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 Ramsay; Deborah 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

doi:10.1136/bmj.i4919

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 Ramsay

Deborah 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 journal › Article (Academic Journal) › peer-review

17117 Citations (Scopus)

1438 Downloads (Pure)

Abstract

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 language	English
Article number	i4919
Number of pages	7
Journal	BMJ
Volume	355
DOIs	https://doi.org/10.1136/bmj.i4919
Publication status	Published - 12 Oct 2016

Research Groups and Themes

BTC (Bristol Trials Centre)
Centre for Surgical Research

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10.1136/bmj.i4919

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This is the final published version of the article (version of record). It first appeared online via BMJ at http://www.bmj.com/content/355/bmj.i4919. Please refer to any applicable terms of use of the publisher.
Final published version, 315 KBLicence: CC BY-NC
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This is the final published version of the article (version of record). It first appeared online via BMJ at http://www.bmj.com/content/355/bmj.i4919. Please refer to any applicable terms of use of the publisher.
Final published version, 74.3 KBLicence: CC BY-NC

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ACROBAT-RT: Refinment of and extensions to the Cochrane Risk of Bias tool for Randomised trials
Savovic, J. (Principal Investigator)
1/05/15 → 31/10/16
Project: Research
NIHR CLAHRC - UHB
Donovan , J. L. (Principal Investigator)
1/01/14 → 30/09/19
Project: Research, Parent
IEU Theme 3
Windmeijer, F. (Principal Investigator), Tilling, K. M. (Researcher) & Tilling, K. M. (Principal Investigator)
1/06/13 → 31/03/18
Project: Research

Professor Julian P T Higgins
- Julian.Higginsbristol.acuk
- Public Health and Primary Care - Professor of Evidence Synthesis
- Bristol Population Health Science Institute
Person: Academic , Member
Emeritus Professor Barnaby C Reeves
- Barney.Reevesbristol.acuk
- Bristol Medical School - Emeritus Professor
Person: Honorary and Visiting Academic
Professor Jelena Savovic
- jelena.savovicbristol.acuk
- Public Health and Primary Care - Professor of Epidemiology and Evidence Synthesis
- Bristol Population Health Science Institute
Person: Academic , Member

Cite this

Sterne, J., Hernán, M. A., Reeves, B., Savović, J., Berkman, N. D., Viswanathan, M., Henry, D., Altman, D. G., Ansari, M. T., Boutron, I., Carpenter, J. R., Chan, A.-W., Churchill, R., Deeks, J. J., Hróbjartsson, A., Kirkham, J., Juni, P., Loke, Y. K., Pigott, T. D., ... Higgins, J. (2016). ROBINS-I: a tool for assessing risk of bias in non-randomized studies of interventions. BMJ, 355, Article i4919. https://doi.org/10.1136/bmj.i4919

@article{04942354880545b0aeeacbd1550438b9,

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

abstract = "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.",

author = "Jonathan Sterne and Hern{\'a}n, \{Miguel A\} and Barnaby Reeves and Jelena Savovi{\'c} and Berkman, \{Nancy D\} and M Viswanathan and David Henry and Altman, \{Douglas G\} and Ansari, \{Mohammed T\} and Isabelle Boutron and Carpenter, \{James R\} and An-Wen Chan and Rachel Churchill and Deeks, \{Jonathan J\} and Asbj{\o}rn Hr{\'o}bjartsson and Jamie Kirkham and Peter Juni and Loke, \{Yoon K\} and Pigott, \{Terri D\} and Ramsay, \{Craig R\} and Deborah Regidor and Rothstein, \{Hannah R\} and Lakhbir Sandhu and Holger Sch{\"u}nemann and Beverley Shea and Ian Shrier and Peter Tugwell and Lucy Turner and Valentine, \{Jeffrey C\} and Hugh Waddington and E Waters and Wells, \{George A\} and Penny Whiting and Julian Higgins",

year = "2016",

month = oct,

day = "12",

doi = "10.1136/bmj.i4919",

language = "English",

volume = "355",

journal = "BMJ",

issn = "0959-8138",

publisher = "BMJ Publishing Group",

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Sterne, J, Hernán, MA, Reeves, B , Savović, J, Berkman, ND, Viswanathan, M, Henry, D, Altman, DG, Ansari, MT, Boutron, I, Carpenter, JR, Chan, A-W, Churchill, R, Deeks, JJ, Hróbjartsson, A, Kirkham, J, Juni, P, Loke, YK, Pigott, TD, Ramsay, CR, Regidor, D, Rothstein, HR, Sandhu, L, Schünemann, H, Shea, B, Shrier, I, Tugwell, P, Turner, L, Valentine, JC, Waddington, H, Waters, E, Wells, GA, Whiting, P & Higgins, J 2016, 'ROBINS-I: a tool for assessing risk of bias in non-randomized studies of interventions', BMJ, vol. 355, i4919. https://doi.org/10.1136/bmj.i4919

TY - JOUR

T1 - ROBINS-I

T2 - a tool for assessing risk of bias in non-randomized studies of interventions

AU - Sterne, Jonathan

AU - Hernán, Miguel A

AU - Reeves, Barnaby

AU - Savović, Jelena

AU - Berkman, Nancy D

AU - Viswanathan, M

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 J

AU - Hróbjartsson, Asbjørn

AU - Kirkham, Jamie

AU - Juni, Peter

AU - Loke, Yoon K

AU - Pigott, Terri D

AU - Ramsay, Craig R

AU - Regidor, Deborah

AU - Rothstein, Hannah R

AU - Sandhu, Lakhbir

AU - Schünemann, Holger

AU - Shea, Beverley

AU - Shrier, Ian

AU - Tugwell, Peter

AU - Turner, Lucy

AU - Valentine, Jeffrey C

AU - Waddington, Hugh

AU - Waters, E

AU - Wells, George A

AU - Whiting, Penny

AU - Higgins, Julian

PY - 2016/10/12

Y1 - 2016/10/12

N2 - 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.

AB - 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.

U2 - 10.1136/bmj.i4919

DO - 10.1136/bmj.i4919

M3 - Article (Academic Journal)

C2 - 27733354

SN - 0959-8138

VL - 355

JO - BMJ

JF - BMJ

M1 - i4919

ER -

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

Abstract

Research Groups and Themes

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Projects

ACROBAT-RT: Refinment of and extensions to the Cochrane Risk of Bias tool for Randomised trials

NIHR CLAHRC - UHB

IEU Theme 3

Profiles

Professor Julian P T Higgins

Emeritus Professor Barnaby C Reeves

Professor Jelena Savovic

Cite this