- To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects.
- 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.
- Meta-analyses from the Cochrane Pregnancy and Childbirth Database.
The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding.
- 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).
- 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
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0336947
Code Inist : 002B30A01A1. Création : 01/03/1996.