title: Bias in clinical intervention research.
abstract: 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.
authors.affiliation: Copenhagen Trial Unit, Center for Clinical Intervention Research, Cochrane Hepato-Biliary Group, Rigshospitalet, DK-2100 Copenhagen, Denmark. lgluud@ctu.rh.dk
authors.forename: Lise Lotte
authors.initials: LL
authors.lastname: Gluud
mesh_terms: D019317:Evidence-Based Medicine / Q000592:standards*; D006801:Humans; D016017:Odds Ratio; D017594:Publication Bias; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012109:Research Support as Topic; D018401:Sample Size; D015983:Selection Bias