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  1. Empirical evidence of bias : dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

    Article - En anglais

    Objective

    - To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects.

    Design

    - An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects.

    Data Sources

    - Meta-analyses from the Cochrane Pregnancy and Childbirth Database.

    Main Outcome Measures

    The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding.

    Results

    - Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P<. 001).

    Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality).

    Conclusions

    - This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias.

    Mots-clés Pascal : Homme, Etude critique, Qualité, Méthodologie, Estimation, Efficacité traitement

    Mots-clés Pascal anglais : Human, Critical study, Quality, Methodology, Estimation, Treatment efficiency

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 95-0336947

    Code Inist : 002B30A01A1. Création : 01/03/1996.