ROBINS-I: a tool for assessing risk of bias in non-randomized studies of interventions

Jonathan AC Sterne* (Corresponding Author), Miguel A Hernán, Barnaby C Reeves, Jelena Savović, Nancy D Berkman, Meera Viswanathan, David Henry, Douglas G Altman, Mohammed T Ansari, Isabelle Boutron, James R Carpenter, An-Wen Chan, Rachel Churchill, Jonathan J Deeks, Asbjørn Hróbjartsson, Jamie Kirkham, Peter Jüni, Yoon K Loke, Theresa D Pigott, Craig R RamsayDeborah Regidor, Hannah R Rothstein, Lakhbir Sandhu, Pasqualina L Santaguida, Holger J Schünemann, Beverly Shea, Ian Shrier, Peter Tugwell, Lucy Turner, Jeffrey C Valentine, Hugh Waddington, Elizabeth Waters, George A Wells, Penny F Whiting, Julian Pt Higgins

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Non-randomised studies of the effects of interventions are critical to many areas of healthcare evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I (“Risk Of Bias In Non-randomised Studies - of Interventions”), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomisation to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomised studies.
Original languageEnglish
Article numberi4919
Number of pages7
Publication statusPublished - 12 Oct 2016

Bibliographical note

Development of ROBINS-I was funded by a Methods Innovation Fund grant from Cochrane and Medical Research Council grant MR/M025209/1. Sterne and Higgins are members of the Medical Research Council Integrative Epidemiology Unit at the University of Bristol which is supported by the Medical Research Council and the University of Bristol (grant MC_UU_12013/9). This research was
partly funded by NIH grant P01 CA134294. Sterne was supported by National Institute for Health Research Senior Investigator award NF-SI-0611-10168. Savović and Whiting were supported by National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West). Reeves was supported by the National Institute for Health Research Bristol Biomedical Research Unit in Cardiovascular Disease. None of the funders had a role in the development of the ROBINS-I tool, although employees of Cochrane contributed to some of the meetings and workshops. The views expressed are those of the authors and not necessarily those of Cochrane, the NHS, the NIHR or the Department of Health.


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