Key Points: 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. RoB 2 is structured into a fixed set of domains of bias, focusing on different aspects of trial design, conduct and reporting. Each assessment using the RoB 2 tool focuses on a specific result from a randomized trial. 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. A judgement about the risk of bias arising from each domain is proposed by an algorithm, based on answers to the signalling questions. Judgements can be ‘Low’, or ‘High’ risk of bias, or can express ‘Some concerns’. Answers to signalling questions and judgements about risk of bias should be supported by written justifications. The overall risk of bias for the result is the least favourable assessment across the domains of bias. Both the proposed domain-level and overall risk-of-bias judgements can be overridden by the review authors, with justification.
|Title of host publication||Cochrane Handbook for Systematic Reviews of Interventions|
|Editors||Julian P. T. Higgins, James Thomas, Jacqueline Chandler, Miranda Cumpston, Tianjing Li, Matthew J. Page, Vivian A. Welch|
|Place of Publication||Chichester UK|
|Number of pages||24|
|ISBN (Print)||9781119536628, 9781119536611|
|Publication status||Published - Sep 2019|
Higgins, J. P. T., Savović, J., Page, M., Elbers, R., & Sterne, J. A. C. (2019). Assessing risk of bias in a randomized trial. In J. P. T. Higgins, J. Thomas, J. Chandler, M. Cumpston, T. Li, M. J. Page, & V. A. Welch (Eds.), Cochrane Handbook for Systematic Reviews of Interventions (2nd ed., pp. 205-228). Wiley-Blackwell.