Faculty Bibliography

Objectives: An unmet need for reliable, validated and widely accepted outcome measures for trials in Behcets syndrome (BS) was identified through: a systematic review; a survey among Behcets experts; and an outcome measures interest group meeting during the 16th International Conference on BS The OMERACT BS 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 for BS starting with a Delphi. This abstract describes the results for round one of the Delphi. Methods: A list of possible domains and outcomes was prepared using the results of a systematic literature review on outcomes assessed in previous Behcets studies, qualitative patient interviews, and expert opinion. A three round Delphi has 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 more than seventy percent of either physicians or patients resulted in an item 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, Ophthalmology, Internal Medicine, Dermatology, Gastroenterology, and Neurology. Among the participating patients there was good representation of each type of organ involvement please see Table 1 for results. In addition to these domains, more than seventy percent of patients endorsed the assessment of pain, fatigue, sleep, sexual functioning, psychological functioning, and acute phase reactants in all trials of BS. Conclusions: 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 will also be useful. Rating and ranking of these domains and subdomains in the next two rounds will enable the development of a core set of domains to be assessed in trials of BS

Objective/UNASSIGNED:To compare patients with a primary diagnosis of osteoarthritis (OA) versus rheumatoid arthritis (RA) for scores on a patient self-report MDHAQ/RAPID3 (Multidimensional Health Assessment Questionnaire/Routine Assessment of Patient Index Data 3), and for physician global assessment (DOCGL). Methods/UNASSIGNED:All patients with all diagnoses complete an MDHAQ/RAPID3 at all routine rheumatology visits in the waiting area before seeing a rheumatologist at four sites, one in Australia and three in the USA. The two-page MDHAQ includes 0-10 scores for physical function (in 10 activities), pain and patient global assessment [on 0-10 visual analogue scales (VAS)], compiled into a 0-30 RAPID3, as well as fatigue and self-report painful joint count scales. Rheumatologists estimate a 0-10 DOCGL VAS. Demographic, MDHAQ/RAPID3 and DOCGL data from a random visit were compared in patients with RA versus patients with OA using multivariate analysis of variance, adjusted for age, disease duration and formal education level. Results/UNASSIGNED:Median RAPID3 was higher in OA versus RA at all four sites (11.7-16.8 vs 6.2-11.8) (p<0.001 at three sites). Median DOCGL in OA versus RA was 5 vs 4, 4 vs 3.7, 2.2 vs 2.5 and 2 vs 1. Patterns were similar for individual RAPID3 items, fatigue and painful joint scales, and in stratified analyses of patients aged 55-70. Conclusion/UNASSIGNED:Patient MDHAQ/RAPID3 and physician DOCGL indicate similar or higher disease burden in OA versus RA. Routine MDHAQ/RAPID3 allows direct comparisons of the two diseases. The findings suggest possible revision of current clinical and public policy views concerning OA.