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Review
. 2015 Sep 3;5(9):e008562.
doi: 10.1136/bmjopen-2015-008562.

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

Susan Armijo-Olivo  1 , Humam Saltaji  2 , Bruno R da Costa  3 , Jorge Fuentes  4 , Christine Ha  5 , Greta G Cummings  6
Affiliations
Review

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

Susan Armijo-Olivo et al. BMJ Open. .

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 meta-meta-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.

Keywords: allocation concealment; meta-epidemiological; physical therapy; risk of bias; sequence generation.

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Figures

Figure 1
Figure 1
Diagram for identification of studies.
Figure 2
Figure 2
Forest plot of the differences in effect sizes between trials with and without adequate sequence generation.
Figure 3
Figure 3
Forest plot of the differences in effect sizes between trials with and without sequence generation stratified by meta-analyses characteristics (effect size magnitude, heterogeneity, type outcome and physical therapy area).
Figure 4
Figure 4
Forest plot of the differences in effect sizes between trials with and without adequate concealment of allocation.
Figure 5
Figure 5
Forest plot of the differences in effect sizes between trials with and without adequate concealment of allocation stratified by meta-analyses characteristics (effect size magnitude, heterogeneity, type outcome and physical therapy area).
Figure 6
Figure 6
Pooled data of the effect of concealment of allocation on treatment effect estimates using continuous outcomes.
See this image and copyright information in PMC

References

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