Journal
JOURNAL OF RHEUMATOLOGY
Volume 41, Issue 3, Pages 569-573Publisher
J RHEUMATOL PUBL CO
DOI: 10.3899/jrheum.131246
Keywords
GOUT; OUTCOME MEASURES; PSYCHOMETRICS
Categories
Funding
- Takeda
- Savient
- Ardea
- Regeneron
- Allergan
- URL pharmaceuticals
- Novartis
- Fonterra
- Savient Pharmaceuticals
- Ardea Biosciences
- Metabolex
- Nuon Therapeutics
- Pharmos
- Biosciences
- BioCryst
- Takeda Pharmaceutical
- Savient Pharmaceutical
- Regeneron Pharmaceuticals
- Metabolex Pharmaceuticals
- BioCryst Pharmaceuticals
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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.
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