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

Armijo-Olivo S, Saltaji H, da Costa BR, Fuentes J, Ha C, Cummings GG - BMJ Open (2015)

Bottom Line: Data extraction including assessments of random sequence generation and allocation concealment was conducted independently by two reviewers.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).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.

View Article: PubMed Central - PubMed

Affiliation: CLEAR Outcomes (Connecting Leadership, Education and Research) Research Program, University of Alberta, Edmonton Clinic Health Academy (ECHA), Edmonton, Alberta, Canada Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada Faculty of Rehabilitation Medicine, Rehabilitation Research Center, University of Alberta, Edmonton, Alberta, Canada.

No MeSH data available.


Forest plot of the differences in effect sizes between trials with and without adequate concealment of allocation.
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BMJOPEN2015008562F4: Forest plot of the differences in effect sizes between trials with and without adequate concealment of allocation.

Mentions: For the purpose of analysing the effect of allocation concealment on treatment effects, 17 meta-analyses including 198 trials and analysing 27 011 patients contributed to this analysis. Figure 4 shows the forest plot of the differences in ES between trial with adequate and inadequate allocation concealment. 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). The results of the stratified analyses are displayed in figure 5. None of the meta-analyses characteristics had a statistically significant interaction. When focusing on trials with appropriate allocation concealment (category 1 and 2) versus trials with clearly inappropriate methods of concealment (category 4), the difference was not statistically significant (ES=0.26; 95% CI −0.04 to 0.55). However, trials with clearly inappropriate methods of concealment (category 4) tended to overestimate the treatment effects. The same was the case when comparing the trials with appropriate allocation concealment (category 1 and 2) versus trials with unclear or unreported concealment of allocation (ES=0.20; 95% CI 0.05 to 0.34). This time, the difference between these trials was statistically significant.


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

Armijo-Olivo S, Saltaji H, da Costa BR, Fuentes J, Ha C, Cummings GG - BMJ Open (2015)

Forest plot of the differences in effect sizes between trials with and without adequate concealment of allocation.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4563231&req=5

BMJOPEN2015008562F4: Forest plot of the differences in effect sizes between trials with and without adequate concealment of allocation.
Mentions: For the purpose of analysing the effect of allocation concealment on treatment effects, 17 meta-analyses including 198 trials and analysing 27 011 patients contributed to this analysis. Figure 4 shows the forest plot of the differences in ES between trial with adequate and inadequate allocation concealment. 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). The results of the stratified analyses are displayed in figure 5. None of the meta-analyses characteristics had a statistically significant interaction. When focusing on trials with appropriate allocation concealment (category 1 and 2) versus trials with clearly inappropriate methods of concealment (category 4), the difference was not statistically significant (ES=0.26; 95% CI −0.04 to 0.55). However, trials with clearly inappropriate methods of concealment (category 4) tended to overestimate the treatment effects. The same was the case when comparing the trials with appropriate allocation concealment (category 1 and 2) versus trials with unclear or unreported concealment of allocation (ES=0.20; 95% CI 0.05 to 0.34). This time, the difference between these trials was statistically significant.

Bottom Line: Data extraction including assessments of random sequence generation and allocation concealment was conducted independently by two reviewers.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).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.

View Article: PubMed Central - PubMed

Affiliation: CLEAR Outcomes (Connecting Leadership, Education and Research) Research Program, University of Alberta, Edmonton Clinic Health Academy (ECHA), Edmonton, Alberta, Canada Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada Faculty of Rehabilitation Medicine, Rehabilitation Research Center, University of Alberta, Edmonton, Alberta, Canada.

No MeSH data available.