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[S2E2] Chapter 8

Cite this chapter as: Higgins JPT, Savović J, Page MJ, Elbers RG, Sterne JAC. Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). Cochrane, 2022. Available from

[S2E2] Chapter 8

Cochrane Reviews include an assessment of the risk of bias in each included study (see Chapter 7 for a general discussion of this topic). When randomized trials are included, the recommended tool is the revised version of the Cochrane tool, known as RoB 2, described in this chapter. The RoB 2 tool provides a framework for assessing the risk of bias in a single result (an estimate of the effect of an experimental intervention compared with a comparator intervention on a particular outcome) from any type of randomized trial.

The RoB 2 tool is structured into domains through which bias might be introduced into the result. These domains were identified based on both empirical evidence and theoretical considerations. This chapter summarizes the main features of RoB 2 applied to individually randomized parallel-group trials. It describes the process of undertaking an assessment using the RoB 2 tool, summarizes the important issues for each domain of bias, and ends with a list of the key differences between RoB 2 and the earlier version of the tool. Variants of the RoB 2 tool specific to cluster-randomized trials and crossover trials are summarized in Chapter 23. 041b061a72

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