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Publication - Professor Julian Higgins

    RoB 2

    a revised tool for assessing risk of bias in randomised trials

    Citation

    Sterne, J, Savović, J, Page, M, Elbers, R, Blencowe, N, Boutron, I, Cates, CJ, Cheng, H-Y, Corbett, M, Eldridge, S, Emberson, J, Hernán, MA, Hopewell, S, Hróbjartsson, A, Junqueira, D, Juni, P, Kirkham, J, Lasserson, T, Li, T, McAleenan, A, Reeves, B, Shepperd, S, Shrier, I, Stewart, L, Tilling, K, White, IR, Whiting, P & Higgins, J, 2019, ‘RoB 2: a revised tool for assessing risk of bias in randomised trials’. BMJ, vol 366.

    Abstract

    Summary points
    • Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for assessing risk of bias in randomised trials is the Cochrane Risk of Bias tool, which was introduced in 2008.
    • Potential improvements to the Cochrane risk of bias tool were identified based on reviews of the literature, user experience and feedback, approaches used in other risk of bias tools, and recent developments in estimation of intervention effects from randomised trials.
    • We developed and piloted a revised tool for assessing risk of bias in randomised trials (RoB 2).
    • Bias is addressed in five distinct domains, within each of which answers to signalling questions lead to judgements of “low risk of bias”, “some concerns” or “high risk of bias”.
    • The judgements within each domain lead to an overall risk of bias judgement for the result being assessed. This should facilitate stratification of meta-analyses according to risk of bias.

    Full details in the University publications repository