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Sample records for reported outcomes pro

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

    Science.gov (United States)

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

    2016-01-05

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2011-12-01

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

  4. 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

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

    Science.gov (United States)

    Gerson, C D; Gerson, M-J

    2014-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

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

  7. 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.

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

    OpenAIRE

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

    2014-01-01

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

  9. Informative value of Patient Reported Outcomes (PRO in Health Technology Assessment (HTA

    Directory of Open Access Journals (Sweden)

    Brettschneider, Christian

    2011-01-01

    Full Text Available Background: “Patient-Reported Outcome” (PRO is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. Methods: For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI. The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment. For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report’s chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. Results: Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to

  10. 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....

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

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

    2017-11-20

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

  12. High-precision radiotherapy for meningiomas. Long-term results and patient-reported outcome (PRO)

    Energy Technology Data Exchange (ETDEWEB)

    Kessel, Kerstin A.; Fischer, Hanna; Combs, Stephanie E. [Technical University of Munich (TUM), Department of Radiation Oncology, Munich (Germany); Helmholtz Zentrum Muenchen (HMGU), Institute for Innovative Radiotherapy (iRT), Department of Radiation Sciences DRS, Neuherberg (Germany); Oechnser, Markus [Technical University of Munich (TUM), Department of Radiation Oncology, Munich (Germany); Zimmer, Claus [Technical University of Munich (TUM), Department of Neuroradiology, Munich (Germany); Meyer, Bernhard [Technical University of Munich (TUM), Department of Neurosurgery, Munich (Germany)

    2017-11-15

    To evaluate long-term outcome after high-precision radiotherapy (RT) of meningioma patients in terms of survival and side effects. We analyzed 275 meningioma cases: 147 low-grade and 43 high-grade meningiomas (WHO II: n = 40, III: n = 3). In all, 85 patients had no pathologically confirmed histology but were determined as low-grade based on multimodal imaging. Surgery was performed in 183 cases. RT was delivered as either radiosurgery (RS, n = 16), fractionated stereotactic radiotherapy (FSRT, n = 241), or intensity-modulated radiation therapy (IMRT, n = 18). Of 218 patients contacted for patient-reported-outcome (PRO), 207 responded (95%). Median follow-up was 7.2 years. For low-grade meningioma the survival rate (OS) was 97% at 3 years, 85% at 10 years, and 64% at 15 years, for atypical meningioma 91% at 3 years, 62% at 10 years, and 50% at 15 years. Local control rate (PFS) for low-grade meningioma was 91% at 3 years, 87% at 5 years, and 86% at 10 years, for atypical cases 67% at 3 years and 55% at 5 years. Of all, 3.0% of patients reported worsened or new symptoms grade ≥3 during RT and the first 6 months thereafter; 17.5% reported a deterioration after more than 2 years. We found the prognostic factors tumor volume and age significantly influencing OS and PFS. Complemented by PRO, we found long-term low toxicity rates in addition to excellent local control. Thus, due to the beneficial risk-benefit profile of benign and high-risk meningiomas, RT should be performed as adjuvant treatment and should not be postponed until tumor progression. (orig.) [German] Langzeitergebnisse nach Hochpraezisionsstrahlentherapie (RT) von Patienten mit Meningeomen hinsichtlich Ueberleben und Nebenwirkungen. Es wurden 275 Meningeomfaelle untersucht: 145 benigne (WHO I), 40 atypische (WHO II) und 3 anaplastische (WHO III) Meningeome; bei 85 Patienten bestand keine histologische Sicherung. Voroperiert waren 183 Faelle (67 %). Bei 16 Patienten wurde eine Radiochirurgie (RS

  13. 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...

  14. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

    Science.gov (United States)

    Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

    2018-02-06

    Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n

  15. 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...

  16. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  18. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report.

    Science.gov (United States)

    Rothman, Margaret; Burke, Laurie; Erickson, Pennifer; Leidy, Nancy Kline; Patrick, Donald L; Petrie, Charles D

    2009-01-01

    Patient-reported outcome (PRO) instruments are used to evaluate the effect of medical products on how patients feel or function. This article presents the results of an ISPOR task force convened to address good clinical research practices for the use of existing or modified PRO instruments to support medical product labeling claims. The focus of the article is on content validity, with specific reference to existing or modified PRO instruments, because of the importance of content validity in selecting or modifying an existing PRO instrument and the lack of consensus in the research community regarding best practices for establishing and documenting this measurement property. Topics addressed in the article include: definition and general description of content validity; PRO concept identification as the important first step in establishing content validity; instrument identification and the initial review process; key issues in qualitative methodology; and potential threats to content validity, with three case examples used to illustrate types of threats and how they might be resolved. A table of steps used to identify and evaluate an existing PRO instrument is provided, and figures are used to illustrate the meaning of content validity in relationship to instrument development and evaluation. RESULTS & RECOMMENDATIONS: Four important threats to content validity are identified: unclear conceptual match between the PRO instrument and the intended claim, lack of direct patient input into PRO item content from the target population in which the claim is desired, no evidence that the most relevant and important item content is contained in the instrument, and lack of documentation to support modifications to the PRO instrument. In some cases, careful review of the threats to content validity in a specific application may be reduced through additional well documented qualitative studies that specifically address the issue of concern. Published evidence of the content

  19. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report.

    Science.gov (United States)

    Coons, Stephen Joel; Gwaltney, Chad J; Hays, Ron D; Lundy, J Jason; Sloan, Jeff A; Revicki, Dennis A; Lenderking, William R; Cella, David; Basch, Ethan

    2009-06-01

    Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR's ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted. The task force was composed of the leadership team of ISPOR's ePRO Working Group and members of another group (i.e., ePRO Consensus Development Working Group) that had already begun to develop recommendations regarding ePRO good research practices. The resulting task force membership reflected a broad array of backgrounds, perspectives, and expertise that enriched the development of this report. The prior work became the starting point for the Task Force report. A subset of the task force members became the writing team that prepared subsequent iterations of the report that were distributed to the full task force for review and feedback. In addition, review beyond the task force was sought and obtained. Along with a presentation and discussion period at an ISPOR meeting

  20. Validity and Reliability of the U.S. National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Science.gov (United States)

    Dueck, Amylou C.; Mendoza, Tito R.; Mitchell, Sandra A.; Reeve, Bryce B.; Castro, Kathleen M.; Rogak, Lauren J.; Atkinson, Thomas M.; Bennett, Antonia V.; Denicoff, Andrea M.; O'Mara, Ann M.; Li, Yuelin; Clauser, Steven B.; Bryant, Donna M.; Bearden, James D.; Gillis, Theresa A.; Harness, Jay K.; Siegel, Robert D.; Paul, Diane B.; Cleeland, Charles S.; Schrag, Deborah; Sloan, Jeff A.; Abernethy, Amy P.; Bruner, Deborah W.; Minasian, Lori M.; Basch, Ethan

    2016-01-01

    Importance Symptomatic adverse events (AEs) in cancer trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective, the NCI developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic AEs directly from patients. Objective To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. Design Participants completed PRO-CTCAE items on tablet computers in clinic waiting rooms at two visits 1-6 weeks apart. A subset completed PRO-CTCAE items during an additional visit one business day after the first visit. Setting Nine U.S. cancer centers and community oncology practices. Participants 975 adult cancer patients undergoing outpatient chemotherapy and/or radiation enrolled between January 2011 and February 2012. Eligibility required participants to read English and be without clinically significant cognitive impairment. Main Outcome(s) and Measure(s) Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). Results 940/975 (96%) and 852/940 (91%) participants completed PRO-CTCAE items at each visit. 938/940 (99.8%) participants (53% female, median age 59, 32% high school education or less, 17% ECOG PS 2-4) reported having at least one symptom. All PRO-CTCAE items had at least one correlation in the expected direction with a QLQ-C30 scale (111/124 P<.05). Stronger correlations were seen between PRO-CTCAE items and conceptually-related QLQ-C30 domains. Scores for 94/124 PRO-CTCAE items were higher in the ECOG PS 2-4 versus 0-1 group (58/124 P<.05). Overall, 119/124 items met at least one construct validity criterion. Test-retest reliability was acceptable for 36/49 pre-specified items (median intra-class correlation coefficient

  1. 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....

  2. 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...

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

    Science.gov (United States)

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

    2018-01-01

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

  4. Validation of the LupusPRO version 1.8: an update to a disease-specific patient-reported outcome tool for systemic lupus erythematosus.

    Science.gov (United States)

    Azizoddin, D R; Weinberg, S; Gandhi, N; Arora, S; Block, J A; Sequeira, W; Jolly, M

    2018-04-01

    Objectives LupusPRO has shown good measurement properties as a disease-specific patient-reported outcome tool in systemic lupus erythematosus (SLE). For the purpose of clinical trials, the version 1.7 (v1.7) domain of Pain-Vitality was separated into distinct Pain, Vitality and Sleep domains in v1.8, and the psychometric properties examined. Methods A total of 131 consecutive SLE patients were self-administered surveys assessing fatigue (FACIT, SF-36), pain (Pain Inventory, SF-36), insomnia (Insomnia Severity Index), emotional health (PHQ-9, SF-36) and quality of life (SF-36, LupusPRO) at routine care visits. Internal consistency reliability (ICR) for each domain was obtained using Cronbach's alpha. The convergent construct validity of LupusPRO domains with corresponding SF-36 domains or tools were tested using Spearman correlation. Varimax rotations were conducted to assess factor structures of the LupusPRO v1.8. Results Mean (SD) age was 40.04 (14.10) years. Scores from the LupusPRO-Sleep domain strongly correlated with insomnia scores, while LupusPRO-Vitality correlated strongly with fatigue (FACIT) and SF-36 vitality. The LupusPRO-Pain domain correlated strongly with pain (SF36 Bodily-Pain, Pain Inventory) scores. Similarly, the LupusPRO domains of Physical and Emotional Health had significant correlations with corresponding SF-36 domains. The ICR for HRQoL and non-HRQoL were 0.96 and 0.81. LupusPRO (domains HRQoL and QoL) scores correlated with disease activity. Principal component analysis included seven factor loadings presenting for the HRQOL subscales (combined Sleep, Vitality, and Pain), and three factors for the NHRQoL (Combined Coping and Social Support). Conclusions LupusPRO v1.8 (including its Sleep, Vitality, and Pain domains) has acceptable reliability and validity. Use of LupusPRO as an outcome measure in clinical trials would facilitate responsiveness assessment.

  5. Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force.

    Science.gov (United States)

    Matza, Louis S; Patrick, Donald L; Riley, Anne W; Alexander, John J; Rajmil, Luis; Pleil, Andreas M; Bullinger, Monika

    2013-06-01

    Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label. The purpose of the current task force report is to recommend good practices for pediatric PRO research that is conducted to inform regulatory decision making and support claims made in medical product labeling. The recommendations are based on the consensus of an interdisciplinary group of researchers who were assembled for a task force associated with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). In those areas in which supporting evidence is limited or in which general principles may not apply to every situation, this task force report identifies factors to consider when making decisions about the design and use of pediatric PRO instruments, while highlighting issues that require further research. Five good research practices are discussed: 1) Consider developmental differences and determine age-based criteria for PRO administration: Four age groups are discussed on the basis of previous research (<5 years old, 5-7 years, 8-11 years, and 12-18 years). These age groups are recommended as a starting point when making decisions, but they will not fit all PRO instruments or the developmental stage of every child. Specific age ranges should be determined individually for each population and PRO instrument. 2) Establish content validity of pediatric PRO instruments: This section discusses the advantages of using children as content experts, as well as strategies for concept elicitation and cognitive interviews with children. 3) Determine whether an informant-reported outcome instrument is necessary: The distinction between two types of informant-reported measures (proxy vs. observational) is discussed, and recommendations are provided. 4) Ensure that the instrument is designed and formatted appropriately for the target age group. Factors to

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

    Science.gov (United States)

    Protopapa, Evangelia; van der Meulen, Jan; Moore, Caroline M; Smith, Sarah C

    2017-10-01

    To critically review conceptual frameworks for available patient-reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient-Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer-specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer-specific PROs: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Expanded Prostate Cancer Index Composite-50 (EPIC-50), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), Functional Assessment of Cancer Therapy - Prostate Cancer Subscale (FACT-P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - prostate specific 25-item (EORTC QLQ-PR25), Prostate Cancer - Quality of Life (PC-QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health-related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work

  7. Human melioidosis reported by ProMED

    Directory of Open Access Journals (Sweden)

    Katherinn Melissa Nasner-Posso

    2015-06-01

    Conclusions: Internet-based reporting systems such as ProMED are useful to gather information and synthesize knowledge on emerging infections. Although certain areas need to be improved, ProMED provided good information about melioidosis.

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

    Science.gov (United States)

    Watt, Torquil; Barbesino, Giuseppe; Bjorner, Jakob Bue; Bonnema, Steen Joop; Bukvic, Branka; Drummond, Russell; Groenvold, Mogens; Hegedüs, Laszlo; Kantzer, Valeska; Lasch, Kathryn E; Marcocci, Claudio; Mishra, Anjali; Netea-Maier, Romana; Ekker, Merel; Paunovic, Ivan; Quinn, Terence J; Rasmussen, Åse Krogh; Russell, Audrey; Sabaretnam, Mayilvaganan; Smit, Johannes; Törring, Ove; Zivaljevic, Vladan; Feldt-Rasmussen, Ulla

    2015-03-01

    Thyroid diseases are common and often affect quality of life (QoL). No cross-culturally validated patient-reported outcome measuring thyroid-related QoL is available. The purpose of the present study was to test the cross-cultural validity of the newly developed thyroid-related patient-reported outcome ThyPRO, using tests for differential item functioning (DIF) according to language version. The ThyPRO consists of 85 items summarized in 13 multi-item scales and one single item. Scales cover physical and mental symptoms, well-being and function as well as social and daily function and cosmetic concerns. Translation applied standard forward-backward methodology with subsequent cognitive interviews and reviews. Responses (N = 1,810) to the ThyPRO were collected in seven countries: UK (n = 166), The Netherlands (n = 147), Serbia (n = 150), Italy (n = 110), India (n = 148), Denmark (n = 902) and Sweden (n = 187). Translated versions were compared pairwise to the English version by examining uniform and nonuniform DIF, i.e., whether patients from different countries respond differently to a particular item, although they have identical level of the concept measured by the item. Analyses were controlled for thyroid diagnosis. DIF was investigated by ordinal logistic regression, testing for both statistical significance and magnitude (ΔR (2) > 0.02). Scale level was estimated by the sum score, after purification. For twelve of the 84 tested items, DIF was identified in more than one language. Eight of these were small, but four were indicative of possible low translatability. Twenty-one instances of DIF in single languages were identified, indicating potential problems with the particular translation. However, only seven were of a magnitude which could affect scale scores, most of which could be explained by sample differences not controlled for. The ThyPRO has good cross-cultural validity with only minor cross-cultural invariance and is recommended for use in

  9. A concept taxonomy and an instrument hierarchy: tools for establishing and evaluating the conceptual framework of a patient-reported outcome (PRO) instrument as applied to product labeling claims.

    Science.gov (United States)

    Erickson, Pennifer; Willke, Richard; Burke, Laurie

    2009-01-01

    To facilitate development and evaluation of a PRO instrument conceptual framework, we propose two tools--a PRO concept taxonomy and a PRO instrument hierarchy. FDA's draft guidance on patient reported outcome (PRO) measures states that a clear description of the conceptual framework of an instrument is useful for evaluating its adequacy to support a treatment benefit claim for use in product labeling the draft guidance, however does not propose tools for establishing or evaluating a PRO instrument's conceptual framework. We draw from our review of PRO concepts and instruments that appear in prescription drug labeling approved in the United States from 1997 to 2007. We propose taxonomy terms that define relationships between PRO concepts, including "family,"compound concept," and "singular concept." Based on the range of complexity represented by the concepts, as defined by the taxonomy, we propose nine instrument orders for PRO measurement. The nine orders range from individual event counts to multi-item, multiscale instruments. This analysis of PRO concepts and instruments illustrates that the taxonomy and hierarchy are applicable to PRO concepts across a wide range of therapeutic areas and provide a basis for defining the instrument conceptual framework complexity. Although the utility of these tools in the drug development, review, and approval processes has not yet been demonstrated, these tools could be useful to improve communication and enhance efficiency in the instrument development and review process.

  10. 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...

  11. The provider perspective: investigating the effect of the Electronic Patient-Reported Outcome (ePRO) mobile application and portal on primary care provider workflow.

    Science.gov (United States)

    Hans, Parminder K; Gray, Carolyn Steele; Gill, Ashlinder; Tiessen, James

    2018-03-01

    Aim This qualitative study investigates how the Electronic Patient-Reported Outcome (ePRO) mobile application and portal system, designed to capture patient-reported measures to support self-management, affected primary care provider workflows. The Canadian health system is facing an ageing population that is living with chronic disease. Disruptive innovations like mobile health technologies can help to support health system transformation needed to better meet the multifaceted needs of the complex care patient. However, there are challenges with implementing these technologies in primary care settings, in particular the effect on primary care provider workflows. Over a six-week period interdisciplinary primary care providers (n=6) and their complex care patients (n=12), used the ePRO mobile application and portal to collaboratively goal-set, manage care plans, and support self-management using patient-reported measures. Secondary thematic analysis of focus groups, training sessions, and issue tracker reports captured user experiences at a Toronto area Family Health Team from October 2014 to January 2015. Findings Key issues raised by providers included: liability concerns associated with remote monitoring, increased documentation activities due to a lack of interoperability between the app and the electronic patient record, increased provider anxiety with regard to the potential for the app to disrupt and infringe upon appointment time, and increased demands for patient engagement. Primary care providers reported the app helped to focus care plans and to begin a collaborative conversation on goal-setting. However, throughout our investigation we found a high level of provider resistance evidenced by consistent attempts to shift the app towards fitting with existing workflows rather than adapting much of their behaviour. As health systems seek innovative and disruptive models to better serve this complex patient population, provider change resistance will need to

  12. Feasibility and acceptability of electronic symptom surveillance with clinician feedback using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Danish prostate cancer patients

    DEFF Research Database (Denmark)

    Baeksted, Christina; Pappot, Helle; Nissen, Aase

    2017-01-01

    Background: The aim was to examine the feasibility, acceptability and clinical utility of electronic symptom surveillance with clinician feedback using a subset of items drawn from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a cancer...

  13. Human melioidosis reported by ProMED.

    Science.gov (United States)

    Nasner-Posso, Katherinn Melissa; Cruz-Calderón, Stefania; Montúfar-Andrade, Franco E; Dance, David A B; Rodriguez-Morales, Alfonso J

    2015-06-01

    There are limited sources describing the global burden of emerging diseases. A review of human melioidosis reported by ProMED was performed and the reliability of the data retrieved assessed in comparison to published reports. The effectiveness of ProMED was evaluated as a source of epidemiological data by focusing on melioidosis. Using the keyword 'melioidosis' in the ProMED search engine, all of the information from the reports and collected data was reviewed using a structured form, including the year, country, gender, occupation, number of infected individuals, and number of fatal cases. One hundred and twenty-four entries reported between January 1995 and October 2014 were identified. A total of 4630 cases were reported, with death reported in 505 cases, suggesting a misleadingly low overall case fatality rate (CFR) of 11%. Of 20 cases for which the gender was reported, 12 (60%) were male. Most of the cases were reported from Australia, Thailand, Singapore, Vietnam, and Malaysia, with sporadic reports from other countries. Internet-based reporting systems such as ProMED are useful to gather information and synthesize knowledge on emerging infections. Although certain areas need to be improved, ProMED provided good information about melioidosis. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

    International Nuclear Information System (INIS)

    Basch, Ethan; Pugh, Stephanie L.; Dueck, Amylou C.; Mitchell, Sandra A.; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J.; Gatewood, Marcha; Reeve, Bryce B.; Mendoza, Tito R.; O'Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M.; Bennett, Antonia V.; Setser, Ann; Schrag, Deborah

    2017-01-01

    Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by

  15. Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Basch, Ethan, E-mail: ebasch@med.unc.edu [Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (United States); Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Pugh, Stephanie L. [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Dueck, Amylou C. [Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona (United States); Mitchell, Sandra A. [Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland (United States); Berk, Lawrence [Radiation Oncology, University of South Florida, Tampa, Florida (United States); Fogh, Shannon [Department of Radiation Oncology, University of California, San Francisco, San Francisco, California (United States); Rogak, Lauren J. [Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (United States); Gatewood, Marcha [Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia (United States); Reeve, Bryce B. [Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Mendoza, Tito R. [Department of Symptom Research, The University of Texas MD. Anderson Cancer Center, Houston, Texas (United States); O' Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M. [Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland (United States); Bennett, Antonia V. [Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Setser, Ann [Setser Health Consulting, LLC, St. Louis, Missouri (United States); Schrag, Deborah [Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts (United States); and others

    2017-06-01

    Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be

  16. Feasibility and acceptability of electronic symptom surveillance with clinician feedback using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Danish prostate cancer patients

    DEFF Research Database (Denmark)

    Bæksted, Christina; Pappot, Helle; Nissen, Aase

    2017-01-01

    -CTCAE questionnaire on tablet computers using AmbuFlex software at each treatment visit in the outpatient clinic. In total, 22 symptomatic toxicities (41 PRO-CTCAE items), corresponding to the symptomatic adverse-events profile associated with the regimens commonly used for prostate cancer treatment (Docetaxel......Background: The aim was to examine the feasibility, acceptability and clinical utility of electronic symptom surveillance with clinician feedback using a subset of items drawn from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a cancer...

  17. 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

  18. 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.

    Science.gov (United States)

    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.

  19. High Level of Agreement between Electronic and Paper Mode of Administration of a Thyroid-Specific Patient-Reported Outcome, ThyPRO

    DEFF Research Database (Denmark)

    Rasmussen, Sofie Larsen; Rejnmark, Lars; Ebbehøj, Eva

    2016-01-01

    to the original must be demonstrated. The aim of the present study was to assess the equivalence between the paper version and the electronic version of the thyroid-related quality-of-life questionnaire ThyPRO. METHODS: Patients with Graves' hyperthyroidism or autoimmune hypothyroidism in a clinically stable...

  20. Cross-cultural adaptation and linguistic validation of age-group-specific haemophilia patient-reported outcome (PRO) instruments for patients and parents

    DEFF Research Database (Denmark)

    von Mackensen, S; Campos, I G; Acquadro, C

    2013-01-01

    , culturally adapted and linguistically validated translations have been developed; some instruments have been translated into 61 languages. Here, we report the process used for cultural adaptation of the Haemo-QoL, Haem-A-QoL and Hemo-Sat into 28 languages. Equivalent concepts for 22 items that were difficult...... to adapt culturally for particular languages were identified and classed as semantic/conceptual (17 items), cultural (three items), idiomatic (one item), and grammatical (one item) problems. This has resulted in linguistically validated versions of these instruments, which can be used to assess HRQo...

  1. Using Patient-Reported Outcome Measures (PROMs) to promote quality of care and safety in the management of patients with Advanced Chronic Kidney disease (PRO-trACK project): a mixed-methods project protocol.

    Science.gov (United States)

    Aiyegbusi, Olalekan Lee; Kyte, Derek; Cockwell, Paul; Marshall, Tom; Dutton, Mary; Slade, Anita; Marklew, Neil; Price, Gary; Verdi, Rav; Waters, Judi; Sharpe, Keeley; Calvert, Melanie

    2017-06-30

    Advanced chronic kidney disease (CKD) has a major effect on the quality of life and health status of patients and requires accurate and responsive management. The use of electronic patient-reported outcome measures (ePROMs) could assist patients with advanced pre-dialysis CKD, and the clinicians responsible for their care, by identifying important changes in symptom burden in real time. We report the protocol for 'Using Patient-Reported Outcome measures (PROMs) to promote quality of care and safety in the management of patients with Advanced Chronic Kidney Disease' (PRO-trACK) project, which will explore the feasibility and validity of an ePROM system for use in patients with advanced CKD. The project will use a mixed-methods approach in three studies: (1) usability testing of the ePROM system involving up to 30 patients and focusing on acceptability and technical performance/stability; (2) ascertaining the views of patient and clinician stakeholders on the optimal use and administration of the CKD ePROM system-this will involve qualitative face-to-face/telephone interviewing with up to 30 patients or until saturation is achieved, focus groups with up to 15 clinical staff, management and IT team members; (3) psychometric assessment of the system, within a cohort of at least 180 patients with advanced CKD, to establish the measurement properties of the ePROM. This project was approved by the West Midlands Edgbaston Research Ethics Committee (Reference 17/WM/0010) and received Health Research Authority (HRA) approval on 24 February 2017.The findings from this project will be provided to clinicians at the Department of Renal Medicine, Queen Elizabeth Hospitals, Birmingham (QEHB), NHS England, presented at conferences and to the Kidney Patients' Association, British Kidney Patient Association and the British Renal Society. Articles based on the findings will be written and submitted for publication in peer-reviewed journals. © Article author(s) (or their employer

  2. Enabling symptom self-management via use of an electronic patient-reported outcomes (ePRO system to increase self-efficacy of patients with cancer receiving active chemotherapy treatment

    Directory of Open Access Journals (Sweden)

    Grigorios Kotronoulas

    2015-10-01

    investigate the effects of an electronic patient-reported outcomes (ePRO system, the Advanced Symptom Management System (ASyMS, on patient outcomes including improvement in self-efficacy, symptom management, supportive care needs, psychological status, work presenteeism, and well-being; health system costs; and the current clinical practice. The primary aim of eSMART is to evaluate the short and long term impact of the ASyMS technology on patient reported outcomes in people with breast cancer, colorectal cancer or haematological malignancies receiving first-line chemotherapy. In addition, eSMART will evaluate the cost-benefit of remote patient-monitoring and changes in clinical practice as a result of the application of the ASyMS intervention in different European healthcare settings. The study is currently recruiting patients, thus no data will be available for presentation. This presentation will nonetheless aim to present and discuss the hypothesis that provision of symptom self-management advice may be an important mechanism to improve patient self-efficacy, which may establish a self-sustained cycle where self-care advice provision enables patient self-efficacy and this in turn further increases patient involvement in self-management that can ultimately lead to improved patient outcomes. Method(s/Results: The current study has been informed by the Medical Research Council Complex Interventions Framework (Anderson, 2008; Craig and Petticrew, 2012; Mackenzie et al., 2010, and the Holistic Framework to improve the Uptake and Impact of e-Health Technologies (van Gemert-Pijnen et al., 2011. The eSMART programme of work comprises two parts that will take place over a period of five years. The first part consists of preparatory work to refine the ASyMS intervention for use in a multi-national context, and concludes with a feasibility testing period to establish the technological readiness of the system prior to its use in the second part. The second part will employ a repeated

  3. A patient-reported outcome measure to identify occurrence and distress of post-surgery symptoms of WOMen with vulvAr Neoplasia (WOMAN-PRO) - a cross sectional study.

    Science.gov (United States)

    Senn, Beate; Eicher, Manuela; Mueller, Michael D; Hornung, René; Fink, Daniel; Baessler, Kaven; Hampl, Monika; Denhaerynck, Kris; Spirig, Rebecca; Engberg, Sandra

    2013-04-01

    The aim of the study was to describe the (a) symptom experience of women with vulvar intraepithelial neoplasia and vulvar cancer (vulvar neoplasia) during the first week after hospital discharge, and (b) associations between age, type of disease, stage of disease, the extent of surgical treatment and symptom experience. This cross-sectional study was conducted in eight hospitals in Germany and Switzerland (Clinical Trial ID: NCT01300663). Symptom experience after surgical treatment in women with vulvar neoplasia was measured with our newly developed WOMAN-PRO instrument. Outpatients (n=65) rated 31 items. We used descriptive statistics and regression analysis. The average number of symptoms reported per patient was 20.2 (SD 5.77) with a range of 5 to 31 symptoms. The three most prevalent wound-related symptoms were 'swelling' (n=56), 'drainage' (n=54) and 'pain' (n=52). The three most prevalent difficulties in daily life were 'sitting' (n=63), 'wearing clothes' (n=56) and 'carrying out my daily activities' (n=51). 'Tiredness' (n=62), 'insecurity' (n=54) and 'feeling that my body has changed' (n=50) were the three most prevalent psychosocial symptoms/issues. The most distressing symptoms were 'sitting' (Mean 2.03, SD 0.88), 'open spot (e.g. opening of skin or suture)' (Mean 1.91, SD 0.93), and 'carrying out my daily activities' (Mean 1.86, SD 0.87), which were on average reported as 'quite a bit' distressing. Negative associations were found between psychosocial symptom experience and age. WOMAN-PRO data showed a high symptom prevalence and distress, call for a comprehensive symptom assessment, and may allow identification of relevant areas in symptom management. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. Prediction about severity and outcome of sepsis by pro-atrial natriuretic peptide and pro-adrenomedullin.

    Science.gov (United States)

    Wang, Rui-lan; Kang, Fu-xin

    2010-06-01

    Measurement of biomarkers is a potential approach to early prediction of the risk of mortality in patients with sepsis. The aim of the present study was to evaluate the prognostic value of pro-atrial natriuretic peptide (pro-ANP) and pro-adrenomedullin (pro-ADM) levels in a cohort of medical intensive care patients and to compare it with that of other known biomarkers and physiological scores. Blood samples of 51 consecutive critically ill patients admitted to the intensive care unit and 53 age-matched healthy control people were evaluated in this prospective study. The prognostic value of pro-ANP and pro-ADM levels was compared with that of acute physiology and chronic health evaluation (APACHE) II scores and various biomarkers such as C-reactive protein, interleukin-6 and procalcitonin. Pro-ANP and pro-ADM were detected by a new sandwich immunoassay. On admission, 25 patients had systemic inflammatory response syndrome (SIRS), 12 sepsis, 9 severe sepsis and 5 septic shock. At that time, the median levels (ng/ml) of pro-ANP and pro-ADM were 87.22 and 0.34 respectively in patients with SIRS, 1533.30 and 2.23 in those with sepsis, 1098.73 and 4.57 in those with severe sepsis, and 1933.94 and 8.21 in those with septic shock. With the increasing severity of disease, the levels of pro-ANP and pro-ADM were gradually increased. On admission, the circulating levels of pro-ANP and pro-ADM in patients with sepsis, severe sepsis, or septic shock were significantly higher in non-survivors than in survivors (P less than 0.05). In a receiver operating characteristic curve analysis for the survival of patients with sepsis, the areas under the curve (AUCs) for pro-ANP and pro-ADM were 0.89 and 0.87 respectively, which was similar to the AUCs for procalcitonin and APACHE II scores. Pro-ANP and pro-ADM are valuable biomarkers for prediction of severity of septic patients.

  5. Learning Outcomes Report

    NARCIS (Netherlands)

    Stoyanov, Slavi; Spoelstra, Howard; Burgoyne, Louise; O’Tuathaigh, Colm

    2018-01-01

    Aim of the study The learning outcomes study, conducted as part of WP3 of the BioApp project, has as objectives: (a) generating a comprehensive list of the learning outcomes; (b) reaching an agreement on the scope and priority of the learning outcomes, and (c) making suggestions for the further

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

    Science.gov (United States)

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

    2011-12-08

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

  7. 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 ...

  8. Increased NT-pro-B-type natriuretic peptide independently predicts outcome following catheter ablation of atrial fibrillation

    DEFF Research Database (Denmark)

    Nilsson, Brian; Goetze, Jens Peter; Chen, Xu

    2009-01-01

    AIMS: To investigate whether NT-proBNP before ablation treatment and after exercise testing has predictive information regarding the clinical outcome following pulmonary vein isolation in patients with atrial fibrillation (AF). METHODS: NT-proBNP analysis were obtained before the ablation (before...

  9. 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

  10. Development of the PRO-LOCA Probabilistic Fracture Mechanics Code, MERIT Final Report

    International Nuclear Information System (INIS)

    Scott, Paul; Kurth, Robert; Cox, Andrew; Olson, Rick; Rudland, Dave

    2010-12-01

    The MERIT project has been an internationally financed program with the main purpose of developing probabilistic models for piping failure of nuclear components and to include these models in a probabilistic code named PRO-LOCA. The principal objective of the project has been to develop probabilistic models for piping failure of nuclear components and to include these models in a probabilistic code. The MERIT program has produced a code named PRO-LOCA with the following features: - Crack initiation models for fatigue or stress corrosion cracking for previously unflawed material. - Subcritical crack growth models for fatigue and stress corrosion cracking for both initiated and pre-existing circumferential defects. - Models for flaw detection by inspections and leak detection. - Crack stability. The PRO-LOCA code can thus predict the leak or break frequency for the whole sequence of initiation, subcritical crack growth until wall penetration and leakage, instability of the through-wall crack (pipe rupture). The outcome of the PRO-LOCA code are a sequence of failure frequencies which represents the probability of surface crack developing, a through-wall crack developing and six different sizes of crack opening areas corresponding to different leak flow rates or LOCA categories. Note that the level of quality assurance of the PRO-LOCA code is such that the code in its current state of development is considered to be more of a research code than a regulatory tool.

  11. Development of the PRO-LOCA Probabilistic Fracture Mechanics Code, MERIT Final Report

    Energy Technology Data Exchange (ETDEWEB)

    Scott, Paul; Kurth, Robert; Cox, Andrew; Olson, Rick (Battelle Columbus (United States)); Rudland, Dave (Nuclear Regulatory Commission (United States))

    2010-12-15

    The MERIT project has been an internationally financed program with the main purpose of developing probabilistic models for piping failure of nuclear components and to include these models in a probabilistic code named PRO-LOCA. The principal objective of the project has been to develop probabilistic models for piping failure of nuclear components and to include these models in a probabilistic code. The MERIT program has produced a code named PRO-LOCA with the following features: - Crack initiation models for fatigue or stress corrosion cracking for previously unflawed material. - Subcritical crack growth models for fatigue and stress corrosion cracking for both initiated and pre-existing circumferential defects. - Models for flaw detection by inspections and leak detection. - Crack stability. The PRO-LOCA code can thus predict the leak or break frequency for the whole sequence of initiation, subcritical crack growth until wall penetration and leakage, instability of the through-wall crack (pipe rupture). The outcome of the PRO-LOCA code are a sequence of failure frequencies which represents the probability of surface crack developing, a through-wall crack developing and six different sizes of crack opening areas corresponding to different leak flow rates or LOCA categories. Note that the level of quality assurance of the PRO-LOCA code is such that the code in its current state of development is considered to be more of a research code than a regulatory tool.

  12. 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.

  13. Patient reported outcome measures (PROMs)

    DEFF Research Database (Denmark)

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

    2018-01-01

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

  14. 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

  15. Reforming Agricultural Trade for Developing Countries : Volume 1. Key Issues for a Pro-Development Outcome of the Doha Round

    OpenAIRE

    McCalla, Alex F.; Nash, John

    2007-01-01

    Reforming agricultural trade for developing countries is a two-volume set. The first volume is subtitled Key issues for a pro- development outcome of the Doha Round, and it is focused on specific concerns that are being encountered in the agricultural negotiations, and on strategies for dealing with them to arrive at a final agreement that will significantly spur growth and reduce poverty in developing countries. The companion volume is subtitled Quantifying the impact of multilateral trade r...

  16. 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

  17. 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

  18. 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...

  19. 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

  20. Patient reported outcomes in hip arthroplasty registries.

    Science.gov (United States)

    Paulsen, Aksel

    2014-05-01

    -retest). I found that the translated PRO had good feasibility, an excellent response rate, no floor effect, but a high ceiling effect (as was expected with our postoperative patients) and few patients missed too many items to calculate a sum score. The translated PRO had high test-retest reliability and very high internal consistency, and appears to be a valid and reliable tool for outcome studies on THA patients in a hip registry setting. The MCII and PASS study included 1,335 patients, and I estimated that one year after THA, an improvement of 38-55% from mean baseline PRO score and absolute follow-up scores of 57-91% of the maximum score correspond to a minimal important improvement and acceptable symptom state, respectively.

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

    Science.gov (United States)

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

    2016-05-01

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

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

    Science.gov (United States)

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

    2017-09-01

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

  3. HyPro: A Financial Tool for Simulating Hydrogen Infrastructure Development, Final Report

    Energy Technology Data Exchange (ETDEWEB)

    Brian D. James, Peter O. Schmidt, Julie Perez

    2008-12-01

    This report summarizes a multi-year Directed Technologies Inc. (DTI) project to study the build-out of hydrogen production facilities during the transition from gasoline internal combustion engine vehicle to hydrogen fuel cell vehicles. The primary objectives of the project are to develop an enhanced understanding of hydrogen production issues during the transition period (out to 2050) and to develop recommendations for the DOE on areas of further study. These objectives are achieved by conducting economic and scenario analysis to predict how industry would provide the hydrogen production, delivery and dispensing capabilities necessary to satisfy increased hydrogen demand. The primary tool used for the analysis is a custom created MatLab simulation tool entitled HyPro (short for Hydrogen Production). This report describes the calculation methodology used in HyPro, the baseline assumptions, the results of the baseline analysis and several corollary studies. The appendices of this report included a complete listing of model assumptions (capital costs, efficiencies, feedstock prices, delivery distances, etc.) and a step-by-step manual on the specific operation of the HyPro program. This study was made possible with funding from the U.S. Department of Energy (DOE).

  4. The interrelationship between preoperative anemia and N-terminal pro-B-type natriuretic peptide: the effect on predicting postoperative cardiac outcome in vascular surgery patients.

    Science.gov (United States)

    Goei, Dustin; Flu, Willem-Jan; Hoeks, Sanne E; Galal, Wael; Dunkelgrun, Martin; Boersma, Eric; Kuijper, Ruud; van Kuijk, Jan-Peter; Winkel, Tamara A; Schouten, Olaf; Bax, Jeroen J; Poldermans, Don

    2009-11-01

    N-terminal pro-B-type natriuretic peptide (NT-proBNP) predicts adverse cardiac outcome in patients undergoing vascular surgery. However, several conditions might influence this prognostic value, including anemia. In this study, we evaluated whether anemia confounds the prognostic value of NT-proBNP for predicting cardiac events in patients undergoing vascular surgery. A detailed cardiac history, resting echocardiography, and hemoglobin and NT-proBNP levels were obtained in 666 patients before vascular surgery. Anemia was defined as serum hemoglobin value of NT-proBNP for the prediction of the composite end point. Multivariable regression analysis was used to assess the additional value of NT-proBNP for the prediction of postoperative cardiac events in nonanemic and anemic patients. Anemia was present in 206 patients (31%) before surgery. Hemoglobin level was inversely related with the NT-proBNP levels (beta coefficient = -2.242; P = 0.025). The optimal predictive cutoff value of NT-proBNP for predicting the composite cardiovascular outcome was 350 pg/mL. After adjustment for clinical cardiac risk factors, both anemia (odds ratio [OR] 1.53; 95% confidence interval [CI]: 1.07-2.99) and increased levels of NT-proBNP (OR 4.09; 95% CI: 2.19-7.64) remained independent predictors for postoperative cardiac events. However, increased levels of NT-proBNP were not predictive for the risk of adverse cardiac events in the subgroup of anemic patients (OR 2.16; 95% CI: 0.90-5.21). Both anemia and NT-proBNP are independently associated with an increased risk for postoperative cardiac events in patients undergoing vascular surgery. NT-proBNP has less predictive value in anemic patients.

  5. Radiological reporting system developed with FileMakerPro. Cooperation with HIS, RIS, and PACS

    International Nuclear Information System (INIS)

    Kawakami, Satoshi

    2004-01-01

    This article briefly describes our original radiological reporting system. This system was developed with the widely used database software FileMakerPro (ver 5.5). The reporting system can obtain information about patients and examinations from a radiology information system (RIS) by the Open DataBase Connectivity (ODBC) technique. By clicking the button on the reporting system, the corresponding Digital Imaging and Communications in Medicine (DICOM) images can be displayed on a picture archiving and communication system (PACS) workstation monitor. Reference images in JPEG format can be easily moved from PACS to the reporting system. Reports produced by the reporting system are distributed to the hospital information system (HIS) in Portable Document Format (PDF), through another web server. By utilizing the capacity of FileMakerPro, the human-machine interface of the system has been able to be improved easily. In addition, cooperation with HIS, RIS, and PACS could be constructed. Therefore, this original system would contribute to increasing the efficiency of radiological diagnosis. (author)

  6. 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

  7. A ProCoS II Project Final Report: ESPRIT Basic Research project 707

    DEFF Research Database (Denmark)

    Bowen, J. P.; Hoare, C. A. R.; Langmaack, Hans

    1996-01-01

    An overview of the research and associated activities of the Europeancollaborative ESPRIT Basic Research ProCoS II project (no. 7071) on``Provably Correct Systems'' which ran from 1992 to 1995 is presented.This was a follow-on project to ProCoS (no. 3104) and ran inparallel with the ProCoS Working...

  8. Usefulness of repeated N-terminal pro-B-type natriuretic peptide measurements as incremental predictor for long-term cardiovascular outcome after vascular surgery.

    Science.gov (United States)

    Goei, Dustin; van Kuijk, Jan-Peter; Flu, Willem-Jan; Hoeks, Sanne E; Chonchol, Michel; Verhagen, Hence J M; Bax, Jeroen J; Poldermans, Don

    2011-02-15

    Plasma N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) levels improve preoperative cardiac risk stratification in vascular surgery patients. However, single preoperative measurements of NT-pro-BNP cannot take into account the hemodynamic stress caused by anesthesia and surgery. Therefore, the aim of the present study was to assess the incremental predictive value of changes in NT-pro-BNP during the perioperative period for long-term cardiac mortality. Detailed cardiac histories, rest left ventricular echocardiography, and NT-pro-BNP levels were obtained in 144 patients before vascular surgery and before discharge. The study end point was the occurrence of cardiovascular death during a median follow-up period of 13 months (interquartile range 5 to 20). Preoperatively, the median NT-pro-BNP level in the study population was 314 pg/ml (interquartile range 136 to 1,351), which increased to a median level of 1,505 pg/ml (interquartile range 404 to 6,453) before discharge. During the follow-up period, 29 patients (20%) died, 27 (93%) from cardiovascular causes. The median difference in NT-pro-BNP in the survivors was 665 pg/ml, compared to 5,336 pg/ml in the patients who died (p = 0.01). Multivariate Cox regression analyses, adjusted for cardiac history and cardiovascular risk factors (age, angina pectoris, myocardial infarction, stroke, diabetes mellitus, renal dysfunction, body mass index, type of surgery and the left ventricular ejection fraction), demonstrated that the difference in NT-pro-BNP level between pre- and postoperative measurement was the strongest independent predictor of cardiac outcome (hazard ratio 3.06, 95% confidence interval 1.36 to 6.91). In conclusion, the change in NT-pro-BNP, indicated by repeated measurements before surgery and before discharge is the strongest predictor of cardiac outcomes in patients who undergo vascular surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2013-01-01

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

  10. 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

  11. Amino-terminal pro-brain natriuretic peptide as a predictor of outcome in patients admitted to intensive care. A prospective observational study.

    Science.gov (United States)

    De Geer, Lina; Fredrikson, Mats; Oscarsson, Anna

    2012-06-01

    Amino-terminal pro-brain-type natriuretic peptide is known to predict outcome in patients with heart failure, but its role in an intensive care setting is not yet fully established. To assess the incidence of elevated amino-terminal pro-brain natriuretic peptide (NT-pro-BNP) on admission to intensive care and its relation to death in the ICU and within 30 days. Prospective, observational cohort study. A mixed non-cardiothoracic tertiary ICU in Sweden. NT-pro-BNP was collected from 481 consecutive patients on admission to intensive care, in addition to data on patient characteristics and outcome. A receiver-operating characteristic curve was used to identify a discriminatory level of significance, a stepwise logistic regression analysis to correct for other clinical factors and a Kaplan-Meier analysis to assess survival. The correlation between Simplified Acute Physiology Score (SAPS) 3, Sequential Organ Failure Assessment score (SOFA) and NT-pro-BNP was analysed using Spearman's correlation test. Quartiles of NT-pro-BNP elevation were compared for baseline data and outcome using a logistic regression model. An NT-pro-BNP more than 1380 ng -l on admission was an independent predictor of death in the ICU and within 30 days [odds ratio (OR) 2.6; 95% confidence interval (CI), 1.5 to 4.4] and was present in 44% of patients. Thirty-three percent of patients with NT-pro-BNP more than 1380 ng -1, and 14.6% of patients below that threshold died within 30 days (log rank P=0.005). NT-pro-BNP correlated moderately with SAPS 3 and with SOFA on admission (Spearman's ρ 0.5552 and 0.5129, respectively). In quartiles of NT-pro-BNP elevation on admission, severity of illness and mortality increased significantly (30-day mortality 36.1%; OR 3.9; 95% CI, 2.0 to 7.3 in the quartile with the highest values, vs. 12.8% in the lowest quartile). We conclude that NT-pro-BNP is commonly elevated on admission to intensive care, that it increases with severity of illness and that it is an

  12. Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: Oncology Examples.

    Science.gov (United States)

    Brogan, Andrew P; DeMuro, Carla; Barrett, Amy M; D'Alessio, Denise; Bal, Vasudha; Hogue, Susan L

    2017-02-01

    Health authorities and payers increasingly recognize the importance of patient perspectives and patient-reported outcomes (PROs) in health care decision making. However, given the broad variety of PRO endpoints included in clinical programs and variations in the timing of PRO data collection and country-specific needs, the role of PRO data in reimbursement decisions requires characterization. To (a) determine the effect of PRO data on market access and reimbursement decisions for oncology products in multiple markets and (b) assess the effect of PRO data collected after clinical progression on payer decision making. A 3-part assessment (targeted literature review, qualitative one-on-one interviews, and online survey) was undertaken. Published literature was identified through searches in PubMed/MEDLINE and Embase. In addition, a targeted search was conducted of health technology assessment (HTA) agency websites in the United States, the United Kingdom, France, and Germany. Qualitative one-on-one interviews were conducted with 16 payers from the RTI Health Solutions global advisory panel in 14 markets (Australia, Brazil, France, Germany, Italy, South Korea, Netherlands, Poland, Spain, Sweden, Taiwan, Turkey, the United Kingdom, and the United States [n = 3]). Of the 200 payers and payer advisors from the global advisory panel invited to participate in the online survey, 20 respondents (China, France, Germany, Spain [n = 2], Taiwan, the United Kingdom, and the United States [n = 13]) completed the survey, and 6 respondents (Australia, South Korea, and the United States [n = 4]) partially completed the survey. Reviews of the literature and publicly available HTAs and reimbursement decisions suggested that HTA bodies and payers have varying experience with and confidence in PRO data. Payers participating in the survey indicated that PRO data may be especially influential in oncology compared with other therapeutic areas. Payers surveyed offered little differentiation

  13. 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

  14. 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

  15. 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...

  16. 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

  17. Two-year outcomes of pro re nata ranibizumab monotherapy for exudative age-related macular degeneration in Japanese patients

    Directory of Open Access Journals (Sweden)

    Yamamoto A

    2013-04-01

    Full Text Available Akiko Yamamoto,1 Annabelle A Okada,1 Atsuhiko Sugitani,1,2 Daisuke Kunita,1 Tosho Rii,1 Reiji Yokota1 1Department of Ophthalmology, Kyorin University School of Medicine, Tokyo, Japan; 2Department of Ophthalmology, Kugayama Hospital, Tokyo, Japan Purpose: To describe outcomes of intravitreal ranibizumab using a pro re nata regimen for treatment-naive exudative age-related macular degeneration (AMD, in Japanese patients over the first 2 years. Methods: Clinical records were retrospectively reviewed of 48 eyes of 48 patients with treatment-naive exudative AMD who underwent intravitreal ranibizumab therapy. After three monthly injections (induction, patients were examined monthly, and subsequent injections were performed as needed (pro re nata for any residual activity, by fundus biomicroscopy and imaging studies, regardless of severity. Results: Twenty-nine (60% of the patients were men, and 19 (40% were women; the mean age was 76.1 years. Of the 48 eyes evaluated, 17 (35% had findings consistent with polypoidal choroidal vasculopathy, and five (10% with retinal angiomatous proliferation. A mean of 6.0 ranibizumab injections were given in the first year, 3.5 in the second year, and 9.5 over the 2-year period. The best-corrected visual acuity (logarithm of minimum angle of resolution improved significantly, from 0.35 at baseline to 0.21 at 12 months (P < 0.01, and remained stable at 0.21 at 24 months (P < 0.01. The mean central macular thickness decreased significantly, from 355.4 µm at baseline to 237.9 µm at 12 months (P < 0.01 and 247.7 µm at 24 months (P < 0.01. Conclusion: Improved visual acuity and decreased central macular thickness were observed and maintained over a 2-year period, in a Japanese population receiving 3 monthly induction injections followed by a pro re nata regimen of ranibizumab for exudative AMD. Keywords: optical coherence tomography, polypoidal choroidal vasculopathy, retinal angiomatous proliferation

  18. Effect of telmisartan on functional outcome, recurrence, and blood pressure in patients with acute mild ischemic stroke: a PRoFESS subgroup analysis

    DEFF Research Database (Denmark)

    Bath, Philip M W; Martin, Reneé H; Palesch, Yuko

    2009-01-01

    BACKGROUND AND PURPOSE: High blood pressure (BP) is common in acute ischemic stroke and associated independently with a poor functional outcome. However, the management of BP acutely remains unclear because no large trials have been completed. METHODS: The factorial PRoFESS secondary stroke preve...

  19. 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...

  20. Neutrophil Gelatinase-Associated Lipocalin (NGAL), Pro-Matrix Metalloproteinase-9 (pro-MMP-9) and Their Complex Pro-MMP-9/NGAL in Leukaemias

    Energy Technology Data Exchange (ETDEWEB)

    Bouchet, Sandrine; Bauvois, Brigitte, E-mail: brigitte.bauvois@crc.jussieu.fr [INSERM U1138, Université Pierre et Marie Curie, Université Paris-Descartes, Centre de Recherche des Cordeliers, Paris 75006 (France)

    2014-04-04

    Matrix metalloproteinase (MMP)-9 and neutrophil gelatinase-associated lipocalin (NGAL) have gained attention as cancer biomarkers. The inactive zymogen form of MMP-9 (pro-MMP-9) also exists as a disulphide-linked heterodimer bound to NGAL in humans. Leukaemias represent a heterogeneous group of neoplasms, which vary in their clinical behavior and pathophysiology. In this review, we summarize the current literature on the expression profiles of pro-MMP-9 and NGAL as prognostic factors in leukaemias. We also report the expression of the pro-MMP-9/NGAL complex in these diseases. We discuss the roles of (pro)-MMP-9 (active and latent forms) and NGAL in tumour development, and evaluate the mechanisms by which pro-MMP-9/NGAL may influence the actions of (pro)-MMP-9 and NGAL in cancer. Emerging knowledge about the coexpression and the biology of (pro)-MMP-9, NGAL and their complex in cancer including leukaemia may improve treatment outcomes.

  1. Promoting Pro-Environmental Attitudes and Reported Behaviors of Malaysian Pre-Service Teachers Using Green Chemistry Experiments

    Science.gov (United States)

    Karpudewan, Mageswary; Ismail, Zurida; Roth, Wolff-Michael

    2012-01-01

    Environmental degradation is a general problem but it is often more serious in developing nations where levels of awareness are lower than in industrialized countries. There is, therefore, a need particularly in developing countries to increase pro-environmental attitudes and behaviors. In this paper, we report the results of a quasi-experimental…

  2. 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...

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

    OpenAIRE

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

    2017-01-01

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

  4. 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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2017-06-01

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

  7. 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

  8. Midregional-proAtrial Natriuretic Peptide and High Sensitive Troponin T Strongly Predict Adverse Outcome in Patients Undergoing Percutaneous Repair of Mitral Valve Regurgitation.

    Directory of Open Access Journals (Sweden)

    Jochen Wöhrle

    Full Text Available It is not known whether biomarkers of hemodynamic stress, myocardial necrosis, and renal function might predict adverse outcome in patients undergoing percutaneous repair of severe mitral valve insufficiency. Thus, we aimed to assess the predictive value of various established and emerging biomarkers for major adverse cardiovascular events (MACE in these patients.Thirty-four patients with symptomatic severe mitral valve insufficiency with a mean STS-Score for mortality of 12.6% and a mean logistic EuroSCORE of 19.7% undergoing MitraClip therapy were prospectively included in this study. Plasma concentrations of mid regional-proatrial natriuretic peptide (MR-proANP, Cystatin C, high-sensitive C-reactive protein (hsCRP, high-sensitive troponin T (hsTnT, N-terminal B-type natriuretic peptide (NT-proBNP, galectin-3, and soluble ST-2 (interleukin 1 receptor-like 1 were measured directly before procedure. MACE was defined as cardiovascular death and hospitalization for heart failure (HF.During a median follow-up of 211 days (interquartile range 133 to 333 days, 9 patients (26.5% experienced MACE (death: 7 patients, rehospitalization for HF: 2 patients. Thirty day MACE-rate was 5.9% (death: 2 patients, no rehospitalization for HF. Baseline concentrations of hsTnT (Median 92.6 vs 25.2 ng/L, NT-proBNP (Median 11251 vs 1974 pg/mL and MR-proANP (Median 755.6 vs 318.3 pmol/L, all p<0.001 were clearly higher in those experiencing an event vs event-free patients, while other clinical variables including STS-Score and logistic EuroSCORE did not differ significantly. In Kaplan-Meier analyses, NT-proBNP and in particular hsTnT and MR-proANP above the median discriminated between those experiencing an event vs event-free patients. This was further corroborated by C-statistics where areas under the ROC curve for prediction of MACE using the respective median values were 0.960 for MR-proANP, 0.907 for NT-proBNP, and 0.822 for hsTnT.MR-proANP and hsTnT strongly

  9. 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...

  10. 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),

  11. Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

    Science.gov (United States)

    Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

    2014-01-01

    Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient

  12. Pro B-type natriuretic peptide plasma value: a new criterion for the prediction of short- and long-term outcomes after transcatheter aortic valve implantation.

    Science.gov (United States)

    López-Otero, Diego; Trillo-Nouche, Ramiro; Gude, Francisco; Cid-Álvarez, Belen; Ocaranza-Sanchez, Raimundo; Alvarez, Melisa Santas; Lear, Pamela V; Gonzalez-Juanatey, José R

    2013-09-30

    To determine the prognostic value of pro B-type natriuretic peptide (pro-BNP) to predict mortality after transcatheter aortic valve implantation (TAVI). Logistic EuroSCORE (LES) overestimates observed mortality after TAVI. A new risk score specific to TAVI is needed to accurately assess mortality and outcome. Eighty-five patients were included. Indications for TAVI were nonoperable or surgically high-risk patients (LES>20%). Pro-BNP was measured 24h before the procedure. Cox proportional hazards model was used to evaluate clinical factors. The predictive accuracy of these Cox models was determined by using time-dependent receiver operating characteristic (ROC) curves. Pro-BNP levels (log-transformed) were significantly higher in non-survivors than in survivors at 30 days (3.36 ± 0.43 vs. 3.81 ± 0.43, p<0.004) and at the end of follow-up (3.34 ± 0.42 vs. 3.63 ± 0.48, p<0.011). Multivariate analysis revealed that only increased log pro-BNP levels were associated with higher mortality rate at short [hazard ratio (HR) (95% confidence intervals (CI)]=5.35 (1.74-16.5), p=0.003] and long-term follow-ups [HR=11 (CI: 1.51-81.3), p=0.018]. LES was not associated with increased mortality at either time point [HR=1.03 (CI: 0.95-1.10), p=0.483 and HR=1.03 (CI: 0.98-1.07), p=0.230, respectively]. At 30, 90, 180, and 365 days, the c-index was 0.72 for log pro-BNP and 0.63 for LES (p=0.044). Pre-procedure log transform of plasma pro-BNP levels are an independent and strong predictor of short- and long-term outcomes after TAVI and are more discriminatory than LES. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  13. SolarProTeam - Final report; Solar production technology melts architects

    Energy Technology Data Exchange (ETDEWEB)

    2010-07-01

    To this date, no module manufacturing line has been able to produce special designed multiple function modules or Custom Design Solution (hereafter CDS) modules at costs that are anywhere near the costs of standard modules. The goal of this R and D project was to provide the basis for eliminating the multiplication of costs for specialised modules. The purpose of the SolarProTeam R and D project is to form the foundation of special production equipment and production lay-out in order to realise a cost-effective CDS module production line. The main results derive from research and development of: (1) A number of new module designs corresponding to the special demands of end-users. For instance, black shiny modules with high efficiency; long large black modules with in-built thermal absorbers; flexible high voltage lightweight modules for ground water pumping; large area curved colorful modules with for architecturally advanced buildings; a solar tree for power supply placed along roads and in public places. Module designs are reported. (2) A new general concept 'Q-keys' based on a master plan and specially designed modules integrating both very large and medium sized individual solar plants in the environment of the end-user. I.e., in addition to integration with regard to architectural and environment demands, integration with respect to technical demands are met, such as storage, desalination plants, cooling, mini-grids, the general grid, etc. The Q-keys concept emphasizes the financial issue in that the solar plants are competitive with coal generated electricity and stand-alone diesel generation of electricity. (3) Fully automated production equipment and a semi-automatic module production line, which can mass produce advanced multifunctional and/or architecturally integrated modules at a cost effective price. The equipment and production line were inspired by the functional and technological demands of different types of costumer designed modules. Due

  14. Effect of telmisartan on functional outcome, recurrence, and blood pressure in patients with acute mild ischemic stroke: a PRoFESS subgroup analysis

    DEFF Research Database (Denmark)

    Bath, Philip M W; Martin, Reneé H; Palesch, Yuko

    2009-01-01

    BACKGROUND AND PURPOSE: High blood pressure (BP) is common in acute ischemic stroke and associated independently with a poor functional outcome. However, the management of BP acutely remains unclear because no large trials have been completed. METHODS: The factorial PRoFESS secondary stroke...... prevention trial assessed BP-lowering and antiplatelet strategies in 20 332 patients; 1360 were enrolled within 72 hours of ischemic stroke, with telmisartan (angiotensin receptor antagonist, 80 mg/d, n=647) vs placebo (n=713). For this nonprespecified subgroup analysis, the primary outcome was functional...... outcome at 30 days; secondary outcomes included death, recurrence, and hemodynamic measures at up to 90 days. Analyses were adjusted for baseline prognostic variables and antiplatelet assignment. RESULTS: Patients were representative of the whole trial (age 67 years, male 65%, baseline BP 147/84 mm Hg...

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

    Science.gov (United States)

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

    2017-09-01

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

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

    Directory of Open Access Journals (Sweden)

    Perrier Laure-Lou

    2005-03-01

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

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

    Science.gov (United States)

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

    2010-02-01

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

  18. 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.

  19. 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...

  20. Are validated patient-reported outcomes used on children in pediatric otolaryngology? A systematic review.

    Science.gov (United States)

    Wong, Kevin; Piraquive, Jacquelyn; Troiano, Chelsea A; Sulibhavi, Anita; Grundfast, Kenneth M; Levi, Jessica R

    2018-02-01

    Review the pediatric otolaryngology literature to 1) identify studies in which children completed patient-reported outcome (PRO) measures and 2) appraise the psychometric quality and validity of these PROs as they apply to pediatrics. In October 2016, a systematic review was performed by two reviewers on PubMed/MEDLINE and EMBASE for all otolaryngology-related studies that utilized PROs in children. Inclusion criteria included articles that required children (ageotolaryngology and some studies utilized PROs that were not validated or not validated for use in this age group. Future efforts to design and validate more instruments may be warranted. Copyright © 2017. Published by Elsevier B.V.

  1. Measurement and control of bias in patient reported outcomes using multidimensional item response theory.

    Science.gov (United States)

    Dowling, N Maritza; Bolt, Daniel M; Deng, Sien; Li, Chenxi

    2016-05-26

    Patient-reported outcome (PRO) measures play a key role in the advancement of patient-centered care research. The accuracy of inferences, relevance of predictions, and the true nature of the associations made with PRO data depend on the validity of these measures. Errors inherent to self-report measures can seriously bias the estimation of constructs assessed by the scale. A well-documented disadvantage of self-report measures is their sensitivity to response style (RS) effects such as the respondent's tendency to select the extremes of a rating scale. Although the biasing effect of extreme responding on constructs measured by self-reported tools has been widely acknowledged and studied across disciplines, little attention has been given to the development and systematic application of methodologies to assess and control for this effect in PRO measures. We review the methodological approaches that have been proposed to study extreme RS effects (ERS). We applied a multidimensional item response theory model to simultaneously estimate and correct for the impact of ERS on trait estimation in a PRO instrument. Model estimates were used to study the biasing effects of ERS on sum scores for individuals with the same amount of the targeted trait but different levels of ERS. We evaluated the effect of joint estimation of multiple scales and ERS on trait estimates and demonstrated the biasing effects of ERS on these trait estimates when used as explanatory variables. A four-dimensional model accounting for ERS bias provided a better fit to the response data. Increasing levels of ERS showed bias in total scores as a function of trait estimates. The effect of ERS was greater when the pattern of extreme responding was the same across multiple scales modeled jointly. The estimated item category intercepts provided evidence of content independent category selection. Uncorrected trait estimates used as explanatory variables in prediction models showed downward bias. A

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2017-05-01

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

  4. 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...

  5. The Pro12Ala Polymorphism of PPAR-γ Gene Is Associated with Sepsis Disease Severity and Outcome in Chinese Han Population

    Directory of Open Access Journals (Sweden)

    Guoda Ma

    2014-01-01

    Full Text Available Peroxisome proliferator-activated receptor-γ (PPAR-γ is a ligand-binding nuclear receptor, and its activation plays a prominent role in regulating the inflammatory response. Therefore, PPAR-γ has been suggested as a candidate gene for sepsis. In the present study, we investigated the association between the Pro12Ala polymorphism of PPAR-γ and sepsis in a Han Chinese population. A total of 308 patients with sepsis and 345 healthy controls were enrolled in this study. Genotyping was performed using the polymerase chain reaction-ligation detection reaction (PCR-LDR method. No significant differences were detected in the allele and genotype distributions of the PPAR-γ Pro12Ala SNP between septic patients and controls (P=0.622 for genotype; P=0.629 for allele. However, stratification by subtypes (sepsis, septic shock, and severe sepsis revealed a statistically significant difference in the frequency of the Ala allele and Ala-carrier genotype between the patients with the sepsis subtype and the healthy controls (P=0.014 for allele and P=0.012, for genotype. Moreover, significant differences were found in the frequency of the Ala allele and genotype between the sepsis survivors and nonsurvivors (all P=0.002. In the survivors, the PPAR-γ Pro12Ala genotype was significantly associated with decreased disease severity and recovery time (all P<0.001. Thus, genetic polymorphism is thought to play a role in the development and outcome of sepsis.

  6. Collecting, Integrating, and Disseminating Patient-Reported Outcomes for Research in a Learning Healthcare System.

    Science.gov (United States)

    Harle, Christopher A; Lipori, Gloria; Hurley, Robert W

    2016-01-01

    Advances in health policy, research, and information technology have converged to increase the electronic collection and use of patient-reported outcomes (PROs). Therefore, it is important to share lessons learned in implementing PROs in research information systems. The purpose of this case study is to describe a novel information system for electronic PROs and lessons learned in implementing that system to support research in an academic health center. The system incorporates freely available and commercial software and involves clinical and research workflows that support the collection, transformation, and research use of PRO data. The software and processes that comprise the system serve three main functions, (i) collecting electronic PROs in clinical care, (ii) integrating PRO data with non-patient generated clinical data, and (iii) disseminating data to researchers through the institution's research informatics infrastructure, including the i2b2 (Informatics for Integrating Biology and the Bedside) system. Our successful design and implementation was driven by three overarching strategies. First, we selected and implemented multiple interfaced technologies to support PRO collection, management, and research use. Second, we aimed to use standardized approaches to measuring PROs, sending PROs between systems, and disseminating PROs. Finally, we focused on using technologies and processes that aligned with existing clinical research information management strategies within our organization. These experiences and lessons may help future implementers and researchers enhance the scale and sustainable use of systems for research use of PROs.

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

    Science.gov (United States)

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

    2016-12-01

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

  8. Establishing construct validity for the thyroid-specific patient reported outcome measure (ThyPRO)

    DEFF Research Database (Denmark)

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

    2009-01-01

    , evaluating lack of convergent validity (item-own scale polyserial correlation correlation higher than item-own scale correlation) of the hypothesized scale structure. Analyses were repeated in clinical and sociodemographic subgroups and with Pearson...... complete convergent validity and only two instances of lack of discriminant validity. Pearson correlations yielded similar results. Across all subgroups, convergent validity was complete, and discriminant validity was found in 99.2% of tests. Lack of discriminant validity was mainly between physical...... correlations. Reliability was estimated by Cronbach's alpha, both conventionally and with polychoric correlations. RESULTS: In total, 904 patients (69%) responded. Initial multitrait scaling analysis identified 25 scaling errors. Twelve items were omitted from the scale structure, and a re-analysis showed...

  9. In-hospital and long-term outcomes of congestive heart failure: Predictive value of B-type and amino-terminal pro-B-type natriuretic peptides and their ratio.

    Science.gov (United States)

    Dai, Yuxiang; Yang, Jun; Takagi, Atsutoshi; Konishi, Hakuoh; Miyazaki, Tetsuro; Masuda, Hiroshi; Shimada, Kazunori; Miyauchi, Katsumi; Daida, Hiroyuki

    2017-08-01

    Relative changes in B-type natriuretic peptide (BNP) and amino terminal pro-BNP (NT-proBNP) levels may help to assess the risk of congestive heart failure (CHF). However, whether these levels at the time of admission enable the prediction of outcomes with acute exacerbation remains unknown. The current study determined the abilities of BNP, NT-proBNP and their ratio to predict in-hospital and long-term outcomes of patients with CHF. Patients who were admitted to the cardiac care unit of Juntendo University Hospital (Tokyo, Japan) with acute CHF onset were consecutively enrolled into the present observational study. Serum levels of BNP and NT-proBNP were immediately measured on admission, and other biomarkers and clinical data were also investigated. Of 195 enrolled patients, 16 (8.2%) succumbed to CHF in hospital and 124 (69.3%) reached the endpoint of mortality or readmission following a median follow-up of 14 months. Multiple linear regression analysis revealed body mass index, low density lipoprotein cholesterol, hemoglobin, estimated glomerular filtration rate and C-reactive protein as independent predictors of the NT-proBNP/BNP ratio. BNP, NT-proBNP and their ratio were significantly higher among those who succumbed to CHF than in those who remained alive in hospital (P<0.05). Logistic regression analysis indicated that the ratio was an independent predictor for in-hospital mortality and long-term outcomes. In conclusion, the ratio of NT-proBNP to BNP more effectively predicts in-hospital outcomes than either factor alone and it may also help to predict outcomes among patients with acute exacerbation of HF.

  10. Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

    Science.gov (United States)

    Bruner, Deborah Watkins; Bryan, Charlene J.; Aaronson, Neil; Blackmore, C. Craig; Brundage, Michael; Cella, David; Ganz, Patricia A.; Gotay, Carolyn; Hinds, Pamela S.; Kornblith, Alice B.; Movsas, Benjamin; Sloan, Jeff; Wenzel, Lari; Whalen, Giles

    2016-01-01

    Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need

  11. Evaluation of the ProPublica Surgeon Scorecard "Adjusted Complication Rate" Measure Specifications.

    Science.gov (United States)

    Ban, Kristen A; Cohen, Mark E; Ko, Clifford Y; Friedberg, Mark W; Stulberg, Jonah J; Zhou, Lynn; Hall, Bruce L; Hoyt, David B; Bilimoria, Karl Y

    2016-10-01

    The ProPublica Surgeon Scorecard is the first nationwide, multispecialty public reporting of individual surgeon outcomes. However, ProPublica's use of a previously undescribed outcome measure (composite of in-hospital mortality or 30-day related readmission) and inclusion of only inpatients have been questioned. Our objectives were to (1) determine the proportion of cases excluded by ProPublica's specifications, (2) assess the proportion of inpatient complications excluded from ProPublica's measure, and (3) examine the validity of ProPublica's outcome measure by comparing performance on the measure to well-established postoperative outcome measures. Using ACS-NSQIP data (2012-2014) for 8 ProPublica procedures and for All Operations, the proportion of cases meeting all ProPublica inclusion criteria was determined. We assessed the proportion of complications occurring inpatient, and thus not considered by ProPublica's measure. Finally, we compared risk-adjusted performance based on ProPublica's measure specifications to established ACS-NSQIP outcome measure performance (eg, death/serious morbidity, mortality). ProPublica's inclusion criteria resulted in elimination of 82% of all operations from assessment (range: 42% for total knee arthroplasty to 96% for laparoscopic cholecystectomy). For all ProPublica operations combined, 84% of complications occur during inpatient hospitalization (range: 61% for TURP to 88% for total hip arthroplasty), and are thus missed by the ProPublica measure. Hospital-level performance on the ProPublica measure correlated weakly with established complication measures, but correlated strongly with readmission (R = 0.834, P Scorecard is questionable.

  12. Content Validity of Patient-Reported Outcome Instruments used with Pediatric Patients with Facial Differences: A Systematic Review.

    Science.gov (United States)

    Wickert, Natasha M; Wong Riff, Karen W Y; Mansour, Mark; Forrest, Christopher R; Goodacre, Timothy E E; Pusic, Andrea L; Klassen, Anne F

    2018-01-01

    Objective The aim of this systematic review was to identify patient-reported outcome (PRO) instruments used in research with children/youth with conditions associated with facial differences to identify the health concepts measured. Design MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from 2004 to 2016 to identify PRO instruments used in acne vulgaris, birthmarks, burns, ear anomalies, facial asymmetries, and facial paralysis patients. We performed a content analysis whereby the items were coded to identify concepts and categorized as positive or negative content or phrasing. Results A total of 7,835 articles were screened; 6 generic and 11 condition-specific PRO instruments were used in 96 publications. Condition-specific instruments were for acne (four), oral health (two), dermatology (one), facial asymmetries (two), microtia (one), and burns (one). The PRO instruments provided 554 items (295 generic; 259 condition specific) that were sorted into 4 domains, 11 subdomains, and 91 health concepts. The most common domain was psychological (n = 224 items). Of the identified items, 76% had negative content or phrasing (e.g., "Because of the way my face looks I wish I had never been born"). Given the small number of items measuring facial appearance (n = 19) and function (n = 22), the PRO instruments reviewed lacked content validity for patients whose condition impacted facial function and/or appearance. Conclusions Treatments can change facial appearance and function. This review draws attention to a problem with content validity in existing PRO instruments. Our team is now developing a new PRO instrument called FACE-Q Kids to address this problem.

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

    Science.gov (United States)

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

    2013-03-01

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

  14. Validity and reliability of the novel thyroid-specific quality of life questionnaire, ThyPRO

    DEFF Research Database (Denmark)

    Watt, Torquil; Hegedus, Laszlo; Grønvold, Mogens

    2010-01-01

    Appropriate scale validity and internal consistency reliability have recently been documented for the new thyroid-specific quality of life (QoL) patient-reported outcome (PRO) measure for benign thyroid disorders, the ThyPRO. However, before clinical use, clinical validity and test...

  15. Healthcare Professionals' Preferences and Perceived Barriers for Routine Assessment of Patient-Reported Outcomes in Pediatric Oncology Practice: Moving Toward International Processes of Change

    NARCIS (Netherlands)

    Schepers, Sasja A.; Haverman, Lotte; Zadeh, Sima; Grootenhuis, Martha A.; Wiener, Lori

    2016-01-01

    Using patient-reported outcomes (PROs) in clinical practice has been shown to enhance detection of health-related quality of life problems and satisfaction with care in children with cancer. This study seeks to identify which PRO information healthcare professionals (HCPs) find useful and what the

  16. 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.

  17. 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.

  18. Pro Puppet

    CERN Document Server

    Krum, Spencer; Kero, Ben; Turnbull, James; McCune, Jeffrey

    2013-01-01

    Pro Puppet, Second Edition, now updated for Puppet 3, is an in-depth guide to installing, using, and developing the popular configuration management tool Puppet. Puppet provides a way to automate everything from user management to server configuration. You'll learn how Puppet has changed in the latest version, how to use it on a variety of platforms, including Windows, how to work with Puppet modules, and how to use Hiera. Puppet is a must-have tool for system administrators, and Pro Puppet will teach you how to maximize its capabilities and customize it for your environment.

  19. Pro Puppet

    CERN Document Server

    Turnbull, James

    2011-01-01

    Pro Puppet is an in-depth guide to installing, using, and developing the popular configuration management tool Puppet. The book is a comprehensive follow-up to the previous title Pulling Strings with Puppet. Puppet provides a way to automate everything from user management to server configuration. You'll learn how to create Puppet recipes, extend Puppet, and use Facter to gather configuration data from your servers. Puppet is a must-have tool for system administrators, and Pro Puppet will teach you how to maximize its capabilities and customize it for your environment. * Install and configure

  20. Pro Python

    CERN Document Server

    Alchin, Marty

    2010-01-01

    You've learned the basics of Python, but how do you take your skills to the next stage? Even if you know enough to be productive, there are a number of features that can take you to the next level in Python. Pro Python explores concepts and features normally left to experimentation, allowing you to be even more productive and creative. In addition to pure code concerns, Pro Python will develop your programming techniques and approaches, which will help make you a better Python programmer. Not only will this book help your code, it will also help you understand and interact with the many establ

  1. Pro-ACT II: integrating utilization management, discharge planning, and nursing case management into the outcomes manager role.

    Science.gov (United States)

    Brett, J L; Bueno, M; Royal, N; Kendall-Sengin, K

    1997-02-01

    Building on redesign efforts that created case management, clinical care technicians, support service hosts, and pharmacy technician roles, this redesign focused on integrating case management, utilization management, and discharge planning functions into a new outcomes manager role. The authors describe the process of developing and implementing the new role and outline specific actions that eliminated redundancy and inefficiency. Results of the evaluation of the project are reviewed, including full-time equivalent and salary savings and employee and physician satisfaction improvements.

  2. Hybrid surgery-radiosurgery therapy for metastatic epidural spinal cord compression: A prospective evaluation using patient-reported outcomes.

    Science.gov (United States)

    Barzilai, Ori; Amato, Mary-Kate; McLaughlin, Lily; Reiner, Anne S; Ogilvie, Shahiba Q; Lis, Eric; Yamada, Yoshiya; Bilsky, Mark H; Laufer, Ilya

    2018-05-01

    Patient-reported outcomes (PRO) represent an important measure of cancer therapy effect. For patients with metastatic epidural spinal cord compression (MESCC), hybrid therapy using separation surgery and stereotactic radiosurgery preserves neurologic function and provides tumor control. There is currently a paucity of data reporting PRO after such combined modality therapy for MESCC. Delineation of hybrid surgery-radiosurgery therapy effect on PRO validates the hybrid approach as an effective therapy resulting in meaningful symptom relief. Brief Pain Inventory (BPI) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP), PROs validated in the cancer population, were prospectively collected. Patients with MESCC who underwent separation surgery followed by stereotactic radiosurgery were included. Separation surgery included a posterolateral approach without extensive cytoreductive tumor excision. A median postoperative radiosurgery dose of 2700 cGy was delivered. The change in PRO 3 months after the hybrid therapy represented the primary study outcome. Preoperative and postoperative evaluations were analyzed using the Wilcoxon signed-rank test for matched pairs. One hundred eleven patients were included. Hybrid therapy resulted in a significant reduction in the BPI items "worst" and "right now" pain ( P < .0001), and in all BPI constructs (severity, interference with daily activities, and pain experience, P < .001). The MDASI-SP demonstrated reduction in spine-specific pain severity and interference with general activity ( P < .001), along with decreased symptom interference ( P < .001). Validated PRO instruments showed that in patients with MESCC, hybrid therapy with separation surgery and radiosurgery results in a significant decrease in pain severity and symptom interference. These prospective data confirm the benefit of hybrid therapy for treatment of MESCC and should facilitate referral of patients with MESCC for surgical evaluation.

  3. 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

  4. Patient-Reported Outcome Coordinator Did Not Improve Quality of Life Assessment Response Rates: A Report from the Children's Oncology Group.

    Directory of Open Access Journals (Sweden)

    Donna Johnston

    Full Text Available Health related quality of life (HRQL assessments during therapy for pediatric cancer provide valuable information to better understand the patient experience. Our objective was to determine the impact of a patient-reported outcome (PRO coordinator on HRQL questionnaire completion rates during a pediatric acute myeloid leukemia (AML trial.AAML1031 is a multicenter Children's Oncology Group therapeutic trial for de novo AML with a secondary aim to assess HRQL of children and adolescents treated with chemotherapy and hematopoietic stem cell transplantation (HSCT. Parents/guardians are the primary respondents and four questionnaires are administered at eight time points. The questionnaires are the PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and the Pediatric Inventory for Parents. To improve response rates, a central PRO coordinator was instituted and reminded sites about upcoming and delinquent questionnaires. The proportion of HRQL questionnaires completed were compared prior to, and following institution of the PRO coordinator. This analysis evaluated the first five assessment time points.There were231 families who consented to participate in the HRQL aim. Overall response rates for all questionnaires were 73-83%. At time point 1, within 14 days of chemotherapy initiation, post-PRO coordinator completion rates were significantly higher for three of four questionnaires. However, the effect was not sustained and at time point 4, one month following last chemotherapy or HSCT, completion rates were significantly lower post-PRO coordinator for all four questionnaires.Addition of a central PRO coordinator did not result in sustained improvement in HRQL questionnaire completion rates. Efforts to improve response rates must consider other strategies.

  5. Outcome discrepancies and selective reporting: impacting the leading journals?

    Science.gov (United States)

    Fleming, Padhraig S; Koletsi, Despina; Dwan, Kerry; Pandis, Nikolaos

    2015-01-01

    Selective outcome reporting of either interesting or positive research findings is problematic, running the risk of poorly-informed treatment decisions. We aimed to assess the extent of outcome and other discrepancies and possible selective reporting between registry entries and published reports among leading medical journals. Randomized controlled trials published over a 6-month period from July to December 31st, 2013, were identified in five high impact medical journals: The Lancet, British Medical Journal, New England Journal of Medicine, Annals of Internal Medicine and Journal of American Medical Association were obtained. Discrepancies between published studies and registry entries were identified and related to factors including registration timing, source of funding and presence of statistically significant results. Over the 6-month period, 137 RCTs were found. Of these, 18% (n = 25) had discrepancies related to primary outcomes with the primary outcome changed in 15% (n = 20). Moreover, differences relating to non-primary outcomes were found in 64% (n = 87) with both omission of pre-specified non-primary outcomes (39%) and introduction of new non-primary outcomes (44%) common. No relationship between primary or non-primary outcome change and registration timing (prospective or retrospective; P = 0.11), source of funding (P = 0.92) and presence of statistically significant results (P = 0.92) was found. Discrepancies between registry entries and published articles for primary and non-primary outcomes were common among trials published in leading medical journals. Novel approaches are required to address this problem.

  6. The Impact of Prolonged Participation in a Pro-Social Cognitive Behavioral Skills Program on Elementary Age Students, with Behavior Related Disorders, Behavior Accelerative, Behavior Reductive, and Return to Regular Classroom Outcomes

    Science.gov (United States)

    Esser, Ted H.

    2012-01-01

    Overall, pretest-posttest results indicated statistically significant pretest beginning program compared to posttest ending program percentage of behavioral improvement for on task, following directions, and positive interactions outcomes improvement for individual students who completed the elementary grades pro-social cognitive behavioral skills…

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

    Science.gov (United States)

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

    2015-06-01

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

  8. Neutrophil Gelatinase-Associated Lipocalin (NGAL, Pro-Matrix Metalloproteinase-9 (pro-MMP-9 and Their Complex Pro-MMP-9/NGAL in Leukaemias

    Directory of Open Access Journals (Sweden)

    Sandrine Bouchet

    2014-04-01

    Full Text Available Matrix metalloproteinase (MMP-9 and neutrophil gelatinase-associated lipocalin (NGAL have gained attention as cancer biomarkers. The inactive zymogen form of MMP-9 (pro-MMP-9 also exists as a disulphide-linked heterodimer bound to NGAL in humans. Leukaemias represent a heterogeneous group of neoplasms, which vary in their clinical behavior and pathophysiology. In this review, we summarize the current literature on the expression profiles of pro-MMP-9 and NGAL as prognostic factors in leukaemias. We also report the expression of the pro-MMP-9/NGAL complex in these diseases. We discuss the roles of (pro-MMP-9 (active and latent forms and NGAL in tumour development, and evaluate the mechanisms by which pro-MMP-9/NGAL may influence the actions of (pro-MMP-9 and NGAL in cancer. Emerging knowledge about the coexpression and the biology of (pro-MMP-9, NGAL and their complex in cancer including leukaemia may improve treatment outcomes.

  9. 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.

  10. OUTCOME OF MULTIVISCERAL ECHINOCOCCOSIS: A CASE REPORT

    Directory of Open Access Journals (Sweden)

    Hajric Zlata

    2017-08-01

    Full Text Available Introduction: The pathogen of multivisceral echinococcosis is the same agent as for single-organ echinococcosis: Echinococcus granulosus.According to the consensus of experts under the aegis of the WHO-IWGE - WHO-Informal Working Group on Echinococcosis options of treatment should be: (1 percutaneous treatment, (2 surgery, (3 anti-infective drug treatment or (4 watch and waitapproach or combinations thereof. Case report: The presented case was a seven-year-old Caucasian boy, a permanent resident of rural region near Tuzla, Bosnia and Herzegovina, who had a history of asymptomatic giant liver and small lung hydatid cyst (multivisceral echinococcosis. We consider that the patient was in the phase of secondary hydatidosis even before undergoing the first treatment PAIR method of liver and continued with adjunctive chemotherapy. Two weeks after discharge, during the adjunctive chemotherapy he had one of possible complication where pre-existed smal lung hydatid cyst gotinflamed and performed an abscess massand potential septic risk, which required surgical and antibiotic treatment. Surgery and early postoperative course were normal and the patient was discharged with recommendation to continue with previously started adjunctive chemotherapy (Albendazol according to treatment protocol. Conclusion: Most infected persons are asymptomatic and clinical manifestations vary according to the anatomic location of the cyst, so we want to indicate the importance of routine ultrasound screening of preschool children, and eventually X ray chest scan.This case report highlights the necessity of caution with choosing appropriate treatment, even though size of cyst can be irrelevant to take surgical treatment in first line instead of medical therapy.

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

    Directory of Open Access Journals (Sweden)

    Jones PW

    2016-12-01

    Full Text Available Paul W Jones,1,2 Stephen Rennard,3,4 Maggie Tabberer,5 John H Riley,2 Mitra Vahdati-Bolouri,2 Neil C Barnes2,6 1Institute for Infection and Immunity, University of London, London, 2Global Respiratory Franchise, GlaxoSmithKline, Uxbridge, UK; 3Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha, NE, USA; 4Clinical Discovery Unit, AstraZeneca, Cambridge, 5Global R&D, GlaxoSmithKline, Uxbridge, 6William Harvey Institute, Bart’s and the London School of Medicine and Dentistry, London, UK Abstract: One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of

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

    Science.gov (United States)

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

    2015-07-01

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

  13. Dynamic detection of N-terminal pro-B-type natriuretic peptide helps to predict the outcome of patients with major trauma.

    Science.gov (United States)

    Qian, A; Zhang, M; Zhao, G

    2015-02-01

    NT-proBNP and BNP have been demonstrated to be prognostic markers in cardiac disease and sepsis. However, the prognostic value and the dynamic changes of BNP or NT-proBNP in trauma patients remain unclear. The present study was conducted to investigate the dynamic changes of NT-proBNP in patients with major trauma (injury severity score ≥16), determine whether NT-proBNP could be used as a simple index to predict mortality in major trauma patients. This prospective observational study included 60 patients with major trauma. Serum NT-proBNP levels were measured on the 1st, 3rd and 7th day after injury The NT-proBNP levels in survivors were compared with those in non-survivors. The efficacy of NT-proBNP to predict survival was analyzed using receiver operating characteristic curves. An analysis of correlations between NT-proBNP and various factors, including injury severity score, Glasgow coma score, acute physiology and chronic health evaluation II, central venous pressure, creatine kinase-MB, cardiac troponin I and procalcitonin (PCT) was performed. NT-proBNP levels in patients with traumatic brain injury were compared with those in patients without traumatic brain injury. A comparison of NT-proBNP levels between patients with and without sepsis was also performed at each time point. NT-proBNP levels in non-survivors were significantly higher than those in survivors at all the indicated time points. In the group of non-survivors, NT-proBNP levels on the 7th day were markedly higher than those on the 1st day. In contrast, NT-proBNP levels in survivors showed a reduction over time. The efficacy of NT-proBNP to predict survival was analyzed using ROC curves, and there was no difference in the area under the ROC between NT-proBNP and APACHE II/ISS at the three time points. A significant correlation was found between NT-proBNP and ISS on the 1st day, NT-proBNP and CK-MB, Tn-I and APACHE II on the 3rd day, NT-proBNP and PCT on the 7th day. There were no significant

  14. 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.

  15. 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.

  16. Reporting clinical outcomes of breast reconstruction: a systematic review.

    Science.gov (United States)

    Potter, S; Brigic, A; Whiting, P F; Cawthorn, S J; Avery, K N L; Donovan, J L; Blazeby, J M

    2011-01-05

    Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

  17. Relationship between hospital financial performance and publicly reported outcomes.

    Science.gov (United States)

    Nguyen, Oanh Kieu; Halm, Ethan A; Makam, Anil N

    2016-07-01

    Hospitals that have robust financial performance may have improved publicly reported outcomes. To assess the relationship between hospital financial performance and publicly reported outcomes of care, and to assess whether improved outcome metrics affect subsequent hospital financial performance. Observational cohort study. Hospital financial data from the Office of Statewide Health Planning and Development in California in 2008 and 2012 were linked to data from the Centers for Medicare and Medicaid Services Hospital Compare website. Hospital financial performance was measured by net revenue by operations, operating margin, and total margin. Outcomes were 30-day risk-standardized mortality and readmission rates for acute myocardial infarction (AMI), congestive heart failure (CHF), and pneumonia (PNA). Among 279 hospitals, there was no consistent relationship between measures of financial performance in 2008 and publicly reported outcomes from 2008 to 2011 for AMI and PNA. However, improved hospital financial performance (by any of the 3 measures) was associated with a modest increase in CHF mortality rates (ie, 0.26% increase in CHF mortality rate for every 10% increase in operating margin [95% confidence interval: 0.07%-0.45%]). Conversely, there were no significant associations between outcomes from 2008 to 2011 and subsequent financial performance in 2012 (P > 0.05 for all). Robust financial performance is not associated with improved publicly reported outcomes for AMI, CHF, and PNA. Financial incentives in addition to public reporting, such as readmissions penalties, may help motivate hospitals with robust financial performance to further improve publicly reported outcomes. Reassuringly, improved mortality and readmission rates do not necessarily lead to loss of revenue. Journal of Hospital Medicine 2016;11:481-488. © 2016 Society of Hospital Medicine. © 2016 Society of Hospital Medicine.

  18. 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

  19. Are written information or counseling (WOMAN-PRO II program) able to improve patient satisfaction and the delivery of health care of women with vulvar neoplasms? Secondary outcomes of a multicenter randomized controlled trial

    Science.gov (United States)

    Gehrig, Larissa; Kobleder, Andrea; Werner, Birgit; Denhaerynck, Kris; Senn, Beate

    2017-01-01

    Background: Patients with vulvar neoplasms report a lack of information, missing support in self-management and a gap in delivery of health care. Aim: The aim of the study was to investigate if written information or counseling based on the WOMAN-PRO II program are able to improve patient satisfaction and the delivery of health care from the health professional's perspective of women with vulvar neoplasms. Method: Patient satisfaction and the delivery of health care have been investigated as two secondary outcomes in a multicenter randomized controlled parallel-group phase II study (Clinical Trial ID: NCT01986725). In total, 49 women, from four hospitals (CH, AUT), completed the questionnaire PACIC-S11 after written information (n = 13) and counseling (n = 36). The delivery of health care was evaluated by ten Advanced Practice Nurses (APNs) by using the G-ACIC before and after implementing counseling based on the WOMAN-PRO II program. Results: There were no significant differences between the two groups identified (p = 0.25). Only few aspects were rated highly by all women, such as the overall satisfaction (M = 80.3 %) and satisfaction with organization of care (M = 83.0 %). The evaluation of delivery of health care by APNs in women who received counseling improved significantly (p = 0.031). Conclusions: There are indications, that the practice of both interventions might have improved patient satisfaction and counseling the delivery of health care. The aspects that have been rated low in the PACIC-S11 and G-ACIC indicate possibilities to optimize the delivery of health care.

  20. The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study.

    Science.gov (United States)

    Raphaelis, Silvia; Mayer, Hanna; Ott, Stefan; Mueller, Michael D; Steiner, Enikö; Joura, Elmar; Senn, Beate

    2017-07-01

    To determine whether written information and/or counseling based on the WOMAN-PRO II Program decreases symptom prevalence in women with vulvar neoplasia by a clinically relevant degree, and to explore the differences between the 2 interventions in symptom prevalence, symptom distress prevalence, and symptom experience. A multicenter randomized controlled parallel-group phase II trial with 2 interventions provided to patients after the initial diagnosis was performed in Austria and Switzerland. Women randomized to written information received a predefined set of leaflets concerning wound care and available healthcare services. Women allocated to counseling were additionally provided with 5 consultations by an Advanced Practice Nurse (APN) between the initial diagnosis and 6months post-surgery that focused on symptom management, utilization of healthcare services, and health-related decision-making. Symptom outcomes were simultaneously measured 5 times to the counseling time points. A total of 49 women with vulvar neoplasia participated in the study. Symptom prevalence decreased in women with counseling by a clinically relevant degree, but not in women with written information. Sporadically, significant differences between the 2 interventions could be observed in individual items, but not in the total scales or subscales of the symptom outcomes. The results indicate that counseling may reduce symptom prevalence in women with vulvar neoplasia by a clinically relevant extent. The observed group differences between the 2 interventions slightly favor counseling over written information. The results justify testing the benefit of counseling thoroughly in a comparative phase III trial. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Pro Hadoop

    CERN Document Server

    Venner, J

    2009-01-01

    You've heard the hype about Hadoop: it runs petabyte--scale data mining tasks insanely fast, it runs gigantic tasks on clouds for absurdly cheap, it's been heavily committed to by tech giants like IBM, Yahoo!, and the Apache Project, and it's completely open source (thus free). But what exactly is it, and more importantly, how do you even get a Hadoop cluster up and running? From Apress, the name you've come to trust for hands--on technical knowledge, Pro Hadoop brings you up to speed on Hadoop. You learn the ins and outs of MapReduce; how to structure a cluster, design, and implement the Hado

  2. 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

  3. 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.

  4. 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

  5. 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

  6. Validity and reliability of the novel thyroid-specific quality of life questionnaire, ThyPRO

    DEFF Research Database (Denmark)

    Watt, Torquil; Hegedüs, Laszlo; Groenvold, Mogens

    2010-01-01

    Background Appropriate scale validity and internal consistency reliability have recently been documented for the new thyroid-specific quality of life (QoL) patient-reported outcome (PRO) measure for benign thyroid disorders, the ThyPRO. However, before clinical use, clinical validity and test......-retest reliability should be evaluated. Aim To investigate clinical ('known-groups') validity and test-retest reliability of the Danish version of the ThyPRO. Methods For each of the 13 ThyPRO scales, we defined groups expected to have high versus low scores ('known-groups'). The clinical validity (known......-groups validity) was evaluated by whether the ThyPRO scales could detect expected differences in a cross-sectional study of 907 thyroid patients. Test-retest reliability was evaluated by intra-class correlations of two responses to the ThyPRO 2 weeks apart in a subsample of 87 stable patients. Results On all 13...

  7. Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea

    Directory of Open Access Journals (Sweden)

    Delgado-Herrera L

    2016-06-01

    Full Text Available Leticia Delgado-Herrera,1 Kathryn Lasch,2 Ana Popielnicki,3 Akito Nishida,4 Rob Arbuckle,5 Benjamin Banderas,6 Susan Zentner,1 Ingrid Gagainis,1 Bernhardt Zeiher1 1Astellas Pharma Global Development, Northbrook, IL, 2Pharmerit International, Newton, MA, USA; 3TransPerfect, Linguistic Validation Group, Boston, MA, USA; 4Development Project Management, Astellas Pharma Inc, Tokyo, Japan; 5Patient-Centered Outcomes Adelphi Values, Bollington, UK; 6Patient-Centered Outcomes Adelphi Values, Boston, MA, USA Background and objective: Following a 2009 US Food and Drug Administration guidance, a new patient-reported outcome (PRO instrument was developed to support end points in multinational clinical trials assessing irritable bowel syndrome with diarrhea (IBS-D symptom severity. Our objective was to assess the translatability of the IBS-D PRO instrument into ten languages, and subsequently perform a cultural adaptation/linguistic validation of the questionnaire into Japanese and US Spanish. Materials and methods: Translatability assessments of the US English version of the IBS-D PRO were performed by experienced PRO translators who were native speakers of each target language and currently residing in target-language countries. Languages were Chinese (People’s Republic of China, Dutch (the Netherlands, French (Belgium, German (Germany, Japanese (Japan, Polish (Poland, Portuguese (Brazil, Russian (Russia, Spanish (Mexico, and Spanish (US. The project team assessed the instrument to identify potential linguistic and/or cultural adaptation issues. After the issues identified were resolved, the instrument was translated into Spanish (US and Japanese through a process of two forward translations, one reconciled translation, and one backward translation. The project team reviewed the translated versions before the instruments were evaluated by cognitive debriefing interviews with samples of five Spanish (US and five Japanese IBS-D patients. Results

  8. 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.

  9. Patient reported outcomes: looking beyond the label claim

    Directory of Open Access Journals (Sweden)

    Doward Lynda C

    2010-08-01

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

  10. Few items in the thyroid-related quality of life instrument ThyPRO exhibited differential item functioning

    DEFF Research Database (Denmark)

    Watt, Torquil; Grønvold, Mogens; Hegedüs, Laszlo

    2014-01-01

    To evaluate the extent of differential item functioning (DIF) within the thyroid-specific quality of life patient-reported outcome measure, ThyPRO, according to sex, age, education and thyroid diagnosis.......To evaluate the extent of differential item functioning (DIF) within the thyroid-specific quality of life patient-reported outcome measure, ThyPRO, according to sex, age, education and thyroid diagnosis....

  11. 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.

  12. 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

  13. Communicating patient-reported outcome scores using graphic formats: results from a mixed-methods evaluation.

    Science.gov (United States)

    Brundage, Michael D; Smith, Katherine C; Little, Emily A; Bantug, Elissa T; Snyder, Claire F

    2015-10-01

    Patient-reported outcomes (PROs) promote patient-centered care by using PRO research results ("group-level data") to inform decision making and by monitoring individual patient's PROs ("individual-level data") to inform care. We investigated the interpretability of current PRO data presentation formats. This cross-sectional mixed-methods study randomized purposively sampled cancer patients and clinicians to evaluate six group-data or four individual-data formats. A self-directed exercise assessed participants' interpretation accuracy and ratings of ease-of-understanding and usefulness (0 = least to 10 = most) of each format. Semi-structured qualitative interviews explored helpful and confusing format attributes. We reached thematic saturation with 50 patients (44 % < college graduate) and 20 clinicians. For group-level data, patients rated simple line graphs highest for ease-of-understanding and usefulness (median 8.0; 33 % selected for easiest to understand/most useful) and clinicians rated simple line graphs highest for ease-of-understanding and usefulness (median 9.0, 8.5) but most often selected line graphs with confidence limits or norms (30 % for each format for easiest to understand/most useful). Qualitative results support that clinicians value confidence intervals, norms, and p values, but patients find them confusing. For individual-level data, both patients and clinicians rated line graphs highest for ease-of-understanding (median 8.0 patients, 8.5 clinicians) and usefulness (median 8.0, 9.0) and selected them as easiest to understand (50, 70 %) and most useful (62, 80 %). The qualitative interviews supported highlighting scores requiring clinical attention and providing reference values. This study has identified preferences and opportunities for improving on current formats for PRO presentation and will inform development of best practices for PRO presentation. Both patients and clinicians prefer line graphs across group-level data and individual

  14. Association of N-terminal pro-B-type natriuretic peptide with contrast-induced nephropathy and long-term outcomes in patients with chronic kidney disease and relative preserved left ventricular function.

    Science.gov (United States)

    Liu, Yuan-hui; Liu, Yong; Zhou, Ying-ling; Yu, Dan-qing; He, Peng-cheng; Xie, Nian-jin; Li, Hua-long; Wei-Guo; Chen, Ji-yan; Tan, Ning

    2015-04-01

    The aim of the present article was to evaluate the association of N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) with contrast-induced nephropathy (CIN) and long-term outcomes in patients with chronic kidney disease (CKD) and relative preserved left ventricular function (LVF) undergoing percutaneous coronary intervention (PCI). We prospectively enrolled 1203 consecutive patients with CKD and preserved LVF undergoing elective PCI. The primary end point was the development of CIN, defined as an absolute increase in serum creatinine (SCr) ≥0.5 mg/dL, from baseline within 48 to 72 hours after contrast medium exposure. CIN incidence varied from 2.2% to 5.2%. Univariate logistic analysis showed that lg-NT-pro-BNP was significantly associated with CIN (odds ratio [OR] = 3.93, 95% confidence interval [CI], 2.22-6.97, P pro-BNP remained a significant predictor of CIN (OR = 3.30, 95% CI, 1.57-6.93, P = 0.002), even after adjusting for potential confounding risk factors. These results were confirmed by using other CIN criteria, which were defined as elevations of the SCr by 25% or 0.5 and 0.3 mg/dL from the baseline. The best cutoff value of lg-NT-pro-BNP for detecting CIN was 2.73 pg/mL (537 pg/mL) with 73.1% sensitivity and 70.0% specificity according to the receiver operating characteristic (ROC) analysis (C statistic = 0.754, 95% CI, 0.67-0.84, P pro-BNP ≥537 pg/mL (2.73 pg/mL, lg-NT-pro-BNP) was associated with an increased risk of all-cause mortality and composite end points during 2.5 years of follow-up. NT-pro-BNP ≥537 pg/mL is independently associated with an increased risk of CIN with different definitions and poor clinical outcomes in patients with CKD and relative preserved LVF undergoing PCI.

  15. 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...

  16. 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.

  17. 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.

  18. Utility of a patient-reported outcome in measuring functional impairment during autologous stem cell transplant in patients with multiple myeloma.

    Science.gov (United States)

    Shah, Nina; Shi, Qiuling; Giralt, Sergio; Williams, Loretta; Bashir, Qaiser; Qazilbash, Muzaffar; Champlin, Richard E; Cleeland, Charles S; Wang, Xin Shelley

    2018-04-01

    We aimed to determine the utility of a patient-reported outcome (PRO) as it relates to patient performed testing (PPT) for measuring functional status in multiple myeloma patients after autologous hematopoietic stem cell transplantation (auto-HCT). Symptom interference on walking (a PRO) was measured by the MD Anderson Symptom Inventory (MDASI). PPT was assessed via 6-min walk test (6MWT). Mixed effects modeling was used to examine (1) the longitudinal relationship between the MDASI score and 6MWT distance and (2) the MDASI scores between patients who did or did not complete the 6WMT. Receiver operating characteristic (ROC) curve analysis was performed to quantify the construct validity of the PRO by differentiating performance status. Seventy-nine patients were included. Mean 6MWT distance significantly correlated with MDASI-walking interference score (PRO) over the first month of auto-HCT (est = 6.09, p = 0.006). There was a significantly higher completion rate for MDASI versus 6MWT at each time point (p Patients who completed the 6MWT reported less interference on walking during the study period (est = 1.61, p patients undergoing auto-HCT. As patients with poorer functional status during therapy are less likely to complete PPT, this PRO may offer a more practical quantitative measure of functioning in patients.

  19. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

    Science.gov (United States)

    Gnanasakthy, Ari; DeMuro, Carla; Clark, Marci; Haydysch, Emily; Ma, Esprit; Bonthapally, Vijayveer

    2016-06-01

    To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging. © 2016 by American Society of Clinical Oncology.

  20. Body hair transplantation: Case report of successful outcome

    Directory of Open Access Journals (Sweden)

    Venkataram Mysore

    2013-01-01

    Full Text Available Transplantation of body hair in to scalp has been suggested as an option to treat extensive cases of baldness with poor donor scalp. However, evidence about its long-term efficacy is yet lacking, with very few published reports and the routine use of the technique is still controversial. We report the satisfactory outcome in a case of extensive baldness in whom hairs from different donor areas such as chest, abdomen, arms, thighs were transplanted on to scalp.

  1. Personality, Organizational Orientations and Self-Reported Learning Outcomes

    Science.gov (United States)

    Bamber, David; Castka, Pavel

    2006-01-01

    Purpose: To identify competencies connecting personality, organizational orientations and self-reported learning outcomes (as measured by concise Likert-type scales), for individuals who are learning for their organizations. Design/methodology/approach: Five concise factor scales were constructed to represent aspects of personality. Three further…

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

    Science.gov (United States)

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

    2013-12-20

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

  3. Assessment of health risks related to the use of a millimetre wave body scanner ProVision 100. Collective expertise report

    International Nuclear Information System (INIS)

    Azoulay, Alain; Debouzy, Jean-Claude; DORe, Jean-Francois; Hours, Martine; Vecchia, Paolo; Fite, Johanna; Saddoki, Sophia; Merckel, Olivier; Telle Lamberton, Maylis

    2010-02-01

    The ProVision 100 is a body scanner which allows images of the whole body to be obtained for safety purposes, without any exposure to ionising radiations, in a reliable and non-intrusive way in comparison with pat-down searching. Its technology is based on the use of so-called 'millimetre' waves, between 24 and 30 GHz. This expertise report is an answer to a public body request for an assessment of health risks related to the use of such a device. The authors first present the context of this investigation, and then present various aspects of waves with a frequency greater than 1 GHz (physical properties, exposure sources, biological effects, health effects, regulation related to public exposure to electromagnetic waves). The ProVision 100 is then presented: operation parameters, emitted power, control capacity, gantry operation, obtained image, gantry usages, other technologies for body scanners). They report the assessment of the exposure of persons scanned by the Provision 100 gantry (assessment of electromagnetic field levels, assessment of exposure to millimetre waves), and the assessment of health risks related to the use of ProVision 100 (depth of penetration of waves into the body, issue of potential thermal and non thermal effects, and of interaction with medical devices). Issues related to privacy and human rights in relationship with the use of body scanners are then briefly discussed

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

    Science.gov (United States)

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

    2017-09-01

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

  5. [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.

  6. N-terminal pro-brain natriuretic peptide and high-sensitivity troponin T exhibit additive prognostic value for the outcome of critically ill patients.

    Science.gov (United States)

    Lenz, Max; Krychtiuk, Konstantin A; Goliasch, Georg; Distelmaier, Klaus; Wojta, Johann; Heinz, Gottfried; Speidl, Walter S

    2018-04-01

    Patients treated at medical intensive care units suffer from various pathologies and often present with elevated troponin T (TnT) and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. Both markers may reflect different forms of cardiac involvement in critical illness. Therefore, the aim of our study was to examine the synergistic prognostic potential of NT-proBNP and high-sensitivity TnT (hs)TnT in unselected critically ill patients. We included all consecutive patients admitted to our intensive care unit within one year, excluding those suffering from acute myocardial infarction or undergoing cardiac surgery and measured NT-proBNP and TnT plasma levels on the day of admission and 72 hours thereafter. Of the included 148 patients, 52% were male, mean age was of 64.2 ± 16.8 years and 30-day mortality was 33.2%. Non-survivors showed significantly higher NT-proBNP and TnT plasma levels as compared with survivors ( pvalue. This might be attributed to a difference in underlying pathomechanisms and an assessment of synergistic risk factors.

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

    Directory of Open Access Journals (Sweden)

    Lasch Kathryn

    2012-04-01

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

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

    NARCIS (Netherlands)

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

    2017-01-01

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

  9. 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.

  10. Micro-CT evaluation of several glide path techniques and ProTaper Next shaping outcomes in maxillary first molar curved canals.

    Science.gov (United States)

    Alovisi, M; Cemenasco, A; Mancini, L; Paolino, D; Scotti, N; Bianchi, C C; Pasqualini, D

    2017-04-01

    To evaluate the ability of ProGlider instruments, PathFiles and K-files to maintain canal anatomy during glide path preparation using X-ray computed micro-tomography (micro-CT). Forty-five extracted maxillary first permanent molars were selected. Mesio-buccal canals were randomly assigned (n = 15) to manual K-file, PathFile or ProGlider groups for glide path preparation. Irrigation was achieved with 5% NaOCl and 10% EDTA. After glide path preparation, each canal was shaped with ProTaper Next X1 and X2 to working length. Specimens were scanned (isotropic voxel size 9.1 μm) for matching volumes and surface areas and post-treatment analyses. Canal volume, surface area, centroid shift, canal geometry variation through ratio of diameter ratios and ratio of cross-sectional areas were assessed in the apical and coronal levels and at the point of maximum canal curvature. One-way factorial anovas were used to evaluate the significance of instrument in the various canal regions. Post-glide path analysis revealed that instrument factor was significant at the apical level for both the ratio of diameter ratios and the ratio of cross-sectional areas (P flare the root canal compared with K-file and PathFile. PathFile and ProGlider demonstrated a significantly lower centroid shift compared with K-file at the apical level (P = 0.023). Post-shaping analysis demonstrated a more centred preparation of ProGlider, compared with PathFile and K-files, with no significant differences for other parameters. Use of ProGlider instruments led to less canal transportation than PathFiles and K-files. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

    Hunter, Robert; Cameron, Rosie; Norrie, John

    2009-02-01

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

  13. Reporting outcomes of back pain trials: a modified Delphi study

    DEFF Research Database (Denmark)

    Froud, R.; Eldridge, S.; Kovacs, F.

    2011-01-01

    trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi......BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain...... process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement. RESULTS: A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes...

  14. 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....

  15. Impact of daily number of urgency urinary incontinence episodes on overactive bladder patient reported outcomes.

    Science.gov (United States)

    Angulo, J C; Brenes, F J; Lizarraga, I; Rejas, J; Trillo, S; Ochayta, D; Arumi, D

    2016-04-01

    To explore the impact of urgency urinary incontinence (UUI) on well-being in non-institutionalized patients with overactive bladder (OAB) in a community sample. A cross-sectional web-based study was conducted in the general population, including males and females, >18 years of age. Patients with probable OAB were identified using a validated algorithm together with a score ≥8 on the OAB-V8 scale. Presence of coping behavior was considered determinant for the clinical diagnosis of OAB. Individual well-being was determined through a battery of patient-reported outcomes (PRO) measurements including assessment of health-related quality of life (EQ-5D), sleep disturbances (MOS Sleep), and life satisfaction (LISAT-8). Patients were grouped according to the number of daily UUI episodes (UUI severity): 0 (dry OAB),1, 2-3, or ≥4. Multivariate analysis to evaluate factors independently affecting quality of life was undertaken. A total of 396 patients (52.5% women, mean age: 55.3 [11.1] years, OAB-V8 mean score: 14.5 [7.9]) out of 2035 subjects participating from the general population met the criteria for OAB: 203 (51.3%) with 0episodes, 119 (30.1%) with 1, 52 (13.1%) with 2 or 3, and 22 (5.6%) with ≥4 episodes. A statistically significant linear adjusted association was found between number of UUI episodes and PRO scores. Participants with more episodes had poorer health profiles and self-evaluated quality of life, worse life satisfaction, and more sleep disturbances and fewer hours of sleep per night. Number of incontinence episodes was independent factor to affect quality of life using both LISAT-8 and MOS questionnaires. Severity of UUI was significantly associated with poorer individual well-being in subjects with OAB in a community sample in Spain. Copyright © 2015 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Tim Croudace

    2016-10-01

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

  17. Troponin T, N-terminal pro natriuretic peptide and a patent ductus arteriosus scoring system predict death before discharge or neurodevelopmental outcome at 2 years in preterm infants.

    LENUS (Irish Health Repository)

    El-Khuffash, Afif F

    2011-03-01

    There is little consensus regarding the use of echocardiography in patent ductus arteriosus (PDA) treatment in preterm infants. The use of troponin T (cTnT) and N-terminal Pro-BNP (NTpBNP) in combination with echocardiography assessment may facilitate the development of a superior predictive model.

  18. Relative Importance of History of Heart Failure Hospitalization and N-Terminal Pro-B-Type Natriuretic Peptide Level as Predictors of Outcomes in Patients With Heart Failure and Preserved Ejection Fraction.

    Science.gov (United States)

    Kristensen, Søren L; Jhund, Pardeep S; Køber, Lars; McKelvie, Robert S; Zile, Michael R; Anand, Inder S; Komajda, Michel; Cleland, John G F; Carson, Peter E; McMurray, John J V

    2015-06-01

    The aim of this study was to investigate N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and recent heart failure (HF) hospitalization as predictors of future events in heart failure - preserved ejection fraction (HF-PEF). Recently, doubt has been expressed about the value of a history of HF hospitalization as a predictor of adverse cardiovascular outcomes in patients with HF and HF-PEF. We estimated rates and adjusted hazard ratios (HRs) for the composite endpoint of cardiovascular death or HF hospitalization, according to history of recent HF hospitalization and baseline NT-proBNP level in the I-PRESERVE (Irbesartan in Heart Failure with Preserved systolic function) trial. Rates of composite endpoints in patients with (n = 804) and without (n = 1,963) a recent HF hospitalization were 12.78 (95% confidence interval [CI]: 11.47 to 14.24) and 4.49 (95% CI: 4.04 to 4.99) per 100 person-years, respectively (HR: 2.71; 95% CI: 2.33 to 3.16). For patients with NT-proBNP concentrations >360 pg/ml (n = 1,299), the event rate was 11.51 (95% CI: 10.54 to 12.58) compared to 3.04 (95% CI: 2.63 to 3.52) per 100 person-years in those with a lower level of NT-proBNP (n = 1468) (HR: 3.19; 95% CI: 2.68 to 3.80). In patients with no recent HF hospitalization and NT-proBNP ≤360 pg/ml (n = 1,187), the event rate was 2.43 (95% CI: 2.03 to 2.90) compared with 17.79 (95% CI: 15.77 to 20.07) per 100 person-years when both risk predictors were present (n = 523; HR: 6.18; 95% CI: 4.96 to 7.69). Recent hospitalization for HF or an elevated level of NT-proBNP identified patients at higher risk for cardiovascular events, and this risk was increased further when both factors were present. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  1. 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.

  2. 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.

  3. 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.

  4. 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...

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

    DEFF Research Database (Denmark)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2017-03-01

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

  7. Gas tax fund and public transit fund outcomes report

    International Nuclear Information System (INIS)

    2009-01-01

    Federal gas tax and public transit agreements were signed in 2005 by the Government of Canada, the Province of Ontario, the Association of Municipalities of Ontario (AMO) and the City of Toronto in order to address long-term community sustainability and invest in municipal infrastructure. The agreement committed to providing $1.9 billion to Ontario municipalities over a 5-year period. An additional $2.4 billion has been provided for a further 4-year period from 2010 to 2014. The funds are used by communities to invest in capacity building or environmentally sustainable municipal infrastructure projects. This report identified the intermediate and ultimate outcomes of the federal gas tax fund and public transit fund as of December 2008. Outcomes were presented in the categories of community energy systems, public transit, water and wastewater, solid waste, and roads and bridges. Funding highlights and economic spin-offs for the projects were also presented, as well as summaries of ancillary social outcomes. 6 tabs., 4 figs.

  8. Pro Sql Azure

    CERN Document Server

    Klein, Scott

    2010-01-01

    SQL Azure represents Microsoft's cloud-based delivery of its enterprise-caliber, SQL Server database management system (formerly under the code name "Oslo"). Pro SQL Azure introduces you to this new platform, showing you how to program and administer it in a variety of cloud computing scenarios. You'll learn to program SQL Azure from Silverlight, ASP.NET, WinForms, and from SQL Reporting Services. You'll also understand how to manage the platform by planning for scalability, troubleshooting performance issues, and implementing strong security. * Shows how to use SQL Azure from Silver

  9. PRO development: rigorous qualitative research as the crucial foundation

    OpenAIRE

    Lasch, Kathryn Eilene; Marquis, Patrick; Vigneux, Marc; Abetz, Linda; Arnould, Benoit; Bayliss, Martha; Crawford, Bruce; Rosa, Kathleen

    2010-01-01

    Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented ...

  10. 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.

  11. Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice.

    Science.gov (United States)

    Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob

    2015-09-01

    Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.

  12. 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.

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

    Science.gov (United States)

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

    2017-09-01

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

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

    Science.gov (United States)

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

    2018-03-01

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

  15. Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments.

    Science.gov (United States)

    Taylor, Fiona; Reasner, David S; Carson, Robyn T; Deal, Linda S; Foley, Catherine; Iovin, Ramon; Lundy, J Jason; Pompilus, Farrah; Shields, Alan L; Silberg, Debra G

    2016-10-01

    The aim was to document, from the perspective of the empirical literature, the primary symptoms of functional dyspepsia (FD), evaluate the extent to which existing questionnaires target those symptoms, and, finally, identify any missing evidence that would impact the questionnaires' use in regulated clinical trials to assess treatment efficacy claims intended for product labeling. A literature review was conducted to identify the primary symptoms of FD and existing symptom-based FD patient-reported outcome (PRO) instruments. Following a database search, abstracts were screened and articles were retrieved for review. The primary symptoms of FD were organized into a conceptual model and the PRO instruments were evaluated for conceptual coverage as well as compared against evidentiary requirements presented in the FDA's PRO Guidance for Industry. Fifty-six articles and 16 instruments assessing FD symptoms were reviewed. Concepts listed in the Rome III criteria for FD (n = 7), those assessed by existing FD instruments (n = 34), and symptoms reported by patients in published qualitative research (n = 6) were summarized in the FD conceptual model. Except for vomiting, all of the identified symptoms from the published qualitative research reports were also specified in the Rome III criteria. Only three of the 16 instruments, the Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI), measure all seven FD symptoms defined by the Rome III criteria. Among these three, each utilizes a 2-week recall period and 5-point Likert-type scale, and had evidence of patient involvement in development. Despite their coverage, when these instruments were evaluated in light of regulatory expectations, several issues jeopardized their potential qualification for substantiation of a labeling claim. No existing PRO instruments that measured all seven symptoms adhered to the regulatory principles necessary to support product

  16. 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...

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

    Science.gov (United States)

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

    2014-01-01

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

  18. 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.

  19. Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems.

    Science.gov (United States)

    Winnette, Randall; Zárate, Victor; Machnicki, Gerardo; DeMuro, Carla; Gawlicki, Mary; Gnanasakthy, Ari

    2015-12-01

    Patient-reported outcomes (PROs) are increasingly used to demonstrate the value of interventions and support health technology assessment (HTA). The objective of this work was to analyze trends regarding PROs in Latin America (LatAm), highlight challenges in the application of PROs in this region, and suggest solutions. A team of researchers with expertise in PROs conducted a nonsystematic PubMed literature search pertaining to the use of PROs in LatAm. The experts also drew on their experience working with PROs to assess the application of PROs in LatAm. The literature search yielded more than 4000 publications, with an increasing publication rate in recent years. PROs are being used in LatAm in various study types: instrument validation, phase III international clinical trials, health service research. A large Inter-American Development Bank study demonstrates the growing importance of PROs in the region. The growth in local value sets for the EuroQol five-dimensional questionnaire in LatAm reflects the regional emergence of HTA systems. Operational challenges relate to ensuring the use of good-quality questionnaires that, at a minimum, have undergone appropriate cultural adaptation and ideally have established psychometric properties. PROs are increasingly important in LatAm. Future efforts should aim to strengthen the operational and research infrastructure around PROs in the region. Innovation should be encouraged, including studying alternative methods of eliciting health utilities for economic evaluation. A wider scope around PRO uses for decision making by HTA bodies is an international trend with potential positive prospects in LatAm. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  20. 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.

  1. 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.

  2. Pro Tools HD

    CERN Document Server

    Camou, Edouard

    2013-01-01

    An easy-to-follow guide for using Pro Tools HD 11 effectively.This book is ideal for anyone who already uses ProTools and wants to learn more, or is new to Pro Tools HD and wants to use it effectively in their own audio workstations.

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

    DEFF Research Database (Denmark)

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

    2017-01-01

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

  4. Hyperammonemia: A Report of Maternal Biliary Cirrhosis and Neonatal Outcome

    Directory of Open Access Journals (Sweden)

    Deana J. Hussamy

    2013-01-01

    Full Text Available Although uncommon during pregnancy, cirrhosis results in multiple medical complications impacting both mother and fetus. Previous reports suggest liver dysfunction in pregnancy causes accumulation of neurotoxins within the maternal compartment that increases neonatal morbidity through placental transfer. We present a case of a 36-year-old G2P1 female with history of biliary cirrhosis presenting at 32-weeks' gestation with hepatic congestion progressing to hepatic encephalopathy prompting delivery. Umbilical cord sampling and postnatal infant testing demonstrated elevated ammonia levels which resolved by 12 hours of life without intervention. At discharge, the infant did not demonstrate evidence of neurologic deficit. We conclude that acute maternal hepatic encephalopathy and hyperammonemia due to chronic liver disease do not portend adverse neonatal outcomes, notably encephalopathy.

  5. Patient-reported outcome measures in arthroplasty registries

    DEFF Research Database (Denmark)

    Rolfson, Ola; Bohm, Eric; Franklin, Patricia

    2016-01-01

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

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

    Science.gov (United States)

    Anfray, Caroline

    2009-12-01

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

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

    Science.gov (United States)

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

    2015-07-01

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

  8. What are the appropriate methods for analyzing patient-reported outcomes in randomized trials when data are missing?

    Science.gov (United States)

    Hamel, J F; Sebille, V; Le Neel, T; Kubis, G; Boyer, F C; Hardouin, J B

    2017-12-01

    Subjective health measurements using Patient Reported Outcomes (PRO) are increasingly used in randomized trials, particularly for patient groups comparisons. Two main types of analytical strategies can be used for such data: Classical Test Theory (CTT) and Item Response Theory models (IRT). These two strategies display very similar characteristics when data are complete, but in the common case when data are missing, whether IRT or CTT would be the most appropriate remains unknown and was investigated using simulations. We simulated PRO data such as quality of life data. Missing responses to items were simulated as being completely random, depending on an observable covariate or on an unobserved latent trait. The considered CTT-based methods allowed comparing scores using complete-case analysis, personal mean imputations or multiple-imputations based on a two-way procedure. The IRT-based method was the Wald test on a Rasch model including a group covariate. The IRT-based method and the multiple-imputations-based method for CTT displayed the highest observed power and were the only unbiased method whatever the kind of missing data. Online software and Stata® modules compatibles with the innate mi impute suite are provided for performing such analyses. Traditional procedures (listwise deletion and personal mean imputations) should be avoided, due to inevitable problems of biases and lack of power.

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

    Science.gov (United States)

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

    2012-01-01

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

  10. Micro-Computed Tomography Evaluation of ProTaper Next and BioRace Shaping Outcomes in Maxillary First Molar Curved Canals.

    Science.gov (United States)

    Pasqualini, Damiano; Alovisi, Mario; Cemenasco, Andrea; Mancini, Lucia; Paolino, Davide Salvatore; Bianchi, Caterina Chiara; Roggia, Andrea; Scotti, Nicola; Berutti, Elio

    2015-10-01

    The aim of this micro-computed tomography study was to describe the shaping properties of ProGlider/ProTaper Next (PG/PTN) and ScoutRace/BioRace (SR/BR) nickel-titanium rotary systems. Thirty maxillary first permanent molars were selected. Mesiobuccal canals were randomly assigned (n = 15) to PG/PTN or SR/BR groups. Irrigation was performed with 5% NaOCl and 10% EDTA. Specimens were scanned (voxel size, 9.1 μm) for matching volumes and surface areas and post-treatment analyses. Root canal centering ability, canal geometry enlargement, and thickness of dentinal wall at inner curvature were assessed at apical level and point of maximum curvature. Results were analyzed with 4 one-way analyses of variance. Canal centering ability was superior in PG/PTN (P = .006 at apical level, P = .025 at point of maximum curvature). PG/PTN demonstrated a more conservative increase of canal areas (P = .027 at apical level, P = .038 at point of maximum curvature). Centrifugal increase in canal diameters did not significantly differ between groups (P = .65 at apical level, P = .61 at point of maximum curvature). Inner dentinal wall thickness was less reduced with PG/PTN compared with SR/BR, with no statistical differences (P = .23 at point of maximum curvature, P = .89 at apical level). PG/PTN shaping taper ranged between 6% and 7%. Neither system produced significant shaping errors in curved canals. PG/PTN system showed better preservation of canal anatomy. PTN offset section did not influence final preparation taper. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  11. 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.

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

    Science.gov (United States)

    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.

  13. HUMAN HEALTH OUTCOMES AND ACCOUNTABILITY - RISK POLICY REPORT

    Science.gov (United States)

    EPA is identifying human health "outcomes" as part of a significant shift in how the Agency frames questions and assesses its impact on environmental quality. These outcomes, while complementing traditional process indicators such as decreases in emissions, discharges and pollut...

  14. Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop.

    Science.gov (United States)

    Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C; Evangelidis, Nicole; Tugwell, Peter; Crowe, Sally; Van Biesen, Wim; Winkelmayer, Wolfgang C; O'Donoghue, Donal; Tam-Tham, Helen; Shen, Jenny I; Pinter, Jule; Larkins, Nicholas; Youssouf, Sajeda; Mandayam, Sreedhar; Ju, Angela; Craig, Jonathan C

    2017-01-01

    Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  15. Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Consensus Workshop

    Science.gov (United States)

    Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C.; Evangelidis, Nicole; Tugwell, Peter; Crowe, Sally; Van Biesen, Wim; Winkelmayer, Wolfgang C.; O’Donoghue, Donal; Tam-Tham, Helen; Shen, Jenny; Pinter, Jule; Larkins, Nicholas; Youssouf, Sajeda; Mandayam, Sreedhar; Ju, Angela; Craig, Jonathan C.

    2017-01-01

    Evidence-informed decision-making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient-centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis. Key stakeholders including eight patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations; flexibility to consider evolving priorities over time; deconstruction of language and meaning for conceptual consistency and clarity; understanding of potential overlap and associations between outcomes; and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive and validated outcome measures that could be used in clinical care (quality ndicators) and trials (including pragmatic trials), and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment, and improved patient outcomes. PMID:27497527

  16. RAAK PRO project: measuring safety in aviation : concept for the design of new metrics

    NARCIS (Netherlands)

    Karanikas, Nektarios; Kaspers, Steffen; Roelen, Alfred; Piric, Selma; van Aalst, Robbert; de Boer, Robert

    2017-01-01

    Following the completion of the 1st phase of the RAAK PRO project Aviation Safety Metrics, during which the researchers mapped the current practice in safety metrics and explored the validity of monotonic relationships of SMS, activity and demographic metrics with safety outcomes, this report

  17. FileMaker Pro 9

    CERN Document Server

    Coffey, Geoff

    2007-01-01

    FileMaker Pro 9: The Missing Manual is the clear, thorough and accessible guide to the latest version of this popular desktop database program. FileMaker Pro lets you do almost anything with the information you give it. You can print corporate reports, plan your retirement, or run a small country -- if you know what you're doing. This book helps non-technical folks like you get in, get your database built, and get the results you need. Pronto.The new edition gives novices and experienced users the scoop on versions 8.5 and 9. It offers complete coverage of timesaving new features such as the Q

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

    Science.gov (United States)

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

    2008-10-16

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

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

    Directory of Open Access Journals (Sweden)

    Draelos Zoe

    2008-10-01

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

  20. p.Ser252Trp and p.Pro253Arg mutations in FGFR2 gene causing Apert syndrome: the first clinical and molecular report of Indonesian patients.

    Science.gov (United States)

    Mundhofir, Farmaditya E P; Sistermans, Erik A; Faradz, Sultana M H; Hamel, Ben C J

    2013-03-01

    Apert syndrome (AS) is a rare autosomal dominant disorder characterised by craniosynostosis and limb malformations, and is associated with congenital heart disease and other systemic malformations, including intellectual disability. We report two Indonesian patients with AS, in whom molecular analysis detected p.Ser252Trp (c.755C>G) and p.Pro253Arg (c.758C>G) mutations in the fibroblast growth factor receptor 2 (FGFR2) gene, respectively. Although the syndrome has been frequently described, this is the first clinical report of AS confirmed by molecular analysis in Indonesia. The difference in severity of clinical features in the two patients may be consistent with a genotype-phenotype correlation of the FGFR2mutation. The management of individuals with AS is best achieved within a multidisciplinary setting. However, in most developing countries, early intervention may be delayed due to late diagnosis, a lack of facilities and financial constraints. This report underpins the benefits of early diagnosis for AS management.

  1. Acquired spondylolysis after implantation of a lumbar ProDisc II prosthesis: case report and review of the literature.

    Science.gov (United States)

    Schulte, Tobias L; Lerner, Thomas; Hackenberg, Lars; Liljenqvist, Ulf; Bullmann, Viola

    2007-10-15

    A case of acquired lumbar spondylolysis following lumbar disc arthroplasty L5-S1 in an 40-year-old woman and review of the literature. To present and discuss a case of acquired lumbar spondylolysis after implantation of an artificial disc L5-S1 that may have impaired a good clinical result requiring additional posterior lumbar instrumentation and fusion in order to improve understanding of this condition and to propose an effective method of surgical management. Lumbar disc arthroplasty is a possible surgical option for patients with degenerative disc disease. Acquired spondylolysis is a rare but known complication of spinal fusion but has never been described as a consequence of mobile disc arthroplasty. The authors present the first case in the literature who developed this complication. A 40-year-old woman with severe osteochondrosis L5-S1 and discogenic lumbar back pain underwent implantation of an artificial disc. Surgery and postoperative course were uneventful and the patient improved significantly as for back pain and mobility. Eighteen months after surgery, the patient was again admitted to our outpatient clinic for back pain that had slowly increased over time. The radiologic workup showed a new spondylolysis L5 without a spondylolisthesis. Because of unsuccessful conservative treatment, the patient underwent posterior lumbar instrumentation and fusion L5-S1, leading to a significant pain reduction and a good clinical outcome. Spine surgeons should be aware of the possibility of lumbar disc arthroplasty to induce acquired spondylolysis impairing good clinical results.

  2. 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.

  3. 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.

  4. Content Validity of the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q): A Patient-Reported Outcome Measure to Evaluate Symptoms of Hypogonadism.

    Science.gov (United States)

    Gelhorn, Heather L; Vernon, Margaret K; Stewart, Katie D; Miller, Michael G; Brod, Meryl; Althof, Stanley E; DeRogatis, Leonard R; Dobs, Adrian; Seftel, Allen D; Revicki, Dennis A

    2016-04-01

    Hypogonadism, or low testosterone, is a common disorder. There are currently no patient-reported outcome (PRO) instruments designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. The purpose of this study was to develop a PRO instrument, the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) and to assess its content validity. A literature review, expert clinician input, and qualitative concept elicitation with 39 male hypogonadism patients (four focus groups: n = 25; individual interviews: n = 14; mean age 52.3 ± 14.3 years) from the USA were used to develop the draft HIS-Q. Subsequent cognitive interviews (n = 29; mean age 51.5 ± 15.4 years) were used to evaluate content validity. Emergent discussion with participants yielded symptoms within the sexual, physical, energy, sleep, cognition, and mood domains. Low libido and tiredness were most commonly reported. The initial version of the HIS-Q includes 53 items that were consistently understood by the participants, who found the instrument to be relevant to their experiences with hypogonadism and comprehensive in the content coverage of symptoms. The HIS-Q is a comprehensive PRO measure of hypogonadism symptom severity in males. Its design elements, including the response options and recall period, were suitable, and content validity was confirmed.

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

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

    2018-04-18

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

  7. 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....

  8. Core outcome sets in dermatology: report from the second meeting of the International Cochrane Skin Group Core Outcome Set Initiative.

    Science.gov (United States)

    Kottner, J; Jacobi, L; Hahnel, E; Alam, M; Balzer, K; Beeckman, D; Busard, C; Chalmers, J; Deckert, S; Eleftheriadou, V; Furlan, K; Horbach, S E R; Kirkham, J; Nast, A; Spuls, P; Thiboutot, D; Thorlacius, L; Weller, K; Williams, H C; Schmitt, J

    2018-04-01

    Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers. © 2018 British Association of Dermatologists.

  9. PRO development: rigorous qualitative research as the crucial foundation.

    Science.gov (United States)

    Lasch, Kathryn Eilene; Marquis, Patrick; Vigneux, Marc; Abetz, Linda; Arnould, Benoit; Bayliss, Martha; Crawford, Bruce; Rosa, Kathleen

    2010-10-01

    Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented at all, most PRO validation articles give little for the reader to evaluate the content validity of the measures and the credibility and trustworthiness of the methods used to develop them. Increasingly, however, scientists and authorities want to be assured that PRO items and scales have meaning and relevance to subjects. This article was developed by an international, interdisciplinary group of psychologists, psychometricians, regulatory experts, a physician, and a sociologist. It presents rigorous and appropriate qualitative research methods for developing PROs with content validity. The approach described combines an overarching phenomenological theoretical framework with grounded theory data collection and analysis methods to yield PRO items and scales that have content validity.

  10. Improving energy audit process and report outcomes through planning initiatives

    Science.gov (United States)

    Sprau Coulter, Tabitha L.

    Energy audits and energy models are an important aspect of the retrofit design process, as they provide project teams with an opportunity to evaluate a facilities current building systems' and energy performance. The information collected during an energy audit is typically used to develop an energy model and an energy audit report that are both used to assist in making decisions about the design and implementation of energy conservation measures in a facility. The current lack of energy auditing standards results in a high degree of variability in energy audit outcomes depending on the individual performing the audit. The research presented is based on the conviction that performing an energy audit and producing a value adding energy model for retrofit buildings can benefit from a revised approach. The research was divided into four phases, with the initial three phases consisting of: 1.) process mapping activity - aimed at reducing variability in the energy auditing and energy modeling process. 2.) survey analysis -- To examine the misalignment between how industry members use the top energy modeling tools compared to their intended use as defined by software representatives. 3.) sensitivity analysis -- analysis of the affect key energy modeling inputs are having on energy modeling analysis results. The initial three phases helped define the need for an improved energy audit approach that better aligns data collection with facility owners' needs and priorities. The initial three phases also assisted in the development of a multi-criteria decision support tool that incorporates a House of Quality approach to guide a pre-audit planning activity. For the fourth and final research phase explored the impacts and evaluation methods of a pre-audit planning activity using two comparative energy audits as case studies. In each case, an energy audit professionals was asked to complete an audit using their traditional methods along with an audit which involved them first

  11. Excluding infection through procalcitonin testing improves outcomes of congestive heart failure patients presenting with acute respiratory symptoms: results from the randomized ProHOSP trial.

    Science.gov (United States)

    Schuetz, Philipp; Kutz, Alexander; Grolimund, Eva; Haubitz, Sebastian; Demann, Désirée; Vögeli, Alaadin; Hitz, Fabienne; Christ-Crain, Mirjam; Thomann, Robert; Falconnier, Claudine; Hoess, Claus; Henzen, Christoph; Marlowe, Robert J; Zimmerli, Werner; Mueller, Beat

    2014-08-20

    We sought to determine whether exclusion of infection and antibiotic stewardship with the infection biomarker procalcitonin improves outcomes in congestive heart failure (CHF) patients presenting to emergency departments with respiratory symptoms and suspicion of respiratory infection. We performed a secondary analysis of patients with a past medical history of CHF formerly included in a Swiss multicenter randomized-controlled trial. The trial compared antibiotic stewardship according to a procalcitonin algorithm or state-of-the-art guidelines (controls). The primary endpoint was a 30-day adverse outcome (death, intensive care unit admission); the secondary endpoints included a 30-day antibiotic exposure. In the 110/233 analyzed patients (47.2%) with low initial procalcitonin (<0.25 μg/L), suggesting the absence of systemic bacterial infection, those randomized to procalcitonin guidance (n=50) had a significantly lower adverse outcome rate compared to controls (n=60): 4% vs. 20% (absolute difference -16.0%, 95% confidence interval (CI) -28.4% to -3.6%, P=0.01), and significantly reduced antibiotic exposure [days] (mean 3.7 ± 4.0 vs. 6.5 ± 4.4, difference -2.8 [95% CI, -4.4 to -1.2], P<0.01). When initial procalcitonin was ≥0.25 μg/L, procalcitonin-guided patients had significantly reduced antibiotic exposure due to early stop of therapy without any difference in adverse outcomes (25.8% vs. 24.6%, difference [95% CI] 1.2% [-14.5% to 16.9%, P=0.88]). CHF patients presenting to the emergency department with respiratory symptoms and suspicion for respiratory infection had decreased antibiotic exposure and improved outcomes when procalcitonin measurement was used to exclude bacterial infection and guide antibiotic treatment. These data provide further evidence for the potential harmful effects of antibiotic / fluid treatment when used instead of diuretics and heart failure medication in clinically symptomatic CHF patients without underlying infection. Copyright

  12. Surfing for thinness: a pilot study of pro-eating disorder Web site usage in adolescents with eating disorders.

    Science.gov (United States)

    Wilson, Jenny L; Peebles, Rebecka; Hardy, Kristina K; Litt, Iris F

    2006-12-01

    Pro-eating disorder Web sites are communities of individuals who engage in disordered eating and use the Internet to discuss their activities. Pro-recovery sites, which are less numerous, express a recovery-oriented perspective. This pilot study investigated the awareness and usage of pro-eating disorder Web sites among adolescents with eating disorders and their parents and explored associations with health and quality of life. This was a cross-sectional study of 698 families of patients (aged 10-22 years) diagnosed with an eating disorder at Stanford between 1997 and 2004. Anonymous surveys were mailed and offered in clinic. Survey content included questions about disease severity, health outcomes, Web site usage, and parental knowledge of eating disorder Web site usage. Surveys were returned by 182 individuals: 76 patients and 106 parents. Parents frequently (52.8%) were aware of pro-eating disorder sites, but an equal number did not know whether their child visited these sites, and only 27.6% had discussed them with their child. Most (62.5%) parents, however, did not know about pro-recovery sites. Forty-one percent of patients visited pro-recovery sites, 35.5% visited pro-eating disorder sites, 25.0% visited both, and 48.7% visited neither. While visiting pro-eating disorder sites, 96.0% reported learning new weight loss or purging techniques. However, 46.4% of pro-recovery site visitors also learned new techniques. Pro-eating disorder site users did not differ from nonusers in health outcomes but reported spending less time on school or schoolwork and had a longer duration of illness. Users of both pro-eating disorder and pro-recovery sites were hospitalized more than users of neither site. Pro-eating disorder site usage was prevalent among adolescents with eating disorders, yet parents had little knowledge of this. Although use of these sites was not associated with other health outcomes, usage may have a negative impact on quality of life and result in

  13. Post-Inpatient Brain Injury Rehabilitation Outcomes: Report from the National OutcomeInfo Database

    OpenAIRE

    Malec, James F.; Kean, Jacob

    2016-01-01

    This study examined outcomes for intensive residential and outpatient/community-based post-inpatient brain injury rehabilitation (PBIR) programs compared with supported living programs. The goal of supported living programs was stable functioning (no change). Data were obtained for a large cohort of adults with acquired brain injury (ABI) from the OutcomeInfo national database, a web-based database system developed through National Institutes of Health (NIH) Small Business Technology Transfer...

  14. Measurement properties of ThyPRO short-form (ThyPRO-39) for use in Chinese patients with benign thyroid diseases.

    Science.gov (United States)

    Wong, Carlos K H; Choi, Edmond P H; Woo, Y C; Lang, Brian H H

    2018-04-18

    To evaluate the validity and reliability of a newly-translated Thyroid-specific Patient-Reported Outcome short-form (ThyPRO-39) instrument for ethnic-Chinese patients suffering from benign thyroid diseases. The translation and cross-cultural adaptation of the English ThyPRO-39 were performed using the double forward translation, reconciliation, single backward translation, and cognitive debriefing, followed by a panel review. Cross-sectional data of 308 patients with benign thyroid diseases were utilized for this psychometric evaluation of ThyPRO-39 instrument. Convergent validity between similar construct in the ThyPRO-39, SF-6D, and SF-12v2 was assessed using Spearman correlations. The internal construct validity was assessed by corrected item-total correlations. Sensitivity of the ThyPRO-39 domain scores was determined by performing known group comparisons by independent t test. The internal consistency reliability was assessed by Cronbach's alpha coefficient. Significant floor effects were observed in 9 out of 13 domains of the ThyPRO-39. The hypothesized correlations between similar constructs in the ThyPRO-39 and the SF-12v2 and SF-6D were generally observed, supporting convergent validity. The internal construct validity was supported in most items, except eight items in six scales. Scale score of hyperthyroid symptoms of the ThyPRO-39 was significantly higher in the group with Graves' disease or hyperthyroid disease than the group without Graves' disease nor hyperthyroid disease. Scale scores of eye symptoms and impaired daily life were significantly higher in the incidental group than the non-incidental group. For six domains (hyperthyroid symptoms, hypothyroid symptoms, eye symptoms, tiredness, depressivity, and emotional susceptibility), Cronbach's alpha did not reach the recommended standard of 0.7. This was the first psychometric study to translate and adapt the ThyPRO-39 instrument for non-Caucasian patients, and report its validity and reliability

  15. 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.

  16. 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...

  17. 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...

  18. Which is the most useful patient-reported outcome in femoroacetabular impingement? Test-retest reliability of six questionnaires.

    Science.gov (United States)

    Hinman, Rana S; Dobson, Fiona; Takla, Amir; O'Donnell, John; Bennell, Kim L

    2014-03-01

    The most reliable patient-reported outcomes (PROs) for people with femoroacetabular impingement (FAI) is unknown because there have been no direct comparisons of questionnaires. Thus, the aim was to evaluate the test-retest reliability of six existing PROs in a single cohort of young active people with hip/groin pain consistent with a clinical diagnosis of FAI. Young adults with clinical FAI completed six PRO questionnaires on two occasions, 1-2 weeks apart. The PROs were modified Harris Hip Score, Hip dysfunction and Osteoarthritis Score, Hip Outcome Score, Non-Arthritic Hip Score, International Hip Outcome Tool, Copenhagen Hip and Groin Outcome Score. 30 young adults (mean age 24 years, SD 4 years, range 18-30 years; 15 men) with stable symptoms participated. Intraclass correlation coefficient(3,1) values ranged from 0.73 to 0.93 (95% CI 0.38 to 0.98) indicating that most questionnaires reached minimal reliability benchmarks. Measurement error at the individual level was quite large for most questionnaires (minimal detectable change (MDC95) 12.4-35.6, 95% CI 8.7 to 54.0). In contrast, measurement error at the group level was quite small for most questionnaires (MDC95 2.2-7.3, 95% CI 1.6 to 11). The majority of the questionnaires were reliable and precise enough for use at the group level. Samples of only 23-30 individuals were required to achieve acceptable measurement variation at the group level. Further direct comparisons of these questionnaires are required to assess other measurement properties such as validity, responsiveness and meaningful change in young people with FAI.

  19. Pro-social Motivation beyond Firm Boundaries

    DEFF Research Database (Denmark)

    Foss, Nicolai; Milagres, Rosileia

    2014-01-01

    , contradicting the above argument. More constructively, the case of the Genolyptus network points to the importance of intensive communication, rewards that are tied to joint outcomes, knowledge-based authority and consensual decision-making as support arrangements that can build and sustain pro......An influential body of literature in macro-management research (notably, organization theory and strategic management) associates pro-social motivation solely with firm-like organizations, suggesting that such motivation cannot thrive under more market-like arrangements. We question this argument...... on theoretical, as well as empirical, grounds. As to the latter, we discuss the specific case of a network of firms in Brazil, the Genolyptus network. We argue that this particular network manifests strong pro-social motivations. This implies that pro-social motivations may thrive beyond corporate boundaries...

  20. The Impact of Participation in Online Cancer Communities on Patient Reported Outcomes: Systematic Review.

    Science.gov (United States)

    van Eenbergen, Mies C; van de Poll-Franse, Lonneke V; Heine, Peter; Mols, Floortje

    2017-09-28

    In recent years, the question of how patients' participating in online communities affects various patient reported outcomes (PROs) has been investigated in several ways. This study aimed to systematically review all relevant literature identified using key search terms, with regard to, first, changes in PROs for cancer patients who participate in online communities and, second, the characteristics of patients who report such effects. A computerized search of the literature via PubMed (MEDLINE), PsycINFO (5 and 4 stars), Cochrane Central Register of Controlled Trials, and ScienceDirect was performed. Last search was conducted in June 2017. Studies with the following terms were included: (cancer patient) and (support group or health communities) and (online or Internet). A total of 21 studies were included and independently assessed by 2 investigators using an 11-item quality checklist. The methodological quality of the selected studies varied: 12 were of high quality, eight were of adequate quality, and only one was of low quality. Most of the respondents were women (about 80%), most with breast cancer; their mean age was 50 years. The patients who were active in online support groups were mostly younger and more highly educated than the nonusers. The investigated PROs included general well-being (ie, mood and health), anxiety, depression, quality of life, posttraumatic growth, and cancer-related concerns. Only marginal effects-that is, PRO improvements-were found; in most cases they were insignificant, and in some cases they were contradictory. The main shortcoming of this kind of study is the lack of methodological instruments for reliable measurements. Furthermore, some patients who participate in online communities or interact with peers via Internet do not expect to measure changes in their PROs. If cancer survivors want to meet other survivors and share information or get support, online communities can be a trustworthy and reliable platform to facilitate

  1. [Pro Familia statistics for 1974].

    Science.gov (United States)

    1975-09-01

    Statistics for 1974 for the West German family planning organization Pro Familia are reported. 56 offices are now operating, and 23,726 clients were seen. Men were seen more frequently than previously. 10,000 telephone calls were also handled. 16-25 year olds were increasingly represented in the clientele, as were unmarried persons of all ages. 1,242 patients were referred to physicians or clinics for clinical diagnosis.

  2. 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.

  3. Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews.

    Science.gov (United States)

    Saini, Pooja; Loke, Yoon K; Gamble, Carrol; Altman, Douglas G; Williamson, Paula R; Kirkham, Jamie J

    2014-11-21

    To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews. Cohort study of systematic reviews from two databases. Outcome reporting bias in trials for harm outcomes (ORBIT II) in systematic reviews from the Cochrane Library and a separate cohort of systematic reviews of adverse events. 92 systematic reviews of randomised controlled trials and non-randomised studies published in the Cochrane Library between issue 9, 2012 and issue 2, 2013 (Cochrane cohort) and 230 systematic reviews published between 1 January 2007 and 31 December 2011 in other publications, synthesising data on harm outcomes (adverse event cohort). A 13 point classification system for missing outcome data on harm was developed and applied to the studies. 86% (79/92) of reviews in the Cochrane cohort did not include full data from the main harm outcome of interest of each review for all of the eligible studies included within that review; 76% (173/230) for the adverse event cohort. Overall, the single primary harm outcome was inadequately reported in 76% (705/931) of the studies included in the 92 reviews from the Cochrane cohort and not reported in 47% (4159/8837) of the 230 reviews in the adverse event cohort. In a sample of primary studies not reporting on the single primary harm outcome in the review, scrutiny of the study publication revealed that outcome reporting bias was suspected in nearly two thirds (63%, 248/393). The number of reviews suspected of outcome reporting bias as a result of missing or partially reported harm related outcomes from at least one eligible study is high. The declaration of important harms and the quality of the reporting of harm outcomes must be improved in both primary studies and systematic reviews. © Saini et al 2014.

  4. 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.

  5. Impact of septate uterus on obstetric outcome: case report | Ondieki ...

    African Journals Online (AJOL)

    Septate uterus is mostly seen in women with infertility and recurrent pregnancy wastage. Reproductive outcome in women with septate uterus includes increased incidence of spontaneous abortion, premature birth, and abnormal foetal presentations. (1, 2) A case of septate uterus is presented and literature reviewed.

  6. 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...

  7. 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...

  8. Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design?

    Directory of Open Access Journals (Sweden)

    Jennifer Ai-Lian Woo

    2015-03-01

    Full Text Available Purpose: Stereotactic body radiation therapy (SBRT is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO endpoints for clinical trials for early stage prostate cancer RT is lacking. To aid in trial design, this study presents PROs over 36 months following SBRT for clinically localized prostate cancer. Methods: 174 hormone-naïve patients were treated with 35-36.25 Gy SBRT in 5 fractions. Patients completed the EPIC-26 questionnaire at baseline and all follow-ups; the proportion of patients developing a clinically significant decline in each EPIC domain was determined. The minimally important difference (MID was defined as a change of one-half SD from the baseline. Per RTOG 0938, we examined the percentage of patients who reported decline in EPIC urinary summary score of >2 points and EPIC bowel summary score of >5 points from baseline to one year. Results: 174 patients received SBRT with minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline in EPIC urinary/bowel scores was 34%/30%, 40%/32.2%, and 32.8%/21.5% at 6, 12, and 36 months. The percentage of patients reporting decline in the EPIC urinary summary score of >2 points was 43.2%, 51.6% and 41.8% at 6, 12, and 36 months. The percentage of patients reporting decline in EPIC bowel domain summary score of >5 points was 29.6% 29% and 22.4% at 6, 12, and 36 months. Conclusion: Our treatment protocol meets the RTOG 0938 criteria for advancing to a Phase III trial compared to conventionally fractionated RT. Between 12-36 months, the proportion of patients reporting decrease in both EPIC urinary and bowel scores declined, suggesting late improvement in these domains. Further investigation is needed to elucidate 1 which domains bear the greatest influence on post-treatment QOL, and 2 at what time point PRO endpoint(s should be assessed.

  9. Multidisciplinary rehabilitation can impact on health-related quality of life outcome in radical cystectomy: secondary reported outcome of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jensen BT

    2014-07-01

    on global HRQoL due to a physical rehabilitation program. However, pre- and postoperative physical rehabilitation can significantly and positively impact on HRQoL aspects related to bowel management and respiratory function (dyspnea without compromising inpatient satisfaction. These results highlight the role of multimodal rehabilitation, including physical exercises in fast-track RC. Keywords: rehabilitation, bladder cancer, health-related quality of life, physical exercise, patient-reported outcome (PRO

  10. Pixel or Paper? Validation of a Mobile Technology for Collecting Patient-Reported Outcomes in Rheumatoid Arthritis.

    Science.gov (United States)

    Epis, Oscar Massimiliano; Casu, Cinzia; Belloli, Laura; Schito, Emanuela; Filippini, Davide; Muscarà, Marina; Gentile, Maria Giovanna; Perez Cagnone, Paula Carina; Venerelli, Chiara; Sonnati, Massimo; Schiavetti, Irene; Bruschi, Eleonora

    2016-11-16

    In the management of chronic disease, new models for telemonitoring of patients combined with the choice of electronic patient-reported outcomes (ePRO) are being encouraged, with a clear improvement of both patients' and parents' quality of life. An Italian study demonstrated that ePRO were welcome in patients with rheumatoid arthritis (RA), with excellent matching data. The aim of this study is to evaluate the level of agreement between electronic and paper-and-pencil questionnaire responses. This is an observational prospective study. Patients were randomly assigned to first complete the questionnaire by paper and pencil and then by tablet or in the opposite order. The questionnaire consisted of 3 independent self-assessment visual rating scales (Visual Analog Scale, Global Health score, Patient Global Assessment of Disease Activity) commonly used in different adult patients, including those with rheumatic diseases. A total of 185 consecutive RA patients were admitted to hospital and were enrolled and completed the questionnaire both on paper and on electronic versions. For all the evaluated items, the intrarater degree of agreement between 2 approaches was found to be excellent (intraclass correlation coefficient>0.75, P<.001). An electronic questionnaire is uploaded in a dedicated Web-based tool that could implement a telemonitoring system aimed at improving the follow-up of RA patients. High intrarater reliability between paper and electronic methods of data collection encourage the use of a new digital app with consequent benefit for the overall health care system. ©Oscar Massimiliano Epis, Cinzia Casu, Laura Belloli, Emanuela Schito, Davide Filippini, Marina Muscarà, Maria Giovanna Gentile, Paula Carina Perez Cagnone, Chiara Venerelli, Massimo Sonnati, Irene Schiavetti, Eleonora Bruschi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.11.2016.

  11. Overview of classical test theory and item response theory for the quantitative assessment of items in developing patient-reported outcomes measures.

    Science.gov (United States)

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

    2014-05-01

    The US Food and Drug Administration's guidance for industry document on patient-reported outcomes (PRO) defines content validity as "the extent to which the instrument measures the concept of interest" (FDA, 2009, p. 12). According to Strauss and Smith (2009), construct validity "is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity" (p. 7). Hence, both qualitative and quantitative information are essential in evaluating the validity of measures. We review classical test theory and item response theory (IRT) approaches to evaluating PRO measures, including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized "difficulty" (severity) order of items is represented by observed responses. If a researcher has few qualitative data and wants to get preliminary information about the content validity of the instrument, then descriptive assessments using classical test theory should be the first step. As the sample size grows during subsequent stages of instrument development, confidence in the numerical estimates from Rasch and other IRT models (as well as those of classical test theory) would also grow. Classical test theory and IRT can be useful in providing a quantitative assessment of items and scales during the content-validity phase of PRO-measure development. Depending on the particular type of measure and the specific circumstances, the classical test theory and/or the IRT should be considered to help maximize the content validity of PRO measures. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

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

    Science.gov (United States)

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

    2016-06-14

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

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

    Science.gov (United States)

    Powell, J; Powell, S; Robson, A

    2018-01-01

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

  14. Variable reporting of functional outcomes and return to play in superior labrum anterior and posterior tear.

    Science.gov (United States)

    Steinhaus, Michael E; Makhni, Eric C; Lieber, Adam C; Kahlenberg, Cynthia A; Gulotta, Lawrence V; Romeo, Anthony A; Verma, Nikhil N

    2016-11-01

    Outcomes assessments after superior labrum anterior and posterior (SLAP) tear/repair are highly varied, making it difficult to draw comparisons across the literature. This study examined the inconsistency in outcomes reporting in the SLAP tear literature. We hypothesize that there is significant variability in outcomes reporting and that although most studies may report return to play, time to return reporting will be highly variable. The PubMed, Medline, Scopus, and Embase databases were systematically reviewed for studies from January 2000 to December 2014 reporting outcomes after SLAP tear/repair. Two reviewers assessed each study, and those meeting inclusion criteria were examined for pertinent data. Outcomes included objective (range of motion, strength, clinical examinations, and imaging) and subjective (patient-reported outcomes, satisfaction, activities of daily living, and return to play) measures. Of the 56 included studies, 43% documented range of motion, 14% reported strength, and 16% noted postoperative imaging. There was significant variation in use of patient-reported outcomes measures, with the 3 most commonly noted measures reported in 20% to 55% of studies. Return to play was noted in 75% of studies, and 23% reported time to return, with greater rates in elite athletes. Eleven studies (20%) did not report follow-up or noted data with <12 months of follow-up. The SLAP literature is characterized by substantial variability in outcomes reporting, with time to return to play noted in few studies. Efforts to standardize outcomes reporting would facilitate comparisons across the literature and improve our understanding of the prognosis of this injury. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  15. N-terminal pro-atrial natriuretic peptide measurement in plasma suggests covalent modification

    DEFF Research Database (Denmark)

    Hunter, Ingrid; Alehagen, Urban; Dahlström, Ulf

    2011-01-01

    different proANP assays on clinical outcome. METHODS: We examined 474 elderly patients with symptoms of heart failure presenting in a primary healthcare setting. Samples were analyzed with an automated immunoluminometric midregion proANP (MR-proANP) assay and a new processing-independent assay (PIA.......74 (95% CI, 0.66–0.81); P = 0.32]. The prognostic ability to report cardiovascular mortality during a 10-year follow-up revealed AUC values of 0.66 (95% CI, 0.60–0.71) for the proANP PIA and 0.69 (95% CI, 0.63–0.74) for the MR-proANP assay (P = 0.08, for comparing the 2 assays). CONCLUSIONS: Our data......BACKGROUND: The N-terminal fragment of cardiac-derived pro–B-type natriuretic peptide is a glycosylated polypeptide. It is unknown whether N-terminal pro–atrial natriuretic peptide (proANP) fragments are also covalently modified. We therefore evaluated the clinical performance of 2 distinctly...

  16. Nicaragua - ProNicaragua

    Data.gov (United States)

    Millennium Challenge Corporation — The focus of this performance evaluation was whether or not the ProNicaragua Activity’s program logic was sound and successful and had the intended benefits related...

  17. 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

  18. Post-Inpatient Brain Injury Rehabilitation Outcomes: Report from the National OutcomeInfo Database.

    Science.gov (United States)

    Malec, James F; Kean, Jacob

    2016-07-15

    This study examined outcomes for intensive residential and outpatient/community-based post-inpatient brain injury rehabilitation (PBIR) programs compared with supported living programs. The goal of supported living programs was stable functioning (no change). Data were obtained for a large cohort of adults with acquired brain injury (ABI) from the OutcomeInfo national database, a web-based database system developed through National Institutes of Health (NIH) Small Business Technology Transfer (STTR) funding for monitoring progress and outcomes in PBIR programs primarily with the Mayo-Portland Adaptability Inventory (MPAI-4). Rasch-derived MPAI-4 measures for cases from 2008 to 2014 from 9 provider organizations offering programs in 23 facilities throughout the United States were examined. Controlling for age at injury, time in program, and time since injury on admission (chronicity), both intensive residential (n = 205) and outpatient/community-based (n = 2781) programs resulted in significant (approximately 1 standard deviation [SD]) functional improvement on the MPAI-4 Total Score compared with supported living (n = 101) programs (F = 18.184, p MPAI-4 Ability (F = 14.135, p 1 year post-injury) showed significant, but smaller (approximately 0.5 SD) change on the MPAI-4 relative to supported living programs (F = 17.562, p < 0.001). Results indicate that intensive residential and outpatient/community-based PIBR programs result in substantial positive functional changes moderated by chronicity.

  19. Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials.

    Science.gov (United States)

    Hopewell, Sally; Witt, Claudia M; Linde, Klaus; Icke, Katja; Adedire, Olubusola; Kirtley, Shona; Altman, Douglas G

    2018-01-11

    Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics. Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the

  20. Gemfibrozil pretreatment resulted in a sexually dimorphic outcome in the rat models of global cerebral ischemia-reperfusion via modulation of mitochondrial pro-survival and apoptotic cell death factors as well as MAPKs.

    Science.gov (United States)

    Mohagheghi, Fatemeh; Ahmadiani, Abolhassan; Rahmani, Behrouz; Moradi, Fatemeh; Romond, Nathalie; Khalaj, Leila

    2013-07-01

    Inducers of mitochondrial biogenesis are widely under investigation for use in a novel therapeutic approach in neurodegenerative disorders. The ability of Gemfibrozil, a fibrate, is investigated for the first time to modulate mitochondrial pro-survival factors involved in the mitochondrial biogenesis signaling pathway, including peroxisome proliferator-activated receptor coactivator-1α (PGC-1α), nuclear respiratory factor (NRF-1), and mitochondrial transcription factor A (TFAM) in the brain. Gemfibozil is clinically administered to control hyperlipidemia. It secondarily prevents cardiovascular events such as cardiac arrest in susceptible patients. In this study, pretreatment of animals with gemfibrozil prior to ischemia-reperfusion (I/R) resulted in a sexually dimorphic outcome. While the expression of NRF-1 and TFAM were induced in gemfibrozil-pretreated met-estrous females, they were suppressed in males. Gemfibrozil also proved to be neuroprotective in met-estrous females, as it inhibited caspase-dependent apoptosis while in males it led to hippocampal neurodegeneration via activation of both the caspase-dependent and caspase-independent apoptosis. In the mitogen-activated protein kinase (MAPKs) pathway, gemfibrozil pretreatment induced the expression of extracellular signal-regulated kinases (ERK1/2) in met-estrous females and reduced it in males. These findings correlatively point to the sexual-dimorphic effects of gemfibrozil in global cerebral I/R context by affecting important factors involved in the mitochondrial biogenesis, MAPKs, and apoptotic cell death pathways.

  1. Pengungkapan Pro Forma, Mendukung atau Menyesatkan Investor?

    Directory of Open Access Journals (Sweden)

    Yohanis Rura

    2010-12-01

    Full Text Available Pro forma is originated from Latin. It contains different meaning depends on which discipline it is used. In accounting, pro forma disclosure is used to show effect of important transaction which occurs after the end of periods, or which occurs during period but not fully reflected in historical cost financial statement of a firm. Pro forma disclosure has the objective to support (but might mislead investor in decision making focused on particular influence of important transaction. Company with low GAAP profit information; less profitable company and has higher level of debt but more liquid, whose P-E ratio and market to book is higher than other companies in the industry; has the tendency to do pro forma disclosure. Pro forma disclosure has been supported by several theories such as: efficient market theory, catering theory, agency theory, signaling theory, and stakeholder theory. However, there are problems in reporting pro forma figures. There is no standard to it. Therefore, information on pro forma disclosure might also mislead less sophisticated investor.

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

    Directory of Open Access Journals (Sweden)

    DeWalt Darren A

    2009-01-01

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

  3. An exploratory study of whether pregnancy outcomes influence maternal self-reported history of child maltreatment.

    Science.gov (United States)

    Cammack, Alison L; Hogue, Carol J; Drews-Botsch, Carolyn D; Kramer, Michael R; Pearce, Brad D; Knight, Bettina; Stowe, Zachary N; Newport, D Jeffrey

    2018-02-22

    Childhood maltreatment is common and has been increasingly studied in relation to perinatal outcomes. While retrospective self-report is convenient to use in studies assessing the impact of maltreatment on perinatal outcomes, it may be vulnerable to bias. We assessed bias in reporting of maltreatment with respect to women's experiences of adverse perinatal outcomes in a cohort of 230 women enrolled in studies of maternal mental illness. Each woman provided a self-reported history of childhood maltreatment via the Childhood Trauma Questionnaire at two time points: 1) the preconception or prenatal period and 2) the postpartum period. While most women's reports of maltreatment agreed, there was less agreement for physical neglect among women experiencing adverse perinatal outcomes. Further, among women who discrepantly reported maltreatment, those experiencing adverse pregnancy outcomes tended to report physical neglect after delivery but not before, and associations between physical neglect measured after delivery and adverse pregnancy outcomes were larger than associations that assessed physical neglect before delivery. There were larger associations between post-delivery measured maltreatment and perinatal outcomes among women who had not previously been pregnant and in those with higher postpartum depressive symptoms. Although additional larger studies in the general population are necessary to replicate these findings, they suggest retrospective reporting of childhood maltreatment, namely physical neglect, may be prone to systematic differential recall bias with respect to perinatal outcomes. Measures of childhood maltreatment reported before delivery may be needed to validly estimate associations between maternal exposure to childhood physical neglect and perinatal outcomes. Copyright © 2018 Elsevier Ltd. All rights reserved.

  4. Long-lived radionuclides in seabed of the Baltic Sea. Report of the sediment baseline study of HELCOM MORS-PRO in 2000-2005

    International Nuclear Information System (INIS)

    Ilus, E.; Jukka Mattila, J.; Nielsen, S.P.; Jakobson, E.; Herrmann, J.; Graveris, V.; Vilimaite-Silobritiene, B.; Suplinska, M.; Stepanov, A.; Luening, M.

    2007-01-01

    when considering sediment results. This report presents the results of a Sediment Baseline Study carried out by the HELCOM Project Group for Monitoring of Radioactive Substances in the Baltic Sea (HELCOM MORS-PRO) in 2000-2005. The goal of the study was to complement the knowledge and inventories of long-lived radionuclides in the seabed of the Baltic Sea by providing additional data from so-called 'white areas' lacking data, and from radionuclides that were not measured in earlier surveys. (orig.)

  5. COLLIDE Pro Helvetia Award

    CERN Multimedia

    2016-01-01

    The COLLIDE Pro Helvetia Award is run in partnership with Pro Helvetia, giving the opportunity to Swiss artists to do research at CERN for three months.   From left to right: Laura Perrenoud, Marc Dubois and Simon de Diesbach. The photo shows their VR Project, +2199. Fragment.In are the winning artists of COLLIDE Pro Helvetia. They came to CERN for two months in 2015, and will now continue their last month in the laboratory. Fragment.In is a Swiss based interaction design studio. They create innovative projects, interactive installations, video and game design. Read more about COLLIDE here.

  6. Hra pro Android OS

    OpenAIRE

    Salvet, Lukáš

    2017-01-01

    Tato práce se zabývá tvorbou 2D hry pro zařízení s operačním systémem Android. Popisuje možnost tvorby her v tomto prostředí. Hlavně pak využití knihovny OpenGL ES 2.0, kterou jsem pro implementaci použil. Dále je v práci popsáno renderování textu, použití Google play games services pro achievementy a leaderboard, testování hry, atd. Beta verze hry byla vydána na Google Play. This work deals with creating 2D games for devices running Android. It describes the ability to create games in thi...

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

    Science.gov (United States)

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

    2018-01-15

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

  8. Revisiting the Surveillance Epidemiology and End Results Cancer Registry and Medicare Health Outcomes Survey (SEER-MHOS) Linked Data Resource for Patient-Reported Outcomes Research in Older Adults with Cancer.

    Science.gov (United States)

    Kent, Erin E; Malinoff, Rochelle; Rozjabek, Heather M; Ambs, Anita; Clauser, Steven B; Topor, Marie A; Yuan, Gigi; Burroughs, James; Rodgers, Anne B; DeMichele, Kimberly

    2016-01-01

    Researchers and clinicians are increasingly recognizing the value of patient-reported outcome (PRO) data to better characterize people's health and experiences with illness and care. Considering the rising prevalence of cancer in adults aged 65 and older, PRO data are particularly relevant for older adults with cancer, who often require complex cancer care and have additional comorbid conditions. A data linkage between the Surveillance Epidemiology and End Results (SEER) cancer registry and the Medicare Health Outcomes Survey (MHOS) was created through a partnership between the National Cancer Institute and the Centers for Medicare and Medicaid Services that created the opportunity to examine PROs in Medicare Advantage enrollees with and without cancer. The December 2013 linkage of SEER-MHOS data included the linked data for 12 cohorts, bringing the number of individuals in the linked data set to 95,723 with cancer and 1,510,127 without. This article reviews the features of the resource and provides information on some descriptive characteristics of the individuals in the data set (health-related quality of life, body mass index, fall risk management, number of unhealthy days in the past month). Individuals without (n=258,108) and with (n=3,440) cancer (1,311 men with prostate cancer, 982 women with breast cancer, 689 with colorectal cancer, 458 with lung cancer) were included in the current descriptive analysis. Given increasing longevity, advances in effective therapies and earlier detection, and population growth, the number of individuals aged 65 and older with cancer is expected to reach more than 12 million by 2020. SEER-MHOS provides population-level, self-reported, cancer registry-linked data for person-centered surveillance research on this growing population. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  9. PATIENT-REPORTED OUTCOMES IN RARE LYSOSOMAL STORAGE DISEASES: KEY INFORMANT INTERVIEWS AND A SYSTEMATIC REVIEW PROTOCOL.

    Science.gov (United States)

    Miller, Patricia A; Mulla, Sohail M; Adams-Webber, Thomasin; Sivji, Yasmin; Guyatt, Gordon H; Johnston, Bradley C

    2016-01-01

    To investigate the use, challenges and opportunities associated with using patient-reported outcomes (PROs) in studies with patients with rare lysosomal storage diseases (LSDs), we conducted interviews with researchers and health technology assessment (HTA) experts, and developed the methods for a systematic review of the literature. The purpose of the review is to identify the psychometrically sound generic and disease-specific PROs used in studies with patients with five LSDs of interest: Fabry, Gaucher (Type I), Niemann-Pick (Type B) and Pompe diseases, and mucopolysaccharidosis (Types I and II). Researchers and HTA experts who responded to an email invitation participated in a telephone interview. We used qualitative content analysis to analyze the anonymized transcripts. We conducted a comprehensive literature search for studies that used PROs to investigate burden of disease or to assess the impact of interventions across the five LSDs of interest. Interviews with seven researchers and six HTA experts representing eight countries revealed five themes. These were: (i) the importance of using psychometrically sound PROs in studies with rare diseases, (ii) the paucity of disease-specific PROs, (iii) the importance of having PRO data for economic analyses, (iv) practical and psychometric limitations of existing PROs, and (v) suggestions for new PROs. The systematic review has been completed. The interviews highlight current challenges and opportunities experienced by researchers and HTA experts involved in work with rare LSDs. The ongoing systematic review will highlight the experience, opportunities, and limitations of PROs in LSDs and provide suggestions for future research.

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

    Science.gov (United States)

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

    2018-05-02

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

  11. Pro Android UI

    CERN Document Server

    Jackson, Wallace

    2014-01-01

    If you're an Android application developer, chances areyou're using fixed, scrolling, swipe-able, and other cutting-edge custom UIDesigns in your Android development projects. These UI Design approaches aswell as other Android ViewGroup UI layout containers are the bread and butterof Pro Android User Interface (UI) design and Android User Experience (UX)design and development.Using a top down approach, Pro Android UI shows you how todesign and develop the best user interface for your app, while taking intoaccount the varying device form factors in the increasingly fragmented Androidenvironment

  12. ProCom middleware

    OpenAIRE

    Kunčar, Jiří

    2013-01-01

    The goal of this thesis is to develop and implement parts of a middleware that provides necessary support for the execution of ProCom components on top of the real-time operating system FreeRTOS. The ProCom is a component model for embedded systems developed at Mälardalen University. The primary problem is finding an appropriate balance between the level of abstraction and thoughtful utilization of system resources in embedded devices. The defined target platform has limitations in comparison...

  13. ProCom middleware

    OpenAIRE

    Kuncar, Jiri

    2011-01-01

    The goal of this thesis is to develop and implement parts of a middleware that provides necessary support for the execution of ProCom components on top of the real-time operating system FreeRTOS. ProCom is a component model for embedded systems developed at Mälardalen University. The primary problem is finding an appropriate balance between the level of abstraction and thoughtful utilization of system resources in embedded devices. The defined target platform has limitations in comparison to ...

  14. Pro Android 3

    CERN Document Server

    Hashimi, Sayed Ibrahim; MacLean, Dave

    2011-01-01

    Pro Android 3 starts with the basics, giving you a firm foundation in Android development. It then builds on this foundation to teach you how to build real-world and fun mobile applications using the new Android 3.0 SDK. This book covers advanced concepts in detail including maps, geocoding, services, live folders, drag and drop, touchscreens, and the new Android 3.0 features: fragments and ActionBar. Pro Android 3 is uniquely comprehensive: it covers sensors, text to speech, OpenGL, live widgets, search, and the audio and video APIs. Using the code-heavy tutorials and expert advice, you'll qu

  15. Pro Android 2

    CERN Document Server

    Hashimi, S; MacLean, Dave

    2010-01-01

    Pro Android 2 shows you how to build real-world and fun mobile applications using Google's latest Android SDK. This new edition is fully updated for Android 2, covering everything from the fundamentals of building applications for embedded devices to advanced concepts such as custom 3D components, OpenGL, and touchscreens including gestures. While other Android development guides simply discuss topics, Pro Android 2 offers the combination of expert insight and real sample applications that work. * Discover the design and architecture of the Android SDK through practical examples, and how to bu

  16. Pro NET Best Practices

    CERN Document Server

    Ritchie, Stephen D

    2011-01-01

    Pro .NET Best Practices is a practical reference to the best practices that you can apply to your .NET projects today. You will learn standards, techniques, and conventions that are sharply focused, realistic and helpful for achieving results, steering clear of unproven, idealistic, and impractical recommendations. Pro .NET Best Practices covers a broad range of practices and principles that development experts agree are the right ways to develop software, which includes continuous integration, automated testing, automated deployment, and code analysis. Whether the solution is from a free and

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

    Science.gov (United States)

    Li, Yuelin; Baser, Ray

    2012-08-15

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

  18. [Long-term outcomes after hypospadias surgery: Sexual reported outcomes and quality of life in adulthood].

    Science.gov (United States)

    Even, L; Bouali, O; Moscovici, J; Huyghe, E; Pienkowski, C; Rischmann, P; Galinier, P; Game, X

    2015-09-01

    To evaluate outcomes and long-term sexual quality of life after hypospadias surgery. Seventeen-years-old patients operated for a posterior hypospadias in childhood were included in a transversal study. Fifteen patients, among the forty children treated since 1997, accepted to participate. These young men (mean age at the first surgery was 27.9±20months) were clinically reviewed and responded to questionnaires (EUROQOL 5, IIEF15 and non-validated questionnaire). This study arises about 8.4±5years after the last visit in paediatric department. Mean study age was 21.2±4.7years. One third of patients thought that global quality of life was distorted. Although 33% of the patients had erectile dysfunction, 80% were satisfied with their sexual quality of life. The most important complains were relative to the penile appearance. Number of procedures was not predictive of patient's satisfaction about penile function and appearance. Thirty-three percents of the patients would have been satisfied to have psychological and medical support. They would be interested in having contact with patients who suffered from the same congenital abnormality. These patients had functional and esthetical disturbances. This visit leads to a specific visit in 20% cases. In this study, medical follow-up does not seem to be counselling and had to be adapted. Adequate follow-up transition between paediatric and adult departments especially during adolescence seems to be necessary. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  19. 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....

  20. Reliability of patient-reported outcome instruments in US adults with hemophilia: the Pain, Functional Impairment and Quality of life (P-FiQ study

    Directory of Open Access Journals (Sweden)

    Kempton CL

    2017-09-01

    Full Text Available Christine L Kempton,1 Michael Wang,2 Michael Recht,3 Anne Neff,4 Amy D Shapiro,5 Amit Soni,6 Roshni Kulkarni,7 Tyler W Buckner,2 Katharine Batt,8 Neeraj N Iyer,9 David L Cooper9 1Departments of Pediatrics and Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA, USA; 2Hemophilia and Thrombosis Center, University of Colorado School of Medicine, Aurora, CO, USA; 3The Hemophilia Center, Oregon Health & Science University, Portland, OR, USA; 4Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH, USA; 5Indiana Hemophilia & Thrombosis Center, Indianapolis, IN, USA; 6Center for Inherited Blood Disorders and CHOC Children’s Hospital/UC Irvine, Orange, CA, USA; 7MSU Center for Bleeding and Clotting Disorders, Michigan State University, East Lansing, MI, USA; 8Hematology and Oncology, Wake Forest School of Medicine, Winston-Salem, NC, USA; 9Clinical, Medical and Regulatory Affairs, Novo Nordisk Inc., Plainsboro, NJ, USA Background: Hemophilia is marked by frequent joint bleeding, resulting in pain and functional impairment.Objective: This study aimed to assess the reliability of five patient-reported outcome (PRO instruments in people with hemophilia (PWH in a non-bleeding state.Methods: Adult male PWH of any severity and inhibitor status, with a history of joint pain or bleeding, completed a pain history and five PRO instruments (EQ-5D-5L, Brief Pain Inventory v2 [BPI], International Physical Activity Questionnaire [IPAQ], Short Form 36 Health Survey v2 [SF-36v2], and Hemophilia Activities List [HAL] during their routine comprehensive care visit. Patients were approached to complete the PRO instruments again at the end of their visit while in a similar non-bleeding state. Concordance of individual questionnaire items and correlation between domain scores were assessed using intra-class correlation coefficient (ICC.Results: Participants completing the retest (n=164 had a median age of 33.9 years. Median time for

  1. 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...

  2. 77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

    Science.gov (United States)

    2012-11-07

    ...] Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation... Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation.'' FDA is co... (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related...

  3. 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

  4. Outcome of mucormycosis after treatment: report of five cases

    Directory of Open Access Journals (Sweden)

    F. Bellazreg

    2015-07-01

    Full Text Available Mucormycoses are serious infections caused by filamentous fungi of the order Mucorales. They occur most often in immunocompromised patients. We report five cases of mucormycosis in patients hospitalized in the Infectious Diseases Department in Sousse – Tunisia between 2000 and 2013. They were 4 males and one female, mean age 60 years. Three patients were diabetic and one patient had acute leukemia. The locations of mucormycosis were rhinocerebral, rhino-orbital, auricular, pulmonary and cutaneous. The Mucorales isolated were Rhizopus arrhizus in 3 cases and Lichteimia in 2 cases. All patients were treated with amphotericin B and 2 patients had, in addition, surgical debridement. Two patients died and 2 kept peripheral facial paralysis.

  5. 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.

  6. Pro OpenSSH

    CERN Document Server

    Stahnke, Michael

    2006-01-01

    SSH, acronym for Secure Socket Shell, is for users and administrators wishing to establish secure communication between disparate networks. 'Pro OpenSSH', authored by two Fortune 100 system administrators, provides readers with a highly practical reference for configuring and deploying OpenSSH in their own environment.

  7. NT-proBNP

    DEFF Research Database (Denmark)

    Andersen, Charlotte; Mellemkjær, Søren; Hilberg, Ole

    2016-01-01

    BACKGROUND: Pulmonary hypertension (PH) is a serious complication to interstitial lung disease (ILD) and has a poor prognosis. PH is often diagnosed by screening with echocardiography followed by right heart catheterisation. A previous study has shown that a value of NT-pro-brain natriuretic...

  8. 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...

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

    Science.gov (United States)

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

    2016-07-01

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

  10. Reliability, Validity, and Responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) Scores in Influenza-Positive Patients.

    Science.gov (United States)

    Powers, John H; Bacci, Elizabeth D; Guerrero, M Lourdes; Leidy, Nancy Kline; Stringer, Sonja; Kim, Katherine; Memoli, Matthew J; Han, Alison; Fairchok, Mary P; Chen, Wei-Ju; Arnold, John C; Danaher, Patrick J; Lalani, Tahaniyat; Ridoré, Michelande; Burgess, Timothy H; Millar, Eugene V; Hernández, Andrés; Rodríguez-Zulueta, Patricia; Smolskis, Mary C; Ortega-Gallegos, Hilda; Pett, Sarah; Fischer, William; Gillor, Daniel; Macias, Laura Moreno; DuVal, Anna; Rothman, Richard; Dugas, Andrea; Ruiz-Palacios, Guillermo M

    2018-02-01

    To assess the reliability, validity, and responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) scores for quantifying the presence and severity of influenza symptoms. An observational prospective cohort study of adults (≥18 years) with influenza-like illness in the United States, the United Kingdom, Mexico, and South America was conducted. Participants completed the 37-item draft FLU-PRO daily for up to 14 days. Item-level and factor analyses were used to remove items and determine factor structure. Reliability of the final tool was estimated using Cronbach α and intraclass correlation coefficients (2-day reliability). Convergent and known-groups validity and responsiveness were assessed using global assessments of influenza severity and return to usual health. Of the 536 patients enrolled, 221 influenza-positive subjects comprised the analytical sample. The mean age of the patients was 40.7 years, 60.2% were women, and 59.7% were white. The final 32-item measure has six factors/domains (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic), with a higher order factor representing symptom severity overall (comparative fit index = 0.92; root mean square error of approximation = 0.06). Cronbach α was high (total = 0.92; domain range = 0.71-0.87); test-retest reliability (intraclass correlation coefficient, day 1-day 2) was 0.83 for total scores and 0.57 to 0.79 for domains. Day 1 FLU-PRO domain and total scores were moderately to highly correlated (≥0.30) with Patient Global Rating of Flu Severity (except nose and throat). Consistent with known-groups validity, scores differentiated severity groups on the basis of global rating (total: F = 57.2, P FLU-PRO score improvement by day 7 than did those who did not, suggesting score responsiveness. Results suggest that FLU-PRO scores are reliable, valid, and responsive to change in influenza-positive adults. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes

  11. Registration status and outcome reporting of trials published in core headache medicine journals.

    Science.gov (United States)

    Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

    2015-11-17

    To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

  12. 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.

  13. Student Self-Reported Learning Outcomes of Field Trips: The pedagogical impact

    Science.gov (United States)

    Lavie Alon, Nirit; Tal, Tali

    2015-05-01

    In this study, we used the classification and regression trees (CART) method to draw relationships between student self-reported learning outcomes in 26 field trips to natural environments and various characteristics of the field trip that include variables associated with preparation and pedagogy. We wished to examine the extent to which the preparation for the field trip, its connection to the school curriculum, and the pedagogies used, affect students' self-reported outcomes in three domains: cognitive, affective, and behavioral; and the extent the students' socioeconomic group and the guide's affiliation affect students' reported learning outcomes. Given that most of the field trips were guide-centered, the most important variable that affected the three domains of outcomes was the guide's storytelling. Other variables that showed relationships with self-reported outcomes were physical activity and making connections to everyday life-all of which we defined as pedagogical variables. We found no significant differences in student self-reported outcomes with respect to their socioeconomic group and the guide's organizational affiliation.

  14. 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.

  15. 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.

  16. Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study.

    Science.gov (United States)

    Yagi, Minami; Tanaka, Atsushi; Namisaki, Tadashi; Takahashi, Atsushi; Abe, Masanori; Honda, Akira; Matsuzaki, Yasushi; Ohira, Hiromasa; Yoshiji, Hitoshi; Takikawa, Hajime

    2018-04-16

    Patients with primary biliary cholangitis (PBC) frequently suffer from pruritus, which can severely impair their health-related quality of life (HRQOL). Nalfurafine hydrochloride, a selective κ-opioid receptor agonist, was recently approved in Japan for refractory pruritus in patients with chronic liver diseases, but it still remains unclear whether this treatment improves the patient-reported outcome (PRO) in PBC patients with refractory pruritus. Herein, we conducted a multicenter, post-marketing, single-arm prospective study to investigate the efficacy of nalfurafine in terms of PRO, and the associations of the efficacy with any clinical characteristics. After screening for pruritus in 496 patients with PBC using PBC-40 and the visual analog scale (VAS), we identified 141 patients with moderate to severe pruritus; these were invited to participate in the study. The participants received 2.5 μg nalfurafine once daily for 12 weeks, and pruritus and HRQOL were assessed in week 12 of this treatment. Generic HRQOL, short form 36, blood chemistries, and serum autotaxin levels were also measured at baseline and at week 12. Forty-four patients participated in this study. The mean PBC-40 itch domain scores and VAS declined during the study period, from 8.56 to 7.63 (P = 0.041) and from 42.9 to 29.3 (P = 0.001) at baseline and at week 12, respectively, indicating a significant effect of nalfurafine. The other domains of PBC-40 and all domains of SF-36 were not significantly altered by this treatment. We failed to find any association between the change in VAS and PBC-40 itch scores and any clinical variable. Serum autotaxin levels were significantly increased during the study period. This study demonstrated that nalfurafine improved pruritus in patients with PBC, independent of their clinical characteristics, but had a limited effect on the PRO.

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

    Science.gov (United States)

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

    2018-03-01

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

  18. Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

    Science.gov (United States)

    Begum, Rasheda; Kolstoe, Simon

    2015-07-25

    Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias. As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications. Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32%. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57%) of the published studies. This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

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

    Science.gov (United States)

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

    2014-06-26

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

  20. The OnyCOE-t™ questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis

    Directory of Open Access Journals (Sweden)

    Kianifard Farid

    2006-08-01

    Full Text Available Abstract Background This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t™, a questionnaire specifically designed to measure patient-reported outcomes (PRO associated with toenail onychomycosis. Methods 504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD® trial completed the OnyCOE-t™ at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t™ is composed of 6 multi-item scales and 1 single-item scale. These include a 7-item Toenail Symptom assessment, which comprises both Symptom Frequency and Symptom Bothersomeness scales; an 8-item Appearance Problems scale; a 7-item Physical Activities Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific items are included in the OnyCOE-t™. Clinical data, in particular the percent clearing of mycotic involvement in the target toenail, and OnyCOE-t™ responses were used to evaluate the questionnaire's reliability, validity, responsiveness, and the minimally clinical important difference (MCID. Results The OnyCOE-t™ was shown to be reliable and valid. Construct validity and known groups validity were acceptable. Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 1.31, 1.13, and 1.11, respectively. MCID was evaluated for three different clinical measures, and indicated that approximately an 8.5-point change (on a 0 to 100 scale was clinically meaningful based on a 25% improvement in target nail clearing. Conclusion The OnyCOE-t™ questionnaire is a unique, toenail-specific PRO

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

    Science.gov (United States)

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

    2014-01-01

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

  2. 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...

  3. Comparison of Provider-Assessed and Patient-Reported Outcome Measures of Acute Skin Toxicity During a Phase III Trial of Mometasone Cream Versus Placebo During Breast Radiotherapy: The North Central Cancer Treatment Group (N06C4)

    International Nuclear Information System (INIS)

    Neben-Wittich, Michelle A.; Atherton, Pamela J.; Schwartz, David J.; Sloan, Jeff A.; Griffin, Patricia C.; Deming, Richard L.; Anders, Jon C.; Loprinzi, Charles L.; Burger, Kelli N.; Martenson, James A.; Miller, Robert C.

    2011-01-01

    Purpose: Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider-assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs. Methods and Materials: Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: 0.7, strong. Results: CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness. Conclusions: The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash, redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity.

  4. Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

    Science.gov (United States)

    Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

    2017-10-01

    Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy

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

    Science.gov (United States)

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

    2017-01-01

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

  6. Outcome Reporting Bias in Government-Sponsored Policy Evaluations: A Qualitative Content Analysis of 13 Studies.

    Directory of Open Access Journals (Sweden)

    Arnaud Vaganay

    Full Text Available The reporting of evaluation outcomes can be a point of contention between evaluators and policy-makers when a given reform fails to fulfil its promises. Whereas evaluators are required to report outcomes in full, policy-makers have a vested interest in framing these outcomes in a positive light-especially when they previously expressed a commitment to the reform. The current evidence base is limited to a survey of policy evaluators, a study on reporting bias in education research and several studies investigating the influence of industry sponsorship on the reporting of clinical trials. The objective of this study was twofold. Firstly, it aimed to assess the risk of outcome reporting bias (ORB or 'spin' in pilot evaluation reports, using seven indicators developed by clinicians. Secondly, it sought to examine how the government's commitment to a given reform may affect the level of ORB found in the corresponding evaluation report. To answer these questions, 13 evaluation reports were content-analysed, all of which found a non-significant effect of the intervention on its stated primary outcome. These reports were systematically selected from a dataset of 233 pilot and experimental evaluations spanning three policy areas and 13 years of government-commissioned research in the UK. The results show that the risk of ORB is real. Indeed, all studies reviewed here resorted to at least one of the presentational strategies associated with a risk of spin. This study also found a small, negative association between the seniority of the reform's champion and the risk of ORB in the evaluation of that reform. The publication of protocols and the use of reporting guidelines are recommended.

  7. Pro forma: impact on communication skills?

    Science.gov (United States)

    Morris, Marie; Donohoe, Gary; Hennessy, Martina; O Ciardha, Caoilte

    2013-10-01

    A doctor performs 160 000-300 000 interviews during a lifetime career, thus making the medical interview the most common procedure in clinical medicine. It is reported that 60-80 per cent of diagnosis is based on history taking, yet there is little published data advising on the best method for medical students to initially attain and further refine these core skills during their medical degree. Medical students interviewed two patients: using an open interview first, based on the Calgary-Cambridge approach, and then using a structured pro forma. The students' medical data were assessed by a senior lecturer, and their communication skills were assessed by a behavioural scientist and by the patients. An exact Wilcoxon paired signed rank test was conducted to determine whether there was a difference between the open interview and pro forma methods for history taking and communication skills. The test yielded p-values of 0.0017 and 0.069, respectively, with the pro forma method providing a statistically significantly higher history-taking score and communication score than the open interview method. Subjectively, patients reported the pro forma method as being preferable. Medical students in the early years of training benefit from a structured history-taking pro forma to assist them gather an accurate data set without compromising their interpersonal and communication skills. © 2013 John Wiley & Sons Ltd.

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

    OpenAIRE

    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 impo...

  9. Relative Importance of History of Heart Failure Hospitalization and N-Terminal Pro-B-Type Natriuretic Peptide Level as Predictors of Outcomes in Patients With Heart Failure and Preserved Ejection Fraction

    DEFF Research Database (Denmark)

    Kristensen, Søren L; Jhund, Pardeep S; Køber, Lars

    2015-01-01

    of NT-proBNP (n = 1468) (HR: 3.19; 95% CI: 2.68 to 3.80). In patients with no recent HF hospitalization and NT-proBNP ≤360 pg/ml (n = 1,187), the event rate was 2.43 (95% CI: 2.03 to 2.90) compared with 17.79 (95% CI: 15.77 to 20.07) per 100 person-years when both risk predictors were present (n = 523......; HR: 6.18; 95% CI: 4.96 to 7.69). CONCLUSIONS: Recent hospitalization for HF or an elevated level of NT-proBNP identified patients at higher risk for cardiovascular events, and this risk was increased further when both factors were present.......OBJECTIVES: The aim of this study was to investigate N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and recent heart failure (HF) hospitalization as predictors of future events in heart failure - preserved ejection fraction (HF-PEF). BACKGROUND: Recently, doubt has been expressed...

  10. 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.

  11. 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

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

    Science.gov (United States)

    Weiler, Anne

    2016-01-01

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

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

    Science.gov (United States)

    Ni Riordain, R; McCreary, C

    2013-04-01

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

  14. 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

  15. Comparison of victims' reports and court records of intimate partner violence perpetrators' criminal case outcomes.

    Science.gov (United States)

    Bell, Margret E; Larsen, Sadie E; Goodman, Lisa A; Dutton, Mary Ann

    2013-09-01

    Intimate partner violence (IPV) victims often report feeling confused and uninformed about court proceedings, including even about the final disposition of the case against their partner. This is problematic because victims' decisions in responding to subsequent abuse may be significantly influenced by their beliefs about the outcomes of prior court experiences. Also, researchers often rely on victim report of court case outcomes; discrepancies between women's reports and official records may account for some of the conflicting findings in the empirical literature. In the current study, we compared the reports of case outcome given by 81 women recruited immediately after the final hearing of an IPV-related criminal case against their perpetrator with court records of case outcome. Findings revealed a fair level of agreement between women's reports and court files that was significantly different from the level of agreement expected by chance, but far from perfect. Level of agreement increased substantially when cases involving suspended sentences were removed. In reviewing these findings, we discuss the extent to which results can or cannot be interpreted as reflecting the accuracy of women's knowledge and review their implications for IPV researchers and court systems.

  16. Pro Linux System Administration

    CERN Document Server

    Turnbull, James

    2009-01-01

    We can all be Linux experts, provided we invest the time in learning the craft of Linux administration. Pro Linux System Administration makes it easy for small to medium--sized businesses to enter the world of zero--cost software running on Linux and covers all the distros you might want to use, including Red Hat, Ubuntu, Debian, and CentOS. Authors, and systems infrastructure experts James Turnbull, Peter Lieverdink, and Dennis Matotek take a layered, component--based approach to open source business systems, while training system administrators as the builders of business infrastructure. If

  17. Pro Android Games

    CERN Document Server

    Silva, Vladimir

    2010-01-01

    Do you remember landmark games like Wolfenstein 3D, Doom, and Asteroids? Well, here's an exciting opportunity to build and/or port these games to one of the hottest mobile and netbooks platforms today: Google's Android. Pro Android Games teaches you how to build cool games like Space Blaster and the classic Asteroids from scratch on the latest Android platform. This book also shows you how to port other classic freeware/shareware games like Doom and Wolfenstein 3D from C using the Java Native Interface (JNI) for Android. This book is all about a unique perspective in Android game development:

  18. Pro Access 2010 Development

    CERN Document Server

    Collins, Mark

    2011-01-01

    Pro Access 2010 Development is a fundamental resource for developing business applications that take advantage of the features of Access 2010 and the many sources of data available to your business. In this book, you'll learn how to build database applications, create Web-based databases, develop macros and Visual Basic for Applications (VBA) tools for Access applications, integrate Access with SharePoint and other business systems, and much more. Using a practical, hands-on approach, this book will take you through all the facets of developing Access-based solutions, such as data modeling, co

  19. Pro Spring Integration

    CERN Document Server

    Lui, M; Chan, Andy; Long, Josh

    2011-01-01

    Pro Spring Integration is an authoritative book from the experts that guides you through the vast world of enterprise application integration (EAI) and application of the Spring Integration framework towards solving integration problems. The book is:. * An introduction to the concepts of enterprise application integration * A reference on building event-driven applications using Spring Integration * A guide to solving common integration problems using Spring Integration What makes this book unique is its coverage of contemporary technologies and real-world information, with a focus on common p

  20. Pro Android games

    CERN Document Server

    Nardone, Massimo

    2016-01-01

    Combining actionable, real-world source code with graphics, Pro Android Games, Third Edition shows you how to build more sophisticated and addictive Android game apps with minimum effort. Harness the power of the latest Android 5.0 SDK to bring countless legendary, action-packed PC games to the Android platform. With actionable real-world source code, this one of a kind book shows you how to build more sophisticated and addictive Android game apps, by leveraging the power of the recent advancements found in the new Android 5.0 software development kit as well as those you've counted on in e

  1. Pro Android Flash

    CERN Document Server

    Chin, Stephen; Campesato, Oswald

    2011-01-01

    Did you know you can take your Flash skills beyond the browser, allowing you to make apps for Android, iOS and the BlackBerry Tablet OS? Build dynamic apps today starting with the easy-to-use Android smartphones and tablets. Then, take your app to other platforms without writing native code. Pro Android Flash is the definitive guide to building Flash and other rich Internet applications (RIAs) on the Android platform. It covers the most popular RIA frameworks for Android developers - Flash and Flex - and shows how to build rich, immersive user experiences on both Android smartphones and tablet

  2. Pro Spring security

    CERN Document Server

    Scarioni, Carlo

    2013-01-01

    Security is a key element in the development of any non-trivial application. The Spring Security Framework provides a comprehensive set of functionalities to implement industry-standard authentication and authorization mechanisms for Java applications. Pro Spring Security will be a reference and advanced tutorial that will do the following: Guides you through the implementation of the security features for a Java web application by presenting consistent examples built from the ground-up. Demonstrates the different authentication and authorization methods to secure enterprise-level applications

  3. Pro NuGet

    CERN Document Server

    Balliauw, Maarten

    2014-01-01

    Pro NuGet will give you a solid, practical, understanding of both how to keep your software dependencies under control and what best-practices have been developed within the NuGet community to ensure long-term reliability. Whether you're working entirely with .NET assemblies or also using CSS, HTML and JavaScript files within your applications this book will show you how to manage their requirements smoothly and reliably.As sponsors of the NuGet project Microsoft have led the way in showing how NuGet can be used to great effect; showing how it is now virtually indispensable to anyone working w

  4. Pro Spring Batch

    CERN Document Server

    Minella, Michael T

    2011-01-01

    Since its release, Spring Framework has transformed virtually every aspect of Java development including web applications, security, aspect-oriented programming, persistence, and messaging. Spring Batch, one of its newer additions, now brings the same familiar Spring idioms to batch processing. Spring Batch addresses the needs of any batch process, from the complex calculations performed in the biggest financial institutions to simple data migrations that occur with many software development projects. Pro Spring Batch is intended to answer three questions: *What? What is batch processing? What

  5. Pro Java ME Apps

    CERN Document Server

    Iliescu, Ovidiu

    2011-01-01

    Pro Java ME Apps gives you, the developer, the know-how required for writing sophisticated Java ME applications and for taking advantage of this huge potential market. Java ME is the largest mobile software platform in the world, supported by over 80% of all phones. You'll cover what Java ME is and how it compares to other mobile software platforms, how to properly design and structure Java ME applications, how to think like an experienced Java ME developer, what common problems and pitfalls you may run into, how to optimize your code, and many other key topics. Unlike other Java ME books out

  6. Pro WCF 4

    CERN Document Server

    Pathak, Nishith

    2011-01-01

    Pro WCF 4.0: Practical Microsoft SOA Implementation is a complete guide to Windows Communication Foundation from the service-oriented architecture (SOA) perspective, showing you why WCF is important to service-oriented architecture and development. This book provides deep insight into the functionality of WCF, which shipped with .NET 4.0-like service discovery, routing service, simplified configuration, and other advanced features. Included in this title are informative examples that will aid the reader in understanding and implementing these important additions. This book also covers the unif

  7. 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...

  8. Superkapacitory pro akumulaci energie

    OpenAIRE

    Kovařík, Jakub

    2017-01-01

    Tato práce se zabývá návrhem DC/DC měniče určeného pro nabíjení superkapacitoru a pro následnou transformaci napětí na požadovanou hodnotu. V textu jsou uvedeny snižující a zvyšující spínaný měnič napětí včetně výpočtu jednotlivých součástek a také schéma měniče, který kombinuje oba dva typy. Pomocí simulačních programů byla ověřena funkce jednotlivých zapojení, které mohou posloužit jako záložní zdroj elektrické energie menšího výkonu. This paper describes the design of DC/DC converters d...

  9. 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.

  10. 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...

  11. Exploring Outcomes and Initial Self-Report of Client Motivation in a College Counseling Center

    Science.gov (United States)

    Ilagan, Guy; Vinson, Michael L.; Sharp, Julia L.; Ilagan, Jill; Oberman, Aaron

    2015-01-01

    Objective: To explore the association between college counseling center clients' initial self-report of motivation and counseling outcome. Participants: The sample was composed of 331 student clients who utilized a college counseling center from August 2007 to August 2009. The college is a public, mid-size, urban university in the Southeast.…

  12. 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...

  13. 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

  14. 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

  15. 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...

  16. The Graduation Cliff: Improving the Post-School Outcomes of Students with Disabilities. Summary Report

    Science.gov (United States)

    McFadden, Erica Skogebo; Daugherty, David B.; Lee, Sang Eun; Fisher, Kim W.; Hack, Anthony; Spyra, Ed

    2015-01-01

    There is a federal movement to improve student outcomes targeting some of these predictors in several recently launched initiatives, but where does Arizona stand? What are we currently doing to move the needle, and what do we still need to do? This report prepared for the Arizona Developmental Disabilities Planning Council has two objectives: (1)…

  17. 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

  18. 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

  19. 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

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

    NARCIS (Netherlands)

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

    2013-01-01

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

  1. 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...

  2. 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

  3. Potential for erroneous interpretation of poisoning outcomes due to changes in National Poison Data System reporting.

    Science.gov (United States)

    Anderson, Bruce; Ke, Xuehua; Klein-Schwartz, Wendy

    2010-08-01

    In 2006, the annual report of poison centers in the United States changed the method of reporting profiles for generic substance categories from all exposures to single-substance exposures only. The objective of this study is to describe the potential impact of this reporting change on longitudinal analysis of outcomes. Generic substance categories with data available for all years of the study were manually extracted from Table 22 of the National Poison Data System (NPDS) annual reports for 2002-2007. For each generic substance category, the following data were extracted for each of the 6 years: total number of substance mentions (2002-2005) or single-substance exposures (2006-2007), reason (unintentional or intentional), pediatric exposures (children age average annual number of reported deaths by substance category decreased by 80.8%, from 2,229 in year 2002-2005 to 428 after the 2006 reporting change (p average annual number of reported major outcomes by substance category dropped by 76.0% (p average number of deaths and major effects by substance category decreased by about 50% from 394 and 4,639 per year during 2002-2005 to 198 deaths (p average rates of reported deaths (61.7 and 35.9%) and major effects (36.3 and 11.2%) for drug categories and nondrug categories, respectively (p change in 2006 will yield inaccurate results if the change in reporting methodology is not taken into account.

  4. Construct validity of patient-reported outcome instruments in US adults with hemophilia: results from the Pain, Functional Impairment, and Quality of life (P-FiQ study

    Directory of Open Access Journals (Sweden)

    Batt K

    2017-08-01

    Full Text Available Katharine Batt,1 Michael Recht,2 David L Cooper,3 Neeraj N Iyer,3 Christine L Kempton4 1Hematology and Oncology, Wake Forest School of Medicine, Winston-Salem, NC, 2The Hemophilia Center, Oregon Health & Science University, Portland, OR, 3Novo Nordisk Inc., Plainsboro, NJ, 4Departments of Pediatrics and Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA, USA Background: People with hemophilia (PWH experience frequent joint bleeding, resulting in pain and functional impairment. Generic and disease-specific patient-reported outcome (PRO instruments have been used in clinical studies, but rarely in the comprehensive hemophilia care setting. Objective: The objective of this study was to assess construct validity of PRO instruments measuring pain, functional impairment, and health-related quality of life in US PWH with a history of joint pain/bleeding. Methods: Adult male PWH completed 4 PRO instruments (EQ-5D-5L with visual analog scale, Brief Pain Inventory v2 Short Form [BPI], SF-36v2, Hemophilia Activities List [HAL] and underwent a musculoskeletal examination (Hemophilia Joint Health Score v2.1 [HJHS]. Construct validity between index and domain scores was evaluated by Pearson product-moment correlation coefficient. Results: A total of 381 PWH were enrolled. EQ-5D-5L Mobility correlated with BPI, SF-36v2, and HAL domains related to pain, physical function, and activity of the lower extremities. EQ-5D-5L Self-Care correlated only with HAL Self-Care. EQ-5D-5L Usual Activities correlated with BPI Pain Interference and domains within SF-36v2 and HAL related to pain and physical function/activities (particularly those involving the lower extremities. EQ-5D-5L Pain/Discomfort correlated with Bodily Pain and Physical Summary on SF-36v2, HAL Overall Activity, and all BPI pain domains. EQ-5D-5L Anxiety/Depression correlated with social/emotional/mental aspects of SF-36v2. On BPI, most pain domains correlated with Bodily

  5. Reporting individual surgeon outcomes does not lead to risk aversion in abdominal aortic aneurysm surgery.

    Science.gov (United States)

    Saratzis, A; Thatcher, A; Bath, M F; Sidloff, D A; Bown, M J; Shakespeare, J; Sayers, R D; Imray, C

    2017-02-01

    INTRODUCTION Reporting surgeons' outcomes has recently been introduced in the UK. This has the potential to result in surgeons becoming risk averse. The aim of this study was to investigate whether reporting outcomes for abdominal aortic aneurysm (AAA) surgery impacts on the number and risk profile (level of fitness) of patients offered elective treatment. METHODS Publically available National Vascular Registry data were used to compare the number of AAAs treated in those centres across the UK that reported outcomes for the periods 2008-2012, 2009-2013 and 2010-2014. Furthermore, the number and characteristics of patients referred for consideration of elective AAA repair at a single tertiary unit were analysed yearly between 2010 and 2014. Clinic, casualty and theatre event codes were searched to obtain all AAAs treated. The results of cardiopulmonary exercise testing (CPET) were assessed. RESULTS For the 85 centres that reported outcomes in all three five-year periods, the median number of AAAs treated per unit increased between the periods 2008-2012 and 2010-2014 from 192 to 214 per year (p=0.006). In the single centre cohort study, the proportion of patients offered elective AAA repair increased from 74% in 2009-2010 to 81% in 2013-2014, with a maximum of 84% in 2012-2013. The age, aneurysm size and CPET results (anaerobic threshold levels) for those eventually offered elective treatment did not differ significantly between 2010 and 2014. CONCLUSIONS The results do not support the assumption that reporting individual surgeon outcomes is associated with a risk averse strategy regarding patient selection in aneurysm surgery at present.

  6. 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.

  7. Prognostic value of plasma midregional pro-adrenomedullin and C-terminal-pro-endothelin-1 in chronic heart failure outpatients.

    Science.gov (United States)

    Adlbrecht, Christopher; Hülsmann, Martin; Strunk, Guido; Berger, Rudolf; Mörtl, Deddo; Struck, Joachim; Morgenthaler, Nils G; Bergmann, Andreas; Jakowitsch, Johannes; Maurer, Gerald; Lang, Irene M; Pacher, Richard

    2009-04-01

    The identification of chronic heart failure (CHF) patients at high risk of adverse outcome remains a challenge. New peptides are emerging that may give additional information. In CHF patients, endothelin (ET) levels predict mortality risk. Adrenomedullin has been shown to predict mortality in ischaemic heart failure, but not in unselected or non-ischaemic CHF patients. Moreover, ADM and ET have never been assessed in one model. The aim of the present study was to assess the prognostic value of midregional-pro-adrenomedullin (MR-proADM) and C-terminal-pro-endothelin-1 (CT-proET-1) in outpatients with CHF. We measured plasma MR-proADM and CT-proET-1 levels in 786 consecutive CHF outpatients and compared them with B-type natriuretic peptide (BNP) levels. At 24-month follow-up, 233 patients had died. A stepwise forward Cox regression model with age, sex, estimated glomerular filtration rate, NYHA > II, left ventricular ejection fraction (LVEF), MR-proADM, CT-proET-1, and BNP as possible predictors revealed that MR-proADM levels [hazard ratio (HR) = 1.77, P II (HR = 1.86, P < 0.001) were predictors of death at 24 months. When the analysis was repeated dependent on NYHA-stage, MR-proADM (HR = 2.12, P < 0.001) and LVEF (HR = 0.96, P = 0.006) were significant markers, but only in patients with mild/moderate CHF. Our data suggest that MR-proADM may be an important prognostic humoral marker, especially in mild/moderately symptomatic and non-ischaemic CHF patients.

  8. 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

  9. Athletic groin pain (part 1): a prospective anatomical diagnosis of 382 patients--clinical findings, MRI findings and patient-reported outcome measures at baseline.

    Science.gov (United States)

    Falvey, É C; King, E; Kinsella, S; Franklyn-Miller, A

    2016-04-01

    Athletic groin pain remains a common field-based team sports time-loss injury. There are few reports of non-surgically managed cohorts with athletic groin pain. To describe clinical presentation/examination, MRI findings and patient-reported outcome (PRO) scores for an athletic groin pain cohort. All patients had a history including demographics, injury duration, sport played and standardised clinical examination. All patients underwent MRI and PRO score to assess recovery. A clinical diagnosis of the injured anatomical structure was made based on these findings. Statistical assessment of the reliability of accepted standard investigations undertaken in making an anatomical diagnosis was performed. 382 consecutive athletic groin pain patients, all male, enrolled. Median time in pain at presentation was (IQR) 36 (16-75) weeks. Most (91%) played field-based ball-sports. Injury to the pubic aponeurosis (PA) 240 (62.8%) was the most common diagnosis. This was followed by injuries to the hip in 81 (21.2%) and adductors in 56 (14.7%) cases. The adductor squeeze test (90° hip flexion) was sensitive (85.4%) but not specific for the pubic aponeurosis and adductor pathology (negative likelihood ratio 1.95). Analysed in series, positive MRI findings and tenderness of the pubic aponeurosis had a 92.8% post-test probability. In this largest cohort of patients with athletic groin pain combining clinical and MRI diagnostics there was a 63% prevalence of PA injury. The adductor squeeze test was sensitive for athletic groin pain, but not specific individual pathologies. MRI improved diagnostic post-test probability. No hernia or incipient hernia was diagnosed. NCT02437942. 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/

  10. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  11. Impact of EPA ingestion on COX- and LOX-mediated eicosanoid synthesis in skin with and without a pro-inflammatory UVR challenge – Report of a randomised controlled study in humans

    Science.gov (United States)

    Pilkington, Suzanne M; Rhodes, Lesley E; Al-Aasswad, Naser M I; Massey, Karen A; Nicolaou, Anna

    2014-01-01

    Scope Eicosapentaenoic acid (EPA), abundant in oily fish, is reported to reduce skin inflammation and provide photoprotection, potential mechanisms include competition with arachidonic acid (AA) for metabolism by cyclooxygenases/lipoxygenases to less pro-inflammatory mediators. We thus examine impact of EPA intake on levels of AA, EPA and their resulting eicosanoids in human skin with or without ultraviolet radiation (UVR) challenge. Methods and results In a double-blind randomised controlled study, 79 females took 5 g EPA-rich or control lipid for 12 wk. Pre- and post-supplementation, red blood cell and skin polyunsaturated fatty acids were assessed by GC, and eicosanoids from unexposed and UVR-exposed skin by LC-MS/MS. Active supplementation increased red blood cell and dermal EPA versus control (both p skin (p skin; 12-hydroxyeicosatetraenoic acids:12-HEPE was lower in UVR-exposed skin (3:1 versus 11:1; p skin EPA:AA content, shifting eicosanoid synthesis towards less pro-inflammatory species, and promoting a regulatory milieu under basal conditions and in response to inflammatory insult. PMID:24311515

  12. 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...

  13. A user's guide to the disease management literature: recommendations for reporting and assessing program outcomes.

    Science.gov (United States)

    Linden, Ariel; Roberts, Nancy

    2005-02-01

    Recently there has been tremendous growth in the number of lay-press articles and peer-reviewed journal articles reporting extraordinary improvements in health status and financial outcomes due to disease management (DM) interventions. However, closer scrutiny of these reports reveals serious flaws in research design and/or analysis, leaving many to question the veracity of the claims. In recent years, there have been numerous contributions to the literature on how to assess the quality of medical research papers. However, these guidelines focus primarily on randomized controlled trials, with little attention given to the observational study designs typically used in DM outcome studies. As such, general guides to evaluating the medical literature are inadequate in their utility to assist authors and readers of DM outcomes research. The purpose of this paper is to provide authors with a clear and comprehensive guide to the reporting of DM outcomes, as well as to educate readers of the DM literature (both lay and peer reviewed) in how to assess the quality of the findings presented.

  14. 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.

  15. 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...

  16. Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

    Science.gov (United States)

    Rivoirard, Romain; Duplay, Vianney; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Magne, Nicolas; Bourmaud, Aurelie

    2016-01-01

    Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31-0.89] (P value = 0.009). Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies.

  17. Associations between Indigenous Australian oral health literacy and self-reported oral health outcomes

    Directory of Open Access Journals (Sweden)

    Jamieson Lisa M

    2010-03-01

    Full Text Available Abstract Objectives To determine oral health literacy (REALD-30 and oral health literacy-related outcome associations, and to calculate if oral health literacy-related outcomes are risk indicators for poor self-reported oral health among rural-dwelling Indigenous Australians. Methods 468 participants (aged 17-72 years, 63% female completed a self-report questionnaire. REALD-30 and oral health literacy-related outcome associations were determined through bivariate analysis. Multivariate modelling was used to calculate risk indicators for poor self-reported oral health. Results REALD-30 scores were lower among those who believed teeth should be infrequently brushed, believed cordial was good for teeth, did not own a toothbrush or owned a toothbrush but brushed irregularly. Tooth removal risk indicators included being older, problem-based dental attendance and believing cordial was good for teeth. Poor self-rated oral health risk indicators included being older, healthcare card ownership, difficulty paying dental bills, problem-based dental attendance, believing teeth should be brushed infrequently and irregular brushing. Perceived need for dental care risk indicators included being female and problem-based dental attendance. Perceived gum disease risk indicators included being older and irregular brushing. Feeling uncomfortable about oro-facial appearance risk indicators included problem-based dental attendance and irregular brushing. Food avoidance risk indicators were being female, difficulty paying dental bills, problem-based dental attendance and irregular brushing. Poor oral health-related quality of life risk indicators included difficulty paying dental bills and problem-based dental attendance. Conclusions REALD-30 was significantly associated with oral health literacy-related outcomes. Oral health literacy-related outcomes were risk indicators for each of the poor self-reported oral health domains among this marginalised population.

  18. proBAMconvert: A Conversion Tool for proBAM/proBed.

    Science.gov (United States)

    Olexiouk, Volodimir; Menschaert, Gerben

    2017-07-07

    The introduction of new standard formats, proBAM and proBed, improves the integration of genomics and proteomics information, thus aiding proteogenomics applications. These novel formats enable peptide spectrum matches (PSM) to be stored, inspected, and analyzed within the context of the genome. However, an easy-to-use and transparent tool to convert mass spectrometry identification files to these new formats is indispensable. proBAMconvert enables the conversion of common identification file formats (mzIdentML, mzTab, and pepXML) to proBAM/proBed using an intuitive interface. Furthermore, ProBAMconvert enables information to be output both at the PSM and peptide levels and has a command line interface next to the graphical user interface. Detailed documentation and a completely worked-out tutorial is available at http://probam.biobix.be .

  19. 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.

  20. C3-PRO: Connecting ResearchKit to the Health System Using i2b2 and FHIR.

    Directory of Open Access Journals (Sweden)

    Pascal B Pfiffner

    Full Text Available A renewed interest by consumer information technology giants in the healthcare domain is focused on transforming smartphones into personal health data storage devices. With the introduction of the open source ResearchKit, Apple provides a framework for researchers to inform and consent research subjects, and to readily collect personal health data and patient reported outcomes (PRO from distributed populations. However, being research backend agnostic, ResearchKit does not provide data transmission facilities, leaving research apps disconnected from the health system. Personal health data and PROs are of the most value when presented in context along with health system data. Our aim was to build a toolchain that allows easy and secure integration of personal health and PRO data into an open source platform widely adopted across 140 academic medical centers. We present C3-PRO: the Consent, Contact, and Community framework for Patient Reported Outcomes. This open source toolchain connects, in a standards-compliant fashion, any ResearchKit app to the widely-used clinical research infrastructure Informatics for Integrating Biology and the Bedside (i2b2. C3-PRO leverages the emerging health data standard Fast Healthcare Interoperability Resources (FHIR.

  1. C3-PRO: Connecting ResearchKit to the Health System Using i2b2 and FHIR.

    Science.gov (United States)

    Pfiffner, Pascal B; Pinyol, Isaac; Natter, Marc D; Mandl, Kenneth D

    2016-01-01

    A renewed interest by consumer information technology giants in the healthcare domain is focused on transforming smartphones into personal health data storage devices. With the introduction of the open source ResearchKit, Apple provides a framework for researchers to inform and consent research subjects, and to readily collect personal health data and patient reported outcomes (PRO) from distributed populations. However, being research backend agnostic, ResearchKit does not provide data transmission facilities, leaving research apps disconnected from the health system. Personal health data and PROs are of the most value when presented in context along with health system data. Our aim was to build a toolchain that allows easy and secure integration of personal health and PRO data into an open source platform widely adopted across 140 academic medical centers. We present C3-PRO: the Consent, Contact, and Community framework for Patient Reported Outcomes. This open source toolchain connects, in a standards-compliant fashion, any ResearchKit app to the widely-used clinical research infrastructure Informatics for Integrating Biology and the Bedside (i2b2). C3-PRO leverages the emerging health data standard Fast Healthcare Interoperability Resources (FHIR).

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

    Science.gov (United States)

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

    2017-07-01

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

  3. Outcome reporting across randomised trials and observational studies evaluating treatments for Twin-Twin Transfusion Syndrome: a systematic review.

    Science.gov (United States)

    Perry, Helen; Duffy, James M N; Umadia, Ogochukwu; Khalil, Asma

    2018-04-01

    Twin-Twin Transfusion syndrome is associated with significant mortality and morbidity. Potential treatments require robust evaluation. The aim of this study was to evaluate outcome reporting across observational studies and randomised controlled trials assessing treatments for twin-twin transfusion syndrome (TTTS). Cochrane Central Register of Controlled Trials, EMBASE and Medline were searched from inception to August 2016. Observational studies and randomised controlled trials reporting outcomes following a treatment for TTTS in monochorionic-diamniotic twin pregnancies and monochorionic-triamniotic or dichorionic-triamniotic triplet pregnancies were included. We systematically extracted and categorised outcome reporting. Six randomised trials and 94 observational studies, reporting data from 20,071 maternal participants and 3,199 children, were included. Six different treatments were evaluated. Included studies reported sixty-two different outcomes, including 10 fetal, 28 neonatal, 6 early childhood and 18 maternal outcomes. The outcomes were inconsistently reported across trials. For example, when considering offspring mortality, 31 studies (31%) reported live birth, 31 studies (31%) reported intrauterine death, 49 studies (49%) reported neonatal mortality, and 17 studies (17%) reported perinatal mortality. Four studies (4%) reported respiratory distress syndrome. Only 19 (19%) of studies were designed for long-term follow-up and 11 of these studies (11%) reported cerebral palsy. Most studies evaluating treatments for TTTS, have often neglected to report clinically important outcomes, especially neonatal morbidity outcomes. Most studies are not designed for long-term follow-up. The development of a core outcome set could help standardised outcome collection and reporting in Twin-Twin Transfusion syndrome studies. This article is protected by copyright. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Laughon Matthew M

    2011-07-01

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

  5. 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.

  6. International confederation for cleft lip and palate and related craniofacial anomalies task force report: holistic outcomes.

    Science.gov (United States)

    Broder, Hillary L

    2014-11-01

    Objective : This paper describes the process and outcomes of the 2013 American Cleft Palate-Craniofacial Association task force on Holistic Outcomes. The goals and membership of the task force are presented. Methods : Using internet communication, the group introduced themselves, shared ideas and information related to holistic assessment and implementation of using a validated holistic measure, the Child Oral Health Impact Profile (COHIP) at participating international sites. Results : Data from the sites were analyzed using descriptive statistics. Administration of the COHIP was successful. It varied from self-completion as well as verbal presentation due to language differences and a function of the short time period to complete collection. Additionally qualitative comments were reported by the task force site directors. Conclusions : Future directions for holistic assessment and communication among task force members and sites were discussed at the Congress and are presented in this report.

  7. 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.

  8. Grid laser with modified pro re nata injection of bevacizumab and ranibizumab in macular edema due to branch retinal vein occlusion: MARVEL report no 2.

    Science.gov (United States)

    Narayanan, Raja; Panchal, Bhavik; Stewart, Michael W; Das, Taraprasad; Chhablani, Jay; Jalali, Subhadra; Hasnat Ali, Mohd

    2016-01-01

    The purpose of this study was to prospectively study the efficacy of grid laser combined with intravitreal bevacizumab or ranibizumab in eyes with macular edema due to branch retinal vein occlusion. Treatment-naïve eyes were enrolled to receive injections of ranibizumab or bevacizumab. During the first 6 months, patients were evaluated monthly and injected if the best-corrected visual acuity changed by five or more letters or fluid was noted on spectral domain optical coherence tomography (OCT); during the next 6 months, patients were evaluated bimonthly and injected only if the best-corrected visual acuity decreased by five or more letters with the associated fluid. Grid laser photocoagulation was performed if there was fluid on OCT and was repeated if patients were eligible after a minimum interval of 3 months. The mean numbers of ranibizumab and bevacizumab injections were, respectively, 3.2±1.5 and 3.0±1.4 in the first 6 months and 0.3±0.6 and 0.3±0.6 in the last 6 months. Moreover, 55/75 (73.33%) participants did not receive any injections in the last 6 months. The mean reductions in central retinal thickness at 12 months were 165.67 μm (P<0.001; 95% confidence interval -221.50 to -135.0) in the ranibizumab group and 184.78 μm (P<0.001; 95% confidence interval -246.49 to -140.0) in the bevacizumab group (P=0.079). More patients in the bevacizumab group compared to those in the ranibizumab group required rescue laser at 12 months (20 vs eleven; P=0.06). Bimonthly evaluations after month 6 with very few pro re nata injections were effective in maintaining visual gains achieved during the first 6 months. Grid laser photocoagulation is effective in maintaining the vision even in the presence of fluid on OCT, although it's required more often in patients treated with bevacizumab.

  9. Grid laser with modified pro re nata injection of bevacizumab and ranibizumab in macular edema due to branch retinal vein occlusion: MARVEL report no 2

    Science.gov (United States)

    Narayanan, Raja; Panchal, Bhavik; Stewart, Michael W; Das, Taraprasad; Chhablani, Jay; Jalali, Subhadra; Hasnat Ali, Mohd

    2016-01-01

    Purpose The purpose of this study was to prospectively study the efficacy of grid laser combined with intravitreal bevacizumab or ranibizumab in eyes with macular edema due to branch retinal vein occlusion. Patients and methods Treatment-naïve eyes were enrolled to receive injections of ranibizumab or bevacizumab. During the first 6 months, patients were evaluated monthly and injected if the best-corrected visual acuity changed by five or more letters or fluid was noted on spectral domain optical coherence tomography (OCT); during the next 6 months, patients were evaluated bimonthly and injected only if the best-corrected visual acuity decreased by five or more letters with the associated fluid. Grid laser photocoagulation was performed if there was fluid on OCT and was repeated if patients were eligible after a minimum interval of 3 months. Results The mean numbers of ranibizumab and bevacizumab injections were, respectively, 3.2±1.5 and 3.0±1.4 in the first 6 months and 0.3±0.6 and 0.3±0.6 in the last 6 months. Moreover, 55/75 (73.33%) participants did not receive any injections in the last 6 months. The mean reductions in central retinal thickness at 12 months were 165.67 μm (P<0.001; 95% confidence interval −221.50 to −135.0) in the ranibizumab group and 184.78 μm (P<0.001; 95% confidence interval −246.49 to −140.0) in the bevacizumab group (P=0.079). More patients in the bevacizumab group compared to those in the ranibizumab group required rescue laser at 12 months (20 vs eleven; P=0.06). Conclusion Bimonthly evaluations after month 6 with very few pro re nata injections were effective in maintaining visual gains achieved during the first 6 months. Grid laser photocoagulation is effective in maintaining the vision even in the presence of fluid on OCT, although it’s required more often in patients treated with bevacizumab. PMID:27330272

  10. Biblio-Link and Pro-Cite: The Searcher's Workstation.

    Science.gov (United States)

    Hoyle, Norman; McNamara, Kathleen

    1987-01-01

    Describes the Biblio-Link and Pro-Cite software packages, which can be used together to create local databases with downloaded records, or to reorganize and repackage downloaded records for client reports. (CLB)

  11. 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....

  12. Impact of police-reported intimate partner violence during pregnancy on birth outcomes.

    Science.gov (United States)

    Lipsky, Sherry; Holt, Victoria L; Easterling, Thomas R; Critchlow, Cathy W

    2003-09-01

    To examine the relationship of police-reported intimate partner violence during pregnancy and adverse birth outcomes. We conducted a population-based, retrospective, cohort study in Seattle, Washington, using Seattle police data and Washington State birth certificate files from January 1995 through September 1999. Exposed subjects were women with an intimate partner violence incident reported to police during pregnancy and who subsequently had a singleton live birth or fetal death registered in the state of Washington. Unexposed subjects were randomly selected Seattle residents with a singleton live birth or fetal death in the same time period and who did not report an incident. The main outcome measures were low birth weight (LBW less than 2500 g), very LBW (VLBW less than 1500 g), preterm birth (20-36 weeks' gestation), very preterm birth (20-31 weeks), and neonatal death (before discharge). Women reporting any partner violence during pregnancy were significantly more likely to have a LBW infant (adjusted odds ratio [aOR] 1.70; 95% confidence interval [CI] 1.20, 2.40), a VLBW infant (aOR 2.54; 95% CI 1.32, 4.91), a preterm birth (aOR 1.61; 95% CI 1.14, 2.28), a very preterm birth (aOR 3.71; 95% CI 1.80, 7.63), and a neonatal death (aOR 3.49; 95% CI 1.43, 8.50). Police-reported partner violence during pregnancy is significantly associated with an increased risk of adverse birth outcomes. There is a critical need to identify pregnancy among women with reported incidents and to provide women health and social service information and referrals, particularly referrals to high-risk pregnancy programs.

  13. Intensity Modulated Proton Therapy Versus Intensity Modulated Photon Radiation Therapy for Oropharyngeal Cancer: First Comparative Results of Patient-Reported Outcomes

    Energy Technology Data Exchange (ETDEWEB)

    Sio, Terence T. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona (United States); Lin, Huei-Kai; Shi, Qiuling [Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Gunn, G. Brandon [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Cleeland, Charles S. [Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack; Hernandez, Mike [Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Blanchard, Pierre; Thaker, Nikhil G.; Phan, Jack; Rosenthal, David I.; Garden, Adam S.; Morrison, William H.; Fuller, C. David [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Mendoza, Tito R. [Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Mohan, Radhe [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Wang, Xin Shelley [Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Frank, Steven J., E-mail: sjfrank@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2016-07-15

    Purpose: We hypothesized that patients with oropharyngeal cancer treated with intensity modulated proton therapy (IMPT) would have lower symptom burdens, as measured by patient-reported outcome (PRO) surveys, than patients treated with intensity modulated photon therapy (IMRT). Methods and Materials: Patients were treated for oropharyngeal cancer from 2006 to 2015 through prospective registries with concurrent chemotherapy and IMPT or chemotherapy and IMRT and completed the MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) module at various times before treatment (baseline), during treatment (acute phase), within the first 3 months after treatment (subacute phase), and afterward (chronic phase). Individual symptoms and the top 5 and top 11 most severe symptoms were summarized and compared between the radiation therapy modalities. Results: PRO data were collected and analyzed from 35 patients treated with chemotherapy and IMPT and from 46 treated with chemotherapy and IMRT. The baseline symptom burdens were similar between both groups. The overall top 5 symptoms were food taste problems (mean score 4.91 on a 0-10 scale), dry mouth (4.49), swallowing/chewing difficulties (4.26), lack of appetite (4.08), and fatigue (4.00). Among the top 11 symptoms, changes in taste and appetite during the subacute and chronic phases favored IMPT (all P<.048). No differences in symptom burden were detected between modalities during the acute and chronic phases by top-11 symptom scoring. During the subacute phase, the mean (±standard deviation) top 5 MDASI scores were 5.15 ± 2.66 for IMPT versus 6.58 ± 1.98 for IMRT (P=.013). Conclusions: According to the MDASI-HN, symptom burden was lower among the IMPT patients than among the IMRT patients during the subacute recovery phase after treatment. A prospective randomized clinical trial is underway to define the value of IMPT for the management of head and neck tumors.

  14. Imputation by the mean score should be avoided when validating a Patient Reported Outcomes questionnaire by a Rasch model in presence of informative missing data

    LENUS (Irish Health Repository)

    Hardouin, Jean-Benoit

    2011-07-14

    Abstract Background Nowadays, more and more clinical scales consisting in responses given by the patients to some items (Patient Reported Outcomes - PRO), are validated with models based on Item Response Theory, and more specifically, with a Rasch model. In the validation sample, presence of missing data is frequent. The aim of this paper is to compare sixteen methods for handling the missing data (mainly based on simple imputation) in the context of psychometric validation of PRO by a Rasch model. The main indexes used for validation by a Rasch model are compared. Methods A simulation study was performed allowing to consider several cases, notably the possibility for the missing values to be informative or not and the rate of missing data. Results Several imputations methods produce bias on psychometrical indexes (generally, the imputation methods artificially improve the psychometric qualities of the scale). In particular, this is the case with the method based on the Personal Mean Score (PMS) which is the most commonly used imputation method in practice. Conclusions Several imputation methods should be avoided, in particular PMS imputation. From a general point of view, it is important to use an imputation method that considers both the ability of the patient (measured for example by his\\/her score), and the difficulty of the item (measured for example by its rate of favourable responses). Another recommendation is to always consider the addition of a random process in the imputation method, because such a process allows reducing the bias. Last, the analysis realized without imputation of the missing data (available case analyses) is an interesting alternative to the simple imputation in this context.

  15. Intensity Modulated Proton Therapy Versus Intensity Modulated Photon Radiation Therapy for Oropharyngeal Cancer: First Comparative Results of Patient-Reported Outcomes

    International Nuclear Information System (INIS)

    Sio, Terence T.; Lin, Huei-Kai; Shi, Qiuling; Gunn, G. Brandon; Cleeland, Charles S.; Lee, J. Jack; Hernandez, Mike; Blanchard, Pierre; Thaker, Nikhil G.; Phan, Jack; Rosenthal, David I.; Garden, Adam S.; Morrison, William H.; Fuller, C. David; Mendoza, Tito R.; Mohan, Radhe; Wang, Xin Shelley; Frank, Steven J.

    2016-01-01

    Purpose: We hypothesized that patients with oropharyngeal cancer treated with intensity modulated proton therapy (IMPT) would have lower symptom burdens, as measured by patient-reported outcome (PRO) surveys, than patients treated with intensity modulated photon therapy (IMRT). Methods and Materials: Patients were treated for oropharyngeal cancer from 2006 to 2015 through prospective registries with concurrent chemotherapy and IMPT or chemotherapy and IMRT and completed the MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) module at various times before treatment (baseline), during treatment (acute phase), within the first 3 months after treatment (subacute phase), and afterward (chronic phase). Individual symptoms and the top 5 and top 11 most severe symptoms were summarized and compared between the radiation therapy modalities. Results: PRO data were collected and analyzed from 35 patients treated with chemotherapy and IMPT and from 46 treated with chemotherapy and IMRT. The baseline symptom burdens were similar between both groups. The overall top 5 symptoms were food taste problems (mean score 4.91 on a 0-10 scale), dry mouth (4.49), swallowing/chewing difficulties (4.26), lack of appetite (4.08), and fatigue (4.00). Among the top 11 symptoms, changes in taste and appetite during the subacute and chronic phases favored IMPT (all P<.048). No differences in symptom burden were detected between modalities during the acute and chronic phases by top-11 symptom scoring. During the subacute phase, the mean (±standard deviation) top 5 MDASI scores were 5.15 ± 2.66 for IMPT versus 6.58 ± 1.98 for IMRT (P=.013). Conclusions: According to the MDASI-HN, symptom burden was lower among the IMPT patients than among the IMRT patients during the subacute recovery phase after treatment. A prospective randomized clinical trial is underway to define the value of IMPT for the management of head and neck tumors.

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

    Science.gov (United States)

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

    2018-06-01

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

  17. Profiling the ‘Pro-environmental Individual’: A Personality Perspective

    Science.gov (United States)

    Markowitz, Ezra M.; Goldberg, Lewis R.; Ashton, Michael C.; Lee, Kibeom

    2011-01-01

    There is considerable scientific interest in the psychological correlates of pro-environmental behaviors. Much research has focused on demographic and social-psychological characteristics of individuals who consistently perform such actions. Here, we report the results of two studies in which we explored relations between broad personality traits and pro-environmental actions. Using a wide variety of behavior and personality measures, we consistently found moderate positive relations between Openness to Experience and pro-environmental activities in both a community sample (Study 1: N = 778) and an undergraduate student sample (Study 2: N = 115). In Study 2 we showed that the effect of Openness on pro-environmental behaviors was fully mediated by individuals’ environmental attitudes and connection to nature. Our findings suggest that high levels of aesthetic appreciation, creativity, and inquisitiveness, but not personality traits associated with altruism, may have motivated the performance of pro-environmental actions among our respondents. Implications for intervention development are discussed. PMID:21241310

  18. 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

  19. Pooling of cross-cultural PRO data in multinational clinical trials: how much can poor measurement affect statistical power?

    Science.gov (United States)

    Regnault, Antoine; Hamel, Jean-François; Patrick, Donald L

    2015-02-01

    Cultural differences and/or poor linguistic validation of patient-reported outcome (PRO) instruments may result in differences in the assessment of the targeted concept across languages. In the context of multinational clinical trials, these measurement differences may add noise and potentially measurement bias to treatment effect estimation. Our objective was to explore the potential effect on treatment effect estimation of the "contamination" of a cultural subgroup by a flawed PRO measurement. We ran a simulation exercise in which the distribution of the score in the overall sample was considered a mixture of two normal distributions: a standard normal distribution was assumed in a "main" subgroup and a normal distribution which differed either in mean (bias) or in variance (noise) in a "contaminated" subgroup (the subgroup with potential flaws in the PRO measurement). The observed power was compared to the expected power (i.e., the power that would have been observed if the subgroup had not been contaminated). Even if differences between the expected and observed power were small, some substantial differences were obtained (up to a 0.375 point drop in power). No situation was systematically protected against loss of power. The impact of poor PRO measurement in a cultural subgroup may induce a notable drop in the study power and consequently reduce the chance of showing an actual treatment effect. These results illustrate the importance of the efforts to optimize conceptual and linguistic equivalence of PRO measures when pooling data in international clinical trials.

  20. 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

  1. 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.

  2. Effect of Pancreatic Hormones on pro-Atrial Natriuretic Peptide in Humans

    DEFF Research Database (Denmark)

    Zois, Nora E.; Terzic, Dijana; Faerch, Kristine

    2017-01-01

    Plasma concentrations of pro-Atrial natriuretic peptide, proANP, are decreased in obesity and diabetes. Decreased proANP concentrations have also been noted after meal intake, and recently, a glucose-mediated regulation of ANP gene expression was reported. Hence, we evaluated the effects of insul...

  3. Failed obstetric tracheal intubation and postoperative respiratory support with the ProSeal laryngeal mask airway

    NARCIS (Netherlands)

    Keller, Christian; Brimacombe, Joseph; Lirk, Philipp; Pühringer, Fritz

    2004-01-01

    The ProSeal laryngeal mask airway (ProSeal LMA) provides a better seal and probably better airway protection than the classic laryngeal mask airway (classic LMA). We report the use of the ProSeal LMA in a 26-yr-old female with HELLP syndrome for failed obstetric intubation and postoperative

  4. 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

  5. A proposed set of metrics for standardized outcome reporting in the management of low back pain.

    Science.gov (United States)

    Clement, R Carter; Welander, Adina; Stowell, Caleb; Cha, Thomas D; Chen, John L; Davies, Michelle; Fairbank, Jeremy C; Foley, Kevin T; Gehrchen, Martin; Hagg, Olle; Jacobs, Wilco C; Kahler, Richard; Khan, Safdar N; Lieberman, Isador H; Morisson, Beth; Ohnmeiss, Donna D; Peul, Wilco C; Shonnard, Neal H; Smuck, Matthew W; Solberg, Tore K; Stromqvist, Bjorn H; Hooff, Miranda L Van; Wasan, Ajay D; Willems, Paul C; Yeo, William; Fritzell, Peter

    2015-01-01

    Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set. An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions. Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on pre-existing tools. The outcome measures recommended here are structured around specific etiologies of LBP, span a patient's entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.

  6. Psychosocial outcomes and counselee satisfaction following genetic counseling for hereditary breast and ovarian cancer: A patient-reported outcome study.

    Science.gov (United States)

    Oberguggenberger, Anne; Sztankay, Monika; Morscher, Raphael Johannes; Sperner-Unterweger, Barbara; Weber, Ingrid; Hubalek, Michael; Kemmler, Georg; Zschocke, Johannes; Martini, Caroline; Egle, Daniel; Dünser, Martina; Gamper, Eva; Meraner, Verena

    2016-10-01

    We investigated the psychosocial consequences of genetic counseling and testing (GCT) for hereditary breast and ovarian cancer (HBOC) at follow-up in a "real-life" sample of counselees at an Austrian tertiary care center. The study cohort included counselees who had undergone genetic counseling for HBOC and completed a follow-up self-report questionnaire battery on psychosocial outcomes (quality of life, psychological distress, satisfaction with counseling and decisions). For comparison of distress, we recruited a reference sample of breast cancer survivors (BCS; n=665) who had not requested GCT in the same setting. Overall, counselees did not exhibit increased levels of anxiety and depression when compared to BCS. No specific follow-up deleterious psychosocial consequences were detected among the former group. Of the 137 counselees, 22.6% and 9.8% experienced clinically relevant levels of anxiety and depression, respectively, at an average follow-up time of 1.8years. However, both anxiety and depression significantly decreased with time and were alike between counselees with and without cancer diagnosis. Follow-up cancer worry seems to be significantly higher among counselees who had not undergone genetic testing or were undecided about it than among counselees who had been tested. Our results strongly support GCT as part of routine care for patients with HBOC. The risk factors of increased distress in specific subgroups of counselees, such as recent cancer diagnosis or uncertainty about testing, warrant further exploration and specific attention in clinical routines. Particularly, the psychological needs of undecided counselees warrant ongoing attention and potential follow-ups. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Intracerebroventricular Infusion of the (Pro)renin Receptor Antagonist PRO20 Attenuates Deoxycorticosterone Acetate-Salt–Induced Hypertension

    Science.gov (United States)

    Li, Wencheng; Sullivan, Michelle N.; Zhang, Sheng; Worker, Caleb J.; Xiong, Zhenggang; Speth, Robert C.; Feng, Yumei

    2016-01-01

    We previously reported that binding of prorenin to the (pro)renin receptor (PRR) plays a major role in brain angiotensin II formation and the development of deoxycorticosterone acetate (DOCA)-salt hypertension. Here, we designed and developed an antagonistic peptide, PRO20, to block prorenin binding to the PRR. Fluorescently labeled PRO20 bound to both mouse and human brain tissues with dissociation constants of 4.4 and 1.8 nmol/L, respectively. This binding was blocked by coincubation with prorenin and was diminished in brains of neuron-specific PRR-knockout mice, indicating specificity of PRO20 for PRR. In cultured human neuroblastoma cells, PRO20 blocked prorenin-induced calcium influx in a concentration- and AT1 receptor–dependent manner. Intracerebroventricular infusion of PRO20 dose-dependently inhibited prorenin-induced hypertension in C57Bl6/J mice. Furthermore, acute intracerebroventricular infusion of PRO20 reduced blood pressure in both DOCA-salt and genetically hypertensive mice. Chronic intracerebroventricular infusion of PRO20 attenuated the development of hypertension and the increase in brain hypothalamic angiotensin II levels induced by DOCA-salt. In addition, chronic intracerebroventricular infusion of PRO20 improved autonomic function and spontaneous baroreflex sensitivity in mice treated with DOCA-salt. In summary, PRO20 binds to both mouse and human PRRs and decreases angiotensin II formation and hypertension induced by either prorenin or DOCA-salt. Our findings highlight the value of the novel PRR antagonist, PRO20, as a lead compound for a novel class of antihypertensive agents and as a research tool to establish the validity of brain PRR antagonism as a strategy for treating hypertension. PMID:25421983

  8. Intracerebroventricular infusion of the (Pro)renin receptor antagonist PRO20 attenuates deoxycorticosterone acetate-salt-induced hypertension.

    Science.gov (United States)

    Li, Wencheng; Sullivan, Michelle N; Zhang, Sheng; Worker, Caleb J; Xiong, Zhenggang; Speth, Robert C; Feng, Yumei

    2015-02-01

    We previously reported that binding of prorenin to the (pro)renin receptor (PRR) plays a major role in brain angiotensin II formation and the development of deoxycorticosterone acetate (DOCA)-salt hypertension. Here, we designed and developed an antagonistic peptide, PRO20, to block prorenin binding to the PRR. Fluorescently labeled PRO20 bound to both mouse and human brain tissues with dissociation constants of 4.4 and 1.8 nmol/L, respectively. This binding was blocked by coincubation with prorenin and was diminished in brains of neuron-specific PRR-knockout mice, indicating specificity of PRO20 for PRR. In cultured human neuroblastoma cells, PRO20 blocked prorenin-induced calcium influx in a concentration- and AT(1) receptor-dependent manner. Intracerebroventricular infusion of PRO20 dose-dependently inhibited prorenin-induced hypertension in C57Bl6/J mice. Furthermore, acute intracerebroventricular infusion of PRO20 reduced blood pressure in both DOCA-salt and genetically hypertensive mice. Chronic intracerebroventricular infusion of PRO20 attenuated the development of hypertension and the increase in brain hypothalamic angiotensin II levels induced by DOCA-salt. In addition, chronic intracerebroventricular infusion of PRO20 improved autonomic function and spontaneous baroreflex sensitivity in mice treated with DOCA-salt. In summary, PRO20 binds to both mouse and human PRRs and decreases angiotensin II formation and hypertension induced by either prorenin or DOCA-salt. Our findings highlight the value of the novel PRR antagonist, PRO20, as a lead compound for a novel class of antihypertensive agents and as a research tool to establish the validity of brain PRR antagonism as a strategy for treating hypertension. © 2014 American Heart Association, Inc.

  9. Grid laser with modified pro re nata injection of bevacizumab and ranibizumab in macular edema due to branch retinal vein occlusion: MARVEL report no 2

    Directory of Open Access Journals (Sweden)

    Narayanan R

    2016-06-01

    with very few pro re nata injections were effective in maintaining visual gains achieved during the first 6 months. Grid laser photocoagulation is effective in maintaining the vision even in the presence of fluid on OCT, although it’s required more often in patients treated with bevacizumab.Keywords: PRN dosing, grid laser, visual acuity, randomized clinical trial 

  10. Interpersonal conflicts at work as a predictor of self-reported health outcomes and occupational mobility.

    Science.gov (United States)

    De Raeve, L; Jansen, N W H; van den Brandt, P A; Vasse, R; Kant, I J

    2009-01-01

    The aim of this prospective study was to examine the relationship between interpersonal conflicts at work and subsequent self-reported health outcomes (self-reported general health, need for recovery, and prolonged fatigue) and occupational mobility (internal mobility ie, changing job function, and external mobility ie, changing employers). Data from the Maastricht Cohort Study on fatigue at work (n = 5582 for co-worker conflict; n = 5530 for supervisor conflict) were used. Interpersonal conflict with either co-workers or supervisors was assessed between baseline and 1-year follow-up. Outcomes were studied every 4 months between 1-year and 2-year follow-up. Logistic regression analyses using generalised estimating equations were conducted for each of the dichotomous outcomes, while controlling for demographic factors, the presence of a long-term illness, other workplace stressors, coping, and outcome at baseline. Analyses were conducted for men only. At baseline, conflicts with co-workers occurred in 7.2% of the study population, while conflicts with supervisors occurred in 9.5% of the study population. In general, this study showed that co-worker conflict was a statistically significant risk factor for the onset of an elevated need for recovery, prolonged fatigue, poor general health and external occupational mobility. Supervisor conflict was a significant risk factor for the onset of an elevated need for recovery, prolonged fatigue, external occupational mobility, and internal occupational mobility. The results of this study indicate a possible causal relationship between interpersonal conflicts at work and self-reported health and occupational mobility. Given the considerable impact of interpersonal conflicts at work on the individual worker and on the organisation, and the fact that interpersonal conflicts at work are highly prevalent, these findings underline the need for interventions aimed at preventing the occurrence of interpersonal conflicts at work, or

  11. p.Ser252Trp and p.Pro253Arg mutations in FGFR2 gene causing Apert syndrome: the first clinical and molecular report of Indonesian patients

    NARCIS (Netherlands)

    Mundhofir, F.E.P.; Sistermans, E.A.; Faradz, S.M.H.; Hamel, B.C.J.

    2013-01-01

    Apert syndrome (AS) is a rare autosomal dominant disorder characterised by craniosynostosis and limb malformations, and is associated with congenital heart disease and other systemic malformations, including intellectual disability. We report two Indonesian patients with AS, in whom molecular

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

    Science.gov (United States)

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

    2012-08-01

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

  13. 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

  14. Capacity building permitting comprehensive monitoring of a severe case of Lassa hemorrhagic fever in Sierra Leone with a positive outcome: Case Report

    Directory of Open Access Journals (Sweden)

    Fonnie Mbalu

    2011-06-01

    Full Text Available Abstract Lassa fever is a neglected tropical disease with a significant impact on the health care system of endemic West African nations. To date, case reports of Lassa fever have focused on laboratory characterisation of serological, biochemical and molecular aspects of the disease imported by infected individuals from Western Africa to the United States, Canada, Europe, Japan and Israel. Our report presents the first comprehensive real time diagnosis and characterization of a severe, hemorrhagic Lassa fever case in a Sierra Leonean individual admitted to the Kenema Government Hospital Lassa Fever Ward. Fever, malaise, unresponsiveness to anti-malarial and antibiotic drugs, followed by worsening symptoms and onset of haemorrhaging prompted medical officials to suspect Lassa fever. A recombinant Lassa virus protein based diagnostic was employed in diagnosing Lassa fever upon admission. This patient experienced a severe case of Lassa hemorrhagic fever with dysregulation of overall homeostasis, significant liver and renal system involvement, the interplay of pro- and anti-inflammatory cytokines during the course of hospitalization and an eventual successful outcome. These studies provide new insights into the pathophysiology and management of this viral illness and outline the improved infrastructure, research and real-time diagnostic capabilities within LASV endemic areas.

  15. Pro Forma Registration of Companies

    DEFF Research Database (Denmark)

    Werlauff, Erik

    2010-01-01

    The article analyses the view taken by Community law on companies' pro forma registration in another EU or EEA country. Community law recognises pro forma registration under company law, i.e. a brass plate is sufficient, whereas it does not recognise pro forma registration under tax law, i.......e. a brass plate is not sufficient. The article provides reasons for the differential treatment of the two contexts and clarifies the difference on the basis of the Hubbard criterion, in which it was ruled that the effectiveness of Community law cannot vary according to the various branches of national law....

  16. 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

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

    Science.gov (United States)

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

    2017-06-01

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

  18. Cross-cultural translation and measurement properties of the Polish version of the Knee injury and Osteoarthritis Outcome Score (KOOS) following anterior cruciate ligament reconstruction

    DEFF Research Database (Denmark)

    Paradowski, Przemysław T; Witoński, Dariusz; Kęska, Rafał

    2013-01-01

    Knee Injury and Osteoarthritis Outcome Score (KOOS) is available in over 30 languages and a commonly used Patient-Reported Outcome (PRO) for assessment of treatment effects following knee surgery. The aim of the study was to report the linguistic translational process and evaluate the psychometri...... properties of the Polish version of the KOOS questionnaire....

  19. 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

  20. Pro SQL Server 2008 Analysis Services

    CERN Document Server

    Janus, Philo B

    2009-01-01

    Every business has a reams of business data locked away in databases, business systems, and spreadsheets. While you may be able to build some reports by pulling a few of these repositories together, actually performing any kind of analysis on the data that runs your business can range from problematic to impossible. Pro SQL Server 2008 Analysis Services will show you how to pull that data together and present it for reporting and analysis in a way that makes the data accessible to business users, instead of needing to rely on the IT department every time someone needs a different report. * Acc

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

    Science.gov (United States)

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

    2013-03-01

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

  2. 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.

  3. Psychometric properties of carer-reported outcome measures in palliative care: A systematic review

    Science.gov (United States)

    Michels, Charlotte TJ; Boulton, Mary; Adams, Astrid; Wee, Bee; Peters, Michele

    2016-01-01

    Background: Informal carers face many challenges in caring for patients with palliative care needs. Selecting suitable valid and reliable outcome measures to determine the impact of caring and carers’ outcomes is a common problem. Aim: To identify outcome measures used for informal carers looking after patients with palliative care needs, and to evaluate the measures’ psychometric properties. Design: A systematic review was conducted. The studies identified were evaluated by independent reviewers (C.T.J.M., M.B., M.P.). Data regarding study characteristics and psychometric properties of the measures were extracted and evaluated. Good psychometric properties indicate a high-quality measure. Data sources: The search was conducted, unrestricted to publication year, in the following electronic databases: Applied Social Sciences Index and Abstracts, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, PubMed, PsycINFO, Social Sciences Citation Index and Sociological Abstracts. Results: Our systematic search revealed 4505 potential relevant studies, of which 112 studies met the inclusion criteria using 38 carer measures for informal carers of patients with palliative care needs. Psychometric properties were reported in only 46% (n = 52) of the studies, in relation to 24 measures. Where psychometric data were reported, the focus was mainly on internal consistency (n = 45, 87%), construct validity (n = 27, 52%) and/or reliability (n = 14, 27%). Of these, 24 measures, only four (17%) had been formally validated in informal carers in palliative care. Conclusion: A broad range of outcome measures have been used for informal carers of patients with palliative care needs. Little formal psychometric testing has been undertaken. Furthermore, development and refinement of measures in this field is required. PMID:26407683

  4. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention.

    Science.gov (United States)

    Shorter, G W; Heather, N; Bray, Jeremy W; Giles, E L; Holloway, A; Barbosa, C; Berman, A H; O'Donnell, A J; Clarke, M; Stockdale, K J; Newbury-Birch, D

    2017-12-22

    The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI. ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

  5. 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

  6. 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.

  7. 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.

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Frei Anja

    2011-12-01

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

  10. Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy: A systematic review.

    Science.gov (United States)

    Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen; Dodd, Jodie M; Guelfi, Kym; Teede, Helena; Surita, Fernanda; Jensen, Dorte M; Geiker, Nina R W; Astrup, Arne; Yeo, SeonAe; Kinnunen, Tarja I; Stafne, Signe N; Cecatti, Jose G; Bogaerts, Annick; Hauner, Hans; Mol, Ben W; Scudeller, Tânia T; Vinter, Christina A; Renault, Kristina M; Devlieger, Roland; Thangaratinam, Shakila; Khan, Khalid S

    2017-07-01

    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. 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. 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 (60.6%, 40/66), were the commonly reported 'critically important' outcomes. Gestational weight gain (84.5%, 56/66) and birth weight (87.9%, 58/66) were reported in most papers, although not considered critically important. The median quality of reporting was 0.60 (interquartile range 0.25, 0.83) for a maximum score of one. Study and journal characteristics did not affect quality. Many studies on lifestyle interventions in pregnancy do not report critically important outcomes, highlighting the need for core outcome set development. © 2017 Japan Society of Obstetrics and Gynecology.

  11. Triple osteotomy for the correction of severe hallux valgus deformity: Patient reported outcomes and radiological evaluation.

    Science.gov (United States)

    Booth, Sean; Bhosale, Abhijit; Mustafa, Abubakar; Shenoy, Ravi; Pillai, Anand

    2016-08-01

    Symptomatic Hallux valgus can be treated with metatarsal osteotomy combined with proximal phalangeal osteotomy, however this might not be sufficient to treat severe HV deformities. Fifteen feet in eleven female patients treated with double first metatarsal and proximal phalanx osteotomies without lateral release were prospectively studied and outcome measures including radiological angles and validated patient reported outcome scores collected. Mean radiological follow up was 15 months and PROMs data 17 months. Mean hallux valgus and intermetatarsal angles were corrected from 45 to 24.7° and 18.7 to 7.4° respectively. There was an eight degree recurrence of hallux valgus angle. There was no wound problems, non-unions or evidence of avascular necrosis. The EQ-5D descriptive index showed a non-statistically significant improvement. All three elements of the MOxFQ score showed a statistically significant improvement: Forefoot pain (59-26.8), Walking and Stability (49.9-29.6) and Social Interaction (56.4-33.1) CONCLUSION: Triple osteotomy, without a lateral soft tissue release, leads to good radiological and functional outcomes in those with severe hallux valgus deformity. Patients need to be warned of the recovery time and potential for future metalwork removal. The risk of early recurrence suggests that a lateral release should be included in order to maintain a long lasting correction. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Content validity and electronic PRO (ePRO) usability of the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) in mesothelioma patients.

    Science.gov (United States)

    Gelhorn, Heather L; Skalicky, Anne M; Balantac, Zaneta; Eremenco, Sonya; Cimms, Tricia; Halling, Katarina; Hollen, Patricia J; Gralla, Richard J; Mahoney, Martin C; Sexton, Chris

    2018-02-01

    Obtaining qualitative data directly from the patient perspective enhances the content validity of patient-reported outcome (PRO) instruments. The objective of this qualitative study was to evaluate the content validity of the Lung Cancer Symptom Scale for Mesothelioma (LCSS-Meso) and its usability on an electronic device. A cross-sectional methodological study, using a qualitative approach, was conducted among patients recruited from four clinical sites. The primary target population included patients with pleural mesothelioma; data were also collected from patients with peritoneal mesothelioma on an exploratory basis. Semi-structured interviews were conducted consisting of concept elicitation, cognitive interviewing, and evaluation of electronic patient-reported outcome (ePRO) usability. Participants (n = 21) were interviewed in person (n = 9) or by telephone (n = 12); 71% were male with a mean age of 69 years (SD = 14). The most common signs and symptoms experienced by participants with pleural mesothelioma (n = 18) were shortness of breath, fluid build-up, pain, fatigue, coughing, and appetite loss. The most commonly described symptoms for those with peritoneal mesothelioma (n = 4) were bloating, changes in appetite, fatigue, fluid build-up, shortness of breath, and pain. Participants with pleural mesothelioma commonly described symptoms assessed by the LCSS-Meso in language consistent with the questionnaire and a majority understood and easily completed each of the items. The ePRO version was easy to use, and there was no evidence that the electronic formatting changed the way participants responded to the questions. Results support the content validity of the LCSS-Meso and the usability of the electronic format for use in assessing symptoms among patients with pleural mesothelioma.

  13. The ProVent model learns to speak French.

    Science.gov (United States)

    Cox, Christopher E

    2014-10-20

    Leroy and colleagues report on the accuracy of the Prolonged Mechanical Ventilation Prognostic Model ('ProVent') in a cohort study of patients ventilated for at least 21 days in one of three hospitals in the north of France. This study is noteworthy because it is the first to describe the performance of the ProVent model both outside the US and in a community hospital-based setting.

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

    Science.gov (United States)

    Bhuskute, Aditi; Skirko, Jonathan R; Roth, Christina; Bayoumi, Ahmed; Durbin-Johnson, Blythe; Tollefson, Travis T

    2017-09-01

    Patients with cleft palate and other causes of velopharyngeal insufficiency (VPI) suffer adverse effects on social interactions and communication. Measurement of these patient-reported outcomes is needed to help guide surgical and nonsurgical care. To further validate the VPI Effects on Life Outcomes (VELO) instrument, measure the change in quality of life (QOL) after speech surgery, and test the association of change in speech with change in QOL. Prospective descriptive cohort including children and young adults undergoing speech surgery for VPI in a tertiary academic center. Participants completed the validated VELO instrument before and after surgical treatment. The main outcome measures were preoperative and postoperative VELO scores and the perceptual speech assessment of speech intelligibility. The VELO scores are divided into subscale domains. Changes in VELO after surgery were analyzed using linear regression models. VELO scores were analyzed as a function of speech intelligibility adjusting for age and cleft type. The correlation between speech intelligibility rating and VELO scores was estimated using the polyserial correlation. Twenty-nine patients (13 males and 16 females) were included. Mean (SD) age was 7.9 (4.1) years (range, 4-20 years). Pharyngeal flap was used in 14 (48%) cases, Furlow palatoplasty in 12 (41%), and sphincter pharyngoplasty in 1 (3%). The mean (SD) preoperative speech intelligibility rating was 1.71 (1.08), which decreased postoperatively to 0.79 (0.93) in 24 patients who completed protocol (P Speech Intelligibility was correlated with preoperative and postoperative total VELO score (P speech intelligibility. Speech surgery improves VPI-specific quality of life. We confirmed validation in a population of untreated patients with VPI and included pharyngeal flap surgery, which had not previously been included in validation studies. The VELO instrument provides patient-specific outcomes, which allows a broader understanding of the

  15. 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.

  16. 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.

  17. 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

  18. Successful Pregnancy Outcome in Recurrent Ovarian Cancer in a 26 Year Old: A Case Report

    Directory of Open Access Journals (Sweden)

    Savita Rani Singhal

    2018-06-01

    Full Text Available Objective: To report a case of Successful Pregnancy Outcome in Recurrent Ovarian Cancer in a 26 year Old. Case Report: A 26 years old primigravida presented in antenatal clinic at 23 weeks of pregnancy with recurrence of ovarian cancer of mucinous type. Following refusal of surgical management, two courses of single dose carboplatin was administered. However, before third cycle of chemotherapy could be administered ,there was deranged liver functions tests, following which elective Cesarean section with staging laparotomy was planned at 34 weeks for breech presentation with oligohydramnios. A live healthy baby girl 2.3kg was delivered. Total abdominal hysterectomy with right salpingo-oopherectomy, infracolic omentectomy, appendectomy was done. The final diagnosis was recurrent mucinous ovarian adenocarcinoma. Postoperatively, she was given six cycles of chemotherapy (carboplatin and paclitaxel. Conclusion: Chemotherapy and surgery, both are safe beyond first trimester and multidisciplinary treatment must be planned after taking into account the wishes of couple.

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

    Directory of Open Access Journals (Sweden)

    Nelson LM

    2014-09-01

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

  20. Overall comparative analysis of management and outcomes of cardiac cases reported on board merchant ships.

    Science.gov (United States)

    Apostolatos, Charalampos; Andria, Vivian; Licari, Julie

    Telemedical assistance has always been the cornerstone of medical care on board. Significant technological progress has provided improved scientific tools and equipment for high-quality communication and prompt management of either minor incidents or major emergencies on board. Med Solutions International is a medical management company, offering services exclusively to the maritime industry. Registered vessels contact the medical team and healthcare professionals provide immediate guidelines for onboard management as well as necessary action thereafter, i.e. examination ashore or urgent medical evacuation. Since cardiac conditions or diseases are potentially the most dangerous when traveling at sea, it is of major importance to analyse and evaluate the overall management and outcomes of cases reporting symptoms of possible heart disease so as to improve telemedical assistance services in future. The study included cases reporting cardiac symptoms from 5 major shipping companies during the year 2016. Data was collected from telecommunication, emails and seafarers' final medical reports. A descriptive analysis of overall management and outcomes was performed. The study showed that the number of confirmed cardiovascular cases on board was very low. Among 551 total cases and 44 cases with reported cardiac symptoms there was only one heart attack, one pulmonary oedema and one suspected myocarditis. In the majority of cases, chest pain was musculoskeletal or due to respiratory infection. Symptoms resulting from issues such as stress or anxiety often present as potential cardiac conditions. Stress may also amplify the severity of symptoms. Language barriers between the seafarer, the master and the doctor often make communication very difficult. According to our findings there are grounds to intensify the prevention process through more efficient pre-employment medical examinations and improve management on board through more intensive training. Communication problems

  1. A Hierarchy of Patient-Reported Outcomes for Meta-Analysis of Knee Osteoarthritis Trials: Empirical Evidence from a Survey of High Impact Journals

    Directory of Open Access Journals (Sweden)

    Carsten Juhl

    2012-01-01

    Full Text Available 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 journals chosen a priori. Eligible studies were randomised controlled trials, using two or more PROs measuring pain and/or disability. Results. A literature search identified 402 publications and 38 trials were included, resulting in 54 randomised comparisons. Thirty-five trials had sufficient data on pain and 15 trials on disability. The WOMAC “pain” and “function” subscales were the most responsive composite scores. The following list was developed. Pain: (1 WOMAC “pain” subscale, (2 pain during activity (VAS, (3 pain during walking (VAS, (4 general knee pain (VAS, (5 pain at rest (VAS, (6 other composite pain scales, and (7 other single item measures. Disability: (1 WOMAC “function” subscale, (2 SF-36 “physical function” subscale, (3 SF-36 (Physical composite score, and (4 Other composite disability scores. Conclusions. As choosing the PRO most favourable for the intervention from individual trials can lead to biased estimates, using a prioritised list as developed in this study is recommended to reduce risk of biased selection of PROs in meta-analyses.

  2. Key issues affecting quality of life and patient-reported outcomes in prostate cancer: an analysis conducted in 2128 patients with initial psychometric assessment of the prostate cancer symptom scale (PCSS).

    Science.gov (United States)

    Msaouel, Pavlos; Gralla, Richard J; Jones, Randy A; Hollen, Patricia J

    2017-09-01

    Evidence-based quality of life (QL) questionnaires require the identification of issues of importance to patients. The primary aim of this study was to inform providers on patient-expressed issues while enhancing the content validity of instruments assessing QL and patient-reported outcomes (PROs) in prostate cancer. The study provided additional psychometric properties for the new PRO and QL instrument, the Prostate Cancer Symptom Scale (PCSS). An anonymous web-based survey of 2128 patients with prostate cancer was conducted with patients rating 18 QL items on a five-point scale. Most respondents (74%) were aged 55-74 years, had early stage disease at diagnosis (81%) and were diagnosed within 2 years of the survey (81%). The top five-rated issues were: overall QL, ability to perform normal activities, maintaining independence, ability to sleep and not being a burden. These items were ranked as either 'very important' or 'important' by at least 88% of patients. None of the most highly ranked issues were symptoms. Instead, the highest ranked items were global issues reflecting the impact of symptoms on patients. In addition to the enhanced content validity findings, good reliability results and initial support for construct validity are reported for the PCSS. This is the largest survey providing patient-expressed background for content validity for QL and PRO measures. The findings of this study should aid development of newer practical questionnaires, such as the PCSS, which can be adapted to electronic platforms enhancing rapid and accurate PRO and QL evaluation. 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/.

  3. Self-reported exercise and longitudinal outcomes in cystic fibrosis: a retrospective cohort study.

    Science.gov (United States)

    Collaco, Joseph M; Blackman, Scott M; Raraigh, Karen S; Morrow, Christopher B; Cutting, Garry R; Paranjape, Shruti M

    2014-10-06

    Cystic fibrosis (CF) is characterized by recurrent respiratory infections and progressive lung disease. Whereas exercise may contribute to preserving lung function, its benefit is difficult to ascertain given the selection bias of healthier patients being more predisposed to exercise. Our objective was to examine the role of self-reported exercise with longitudinal lung function and body mass index (BMI) measures in CF. A total of 1038 subjects with CF were recruited through the U.S. CF Twin-Sibling Study. Questionnaires were used to determine exercise habits. Questionnaires, chart review, and U.S. CF Foundation Patient Registry data were used to track outcomes. Within the study sample 75% of subjects self-reported regular exercise. Exercise was associated with an older age of diagnosis (p = 0.002), older age at the time of ascertainment (p nutritional and pulmonary outcomes in cystic fibrosis for adults. Although prospective studies are needed to confirm these associations, programs to promote regular exercise among individuals with cystic fibrosis would be beneficial.

  4. The Premature Ejaculation Profile: validation of self-reported outcome measures for research and practice.

    Science.gov (United States)

    Patrick, Donald L; Giuliano, François; Ho, Kai Fai; Gagnon, Dennis D; McNulty, Pauline; Rothman, Margaret

    2009-02-01

    To evaluate the reliability and validity of the Premature Ejaculation Profile (PEP), a self-reported outcome instrument for evaluating domains of PE and its treatment, comprised of four single-item measures, a profile, and an index score. Data were from men participating in observational studies in the USA (PE, 207 men; non-PE, 1380) and Europe (PE, 201; non-PE, 914) and from men with PE (1238) participating in a phase III randomized, placebo-controlled clinical trial of dapoxetine. The PEP contains four measures: perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty related to ejaculation, each assessed on five-point response scales. Test-retest reliability, known-groups validity, and ability to detect a patient-reported global impression of change (PGI) in condition were evaluated for the individual PEP measures and a PEP index score (the mean of all four measures). Profile analysis was conducted using multivariate analysis of variance. All PEP measures showed acceptable reliability (intraclass correlation coefficients ranged from 0.66 to 0.83) and mean scores for all measures differed significantly between PE and non-PE groups (P measures. The PEP profiles of men with and without PE differed significantly (P measure for use in monitoring outcomes of men with PE.

  5. Bullying and sexual harassment of junior doctors in New South Wales, Australia: rate and reporting outcomes.

    Science.gov (United States)

    Llewellyn, Anthony; Karageorge, Aspasia; Nash, Louise; Li, Wenlong; Neuen, Dennis

    2018-02-16

    Objective The aim of this study was to describe rates of exposure to bullying and sexual harassment in junior doctors in first- or second-year prevocational medical training (PGY1 or PGY2 respectively) positions in New South Wales (NSW) and the Australian Capital Territory (ACT), and to explore the types of actions taken in response. Methods A cross-sectional survey of junior doctors in PGY1 or PGY2 positions was undertaken in 2015 and 2016 (n=374 and 440 respectively). Thematic analysis was undertaken on free-text responses to describe the reporting process and outcomes in more depth. Results The estimated response rate was 17-20%. Results from both surveys followed almost identical trends. Most respondents in 2015 and 2016 reported being bullied (n=203 (54.3%) and 253 (57.5%) respectively), 16-19% reported sexual harassment (n=58 and 82 respectively) and 29% of females reported sexual harassment. Qualitative analysis elucidated reasons for not taking action in response to bullying and harassment, including workplace normalisation of these behaviours, fear of reprisal and lack of knowledge or confidence in the reporting process. For respondents who did take action, most reported ineffective or personally harmful outcomes when reporting to senior colleagues, including being dismissed or blamed, and an intention not to trust the process in the future. Conclusions The findings suggest that interventions targeted at the level of junior doctors to improve the culture of bullying and harassment in medicine are unlikely to be helpful. Different approaches that address the problem in a more systemic way are needed, as is further research about the effectiveness of such interventions. What is known about the topic? Bullying and sexual harassment are common workplace experiences in the medical profession. What does this paper add? Over half the junior doctors in the present study experienced bullying and nearly one-fifth experienced sexual harassment. Junior doctors are

  6. Pro Kapital sihib ida suunas / Raigo Neudorf

    Index Scriptorium Estoniae

    Neudorf, Raigo

    2007-01-01

    Peamiselt itaallastele kuuluv kinnisvaraarendaja Pro Kapital Group suunab edaspidi oma põhitegevuse Venemaale ja Ukrainasse, kuid jätkab kinnisvaraprojektide arendamisega Eestis ja Lätis. Vt. samas: Preatoni juhib Domina tegevust; Pro Kapital laiendab Kristiine keskust; Arco Vara juht kiidab Pro Kapitali ning nende projekte; Kümme aastat Pro Kapitali juhina

  7. Translating patient reported outcome measures: methodological issues explored using cognitive interviewing with three rheumatoid arthritis measures in six European languages

    NARCIS (Netherlands)

    Hewlett, Sarah E.; Nicklin, Joanna; Bode, Christina; Carmona, Loretto; Dures, Emma; Engelbrecht, Matthias; Hagel, Sofia; Kirwan, John R.; Molto, Anna; Redondo, Marta; Gossec, Laure

    2016-01-01

    Objective. Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and

  8. 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

  9. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  10. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  11. The Electronic Patient Reported Outcome Tool: Testing Usability and Feasibility of a Mobile App and Portal to Support Care for Patients With Complex Chronic Disease and Disability in Primary Care Settings

    Science.gov (United States)

    Gill, Ashlinder; Khan, Anum Irfan; Hans, Parminder Kaur; Kuluski, Kerry; Cott, Cheryl

    2016-01-01

    Background People experiencing complex chronic disease and disability (CCDD) face some of the greatest challenges of any patient population. Primary care providers find it difficult to manage multiple discordant conditions and symptoms and often complex social challenges experienced by these patients. The electronic Patient Reported Outcome (ePRO) tool is designed to overcome some of these challenges by supporting goal-oriented primary care delivery. Using the tool, patients and providers collaboratively develop health care goals on a portal linked to a mobile device to help patients and providers track progress between visits. Objectives This study tested the usability and feasibility of adopting the ePRO tool into a single interdisciplinary primary health care practice in Toronto, Canada. The Fit between Individuals, Fask, and Technology (FITT) framework was used to guide our assessment and explore whether the ePRO tool is: (1) feasible for adoption in interdisciplinary primary health care practices and (2) usable from both the patient and provider perspectives. This usability pilot is part of a broader user-centered design development strategy. Methods A 4-week pilot study was conducted in which patients and providers used the ePRO tool to develop health-related goals, which patients then monitored using a mobile device. Patients and providers collaboratively set goals using the system during an initial visit and had at least 1 follow-up visit at the end of the pilot to discuss progress. Focus groups and interviews were conducted with patients and providers to capture usability and feasibility measures. Data from the ePRO system were extracted to provide information regarding tool usage. Results Six providers and 11 patients participated in the study; 3 patients dropped out mainly owing to health issues. The remaining 8 patients completed 210 monitoring protocols, equal to over 1300 questions, with patients often answering questions daily. Providers and patients

  12. Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine

    DEFF Research Database (Denmark)

    Liu, Jian-Ping; Han, Mei; Li, Xin-Xue

    2013-01-01

    Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.......Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications....

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

    Directory of Open Access Journals (Sweden)

    van der Meulen Jan

    2008-04-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

  15. Improving Clinical Outcomes in Patients With Methicillin-Sensitive Staphylococcus aureus Bacteremia and Reported Penicillin Allergy.

    Science.gov (United States)

    Blumenthal, Kimberly G; Parker, Robert A; Shenoy, Erica S; Walensky, Rochelle P

    2015-09-01

    Methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia is a morbid infection. First-line MSSA therapies (nafcillin, oxacillin, cefazolin) are generally avoided in the 10% of patients reporting penicillin (PCN) allergy, but most of these patients are not truly allergic. We used a decision tree with sensitivity analyses to determine the optimal evaluation and treatment for patients with MSSA bacteremia and reported PCN allergy. Our model simulates 3 strategies: (1) no allergy evaluation, give vancomycin (Vanc); (2) allergy history-guided treatment: if history excludes anaphylactic features, give cefazolin (Hx-Cefaz); and (3) complete allergy evaluation with history-appropriate PCN skin testing: if skin test negative, give cefazolin (ST-Cefaz). Model outcomes included 12-week MSSA cure, recurrence, and death; allergic reactions including major, minor, and potentially iatrogenic; and adverse drug reactions. Vanc results in the fewest patients achieving MSSA cure and the highest rate of recurrence (67.3%/14.8% vs 83.4%/9.3% for Hx-Cefaz and 84.5%/8.9% for ST-Cefaz) as well as the greatest frequency of allergic reactions (3.0% vs 2.4% for Hx-Cefaz and 1.7% for ST-Cefaz) and highest rates of adverse drug reactions (5.2% vs 4.6% for Hx-Cefaz and 4.7% for ST-Cefaz). Even in a "best case for Vanc" scenario, Vanc yields the poorest outcomes. ST-Cefaz is preferred to Hx-Cefaz although sensitive to input variations. Patients with MSSA bacteremia and a reported PCN allergy should have the allergy addressed for optimal treatment. Full allergy evaluation with skin testing seems to be preferred, although more data are needed. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  16. Race matters: a systematic review of racial/ethnic disparity in Society for Assisted Reproductive Technology reported outcomes.

    Science.gov (United States)

    Wellons, Melissa F; Fujimoto, Victor Y; Baker, Valerie L; Barrington, Debbie S; Broomfield, Diana; Catherino, William H; Richard-Davis, Gloria; Ryan, Mary; Thornton, Kim; Armstrong, Alicia Y

    2012-08-01

    To systematically review the reporting of race/ethnicity in Society for Assisted Reproductive Technology (SART) Clinic Outcome Reporting System (CORS) publications. Systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology of literature published in PubMed on race/ethnicity that includes data from SART CORS. Not applicable. Not applicable. In vitro fertilization cycles reported to SART. Any outcomes reported in SART CORS. Seven publications were identified that assessed racial/ethnic disparities in IVF outcomes using SART data. All reported a racial/ethnic disparity. However, more than 35% of cycles were excluded from analysis because of missing race/ethnicity data. Review of current publications of SART data suggests significant racial/ethnic disparities in IVF outcomes. However, the potential for selection bias limits confidence in these findings, given that fewer than 65% of SART reported cycles include race/ethnicity. Our understanding of how race/ethnicity influences ART outcome could be greatly improved if information on race/ethnicity was available for all reported cycles. Copyright © 2012 American Society for Reproductive Medicine. All rights reserved.

  17. [Sacrocolpopexy - pro laparoscopic].

    Science.gov (United States)

    Hatzinger, M; Sohn, M

    2012-05-01

    Innovative techniques have a really magical attraction for physicians as well as for patients. The number of robotic-assisted procedures worldwide has almost tripled from 80,000 procedures in the year 2007 to 205,000 procedures in 2010. In the same time the total number of Da Vinci surgery systems sold climbed from 800 to 1,400. Advantages, such as three-dimensional visualization, a tremor-filter, an excellent instrument handling with 6 degrees of freedom and better ergonomics, together with aggressive marketing led to a veritable flood of new Da Vinci acquisitions in the whole world. Many just took the opportunity to introduce a new instrument to save a long learning curve and start immediately in the surgical master class.If Da Vinci sacrocolpopexy is compared with the conventional laparoscopic approach, robotic-assisted sacrocolpopexy shows a significantly longer duration of the procedure, a higher need for postoperative analgesics, much higher costs and an identical functional outcome without any advantage over the conventional laparoscopic approach. Although the use of robotic-assisted systems shows a significantly lower learning curve for laparoscopic beginners, it only shows minimal advantages for the experienced laparoscopic surgeon. Therefore it remains uncertain whether robotic-assisted surgery shows a significant advantage compared to the conventional laparoscopic surgery, especially with small reconstructive laparoscopic procedures such as sacrocolpopexy.

  18. 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

  19. Self-Reported and FEMA Flood Exposure Assessment after Hurricane Sandy: Association with Mental Health Outcomes.

    Directory of Open Access Journals (Sweden)

    Wil Lieberman-Cribbin

    Full Text Available Hurricane Sandy caused extensive physical and economic damage; the long-term mental health consequences are unknown. Flooding is a central component of hurricane exposure, influencing mental health through multiple pathways that unfold over months after flooding recedes. Here we assess the concordance in self-reported and Federal Emergency Management (FEMA flood exposure after Hurricane Sandy and determine the associations between flooding and anxiety, depression, and post-traumatic stress disorder (PTSD. Self-reported flood data and mental health symptoms were obtained through validated questionnaires from New York City and Long Island residents (N = 1231 following Sandy. Self-reported flood data was compared to FEMA data obtained from the FEMA Modeling Task Force Hurricane Sandy Impact Analysis. Multivariable logistic regressions were performed to determine the relationship between flooding exposure and mental health outcomes. There were significant discrepancies between self-reported and FEMA flood exposure data. Self-reported dichotomous flooding was positively associated with anxiety (ORadj: 1.5 [95% CI: 1.1-1.9], depression (ORadj: 1.7 [1.3-2.2], and PTSD (ORadj: 2.5 [1.8-3.4], while self-reported continuous flooding was associated with depression (ORadj: 1.1 [1.01-1.12] and PTSD (ORadj: 1.2 [1.1-1.2]. Models with FEMA dichotomous flooding (ORadj: 2.1 [1.5-2.8] or FEMA continuous flooding (ORadj: 1.1 [1.1-1.2] were only significantly associated with PTSD. Associations between mental health and flooding vary according to type of flood exposure measure utilized. Future hurricane preparedness and recovery efforts must integrate micro and macro-level flood exposures in order to accurately determine flood exposure risk during storms and realize the long-term importance of flooding on these three mental health symptoms.

  20. Clinical and Patient-reported Outcomes in Patients with Psoriatic Arthritis (PsA) by Body Surface Area Affected by Psoriasis: Results from the Corrona PsA/Spondyloarthritis Registry.

    Science.gov (United States)

    Mease, Philip J; Karki, Chitra; Palmer, Jacqueline B; Etzel, Carol J; Kavanaugh, Arthur; Ritchlin, Christopher T; Malley, Wendi; Herrera, Vivian; Tran, Melody; Greenberg, Jeffrey D

    2017-08-01

    Psoriatic arthritis (PsA) is commonly comorbid with psoriasis; the extent of skin lesions is a major contributor to psoriatic disease severity/burden. We evaluated whether extent of skin involvement with psoriasis [body surface area (BSA) > 3% vs ≤ 3%] affects overall clinical and patient-reported outcomes (PRO) in patients with PsA. Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and PRO at registry enrollment were assessed for patients with PsA aged ≥ 18 years with BSA > 3% versus ≤ 3%. Regression models were used to evaluate associations of BSA level with outcome [modified minimal disease activity (MDA), Health Assessment Questionnaire (HAQ) score, patient-reported pain and fatigue, and the Work Productivity and Activity Impairment questionnaire score]. Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologics, disease-modifying antirheumatic drug, and prednisone use. This analysis included 1240 patients with PsA with known BSA level (n = 451, BSA > 3%; n = 789, BSA ≤ 3%). After adjusting for potential confounding variables, patients with BSA > 3% versus ≤ 3% had greater patient-reported pain and fatigue and higher HAQ scores (p = 2.33 × 10 -8 , p = 0.002, and p = 1.21 × 10 -7 , respectively), were 1.7× more likely not to be in modified MDA (95% CI 1.21-2.41, p = 0.002), and were 2.1× more likely to have overall work impairment (1.37-3.21, p = 0.0001). These Corrona Registry data show that substantial skin involvement (BSA > 3%) is associated with greater PsA disease burden, underscoring the importance of assessing and effectively managing psoriasis in patients with PsA because this may be a contributing factor in PsA severity.

  1. A promising method for identifying cross-cultural differences in patient perspective: the use of Internet-based focus groups for content validation of new patient reported outcome assessments.

    Science.gov (United States)

    Atkinson, Mark J; Lohs, Jan; Kuhagen, Ilka; Kaufman, Julie; Bhaidani, Shamsu

    2006-09-22

    This proof of concept (POC) study was designed to evaluate the use of an Internet-based bulletin board technology to aid parallel cross-cultural development of thematic content for a new set of patient-reported outcome measures (PROs). The POC study, conducted in Germany and the United States, utilized Internet Focus Groups (IFGs) to assure the validity of new PRO items across the two cultures--all items were designed to assess the impact of excess facial oil on individuals' lives. The on-line IFG activities were modeled after traditional face-to-face focus groups and organized by a common 'Topic' Guide designed with input from thought leaders in dermatology and health outcomes research. The two sets of IFGs were professionally moderated in the native language of each country. IFG moderators coded the thematic content of transcripts, and a frequency analysis of code endorsement was used to identify areas of content similarity and difference between the two countries. Based on this information, draft PRO items were designed and a majority (80%) of the original participants returned to rate the relative importance of the newly designed questions. The use of parallel cross-cultural content analysis of IFG transcripts permitted identification of the major content themes in each country as well as exploration of the possible reasons for any observed differences between the countries. Results from coded frequency counts and transcript reviews informed the design and wording of the test questions for the future PRO instrument(s). Subsequent ratings of item importance also deepened our understanding of potential areas of cross-cultural difference, differences that would be explored over the course of future validation studies involving these PROs. The use of IFGs for cross-cultural content development received positive reviews from participants and was found to be both cost and time effective. The novel thematic coding methodology provided an empirical platform on which to

  2. Listeria monocytogenes endophthalmitis - case report and review of risk factors and treatment outcomes.

    Science.gov (United States)

    Bajor, Anna; Luhr, Anke; Brockmann, Dorothee; Suerbaum, Sebastian; Framme, Carsten; Sedlacek, Ludwig

    2016-07-16

    The majority of cases of endophthalmitis are caused by exogenous pathogens; only 5-10 % are of endogenous origin. One cause of these rare cases of endogenous endophthalmitis is Listeria monocytogenes. Twenty-six cases of endophthalmitis due to this pathogen have been published over the last twenty years. The aim of this review is to summarize the main risk factors and common clinical findings of endogenous endophthalmitis due to Listeria monocytogenes. We report on a 62-year-old female presenting with a sterile hypopyon iritis with secondary glaucoma and an underlying rheumatoid disease. In microbiological analysis we identified Listeria monocytogenes. Further we searched through all published cases for typical signs, risk factors, details of medical and surgical treatment and outcome of endogenous endophthalmitis due to this rare pathogen. Ocular symptoms in almost all of these published cases included pain, redness of the eye, and decreased vision. Main clinical features included elevated intraocular pressure and fibrinous anterior chamber reaction, as well as a dark hypopyon. While the infection is typically spread endogenously, neither an exogenous nor endogenous source of infection could be identified in most cases. Immunocompromised patients are at higher risk of being infected than immunocompetent patients. The clinical course of endophthalmitis caused by Listeria monocytogenes had different visual outcomes. In some cases, the infection led to enucleation, blindness, or strong visual loss, whereas most patients showed a tendency of visual improvement during therapy. Early diagnosis and treatment initiation are crucial factors in the outcome of endogenous endophthalmitis caused by Listeria monocytogenes. This possible differential diagnosis should be kept in mind while treating patients with presumable sterile hypopyon and anterior uveitis having a high intraocular pressure. A bacterial source should be considered with a prompt initiation of systemic

  3. Pro asynchronous programming with .NET

    CERN Document Server

    Blewett, Richard; Ltd, Rock Solid Knowledge

    2014-01-01

    Pro Asynchronous Programming with .NET teaches the essential skill of asynchronous programming in .NET. It answers critical questions in .NET application development, such as: how do I keep my program responding at all times to keep my users happy how do I make the most of the available hardware how can I improve performanceIn the modern world, users expect more and more from their applications and devices, and multi-core hardware has the potential to provide it. But it takes carefully crafted code to turn that potential into responsive, scalable applications.With Pro Asynchronous Programming

  4. 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

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

    Science.gov (United States)

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

    2015-12-01

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