Comment

. 2019 Aug 28:366:l4898.

doi: 10.1136/bmj.l4898.

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

Jonathan A C Sterne^{1

2}, Jelena Savović^{3

4}, Matthew J Page⁵, Roy G Elbers³, Natalie S Blencowe^{3

2}, Isabelle Boutron^{6

7

8}, Christopher J Cates⁹, Hung-Yuan Cheng^{3

2}, Mark S Corbett¹⁰, Sandra M Eldridge¹¹, Jonathan R Emberson¹², Miguel A Hernán¹³, Sally Hopewell¹⁴, Asbjørn Hróbjartsson^{15

16

17}, Daniela R Junqueira¹⁸, Peter Jüni¹⁹, Jamie J Kirkham²⁰, Toby Lasserson²¹, Tianjing Li²², Alexandra McAleenan³, Barnaby C Reeves^{2

23}, Sasha Shepperd²⁴, Ian Shrier²⁵, Lesley A Stewart¹⁰, Kate Tilling^{3

2

26}, Ian R White²⁷, Penny F Whiting^{3

4}, Julian P T Higgins^{3

2

4}

Affiliations

¹ Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 2BN, UK jonathan.sterne@bristol.ac.uk.
² NIHR Bristol Biomedical Research Centre, Bristol, UK.
³ Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 2BN, UK.
⁴ NIHR CLAHRC West, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
⁵ School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
⁶ METHODS team, Epidemiology and Biostatistics Centre, INSERM UMR 1153, Paris, France.
⁷ Paris Descartes University, Paris, France.
⁸ Cochrane France, Paris, France.
⁹ Population Health Research Institute, St George's, University of London, London, UK.
¹⁰ Centre for Reviews and Dissemination, University of York, York, UK.
¹¹ Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health, Queen Mary University of London, UK.
¹² MRC Population Heath Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
¹³ Departments of Epidemiology and Biostatistics, Harvard T H Chan School of Public Health, Harvard-MIT Division of Health Sciences of Technology, Boston, MA, USA.
¹⁴ Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
¹⁵ Centre for Evidence-Based Medicine Odense, Odense University Hospital, Odense, Denmark.
¹⁶ Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
¹⁷ Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
¹⁸ Department of Emergency Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
¹⁹ Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
²⁰ Centre for Biostatistics, University of Manchester, Manchester, UK.
²¹ Editorial and Methods Department, Cochrane Central Executive, London, UK.
²² Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
²³ Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
²⁴ Nuffield Department of Population Health, University of Oxford, Oxford, UK.
²⁵ Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
²⁶ MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK.
²⁷ MRC Clinical Trials Unit, University College London, London, UK.

PMID: 31462531
DOI: 10.1136/bmj.l4898

Free article

Comment

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

Jonathan A C Sterne et al. BMJ. 2019.

Free article

. 2019 Aug 28:366:l4898.

doi: 10.1136/bmj.l4898.

Authors

Affiliations

¹ Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 2BN, UK jonathan.sterne@bristol.ac.uk.
² NIHR Bristol Biomedical Research Centre, Bristol, UK.
³ Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 2BN, UK.
⁴ NIHR CLAHRC West, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
⁵ School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
⁶ METHODS team, Epidemiology and Biostatistics Centre, INSERM UMR 1153, Paris, France.
⁷ Paris Descartes University, Paris, France.
⁸ Cochrane France, Paris, France.
⁹ Population Health Research Institute, St George's, University of London, London, UK.
¹⁰ Centre for Reviews and Dissemination, University of York, York, UK.
¹¹ Pragmatic Clinical Trials Unit, Centre for Primary Care and Public Health, Queen Mary University of London, UK.
¹² MRC Population Heath Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
¹³ Departments of Epidemiology and Biostatistics, Harvard T H Chan School of Public Health, Harvard-MIT Division of Health Sciences of Technology, Boston, MA, USA.
¹⁴ Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
¹⁵ Centre for Evidence-Based Medicine Odense, Odense University Hospital, Odense, Denmark.
¹⁶ Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
¹⁷ Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
¹⁸ Department of Emergency Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
¹⁹ Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
²⁰ Centre for Biostatistics, University of Manchester, Manchester, UK.
²¹ Editorial and Methods Department, Cochrane Central Executive, London, UK.
²² Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
²³ Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
²⁴ Nuffield Department of Population Health, University of Oxford, Oxford, UK.
²⁵ Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
²⁶ MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK.
²⁷ MRC Clinical Trials Unit, University College London, London, UK.

PMID: 31462531
DOI: 10.1136/bmj.l4898

No abstract available

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform 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.

Comment on

The Cochrane Collaboration's tool for assessing risk of bias in randomised trials.
Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA; Cochrane Bias Methods Group; Cochrane Statistical Methods Group. Higgins JP, et al. BMJ. 2011 Oct 18;343:d5928. doi: 10.1136/bmj.d5928. BMJ. 2011. PMID: 22008217 Free PMC article.

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

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

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