Clinical trial registration in physiotherapy journals: Recommendations from the International Society of Physiotherapy Journal Editors

Costa, Leonardo Oliveira Pena; Lin, Chung‐Wei Christine; Bevilaqua-Grossi, Débora; Mancini, Marisa C.; Swisher, Anne K.; Cook, Chad; Vaughn, Dan; Elkins, Mark R.; Sheikh, Umer; Moore, Ann; Jull, Gwendolen; Craik, Rebecca L.; Maher, Christopher G.; Guirro, Rinaldo Roberto de Jesus; Marques, Amélia Pasqual; Harms, Michèle; Brooks, Dina; Simoneau, Guy G.; Strupstad, John Henry

doi:10.1016/j.math.2012.10.009

Cited by 9 publications

(7 citation statements)

References 10 publications

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“…Further, only four of the included twelve trials had a pre-registered and publicly available trial protocol summary, and none had a public available full trial protocol. The processes of trial pre-registration and protocol publication could contribute to more detailed description of exercise interventions as trial protocol guidelines would refer to the above mentioned templates for reporting exercise characteristics 62,63 .…”

Section: Dose-responsementioning

confidence: 99%

The relationship between prescribed pre-operative knee-extensor exercise dosage and effect on knee-extensor strength prior to and following total knee arthroplasty: a systematic review and meta-regression analysis of randomized controlled trials

Husted

Juhl

Troelsen

et al. 2020

Osteoarthritis and Cartilage

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Objective: The aim of this systematic review was to evaluate the relationship between prescribed kneeextensor strength exercise dosage in pre-operative exercise intervention and the effect on knee-extensor muscle strength prior to and following TKA. Additional meta-analyses report the effect of pre-habilitation on outcomes prior to and following TKA. Design: A systematic literature search was performed including RCT's evaluating the effect of preoperative exercise prior to and following TKA. Meta-regression analysis was performed to evaluate the dose-response relationship between prescribed exercise dose and the pooled effect, measured as standardized mean difference (SMD). The prescribed exercise dose was quantified using a formula accounting for as many exercise descriptors as possible. Risk of bias in the included trials was assessed using the Cochrane Risk of Bias Tool. Results: Twelve trials with 616 patients were included. Meta-regression analysis showed no relationship between prescribed pre-operative knee-extensor exercise dosage and change in knee-extensor strength neither prior to (slope 0.0005 [95%CI-0.007 to 0.008]) or 3 months following TKA (slope 0.0014 [95%CI-0.006 to 0.009]). Prior to TKA, a moderate effect favoring pre-operative exercise for increase in kneeextensor strength was found (SMD 0.50 [95%CI 0.12 to 0.88]), but not at 3 months following TKA (SMD-0.01 [95%CI-0.45 to 0.43]). Risk of bias was generally assessed as unclear. Conclusion: Meta-regression analysis of existing trials suggests no relationship between the prescribed pre-operative knee-extensor exercise dosage and the change in knee-extensor strength observed prior to and following TKA. Pre-operative exercise including knee-extensor muscle strength exercise increased knee-extensor strength moderately prior to but not 3 months following TKA.

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Section: Dose-responsementioning

confidence: 99%

The relationship between prescribed pre-operative knee-extensor exercise dosage and effect on knee-extensor strength prior to and following total knee arthroplasty: a systematic review and meta-regression analysis of randomized controlled trials

Husted

Juhl

Troelsen

et al. 2020

Osteoarthritis and Cartilage

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“…More than one-third of the included trials were unregistered even at the time of article publication. Prospective registration of only 22% of included papers also suggests that adherence to the specific ICMJE, ISPJE and Declaration of Helsinki recommendations is not widespread (De Angelis et al 2004;World Medical Association 2008;Costa et al 2013). This prospective registration figure falls slightly short of that of 31% identified by Harriman and Patel (2016) in a search of all clinical trials published in the BMC series in 2013.…”

Section: Discussionmentioning

confidence: 99%

“…Despite the advantages conferred by appropriate randomised controlled trial (RCT) designs for minimising bias in individual studies, the value of this evidence to clinical practice can be undermined by other sources of bias. These include selective trial reporting, which may arise from researchers not submitting their work for peer-review or publishers not accepting a research report (De Angelis et al 2004;Costa et al 2013).…”

Section: Introductionmentioning

confidence: 99%

“…To address this issue of selective outcome reporting, the International Committee of Medical Journal Editors (ICMJE) mandated prospective trial registration as a prerequisite for publishing clinical trial reports (De Angelis et al 2004). This initiative was followed by a similar recommendation from the International Society of Physiotherapy Journal Editors (ISPJE) in 2013 (Costa et al 2013). The Food and Drug Administration Amendments Act of 2007 (FDAAA) even places a legal obligation on sponsors and investigators to register certain clinical trials of FDA-regulated biologics, drugs and devices prospectively on ClinicalTrials.gov (Zarin et al 2016).…”

Section: Introductionmentioning

confidence: 99%

“…Despite the implementation of large-scale projects to reduce reporting bias, cross-sectional investigations of published RCTs have revealed incomplete uptake and mixed approaches to trial registration since the release of the ICMJE statement in 2004 (Costa et al 2013). Babu et al (2014) reported that only 29% of English articles reported trial registration in MEDLINE-indexed ISPJE journals.…”

Section: Introductionmentioning

confidence: 99%

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The association between registration status and reported outcomes in physiotherapy randomised controlled trials

Ellaway-Barnard

Killick

Peryer

et al. 2020

International Journal of Therapy and Rehabilitation

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Background/Aims Clinical trial registration has been proposed as a method of mitigating selective reporting in scientific research. It remains unknown whether trial registration is associated with reported outcomes in physiotherapy trials. This study aimed to analyse the association between registration status and outcome (the rejection or acceptance of a primary null hypothesis) for physiotherapy randomised controlled trials. Methods All randomised controlled trials reporting a physiotherapy intervention in publications listed in PubMed between 1 January 2017 and 30 June 2017 were included. Trial registration was determined based on the reporting of a registration number in the primary article or by identifying trials through trial registries. Results Of the 291 trials analysed, 176 (60.5%) were registered; 115 (39.5%) were not. There was no significant association between trial registration and outcome on multivariate analyses (Odds Ratio 1.65; 95% Confidence Interval (0.92–2.96); P=0.09). Only 22% of trials were prospectively registered. Conclusions Registration status and trial outcome are not associated in randomised controlled trials of physiotherapy interventions. The rate of physiotherapy trial registration remains low.

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Editors reflections on 2013 and plans for new initiatives in 2014

Moore

Jull

2014

Manual Therapy

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Clinical trial registration in physiotherapy journals: Recommendations from the International Society of Physiotherapy Journal Editors

Cited by 9 publications

References 10 publications

The relationship between prescribed pre-operative knee-extensor exercise dosage and effect on knee-extensor strength prior to and following total knee arthroplasty: a systematic review and meta-regression analysis of randomized controlled trials

The relationship between prescribed pre-operative knee-extensor exercise dosage and effect on knee-extensor strength prior to and following total knee arthroplasty: a systematic review and meta-regression analysis of randomized controlled trials

The association between registration status and reported outcomes in physiotherapy randomised controlled trials

Editors reflections on 2013 and plans for new initiatives in 2014

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