RT Journal Article
SR Electronic
T1 Current Status, Goals, and Research Agenda for Outcome Measures Development in Behçet Syndrome: Report from OMERACT 2014
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2436
OP 2441
DO 10.3899/jrheum.141147
VO 42
IS 12
A1 Gulen Hatemi
A1 Yesim Ozguler
A1 Haner Direskeneli
A1 Alfred Mahr
A1 Ahmet Gul
A1 Virna Levi
A1 Sibel Z. Aydin
A1 Gonca Mumcu
A1 Ozlem Sertel-Berk
A1 Randall M. Stevens
A1 Hasan Yazici
A1 Peter A. Merkel
YR 2015
UL http://www.jrheum.org/content/42/12/2436.abstract
AB Objective. There is an unmet need for reliable, validated, and widely accepted outcomes and outcome measures for use in clinical trials in Behçet syndrome (BS). Our report summarizes initial steps taken by the Outcome Measures in Rheumatology (OMERACT) vasculitis working group toward developing a core set of outcome measures for BS according to the OMERACT methodology, including the OMERACT Filter 2.0, and discussions during the first meeting of the BS working group held during OMERACT 12 (2014).Methods. During OMERACT 12, some of the important challenges in developing outcomes for BS were outlined and discussed, and a research agenda was drafted.Results. Among topics discussed were the advantages and disadvantages of a composite measure for BS that evaluates several organs/organ systems; bringing patients and physicians together for discussions about how to assess disease activity; use of organ-specific measures developed for other diseases; and the inclusion of generic, disease-specific, or organ-specific measures. The importance of incorporating patients’ perspectives, concerns, and ideas into outcome measure development was emphasized.Conclusion. The planned research agenda includes conducting a Delphi exercise among physicians from different specialties that are involved in the care of patients with BS and among patients with BS, with the aim of identifying candidate domains and subdomains to be assessed in randomized clinical trials of BS, and candidate items for a composite measure. The ultimate goal of the group is to develop a validated and widely accepted core set of outcomes and outcome measures for use in clinical trials in BS.