| Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards. | |
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MedLine Citation:
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PMID: 22987144 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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PURPOSE: To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs. METHODS: A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance. RESULTS: Forty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either 'essential' or 'desirable' when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors. CONCLUSIONS: ISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy. |
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Authors:
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Michael Brundage; Jane Blazeby; Dennis Revicki; Brenda Bass; Henrica de Vet; Helen Duffy; Fabio Efficace; Madeleine King; Cindy L K Lam; David Moher; Jane Scott; Jeff Sloan; Claire Snyder; Susan Yount; Melanie Calvert |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-9-18 |
Journal Detail:
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Title: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation Volume: - ISSN: 1573-2649 ISO Abbreviation: Qual Life Res Publication Date: 2012 Sep |
Date Detail:
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Created Date: 2012-9-18 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9210257 Medline TA: Qual Life Res Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Queen's University, Kingston, ON, Canada. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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