Reporting Quality of Randomized Controlled Trials Evaluating Non- Vitamin K Oral Anticoagulants in Atrial Fibrillation:A systematic review

Author:

Yang YueGuang1,Han YuBo2,Zou GuoLiang2,Sui YanBo2,Jin Juan2,Liu Li2

Affiliation:

1. Heilongjiang University of Chinese Medicine

2. The First Department of Cardiovascular,First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Abstract

Abstract Background: Randomized controlled trials (RCTs) are subject to bias if they lack methodological quality. Furthermore, optimal and transparent reporting of RCT findings aids their critical appraisal and interpretation. This study aimed to comprehensively evaluate the report quality of RCTs of non-vitamin K oral anticoagulants (NOACs) for the treatment of atrial fibrillation (AF) and to analyze the factors influencing the quality. Methods: By searching PubMed, Embase, Web of Science, and Cochrane Library databases RCTs published from inception to 2022 evaluating the efficacy of NOACs on AF were collected. By using the 2010 Consolidated Standards for Reporting Tests (CONSORT) statement, the overall quality of each report was assessed. Results: Sixty-twoRCTs were retrieved in this study. The median of overall quality score in 2010 was 14 (range: 8.5-20). The extent of compliance with the Consolidated Standards of Reporting Trials reporting guideline differed substantially across items: 9 items were reported adequately (more than 90%), and 3 were reported adequately in less than 10% of trials. Multivariate linear regression analysis showed that the higher reporting scores were associated with higher journal impact factor (P = 0.02), international collaboration (P < 0.01), and Sources of trial funding (P = 0.04). Conclusions: Although a large number of randomized controlled trials of NOACs for the treatment of AFwere published after the CONTORT statement in 2010, the overall quality is still not satisfactory, thus weakening their potential utility and may mislead clinical decisions. This survey provides the first hint for researchers conducting trials of NOACs for AF to improve the quality of reports and to actively apply the CONSORT statement.

Publisher

Research Square Platform LLC

Reference33 articles.

1. Most noninferiority trials were not designed to preserve active comparator treatment effects;Tsui M;J Clin Epidemiol,2019

2. Calvert M, King M, Mercieca-Bebber R, Aiyegbusi O, Kyte D, Slade A, Chan AW, Basch E, Bell J, Bennett A et al. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.Bmj Open2021, 11(6).

3. The CONSORT statement;Cuschieri S;Saudi J Anaesth,2019

4. The Euro Heart Survey and EURObservational Research Programme (EORP) in atrial fibrillation registries: contribution to epidemiology, clinical management and therapy of atrial fibrillation patients over the last 20 years;Vitolo M;Intern Emerg Med,2020

5. Revisiting the risks of incident atrial fibrillation: a narrative review. Part 2;Panchal G;Kardiologia Polska,2019

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