5/19/2023 0 Comments We were here together chapter 8Variants of the RoB 2 tool specific to cluster-randomized trials and crossover trials are summarized in Chapter 23. 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. This chapter summarizes the main features of RoB 2 applied to individually randomized parallel-group trials. These domains were identified based on both empirical evidence and theoretical considerations. The RoB 2 tool is structured into domains through which bias might be introduced into the result. 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. When randomized trials are included, the recommended tool is the revised version of the Cochrane tool, known as RoB 2, described in this chapter. Available from 8.1 IntroductionĬochrane Reviews include an assessment of the risk of bias in each included study (see Chapter 7 for a general discussion of this topic). Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Chapter 8: Assessing risk of bias in a randomized trial. Both the proposed domain-level and overall risk-of-bias judgements can be overridden by the review authors, with justification.Ĭite this chapter as: Higgins JPT, Savović J, Page MJ, Elbers RG, Sterne JAC. 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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