Quality of reporting of harms in clinical trials on exercise therapy in patients with rheumatoid arthritis or axial spondyloarthritis : a systematic review

Teuwen, M.; Vliet Vlieland, T. P. M.; van Weely, S. F. E; Schoones, J. W.; Rausch Osthoff, A. K.; Juhl, C.; Niedermann Schneider, K.; Gademan, M. G. J.; van den Ende, C.

doi:10.1136/annrheumdis-2023-eular.1994

Publication type:	Conference poster
Type of review:	Peer review (abstract)
Title:	Quality of reporting of harms in clinical trials on exercise therapy in patients with rheumatoid arthritis or axial spondyloarthritis : a systematic review
Authors:	Teuwen, M. Vliet Vlieland, T. P. M. van Weely, S. F. E Schoones, J. W. Rausch Osthoff, A. K. Juhl, C. Niedermann Schneider, K. Gademan, M. G. J. van den Ende, C.
et. al:	No
DOI:	10.1136/annrheumdis-2023-eular.1994
Published in:	Annals of the Rheumatic Diseases
Volume(Issue):	82
Issue:	Suppl 1
Page(s):	571
Conference details:	Annual European Congress of Rheumatology EULAR, Milan, Italy, 31 May - 3 June 2023
Issue Date:	Jun-2023
Publisher / Ed. Institution:	BMJ Publishing Group
Language:	English
Subjects:	Safety; Inflammatory arthritides; Systematic review
Subject (DDC):	615.82: Physical therapy 616.7: Diseases of musculoskeletal system and orthopaedics
Abstract:	Background: Exercise therapy has proven effective for people with rheumatic and musculoskeletal diseases (RMDs), including those with inflammatory arthritis such as rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) [1-2]. Exercise therapy is generally considered safe for people with RMDs, although the evidence is scarce. A few reviews reported on the nature and risk of harms of exercise therapy in RMDs, but none of them specifically addressed the quality of reporting of harms of exercise therapy in studies including people with inflammatory arthritis. Objectives: This study aimed to describe the quality of reporting of harms in clinical studies on the effectiveness of exercise therapy in people with RA or axSpA. Methods: RCTs with at least one treatment arm consisting of supervised exercise therapy in people with RA or axSpA were included. Eight electronic databases were searched up to November 2021. Two researchers independently selected studies for inclusion and extracted data and in case of disagreement a third researcher was consulted. Data extraction included study characteristics and fulfillment of a set of quality aspects derived from the Consolidated Standards of Reporting Trials (CONSORT) Extension for Reporting Harms Outcomes [3], predefined on the basis of consensus among authors (Table 1). Harms outcomes were defined as adverse events reported on individual level irrespective of causality or negative effects on group level (only if explicitly designated as measurement of potential harm). We considered the reporting on harms outcomes of sufficient quality if the authors reported at least 1) the methodology for active surveillance of harms outcomes (item 2a); and 2) the observed number and the nature of harms (items 3b and 3c). Results: The search yielded 5921 records, of which 64 studies (n= 41 RA, n=23 axSpA; described in 83 papers) were included. Of those studies in RA and axSpA, 34 (83%) and 15 (65%) included any information on harms, with 12 (29%) and 3 (13%) reporting active surveillance and 22 (54%) and 5 (22%) reporting on harms outcomes in the results section, respectively (see Table 1). In total, 10 of the 41 (24%) RA studies and 2 of the 23 (9%) axSpA studies fulfilled the predefined criteria for sufficient quality of reporting. Conclusion: The quality of reporting on harms outcomes is insufficient in the majority of RCTs on exercise therapy in people with RA or axSpA, with overall poorer quality in studies on axSpA which impedes substantiated conclusions about harms of exercise therapy. Our findings stress the need for consensus on the definition, classification, assessment and reporting of harms outcomes in trials on the effects of exercise therapy.
URI:	https://digitalcollection.zhaw.ch/handle/11475/28109
Fulltext version:	Published version
License (according to publishing contract):	Licence according to publishing contract
Departement:	School of Health Sciences
Organisational Unit:	Institute of Physiotherapy (IPT)
Appears in collections:	Publikationen Gesundheit

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Teuwen, M., Vliet Vlieland, T. P. M., van Weely, S. F. E., Schoones, J. W., Rausch Osthoff, A. K., Juhl, C., Niedermann Schneider, K., Gademan, M. G. J., & van den Ende, C. (2023). Quality of reporting of harms in clinical trials on exercise therapy in patients with rheumatoid arthritis or axial spondyloarthritis : a systematic review [Conference poster]. Annals of the Rheumatic Diseases, 82(Suppl 1), 571. https://doi.org/10.1136/annrheumdis-2023-eular.1994

Teuwen, M. et al. (2023) ‘Quality of reporting of harms in clinical trials on exercise therapy in patients with rheumatoid arthritis or axial spondyloarthritis : a systematic review’, in Annals of the Rheumatic Diseases. BMJ Publishing Group, p. 571. Available at: https://doi.org/10.1136/annrheumdis-2023-eular.1994.

M. Teuwen et al., “Quality of reporting of harms in clinical trials on exercise therapy in patients with rheumatoid arthritis or axial spondyloarthritis : a systematic review,” in Annals of the Rheumatic Diseases, Jun. 2023, vol. 82, no. Suppl 1, p. 571. doi: 10.1136/annrheumdis-2023-eular.1994.

TEUWEN, M., T. P. M. VLIET VLIELAND, S. F. E VAN WEELY, J. W. SCHOONES, A. K. RAUSCH OSTHOFF, C. JUHL, K. NIEDERMANN SCHNEIDER, M. G. J. GADEMAN und C. VAN DEN ENDE, 2023. Quality of reporting of harms in clinical trials on exercise therapy in patients with rheumatoid arthritis or axial spondyloarthritis : a systematic review. In: Annals of the Rheumatic Diseases. Conference poster. BMJ Publishing Group. Juni 2023. S. 571

Teuwen, M., T. P. M. Vliet Vlieland, S. F. E van Weely, J. W. Schoones, A. K. Rausch Osthoff, C. Juhl, K. Niedermann Schneider, M. G. J. Gademan, and C. van den Ende. 2023. “Quality of Reporting of Harms in Clinical Trials on Exercise Therapy in Patients with Rheumatoid Arthritis or Axial Spondyloarthritis : A Systematic Review.” Conference poster. In Annals of the Rheumatic Diseases, 82:571. BMJ Publishing Group. https://doi.org/10.1136/annrheumdis-2023-eular.1994.

Teuwen, M., et al. “Quality of Reporting of Harms in Clinical Trials on Exercise Therapy in Patients with Rheumatoid Arthritis or Axial Spondyloarthritis : A Systematic Review.” Annals of the Rheumatic Diseases, vol. 82, no. Suppl 1, BMJ Publishing Group, 2023, p. 571, https://doi.org/10.1136/annrheumdis-2023-eular.1994.