ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions

Jonathan Ac Sterne, 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 Deeks, Asbjørn Hróbjartsson, Jamie Kirkham, Peter Jüni, Yoon K. Loke, Theresa D. Pigott, Craig R. Ramsay & 15 others Deborah 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

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934 Citations (Scopus)

Abstract

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
JournalBMJ: British Medical Journal
Volume355
DOIs
Publication statusPublished - 2016
Externally publishedYes

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Sterne, J. A., Hernán, M. A., Reeves, B. C., Savović, J., Berkman, N. D., Viswanathan, M., ... Higgins, J. P. (2016). ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions. BMJ: British Medical Journal, 355, [i4919]. https://doi.org/10.1136/bmj.i4919
Sterne, Jonathan Ac ; Hernán, Miguel A. ; Reeves, Barnaby C. ; Savović, Jelena ; Berkman, Nancy D. ; Viswanathan, Meera ; Henry, David ; Altman, Douglas G ; Ansari, Mohammed T. ; Boutron, Isabelle ; Carpenter, James R. ; Chan, An Wen ; Churchill, Rachel ; Deeks, Jonathan ; Hróbjartsson, Asbjørn ; Kirkham, Jamie ; Jüni, Peter ; Loke, Yoon K. ; Pigott, Theresa D. ; Ramsay, Craig R. ; Regidor, Deborah ; Rothstein, Hannah R. ; Sandhu, Lakhbir ; Santaguida, Pasqualina L. ; Schünemann, Holger J. ; Shea, Beverly ; Shrier, Ian ; Tugwell, Peter ; Turner, Lucy ; Valentine, Jeffrey C. ; Waddington, Hugh ; Waters, Elizabeth ; Wells, George A. ; Whiting, Penny F. ; Higgins, Julian Pt. / ROBINS-I : A tool for assessing risk of bias in non-randomised studies of interventions. In: BMJ: British Medical Journal. 2016 ; Vol. 355.
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abstract = "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.",
author = "Sterne, {Jonathan Ac} and Hern{\'a}n, {Miguel A.} and Reeves, {Barnaby C.} and Jelena Savovi{\"A}‡ and Berkman, {Nancy D.} and Meera Viswanathan and David Henry and Altman, {Douglas G} and Ansari, {Mohammed T.} and Isabelle Boutron and Carpenter, {James R.} and Chan, {An Wen} and Rachel Churchill and Jonathan Deeks and Asbj{\o}rn Hr{\'o}bjartsson and Jamie Kirkham and Peter J{\"u}ni and Loke, {Yoon K.} and Pigott, {Theresa D.} and Ramsay, {Craig R.} and Deborah Regidor and Rothstein, {Hannah R.} and Lakhbir Sandhu and Santaguida, {Pasqualina L.} and Sch{\"u}nemann, {Holger J.} and Beverly Shea and Ian Shrier and Peter Tugwell and Lucy Turner and Valentine, {Jeffrey C.} and Hugh Waddington and Elizabeth Waters and Wells, {George A.} and Whiting, {Penny F.} and Higgins, {Julian Pt}",
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Sterne, JA, Hernán, MA, Reeves, BC, Savović, J, Berkman, ND, Viswanathan, M, Henry, D, Altman, DG, Ansari, MT, Boutron, I, Carpenter, JR, Chan, AW, Churchill, R, Deeks, J, Hróbjartsson, A, Kirkham, J, Jüni, P, Loke, YK, Pigott, TD, Ramsay, CR, Regidor, D, Rothstein, HR, Sandhu, L, Santaguida, PL, Schünemann, HJ, Shea, B, Shrier, I, Tugwell, P, Turner, L, Valentine, JC, Waddington, H, Waters, E, Wells, GA, Whiting, PF & Higgins, JP 2016, 'ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions' BMJ: British Medical Journal, vol. 355, i4919. https://doi.org/10.1136/bmj.i4919

ROBINS-I : A tool for assessing risk of bias in non-randomised studies of interventions. / Sterne, Jonathan Ac; Hernán, Miguel A.; Reeves, Barnaby C.; Savović, Jelena; Berkman, Nancy D.; Viswanathan, Meera; Henry, David; Altman, Douglas G; Ansari, Mohammed T.; Boutron, Isabelle; Carpenter, James R.; Chan, An Wen; Churchill, Rachel; Deeks, Jonathan; Hróbjartsson, Asbjørn; Kirkham, Jamie; Jüni, Peter; Loke, Yoon K.; Pigott, Theresa D.; Ramsay, Craig R.; Regidor, Deborah; Rothstein, Hannah R.; Sandhu, Lakhbir; Santaguida, Pasqualina L.; Schünemann, Holger J.; Shea, Beverly; Shrier, Ian; Tugwell, Peter; Turner, Lucy; Valentine, Jeffrey C.; Waddington, Hugh; Waters, Elizabeth; Wells, George A.; Whiting, Penny F.; Higgins, Julian Pt.

In: BMJ: British Medical Journal, Vol. 355, i4919, 2016.

Research output: Contribution to journalArticleResearchpeer-review

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T2 - A tool for assessing risk of bias in non-randomised studies of interventions

AU - Sterne, Jonathan Ac

AU - Hernán, Miguel A.

AU - Reeves, Barnaby C.

AU - Savović, Jelena

AU - Berkman, Nancy D.

AU - Viswanathan, Meera

AU - Henry, David

AU - Altman, Douglas G

AU - Ansari, Mohammed T.

AU - Boutron, Isabelle

AU - Carpenter, James R.

AU - Chan, An Wen

AU - Churchill, Rachel

AU - Deeks, Jonathan

AU - Hróbjartsson, Asbjørn

AU - Kirkham, Jamie

AU - Jüni, Peter

AU - Loke, Yoon K.

AU - Pigott, Theresa D.

AU - Ramsay, Craig R.

AU - Regidor, Deborah

AU - Rothstein, Hannah R.

AU - Sandhu, Lakhbir

AU - Santaguida, Pasqualina L.

AU - Schünemann, Holger J.

AU - Shea, Beverly

AU - Shrier, Ian

AU - Tugwell, Peter

AU - Turner, Lucy

AU - Valentine, Jeffrey C.

AU - Waddington, Hugh

AU - Waters, Elizabeth

AU - Wells, George A.

AU - Whiting, Penny F.

AU - Higgins, Julian Pt

PY - 2016

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AB - 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.

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U2 - 10.1136/bmj.i4919

DO - 10.1136/bmj.i4919

M3 - Article

VL - 355

JO - BMJ (Clinical research ed.)

JF - BMJ (Clinical research ed.)

SN - 0959-535X

M1 - i4919

ER -

Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M et al. ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions. BMJ: British Medical Journal. 2016;355. i4919. https://doi.org/10.1136/bmj.i4919