Abstract
Objective. To determine the extent to which participants at the Outcome Measures in Rheumatology (OMERACT) 11 meeting agree that instruments used in clinical trials to measure OMERACT core outcome domains in acute gout fulfill OMERACT filter requirements of truth, discrimination, and feasibility; and where future research efforts need to be directed.
Methods. Results of a systematic literature review and analysis of individual-level data from recent clinical studies of acute gout were presented to OMERACT participants. The information was discussed in breakout groups, and opinion was defined by subsequent voting in a plenary session. Endorsement was defined as at least 70% of participants voting in agreement with the proposition (where the denominator excluded those participants who did not vote or who voted “don’t know”).
Results. The following measures were endorsed for use in clinical trials of acute gout: (1) 5-point Likert scale and/or visual analog scale (0 to 100 mm) to measure pain; (2) 4-point Likert scale for joint swelling; (3) 4-point Likert scale for joint tenderness; and (4) 5-point Likert scale for patient global assessment of response to treatment. Measures for the activity limitations domain were not endorsed.
Conclusion. Measures of pain, joint swelling, joint tenderness, and patient global assessment in acute gout were endorsed at OMERACT 11. These measures should now be used in clinical trials of acute gout.
Footnotes
-
Supported with the resources and the use of facilities at the Birmingham VA Medical Center, Alabama, USA (J. Singh) and University of Otago, New Zealand (W. Taylor). J. Singh has received research grants from Takeda and Savient; and consultant fees from Savient, Takeda, Ardea, Regeneron, Allergan, URL pharmaceuticals and Novartis; and is a member of the executive of OMERACT, which receives arms-length funding from 36 companies; a member of the American College of Rheumatology Guidelines Subcommittee of the Quality of Care Committee; and a member of the Veterans Affairs Rheumatology Field Advisory Committee. N. Dalbeth has acted as a consultant for Ardea Biosciences, Metabolex, Novartis, and Takeda; her institution has received funding from Fonterra, and she is a named inventor on a patent related to milk products and gout. L. Simon has served on the Board of Directors for Savient Pharmaceuticals, and as a consultant for Takeda. J. Sundy has received research support from Savient Pharmaceuticals, Regeneron, Ardea Biosciences, Metabolex, Nuon Therapeutics, Pharmos; and consulting funds from Savient Pharmaceuticals, Regeneron, Novartis, Ardea Biosciences, Metabolex, Nuon Therapeutics, BioCryst, and Pharmos. V. Strand has received consultant fees from Metabolex, Novartis, and Savient. D. Khanna has received consultant fees from Ardea, Takeda, Novartis, and Savient; and has served on a Speaker Bureau for Savient. N. Schlesinger has received research grants from Novartis, worked on the Advisory Board for Novartis, Takeda, Savient, Enzyme Rx, URL Pharma; served on the Speaker Bureau for Novartis, Takeda, and Savient; and received consultant fees from Novartis and Takeda. K. Saag has received consultant fees from Ardea, Regeneron, and Takeda and served on the Data Safety Monitoring Board for BioCryst. R. Schumacher has received a grant from Takeda and is a consultant with Regeneron, Novartis, Ardea, Metabolex, Savient, BioCryst, Westward, and Pfizer. N. Edwards has received consultant fees from Takeda Pharmaceutical, Savient Pharmaceutical, Ardea Biosciences, Regeneron Pharmaceuticals, Metabolex Pharmaceuticals, and BioCryst Pharmaceuticals. Views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government.
