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

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

Medicine(all)

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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, [l4898]. https://doi.org/10.1136/bmj.l4898

RoB 2 : A revised tool for assessing risk of bias in randomised trials. / Sterne, Jonathan A.C.; Savović, Jelena; Page, Matthew J.; Elbers, Roy G.; Blencowe, Natalie S.; Boutron, Isabelle; Cates, Christopher J.; Cheng, Hung Yuan; Corbett, Mark S.; Eldridge, Sandra M.; Emberson, Jonathan R.; Hernán, Miguel A.; Hopewell, Sally; Hróbjartsson, Asbjørn; Junqueira, Daniela R.; Jüni, Peter; Kirkham, Jamie J.; Lasserson, Toby; Li, Tianjing; McAleenan, Alexandra; Reeves, Barnaby C.; Shepperd, Sasha; Shrier, Ian; Stewart, Lesley A.; Tilling, Kate; White, Ian R.; Whiting, Penny F.; Higgins, Julian P.T.

In: The BMJ, Vol. 366, l4898, 2019.

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

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

Sterne, Jonathan A.C. ; Savović, Jelena ; Page, Matthew J. ; Elbers, Roy G. ; Blencowe, Natalie S. ; Boutron, Isabelle ; Cates, Christopher J. ; Cheng, Hung Yuan ; Corbett, Mark S. ; Eldridge, Sandra M. ; Emberson, Jonathan R. ; Hernán, Miguel A. ; Hopewell, Sally ; Hróbjartsson, Asbjørn ; Junqueira, Daniela R. ; Jüni, Peter ; Kirkham, Jamie J. ; Lasserson, Toby ; Li, Tianjing ; McAleenan, Alexandra ; Reeves, Barnaby C. ; Shepperd, Sasha ; Shrier, Ian ; Stewart, Lesley A. ; Tilling, Kate ; White, Ian R. ; Whiting, Penny F. ; Higgins, Julian P.T. / RoB 2 : A revised tool for assessing risk of bias in randomised trials. In: The BMJ. 2019 ; Vol. 366.

@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: disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the MRC and Wellcome Trust for the submitted work; JACS reports grants from the MRC and NIHR during the conduct of the study; JS reports grants from the MRC, Cochrane Collaboration, and NIHR during the conduct of the study; CJC is one of the coordinating editors of Cochrane Airways and has responsibility for training Cochrane authors in the UK in Cochrane methodology (including the assessment of risks of bias); JRE reports grants from the MRC and Boehringer Ingelheim, outside the submitted work; MAH reports grants from the National Institutes of Health (NIH) during the conduct of the study; PJ serves as an unpaid member of the steering group of cardiovascular trials funded by Astra Zeneca, Biotronik, Biosensors, St Jude Medical, and The Medicines Company, has received research grants to the institution from Astra Zeneca, Biotronik, Biosensors International, Eli Lilly, and The Medicines Company, and honorariums to the institution for participation in advisory boards from Amgen, but has not received personal payments by any pharmaceutical company or device manufacturer; JJK reports personal fees from BMJ outside the submitted work; TLa is an employee of Cochrane; TLi reports grants from the NIH National Eye Institute, and the Patient-Centered Outcomes Research Institute during the conduct of the study; AM reports grants from MRC and Cancer Research UK during the conduct of the study; KT reports grants from MRC during the conduct of the study and personal fees from CHDI outside the submitted work; JPTH reports grants from the MRC and Cochrane Collaboration during the conduct of the study; the authors declare no other relationships or activities that could appear to have influenced the submitted work. 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 = "British Medical Journal",

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: disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the MRC and Wellcome Trust for the submitted work; JACS reports grants from the MRC and NIHR during the conduct of the study; JS reports grants from the MRC, Cochrane Collaboration, and NIHR during the conduct of the study; CJC is one of the coordinating editors of Cochrane Airways and has responsibility for training Cochrane authors in the UK in Cochrane methodology (including the assessment of risks of bias); JRE reports grants from the MRC and Boehringer Ingelheim, outside the submitted work; MAH reports grants from the National Institutes of Health (NIH) during the conduct of the study; PJ serves as an unpaid member of the steering group of cardiovascular trials funded by Astra Zeneca, Biotronik, Biosensors, St Jude Medical, and The Medicines Company, has received research grants to the institution from Astra Zeneca, Biotronik, Biosensors International, Eli Lilly, and The Medicines Company, and honorariums to the institution for participation in advisory boards from Amgen, but has not received personal payments by any pharmaceutical company or device manufacturer; JJK reports personal fees from BMJ outside the submitted work; TLa is an employee of Cochrane; TLi reports grants from the NIH National Eye Institute, and the Patient-Centered Outcomes Research Institute during the conduct of the study; AM reports grants from MRC and Cancer Research UK during the conduct of the study; KT reports grants from MRC during the conduct of the study and personal fees from CHDI outside the submitted work; JPTH reports grants from the MRC and Cochrane Collaboration during the conduct of the study; the authors declare no other relationships or activities that could appear to have influenced the submitted work. 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.

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DO - 10.1136/bmj.l4898

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JO - British Medical Journal

JF - British Medical Journal

SN - 0959-8146

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ER -

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

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