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Version 2 of the ROBINS-I tool to assess risk of bias in non-randomized studies of interventions

Event date
- (09:00 - 10:00 BST)
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Learning Live. Methods Support Unit Web Clinic. A monthly web clinic for Cochrane authors, editors and staff

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. 

Julian Higgins introduced the new ROBINS-I tool and its implementation in online software. The webinar was delivered in October 2025 and below you will find the recording, together with the accompanying slides to download [PDF]. 


Presenter Bio

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. 

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