The overall risk of bias for the result is the least favourable assessment across the domains of bias. Judgements can be ‘Low’, or ‘High’ risk of bias, or can express ‘Some concerns’.Īnswers to signalling questions and judgements about risk of bias should be supported by written justifications. Within each domain, a series of questions (‘signalling questions’) aim to elicit information about features of the trial that are relevant to risk of bias.Ī judgement about the risk of bias arising from each domain is proposed by an algorithm, based on answers to the signalling questions. RoB 2 is structured into a fixed set of domains of bias, focusing on different aspects of trial design, conduct and reporting.Įach assessment using the RoB 2 tool focuses on a specific result from a randomized trial.
This chapter details version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2), the recommended tool for use in Cochrane Reviews.
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