Gulen Hatemi1, Yesim Ozguler1, Haner Direskeneli1, Alfred Mahr1, Ahmet Gul1, Virna Levi1, Sibel Z Aydin1, Gonca Mumcu1, Ozlem Sertel-Berk1, Randall M Stevens1, Hasan Yazici1, Peter A Merkel1. 1. From the Division of Rheumatology, Department of Internal Medicine, Istanbul University Cerrahpasa Faculty of Medicine, Istanbul; Division of Rheumatology, Marmara University Faculty of Medicine, Istanbul, Turkey; Department of Internal Medicine, University Paris Diderot, Paris, France; Division of Rheumatology, Koc University Faculty of Medicine, Istanbul; Faculty of Health Sciences, Marmara University; Department of Psychology, Istanbul University, Istanbul, Turkey; Celgene Corporation, Warren, New Jersey; Rutgers, Robert Wood Johnson Medical School, Department of Rheumatology, New Brunswick, New Jersey; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.G. Hatemi, MD, Associate Professor of Medicine, Division of Rheumatology, Department of Internal Medicine, Istanbul University Cerrahpasa Faculty of Medicine; Y. Ozguler, MD, Fellow in Rheumatology, Division of Rheumatology, Istanbul University Cerrahpasa Faculty of Medicine; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University Faculty of Medicine; A. Mahr, MD, PhD, Professor of Internal Medicine, Department of Internal Medicine, University Paris Diderot; A. Gul, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University; V. Levi, BA, Patient Research Partner, Istanbul; S.Z. Aydin, MD, Associate Professor of Rheumatology, Division of Rheumatology, Koc University Faculty of Medicine; G. Mumcu, DDS, PhD, Professor in Health Management, Faculty of Health Sciences, Marmara University; O. Sertel-Berk, MA, Associate Professor of Psychology, Department of Psychology, Istanbul University; R.M. Stevens, MD, Celgene Corporation, and Clinical Professor of Medicine, Rutgers, Robert Wood Johnson Medical School, Department of Rheumatology; H. Yazici, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul Universit
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.
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.
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