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Objective. To review a novel approach for constructing composite response criteria for use in chronic gout clinical trials that implements a method of multicriteria decision-making.
Methods. Preliminary work with paper patient profiles led to a restricted set of core-set domains that were examined using 1000MindsTM by rheumatologists with an interest in gout, and (separately) by OMERACT registrants prior to OMERACT 10. These results and the 1000Minds approach were discussed during OMERACT 10 to help guide next steps in developing composite response criteria.
Results. There were differences in how individual indicators of response were weighted between gout experts and OMERACT registrants. Gout experts placed more weight upon changes in uric acid levels, whereas OMERACT registrants placed more weight upon reducing flares. Discussion highlighted the need for a “pain” domain to be included, for “worsening” to be an additional level within each indicator, for a group process to determine the decision-making within a 1000Minds exercise, and for the value of patient involvement.
Conclusion. Although there was not unanimous support for the 1000Minds approach to inform the construction of composite response criteria, there is sufficient interest to justify ongoing development of this methodology and its application to real clinical trial data.
Partially supported by a University of Otago Matched Funding Summer Scholarship and ACR-EULAR Grant through the University of Pennsylvania; also supported with resources and use of facilities at Birmingham VA Medical Center (Dr. Singh). Dr. Khanna is the recipient of an American College of Rheumatology REF Clinical Investigator Award (Quality of Life and Healthcare Utilization in Chronic Gout) and Co-Investigator on NIH/NIAMS 1AR057936 (Development and Initial Validation of PROMIS GI Distress Scale), Khanna, D; Spiegel B, co-principal investigators. Dr. Neogi is a recipient of NIAMS 5K23AR55127. Dr. Singh has received speaker honoraria from Abbott; research and travel grants from Allergan, Takeda, Savient, Wyeth, and Amgen; and consultant fees from Savient, URL Pharmaceuticals, and Novartis. Dr. Saag has received honoraria from Novartis, Amgen, and Lilly, has conducted clinical trials with Takeda, Novartis, and Regeneron, and serves on the Board of Directors of the Gout and Uric Acid Society. Ms MacDonald is an employee of Takeda Global Research and Development. Dr. Edwards has received consultant fees from Takeda and Savient. Dr. Simon has served on the Board of Directors for Savient Pharmaceuticals, and as a consultant for Takeda. Dr. Becker has been a consultant for Takeda, Savient, BioCryst, URL/Pharma, Ardea, and Regeneron. Dr. Schumacher has received consulting fees from Takeda, Savient, Regeneron, Novartis, and Pfizer.