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Published on: May 27, 2022
Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an
Sabrina M Nielsen1,2, Peter Tugwell1,2, Maarten P T de Wit1,2
1From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; The Rheumatology Research Unit, Department of Rheumatology, Odense University Hospital; Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Children's Hospital of Eastern Ontario Research Institute; Department of Pediatrics and School of Rehabilitation Sciences, University of Ottawa, Ottawa; Institute for Work and Health, Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute and the Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; Department of Epidemiology and Biostatistics; Amsterdam Rheumatology and Immunology Center; Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam; Department of Rheumatology, and Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre; Care and Public Health Research Institute, Maastricht University, Maastricht; University of Twente, Department of Psychology, Health and Technology, Enschede, the Netherlands; Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles; Medicine Service, VA Medical Center, Birmingham; Department of Medicine, School of Medicine, University of Alabama, and Division of Epidemiology, School of Public Health, University of Alabama, Birmingham, Alabama; Department of Rehabilitation and Movement Science, College of Nursing and Health Sciences, University of Vermont, Burlington, Vermont; University of Washington, Seattle, Washington, USA; Swiss Paraplegic Research, Nottwil, Switzerland; Université de Lorraine, EA 4360 Approches Épidémiologiques et Psychologiques (APEMAC), Nancy, France; University of Florence, Florence, Italy; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria; European Medicines Agency, London, UK; Faculty of Medicine and Health University of Sydney and Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.
Objective:
The Contextual Factors Working Group aims to provide guidance on addressing contextual factors in rheumatology trials within OMERACT.
Methods:
During the Special Interest Group session at OMERACT 2018, preliminary results were presented from a case scenario survey and semistructured interviews, including contextual factors mentioned in these. A group-based exercise sought to identify and rank important generic contextual factors.
Results:
A total of 79 candidate factors were listed. Across the 3 groups, gender/sex, comorbidities, and the healthcare system were ranked as most important.
Conclusion:
The identified important contextual factor domains may be considered a provisional list pending further research.
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