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.

Authors: Bellamy N (1) , Kirwan J (2) , Boers M (3) , Brooks P (4) , Strand V (5) , Tugwell P (6) , Altman R (7) , Brandt K (8) , Dougados M (9) , Lequesne MG (10)
(1) London Health Sciences Centre, Victoria Campus (2) Bristol Royal Infirmary (3) University Hospital Maastricht (4) St. Vincent’s Hospital (5) Stanford University (6) University of Ottawa (7) University of Miami School of Medicine (8) Indiana University School of Medicine (9) Pain Clinic, Hospital Cochin (10) College de Medecine des Hôpitaux de Paris
Source: J Rheumatol. 1997 Apr;24(4):799-802.
DOI: Not specified Publication date: 1997 Apr E-Publication date: Not specified Availability: full text Copyright: Not specified
Language: English Countries: Not specified Location: Not specified Correspondence address: Dr. N. Bellamy,
Ste. 303 Colborne, Bldg., London Health Sciences Centre, 375 South Street, London, ON N6A 4G5,


Article 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.

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