RoB 2: A revised tool for assessing risk of bias in randomised trials

Jonathan A.C. Sterne; Jelena Savović; Matthew J. Page; Roy G. Elbers; Natalie S. Blencowe; Isabelle Boutron; Christopher J. Cates; Hung Yuan Cheng; Mark S. Corbett; Sandra M. Eldridge; Jonathan R. Emberson; Miguel A. Hernán; Sally Hopewell; Asbjørn Hróbjartsson; Daniela R. Junqueira; Peter Jüni; Jamie J. Kirkham; Toby Lasserson; Tianjing Li; Alexandra McAleenan; Barnaby C. Reeves; Sasha Shepperd; Ian Shrier; Lesley A. Stewart; Kate Tilling; Ian R. White; Penny F. Whiting; Julian P.T. Higgins

doi:10.1136/bmj.l4898

RoB 2: A revised tool for assessing risk of bias in randomised trials

Jonathan A.C. Sterne, Jelena Savović, Matthew J. Page, Roy G. Elbers, Natalie S. Blencowe, Isabelle Boutron, Christopher J. Cates, Hung Yuan Cheng, Mark S. Corbett, Sandra M. Eldridge, Jonathan R. Emberson, Miguel A. Hernán, Sally Hopewell, Asbjørn Hróbjartsson, Daniela R. Junqueira, Peter Jüni, Jamie J. Kirkham, Toby Lasserson, Tianjing Li, Alexandra McAleenanBarnaby C. Reeves, Sasha Shepperd, Ian Shrier, Lesley A. Stewart, Kate Tilling, Ian R. White, Penny F. Whiting, Julian P.T. Higgins

Bloomberg School of Public Health

Research output: Contribution to journal › Article › peer-review

1542 Scopus citations

Original language	English (US)
Article number	l4898
Journal	The BMJ
Volume	366
DOIs	https://doi.org/10.1136/bmj.l4898
State	Published - 2019

ASJC Scopus subject areas

General Medicine

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10.1136/bmj.l4898

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Sterne, J. A. C., Savović, J., Page, M. J., Elbers, R. G., Blencowe, N. S., Boutron, I., Cates, C. J., Cheng, H. Y., Corbett, M. S., Eldridge, S. M., Emberson, J. R., Hernán, M. A., Hopewell, S., Hróbjartsson, A., Junqueira, D. R., Jüni, P., Kirkham, J. J., Lasserson, T., Li, T., ... Higgins, J. P. T. (2019). RoB 2: A revised tool for assessing risk of bias in randomised trials. The BMJ, 366, Article l4898. https://doi.org/10.1136/bmj.l4898

Sterne, JAC, Savović, J, Page, MJ, Elbers, RG, Blencowe, NS, Boutron, I, Cates, CJ, Cheng, HY, Corbett, MS, Eldridge, SM, Emberson, JR, Hernán, MA, Hopewell, S, Hróbjartsson, A, Junqueira, DR, Jüni, P, Kirkham, JJ, Lasserson, T, Li, T, McAleenan, A, Reeves, BC, Shepperd, S, Shrier, I, Stewart, LA, Tilling, K, White, IR, Whiting, PF & Higgins, JPT 2019, 'RoB 2: A revised tool for assessing risk of bias in randomised trials', The BMJ, vol. 366, l4898. https://doi.org/10.1136/bmj.l4898

@article{b5e2b401c83e4154afa6214bff5b6ad8,

title = "RoB 2: A revised tool for assessing risk of bias in randomised trials",

author = "Sterne, {Jonathan A.C.} and Jelena Savovi{\'c} and Page, {Matthew J.} and Elbers, {Roy G.} and Blencowe, {Natalie S.} and Isabelle Boutron and Cates, {Christopher J.} and Cheng, {Hung Yuan} and Corbett, {Mark S.} and Eldridge, {Sandra M.} and Emberson, {Jonathan R.} and Hern{\'a}n, {Miguel A.} and Sally Hopewell and Asbj{\o}rn Hr{\'o}bjartsson and Junqueira, {Daniela R.} and Peter J{\"u}ni and Kirkham, {Jamie J.} and Toby Lasserson and Tianjing Li and Alexandra McAleenan and Reeves, {Barnaby C.} and Sasha Shepperd and Ian Shrier and Stewart, {Lesley A.} and Kate Tilling and White, {Ian R.} and Whiting, {Penny F.} and Higgins, {Julian P.T.}",

note = "Funding Information: The development of the RoB 2 tool was supported by the UK Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/2- N61), with the support of the host MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures, MR/K025643/1), by MRC research grant MR/M025209/1, and by a grant from the Cochrane Collaboration. JACS, SME, and JPTH are National Institute for Health Research (NIHR) senior investigators. JACS, NSB, H-YC, BCR, and JPTH are supported by NIHR Bristol Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. JACS, JPTH, and KT are members of the MRC Integrative Epidemiology Unit at the University of Bristol (supported by MRC grant MC-UU-00011/3) and the University of Bristol. JS, PFW, and JPTH are supported by the NIHR Collaboration for Leadership in Applied Health Research and Care West (CLAHRC West) at University Hospitals Bristol NHS Foundation Trust. PJ is a tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases supported by the Canada Research Chairs Programme. MJP was supported by an Early Career Fellowship from the Australian National Health and Medical Research Council (NHMRC 1088535). IRW was supported by the MRC Programme MC-UU-12023/21. Funding Information: Funding: The development of the RoB 2 tool was supported by the UK Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/2-N61), with the support of the host MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures, MR/K025643/1), by MRC research grant MR/ M025209/1, and by a grant from the Cochrane Collaboration. JACS, SME, and JPTH are National Institute for Health Research (NIHR) senior investigators. JACS, NSB, H-YC, BCR, and JPTH are supported by NIHR Bristol Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. JACS, JPTH, and KT are members of the MRC Integrative Epidemiology Unit at the University of Bristol (supported by MRC grant MC_UU_00011/3) and the University of Bristol. JS, PFW, and JPTH are supported by the NIHR Collaboration for Leadership in Applied Health Research and Care West (CLAHRC West) at University Hospitals Bristol NHS Foundation Trust. PJ is a tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases supported by the Canada Research Chairs Programme. MJP was supported by an Early Career Fellowship from the Australian National Health and Medical Research Council (NHMRC 1088535). IRW was supported by the MRC Programme MC_UU_12023/21. The views expressed in this article are those of the authors and do not necessarily represent those of the UK National Health Service, NIHR, MRC, or Department of Health and Social Care, or the Australian NHMRC. Development of the RoB tool, writing the paper and the decision to submit for publication were independent of all research funders.",

year = "2019",

doi = "10.1136/bmj.l4898",

language = "English (US)",

volume = "366",

journal = "The BMJ",

issn = "0959-8146",

publisher = "BMJ Publishing Group",

}

TY - JOUR

T1 - RoB 2

T2 - A revised tool for assessing risk of bias in randomised trials

AU - Sterne, Jonathan A.C.

AU - Savović, Jelena

AU - Page, Matthew J.

AU - Elbers, Roy G.

AU - Blencowe, Natalie S.

AU - Boutron, Isabelle

AU - Cates, Christopher J.

AU - Cheng, Hung Yuan

AU - Corbett, Mark S.

AU - Eldridge, Sandra M.

AU - Emberson, Jonathan R.

AU - Hernán, Miguel A.

AU - Hopewell, Sally

AU - Hróbjartsson, Asbjørn

AU - Junqueira, Daniela R.

AU - Jüni, Peter

AU - Kirkham, Jamie J.

AU - Lasserson, Toby

AU - Li, Tianjing

AU - McAleenan, Alexandra

AU - Reeves, Barnaby C.

AU - Shepperd, Sasha

AU - Shrier, Ian

AU - Stewart, Lesley A.

AU - Tilling, Kate

AU - White, Ian R.

AU - Whiting, Penny F.

AU - Higgins, Julian P.T.

N1 - Funding Information: The development of the RoB 2 tool was supported by the UK Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/2- N61), with the support of the host MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures, MR/K025643/1), by MRC research grant MR/M025209/1, and by a grant from the Cochrane Collaboration. JACS, SME, and JPTH are National Institute for Health Research (NIHR) senior investigators. JACS, NSB, H-YC, BCR, and JPTH are supported by NIHR Bristol Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. JACS, JPTH, and KT are members of the MRC Integrative Epidemiology Unit at the University of Bristol (supported by MRC grant MC-UU-00011/3) and the University of Bristol. JS, PFW, and JPTH are supported by the NIHR Collaboration for Leadership in Applied Health Research and Care West (CLAHRC West) at University Hospitals Bristol NHS Foundation Trust. PJ is a tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases supported by the Canada Research Chairs Programme. MJP was supported by an Early Career Fellowship from the Australian National Health and Medical Research Council (NHMRC 1088535). IRW was supported by the MRC Programme MC-UU-12023/21. Funding Information: Funding: The development of the RoB 2 tool was supported by the UK Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/2-N61), with the support of the host MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures, MR/K025643/1), by MRC research grant MR/ M025209/1, and by a grant from the Cochrane Collaboration. JACS, SME, and JPTH are National Institute for Health Research (NIHR) senior investigators. JACS, NSB, H-YC, BCR, and JPTH are supported by NIHR Bristol Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. JACS, JPTH, and KT are members of the MRC Integrative Epidemiology Unit at the University of Bristol (supported by MRC grant MC_UU_00011/3) and the University of Bristol. JS, PFW, and JPTH are supported by the NIHR Collaboration for Leadership in Applied Health Research and Care West (CLAHRC West) at University Hospitals Bristol NHS Foundation Trust. PJ is a tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases supported by the Canada Research Chairs Programme. MJP was supported by an Early Career Fellowship from the Australian National Health and Medical Research Council (NHMRC 1088535). IRW was supported by the MRC Programme MC_UU_12023/21. The views expressed in this article are those of the authors and do not necessarily represent those of the UK National Health Service, NIHR, MRC, or Department of Health and Social Care, or the Australian NHMRC. Development of the RoB tool, writing the paper and the decision to submit for publication were independent of all research funders.

PY - 2019

Y1 - 2019

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U2 - 10.1136/bmj.l4898

DO - 10.1136/bmj.l4898

M3 - Article

C2 - 31462531

AN - SCOPUS:85071628750

SN - 0959-8146

VL - 366

JO - The BMJ

JF - The BMJ

M1 - l4898

ER -

RoB 2: A revised tool for assessing risk of bias in randomised trials

ASJC Scopus subject areas

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