Background/Purpose: An unmet need for reliable, validated, and widely accepted outcome measures for trials in BehetÕs syndrome (BS) was identified through: i) a systematic review; ii) a survey among BehetÕs experts; and iii) an outcome measures interest group meeting during the 16^th International Conference on BehetÕs Disease (1,2). The OMERACT BehetÕs Syndrome Working Group has been working to advance outcome measures in BS with the goal of creating a core set of data-driven measures for use in clinical trials. To identify domains, subdomains, and outcomes to be assessed in trials of BS, a Delphi exercise among BS experts and patients with BS has been initiated. This abstract describes the results for round 1 of the Delphi.

Methods: A list of possible domains, subdomains, and outcomes was prepared using the results of a systematic literature review on outcomes assessed in previous studies in BS, patient priorities identified through qualitative interviews, and expert opinion. A 3-round Delphi was begun among physicians from different specialties experienced in BS and among patients with BS. The patient survey was the same as the physician survey with medical terms explained. The web-based survey was formatted in both English and Turkish and emailed to 123 physicians and 130 patients. Agreement by ³70% of either physicians or patients resulted in an item being accepted.

Results: 74 physicians and 35 patients participated in Round 1. The physicians were experts in BS from 21 countries and from within a wide range of specialties, including Rheumatology (50%), Ophthalmology (12%), Internal Medicine (12%), Dermatology (16%), Gastroenterology (3%), and Neurology (1%). Among the participating patients there was good representation of each type of organ involvement. Table 1 shows the domains to be measured in all trials in BS that received ³70% endorsement by expert physicians and the additional subdomains endorsed for trials for each type of involvement. In addition to all of the domains identified by physicians, ³70% of patients endorsed the assessment of pain, fatigue, sleep, sexual functioning, psychological functioning, and acute phase reactants in all trials of BS.

Conclusion: Multiple disease-related domains in BS have been identified by physicians and patients as important to address in clinical trials, suggesting that a core set for all trials will be needed and subdomains for subsets of disease (specific manifestations) will also be useful. Rating and ranking of these domains and subdomains in the next 2 rounds will enable the development of a core set of domains to be assessed in clinical trials of BS. Table 1. Domains and subdomains of BehetÕs syndrome endorsed by ³70% of physician-experts as necessary to measure in clinical trials