/formoterol pMDI is effective and well tolerated and has additional therapeutic benefits that may be important from the patient’s perspective.Keywords: budesonide, formoterol, patient-reported outcomes, efficacy, tolerability, onset of effect

  20. International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome instrument for children and young adults with cleft lip and/or palate (CLEFT-Q).

    Science.gov (United States)

    Wong Riff, Karen W Y; Tsangaris, Elena; Goodacre, Tim; Forrest, Christopher R; Pusic, Andrea L; Cano, Stefan J; Klassen, Anne F

    2017-01-11

    Patient-reported outcome (PRO) instruments should be developed according to rigorous guidelines in order to provide clinically meaningful, scientifically sound measurement. Understanding the methodology behind instrument development informs the selection of the most appropriate tool. This mixed methods protocol describes the development of an internationally applicable PRO instrument, the CLEFT-Q, for evaluating outcomes of treatment for cleft lip and/or palate (CL/P). The study includes three main phases that occur iteratively and interactively. In phase I, we determine what concepts are important to patients regarding their outcome. A conceptual framework for the CLEFT-Q is formed through a systematic review and an extensive international qualitative study. The systematic review ascertains what concepts have previously been measured in patients with CL/P. The qualitative study employs interpretive description and involves in-depth interviews with patients in high-income and lower-middle income countries. Preliminary items are generated from the qualitative data. Preliminary scales are then created for each theme in the framework. Cognitive debriefing interviews and expert clinician input are used to refine the scales in an iterative process. In phase II, the preliminary scales are administered to a large international group of patients with CL/P. The modern psychometric method of Rasch Measurement Theory analysis is employed to define the measurement characteristics. The preliminary scales are shortened based on these results. In phase III, further tests assess reliability, validity and responsiveness of the instrument. The study is approved by Research Ethics Boards for each participating site. Findings from this study will be published in open access peer-reviewed journals and presented at national and international conferences. Integrated knowledge translation is employed to engage stakeholders from the outset of the study. Successful execution of the CLEFT

  1. Patient-reported outcome after fast-track knee arthroplasty

    DEFF Research Database (Denmark)

    Larsen, Kristian; Hansen, Torben B; Søballe, Kjeld

    2012-01-01

    PURPOSE: The purpose of this study was to describe patient-related functional outcomes after fast-track total knee arthroplasty and unicompartmental knee arthroplasty. Furthermore, we wanted to assess physical areas where an additional need for rehabilitation could be identified, and finally, we...

  2. Mixed-methods development of a new patient-reported outcome instrument for chronic low back pain: part 1-the Patient Assessment for Low Back Pain - Symptoms (PAL-S).

    Science.gov (United States)

    Martin, Mona L; Blum, Steven I; Liedgens, Hiltrud; Bushnell, Donald M; McCarrier, Kelly P; Hatley, Noël V; Ramasamy, Abhilasha; Freynhagen, Rainer; Wallace, Mark; Argoff, Charles; Eerdekens, Mariёlle; Kok, Maurits; Patrick, Donald L

    2018-06-01

    We describe the mixed-methods (qualitative and quantitative) development and preliminary validation of the Patient Assessment for Low Back Pain-Symptoms (PAL-S), a patient-reported outcome measure for use in chronic low back pain (cLBP) clinical trials. Qualitative methods (concept elicitation and cognitive interviews) were used to identify and refine symptom concepts and quantitative methods (classical test theory and Rasch measurement theory) were used to evaluate item- and scale-level performance of the measure using an iterative approach. Patients with cLBP participated in concept elicitation interviews (N = 43), cognitive interviews (N = 38), and interview-based assessment of paper-to-electronic mode equivalence (N = 8). A web-based sample of patients with self-reported cLBP participated in quantitative studies to evaluate preliminary (N = 598) and revised (n = 401) drafts and a physician-diagnosed cohort of patients with cLBP (N = 45) participated in preliminary validation of the measure. The PAL-S contained 14 items describing symptoms (overall pain, sharp, prickling, sensitive, tender, radiating, shocking, shooting, burning, squeezing, muscle spasms, throbbing, aching, and stiffness). Item-level performance, scale structure, and scoring seemed to be appropriate. One-week test-retest reproducibility was acceptable (intraclass correlation coefficient 0.81 [95% confidence interval, 0.61-0.91]). Convergent validity was demonstrated with total score and MOS-36 Bodily Pain (Pearson correlation -0.79), Neuropathic Pain Symptom Inventory (0.73), Roland-Morris Disability Questionnaire (0.67), and MOS-36 Physical Functioning (-0.65). Individual item scores and total score discriminated between numeric rating scale tertile groups and painDETECT categories. Respondent interpretation of paper and electronic administration modes was equivalent. The PAL-S has demonstrated content validity and is potentially useful to assess treatment benefit in cLBP clinical trials.

  3. The development and validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the acute respiratory tract infection questionnaire.

    Science.gov (United States)

    Aabenhus, Rune; Thorsen, Hanne; Siersma, Volkert; Brodersen, John

    2013-01-01

    Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. Qualitative interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model to test dimensionality, objectivity, and reliability of items. Test of known groups' validity was conducted by comparing participants with and without an ARTI. The final version of the ARTIQ consisted of 38 items covering five dimensions (Physical-upper, Physical-lower, Psychological, Sleep, and Medicine) and five single items. All final dimensions were confirmed to fit the Rasch model, thus enabling sum-scaling of responses. The ARTIQ scores in participants with an ARTI were significantly higher than in those without ARTI (known groups' validity). A self-administered, multidimensional, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

  4. Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears

    DEFF Research Database (Denmark)

    Thorlund, Jonas Bloch; Englund, Martin; Christensen, Robin

    2017-01-01

    OBJECTIVES: To compare patient reported outcomes from before surgery to 52 weeks after surgery between individuals undergoing arthroscopic partial meniscectomy for traumatic meniscal tears and those for degenerative meniscal tears. DESIGN: Comparative prospective cohort study. SETTING: Four public......-55, and undergoing arthroscopic partial meniscectomy for a traumatic or degenerative meniscal tear (defined by a combination of age and symptom onset). INTERVENTIONS: Both participant groups underwent arthroscopic partial meniscectomy for a meniscal tear, with operating surgeons recording relevant information......% women) with a traumatic or degenerative meniscal tear (n=141, mean age 38.7 years (standard deviation 10.9); n=256, 46.6 years (6.4); respectively) were included in the main analysis. At 52 weeks after arthroscopic partial meniscectomy, 55 (14%) patients were lost to follow-up. Statistically...

  5. Cross-cultural validation of a disease-specific patient-reported outcome measure for lupus in Philippines.

    Science.gov (United States)

    Navarra, S V; Tanangunan, R M D V; Mikolaitis-Preuss, R A; Kosinski, M; Block, J A; Jolly, M

    2013-03-01

    LupusPRO is a disease-targeted patient-reported outcome measure that was developed and validated among US patients with systemic lupus erythematosus (SLE). We report the cross-cultural validation results of the LupusPRO English-language version among Filipino SLE patients. The 43-item LupusPRO was pretested in 15 SLE individuals, then administered to 106 SLE patients, along with short-form SF36 and the EQ5D visual analogue scale. A mail/drop-back LupusPRO and change in health status item survey were returned within two to three days. Demographics, clinical and serological characteristics, disease activity and damage measured by PGA, SELENA-SLEDAI, LFA Flare, and SLICC-ACR SLE damage index (SDI) were collected. Internal consistency reliability (ICR), test-retest reliability (TRT), convergent validity (corresponding SF36 domains) and criterion validity (against general health and disease activity measures) were tested. Reported p values are two tailed. A total of 121 Filipino SLE subjects (95% women, median age 31.0 ± 16 years) with at least a high school level of English instruction participated. Median (IQR) PGA, SLEDAI and SDI were 0.0 (1.0), 2.0 (10) and 0 (1), respectively. ICR exceeded 0.7 for all domains except the lupus symptoms domain. TRT was greater than 0.85 for all LupusPRO domains. Convergent and criterion validity were observed against corresponding SF36 domains and disease activity measures. The tool was well received by patients. Confirmatory factor analysis showed good fit. English LupusPRO has fair psychometric properties among SLE patients in the Philippines, and is now available for inclusion in clinical trials and longitudinal studies to test responsiveness to change.

  6. Patient-Reported Esthetic and Functional Outcomes of Primary Total Laparoscopic Intestinal Vaginoplasty in Transgender Women With Penoscrotal Hypoplasia

    NARCIS (Netherlands)

    Bouman, M.B.; Sluis, W.B. van der; Woudenberg Hamstra, L.E. van; Buncamper, M.E.; Kreukels, B.P.; Meijerink, W.J.H.J.; Mullender, M.G.

    2016-01-01

    INTRODUCTION: Puberty-suppressing hormonal treatment may result in penoscrotal hypoplasia in transgender women, making standard penile inversion vaginoplasty not feasible. For these patients, intestinal vaginoplasty is a surgical alternative, but knowledge on patient-reported postoperative outcomes

  7. Reliability of patient-reported outcomes in rheumatoid arthritis patients: an observational prospective study.

    Science.gov (United States)

    Studenic, Paul; Stamm, Tanja; Smolen, Josef S; Aletaha, Daniel

    2016-01-01

    Patient-reported outcomes (PROs) such as pain, patient global assessment (PGA) and fatigue are regularly assessed in RA patients. In the present study, we aimed to explore the reliability and smallest detectable differences (SDDs) of these PROs, and whether the time between assessments has an impact on reliability. Forty RA patients on stable treatment reported the three PROs daily over two subsequent months. We assessed the reliability of these measures by calculating intraclass correlation coefficients (ICCs) and the SDDs for 1-, 7-, 14- and 28-day test-retest intervals. Overall, SDD and ICC were 25 mm and 0.67 for pain, 25 mm and 0.71 for PGA and 30 mm and 0.66 for fatigue, respectively. SDD was higher with longer time period between assessments, ranging from 19 mm (1-day intervals) to 30 mm (28-day intervals) for pain, 19 to 33 mm for PGA, and 26 to 34 mm for fatigue; correspondingly, ICC was smaller with longer intervals, and ranged between the 1- and the 28-day interval from 0.80 to 0.50 for pain, 0.83 to 0.57 for PGA and 0.76 to 0.58 for fatigue. The baseline simplified disease activity index did not have any influence on reliability. Lower baseline PRO scores led to smaller SDDs. Reliability of pain, PGA and fatigue measurements is dependent on the tested time interval and the baseline levels. The relatively high SDDs, even for patients in the lowest tertiles of their PROs, indicate potential issues for assessment of the presence of remission. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  8. Symptom recovery after thoracic surgery: Measuring patient-reported outcomes with the MD Anderson Symptom Inventory.

    Science.gov (United States)

    Fagundes, Christopher P; Shi, Qiuling; Vaporciyan, Ara A; Rice, David C; Popat, Keyuri U; Cleeland, Charles S; Wang, Xin Shelley

    2015-09-01

    Measuring patient-reported outcomes (PROs) has become increasingly important for assessing quality of care and guiding patient management. However, PROs have yet to be integrated with traditional clinical outcomes (such as length of hospital stay), to evaluate perioperative care. This study aimed to use longitudinal PRO assessments to define the postoperative symptom recovery trajectory in patients undergoing thoracic surgery for lung cancer. Newly diagnosed patients (N = 60) with stage I or II non-small cell lung cancer who underwent either standard open thoracotomy or video-assisted thoracoscopic surgery lobectomy reported multiple symptoms from before surgery to 3 months after surgery, using the MD Anderson Symptom Inventory. We conducted Kaplan-Meier analyses to determine when symptoms returned to presurgical levels and to mild-severity levels during recovery. The most-severe postoperative symptoms were fatigue, pain, shortness of breath, disturbed sleep, and drowsiness. The median time to return to mild symptom severity for these 5 symptoms was shorter than the time to return to baseline severity, with fatigue taking longer. Recovery from pain occurred more quickly for patients who underwent lobectomy versus thoracotomy (8 vs 18 days, respectively; P = .022). Patients who had poor preoperative performance status or comorbidities reported higher postoperative pain (all P < .05). Assessing symptoms from the patient's perspective throughout the postoperative recovery period is an effective strategy for evaluating perioperative care. This study demonstrates that the MD Anderson Symptom Inventory is a sensitive tool for detecting symptomatic recovery, with an expected relationship among surgery type, preoperative performance status, and comorbid conditions. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  9. Delivery of Patient-Reported Outcome Instruments by Automated Mobile Phone Text Messaging.

    Science.gov (United States)

    Anthony, Christopher A; Lawler, Ericka A; Glass, Natalie A; McDonald, Katelyn; Shah, Apurva S

    2017-11-01

    Patient-reported outcome (PRO) instruments allow patients to interpret their health and are integral in evaluating orthopedic treatments and outcomes. The purpose of this study was to define: (1) correlation between PROs collected by automated delivery of text messages on mobile phones compared with paper delivery; and (2) patient use characteristics of a technology platform utilizing automated delivery of text messages on mobile phones. Paper versions of the 12-Item Short Form Health Survey (SF-12) and the short form of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) were completed by patients in orthopedic hand and upper extremity clinics. Over the next 48 hours, the same patients also completed the mobile phone portion of the study outside of the clinic which included text message delivery of the SF-12 and QuickDASH, assigned in a random order. Correlations between paper and text message delivery of the 2 PROs were assessed. Among 72 patients, the intraclass correlation coefficient (ICC) between the written and mobile phone delivery of QuickDASH was 0.91 (95% confidence interval [CI], 0.85-0.95). The ICC between the paper and mobile phone delivery of the SF-12 physical health composite score was 0.88 (95% CI, 0.79-0.93) and 0.86 (95% CI, 0.75-0.92) for the SF-12 mental health composite score. We find that text message delivery using mobile phones permits valid assessment of SF-12 and QuickDASH scores. The findings suggest that software-driven automated delivery of text communication to patients via mobile phones may be a valid method to obtain other PRO scores in orthopedic patients.

  10. Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort.

    Science.gov (United States)

    Noar, Mark; Squires, Patrick; Khan, Sulman

    2017-07-01

    Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring symptoms and need for continuous medication use. Refractory LNF patients may receive radiofrequency energy delivery to the lower esophageal sphincter (Stretta) to ameliorate symptoms and medication requirements. The aim was to assess and compare long-term patient-reported outcomes of Stretta in refractory patients with and without previous LNF. We prospectively assessed and compared patient-reported outcomes in 18 refractory LNF patients and 81 standard refractory GERD patients that all underwent Stretta during 10-year follow-up. Patient-reported outcomes measured were GERD-HRQL (health-related quality of life), patient satisfaction scores, and daily medication requirements. The refractory LNF subset demonstrated median improvements in GERD-HRQL, satisfaction, and medication use at all follow-up time points ≥6 months to 10 years, which was significant from a baseline of both on- and off-medications (p  0.05) after Stretta. At 10 years, no significant differences were noted between refractory LNF and standard Stretta subsets regarding medication use (p = 0.088), patient satisfaction (p = 0.573), and GERD-HRQL (p = 0.075). Stretta procedures were completed without difficulty or significant intraoperative or long-term adverse events. Within a small cohort of refractory LNF patients, Stretta resulted in sustained improvement over 10 years with equivalent outcomes to non-LNF standard Stretta patients. Refractory LNF patients are a subpopulation that may be safely, effectively, and robustly aided by Stretta with fewer complications compared to redo of Nissen or chronic medication use.

  11. Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes

    Directory of Open Access Journals (Sweden)

    Yoshifumi Saisho

    2018-05-01

    Full Text Available The efficacy of diabetes treatment should not be evaluated solely by HbA1c levels as they should also focus on patient-reported outcomes (PROs, such as patient satisfaction, wellbeing and quality of life. The Diabetes Treatment Satisfaction Questionnaire (DTSQ has been developed to assess patient satisfaction with diabetes treatment. DTSQ has been translated into more than 100 languages and is widely used in many countries, since it is relatively easy to answer and is used for both patients with and without medical therapy. Novel therapeutic options, such as insulin analogs, incretin-based therapy and sodium-glucose cotransporter 2 (SGLT2 inhibitors, have been shown to improve patient satisfaction using DTSQ for assessments. DTSQ is not only used for comparisons between different medications or treatment strategies, but also can be used to assess the quality of diabetes care in clinical settings. This is important as an improvement in treatment satisfaction may enhance patients’ self-efficacy and adherence to therapy, leading to the achievement of long-term stable glycemic control and reduced risk of diabetic complications. In this review, we summarize the current topics in DTSQ, introducing our own experience, and discuss the role of PROs in diabetes treatment.

  12. Differences in self-reported outcomes of open prostatectomy patients and robotic prostatectomy patients in an international web-based survey.

    Science.gov (United States)

    O'Shaughnessy, Peter Kevin; Laws, Thomas A; Pinnock, Carol; Moul, Judd W; Esterman, Adrian

    2013-12-01

    To compare patient reported outcomes between robotic assisted surgery and non-robotic assisted surgery. This was an international web-based survey based on a qualitative research and literature review, an internet-based questionnaire was developed with approximately 70 items. The questionnaire included both closed and open-ended questions. Responses were received from 193 men of whom 86 had received either open (OP) or robotic (RALP) surgery. A statistically significant (p=0.027), ranked analysis of covariance was found demonstrating higher recent distress in the robotic (RALP) surgery group. Although not statistically significant, there was a pattern of men having robotic (RALP) surgery reporting fewer urinary and bowel problems, but having a greater rate of sexual dysfunction. Men who opt for robotic surgery may have higher expectations for robotic (RALP) surgery, when these expectations are not fully met they may be less likely to accept the consequences of this major cancer surgery. Information regarding surgical choice needs to be tailored to ensure that men diagnosed with prostate cancer are fully informed of not only short term surgical and physical outcomes such as erectile dysfunction and incontinence, but also of potential issues with regards to masculinity, lifestyle and sexual health. Copyright © 2013. Published by Elsevier Ltd.

  13. Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain.

    Science.gov (United States)

    Ramasamy, Abhilasha; Martin, Mona L; Blum, Steven I; Liedgens, Hiltrud; Argoff, Charles; Freynhagen, Rainer; Wallace, Mark; McCarrier, Kelly P; Bushnell, Donald M; Hatley, Noël V; Patrick, Donald L

    2017-06-01

     To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims.  Literature review of existing PRO measures.  Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes.  Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris Disability Questionnaire, Brief Pain Inventory and Brief Pain Inventory Short Form, Musculoskeletal Outcomes Data Evaluation and Management System Spine Module, Orebro Musculoskeletal Pain Questionnaire, and the West Haven-Yale Multidimensional Pain Inventory Interference Scale. The instruments varied in the aspects of pain and/or impacts that they assessed, and none of the instruments fulfilled all criteria for use in clinical trials to support labeling claims based on recommendations outlined in the FDA PRO guidance.  There is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  14. Initial report of the cancer Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function committee: review of sexual function measures and domains used in oncology.

    Science.gov (United States)

    Jeffery, Diana D; Tzeng, Janice P; Keefe, Francis J; Porter, Laura S; Hahn, Elizabeth A; Flynn, Kathryn E; Reeve, Bryce B; Weinfurt, Kevin P

    2009-03-15

    For this report, the authors described the initial activities of the Cancer Patient-Reported Outcomes Measurement Information System (PROMIS)-Sexual Function domain group, which is part of the National Institutes of Health Roadmap Initiative to develop brief questionnaires or individually tailored assessments of quality-of-life domains. Presented are a literature review of sexual function measures used in cancer populations and descriptions of the domains found in those measures. By using a consensus-driven approach, an electronic bibliographic search was conducted for articles that were published from 1991 to 2007, and 486 articles were identified for in-depth review. In total, 257 articles reported the administration of a psychometrically evaluated sexual function measure to individuals who were diagnosed with cancer. Apart from the University of California-Los Angeles Prostate Cancer Index, the International Index of Erectile Function, and the Female Sexual Function Index, the 31 identified measures have not been tested widely in cancer populations. Most measures were multidimensional and included domains related to the sexual response cycle and to general sexual satisfaction. The current review supports the need for a flexible, psychometrically robust measure of sexual function for use in oncology settings and strongly justifies the development of the PROMIS-Sexual Function instrument. When the PROMIS-Sexual Function instrument is available publicly, cancer clinicians and researchers will have another measure with which to assess patient-reported sexual function outcomes in addition to the few legacy measures that were identified through this review. Copyright (c) 2009 American Cancer Society.

  15. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.

    Science.gov (United States)

    Strand, Vibeke; van Vollenhoven, Ronald F; Lee, Eun Bong; Fleischmann, Roy; Zwillich, Samuel H; Gruben, David; Koncz, Tamas; Wilkinson, Bethanie; Wallenstein, Gene

    2016-06-01

    To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep). At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab. Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  16. SRTR center-specific reporting tools: Posttransplant outcomes.

    Science.gov (United States)

    Dickinson, D M; Shearon, T H; O'Keefe, J; Wong, H-H; Berg, C L; Rosendale, J D; Delmonico, F L; Webb, R L; Wolfe, R A

    2006-01-01

    Measuring and monitoring performance--be it waiting list and posttransplant outcomes by a transplant center, or organ donation success by an organ procurement organization and its partnering hospitals--is an important component of ensuring good care for people with end-stage organ failure. Many parties have an interest in examining these outcomes, from patients and their families to payers such as insurance companies or the Centers for Medicare and Medicaid Services; from primary caregivers providing patient counseling to government agencies charged with protecting patients. The Scientific Registry of Transplant Recipients produces regular, public reports on the performance of transplant centers and organ procurement organizations. This article explains the statistical tools used to prepare these reports, with a focus on graft survival and patient survival rates of transplant centers--especially the methods used to fairly and usefully compare outcomes of centers that serve different populations. The article concludes with a practical application of these statistics--their use in screening transplant center performance to identify centers that may need remedial action by the OPTN/UNOS Membership and Professional Standards Committee.

  17. Rasch-family models are more valuable than score-based approaches for analysing longitudinal patient-reported outcomes with missing data.

    Science.gov (United States)

    de Bock, Élodie; Hardouin, Jean-Benoit; Blanchin, Myriam; Le Neel, Tanguy; Kubis, Gildas; Bonnaud-Antignac, Angélique; Dantan, Étienne; Sébille, Véronique

    2016-10-01

    The objective was to compare classical test theory and Rasch-family models derived from item response theory for the analysis of longitudinal patient-reported outcomes data with possibly informative intermittent missing items. A simulation study was performed in order to assess and compare the performance of classical test theory and Rasch model in terms of bias, control of the type I error and power of the test of time effect. The type I error was controlled for classical test theory and Rasch model whether data were complete or some items were missing. Both methods were unbiased and displayed similar power with complete data. When items were missing, Rasch model remained unbiased and displayed higher power than classical test theory. Rasch model performed better than the classical test theory approach regarding the analysis of longitudinal patient-reported outcomes with possibly informative intermittent missing items mainly for power. This study highlights the interest of Rasch-based models in clinical research and epidemiology for the analysis of incomplete patient-reported outcomes data. © The Author(s) 2013.

  18. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    OpenAIRE

    Eisenstein, Eric L.; Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2010-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators ...

  19. The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement

    DEFF Research Database (Denmark)

    Rosenlund, Signe; Broeng, Leif; Jensen, Carsten

    2014-01-01

    BACKGROUND: Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach...... Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include...... physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year. METHODS/DESIGN: The trial...

  20. Challenges and Opportunities in Using Patient-Reported Outcomes in Quality Measurement in Rheumatology

    OpenAIRE

    Wahl, Elizabeth; Yazdany, Jinoos

    2016-01-01

    Use of Patient-reported outcome measures (PROs) in rheumatology research is widespread, but use of PRO data to evaluate the quality of rheumatologic care delivered is less well established. This article reviews the use of PROs in assessing healthcare quality, and highlights challenges and opportunities specific to their use in rheumatology quality measurement. We first explore other countries’ experiences collecting and evaluating national PRO data to assess quality of care. We describe the c...

  1. Creating guidance for the use of patient reported outcome measures (PROMS) in clinical palliatieve care.

    NARCIS (Netherlands)

    Vliet, L.M. van; Harding, R.; Bausewein, C.; Payne, S.; Higginson, I.J.

    2014-01-01

    Introduction: Routine use of Patient Reported Outcome Measures (PROMs) in clinical practice can influence care but is not always achieved. One reason for this seems to be a lack of guidance on how to use PROMs in palliative care practice. This project aimed to provide such guidance. Aim(s) and

  2. Patient-reported outcome after fast-track hip arthroplasty: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Hansen Torben B

    2010-11-01

    Full Text Available Abstract Background A fast-track intervention with a short preoperative optimization period and short postoperative hospitalization has a potential for reduced convalescence and thereby a reduced need for postoperative rehabilitation. The purpose of this study was to describe patient-related outcomes, the need for additional rehabilitation after a fast-track total hip arthroplasty (THA, and the association between generic and disease specific outcomes. Methods The study consisted of 196 consecutive patients of which none received additional rehabilitation beyond an instructional exercise plan at discharge, which was adjusted at one in-patient visit. The patients filled in 3 questionnaires to measure health-related quality-of-life (HRQOL and hip specific function (EQ-5 D, SF36, and Harris Hip Score (HHS at 2 time points pre- and 2 time points postoperatively. The observed results were compared to normative population data for EQ-5 D, SF36, and HHS. Results 3-months postoperatively patients had reached a HRQOL level of 0.84 (SD, 0.14, which was similar to the population norm (P = 0.33, whereas they exceeded the population norm at 12 months postoperatively (P P P = 0.35. For HHS, patients never reached the population norm within 12 months postoperatively. Generic and disease specific outcomes were strongly associated. Conclusions If HRQOL is considered the primary outcome after THA, the need for additional postoperative rehabilitation for all THA patients following a fast-track intervention is questionable. However, a pre- or early postoperative physical intervention seems relevant if the PF of the population norm should be reached at 3 months. If disease specific outcome is considered the primary outcome after fast-track THA, clear goals for the rehabilitation must be established before patient selection, intervention type and timing of intervention can be made.

  3. Establishment of a Web-based System for Collection of Patient-reported Outcomes After Radical Prostatectomy in a Statewide Quality Improvement Collaborative.

    Science.gov (United States)

    Lucas, Steven M; Kim, Tae-Kyung; Ghani, Khurshid R; Miller, David C; Linsell, Susan; Starr, Jay; Peabody, James O; Hurley, Patrick; Montie, James; Cher, Michael L

    2017-09-01

    To report on the establishment of a unified, electronic patient-reported outcome (PRO) infrastructure and pilot results from the first 5 practices enrolled in the web-based collection system developed by the Michigan Urological Surgery Improvement Collaborative. Eligible patients were those undergoing radical prostatectomy of 5 academic and community practices. PRO was obtained using a validated 21-item web-based questionnaire, regarding urinary function, erection function, and sexual interest and satisfaction. Data were collected preoperatively, at 3 months, and 6 months postoperatively. Patients were provided a link via email to complete the surveys. Perioperative and PRO data were analyzed as reports for individual patients and summary performance reports for individual surgeons. Among 773 eligible patients, 688 (89%) were enrolled preoperatively. Survey completion rate was 88%, 84%, and 90% preoperatively, at 3 months, and 6 months. Electronic completion rates preoperatively, at 3 months, and 6 months were 70%, 70%, and 68%, respectively. Mean urinary function scores were 18.3, 14.3, and 16.6 (good function ≥ 17), whereas mean erection scores were 18.7, 7.3, and 9.1 (good erection score ≥ 22) before surgery, at 3 months, and 6 months. Variation was noted for erectile function among the practices. Collection of electronic PRO via this unified, web-based format was successful and provided results that reflect expected recovery and identify opportunities for improvement. This will be extended to more practices statewide to improve outcomes after radical prostatectomy. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

    Science.gov (United States)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Groenvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel

    2016-11-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  6. Achieving optimal delivery of follow-up care for prostate cancer survivors: improving patient outcomes

    Directory of Open Access Journals (Sweden)

    Hudson SV

    2015-03-01

    Full Text Available Shawna V Hudson,1 Denalee M O’Malley,2 Suzanne M Miller3 1Department of Family Medicine and Community Health, Rutgers Robert Wood Johnson Medical School, Somerset, 2Rutgers School of Social Work, New Brunswick, NJ, 3Cancer Prevention and Control Program, Fox Chase Cancer Center/Temple University Health System, Philadelphia, PA, USA Background: Prostate cancer is the most commonly diagnosed cancer in men in the US, and the second most prevalent cancer in men worldwide. High incidence and survival rates for prostate cancer have resulted in a large and growing population of long-term prostate cancer survivors. Long-term follow-up guidelines have only recently been developed to inform approaches to this phase of care for the prostate cancer population. Methods: A PubMed search of English literature through August 2014 was performed. Articles were retrieved and reviewed to confirm their relevance. Patient-reported measures that were used in studies of long-term prostate cancer survivors (ie, at least 2 years posttreatment were reviewed and included in the review. Results: A total of 343 abstracts were initially identified from the database search. After abstract review, 105 full-text articles were reviewed of which seven met inclusion criteria. An additional 22 articles were identified from the references of the included articles, and 29 were retained. From the 29 articles, 68 patient-reported outcome measures were identified. The majority (75% were multi-item scales that had been previously validated in existing literature. We identified four main areas of assessment: 1 physical health; 2 quality of life – general, physical, and psychosocial; 3 health promotion – physical activity, diet, and tobacco cessation; and 4 care quality outcomes. Conclusion: There are a number of well-validated measures that assess patient-reported outcomes that document key aspects of long-term follow-up with respect to patient symptoms and quality of life. However

  7. Diabetes technology: improving care, improving patient-reported outcomes and preventing complications in young people with Type 1 diabetes.

    Science.gov (United States)

    Prahalad, P; Tanenbaum, M; Hood, K; Maahs, D M

    2018-04-01

    With the evolution of diabetes technology, those living with Type 1 diabetes are given a wider arsenal of tools with which to achieve glycaemic control and improve patient-reported outcomes. Furthermore, the use of these technologies may help reduce the risk of acute complications, such as severe hypoglycaemia and diabetic ketoacidosis, as well as long-term macro- and microvascular complications. In addition, diabetes technology can have a beneficial impact on psychosocial health by reducing the burden of diabetes. Unfortunately, diabetes goals are often unmet and people with Type 1 diabetes too frequently experience acute and long-term complications of this condition, in addition to often having less than ideal psychosocial outcomes. Increasing realization of the importance of patient-reported outcomes is leading to diabetes care delivery becoming more patient-centred. Diabetes technology in the form of medical devices, digital health and big data analytics have the potential to improve clinical care and psychosocial support, resulting in lower rates of acute and chronic complications, decreased burden of diabetes care, and improved quality of life. © 2018 Diabetes UK.

  8. What Factors are Predictive of Patient-reported Outcomes? A Prospective Study of 337 Shoulder Arthroplasties.

    Science.gov (United States)

    Matsen, Frederick A; Russ, Stacy M; Vu, Phuong T; Hsu, Jason E; Lucas, Robert M; Comstock, Bryan A

    2016-11-01

    Although shoulder arthroplasties generally are effective in improving patients' comfort and function, the results are variable for reasons that are not well understood. We posed two questions: (1) What factors are associated with better 2-year outcomes after shoulder arthroplasty? (2) What are the sensitivities, specificities, and positive and negative predictive values of a multivariate predictive model for better outcome? Three hundred thirty-nine patients having a shoulder arthroplasty (hemiarthroplasty, arthroplasty for cuff tear arthropathy, ream and run arthroplasty, total shoulder or reverse total shoulder arthroplasty) between August 24, 2010 and December 31, 2012 consented to participate in this prospective study. Two patients were excluded because they were missing baseline variables. Forty-three patients were missing 2-year data. Univariate and multivariate analyses determined the relationship of baseline patient, shoulder, and surgical characteristics to a "better" outcome, defined as an improvement of at least 30% of the maximal possible improvement in the Simple Shoulder Test. The results were used to develop a predictive model, the accuracy of which was tested using a 10-fold cross-validation. After controlling for potentially relevant confounding variables, the multivariate analysis showed that the factors significantly associated with better outcomes were American Society of Anesthesiologists Class I (odds ratio [OR], 1.94; 95% CI, 1.03-3.65; p = 0.041), shoulder problem not related to work (OR, 5.36; 95% CI, 2.15-13.37; p factors listed above. The area under the receiver operating characteristic curve generated from the cross-validated enhanced predictive model was 0.79 (generally values of 0.7 to 0.8 are considered fair and values of 0.8 to 0.9 are considered good). The false-positive fraction and the true-positive fraction depended on the cutoff probability selected (ie, the selected probability above which the prediction would be classified as

  9. Survey and online discussion groups to develop a patient-rated outcome measure on acceptability of treatment response in vitiligo

    Science.gov (United States)

    2014-01-01

    Background Vitiligo is a chronic depigmenting skin disorder which affects around 0.5-1% of the world’s population. The outcome measures used most commonly in trials to judge treatment success focus on repigmentation. Patient-reported outcome measures of treatment success are rarely used, although recommendations have been made for their inclusion in vitiligo trials. This study aimed to evaluate the face validity of a new patient-reported outcome measure of treatment response, for use in future trials and clinical practice. Method An online survey to gather initial views on what constitutes treatment success for people with vitiligo or their parents/carers, followed by online discussion groups with patients to reach consensus on what constitutes treatment success for individuals with vitiligo, and how this can be assessed in the context of trials. Participants were recruited from an existing database of vitiligo patients and through posts on the social network sites Facebook and Twitter. Results A total of 202 survey responses were received, of which 37 were excluded and 165 analysed. Three main themes emerged as important in assessing treatment response: a) the match between vitiligo and normal skin (how well it blends in); b) how noticeable the vitiligo is and c) a reduction in the size of the white patches. The majority of respondents said they would consider 80% or more repigmentation to be a worthwhile treatment response after 9 months of treatment. Three online discussion groups involving 12 participants led to consensus that treatment success is best measured by asking patients how noticeable their vitiligo is after treatment. This was judged to be best answered using a 5-point Likert scale, on which a score of 4 or 5 represents treatment success. Conclusions This study represents the first step in developing a patient reported measure of treatment success in vitiligo trials. Further work is now needed to assess its construct validity and responsiveness to

  10. Patient-reported outcomes of catheter-based accelerated partial breast brachytherapy and whole breast irradiation, a single institution experience.

    Science.gov (United States)

    Jethwa, Krishan R; Kahila, Mohamed M; Mara, Kristin C; Harmsen, William S; Routman, David M; Pumper, Geralyn M; Corbin, Kimberly S; Sloan, Jeff A; Ruddy, Kathryn J; Hieken, Tina J; Park, Sean S; Mutter, Robert W

    2018-05-01

    Accelerated partial breast irradiation (APBI) and whole breast irradiation (WBI) are treatment options for early-stage breast cancer. The purpose of this study was to compare patient-reported-outcomes (PRO) between patients receiving multi-channel intra-cavitary brachytherapy APBI or WBI. Between 2012 and 2015, 131 patients with ductal carcinoma in situ (DCIS) or early stage invasive breast cancer were treated with adjuvant APBI (64) or WBI (67) and participated in a PRO questionnaire. The linear analog scale assessment (LASA), harvard breast cosmesis scale (HBCS), PRO-common terminology criteria for adverse events- PRO (PRO-CTCAE), and breast cancer treatment outcome scale (BCTOS) were used to assess quality of life (QoL), pain, fatigue, aesthetic and functional status, and breast cosmesis. Comparisons of PROs were performed using t-tests, Wilcoxon rank-sum, Chi square, Fisher exact test, and regression methods. Median follow-up from completion of radiotherapy and questionnaire completion was 13.3 months. There was no significant difference in QoL, pain, or fatigue severity, as assessed by the LASA, between treatment groups (p > 0.05). No factors were found to be predictive of overall QoL on regression analysis. BCTOS health-related QoL scores were similar between treatment groups (p = 0.52).The majority of APBI and WBI patients reported excellent/good breast cosmesis, 88.5% versus 93.7% (p = 0.37). Skin color change (p = 0.011) and breast elevation (p = 0.01) relative to baseline were more common in the group receiving WBI. APBI and WBI were both associated with favorable patient-reported outcomes in early follow-up. APBI resulted in a lesser degree of patient-reported skin color change and breast elevation relative to baseline.

  11. Bilateral Arthrodesis of the Ankle Joint: Self-Reported Outcomes in 35 Patients From the Swedish Ankle Registry.

    Science.gov (United States)

    Henricson, Anders; Kamrad, Ilka; Rosengren, Björn; Carlsson, Åke

    Bilateral ankle arthrodesis is seldom performed, and results concerning the outcome and satisfaction can only sparsely be found in published studies. We analyzed the data from 35 patients who had undergone bilateral ankle arthrodesis in the Swedish Ankle Registry using patient-reported generic and region-specific outcome measures. Of 36 talocrural arthrodeses and 34 tibio-talar-calcaneal arthrodeses, 6 ankles (9%) had undergone repeat arthrodesis because of nonunion. After a mean follow-up period of 47 ± 5 (range 12 to 194) months, the mean scores were as follows: self-reported foot and ankle score, 33 ± 10 (range 4 to 48); the EuroQol Group's EQ-5D ™ score, 0.67 ± 0.28 (range -0.11 to 1), the EuroQol Group's visual analog scale score, 70 ± 19 (range 20 to 95), 36-item Short Form Health Survey (SF-36) physical domain, 39 ± 11 (range 16 to 58); and SF-36 mental domain, 54 ± 14 (range 17 to 71). Patients with rheumatoid arthritis seemed to have similar self-reported foot and ankle scores but possibly lower EQ-5D ™ and SF-36 scores. Those with talocrural arthrodeses scored higher than did those with tibio-talar-calcaneal arthrodeses on the EQ5D ™ and SF-36 questionnaires (p = .03 and p = .04). In 64 of 70 ankles (91%), the patients were satisfied or very satisfied with the outcome. In conclusion, we consider bilateral ankle arthrodesis to be a reasonable treatment for symptomatic hindfoot arthritis, with high postoperative mid-term satisfaction and satisfactory scores on the patient-reported generic and region-specific outcome measures, when no other treatment option is available. Copyright © 2016 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

  12. Nurses' extended work hours: Patient, nurse and organizational outcomes.

    Science.gov (United States)

    Kunaviktikul, W; Wichaikhum, O; Nantsupawat, A; Nantsupawat, R; Chontawan, R; Klunklin, A; Roongruangsri, S; Nantachaipan, P; Supamanee, T; Chitpakdee, B; Akkadechanunt, T; Sirakamon, S

    2015-09-01

    Nursing shortages have been associated with increased nurse workloads that may result in work errors, thus impacting patient, nurse and organizational outcomes. To examine for the first time in Thailand nurses' extended work hours (working more than 40 h per week) and its relationship to patient, nurse and organizational outcomes. Using multistage sampling, 1524 registered nurses working in 90 hospitals across Thailand completed demographic forms: the Nurses' Extended Work Hours Form; the Patient, Nurse, Organizational Outcomes Form; the Organizational Productivity Questionnaire and the Maslach Burnout Inventory. The data were analysed using descriptive statistics, Spearman's rank correlation and logistic regression. The average extended work hour of respondents was 18.82 h per week. About 80% worked two consecutive shifts. The extended work hours had a positive correlation with patient outcomes, such as patient identification errors, pressure ulcers, communication errors and patient complaints and with nurse outcomes of emotional exhaustion and depersonalization. Furthermore, we found a negative correlation between extended work hours and job satisfaction as a whole, intent to stay and organizational productivity. Nurses who had extended work hours of >16 h per week were significantly more likely to perceive all four adverse patient outcomes than participants working an extended ≤8 h per week. Patient outcomes were measured by respondents' self-reports. This may not always reflect the real occurrence of adverse events. Associations between extended work hours and outcomes for patients, nurses and the organization were found. The findings demonstrate that working two shifts (16 h) more than the regular work hours lead to negative outcomes for patients, nurses and the organization. Our findings add to increasing international evidence that nurses' poor working conditions result in negative outcomes for professionals, patients and health systems

  13. The Role of Technical Advances in the Adoption and Integration of Patient-Reported Outcomes in Clinical Care

    Science.gov (United States)

    Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.

    2016-01-01

    Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135

  14. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  15. Coronary artery disease prevalence and outcome in patients hospitalized with acute heart failure: an observational report from seven Middle Eastern countries.

    Science.gov (United States)

    Salam, Amar M; Sulaiman, Kadhim; Al-Zakwani, Ibrahim; Alsheikh-Ali, Alawi; Aljaraallah, Mohammed; Al Faleh, Husam; Elasfar, Abdelfatah; Panduranga, Prasanth; Singh, Rajvir; Abi Khalil, Charbel; Al Suwaidi, Jassim

    2016-12-01

    The purpose of this study was to report prevalence, clinical characteristics, precipitating factors, management and outcome of patients with coronary artery disease (CAD) among patients hospitalized with heart failure (HF) in seven Middle Eastern countries and compare them to non-CAD patients. Data were derived from Gulf CARE (Gulf aCute heArt failuRe rEgistry), a prospective multicenter study of 5005 consecutive patients hospitalized with acute HF during February-November 2012 in 7 Middle Eastern countries. The prevalence of CAD among Acute Heart Failure (AHF) patients was 60.2% and varied significantly among the 7 countries (Qatar 65.7%, UAE 66.6%, Kuwait 68.0%, Oman 65.9%, Saudi Arabia 62.5%, Bahrain 52.7% and Yemen 49.1%) with lower values in the lower income countries. CAD patients were older and more likely to have diabetes, hypertension, dyslipidemia and chronic kidney disease. Moreover, CAD patients were more likely to have history of cerebrovascular and peripheral vascular disease when compared to non-CAD patients. In-hospital mortality rates were comparable although CAD patients had more frequent re-hospitalization and worse long-term outcome. However, CAD was not an independent predictor of poor outcome. The prevalence of CAD amongst patients with HF in the Middle East is variable and may be related to healthcare sources. Regional and national studies are needed for assessing further the impact of various etiologies of HF and for developing appropriate strategies to combat this global concern.

  16. Toward Ensuring Health Equity: Readability and Cultural Equivalence of OMERACT Patient-reported Outcome Measures.

    Science.gov (United States)

    Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle; Welch, Vivian; Rader, Tamara; Lyddiatt, Anne; Clerehan, Rosemary; Christensen, Robin; Boonen, Annelies; Goel, Niti; Maxwell, Lara J; Toupin-April, Karine; De Wit, Maarten; Barton, Jennifer; Flurey, Caroline; Jull, Janet; Barnabe, Cheryl; Sreih, Antoine G; Campbell, Willemina; Pohl, Christoph; Duruöz, Mehmet Tuncay; Singh, Jasvinder A; Tugwell, Peter S; Guillemin, Francis

    2015-12-01

    The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.

  17. Pregnancy Outcomes Among Patients With Vasculitis

    Science.gov (United States)

    Clowse, Megan E. B.; Richeson, Rachel L.; Pieper, Carl; Merkel, Peter A.

    2015-01-01

    Objective Pregnancy outcomes of patients with vasculitis are unknown, but are of great concern to patients and physicians. Through an online survey, this study assessed pregnancy outcomes among patients with vasculitis. Methods Participants in the Vasculitis Clinical Research Consortium Patient Contact Registry were invited to respond to an anonymous, internet-based survey that included questions about pregnancy outcomes, the timing of pregnancy relative to a diagnosis of vasculitis, and medication use. Results A total of 350 women and 113 men completed the survey. After a diagnosis of vasculitis, 74 pregnancies were reported by women and 18 conceptions were reported by men. The rate of pregnancy loss was higher among women who conceived after a diagnosis of vasculitis compared to those who conceived prior to diagnosis (33.8% versus 22.4%; P = 0.04). Among women, the rate of preterm births increased significantly for pregnancies conceived after a diagnosis of vasculitis relative to those conceived before diagnosis (23.3% versus 11.4%; P = 0.03). Only 18% of women reported worsening of vasculitis during pregnancy, but those who experienced increased vasculitis activity were more likely to deliver preterm. Exposure to cyclophosphamide or prednisone did not appear to impact pregnancy outcomes; however, the number of pregnancies among women taking these medications was small. Among the pregnancies conceived by men with vasculitis, the timing of diagnosis had no significant effect on the rate of pregnancy loss. Conclusion Women who conceived after a diagnosis of vasculitis had a higher rate of pregnancy loss than those who conceived prior to diagnosis. Vasculitis did not worsen during the majority of pregnancies conceived after diagnosis. PMID:23401494

  18. Treatment of patients with hand osteoarthritis : outcome measures, patient satisfaction, and economic evaluation

    NARCIS (Netherlands)

    Marks, Miriam

    2014-01-01

    The aim of this thesis was to investigate the limitations in daily life, outcome measures, clinical outcomes with the emphasis on patient satisfaction, and economic aspects of the treatment of hand osteoarthritis (OA). Patients with hand OA report severe restrictions in daily life, in particular in

  19. Systematic literature review of patient-reported outcome measures used in assessment and measurement of sleep disorders in chronic obstructive pulmonary disease.

    Science.gov (United States)

    Garrow, Adam P; Yorke, Janelle; Khan, Naimat; Vestbo, Jørgen; Singh, Dave; Tyson, Sarah

    2015-01-01

    Sleep problems are common in patients with chronic obstructive pulmonary disease (COPD), but the validity of patient-reported outcome measures (PROMs) that measure sleep dysfunction has not been evaluated. We have reviewed the literature to identify disease-specific and non-disease-specific sleep PROMs that have been validated for use in COPD patients. The review also examined the psychometric properties of identified sleep outcome measures and extracted point and variability estimates of sleep instruments used in COPD studies. The online EMBASE, MEDLINE, PsycINFO, and SCOPUS databases for all years to May 2014 were used to source articles for the review. The review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Criteria from the Medical Outcomes Trust Scientific Advisory Committee guidelines were used to evaluate the psychometric properties of all sleep PROMs identified. One COPD-specific and six non-COPD-specific sleep outcome measures were identified and 44 papers met the review selection criteria. We only identified one instrument, the COPD and Asthma Sleep Impact Scale, which was developed specifically for use in COPD populations. Ninety percent of the identified studies used one of two non-disease-specific sleep scales, ie, the Pittsburgh Sleep Quality Index and/or the Epworth Sleep Scale, although neither has been tested for reliability or validity in people with COPD. The results highlight a need for existing non-disease-specific instruments to be validated in COPD populations and also a need for new disease-specific measures to assess the impact of sleep problems in COPD.

  20. Patient-reported outcomes 5 years after laser in situ keratomileusis.

    Science.gov (United States)

    Schallhorn, Steven C; Venter, Jan A; Teenan, David; Hannan, Stephen J; Hettinger, Keith A; Pelouskova, Martina; Schallhorn, Julie M

    2016-06-01

    To assess vision-related, quality-of-life outcomes 5 years after laser in situ keratomileusis (LASIK) and determine factors predictive of patient satisfaction. Optical Express, Glasgow, Scotland. Retrospective case series. Data from patients who had attended a clinical examination 5 years after LASIK were analyzed. All treatments were performed using the Visx Star S4 IR excimer laser. Patient-reported satisfaction, the effect of eyesight on various activities, visual phenomena, and ocular discomfort were evaluated 5 years postoperatively. Multivariate regression analysis was performed to determine factors affecting patient satisfaction. The study comprised 2530 patients (4937 eyes) who had LASIK. The mean age at the time of surgery was 42.4 years ± 12.5 (SD), and the preoperative manifest spherical equivalent ranged from -11.0 diopters (D) to +4.88 D. Five years postoperatively, 79.3% of eyes were within ±0.50 D of emmetropia and 77.7% of eyes achieved monocular uncorrected distance visual acuity (UDVA) and 90.6% of eyes achieved binocular UDVA of 20/20 or better. Of the patients, 91.0% said they were satisfied with their vision and 94.9% did not wear distance correction. Less than 2.0% of patients noticed visual phenomena, even with spectacle correction. Major predictors of patient satisfaction 5 years postoperatively were postoperative binocular UDVA (37.6% variance explained by regression model), visual phenomena (relative contribution of 15.0%), preoperative and postoperative sphere and their interactions (11.6%), and eyesight-related difficulties with various activities such as night driving, outdoor activities, and reading (10.2%). Patient-reported quality-of-life and satisfaction rates remained high 5 years after LASIK. Uncorrected vision was the strongest predictor of satisfaction. Dr. S.C. Schallhorn is a consultant to Abbott Medical Optics, Inc., Zeiss Meditec AG, and Autofocus Inc. and a global medical director for Optical Express. No other

  1. Core outcome sets in dermatology: report from the second meeting of the International Cochrane Skin Group Core Outcome Set Initiative.

    Science.gov (United States)

    Kottner, J; Jacobi, L; Hahnel, E; Alam, M; Balzer, K; Beeckman, D; Busard, C; Chalmers, J; Deckert, S; Eleftheriadou, V; Furlan, K; Horbach, S E R; Kirkham, J; Nast, A; Spuls, P; Thiboutot, D; Thorlacius, L; Weller, K; Williams, H C; Schmitt, J

    2018-04-01

    Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers. © 2018 British Association of Dermatologists.

  2. High Variability in Outcome Reporting Patterns in High-Impact ACL Literature.

    Science.gov (United States)

    Makhni, Eric C; Padaki, Ajay S; Petridis, Petros D; Steinhaus, Michael E; Ahmad, Christopher S; Cole, Brian J; Bach, Bernard R

    2015-09-16

    ACL (anterior cruciate ligament) reconstruction is one of the most commonly performed and studied procedures in modern sports medicine. A multitude of objective and subjective patient outcome measures exists; however, nonstandardized reporting patterns of these metrics may create challenges in objectively analyzing pooled results from different studies. The goal of this study was to document the variability in outcome reporting patterns in high-impact orthopaedic studies of ACL reconstruction. All clinical studies pertaining to ACL reconstruction in four high-impact-factor orthopaedic journals over a five-year period were reviewed. Biomechanical, basic science, and imaging studies were excluded, as were studies with fewer than fifty patients, yielding 119 studies for review. Incorporation of various objective and subjective outcomes was noted for each study. Substantial variability in reporting of both objective and subjective measures was noted in the study cohort. Although a majority of studies reported instrumented laxity findings, there was substantial variability in the type and method of laxity reporting. Most other objective outcomes, including range of motion, strength, and complications, were reported in <50% of all studies. Return to pre-injury level of activity was infrequently reported (24% of studies), as were patient satisfaction and pain assessment following surgery (8% and 13%, respectively). Of the patient-reported outcomes, the International Knee Documentation Committee (IKDC), Lysholm, and Tegner scores were most often reported (71%, 63%, and 42%, respectively). Substantial variability in outcome reporting patterns exists among high-impact studies of ACL reconstruction. Such variability may create challenges in interpreting results and pooling them across different studies. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

  3. Cosmetic Outcomes and Complications Reported by Patients Having Undergone Breast-Conserving Treatment

    International Nuclear Information System (INIS)

    Hill-Kayser, Christine E.; Vachani, Carolyn; Hampshire, Margaret K.; Di Lullo, Gloria A.; Metz, James M.

    2012-01-01

    Purpose: Over the past 30 years, much work in treatment of breast cancer has contributed to improvement of cosmetic and functional outcomes. The goal of breast-conservation treatment (BCT) is avoidance of mastectomy through use of lumpectomy and adjuvant radiation. Modern data demonstrate “excellent” or “good” cosmesis in >90% of patients treated with BCT. Methods and Materials: Patient-reported data were gathered via a convenience sample frame from breast cancer survivors using a publically available, free, Internet-based tool for creation of survivorship care plans. During use of the tool, breast cancer survivors are queried as to the cosmetic appearance of the treated breast, as well as perceived late effects. All data have been maintained anonymously with internal review board approval. Results: Three hundred fifty-four breast cancer survivors having undergone BCT and voluntarily using this tool were queried with regard to breast cosmesis and perceived late effects. Median diagnosis age was 48 years, and median current age 52 years. “Excellent” cosmesis was reported by 27% (n = 88), “Good” by 44% (n = 144), “Fair” by 24% (n = 81), and “Poor” by 5% (n = 18). Of the queries posted to survivors after BCT, late effects most commonly reported were cognitive changes (62%); sexual concerns (52%); changes in texture and color of irradiated skin (48%); chronic pain, numbness, or tingling (35%); and loss of flexibility in the irradiated area (30%). Survivors also described osteopenia/osteoporosis (35%), cardiopulmonary problems (12%), and lymphedema (19%). Conclusions: This anonymous tool uses a convenience sample frame to gather patient reported assessments of cosmesis and complications after breast cancer. Among the BCT population, cosmetic assessment by survivors appears less likely to be “excellent” or “good” than would be expected, with 30% of BCT survivors reporting “fair” or “poor” cosmesis. Patient reported incidence of

  4. Patient-reported outcomes for total hip and knee arthroplasty

    DEFF Research Database (Denmark)

    Collins, Natalie J; Roos, Ewa M.

    2012-01-01

    Although the effectiveness of THA and TKA as interventions for end-stage degenerative joint disease has been well established, the use of instruments that measure outcome from the patient's perspective are relatively poorly investigated. Considering the increasing prevalence, associated risks, an...

  5. Association of Velopharyngeal Insufficiency With Quality of Life and Patient-Reported Outcomes After Speech Surgery.

    Science.gov (United States)

    Bhuskute, Aditi; Skirko, Jonathan R; Roth, Christina; Bayoumi, Ahmed; Durbin-Johnson, Blythe; Tollefson, Travis T

    2017-09-01

    Patients with cleft palate and other causes of velopharyngeal insufficiency (VPI) suffer adverse effects on social interactions and communication. Measurement of these patient-reported outcomes is needed to help guide surgical and nonsurgical care. To further validate the VPI Effects on Life Outcomes (VELO) instrument, measure the change in quality of life (QOL) after speech surgery, and test the association of change in speech with change in QOL. Prospective descriptive cohort including children and young adults undergoing speech surgery for VPI in a tertiary academic center. Participants completed the validated VELO instrument before and after surgical treatment. The main outcome measures were preoperative and postoperative VELO scores and the perceptual speech assessment of speech intelligibility. The VELO scores are divided into subscale domains. Changes in VELO after surgery were analyzed using linear regression models. VELO scores were analyzed as a function of speech intelligibility adjusting for age and cleft type. The correlation between speech intelligibility rating and VELO scores was estimated using the polyserial correlation. Twenty-nine patients (13 males and 16 females) were included. Mean (SD) age was 7.9 (4.1) years (range, 4-20 years). Pharyngeal flap was used in 14 (48%) cases, Furlow palatoplasty in 12 (41%), and sphincter pharyngoplasty in 1 (3%). The mean (SD) preoperative speech intelligibility rating was 1.71 (1.08), which decreased postoperatively to 0.79 (0.93) in 24 patients who completed protocol (P Speech Intelligibility was correlated with preoperative and postoperative total VELO score (P speech intelligibility. Speech surgery improves VPI-specific quality of life. We confirmed validation in a population of untreated patients with VPI and included pharyngeal flap surgery, which had not previously been included in validation studies. The VELO instrument provides patient-specific outcomes, which allows a broader understanding of the

  6. Assessing the impact of a remote digital coaching engagement program on patient-reported outcomes in asthma.

    Science.gov (United States)

    Rasulnia, Mazi; Burton, Billy Stephen; Ginter, Robert P; Wang, Tracy Y; Pleasants, Roy Alton; Green, Cynthia L; Lugogo, Njira

    2017-08-11

    Low adherence and poor outcomes provide opportunity for digital coaching to engage patients with uncontrolled asthma in their care to improve outcomes. To examine the impact of a remote digital coaching program on asthma control and patient experience. We recruited 51 adults with uncontrolled asthma, denoted by albuterol use of >2 times per week and/or exacerbations requiring corticosteroids, and applied a 12-week patient-centered remote digital coaching program using a combination of educational pamphlets, symptom trackers, best peak flow establishment, physical activity, and dietary counseling, as well as coaches who implemented emotional enforcement to motivate disease self-management through telephone, text, and email. Baseline and post-intervention measures were quality of life (QOL), spirometry, Asthma Control Test (ACT), Asthma Symptom Utility Index (ASUI), rescue albuterol use, and exacerbation history. Among 51 patients recruited, 40 completed the study. Eight subjects required assistance reading medical materials. Significant improvements from baseline were observed for Patient-Reported Outcomes Measurement Information System mental status (p = 0.010), body weight, and outpatient exacerbation frequency (p = 0.028). The changes from baseline in ACT (p = 0.005) were statistically significant but did not achieve the pre-specified minimum clinically important difference (MCID), whereas for ASUI, the MCID and statistical significance were achieved. Spirometry and rescue albuterol use were no different. A patient-oriented, remote digital coaching program that utilized trained health coaches and digital materials led to statistically significant improvement in mental status, outpatient exacerbations, body weight, and ASUI. Digital coaching programs may improve some outcomes in adults with uncontrolled asthma.

  7. Patient-reported mental and physical health outcomes are independent predictors of one-year mortality and cardiac events across cardiac diagnoses. Findings from the national DenHeart survey."

    DEFF Research Database (Denmark)

    Berg, Selina Kikkenborg; Thorup, Charlotte Brun; Borregaard, Britt

    2018-01-01

    -reported outcomes at hospital discharge as a predictor of mortality and cardiac events. Design: A cross-sectional survey with register follow-up. Methods: Participants: All patients discharged from April 2013 to April 2014 from five national heart centres in Denmark. Main outcomes: Patient-reported outcomes......Aims: Patient-reported quality of life and anxiety/depression scores provide important prognostic information independently of traditional clinical data. The aims of this study were to describe: (a) mortality and cardiac events one year after hospital discharge across cardiac diagnoses; (b) patient...

  8. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial.

    Science.gov (United States)

    Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George

    2017-06-01

    To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.

  9. The impact of patient-reported outcome measures in clinical practice for pain: a systematic review.

    Science.gov (United States)

    Holmes, Michelle M; Lewith, George; Newell, David; Field, Jonathan; Bishop, Felicity L

    2017-02-01

    Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain. An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument. Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive. Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains.

  10. Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design?

    Directory of Open Access Journals (Sweden)

    Jennifer Ai-Lian Woo

    2015-03-01

    Full Text Available Purpose: Stereotactic body radiation therapy (SBRT is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO endpoints for clinical trials for early stage prostate cancer RT is lacking. To aid in trial design, this study presents PROs over 36 months following SBRT for clinically localized prostate cancer. Methods: 174 hormone-naïve patients were treated with 35-36.25 Gy SBRT in 5 fractions. Patients completed the EPIC-26 questionnaire at baseline and all follow-ups; the proportion of patients developing a clinically significant decline in each EPIC domain was determined. The minimally important difference (MID was defined as a change of one-half SD from the baseline. Per RTOG 0938, we examined the percentage of patients who reported decline in EPIC urinary summary score of >2 points and EPIC bowel summary score of >5 points from baseline to one year. Results: 174 patients received SBRT with minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline in EPIC urinary/bowel scores was 34%/30%, 40%/32.2%, and 32.8%/21.5% at 6, 12, and 36 months. The percentage of patients reporting decline in the EPIC urinary summary score of >2 points was 43.2%, 51.6% and 41.8% at 6, 12, and 36 months. The percentage of patients reporting decline in EPIC bowel domain summary score of >5 points was 29.6% 29% and 22.4% at 6, 12, and 36 months. Conclusion: Our treatment protocol meets the RTOG 0938 criteria for advancing to a Phase III trial compared to conventionally fractionated RT. Between 12-36 months, the proportion of patients reporting decrease in both EPIC urinary and bowel scores declined, suggesting late improvement in these domains. Further investigation is needed to elucidate 1 which domains bear the greatest influence on post-treatment QOL, and 2 at what time point PRO endpoint(s should be assessed.

  11. Improving Clinical Outcomes in Patients With Methicillin-Sensitive Staphylococcus aureus Bacteremia and Reported Penicillin Allergy.

    Science.gov (United States)

    Blumenthal, Kimberly G; Parker, Robert A; Shenoy, Erica S; Walensky, Rochelle P

    2015-09-01

    Methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia is a morbid infection. First-line MSSA therapies (nafcillin, oxacillin, cefazolin) are generally avoided in the 10% of patients reporting penicillin (PCN) allergy, but most of these patients are not truly allergic. We used a decision tree with sensitivity analyses to determine the optimal evaluation and treatment for patients with MSSA bacteremia and reported PCN allergy. Our model simulates 3 strategies: (1) no allergy evaluation, give vancomycin (Vanc); (2) allergy history-guided treatment: if history excludes anaphylactic features, give cefazolin (Hx-Cefaz); and (3) complete allergy evaluation with history-appropriate PCN skin testing: if skin test negative, give cefazolin (ST-Cefaz). Model outcomes included 12-week MSSA cure, recurrence, and death; allergic reactions including major, minor, and potentially iatrogenic; and adverse drug reactions. Vanc results in the fewest patients achieving MSSA cure and the highest rate of recurrence (67.3%/14.8% vs 83.4%/9.3% for Hx-Cefaz and 84.5%/8.9% for ST-Cefaz) as well as the greatest frequency of allergic reactions (3.0% vs 2.4% for Hx-Cefaz and 1.7% for ST-Cefaz) and highest rates of adverse drug reactions (5.2% vs 4.6% for Hx-Cefaz and 4.7% for ST-Cefaz). Even in a "best case for Vanc" scenario, Vanc yields the poorest outcomes. ST-Cefaz is preferred to Hx-Cefaz although sensitive to input variations. Patients with MSSA bacteremia and a reported PCN allergy should have the allergy addressed for optimal treatment. Full allergy evaluation with skin testing seems to be preferred, although more data are needed. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  12. Using Patient-Reported Information to Improve Clinical Practice.

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    Schlesinger, Mark; Grob, Rachel; Shaller, Dale

    2015-12-01

    To assess what is known about the relationship between patient experience measures and incentives designed to improve care, and to identify how public policy and medical practices can promote patient-valued outcomes in health systems with strong financial incentives. Existing literature (gray and peer-reviewed) on measuring patient experience and patient-reported outcomes, identified from Medline and Cochrane databases; evaluations of pay-for-performance programs in the United States, Europe, and the Commonwealth countries. We analyzed (1) studies of pay-for-performance, to identify those including metrics for patient experience, and (2) studies of patient experience and of patient-reported outcomes to identify evidence of influence on clinical practice, whether through public reporting or private reporting to clinicians. First, we identify four forms of "patient-reported information" (PRI), each with distinctive roles shaping clinical practice: (1) patient-reported outcomes measuring self-assessed physical and mental well-being, (2) surveys of patient experience with clinicians and staff, (3) narrative accounts describing encounters with clinicians in patients' own words, and (4) complaints/grievances signaling patients' distress when treatment or outcomes fall short of expectations. Because these forms vary in crucial ways, each must be distinctively measured, deployed, and linked with financial incentives. Second, although the literature linking incentives to patients experience is limited, implementing pay-for-performance systems appears to threaten certain patient-valued aspects of health care. But incentives can be made compatible with the outcomes patients value if: (a) a sufficient portion of incentives is tied to patient-reported outcomes and experiences, (b) incentivized forms of PRI are complemented by other forms of patient feedback, and (c) health care organizations assist clinicians to interpret and respond to PRI. Finally, we identify roles for the

  13. Treatment Adherence and Outcomes of Antiretroviral Agents in HIV Positive Patients

    International Nuclear Information System (INIS)

    Tahir, N. B.; Uddin, Q. T.

    2014-01-01

    Objective: To describe the treatment outcomes in terms of adherence, outcomes and side effects of antiretroviral (ARV) agents. Study Design: An observational study. Place and Duration of Study: Teaching Hospital of Khyber Medical University, Institute of Medical Sciences, Kohat, from February 2007 to December 2012. Methodology: Human Immunodeficiency Virus (HIV) positive patients, taking 1st line ARV agents for at least 6 months were included. Adherence was calculated by self report on asking the number of doses missed in last 30 days. ARVs were provided on monthly basis. Adherence data was noted over a period of 6 months. ARVs outcomes were recorded in the form of adherence, CD4 count, functional status of the patient, change in weight, further transmission of the disease, number of hospital admissions and deaths. Adverse Drug Reactions (ARDs) to ARVs were assessed clinically and by laboratory markers. Mean and standard deviation were calculated for numerical variables while frequencies and percentages were calculated for categorical variables. Results: Total number of patients included in this study were 107. Out of them, 66.4% were males and 33.6% were females. The mean age was 39.9 +- 13.80 years. Patients taking AZT/3TC/NVP, AZT/3TC/EFZ, D4T/3TC/NVP, D4T/3TC/EFZ, TNF/3TC/NVP or EFZ were 49.5%, 22.4%, 10.3%, 4.7% and 13% respectively. Most adverse affects were observed in 10 days to 90 days of initiation of therapy. Rash was observed in 71 (66.4%) patients, anaemia in 4 (3.7%) patients while only one patient (0.93%) had nausea / vomiting. Thirty (28%) patients reported no side effects. Out of 107 patients, 98 (91.5%) were alive whereas 9 (8.4%) died at the end of the study period. Twelve patients had one hospital admission (11.21%) whereas 9 (8.4%) patients had two admissions during the study period. The first mean CD4 was 325.27 cells /mcL whereas mean last CD4 count was 389.86 cells/mcL. Conclusion: ARVs have very satisfactory outcomes in HIV/AIDS patients

  14. Training hospital staff on spiritual care in palliative care influences patient-reported outcomes: Results of a quasi-experimental study.

    Science.gov (United States)

    van de Geer, Joep; Groot, Marieke; Andela, Richtsje; Leget, Carlo; Prins, Jelle; Vissers, Kris; Zock, Hetty

    2017-09-01

    Spiritual care is reported to be important to palliative patients. There is an increasing need for education in spiritual care. To measure the effects of a specific spiritual care training on patients' reports of their perceived care and treatment. A pragmatic controlled trial conducted between February 2014 and March 2015. The intervention was a specific spiritual care training implemented by healthcare chaplains to eight multidisciplinary teams in six hospitals on regular wards in which patients resided in both curative and palliative trajectories. In total, 85 patients were included based on the Dutch translation of the Supportive and Palliative Care Indicators Tool. Data were collected in the intervention and control wards pre- and post-training using questionnaires on physical symptoms, spiritual distress, involvement and attitudes (Spiritual Attitude and Involvement List) and on the perceived focus of healthcare professionals on patients' spiritual needs. All 85 patients had high scores on spiritual themes and involvement. Patients reported that attention to their spiritual needs was very important. We found a significant ( p = 0.008) effect on healthcare professionals' attention to patients' spiritual and existential needs and a significant ( p = 0.020) effect in favour of patients' sleep. No effect on the spiritual distress of patients or their proxies was found. The effects of spiritual care training can be measured using patient-reported outcomes and seemed to indicate a positive effect on the quality of care. Future research should focus on optimizing the spiritual care training to identify the most effective elements and developing strategies to ensure long-term positive effects. This study was registered at the Dutch Trial Register: NTR4559.

  15. Quality of life and urolithiasis: the patient - reported outcomes measurement information system (PROMIS

    Directory of Open Access Journals (Sweden)

    Nishant Patel

    Full Text Available ABSTRACT Background: With a high rate of recurrence, urolithiasis is a chronic disease that impacts quality of life. The Patient Reported Outcomes Measurement Information System is an NIH validated questionnaire to assess patient quality of life. We evaluated the impact of urolithiasis on quality of life using the NIH-sponsored PROMIS-43 questionnaire. Materials and Methods: Patients reporting to the kidney stone clinic were interviewed to collect information on stone history and demographic information and were asked to complete the PROMIS-43 questionnaire. Quality of life scores were analyzed using gender and age matched groups for the general US population. Statistical comparisons were made based on demographic information and patient stone history. Statistical significance was P<0.05. Results: 103 patients completed the survey. 36% of respondents were male, the average age of the group was 52 years old, with 58% primary income earners, and 35% primary caregivers. 7% had never passed a stone or had a procedure while 17% passed 10 or more stones in their lifetime. Overall, pain and physical function were worse in patients with urolithiasis. Primary income earners had better quality of life while primary caregivers and those with other chronic medical conditions were worse. Patients on dietary and medical therapy had better quality of life scores. Conclusions: Urolithiasis patients subjectively have worse pain and physical function than the general population. The impact of pain on quality of life was greatest in those patients who had more stone episodes, underscoring the importance of preventive measures. Stone prevention measures improve quality of life.

  16. eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

    Science.gov (United States)

    Girgis, Afaf; Durcinoska, Ivana; Levesque, Janelle V; Gerges, Martha; Sandell, Tiffany; Arnold, Anthony; Delaney, Geoff P

    2017-10-02

    Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants' assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean

  17. Clinician characteristics, communication, and patient outcome in oncology: a systematic review.

    Science.gov (United States)

    De Vries, A M M; de Roten, Y; Meystre, C; Passchier, J; Despland, J-N; Stiefel, F

    2014-04-01

    The aim of this study was to review the literature on clinician characteristics influencing patient-clinician communication or patient outcome in oncology. Studies investigating the association of clinician characteristics with quality of communication and with outcome for adult cancer patients were systematically searched in MEDLINE, PSYINFO, PUBMED, EMBASE, CINHAL, Web of Science and The Cochrane Library up to November 2012. We used the preferred reporting items for systematic reviews and meta-analyses statement to guide our review. Articles were extracted independently by two of the authors using predefined criteria. Twenty seven articles met the inclusion criteria. Clinician characteristics included a variety of sociodemographic, relational, and personal characteristics. A positive impact on quality of communication and/or patient outcome was reported for communication skills training, an external locus of control, empathy, a socioemotional approach, shared decision-making style, higher anxiety, and defensiveness. A negative impact was reported for increased level of fatigue and burnout and expression of worry. Professional experience of clinicians was not related to communication and/or to patient outcome, and divergent results were reported for clinician gender, age, stress, posture, and confidence or self-efficacy. Various clinician characteristics have different effects on quality of communication and/or patient outcome. Research is needed to investigate the pathways leading to effective communication between clinicians and patients. Copyright © 2013 John Wiley & Sons, Ltd.

  18. Patient reported outcomes in hip arthroplasty registries.

    Science.gov (United States)

    Paulsen, Aksel

    2014-05-01

    PROs are used increasingly in orthopedics and in joint registries, but still many aspects of use in this area have not been examined in depth. To be able to introduce PROs in the DHR in a scientific fashion, my studies were warranted; the feasibility of four often used PROs (OHS, HOOS, EQ-5D and SF-12) was examined in a registry context. Having the PROs in the target language is an absolute necessity, so I translated, cross-culturally adapted and validated a Danish language version of an often used PRO (OHS), since this PRO had no properly developed Danish language version. To minimize data loss and to maximize the data quality I validated our data capture procedure, an up to date AFP system, by comparing scannable, paper-based PROs, with manual single-key- and double-key entered data. To help further registry-PRO studies, I calculated the number of patients needed to discriminate between subgroups of age, sex, diagnosis, and prosthesis type for each of four often used PROs (OHS, HOOS, EQ-5D and SF-12), and to simplify the clinical interpretation of PRO scores and PRO change scores in PRO studies, I estimated MCII and PASS for two often used PROs (EQ-5D and HOOS). The feasibility study included 5,747 THA patients registered in the DHR, and I found only minor differences between the disease-specific and the generic PROs regarding ceiling and floor effects as well as discarded items. The HOOS, the OHS, the SF-12, and the EQ-5D are all appropriate PROs for administration in a hip registry. I found that group sizes from 51 to 1,566 were needed for subgroup analysis, depending on descriptive factors and choice of PRO. The AFP study included 200 THA patients (398 PROs, 4,875 items and 21,887 data fields), and gave excellent results provided use of highly structured questionnaires. OMR performed equally as well as manual double-key entering, and better than single-key entering. The PRO translation and validation study included 2,278 patients (and 212 patients for the test

  19. Development of an International Prostate Cancer Outcomes Registry.

    Science.gov (United States)

    Evans, Sue M; Nag, Nupur; Roder, David; Brooks, Andrew; Millar, Jeremy L; Moretti, Kim L; Pryor, David; Skala, Marketa; McNeil, John J

    2016-04-01

    To establish a Prostate Cancer Outcomes Registry-Australia and New Zealand (PCOR-ANZ) for monitoring outcomes of prostate cancer treatment and care, in a cost-effective manner. Stakeholders were recruited based on their interest, importance in achieving the monitoring and reporting of clinical practice and patient outcomes, and in amalgamation of existing registries. Each participating jurisdiction is responsible for local governance, site recruitment, data collection, and data transfer into the PCOR-ANZ. To establish each local registry, hospitals and clinicians within a jurisdiction were approached to voluntarily contribute to the registry following relevant ethical approval. Patient contact occurs following notification of prostate cancer through a hospital or pathology report, or from a cancer registry. Patient registration is based on an opt-out model. The PCOR-ANZ is a secure web-based registry adhering to ISO 27001 standards. Based on a standardised minimum data set, information on demographics, diagnosis, treatment, outcomes, and patient reported quality of life, are collected. Eight of nine jurisdictions have agreed to contribute to the PCOR-ANZ. Each jurisdiction has commenced implementation of necessary infrastructure to support rapid rollout. PCOR-ANZ has defined a minimum data set for collection, to enable analysis of key quality indicators that will aid in assessing clinical practice and patient focused outcomes. PCOR-ANZ will provide a useful resource of risk-adjusted evidence-based data to clinicians, hospitals, and decision makers on prostate cancer clinical practice. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

  20. Patient-reported outcomes in adults with congenital heart disease: Inter-country variation, standard of living and healthcare system factors

    NARCIS (Netherlands)

    Moons, Philip; Kovacs, Adrienne H.; Luyckx, Koen; Thomet, Corina; Budts, Werner; Enomoto, Junko; Sluman, Maayke A.; Yang, Hsiao-Ling; Jackson, Jamie L.; Khairy, Paul; Cook, Stephen C.; Subramanyan, Raghavan; Alday, Luis; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Mackie, Andrew S.; Menahem, Samuel; Caruana, Maryanne; Veldtman, Gruschen; Soufi, Alexandra; Fernandes, Susan M.; White, Kamila; Callus, Edward; Kutty, Shelby; van Bulck, Liesbet; Apers, Silke

    2018-01-01

    Aims: Geographical differences in patient-reported outcomes (PROs) of adults with congenital heart disease (ConHD) have been observed, but are poorly understood. We aimed to: (1) investigate inter-country variation in PROs in adults with ConHD; (2) identify patient-related predictors of PROs; and

  1. Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys.

    Science.gov (United States)

    Biggane, Alice M; Brading, Lucy; Ravaud, Philippe; Young, Bridget; Williamson, Paula R

    2018-02-17

    There are numerous challenges in including patients in a core outcome set (COS) study, these can vary depending on the patient group. This study describes current efforts to include patients in the development of COS, with the aim of identifying areas for further improvement and study. Using the COMET database, corresponding authors of COS projects registered or published from 1 January 2013 to 2 February 2017 were invited via a personalised email to participate in a short online survey. The survey and emails were constructed to maximise the response rate by following the academic literature on enhancing survey responses. Personalised reminder emails were sent to non-responders. This survey explored the frequency of patient input in COS studies, who was involved, what methods were used and whether or not the COS development was international. One hundred and ninety-two COS developers were sent the survey. Responses were collected from 21 February 2017 until 7 May 2017. One hundred and forty-six unique developers responded, yielding a 76% response rate and data in relation to 195 unique COSs (as some developers had worked on multiple COSs). Of focus here are their responses regarding 162 COSs at the published, completed or ongoing stages of development. Inclusion of patient participants was indicated in 87% (141/162) of COSs in the published completed or ongoing stages and over 94% (65/69) of ongoing COS projects. Nearly half (65/135) of COSs included patient participants from two or more countries and 22% (30/135) included patient participants from five or more countries. The Delphi survey was reported as being used singularly or in combination with other methods in 85% (119/140) of projects. Almost a quarter (16/65) of ongoing studies reported using a combination of qualitative interviews, Delphi survey and consensus meeting. These findings indicated that the Delphi survey is the most popular method of facilitating patient participation, while the combination of

  2. Translating patient reported outcome measures: methodological issues explored using cognitive interviewing with three rheumatoid arthritis measures in six European languages

    NARCIS (Netherlands)

    Hewlett, Sarah E.; Nicklin, Joanna; Bode, Christina; Carmona, Loretto; Dures, Emma; Engelbrecht, Matthias; Hagel, Sofia; Kirwan, John R.; Molto, Anna; Redondo, Marta; Gossec, Laure

    2016-01-01

    Objective. Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and

  3. Development and content validation of a patient-reported endometriosis pain daily diary.

    Science.gov (United States)

    van Nooten, Floortje E; Cline, Jennifer; Elash, Celeste A; Paty, Jean; Reaney, Matthew

    2018-01-04

    Endometriosis is a common gynecological disorder that causes inflammation and pelvic pain. Endometriosis-related pain is best captured with patient-reported outcome (PRO) measures, however, assessment of endometriosis-related pain in clinical trials has been difficult in the absence of a reliable and valid PRO instrument. We describe the development of the Endometriosis Pain Daily Diary (EPDD), an electronic PRO developed as a survey instrument to assess endometriosis-related pain and its impact on patients' lives. The EPDD was initially developed on the basis of an existing Endometriosis Pain and Bleeding Diary, a targeted review of relevant literature, clinical expert interviews, and open-ended (concept elicitation) patient interviews in the United States (US) and Japan which captured patients' experience with endometriosis. Cognitive interviews of patients with endometriosis were conducted to evaluate patient comprehension of the EPDD items. A conceptual model of endometriosis was developed, and meetings with US and European regulatory authorities provided feedback for validating the EPDD in the context of clinical trials. Translatability assessments of the EPDD were conducted to confirm its appropriate interpretation and ease of completion across 17 languages. The iterative development progressed through three versions of the instrument. The EPDDv1 included 18 items relating to dysmenorrhea/pelvic pain, dyspareunia and sexual activity, bleeding, hot flashes, daily activities, and use of rescue medication. The EPDDv2 was a larger 43-item survey tested in cognitive interviews and subsequently revised to yield the current 11-item EPDDv3, consisting of five core items relating to dysmenorrhea, non-menstrual pelvic pain, and dyspareunia, and six extension items relating to sexual activity, daily activities, and use of rescue medication. The EPDD is a PRO for the evaluation of endometriosis-related pain and its associated impacts on patients' lives. The EPDD

  4. Developing a risk prediction model for the functional outcome after hip arthroscopy.

    Science.gov (United States)

    Stephan, Patrick; Röling, Maarten A; Mathijssen, Nina M C; Hannink, Gerjon; Bloem, Rolf M

    2018-04-19

    Hip arthroscopic treatment is not equally beneficial for every patient undergoing this procedure. Therefore, the purpose of this study was to develop a clinical prediction model for functional outcome after surgery based on preoperative factors. Prospective data was collected on a cohort of 205 patients having undergone hip arthroscopy between 2011 and 2015. Demographic and clinical variables and patient reported outcome (PRO) scores were collected, and considered as potential predictors. Successful outcome was defined as either a Hip Outcome Score (HOS)-ADL score of over 80% or improvement of 23%, defined by the minimal clinical important difference, 1 year after surgery. The prediction model was developed using backward logistic regression. Regression coefficients were converted into an easy to use prediction rule. The analysis included 203 patients, of which 74% had a successful outcome. Female gender (OR: 0.37 (95% CI 0.17-0.83); p = 0.02), pincer impingement (OR: 0.47 (95% CI 0.21-1.09); p = 0.08), labral tear (OR: 0.46 (95% CI 0.20-1.06); p = 0.07), HOS-ADL score (IQR OR: 2.01 (95% CI 0.99-4.08); p = 0.05), WHOQOL physical (IQR OR: 0.43 (95% CI 0.22-0.87); p = 0.02) and WHOQOL psychological (IQR OR: 2.40 (95% CI 1.38-4.18); p = prediction model of successful functional outcome 1 year after hip arthroscopy. The model's discriminating accuracy turned out to be fair, as 71% (95% CI: 64-80%) of the patients were classified correctly. The developed prediction model can predict the functional outcome of patients that are considered for a hip arthroscopic intervention, containing six easy accessible preoperative risk factors. The model can be further improved trough external validation and/or adding additional potential predictors.

  5. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

    Directory of Open Access Journals (Sweden)

    Jones PW

    2016-12-01

    Full Text Available Paul W Jones,1,2 Stephen Rennard,3,4 Maggie Tabberer,5 John H Riley,2 Mitra Vahdati-Bolouri,2 Neil C Barnes2,6 1Institute for Infection and Immunity, University of London, London, 2Global Respiratory Franchise, GlaxoSmithKline, Uxbridge, UK; 3Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha, NE, USA; 4Clinical Discovery Unit, AstraZeneca, Cambridge, 5Global R&D, GlaxoSmithKline, Uxbridge, 6William Harvey Institute, Bart’s and the London School of Medicine and Dentistry, London, UK Abstract: One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of

  6. PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study.

    Science.gov (United States)

    Katzan, Irene L; Lapin, Brittany

    2018-01-01

    The International Consortium for Health Outcomes Measurement recently included the 10-item PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) scale as part of their recommended Standard Set of Stroke Outcome Measures. Before collection of PROMIS GH is broadly implemented, it is necessary to assess its performance in the stroke population. The objective of this study was to evaluate the psychometric properties of PROMIS GH in patients with ischemic stroke and intracerebral hemorrhage. PROMIS GH and 6 PROMIS domain scales measuring same/similar constructs were electronically collected on 1102 patients with ischemic and hemorrhagic strokes at various stages of recovery from their stroke who were seen in a cerebrovascular clinic from October 12, 2015, through June 2, 2017. Confirmatory factor analysis was performed to evaluate the adequacy of 2-factor structure of component scores. Test-retest reliability and convergent validity of PROMIS GH items and component scores were assessed. Discriminant validity and responsiveness were compared between PROMIS GH and PROMIS domain scales measuring the same or related constructs. Analyses were repeated stratified by stroke subtype and modified Rankin Scale score validity was good with significant correlations between all PROMIS GH items and PROMIS domain scales ( P 0.5) was demonstrated for 8 of the 10 PROMIS GH items. Reliability and validity remained consistent across stroke subtype and disability level (modified Rankin Scale, <2 versus ≥2). PROMIS GH exhibits acceptable performance in patients with stroke. Our findings support International Consortium for Health Outcomes Measurement recommendation to use PROMIS GH as part of the standard set of outcome measures in stroke. © 2017 American Heart Association, Inc.

  7. The development of a clinical outcomes survey research application: Assessment Center.

    Science.gov (United States)

    Gershon, Richard; Rothrock, Nan E; Hanrahan, Rachel T; Jansky, Liz J; Harniss, Mark; Riley, William

    2010-06-01

    The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment Center) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer "scrum" sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed.

  8. Results of a Qualitative Study to Develop a Patient Reported Outcome Measure for Patients with 4 Subtypes of Soft Tissue Sarcoma

    Directory of Open Access Journals (Sweden)

    Anne M. Skalicky

    2017-01-01

    Full Text Available Objective. The objective of this research was to develop a disease-specific symptom inventory for soft tissue sarcoma. Methods. Literature review and clinical expert and patient interviews were conducted to determine disease-specific symptoms important to patients with one of the four STS subtypes. Clinical experts identified the most relevant STS symptom items from the item pool developed from literature review. Concept elicitation interviews were conducted with patients to elicit their STS symptom experiences followed by a completion of the draft symptom list via web survey. A cognitive interview was conducted on the comprehension and importance of the symptom items. Results. Eighty-three symptom items were compiled and discussed with three clinical experts who identified 26 symptoms specific to the four STS subtypes. A total sample of 27 STS participants with self-reported leiomyosarcoma (74%, undifferentiated sarcoma (15%, synovial sarcoma (7%, or liposarcoma (4% diagnosis completed the web survey and 10 were interviewed. The draft 12-item STS-specific symptom inventory includes abdominal pain, pressure in abdomen, early satiety, bloating, gastrointestinal pain, muscle pain, bone pain, heavy menstrual flow, shortness of breath, chest pain, cough, and painful menstruation. Conclusion. A number of symptoms are common across STS subtypes and may form a single STS symptom inventory.

  9. A Wireless Health Outcomes Monitoring System (WHOMS: development and field testing with cancer patients using mobile phones

    Directory of Open Access Journals (Sweden)

    Brunelli Cinzia

    2004-06-01

    Full Text Available Abstract Background Health-Related Quality of Life assessment is widely used in clinical research, but rarely in clinical practice. Barriers including practical difficulties administering printed questionnaires have limited their use. Telehealth technology could reduce these barriers and encourage better doctor-patient interaction regarding patient symptoms and quality-of-life monitoring. The aim of this study was to develop a new system for transmitting patients' self-reported outcomes using mobile phones or the internet, and to test whether patients can and will use the system via a mobile phone. Methods We have developed a prototype of a Wireless Health Outcomes Monitoring System, which allows structured questionnaires to be sent to the patient by their medical management team. The patients' answers are directly sent to an authorised website immediately accessible by the medical team, and are displayed in a graphic format that highlights the patient's state of health. In the present study, 97 cancer inpatients were asked to complete a ten-item questionnaire. The questionnaire was delivered by display on a mobile phone, and was answered by the patients using the mobile phone keypad. Results Of the 97 patients, 56 (58% attempted the questionnaire, and all of these 56 completed it. Only 6% of the total number of questions were left unanswered by patients. Forty-one (42% patients refused to participate, mostly due to their lack of familiarity with mobile phone use. Compared with those who completed the questionnaire, patients who refused to participate were older, had fewer years of education and were less familiar with new communications technology (mobile phone calls, mobile phone SMS, internet, email. Conclusion More than half of the patients self-completed the questionnaire using the mobile phone. This proportion may increase with the use of multichannel communications which can be incorporated into the system. The proportion may also

  10. Intercentre variance in patient reported outcomes is lower than objective rheumatoid arthritis activity measures

    DEFF Research Database (Denmark)

    Khan, Nasim Ahmed; Spencer, Horace Jack; Nikiphorou, Elena

    2017-01-01

    Objective: To assess intercentre variability in the ACR core set measures, DAS28 based on three variables (DAS28v3) and Routine Assessment of Patient Index Data 3 in a multinational study. Methods: Seven thousand and twenty-three patients were recruited (84 centres; 30 countries) using a standard...... built to adjust for the remaining ACR core set measure (for each ACR core set measure or each composite index), socio-demographics and medical characteristics. ANOVA and analysis of covariance models yielded similar results, and ANOVA tables were used to present variance attributable to recruiting...... centre. Results: The proportion of variances attributable to recruiting centre was lower for patient reported outcomes (PROs: pain, HAQ, patient global) compared with objective measures (joint counts, ESR, physician global) in all models. In the full model, variance in PROs attributable to recruiting...

  11. Communicating patient-reported outcome scores using graphic formats: results from a mixed-methods evaluation.

    Science.gov (United States)

    Brundage, Michael D; Smith, Katherine C; Little, Emily A; Bantug, Elissa T; Snyder, Claire F

    2015-10-01

    Patient-reported outcomes (PROs) promote patient-centered care by using PRO research results ("group-level data") to inform decision making and by monitoring individual patient's PROs ("individual-level data") to inform care. We investigated the interpretability of current PRO data presentation formats. This cross-sectional mixed-methods study randomized purposively sampled cancer patients and clinicians to evaluate six group-data or four individual-data formats. A self-directed exercise assessed participants' interpretation accuracy and ratings of ease-of-understanding and usefulness (0 = least to 10 = most) of each format. Semi-structured qualitative interviews explored helpful and confusing format attributes. We reached thematic saturation with 50 patients (44 % < college graduate) and 20 clinicians. For group-level data, patients rated simple line graphs highest for ease-of-understanding and usefulness (median 8.0; 33 % selected for easiest to understand/most useful) and clinicians rated simple line graphs highest for ease-of-understanding and usefulness (median 9.0, 8.5) but most often selected line graphs with confidence limits or norms (30 % for each format for easiest to understand/most useful). Qualitative results support that clinicians value confidence intervals, norms, and p values, but patients find them confusing. For individual-level data, both patients and clinicians rated line graphs highest for ease-of-understanding (median 8.0 patients, 8.5 clinicians) and usefulness (median 8.0, 9.0) and selected them as easiest to understand (50, 70 %) and most useful (62, 80 %). The qualitative interviews supported highlighting scores requiring clinical attention and providing reference values. This study has identified preferences and opportunities for improving on current formats for PRO presentation and will inform development of best practices for PRO presentation. Both patients and clinicians prefer line graphs across group-level data and individual

  12. Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop.

    Science.gov (United States)

    Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C; Evangelidis, Nicole; Tugwell, Peter; Crowe, Sally; Van Biesen, Wim; Winkelmayer, Wolfgang C; O'Donoghue, Donal; Tam-Tham, Helen; Shen, Jenny I; Pinter, Jule; Larkins, Nicholas; Youssouf, Sajeda; Mandayam, Sreedhar; Ju, Angela; Craig, Jonathan C

    2017-01-01

    Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  13. Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Consensus Workshop

    Science.gov (United States)

    Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C.; Evangelidis, Nicole; Tugwell, Peter; Crowe, Sally; Van Biesen, Wim; Winkelmayer, Wolfgang C.; O’Donoghue, Donal; Tam-Tham, Helen; Shen, Jenny; Pinter, Jule; Larkins, Nicholas; Youssouf, Sajeda; Mandayam, Sreedhar; Ju, Angela; Craig, Jonathan C.

    2017-01-01

    Evidence-informed decision-making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient-centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis. Key stakeholders including eight patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations; flexibility to consider evolving priorities over time; deconstruction of language and meaning for conceptual consistency and clarity; understanding of potential overlap and associations between outcomes; and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive and validated outcome measures that could be used in clinical care (quality ndicators) and trials (including pragmatic trials), and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment, and improved patient outcomes. PMID:27497527

  14. Authentic leadership and nurse-assessed adverse patient outcomes.

    Science.gov (United States)

    Wong, Carol A; Giallonardo, Lisa M

    2013-07-01

    Our purpose was to test a model examining relationships among authentic leadership, nurses' trust in their manager, areas of work life and nurse-assessed adverse patient outcomes. Although several work environment factors have been cited as critical to patient outcomes, studies linking nursing leadership styles with patient outcomes are limited suggesting the need for additional research to investigate the mechanisms by which leadership may influence patient outcomes. Secondary analysis of data collected in a cross-sectional survey of 280 (48% response rate) registered nurses working in acute care hospitals in Ontario was conducted using structural equation modelling. The final model fit the data acceptably (χ(2) = 1.30, df = 2, P = 0.52, IFI = 0.99, CFI = 1.00, RMSEA = 0.00). Authentic leadership was significantly associated with decreased adverse patient outcomes through trust in the manager and areas of work life. The findings suggest that nurses who see their managers as demonstrating high levels of authentic leadership report increased trust, greater congruence in the areas of work life and lower frequencies of adverse patient outcomes. Managers who emphasize transparency, balanced processing, self-awareness and high ethical standards in their interactions with nurses may contribute to safer work environments for patients and nurses. © 2013 John Wiley & Sons Ltd.

  15. Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments.

    Science.gov (United States)

    Taylor, Fiona; Reasner, David S; Carson, Robyn T; Deal, Linda S; Foley, Catherine; Iovin, Ramon; Lundy, J Jason; Pompilus, Farrah; Shields, Alan L; Silberg, Debra G

    2016-10-01

    The aim was to document, from the perspective of the empirical literature, the primary symptoms of functional dyspepsia (FD), evaluate the extent to which existing questionnaires target those symptoms, and, finally, identify any missing evidence that would impact the questionnaires' use in regulated clinical trials to assess treatment efficacy claims intended for product labeling. A literature review was conducted to identify the primary symptoms of FD and existing symptom-based FD patient-reported outcome (PRO) instruments. Following a database search, abstracts were screened and articles were retrieved for review. The primary symptoms of FD were organized into a conceptual model and the PRO instruments were evaluated for conceptual coverage as well as compared against evidentiary requirements presented in the FDA's PRO Guidance for Industry. Fifty-six articles and 16 instruments assessing FD symptoms were reviewed. Concepts listed in the Rome III criteria for FD (n = 7), those assessed by existing FD instruments (n = 34), and symptoms reported by patients in published qualitative research (n = 6) were summarized in the FD conceptual model. Except for vomiting, all of the identified symptoms from the published qualitative research reports were also specified in the Rome III criteria. Only three of the 16 instruments, the Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI), measure all seven FD symptoms defined by the Rome III criteria. Among these three, each utilizes a 2-week recall period and 5-point Likert-type scale, and had evidence of patient involvement in development. Despite their coverage, when these instruments were evaluated in light of regulatory expectations, several issues jeopardized their potential qualification for substantiation of a labeling claim. No existing PRO instruments that measured all seven symptoms adhered to the regulatory principles necessary to support product

  16. Lymphoma InterVEntion (LIVE) : Patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: Study protocol for a randomised controlled trial

    NARCIS (Netherlands)

    Arts, L.P.J.; van de Poll-Franse, L.V.; Van Den Berg, Sanne W.; Prins, Judith B.; Husson, Olga; Mols, F.; Brands-nijenhuis, Angelique V. M.; Tick, Lidwine; Oerlemans, S.

    2017-01-01

    Background Patients with lymphoma are at risk of experiencing adverse physical and psychosocial problems from their cancer and its treatment. Regular screening of these symptoms by the use of patient-reported outcomes (PROs) could increase timely recognition and adequate symptom management.

  17. Lymphoma InterVEntion (LIVE) - patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: study protocol for a randomised controlled trial

    NARCIS (Netherlands)

    Arts, L.P.J.; Poll-Franse, L.V. van de; Berg, S.W. van den; Prins, J.B.; Husson, O.; Mols, F.; Brands-Nijenhuis, A.V.M.; Tick, L.; Oerlemans, S.

    2017-01-01

    BACKGROUND: Patients with lymphoma are at risk of experiencing adverse physical and psychosocial problems from their cancer and its treatment. Regular screening of these symptoms by the use of patient-reported outcomes (PROs) could increase timely recognition and adequate symptom management.

  18. Using patient acuity data to manage patient care outcomes and patient care costs.

    Science.gov (United States)

    Van Slyck, A; Johnson, K R

    2001-01-01

    This article describes actual reported uses for patient acuity data that go beyond historical uses in determining staffing allocations. These expanded uses include managing patient care outcomes and health care costs. The article offers the patient care executive examples of how objective, valid, and reliable data are used to drive approaches to effectively influence decision making in an increasingly competitive health care environment.

  19. Nurse dose: linking staffing variables to adverse patient outcomes.

    Science.gov (United States)

    Manojlovich, Milisa; Sidani, Souraya; Covell, Christine L; Antonakos, Cathy L

    2011-01-01

    Inconsistent findings in more than 100 studies have made it difficult to explain how variation in nurse staffing affects patient outcomes. Nurse dose, defined as the level of nurses required to provide patient care in hospital settings, draws on variables used in staffing studies to describe the influence of many staffing variables on outcomes. The aim of this study was to examine the construct validity of nurse dose by determining its association with methicillin-resistant Staphylococcus aureus (MRSA) infections and reported patient falls on a sample of inpatient adult acute care units. Staffing data came from 26 units in Ontario, Canada, and Michigan. Financial and human resource data were data sources for staffing variables. Sources of data for MRSA came from infection control departments. Incident reports were the data source for patient falls. Data analysis consisted of bivariate correlations and Poisson regression. Bivariate correlations revealed that nurse dose attributes (active ingredient and intensity) were associated significantly with both outcomes. Active ingredient (education, experience, skill mix) and intensity (full-time employees, registered nurse [RN]:patient ratio, RN hours per patient day) were significant predictors of MRSA. Coefficients for both attributes were negative and almost identical. Both attributes were significant predictors of reported patient falls, and coefficients were again negative, but coefficient sizes differed. By conceptualizing nurse and staffing variables (education, experience, skill mix, full-time employees, RN:patient ratio, RN hours per patient day) as attributes of nurse dose and by including these in the same analysis, it is possible to determine their relative influence on MRSA infections and reported patient falls.

  20. Long-term outcomes for patients with chronic lymphocytic leukemia who discontinue ibrutinib.

    Science.gov (United States)

    Jain, Preetesh; Thompson, Philip A; Keating, Michael; Estrov, Zeev; Ferrajoli, Alessandra; Jain, Nitin; Kantarjian, Hagop; Burger, Jan A; O'Brien, Susan; Wierda, William G

    2017-06-15

    Ibrutinib is a Bruton tyrosine kinase inhibitor and is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) in frontline and relapsed/refractory settings. The authors previously reported poor outcomes for patients who discontinued ibrutinib; however, long-term outcomes were not reported. Data from 320 patients who received ibrutinib on clinical studies between 2010 and 2015 at The University of Texas MD Anderson Cancer Center were retrospectively analyzed. Long-term outcomes among patients with CLL after they discontinued ibrutinib were analyzed. Ninety of 320 patients (28%) who were treated on ibrutinib-based regimens discontinued ibrutinib. Of these, 80 had relapsed/refractory disease, and 10 were treatment-naive. The median time to discontinuation was 15 months (range, 1.2-54 months). After a median follow-up of 38 months after starting ibrutinib, 40 patients (44%) remained alive. Major reasons for ibrutinib discontinuation were intolerance (n = 29; 32%), miscellaneous (n = 28; 31%), progression (n = 19; 21%), and Richter transformation (RT) (n = 9; 10%). The median survival according to the reason for discontinuation was 33 months for ibrutinib intolerance, 11 months for miscellaneous causes, 16 months for progressive CLL, and 2 months for RT. Among the 19 patients who had progressive CLL, 42% responded to subsequent therapy. Ibrutinib discontinuation was observed during therapy. Patients with CLL who had disease transformation had especially poor outcomes, whereas those who developed progressive disease during ibrutinib therapy had a median survival of ibrutinib therapy is of critical importance. Cancer 2017;123:2268-2273. © 2017 American Cancer Society. © 2017 American Cancer Society.

  1. Surgery for the correction of hallux valgus: minimum five-year results with a validated patient-reported outcome tool and regression analysis.

    Science.gov (United States)

    Chong, A; Nazarian, N; Chandrananth, J; Tacey, M; Shepherd, D; Tran, P

    2015-02-01

    This study sought to determine the medium-term patient-reported and radiographic outcomes in patients undergoing surgery for hallux valgus. A total of 118 patients (162 feet) underwent surgery for hallux valgus between January 2008 and June 2009. The Manchester-Oxford Foot Questionnaire (MOXFQ), a validated tool for the assessment of outcome after surgery for hallux valgus, was used and patient satisfaction was sought. The medical records and radiographs were reviewed retrospectively. At a mean of 5.2 years (4.7 to 6.0) post-operatively, the median combined MOXFQ score was 7.8 (IQR:0 to 32.8). The median domain scores for pain, walking/standing, and social interaction were 10 (IQR: 0 to 45), 0 (IQR: 0 to 32.1) and 6.3 (IQR: 0 to 25) respectively. A total of 119 procedures (73.9%, in 90 patients) were reported as satisfactory but only 53 feet (32.7%, in 43 patients) were completely asymptomatic. The mean (SD) correction of hallux valgus, intermetatarsal, and distal metatarsal articular angles was 18.5° (8.8°), 5.7° (3.3°), and 16.6° (8.8°), respectively. Multivariable regression analysis identified that an American Association of Anesthesiologists grade of >1 (Incident Rate Ratio (IRR) = 1.67, p-value = 0.011) and recurrent deformity (IRR = 1.77, p-value = 0.003) were associated with significantly worse MOXFQ scores. No correlation was found between the severity of deformity, the type, or degree of surgical correction and the outcome. When using a validated outcome score for the assessment of outcome after surgery for hallux valgus, the long-term results are worse than expected when compared with the short- and mid-term outcomes, with 25.9% of patients dissatisfied at a mean follow-up of 5.2 years. ©2015 The British Editorial Society of Bone & Joint Surgery.

  2. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Patient-Reported Outcomes in an Enhanced Recovery Pathway.

    Science.gov (United States)

    Abola, Ramon E; Bennett-Guerrero, Elliott; Kent, Michael L; Feldman, Liane S; Fiore, Julio F; Shaw, Andrew D; Thacker, Julie K M; Gan, Tong J; Miller, Timothy E; Hedrick, Traci L; McEvoy, Matthew D; Mythen, Michael G; Bergamaschi, Roberto; Gupta, Ruchir; Holubar, Stefan D; Senagore, Anthony J; Wischmeyer, Paul E; Carli, Franco; Evans, David C; Guilbert, Sarah; Kozar, Rosemary; Pryor, Aurora; Thiele, Robert H; Everett, Sotiria; Grocott, Mike

    2017-12-29

    Patient-reported outcomes (PROs) are measures of health status that come directly from the patient. PROs are an underutilized tool in the perioperative setting. Enhanced recovery pathways (ERPs) have primarily focused on traditional measures of health care quality such as complications and hospital length of stay. These measures do not capture postdischarge outcomes that are meaningful to patients such as function or freedom from disability. PROs can be used to facilitate shared decisions between patients and providers before surgery and establish benchmark recovery goals after surgery. PROs can also be utilized in quality improvement initiatives and clinical research studies. An expert panel, the Perioperative Quality Initiative (POQI) workgroup, conducted an extensive literature review to determine best practices for the incorporation of PROs in an ERP. This international group of experienced clinicians from North America and Europe met at Stony Brook, NY, on December 2-3, 2016, to review the evidence supporting the use of PROs in the context of surgical recovery. A modified Delphi method was used to capture the collective expertise of a diverse group to answer clinical questions. During 3 plenary sessions, the POQI PRO subgroup presented clinical questions based on a literature review, presented evidenced-based answers to those questions, and developed recommendations which represented a consensus opinion regarding the use of PROs in the context of an ERP. The POQI workgroup identified key criteria to evaluate patient-reported outcome measures (PROMs) for their incorporation in an ERP. The POQI workgroup agreed on the following recommendations: (1) PROMs in the perioperative setting should be collected in the framework of physical, mental, and social domains. (2) These data should be collected preoperatively at baseline, during the immediate postoperative time period, and after hospital discharge. (3) In the immediate postoperative setting, we recommend using

  3. A case-control study of the effectiveness of tissue plasminogen activator on 6 month patients--reported outcomes and health care utilization.

    Science.gov (United States)

    Lang, Catherine E; Bland, Marghuretta D; Cheng, Nuo; Corbetta, Maurizio; Lee, Jin-Moo

    2014-01-01

    We examined the benefit of tissue plasminogen activator (tPA), delivered as part of usual stroke management, on patient-reported outcomes and health care utilization. Using a case control design, patients who received tPA as part of usual stroke management were compared with patients who would have received tPA had they arrived to the hospital within the therapeutic time window. Data were collected from surveys 6 months after stroke using standardized patient-reported outcome measures and questions about health care utilization. Demographic and medical data were acquired from hospital records. Patients were matched on stroke severity, age, race, and gender. Matching was done with 1:2 ratio of tPA to controls. Results were compared between groups with 1-tailed tests because of a directionally specific hypothesis in favor of the tPA group. The tPA (n = 78) and control (n = 156) groups were matched across variables, except for stroke severity, which was better in the control group; subsequent analyses controlled for this mismatch. The tPA group reported better physical function, communication, cognitive ability, depressive symptomatology, and quality of life/participation compared with the control group. Fewer people in the tPA group reported skilled nursing facility stays, emergency department visits, and rehospitalizations after their stroke compared with controls. Reports of other postacute services were not different between groups. Although it is known that tPA reduces disability, this is the first study to demonstrate the effectiveness of tPA in improving meaningful, patient-reported outcomes. Thus, use of tPA provides a large benefit to the daily lives of people with ischemic stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  4. Epoetin alfa improves anemia and anemia-related, patient-reported outcomes in patients with breast cancer receiving myelotoxic chemotherapy: Results of a european, multicenter, randomized, controlled trial

    NARCIS (Netherlands)

    P. Pronzato (Paolo); E. Cortesi (Enrico); C.C.D. van der Rijt (Carin); A. Bols (Alain); J.A. Moreno-Nogueira (José); C.F. de Oliveira; P. Barrett-Lee (Peter); P.J. Ostler (Peter); R. Rosso (Ricardo)

    2010-01-01

    textabstractPurpose. To evaluate the effects of epoetin alfa on patient- reported outcomes (PROs) in patients with breast cancer receiving myelotoxic chemotherapy. Materials and Methods. Women with hemoglobin concentrations ≤12.0 g/dl and an Eastern Cooperative Oncology Group performance status

  5. The establishment of the GENEQOL consortium to investigate the genetic disposition of patient-reported quality-of-life outcomes

    NARCIS (Netherlands)

    Sprangers, M.A.G.; Sloan, J.A.; Veenhoven, R.; Cleeland, C.S.; Halyard, M.Y.; Abertnethy, A.P.; Baas, F.; Barsevick, A.M.; Bartels, M.; Boomsma, D.I.; Chauhan, C.; Dueck, A.C.; Frost, M.H.; Hall, P.; Klepstad, P.; Martin, N.G.; Miaskowski, C.; Mosing, M.; Movsas, B.; van Noorden, C.J.F.; Patrick, D.L.; Pedersen, N.L.; Ropka, M.E.; Shi, Q.; Shinozaki, G.; Singh, J.A.; Yang, P.; Zwinderman, A.H.

    2009-01-01

    To our knowledge, no comprehensive, interdisciplinary initiatives have been taken to examine the role of genetic variants on patient-reported qualityof-life outcomes. The overall objective of this paper is to describe the establishment of an international and interdisciplinary consortium, the

  6. The establishment of the GENEQOL consortium to investigate the genetic disposition of patient reported quality-of-life outcomes

    NARCIS (Netherlands)

    M.A.G. Sprangers (Mirjam); J.A. Sloan (Jeff); R. Veenhoven (Ruut); C.S. Cleeland (Charles); M.Y. Halyard (Michele); A.P. Abertnethy (Amy); F. Baas (Frank); A.M. Barsevick (Andrea); M. Bartels (Meike); D.I. Boomsma (Dorret); C. Chauhan (Cynthia); A.C. Dueck (Amylou); M.H. Frost (Marlene); P. Hall (Per); P. Klepstad (Pal); N.G. Martin (Nicholas); C. Miaskowski (Christine); M. Mosing (Miriam); B. Movsas (Benjamin); C.J.F. van Noorden (Cornelis); D.L. Patrick (Donald); N.L. Pedersen (Nancy); M.E. Ropka (Mary); Q. Shi (Quiling); G. Shinozaki (Gen); J.A. Singh (Jasvinder); P. Yang (Ping); A.H. Zwinderman (Ailko)

    2009-01-01

    textabstractTo our knowledge, no comprehensive, interdisciplinary initiatives have been taken to examine the role of genetic variants on patient-reported quality-of-life outcomes. The overall objective of this paper is to describe the establishment of an international and interdisciplinary

  7. Information perception, wishes, and satisfaction in ambulatory cancer patients under active treatment: patient-reported outcomes with QLQ-INFO25

    Science.gov (United States)

    Pinto, Ana Catarina; Ferreira-Santos, Fernando; Lago, Lissandra Dal; de Azambuja, Evandro; Pimentel, Francisco Luís; Piccart-Gebhart, Martine; Razavi, Darius

    2014-01-01

    Background Information is vital to cancer patients. Physician–patient communication in oncology presents specific challenges. The aim of this study was to evaluate self-reported information of cancer patients in ambulatory care at a comprehensive cancer centre and examine its possible association with patients’ demographic and clinical characteristics. Patients and methods This study included adult patients with solid tumours undergoing chemotherapy at the Institute Jules Bordet’s Day Hospital over a ten-day period. EORTC QLQ-C30 and QLQ-INFO25 questionnaires were administered. Demographic and clinical data were collected. Descriptive and inferential statistics were used. Results 101 (99%) fully completed the questionnaires. They were mostly Belgian (74.3%), female (78.2%), with a mean age of 56.9 ± 12.8 years. The most frequent tumour was breast cancer (58.4%). Patients were well-informed about the disease and treatments, but presented unmet information domains. The Jules Bordet patients desired more information on treatment side effects, long-term outcome, nutrition, and recurrence symptoms. Patients on clinical trials reported having received less information about their disease and less written information than patients outside clinical trials. Higher information levels were associated with higher quality of life (QoL) scores and higher patient satisfaction. Conclusion Patients were satisfied with the information they received and this correlated with higher QoL, but they still expressed unmet information wishes. Additional studies are required to investigate the quality of the information received by patients enrolled in clinical trials. PMID:24834120

  8. Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.

    Science.gov (United States)

    Acquadro, Catherine; Patrick, Donald L; Eremenco, Sonya; Martin, Mona L; Kuliś, Dagmara; Correia, Helena; Conway, Katrin

    2017-01-01

    This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.

  9. Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: Oncology Examples.

    Science.gov (United States)

    Brogan, Andrew P; DeMuro, Carla; Barrett, Amy M; D'Alessio, Denise; Bal, Vasudha; Hogue, Susan L

    2017-02-01

    Health authorities and payers increasingly recognize the importance of patient perspectives and patient-reported outcomes (PROs) in health care decision making. However, given the broad variety of PRO endpoints included in clinical programs and variations in the timing of PRO data collection and country-specific needs, the role of PRO data in reimbursement decisions requires characterization. To (a) determine the effect of PRO data on market access and reimbursement decisions for oncology products in multiple markets and (b) assess the effect of PRO data collected after clinical progression on payer decision making. A 3-part assessment (targeted literature review, qualitative one-on-one interviews, and online survey) was undertaken. Published literature was identified through searches in PubMed/MEDLINE and Embase. In addition, a targeted search was conducted of health technology assessment (HTA) agency websites in the United States, the United Kingdom, France, and Germany. Qualitative one-on-one interviews were conducted with 16 payers from the RTI Health Solutions global advisory panel in 14 markets (Australia, Brazil, France, Germany, Italy, South Korea, Netherlands, Poland, Spain, Sweden, Taiwan, Turkey, the United Kingdom, and the United States [n = 3]). Of the 200 payers and payer advisors from the global advisory panel invited to participate in the online survey, 20 respondents (China, France, Germany, Spain [n = 2], Taiwan, the United Kingdom, and the United States [n = 13]) completed the survey, and 6 respondents (Australia, South Korea, and the United States [n = 4]) partially completed the survey. Reviews of the literature and publicly available HTAs and reimbursement decisions suggested that HTA bodies and payers have varying experience with and confidence in PRO data. Payers participating in the survey indicated that PRO data may be especially influential in oncology compared with other therapeutic areas. Payers surveyed offered little differentiation

  10. Sex Differences in Patient-Reported Outcomes After Anterior Cruciate Ligament Reconstruction: Data From the Swedish Knee Ligament Register

    DEFF Research Database (Denmark)

    Ageberg, Eva; Forssblad, Magnus; Herbertsson, Pär

    2010-01-01

    BACKGROUND: Female gender is a risk factor for sustaining anterior cruciate ligament (ACL) injury. However, little is known about possible sex differences in patients with ACL injury/reconstruction. PURPOSE: To study sex differences in patient-reported outcomes before and at 1 and 2 years after ACL...... in KOOS and EQ-5D preoperatively, 1 and 2 years postoperatively, and over time. RESULTS: Preoperatively, female patients reported worse scores than male patients in 4 KOOS subscales (pain, symptoms, sport/recreation, quality of life) and EQ-5D, with the largest difference seen in KOOS sport....../recreation (mean difference, 4.7; 95% confidence interval [CI], 3.0-6.3). At 1 year postoperatively, female patients reported worse scores than male patients in KOOS pain (mean difference, 1.4; 95% CI, 0.4-2.4) and KOOS sport/recreation (mean difference, 2.7; 95% CI, 0.9-4.4) and at 2 years postoperatively in KOOS...

  11. Development of a new occupational balance-questionnaire: incorporating the perspectives of patients and healthy people in the design of a self-reported occupational balance outcome instrument.

    Science.gov (United States)

    Dür, Mona; Steiner, Günter; Fialka-Moser, Veronika; Kautzky-Willer, Alexandra; Dejaco, Clemens; Prodinger, Birgit; Stoffer, Michaela Alexandra; Binder, Alexa; Smolen, Josef; Stamm, Tanja Alexandra

    2014-04-05

    Self-reported outcome instruments in health research have become increasingly important over the last decades. Occupational therapy interventions often focus on occupational balance. However, instruments to measure occupational balance are scarce. The aim of the study was therefore to develop a generic self-reported outcome instrument to assess occupational balance based on the experiences of patients and healthy people including an examination of its psychometric properties. We conducted a qualitative analysis of the life stories of 90 people with and without chronic autoimmune diseases to identify components of occupational balance. Based on these components, the Occupational Balance-Questionnaire (OB-Quest) was developed. Construct validity and internal consistency of the OB-Quest were examined in quantitative data. We used Rasch analyses to determine overall fit of the items to the Rasch model, person separation index and potential differential item functioning. Dimensionality testing was conducted by the use of t-tests and Cronbach's alpha. The following components emerged from the qualitative analyses: challenging and relaxing activities, activities with acknowledgement by the individual and by the sociocultural context, impact of health condition on activities, involvement in stressful activities and fewer stressing activities, rest and sleep, variety of activities, adaptation of activities according to changed living conditions and activities intended to care for oneself and for others. Based on these, the seven items of the questionnaire (OB-Quest) were developed. 251 people (132 with rheumatoid arthritis, 43 with systematic lupus erythematous and 76 healthy) filled in the OB-Quest. Dimensionality testing indicated multidimensionality of the questionnaire (t = 0.58, and 1.66 after item reduction, non-significant). The item on the component rest and sleep showed differential item functioning (health condition and age). Person separation index was 0

  12. Individual Prognosis of Symptom Burden and Functioning in Chronic Diseases: A Generic Method Based on Patient-Reported Outcome (PRO) Measures

    DEFF Research Database (Denmark)

    Hjollund, Niels Henrik Ingvar

    2017-01-01

    BACKGROUND: Information to the patient about the long-term prognosis of symptom burden and functioning is an integrated part of clinical practice, but relies mostly on the clinician’s personal experience. Relevant prognostic models based on patient-reported outcome (PRO) data with repeated measur...

  13. Refractive lens exchange in younger and older presbyopes: comparison of complication rates, 3 months clinical and patient-reported outcomes.

    Science.gov (United States)

    Schallhorn, Steven C; Schallhorn, Julie M; Pelouskova, Martina; Venter, Jan A; Hettinger, Keith A; Hannan, Stephen J; Teenan, David

    2017-01-01

    To compare refractive and visual outcomes, patient satisfaction, and complication rates among different age categories of patients who underwent refractive lens exchange (RLE). A stratified, simple random sample of patients matched on preoperative sphere and cylinder was selected for four age categories: 45-49 years (group A), 50-54 years (group B), 55-59 years (group C), and 60-65 years (group D). Each group contained 320 patients. All patients underwent RLE with a multifocal intraocular lens at least in one eye. Three months postoperative refractive/visual and patient-reported outcomes are presented. The percentage of patients that achieved binocular uncorrected distance visual acuity 20/20 or better was 91.6% (group A), 93.8% (group B), 91.6% (group C), 88.8% (group D), P =0.16. Binocularly, 80.0% of patients in group A, 84.7% in group B, 78.9% in group C, and 77.8% in group D achieved 20/30 or better uncorrected near visual acuity ( P =0.13). The proportion of eyes within 0.50 D of emmetropia was 84.4% in group A, 86.8% in group B, 85.7% in group C, and 85.8% in group D ( P =0.67). There was no statistically significant difference in postoperative satisfaction, visual phenomena, dry eye symptoms, distance or near vision activities. Apart from higher rate of iritis in the age group 50-55 years, there was no statistically significant difference in postoperative complication rates. RLE can be safely performed in younger as well as older presbyopes. No significant difference was found in clinical or patient-reported outcomes.

  14. The Impact of Heavy Perceived Nurse Workloads on Patient and Nurse Outcomes

    Directory of Open Access Journals (Sweden)

    Maura MacPhee

    2017-03-01

    Full Text Available This study investigated the relationships between seven workload factors and patient and nurse outcomes. (1 Background: Health systems researchers are beginning to address nurses’ workload demands at different unit, job and task levels; and the types of administrative interventions needed for specific workload demands. (2 Methods: This was a cross-sectional correlational study of 472 acute care nurses from British Columbia, Canada. The workload factors included nurse reports of unit-level RN staffing levels and patient acuity and patient dependency; job-level nurse perceptions of heavy workloads, nursing tasks left undone and compromised standards; and task-level interruptions to work flow. Patient outcomes were nurse-reported frequencies of medication errors, patient falls and urinary tract infections; and nurse outcomes were emotional exhaustion and job satisfaction. (3 Results: Job-level perceptions of heavy workloads and task-level interruptions had significant direct effects on patient and nurse outcomes. Tasks left undone mediated the relationships between heavy workloads and nurse and patient outcomes; and between interruptions and nurse and patient outcomes. Compromised professional nursing standards mediated the relationships between heavy workloads and nurse outcomes; and between interruptions and nurse outcomes. (4 Conclusion: Administrators should work collaboratively with nurses to identify work environment strategies that ameliorate workload demands at different levels.

  15. Core Outcome Set-STAndards for Development: The COS-STAD recommendations.

    Directory of Open Access Journals (Sweden)

    Jamie J Kirkham

    2017-11-01

    Full Text Available The use of core outcome sets (COS ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR].An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers, and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1-9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process.The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using

  16. Core Outcome Set-STAndards for Development: The COS-STAD recommendations.

    Science.gov (United States)

    Kirkham, Jamie J; Davis, Katherine; Altman, Douglas G; Blazeby, Jane M; Clarke, Mike; Tunis, Sean; Williamson, Paula R

    2017-11-01

    The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]). An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1-9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process. The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable

  17. The establishment of the GENEQOL consortium to investigate the genetic disposition of patient-reported quality-of-life outcomes

    NARCIS (Netherlands)

    Sprangers, Mirjam A. G.; Sloan, Jeff A.; Veenhoven, Ruut; Cleeland, Charles S.; Halyard, Michele Y.; Abertnethy, Amy P.; Baas, Frank; Barsevick, Andrea M.; Bartels, Meike; Boomsma, Dorret I.; Chauhan, Cynthia; Dueck, Amylou C.; Frost, Marlene H.; Hall, Per; Klepstad, Pål; Martin, Nicholas G.; Miaskowski, Christine; Mosing, Miriam; Movsas, Benjamin; van Noorden, Cornelis J. F.; Patrick, Donald L.; Pedersen, Nancy L.; Ropka, Mary E.; Shi, Quiling; Shinozaki, Gen; Singh, Jasvinder A.; Yang, Ping; Zwinderman, Ailko H.

    2009-01-01

    To our knowledge, no comprehensive, interdisciplinary initiatives have been taken to examine the role of genetic variants on patient-reported quality-of-life outcomes. The overall objective of this paper is to describe the establishment of an international and interdisciplinary consortium, the

  18. A description of the severity of equestrian-related injuries (ERIs) using clinical parameters and patient-reported outcomes.

    Science.gov (United States)

    Papachristos, Alexander; Edwards, Elton; Dowrick, Adam; Gosling, Cameron

    2014-09-01

    Despite a number of injury prevention campaigns and interventions, horse riding continues to be a dangerous activity, resulting in more accidents per hour than motorcycling, skiing and football. Injuries are often serious, with one in four patients requiring admission to hospital. This study aims to describe the severity of equestrian-related injuries (ERIs) using both clinical parameters and patient-reported outcomes. A retrospective study of all patients aged ≥18 years admitted to The Alfred Hospital between January 2003 and January 2008 with an ERI was performed. Specific clinical data were extracted from the medical record. In addition, a questionnaire was conducted identifying the details of the accident, the required recovery time and levels of ongoing pain and physical disability. During the study period 172 patients met the inclusion criteria. There were three deaths (2%). Eighty-two patients (48%) suffered head injuries. Forty-one patients (24%) were admitted to the ICU and 31 patients (18%) required mechanical ventilation. On discharge, 41 patients (24%) required transfer to a sub-acute rehabilitation facility. One-hundred-and-twenty-four patients (72%) completed the questionnaire. Thirty-nine respondents (31%) were not wearing a helmet. Among patients injured for more than 6 months, 38 (35%) still experienced moderate or severe pain or disability. Ninety-five patients had returned to work at the time of review, among which 47(50%) required longer than 6 months to recover, and 40 (42%) returned at a reduced capacity. The clinical and patient-reported outcomes of ERIs requiring hospital admission are poor. Persistent pain and disability are common, even up to 5 years post-injury. A large proportion of patients required longer than 6 months to return to work and many return at a reduced capacity. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice.

    Science.gov (United States)

    Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob

    2015-09-01

    Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.

  20. Patient-Reported Esthetic and Functional Outcomes of Primary Total Laparoscopic Intestinal Vaginoplasty in Transgender Women With Penoscrotal Hypoplasia.

    Science.gov (United States)

    Bouman, Mark-Bram; van der Sluis, Wouter B; van Woudenberg Hamstra, Leonora E; Buncamper, Marlon E; Kreukels, Baudewijntje P C; Meijerink, Wilhelmus J H J; Mullender, Margriet G

    2016-09-01

    Puberty-suppressing hormonal treatment may result in penoscrotal hypoplasia in transgender women, making standard penile inversion vaginoplasty not feasible. For these patients, intestinal vaginoplasty is a surgical alternative, but knowledge on patient-reported postoperative outcomes and quality of life is lacking. To assess patient-reported functional and esthetic outcomes, quality of life, satisfaction, and sexual well-being after primary total laparoscopic intestinal vaginoplasty in transgender women. A survey study was performed on transgender women who underwent primary total laparoscopic intestinal vaginoplasty with at least 1 year of clinical follow-up. Thirty-one transgender women completed the questionnaires (median age at time of surgery = 19.1 years, range = 18.3-45.0) after a median clinical follow-up of 2.2 years (range = 0.8-7.5). Consenting women were asked to complete a combined questionnaire of the Subjective Happiness Scale, the Satisfaction With Life Scale, Cantril's Ladder of Life Scale, the Female Sexual Function Index, the Female Genital Self-Imaging Scale, the Amsterdam Hyperactive Pelvic Floor Scale-Women, and a questionnaire addressing postoperative satisfaction. Patient-reported functional and esthetic outcomes and postoperative quality of life. Patients graded their life satisfaction a median of 8.0 (range = 4.0-10.0) on Cantril's Ladder of Life Scale. Patients scored a mean total score of 27.7 ± 5.8 on the Satisfaction With Life Scale, which indicated high satisfaction with life, and a mean total score of 5.6 ± 1.4 on the Subjective Happiness Scale. Functionality was graded a median score of 8.0 of 10 (range = 1.0-10.0) and esthetics a score of 8.0 out of 10 (range = 3.0-10.0). The mean Female Sexual Function Index total score of sexually active transgender women was 26.0 ± 6.8. This group of relatively young transgender women reported satisfactory functional and esthetic results of the neovagina and a good quality of life

  1. Self-Reported Cognitive Outcomes in Patients With Brain Metastases Before and After Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Cole, Ansa Maer [Department of Radiation Oncology, Medical School Hannover, Hannover (Germany); Scherwath, Angela [Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg (Germany); Ernst, Gundula [Department of Medical Psychology, Medical School Hannover, Hannover (Germany); Lanfermann, Heinrich [Institute for Neuroradiology, Medical School Hannover, Hannover (Germany); Bremer, Michael [Department of Radiation Oncology, Medical School Hannover, Hannover (Germany); Steinmann, Diana, E-mail: steinmann.diana@mh-hannover.de [Department of Radiation Oncology, Medical School Hannover, Hannover (Germany)

    2013-11-15

    Purpose: Patients with brain metastases may experience treatment-related cognitive deficits. In this study, we prospectively assessed the self-reported cognitive abilities of patients with brain metastases from any solid primary cancer before and after irradiation of the brain. Methods and Materials: The treatment group (TG) consisted of adult patients (n=50) with brain metastases who received whole or partial irradiation of the brain without having received prior radiation therapy (RT). The control group (CG) consisted of breast cancer patients (n=27) without cranial involvement who were treated with adjuvant RT. Patients were recruited between May 2008 and December 2010. Self-reported cognitive abilities were acquired before RT and 6 weeks, 3 months, and 6 months after irradiation. The information regarding the neurocognitive status was collected by use of the German questionnaires for self-perceived deficits in attention (FEDA) and subjectively experienced everyday memory performance (FEAG). Results: The baseline data showed a high proportion of self-perceived neurocognitive deficits in both groups. A comparison between the TG and the CG regarding the course of self-reported outcomes after RT showed significant between-group differences for the FEDA scales 2 and 3: fatigue and retardation of daily living activities (P=.002) and decrease in motivation (P=.032) with an increase of attention deficits in the TG, but not in the CG. There was a trend towards significance in FEDA scale 1: distractibility and retardation of mental processes (P=.059) between the TG and the CG. The FEAG assessment presented no significant differences. An additional subgroup analysis within the TG was carried out. FEDA scale 3 showed significant differences in the time-related progress between patients with whole-brain RT and those receiving hypofractionated stereotactic RT (P=.025), with less decrease in motivation in the latter group. Conclusion: Self-reported attention declined in

  2. Self-Reported Cognitive Outcomes in Patients With Brain Metastases Before and After Radiation Therapy

    International Nuclear Information System (INIS)

    Cole, Ansa Maer; Scherwath, Angela; Ernst, Gundula; Lanfermann, Heinrich; Bremer, Michael; Steinmann, Diana

    2013-01-01

    Purpose: Patients with brain metastases may experience treatment-related cognitive deficits. In this study, we prospectively assessed the self-reported cognitive abilities of patients with brain metastases from any solid primary cancer before and after irradiation of the brain. Methods and Materials: The treatment group (TG) consisted of adult patients (n=50) with brain metastases who received whole or partial irradiation of the brain without having received prior radiation therapy (RT). The control group (CG) consisted of breast cancer patients (n=27) without cranial involvement who were treated with adjuvant RT. Patients were recruited between May 2008 and December 2010. Self-reported cognitive abilities were acquired before RT and 6 weeks, 3 months, and 6 months after irradiation. The information regarding the neurocognitive status was collected by use of the German questionnaires for self-perceived deficits in attention (FEDA) and subjectively experienced everyday memory performance (FEAG). Results: The baseline data showed a high proportion of self-perceived neurocognitive deficits in both groups. A comparison between the TG and the CG regarding the course of self-reported outcomes after RT showed significant between-group differences for the FEDA scales 2 and 3: fatigue and retardation of daily living activities (P=.002) and decrease in motivation (P=.032) with an increase of attention deficits in the TG, but not in the CG. There was a trend towards significance in FEDA scale 1: distractibility and retardation of mental processes (P=.059) between the TG and the CG. The FEAG assessment presented no significant differences. An additional subgroup analysis within the TG was carried out. FEDA scale 3 showed significant differences in the time-related progress between patients with whole-brain RT and those receiving hypofractionated stereotactic RT (P=.025), with less decrease in motivation in the latter group. Conclusion: Self-reported attention declined in

  3. Patient-Reported Outcomes, Quality of Life, and Satisfaction Rates in Young Patients Aged 50 Years or Younger After Total Knee Arthroplasty.

    Science.gov (United States)

    Goh, Graham Seow-Hng; Liow, Ming Han Lincoln; Bin Abd Razak, Hamid Rahmatullah; Tay, Darren Keng-Jin; Lo, Ngai-Nung; Yeo, Seng-Jin

    2017-02-01

    Recent studies have shown a discrepancy between traditional functional outcomes and patient satisfaction, with some reporting less than 85% satisfaction in older patients undergoing total knee arthroplasty (TKA). As native knee biomechanics are not completely replicated, the resulting functional limitations may cause dissatisfaction in higher-demand individuals. Few studies have recorded patient-reported outcomes, health-related quality of life scores, and patient satisfaction in a young population undergoing TKA. One hundred thirty-six primary TKAs were performed in 114 patients aged 50 years or younger (mean age, 47.0 years; range, 30-50 years) at a single institution. The main diagnoses were osteoarthritis (85%) and rheumatoid arthritis (10%). The range of motion, Knee Society Score, Oxford Knee Score, and Physical and Mental Component Scores of Short Form-36 increased significantly (P patients had good/excellent knee scores, 71.3% had good/excellent function scores, 94.9% met the minimal clinically important difference for the Oxford Knee Score, and 84.6% met the minimal clinically important difference for the Physical Component Score. We found that 88.8% of patients were satisfied with their surgeries, whereas 86.8% had their expectations fulfilled. Survivorship using revision as an end point was 97.8% at a mean of 7 years (range, 3-16 years). Patients aged 50 years or younger undergoing TKA can experience significant improvements in their quality of life, have their expectations met, and be satisfied with their surgeries, at rates similar to those of non-age-restricted populations. Surgeons should inform them of these benefits and the potential risk of revision surgery in the future, albeit increasingly shown to be low. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. The selection of core International Classification of Functioning, Disability, and Health (ICF) categories for patient-reported outcome measurement in spine trauma patients-results of an international consensus process

    NARCIS (Netherlands)

    Sadiqi, Said; Lehr, A. Mechteld; Post, Marcel W.; Jacobs, Wilco C. H.; Aarabi, Bizhan; Chapman, Jens R.; Dunn, Robert N.; Dvorak, Marcel F.; Fehlings, Michael G.; Rajasekaran, S.; Vialle, Luiz R.; Vaccaro, Alexander R.; Oner, F. Cumhur

    BACKGROUND CONTEXT: There is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies. PURPOSE: The paper aimed to report

  5. Content Validity of Patient-Reported Outcome Instruments used with Pediatric Patients with Facial Differences: A Systematic Review.

    Science.gov (United States)

    Wickert, Natasha M; Wong Riff, Karen W Y; Mansour, Mark; Forrest, Christopher R; Goodacre, Timothy E E; Pusic, Andrea L; Klassen, Anne F

    2018-01-01

    Objective The aim of this systematic review was to identify patient-reported outcome (PRO) instruments used in research with children/youth with conditions associated with facial differences to identify the health concepts measured. Design MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from 2004 to 2016 to identify PRO instruments used in acne vulgaris, birthmarks, burns, ear anomalies, facial asymmetries, and facial paralysis patients. We performed a content analysis whereby the items were coded to identify concepts and categorized as positive or negative content or phrasing. Results A total of 7,835 articles were screened; 6 generic and 11 condition-specific PRO instruments were used in 96 publications. Condition-specific instruments were for acne (four), oral health (two), dermatology (one), facial asymmetries (two), microtia (one), and burns (one). The PRO instruments provided 554 items (295 generic; 259 condition specific) that were sorted into 4 domains, 11 subdomains, and 91 health concepts. The most common domain was psychological (n = 224 items). Of the identified items, 76% had negative content or phrasing (e.g., "Because of the way my face looks I wish I had never been born"). Given the small number of items measuring facial appearance (n = 19) and function (n = 22), the PRO instruments reviewed lacked content validity for patients whose condition impacted facial function and/or appearance. Conclusions Treatments can change facial appearance and function. This review draws attention to a problem with content validity in existing PRO instruments. Our team is now developing a new PRO instrument called FACE-Q Kids to address this problem.

  6. Lessons Learned from Developing a Patient Engagement Panel: An OCHIN Report.

    Science.gov (United States)

    Arkind, Jill; Likumahuwa-Ackman, Sonja; Warren, Nate; Dickerson, Kay; Robbins, Lynn; Norman, Kathy; DeVoe, Jennifer E

    2015-01-01

    There is renewed interest in patient engagement in clinical and research settings, creating a need for documenting and publishing lessons learned from efforts to meaningfully engage patients. This article describes early lessons learned from the development of OCHIN's Patient Engagement Panel (PEP). OCHIN supports a national network of more than 300 community health centers (CHCs) and other primary care settings that serve over 1.5 million patients annually across nearly 20 states. The PEP was conceived in 2009 to harness the CHC tradition of patient engagement in this new era of patient-centered outcomes research and to ensure that patients were engaged throughout the life cycle of our research projects, from conception to dissemination. Developed by clinicians and researchers within our practice-based research network, recruitment of patients to serve as PEP members began in early 2012. The PEP currently has a membership of 18 patients from 3 states. Over the past 24 months, the PEP has been involved with 12 projects. We describe developing the PEP and challenges and lessons learned (eg, recruitment, funding model, creating value for patient partners, compensation). These lessons learned are relevant not only for research but also for patient engagement in quality improvement efforts and other clinical initiatives. © Copyright 2015 by the American Board of Family Medicine.

  7. Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO.

    Science.gov (United States)

    Watt, Torquil; Barbesino, Giuseppe; Bjorner, Jakob Bue; Bonnema, Steen Joop; Bukvic, Branka; Drummond, Russell; Groenvold, Mogens; Hegedüs, Laszlo; Kantzer, Valeska; Lasch, Kathryn E; Marcocci, Claudio; Mishra, Anjali; Netea-Maier, Romana; Ekker, Merel; Paunovic, Ivan; Quinn, Terence J; Rasmussen, Åse Krogh; Russell, Audrey; Sabaretnam, Mayilvaganan; Smit, Johannes; Törring, Ove; Zivaljevic, Vladan; Feldt-Rasmussen, Ulla

    2015-03-01

    Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version. The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social and daily function and cosmetic concerns. Translation applied standard forward-backward methodology with subsequent cognitive interviews and reviews. Responses (N = 1,810) to the ThyPRO were collected in seven countries: UK (n = 166), The Netherlands (n = 147), Serbia (n = 150), Italy (n = 110), India (n = 148), Denmark (n = 902) and Sweden (n = 187). Translated versions were compared pairwise to the English version by examining uniform and nonuniform DIF, i.e., whether patients from different countries respond differently to a particular item, although they have identical level of the concept measured by the item. Analyses were controlled for thyroid diagnosis. DIF was investigated by ordinal logistic regression, testing for both statistical significance and magnitude (ΔR (2) > 0.02). Scale level was estimated by the sum score, after purification. For twelve of the 84 tested items, DIF was identified in more than one language. Eight of these were small, but four were indicative of possible low translatability. Twenty-one instances of DIF in single languages were identified, indicating potential problems with the particular translation. However, only seven were of a magnitude which could affect scale scores, most of which could be explained by sample differences not controlled for. The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in

  8. Worse patient-reported outcome after lateral approach than after anterior and posterolateral approach in primary hip arthroplasty. A cross-sectional questionnaire study of 1,476 patients 1-3 years after surgery.

    Science.gov (United States)

    Amlie, Einar; Havelin, Leif I; Furnes, Ove; Baste, Valborg; Nordsletten, Lars; Hovik, Oystein; Dimmen, Sigbjorn

    2014-09-01

    The surgical approach in total hip arthroplasty (THA) is often based on surgeon preference and local traditions. The anterior muscle-sparing approach has recently gained popularity in Europe. We tested the hypothesis that patient satisfaction, pain, function, and health-related quality of life (HRQoL) after THA is not related to the surgical approach. 1,476 patients identified through the Norwegian Arthroplasty Register were sent questionnaires 1-3 years after undergoing THA in the period from January 2008 to June 2010. Patient-reported outcome measures (PROMs) included the hip disability osteoarthritis outcome score (HOOS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), health-related quality of life (EQ-5D-3L), visual analog scales (VAS) addressing pain and satisfaction, and questions about complications. 1,273 patients completed the questionnaires and were included in the analysis. Adjusted HOOS scores for pain, other symptoms, activities of daily living (ADL), sport/recreation, and quality of life were significantly worse (p < 0.001 to p = 0.03) for the lateral approach than for the anterior approach and the posterolateral approach (mean differences: 3.2-5.0). These results were related to more patient-reported limping with the lateral approach than with the anterior and posterolateral approaches (25% vs. 12% and 13%, respectively; p < 0.001). Patients operated with the lateral approach reported worse outcomes 1-3 years after THA surgery. Self-reported limping occurred twice as often in patients who underwent THA with a lateral approach than in those who underwent THA with an anterior or posterolateral approach. There were no significant differences in patient-reported outcomes after THA between those who underwent THA with a posterolateral approach and those who underwent THA with an anterior approach.

  9. Patient Satisfaction Reporting for the Treatment of Femoroacetabular Impingement.

    Science.gov (United States)

    Kahlenberg, Cynthia A; Nwachukwu, Benedict U; Schairer, William W; McCormick, Frank; Ranawat, Anil S

    2016-08-01

    The purpose of this study was to evaluate how patient satisfaction after surgical femoroacetabular impingement (FAI) treatment is measured and reported in the current evidence base. A review of the MEDLINE database was performed. Clinical outcome studies of FAI that reported a measure of patient satisfaction were included. Patient demographics, clinical outcome scores, and patient satisfaction measures were extracted. The NewCastle Ottawa Scale (NOS) was used to grade quality. Statistical analysis was primarily descriptive. Twenty-six studies met inclusion criteria; the mean NOS score among included studies was 5.7. Most studies were level 3 or 4 (n = 25, 96.1%). A 0 to 10 numeric scale, described by some studies as a visual analog scale, was the most commonly used method to assess satisfaction (n = 21; 80.8%), and mean reported scores ranged from 6.8 to 9.2 out of 10. Four studies (15.4%) used an ordinal scale, and 1 study (3.8%) used willingness to undergo surgery again as the measure of satisfaction. None of the included studies assessed preoperative satisfaction or patient expectation. Pooled cohort analysis was limited by significant overlapping study populations. Predictors of patients' satisfaction identified in included studies were presence of arthritis and postoperative outcome scores. Patient satisfaction was not uniformly assessed in the literature. Most studies used a 0- to 10-point satisfaction scale, but none distinguished between the process of care and the outcome of care. Although satisfaction scores were generally high, the quality of the methodologies in the studies that reported satisfaction was low, and the studies likely included overlapping patient populations. More work needs to be done to develop standardized ways for assessing patient satisfaction after arthroscopic hip surgery and other procedures in orthopaedic sports medicine. Level III, systematic review of Level III studies. Copyright © 2016 Arthroscopy Association of North

  10. Using patient reported outcome measures in health services: A qualitative study on including people with low literacy skills and learning disabilities

    NARCIS (Netherlands)

    Jahagirdar, D.; Kroll, T.; Ritchie, K.; Wyke, S.

    2012-01-01

    ABSTRACT: BACKGROUND: Patient reported outcome measures (PROMs) are self-report measures of health status increasingly promoted for use in healthcare quality improvement. However people with low literacy skills or learning disabilities may find PROMs hard to complete. Our study investigated

  11. Effects of hospital care environment on patient mortality and nurse outcomes.

    Science.gov (United States)

    Aiken, Linda H; Clarke, Sean P; Sloane, Douglas M; Lake, Eileen T; Cheney, Timothy

    2008-05-01

    The objective of this study was to analyze the net effects of nurse practice environments on nurse and patient outcomes after accounting for nurse staffing and education. Staffing and education have well-documented associations with patient outcomes, but evidence on the effect of care environments on outcomes has been more limited. Data from 10,184 nurses and 232,342 surgical patients in 168 Pennsylvania hospitals were analyzed. Care environments were measured using the practice environment scales of the Nursing Work Index. Outcomes included nurse job satisfaction, burnout, intent to leave, and reports of quality of care, as well as mortality and failure to rescue in patients. Nurses reported more positive job experiences and fewer concerns with care quality, and patients had significantly lower risks of death and failure to rescue in hospitals with better care environments. Care environment elements must be optimized alongside nurse staffing and education to achieve high quality of care.

  12. Correlations between FEV1 and patient-reported outcomes: A pooled analysis of 23 clinical trials in patients with chronic obstructive pulmonary disease.

    Science.gov (United States)

    Donohue, James F; Jones, Paul W; Bartels, Christian; Marvel, Jessica; D'Andrea, Peter; Banerji, Donald; Morris, David G; Patalano, Francesco; Fogel, Robert

    2018-04-01

    In clinical trials of inhaled bronchodilators, chronic obstructive pulmonary disease (COPD) guidelines recommend that patient-reported outcomes (PROs) are assessed alongside lung function. How these endpoints are related is unclear. Pooled longitudinal data from 23 randomised controlled COPD studies were analyzed (N = 23,213). Treatments included long-acting β 2 agonists, long-acting muscarinic antagonists (LABAs or LAMAs) and the LABA/LAMA combination QVA149. Outcome measures were Transition Dyspnoea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) scores, COPD exacerbation frequency and rescue medication use. Relationships between changes in trough forced expiratory volume in one second (ΔFEV 1 ) and outcomes following treatment were assessed using correlations of data summaries and model-based analysis: generalized linear mixed-effect regression modelling to determine if ΔFEV 1 could predict patient outcomes with different treatments. Mean age was 64 years, 73% were male, and most had moderate (45%) or severe (52%) disease. Statistically significant correlations were observed between ΔFEV 1 and each outcome measure (exacerbations Rs = 0.05; rescue medication, SGRQ, TDI, r = 0.11-0.16; all p < .001). Patients with greater improvements in trough FEV 1 had on average better SGRQ and TDI scores, fewer exacerbations, and used less rescue medication. For SGRQ and TDI scores, minimal clinically important differences were observed over the range of pooled ΔFEV 1 values. Model-based predictions confirmed the treatment effect was partly explained by changes in FEV 1 from baseline with improvements in PROs observed across all treatments when trough FEV 1 improved. Across all endpoints active treatments were better than placebo (p < .0001), and LABA/LAMA treatment resulted in numerically better treatment outcomes than either monocomponent. These data suggest that FEV 1 improvements post-bronchodilation correlate with PRO improvements

  13. Developing a theoretical framework to illustrate associations among patient satisfaction, body image and quality of life for women undergoing breast reconstruction.

    Science.gov (United States)

    Fingeret, Michelle Cororve; Nipomnick, Summer W; Crosby, Melissa A; Reece, Gregory P

    2013-10-01

    Within the field of breast reconstruction there is increasing focus on patient-reported outcomes related to satisfaction, body image, and quality of life. These outcomes are deemed highly relevant because the primary goal of breast reconstruction is to recreate the appearance of a breast (or breasts) that is satisfying to the patient. Prominent researchers have suggested the need to develop improved standards for outcome evaluation which can ultimately benefit patients as well as physicians. The purpose of this article is to summarize key findings in the area of patient-reported outcomes for breast reconstruction and introduce a theoretical framework for advancing research in this field. We conducted an extensive literature review of outcome studies for breast reconstruction focusing on patient-reported results. We developed a theoretical framework illustrating core patient-reported outcomes related to breast reconstruction and factors associated with these outcomes. Our theoretical model highlights domains and distinguishing features of patient satisfaction, body image, and quality of life outcomes for women undergoing breast reconstruction. This model further identifies a broad range of variables (e.g., historical/premorbid influences, disease and treatment-related factors) that have been found to influence patient-reported outcomes and need to be taken into consideration when designing future research in this area. Additional attention is given to examining the relationship between patient reported outcomes and outside evaluation of breast reconstruction. Our proposed theoretical framework suggests key opportunities to expand research in this area with the goal of optimizing body image adjustment, satisfaction, and psychosocial outcomes for the individual patient. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. Utility of a patient-reported outcome in measuring functional impairment during autologous stem cell transplant in patients with multiple myeloma.

    Science.gov (United States)

    Shah, Nina; Shi, Qiuling; Giralt, Sergio; Williams, Loretta; Bashir, Qaiser; Qazilbash, Muzaffar; Champlin, Richard E; Cleeland, Charles S; Wang, Xin Shelley

    2018-04-01

    We aimed to determine the utility of a patient-reported outcome (PRO) as it relates to patient performed testing (PPT) for measuring functional status in multiple myeloma patients after autologous hematopoietic stem cell transplantation (auto-HCT). Symptom interference on walking (a PRO) was measured by the MD Anderson Symptom Inventory (MDASI). PPT was assessed via 6-min walk test (6MWT). Mixed effects modeling was used to examine (1) the longitudinal relationship between the MDASI score and 6MWT distance and (2) the MDASI scores between patients who did or did not complete the 6WMT. Receiver operating characteristic (ROC) curve analysis was performed to quantify the construct validity of the PRO by differentiating performance status. Seventy-nine patients were included. Mean 6MWT distance significantly correlated with MDASI-walking interference score (PRO) over the first month of auto-HCT (est = 6.09, p = 0.006). There was a significantly higher completion rate for MDASI versus 6MWT at each time point (p Patients who completed the 6MWT reported less interference on walking during the study period (est = 1.61, p patients undergoing auto-HCT. As patients with poorer functional status during therapy are less likely to complete PPT, this PRO may offer a more practical quantitative measure of functioning in patients.

  15. Outcomes-focused knowledge translation: a framework for knowledge translation and patient outcomes improvement.

    Science.gov (United States)

    Doran, Diane M; Sidani, Souraya

    2007-01-01

    Regularly accessing information that is current and reliable continues to be a challenge for front-line staff nurses. Reconceptualizing how nurses access information and designing appropriate decision support systems to facilitate timely access to information may be important for increasing research utilization. An outcomes-focused knowledge translation framework was developed to guide the continuous improvement of patient care through the uptake of research evidence and feedback data about patient outcomes. The framework operationalizes the three elements of the PARIHS framework at the point of care. Outcomes-focused knowledge translation involves four components: (a) patient outcomes measurement and real-time feedback about outcomes achievement; (b) best-practice guidelines, embedded in decision support tools that deliver key messages in response to patient assessment data; (c) clarification of patients' preferences for care; and (d) facilitation by advanced practice nurses and practice leaders. In this paper the framework is described and evidence is provided to support theorized relationships among the concepts in the framework. The framework guided the design of a knowledge translation intervention aimed at continuous improvement of patient care and evidence-based practice, which are fostered through real-time feedback data about patient outcomes, electronic access to evidence-based resources at the point of care, and facilitation by advanced practice nurses. The propositions in the framework need to be empirically tested through future research.

  16. International collaboration including patients is essential to develop new therapies for patients with myositis.

    Science.gov (United States)

    Lundberg, Ingrid E; Vencovsky, Jiri

    2017-05-01

    To discuss the needs for international collaborations between investigators in different disciplines working with myositis and with patients with myositis. Recent advances in detection of several myositis-specific autoantibodies that are associated with distinct clinical phenotypes, will enable studies in new well defined clinically homogenous subgroups of myositis This is likely to lead to development of new information on molecular pathogenesis that might be different in different myositis subgroups. Subgrouping patients according to autoantibody profile may also be important to assess outcome, to identify prognostic biomarkers and in clinical trials. As these are rare disorders international collaboration is essential to enrol large enough cohorts of the subgroups. To facilitate such collaboration we have developed a web-based international myositis register, www.euromyositis.eu, which includes validated outcome measures and patient reported outcome measures. This register is to support research but also to support decision-making in the clinic. We welcome investigators to join the Euromyositis register. Myositis is a heterogeneous disorder with varying treatment response and outcome. There is a high unmet need for new therapies which can only be achieved by increased knowledge on molecular disease mechanisms. Subgrouping patients according to autoantibody profile may be a new way forward to get a better understanding on disease mechanisms and to develop novel therapies.

  17. A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

    Science.gov (United States)

    Højgaard, Pil; Klokker, Louise; Orbai, Ana-Maria; Holmsted, Kim; Bartels, Else M; Leung, Ying Ying; Goel, Niti; de Wit, Maarten; Gladman, Dafna D; Mease, Philip; Dreyer, Lene; Kristensen, Lars E; FitzGerald, Oliver; Tillett, William; Gossec, Laure; Helliwell, Philip; Strand, Vibeke; Ogdie, Alexis; Terwee, Caroline B; Christensen, Robin

    2018-04-01

    An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. Theoretical framework and methodological development of common subjective health outcome measures in osteoarthritis: a critical review

    Directory of Open Access Journals (Sweden)

    Johnston Marie

    2007-03-01

    Full Text Available Abstract Subjective measures involving clinician ratings or patient self-assessments have become recognised as an important tool for the assessment of health outcome. The value of a health outcome measure is usually assessed by a psychometric evaluation of its reliability, validity and responsiveness. However, psychometric testing involves an accumulation of evidence and has recognised limitations. It has been suggested that an evaluation of how well a measure has been developed would be a useful additional criteria in assessing the value of a measure. This paper explored the theoretical background and methodological development of subjective health status measures commonly used in osteoarthritis research. Fourteen subjective health outcome measures commonly used in osteoarthritis research were examined. Each measure was explored on the basis of their i theoretical framework (was there a definition of what was being assessed and was it part of a theoretical model? and ii methodological development (what was the scaling strategy, how were the items generated and reduced, what was the response format and what was the scoring method?. Only the AIMS, SF-36 and WHOQOL defined what they were assessing (i.e. the construct of interest and no measure assessed was part of a theoretical model. None of the clinician report measures appeared to have implemented a scaling procedure or described the rationale for the items selected or scoring system. Of the patient self-report measures, the AIMS, MPQ, OXFORD, SF-36, WHOQOL and WOMAC appeared to follow a standard psychometric scaling method. The DRP and EuroQol used alternative scaling methods. The review highlighted the general lack of theoretical framework for both clinician report and patient self-report measures. This review also drew attention to the wide variation in the methodological development of commonly used measures in OA. While, in general the patient self-report measures had good methodological

  19. Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set.

    Science.gov (United States)

    Khalil, Asma; Perry, Helen; Duffy, James; Reed, Keith; Baschat, Ahmet; Deprest, Jan; Hecher, Kurt; Lewi, Liesbeth; Lopriore, Enrico; Oepkes, Dick

    2017-07-14

    Twin-Twin Transfusion Syndrome (TTTS) is associated with an increased risk of perinatal mortality and morbidity. Several treatment interventions have been described for TTTS, including fetoscopic laser surgery, amnioreduction, septostomy, expectant management, and pregnancy termination. Over the last decade, fetoscopic laser surgery has become the primary treatment. The literature to date reports on many different outcomes, making it difficult to compare results or combine data from individual studies, limiting the value of research to guide clinical practice. With the advent and ongoing development of new therapeutic techniques, this is more important than ever. The development and use of a core outcome set has been proposed to address these issues, prioritising outcomes important to the key stakeholders, including patients. We aim to produce, disseminate, and implement a core outcome set for TTTS. An international steering group has been established to oversee the development of this core outcome set. This group includes healthcare professionals, researchers and patients. A systematic review is planned to identify previously reported outcomes following treatment for TTTS. Following completion, the identified outcomes will be evaluated by stakeholders using an international, multi-perspective online modified Delphi method to build consensus on core outcomes. This method encourages the participants towards consensus 'core' outcomes. All key stakeholders will be invited to participate. The steering group will then hold a consensus meeting to discuss results and form a core outcome set to be introduced and measured. Once core outcomes have been agreed, the next step will be to determine how they should be measured, disseminated, and implemented within an international context. The development, dissemination, and implementation of a core outcome set in TTTS will enable its use in future clinical trials, systematic reviews and clinical practice guidelines. This is

  20. SCIRehab uses practice-based evidence methodology to associate patient and treatment characteristics with outcomes.

    Science.gov (United States)

    Whiteneck, Gale G; Gassaway, Julie

    2013-04-01

    To describe the application of practice-based evidence (PBE) methodology to spinal cord injury (SCI) rehabilitation in the SCIRehab study, and to summarize associations of patient characteristics and treatment interventions to outcomes. Prospective observational study. Six SCI rehabilitation centers. Patients with traumatic SCI (N=1376) admitted for first rehabilitation. Not applicable. FIM and residence at discharge, and FIM, residence, Craig Handicap Assessment and Reporting Technique, work/school status, Patient Health Questionnaire-9, Diener Satisfaction with Life Scale, rehospitalization, and presence of pressure ulcers at 1 year postinjury. Patient demographic and injury characteristics explained significant variation in rehabilitation outcomes, particularly functional outcomes. Regression modeling also identified a large number of significant associations with outcomes when total time in each discipline was modeled and when models were developed for each discipline, examining time spent in the many specific interventions provided by each discipline. The application of PBE methodology in the SCIRehab study provided extensive information about the process of inpatient SCI rehabilitation. While patient demographic and injury characteristics explain substantial variation in rehabilitation outcomes, particularly functional outcomes, significant relations also were found between the type and quantity of treatment interventions delivered by each rehabilitation discipline and a broad range of outcomes. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  1. Correlation between pain response and improvements in patient-reported outcomes and health-related quality of life in duloxetine-treated patients with diabetic peripheral neuropathic pain

    Directory of Open Access Journals (Sweden)

    Ogawa K

    2015-08-01

    Full Text Available Kei Ogawa,1 Shinji Fujikoshi,2 William Montgomery,3 Levent Alev1 1Medical Science, 2Statistical Science, Eli Lilly Japan K.K., Kobe, Japan; 3Global Patient Outcomes and Real World Evidence, Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia Objective: We assessed whether quality of life (QoL improvement in duloxetine-treated patients with diabetic peripheral neuropathic pain (DPNP correlates with the extent of pain relief.Methods: Pooled data from three multicountry, double-blind, 12-week, placebo-controlled trials of duloxetine-treated (duloxetine 60 mg once daily; total number =335 patients with DPNP were analyzed. Based on improvement in 24-hour average pain scores, patients were stratified into four groups. Improvement in QoL, which was measured as the change from baseline in two patient-reported health outcome measures (Short Form [SF]-36 and five-dimension version of the EuroQol Questionnaire [EQ-5D], was evaluated and compared among the four groups. Pearson’s correlation coefficient was calculated to assess the correlation between improvement in pain scores and improvement in QoL.Results: The group with more pain improvement generally showed greater mean change from baseline in all of the SF-36 scale scores and on the EQ-5D index. Pearson’s correlation coefficients ranged from 0.114 to 0.401 for the SF-36 scale scores (P<0.05, and it was 0.271 for the EQ-5D (P<0.001.Conclusion: Improvement in pain scores was positively correlated with improvement in QoL and patient-reported outcomes in duloxetine-treated patients. Keywords: diabetic peripheral neuropathic pain, duloxetine, efficacy, function, quality of life

  2. Triple osteotomy for the correction of severe hallux valgus deformity: Patient reported outcomes and radiological evaluation.

    Science.gov (United States)

    Booth, Sean; Bhosale, Abhijit; Mustafa, Abubakar; Shenoy, Ravi; Pillai, Anand

    2016-08-01

    Symptomatic Hallux valgus can be treated with metatarsal osteotomy combined with proximal phalangeal osteotomy, however this might not be sufficient to treat severe HV deformities. Fifteen feet in eleven female patients treated with double first metatarsal and proximal phalanx osteotomies without lateral release were prospectively studied and outcome measures including radiological angles and validated patient reported outcome scores collected. Mean radiological follow up was 15 months and PROMs data 17 months. Mean hallux valgus and intermetatarsal angles were corrected from 45 to 24.7° and 18.7 to 7.4° respectively. There was an eight degree recurrence of hallux valgus angle. There was no wound problems, non-unions or evidence of avascular necrosis. The EQ-5D descriptive index showed a non-statistically significant improvement. All three elements of the MOxFQ score showed a statistically significant improvement: Forefoot pain (59-26.8), Walking and Stability (49.9-29.6) and Social Interaction (56.4-33.1) CONCLUSION: Triple osteotomy, without a lateral soft tissue release, leads to good radiological and functional outcomes in those with severe hallux valgus deformity. Patients need to be warned of the recovery time and potential for future metalwork removal. The risk of early recurrence suggests that a lateral release should be included in order to maintain a long lasting correction. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Global patient outcomes after elective surgery

    DEFF Research Database (Denmark)

    2016-01-01

    BACKGROUND: As global initiatives increase patient access to surgical treatments, there remains a need to understand the adverse effects of surgery and define appropriate levels of perioperative care. METHODS: We designed a prospective international 7-day cohort study of outcomes following elective...... adult inpatient surgery in 27 countries. The primary outcome was in-hospital complications. Secondary outcomes were death following a complication (failure to rescue) and death in hospital. Process measures were admission to critical care immediately after surgery or to treat a complication and duration...... to a critical care unit as routine immediately after surgery, of whom 2198 (50.4%) developed a complication, with 105 (2.4%) deaths. A total of 1233 patients (16.4%) were admitted to a critical care unit to treat complications, with 119 (9.7%) deaths. Despite lower baseline risk, outcomes were similar in low...

  4. Knowledge Representation in Patient Safety Reporting: An Ontological Approach

    Directory of Open Access Journals (Sweden)

    Liang Chen

    2016-10-01

    Full Text Available Purpose: The current development of patient safety reporting systems is criticized for loss of information and low data quality due to the lack of a uniformed domain knowledge base and text processing functionality. To improve patient safety reporting, the present paper suggests an ontological representation of patient safety knowledge. Design/methodology/approach: We propose a framework for constructing an ontological knowledge base of patient safety. The present paper describes our design, implementation, and evaluation of the ontology at its initial stage. Findings: We describe the design and initial outcomes of the ontology implementation. The evaluation results demonstrate the clinical validity of the ontology by a self-developed survey measurement. Research limitations: The proposed ontology was developed and evaluated using a small number of information sources. Presently, US data are used, but they are not essential for the ultimate structure of the ontology. Practical implications: The goal of improving patient safety can be aided through investigating patient safety reports and providing actionable knowledge to clinical practitioners. As such, constructing a domain specific ontology for patient safety reports serves as a cornerstone in information collection and text mining methods. Originality/value: The use of ontologies provides abstracted representation of semantic information and enables a wealth of applications in a reporting system. Therefore, constructing such a knowledge base is recognized as a high priority in health care.

  5. Intermediate and Long-term Outcomes of Giant Fibroadenoma Excision in Adolescent and Young Adult Patients.

    Science.gov (United States)

    Cerrato, Felecia E; Pruthi, Sandhya; Boughey, Judy C; Simmons, Patricia S; Salje, Barbara; Nuzzi, Laura C; Lemaine, Valerie; Labow, Brian I

    2015-01-01

    Giant fibroadenomas (5 cm or greater) are benign breast masses that often present in adolescence and require surgical excision. Long-term outcomes, recurrence rates, and the need for additional reconstructive surgery in this population are unknown. Patients aged 11-25 years whose pathology reports indicated the presence of a giant fibroadenoma were eligible for this study. Medical records were reviewed for presentation, treatment, and outcomes. A subset of patients completed an investigator-designed long-term outcome survey to measure additional outcomes and the desire or need for subsequent reconstructive surgery. Forty-six patients with at least one giant fibroadenoma (mean size 7.4 ± 2.8 cm) were identified. Most patients underwent excision with a periaroeolar incision (n = 31), and an enucleation technique (n = 41), and four patients underwent immediate breast reconstruction. Thirty-three patients had complete medical records with a mean follow-up time of 2.2 ± 4.1 years and no complaints of asymmetry, additional breast deformities, or reconstructive surgery procedures documented. In addition, nine patients completed the investigator-designed survey with a mean follow-up time of 10.1 ± 8.7 years (range 1.5-27.0). Three of these patients reported postoperative breast asymmetry and the desire to pursue reconstructive surgery. Aesthetic outcomes of giant fibroadenoma excision may be satisfactory for many patients without immediate reconstruction, but for others, the need for reconstructive surgery may arise during development. Providers should address this potential need prior to discussing treatment options and during postoperative follow-up. Caution should be exercised before recommending immediate reconstruction. © 2015 Wiley Periodicals, Inc.

  6. Patient-Reported Outcome (PRO) questionnaires for young-aged to middle-aged adults with hip and groin disability

    DEFF Research Database (Denmark)

    Thorborg, K.; Tijssen, M.; Habets, B.

    2015-01-01

    BACKGROUND/AIM: To recommend Patient-Reported Outcome (PRO) questionnaires to measure hip and groin disability in young-aged to middle-aged adults. METHODS: A systematic review was performed in June 2014. The methodological quality of the studies included was determined using the COnsensus......-based Standards for the selection of health Measurement INstruments list (COSMIN) together with standardised evaluations of measurement properties of each PRO. RESULTS: Twenty studies were included. Nine different questionnaires for patients with hip disability, and one for hip and groin disability, were...

  7. Changes in Patient and Nurse Outcomes Associated with Magnet Hospital Recognition

    Science.gov (United States)

    Kutney-Lee, Ann; Stimpfel, Amy Witkoski; Sloane, Douglas M.; Cimiotti, Jeannie P.; Quinn, Lisa W.; Aiken, Linda H.

    2015-01-01

    Background Research has documented an association between Magnet hospitals and better outcomes for nurses and patients. However, little longitudinal evidence exists to support a causal link between Magnet recognition and outcomes. Objective To compare changes over time in surgical patient outcomes, nurse-reported quality, and nurse outcomes in a sample of hospitals that attained Magnet recognition between 1999 and 2007 with hospitals that remained non-Magnet. Research Design Retrospective, two-stage panel design using four secondary data sources. Subjects 136 Pennsylvania hospitals (11 “emerging” Magnets and 125 non-Magnets) Measures American Nurses Credentialing Center Magnet recognition; risk-adjusted rates of surgical 30-day mortality and failure-to-rescue, nurse-reported quality measures, and nurse outcomes; the Practice Environment Scale of the Nursing Work Index Methods Fixed effects difference models were used to compare changes in outcomes between emerging Magnet hospitals and hospitals that remained non-Magnet. Results Emerging Magnet hospitals demonstrated markedly greater improvements in their work environments than other hospitals. On average, the changes in 30-day surgical mortality and failure-to-rescue rates over the study period were more pronounced in emerging Magnet hospitals than in non-Magnet hospitals, by 2.4 fewer deaths per 1000 patients (pMagnet hospitals and non-Magnet hospitals were observed in nurse-reported quality of care and nurse outcomes. Conclusions In general, Magnet recognition is associated with significant improvements over time in the quality of the work environment, and in patient and nurse outcomes that exceed those of non-Magnet hospitals. PMID:25906016

  8. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

    Science.gov (United States)

    Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

    2018-02-06

    Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n

  9. Using Delphi methodology in the development of a new patient-reported outcome measure for stroke survivors with visual impairment.

    Science.gov (United States)

    Hepworth, Lauren R; Rowe, Fiona J

    2018-02-01

    The aim of this study was to ascertain what items stroke survivors and stroke care professionals think are important when assessing quality of life for stroke survivors with visual impairment for inclusion in the new patient-reported outcome measure. A reactive Delphi process was used in a three-round electronic-based survey. The items presented consisted of 62 items originally sourced from a systematic review of existing vision-related quality of life instruments and stroke survivor interviews, reduced and refined following a ranking exercise and pilot with stroke survivors with visual impairment. Stakeholders (stroke survivors/clinicians) were invited to take part in the process. A consensus definition of ≥70% was decided a priori. Participants were asked to rank importance on a 9-point scale and categorize the items by relevance to types of visual impairment following stroke or not relevant. Analysis of consensus, stability, and agreement was conducted. In total, 113 participants registered for the Delphi survey of which 47 (41.6%) completed all three rounds. Response rates to the three rounds were 78/113 (69.0%), 61/76 (81.3%), and 49/64 (76.6%), respectively. The participants included orthoptists (45.4%), occupational therapists (44.3%), and stroke survivors (10.3%). Consensus was reached on 56.5% of items in the three-round process, all for inclusion. A consensus was reached for 83.8% in the categorization of items. The majority (82.6%) of consensus were for relevant to 'all visual impairment following stroke'; two items were deemed 'not relevant'. The lack of item reduction achieved by this Delphi process highlights the need for additional methods of item reduction in the development of a new PROM for visual impairment following stroke. These results will be considered alongside Rasch analysis to achieve further item reduction. However, the Delphi survey remains important as it provides clinical and patient insight into each item rather than purely relying

  10. Development of a Patient-Reported Palliative Care-Specific Health Classification System: The POS-E.

    Science.gov (United States)

    Dzingina, Mendwas; Higginson, Irene J; McCrone, Paul; Murtagh, Fliss E M

    2017-06-01

    Generic preference-based measures are commonly used to estimate quality-adjusted life-years (QALYs) to inform resource-allocation decisions. However, concerns have been raised that generic measures may be inappropriate in palliative care. Our objective was to derive a health-state classification system that is amenable to valuation from the ten-item Palliative Care Outcome Scale (POS), a widely used patient-reported outcome measure in palliative care. The dimensional structure of the original POS was assessed using factor analysis. Item performance was assessed, using Rasch analysis and psychometric criteria, to enable the selection of items that represent the dimensions covered by the POS. Data from six studies of patients receiving palliative care were combined (N = 1011) and randomly split into two halves for development and validation. Analysis was undertaken on the development data, and results were validated by repeating the analysis with the validation dataset. Following Rasch and factor analyses, a classification system of seven items was derived. Each item had two to three levels. Rasch threshold map helped identify a set of 14 plausible health states that can be used for the valuation of the instrument to derive a preference-based index. Combining factor analysis and Rasch analysis with psychometric criteria provides a valid method of constructing a classification system for a palliative care-specific preference-based measure. The next stage is to obtain preference weights so the measure can be used in economic evaluations in palliative care.

  11. Self-reported outcomes of aural rehabilitation for adult hearing aid users in a developing South African context

    Directory of Open Access Journals (Sweden)

    Elaine Pienaar

    2010-12-01

    Full Text Available Hearing impairment has far reaching consequences for affected individuals, in terms of quality of life indicators. In a developing South African context the hearing impaired population is faced with limited aural rehabilitation services. This study evaluated self-reported outcomes of aural rehabilitation in a group of adults in the public healthcare sector with a standardized outcomes measurement tool (IOI-HA. Sixty-one respondents participated (44% males; 56% females, with a mean age of 69.7 years. Results revealed that the majority of respondents experienced favourable outcomes in all domains of the inventory comprising of: daily use of hearing aids, benefits provided by hearing aids, residual activity limitation, satisfaction with hearing aids, residual participation restriction, impact of hearing difficulties on others, and changes in quality of life. Statistically significant relationships were obtained between the daily use of hearing aids, the degree of hearing loss, and the type of hearing aids fitted, as well as the benefits received from hearing aids in difficult listening environments (p < 0.05. Despite challenges of developing contexts, the mean scores distribution compared positively to similar reports from developed countries. Outcomes of improved quality of life emphasize the importance of providing affordable hearing aids and services to all hearing impaired individuals in South Africa.

  12. Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit.

    Science.gov (United States)

    Agha, Riaz A; Pidgeon, Thomas E; Borrelli, Mimi R; Dowlut, Naeem; Orkar, Ter-Er K; Ahmed, Maziyah; Pujji, Ojas; Orgill, Dennis P

    2018-05-01

    Autologous fat grafting is an important part of the reconstructive surgeon's toolbox when treating women affected by breast cancer and subsequent tumor extirpation. The debate over safety and efficacy of autologous fat grafting continues within the literature. However, work performed by the authors' group has shown significant heterogeneity in outcome reporting. Core outcome sets have been shown to reduce heterogeneity in outcome reporting. The authors' goal was to develop a core outcome set for autologous fat grafting in breast reconstruction. The authors published their protocol a priori. A Delphi consensus exercise among key stakeholders was conducted using a list of outcomes generated from their previous work. These outcomes were divided into six domains: oncologic, clinical, aesthetic and functional, patient-reported, process, and radiologic. In the first round, 55 of 78 participants (71 percent) completed the Delphi consensus exercise. Consensus was reached on nine of the 13 outcomes. The clarity of the results and lack of additional suggested outcomes deemed further rounds to be unnecessary. The VOGUE Study has led to the development of a much-needed core outcome set in the active research front and clinical area of autologous fat grafting. The authors hope that clinicians will use this core outcome set to audit their practice, and that researchers will implement these outcomes in their study design and reporting of autologous fat grafting outcomes. The authors encourage journals and surgical societies to endorse and encourage use of this core outcome set to help refine the scientific quality of the debate, the discourse, and the literature. Therapeutic, V.

  13. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure

    DEFF Research Database (Denmark)

    Roos, Ewa M.; Roos, H P; Lohmander, L S

    1998-01-01

    There is broad consensus that good outcome measures are needed to distinguish interventions that are effective from those that are not. This task requires standardized, patient-centered measures that can be administered at a low cost. We developed a questionnaire to assess short- and long......-term patient-relevant outcomes following knee injury, based on the WOMAC Osteoarthritis Index, a literature review, an expert panel, and a pilot study. The Knee injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport...

  14. Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.

    Science.gov (United States)

    Strand, Vibeke; Kremer, Joel M; Gruben, David; Krishnaswami, Sriram; Zwillich, Samuel H; Wallenstein, Gene V

    2017-04-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared patient-reported outcomes (PROs) in patients with RA treated with tofacitinib or placebo in combination with conventional disease-modifying antirheumatic drugs (DMARDs). In a 12-month, phase III randomized controlled trial (ORAL Sync), patients (n = 795) with active RA and previous inadequate response to therapy with ≥1 conventional or biologic DMARD were randomized 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. PROs included patient global assessment of arthritis (PtGA), patient assessment of arthritis pain (Pain), physical function (Health Assessment Questionnaire disability index [HAQ DI]), health-related quality of life (Short Form 36 health survey [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]). At month 3, statistically significant improvements from baseline versus placebo were reported in PtGA, Pain, HAQ DI, all 8 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ DI, 7 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. Improvements were sustained to month 12. Significantly more tofacitinib-treated patients reported improvements of greater than or equal to the minimum clinically important differences at month 3 versus placebo in all PROs, except the SF-36 role-emotional domain (significant for tofacitinib 10 mg BID). Patients with active RA treated with tofacitinib combined with background conventional DMARD therapy reported sustained, significant, and clinically meaningful improvements in PROs versus placebo. © 2016, The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

  15. Validity and Reliability of the U.S. National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Science.gov (United States)

    Dueck, Amylou C.; Mendoza, Tito R.; Mitchell, Sandra A.; Reeve, Bryce B.; Castro, Kathleen M.; Rogak, Lauren J.; Atkinson, Thomas M.; Bennett, Antonia V.; Denicoff, Andrea M.; O'Mara, Ann M.; Li, Yuelin; Clauser, Steven B.; Bryant, Donna M.; Bearden, James D.; Gillis, Theresa A.; Harness, Jay K.; Siegel, Robert D.; Paul, Diane B.; Cleeland, Charles S.; Schrag, Deborah; Sloan, Jeff A.; Abernethy, Amy P.; Bruner, Deborah W.; Minasian, Lori M.; Basch, Ethan

    2016-01-01

    Importance Symptomatic adverse events (AEs) in cancer trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective, the NCI developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic AEs directly from patients. Objective To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. Design Participants completed PRO-CTCAE items on tablet computers in clinic waiting rooms at two visits 1-6 weeks apart. A subset completed PRO-CTCAE items during an additional visit one business day after the first visit. Setting Nine U.S. cancer centers and community oncology practices. Participants 975 adult cancer patients undergoing outpatient chemotherapy and/or radiation enrolled between January 2011 and February 2012. Eligibility required participants to read English and be without clinically significant cognitive impairment. Main Outcome(s) and Measure(s) Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). Results 940/975 (96%) and 852/940 (91%) participants completed PRO-CTCAE items at each visit. 938/940 (99.8%) participants (53% female, median age 59, 32% high school education or less, 17% ECOG PS 2-4) reported having at least one symptom. All PRO-CTCAE items had at least one correlation in the expected direction with a QLQ-C30 scale (111/124 P<.05). Stronger correlations were seen between PRO-CTCAE items and conceptually-related QLQ-C30 domains. Scores for 94/124 PRO-CTCAE items were higher in the ECOG PS 2-4 versus 0-1 group (58/124 P<.05). Overall, 119/124 items met at least one construct validity criterion. Test-retest reliability was acceptable for 36/49 pre-specified items (median intra-class correlation coefficient

  16. Reporting outcomes of back pain trials: a modified Delphi study

    DEFF Research Database (Denmark)

    Froud, R.; Eldridge, S.; Kovacs, F.

    2011-01-01

    trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi......BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain...... process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement. RESULTS: A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes...

  17. Hybrid surgery-radiosurgery therapy for metastatic epidural spinal cord compression: A prospective evaluation using patient-reported outcomes.

    Science.gov (United States)

    Barzilai, Ori; Amato, Mary-Kate; McLaughlin, Lily; Reiner, Anne S; Ogilvie, Shahiba Q; Lis, Eric; Yamada, Yoshiya; Bilsky, Mark H; Laufer, Ilya

    2018-05-01

    Patient-reported outcomes (PRO) represent an important measure of cancer therapy effect. For patients with metastatic epidural spinal cord compression (MESCC), hybrid therapy using separation surgery and stereotactic radiosurgery preserves neurologic function and provides tumor control. There is currently a paucity of data reporting PRO after such combined modality therapy for MESCC. Delineation of hybrid surgery-radiosurgery therapy effect on PRO validates the hybrid approach as an effective therapy resulting in meaningful symptom relief. Brief Pain Inventory (BPI) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP), PROs validated in the cancer population, were prospectively collected. Patients with MESCC who underwent separation surgery followed by stereotactic radiosurgery were included. Separation surgery included a posterolateral approach without extensive cytoreductive tumor excision. A median postoperative radiosurgery dose of 2700 cGy was delivered. The change in PRO 3 months after the hybrid therapy represented the primary study outcome. Preoperative and postoperative evaluations were analyzed using the Wilcoxon signed-rank test for matched pairs. One hundred eleven patients were included. Hybrid therapy resulted in a significant reduction in the BPI items "worst" and "right now" pain ( P < .0001), and in all BPI constructs (severity, interference with daily activities, and pain experience, P < .001). The MDASI-SP demonstrated reduction in spine-specific pain severity and interference with general activity ( P < .001), along with decreased symptom interference ( P < .001). Validated PRO instruments showed that in patients with MESCC, hybrid therapy with separation surgery and radiosurgery results in a significant decrease in pain severity and symptom interference. These prospective data confirm the benefit of hybrid therapy for treatment of MESCC and should facilitate referral of patients with MESCC for surgical evaluation.

  18. Does routinely collected patient-reported outcome data represent the actual case-mix of elective coronary revascularization patients?

    Science.gov (United States)

    Oinasmaa, Salla; Heiskanen, Jari; Hartikainen, Juha; Hippeläinen, Mikko; Miettinen, Heikki; Martikainen, Janne; Roine, Risto P; Tolppanen, Anna-Maija

    2018-04-01

    Patient-reported outcomes (PROs) are valuable for effectiveness evaluation, but it is unknown whether the patient views obtained represent the actual case mix. We studied the representativeness of the responses obtained to a routinely administered health-related quality of life (HRQoL) questionnaire in a cardiology unit. Elective coronary artery bypass grafting (CABG; n = 404) and percutaneous coronary intervention (PCI; n = 738) patients operated during June 2012 to August 2014 in the Heart Center, Kuopio University Hospital. The characteristics of the patients with a baseline (n = 260 and 290 for CABG and PCI, respectively) or both baseline and follow-up HRQoL measurements (n = 203 and 189 for CABG and PCI, respectively) were compared with those who did not respond (n = 144 and 448 for CABG and PCI). Baseline questionnaires were less likely obtained from older CABG patients (odds ratio 0.51, 95% confidence interval 0.28-0.91) and those with more severe disease (0.20, 0.05-0.79). Among PCI patients, women (0.64, 0.45-0.91), smokers (0.74, 0.53-1.04), and those with more severe disease (0.26, 0.13-0.52) or more hospital days were underrepresented. Routinely collected PROs in cardiac patients may be biased towards younger and healthier patients. This needs to be recognized when evaluating the representativeness of such data. The routine collection of these data should be adequately resourced.

  19. Transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures: A randomized controlled study with patient-reported outcome.

    Science.gov (United States)

    Galal, Sherif; Safwat, Wael

    2017-01-01

    The 5th metacarpal fractures accounts for 38% of all hand fractures given that the neck is the weakest point in metacarpals, so neck fracture is the most common metacarpal fracture. Surgical fixation is also advocated for such fractures to prevent mal-rotation of the little finger which will lead to fingers overlap in a clenched fist. Various methods are available for fixation of such fractures, like intramedullary & transverse pinning. There are very few reports in the literature comparing both techniques. Authors wanted to compare outcomes and complications of transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures. A single-center, parallel group, prospective, randomized study was conducted at an academic Level 1 Trauma Center from October 2014 to December 2016. A total of 80 patients with 5th metacarpal's neck fractures were randomized to pinning using either transverse pinning (group A) or intramedullary pinning (group B). Patients were assessed clinically on range of motion, patient-reported outcome using the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire & radiographically. Two blinded observers assessed outcomes. At final follow up for each patient (12 months) the statistically significant differences were observed in operative time, the transverse pinning group showed shorter operative time, as well as complication rate as complications were observed only in intramedullary pinning group. No differences were found in range of motion or the Quick -DASH score. Both techniques are equally safe and effective treatment option for 5th metacarpal's neck fractures. The only difference was shorter operative time & less incidence of complications in transverse pinning group. Level II, Therapeutic study.

  20. Report from a quality assurance program on patients undergoing the MILD procedure.

    Science.gov (United States)

    Durkin, Brian; Romeiser, Jamie; Shroyer, A Laurie W; Schiller, Robin; Bae, Jin; Davis, Raphael P; Peyster, Robert; Benveniste, Helene

    2013-05-01

    To characterize trends in pain and functional outcomes and identify risk factors in patients with lumbar spinal stenosis (LSS) and neurogenic claudication undergoing the "Minimally Invasive Lumbar Decompression" (MILD) procedure. Retrospective observational cohort study. Academic multidisciplinary pain center at Stony Brook Medicine. Patients undergoing the MILD procedure from October 2010 to November 2012. De-identified perioperative, pain and function related data for 50 patients undergoing MILD were extracted from the Center for Pain Management's quality assessment database. Data included numerical rating scale (NRS), symptom severity and physical function (Zurich Claudication Questionnaire), functional status (Oswestry Disability Index [ODI]), pain interference scores (National Institutes of Health Patient-Reported Outcomes Measurement Information System [PROMIS]), and patients' self-reported low back and lower extremity pain distribution. No MILD patient incurred procedure-related complications. Average NRS scores decreased postoperatively and 64.3% of patients reported less pain at 3 months. Clinically meaningful functional ODI improvements of at least 20% from baseline were present in 25% of the patients at 6 months. Preliminary analysis of changes in PROMIS scores at 3 months revealed that pre-MILD "severe" lumbar canal stenosis may be associated with high risk of "no improvement." No such impact was observed for NRS or ODI outcomes. Overall, pain is reduced and functional status improved in LSS patients following the MILD procedure at 3 and 6 months. Given the small sample size, it is not yet possible to identify patient subgroups at risk for "no improvement." Continued follow-up of longer-term outcomes appears warranted to develop evidence-based patient selection criteria. Wiley Periodicals, Inc.

  1. Patient-centered and visual quality outcomes of premium cataract surgery: a systematic review.

    Science.gov (United States)

    Wang, Sophia Y; Stem, Maxwell S; Oren, Gale; Shtein, Roni; Lichter, Paul R

    2017-06-26

    Over 8 million cataract surgeries are performed in the United States and the European Union annually, with many patients choosing to pay out of pocket for premium options including premium intraocular lens implants (IOLs) or laser-assisted cataract surgery (LACS). This report provides a systematic review evaluating patient-centered and visual quality outcomes comparing standard monofocal IOLs to premium cataract surgery options. PubMed and EMBASE were searched for publications published between January 1, 1980, and September 18, 2016, on multifocal, accommodative, and toric IOLs, monovision, and LACS, which reported on 1) dysphotopsias, 2) contrast sensitivity, 3) spectacle independence, 4) vision-related quality of life or patient satisfaction, and 5) IOL exchange. Multifocal lenses achieved higher rates of spectacle independence compared to monofocal lenses but also had higher reported frequency of dysphotopsia and worse contrast sensitivity, especially with low light or glare. Accommodative lenses were not associated with reduced contrast sensitivity or more dysphotopsia but had only modest improvements in spectacle independence compared to monofocal lenses. Studies of monovision did not target a sufficiently myopic outcome in the near-vision eye to achieve the full potential for spectacle independence. Patients reported high levels of overall satisfaction regardless of implanted IOL. No studies correlated patient-reported outcomes with patient expectations. Studies are needed to thoroughly compare patient-reported outcomes with concomitant patient expectations. In light of the substantial patient costs for premium options, patients and their surgeons will benefit from a better understanding of which surgical options best meet patients' expectations and how those expectations can be impacted by premium versus monofocal-including monovision-options.

  2. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials

    DEFF Research Database (Denmark)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E

    2016-01-01

    in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety......OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety...... that patients consider relevant so that they will be able to make informed decisions. CONCLUSION: The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach....

  3. Nursing unit teams matter: Impact of unit-level nurse practice environment, nurse work characteristics, and burnout on nurse reported job outcomes, and quality of care, and patient adverse events--a cross-sectional survey.

    Science.gov (United States)

    Van Bogaert, Peter; Timmermans, Olaf; Weeks, Susan Mace; van Heusden, Danny; Wouters, Kristien; Franck, Erik

    2014-08-01

    To investigate the impact of nurse practice environment factors, nurse work characteristics, and burnout on nurse reported job outcomes, quality of care, and patient adverse events variables at the nursing unit level. Nurse practice environment studies show growing insights and knowledge about determining factors for nurse workforce stability, quality of care, and patient safety. Until now, international studies have primarily focused on variability at the hospital level; however, insights at the nursing unit level can reveal key factors in the nurse practice environment. A cross-sectional design with a survey. In a cross-sectional survey, a sample of 1108 nurses assigned to 96 nursing units completed a structured questionnaire composed of various validated instruments measuring nurse practice environment factors, nurse work characteristics, burnout, nurse reported job outcomes, quality of care, and patient adverse events. Associations between the variables were examined using multilevel modelling techniques. Various unit-level associations (simple models) were identified between nurse practice environment factors, nurse work characteristics, burnout dimensions, and nurse reported outcome variables. Multiple multilevel models showed various independent variables such as nursing management at the unit level, social capital, emotional exhaustion, and depersonalization as important predictors of nurse reported outcome variables such job satisfaction, turnover intentions, quality of care (at the unit, the last shift, and in the hospital within the last year), patient and family complaints, patient and family verbal abuse, patient falls, nosocomial infections, and medications errors. Results suggested a stable nurse work force, with the capability to achieve superior quality and patient safety outcomes, is associated with unit-level favourable perceptions of nurse work environment factors, workload, decision latitude, and social capital, as well low levels of burnout

  4. Disease burden and patient reported outcomes among patients with moderate to severe psoriasis: an ethnography study

    Directory of Open Access Journals (Sweden)

    Narayanan S

    2014-12-01

    Full Text Available Siva Narayanan,1 Victoria Guyatt,2 Alessandra Franceschetti,3 Emily L Hautamaki1 1Ipsos Healthcare, Columbia, MD, USA; 2Ipsos Ethnography Centre of Excellence (ECE, London, UK; 3Ipsos Healthcare, London, UK Objectives: To assess the impact of psoriasis on health-related quality of life (HRQoL.Methods: An ethnographic study of patients with moderate to severe psoriasis was conducted in the US, France, Germany, Italy, Spain, UK, Brazil, and Canada to explore patients' views on treatment and the impact of psoriasis on HRQoL. Anthropologists and ethnographers spent a minimum of 5.5 hours with each consented patient and filmed their behaviors in everyday situations. Visual data and notes were analyzed to identify HRQoL-related themes.Results: The study included 50 adult patients. Patients described their appearance with disgust and self-loathing. Frustration was expressed due to a perceived lack of control of their lives. Prior to initiation of biologic treatment, daily rituals absorbed a good part of their day, including applying creams, checking one's appearance, and covering the body. Due to a lack of cultural discourse and patient's difficulty in articulating the impact of psoriasis, partners and family did not know how to react nor did they realize the full extent of the problem, and many patients experienced perceived social discrimination due to psoriasis, leaving them with feelings of isolation. Patients established on biologic treatment noticed a significant physical improvement and regained confidence, but psychosocial impacts, including social isolation, remained.Conclusion: This ethnographic study vividly depicted the unarticulated and emotional impact of psoriasis on the everyday lives of patients and presents an effective method of assessing HRQoL in chronic diseases.Keywords: psoriasis, health-related quality of life, ethnography, patient reported outcomes, conceptual model

  5. Radiographic outcome in Hispanic early rheumatoid arthritis patients treated with conventional disease modifying anti-rheumatic drugs

    International Nuclear Information System (INIS)

    Contreras-Yanez, Irazu; Rull-Gabayet, Marina; Vazquez-LaMadrid, Jorge; Pascual-Ramos, Virginia

    2011-01-01

    Objectives: To determine rates of incident erosive disease in early rheumatoid arthritis patients, to identify baseline predictors and to evaluate erosion's impact on patient-reported outcomes. Methods: 82 patients with ≤12 months of disease duration, ≥3 years of follow-up and conventional treatment were included. Consecutive evaluations assessed swollen and tender joint counts, treatment and comorbidity, acute reactant-phase determinations and patient-reported outcomes. Digitized radiographs of the hands and feet were obtained at baseline and yearly thereafter. RA was defined as erosive when at least one unequivocal cortical bone defect was detected. Descriptive statistics and Cox regression analysis were performed. Results: At baseline, 71 of the patients were Female Sign , population median (range) age was of 38.7 (16-78.2) years, 58 patients had antibodies and all the patients had active disease and substantial disability. Follow-up cohort was of 299.3 person-years. At last follow-up (49 ± 13.8 months), 28 patients developed erosions. Erosion's location was the feet, in 12 patients. Incident rates of erosive disease at one, two, three and four years were of 8.1, 12.8, 13.8 and 5.6 per 100 person-years, respectively. Higher C-reactive protein (HR: 1.20, 95%CI: 1.04-1.4, p = 0.01) and positive antibodies (HR: 5.09, 95%CI: 1.08-23.86, p = 0.04) were baseline predictors of incident erosive disease. Erosions had minor impact on patient-reported outcomes. Conclusion: Rheumatoid arthritis patients with antibodies and higher C reactive protein at baseline are at risk for incident erosions which appear most frequently at the feet. Up to 1/3 patients conventionally treated develop incident erosions, which minimally impact function.

  6. Radiographic outcome in Hispanic early rheumatoid arthritis patients treated with conventional disease modifying anti-rheumatic drugs

    Energy Technology Data Exchange (ETDEWEB)

    Contreras-Yanez, Irazu, E-mail: uzari02@hotmail.com.mx [Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Vasco de Quiroga 15, Seccion XVI, C.P. 14000, Tlalpan, Mexico, D.F. (Mexico); Rull-Gabayet, Marina, E-mail: rull.marina@gmail.com [Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Vasco de Quiroga 15, Seccion XVI, C.P. 14000, Tlalpan, Mexico, D.F. (Mexico); Vazquez-LaMadrid, Jorge, E-mail: docjvlradiologo@yahoo.com [Department of Radiology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Vasco de Quiroga 15, Seccion XVI, C.P. 14000, Tlalpan, Mexico, D.F. (Mexico); Pascual-Ramos, Virginia, E-mail: virtichu@gmail.com.mx [Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Vasco de Quiroga 15, Seccion XVI, C.P. 14000, Tlalpan, Mexico, D.F. (Mexico)

    2011-08-15

    Objectives: To determine rates of incident erosive disease in early rheumatoid arthritis patients, to identify baseline predictors and to evaluate erosion's impact on patient-reported outcomes. Methods: 82 patients with {<=}12 months of disease duration, {>=}3 years of follow-up and conventional treatment were included. Consecutive evaluations assessed swollen and tender joint counts, treatment and comorbidity, acute reactant-phase determinations and patient-reported outcomes. Digitized radiographs of the hands and feet were obtained at baseline and yearly thereafter. RA was defined as erosive when at least one unequivocal cortical bone defect was detected. Descriptive statistics and Cox regression analysis were performed. Results: At baseline, 71 of the patients were Female Sign , population median (range) age was of 38.7 (16-78.2) years, 58 patients had antibodies and all the patients had active disease and substantial disability. Follow-up cohort was of 299.3 person-years. At last follow-up (49 {+-} 13.8 months), 28 patients developed erosions. Erosion's location was the feet, in 12 patients. Incident rates of erosive disease at one, two, three and four years were of 8.1, 12.8, 13.8 and 5.6 per 100 person-years, respectively. Higher C-reactive protein (HR: 1.20, 95%CI: 1.04-1.4, p = 0.01) and positive antibodies (HR: 5.09, 95%CI: 1.08-23.86, p = 0.04) were baseline predictors of incident erosive disease. Erosions had minor impact on patient-reported outcomes. Conclusion: Rheumatoid arthritis patients with antibodies and higher C reactive protein at baseline are at risk for incident erosions which appear most frequently at the feet. Up to 1/3 patients conventionally treated develop incident erosions, which minimally impact function.

  7. Refractive lens exchange in younger and older presbyopes: comparison of complication rates, 3 months clinical and patient-reported outcomes

    Directory of Open Access Journals (Sweden)

    Schallhorn SC

    2017-08-01

    Full Text Available Steven C Schallhorn,1–3 Julie M Schallhorn,1 Martina Pelouskova,3 Jan A Venter,3 Keith A Hettinger,3 Stephen J Hannan,3 David Teenan3 1Department of Ophthalmology, University of California, San Francisco, CA, USA; 2Roski Eye Institute, University of Southern California, Los Angeles, CA, USA; 3Optical Express, Glasgow UK Purpose: To compare refractive and visual outcomes, patient satisfaction, and complication rates among different age categories of patients who underwent refractive lens exchange (RLE. Methods: A stratified, simple random sample of patients matched on preoperative sphere and cylinder was selected for four age categories: 45–49 years (group A, 50–54 years (group B, 55–59 years (group C, and 60–65 years (group D. Each group contained 320 patients. All patients underwent RLE with a multifocal intraocular lens at least in one eye. Three months postoperative refractive/visual and patient-reported outcomes are presented. Results: The percentage of patients that achieved binocular uncorrected distance visual acuity 20/20 or better was 91.6% (group A, 93.8% (group B, 91.6% (group C, 88.8% (group D, P=0.16. Binocularly, 80.0% of patients in group A, 84.7% in group B, 78.9% in group C, and 77.8% in group D achieved 20/30 or better uncorrected near visual acuity (P=0.13. The proportion of eyes within 0.50 D of emmetropia was 84.4% in group A, 86.8% in group B, 85.7% in group C, and 85.8% in group D (P=0.67. There was no statistically significant difference in postoperative satisfaction, visual phenomena, dry eye symptoms, distance or near vision activities. Apart from higher rate of iritis in the age group 50–55 years, there was no statistically significant difference in postoperative complication rates. Conclusion: RLE can be safely performed in younger as well as older presbyopes. No significant difference was found in clinical or patient-reported outcomes. Keywords: refractive lens exchange, multifocal IOLs, younger

  8. The effectiveness of Internet-based e-learning on clinician behaviour and patient outcomes: A systematic review.

    Science.gov (United States)

    Sinclair, Peter M; Kable, Ashley; Levett-Jones, Tracy; Booth, Debbie

    2016-05-01

    The contemporary health workforce has a professional responsibility to maintain competency in practice. However, some difficulties exist with access to ongoing professional development opportunities, particularly for staff in rural and remote areas and those not enrolled in a formal programme of study. E-learning is at the nexus of overcoming these challenges. The benefits of e-learning have been reported in terms of increased accessibility to education, improved self-efficacy, knowledge generation, cost effectiveness, learner flexibility and interactivity. What is less clear, is whether improved self-efficacy or knowledge gained through e-learning influences healthcare professional behaviour or skill development, whether these changes are sustained, and whether these changes improve patient outcomes. To identify, appraise and synthesise the best available evidence for the effectiveness of e-learning programmes on health care professional behaviour and patient outcomes. A systematic review of randomised controlled trials was conducted to assess the effectiveness of e-learning programmes on clinician behaviour and patient outcomes. Electronic databases including CINAHL, Embase, ERIC, MEDLINE, Mosby's Index, Scopus and Cochrane - CENTRAL were searched in July 2014 and again in July 2015. Studies were reviewed and data extracted by two independent reviewers using the Joanna Briggs Institute standardised critical appraisal and data extraction instruments. Seven trials met the inclusion criteria for the analysis. Due to substantial instructional design, subject matter, study population, and methodological variation between the identified studies, statistical pooling was not possible and a meta-analysis could not be performed. Consequently, the findings of this systematic review are presented as a narrative review. The results suggest that e-learning was at least as effective as traditional learning approaches, and superior to no instruction at all in improving health

  9. Favorable Pregnancy Outcomes in a Patient with Takayasu’s Arteritis: A Case Report

    Directory of Open Access Journals (Sweden)

    Sima Kadkhodayan

    2016-10-01

    Full Text Available Background & aim: Takayasu’s arteritis is a rare, chronic vasculitis, affecting women of reproductive age. With disease progression, evidence of vascular involvement and insufficiency becomes clinically apparent due to the narrowing or occlusion of the proximal or distal branches of the aorta. Therefore, pregnancy-related complications, such as superimposed preeclampsia, renal failure, and congestive heart failure, may be encountered in these patients. Case report: In this report, we present the case of a 23-year-old, Iranian, primigravida woman with a prior history of Takayasu’s arteritis, which was diagnosed two years before her pregnancy. The patient’s primary presentations were thrombocytosis (more than one million per milliliter, weight loss, and weakness in the shoulders and arms, appearing two years before her pregnancy. Following spontaneous pregnancy, the patient received regular perinatal care by a medical team, consisting of an obstetrician, a rheumatologist, a radiologist, and a nephrologist. Pregnancy termination was planned due to the preterm premature rupture of membranes (PPROM at 36 weeks of gestation. A normal live male neonate (weight= 3100 g was born with a normal Apgar score (8-8. Conclusion: Based on the findings, a multidisciplinary collaboration between rheumatologists, nephrologists, and obstetricians is required to achieve optimal maternal and neonatal outcomes.

  10. Radiation Therapy Versus No Radiation Therapy to the Neo-breast Following Skin-Sparing Mastectomy and Immediate Autologous Free Flap Reconstruction for Breast Cancer: Patient-Reported and Surgical Outcomes at 1 Year-A Mastectomy Reconstruction Outcomes Consortium (MROC) Substudy.

    Science.gov (United States)

    Cooke, Andrew L; Diaz-Abele, Julian; Hayakawa, Tom; Buchel, Ed; Dalke, Kimberly; Lambert, Pascal

    2017-09-01

    To determine whether adjuvant radiation therapy (RT) is associated with adverse patient-reported outcomes and surgical complications 1 year after skin-sparing mastectomy and immediate autologous free flap reconstruction for breast cancer. We compared 24 domains of patient-reported outcome measures 1 year after autologous reconstruction between patients who received adjuvant RT and those who did not. A total of 125 patients who underwent surgery between 2012 and 2015 at our institution were included from the Mastectomy Reconstruction Outcomes Consortium study database. Adjusted multivariate models were created incorporating RT technical data, age, cancer stage, estrogen receptor, chemotherapy, breast size, body mass index, and income to determine whether RT was associated with outcomes. At 1 year after surgery, European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire breast symptoms were significantly greater in 64 patients who received RT (8-point difference on 100-point ordinal scale, PBREAST-Q (Post-operative Reconstruction Module), Patient-Report Outcomes Measurement Information System Profile 29, McGill Pain Questionnaire-Short Form (MPQ-SF) score, Generalized Anxiety Disorder Scale, and Patient Health Questionnaire-were not statistically different between groups. Surgical complications were uncommon and did not differ by treatment. RT to the neo-breast compared with no RT following immediate autologous free flap reconstruction for breast cancer is well tolerated at 1 year following surgery despite patients undergoing RT also having a higher cancer stage and more intensive surgical and systemic treatment. Neo-breast symptoms are more common in patients receiving RT by the EORTC Breast Cancer-Specific Quality of Life Questionnaire but not by the BREAST-Q. Patient-reported results at 1 year after surgery suggest RT following immediate autologous free flap breast reconstruction is well tolerated

  11. Impact of depressive symptoms on subjective well-being: the importance of patient-reported outcomes in schizophrenia

    Directory of Open Access Journals (Sweden)

    Haro JM

    2011-09-01

    when discriminating between depressive severity levels (0.84, followed by emotional regulation (0.80, social integration (0.78, physical functioning and self-control (0.77, and mental functioning (0.73. Total SWN-K and its five subscales showed a significant linear trend against CDSS severity levels (P < 0.001.Conclusion: The presence of moderate to severe depressive symptoms was relatively high, and correlated inversely with patients’ subjective well-being. Routine assessment of patient-reported measures in patients with schizophrenia might reduce potential discrepancy between patient and physician assessment, increase therapeutic alliance, and improve outcome.Keywords: schizophrenia, subjective well-being, patient-reported outcome, depressive symptoms 

  12. Patient Satisfaction and Short-Term Outcome in Elective Cranial Neurosurgery.

    Science.gov (United States)

    Reponen, Elina; Tuominen, Hanna; Hernesniemi, Juha; Korja, Miikka

    2015-11-01

    Patient-reported experience is often used as a measure for quality of care, but no reports on patient satisfaction after cranial neurosurgery exist. To study the association of overall patient satisfaction and surgical outcome and to evaluate the applicability of overall patient satisfaction as a proxy for quality of care in elective cranial neurosurgery. We conducted an observational study on the relationship of overall patient satisfaction at 30 postoperative days with surgical and functional outcome (modified Rankin Scale [mRS] score) in a prospective, consecutive, and unselected cohort of 418 adult elective craniotomy patients enrolled between December 2011 and December 2012 at Helsinki University Hospital, Helsinki, Finland. Postoperative overall (subjective and objective) morbidity was present in 194 (46.4%) patients; yet almost 94% of all study patients reported high overall satisfaction. Low overall patient satisfaction at 30 days was not associated with postoperative major morbidity in elective cranial neurosurgery. Dependent functional status (mRS score ≥3) at 30 days, minor infections, poor postoperative subjective overall health status, and patient-reported severe symptoms (double vision, poor balance) may contribute to unsatisfactory patient experience. Overall patient satisfaction with elective cranial neurosurgery is high. Even 9 of 10 patients with postoperative major morbidity rated high overall patient satisfaction at 30 days. Overall patient satisfaction may merely reflect patient experience and subjective postoperative health status, and therefore it is a poor proxy for quality of care in elective cranial neurosurgery.

  13. Patient-reported outcomes, body composition, and nutrition status in patients with head and neck cancer: Results from an exploratory randomized controlled exercise trial.

    Science.gov (United States)

    Capozzi, Lauren C; McNeely, Margaret L; Lau, Harold Y; Reimer, Raylene A; Giese-Davis, Janine; Fung, Tak S; Culos-Reed, S Nicole

    2016-04-15

    Patients with head and neck cancer experience loss of weight and muscle mass, decreased functioning, malnutrition, depression, and declines in quality of life during and after treatment. The purpose of this exploratory randomized study was to determine the optimal timing for the initiation of a lifestyle and progressive resistance exercise training intervention (during or after radiation therapy), as determined by intervention adherence and by comparing between-group outcomes across 24 weeks. Sixty patients with head and neck cancer were randomized to engage in a 12-week lifestyle intervention and progressive resistance-training program either during radiation treatment or immediately after completion. The primary outcome of body composition--specifically, lean body mass, body mass index, and body fat--as well as secondary outcomes of fitness, quality of life, depression, and nutrition status were evaluated. The progressive resistance-training intervention carried out during treatment did not significantly influence the primary outcome of body composition, despite a significant increase in weekly physical activity reported by the intervention group. A small-to-medium intervention effect was noted for some secondary outcomes, including fitness, quality of life, and nutrition status. Regardless of whether patients received the immediate or delayed progressive resistance-training intervention, the analysis revealed a main effect of time on body composition, fitness, quality of life, depression, and nutritional scores. Although the intervention during treatment did not reduce the loss of lean body mass, delaying the exercise program until after treatment completion was associated with improved intervention adherence, a finding with important clinical implications. © 2016 American Cancer Society.

  14. Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative.

    Science.gov (United States)

    Kahn, Timothy L; Soheili, Aydin; Schwarzkopf, Ran

    2013-12-01

    Total knee arthroplasty (TKA) is the preferred surgical treatment for end-stage osteoarthritis. However, substantial numbers of patients still experience poor outcomes. Consequently, it is important to identify which patient characteristics are predictive of outcomes in order to guide clinical decisions. Our hypothesis is that preoperative patient-reported outcome measures and radiographic measures may help to predict TKA outcomes. Using cohort data from the Osteoarthritis Initiative, we studied 172 patients who underwent TKA. For each patient, we compiled pre- and postoperative Western Ontario and McMaster University Arthritis Index (WOMAC) scores. Radiographs were measured for knee joint angles, femorotibial angles, anatomical lateral distal femoral angles, and anatomical medial proximal tibial angles; Kellgren and Lawrence (KL) grades were assigned to each compartment of the knee. All studied measurements were compared to WOMAC outcomes. Preoperative WOMAC disability, pain, and total scores were positively associated with postoperative WOMAC total scores (P = .010, P = .010, and P = .009, respectively) and were associated with improvement in WOMAC total scores (P < .001, P < .001, and P < .001, respectively). For radiographic measurements, preoperative joint angles were positively associated with improvements in postoperative WOMAC total scores (P = .044). Combined KL grades (medial and lateral compartments) were negatively correlated with postoperative WOMAC disability and pain scores (P = .045 and P = .044) and were positively correlated with improvements in WOMAC total scores (P = .001). All preoperative WOMAC scores demonstrated positive associations with postoperative WOMAC scores, while among the preoperative radiographic measurements only combined KL grades and joint angles showed any correlation with postoperative WOMAC scores. Higher preoperative KL grades and joint angles were associated with better (lower) postoperative WOMAC scores, demonstrating an

  15. Do treatment quality indicators predict cardiovascular outcomes in patients with diabetes?

    Directory of Open Access Journals (Sweden)

    Grigory Sidorenkov

    Full Text Available BACKGROUND: Landmark clinical trials have led to optimal treatment recommendations for patients with diabetes. Whether optimal treatment is actually delivered in practice is even more important than the efficacy of the drugs tested in trials. To this end, treatment quality indicators have been developed and tested against intermediate outcomes. No studies have tested whether these treatment quality indicators also predict hard patient outcomes. METHODS: A cohort study was conducted using data collected from >10.000 diabetes patients in the Groningen Initiative to Analyze Type 2 Treatment (GIANTT database and Dutch Hospital Data register. Included quality indicators measured glucose-, lipid-, blood pressure- and albuminuria-lowering treatment status and treatment intensification. Hard patient outcome was the composite of cardiovascular events and all-cause death. Associations were tested using Cox regression adjusting for confounding, reporting hazard ratios (HR with 95% confidence intervals. RESULTS: Lipid and albuminuria treatment status, but not blood pressure lowering treatment status, were associated with the composite outcome (HR = 0.77, 0.67-0.88; HR = 0.75, 0.59-0.94. Glucose lowering treatment status was associated with the composite outcome only in patients with an elevated HbA1c level (HR = 0.72, 0.56-0.93. Treatment intensification with glucose-lowering but not with lipid-, blood pressure- and albuminuria-lowering drugs was associated with the outcome (HR = 0.73, 0.60-0.89. CONCLUSION: Treatment quality indicators measuring lipid- and albuminuria-lowering treatment status are valid quality measures, since they predict a lower risk of cardiovascular events and mortality in patients with diabetes. The quality indicators for glucose-lowering treatment should only be used for restricted populations with elevated HbA1c levels. Intriguingly, the tested indicators for blood pressure-lowering treatment did not predict patient

  16. [Patient evaluation and outcome measures].

    Science.gov (United States)

    Nieto Pol, Enrique

    2014-01-01

    Both the initial evaluation and follow-up of patients with osteoarthritis require systematic evaluation of the indicators that provide information on the degree of involvement of the disease and allow its quantification. Reliable measures of disease progression help decision-making by clinicians and provide valid information on treatment response and the effectiveness of the distinct therapeutic interventions. The instruments recommended in research, as outcome measures in osteoarthritis, are pain evaluation, assessment of physical function, and self-reported global evaluation. In studies lasting more than 1 year, structural changes are evaluated through simple X-ray. Self-reported quality of life assessment and physician global assessment are also recommended as options. These indicators should be incorporated into routine clinical practice for adequate evaluation and correct follow-up of patients with osteoarthritis. The recommended pain evaluation method for use in clinical practice is the visual analog scale (VAS). The best instrument to evaluate physical function in patients with hip or knee osteoarthritis is the WOMAC scale (Western Ontario and McMaster Universities Osteoarthritis Index). For patient-reported global assessment in routine practice, the recommended scales are VAS or the SF-12 (12-item short-form health survey). Copyright © 2014 Elsevier España, S.L. All rights reserved.

  17. Endoscopic Endonasal Transsphenoidal Approach for Apoplectic Pituitary Tumor: Surgical Outcomes and Complications in 45 Patients.

    Science.gov (United States)

    Zhan, Rucai; Li, Xueen; Li, Xingang

    2016-02-01

    Objective To assess the safety and effectiveness of the endoscopic endonasal transsphenoidal approach (EETA) for apoplectic pituitary adenoma. Design A retrospective study. Setting Qilu Hospital of Shandong University; Brain Science Research Institute, Shandong University. Participants Patients admitted to Qilu Hospital of Shandong University who were diagnosed with an apoplectic pituitary tumor and underwent EETA for resection of the tumor. Main Outcome Measures In total 45 patients were included in a retrospective chart review. Data regarding patient age, sex, presentation, lesion size, surgical procedure, extent of resection, clinical outcome, and surgical complications were obtained from the chart review. Results In total, 38 (92.7%) of 41 patients with loss of vision obtained visual remission postoperatively. In addition, 16 patients reported a secreting adenoma, and postsurgical hormonal levels were normal or decreased in 14 patients. All other symptoms, such as headache and alteration of mental status, recovered rapidly after surgery. Two patients (4.4%) incurred cerebrospinal fluid leakage. Six patients (13.3%) experienced transient diabetes insipidus (DI) postoperatively, but none of these patients developed permanent DI. Five patients (11.1%) developed hypopituitarism and were treated with replacement of hormonal medicine. No cases of meningitis, carotid artery injury, or death related to surgery were reported. Conclusion EETA offers a safe and effective surgical option for apoplectic pituitary tumors and is associated with low morbidity and mortality.

  18. Effects of neuromuscular training (NEMEX-TJR) on patient-reported outcomes and physical function in severe primary hip or knee osteoarthritis

    DEFF Research Database (Denmark)

    Ageberg, Eva; Nilsdotter, Anna; Kosek, Eva

    2013-01-01

    The benefits of exercise in mild and moderate knee or hip osteoarthritis (OA) are apparent, but the evidence in severe OA is less clear. We recently reported that neuromuscular training was well tolerated and feasible in patients with severe primary hip or knee OA. The aims of this controlled bef...... before-and-after study were to compare baseline status to an age-matched population-based reference group and to examine the effects of neuromuscular training on patient-reported outcomes and physical function in patients with severe primary OA of the hip or knee.......The benefits of exercise in mild and moderate knee or hip osteoarthritis (OA) are apparent, but the evidence in severe OA is less clear. We recently reported that neuromuscular training was well tolerated and feasible in patients with severe primary hip or knee OA. The aims of this controlled...

  19. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD).

    Science.gov (United States)

    Simpson, Eric L; Gadkari, Abhijit; Worm, Margitta; Soong, Weily; Blauvelt, Andrew; Eckert, Laurent; Wu, Richard; Ardeleanu, Marius; Graham, Neil M H; Pirozzi, Gianluca; Sutherland, E Rand; Mastey, Vera

    2016-09-01

    Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies. We sought to evaluate dupilumab treatment on patient-reported outcomes in adults with moderate to severe AD. Adults (N = 380) with moderate to severe AD inadequately controlled by topical medications were randomized to 16 weeks of double-blind, subcutaneous treatment with dupilumab 100 mg every 4 weeks, 200 mg every 2 weeks, 300 mg every 2 weeks, 300 mg once weekly, or placebo. Patient-reported outcomes included pruritus numeric rating scale; patient-reported sleep item on Scoring AD scale; Patient-Oriented Eczema Measure; Hospital Anxiety and Depression Scale; Dermatology Life Quality Index; and 5-dimension 3-level EuroQol. Dupilumab reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on numeric rating scale (P health-related quality of life on Dermatology Life Quality Index and 5-dimension 3-level EuroQol (P mental health, and health-related quality of life; the two 300-mg dose regimens resulted in greatest benefits. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  20. The Electronic Patient Reported Outcome Tool: Testing Usability and Feasibility of a Mobile App and Portal to Support Care for Patients With Complex Chronic Disease and Disability in Primary Care Settings

    Science.gov (United States)

    Gill, Ashlinder; Khan, Anum Irfan; Hans, Parminder Kaur; Kuluski, Kerry; Cott, Cheryl

    2016-01-01

    Background People experiencing complex chronic disease and disability (CCDD) face some of the greatest challenges of any patient population. Primary care providers find it difficult to manage multiple discordant conditions and symptoms and often complex social challenges experienced by these patients. The electronic Patient Reported Outcome (ePRO) tool is designed to overcome some of these challenges by supporting goal-oriented primary care delivery. Using the tool, patients and providers collaboratively develop health care goals on a portal linked to a mobile device to help patients and providers track progress between visits. Objectives This study tested the usability and feasibility of adopting the ePRO tool into a single interdisciplinary primary health care practice in Toronto, Canada. The Fit between Individuals, Fask, and Technology (FITT) framework was used to guide our assessment and explore whether the ePRO tool is: (1) feasible for adoption in interdisciplinary primary health care practices and (2) usable from both the patient and provider perspectives. This usability pilot is part of a broader user-centered design development strategy. Methods A 4-week pilot study was conducted in which patients and providers used the ePRO tool to develop health-related goals, which patients then monitored using a mobile device. Patients and providers collaboratively set goals using the system during an initial visit and had at least 1 follow-up visit at the end of the pilot to discuss progress. Focus groups and interviews were conducted with patients and providers to capture usability and feasibility measures. Data from the ePRO system were extracted to provide information regarding tool usage. Results Six providers and 11 patients participated in the study; 3 patients dropped out mainly owing to health issues. The remaining 8 patients completed 210 monitoring protocols, equal to over 1300 questions, with patients often answering questions daily. Providers and patients

  1. Are validated patient-reported outcomes used on children in pediatric otolaryngology? A systematic review.

    Science.gov (United States)

    Wong, Kevin; Piraquive, Jacquelyn; Troiano, Chelsea A; Sulibhavi, Anita; Grundfast, Kenneth M; Levi, Jessica R

    2018-02-01

    Review the pediatric otolaryngology literature to 1) identify studies in which children completed patient-reported outcome (PRO) measures and 2) appraise the psychometric quality and validity of these PROs as they apply to pediatrics. In October 2016, a systematic review was performed by two reviewers on PubMed/MEDLINE and EMBASE for all otolaryngology-related studies that utilized PROs in children. Inclusion criteria included articles that required children (ageotolaryngology and some studies utilized PROs that were not validated or not validated for use in this age group. Future efforts to design and validate more instruments may be warranted. Copyright © 2017. Published by Elsevier B.V.

  2. Overview of classical test theory and item response theory for the quantitative assessment of items in developing patient-reported outcomes measures.

    Science.gov (United States)

    Cappelleri, Joseph C; Jason Lundy, J; Hays, Ron D

    2014-05-01

    The US Food and Drug Administration's guidance for industry document on patient-reported outcomes (PRO) defines content validity as "the extent to which the instrument measures the concept of interest" (FDA, 2009, p. 12). According to Strauss and Smith (2009), construct validity "is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity" (p. 7). Hence, both qualitative and quantitative information are essential in evaluating the validity of measures. We review classical test theory and item response theory (IRT) approaches to evaluating PRO measures, including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized "difficulty" (severity) order of items is represented by observed responses. If a researcher has few qualitative data and wants to get preliminary information about the content validity of the instrument, then descriptive assessments using classical test theory should be the first step. As the sample size grows during subsequent stages of instrument development, confidence in the numerical estimates from Rasch and other IRT models (as well as those of classical test theory) would also grow. Classical test theory and IRT can be useful in providing a quantitative assessment of items and scales during the content-validity phase of PRO-measure development. Depending on the particular type of measure and the specific circumstances, the classical test theory and/or the IRT should be considered to help maximize the content validity of PRO measures. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

  3. The Examination of Patient-Reported Outcomes and Postural Control Measures in Patients With and Without a History of ACL Reconstruction: A Case Control Study.

    Science.gov (United States)

    Hoch, Johanna M; Sinnott, Cori W; Robinson, Kendall P; Perkins, William O; Hartman, Jonathan W

    2018-03-01

    There is a lack of literature to support the diagnostic accuracy and cut-off scores of commonly used patient-reported outcome measures (PROMs) and clinician-oriented outcomes such as postural-control assessments (PCAs) when treating post-ACL reconstruction (ACLR) patients. These scores could help tailor treatments, enhance patient-centered care and may identify individuals in need of additional rehabilitation. To determine if differences in 4-PROMs and 3-PCAs exist between post-ACLR and healthy participants, and to determine the diagnostic accuracy and cut-off scores of these outcomes. Case control. Laboratory. A total of 20 post-ACLR and 40 healthy control participants. The participants completed 4-PROMs (the Disablement in the Physically Active Scale [DPA], The Fear-Avoidance Belief Questionnaire [FABQ], the Knee Osteoarthritis Outcomes Score [KOOS] subscales, and the Tampa Scale of Kinesiophobia [TSK-11]) and 3-PCAs (the Balance Error Scoring System [BESS], the modified Star Excursion Balance Test [SEBT], and static balance on an instrumented force plate). Mann-Whitney U tests examined differences between groups. Receiver operating characteristic (ROC) curves were employed to determine sensitivity and specificity. The Area Under the Curve (AUC) was calculated to determine the diagnostic accuracy of each instrument. The Youdin Index was used to determine cut-off scores. Alpha was set a priori at P < 0.05. There were significant differences between groups for all PROMs (P < 0.05). There were no differences in PCAs between groups. The cut-off scores should be interpreted with caution for some instruments, as the scores may not be clinically applicable. Post-ACLR participants have decreased self-reported function and health-related quality of life. The PROMs are capable of discriminating between groups. Clinicians should consider using the cut-off scores in clinical practice. Further use of the instruments to examine detriments after completion of standard

  4. Patient experiences and outcomes following facial skin cancer surgery: A qualitative study.

    Science.gov (United States)

    Lee, Erica H; Klassen, Anne F; Lawson, Jessica L; Cano, Stefan J; Scott, Amie M; Pusic, Andrea L

    2016-08-01

    Early melanoma and non-melanoma skin cancer of the facial area are primarily treated with surgery. Little is known about the outcomes of treatment for facial skin cancer patients. The objective of the study was to identify concerns about aesthetics, procedures and health from the patients' perspective after facial skin surgery. Semi-structured in-depth interviews were conducted with 15 participants. Line-by-line coding was used to establish categories and develop themes. We identified five major themes on the impact of skin cancer surgery: appearance-related concerns; psychological (e.g., fear of new cancers or recurrence); social (e.g. impact on social activities and interaction); physical (e.g. pain and swelling) concerns and satisfaction with the experience of care (e.g., satisfaction with surgeon). The priority of participants was the removal of the facial skin cancer, as this reduced their overall worry. The aesthetic outcome was secondary but important, as it had important implications on the participants' social and psychological functioning. The participants' experience with the care provided by the surgeon and staff also contributed to their satisfaction with their treatment. This conceptual framework provides the basis for the development of a new patient-reported outcome instrument. © 2015 The Australasian College of Dermatologists.

  5. High-precision radiotherapy for meningiomas. Long-term results and patient-reported outcome (PRO)

    Energy Technology Data Exchange (ETDEWEB)

    Kessel, Kerstin A.; Fischer, Hanna; Combs, Stephanie E. [Technical University of Munich (TUM), Department of Radiation Oncology, Munich (Germany); Helmholtz Zentrum Muenchen (HMGU), Institute for Innovative Radiotherapy (iRT), Department of Radiation Sciences DRS, Neuherberg (Germany); Oechnser, Markus [Technical University of Munich (TUM), Department of Radiation Oncology, Munich (Germany); Zimmer, Claus [Technical University of Munich (TUM), Department of Neuroradiology, Munich (Germany); Meyer, Bernhard [Technical University of Munich (TUM), Department of Neurosurgery, Munich (Germany)

    2017-11-15

    To evaluate long-term outcome after high-precision radiotherapy (RT) of meningioma patients in terms of survival and side effects. We analyzed 275 meningioma cases: 147 low-grade and 43 high-grade meningiomas (WHO II: n = 40, III: n = 3). In all, 85 patients had no pathologically confirmed histology but were determined as low-grade based on multimodal imaging. Surgery was performed in 183 cases. RT was delivered as either radiosurgery (RS, n = 16), fractionated stereotactic radiotherapy (FSRT, n = 241), or intensity-modulated radiation therapy (IMRT, n = 18). Of 218 patients contacted for patient-reported-outcome (PRO), 207 responded (95%). Median follow-up was 7.2 years. For low-grade meningioma the survival rate (OS) was 97% at 3 years, 85% at 10 years, and 64% at 15 years, for atypical meningioma 91% at 3 years, 62% at 10 years, and 50% at 15 years. Local control rate (PFS) for low-grade meningioma was 91% at 3 years, 87% at 5 years, and 86% at 10 years, for atypical cases 67% at 3 years and 55% at 5 years. Of all, 3.0% of patients reported worsened or new symptoms grade ≥3 during RT and the first 6 months thereafter; 17.5% reported a deterioration after more than 2 years. We found the prognostic factors tumor volume and age significantly influencing OS and PFS. Complemented by PRO, we found long-term low toxicity rates in addition to excellent local control. Thus, due to the beneficial risk-benefit profile of benign and high-risk meningiomas, RT should be performed as adjuvant treatment and should not be postponed until tumor progression. (orig.) [German] Langzeitergebnisse nach Hochpraezisionsstrahlentherapie (RT) von Patienten mit Meningeomen hinsichtlich Ueberleben und Nebenwirkungen. Es wurden 275 Meningeomfaelle untersucht: 145 benigne (WHO I), 40 atypische (WHO II) und 3 anaplastische (WHO III) Meningeome; bei 85 Patienten bestand keine histologische Sicherung. Voroperiert waren 183 Faelle (67 %). Bei 16 Patienten wurde eine Radiochirurgie (RS

  6. Total Gastrectomy for Hereditary Diffuse Gastric Cancer at a Single Center: Postsurgical Outcomes in 41 Patients.

    Science.gov (United States)

    Strong, Vivian E; Gholami, Sepideh; Shah, Manish A; Tang, Laura H; Janjigian, Yelena Y; Schattner, Mark; Selby, Luke V; Yoon, Sam S; Salo-Mullen, Erin; Stadler, Zsofia K; Kelsen, David; Brennan, Murray F; Coit, Daniel G

    2017-12-01

    The aim of this study was to describe postoperative outcomes of total gastrectomy at our institution for patients with hereditary diffuse gastric cancer (HDGC). HDGC, which is mainly caused by germline mutations in the E-cadherin gene (CDH1), renders a lifetime risk of gastric cancer of up to 70%, prompting a recommendation for prophylactic total gastrectomy. A prospective gastric cancer database identified 41 patients with CDH1 mutation who underwent total gastrectomy during 2005 to 2015. Perioperative, histopathologic, and long-term data were collected. Of the 41 patients undergoing total gastrectomy, median age was 47 years (range 20 to 71). There were 14 men and 27 women, with 25 open operations and 16 minimally invasive operations. Median length of stay was 7 days (range 4 to 50). In total, 11 patients (27%) experienced a complication requiring intervention, and there was 1 peri-operative mortality (2.5%). Thirty-five patients (85%) demonstrated 1 or more foci of intramucosal signet ring cell gastric cancer in the examined specimen. At 16 months median follow-up, the median weight loss was 4.7 kg (15% of preoperative weight). By 6 to 12 months postoperatively, weight patterns stabilized. Overall outcome was reported to be "as expected" by 40% of patients and "better than expected" by 45%. Patient-reported outcomes were similar to those of other patients undergoing total gastrectomy. Total gastrectomy should be considered for all CDH1 mutation carriers because of the high risk of invasive diffuse-type gastric cancer and lack of reliable surveillance options. Although most patients have durable weight loss after total gastrectomy, weights stabilize at about 6 to 12 months postoperatively, and patients report outcomes as being good to better than their preoperative expectations. No patients have developed gastric cancer recurrence after resections.

  7. Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome measures: a comparison of worked examples.

    Science.gov (United States)

    Petrillo, Jennifer; Cano, Stefan J; McLeod, Lori D; Coon, Cheryl D

    2015-01-01

    To provide comparisons and a worked example of item- and scale-level evaluations based on three psychometric methods used in patient-reported outcome development-classical test theory (CTT), item response theory (IRT), and Rasch measurement theory (RMT)-in an analysis of the National Eye Institute Visual Functioning Questionnaire (VFQ-25). Baseline VFQ-25 data from 240 participants with diabetic macular edema from a randomized, double-masked, multicenter clinical trial were used to evaluate the VFQ at the total score level. CTT, RMT, and IRT evaluations were conducted, and results were assessed in a head-to-head comparison. Results were similar across the three methods, with IRT and RMT providing more detailed diagnostic information on how to improve the scale. CTT led to the identification of two problematic items that threaten the validity of the overall scale score, sets of redundant items, and skewed response categories. IRT and RMT additionally identified poor fit for one item, many locally dependent items, poor targeting, and disordering of over half the response categories. Selection of a psychometric approach depends on many factors. Researchers should justify their evaluation method and consider the intended audience. If the instrument is being developed for descriptive purposes and on a restricted budget, a cursory examination of the CTT-based psychometric properties may be all that is possible. In a high-stakes situation, such as the development of a patient-reported outcome instrument for consideration in pharmaceutical labeling, however, a thorough psychometric evaluation including IRT or RMT should be considered, with final item-level decisions made on the basis of both quantitative and qualitative results. Copyright © 2015. Published by Elsevier Inc.

  8. Surgical Outcome in Patients with Spontaneous Supratentorial Intracerebral Hemorrhage

    Directory of Open Access Journals (Sweden)

    Rendevski Vladimir

    2017-12-01

    Full Text Available The aim of the paper was to evaluate the surgical outcome in patients with spontaneous supratentorial intracerebral hemorrhage (ICH after surgical intervention, in respect to the initial clinical conditions, age, sex, hemispheric side and anatomic localization of ICH. Thirty-eight surgically treated patients with spontaneous supratentorial intracerebral hemorrhage were included in the study. The surgical outcome was evaluated three months after the initial admission, according to the Glasgow Outcome Scale (GOS. The surgical treatment was successful in 14 patients (37%, whereas it was unsuccessful in 24 patients (63%. We have detected a significant negative correlation between the Glasgow Coma Scale (GCS scores on admission and the GOS scores after three months, suggesting worse neurological outcome in patients with initially lower GCS scores. The surgical outcome in patients with ICH was not affected by the sex, the hemispheric side and the anatomic localization of ICH, but the age of the patients was estimated as a significant factor for their functional outcome, with younger patients being more likely to be treated successfully. The surgical outcome is affected from the initial clinical state of the patients and their age. The treatment of ICH is still an unsolved clinical problem and the development of new surgical techniques with larger efficiency in the evacuation of the hematoma is necessary, thus making a minimal damage to the normal brain tissue, as well as decreasing the possibility of postoperative bleeding.

  9. Outcomes management of mechanically ventilated patients: utilizing informatics technology.

    Science.gov (United States)

    Smith, K R

    1998-11-01

    This article examines an informatics system developed for outcomes management of the mechanically ventilated adult population, focusing on weaning the patient from mechanical ventilation. The link between medical informatics and outcomes management is discussed, along with the development of methods, tools, and data sets for outcomes management of the mechanically ventilated adult population at an acute care academic institution. Pros and cons of this system are identified, and specific areas for improvement of future health care outcomes medical informatics systems are discussed.

  10. Structural pathology is not related to patient-reported pain and function in patients undergoing meniscal surgery

    DEFF Research Database (Denmark)

    Christensen, Simon Tornbjerg; Nissen, Nis; Englund, Martin

    2017-01-01

    BACKGROUND: The relationship between meniscal tears and other joint pathologies with patient-reported symptoms is not clear. We investigated associations between structural knee pathologies identified at surgery with preoperative knee pain and function in patients undergoing arthroscopic meniscal...... of meniscal tears questionnaire, supplemented with information extracted from surgery reports. Following hypothesis-driven preselection of candidate variables, backward elimination regressions were performed to investigate associations between patient-reported outcomes and structural knee pathologies. RESULTS...... surgery. METHODS: This study included 443 patients from the Knee Arthroscopy Cohort Southern Denmark (KACS), a prospective cohort following patients 18 years or older undergoing arthroscopic meniscal surgery at 4 hospitals between 1 February 2013 and 31 January 2014. Patient-reported outcomes, including...

  11. Benefits of global partnerships to facilitate access to medicines in developing countries: a multi-country analysis of patients and patient outcomes in GIPAP

    Directory of Open Access Journals (Sweden)

    Vandoros Sotiris

    2009-12-01

    Full Text Available Abstract Background Access to medicines in developing countries continues to be a significant problem due to lack of insurance and lack of affordability. Chronic Myeloid Leukemia (CML, a rare disease, can be treated effectively, but the pharmaceutical treatment available (imatinib is costly and unaffordable by most patients. GIPAP, is a programme set up between a manufacturer and an NGO to provide free treatment to eligible CML patients in 80 countries worldwide. Objectives To discuss the socio-economic and demographic characteristics of patients participating in GIPAP; to research the impact GIPAP is having on health outcomes (survival of assistance-eligible CML patients; and to discuss the determinants of such outcomes and whether there are any variations according to socio-economic, demographic, or geographical criteria. Methods Data for 13,568 patients across 15 countries, available quarterly, were analysed over the 2005-2007 period. Ordered Probit panel data analysis was used to analyze the determinants of a patient's progress in terms of participation in the programme. Four waves of patients entering quarterly in 2005 were used to evaluate patient survival over the sample period. Results All patients in the sample are eligible to receive treatment provided they report to a facility quarterly. 62.3% of patients were male and 37.7% female. The majority (84.4% entered during the chronic phase of the disease and their average age was 38.4 years. Having controlled for age, location and occupation, the analysis showed that patients were significantly much more likely to move towards a better health state after receiving treatment irrespective of their disease stage at the point of entry to the program (OR = 30.5, α = 1%; and that the larger the gap between diagnosis and approval for participation in the program, the more likely it is that patients' condition deteriorates (OR = 0.995, α = 1%, due to absence of treatment. Regressions to account

  12. Benefits of global partnerships to facilitate access to medicines in developing countries: a multi-country analysis of patients and patient outcomes in GIPAP.

    Science.gov (United States)

    Kanavos, Panos; Vandoros, Sotiris; Garcia-Gonzalez, Pat

    2009-12-31

    Access to medicines in developing countries continues to be a significant problem due to lack of insurance and lack of affordability. Chronic Myeloid Leukemia (CML), a rare disease, can be treated effectively, but the pharmaceutical treatment available (imatinib) is costly and unaffordable by most patients. GIPAP, is a programme set up between a manufacturer and an NGO to provide free treatment to eligible CML patients in 80 countries worldwide. To discuss the socio-economic and demographic characteristics of patients participating in GIPAP; to research the impact GIPAP is having on health outcomes (survival) of assistance-eligible CML patients; and to discuss the determinants of such outcomes and whether there are any variations according to socio-economic, demographic, or geographical criteria. Data for 13,568 patients across 15 countries, available quarterly, were analysed over the 2005-2007 period. Ordered Probit panel data analysis was used to analyze the determinants of a patient's progress in terms of participation in the programme. Four waves of patients entering quarterly in 2005 were used to evaluate patient survival over the sample period. All patients in the sample are eligible to receive treatment provided they report to a facility quarterly. 62.3% of patients were male and 37.7% female. The majority (84.4%) entered during the chronic phase of the disease and their average age was 38.4 years. Having controlled for age, location and occupation, the analysis showed that patients were significantly much more likely to move towards a better health state after receiving treatment irrespective of their disease stage at the point of entry to the program (OR = 30.5, alpha = 1%); and that the larger the gap between diagnosis and approval for participation in the program, the more likely it is that patients' condition deteriorates (OR = 0.995, alpha = 1%), due to absence of treatment. Regressions to account for the effect of large countries (India, China

  13. Measurement and control of bias in patient reported outcomes using multidimensional item response theory.

    Science.gov (United States)

    Dowling, N Maritza; Bolt, Daniel M; Deng, Sien; Li, Chenxi

    2016-05-26

    Patient-reported outcome (PRO) measures play a key role in the advancement of patient-centered care research. The accuracy of inferences, relevance of predictions, and the true nature of the associations made with PRO data depend on the validity of these measures. Errors inherent to self-report measures can seriously bias the estimation of constructs assessed by the scale. A well-documented disadvantage of self-report measures is their sensitivity to response style (RS) effects such as the respondent's tendency to select the extremes of a rating scale. Although the biasing effect of extreme responding on constructs measured by self-reported tools has been widely acknowledged and studied across disciplines, little attention has been given to the development and systematic application of methodologies to assess and control for this effect in PRO measures. We review the methodological approaches that have been proposed to study extreme RS effects (ERS). We applied a multidimensional item response theory model to simultaneously estimate and correct for the impact of ERS on trait estimation in a PRO instrument. Model estimates were used to study the biasing effects of ERS on sum scores for individuals with the same amount of the targeted trait but different levels of ERS. We evaluated the effect of joint estimation of multiple scales and ERS on trait estimates and demonstrated the biasing effects of ERS on these trait estimates when used as explanatory variables. A four-dimensional model accounting for ERS bias provided a better fit to the response data. Increasing levels of ERS showed bias in total scores as a function of trait estimates. The effect of ERS was greater when the pattern of extreme responding was the same across multiple scales modeled jointly. The estimated item category intercepts provided evidence of content independent category selection. Uncorrected trait estimates used as explanatory variables in prediction models showed downward bias. A

  14. An individual patient data meta-analysis on characteristics, treatments and outcomes of the glioblastoma/gliosarcoma patients with central nervous system metastases reported in literature until 2013

    DEFF Research Database (Denmark)

    Pietschmann, Sophie; von Bueren, André O; Henke, Guido

    2014-01-01

    Dissemination of high-grade gliomas (WHO IV) has been investigated poorly so far. We conducted an extensive analysis of the characteristics, treatments and outcomes of the glioblastoma multiforme (GBM)/gliosarcoma (GS) patients with central nervous system (CNS) metastases reported in literature...... until April 2013. PubMed and Web of Science searches for peer-reviewed articles pertaining to GBM/GS patients with metastatic disease were conducted using predefined keywords. Additionally, we performed hand search following the references from the selected papers. Cases in which the metastases...... exclusively occurred outside the CNS were excluded. 110 publications reporting on 189 patients were eligible. There was a significant increase in the number of reported cases over the last decades. We calculated a median overall survival from diagnosis of metastasis (from initial diagnosis of GBM/GS) of 3...

  15. Reliability, Validity, and Responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) Scores in Influenza-Positive Patients.

    Science.gov (United States)

    Powers, John H; Bacci, Elizabeth D; Guerrero, M Lourdes; Leidy, Nancy Kline; Stringer, Sonja; Kim, Katherine; Memoli, Matthew J; Han, Alison; Fairchok, Mary P; Chen, Wei-Ju; Arnold, John C; Danaher, Patrick J; Lalani, Tahaniyat; Ridoré, Michelande; Burgess, Timothy H; Millar, Eugene V; Hernández, Andrés; Rodríguez-Zulueta, Patricia; Smolskis, Mary C; Ortega-Gallegos, Hilda; Pett, Sarah; Fischer, William; Gillor, Daniel; Macias, Laura Moreno; DuVal, Anna; Rothman, Richard; Dugas, Andrea; Ruiz-Palacios, Guillermo M

    2018-02-01

    To assess the reliability, validity, and responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) scores for quantifying the presence and severity of influenza symptoms. An observational prospective cohort study of adults (≥18 years) with influenza-like illness in the United States, the United Kingdom, Mexico, and South America was conducted. Participants completed the 37-item draft FLU-PRO daily for up to 14 days. Item-level and factor analyses were used to remove items and determine factor structure. Reliability of the final tool was estimated using Cronbach α and intraclass correlation coefficients (2-day reliability). Convergent and known-groups validity and responsiveness were assessed using global assessments of influenza severity and return to usual health. Of the 536 patients enrolled, 221 influenza-positive subjects comprised the analytical sample. The mean age of the patients was 40.7 years, 60.2% were women, and 59.7% were white. The final 32-item measure has six factors/domains (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic), with a higher order factor representing symptom severity overall (comparative fit index = 0.92; root mean square error of approximation = 0.06). Cronbach α was high (total = 0.92; domain range = 0.71-0.87); test-retest reliability (intraclass correlation coefficient, day 1-day 2) was 0.83 for total scores and 0.57 to 0.79 for domains. Day 1 FLU-PRO domain and total scores were moderately to highly correlated (≥0.30) with Patient Global Rating of Flu Severity (except nose and throat). Consistent with known-groups validity, scores differentiated severity groups on the basis of global rating (total: F = 57.2, P FLU-PRO score improvement by day 7 than did those who did not, suggesting score responsiveness. Results suggest that FLU-PRO scores are reliable, valid, and responsive to change in influenza-positive adults. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes

  16. Patients’ attitudes and perceptions of two health-related quality-of-life questionnaires used to collect patient-reported outcome measures in the English National Health Service: A qualitative study of patients undergoing cardiac interventions

    Directory of Open Access Journals (Sweden)

    Bashir M Matata

    2013-09-01

    Full Text Available Objectives: To explore patients’ views on the EuroQol-5D and Coronary Revascularisation Outcome Questionnaire, tools currently used for collecting patient-reported outcome measures in the English National Health Service. The key questions were as follows: (1 whether patients consider them sensitive enough to detect change in their health after cardiovascular disease interventions and (2 whether they consider the health-related quality-of-life questions as meaningful. Methods: Data were collected on patients’ views using focus groups. We held four focus groups selecting participants on the basis of their baseline and follow-up EuroQol-5D scores. Data were analysed using framework analysis and grounded theory. Results: Focus group participants confirmed that they had derived substantial health benefits from their cardiac interventions despite the lack of measurable effects on the EuroQol-5D scores. Participants felt that the EuroQol-5D questionnaire was limited because of the following reasons: Their health fluctuates from day to day. They had difficulty assessing their general health status on the visual analogue scale. They felt that the Coronary Revascularisation Outcome Questionnaire was limited because of the following reasons: They did not understand the clinical terms used. The impact of tiredness on their quality of life was not captured. They were unable to distinguish between the effects of their heart condition and other health issues. Additionally, neither questionnaire considers the adjustments people have made to their domestic arrangements to improve their health-related quality of life. Conclusion: This study provides evidence that the two questionnaires do not capture some aspects of health that patients consider important. Furthermore, the presence of co-morbidities masks the symptoms relating to the heart disease and the effect of their cardiac interventions. Future work on patient-reported outcome measures should consider

  17. Patient outcomes in simulation-based medical education: a systematic review.

    Science.gov (United States)

    Zendejas, Benjamin; Brydges, Ryan; Wang, Amy T; Cook, David A

    2013-08-01

    Evaluating the patient impact of health professions education is a societal priority with many challenges. Researchers would benefit from a summary of topics studied and potential methodological problems. We sought to summarize key information on patient outcomes identified in a comprehensive systematic review of simulation-based instruction. Systematic search of MEDLINE, EMBASE, CINAHL, PsychINFO, Scopus, key journals, and bibliographies of previous reviews through May 2011. Original research in any language measuring the direct effects on patients of simulation-based instruction for health professionals, in comparison with no intervention or other instruction. Two reviewers independently abstracted information on learners, topics, study quality including unit of analysis, and validity evidence. We pooled outcomes using random effects. From 10,903 articles screened, we identified 50 studies reporting patient outcomes for at least 3,221 trainees and 16,742 patients. Clinical topics included airway management (14 studies), gastrointestinal endoscopy (12), and central venous catheter insertion (8). There were 31 studies involving postgraduate physicians and seven studies each involving practicing physicians, nurses, and emergency medicine technicians. Fourteen studies (28 %) used an appropriate unit of analysis. Measurement validity was supported in seven studies reporting content evidence, three reporting internal structure, and three reporting relations with other variables. The pooled Hedges' g effect size for 33 comparisons with no intervention was 0.47 (95 % confidence interval [CI], 0.31-0.63); and for nine comparisons with non-simulation instruction, it was 0.36 (95 % CI, -0.06 to 0.78). Focused field in education; high inconsistency (I(2) > 50 % in most analyses). Simulation-based education was associated with small-moderate patient benefits in comparison with no intervention and non-simulation instruction, although the latter did not reach statistical

  18. Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments.

    Science.gov (United States)

    Protopapa, Evangelia; van der Meulen, Jan; Moore, Caroline M; Smith, Sarah C

    2017-10-01

    To critically review conceptual frameworks for available patient-reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient-Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer-specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer-specific PROs: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Expanded Prostate Cancer Index Composite-50 (EPIC-50), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), Functional Assessment of Cancer Therapy - Prostate Cancer Subscale (FACT-P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - prostate specific 25-item (EORTC QLQ-PR25), Prostate Cancer - Quality of Life (PC-QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health-related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work

  19. Does radiography advanced practice improve patient outcomes and health service quality? A systematic review.

    Science.gov (United States)

    Hardy, Maryann; Johnson, Louise; Sharples, Rachael; Boynes, Stephen; Irving, Donna

    2016-06-01

    To investigate the impact of radiographer advanced practice on patient outcomes and health service quality. Using the World Health Organization definition of quality, this review followed the Centre for Reviews and Dissemination guidance for undertaking reviews in healthcare. A range of databases were searched using a defined search strategy. Included studies were assessed for quality using a tool specifically developed for reviewing studies of diverse designs, and data were systematically extracted using electronic data extraction pro forma. 407 articles were identified and reviewed against the inclusion/exclusion criteria. Nine studies were included in the final review, the majority (n = 7) focusing on advanced radiography practice within the UK. Advanced practice activities considered were radiographer reporting, leading patient review clinics and barium enema examinations. The articles were generally considered to be of low-to-moderate quality, with most evaluating advanced practice within a single centre. With respect to specific quality dimensions, the included studies considered cost reduction, patient morbidity, time to treatment and patient satisfaction. No articles reported data relating to time to diagnosis, time to recovery or patient mortality. Radiographer advanced practice is an established activity both in the UK and internationally. However, evidence of the impact of advanced practice in terms of patient outcomes and service quality is limited. This systematic review is the first to examine the evidence base surrounding advanced radiography practice and its impact on patient outcomes and health service quality.

  20. Feasibility of using a handheld electronic device for the collection of patient reported outcomes data from children

    OpenAIRE

    Vinney, Lisa A.; Grade, John; Connor, Nadine P.

    2011-01-01

    The manner in which a communication disorder affects health-related quality of life (QOL) in children is not known. Unfortunately, collection of quality of life data via traditional paper measures is labor intensive and has several other limitations, which hinder the investigation of pediatric quality of life in children. Currently, there is not sufficient research regarding the use of electronic devices to collect pediatric patient reported outcomes in order to address such limitations. Thus...

  1. Patient Satisfaction with Surgical Outcome after Hypospadias Correction

    NARCIS (Netherlands)

    Dokter, E.M.J.; Moues, C.M.; Rooij, I.A.L.M. van; Biezen, J.J. van der

    2017-01-01

    Background: Hypospadias is a congenital malformation in which surgical correction is indicated in most cases. Postoperative patient satisfaction is important because of its influence on the child's psychological development. Objective: To evaluate patient satisfaction with surgical outcome after

  2. Change of Patient-Reported Aesthetic Outcome Over Time and Identification of Factors Characterizing Poor Aesthetic Outcome After Breast-Conserving Therapy: Long-Term Results of a Prospective Cohort Study.

    Science.gov (United States)

    Hennigs, André; Biehl, Hannah; Rauch, Geraldine; Golatta, Michael; Tabatabai, Patrik; Domschke, Christoph; Schott, Sarah; Wallwiener, Markus; Schütz, Florian; Sohn, Christof; Heil, Jörg

    2016-05-01

    We analyzed the change of aesthetic outcome (AO) over time and explored factors characterizing poor AO after breast-conserving surgery (BCS). This prospective single-center cohort study included 849 patients preoperatively planned for BCS between September 2007 and December 2011. Long-term follow-up was made once in 2013. AO was measured by the Aesthetic Status (AS) of the Breast Cancer Treatment Outcome Scale questionnaire. Clinical, surgical, and pathologic variables were evaluated to identify predictors of poor AO. We applied single factor variance analyses and univariable logistic regression analyses for outcome analysis. The long-term follow-up rate in 2013 was 73 % (621 nonrecurrent with final BCS). A poor or fair AO was reported in 30 (4.8 %) and 98 (15.8 %) of these 621 patients, respectively. Single factor variance analysis showed a negative impact of higher specimen weight on AO (p procedures.

  3. [Improving care for cleft lip and palate patients: uniform and patient-orientated outcome measures].

    Science.gov (United States)

    Haj, M; de Gier, H H W; van Veen-van der Hoek, M; Versnel, S L; van Adrichem, L N; Wolvius, E B; Hazelzet, J A; Koudstaal, M J

    2018-02-01

    The quality of care for patients with cleft lip and palate is extremely variable across the world. Treatment protocols differ and methods of data registration are not uniform. Improving this care by means of comparative research is challenging. The best treatment programmes can be identified by uniformly registering patient-orientated outcomes and comparing the outcomes with those of other treatment centres. That knowledge can be used to improve one's own care. An international team consisting of specialists and cleft lip and palate patients has developed a set of outcome measures that are considered by patients to be most important. This team is coordinated by the International Consortium of Health Outcomes Measurement (ICHOM). The cleft lip and palate outcome set can be used by all centres worldwide in following up on cleft lip and palate patients. In the Erasmus Medical Centre in Rotterdam, the 'Zorgmonitor Schisis' (Care Monitor Cleft Lip and Palate) has been built, an application in which these outcome measures are collected at fixed times. Implementing this set of outcome measures in other cleft lip and palate treatment centres and using the outcomes as (inter)national benchmarks will result in transparency and the improvement of the treatment of cleft lip and palate worldwide.

  4. Psychometric properties of carer-reported outcome measures in palliative care: A systematic review

    Science.gov (United States)

    Michels, Charlotte TJ; Boulton, Mary; Adams, Astrid; Wee, Bee; Peters, Michele

    2016-01-01

    Background: Informal carers face many challenges in caring for patients with palliative care needs. Selecting suitable valid and reliable outcome measures to determine the impact of caring and carers’ outcomes is a common problem. Aim: To identify outcome measures used for informal carers looking after patients with palliative care needs, and to evaluate the measures’ psychometric properties. Design: A systematic review was conducted. The studies identified were evaluated by independent reviewers (C.T.J.M., M.B., M.P.). Data regarding study characteristics and psychometric properties of the measures were extracted and evaluated. Good psychometric properties indicate a high-quality measure. Data sources: The search was conducted, unrestricted to publication year, in the following electronic databases: Applied Social Sciences Index and Abstracts, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, PubMed, PsycINFO, Social Sciences Citation Index and Sociological Abstracts. Results: Our systematic search revealed 4505 potential relevant studies, of which 112 studies met the inclusion criteria using 38 carer measures for informal carers of patients with palliative care needs. Psychometric properties were reported in only 46% (n = 52) of the studies, in relation to 24 measures. Where psychometric data were reported, the focus was mainly on internal consistency (n = 45, 87%), construct validity (n = 27, 52%) and/or reliability (n = 14, 27%). Of these, 24 measures, only four (17%) had been formally validated in informal carers in palliative care. Conclusion: A broad range of outcome measures have been used for informal carers of patients with palliative care needs. Little formal psychometric testing has been undertaken. Furthermore, development and refinement of measures in this field is required. PMID:26407683

  5. Tailored and integrated Web-based tools for improving psychosocial outcomes of cancer patients: the DoTTI development framework.

    Science.gov (United States)

    Smits, Rochelle; Bryant, Jamie; Sanson-Fisher, Rob; Tzelepis, Flora; Henskens, Frans; Paul, Christine; Stevenson, William

    2014-03-14

    Effective communication with cancer patients and their families about their disease, treatment options, and possible outcomes may improve psychosocial outcomes. However, traditional approaches to providing information to patients, including verbal information and written booklets, have a number of shortcomings centered on their limited ability to meet patient preferences and literacy levels. New-generation Web-based technologies offer an innovative and pragmatic solution for overcoming these limitations by providing a platform for interactive information seeking, information sharing, and user-centered tailoring. The primary goal of this paper is to discuss the advantages of comprehensive and iterative Web-based technologies for health information provision and propose a four-phase framework for the development of Web-based information tools. The proposed framework draws on our experience of constructing a Web-based information tool for hematological cancer patients and their families. The framework is based on principles for the development and evaluation of complex interventions and draws on the Agile methodology of software programming that emphasizes collaboration and iteration throughout the development process. The DoTTI framework provides a model for a comprehensive and iterative approach to the development of Web-based informational tools for patients. The process involves 4 phases of development: (1) Design and development, (2) Testing early iterations, (3) Testing for effectiveness, and (4) Integration and implementation. At each step, stakeholders (including researchers, clinicians, consumers, and programmers) are engaged in consultations to review progress, provide feedback on versions of the Web-based tool, and based on feedback, determine the appropriate next steps in development. This 4-phase framework is evidence-informed and consumer-centered and could be applied widely to develop Web-based programs for a diverse range of diseases.

  6. Outcome of anesthesia in elective surgical patients with comorbidities.

    Science.gov (United States)

    Eyelade, Olayinka; Sanusi, Arinola; Adigun, Tinuola; Adejumo, Olufemi

    2016-01-01

    Presence of comorbidity in surgical patients may be associated with adverse perioperative events and increased the risk of morbidity and mortality. This audit was conducted to determine the frequencies of comorbidities in elective surgical patients and the outcome of anesthesia in a Tertiary Hospital in Nigeria. Observational study of a cross-section of adult patients scheduled for elective surgery over a 6-month period. A standardized questionnaire was used to document patients' demographics, the presence of comorbidity and type, surgical diagnosis, anesthetic technique, intraoperative adverse events, and outcome of anesthesia. The questionnaire was administered pre- and post-operatively to determine the effects of the comorbidities on the outcome of anesthesia. One hundred and sixty-five adult patients aged between 18 and 84 years were studied. There were 89 (53.9%) females and 76 (46.1%) males. Forty-five (27.3%) have at least one comorbidity. Hypertension was the most common (48.8%) associated illness. Other comorbidities identified include anemia (17.8%), asthma (8.9%), diabetes mellitus (6.7%), chronic renal disease (6.7%), and others. The perioperative period was uneventful in majority of patients (80.6%) despite the presence of comorbidities. Intraoperative adverse events include hypotension, hypertension, shivering, and vomiting. No mortality was reported. Hypertension was the most common comorbidity in this cohort of patients. The presence of comorbidity did not significantly affect the outcome of anesthesia in elective surgical patients.

  7. Long-term follow-up of whiplash injuries reported to insurance companies: a cohort study on patient-reported outcomes and impact of financial compensation.

    Science.gov (United States)

    Rydman, Eric; Ponzer, Sari; Brisson, Rosa; Ottosson, Carin; Pettersson-Järnbert, Hans

    2018-02-10

    The long-term outcome of Whiplash-associated disorder (WADs) has been reported to be poor in populations from medical settings. However, no trials have investigated the long-term prognosis of patients from medico-legal environment. For this group, the "compensation hypothesis" suggests financial compensation being associated with worsened outcome. The aims of this study were to describe long-term (2-4 years) non-recovery rates in participants with WAD recruited from insurance companies and to investigate the association between self-reported non-recovery and financial compensation. 144 participants, reporting neck pain after a motor vehicle accident, were recruited from two major insurance companies in Sweden. Self-reported recovery was measured at 6 months and 2-4 years. Those who received financial compensation from an insurance company were compared with those who received no compensation. The overall non-recovery rate after 2-4 years was 55.9% (66/118). In the non-compensated group, the non-recovery rate was 51.0% (25/49) and in the compensated group 73% (27/37) (p = 0.039). Adjusted OR was 4.33 (1.37-13.66). High level of pain at baseline was a strong predictor of non-recovery [OR 46 (4.7-446.0)]. However, no association was found between pain level at baseline and financial compensation. The non-recovery rate among patients making insurance claims is high, especially among those receiving financial compensation even if causal relationship cannot be determined based on this study. However, lack of association between baseline level of pain and compensation supports the compensation hypothesis.

  8. Effectiveness of massage therapy on post-operative outcomes among patients undergoing cardiac surgery: A systematic review

    Directory of Open Access Journals (Sweden)

    C. Ramesh

    2015-09-01

    Full Text Available The incidence and prevalence of cardiovascular disease (CVD are increasing rapidly in developing countries. Most patients with CVD do not respond to medical treatment and have to undergo cardiac surgery. This highly stressful experience results in increased levels of anxiety for patients. The objective of this review was to evaluate the efficacy of massage therapy on postoperative outcomes among patients undergoing cardiac surgery. A comprehensive literature search was made on PubMed-Medline, CINAHL, Science Direct, Scopus, Web of Science and the Cochrane library databases for original research articles published between 2000 and 2015. Original articles that reported the efficacy of massage therapy in patients undergoing cardiac surgery were included. The Cochrane data extraction form was used to extract data. A total of 297 studies were identified in the literature search. However, only seven studies were eligible for analysis. Of the seven studies, six studies demonstrated the effects of massage therapy on improving post-operative outcomes of patients, while one study found no evidence of improvement. Although the methods varied considerably, most of the studies included in this review reported positive results. Therefore, there is some evidence that massage therapy can lead to positive postoperative outcomes. Evidence of the effectiveness of massage therapy in patients undergoing cardiac surgery remains inconclusive. Additional research is needed to provide a strong evidence base for the use of massage therapy to improve post-operative outcomes and recovery among cardiac surgery patients

  9. Chemotherapy-Induced Peripheral Neuropathy in Long-term Survivors of Childhood Cancer: Clinical, Neurophysiological, Functional, and Patient-Reported Outcomes.

    Science.gov (United States)

    Kandula, Tejaswi; Farrar, Michelle Anne; Cohn, Richard J; Mizrahi, David; Carey, Kate; Johnston, Karen; Kiernan, Matthew C; Krishnan, Arun V; Park, Susanna B

    2018-05-14

    childhood cancer survivors and persisted long term, with concurrent deficits in patient-reported outcomes. Both the type of neurotoxic agent and a targeted clinical neurological assessment are important considerations when screening survivors for long-term neuropathy. Further development of peripheral neuropathy-specific pediatric assessment tools will aid research into neuroprotective and rehabilitative strategies.

  10. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

    Science.gov (United States)

    Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

    2011-12-01

    New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

  11. Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs.

    Science.gov (United States)

    Strand, Vibeke; Kremer, Joel; Wallenstein, Gene; Kanik, Keith S; Connell, Carol; Gruben, David; Zwillich, Samuel H; Fleischmann, Roy

    2015-11-04

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. In this 6-month, phase 3, randomized, placebo-controlled trial, 611 patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR) were randomized 4:4:1:1 to receive: tofacitinib 5 mg BID or tofacitinib 10 mg BID for the duration of the study, or placebo for 3 months followed by tofacitinib 5 mg BID or tofacitinib 10 mg BID. Patient-reported outcomes (PROs) included: Patient Global Assessment of Disease Activity (PtGA); Patient Assessment of Pain (Pain); Health Assessment Questionnaire-Disability Index (HAQ-DI); Medical Outcomes Survey (MOS) Short Form-36 (SF-36); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and MOS Sleep Scale. Time-to-event data (PtGA and Pain) were collected using an interactive voice response system daily diary (baseline through day 14). At month 3, tofacitinib 5 and 10 mg BID demonstrated statistically significant improvements versus placebo in PtGA (both p tofacitinib treatment were rapid in onset and significant improvements were reported at week 2 for PtGA, Pain and HAQ-DI, and differentiation from baseline was seen as early as 3 days after treatment initiation for interactive voice response system (IVRS) PtGA and IVRS Pain. The numbers needed to treat for patients to report changes greater than or equal to the minimum clinically important difference in PtGA, Pain, HAQ-DI, SF-36 Physical Component Summary score and FACIT-F ranged between 4.0-6.1 (5 mg BID) and 3.2-5.0 (10 mg BID). Tofacitinib monotherapy in DMARD-IR patients resulted in statistically significant and clinically meaningful improvements in multiple PROs versus placebo at month 3, with sustained improvements over 6 months. Clinicaltrials.gov registration NCT00814307 , registered 22 December 2008.

  12. Psychometric Characteristics of a Patient Reported Outcome Measure on Ego-Integrity and Despair among Cancer Patients.

    Directory of Open Access Journals (Sweden)

    Gitta Kleijn

    Full Text Available To evaluate psychometric characteristics of a questionnaire (the Northwestern Ego-integrity Scale (NEIS on ego-integrity (the experience of wholeness and meaning in life, even in spite of negative experiences and despair (the experience of regret about the life one has led, and feelings of sadness, failure and hopelessness among cancer patients.Cancer patients (n = 164 completed patient reported outcome measures on ego-integrity and despair (NEIS, psychological distress, anxiety and depression (Hospital Anxiety and Depression Scale (HADS, and quality of life (EORTC QLQ-C30 (cancer survivors, n = 57 or EORTC QLQ-C15-PAL (advanced cancer patients, n = 107. Confirmatory Factor Analysis was used to assess construct validity. Cronbach's alpha was used to assess internal consistency. Convergent validity was tested based on a priori defined hypotheses: a higher level of ego-integrity was expected to be related to a higher level of quality of life, and lower levels of distress, depression and anxiety; a higher level of despair was expected to be related to a lower level of quality of life, and higher levels of distress, depression and anxiety.The majority of all items (94.5% of the NEIS were completed by patients and single item missing rate was below 2%. The two subscales, labeled as Ego-integrity (5 items and Despair (4 items had acceptable internal consistency (Cronbach's alpha .72 and .61, respectively. The Ego-integrity subscale was not significantly associated with quality of life, distress, anxiety, or depression. The Despair subscale correlated significantly (p <.001 with quality of life (r = -.29, distress (r = .44, anxiety (r = .47 and depression (r = .32.The NEIS has good psychometric characteristics to assess ego-integrity and despair among cancer patients.

  13. Patient reported outcome measures (PROMs) following forward planned field-in field IMRT: Results from the Cambridge Breast IMRT trial

    International Nuclear Information System (INIS)

    Mukesh, Mukesh B.; Qian, Wendi; Wilkinson, Jennifer S.; Dorling, Leila; Barnett, Gillian C.; Moody, Anne M.; Wilson, Charles; Twyman, Nicola; Burnet, Neil G.; Wishart, Gordon C.; Coles, Charlotte E.

    2014-01-01

    Background: The use of intensity-modulated radiotherapy (IMRT) in breast cancer reduces clinician-assessed breast tissue toxicity including fibrosis, telangectasia and sub-optimal cosmesis. Patient reported outcome measures (PROMs) are also important as they provide the patient’s perspective. This longitudinal study reports on (a) the effect of forward planned field-in-field IMRT (∼simple IMRT) on PROMs compared to standard RT at 5 years after RT, (b) factors affecting PROMs at 5 years after RT and (c) the trend of PROMs over 5 years of follow up. Methods: PROMs were assessed at baseline (pre-RT), 6, 24 and 60 months after completion of RT using global health (EORTC QLQ C30) and 4 breast symptom questions (BR23). Also, 4 breast RT-specific questions were included at 6, 24 and 60 months: change in skin appearance, firmness to touch, reduction in breast size and overall change in breast appearance since RT. The benefits of simple IMRT over standard RT at 5 years after RT were assessed using standard t-test for global health and logistic regression analysis for breast symptom questions and breast RT-specific questions. Clinical factors affecting PROMs at 5 years were investigated using a multivariate analysis. A repeated mixed model was applied to explore the trend over time for each of PROMs. Results: (89%) 727/815, 84%, 81% and 61% patients completed questionnaires at baseline, 6, 24 and 60 months respectively. Patients reported worse toxicity for all four BR23 breast symptoms at 6 months, which then improved over time (p < 0.0001). They also reported improvement in skin appearance and breast hardness over time (p < 0.0001), with no significant change for breast shrinkage (p = 0.47) and overall breast appearance (p = 0.13). At 5 years, PROMs assessments did not demonstrate a benefit for simple IMRT over standard radiotherapy. Large breast volume, young age, baseline surgical cosmesis and post-operative infection were the most important variables to affect PROMs

  14. Non-dystrophic myotonia: prospective study of objective and patient reported outcomes.

    Science.gov (United States)

    Trivedi, Jaya R; Bundy, Brian; Statland, Jeffrey; Salajegheh, Mohammad; Rayan, Dipa Raja; Venance, Shannon L; Wang, Yunxia; Fialho, Doreen; Matthews, Emma; Cleland, James; Gorham, Nina; Herbelin, Laura; Cannon, Stephen; Amato, Anthony; Griggs, Robert C; Hanna, Michael G; Barohn, Richard J

    2013-07-01

    .6% of sodium channel participants, which increased post-cooling to 57.6% in sodium channel mutations. In evaluation of patients with clinical and electrical myotonia, despite considerable phenotypic overlap, the presence of eye closure myotonia, paradoxical myotonia, and an increase in short exercise test sensitivity post-cooling suggest sodium channel mutations. Outcomes designed to measure stiffness or the electrophysiological correlates of stiffness may prove useful for future clinical trials, regardless of underlying mutation, and include patient-reported stiffness, bedside manoeuvres to evaluate myotonia, muscle specific quality of life instruments and short exercise testing.

  15. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods

    NARCIS (Netherlands)

    Apers, Silke; Kovacs, Adrienne H.; Luyckx, Koen; Alday, Luis; Berghammer, Malin; Budts, Werner; Callus, Edward; Caruana, Maryanne; Chidambarathanu, Shanthi; Cook, Stephen C.; Dellborg, Mikael; Enomoto, Junko; Eriksen, Katrine; Fernandes, Susan M.; Jackson, Jamie L.; Johansson, Bengt; Khairy, Paul; Kutty, Shelby; Menahem, Samuel; Rempel, Gwen; Sluman, Maayke A.; Soufi, Alexandra; Thomet, Corina; Veldtman, Gruschen; Wang, Jou-Kou; White, Kamila; Moons, Philip; Maisuls, Héctor; Cabrera, Marcelo; Eaton, Sarah; Larion, Ruth; FengWang, Qi; van Deyk, Kristien; Goossens, Eva; Rassart, Jessica; Mackie, Andrew; Ballantyne, Ross; Rankin, Kathryn; Norris, Colleen; Taylor, Dylan; Vondermuhll, Isabelle; Windram, Jonathan; Heggie, Pamela; Lasiuk, Gerri; Proietti, Anna; Dore, Annie; Mercier, Lise-Andrée; Mongeon, François-Pierre; Marcotte, François; Mulder, Barbara

    2015-01-01

    Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research

  16. Clinical and patient-reported outcomes of bilateral implantation of a +2.5 diopter multifocal intraocular lens.

    Science.gov (United States)

    Maxwell, Andrew; Holland, Edward; Cibik, Lisa; Fakadej, Anna; Foster, Gary; Grosinger, Les; Moyes, Andrew; Nielsen, Stephen; Silverstein, Steven; Toyos, Melissa; Weinstein, Arthur; Hartzell, Scott

    2017-01-01

    To assess the effectiveness and safety of a multifocal intraocular lens (IOL) with +2.5 diopter (D) additional power compared with a monofocal IOL. Fifteen sites in the United States. Prospective randomized patient- and observer-masked clinical trial. Randomized patients received multifocal or monofocal IOLs bilaterally. Visual acuity (33 cm, 40 cm, 53 cm, 60 cm, 4 m) was measured; safety was assessed through adverse event rates. Patient-reported visual outcomes were evaluated using the Visual Tasks questionnaire. The frequency and severity of visual disturbances were evaluated using the Assessment of Photic Phenomena and Lens EffectS questionnaire. The multifocal IOL (n = 155) provided better corrected distance visual acuity at 53 cm than the monofocal IOL (n = 165) (0.322 versus 0.512 logMAR; between-group difference, -0.190 logMAR; P < .0001) and 40 cm but not at 4 m. Ocular adverse event rates were less than 3.84% in both groups. Serious adverse event rates were comparable between the 2 IOL types. Patients with multifocal IOLs reported less difficulty with near tasks (with and without correction) and intermediate tasks (without correction). Difficulty with extended-intermediate and distance tasks was similar between groups. The most frequently reported self-rated severe phenomena were halos, starbursts, and glare. Most patients (monofocal ≥72%; multifocal ≥73%) reported never experiencing blurred, distorted, or double vision. The +2.5 D multifocal IOL provided better vision at 40 cm and 53 cm and similar vision at 4 m compared with the monofocal IOL. Safety profiles and visual phenomena were comparable between groups. Copyright © 2017 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  17. Content Validity of the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q): A Patient-Reported Outcome Measure to Evaluate Symptoms of Hypogonadism.

    Science.gov (United States)

    Gelhorn, Heather L; Vernon, Margaret K; Stewart, Katie D; Miller, Michael G; Brod, Meryl; Althof, Stanley E; DeRogatis, Leonard R; Dobs, Adrian; Seftel, Allen D; Revicki, Dennis A

    2016-04-01

    Hypogonadism, or low testosterone, is a common disorder. There are currently no patient-reported outcome (PRO) instruments designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. The purpose of this study was to develop a PRO instrument, the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) and to assess its content validity. A literature review, expert clinician input, and qualitative concept elicitation with 39 male hypogonadism patients (four focus groups: n = 25; individual interviews: n = 14; mean age 52.3 ± 14.3 years) from the USA were used to develop the draft HIS-Q. Subsequent cognitive interviews (n = 29; mean age 51.5 ± 15.4 years) were used to evaluate content validity. Emergent discussion with participants yielded symptoms within the sexual, physical, energy, sleep, cognition, and mood domains. Low libido and tiredness were most commonly reported. The initial version of the HIS-Q includes 53 items that were consistently understood by the participants, who found the instrument to be relevant to their experiences with hypogonadism and comprehensive in the content coverage of symptoms. The HIS-Q is a comprehensive PRO measure of hypogonadism symptom severity in males. Its design elements, including the response options and recall period, were suitable, and content validity was confirmed.

  18. The Influence of Obesity on Patient Reported Outcomes following Total Knee Replacement

    Directory of Open Access Journals (Sweden)

    Vandana Ayyar

    2012-01-01

    Full Text Available This study retrospectively analysed the effects of obesity as described by Body Mass Index (BMI on patient reported outcomes following total knee replacement. Participants (105 females and 66 males who had undergone surgery under the care of a single surgeon were included in the review and were grouped according to their preoperative BMI into nonobese ( kg/m2, ( obese ( kg/m2 (. Oxford Knee Score (OKS and Short Form 12 scores (SF12 were taken preoperatively and 6 and 12 months after surgery to analyse differences between groups in the absolute scores as well as changes from before to after surgery. Preoperatively, the obese group had a significantly poorer OKS compared to non obese (44.7 versus 41.2, . There were no statistically significant group effects on follow-up or change scores of the OKS and SF12. Correlations coefficients between BMI and follow-up and change scores were low (. There were no significant differences in the number of complications and revisions (local wound infection, 6.7% non obese, 11% obese, postoperative systemic complication, 8% non obese, 12% obese, revision, 4% nonobese, 3% obese. In conclusion, our findings indicate similar degrees of benefits from the surgery irrespective of patient BMI.

  19. Does Excision of Heterotopic Ossification of the Elbow Result in Satisfactory Patient-Rated Outcomes?

    Science.gov (United States)

    Sandeep, K N; Suresh, G; Gopisankar, B; Abhishek, N; Sujiv, A

    2017-03-01

    Treatment of heterotopic ossification (HO) of the elbow is challenging and fraught with complications. Patients who sustain direct trauma to the elbow joint, the central nervous system, and thermal burns are at increased risk for development of HO. There is a paucity of studies and reports on patient's self-evaluation after the excision of the heterotopic ossification. This retrospective study assessed outcomes after excision of heterotopic ossification around the elbow in a cohort of ten patients operated from 2012 to 2015. The outcome assessment was done by the Mayo Elbow Performance index (MEPI) and the American Shoulder and Elbow Surgeons-Elbow score (ASES-E scores). The mean follow-up was 18.11 months after the operation. The Mayo Elbow Performance Score was excellent in two elbows, good in six and fair in two. The mean gain in flexion-extension arc after excision of HO was 80 degrees. All of the patients had residual flexion deformity postoperatively. Eight of the nine patients were able to do activities requiring flexion at final follow-up. Excision of HO around the elbow is associated with satisfactory patient-rated outcomes in spite of failure to regain full range of motion.

  20. Translation and adaption of the Genetic Counseling Outcome Scale (GCOS-24) to Danish

    DEFF Research Database (Denmark)

    Diness, Birgitte Rode; Overbeck, Gritt; Duelund, T.

    2013-01-01

    Background and aim: The ability to measure patient outcomes from genetic counselling is a prerequisite for evidencebased development of practice. The Genetic Counselling Outcome Scale (GCOS-24) is a recently developed patient reported outcome measure. The aim of this project was to develop a Danish...... perception of genetic counseling and genetic conditions and led to adjustments of the original translation, leading to development of a tool better-suited to the target population. We would recommend the described approach when attempting translation of patient reported outcome measures...

  1. Validity of patient-reported swallowing and speech outcomes in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer.

    Science.gov (United States)

    Rinkel, R N P M; Verdonck-de Leeuw, I M; de Bree, R; Aaronson, N K; Leemans, C R

    2015-04-01

    The objective of this study was to test the construct validity of the patient-reported outcomes Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI) in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer. The study sample consisted of patients treated for oral or oropharyngeal cancer. Outcome measures were the SWAL-QOL and the SHI, and the Functional Rehabilitation Outcomes Grade (FROG), a test to measure oral and shoulder function. Spearman's rank correlation coefficient was used to test associations between the SHI and SWAL-QOL scales, and the FROG scales. During a study period of 3 months, 38 patients (21 males, 17 females; mean age 54 years) were included who visited the outpatient clinic for follow-up care 6-155 months after surgical treatment (n = 14) or combined surgery and radiotherapy (n = 24) for oral (n = 21) or oropharyngeal cancer (n = 17). Most SWAL-QOL and SHI scales (except the SWAL-QOL Fatigue scale) correlated significantly with one or more FROG oral function scales. None of the SWAL-QOL and SHI scales correlated significantly with the FROG shoulder function scale. These results support the construct validity of the SWAL-QOL and SHI questionnaires for assessing speech and swallowing problems in daily life that are moderately but significantly related to oral function. A multidimensional assessment protocol is recommended for use in clinical practice and for research purposes for measuring oral function and swallowing- and speech-related problems in daily life among head and neck cancer patients.

  2. Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea

    Directory of Open Access Journals (Sweden)

    Delgado-Herrera L

    2016-06-01

    Full Text Available Leticia Delgado-Herrera,1 Kathryn Lasch,2 Ana Popielnicki,3 Akito Nishida,4 Rob Arbuckle,5 Benjamin Banderas,6 Susan Zentner,1 Ingrid Gagainis,1 Bernhardt Zeiher1 1Astellas Pharma Global Development, Northbrook, IL, 2Pharmerit International, Newton, MA, USA; 3TransPerfect, Linguistic Validation Group, Boston, MA, USA; 4Development Project Management, Astellas Pharma Inc, Tokyo, Japan; 5Patient-Centered Outcomes Adelphi Values, Bollington, UK; 6Patient-Centered Outcomes Adelphi Values, Boston, MA, USA Background and objective: Following a 2009 US Food and Drug Administration guidance, a new patient-reported outcome (PRO instrument was developed to support end points in multinational clinical trials assessing irritable bowel syndrome with diarrhea (IBS-D symptom severity. Our objective was to assess the translatability of the IBS-D PRO instrument into ten languages, and subsequently perform a cultural adaptation/linguistic validation of the questionnaire into Japanese and US Spanish. Materials and methods: Translatability assessments of the US English version of the IBS-D PRO were performed by experienced PRO translators who were native speakers of each target language and currently residing in target-language countries. Languages were Chinese (People’s Republic of China, Dutch (the Netherlands, French (Belgium, German (Germany, Japanese (Japan, Polish (Poland, Portuguese (Brazil, Russian (Russia, Spanish (Mexico, and Spanish (US. The project team assessed the instrument to identify potential linguistic and/or cultural adaptation issues. After the issues identified were resolved, the instrument was translated into Spanish (US and Japanese through a process of two forward translations, one reconciled translation, and one backward translation. The project team reviewed the translated versions before the instruments were evaluated by cognitive debriefing interviews with samples of five Spanish (US and five Japanese IBS-D patients. Results

  3. Development of a measure of hypodontia patients' expectations of the process and outcome of combined orthodontic and restorative treatment.

    Science.gov (United States)

    Gassem, Afnan Ben; Foxton, Richard; Bister, Dirk; Newton, Tim

    2016-12-01

    To devise and assess the psychometric properties of a measure that investigates hypodontia patients' expectations of the process and outcome of combined orthodontic/restorative treatment. Specialised secondary care facility for individuals with hypodontia. Mixed research design with three phases: (a) Thematic analysis of data from individual interviews with 25 hypodontia patients/16 parents to generate the questionnaire items. (b) Questionnaire design, assessment of readability and face/content validity with 10 patients. (c) Survey of 32 new hypodontia patients to determine the internal consistency of the measure. Three main themes related to the treatment process emerged from the qualitative data: 'hypodontia clinic', 'orthodontic treatment' and 'restorative treatment'. Three main themes were also revealed relating to treatment outcome: 'changes in appearance', 'psychosocial changes' and 'functional changes'. A 28 item questionnaire was constructed using a mix of visual analogue scale (VAS) and categorical response format. The Flesch reading ease score of the measure was 78, equivalent to a reading age of 9-10 years. Face and content validity were good. The overall Cronbach's alpha was 0.80 while for the treatment process and treatment outcome subscales it was 0.71 and 0.88 respectively. A patient-based measure of the process and outcome of combined orthodontic/restorative treatment for hypodontia patients has been developed which has good face and construct validity and satisfactory internal consistency. Patient expectations of treatment are important in determining not only their satisfaction with treatment outcomes but also their engagement with the clinical process. This questionnaire is a first step in operationalising the expectations of hypodontia patients through assessment tools that can then determine whether pre-treatment counselling is required and aid the consent and treatment planning process, thus improving the quality of treatment provided by

  4. Clinical and Patient-reported Outcomes in Patients with Psoriatic Arthritis (PsA) by Body Surface Area Affected by Psoriasis: Results from the Corrona PsA/Spondyloarthritis Registry.

    Science.gov (United States)

    Mease, Philip J; Karki, Chitra; Palmer, Jacqueline B; Etzel, Carol J; Kavanaugh, Arthur; Ritchlin, Christopher T; Malley, Wendi; Herrera, Vivian; Tran, Melody; Greenberg, Jeffrey D

    2017-08-01

    Psoriatic arthritis (PsA) is commonly comorbid with psoriasis; the extent of skin lesions is a major contributor to psoriatic disease severity/burden. We evaluated whether extent of skin involvement with psoriasis [body surface area (BSA) > 3% vs ≤ 3%] affects overall clinical and patient-reported outcomes (PRO) in patients with PsA. Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and PRO at registry enrollment were assessed for patients with PsA aged ≥ 18 years with BSA > 3% versus ≤ 3%. Regression models were used to evaluate associations of BSA level with outcome [modified minimal disease activity (MDA), Health Assessment Questionnaire (HAQ) score, patient-reported pain and fatigue, and the Work Productivity and Activity Impairment questionnaire score]. Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologics, disease-modifying antirheumatic drug, and prednisone use. This analysis included 1240 patients with PsA with known BSA level (n = 451, BSA > 3%; n = 789, BSA ≤ 3%). After adjusting for potential confounding variables, patients with BSA > 3% versus ≤ 3% had greater patient-reported pain and fatigue and higher HAQ scores (p = 2.33 × 10 -8 , p = 0.002, and p = 1.21 × 10 -7 , respectively), were 1.7× more likely not to be in modified MDA (95% CI 1.21-2.41, p = 0.002), and were 2.1× more likely to have overall work impairment (1.37-3.21, p = 0.0001). These Corrona Registry data show that substantial skin involvement (BSA > 3%) is associated with greater PsA disease burden, underscoring the importance of assessing and effectively managing psoriasis in patients with PsA because this may be a contributing factor in PsA severity.

  5. Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures.

    Science.gov (United States)

    Faraj, Sayf S A; van Hooff, Miranda L; Holewijn, Roderick M; Polly, David W; Haanstra, Tsjitske M; de Kleuver, Marinus

    2017-08-01

    Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD. Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated. The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD. Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.

  6. Different outcomes, psychopathological features, and comorbidities in patients with eating disorders reporting childhood abuse: A 3-year follow-up study.

    Science.gov (United States)

    Castellini, Giovanni; Lelli, Lorenzo; Cassioli, Emanuele; Ciampi, Eleonora; Zamponi, Francesco; Campone, Beatrice; Monteleone, Alessio Maria; Ricca, Valdo

    2018-05-01

    The aim of this study was to evaluate the role of childhood adversities in long-term outcomes in eating disorders (EDs). One hundred thirty-three eating disorder patients were studied by means of the Structured Clinical Interview for DSM-IV and psychometric tests, at baseline, at the end of individual cognitive behavioural therapy, and at 3-year follow-up. As compared with the other patients, those reporting childhood abuse (overall: 24.8%; physical abuse: 20.3%; sexual abuse: 13.6%) showed higher impulsivity, psychiatric comorbidity, lower full recovery at follow-up (12.1% vs. 31%), and higher diagnostic crossover (39.4% vs. 13.0%). The different rates of recovery were mostly due to a higher persistence of depression in abused patients (77.8% vs. 26.7%). Patients with both abuse and neglect had a higher probability of dropout. Eating disorder patients with childhood abuse represent a group of persons with more complex psychopathological features and a worse long-term outcome, thus requiring specific treatment strategies. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

  7. Upper and Lower Urinary Tract Outcomes in Adult Myelomeningocele Patients: A Systematic Review

    Science.gov (United States)

    Veenboer, Paul W.; Bosch, J. L. H. Ruud; van Asbeck, Floris W. A.; de Kort, Laetitia M. O.

    2012-01-01

    Background The introduction of sophisticated treatment of bladder dysfunction and hydrocephalus allows the majority of SB patients to survive into adulthood. However, no systematic review on urological outcome in adult SB patients is available and no follow-up schemes exist. Objectives To systematically summarize the evidence on outcome of urinary tract functioning in adult SB patients. Methods A literature search in PubMed and Embase databases was done. Only papers published in the last 25 years describing patients with open SB with a mean age >18 years were included. We focused on finding differences in the treatment strategies, e.g., clean intermittent catheterization and antimuscarinic drugs versus early urinary diversion, with regard to long-term renal and bladder outcomes. Results A total of 13 articles and 5 meeting abstracts on urinary tract status of adult SB patients were found describing a total of 1564 patients with a mean age of 26.1 years (range 3–74 years, with a few patients incontinence. Renal function was studied in 1128 adult patients. In 290/1128 (25.7%; range 3–81.8%) patients some degree of renal damage was found and end-stage renal disease was seen in 12/958 (1.3%) patients. Detrusor-sphincter dyssynergy and detrusor-overactivity acted as adverse prognostic factors for the development of renal damage. Conclusions These findings should outline follow-up schedules for SB patients, which do not yet exist. Since renal and bladder deterioration continues beyond adolescence, follow-up of these individuals is needed. We recommend standardization in reporting the outcome of urinary tract function in adult SB patients. PMID:23119003

  8. Marital status and outcome of patients presenting with acute coronary syndrome: an observational report.

    Science.gov (United States)

    Hadi Khafaji, Hadi A R; Al Habib, Khalid; Asaad, Nidal; Singh, Rajvir; Hersi, Ahmad; Al Falaeh, Husam; Al Saif, Shukri; Al-Motarreb, Ahmed; Almahmeed, Wael; Sulaiman, Kadhim; Amin, Haitham; Al-Lawati, Jawad; Al-Sagheer, Norah Q; Alsheikh-Ali, Alawi A; Al Suwaidi, Jassim

    2012-12-01

    BACKGROUND & HYPOTHESIS: Data on the clinical characteristics and outcome of patients presenting with acute coronary syndrome (ACS) according to their marital status is not clear. A total of 5334 patients presenting with ACS in 65 hospitals in 6 Middle East countries in the 2nd Gulf Registry of Acute Coronary Events (Gulf RACE-2) were studied according to their marital status (5024 married, 100 single, and 210 widowed patients). When compared to married patients, widowed patients were older and more likely to be female. Widowed patients were more likely to have diabetes mellitus, hypertension, history of heart failure, and peripheral vascular disease and were less likely to be tobacco users when compared to the other groups. Widowed patients were also more likely to present with atypical symptoms and have advanced Killip class. Widowed patients were more likely to present with non-ST-elevation myocardial infarction (NSTEMI) when compared to the other 2 groups. Widowed patients were more likely to have heart failure (P = 0.001), cardiogenic shock (P = 0.001), and major bleeding (P = 0.002) when compared to the other groups. No statistically significant difference was observed in regard to duration of hospital stay, door to needle time in STEMI patients, or cardiac arrhythmias between the various groups. Widowed patients had higher in-hospital, 30-day, and 1-year mortality rates (P = 0.001). Marital status was an independent predictor for in-hospital mortality. Widowed marital status was associated with worse cardiovascular risk profile, and worse in-hospital and 1-year outcome. Future work should be focused on whether the provision of psychosocial support will result in improved outcomes among this high-risk group. © 2012 Wiley Periodicals, Inc.

  9. Learning outcomes associated with patient simulation method in pharmacotherapy education: an integrative review.

    Science.gov (United States)

    Aura, Suvi M; Sormunen, Marjorita S T; Jordan, Sue E; Tossavainen, Kerttu A; Turunen, Hannele E

    2015-06-01

    The aims of this systematic integrative review were to identify evidence for the use of patient simulation teaching methods in pharmacotherapy education and to explore related learning outcomes. A systematic literature search was conducted using 6 databases as follows: CINAHL, PubMed, SCOPUS, ERIC, MEDIC, and the Cochrane Library, using the key words relating to patient simulation and pharmacotherapy. The methodological quality of each study was evaluated. Eighteen articles met the inclusion criteria. The earliest article was published in 2005. The selected research articles were subjected to qualitative content analysis. Patient simulation has been used in pharmacotherapy education for preregistration nursing, dental, medical, and pharmacy students and for the continuing education of nurses. Learning outcomes reported were summarized as follows: (1) commitment to pharmacotherapy learning, (2) development of pharmacotherapy evaluation skills, (3) improvement in pharmacotherapy application skills, and (4) knowledge and understanding of pharmacotherapy. To develop effective teaching methods and ensure health care professionals' competence in medication management, further research is needed to determine the educational and clinical effectiveness of simulation teaching methods.

  10. Improving patient safety in radiotherapy through error reporting and analysis

    International Nuclear Information System (INIS)

    Findlay, Ú.; Best, H.; Ottrey, M.

    2016-01-01

    Aim: To improve patient safety in radiotherapy (RT) through the analysis and publication of radiotherapy errors and near misses (RTE). Materials and methods: RTE are submitted on a voluntary basis by NHS RT departments throughout the UK to the National Reporting and Learning System (NRLS) or directly to Public Health England (PHE). RTE are analysed by PHE staff using frequency trend analysis based on the classification and pathway coding from Towards Safer Radiotherapy (TSRT). PHE in conjunction with the Patient Safety in Radiotherapy Steering Group publish learning from these events, on a triannual and summarised on a biennial basis, so their occurrence might be mitigated. Results: Since the introduction of this initiative in 2010, over 30,000 (RTE) reports have been submitted. The number of RTE reported in each biennial cycle has grown, ranging from 680 (2010) to 12,691 (2016) RTE. The vast majority of the RTE reported are lower level events, thus not affecting the outcome of patient care. Of the level 1 and 2 incidents reported, it is known the majority of them affected only one fraction of a course of treatment. This means that corrective action could be taken over the remaining treatment fractions so the incident did not have a significant impact on the patient or the outcome of their treatment. Analysis of the RTE reports demonstrates that generation of error is not confined to one professional group or to any particular point in the pathway. It also indicates that the pattern of errors is replicated across service providers in the UK. Conclusion: Use of the terminology, classification and coding of TSRT, together with implementation of the national voluntary reporting system described within this report, allows clinical departments to compare their local analysis to the national picture. Further opportunities to improve learning from this dataset must be exploited through development of the analysis and development of proactive risk management strategies

  11. The Impact of Participation in Online Cancer Communities on Patient Reported Outcomes: Systematic Review.

    Science.gov (United States)

    van Eenbergen, Mies C; van de Poll-Franse, Lonneke V; Heine, Peter; Mols, Floortje

    2017-09-28

    In recent years, the question of how patients' participating in online communities affects various patient reported outcomes (PROs) has been investigated in several ways. This study aimed to systematically review all relevant literature identified using key search terms, with regard to, first, changes in PROs for cancer patients who participate in online communities and, second, the characteristics of patients who report such effects. A computerized search of the literature via PubMed (MEDLINE), PsycINFO (5 and 4 stars), Cochrane Central Register of Controlled Trials, and ScienceDirect was performed. Last search was conducted in June 2017. Studies with the following terms were included: (cancer patient) and (support group or health communities) and (online or Internet). A total of 21 studies were included and independently assessed by 2 investigators using an 11-item quality checklist. The methodological quality of the selected studies varied: 12 were of high quality, eight were of adequate quality, and only one was of low quality. Most of the respondents were women (about 80%), most with breast cancer; their mean age was 50 years. The patients who were active in online support groups were mostly younger and more highly educated than the nonusers. The investigated PROs included general well-being (ie, mood and health), anxiety, depression, quality of life, posttraumatic growth, and cancer-related concerns. Only marginal effects-that is, PRO improvements-were found; in most cases they were insignificant, and in some cases they were contradictory. The main shortcoming of this kind of study is the lack of methodological instruments for reliable measurements. Furthermore, some patients who participate in online communities or interact with peers via Internet do not expect to measure changes in their PROs. If cancer survivors want to meet other survivors and share information or get support, online communities can be a trustworthy and reliable platform to facilitate

  12. Patient reported outcomes following stereotactic ablative radiotherapy or surgery for stage IA non-small-cell lung cancer : Results from the ROSEL multicenter randomized trial

    NARCIS (Netherlands)

    Louie, Alexander V.; van Werkhoven, Erik; Chen, Hanbo; Smit, Egbert F.; Paul, Marinus A.; Widder, Joachim; Groen, Harry J. M.; van den Borne, Ben E. E. M.; De Jaeger, Katrien; Slotman, Ben J.; Senan, Suresh

    2015-01-01

    We report quality of life and indirect costs from patient reported outcomes from the ROSEL randomized control trial comparing stereotactic ablative radiotherapy (SABR, also known as stereotactic body radiotherapy or SBRT) versus surgical resection for medically operable stage IA non-small cell lung

  13. Impact of Patient-centered eHealth Applications on Patient Outcomes: A Review on the Mediating Influence of Human Factor Issues.

    Science.gov (United States)

    Wildenbos, G A; Peute, L W; Jaspers, M W M

    2016-11-10

    To examine the evidence of the impact of patient- centered eHealth applications on patient care and to analyze if and how reported human factor issues mediated the outcomes. We searched PubMed (2014-2015) for studies evaluating the impact of patient-centered eHealth applications on patient care (behavior change, self-efficacy, and patient health-related outcomes). The Systems Engineering Initiative for Patient Safety (SEIPS 2.0) model was used as a guidance framework to identify the reported human factors possibly impacting the effectiveness of an eHealth intervention. Of the 348 potentially relevant papers, 10 papers were included for data analysis. None of the 10 papers reported a negative impact of the eHealth intervention. Seven papers involved a randomized controlled trial (RCT) study. Six of these RCTs reported a positive impact of the eHealth intervention on patient care. All 10 papers reported on human factor issues possibly mediating effects of patient-centered eHealth. Human factors involved patient characteristics, perceived social support, and (type of) interaction between patient and provider. While the amount of patient-centered eHealth interventions increases, many questions remain as to whether and to what extent human factors mediate their use and impact. Future research should adopt a formal theory-driven approach towards human factors when investigating those factors' influence on the effectiveness of these interventions. Insights could then be used to better tailor the content and design of eHealth solutions according to patient user profiles, so as to enhance eHealth interventions impact on patient behavior, self-efficacy, and health-related outcomes.

  14. Readability Level of Spanish-Language Patient-Reported Outcome Measures in Audiology and Otolaryngology

    Science.gov (United States)

    Coco, Laura; Colina, Sonia; Atcherson, Samuel R.

    2017-01-01

    Purpose The purpose of this study was to examine the readability level of the Spanish versions of several audiology- and otolaryngology-related patient-reported outcome measures (PROMs) and include a readability analysis of 2 translation approaches when available—the published version and a “functionalist” version—using a team-based collaborative approach including community members. Method Readability levels were calculated using the Fry Graph adapted for Spanish, as well as the Fernandez-Huerta and the Spaulding formulae for several commonly used audiology- and otolaryngology-related PROMs. Results Readability calculations agreed with previous studies analyzing audiology-related PROMs in English and demonstrated many Spanish-language PROMs were beyond the 5th grade reading level suggested for health-related materials written for the average population. In addition, the functionalist versions of the PROMs yielded lower grade-level (improved) readability levels than the published versions. Conclusion Our results suggest many of the Spanish-language PROMs evaluated here are beyond the recommended readability levels and may be influenced by the approach to translation. Moreover, improved readability may be possible using a functionalist approach to translation. Future analysis of the suitability of outcome measures and the quality of their translations should move beyond readability and include an evaluation of the individual's comprehension of the written text. PMID:28892821

  15. Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Basch, Ethan, E-mail: ebasch@med.unc.edu [Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (United States); Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Pugh, Stephanie L. [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Dueck, Amylou C. [Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona (United States); Mitchell, Sandra A. [Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland (United States); Berk, Lawrence [Radiation Oncology, University of South Florida, Tampa, Florida (United States); Fogh, Shannon [Department of Radiation Oncology, University of California, San Francisco, San Francisco, California (United States); Rogak, Lauren J. [Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (United States); Gatewood, Marcha [Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia (United States); Reeve, Bryce B. [Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Mendoza, Tito R. [Department of Symptom Research, The University of Texas MD. Anderson Cancer Center, Houston, Texas (United States); O' Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M. [Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland (United States); Bennett, Antonia V. [Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Setser, Ann [Setser Health Consulting, LLC, St. Louis, Missouri (United States); Schrag, Deborah [Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts (United States); and others

    2017-06-01

    Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be

  16. Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

    International Nuclear Information System (INIS)

    Basch, Ethan; Pugh, Stephanie L.; Dueck, Amylou C.; Mitchell, Sandra A.; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J.; Gatewood, Marcha; Reeve, Bryce B.; Mendoza, Tito R.; O'Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M.; Bennett, Antonia V.; Setser, Ann; Schrag, Deborah

    2017-01-01

    Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by

  17. Examining the Impact of Patient-Reported Hope for Improvement and Patient Satisfaction with Clinician/Treatment on the Outcome of Major Depressive Disorder Treatment.

    Science.gov (United States)

    IsHak, Waguih William; Vilhauer, Jennice; Kwock, Richard; Wu, Fan; Gohar, Sherif; Collison, Katherine; Thomas, Shannon Nicole; Naghdechi, Lancer; Elashoff, David

    This analysis aims at examining if patient-reported variables such as hope for improvement and patient satisfaction with clinician/treatment could influence the outcome major depressive disorder (MDD) treatment, namely depression remission, in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Retrospective cohort study. The STAR*D study was conducted at 18 primary care and 23 psychiatric care settings in the United States from 2001-2007 and was funded by the National Institute of Mental health (NIMH). The analysis contained in this manuscript was conceptualized at the Cedars-Sinai Department of Psychiatry and Behavioral Neurosciences and performed at the UCLA School of Public Health. Using data from STAR*D, the current study used logistic regression and survival analyses to examine the relationship between depressive symptoms remission and two sets of self-reported factors: Hope for improvement and, Patient satisfaction with treatment/clinician. First, more than 90% of STAR*D patients reported having high hope for improvement (agree or strongly agree) and more than 66% endorsed high satisfaction with clinicians and more than 50% expressed high satisfaction with treatments (very or mostly satisfied). Second, hope for improvement was predictive of depression remission (pdepression remission in contrast to satisfaction with clinician/treatment. Future studies should prospectively incorporate patients' subjective attitudes regarding hope for improvement and satisfaction with clinicians and treatments as mediators and moderators of MDD treatment success.

  18. Adherence to HAART: a systematic review of developed and developing nation patient-reported barriers and facilitators.

    Directory of Open Access Journals (Sweden)

    Edward J Mills

    2006-11-01

    Full Text Available Adherence to highly active antiretroviral therapy (HAART medication is the greatest patient-enabled predictor of treatment success and mortality for those who have access to drugs. We systematically reviewed the literature to determine patient-reported barriers and facilitators to adhering to antiretroviral therapy.We examined both developed and developing nations. We searched the following databases: AMED (inception to June 2005, Campbell Collaboration (inception to June 2005, CinAhl (inception to June 2005, Cochrane Library (inception to June 2005, Embase (inception to June 2005, ERIC (inception to June 2005, MedLine (inception to June 2005, and NHS EED (inception to June 2005. We retrieved studies conducted in both developed and developing nation settings that examined barriers and facilitators addressing adherence. Both qualitative and quantitative studies were included. We independently, in duplicate, extracted data reported in qualitative studies addressing adherence. We then examined all quantitative studies addressing barriers and facilitators noted from the qualitative studies. In order to place the findings of the qualitative studies in a generalizable context, we meta-analyzed the surveys to determine a best estimate of the overall prevalence of issues. We included 37 qualitative studies and 47 studies using a quantitative methodology (surveys. Seventy-two studies (35 qualitative were conducted in developed nations, while the remaining 12 (two qualitative were conducted in developing nations. Important barriers reported in both economic settings included fear of disclosure, concomitant substance abuse, forgetfulness, suspicions of treatment, regimens that are too complicated, number of pills required, decreased quality of life, work and family responsibilities, falling asleep, and access to medication. Important facilitators reported by patients in developed nation settings included having a sense of self-worth, seeing positive

  19. Is there a Relationship between Patient Satisfaction and Favorable Surgical Outcomes?

    Science.gov (United States)

    Tevis, Sarah E.; Kennedy, Gregory D.; Kent, K. Craig

    2015-01-01

    Summary Satisfaction of patients with their health care is gaining importance as a measure of hospital quality due to public reporting of these values and an increasing connection between hospital reimbursement and scores on the current tool to measure satisfaction, the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. We found that high hospital and surgical volume and low rates of risk-adjusted mortality are associated with high patient satisfaction. However, other favorable patient outcomes are not consistently associated with positive satisfaction scores on HCAHPS. Contributors to patients' perceptions of their care are likely multifactorial and not related just to outcomes traditionally assessed by surgeons or hospitals. Moving in a direction of patient centered care, with a focus on increased understanding and involvement of patients in the care process, will likely strengthen the relationship between surgical outcomes and patient satisfaction. PMID:26299501

  20. Association of obesity with patient-reported outcomes in patients with axial spondyloarthritis: a cross-sectional study in an urban Asian population.

    Science.gov (United States)

    Lee, Yi Xuan; Kwan, Yu Heng; Png, Wan Yu; Lim, Ka Keat; Tan, Chuen Seng; Lui, Nai Lee; Chew, Eng Hui; Thumboo, Julian; Østbye, Truls; Fong, Warren

    2017-10-01

    To determine if obesity is associated with poorer patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA), we conducted a cross-sectional study using data of the PRESPOND registry from a tertiary referral center in Singapore between 2011 and 2015. Demographics, clinical, and PRO variables were collected. Patients were divided into three categories: normal (BMI < 23 kg/m 2 ), overweight (23 kg/m 2  ≤ BMI < 27.5 kg/m 2 ) and obese (BMI ≥ 27.5 kg/m 2 ), using Asian BMI classification. The dependent variables are Pain score, Bath Ankylosing Spondylitis Patient Global Score (BAS-G), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Health Assessment Questionnaire (HAQ), and Medical Outcomes Study Short Form 36 version 2 (SF-36). Multivariate regression analyses were performed with these dependent variables and obesity categories, adjusting for confounders. Among 194 patients with axSpA, 32% are overweight while 22% are obese. We found that obese patients had significant poorer pain (β: 11.87, 95%CI 2.13, 21.60) and BAS-G scores (β: 10.18, 95%CI 1.59, 18.76) when compared to normal BMI patients. However, obesity was not associated with BASDAI (β 0.50, 95%CI -0.22, 1.22), BASFI (β 0.08, 95%CI -0.66, 0.81), HAQ (β -0.07, 95%CI -0.21, 0.06), physical component summary (β -0.02, 95%CI -4.47, 4.44), and mental component summary (β -2.85, 95%CI -7.57, 1.88) of SF-36. Obesity was associated with pain score and BAS-G but not with BASDAI, BASFI, HAQ, and SF-36. Further study is needed to examine the causal relationship between obesity and poorer PROs.

  1. Capturing and missing the patient's story through outcome measures: A thematic comparison of patient-generated items in PSYCHLOPS with CORE-OM and PHQ-9.

    Science.gov (United States)

    Sales, Célia Md; Neves, Inês Td; Alves, Paula G; Ashworth, Mark

    2017-11-22

    There is increasing interest in individualized patient-reported outcome measures (I-PROMS), where patients themselves indicate the specific problems they want to address in therapy and these problems are used as items within the outcome measurement tool. This paper examined the extent to which 279 items reported in an I-PROM (PSYCHLOPS) added qualitative information which was not captured by two well-established outcome measures (CORE-OM and PHQ-9). Comparison of items was only conducted for patients scoring above the "caseness" threshold on the standardized measures. 107 patients were participating in therapy within addiction and general psychiatric clinical settings. Almost every patient (95%) reported at least one item whose content was not covered by PHQ-9, and 71% reported at least one item not covered by CORE-OM. Results demonstrate the relevance of individualized outcome assessment for capturing data describing the issues of greatest concern to patients, as nomothetic measures do not always seem to capture the whole story. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  2. Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

    Science.gov (United States)

    Milette, Katherine; Roseman, Michelle; Thombs, Brett D

    2011-03-01

    The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. Relative performance of commonly used physical function questionnaires in rheumatoid arthritis and a patient-reported outcomes measurement information system computerized adaptive test

    NARCIS (Netherlands)

    Oude Voshaar, Antonius H.; ten Klooster, Peter M.; Glas, Cornelis A.W.; Vonkeman, Harald Erwin; Krishnan, Eswar; van de Laar, Mart A F J

    2014-01-01

    OBJECTIVE: To evaluate and compare the measurement precision and sensitivity to change of the Health Assessment Questionnaire disability index (HAQ DI), the Short Form 36 physical functioning scale (PF-10), and simulated Patient-Reported Outcomes Measurement Information System (PROMIS) physical

  4. Retrospective study of the effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients

    Directory of Open Access Journals (Sweden)

    Yu Elaine

    2011-06-01

    Full Text Available Abstract Background This retrospective study evaluated the impact of disease progression and of specific sites of metastasis on patient reported outcomes (PROs that assess symptom burden and health related quality of life (HRQoL in women with metastatic breast cancer (mBC. Methods HER-2 negative mBC patients (n = 102 were enrolled from 7 U.S. community oncology practices. Demographic, disease and treatment characteristics were abstracted from electronic medical records and linked to archived Patient Care Monitor (PCM assessments. The PCM is a self-report measure of symptom burden and HRQoL administered as part of routine care in participating practices. Linear mixed models were used to examine change in PCM scores over time. Results Mean age was 57 years, with 72% of patients Caucasian, and 25% African American. Median time from mBC diagnosis to first disease progression was 8.8 months. Metastasis to bone (60%, lung (28% and liver (26% predominated at initial metastatic diagnosis. Results showed that PCM items assessing fatigue, physical pain and trouble sleeping were sensitive to either general effects of disease progression or to effects associated with specific sites of metastasis. Progression of disease was also associated with modest but significant worsening of General Physical Symptoms, Treatment Side Effects, Acute Distress and Impaired Performance index scores. In addition, there were marked detrimental effects of liver metastasis on Treatment Side Effects, and of brain metastasis on Acute Distress. Conclusions Disease progression has a detrimental impact on cancer-related symptoms. Delaying disease progression may have a positive impact on patients' HRQoL.

  5. Pregnancy outcome in patients with pityriasis rosea.

    Science.gov (United States)

    Drago, Francesco; Broccolo, Francesco; Zaccaria, Elisa; Malnati, Mauro; Cocuzza, Clementina; Lusso, Paolo; Rebora, Alfredo

    2008-05-01

    The effect of pityriasis rosea (PR) on the outcome of pregnancy has not been previously reported. We sought to investigate the possible impact of PR in pregnant women. In all, 38 women who developed PR during pregnancy were observed. In one of them, who developed PR at 10 weeks' gestation and aborted 2 weeks later, plasma, peripheral blood mononuclear cells, maternal skin, and placental and embryonic tissues were studied by quantitative calibrated real-time polymerase chain reaction for human herpesviruses (HHV)-6 and -7. Controls included plasma from 36 healthy blood donors, plasma and paraffin-embedded tissue sections from 12 patients with other dermatitides, and from placental and embryonic tissues from one woman who presented with a 19-week intrauterine fetal death. Of the 38 women, 9 had a premature delivery and 5 miscarried. In particular, 62% of the women who developed PR within 15 weeks' gestation aborted. Neonatal hypotonia, weak motility, and hyporeactivity were noted in 6 cases. In the patient studied in detail, HHV-6 DNA was detected in plasma, peripheral blood mononuclear cells, skin, and placenta and embryonic tissues, whereas HHV-7 DNA was absent. HHV-6 p41 antigen was detected by immunohistochemistry in skin lesions, placenta, and embryonic tissues. No herpesvirus DNA was detected in plasma and tissues from control subjects. This is a case series study with a small number of patients. PR may be associated with an active HHV-6 infection. In pregnancy, PR may foreshadow premature delivery with neonatal hypotonia and even fetal demise especially if it develops within 15 weeks' gestation.

  6. Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens

    DEFF Research Database (Denmark)

    Gniadecki, R; Robertson, David; Molta, C T

    2012-01-01

    the impact of skin disease on QoL; the Health Assessment Questionnaire-Disability Index (HAQ-DI), an assessment of physical function; the Hospital Anxiety and Depression Scale (HADS), which screens for anxiety and depression symptoms; and individual questions on general health, disease activity, fatigue......Background Moderate/severe psoriasis combined with psoriatic arthritis (PsA) impairs health-related quality of life (QoL). Etanercept, a fully human tumour necrosis factor-a receptor fusion protein, is approved for treatment of both diseases. Objective To compare patient-reported health outcomes...... additional weeks. PROs included: the EuroQOL-5D (EQ-5D), which measures general health status and consists of the utility index measuring five dimensions of health, and a visual analogue scale (VAS) allowing patients to assess health status; the Dermatology Life Quality Index (DLQI), which measures...

  7. Patient-reported outcomes and socioeconomic status as predictors of clinical outcomes following hematopoietic stem cell transplantation: A study from the BMT CTN 0902 trial

    Science.gov (United States)

    Knight, Jennifer M; Syrjala, Karen L; Majhail, Navneet S; Martens, Michael; Le-Rademacher, Jennifer; Logan, Brent R; Lee, Stephanie J; Jacobsen, Paul B; Wood, William A; Jim, Heather SL; Wingard, John R; Horowitz, Mary M; Abidi, Muneer H; Fei, Mingwei; Rawls, Laura; Rizzo, J Douglas

    2016-01-01

    This secondary analysis of a large, multi-center Blood and Marrow Transplant Clinical Trials Network (BMT CTN) randomized trial assessed whether patient-reported outcomes (PROs) and socioeconomic status (SES) before hematopoietic stem cell transplantation (HCT) are associated with each other and predictive of clinical outcomes including time to hematopoietic recovery, acute graft-versus-host disease, hospitalization days, and overall survival (OS) among 646 allogeneic and autologous HCT recipients. Pre-transplant Cancer and Treatment Distress (CTXD), Pittsburgh Sleep Quality Index (PSQI), and mental and physical component scores (MCS and PCS) of the SF-36 were correlated with each other and with SES variables. PROs and SES variables were further evaluated as predictors of clinical outcomes, with the PSQI and CTXD evaluated as OS predictors (pincome was related to worse physical functioning (p=.005) and increased distress (p=.008); lack of employment pre-transplant was associated with worse physical functioning (p<.01); unmarried status was associated with worse sleep (p=.003). In this large heterogeneous cohort of HCT recipients, while PROs and SES variables were correlated at baseline, they were not associated with any clinical outcomes. Future research should focus on HCT recipients at greater psychosocial disadvantage. PMID:27565521

  8. WBRT vs. APBI: an interim report of patient satisfaction and outcomes

    Directory of Open Access Journals (Sweden)

    Samantha M. Bitter

    2016-02-01

    Full Text Available Purpose : To determine differences in patient’s reported quality of life and self-reported breast cosmesis between whole breast radiation therapy (WBRT and accelerated partial breast irradiation (APBI via single and multi-lumen high-dose-rate (HDR brachytherapy for women with early stage breast cancer. Material and methods: Patient information was retrospectively reviewed and survey data were prospectively collected for women treated between 2004 to 2014 (APBI and 2012 to 2014 (WBRT. Criteria for APBI treatments were ER+ (after 2010, N0 (after 2010, T 0.05. Conclusions : APBI treated patients reported higher cosmetic satisfaction than patients in the matched WBRT cohort. Quality of life scores tended to improve over time. Multi-lumen catheters provided superior cosmetic results compared to single-lumen catheters.

  9. Perceived Social Isolation and Outcomes in Patients With Heart Failure.

    Science.gov (United States)

    Manemann, Sheila M; Chamberlain, Alanna M; Roger, Véronique L; Griffin, Joan M; Boyd, Cynthia M; Cudjoe, Thomas K M; Jensen, Daniel; Weston, Susan A; Fabbri, Matteo; Jiang, Ruoxiang; Finney Rutten, Lila J

    2018-05-23

    Perceived social isolation has been shown to have a negative impact on health outcomes, particularly among older adults. However, these relationships have not been fully examined among patients with heart failure. Residents from 11 southeast Minnesota counties with a first-ever International Classification of Diseases, Ninth Revision ( ICD-9 ) code 428 for heart failure between January 1, 2013, and March 31, 2015 (N=3867), were prospectively surveyed to measure perceived social isolation. A total of 2003 patients returned the survey (response rate, 52%); 1681 patients completed all questions and were retained for analysis. Among these patients (53% men; mean age, 73 years), ≈19% (n=312) had moderate perceived social isolation and 6% (n=108) had high perceived social isolation. After adjustment, patients reporting moderate perceived social isolation did not have an increased risk of death, hospitalizations, or emergency department visits compared with patients reporting low perceived social isolation; however, patients reporting high perceived social isolation had >3.5 times increased risk of death (hazard ratio, 3.74; 95% confidence interval [CI], 1.82-7.70), 68% increased risk of hospitalization (hazard ratio, 1.68; 95% CI, 1.18-2.39), and 57% increased risk of emergency department visits (hazard ratio, 1.57; 95% CI, 1.09-2.27). Compared with patients who self-reported low perceived social isolation, patients reporting moderate perceived social isolation had a 16% increased risk of outpatient visits (rate ratio, 1.16; 95% CI, 1.03-1.31), whereas those reporting high perceived social isolation had a 26% increased risk (rate ratio, 1.26; 95% CI, 1.04-1.53). In patients with heart failure, greater perceived social isolation is associated with an increased risk of death and healthcare use. Assessing perceived social isolation during the clinical encounter with a brief screening tool may help identify patients with heart failure at greater risk of poor outcomes.

  10. Validation study of the Forgotten Joint Score-12 as a universal patient-reported outcome measure.

    Science.gov (United States)

    Matsumoto, Mikio; Baba, Tomonori; Homma, Yasuhiro; Kobayashi, Hideo; Ochi, Hironori; Yuasa, Takahito; Behrend, Henrik; Kaneko, Kazuo

    2015-10-01

    The Forgotten Joint Score-12 (FJS-12) is for patients to forget their artificial joint and is reportedly a useful patient-reported outcome tool for artificial joints. The purpose of this study was to determine whether the FJS-12 is as useful as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) or the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) in Japan. All patients who visited our hospital's hip joint specialists following unilateral THA from August 2013 to July 2014 were evaluated. Medical staff members other than physicians administered three questionnaires. Items evaluated were (1) the reliability of the FJS-12 and (2) correlations between the FJS-12 and the total and subscale scores of the WOMAC or JHEQ. Of 130 patients, 22 were excluded. Cronbach's α coefficient was 0.97 for the FJS-12. The FJS-12 showed a significantly lower score than the WOMAC or JHEQ (p < 0.01). The FJS-12 was moderately correlated with the total WOMAC score (r = 0.522) and its subscale scores for "stiffness" (r = 0.401) and "function" (r = 0.539) and was weakly correlated with the score for "pain" (r = 0.289). The FJS-12 was favorably correlated with the total JHEQ score (r = 0.686) and its subscale scores (r = 0.530-0.643). The FJS-12 was correlated with and showed reliability similar to that of the JHEQ and WOMAC. The FJS-12, which is not affected by culture or lifestyle, may be useful in Japan.

  11. Introducing the Body-QoL®: A New Patient-Reported Outcome Instrument for Measuring Body Satisfaction-Related Quality of Life in Aesthetic and Post-bariatric Body Contouring Patients.

    Science.gov (United States)

    Danilla, Stefan; Cuevas, Pedro; Aedo, Sócrates; Dominguez, Carlos; Jara, Rocío; Calderón, María E; Al-Himdani, Sarah; Rios, Marco A; Taladriz, Cristián; Rodriguez, Diego; Gonzalez, Rolando; Lazo, Ángel; Erazo, Cristián; Benitez, Susana; Andrades, Patricio; Sepúlveda, Sergio

    2016-02-01

    To develop a new patient-reported outcome instrument (PRO) to measure body-related satisfaction quality of life (QoL). Standard 3-phase PRO design was followed; in the first phase, a qualitative design was used in 45 patients to develop a conceptual framework and to create preliminary scale domains and items. In phase 2, large-scale population testing on 1340 subjects was performed to reduce items and domains. In phase 3, final testing of the developed instrument on 34 patients was performed. Statistics used include Factor, RASCH, and multivariate regression analysis. Psychometric properties measured were internal reliability, item-rest, item-test, and test-retest correlations. The PRO-developed instrument is composed of four domains (satisfaction with the abdomen, sex life, self-esteem and social life, and physical symptoms) and 20 items in total. The score can range from 20 (worst) to 100 (best). Responsiveness was 100 %, internal reliability 93.3 %, and test-retest concordance 97.7 %. Body image-related QoL was superior in men than women (p instrument (p measured reliably with the Body-QoL instrument. It can be used to quantify the improvement in cosmetic and post-bariatric patients including non- or minimally invasive procedures, suction assisted lipectomy, abdominoplasty, lipoabdominoplasty, and lower body lift and to give an evidence-based approach to standard practice. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

  12. Defining a core outcome set for adolescent and young adult patients with a spinal deformity.

    Science.gov (United States)

    de Kleuver, Marinus; Faraj, Sayf S A; Holewijn, Roderick M; Germscheid, Niccole M; Adobor, Raphael D; Andersen, Mikkel; Tropp, Hans; Dahl, Benny; Keskinen, Heli; Olai, Anders; Polly, David W; van Hooff, Miranda L; Haanstra, Tsjitske M

    2017-12-01

    Background and purpose - Routine outcome measurement has been shown to improve performance in several fields of healthcare. National spine surgery registries have been initiated in 5 Nordic countries. However, there is no agreement on which outcomes are essential to measure for adolescent and young adult patients with a spinal deformity. The aim of this study was to develop a core outcome set (COS) that will facilitate benchmarking within and between the 5 countries of the Nordic Spinal Deformity Society (NSDS) and other registries worldwide. Material and methods - From August 2015 to September 2016, 7 representatives (panelists) of the national spinal surgery registries from each of the NSDS countries participated in a modified Delphi study. With a systematic literature review as a basis and the International Classification of Functioning, Disability and Health framework as guidance, 4 consensus rounds were held. Consensus was defined as agreement between at least 5 of the 7 representatives. Data were analyzed qualitatively and quantitatively. Results - Consensus was reached on the inclusion of 13 core outcome domains: "satisfaction with overall outcome of surgery", "satisfaction with cosmetic result of surgery", "pain interference", physical functioning", "health-related quality of life", "recreation and leisure", "pulmonary fatigue", "change in deformity", "self-image", "pain intensity", "physical function", "complications", and "re-operation". Panelists agreed that the SRS-22r, EQ-5D, and a pulmonary fatigue questionnaire (yet to be developed) are the most appropriate set of patient-reported measurement instruments that cover these outcome domains. Interpretation - We have identified a COS for a large subgroup of spinal deformity patients for implementation and validation in the NSDS countries. This is the first study to further develop a COS in a global perspective.

  13. Developing a proxy version of the Adult social care outcome toolkit (ASCOT).

    Science.gov (United States)

    Rand, Stacey; Caiels, James; Collins, Grace; Forder, Julien

    2017-05-19

    Social care-related quality of life is a key outcome indicator used in the evaluation of social care interventions and policy. It is not, however, always possible to collect quality of life data by self-report even with adaptations for people with cognitive or communication impairments. A new proxy-report version of the Adult Social Care Outcomes Toolkit (ASCOT) measure of social care-related quality of life was developed to address the issues of wider inclusion of people with cognitive or communication difficulties who may otherwise be systematically excluded. The development of the proxy-report ASCOT questionnaire was informed by literature review and earlier work that identified the key issues and challenges associated with proxy-reported outcomes. To evaluate the acceptability and content validity of the ASCOT-Proxy, qualitative cognitive interviews were conducted with unpaid carers or care workers of people with cognitive or communication impairments. The proxy respondents were invited to 'think aloud' while completing the questionnaire. Follow-up probes were asked to elicit further detail of the respondent's comprehension of the format, layout and content of each item and also how they weighed up the options to formulate a response. A total of 25 unpaid carers and care workers participated in three iterative rounds of cognitive interviews. The findings indicate that the items were well-understood and the concepts were consistent with the item definitions for the standard self-completion version of ASCOT with minor modifications to the draft ASCOT-Proxy. The ASCOT-Proxy allows respondents to rate the proxy-proxy and proxy-patient perspectives, which improved the acceptability of proxy report. A new proxy-report version of ASCOT was developed with evidence of its qualitative content validity and acceptability. The ASCOT-Proxy is ready for empirical testing of its suitability for data collection as a self-completion and/or interview questionnaire, and also

  14. Outcome and quality of life of patients with acute kidney injury after major surgery.

    Science.gov (United States)

    Abelha, F J; Botelho, M; Fernandes, V; Barros, H

    2009-01-01

    In postoperative critically-ill patients who develop Acute Kidney Injury (AKI) it is important to focus on survival and quality of life beyond hospital discharge. The aim of the study was to evaluate outcome and quality of life in patients that develop AKI after major surgery. This retrospective study was carried out in a Post-Anaesthesia Care Unit with five intensive care beds during 2 years. Patients were followed for the development of AKI. Preoperative characteristics, intra-operative management and outcome were evaluated. Six months after discharge, these patients were contacted to complete a Short Form-36 questionnaire (SF-36) and to have their dependency in ADL evaluated. Chi-square or Fischer's exact test were used to compare proportions between groups. A "t test" and a paired "t test" for independent groups was used for comparisons. Of 1584 patients admitted to the PACU, 1200 patients met the inclusion criteria. One hundred-fourteen patients (9.6%) met AKI criteria. Patients with AKI were more severely ill, stayed longer at the PACU. Among 71 hospital survivors at 6 months follow-up, 50 completed the questionnaires. Fifty-two percent of patients reported that their general level of health was better on the day they answered the questionnaire than 12 months earlier. Patients that met AKI criteria after surgery had worse SF-36 scores for physical function, role physical and role emotional domains. Six months after PACU discharge, patients that met AKI criteria were more dependent in I-ADL but not in P-ADL. Patients that develop AKI improved self-perception of quality of life despite having high rate of dependency in ADL tasks. For physical function and role physical domains they had worse scores than PACU patients that did not develop AKI.

  15. Protocol-developing meta-ethnography reporting guidelines (eMERGe).

    Science.gov (United States)

    France, E F; Ring, N; Noyes, J; Maxwell, M; Jepson, R; Duncan, E; Turley, R; Jones, D; Uny, I

    2015-11-25

    , is now used widely in other disciplines. Methodological advances relevant to meta-ethnography conduct exist. The extent of discipline-specific adaptations of meta-ethnography and the fit of any adaptions with the underpinning philosophy of meta-ethnography require investigation. Well-reported meta-ethnography findings could inform clinical decision-making. A bespoke meta-ethnography reporting guideline is needed to improve reporting quality, but to be effective potential users must know it exists, trust it and use it. Therefore, a rigorous study has been designed to develop and promote a guideline. By raising reporting quality, the guideline will maximise the likelihood that high-quality meta-ethnographies will contribute robust evidence to improve health care and patient outcomes.

  16. Reporting combined outcomes with Trifecta and survival, continence, and potency (SCP) classification in 337 patients with prostate cancer treated with image-guided hypofractionated radiotherapy.

    Science.gov (United States)

    Jereczek-Fossa, Barbara A; Zerini, Dario; Fodor, Cristiana; Santoro, Luigi; Maucieri, Andrea; Gerardi, Marianna A; Vischioni, Barbara; Cambria, Raffaella; Garibaldi, Cristina; Cattani, Federica; Vavassori, Andrea; Matei, Deliu V; Musi, Gennaro; De Cobelli, Ottavio; Orecchia, Roberto

    2014-12-01

    To report the image-guided hypofractionated radiotherapy (hypo-IGRT) outcome for patients with localised prostate cancer according to the new outcome models Trifecta (cancer control, urinary continence, and sexual potency) and SCP (failure-free survival, continence and potency). Between August 2006 and January 2011, 337 patients with cT1-T2N0M0 prostate cancer (median age 73 years) were eligible for a prospective longitudinal study on hypo-IGRT (70.2 Gy/26 fractions) in our Department. Patients completed four questionnaires before treatment, and during follow-up: the International Index of Erectile Function-5 (IIEF-5), the International Prostate Symptom Score (IPSS), and the European Organization for Research and Treatment of Cancer prostate-cancer-specific Quality of Life Questionnaires (QLQ) QLQ-PR25 and QLQ-C30. Baseline and follow-up patient data were analysed according to the Trifecta and SCP outcome models. Cancer control, continence and potency were defined respectively as no evidence of disease, score 1 or 2 for item 36 of the QLQ-PR25 questionnaire, and total score of >16 on the IIEF-5 questionnaire. Patients receiving androgen-deprivation therapy (ADT) at any time were excluded. Trifecta criteria at baseline were met in 72 patients (42% of all ADT-free patients with completed questionnaires). Both at 12 and 24 months after hypo-IGRT, 57% of the Trifecta patients at baseline were still meeting the Trifecta criteria (both oncological and functional success according to the SCP model). The main reason for failing the Trifecta criteria during follow-up was erectile dysfunction: in 18 patients after 6 months follow-up, in 12 patients after 12 months follow-up, and in eight patients after 24 months. Actuarial 2-year Trifecta failure-free survival rate was 44% (95% confidence interval 27-60%). In multivariate analysis no predictors of Trifecta failure were identified. Missing questionnaires was the main limitation of the study. The Trifecta and SCP

  17. Developing a tool to measure pharmacoeconomic outcomes of post-surgical pain management interventions.

    Science.gov (United States)

    Keller, Deborah S; Smalarz, Amy; Haas, Eric M

    2016-01-01

    Financial pressures have limited the ability of providers to use medication that may improve clinical outcomes and patient satisfaction. New interventions are often fraught with resistance from individual cost centers. A value realization tool (VRT) is essential for separate cost centers to communicate and comprehend the overall financial and clinical implications of post-surgical pain management medication interventions (PSMI). The goal was to describe development of a VRT. An evaluation of common in-patient PSMI approaches, impacts, and costs was performed. A multidisciplinary task force guided development of the VRT to ensure appropriate representation and relevance to clinical practice. The main outcome was an Excel-based tool that communicates the overall cost/benefit of PSMI for the post-operative patient encounter. The VRT aggregated input data on costs, clinical impact, and nursing burden of PSMI assessment and monitoring into two high-level outcome reports: Overall Cost Impact and Nurse & Patient Impact. Costs included PSMI specific medication, equipment, professional placement, labor, overall/opioid-related adverse events, re-admissions, and length of stay. Nursing impact included level of practice interference, job satisfaction, and patient care metrics. Patient impact included pain scores, opioid use, PACU time, and satisfaction. Reference data was provided for individual institutions that may not collect all variables included in the VRT. The VRT is a valuable way for administrators to assess PSMI cost/benefits and for individual cost centers to see the overall value of individual interventions. The user-friendly, decision-support tool allows the end-user to use built-in referenced or personalized outcome data, increasing relevance to their institutions. This broad picture could facilitate communication across cost centers and evidence-based decisions for appropriate use and impacts of PSMI.

  18. Do Patient-Reported Outcome Measures describe functioning in patients with low back pain, using the Brief International Classification of Functioning, Disability and Health Core Set as a reference?

    DEFF Research Database (Denmark)

    Ibsen, Charlotte; Schiøttz-Christensen, Berit; Melchiorsen, Hanne

    2016-01-01

    OBJECTIVE: To link the items in the Patient-Reported Outcome Measures (PROMs): Roland Morris Disability Questionnaire, Short Form 36 (SF-36) and pain scores, to the Brief International Classification of Functioning, Disability and Health (ICF) Core Set for low back pain, and to examine the extent...... Set (34%). A weak correlation was found between the patients' responses and the clinician's assessment. CONCLUSION: The selected PROMs do not cover the prototypical spectrum of problems encountered in patients with low back pain as defined by the Brief ICF Core Set. The clinical assessment of patients...

  19. Relationship between hospital financial performance and publicly reported outcomes.

    Science.gov (United States)

    Nguyen, Oanh Kieu; Halm, Ethan A; Makam, Anil N

    2016-07-01

    Hospitals that have robust financial performance may have improved publicly reported outcomes. To assess the relationship between hospital financial performance and publicly reported outcomes of care, and to assess whether improved outcome metrics affect subsequent hospital financial performance. Observational cohort study. Hospital financial data from the Office of Statewide Health Planning and Development in California in 2008 and 2012 were linked to data from the Centers for Medicare and Medicaid Services Hospital Compare website. Hospital financial performance was measured by net revenue by operations, operating margin, and total margin. Outcomes were 30-day risk-standardized mortality and readmission rates for acute myocardial infarction (AMI), congestive heart failure (CHF), and pneumonia (PNA). Among 279 hospitals, there was no consistent relationship between measures of financial performance in 2008 and publicly reported outcomes from 2008 to 2011 for AMI and PNA. However, improved hospital financial performance (by any of the 3 measures) was associated with a modest increase in CHF mortality rates (ie, 0.26% increase in CHF mortality rate for every 10% increase in operating margin [95% confidence interval: 0.07%-0.45%]). Conversely, there were no significant associations between outcomes from 2008 to 2011 and subsequent financial performance in 2012 (P > 0.05 for all). Robust financial performance is not associated with improved publicly reported outcomes for AMI, CHF, and PNA. Financial incentives in addition to public reporting, such as readmissions penalties, may help motivate hospitals with robust financial performance to further improve publicly reported outcomes. Reassuringly, improved mortality and readmission rates do not necessarily lead to loss of revenue. Journal of Hospital Medicine 2016;11:481-488. © 2016 Society of Hospital Medicine. © 2016 Society of Hospital Medicine.

  20. Direct repair surgery with screw fixation for young patients with lumbar spondylolysis: patient-reported outcomes and fusion rate in a prospective interventional study.

    Science.gov (United States)

    Lee, Gun Woo; Lee, Sun-Mi; Suh, Bo-Gun

    2015-02-15

    Prospective interventional study. To thoroughly investigate the therapeutic outcomes of direct repair (DR) for young patients with lumbar spondylolysis. DR surgery with screw fixation for a pars defect of lumbar spondylolysis is considered a notable surgical option. However, prior studies do not provide clear information on the significance of DR and its outcomes in young patients with lumbar spondylolysis because most previous studies in this area were conducted with spondylolysis patients of all ages and with low-quality study designs that were retrospective in design and had a small sample size and short follow-up time. A total of 47 young patients with lumbar spine spondylolysis who were surgically treated with DR surgery and followed up for 1 year after surgery were enrolled in this study. The primary outcome was degree of pain assessed by visual analogue scale, which separately recorded pain intensity and pain frequency. Secondary outcomes included (1) patient satisfaction, (2) clinical outcomes based on Oswestry Disability Index score and a 12-item short form health survey, (3) fusion rate of pars defect based on computed tomographic scans, and (4) surgery-related complications. The degree of lower back pain (intensity and frequency) significantly improved at final follow-up compared with preoperative level. However, 6 patients (13%) had no significant improvement, and pain frequency tended to worsen 6 months after the operation. Only 25 patients (53%) were satisfied with DR surgery. One-year postoperative clinical outcomes (Oswestry Disability Index and 12-item short form health survey) significantly improved compared with preoperative levels, but the 2 scores also tended to decrease after 6 months. The union rate of the pars defect was 55% (26/47). There was no significant difference in clinical outcomes between fusion group and nonunion group of the pars defect at the final follow-up. Two patients (4%) experienced surgery-related complications. The