Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2015 Dec;42(12):2436-41.
doi: 10.3899/jrheum.141147. Epub 2015 Sep 15.

Current Status, Goals, and Research Agenda for Outcome Measures Development in Behçet Syndrome: Report from OMERACT 2014

Gulen Hatemi  1 , Yesim Ozguler  1 , Haner Direskeneli  1 , Alfred Mahr  1 , Ahmet Gul  1 , Virna Levi  1 , Sibel Z Aydin  1 , Gonca Mumcu  1 , Ozlem Sertel-Berk  1 , Randall M Stevens  1 , Hasan Yazici  1 , Peter A Merkel  1
Affiliations
Review

Current Status, Goals, and Research Agenda for Outcome Measures Development in Behçet Syndrome: Report from OMERACT 2014

Gulen Hatemi et al. J Rheumatol. 2015 Dec.

Abstract

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.

Keywords: BEHÇET SYNDROME; OUTCOME MEASURES; OUTCOMES.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Questions from the survey of experts in Behçet syndrome.
Figure 2
Figure 2
Experts’ ratings for the relative weight of each item in a composite disease activity score. Ant.: anterior; Post.: posterior; Supf.: superficial; DVT: deep vein thrombosis; VC: vena cava; PAA: pulmonary artery aneurysm; LVA: large vessel arteritis; CNS: central nervous system; inv.: involvement; DST: dural sinus thrombosis; GIS: gastrointestinal.
Figure 3
Figure 3
Experts’ ratings for the necessity of each organ-specific activity tool. CNS: central nervous system.
See this image and copyright information in PMC

References

    1. Kural-Seyahi E, Fresko I, Seyahi N, Ozyazgan Y, Mat C, Hamuryudan V, et al. The long-term mortality and morbidity of Behçet syndrome: a 2-decade outcome survey of 387 patients followed at a dedicated center. Medicine. 2003;82:60–76. - PubMed
    1. Yazici H, Tüzün Y, Pazarli H, Yurdakul S, Ozyazgan Y, Ozdogan H, et al. Influence of age of onset and patient’s sex on the prevalence and severity of manifestations of Behçet’s syndrome. Ann Rheum Dis. 1984;43:783–789. - PMC - PubMed
    1. Hamuryudan V, Hatemi G, Tascilar K, Sut N, Ozyazgan Y, Seyahi E, et al. Prognosis of Behçet’s syndrome among men with mucocutaneous involvement at disease onset: long-term outcome of patients enrolled in a controlled trial. Rheumatology. 2010;49:173–177. - PubMed
    1. Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, et al. Outcome measures used in clinical trials for Behçet syndrome: a systematic review. J Rheumatol. 2014;41:599–612. - PMC - PubMed
    1. Yazici H, Ugurlu S, Seyahi E. Behçet syndrome: is it one condition? Clin Rev Allergy Immunol. 2012;43:275–280. - PubMed

Publication types

LinkOut - more resources