ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions
Jonathan A C SterneSchool of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK [email protected]Miguel A. HernánDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA; and Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA; and Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, Boston, Massachusetts, USABarnaby C ReevesSchool of Clinical Sciences, University of Bristol, Bristol, BS2 8HW, UKJelena SavovićSchool of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West) at University Hospitals Bristol NHS Foundation Trust, Bristol BS1 2NT, UKNancy D BerkmanProgram on Health Care Quality and Outcomes, Division of Health Services and Social Policy Research, RTI International, Research Triangle Park, NC 27709, USAMeera ViswanathanRTI-UNC Evidence-based Practice Center, RTI International, Research Triangle Park, NC 27709, USADavid HenryDalla Lana School of Public Health, University of Toronto, Toronto, Ontario, CanadaDouglas G. AltmanCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UKMohammed AnsariSchool of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, K1H 8M5, CanadaIsabelle BoutronMETHODS Team, Centre of Epidemiology and Statistics Sorbonne Paris Cité Research, INSERM UMR 1153, University Paris Descartes, Paris, FranceJames R. CarpenterDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine and MRC Clinical Trials Unit at UCL, London, UKAn‐Wen ChanWomen's College Research Institute, Department of Medicine, University of Toronto, CanadaRachel ChurchillCentre for Reviews and Dissemination, University of York, York, YO10 5DD, UKJonathan J DeeksInstitute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UKAsbjørn HróbjartssonCenter for Evidence-Based Medicine, University of Southern Denmark & Odense University Hospital, 5000 Odense C, DenmarkJamie J KirkhamDepartment of Biostatistics, University of Liverpool, Liverpool, L69 3GL, UKPeter JüniApplied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St Michael's Hospital, and Department of Medicine, University of Toronto, Toronto, Ontario, CanadaYoon K. LokeNorwich Medical School, University of East Anglia, Norwich NR4 7TJ, UKTheresa D PigottSchool of Education, Loyola University Chicago, Chicago, IL 60611, USACraig RamsayHealth Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UKDeborah L. RegidorEvidence Services, Kaiser Permanente, Care Management Institute, Oakland, CA 94612, USAHannah R. RothsteinDepartment of Management, Zicklin School of Business, Baruch College-CUNY, New York, NY 10010, USALakhbir SandhuDivision of General Surgery, University of Toronto, Toronto, CanadaPasqualina SantaguidaDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, L8S 4K1, CanadaHolger J. SchünemannDepartments of Clinical Epidemiology and Biostatistics and of Medicine, Cochrane Applicability and Recommendations Methods (GRADEing) Group, MacGRADE center, Ontario, L8N 4K1, CanadaBeverly SheaOttawa Hospital Research Institute, Center for Practice Changing Research and School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, K1H 8M5, CanadaIan ShrierCentre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Quebec, CanadaPeter TugwellDepartment of Medicine and School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, CanadaLucy TurnerOttawa Hospital Research Institute, Ottawa, ON, CanadaJeffrey C. ValentineUniversity of Louisville, Louisville, KY 40292, USAHugh WaddingtonInternational Initiative for Impact Evaluation, London School of Hygiene and Tropical Medicine, and London International Development Centre, London, UKElizabeth WatersJack Brockhoff Child Health & Wellbeing Program, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC 3010, AustraliaGeorge A. WellsSchool of Epidemiology, Public Health and Preventive Medicine and Director, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, CanadaPenny WhitingSchool of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK; and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West) at University Hospitals Bristol NHS Foundation Trust, Bristol BS1 2NT, UKJulian P. T. HigginsSchool of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK
2016en
ABI
Abstract
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.
Identifiers
Citations and references
Cited by 40 references