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

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.