Abstract
To describe the quality of reporting and the nature of reported harms in clinical studies on the effectiveness of supervised exercises in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). We performed a systematic review, searching eight databases up to February 2023. Randomized controlled trials (RCTs) evaluating supervised exercises in adults with RA or axSpA were considered eligible. Data on harms were extracted according to the CONSORT Harms 2022 Checklist. Among others, it was recorded if harms were prespecified or non-prespecified. Moreover, the nature of reported harms was listed. Forty RCTs were included for RA and 25 for axSpA, of which 29 (73%) and 13 (52%) reported information on harms. In 13 (33%) RCTs in RA and four (16%) in axSpA, the collection of harms outcomes was described in the methods section. Prespecified outcomes were reported by eight (RA) and two (axSpA) RCTs. Non-specified harms outcomes were reported by six (RA) and four (axSpA) RCTs. Prespecified harms outcomes included measures of pain, disease activity, inflammation, and structural joint changes. The nature of non-prespecified harms outcomes varied largely, with pain being most common. A considerable proportion of trials on supervised exercise in RA or axSpA does not or inadequately report harms outcomes. Pain was the most commonly reported prespecified or non-specified harm. For a considerate interpretation of the balance between benefits and harms of supervised exercise in RA or axSpA, use of the CONSORT Harms 2022 Checklist for the design, conduct and reporting of trials is advocated.
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This project is financially supported by the Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport), The Netherlands; the Netherlands Organisation for Health Research and Development (ZonMw; Project Numbers: 852004018, 852004019); the Dutch Arthritis Society (ReumaNederland); the Royal Dutch Society for Physical Therapy (Koninklijk Nederlands Genootschap voor Fysiotherapie KNGF).
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All authors have made substantial contributions to this project, spanning the conception, design, data acquisition, analysis, data interpretation, and/or the development of new software crucial to our work. MMHT, TPMVV, SFEW, JS, A-KRO, CBJ, KN, MGJG, and CHME made substantial contributions to the conception and design. MMHT, TPMVV, JWS and CHME made substantial contributions to the search strategy and selection of studies. MMHT, TPMVV and CHME have made significant contributions to the data extraction and analysis and interpretation of the data. Additionally, all authors were involved in drafting the manuscript and critically revising it to ensure the inclusion of important intellectual content. They have collectively approved the final version for publication. Moreover, the authors have agreed to be accountable for their respective roles in all aspects of the project, demonstrating their commitment to addressing any inquiries related to the accuracy or integrity of any part of the work with appropriate investigation and resolution. All authors take full responsibility for the integrity and accuracy of all aspects of their work.
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Teuwen, M.M.H., Vlieland, T.P.M.V., van Weely, S.F.E. et al. Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis. Rheumatol Int 44, 25–39 (2024). https://doi.org/10.1007/s00296-023-05502-3
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DOI: https://doi.org/10.1007/s00296-023-05502-3