Assessing Risk of Bias in Randomised Clinical Trials Included in Cochrane Reviews: The why is Easy, the how is a Challenge

Asbjørn Hróbjartsson · Isabelle Boutron · Lucy Turner · Douglas G. Altman · David Moher

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Delphi Technique in Research

Abstract

Randomised clinical trials are o en inadequately reported and may be inadequately conducted.Any associated biases could impact seriously on the findings and conclusion of a systematic review.Authors of systematic reviews thus need to assess the risk of bias in included randomised clinical trials.In this 20th Anniversary editorial, we look at the evolution of guidance on appraising studies included in Cochrane Reviews.Assessing the methodological 'quality' of included trials was addressed from the earliest days of The Cochrane Collaboration, although the phrase 'risk of bias' came into use later.In 1994 one of the first editions of the Cochrane Collaboration Handbook recommended that reviewers should routinely assess the adequacy of allocation concealment, and that they could consider assessing blinding and attrition, based on a seminal empirical study by Schulz and colleagues.[1]Over the next decade several Cochrane Review Groups developed different recommendations for assessing risk of bias.Of 50 Cochrane Review Groups surveyed in 2007, 41 recommended using specific trial characteristics to assess risk of bias and nine either recommended using a quality scale or made this optional.Most groups suggested assessing the randomisation procedure (including concealment of allocation), blinding, and attrition.[2] Assessing risk of bias in randomised clinical trials included in Cochrane Reviews: the why is easy, the how is a challenge (Editorial) 1

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References

2011The Cochrane Collaboration's tool for assessing risk of bias in randomised trials 1995Empirical Evidence of Bias 1995Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials 2004Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials 2012Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials 2010Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects Systematic Review and Meta-regression Analysis 2008Recommendations by Cochrane Review Groups for assessment of the risk of bias in studies 2009Risk of bias versus quality assessment of randomised controlled trials: cross sectional study

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2019S3-Leitlinie zur Diagnostik, Beratung und Behandlung im Kontext von Geschlechtsinkongruenz, Geschlechtsdysphorie und Trans-Gesundheit 2019Disagreements in risk of bias assessment for randomised controlled trials included in more than one Cochrane systematic reviews: a research on research study using cross-sectional design 2015Risk of bias of randomized trials over time 2016Mechanisms and direction of allocation bias in randomised clinical trials

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