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

https://doi.org/10.1016/j.jclinepi.2013.11.013Get rights and content
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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

Outcome assessment (health care)
Clinical trial
Rheumatology
Research design
Biological markers
Reference Standards

Cited by (0)

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

This article presents the main arguments and supporting information on the development of OMERACT Filter 2.0. Further details are provided in a series of publications in the Proceedings of the OMERACT 11 conference, in press at the Journal of Rheumatology. These will be made freely available (see www.omeract.org).

Declaration of authorship and conflict of interest: All authors declare to meet the conditions for authorship. Each has made a substantial contribution to conception and design of the study, data acquisition, data analysis, and interpretation. M.B., J.R.K., and P.T. wrote the initial draft, all others revised the article for important intellectual content. All approved the final version of the submitted manuscript. All authors declare no competing interests.