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

Maarten Boers; John R Kirwan; George Wells; Dorcas Beaton; Laure Gossec; Maria-Antonietta d'Agostino; Philip G Conaghan; Clifton O Bingham 3rd; Peter Brooks; Robert Landewé; Lyn March; Lee S Simon; Jasvinder A Singh; Vibeke Strand; Peter Tugwell

doi:10.1016/j.jclinepi.2013.11.013

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

J Clin Epidemiol. 2014 Jul;67(7):745-53. doi: 10.1016/j.jclinepi.2013.11.013. Epub 2014 Feb 28.

Authors

Affiliations

¹ Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 165, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: eb@vumc.nl.
² University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, United Kingdom.
³ Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
⁴ Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada.
⁵ Department of Rheumatology, Université Pierre et Marie Curie (UPMC), Paris 6, GRC-UMPC 08 (EEMOIS), and Assistance Publique Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Paris, France.
⁶ Department of Rheumatology, Université Versailles-Saint Quentin en Yvelines, Ambroise Pare Hospital, Boulogne-Billancourt, France.
⁷ NIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom.
⁸ Division of Rheumatology, Johns Hopkins University, Baltimore, MD 21224, USA.
⁹ School of Population and Global Health, University of Melbourne, Melbourne, Australia.
¹⁰ Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
¹¹ Institute of Bone and Joint Research, Kolling Institute of Medical Research, University of Sydney, Sydney, Australia; Department of Rheumatology, Royal North Shore Hospital, St. Leonards, New South Wales, Australia.
¹² SDG LLC, Cambridge, MA 02138, USA.
¹³ Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL 35294, USA; Veterans Affairs Medical Center, Birmingham, AL 35294, USA.
¹⁴ Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA 94028, USA.
¹⁵ Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.

PMID: 24582946
DOI: 10.1016/j.jclinepi.2013.11.013

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.

Keywords: Biological markers; Clinical trial; Outcome assessment (health care); Reference Standards; Research design; Rheumatology.

MeSH terms

Consensus
Controlled Clinical Trials as Topic / methods*
Controlled Clinical Trials as Topic / standards*
Health Personnel
Humans
Outcome Assessment, Health Care / methods*
Outcome Assessment, Health Care / standards*
Rheumatic Diseases / therapy
Rheumatology / methods
Rheumatology / standards
Severity of Illness Index
Treatment Outcome