Protocol

Review Question The aim of this review is to investigate the current state of the methodology quality of systematic reviews and meta-analyses published on direct-oral anticoagulants (DOAC) that evaluate its intervention-based outcomes (safety, efficiency, prognosis, harm effects) in the past 3 years (2015-2018) Searches The following databases were comprehensively searched with the aid of a librarian at McMaster University – EMBASE, MEDLINE, Cochrane Library of Systematic Reviews PROSPERO was searched for current ongoing similar studies to be published on DOACs All searches were conducted on February 5th, 2019 Search strategies MEDLINE exp Anticoagulants/ or direct oral anticoagulant.mp. or DOAC.mp. or novel oral anticoagulant.mp. or NOAC.mp. or non vitamin k antagonist anticoagulant.mp. or anticoagulant*.mp. or anticoagulant*.ti. or anti coagulant*.ab. (direct oral anticoagulant or DOAC or novel oral anticoagulant or NOAC or non vitamin k antagonist anticoagulant).ti. (direct oral anticoagulant or DOAC or novel oral anticoagulant or NOAC or non vitamin k antagonist anticoagulant).ab. dabigatran.mp. or Dabigatran/ or dabigatran.ti. or dabigatran.ab. rivaroxaban.mp. or Rivaroxaban/ or rivaroxaban.ti. or rivaroxaban.ab. apixaban.mp. or apixaban/ or apixaban.ti. or apixaban.ab. edoxaban.mp. or edoxaban/ or edoxaban.ti. or edoxaban.ab. or/1-7 systematic review.mp. or systematic review/ or (systematic adj3 review).mp. or (systematic adj3 review).ti. or (systematic adj3 review).ab. meta-analysis/ or meta analysis.mp. or (meta adj 3 analysis).mp. or (meta adj 3 analysis).ti. or (meta adj 3 analysis).ab. SR.mp. or sr.ti. or sr.ab. or ma.mp. or ma.ti. or ma.ab. 8 and (9 or 10 or 11) limit 12 to yr="2013 -Current" EMBASE (direct oral anticoagulant or DOAC or novel oral anticoagulant or NOAC or non vitamin k antagonist anticoagulant*).mp. (direct oral anticoagulant or DOAC or novel oral anticoagulant or NOAC or non vitamin k antagonist anticoagulant).ti. (direct oral anticoagulant or DOAC or novel oral anticoagulant or NOAC or non vitamin k antagonist anticoagulant).ab. dabigatran.mp. or Dabigatran/ or dabigatran.ti. or dabigatran.ab. rivaroxaban.mp. or Rivaroxaban/ or rivaroxaban.ti. or rivaroxaban.ab. apixaban.mp. or apixaban/ or apixaban.ti. or apixaban.ab. edoxaban.mp. or edoxaban/ or edoxaban.ti. or edoxaban.ab. or/1-7 systematic review.mp. or systematic review/ or (systematic adj3 review).mp. or (systematic adj3 review).ti. or (systematic adj3 review).ab. meta-analysis/ or meta analysis.mp. or (meta adj 3 analysis).mp. or (meta adj 3 analysis).ti. or (meta adj 3 analysis).ab. (SR or ma).ti. 9 or 10 or 11 8 and 12 limit 13 to yr="2013 -Current" Cochrane direct oral anticoagulant or DOAC or novel oral anticoagulant or NOAC or non-vitamin k antagonist anticoagulant* or dabigatran or rivaroxaban or apixaban or edoxaban Types of study to be included Studies that are identified as a systematic review and investigated any topics (safety, efficiency, prognosis, harm) of DOACs as a main outcome measure Condition or domain being studied Given the introduction of DOACs, many systematic reviews have been published in the subject area. The main aim of this paper is to systematically identify, appraise the methodology, and summarize the quality of the literature regarding DOACs that is published through systematic reviews Participants/population Inclusion of any systematic reviews published on DOACs that used patient primary data and looked at clinical intervention-based outcomes (safety, efficiency, prognosis, harm effects) of DOACs in the past 3 years Interventions, exposures Any systematic review that used primary data to determine clinical outcomes (safety, efficiency, prognosis, harm effects) related to DOACs Comparators The methodological quality on DOACs will be compared to other medical fields that also have similar reviews evaluating the state of the literature Main outcomes The primary outcome is the methodological quality of the included systematic reviews that will be assessed using AMSTAR 11-point scale Additional outcomes Quality of the reviews throughout each of the past three years Average AMSTAR based on medical journal Average AMSTAR based on primary outcome measure Data extraction (selection and coding) Selection of articles to be included will be based on pre-established criteria. Screening will be done independently in two stages. Two review authors (S.Y and N.C) will conduct pilot screens to ensure high inter-rater reliability (Cohens Kappa > 0.8) prior to commencing complete title and abstract review. In the second stage screening will be done independently using full-text analysis. At each stage, any disagreement amongst the screeners will be discussed by with two other authors until a consensus is made. Data extraction will be done by the same authors and will also be done independently. Evaluation of methodological quality will be done independently by two authors (A.E and A.L), similarly, pilot assessments to ensure high-interrater reliability; a final Kappa value will be calculated. Data to be extracted include: year of publication (E date), journal of publication, citation rate, country of corresponding author, whether a meta-analysis was performed, whether a quality assessment was done (and if so which tool), whether a PRISMA structure was followed, outcomes measured, funding statements and disclosure of conflict Risk of Bias (Quality Assessment) Two authors will use the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) to assess the quality of the systematic reviews to be included. Strategy for data synthesis A meta-analysis is not intended to be done. Table, graphs, and descriptive statistics will be used to summarize findings and analysis while accompanied with written statements. Analysis of subgroups or subsets If there is enough data available; we may use inferential statistics to analyze differences in AMSTAR rating amongst journals (and their impact factor). Impact factor will be determined using the Clarivate 2018 report of journal impact factors. Chi-squared test for variance will be done to assess changes in quality stratified based on year; a p-value of less than 0.05 will be considered statistically significant. Analysis of quality stratified by outcome measure will also be done if sufficient data is available. Contact details for further information Allen Li Lia59@mcmaster.ca Ali Eshaghpour, BHSc Ali.Eshaghpour@Medportal.ca Organizational affiliation of the review McMaster University, Faculty of Health Sciences Michael D. Degroote School of Medicine, McMaster University, Faculty of Health Sciences Review team members and their organizational affiliations Mr. Allen Li, McMaster University, Faculty of Health Sciences Mr. Ali Eshaghpour, Michael D. Degroote School of Medicine, McMaster University, Faculty of Health Sciences Mr. Arshia Javidan, University of Toronto, Faculty of Medicine Ms. Natalie Chen, McMaster University, Faculty of Health Sciences Ms. Sarah Yang, McMaster University, Faculty of Health Sciences Dr. Mark Crowther, Michael D. Degroote School of Medicine, McMaster University, Faculty of Health Sciences

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