What is the influence of randomisation sequence generation and allocation concealment on treatment effects of physical therapy trials? A meta-epidemiological study

BMJ Open
Susan Armijo-OlivoGreta G Cummings

Abstract

To determine if adequacy of randomisation and allocation concealment is associated with changes in effect sizes (ES) when comparing physical therapy (PT) trials with and without these methodological characteristics. Meta-epidemiological study. A random sample of randomised controlled trials (RCTs) included in meta-analyses in the PT discipline were identified. Data extraction including assessments of random sequence generation and allocation concealment was conducted independently by two reviewers. To determine the association between sequence generation, and allocation concealment and ES, a two-level analysis was conducted using a meta-meta-analytic approach. association between random sequence generation and allocation concealment and ES in PT trials. 393 trials included in 43 meta-analyses, analysing 44,622 patients contributed to this study. Adequate random sequence generation and appropriate allocation concealment were accomplished in only 39.7% and 11.5% of PT trials, respectively. Although trials with inappropriate allocation concealment tended to have an overestimate treatment effect when compared with trials with adequate concealment of allocation, the difference was non-statistically significant (ES=0.12; 95% CI -0.06...Continue Reading

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Citations

May 6, 2016·American Journal of Physical Medicine & Rehabilitation·Susan Armijo-OlivoGreta G Cummings
Jun 12, 2017·The Cochrane Database of Systematic Reviews·Jennifer M RyanNeil E O'Connell
Jan 9, 2020·American Journal of Physical Medicine & Rehabilitation·Susan Armijo-OlivoAntti Malmivaara
Dec 19, 2019·American Journal of Physical Medicine & Rehabilitation·Stefano NegriniUNKNOWN RCTRACK Promoters
Feb 18, 2020·Research Synthesis Methods·Susan Armijo-OlivoSandy Campbell
Sep 23, 2020·American Journal of Physical Medicine & Rehabilitation·Jorge FuentesGreta G Cummings
May 20, 2018·BMC Medical Research Methodology·Humam SaltajiCarlos Flores-Mir
Jan 10, 2019·Systematic Reviews·Francesca WuytackDeclan Devane
May 15, 2021·Archives of Physical Medicine and Rehabilitation·Chiara ArientiStefano Negrini
May 15, 2021·Archives of Physical Medicine and Rehabilitation·Susan Armijo-OlivoStefano Negrini
Dec 4, 2021·Chiropractic & Manual Therapies·Luis Fernando Sousa FilhoWalderi Monteiro da Silva Júnior

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