Development of ROBUST-RCT: Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials

Abstract

Recent innovations in evidence based medicine methods, in particular instruments assessing risk of bias in randomised trials, have focused on methodological rigour at the expense of simplicity and practicability. Such a focus could lead to challenges in application and loss of reliability of instruments. To deal with these shortcomings, the Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials (ROBUST-RCT) was created—a rigorously developed, simply structured, and user friendly instrument for assessing risk of bias of randomised controlled trials included in systematic reviews. This paper describes the development of ROBUST-RCT and provides associated documents and a manual of instructions. Although systematic reviews of randomised controlled trials provide the best evidence for the effects of healthcare interventions,1 flaws in trial design and conduct may result in biased estimates of effects, and hence misleading conclusions.2 As a result, risk of bias assessment of randomised controlled trials has become an essential step in the systematic review process. Furthermore, risk of bias represents one domain in the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system of rating certainty of evidence, and trial limitations resulting in risk of bias may lead authors of systematic reviews to rate down the certainty of evidence.34 Although many instruments for assessing risk of bias in randomised controlled trials are available,5 most have important limitations. A systematic survey found that existing instruments often include items that do not deal with risk of bias.5 To be suitable for use in systematic reviews, risk of bias instruments should include only items that deal with risk of bias problems rather than other GRADE domains.3 The most popular and rigorously developed instruments include those offered by the Cochrane Collaboration. The first Cochrane risk of bias instrument6 included an “unclear” response option that …