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Developing a Core Set of Outcome Measures for Behçet Disease: Report from OMERACT 2016
Gulen Hatemi1,2, Alexa Meara1,2, Yesim Ozguler1,2
1From the Division of Rheumatology, Department of Internal Medicine, Istanbul University Cerrahpasa Faculty of Medicine; Division of Rheumatology, Marmara University Faculty of Medicine; Division of Rheumatology, Department of Internal Medicine, Istanbul University Istanbul Faculty of Medicine; Academic Hospital, Istanbul, Turkey; Division of Rheumatology and Immunology, The Ohio State University Wexner Medical Center, Columbus, Ohio; Department of Family Medicine and Community Health, University of Pennsylvania; Division of Rheumatology, Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; New York University School of Medicine, NYU Hospital for Joint Diseases, New York, USA; Department of Internal Medicine, University Paris Diderot, Paris, France.
Objective:
The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group has been working toward developing a data-driven core set of outcome measures for use in clinical trials of Behçet's syndrome [Behçet disease (BD)]. This paper summarizes the group's work through OMERACT 2016, discussions during the meeting, and the future research agenda.
Methods:
Qualitative patient interviews were conducted among 20 patients with BD who have different types of organ involvement. A 3-round Delphi among BD experts and patients was initiated to identify domains, subdomains, and outcomes to be assessed in clinical trials of BD. The results of these studies were discussed during OMERACT 2016 and next steps were planned.
Results:
Patients' perspectives and priorities were identified through qualitative interviews that identified candidate domains and subdomains for inclusion in the Delphi and characterized some shortcomings of the currently used patient-reported outcomes in BD. The first round of the Delphi was completed and several domains or subdomains were endorsed by the experts and/or the patients. Because many more items were endorsed than would be feasible to assess during a clinical trial, rating and ranking of items by physicians and patients was planned as a next critical step. The challenges of assessing specific organ system involvement was also discussed.
Conclusion:
The OMERACT Behçet Syndrome Working Group research program will identify core domains for assessment in BD with the goal of developing a core set of outcome measures for use in all trials of BD with the option to incorporate additional outcomes for specific organ involvement.