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Diagnostic Test Accuracy Systematic Reviews: Evaluation of Completeness of Reporting and Elaboration on Optimal Practices Jean-Paul Salameh Thesis submitted to the University of Ottawa in partial Fulfillment of the requirements for the Degree of Master of Sciences in Epidemiology School of Epidemiology and Public Health Faculty of Medicine University of Ottawa © Jean-Paul Salameh, Ottawa, Canada, 2019 1 Preface All of the work presented henceforth was conducted under the supervision of Dr. David Moher and Dr. Mathew McInnes at the University of Ottawa. No Research Ethics Board approval was required for any the presented projects and associated methods. Chapter 2 has been published in Clinical Chemistry [Salameh JP, Moher D, Thombs BD, McGrath TA, Frank R, Dehmoobad Sharifabadi A, Kraaijpoel N, Levis B, Bossuyt PM, McInnes MDF. Completeness of Reporting of Systematic Reviews of Diagnostic Test Accuracy Based on the PRISMA-DTA Reporting Guideline. Clin Chem. 2018 Sep 20. doi: 10.1373/ clinchem.2018.292987]. Following the thesis defence minor revisions were made to the chapter. I was the lead investigator, responsible for all major areas of concept formation, data collection and analysis, as well as manuscript composition. Moher D was involved in the early stages of concept formation and contributed to manuscript edits. All the remaining authors contributed to the data collection process and manuscript edits. McInnes MDF was the supervisory author on this project and was involved throughout the project in concept formation and manuscript composition. Chapter 3 is an original, unpublished work by Salameh JP, Moher D, Bossuyt PM, McGrath TA, Thombs BD, Hyde CJ, Macaskill P, Deeks J, Leeflang M, Korevaar D, Whiting P, Taikwongi Y, Reitsma JB, Cohen JF, Frank RA, Hunt HA, Hooft L, Rutjes AWS, Willis BH, Gatsonis C, Levis B, and McInnes MDF. This work is intended for publication in the British Medical Journal. Figures 3.1-3.5 and tables 3.1-3.4 are used and reproduced with permission from applicable sources. I was the lead investigator, responsible for all major areas of concept formation, as well as the majority of manuscript composition. Moher D, Bossuyt PM, and Thombs BD were involved in the early stages of concept formation and contributed to manuscript edits. All the remaining authors contributed to the drafting of specific items of the manuscripts and to manuscript edits. McInnes MDF was the supervisory author on this project and was involved throughout the project in concept formation and manuscript edits. Chapter 4 is an original, unpublished work by Salameh JP. Moher D and McInnes MDF contributed to manuscript edits. ii Abstract Systematic reviews of diagnostic test accuracy (DTA) studies are fundamental to the decision-making process in evidence-based medicine. Although such studies are regarded as high-level evidence, these reviews are not always reported completely and transparently. Sub- optimal reporting of DTA systematic reviews compromises their validity, generalizability, and value to key stakeholders. This thesis evaluates the completeness of reporting of published DTA systematic reviews based on the PRISMA-DTA checklist and provides an explanation for the new and modified items (relative to PRISMA), along with their meaning and rationale. Our results demonstrate that recently published reports of DTA systematic reviews are not fully informative, when evaluated against the PRISMA-DTA guidelines: mean reported items=18.6/26(71%, SD=1.9) for PRISMA-DTA; 5.5/11(50%, SD=1.2) for PRISMA-DTA for abstracts. The PRISMA-DTA statement, this document, and the associated website (http://www. prisma-statement.org/Extensions/DTA) are meant to be helpful resources to support the transparent reporting of DTA systematic reviews and guide knowledge translation strategies. iii Acknowledgments This thesis is the product of the joint efforts of many individuals: supervisors, collaborators, colleagues, residents, medical students, friends and family. I am indebted to all of them for their efforts that contributed to the success of this work. I’d like to thank Dr. Matthew McInnes for providing insight, mentorship, and unwavering support throughout this process. I’m grateful for Dr. David Moher’s invaluable advice and guidance to constantly enhance the quality of my work. To Dr. Julian Little, thank you for your pragmatic suggestions and comments during our meetings. To the collaborators and colleagues whose input and contribution were instrumental to the completion of this work - I am grateful for you all: Dr. Patrick Bossuyt, Dr. Brett Thombs, Dr. Trevor McGrath, Dr. Robert Frank, Dr. Noemie Kraaijpoel, Anahita Dehmoobad Sharifabadi, and Brooke Levis. Finally, and most importantly, I thank my family, whose overt support has provided me with the confidence to pursue ambitious goals. My time as a graduate student has also been financially supported through a number of generous scholarships, from several sources. These sources include: • The Government of Ontario (Ontario Graduate Scholarship, OGS). • The University of Ottawa Excellence Scholarship. • The University of Ottawa Graduate Scholarship. • The University of Ottawa Department of Radiology Research Stipend Program. iv Table of Contents Preface................................................................................................................................. ii Abstract .............................................................................................................................. iii Acknowledgments.............................................................................................................. iv Chapter I. General Introduction. ..........................................................................................1 Objectives ................................................................................................................3 Outline......................................................................................................................4 References ................................................................................................................5 Chapter II. Completeness of reporting of systematic reviews of diagnostic test accuracy based on the PRISMA-DTA reporting guideline. ...............................................................................7 List of authors ..........................................................................................................8 Preface......................................................................................................................9 Abstract ..................................................................................................................11 Introduction ............................................................................................................13 Methods..................................................................................................................15 Search .........................................................................................................15 Article Selection.........................................................................................15 Data Extraction ..........................................................................................16 Data Analysis .............................................................................................17 Results ....................................................................................................................19 Completeness of reporting relative to PRISMA-DTA...............................19 Completeness of reporting relative to PRISMA-DTA for Abstracts .........20 Subgroup Analysis .....................................................................................20 Discussion ..............................................................................................................22 Figures....................................................................................................................26 Tables .....................................................................................................................29 References ..............................................................................................................36 Chapter III. The preferred reporting items for systematic review and meta-analysis of Diagnostic Test Accuracy studies (PRISMA-DTA): Explanation and Elaboration. ...........................38 List of Authors .......................................................................................................39 Preface....................................................................................................................41 Abstract ..................................................................................................................43 Introduction ............................................................................................................44 How to Use This Paper ..............................................................................44 PRISMA-DTA Items .........................................................................................................46 Additional Considerations .................................................................................................80 Figures....................................................................................................................83 Boxes......................................................................................................................88