Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.
By M. Boers, J. Kirwan, G. Wells, D. Beaton, L. Gossec, M. D’Agostino, Philip G. Conaghan, C. Bingham, P. Brooks, R. Landewé and 5 more. Journal of Clinical Epidemiology, 2014
757 citations recorded by the source corpus.
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.
Subfields: Oncology, Rheumatology, Sociology and Political Science
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Citations in the corpus
- How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline (2016, positive): “We reached 98 – 99 % consensus that the first step in the selection of OMIs is to agree in detail upon the construct (i.e., outcome or domain) to be measured [11] and the target population (e.g., age, gender, disease characteristics) (Table 2).”
- The COMET Handbook: version 1.0 (2017, background): “0 [31] is a conceptual framework that encompasses ‘the complete content of what is measurable in a trial’.”
- Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. (2016, background): “autologous chondrocyte implantation); and (3) total knee replacement.”