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

Armijo-Olivo, Susan; Fuentes-Contreras, Jorge; Saltaji, Humam; Da Costa, Bruno; Ha, Christine; Cummings, Greta G.

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dc.contributor.author	Armijo-Olivo, Susan
dc.contributor.author	Fuentes-Contreras, Jorge
dc.contributor.author	Saltaji, Humam
dc.contributor.author	Da Costa, Bruno
dc.contributor.author	Ha, Christine
dc.contributor.author	Cummings, Greta G.
dc.date.accessioned	2017-10-30T20:39:25Z
dc.date.available	2017-10-30T20:39:25Z
dc.date.issued	2015
dc.identifier.uri	http://repositorio.ucm.cl/handle/ucm/999
dc.description.abstract	Objective: 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. Design: Meta-epidemiological study. Participants: A random sample of randomised controlled trials (RCTs) included in meta-analyses in the PT discipline were identified. Intervention: 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 metameta-analytic approach. Primary and secondary outcome measures: association between random sequence generation and allocation concealment and ES in PT trials. Results: 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 to 0.30). When pooling our results with those of Nuesch et al, we obtained a pooled statistically significant value (ES=0.14; 95% CI 0.02 to 0.26). There was no difference in ES in trials with appropriate or inappropriate random sequence generation (ES=0.02; 95% CI −0.12 to 0.15). Conclusions: Our results suggest that when evaluating risk of bias of primary RCTs in PT area, systematic reviewers and clinicians implementing research into practice should pay attention to these biases since they could exaggerate treatment effects. Systematic reviewers should perform sensitivity analysis including trials with low risk of bias in these domains as primary analysis and/or in combination with less restrictive analyses. Authors and editors should make sure that allocation concealment and random sequence generation are properly reported in trial reports.	es_CL
dc.language.iso	en	es_CL
dc.rights	Atribución-NoComercial-SinDerivadas 3.0 Chile	*
dc.rights.uri	http://creativecommons.org/licenses/by-nc-nd/3.0/cl/	*
dc.source	BMJ Open, 5, e008562	es_CL
dc.title	What is the influence of randomisation sequence generation and allocation concealment on treatment effects of physical therapy trials? A meta-epidemiological study	es_CL
dc.type	Article	es_CL
dc.ucm.facultad	Facultad de Ciencias de la Salud	es_CL
dc.ucm.indexacion	Scopus	es_CL
dc.ucm.indexacion	Isi	es_CL
dc.ucm.doi	dx.doi.org/10.1136/bmjopen-2015-008562	es_CL