title: ROBIS: A new tool to assess risk of bias in systematic reviews was developed.
abstract: OBJECTIVE
  To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies).
  
  
  METHODS
  We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting.
  
  
  RESULTS
  ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews ("reviews of reviews"), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions.
  
  
  CONCLUSIONS
  ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK; The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol BS1 2NT; Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York YO19 6FD, UK. Electronic address: penny.whiting@bristol.ac.uk.
authors.forename: Penny
authors.initials: P
authors.lastname: Whiting
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK; The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol BS1 2NT.
authors.forename: Jelena
authors.initials: J
authors.lastname: Savović
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK; Centre for Reviews and Dissemination, University of York, York YO10 5DD, UK.
authors.forename: Julian P T
authors.initials: JP
authors.lastname: Higgins
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK.
authors.forename: Deborah M
authors.initials: DM
authors.lastname: Caldwell
authors.affiliation: School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Level Queen's Building, 69 St Michael's Hill, Bristol BS2 8DZ, UK.
authors.forename: Barnaby C
authors.initials: BC
authors.lastname: Reeves
authors.affiliation: Community Information and Epidemiological Technologies Institute of Population Health, 1 Stewart Street, Room 319, Ottawa, Ontario, K1N 6N5, Canada.
authors.forename: Beverley
authors.initials: B
authors.lastname: Shea
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK; The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol BS1 2NT.
authors.forename: Philippa
authors.initials: P
authors.lastname: Davies
authors.affiliation: Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York YO19 6FD, UK; School for Public Health and Primary Care (CAPHRI), Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.
authors.forename: Jos
authors.initials: J
authors.lastname: Kleijnen
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Churchill
mesh_terms: D015982:Bias; D012196:Review Literature as Topic; D018570:Risk Assessment / Q000379:methods*
keywords: Evidence; Meta-analysis; Quality; Risk of bias; Systematic review; Tool