articleAnnals of Internal MedicineSep 18, 2012Closed access

Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials

University of Bristol · Copenhagen University Hospital · +14 more institutions

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Abstract

Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials. Outcome measures were classified as "mortality," "other objective," "or subjective," and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity. Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear (vs. adequate) random-sequence generation (ratio of odds ratios, 0.89 [95%…

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