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

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          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.

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          Most cited references21

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          The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials

          Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate
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            QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies.

            In 2003, the QUADAS tool for systematic reviews of diagnostic accuracy studies was developed. Experience, anecdotal reports, and feedback suggested areas for improvement; therefore, QUADAS-2 was developed. This tool comprises 4 domains: patient selection, index test, reference standard, and flow and timing. Each domain is assessed in terms of risk of bias, and the first 3 domains are also assessed in terms of concerns regarding applicability. Signalling questions are included to help judge risk of bias. The QUADAS-2 tool is applied in 4 phases: summarize the review question, tailor the tool and produce review-specific guidance, construct a flow diagram for the primary study, and judge bias and applicability. This tool will allow for more transparent rating of bias and applicability of primary diagnostic accuracy studies.
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              GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology.

              The "Grades of Recommendation, Assessment, Development, and Evaluation" (GRADE) approach provides guidance for rating quality of evidence and grading strength of recommendations in health care. It has important implications for those summarizing evidence for systematic reviews, health technology assessment, and clinical practice guidelines. GRADE provides a systematic and transparent framework for clarifying questions, determining the outcomes of interest, summarizing the evidence that addresses a question, and moving from the evidence to a recommendation or decision. Wide dissemination and use of the GRADE approach, with endorsement from more than 50 organizations worldwide, many highly influential (http://www.gradeworkinggroup.org/), attests to the importance of this work. This article introduces a 20-part series providing guidance for the use of GRADE methodology that will appear in the Journal of Clinical Epidemiology. Copyright © 2011 Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Role: professor
                Role: professor
                Role: professorial research fellow
                Role: research fellow
                Role: senior health policy research analyst
                Role: director
                Role: professor
                Role: professor
                Role: adjunct professor
                Role: professor
                Role: professor
                Role: Phelan scientist
                Role: professor
                Role: professor
                Role: professor
                Role: lecturer
                Role: professor
                Role: professor
                Role: professor
                Role: professor
                Role: senior consultant
                Role: professor
                Role: resident
                Role: assistant professor
                Role: professor
                Role: investigator
                Role: professor
                Role: senior research associate
                Role: associate professor
                Role: lecturer
                Role: professor (deceased 2015)
                Role: professor
                Role: senior research fellow
                Role: professor
                Journal
                BMJ
                BMJ
                bmj
                The BMJ
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2016
                12 October 2016
                : 355
                : i4919
                Affiliations
                [1 ]School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK
                [2 ]Department 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, USA
                [3 ]School of Clinical Sciences, University of Bristol, Bristol, BS2 8HW, UK
                [4 ]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, UK
                [5 ]Program on Health Care Quality and Outcomes, Division of Health Services and Social Policy Research, RTI International, Research Triangle Park, NC 27709, USA
                [6 ]RTI-UNC Evidence-based Practice Center, RTI International, Research Triangle Park, NC 27709, USA
                [7 ]Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
                [8 ]Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK
                [9 ]School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, K1H 8M5, Canada
                [10 ]METHODS Team, Centre of Epidemiology and Statistics Sorbonne Paris Cité Research, INSERM UMR 1153, University Paris Descartes, Paris, France
                [11 ]Department of Medical Statistics, London School of Hygiene and Tropical Medicine and MRC Clinical Trials Unit at UCL, London, UK
                [12 ]Women's College Research Institute, Department of Medicine, University of Toronto, Canada
                [13 ]Centre for Reviews and Dissemination, University of York, York, YO10 5DD, UK
                [14 ]Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK
                [15 ]Center for Evidence-Based Medicine, University of Southern Denmark & Odense University Hospital, 5000 Odense C, Denmark
                [16 ]Department of Biostatistics, University of Liverpool, Liverpool, L69 3GL, UK
                [17 ]Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St Michael’s Hospital, and Department of Medicine, University of Toronto, Toronto, Ontario, Canada
                [18 ]Norwich Medical School, University of East Anglia, Norwich NR4 7TJ, UK
                [19 ]School of Education, Loyola University Chicago, Chicago, IL 60611, USA
                [20 ]Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK.
                [21 ]Evidence Services, Kaiser Permanente, Care Management Institute, Oakland, CA 94612, USA
                [22 ]Department of Management, Zicklin School of Business, Baruch College—CUNY, New York, NY 10010, USA
                [23 ]Division of General Surgery, University of Toronto, Toronto, Canada
                [24 ]Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, L8S 4K1, Canada
                [25 ]Departments of Clinical Epidemiology and Biostatistics and of Medicine, Cochrane Applicability and Recommendations Methods (GRADEing) Group, MacGRADE center, Ontario, L8N 4K1, Canada
                [26 ]Ottawa 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, Canada
                [27 ]Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
                [28 ]Department of Medicine and School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada
                [29 ]Ottawa Hospital Research Institute, Ottawa, ON, Canada
                [30 ]University of Louisville, Louisville, KY 40292, USA
                [31 ]International Initiative for Impact Evaluation, London School of Hygiene and Tropical Medicine, and London International Development Centre, London, UK
                [32 ]Jack Brockhoff Child Health & Wellbeing Program, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC 3010, Australia
                [33 ]School of Epidemiology, Public Health and Preventive Medicine and Director, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, Canada
                [34 ]School 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, UK
                [35 ]School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK
                Author notes
                Correspondence to: J A C Sterne jonathan.sterne@ 123456bristol.ac.uk
                Article
                stej032658
                10.1136/bmj.i4919
                5062054
                27733354
                4d1fdf2d-19be-44c8-9be1-444364b39cdb
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

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                Medicine

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