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. 2023 May 3;23(1):229.
doi: 10.1186/s12872-023-03258-z.

Reporting quality of randomized controlled trials evaluating non-vitamin K oral anticoagulants in atrial fibrillation: a systematic review

YueGuang Yang  1 , YuBo Han  2 , GuoLiang Zou  2 , YanBo Sui  2 , Juan Jin  2 , Li Liu  3
Affiliations

Reporting quality of randomized controlled trials evaluating non-vitamin K oral anticoagulants in atrial fibrillation: a systematic review

YueGuang Yang et al. BMC Cardiovasc Disord. .

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-two RCTs 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 = 0.01), international collaboration (P < 0.01), and Sources of trial funding (P = 0.02).

Conclusions: Although a large number of randomized controlled trials of NOACs for the treatment of AF were published after the CONSORT 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.

Keywords: Atrial fibrillation; Non-vitamin K oral anticoagulants consolidated; Randomized controlled trial; Reporting quality; Standards of reporting trials statement.

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Conflict of interest statement

The authors declare no conflicts of interest herein.

Figures

Fig. 1
Fig. 1
Selection of randomized clinical trials in the systematic review
Fig. 2
Fig. 2
Overall Quality of Reporting: Rating Based on Items in the 2010 CONSORT Statement (n = 62)
Fig. 3
Fig. 3
The frequency bar graphs of all researched OQS (n = 62)
See this image and copyright information in PMC

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