Developing a composite outcome tool to measure response to treatment in ANCA-associated vasculitis: A mixed methods study from OMERACT 2020 |
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| Affiliation: | 1. Systemic Autoimmunity Branch, National Institutes of Health, NIAMS, 10 Center Drive, Building 10, 10N Rm 311, Bethesda, MD 20892, United States;2. Department of Rheumatology, Policlinico S. Matteo, IRCCS Fondazione, Pavia, Italy;3. University of Pavia, Pavia, Italy;4. Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital & Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark;5. Department of Medicine, University of Cambridge, United Kingdom;6. Department of Rheumatic and Immunologic Diseases, Cleveland Clinic, Cleveland OH, United States;7. Sherborn, MA, United States;8. Clinic for Rheumatology, Cantonal Hospital St. Gallen, Switzerland;9. Vasculitis clinic, Division of Rheumatology, University of Toronto, Toronto, Canada;10. Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada;11. Department of Medicine, University of Ottawa, Ottawa, Canada;12. Reykjavik, Iceland;13. Faculty of Medicine, University of Iceland and Landspitali University Hospital, Reykjavik, Iceland;14. Division of Rheumatology, Department of Medicine, and Division of Clinical Epidemiology, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, United States |
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| Abstract: | ObjectiveThe Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group aims to develop composite response criteria for ANCA-Associated Vasculitis (AAV).MethodsThe project follows the OMERACT approach for composite measures: (i) choose relevant domains; (ii) define high-quality instruments; (iii) decide on a scoring system approach; (iv) put through the OMERACT Filter 2.1 for validation.ResultsA systematic literature review of outcome measures used in clinical trials in AAV and an international Delphi exercise among patients with AAV and clinician-investigators with expertise in AAV have been completed to inform the candidate domains/instruments for the composite response criteria, which are the first two steps in the OMERACT approach for developing composite measures. Results of the systematic literature review and Delphi were presented at the OMERACT 2020 virtual workshop, and feedback was received on the next steps of the project, including the development of a scoring system approach.ConclusionThe ultimate goal of this project is to develop validated composite response criteria for use in clinical trials of AAV. |
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