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... Show moreTo 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. Show less
Knoop, J.; Dekker, J.; Dongen, J.M. van; Leeden, M. van der; Rooij, M. de; Peter, W.F.; ... ; Ostelo, R.W.J.G. 2022
Question: In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup,... Show moreQuestion: In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup, obesity subgroup) in reducing knee pain and improving physical function than usual exercise therapy? Design: Pragmatic cluster randomised controlled trial in a primary care setting. Participants: A total of 335 people with knee osteoarthritis: 153 in an experimental arm and 182 in a control arm. Intervention: Physiotherapy practices were randomised into an experimental arm providing stratified ex-ercise therapy (supplemented by a dietary intervention from a dietician for the obesity subgroup) or a control arm providing usual, non-stratified exercise therapy. Outcome measures: Primary outcomes were knee pain severity (numerical rating scale for pain, 0 to 10) and physical function (Knee Injury and Osteoarthritis Outcome Score subscale activities of daily living, 0 to 100). Measurements were performed at baseline, 3 months (primary endpoint) and 6 and 12 months (follow-up). Intention-to-treat, multilevel, regression analysis was performed. Results: Negligible differences were found between the experimental and control groups in knee pain (mean adjusted difference 0.2, 95% CI -0.4 to 0.7) and physical function (-0.8, 95% CI -4.3 to 2.6) at 3 months. Similar effects between groups were also found for each subgroup separately, as well as at other time points and for nearly all secondary outcome measures. Conclusion: This pragmatic trial demonstrated no added value regarding clinical outcomes of the model of stratified exercise therapy compared with usual exercise therapy. This could be attributed to the experimental arm therapists facing difficulty in effectively applying the model (especially in the obesity subgroup) and to elements of stratified exercise therapy possibly being applied in the control arm. Registration: Netherlands National Trial Register NL7463. [Knoop J, Dekker J, van Dongen JM, van der Leeden M, de Rooij M, Peter WFH, de Joode W, van Bodegom-Vos L, Lopuhaa N, Bennell KL, Lems WF, van der Esch M, Vliet Vlieland TPM, Ostelo RWJG (2022) Stratified exercise therapy does not improve outcomes compared with usual exercise therapy in people with knee osteoarthritis (OCTOPuS study): a cluster randomised trial. Journal of Physiotherapy 68:182-190] (c) 2022 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Show less
