Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0

Maria Antonietta D'Agostino, Maarten Boers, John R. Kirwan, George Wells, Dorcas Beaton, Laure Gossec, Maria-Antonietta D'Agostino, Philip G. Conaghan, Clifton O. Bingham, Peter Brooks, Robert Landewé, Lyn March, Lee S. Simon, Jasvinder A. Singh, Vibeke Strand, Peter Tugwell

Risultato della ricerca: Contributo in rivistaArticolo in rivista

468 Citazioni (Scopus)

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. © 2014 The Authors. Published by Elsevier Inc. All rights reserved.
Lingua originaleEnglish
pagine (da-a)745-753
Numero di pagine9
RivistaJournal of Clinical Epidemiology
Volume67
DOI
Stato di pubblicazionePubblicato - 2014

Keywords

  • Biological markers
  • Treatment Outcome
  • Outcome assessment (health care)
  • Reference Standards
  • Research design
  • Rheumatology
  • Consensus
  • Controlled Clinical Trials as Topic
  • Health Personnel
  • Humans
  • Outcome Assessment, Health Care
  • Rheumatic Diseases
  • Severity of Illness Index
  • Clinical trial

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