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Endpoints in rheumatoid arthritis

P Tugwell¹, M Boers, P Baker

¹Department of Medicine, University of Ottawa, Canada.

The Journal of Rheumatology. Supplement

|October 1, 1994

Summary

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A core set of 8 outcome measures for rheumatoid arthritis (RA) clinical trials was established. Further research is needed to validate these measures and explore additional outcomes like toxicity and cost.

Area of Science:

Rheumatology
Clinical Trials
Outcome Measurement

Background:

The Outcome Measures in Rheumatology Trials (OMERACT) conference has been pivotal in advancing clinical outcome measurement.
Standardized outcome measures are crucial for consistent and comparable rheumatoid arthritis (RA) clinical trial results.

Purpose of the Study:

To establish a preliminary core set of 8 essential endpoints for RA clinical trials of one year or longer.
To outline the need for further validation and refinement of these core measures and their aggregation into indices.

Main Methods:

Consensus was reached on a preliminary core set of 8 outcome measures through conference discussions and nominal group exercises.
A mandate was established for comprehensive testing of assessment techniques, determination of clinical importance, and validation of aggregated outcome indices.

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Main Results:

A preliminary core set of 8 endpoints was agreed upon for RA trials: acute phase reactants, disability, pain, patient and physician global assessments, swollen and tender joint counts, and radiographic joint assessments.
The conference identified the need for systematic exploration of additional outcomes, including drug toxicity, costs, and mortality, for definitive intervention selection.

Conclusions:

The established core set provides a minimum standard for RA clinical trials.
Further research and validation are essential to refine outcome measures, ensure credibility, and inform clinical decision-making, considering broader aspects beyond core endpoints.