Core Outcome Measures in Effectiveness Trials

Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III

General Information

Abstract:
Significant progress has been made in outcome measurement procedures for osteoarthritis (OA) clinical trials, and guidelines have been established by the US Food and Drug Administration, European League Against Rheumatism, the World Health Organization/International League of Associations for Rheumatology, and the Group for the Respect of Ethics and Excellence in Science. However, there remains a need for further international harmonization of measurement procedures used to establish beneficial effects in Phase III clinical trials. A key objective of the OMERACT III conference was to establish a core set of outcome measures for future phase III clinical trials. During the conference, using a combination of discussion and polling procedures, a consensus was reached by at least 90% of participants that the following 4 domains should be evaluated in future phase III trials of knee, hip, and hand OA: pain, physical function, patient global assessment, and, for studies of one year or longer, joint imaging (using standardized methods for taking and rating radiographs, or any demonstrably superior imaging technique). These evidence based preferences, achieved with a high degree of consensus, establish an international standard for future phase III trials and will also facilitate metaanalysis and Cochrane Collaborative Project goals. [References: 6]

Authors:
Bellamy, N. Kirwan, J. Boers, M. Brooks, P. Strand, V. Tugwell, P. Altman, R. Brandt, K. Dougados, M. Lequesne, M.

Publication

Journal:
Journal of Rheumatology
Volume:
24
Issue:
4
Pages:
799 - 802
Year:
1997
DOI:
Further Study Information

Date:
Not stated
Funding source(s):
Not stated

Health Area

Disease Category
Rheumatology

Disease Name
Osteoarthritis

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Not specified

Method(s)

Consensus conference
Survey

Stakeholders Involved

Conference participants

Study Type

COS for clinical trials or clinical research

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