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Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0

Journal of clinical epidemiology, 2014-07, Vol.67 (7), p.745-753 [Peer Reviewed Journal]

The Authors ;2014 The Authors ;2015 INIST-CNRS ;Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved. ;Copyright Elsevier Limited Jul 2014 ;ISSN: 0895-4356 ;EISSN: 1878-5921 ;DOI: 10.1016/j.jclinepi.2013.11.013 ;PMID: 24582946

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Title:
Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0
Author: Boers, Maarten ; Kirwan, John R ; Wells, George ; Beaton, Dorcas ; Gossec, Laure ; d'Agostino, Maria-Antonietta ; Conaghan, Philip G ; Bingham, Clifton O ; Brooks, Peter ; Landewé, Robert ; March, Lyn ; Simon, Lee S ; Singh, Jasvinder A ; Strand, Vibeke ; Tugwell, Peter
Subjects: Analysis. Health state ; Arthritis ; Biological and medical sciences ; Biological markers ; Clinical trial ; Consensus ; Controlled Clinical Trials as Topic - methods ; Controlled Clinical Trials as Topic - standards ; Endorsements ; Epidemiology ; Experts ; Feedback ; General aspects ; Health Personnel ; Humans ; Internal Medicine ; Medical sciences ; Outcome assessment (health care) ; Outcome Assessment (Health Care) - methods ; Outcome Assessment (Health Care) - standards ; Pain ; Patients ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Quality of life ; Reference Standards ; Research design ; Rheumatic Diseases - therapy ; Rheumatology ; Rheumatology - methods ; Rheumatology - standards ; Severity of Illness Index ; Studies ; Treatment Outcome
Is Part Of: Journal of clinical epidemiology, 2014-07, Vol.67 (7), p.745-753
Description: Abstract Background Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Methods Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. Results To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core “Areas,” namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core “Domain” within each of the Areas to formulate the “Core Domain Set.” Next, at least one applicable measurement instrument for each core Domain is identified to formulate a “Core Outcome Measurement Set.” Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants ( n = 125) at the OMERACT 11 consensus conference endorsed this model and process. Conclusion The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.
Publisher: New York, NY: Elsevier Inc
Language: English
Identifier: ISSN: 0895-4356
EISSN: 1878-5921
DOI: 10.1016/j.jclinepi.2013.11.013
PMID: 24582946
Source: MEDLINE
ProQuest Central

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Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0

The Authors ;2014 The Authors ;2015 INIST-CNRS ;Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved. ;Copyright Elsevier Limited Jul 2014 ;ISSN: 0895-4356 ;EISSN: 1878-5921 ;DOI: 10.1016/j.jclinepi.2013.11.013 ;PMID: 24582946

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