Article

Impact of allocation concealment on conclusion drawn from meta-analyses of randomized trials

IT University of Copenhagen, København, Capital Region, Denmark
International Journal of Epidemiology (Impact Factor: 9.2). 09/2007; 36(4). DOI: 10.1093/ije/dym087
Source: OAI

ABSTRACT Background Randomized trials without reported adequate allocation concealment have been shown to overestimate the benefit of experimental interventions. We investigated the robustness of conclusions drawn from meta-analyses to exclusion of such trials. Material Random sample of 38 reviews from The Cochrane Library 2003, issue 2 and 32 other reviews from PubMed accessed in 2002. Eligible reviews presented a binary effect estimate from a meta-analysis of randomized controlled trials as the first statistically significant result that supported a conclusion in favour of one of the interventions. Methods We assessed the methods sections of the trials in each included meta-analysis for adequacy of allocation concealment. We replicated each meta-analysis using the authors' methods but included only trials that had adequate allocation concealment. Conclusions were defined as not supported if our result was not statistically significant. Results Thirty-four of the 70 meta-analyses contained a mixture of trials with unclear or inadequate concealment as well as trials with adequate allocation concealment. Four meta-analyses only contained trials with adequate concealment, and 32, only trials with unclear or inadequate concealment. When only trials with adequate concealment were included, 48 of 70 conclusions (69%; 95% confidence interval: 56–79%) lost support. The loss of support mainly reflected loss of power (the total number of patients was reduced by 49%) but also a shift in the point estimate towards a less beneficial effect. Conclusion Two-thirds of conclusions in favour of one of the interventions were no longer supported if only trials with adequate allocation concealment were included.

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    • "An RCT was assessed to be at low risk of bias based on its performance across two domains – allocation concealment and blinding of outcome assessment. These domains were chosen for bias assessment as the significance of good allocation concealment and outcome assessment blinding in minimising bias and, in particular, overestimation of treatment effect is well supported by empirical evidence [24], [25]. While empirical evidence also exists to support the significance of adequate blinding of participants in reducing exaggeration of estimated treatment effects [25] the inherent difficulty of blinding participants in surgical RCTs necessitated the exclusion of this domain in our assessment. "
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