Gulen Hatemi1,2, Alexa Meara1,2, Yesim Ozguler1,2, Haner Direskeneli1,2, Alfred Mahr1,2, Ebony Easley1,2, Mert Gurcan1,2, Trocon Davis1,2, Ahmet Gul1,2, Yusuf Yazici1,2, Katelyn Zottenberg1,2, Sinem Nihal Esatoglu1,2, Burak Erer1,2, Sevil Kamali1,2, Hasan Yazici1,2, Peter F Cronholm1,2, Peter A Merkel3,4. 1. From the Division of Rheumatology, Department of Internal Medicine, Istanbul University Cerrahpasa Faculty of Medicine; Division of Rheumatology, Marmara University Faculty of Medicine; Division of Rheumatology, Department of Internal Medicine, Istanbul University Istanbul Faculty of Medicine; Academic Hospital, Istanbul, Turkey; Division of Rheumatology and Immunology, The Ohio State University Wexner Medical Center, Columbus, Ohio; Department of Family Medicine and Community Health, University of Pennsylvania; Division of Rheumatology, Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; New York University School of Medicine, NYU Hospital for Joint Diseases, New York, USA; Department of Internal Medicine, University Paris Diderot, Paris, France. 2. G. Hatemi, MD, Associate Professor of Medicine, Division of Rheumatology, Department of Internal Medicine, Istanbul University Cerrahpasa Faculty of Medicine; A. Meara, MD, Clinical Instructor, Division of Rheumatology and Immunology, The Ohio State University Wexner Medical Center; 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; E. Easley, MPH, Department of Family Medicine and Community Health, University of Pennsylvania; M. Gurcan, Medical student, Istanbul University Cerrahpasa Faculty of Medicine; T. Davis, BA, Department of Family Medicine and Community Health, University of Pennsylvania; A. Gul, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University Istanbul Faculty of Medicine; Y. Yazici, MD, Assistant Professor of Medicine, New York University School of Medicine, NYU Hospital for Joint Diseases; K. Zottenberg, patient-partner; S.N. Esatoglu, MD, Fellow in Rheumatology, Division of Rheumatology, Istanbul University Cerrahpasa Faculty of Medicine; B. Erer, MD, Associate Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University Istanbul Faculty of Medicine; S. Kamali, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University Faculty of Medicine; H. Yazici, MD, Professor of Rheumatology, Academic Hospital; P.F. Cronholm, MD, Associate Professor of Family Medicine, Department of Family Medicine and Community Health, University of Pennsylvania; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania. 3. From the Division of Rheumatology, Department of Internal Medicine, Istanbul University Cerrahpasa Faculty of Medicine; Division of Rheumatology, Marmara University Faculty of Medicine; Division of Rheumatology, Department of Internal Medicine, Istanbul University Istanbul Faculty of Medicine; Academic Hospital, Istanbul, Turkey; Division of Rheumatology and Immunology, The Ohio State University Wexner Medical Center, Columbus, Ohio; Department of Family Medicine and Community Health, University of Pennsylvania; Division of Rheumatology, Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; New York University School of Medicine, NYU Hospital for Joint Diseases, New York, USA; Department of Internal Medicine, University Paris Diderot, Paris, France. pmerkel@upenn.edu. 4. G. Hatemi, MD, Associate Professor of Medicine, Division of Rheumatology, Department of Internal Medicine, Istanbul University Cerrahpasa Faculty of Medicine; A. Meara, MD, Clinical Instructor, Division of Rheumatology and Immunology, The Ohio State University Wexner Medical Center; 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; E. Easley, MPH, Department of Family Medicine and Community Health, University of Pennsylvania; M. Gurcan, Medical student, Istanbul University Cerrahpasa Faculty of Medicine; T. Davis, BA, Department of Family Medicine and Community Health, University of Pennsylvania; A. Gul, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University Istanbul Faculty of Medicine; Y. Yazici, MD, Assistant Professor of Medicine, New York University School of Medicine, NYU Hospital for Joint Diseases; K. Zottenberg, patient-partner; S.N. Esatoglu, MD, Fellow in Rheumatology, Division of Rheumatology, Istanbul University Cerrahpasa Faculty of Medicine; B. Erer, MD, Associate Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University Istanbul Faculty of Medicine; S. Kamali, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University Faculty of Medicine; H. Yazici, MD, Professor of Rheumatology, Academic Hospital; P.F. Cronholm, MD, Associate Professor of Family Medicine, Department of Family Medicine and Community Health, University of Pennsylvania; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania. pmerkel@upenn.edu.
Abstract
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group has been working toward developing a data-driven core set of outcome measures for use in clinical trials of Behçet's syndrome [Behçet disease (BD)]. This paper summarizes the group's work through OMERACT 2016, discussions during the meeting, and the future research agenda. METHODS: Qualitative patient interviews were conducted among 20 patients with BD who have different types of organ involvement. A 3-round Delphi among BD experts and patients was initiated to identify domains, subdomains, and outcomes to be assessed in clinical trials of BD. The results of these studies were discussed during OMERACT 2016 and next steps were planned. RESULTS: Patients' perspectives and priorities were identified through qualitative interviews that identified candidate domains and subdomains for inclusion in the Delphi and characterized some shortcomings of the currently used patient-reported outcomes in BD. The first round of the Delphi was completed and several domains or subdomains were endorsed by the experts and/or the patients. Because many more items were endorsed than would be feasible to assess during a clinical trial, rating and ranking of items by physicians and patients was planned as a next critical step. The challenges of assessing specific organ system involvement was also discussed. CONCLUSION: The OMERACT Behçet Syndrome Working Group research program will identify core domains for assessment in BD with the goal of developing a core set of outcome measures for use in all trials of BD with the option to incorporate additional outcomes for specific organ involvement.
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group has been working toward developing a data-driven core set of outcome measures for use in clinical trials of Behçet's syndrome [Behçet disease (BD)]. This paper summarizes the group's work through OMERACT 2016, discussions during the meeting, and the future research agenda. METHODS: Qualitative patient interviews were conducted among 20 patients with BD who have different types of organ involvement. A 3-round Delphi among BD experts and patients was initiated to identify domains, subdomains, and outcomes to be assessed in clinical trials of BD. The results of these studies were discussed during OMERACT 2016 and next steps were planned. RESULTS:Patients' perspectives and priorities were identified through qualitative interviews that identified candidate domains and subdomains for inclusion in the Delphi and characterized some shortcomings of the currently used patient-reported outcomes in BD. The first round of the Delphi was completed and several domains or subdomains were endorsed by the experts and/or the patients. Because many more items were endorsed than would be feasible to assess during a clinical trial, rating and ranking of items by physicians and patients was planned as a next critical step. The challenges of assessing specific organ system involvement was also discussed. CONCLUSION: The OMERACT Behçet Syndrome Working Group research program will identify core domains for assessment in BD with the goal of developing a core set of outcome measures for use in all trials of BD with the option to incorporate additional outcomes for specific organ involvement.
Authors: R R van Tol; E van Zwietering; J Kleijnen; J Melenhorst; L P S Stassen; C D Dirksen; S O Breukink Journal: Int J Colorectal Dis Date: 2018-04-22 Impact factor: 2.571
Authors: Matteo Piga; Alberto Floris; Gerard Espinosa; Luísa Serpa Pinto; Nikolaos Kougkas; Andrea Lo Monaco; Giuseppe Lopalco; Ida Orlando; Vittorio Pirani; Ernestina Santos; George Bertsias; Luca Cantarini; Alberto Cauli; Ricard Cervera; João Correia; Marcello Govoni; Florenzo Iannone; Piergiorgio Neri; Ana Martins Silva; Carlos Vasconcelos; Monica Muntoni; Alessandro Mathieu Journal: RMD Open Date: 2020-07
Authors: Alberto Floris; Gerard Espinosa; Luisa Serpa Pinto; Nikolaos Kougkas; Andrea Lo Monaco; Giuseppe Lopalco; Ida Orlando; George Bertsias; Luca Cantarini; Ricard Cervera; João Correia; Marcello Govoni; Florenzo Iannone; Alessandro Mathieu; Piergiorgio Neri; Ana Martins Silva; Carlos Vasconcelos; Monica Muntoni; Alberto Cauli; Matteo Piga Journal: Arthritis Res Ther Date: 2020-11-25 Impact factor: 5.156