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

被引：12878

作者：

Sterne, Jonathan A. C. ^{[1
]}

Hernan, Miguel A. ^{[2
,3
,4
]}

Reeves, Barnaby C. ^{[5
]}

Savovic, Jelena ^{[1
,6
]}

Berkman, Nancy D. ^{[7
]}

Viswanathan, Meera ^{[8
]}

Henry, David ^{[9
]}

Altman, Douglas G. ^{[10
]}

Ansari, Mohammed T. ^{[11
]}

Boutron, Isabelle ^{[12
]}

Carpenter, James R. ^{[13
,14
]}

Chan, An-Wen ^{[15
]}

Churchill, Rachel ^{[16
]}

Deeks, Jonathan J. ^{[17
]}

Hrobjartsson, Asbjorn ^{[18
,19
]}

Kirkham, Jamie ^{[20
]}

Juni, Peter ^{[21
,22
]}

Loke, Yoon K. ^{[23
]}

Pigott, Theresa D. ^{[24
]}

Ramsay, Craig R. ^{[25
]}

Regidor, Deborah ^{[26
]}

Rothstein, Hannah R. ^{[27
]}

Sandhu, Lakhbir ^{[28
]}

Santaguida, Pasqualina L. ^{[29
]}

Schunemann, Holger J. ^{[30
,31
]}

Shea, Beverly ^{[32
,33
]}

Shrier, Ian ^{[34
]}

Tugwell, Peter ^{[35
,36
]}

Turner, Lucy ^{[37
]}

Valentine, Jeffrey C. ^{[38
]}

Waddington, Hugh ^{[39
,40
]}

Waters, Elizabeth ^{[41
]}

Wells, George A. ^{[42
,43
]}

Whiting, Penny F. ^{[1
,6
]}

Higgins, Julian P. T. ^{[1
]}

机构：

[1] Univ Bristol, Sch Social & Community Med, Bristol BS8 2PS, Avon, England

[2] Harvard TH Chan Sch Publ Hlth, Dept Epidemiol, Boston, MA USA

[3] Harvard TH Chan Sch Publ Hlth, Dept Hlth, Boston, MA USA

[4] Harvard Mit Div Hlth Sci & Technol, Boston, MA USA

[5] Univ Bristol, Sch Clin Sci, Bristol BS2 8HW, Avon, England

[6] Univ Hosp Bristol NHS Fdn Trust, Natl Inst Hlth Res Collaborat Leadership Appl Hlt, Bristol BS1 2NT, Avon, England

[7] RTI Int, Program Hlth Care Qual & Outcomes, Div Hlth Serv & Social Policy Res, Res Triangle Pk, NC 27709 USA

[8] RTI Int, RTI UNC Evidence Based Practice Ctr, Res Triangle Pk, NC 27709 USA

[9] Univ Toronto, Dalla Lana Sch Publ Hlth, Toronto, ON, Canada

[10] Univ Oxford, Ctr Stat Med, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford OX3 7LD, England

[11] Univ Ottawa, Fac Med, Sch Epidemiol Publ Hlth & Prevent Med, Ottawa, ON K1H 8M5, Canada

[12] Univ Paris 05, Ctr Epidemiol & Stat Sorbonne Paris Cite Res, METHODS Team, INSERM,UMR 1153, Paris, France

[13] London Sch Hyg & Trop Med, Dept Med Stat, London, England

[14] UCL, MRC Clin Trials Unit, London, England

[15] Univ Toronto, Dept Med, Womens Coll Res Inst, Toronto, ON M5S 1A1, Canada

[16] Univ York, Ctr Reviews & Disseminat, York YO10 5DD, N Yorkshire, England

[17] Univ Birmingham, Inst Appl Hlth Res, Birmingham B15 2TT, W Midlands, England

[18] Univ Southern Denmark, DK-5000 Odense C, Denmark

[19] Odense Univ Hosp, DK-5000 Odense C, Denmark

[20] Univ Liverpool, Dept Biostat, Liverpool L69 3GL, Merseyside, England

[21] St Michaels Hosp, Li Ka Shing Knowledge Inst, AHRC, Toronto, ON, Canada

[22] Univ Toronto, Dept Med, Toronto, ON, Canada

[23] Univ East Anglia, Norwich Med Sch, Norwich NR4 7TJ, Norfolk, England

[24] Loyola Univ, Sch Educ, Chicago, IL 60611 USA

[25] Univ Aberdeen, Hlth Serv Res Unit, Aberdeen AB25 2ZD, Scotland

[26] Kaiser Permanente, Evidence Serv, Care Management Inst, Oakland, CA 94612 USA

[27] CUNY Bernard M Baruch Coll, Dept Management, Zicklin Sch Business, 17 Lexington Ave, New York, NY 10010 USA

[28] Univ Toronto, Div Gen Surg, Toronto, ON, Canada

[29] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8S 4K1, Canada

[30] Cochrane Applicabil & Recommendat Methods GRADEin, Dept Clin Epidemiol & Biostat, Macgrade Ctr, ON L8N 4K1, Canada

[31] Cochrane Applicabil & Recommendat Methods GRADEin, Dept Med, Macgrade Ctr, ON L8N 4K1, Canada

[32] Univ Ottawa, Fac Med, Ottawa Hosp Res Inst, Ctr Practice Changing Res, Ottawa, ON K1H 8M5, Canada

[33] Univ Ottawa, Fac Med, Sch Epidemiol Publ Hlth & Prevent Med, Ottawa, ON K1H 8M5, Canada

[34] McGill Univ, Lady Davis Inst, Jewish Gen Hosp, Ctr Clin Epidemiol, Montreal, PQ, Canada

[35] Univ Ottawa, Dept Med, Ottawa, ON, Canada

[36] Univ Ottawa, Sch Epidemiol Publ Hlth & Prevent Med, Ottawa, ON, Canada

[37] Ottawa Hosp Res Inst, Ottawa, ON, Canada

[38] Univ Louisville, Louisville, KY 40292 USA

[39] London Sch Hyg & Trop Med, Int Initiat Impact Evaluat, London, England

[40] London Int Dev Ctr, London, England

[41] Univ Melbourne, Jack Brockhoff Child Hlth & Wellbeing Program, Melbourne Sch Populat & Global Hlth, Melbourne, Vic 3010, Australia

[42] Univ Ottawa Heart Inst, Sch Epidemiol Publ Hlth & Prevent Med, Ottawa, ON K1Y 4W7, Canada

[43] Univ Ottawa Heart Inst, Cardiovasc Res Methods Ctr, Ottawa, ON K1Y 4W7, Canada

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2016年 / 355卷

基金：

英国医学研究理事会;

关键词：

SYSTEMATIC REVIEWS; QUALITY; TRIALS;

D O I：

10.1136/bmj.i4919

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：7

共 22 条

[1]

[Anonymous], EPIDEMIOLOG IN PRESS

[2]

[Anonymous], 2012, ETH SCI ISS STUD SAF

[3] Mortality in randomized trials of antioxidant supplements for primary and secondary prevention - Systematic review and meta-analysis [J].

Bjelakovic, Goran ;

Nikolova, Dimitrinka ;

Gluud, Lise Lotte ;

Simonetti, Rosa G. ;

Gluud, Christian .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2007, 297 (08) :842-857

[4]

Black N, 1996, BRIT MED J, V312, P1215

[5]

Deeks J J, 2003, Health Technol Assess, V7, piii

[6] The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions [J].

Downs, SH ;

Black, N .

JOURNAL OF EPIDEMIOLOGY AND COMMUNITY HEALTH, 1998, 52 (06) :377-384

[7]

FEINSTEIN AR, 1983, ANN INTERN MED, V99, P544, DOI 10.7326/0003-4819-99-4-544

[8] Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview [J].

Golder, Su ;

Loke, Yoon K. ;

Bland, Martin .

PLOS MEDICINE, 2011, 8 (05)

[9] GRADE guidelines: A new series of articles in the Journal of Clinical Epidemiology [J].

Guyatt, Gordon H. ;

Oxman, Andrew D. ;

Schuenemann, Holger J. ;

Tugwell, Peter ;

Knottnerus, Andre .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2011, 64 (04) :380-382

[10] Testing the Risk of Bias tool showed low reliability between individual reviewers and across consensus assessments of reviewer pairs [J].

Hartling, Lisa ;

Hamm, Michele P. ;

Milne, Andrea ;

Vandermeer, Ben ;

Santaguida, P. Lina ;

Ansari, Mohammed ;

Tsertsvadze, Alexander ;

Hempel, Susanne ;

Shekelle, Paul ;

Dryden, Donna M. .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2013, 66 (09) :973-981

← 1 2 3 →