Sibel Z Aydin1,2, Haner Direskeneli1,2, Peter A Merkel3,4. 1. From the Division of Rheumatology, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; Division of Rheumatology, Marmara University Faculty of Medicine, Istanbul, Turkey; Division of Rheumatology, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 2. S.Z. Aydin, MD, Associate Professor, Division of Rheumatology, The Ottawa Hospital Research Institute, University of Ottawa; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University Faculty of Medicine; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania. 3. From the Division of Rheumatology, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada; Division of Rheumatology, Marmara University Faculty of Medicine, Istanbul, Turkey; Division of Rheumatology, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA. pmerkel@upenn.edu. 4. S.Z. Aydin, MD, Associate Professor, Division of Rheumatology, The Ottawa Hospital Research Institute, University of Ottawa; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University Faculty of Medicine; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania. pmerkel@upenn.edu.
Abstract
OBJECTIVE: To arrive at consensus for candidate outcomes for disease activity assessment in large-vessel vasculitis (LVV) in clinical trials. METHODS: A Delphi survey including 99 items was circulated among international experts for 3 rounds. RESULTS: Fifty-seven items were accepted for both giant cell arteritis and Takayasu arteritis. Sixty-seven percent of experts voted to have a common approach for both diseases with additional disease-specific items such as weight loss, scalp tenderness/necrosis, morning stiffness, dizziness, visual symptoms, and imaging. CONCLUSION: This study highlights similarities and differences in experts' perspectives for assessing clinical activity in LVV and may guide a consensus-driven core set of validated outcomes.
OBJECTIVE: To arrive at consensus for candidate outcomes for disease activity assessment in large-vessel vasculitis (LVV) in clinical trials. METHODS: A Delphi survey including 99 items was circulated among international experts for 3 rounds. RESULTS: Fifty-seven items were accepted for both giant cell arteritis and Takayasu arteritis. Sixty-seven percent of experts voted to have a common approach for both diseases with additional disease-specific items such as weight loss, scalp tenderness/necrosis, morning stiffness, dizziness, visual symptoms, and imaging. CONCLUSION: This study highlights similarities and differences in experts' perspectives for assessing clinical activity in LVV and may guide a consensus-driven core set of validated outcomes.
Entities:
Keywords:
GIANT CELL ARTERITIS; LARGE VESSEL; OUTCOMES; TAKAYASU ARTERITIS; VASCULITIS
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