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American Journal of Epidemiology Advance Access originally published online on January 27, 2006
American Journal of Epidemiology 2006 163(6):493-501; doi:10.1093/aje/kwj069
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American Journal of Epidemiology Copyright © 2006 by the Johns Hopkins Bloomberg School of Public Health All rights reserved; printed in U.S.A.

Review

Bias in Clinical Intervention Research

Lise Lotte Gluud

From the Copenhagen Trial Unit, Center for Clinical Intervention Research, Cochrane Hepato-Biliary Group, Copenhagen, Denmark

Correspondence to Lise Lotte Gluud, Department 7102, Copenhagen Trial Unit, Cochrane Hepato-Biliary Group, Rigshospitalet, DK-2100 Copenhagen, Denmark (e-mail: lgluud{at}ctu.rh.dk).

Research on bias in clinical trials may help identify some of the reasons why investigators sometimes reach the wrong conclusions about intervention effects. Several quality components for the assessment of bias control have been suggested, but although they seem intrinsically valid, empirical evidence is needed to evaluate their effects on the extent and direction of bias. This narrative review summarizes the findings of methodological studies on the influence of bias in clinical trials. A number of methodological studies suggest that lack of adequate randomization in published trial reports may be associated with more positive estimates of intervention effects. The influence of double-blinding and follow-up is less clear. Several studies have found a significant association between funding sources and pro-industry conclusions. However, the methodological studies also show that bias is difficult to detect and appraise. The extent of bias in individual trials is unpredictable. A-priori exclusion of trials with certain characteristics is not recommended. Appraising bias control in individual trials is necessary to avoid making incorrect conclusions about intervention effects.

bias (epidemiology); evidence-based medicine; meta-analysis; publication bias; selection bias

Abbreviations: CI, confidence interval; ROR, relative odds ratio; SSRIs, selective serotonin reuptake inhibitors


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