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

Jonathan Sterne, Miguel A Hernán, Barnaby Reeves, Jelena Savović, Nancy D Berkman, M 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 Juni, Yoon K Loke, Terri D Pigott, Craig R RamsayDeborah Regidor, Hannah R Rothstein, Lakhbir Sandhu, Holger Schünemann, Beverley Shea, Ian Shrier, Peter Tugwell, Lucy Turner, Jeffrey C Valentine, Hugh Waddington, E Waters, George A Wells, Penny Whiting, Julian Higgins

Research output: Contribution to journalArticle (Academic Journal)peer-review

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Non-randomized studies of the effects of interventions are critical to many areas of health care 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-randomized 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 randomization 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-randomized studies.
Original languageEnglish
Article numberi4919
Number of pages7
Publication statusPublished - 12 Oct 2016

Structured keywords

  • BTC (Bristol Trials Centre)
  • Centre for Surgical Research

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