Rheumatology Advance Access originally published online on July 24, 2007
Rheumatology 2007 46(12):1751-1756; doi:10.1093/rheumatology/kem178
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REVIEWS |
Assessment of outcome in clinical trials of gout—a review of current measures
1Rehabilitation Teaching and Research Unit, Department of Medicine, Wellington School of Medicine and Health Sciences, University of Otago, Wellington, New Zealand, 2Division of Rheumatology, University of Pennsylvania School of Medicine and Veterans Affairs Medical Center, Philadelphia, PA, 3Rheumatology Section, Medicine Service and Center for Epidemiological and Clinical Research, Center for Chronic Disease Outcomes Research at the VA Medical Center, 4Division of Rheumatology, Department of Medicine, University of Minnesota, Minneapolis, MN, USA, 5Malaghan Institute of Medical Research, Wellington and 6Department of Medicine, Faculty of Medicine and Health Sciences, University of Auckland, Auckland, New Zealand.
Correspondence to: Dr William J. Taylor, Department of Medicine, Wellington School of Medicine and Health Sciences, University of Otago, PO Box 7343, Wellington 6242, New Zealand. E-mail: will.taylor{at}otago.ac.nz
| Abstract |
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There has been renewed interest in the treatment of gout with recent reported intervention studies of new agents such as etoricoxib, febuxostat and pegylated-uricase. However, these studies have highlighted the relative paucity of validated outcome measures with which to judge efficacy. This review outlines the published information regarding which endpoints have been measured in randomized clinical trials, what should be measured, what tools or instruments are available for this and the technical properties of such instruments. It highlights recent work that validates measures of tophi, radiographic damage and patient-reported outcomes. The absence of a valid definition of gout-flare or how flare reduction defines response is problematic; this forms the basis for a current ACR-EULAR sponsored project.
Submitted 5 April 2007; Accepted 25 May 2007