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

Area of Science:

• Rheumatology research
• Health outcomes research
• Clinical trial methodology

Background:

• Standardization of outcome measures in clinical trials is lacking, limiting evidence utility.
• The Outcome Measures in Rheumatology (OMERACT) initiative has developed core sets for rheumatologic conditions since 1992.
• Patient involvement in OMERACT began in 2002, necessitating a clear framework.

Purpose of the Study:

• To develop an explicit conceptual framework and process for creating standardized outcome measures.
• To ensure core outcome sets are relevant to patients and decision-makers.
• To address the expanding scope of the OMERACT initiative.

Main Methods:

• Literature searches were conducted.
• An iterative consensus process involving surveys and group meetings with diverse stakeholders was employed.
• Stakeholders included patients, health professionals, and methodologists from rheumatology and other fields.

Main Results:

• A framework with three core "Areas" (Death, Life Impact, Pathophysiological Manifestations) and recommended "Resource Use" emerged.
• The process involves identifying core "Domains" to create a "Core Domain Set," followed by selecting measurement instruments for a "Core Outcome Measurement Set."
• Instruments must be valid, discriminative, and feasible; 96% of OMERACT 11 participants endorsed the model.

Conclusions:

• The OMERACT Filter 2.0 framework and process offer a comprehensive approach to developing core outcome measurement sets.
• This model is designed for rheumatology but has potential as a template for other healthcare areas.
• The framework aims to improve the usefulness of clinical trial evidence for healthcare decisions.