Since it was published in 2016, the ROBINS-I tool has been widely used in systematic reviews that include non-randomized studies of interventions.

Version 2 of the ROBINS-I, released during 2025, implements changes that should make the tool more usable and risk of bias assessments more reliable. The tool now provides algorithms that suggest risk of bias judgements based on answers to signalling questions. It also addresses issues such as bias due to immortal time that were omitted from the 2016 version.

In this Methods Support Unit web clinic, the presenters will introduce the new ROBINS-I tool and its implementation in online software.

Presenter bios

Julian Higgins is Professor of Evidence Synthesis at the University of Bristol, where he co-directs the NIHR Bristol Evidence Synthesis Group and heads the Bristol Appraisal and Review of Research (BARR) group. His research interests span all areas of systematic review and meta-analysis. Among his methods contributions are a Bayesian approach to network meta-analysis, the I-squared statistic to quantify inconsistency across studies in a meta-analysis, simple prediction intervals for random-effects meta-analysis and risk-of-bias assessment tools for clinical trials and other study designs. He has long been an active contributor to Cochrane, is a former member of the Cochrane Collaboration Steering Group, the Cochrane Editorial Board and the Cochrane Scientific Committee, and is currently co-convenor of the Cochrane Bias Methods Group. He has co-edited the Cochrane Handbook for Systematic Reviews of Interventions since 2003.

Jonathan Sterne is Professor of Medical Statistics and Epidemiology at the University of Bristol, Director of the NIHR Bristol Biomedical Research Centre and co-Director of Health Data Research UK South-West. He leads a large team producing novel, high impact research on COVID-19 vaccination and long COVID, based on analyses of up to 55 million people. He has a longstanding interest in methodology for systematic reviews and meta-analysis. He co-led development of the RoB 2 tool for assessing risk of bias in randomised trials and the ROBINS-I and ROBINS-E tools for assessing risk of bias in non-randomised studies of interventions and exposures, respectively. Jonathan is a former co-convenor of the Cochrane Bias Methods Group and has published influential papers on reporting bias in meta-analysis, meta-epidemiology, causal inference and statistical methodology.

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Thursday, 2 October 2025, 08:00 UTC [check the time in your timezone] SIGN UP HERE

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