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What items should be reported to allow readers to evaluate the validity and applicability and to enhance the replicability of systematic reviews of diagnostic test accuracy studies?
This diagnostic test accuracy guideline is an extension of the original Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Two PRISMA items have been omitted, 2 were added, and 17 were modified to reflect specific or optimal contemporary systematic review methods of diagnostic test accuracy studies.
The guideline checklist can facilitate transparent reporting of reviews of diagnostic test accuracy studies, and may help assist evaluations of validity and applicability, enhance replicability of reviews, and make the results more useful for clinicians, journal editors, reviewers, guideline authors, and funders.
Systematic reviews of diagnostic test accuracy synthesize data from primary diagnostic studies that have evaluated the accuracy of 1 or more index tests against a reference standard, provide estimates of test performance, allow comparisons of the accuracy of different tests, and facilitate the identification of sources of variability in test accuracy.
To develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagnostic test accuracy guideline as a stand-alone extension of the PRISMA statement. Modifications to the PRISMA statement reflect the specific requirements for reporting of systematic reviews and meta-analyses of diagnostic test accuracy studies and the abstracts for these reviews.
Established standards from the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network were followed for the development of the guideline. The original PRISMA statement was used as a framework on which to modify and add items. A group of 24 multidisciplinary experts used a systematic review of articles on existing reporting guidelines and methods, a 3-round Delphi process, a consensus meeting, pilot testing, and iterative refinement to develop the PRISMA diagnostic test accuracy guideline. The final version of the PRISMA diagnostic test accuracy guideline checklist was approved by the group.
The systematic review (produced 64 items) and the Delphi process (provided feedback on 7 proposed items; 1 item was later split into 2 items) identified 71 potentially relevant items for consideration. The Delphi process reduced these to 60 items that were discussed at the consensus meeting. Following the meeting, pilot testing and iterative feedback were used to generate the 27-item PRISMA diagnostic test accuracy checklist. To reflect specific or optimal contemporary systematic review methods for diagnostic test accuracy, 8 of the 27 original PRISMA items were left unchanged, 17 were modified, 2 were added, and 2 were omitted.
Conclusions and Relevance
The 27-item PRISMA diagnostic test accuracy checklist provides specific guidance for reporting of systematic reviews. The PRISMA diagnostic test accuracy guideline can facilitate the transparent reporting of reviews, and may assist in the evaluation of validity and applicability, enhance replicability of reviews, and make the results from systematic reviews of diagnostic test accuracy studies more useful.
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Corresponding Author: Matthew D. F. McInnes, MD, Ottawa Hospital-Civic Campus, 1053 Carling Ave, Ottawa, ON K1E 4Y9, Canada (email@example.com).
Correction: This article was corrected on November 26, 2019, to fix the term receiver operating characteristic plot in Table 2.
Accepted for Publication: December 6, 2017.
The PRISMA-DTA Group Authors: Tammy Clifford, PhD; Jérémie F. Cohen, MD, PhD; Jonathan J. Deeks, PhD; Constantine Gatsonis, PhD; Lotty Hooft, PhD; Harriet A. Hunt, MSc; Christopher J. Hyde, PhD; Daniël A. Korevaar, MD, PhD; Mariska M. G. Leeflang, PhD; Petra Macaskill, PhD; Johannes B. Reitsma, MD, PhD; Rachel Rodin, MD, MPH; Anne W. S. Rutjes, PhD; Jean-Paul Salameh, BSc; Adrienne Stevens, MSc; Yemisi Takwoingi, PhD; Marcello Tonelli, MD, SM; Laura Weeks, PhD; Penny Whiting, PhD; Brian H. Willis, MD, PhD.
Affiliations of The PRISMA-DTA Group Authors: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (Salameh); Department of Clinical Epidemiology, Biostatistics and Bioinformatics, University of Amsterdam, Academic Medical Center, Amsterdam, the Netherlands (Korevaar, Leeflang); Canadian Agency for Drugs and Technologies in Health, Ottawa, Ontario (Clifford, Weeks); Department of Pediatrics, Necker-Enfants Malades Hospital, Assistance Publique Hôpitaux de Paris, Paris Descartes University, Paris, France (Cohen); Inserm UMR 1153, Research Center for Epidemiology and Biostatistics Sorbonne Paris Cité, Paris Descartes University, Paris, France (Cohen); University of Birmingham, Birmingham, England (Deeks, Takwoingi, Willis); Brown University, Providence, Rhode Island (Gatsonis); Cochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands (Hooft, Reitsma); University of Exeter, Exeter, England (Hunt, Hyde); University of Sydney, Sydney, Australia (Macaskill); Public Health Agency of Canada, Ottawa, Ontario, Canada (Rodin); Institute of Social and Preventive Medicine, Berner Institut für Hausarztmedizin, University of Bern, Bern, Switzerland (Rutjes); School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada (Salameh); Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (Stevens); Translational Research in Biomedicine Program, School of Medicine, University of Split, Split, Croatia (Stevens); University of Calgary, Calgary, Alberta, Canada (Tonelli); University of Bristol, National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West, Bristol, England (Whiting).
Author Contributions: Dr McInnes had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: McInnes, Moher, McGrath, Bossuyt, Clifford, Cohen, Korevaar, Reitsma, Salameh, Takwoingi, Willis.
Acquisition, analysis, or interpretation of data: McInnes, Thombs, McGrath, Cohen, Gatsonis, Hunt, Hyde, Korevaar, Leeflang, Reitsma, Rutjes, Salameh, Stevens, Takwoingi, Tonelli, Weeks, Whiting, Willis.
Drafting of the manuscript: McInnes, Moher, McGrath, Leeflang, Salameh, Willis.
Critical revision of the manuscript for important intellectual content: McInnes, Thombs, McGrath, Bossuyt, Clifford, Cohen, Deeks, Gatsonis, Hooft, Hunt, Hyde, Korevaar, Leeflang, Macaskill, Reitsma, Rodin, Rutjes, Salameh, Stevens, Takwoingi, Tonelli, Weeks, Whiting, Willis.
Obtained funding: McInnes, Clifford.
Administrative, technical, or material support: McInnes, Moher, Clifford, Hunt, Salameh, Willis.
Supervision: McInnes, Bossuyt, Takwoingi.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: The research was supported by grant 375751 from the Canadian Institute for Health Research; funding from the Canadian Agency for Drugs and Technologies in Health; funding from the Standards for Reporting of Diagnostic Accuracy Studies Group; funding from the University of Ottawa Department of Radiology Research Stipend Program; and funding from the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula.
Role of the Funder/Sponsor: None of the funding sources had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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