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

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

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...

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

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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.

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

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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

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

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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.

Patient outcomes in simulation-based medical education: a systematic review.

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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

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

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

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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.

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

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

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...

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.

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

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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

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.

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

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....

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.

Outcomes-Based Funding and Stakeholder Engagement. Lumina Issue Papers

Science.gov (United States)

Kadlec, Alison; Shelton, Susan

2015-01-01

This paper examines the key aspects of stakeholder engagement that can strengthen the design, implementation and sustainability of outcomes-based funding policies. We seek to help policymakers understand the prevailing starting-point attitudes of institutional stakeholders, primarily college and university administrators, faculty and staff, and…

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 ...

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.

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.

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

healthy children and those with chronic health conditions; (3) Past research in communication disorders indicates that voice and speech disorders may impact quality of life in children; (4) Based on preliminary data, electronic collection of patient reported outcomes in children with and without speech/voice disorders is more efficient and equally feasible, reliable, and acceptable when compared to paper forms. Copyright © 2011 Elsevier Inc. All rights reserved.

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.

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.

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.

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.

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.

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.

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.

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.

Quality of data entry using single entry, double entry and automated forms processing--an example based on a study of patient-reported outcomes

DEFF Research Database (Denmark)

Paulsen, Aksel; Overgaard, Søren; Lauritsen, Jens Martin

2012-01-01

The clinical and scientific usage of patient-reported outcome measures is increasing in the health services. Often paper forms are used. Manual double entry of data is defined as the definitive gold standard for transferring data to an electronic format, but the process is laborious. Automated...

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.

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.

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.

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...

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...

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...

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.

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...

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.

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

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 .

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.

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...

Six habits to enhance MET performance under stress: A discussion paper reviewing team mechanisms for improved patient outcomes.

Science.gov (United States)

Fein, Erich C; Mackie, Benjamin; Chernyak-Hai, Lily; O'Quinn, C Richard V; Ahmed, Ezaz

2016-05-01

Effective team decision making has the potential to improve the quality of health care outcomes. Medical Emergency Teams (METs), a specific type of team led by either critical care nurses or physicians, must respond to and improve the outcomes of deteriorating patients. METs routinely make decisions under conditions of uncertainty and suboptimal care outcomes still occur. In response, the development and use of Shared Mental Models (SMMs), which have been shown to promote higher team performance under stress, may enhance patient outcomes. This discussion paper specifically focuses on the development and use of SMMs in the context of METs. Within this process, the psychological mechanisms promoting enhanced team performance are examined and the utility of this model is discussed through the narrative of six habits applied to MET interactions. A two stage, reciprocal model of both nonanalytic decision making within the acute care environment and analytic decision making during reflective action learning was developed. These habits are explored within the context of a MET, illustrating how applying SMMs and action learning processes may enhance team-based problem solving under stress. Based on this model, we make recommendations to enhance MET decision making under stress. It is suggested that the corresponding habits embedded within this model could be imparted to MET members and tested by health care researchers to assess the efficacy of this integrated decision making approach in respect to enhanced team performance and patient outcomes. Copyright © 2015. Published by Elsevier Ltd.

The use of an iPad to collect patient-reported functional outcome measures in hand surgery.

Science.gov (United States)

Yaffe, Mark; Goyal, Nitin; Kokmeyer, Daniel; Merrell, Gregory A

2015-09-01

The purpose of this study was to evaluate (1) patient preferences regarding iPad and paper-based questionnaires, (2) the efficacy of iPad and paper questionnaires in a hand surgery practice, (3) the influence of questionnaire length on patient preferences and data collection, and (4) patient characteristics associated with a preference for iPad-based questionnaires. Two hundred total patients in a single hand surgery practice were randomly assigned to one of four groups. Each group completed either the Michigan Hand Questionnaire (MHQ) or QuickDASH (QD) using either an iPad or pen and paper. Patient preferences, questionnaire completion and timing, and demographic data were analyzed. The use of an iPad was associated with a statistically stronger preference for the same delivery format in the future compared to paper for the MHQ (93.9 vs 52.1 %, p iPad group found the survey "physically easy" more often compared to the MHQ paper group, while no difference was found among QD groups. Questionnaire timing between iPad and paper groups was similar for the MHQ but statistically longer with the iPad for QD. A significantly higher proportion of patients who preferred the iPad were under the age of 50 compared to those who preferred paper. The addition of an iPad is an efficient and preferable questionnaire format for functional outcome assessment in a hand and upper extremity surgery practice setting. The iPad is particularly preferable for longer outcome questionnaires and for patients under the age of 50.

Diarrhea-predominant irritable bowel syndrome: creation of an electronic version of a patient-reported outcome instrument by conversion from a pen-and-paper version and evaluation of their equivalence

Directory of Open Access Journals (Sweden)

Delgado-Herrera L

2017-07-01

Full Text Available Leticia Delgado-Herrera,1 Benjamin Banderas,2 Oluwafunke Ojo,2 Ritesh Kothari,3 Bernhardt Zeiher1 1Astellas Pharma Global Development, Inc., Northbrook, IL, 2Adelphi Values LLC, Boston, MA, 3ACCESS Medical LLC, Chicago, IL, USA Background: Subjects with diarrhea-predominant irritable bowel syndrome (IBS-D experience abdominal cramping, bloating, pressure, and pain. Due to an absence of clinical biomarkers for IBS-D severity, evaluation of clinical therapy benefits depends on valid and reliable symptom assessments. A patient-reported outcome (PRO instrument has been developed, comprising of two questionnaires – the IBS-D Daily Symptom Diary and IBS-D Symptom Event Log – suitable for clinical trials and real-world settings. This program aimed to support instrument conversion from pen-and-paper to electronic format.Materials and methods: Digital technology (Android/iOS and a traditional mode of administration study in the target population were used to migrate or convert the validated PRO IBS-D pen-and-paper measure to an electronic format. Equivalence interviews, conducted in three waves, each had three parts: 1 conceptual equivalence testing between formats, 2 electronic-version report-history cognitive debriefing, and 3 electronic version usability evaluation. After each interview wave, preliminary analyses were conducted and modifications made to the electronic version, before the next wave. Final revisions were based on a full analysis of equivalence interviews. The final analysis evaluated subjects’ ability to read, understand, and provide meaningful responses to the instruments across both formats. Responses were classified according to conceptual equivalence between formats and mobile-format usability assessed with a questionnaire and open-ended probes.Results: Equivalence interviews (n=25 demonstrated conceptual equivalence between formats. Mobile-application cognitive debriefing showed some subjects experienced difficulty with font

Improving Patient Satisfaction Through Computer-Based Questionnaires.

Science.gov (United States)

Smith, Matthew J; Reiter, Michael J; Crist, Brett D; Schultz, Loren G; Choma, Theodore J

2016-01-01

Patient-reported outcome measures are helping clinicians to use evidence-based medicine in decision making. The use of computer-based questionnaires to gather such data may offer advantages over traditional paper-based methods. These advantages include consistent presentation, prompts for missed questions, reliable scoring, and simple and accurate transfer of information into databases without manual data entry. The authors enrolled 308 patients over a 16-month period from 3 orthopedic clinics: spine, upper extremity, and trauma. Patients were randomized to complete either electronic or paper validated outcome forms during their first visit, and they completed the opposite modality at their second visit, which was approximately 7 weeks later. For patients with upper-extremity injuries, the Penn Shoulder Score (PSS) was used. For patients with lower-extremity injuries, the Foot Function Index (FFI) was used. For patients with lumbar spine symptoms, the Oswestry Disability Index (ODI) was used. All patients also were asked to complete the 36-Item Short Form Health Survey (SF-36) Health Status Survey, version 1. The authors assessed patient satisfaction with each survey modality and determined potential advantages and disadvantages for each. No statistically significant differences were found between the paper and electronic versions for patient-reported outcome data. However, patients strongly preferred the electronic surveys. Additionally, the paper forms had significantly more missed questions for the FFI (P<.0001), ODI (P<.0001), and PSS (P=.008), and patents were significantly less likely to complete these forms (P<.0001). Future research should focus on limiting the burden on responders, individualizing forms and questions as much as possible, and offering alternative environments for completion (home or mobile platforms). Copyright 2016, SLACK Incorporated.

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

ESR concept paper on value-based radiology.

Science.gov (United States)

2017-10-01

The European Society of Radiology (ESR) established a Working Group on Value-Based Imaging (VBI WG) in August 2016 in response to developments in European healthcare systems in general, and the trend within radiology to move from volume- to value-based practice in particular. The value-based healthcare (VBH) concept defines "value" as health outcomes achieved for patients relative to the costs of achieving them. Within this framework, value measurements start at the beginning of therapy; the whole diagnostic process is disregarded, and is considered only if it is the cause of errors or complications. Making the case for a new, multidisciplinary organisation of healthcare delivery centred on the patient, this paper establishes the diagnosis of disease as a first outcome in the interrelated activities of the healthcare chain. Metrics are proposed for measuring the quality of radiologists' diagnoses and the various ways in which radiologists provide value to patients, other medical specialists and healthcare systems at large. The ESR strongly believes value-based radiology (VBR) is a necessary complement to existing VBH concepts. The Society is determined to establish a holistic VBR programme to help European radiologists deal with changes in the evolution from volume- to value-based evaluation of radiological activities. Main Messages • Value-based healthcare defines value as patient's outcome over costs. • The VBH framework disregards the diagnosis as an outcome. • VBH considers diagnosis only if wrong or a cause of complications. • A correct diagnosis is the first outcome that matters to patients. • Metrics to measure radiologists' impacts on patient outcomes are key. • The value provided by radiology is multifaceted, going beyond exam volumes.

Lisfranc injuries: patient- and physician-based functional outcomes.

LENUS (Irish Health Repository)

O'Connor, P A

2012-02-03

The purpose of this study was to assess functional outcome of patients with a Lisfranc fracture dislocation of the foot by applying validated patient- and physician-based scoring systems and to compare these outcome tools. Of 25 injuries sustained by 24 patients treated in our institution between January 1995 and June 2001, 16 were available for review with a mean follow-up period of 36 (10-74) months. Injuries were classified according to Myerson. Outcome instruments used were: (a) Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), (b) Baltimore Painful Foot score (PFS) and (c) American Orthopedic Foot and Ankle Society (AOFAS) mid-foot scoring scale. Four patients had an excellent outcome on the PFS scale, seven were classified as good, three fair and two poor. There was a statistically significant correlation between the PFS and Role Physical (RP) element of the SF-36.

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....

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

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.

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....

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

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.

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

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

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...

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

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

Home exercise programmes supported by video and automated reminders compared with standard paper-based home exercise programmes in patients with stroke: a randomized controlled trial.

Science.gov (United States)

Emmerson, Kellie B; Harding, Katherine E; Taylor, Nicholas F

2017-08-01

To determine whether patients with stroke receiving rehabilitation for upper limb deficits using smart technology (video and reminder functions) demonstrate greater adherence to prescribed home exercise programmes and better functional outcomes when compared with traditional paper-based exercise prescription. Randomized controlled trial comparing upper limb home exercise programmes supported by video and automated reminders on smart technology, with standard paper-based home exercise programmes. A community rehabilitation programme within a large metropolitan health service. Patients with stroke with upper limb deficits, referred for outpatient rehabilitation. Participants were randomly assigned to the control (paper-based home exercise programme) or intervention group (home exercise programme filmed on an electronic tablet, with an automated reminder). Both groups completed their prescribed home exercise programme for four weeks. The primary outcome was adherence using a self-reported log book. Secondary outcomes were change in upper limb function and patient satisfaction. A total of 62 participants were allocated to the intervention ( n = 30) and control groups ( n = 32). There were no differences between the groups for measures of adherence (mean difference 2%, 95% CI -12 to 17) or change in the Wolf Motor Function Test log transformed time (mean difference 0.02 seconds, 95% CI -0.1 to 0.1). There were no between-group differences in how participants found instructions ( p = 0.452), whether they remembered to do their exercises ( p = 0.485), or whether they enjoyed doing their exercises ( p = 0.864). The use of smart technology was not superior to standard paper-based home exercise programmes for patients recovering from stroke. This trial design was registered prospectively with the Australian and New Zealand Clinical Trials Register, ID: ACTRN 12613000786796. http://www.anzctr.org.au/trialSearch.aspx.

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

Comparison of CTT and Rasch-based approaches for the analysis of longitudinal Patient Reported Outcomes.

Science.gov (United States)

Blanchin, Myriam; Hardouin, Jean-Benoit; Le Neel, Tanguy; Kubis, Gildas; Blanchard, Claire; Mirallié, Eric; Sébille, Véronique

2011-04-15

Health sciences frequently deal with Patient Reported Outcomes (PRO) data for the evaluation of concepts, in particular health-related quality of life, which cannot be directly measured and are often called latent variables. Two approaches are commonly used for the analysis of such data: Classical Test Theory (CTT) and Item Response Theory (IRT). Longitudinal data are often collected to analyze the evolution of an outcome over time. The most adequate strategy to analyze longitudinal latent variables, which can be either based on CTT or IRT models, remains to be identified. This strategy must take into account the latent characteristic of what PROs are intended to measure as well as the specificity of longitudinal designs. A simple and widely used IRT model is the Rasch model. The purpose of our study was to compare CTT and Rasch-based approaches to analyze longitudinal PRO data regarding type I error, power, and time effect estimation bias. Four methods were compared: the Score and Mixed models (SM) method based on the CTT approach, the Rasch and Mixed models (RM), the Plausible Values (PV), and the Longitudinal Rasch model (LRM) methods all based on the Rasch model. All methods have shown comparable results in terms of type I error, all close to 5 per cent. LRM and SM methods presented comparable power and unbiased time effect estimations, whereas RM and PV methods showed low power and biased time effect estimations. This suggests that RM and PV methods should be avoided to analyze longitudinal latent variables. Copyright © 2010 John Wiley & Sons, Ltd.

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

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.

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

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...

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

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

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...

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.

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

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...

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.

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

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....

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

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

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.

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

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...

A prospective study of the feasibility and acceptability of a Web-based, electronic patient-reported outcome system in assessing patient recovery after major gynecologic cancer surgery.

Science.gov (United States)

Andikyan, Vaagn; Rezk, Youssef; Einstein, M Heather; Gualtiere, Gina; Leitao, Mario M; Sonoda, Yukio; Abu-Rustum, Nadeem R; Barakat, Richard R; Basch, Ethan M; Chi, Dennis S

2012-11-01

The purposes of this study are to evaluate the feasibility of capturing patient-reported outcomes (PROs) electronically and to identify the most common distressing symptoms in women recovering from major gynecologic cancer surgery. This was a prospective, single-arm pilot study. Eligible participants included those scheduled for a laparotomy for presumed or known gynecologic malignancy. Patients completed a Web-based "STAR" (Symptom Tracking and Reporting for Patients) questionnaire once preoperatively and weekly during the 6-week postoperative period. The questionnaire consisted of the patient adaptation of the NCI CTCAE 3.0 and EORTC QLQ-C30 3.0. When a patient submitted a response that was concerning, an automated email alert was sent to the clinician. The patient's assessment of STAR's usefulness was measured via an exit survey. Forty-nine patients completed the study. The procedures included the following: hysterectomy±staging (67%), resection of tumor (22%), salpingo-oophorectomy (6%), and other (4%). Most patients (82%) completed at least 4 sessions in STAR. The CTC generated 43 alerts. These alerts resulted in 25 telephone contacts with patients, 2 ER referrals, one new appointment, and one pharmaceutical prescription. The 3 most common patient-reported symptoms generating an alert were as follows: poor performance status (19%), nausea (18%), and fatigue (17%). Most patients found STAR useful (80%) and would recommend it to others (85%). Application of a Web-based, electronic STAR system is feasible in the postoperative period, highly accepted by patients, and warrants further study. Poor performance status, nausea, and fatigue were the most common distressing patient-reported symptoms. Copyright © 2012 Elsevier Inc. All rights reserved.

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.

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

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.

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

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.

Science.gov (United States)

Arts, Lindy P J; van de Poll-Franse, Lonneke V; van den Berg, Sanne W; Prins, Judith B; Husson, Olga; Mols, Floortje; Brands-Nijenhuis, Angelique V M; Tick, Lidwine; Oerlemans, Simone

2017-04-28

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. Moreover, self-management interventions intend to enhance knowledge and skills and empower patients to better manage their disease and related problems. The objective of the Lymphoma InterVEntion (LIVE) trial is to examine whether feedback to patients on their PROs and access to a web-based, self-management intervention named Living with lymphoma will increase self-management skills and satisfaction with information, and reduce psychological distress. The LIVE randomised controlled trial consists of three arms: (1) standard care, (2) PRO feedback, and (3) PRO feedback and the Living with lymphoma intervention. Patients who have been diagnosed with Hodgkin lymphoma, non-Hodgkin lymphoma, including chronic lymphocytic leukaemia, as registered in the Netherlands Cancer Registry in various hospitals will be selected for participation. Patients are invited via their haemato-oncologist 6 to 15 months after diagnosis. The PRO feedback includes a graphical overview of patients' own symptom and functioning scores and an option to compare their scores with those of other patients with lymphoma and a normative population of the same age and sex. The Living with lymphoma intervention is based on cognitive behavioural therapy components and includes information, assignments, assessments, and videos. Changes in outcomes from baseline to 16 weeks, 12, and 24 months post intervention will be measured. Primary outcomes are self-management skills, satisfaction with information, and psychological distress. Secondary outcomes are health-related quality of life, illness perceptions, fatigue, and health care use. The results of the LIVE trial will provide novel insights into whether access to PRO feedback

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....

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....

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

Problem-based learning in internal medicine: virtual patients or paper-based problems?

Science.gov (United States)

Sobocan, Monika; Turk, Neja; Dinevski, Dejan; Hojs, Radovan; Pecovnik Balon, Breda

2017-01-01

Teaching using paper problem-based learning (p-PBL) sessions has left some students fatigued with the learning process. Therefore, attempts have been made to replace p-PBL with digitally enhanced, decision-making PBL in the form of virtual patients (VP). Student enthusiasm for substituting p-PBL with VP has not been quantitatively evaluated on the intended educational effects. To determine the educational effects of substituting p-PBL sessions with VP on undergraduate medical students in their internal medicine course. We conducted a randomised controlled study on 34 third-year undergraduate medical students in the academic year 2015-2016. Student performance after an intervention substituting p-PBL sessions with VP was analysed. The educational outcomes were measured with knowledge exams and the Diagnostic Thinking Inventory. There was no difference in exam performance between groups (P > 0.833) immediately after the intervention, or in long term. Nor was there a significant difference in improvement of diagnostic thinking between groups (P > 0.935 and P > 0.320). Our study showed no significant improvement in diagnostic thinking abilities or knowledge exam results with the use of VP. Educators can add VP to sessions to motivate students, but a significant improvement to educational outcome should not be expected. © 2016 Royal Australasian College of Physicians.

[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.

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...

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.

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.

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.

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.

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.

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.

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

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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.

Impact of Patient-centered eHealth Applications on Patient Outcomes: A Review on the Mediating Influence of Human Factor Issues.

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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.

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...

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

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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

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

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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.

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

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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.

Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

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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

Psychometric validation of patient-reported outcome measures assessing chronic constipation

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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

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

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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

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

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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.

Knowledge Representation in Patient Safety Reporting: An Ontological Approach

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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.

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

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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.

Case Study: Converting Paper-based Case Report Forms to an Electronic Format (e-CRF) with ACASI Self-Report Integration.

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Mierzwa, Stan; Souidi, Samir; Akello, Carolyne; Etima, Juliane; Ssebagala, Richard; Nolan, Monica; Kabwigu, Samuel; Nakablito, Clemensia

2017-01-01

This paper will discuss the integration of electronic Case Report Forms (e-CRFs) into an already existing Android-based Audio Computer-Assisted Self-Interview (ACASI) software solution that was developed for a public health project in Kampala, Uganda, the technical outcome results, and lessons learned that may be useful to other projects requiring or considering such a technology solution. The developed product can function without a connection to the Internet and allows for synchronizing collected data once connectivity is possible. Previously, only paper-based CRFs were utilized at the Uganda project site. A subset or select group of CRFs were targeted for integration with ACASI in order to test feasibility and success. Survey volume, error rate, and acceptance of the system, as well as the operational and technical design of the solution, will be discussed.

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...

Standards for Instrument Migration When Implementing Paper Patient-Reported Outcome Instruments Electronically: Recommendations from a Qualitative Synthesis of Cognitive Interview and Usability Studies.

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Muehlhausen, Willie; Byrom, Bill; Skerritt, Barbara; McCarthy, Marie; McDowell, Bryan; Sohn, Jeremy

2018-01-01

To synthesize the findings of cognitive interview and usability studies performed to assess the measurement equivalence of patient-reported outcome (PRO) instruments migrated from paper to electronic formats (ePRO), and make recommendations regarding future migration validation requirements and ePRO design best practice. We synthesized findings from all cognitive interview and usability studies performed by a contract research organization between 2012 and 2015: 53 studies comprising 68 unique instruments and 101 instrument evaluations. We summarized study findings to make recommendations for best practice and future validation requirements. Five studies (9%) identified minor findings during cognitive interview that may possibly affect instrument measurement properties. All findings could be addressed by application of ePRO best practice, such as eliminating scrolling, ensuring appropriate font size, ensuring suitable thickness of visual analogue scale lines, and providing suitable instructions. Similarly, regarding solution usability, 49 of the 53 studies (92%) recommended no changes in display clarity, navigation, operation, and completion without help. Reported usability findings could be eliminated by following good product design such as the size, location, and responsiveness of navigation buttons. With the benefit of accumulating evidence, it is possible to relax the need to routinely conduct cognitive interview and usability studies when implementing minor changes during instrument migration. Application of design best practice and selecting vendor solutions with good user interface and user experience properties that have been assessed in a representative group may enable many instrument migrations to be accepted without formal validation studies by instead conducting a structured expert screen review. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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

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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.

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

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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.

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

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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

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

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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

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

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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.

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...

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

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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.

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.

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

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

care professional behaviour. There was variation in behavioural outcomes depending on the skill being taught, and the learning approach utilised. No papers were identified that reported the effectiveness of an e-learning programme on patient outcomes. This review found insufficient evidence regarding the effectiveness of e-learning on healthcare professional behaviour or patient outcomes, consequently further research in this area is warranted. Future randomised controlled trials should adhere to the CONSORT reporting guidelines in order to improve the quality of reporting, to allow evaluation of the effectiveness of e-learning programmes on healthcare professional behaviour and patient outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

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.

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...

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.

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.

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...

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

Student learning outcomes associated with video vs. paper cases in a public health dentistry course.

Science.gov (United States)

Chi, Donald L; Pickrell, Jacqueline E; Riedy, Christine A

2014-01-01

Educational technologies such as video cases can improve health professions student learning outcomes, but few studies in dentistry have evaluated video-based technologies. The goal of this study was to compare outcomes associated with video and paper cases used in an introductory public health dentistry course. This was a retrospective cohort study with a historical control group. Based on dual coding theory, the authors tested the hypotheses that dental students who received a video case (n=37) would report better affective, cognitive, and overall learning outcomes than students who received a paper case (n=75). One-way ANOVA was used to test the hypotheses across ten cognitive, two affective, and one general assessment measures (α=0.05). Students in the video group reported a significantly higher overall mean effectiveness score than students in the paper group (4.2 and 3.3, respectively; p<0.001). Video cases were also associated with significantly higher mean scores across the remaining twelve measures and were effective in helping students achieve cognitive (e.g., facilitating good discussions, identifying public health problems, realizing how health disparities might impact their future role as dentists) and affective (e.g., empathizing with vulnerable individuals, appreciating how health disparities impact real people) goals. Compared to paper cases, video cases significantly improved cognitive, affective, and overall learning outcomes for dental students.

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

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.

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.

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.

A model-based correction for outcome reporting bias in meta-analysis.

Science.gov (United States)

Copas, John; Dwan, Kerry; Kirkham, Jamie; Williamson, Paula

2014-04-01

It is often suspected (or known) that outcomes published in medical trials are selectively reported. A systematic review for a particular outcome of interest can only include studies where that outcome was reported and so may omit, for example, a study that has considered several outcome measures but only reports those giving significant results. Using the methodology of the Outcome Reporting Bias (ORB) in Trials study of (Kirkham and others, 2010. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. British Medical Journal 340, c365), we suggest a likelihood-based model for estimating the effect of ORB on confidence intervals and p-values in meta-analysis. Correcting for bias has the effect of moving estimated treatment effects toward the null and hence more cautious assessments of significance. The bias can be very substantial, sometimes sufficient to completely overturn previous claims of significance. We re-analyze two contrasting examples, and derive a simple fixed effects approximation that can be used to give an initial estimate of the effect of ORB in practice.

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

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.

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.

Patient value: its nature, measurement, and role in real world evidence studies and outcomes-based reimbursement.

Science.gov (United States)

McKenna, Stephen P; Wilburn, Jeanette

2018-05-01

The assessment of "patient value" is fundamental to clinical trials, real world evidence studies, and outcomes-based reimbursement schemes. Measures of health-related quality-of-life (HRQoL) are widely used in health research. Such measures are effective in determining the presence or absence of symptoms and functional ability. However, HRQoL measures were not intended, nor designed, to determine the value to patients of alternative health states. Functions have no intrinsic value-they are a means to fulfil human needs. However, needs can be met in a variety of ways, for example by adopting different functions or by the provision of social services. It is possible to analyze all functions in terms of the needs they satisfy. A needs model has been applied in health research since the 1990s. It is concerned with the extent to which human needs are fulfilled in the presence of disease and its treatment. It is argued that this is the major concern of the patient. Needs-based measures are patient-centric and produce a valid unidimensional index of outcome. Consequently, they provide a direct means of measuring patient value. This approach provides the possibility of evaluating health services in terms of the value they provide to consumers and payers. It also has a role to play in real-world evidence studies and outcomes-based reimbursement. It is recommended that greater attention is given in future to the development of patient-reported outcome measures that provide direct assessments of patient value.

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...

PAEA Accreditation Task Force Briefing Paper: Moving Toward Profession-Defined, Outcomes-Based Accreditation.

Science.gov (United States)

Bondy, Mary Jo; Fletcher, Sara; Lane, Steven

2017-12-01

In anticipation of a revision to the Standards for Accreditation, the Phyisician Assistant Education Association (PAEA) charged a small task force to develop a strategy for engaging its members in the revision process. Rather than focusing on the current Standards, the task force members recommend a backward design approach to determine the desired outcomes of a successful revision to the Standards. Ultimately, the group believes that shifting to a profession-defined, outcomes-based model for accreditation will allow for greater innovation in physician assistant education and reduce the strain on programs facing resource limitations, particularly clinical site shortages. Task force members value accreditation and urge a paradigm shift in the Standards revision process to focus on meaningful educational outcomes that lead to enhanced program quality and patient safety.

Stakeholder Engagement in a Patient-Reported Outcomes (PRO) Measure Implementation: A Report from the SAFTINet Practice-based Research Network (PBRN).

Science.gov (United States)

Kwan, Bethany M; Sills, Marion R; Graham, Deborah; Hamer, Mika K; Fairclough, Diane L; Hammermeister, K E; Kaiser, Alicyn; de Jesus Diaz-Perez, Maria; Schilling, Lisa M

2016-01-01

Patient-reported outcome (PRO) measures offer value for clinicians and researchers, although priorities and value propositions can conflict. PRO implementation in clinical practice may benefit from stakeholder engagement methods to align research and clinical practice stakeholder perspectives. The objective is to demonstrate the use of stakeholder engagement in PRO implementation. Engaged stakeholders represented researchers and clinical practice representatives from the SAFTINet practice-based research network (PBRN). A stakeholder engagement process involving iterative analysis, deliberation, and decision making guided implementation of a medication adherence PRO measure (the Medication Adherence Survey [MAS]) for patients with hypertension and/or hyperlipidemia. Over 9 months, 40 of 45 practices (89%) implemented the MAS, collecting 3,247 surveys (mean = 72, median = 30, range: 0 - 416). Facilitators included: an electronic health record (EHR) with readily modifiable templates; existing staff, tools and workflows in which the MAS could be integrated (e.g., health risk appraisals, hypertension-specific visits, care coordinators); and engaged leadership and quality improvement teams. Stakeholder engagement appeared useful for promoting PRO measure implementation in clinical practice, in a way that met the needs of both researchers and clinical practice stakeholders. Limitations of this approach and opportunities for improving the PRO data collection infrastructure in PBRNs are discussed. © Copyright 2016 by the American Board of Family Medicine.

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.

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.

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.

Two-year outcome of team-based intensive case management for patients with schizophrenia.

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Aberg-Wistedt, A; Cressell, T; Lidberg, Y; Liljenberg, B; Osby, U

1995-12-01

Two-year outcomes of patients with schizophrenic disorders who were assigned to an intensive, team-based case management program and patients who received standard psychiatric services were assessed. The case management model featured increased staff contact time with patients, rehabilitation plans based on patients' expressed needs, and patients' attendance at team meetings where their rehabilitation plan was discussed. Forty patients were randomly assigned to either the case management group or the control group that received standard services. Patients' use of emergency and inpatient services, their quality of life, the size of their social networks, and their relatives' burden of care were assessed at assignment to the study groups and at two-year follow-up. Patients in the case management group had significantly fewer emergency visits compared with the two years before the study, and their relatives reported significantly reduced burden of care associated with relationships with psychiatric services over the two-year period. The size of patients' social networks increased for the case management group and decreased for the control group. A team-based intensive case management model is an effective intervention in the rehabilitation of patients with chronic schizophrenia.

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...

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

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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

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

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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

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

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...

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...

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

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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

Electronic versus paper-based assessment of health-related quality of life specific to HIV disease: reliability study of the PROQOL-HIV questionnaire.

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Duracinsky, Martin; Lalanne, Christophe; Goujard, Cécile; Herrmann, Susan; Cheung-Lung, Christian; Brosseau, Jean-Paul; Schwartz, Yannick; Chassany, Olivier

2014-04-25

Electronic patient-reported outcomes (PRO) provide quick and usually reliable assessments of patients' health-related quality of life (HRQL). An electronic version of the Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) questionnaire was developed, and its face validity and reliability were assessed using standard psychometric methods. A sample of 80 French outpatients (66% male, 52/79; mean age 46.7 years, SD 10.9) were recruited. Paper-based and electronic questionnaires were completed in a randomized crossover design (2-7 day interval). Biomedical data were collected. Questionnaire version and order effects were tested on full-scale scores in a 2-way ANOVA with patients as random effects. Test-retest reliability was evaluated using Pearson and intraclass correlation coefficients (ICC, with 95% confidence interval) for each dimension. Usability testing was carried out from patients' survey reports, specifically, general satisfaction, ease of completion, quality and clarity of user interface, and motivation to participate in follow-up PROQOL-HIV electronic assessments. Questionnaire version and administration order effects (N=59 complete cases) were not significant at the 5% level, and no interaction was found between these 2 factors (P=.94). Reliability indexes were acceptable, with Pearson correlations greater than .7 and ICCs ranging from .708 to .939; scores were not statistically different between the two versions. A total of 63 (79%) complete patients' survey reports were available, and 55% of patients (30/55) reported being satisfied and interested in electronic assessment of their HRQL in clinical follow-up. Individual ratings of PROQOL-HIV user interface (85%-100% of positive responses) confirmed user interface clarity and usability. The electronic PROQOL-HIV introduces minor modifications to the original paper-based version, following International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ePRO Task

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

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

International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies.

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Kyte, Derek; Reeve, Bryce B; Efficace, Fabio; Haywood, Kirstie; Mercieca-Bebber, Rebecca; King, Madeleine T; Norquist, Josephine M; Lenderking, William R; Snyder, Claire; Ring, Lena; Velikova, Galina; Calvert, Melanie

2016-02-01

In 2014, the European Medicines Agency (EMA) released for comment a draft reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. A twelve-member International Society for Quality of Life Research (ISOQOL) taskforce was convened to coordinate the ISOQOL response. Twenty-one ISOQOL members provided detailed comments and suggestions on the paper: 81 % from academia and 19 % from industry. Taskforce members consolidated and further refined these comments and shared the recommendations with the wider ISOQOL membership. A final response was submitted to the EMA in November 2014. The impending publication of the EMA reflection paper presents a valuable opportunity for ISOQOL to comment on the current direction of EMA PRO guidance and strategy. The EMA paper, although focused on cancer, could serve as a model for using PROs in other conditions, as it provides a useful update surrounding some of the design issues common to all trial research including PRO endpoints. However, we believe there are a number of additional areas in need of greater consideration. The purpose of this commentary is therefore to highlight the strengths of this timely and potentially useful document, but also to outline areas that may warrant further discussion.

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

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...

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.

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....

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

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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.

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.

Psychiatric comorbidity, red flag behaviors, and associated outcomes among office-based buprenorphine patients following Hurricane Sandy.

Science.gov (United States)

Williams, Arthur R; Tofighi, Babak; Rotrosen, John; Lee, Joshua D; Grossman, Ellie

2014-04-01

In October 2012, Bellevue Hospital Center (Bellevue) in New York City was temporarily closed as a result of Hurricane Sandy, the largest hurricane in US history. Bellevue's primary care office-based buprenorphine program was temporarily closed and later relocated to an affiliate public hospital. Previous research indicates that the relationships between disaster exposure, substance use patterns, psychiatric symptoms, and mental health services utilization is complex, with often conflicting findings regarding post-event outcomes (on the individual and community level) and antecedent risk factors. In general, increased use of tobacco, alcohol, and illicit drugs is associated with both greater disaster exposure and the development or exacerbation of other psychiatric symptoms and need for treatment. To date, there is limited published information regarding post-disaster outcomes among patients enrolled in office-based buprenorphine treatment, as the treatment modality has only been relatively approved recently. Patients enrolled in the buprenorphine program at the time of the storm were surveyed for self-reported buprenorphine adherence and illicit substance and alcohol use, as well as disaster-related personal consequences and psychiatric sequelae post-storm. Baseline demographic characteristics and insurance status were available from the medical record. Analysis was descriptive (counts and proportions) and qualitative, coding open-ended responses for emergent themes. There were 132 patients enrolled in the program at the time of the storm; of those, 91 were contacted and 89 completed the survey. Almost half of respondents reported disruption of their buprenorphine supply. Unexpectedly, patients with psychiatric comorbidity were no more likely to report increased use/relapse as a result. Rather, major risk factors associated with increased use or relapse post-storm were: (1) shorter length of time in treatment, (2) exposure to storm losses such as buprenorphine

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.

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

Avatar Web-Based Self-Report Survey System Technology for Public Health Research: Technical Outcome Results and Lessons Learned.

Science.gov (United States)

Savel, Craig; Mierzwa, Stan; Gorbach, Pamina M; Souidi, Samir; Lally, Michelle; Zimet, Gregory; Interventions, Aids

2016-01-01

This paper reports on a specific Web-based self-report data collection system that was developed for a public health research study in the United States. Our focus is on technical outcome results and lessons learned that may be useful to other projects requiring such a solution. The system was accessible from any device that had a browser that supported HTML5. Report findings include: which hardware devices, Web browsers, and operating systems were used; the rate of survey completion; and key considerations for employing Web-based surveys in a clinical trial setting.

[Reliability and validity of the Chinese version on Comprehensive Scores for Financial Toxicity based on the patient-reported outcome measures].

Science.gov (United States)

Yu, H H; Bi, X; Liu, Y Y

2017-08-10

Objective: To evaluate the reliability and validity of the Chinese version on comprehensive scores for financial toxicity (COST), based on the patient-reported outcome measures. Methods: A total of 118 cancer patients were face-to-face interviewed by well-trained investigators. Cronbach's α and Pearson correlation coefficient were used to evaluate reliability. Content validity index (CVI) and exploratory factor analysis (EFA) were used to evaluate the content validity and construct validity, respectively. Results: The Cronbach's α coefficient appeared as 0.889 for the whole questionnaire, with the results of test-retest were between 0.77 and 0.98. Scale-content validity index (S-CVI) appeared as 0.82, with item-content validity index (I-CVI) between 0.83 and 1.00. Two components were extracted from the Exploratory factor analysis, with cumulative rate as 68.04% and loading>0.60 on every item. Conclusion: The Chinese version of COST scale showed high reliability and good validity, thus can be applied to assess the financial situation in cancer patients.

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...

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

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

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

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...

Satisfactory patient-based outcomes after surgical treatment for idiopathic clubfoot: includes surgeon's individualized technique.

Science.gov (United States)

Mahan, Susan T; Spencer, Samantha A; Kasser, James R

2014-09-01

Treatment of idiopathic clubfoot has shifted towards Ponseti technique, but previously surgical management was standard. Outcomes of surgery have varied, with many authors reporting discouraging results. Our purpose was to evaluate a single surgeon's series of children with idiopathic clubfoot treated with a la carte posteromedial and lateral releases using the Pediatric Outcomes Data Collection Instrument (PODCI) with a minimum of 2-year follow-up. A total of 148 patients with idiopathic clubfoot treated surgically by a single surgeon over 15 years were identified, and mailed PODCI questionnaires. Fifty percent of the patients were located and responded, resulting in 74 complete questionnaires. Median age at surgery was 10 months (range, 5.3 to 84.7 mo), male sex 53/74 (71.6%), bilateral surgery 31/74 (41.9%), and average follow-up of 9.7 years. PODCI responses were compared with previously published normal healthy controls using t test for each separate category. Included in the methods is the individual surgeon's operative technique. In PODCIs where a parent reports for their child or adolescent, there was no difference between our data and the healthy controls in any of the 5 categories. In PODCI where an adolescent self-reports, there was no difference in 4 of 5 categories; significant difference was only found between our data (mean = 95.2; SD = 7.427) and normal controls (mean = 86.3; SD = 12.5) in Happiness Scale (P = 0.0031). In this group of idiopathic clubfoot patients, treated with judicious posteromedial release by a single surgeon, primarily when surgery was treatment of choice for clubfoot, patient-based outcomes are not different from their normal healthy peers through childhood and adolescence. While Ponseti treatment has since become the treatment of choice for clubfoot, surgical treatment, in some hands, has led to satisfactory results. Level III.

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.

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...

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

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

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

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...

Comparison of the outcome of burn patients using acute-phase plasma base deficit.

Science.gov (United States)

Salehi, S H; As'adi, K; Mousavi, J

2011-12-31

Background. In recent years, plasma base deficit has been used as a marker to determine the status of tissue perfusion in trauma patients and also to predict the outcome of these patients. This study was performed to investigate the effect of plasma base deficit in predicting burn patient outcome. Methods. This prospective cohort study was performed from October 2009 to October 2010 in the acute phase of burn patients who were admitted within 6 h post-injury to Motahari Burn Hospital in Iran. The patients were divided into two groups based on the plasma base deficit in the first 24 h post-injury: group A, in which the mean plasma base deficit was less than or equal to -6 (more negative), and group B, in which the mean plasma base deficit greater than -6. Statistical analysis was performed using SPSS v.16 software. Results. Thirty-eight patients were enrolled in each group. The mean plasma base deficit in group A (-7.76 ± 2.18 mmol) was significantly less than that in group B (-1.19 ± 2.82) mmol (p 0.05) and despite removal of interfering factors, there were significant differences between the systemic inflammatory response syndrome and the multiple organ dysfunction syndrome score and the percentage of sepsis between the two groups (p 0.05). Conclusion. The plasma base deficit can be used as a valuable marker in the resuscitation of burn patients, along with clinical criteria. Physiological indicators (burn percentage, age, and mucosal burns) are not sufficient to predict mortality and morbidity in burn patients, and it is necessary to investigate the role of biochemical markers such as base deficit in determining the final outcome of burn patients.

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

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

The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function

DEFF Research Database (Denmark)

Lohmann-Jensen, Rasmus; Holsgaard-Larsen, Anders; Emmeluth, Claus

2014-01-01

surgery. The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet. The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function (KOOS-ADL). The secondary aim is to compare post-surgery pain, function...... in sports and recreation, quality of life, and performance-based physical function. The explorative outcomes include; use of pain medication, single-fiber muscle damage, and changes in mechanical muscle function. The primary endpoint will be at 3-months following surgical treatment, and the time...... randomized clinical trial comparing the efficacy of tourniquet assisted TKA on patient-reported physical function supported by a range of performance-based secondary outcome measures. As such it will provide high quality evidence that may help determine whether tourniquet should be used in future TKA...

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

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.

Quality of nursing documentation: Paper-based health records versus electronic-based health records.

Science.gov (United States)

Akhu-Zaheya, Laila; Al-Maaitah, Rowaida; Bany Hani, Salam

2018-02-01

To assess and compare the quality of paper-based and electronic-based health records. The comparison examined three criteria: content, documentation process and structure. Nursing documentation is a significant indicator of the quality of patient care delivery. It can be either paper-based or organised within the system known as the electronic health records. Nursing documentation must be completed at the highest standards, to ensure the safety and quality of healthcare services. However, the evidence is not clear on which one of the two forms of documentation (paper-based versus electronic health records is more qualified. A retrospective, descriptive, comparative design was used to address the study's purposes. A convenient number of patients' records, from two public hospitals, were audited using the Cat-ch-Ing audit instrument. The sample size consisted of 434 records for both paper-based health records and electronic health records from medical and surgical wards. Electronic health records were better than paper-based health records in terms of process and structure. In terms of quantity and quality content, paper-based records were better than electronic health records. The study affirmed the poor quality of nursing documentation and lack of nurses' knowledge and skills in the nursing process and its application in both paper-based and electronic-based systems. Both forms of documentation revealed drawbacks in terms of content, process and structure. This study provided important information, which can guide policymakers and administrators in identifying effective strategies aimed at enhancing the quality of nursing documentation. Policies and actions to ensure quality nursing documentation at the national level should focus on improving nursing knowledge, competencies, practice in nursing process, enhancing the work environment and nursing workload, as well as strengthening the capacity building of nursing practice to improve the quality of nursing care and

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.

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

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.

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

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

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

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.

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

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

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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

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

'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO Data in Trials to Inform Clinical Practice. A Systematic Review.

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Angus G K McNair

Full Text Available The CONSORT extension for patient reported outcomes (PROs aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice.The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30% and 6 (16% combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14% and 1 (7% primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73% and 3 (20% achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2.It is recommended that single papers, with detailed PRO rationale and integrated PRO and

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

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

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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

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

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

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.

Psychometric evaluation of self-report outcome measures for prosthetic applications.

Science.gov (United States)

Hafner, Brian J; Morgan, Sara J; Askew, Robert L; Salem, Rana

2016-01-01

Documentation of clinical outcomes is increasingly expected in delivery of prosthetic services and devices. However, many outcome measures suitable for use in clinical care and research have not been psychometrically tested with prosthesis users. The aim of this study was to determine test-retest reliability, mode-of-administration (MoA) equivalence, standard error of measurement (SEM), and minimal detectable change (MDC) of standardized, self-report instruments that assess constructs of importance to people with lower limb loss. Prosthesis users (n = 201) were randomly assigned to groups based on MoA (i.e., paper, electronic, or mixed-mode). Participants completed two surveys 2 to 3 d apart. Instruments included the Prosthetic Limb Users Survey of Mobility, Prosthesis Evaluation Questionnaire-Mobility Subscale, Activities-Specific Balance Confidence Scale, Quality of Life in Neurological Conditions-Applied Cognition/General Concerns, Patient-Reported Outcomes Measurement Information System Profile, and Socket Comfort Score. Intraclass correlation coefficients indicated all instruments are appropriate for group-level comparisons and select instruments are suitable for individual-level applications. Several instruments showed evidence of possible floor and ceiling effects. All were equivalent across MoAs. SEM and MDC were quantified to facilitate interpretation of outcomes and change scores. These results can enhance clinicians' and researchers' ability to select, apply, and interpret scores from instruments administered to prosthesis users.

Teleophthalmology: improving patient outcomes?

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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

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

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.

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

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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

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...

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

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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

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

Real world heart failure epidemiology and outcome: A population-based analysis of 88,195 patients.

Science.gov (United States)

Farré, Núria; Vela, Emili; Clèries, Montse; Bustins, Montse; Cainzos-Achirica, Miguel; Enjuanes, Cristina; Moliner, Pedro; Ruiz, Sonia; Verdú-Rotellar, José María; Comín-Colet, Josep

2017-01-01

Heart failure (HF) is frequent and its prevalence is increasing. We aimed to evaluate the epidemiologic features of HF patients, the 1-year follow-up outcomes and the independent predictors of those outcomes at a population level. Population-based longitudinal study including all prevalent HF cases in Catalonia (Spain) on December 31st, 2012. Patients were divided in 3 groups: patients without a previous HF hospitalization, patients with a remote (>1 year) HF hospitalization and patients with a recent (population studied. Some comorbidity, an all-cause hospitalization or emergency department visit the previous year were associated with a worse outcome.

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

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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.

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...

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

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.

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

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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

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

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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.

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.

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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.

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

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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.

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.

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

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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.

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

Prevalence of swallowing and speech problems in daily life after chemoradiation for head and neck cancer based on cut-off scores of the patient-reported outcome measures SWAL-QOL and SHI.

Science.gov (United States)

Rinkel, Rico N; Verdonck-de Leeuw, Irma M; Doornaert, Patricia; Buter, Jan; de Bree, Remco; Langendijk, Johannes A; Aaronson, Neil K; Leemans, C René

2016-07-01

The objective of this study is to assess swallowing and speech outcome after chemoradiation therapy for head and neck cancer, based on the patient-reported outcome measures Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI), both provided with cut-off scores. This is a cross-sectional study. Department of Otolaryngology/Head and Neck Surgery of a University Medical Center. Sixty patients, 6 months to 5 years after chemoradiation for head and neck squamous cell carcinoma. Swallowing Quality of Life Questionnaire (SWAL-QOL) and SHI, both validated in Dutch and provided with cut-off scores. Associations were tested between the outcome measures and independent variables (age, gender, tumor stage and site, and radiotherapy technique, time since treatment, comorbidity and food intake). Fifty-two patients returned the SWAL-QOL and 47 the SHI (response rate 87 and 78 %, respectively). Swallowing and speech problems were present in 79 and 55 %, respectively. Normal food intake was noticed in 45, 35 % had a soft diet and 20 % tube feeding. Patients with soft diet and tube feeding reported more swallowing problems compared to patients with normal oral intake. Tumor subsite was significantly associated with swallowing outcome (less problems in larynx/hypopharynx compared to oral/oropharynx). Radiation technique was significantly associated with psychosocial speech problems (less problems in patients treated with IMRT). Swallowing and (to a lesser extent) speech problems in daily life are frequently present after chemoradiation therapy for head and neck cancer. Future prospective studies will give more insight into the course of speech and swallowing problems after chemoradiation and into efficacy of new radiation techniques and swallowing and speech rehabilitation programs.

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),

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.

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...

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

Knowledge Representation in Patient Safety Reporting: An Ontological Approach

OpenAIRE

Liang Chen; Yang Gong

2016-01-01

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 desig...

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.

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

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

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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.

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.

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.

The Cambridge Otology Quality of Life Questionnaire: an otology-specific patient-recorded outcome measure. A paper describing the instrument design and a report of preliminary reliability and validity.

Science.gov (United States)

Martin, T P C; Moualed, D; Paul, A; Ronan, N; Tysome, J R; Donnelly, N P; Cook, R; Axon, P R

2015-04-01

The Cambridge Otology Quality of Life Questionnaire (COQOL) is a patient-recorded outcome measurement (PROM) designed to quantify the quality of life of patients attending otology clinics. Item-reduction model. A systematically designed long-form version (74 items) was tested with patient focus groups before being presented to adult otology patients (n. 137). Preliminary item analysis tested reliability, reducing the COQOL to 24 questions. This was then presented in conjunction with the SF-36 (V1) questionnaire to a total of 203 patients. Subsequently, these were re-presented at T + 3 months, and patients recorded whether they felt their condition had improved, deteriorated or remained the same. Non-responders were contacted by post. A correlation between COQOL scores and patient perception of change was examined to analyse content validity. Teaching hospital and university psychology department. Adult patients attending otology clinics with a wide range of otological conditions. Item reliability measured by item–total correlation, internal consistency and test– retest reliability. Validity measured by correlation between COQOL scores and patient-reported symptom change. Reliability: the COQOL showed excellent internal consistency at both initial presentation (a = 0.90) and 3 months later (a = 0.93). Validity: One-way analysis of variance showed a significant difference between groups reporting change and those reporting no change in quality of life (F(2, 80) = 5.866, P < 0.01). The COQOL is the first otology-specific PROM. Initial studies demonstrate excellent reliability and encouraging preliminary criterion validity: further studies will allow a deeper validation of the instrument.

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

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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.

Can patients report patient safety incidents in a hospital setting? A systematic review.

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Ward, Jane K; Armitage, Gerry

2012-08-01

Patients are increasingly being thought of as central to patient safety. A small but growing body of work suggests that patients may have a role in reporting patient safety problems within a hospital setting. This review considers this disparate body of work, aiming to establish a collective view on hospital-based patient reporting. This review asks: (a) What can patients report? (b) In what settings can they report? (c) At what times have patients been asked to report? (d) How have patients been asked to report? 5 databases (MEDLINE, EMBASE, CINAHL, (Kings Fund) HMIC and PsycINFO) were searched for published literature on patient reporting of patient safety 'problems' (a number of search terms were utilised) within a hospital setting. In addition, reference lists of all included papers were checked for relevant literature. 13 papers were included within this review. All included papers were quality assessed using a framework for comparing both qualitative and quantitative designs, and reviewed in line with the study objectives. Patients are clearly in a position to report on patient safety, but included papers varied considerably in focus, design and analysis, with all papers lacking a theoretical underpinning. In all papers, reports were actively solicited from patients, with no evidence currently supporting spontaneous reporting. The impact of timing upon accuracy of information has yet to be established, and many vulnerable patients are not currently being included in patient reporting studies, potentially introducing bias and underestimating the scale of patient reporting. The future of patient reporting may well be as part of an 'error detection jigsaw' used alongside other methods as part of a quality improvement toolkit.

Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments.

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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

Facebook Facts: Breast Reconstruction Patient-Reported Outcomes Using Social Media.

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Tang, Sherry Y Q; Israel, Jacqueline S; Poore, Samuel O; Afifi, Ahmed M

2018-05-01

Social media are used for information sharing among patients with similar health conditions, and analysis of social media activity could inform clinical decision-making. The aim of this study was to use Facebook to evaluate a cohort of individuals' perceptions of and satisfaction with breast reconstruction. In this observational study, the authors collected and analyzed posts pertaining to autologous and implant-based breast reconstruction from active Facebook groups. Patient satisfaction data were categorized, and a thematic analysis of posts was conducted. Qualitative posts were grouped based on common themes and quantitatively compared using frequency and chi-square analysis. The authors evaluated 500 posts from two Facebook groups. Two hundred sixty-four posts referenced deep inferior epigastric perforator (DIEP) flap reconstruction and 117 were related to implant-based reconstruction. Among individuals referencing DIEP flap reconstruction, 52 percent were satisfied, compared with 20 percent of individuals who referenced satisfaction with implant-based reconstruction (p < 0.0001). Individuals posting about DIEP flaps reported a higher rate of unexpected side effects (p < 0.001) and numbness (p = 0.004). When referencing implant-based reconstruction, individuals reported significantly higher rates of infection, contracture, and implant failure (p < 0.001). Based on the authors' review of social media activity, individuals undergoing DIEP flap breast reconstruction expressed relatively high individual satisfaction despite difficult postoperative recovery. Individuals who referenced implant-based reconstruction mentioned infection and implant failure, leading to high rates of dissatisfaction. Social media appear to provide informational and emotional support to patients. Plastic surgeons can use social media to gather unbiased information of patients' experience to inform clinical conversation and guide clinical practice.

A randomised trial of telemedicine-based treatment versus conventional hospitalisation in patients with severe COPD and exacerbation - effect on self-reported outcome

DEFF Research Database (Denmark)

Schou, Lone; Ostergaard, Birte; Rydahl-Hansen, Susan

2013-01-01

We investigated self-reported outcome in patients with COPD and exacerbation. Consecutive patients were randomised to an intervention group with home telemedicine and a control group who had conventional hospital admission. We assessed Health-Related Quality of Life (HRQoL) using the St George......'s Respiratory Questionnaire, daily activity using Instrumental Activity of Daily Living, anxiety and depression using the Hospital Anxiety and Depression Scale, and self-assessed cognitive decline using Subjective Cognitive Functioning. Data were collected at 3 days, 6 weeks and 3 months after discharge...

Website design: technical, social and medical issues for self-reporting by elderly patients.

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Taylor, Mark J; Stables, Rod; Matata, Bashir; Lisboa, Paulo J G; Laws, Andy; Almond, Peter

2014-06-01

There is growing interest in the use of the Internet for interacting with patients, both in terms of healthcare information provision and information gathering. In this article, we examine the issues in designing healthcare websites for elderly users. In particular, this article uses a year-long case study of the development of a web-based system for self-reporting of symptoms and quality of life with a view to examine the issues relating to website design for elderly users. The issues identified included the technical, social and medical aspects of website design for elderly users. The web-based system developed was based on the European Quality of Life 5-Dimensions health-status questionnaire, a commonly used tool for patient self-reporting of quality of life, and the more specific coronary revascularisation outcome questionnaire. Currently, self-reporting is generally administered in the form of paper-based questionnaires to be completed in the outpatient clinic or at home. There are a variety of issues relating to elderly users, which imply that websites for elderly patients may involve different design considerations to other types of websites.

Patient-reported changes in communication after computer-based script training for aphasia.

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Manheim, Larry M; Halper, Anita S; Cherney, Leora

2009-04-01

To evaluate changes in patient-reported communication difficulty after a home-based, computer-delivered intervention designed to improve conversational skills in adults with aphasia. Delayed treatment design with baseline, preintervention, postintervention, and follow-up observations. Outpatient rehabilitation. Twenty subjects with chronic aphasia. Sessions with the speech-language pathologist to develop personally relevant conversational scripts, followed by 9 weeks of intensive home practice using a computer program loaded on a laptop, and weekly monitoring visits with the speech-language pathologist. Communication Difficulty (CD) subscale of the Burden of Stroke Scale (BOSS). The intervention resulted in a statistically and clinically significant decrease of 6.79 points (P=.038) in the CD subscale of the BOSS during the intervention, maintained during the follow-up period. The findings of this study provide positive albeit preliminary and limited support for the use of a home-based, computer-delivered language intervention program for improving patient-reported communication outcomes in adults with chronic aphasia. Additional research will be required to examine the efficacy and effectiveness of this intervention.

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

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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

Developing a Learning Outcome-Based Question Examination Paper Tool for Universiti Putra Malaysia

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Hassan, Sa'adah; Admodisastro, Novia Indriaty; Kamaruddin, Azrina; Baharom, Salmi; Pa, Noraini Che

2016-01-01

Much attention is now given on producing quality graduates. Therefore, outcome-based education (OBE) in teaching and learning is now being implemented in Malaysia at all levels of education especially at higher education institutions. For implementing OBE, the design of curriculum and courses should be based on specified outcomes. Thus, the…

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

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

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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

Engaging Stakeholders in Patient-Centered Outcomes Research Regarding School-Based Sealant Programs.

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Chi, Donald L; Milgrom, Peter; Gillette, Jane

2018-02-01

Purpose: The purpose of this study was to use qualitative methods to describe the key lessons learned during the stakeholder engagement stage of planning a randomized clinical trial comparing outcomes of silver diamine fluoride (SDF) as an alternative to pit-and-fissure sealants in a school-based delivery system. Methods: Eighteen caregivers and community-based stakeholders with involvement in the school-based sealant program Sealants for Smiles from the state of Montana, were recruited for this qualitative study. United States (U.S.) Patient-Centered Outcomes Research Institute (PCORI) methodology standards were used to develop two semi-structured interview guides consisting of 6 questions. One interview guide was used for telephone interviews with caregivers and the second was used for a stakeholder focus group. Content analytic methods were used to analyze the data. Results: All participants believed that a study comparing SDF and sealants was clinically relevant. Non-caregiver stakeholders agreed with the proposed primary outcome of the study (caries prevention) whereas caregivers also emphasized the importance of child-centered outcomes such as minimizing dental anxiety associated with dental care. Stakeholders described potential concerns associated with SDF such as staining and perceptions of safety and discussed ways to address these concerns through community engagement, appropriate framing of the study, proper consent procedures, and ongoing safety monitoring during the trial. Finally, stakeholders suggested dissemination strategies such as direct communication of findings through professional organizations and encouraging insurance plans to incentivize SDF use by reimbursing dental providers. Conclusions: Involving key stakeholders in early planning is essential in developing patient-centered research questions, outcomes measures, study protocols, and dissemination plans for oral health research involving a school-based delivery system. Copyright © 2018

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

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...

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.

Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: a systematic review protocol.

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Aiyegbusi, Olalekan Lee; Kyte, Derek; Cockwell, Paul; Marshall, Tom; Keeley, Thomas; Gheorghe, Adrian; Calvert, Melanie

2016-10-12

Chronic kidney disease (CKD) is associated with symptoms that can significantly reduce the quality of life (QoL) of patients. Patient-reported outcome measures (PROMs) may facilitate the assessment of the impact of disease and treatment on the QoL, from a patient perspective. PROMs can be used in research and routine clinical practice. A systematic review of studies evaluating the measurement properties of PROMs in adults with CKD will be conducted. MEDLINE, EMBASE, PsycINFO and CINAHL Plus will be systematically searched from inception. Hand searching of reference lists and citations of included studies will be carried out. 2 reviewers will independently screen the titles and abstracts of all the studies retrieved during the systematic search to determine their eligibility. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist will be used to appraise the methodological quality of the selected studies following the full-text review. Data on the study population, questionnaire characteristics and measurement properties will be extracted from the selected papers. Finally, a narrative synthesis of extracted data will be undertaken. Ethical permissions are not required for this study as data from published research articles will be used. Findings will be disseminated through publication in a peer-reviewed journal and presented at conferences. This systematic review will provide a comprehensive assessment of the measurement properties of PROMs currently available for use in adult patients with CKD and present evidence which may inform the selection of measures for use in research and clinical practice. CRD42016035554. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

How Do We Value Postoperative Recovery?: A Systematic Review of the Measurement Properties of Patient-reported Outcomes After Abdominal Surgery.

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

2018-04-01

To appraise the level of evidence supporting the measurement properties of patient-reported outcome measures (PROMs) in the context of postoperative recovery after abdominal surgery. There is growing interest in using PROMs to support value-based care in abdominal surgery; however, to draw valid conclusions regarding patient-reported outcomes data, PROMs with robust measurement properties are required. Eight databases (MEDLINE, EMBASE, Biosis, PsycINFO, The Cochrane Library, CINAHL, Scopus, Web of Science) were searched for studies focused on the measurement properties of PROMs in the context of recovery after abdominal surgery. The methodological quality of individual studies was evaluated using the consensus-based COSMIN checklist. Evidence supporting the measurement properties of each PROM was synthetized according to standardized criteria and compared against the International Society of Quality of Life Research minimum standards for the selection of PROMs for outcomes research. We identified 35 studies evaluating 22 PROMs [12 focused on nonspecific surgical populations (55%), 4 focused on abdominal surgery (18%), and 6 generic PROMs (27%)]. The great majority of the studies (74%) received only poor or fair quality ratings. Measurement properties of PROMs were predominantly supported by limited or unknown evidence. None of the PROMs fulfilled International Society of Quality of Life Research's minimum standards, hindering specific recommendations. There is very limited evidence supporting the measurement properties of existing PROMs used in the context of recovery after abdominal surgery. This precludes the use of these PROMs to support value-based surgical care. Further research is required to bridge this major knowledge gap. International Prospective Register of Systematic Reviews (PROSPERO): CRD42014014349.

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....

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...

Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.

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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.

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

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.

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.

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.

Can Team-Based Care Improve Patient Satisfaction? A Systematic Review of Randomized Controlled Trials

Science.gov (United States)

Wen, Jin; Schulman, Kevin A.

2014-01-01

Background Team-based approaches to patient care are a relatively recent innovation in health care delivery. The effectiveness of these approaches on patient outcomes has not been well documented. This paper reports a systematic review of the relationship between team-based care and patient satisfaction. Methods We searched MEDLINE, EMBASE, Cochrane Library, CINAHL, and PSYCHOINFO for eligible studies dating from inception to October 8, 2012. Eligible studies reported (1) a randomized controlled trial, (2) interventions including both team-based care and non-team-based care (or usual care), and (3) outcomes including an assessment of patient satisfaction. Articles with different settings between intervention and control were excluded, as were trial protocols. The reference lists of retrieved papers were also evaluated for inclusion. Results The literature search yielded 319 citations, of which 77 were screened for further full-text evaluation. Of these, 27 articles were included in the systematic review. The 26 trials with a total of 15,526 participants were included in this systematic review. The pooling result of dichotomous data (number of studies: 10) showed that team-based care had a positive effect on patient satisfaction compared with usual care (odds ratio, 2.09; 95% confidence interval, 1.54 to 2.84); however, combined continuous data (number of studies: 7) demonstrated that there was no significant difference in patient satisfaction between team-based care and usual care (standardized mean difference, −0.02; 95% confidence interval, −0.40 to 0.36). Conclusions Some evidence showed that team-based care is better than usual care in improving patient satisfaction. However, considering the pooling result of continuous data, along with the suboptimal quality of included trials, further large-scale and high-quality randomized controlled trials comparing team-based care and usual care are needed. PMID:25014674

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.

Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy

DEFF Research Database (Denmark)

Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen

2017-01-01

AIM: Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. METHODS: We searched major databases without language restrictions for randomized controlled...... trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting...... as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. RESULTS: Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60...

Does surgical stabilization improve outcomes in patients with isolated multiple distracted and painful non-flail rib fractures?

Science.gov (United States)

Girsowicz, Elie; Falcoz, Pierre-Emmanuel; Santelmo, Nicola; Massard, Gilbert

2012-03-01

A best evidence topic was constructed according to a structured protocol. The question addressed was whether surgical stabilization is effective in improving the outcomes of patients with isolated multiple distracted and painful non-flail rib fractures. Of the 356 papers found using a report search, nine presented the best evidence to answer the clinical question. The authors, journal, date and country of publication, study type, group studied, relevant outcomes and results of these papers are given. We conclude that, on the whole, the nine retrieved studies clearly support the use of surgical stabilization in the management of isolated multiple non-flail and painful rib fractures for improving patient outcomes. The interest and benefit was shown not only in terms of pain (McGill pain questionnaire) and respiratory function (forced vital capacity, forced expiratory volume in 1 s and carbon monoxide diffusing capacity), but also in improved quality of life (RAND 36-Item Health Survey) and reduced socio-professional disability. Indeed, most of the authors justified surgical management based on the fact that the results of surgical stabilization showed improvement in short- and long-term patient outcomes, with fast reduction in pain and disability, as well as lower average wait before recommencing normal activities. Hence, the current evidence shows surgical stabilization to be safe and effective in alleviating post-operative pain and in improving patient recovery, thus enhancing the outcome after isolated multiple rib fractures. However, given the little published evidence, prospective trials are necessary to confirm these encouraging results.

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

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

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

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.

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.

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.

Emerging versions of patient involvement with Patient Reported Outcomes

DEFF Research Database (Denmark)

Langstrup, Henriette

It is a central argument in the growing Danish PRO-arena, that a large-scale collection of PRO from patients in the Danish Healthcare system will pave the way for more genuine patient involvement in clinical decision-making, quality management and governance of the health services. In this paper I...... discuss how patient involvement is being (re)configured when increasingly connected to national visions of participatory healthcare. A central discussion centers on ‘meaningful use’ of patient-generated data promoting patients’ expectations and experiences as a criterion for how to proceed...... with the national use of PRO. But how do assumptions of what constitutes meaning for patients interact with the kinds of roles that patients are expected to take on with PROtools? What forms of participation are assumed to be meaningful and thus good and which are not? In sketching emerging versions of patient...

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...

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

Directory of Open Access Journals (Sweden)

Ghosh S

2012-11-01

Full Text Available Maria Jose Santana,1 David Feeny,2 Sunita Ghosh,3 Dale C Lien41Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada; 2Kaiser Permanente Center for Health Research, Portland, OR, USA; 3Cross Cancer Center, University of Alberta, Edmonton, Alberta, Canada; 4University of Alberta Hospital, Edmonton, Alberta, CanadaPurpose: Transplantation has the potential to produce profound effects on survival and health-related quality of life (HRQL. The inclusion of the patient’s perspective may play an important role in the assessment of the effectiveness of lung transplantation. Patient perspectives are assessed by patient-reported outcome measures, including HRQL measures. We describe how patients’ HRQL among different diagnosis groups can be used by clinicians to monitor and evaluate the outcomes associated with transplantation.Methods: Consecutive lung transplant recipients attending the lung transplant outpatient clinic in a tertiary institution completed the 15-item Health Utilities Index (HUI questionnaire on a touchscreen computer. The results were available to clinicians at every patient visit. The HUI3 covers a range of severity and comorbidities in eight dimensions of health status. Overall HUI3 scores are on a scale in which dead = 0.00 and perfect health = 1.00; disability categories range from no disability = 1 to severe disability <0.70. Single-attribute and overall HUI3 scores were used to compare patients’ HRQL among different diagnosis groups. Random-effect models with time since transplant as a random variable and age, gender, underlying diagnoses, infections, and broncholitis obliterans syndrome as fixed variables were built to identify determinants of health status at 2-years posttransplantation.Results: Two hundred and fourteen lung transplant recipients of whom 61% were male with a mean age of 52 (19–75 years were included in the study. Chronic obstructive pulmonary disease and cystic fibrosis patients displayed

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.

Defining the value framework for prostate brachytherapy using patient-centered outcome metrics and time-driven activity-based costing.

Science.gov (United States)

Thaker, Nikhil G; Pugh, Thomas J; Mahmood, Usama; Choi, Seungtaek; Spinks, Tracy E; Martin, Neil E; Sio, Terence T; Kudchadker, Rajat J; Kaplan, Robert S; Kuban, Deborah A; Swanson, David A; Orio, Peter F; Zelefsky, Michael J; Cox, Brett W; Potters, Louis; Buchholz, Thomas A; Feeley, Thomas W; Frank, Steven J

2016-01-01

Value, defined as outcomes over costs, has been proposed as a measure to evaluate prostate cancer (PCa) treatments. We analyzed standardized outcomes and time-driven activity-based costing (TDABC) for prostate brachytherapy (PBT) to define a value framework. Patients with low-risk PCa treated with low-dose-rate PBT between 1998 and 2009 were included. Outcomes were recorded according to the International Consortium for Health Outcomes Measurement standard set, which includes acute toxicity, patient-reported outcomes, and recurrence and survival outcomes. Patient-level costs to 1 year after PBT were collected using TDABC. Process mapping and radar chart analyses were conducted to visualize this value framework. A total of 238 men were eligible for analysis. Median age was 64 (range, 46-81). Median followup was 5 years (0.5-12.1). There were no acute Grade 3-5 complications. Expanded Prostate Cancer Index Composite 50 scores were favorable, with no clinically significant changes from baseline to last followup at 48 months for urinary incontinence/bother, bowel bother, sexual function, and vitality. Ten-year outcomes were favorable, including biochemical failure-free survival of 84.1%, metastasis-free survival 99.6%, PCa-specific survival 100%, and overall survival 88.6%. TDABC analysis demonstrated low resource utilization for PBT, with 41% and 10% of costs occurring in the operating room and with the MRI scan, respectively. The radar chart allowed direct visualization of outcomes and costs. We successfully created a visual framework to define the value of PBT using the International Consortium for Health Outcomes Measurement standard set and TDABC costs. PBT is associated with excellent outcomes and low costs. Widespread adoption of this methodology will enable value comparisons across providers, institutions, and treatment modalities. Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

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...

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.

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

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

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.

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

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.

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

a better outcome). A cutoff probability of 0.68 yielded the best performance of the model with cross-validation predictions of better outcomes for 236 patients (80%) and worse outcomes for 58 patients (20%); sensitivity of 91% (95% CI, 88%-95%); specificity of 65% (95% CI, 53%-77%); positive predictive value of 92% (95% CI, 88%-95%); and negative predictive value of 64% (95% CI, 51%-76%). We found six easy-to-determine preoperative patient and shoulder factors that were significantly associated with better outcomes of shoulder arthroplasty. A model based on these characteristics had good predictive properties for identifying patients likely to have a better outcome from shoulder arthroplasty. Future research could refine this model with larger patient populations from multiple practices. Level II, therapeutic study.

Outcomes From Pediatric Gastroenterology Maintenance of Certification Using Web-based Modules.

Science.gov (United States)

Sheu, Josephine; Chun, Stanford; O'Day, Emily; Cheung, Sara; Cruz, Rusvelda; Lightdale, Jenifer R; Fishman, Douglas S; Bousvaros, Athos; Huang, Jeannie S

2017-05-01

Beginning in 2013, the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) sponsored and developed subspecialty field-specific quality improvement (QI) activities to provide Part 4 Maintenance of Certification (MOC) credit for ongoing certification of pediatric gastroenterologists by the American Board of Pediatrics. Each activity was a Web-based module that measured clinical practice data repeatedly over at least 3 months as participants implemented rapid cycle change. Here, we examine existing variations in clinical practice among participating pediatric gastroenterologists and determine whether completion of Web-based MOC activities improves patient care processes and outcomes. We performed a cross-sectional and prospective analysis of physician and parent-reported clinical practice data abstracted from Web-based MOC modules on the topics of upper endoscopy, colonoscopy, and informed consent collected from pediatric gastroenterologists from North America from 2013 to 2016. Among 134 participating pediatric gastroenterologists, 56% practitioners practiced at an academic institution and most (94%) were NASPGHAN members. Participating physicians reported data from 6300 procedures. At baseline, notable practice variation across measured activities was demonstrated. Much of the rapid cycle changes implemented by participants involved individual behaviors, rather than system/team-based improvement activities. Participants demonstrated significant improvements on most targeted process and quality care outcomes. Pediatric gastroenterologists and parents reported baseline practice variation, and improvement in care processes and outcomes measured during NASPGHAN-sponsored Web-based MOC QI activities. Subspecialty-oriented Web-based MOC QI activities can reveal targets for reducing unwarranted variation in clinical pediatric practice, and can effectively improve care and patient outcomes.

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.

Defining the Value Framework for Prostate Brachytherapy using Patient-Centered Outcome Metrics and Time-Driven Activity-Based Costing

Science.gov (United States)

Thaker, Nikhil G.; Pugh, Thomas J.; Mahmood, Usama; Choi, Seungtaek; Spinks, Tracy E.; Martin, Neil E.; Sio, Terence T.; Kudchadker, Rajat J.; Kaplan, Robert S.; Kuban, Deborah A.; Swanson, David A.; Orio, Peter F.; Zelefsky, Michael J.; Cox, Brett W.; Potters, Louis; Buchholz, Thomas A.; Feeley, Thomas W.; Frank, Steven J.

2017-01-01

PURPOSE Value, defined as outcomes over costs, has been proposed as a measure to evaluate prostate cancer (PCa) treatments. We analyzed standardized outcomes and time-driven activity-based costing (TDABC) for prostate brachytherapy (PBT) to define a value framework. METHODS AND MATERIALS Patients with low-risk PCa treated with low-dose rate PBT between 1998 and 2009 were included. Outcomes were recorded according to the International Consortium for Health Outcomes Measurement (ICHOM) standard set, which includes acute toxicity, patient-reported outcomes, and recurrence and survival outcomes. Patient-level costs to one year after PBT were collected using TDABC. Process mapping and radar chart analyses were conducted to visualize this value framework. RESULTS A total of 238 men were eligible for analysis. Median age was 64 (range, 46–81). Median follow-up was 5 years (0.5–12.1). There were no acute grade 3–5 complications. EPIC-50 scores were favorable, with no clinically significant changes from baseline to last follow-up at 48 months for urinary incontinence/bother, bowel bother, sexual function, and vitality. Ten-year outcomes were favorable, including biochemical failure-free survival of 84.1%, metastasis-free survival 99.6%, PCa-specific survival 100%, and overall survival 88.6%. TDABC analysis demonstrated low resource utilization for PBT, with 41% and 10% of costs occurring in the operating room and with the MRI scan, respectively. The radar chart allowed direct visualization of outcomes and costs. CONCLUSIONS We successfully created a visual framework to define the value of PBT using the ICHOM standard set and TDABC costs. PBT is associated with excellent outcomes and low costs. Widespread adoption of this methodology will enable value comparisons across providers, institutions, and treatment modalities. PMID:26916105

A systematic review of music therapy practice and outcomes with acute adult psychiatric in-patients.

Science.gov (United States)

Carr, Catherine; Odell-Miller, Helen; Priebe, Stefan

2013-01-01

There is an emerging evidence base for the use of music therapy in the treatment of severe mental illness. Whilst different models of music therapy have been developed in mental health care, none have specifically accounted for the features and context of acute in-patient settings. This review aimed to identify how music therapy is provided for acute adult psychiatric in-patients and what outcomes have been reported. A systematic review using medical, psychological and music therapy databases. Papers describing music therapy with acute adult psychiatric in-patients were included. Analysis utilised narrative synthesis. 98 papers were identified, of which 35 reported research findings. Open group work and active music making for nonverbal expression alongside verbal reflection was emphasised. Aims were engagement, communication and interpersonal relationships focusing upon immediate areas of need rather than longer term insight. The short stay, patient diversity and institutional structure influenced delivery and resulted in a focus on single sessions, high session frequency, more therapist direction, flexible use of musical activities, predictable musical structures, and clear realistic goals. Outcome studies suggested effectiveness in addressing a range of symptoms, but were limited by methodological shortcomings and small sample sizes. Studies with significant positive effects all used active musical participation with a degree of structure and were delivered in four or more sessions. No single clearly defined model exists for music therapy with adults in acute psychiatric in-patient settings, and described models are not conclusive. Greater frequency of therapy, active structured music making with verbal discussion, consistency of contact and boundaries, an emphasis on building a therapeutic relationship and building patient resources may be of particular importance. Further research is required to develop specific music therapy models for this patient group that

A Systematic Review of Music Therapy Practice and Outcomes with Acute Adult Psychiatric In-Patients

Science.gov (United States)

Carr, Catherine; Odell-Miller, Helen; Priebe, Stefan

2013-01-01

Background and Objectives There is an emerging evidence base for the use of music therapy in the treatment of severe mental illness. Whilst different models of music therapy have been developed in mental health care, none have specifically accounted for the features and context of acute in-patient settings. This review aimed to identify how music therapy is provided for acute adult psychiatric in-patients and what outcomes have been reported. Review Methods A systematic review using medical, psychological and music therapy databases. Papers describing music therapy with acute adult psychiatric in-patients were included. Analysis utilised narrative synthesis. Results 98 papers were identified, of which 35 reported research findings. Open group work and active music making for nonverbal expression alongside verbal reflection was emphasised. Aims were engagement, communication and interpersonal relationships focusing upon immediate areas of need rather than longer term insight. The short stay, patient diversity and institutional structure influenced delivery and resulted in a focus on single sessions, high session frequency, more therapist direction, flexible use of musical activities, predictable musical structures, and clear realistic goals. Outcome studies suggested effectiveness in addressing a range of symptoms, but were limited by methodological shortcomings and small sample sizes. Studies with significant positive effects all used active musical participation with a degree of structure and were delivered in four or more sessions. Conclusions No single clearly defined model exists for music therapy with adults in acute psychiatric in-patient settings, and described models are not conclusive. Greater frequency of therapy, active structured music making with verbal discussion, consistency of contact and boundaries, an emphasis on building a therapeutic relationship and building patient resources may be of particular importance. Further research is required to

A systematic review of music therapy practice and outcomes with acute adult psychiatric in-patients.

Directory of Open Access Journals (Sweden)

Catherine Carr

Full Text Available There is an emerging evidence base for the use of music therapy in the treatment of severe mental illness. Whilst different models of music therapy have been developed in mental health care, none have specifically accounted for the features and context of acute in-patient settings. This review aimed to identify how music therapy is provided for acute adult psychiatric in-patients and what outcomes have been reported.A systematic review using medical, psychological and music therapy databases. Papers describing music therapy with acute adult psychiatric in-patients were included. Analysis utilised narrative synthesis.98 papers were identified, of which 35 reported research findings. Open group work and active music making for nonverbal expression alongside verbal reflection was emphasised. Aims were engagement, communication and interpersonal relationships focusing upon immediate areas of need rather than longer term insight. The short stay, patient diversity and institutional structure influenced delivery and resulted in a focus on single sessions, high session frequency, more therapist direction, flexible use of musical activities, predictable musical structures, and clear realistic goals. Outcome studies suggested effectiveness in addressing a range of symptoms, but were limited by methodological shortcomings and small sample sizes. Studies with significant positive effects all used active musical participation with a degree of structure and were delivered in four or more sessions.No single clearly defined model exists for music therapy with adults in acute psychiatric in-patient settings, and described models are not conclusive. Greater frequency of therapy, active structured music making with verbal discussion, consistency of contact and boundaries, an emphasis on building a therapeutic relationship and building patient resources may be of particular importance. Further research is required to develop specific music therapy models for this

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...

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.

Multiple Measures of Outcome in Assessing a Prison-Based Drug Treatment Program

Science.gov (United States)

Prendergast, Michael L.; Hall, Elizabeth A.; Wexler, Harry K.

2003-01-01

Evaluations of prison-based drug treatment programs typically focus on one or two dichotomous outcome variables related to recidivism. In contrast, this paper uses multiple measures of outcomes related to crime and drug use to examine the impact of prison treatment. Crime variables included self-report data of time to first illegal activity,…

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

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.

Operation for recurrent cystocele with anterior colporrhaphy or non-absorbable mesh: patient reported outcomes

DEFF Research Database (Denmark)

Nüssler, Emil Karl; Greisen, Susanne; Kesmodel, Ulrik Schiøler

2013-01-01

Abstract INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare patient reported outcomes and complications after repair of recurrent anterior vaginal wall prolapse in routine health care settings using standard anterior colporrhaphy or non-absorbable mesh. METHODS: The study is based...... on prospective data from the Swedish National Register for Gynaecological Surgery. 286 women were operated on for recurrent anterior vaginal wall prolapse in 2008-2010; 157 women had an anterior colporrhaphy and 129 were operated on with a non-absorbable mesh. Pre-, and perioperative data were collected from...... (0.6 %) in the anterior colporrhaphy group (p = 0.58). The infection rate was higher after mesh (8.5 %) than after anterior colporrhaphy (2.5 %; OR 3.19 ; 1.07-14.25). CONCLUSION: Implantation of synthetic mesh during operation for recurrent cystocele more than doubled the cure rate, whereas...

Patient Reported Outcomes in a New Home-Based Rehabilitation Programme for Prostate Cancer Patients

DEFF Research Database (Denmark)

Villumsen, Brigitta R; Jørgensen, Martin Grønbech; Frystyk, Jan

2015-01-01

The most optimal exercise plan for men with prostate cancer (PC) receiving androgen deprivation therapy needs to be identified. We plan to investigate a 12-week home-based health programme (exergaming) on physical function, fatigue and metabolic parameters in this group. In addition, our study...... will explore the satisfaction and experience with the health game programme. To the best of our knowledge this is the first RCT study to investigate the effect of a home based health game programme on PC patients. No statistical analysis have been made thus far because inclusion is ongoing, however baseline...

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

Using theory and evidence to drive measurement of patient, nurse and organizational outcomes of professional nursing practice.

Science.gov (United States)

Jeffs, Lianne; Sidani, Souraya; Rose, Donald; Espin, Sherry; Smith, Orla; Martin, Kirsten; Byer, Charlie; Fu, Kaiyan; Ferris, Ella

2013-04-01

An evolving body of literature suggests that the implementation of evidence based clinical and professional guidelines and strategies can improve patient care. However, gaps exist in our understanding of the effect of implementation of guidelines on outcomes, particularly patient outcomes. To address this gap, a measurement framework was developed to assess the impact of an organization-wide implementation of two nursing-centric best-practice guidelines on patient, nurse and organizational level outcomes. From an implementation standpoint, we anticipate that our data will show improvements in the following: (i) patient satisfaction scores and safety outcomes; (ii) nurses ability to value and engage in evidence based practice; and (iii) organizational support for evidence-informed nursing care that results in quality patient outcomes. Our measurement framework and multifaceted methodological approach outlined in this paper might serve as a blueprint for other organizations in their efforts to evaluate the impacts associated with implementation of clinical and professional guidelines and best practices. © 2013 Wiley Publishing Asia Pty Ltd.

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

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

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.

[Electronic versus paper-based patient records: a cost-benefit analysis].

Science.gov (United States)

Neubauer, A S; Priglinger, S; Ehrt, O

2001-11-01

The aim of this study is to compare the costs and benefits of electronic, paperless patient records with the conventional paper-based charts. Costs and benefits of planned electronic patient records are calculated for a University eye hospital with 140 beds. Benefit is determined by direct costs saved by electronic records. In the example shown, the additional benefits of electronic patient records, as far as they can be quantified total 192,000 DM per year. The costs of the necessary investments are 234,000 DM per year when using a linear depreciation over 4 years. In total, there are additional annual costs for electronic patient records of 42,000 DM. Different scenarios were analyzed. By increasing the time of depreciation to 6 years, the cost deficit reduces to only approximately 9,000 DM. Increased wages reduce the deficit further while the deficit increases with a loss of functions of the electronic patient record. However, several benefits of electronic records regarding research, teaching, quality control and better data access cannot be easily quantified and would greatly increase the benefit to cost ratio. Only part of the advantages of electronic patient records can easily be quantified in terms of directly saved costs. The small cost deficit calculated in this example is overcompensated by several benefits, which can only be enumerated qualitatively due to problems in quantification.

Are Electronic and Paper Questionnaires Equivalent to Assess Patients with Overactive Bladder?

Science.gov (United States)

Palmer, Cristina; Farhan, Bilal; Nguyen, Nobel; Zhang, Lishi; Do, Rebecca; Nguyen, Danh V; Ghoniem, Gamal

2018-03-30

Overactive bladder syndrome is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence in the absence of urinary tract infection or another obvious pathological condition. Electronic questionnaires have been used in a few specialties with the hope of improving treatment outcomes and patient satisfaction. However, they have not been widely used in the urological field. When treating overactive bladder, the main outcome is to improve patient quality of life. The primary objective of this study was to evaluate whether electronic questionnaires would be equally accepted as or preferred to paper questionnaires. The secondary objective was to look at the preference in relation to patient age, education and iPad® tablet familiarity. We prospectively evaluated the iList® electronic questionnaire application using a friendly iPad tablet in patients with overactive bladder who presented to the urology clinic at our institution. Each of the 80 patients who were recruited randomly completed the validated OABSS (Overactive Bladder Symptom Score) and the PPBC (Patient Perception of Bladder Condition) questionnaires in paper and electronic format on the tablet. Variables potentially associated with the outcomes of interest included demographic data, questionnaire method preference, patient response rate and iPad familiarity. We used the 2-sided Z-test to determine whether the proportion of patients who considered the tablet to be the same, better or much better than paper was significantly greater than 50%. The 2-sided chi-square test was applied to assess whether the intervention effect significantly differed among the demographic subgroups. A total of 80 patients 21 to 87 years old were enrolled in the study from November 2015 to August 2016. Of the patients 53% were female and 49% were 65 years or younger. The incidence of those who considered the tablet to be the same or better than paper was 82.5% (95% CI 74

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...

Patient-Centered Radiology Reporting: Using Online Crowdsourcing to Assess the Effectiveness of a Web-Based Interactive Radiology Report.

Science.gov (United States)

Short, Ryan G; Middleton, Dana; Befera, Nicholas T; Gondalia, Raj; Tailor, Tina D

2017-11-01

The aim of this study was to evaluate the effectiveness of a patient-centered web-based interactive mammography report. A survey was distributed on Amazon Mechanical Turk, an online crowdsourcing platform. One hundred ninety-three US women ≥18 years of age were surveyed and then randomized to one of three simulated BI-RADS ® 0 report formats: standard report, Mammography Quality Standards Act-modeled patient letter, or web-based interactive report. Survey questions assessed participants' report comprehension, satisfaction with and perception of the interpreting radiologist, and experience with the presented report. Two-tailed t tests and χ 2 tests were used to evaluate differences among groups. Participants in the interactive web-based group spent more than double the time viewing the report than the standard report group (160.0 versus 64.2 seconds, P < .001). Report comprehension scores were significantly higher for the interactive web-based and patient letter groups than the standard report group (P < .05). Scores of satisfaction with the interpreting radiologist were significantly higher for the web-based interactive report and patient letter groups than the standard report group (P < .01). There were no significant differences between the patient letter and web-based interactive report groups. Radiology report format likely influences communication effectiveness. For result communication to a non-medical patient audience, patient-centric report formats, such as a Mammography Quality Standards Act-modeled patient letter or web-based interactive report, may offer advantages over the standard radiology report. Future work is needed to determine if these findings are reproducible in patient care settings and to determine how best to optimize radiology result communication to patients. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Association of Velopharyngeal Insufficiency With Quality of Life and Patient-Reported Outcomes After Speech Surgery.

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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

Framework for Advancing the Reporting of Patient Engagement in Rheumatology Research Projects.

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Hamilton, Clayon B; Leese, Jenny C; Hoens, Alison M; Li, Linda C

2017-07-01

The term "patient engagement in research" refers to patients and their surrogates undertaking roles in the research process beyond those of study participants. This paper proposes a new framework for describing patient engagement in research, based on analysis of 30 publications related to patient engagement. Over the past 15 years, patients' perspectives have been instrumental in broadening the scope of rheumatology research and outcome measurement, such as evaluating fatigue in rheumatoid arthritis. Recent reviews, however, highlight low-quality reporting of patient engagement in research. Until we have more detailed information about patient engagement in rheumatology research, our understanding of how patients' perspectives are being integrated into research projects remains limited. When authors follow our guidance on the important components for describing patients' roles and function as "research partners," researchers and other knowledge users will better understand how patients' perspectives were integrated in their research projects.

Assessing the impact of a remote digital coaching engagement program on patient-reported outcomes in asthma.

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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.

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...

Increasing diabetic patient engagement and self-reported medication adherence using a web-based multimedia program.

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Elsabrout, Kerri

2018-05-01

Evidence-based, multimedia applications to supplement clinical care can improve patient engagement and clinical outcomes. Patients with diabetes with potentially devastating complication of foot ulcers present a substantial opportunity to improve engagement. This project examines how providing an online, multimedia self-management program affects patient engagement and self-reported medication adherence scores within 4-6 weeks compared with preprogram scores. Participants included 14 adult, diabetic outpatients receiving care at a Wound Care Center in suburban New York. Participants watched a Type 2 diabetes Emmi educational module on an electronic tablet during a routine wound treatment visit. Self-reported medication adherence was measured immediately before and at 4-6 weeks after the educational intervention. Patient engagement was measured immediately before, immediately after, and at 4-6 weeks postintervention. Self-reported medication adherence results demonstrated a modest increase at the delayed postintervention time. In addition, there was a large increase in engagement scores at the delayed postintervention time. The direction of change for both measures was consistent with the intervention being effective. Incorporating this type of novel, multimedia patient education resource may provide opportunities to enhance diabetes care.

The impact of intensivists' base specialty of training on care process and outcomes of critically ill trauma patients.

Science.gov (United States)

Matsushima, Kazuhide; Goldwasser, Eleanor R; Schaefer, Eric W; Armen, Scott B; Indeck, Matthew C

2013-09-01

The care of the critically ill trauma patients is provided by intensivists with various base specialties of training. The purpose of this study was to investigate the impact of intensivists' base specialty of training on the disparity of care process and patient outcome. We performed a retrospective review of an institutional trauma registry at an academic level 1 trauma center. Two intensive care unit teams staffed by either board-certified surgery or anesthesiology intensivists were assigned to manage critically ill trauma patients. Both teams provided care, collaborating with a trauma surgeon in house. We compared patient characteristics, care processes, and outcomes between surgery and anesthesiology groups using Wilcoxon tests or chi-square tests, as appropriate. We identified a total of 620 patients. Patient baseline characteristics including age, sex, transfer status, injury type, injury severity score, and Glasgow coma scale were similar between groups. We found no significant difference in care processes and outcomes between groups. In a logistic regression model, intensivists' base specialty of training was not a significant factor for mortality (odds ratio, 1.46; 95% confidence interval; 0.79-2.80; P = 0.22) and major complication (odds ratio, 1.11; 95% confidence interval, 0.73-1.67; P = 0.63). Intensive care unit teams collaborating with trauma surgeons had minimal disparity of care processes and similar patient outcomes regardless of intensivists' base specialty of training. Copyright © 2013 Elsevier Inc. All rights reserved.

Training hospital staff on spiritual care in palliative care influences patient-reported outcomes: Results of a quasi-experimental study.