Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis.

Autor:	Natarajan P; St George and Sutherland Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia pragadeshnat9@hotmail.com sam.adie@gmail.com., Menounos S; St George and Sutherland Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia., Harris L; St George and Sutherland Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia.; St George and Sutherland Centre for Clinical Orthopaedic Research Limited, (SCORe), Kogarah, New South Wales, Australia., Monuja M; St George and Sutherland Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia.; St George and Sutherland Centre for Clinical Orthopaedic Research Limited, (SCORe), Kogarah, New South Wales, Australia., Gorelik A; Department of Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia.; Musculoskeletal Health and Wiser Health Care Units, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia., Karjalainen T; Department of Musculoskeletal Diseases, Tampere University Hospital, Tampere, Finland., Buchbinder R; Musculoskeletal Health and Wiser Health Care Units, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia., Harris IA; South West Sydney Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia., Naylor JM; South West Sydney Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia., Adie S; St George and Sutherland Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia pragadeshnat9@hotmail.com sam.adie@gmail.com.; St George and Sutherland Centre for Clinical Orthopaedic Research Limited, (SCORe), Kogarah, New South Wales, Australia.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Apr 18; Vol. 14 (4), pp. e080258. Date of Electronic Publication: 2024 Apr 18.
DOI:	10.1136/bmjopen-2023-080258
Abstrakt:	Objective: To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls. Design: Meta-epidemiological study. Data Sources: Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018. Study Selection: Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis. Outcome Measures: Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up. Results: Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p<0.001). Conclusions: Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout. Prospero Registration Number: CRD42019117364. Competing Interests: Competing interests: RB has received royalties from UpToDate for authoring a chapter unrelated to this paper (Plantar Fasciitis). SA has received grants and/or research contracts from National Health and Medical Research Council, Avant Foundation and ANZ Musculoskeletal Clinical Trial Network as part of Sydney Partnership for Health, Education, Research and Enterprise. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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