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Quality of adverse effect reporting in the clinical trials of comparing direct oral anticoagulants versus warfarin in atrial fibrillation

 College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia

Date of Web Publication22-May-2017

Correspondence Address:
Majid Ali,
College of Pharmacy, Umm al-Qura University, Abdia Campus, Taif Road, Makkah
Saudi Arabia
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/app.app_4_17


Drug classes such as direct oral anticoagulants (DOACs) are relatively new; therefore, it is imperative to report their adverse effects with transparent information, and the quality of these reports in the medical science needs to be assessed. Aim of this study was to assess the quality of adverse effect reporting of DOACs against warfarin in atrial fibrillation (AF) using the Consolidated Standards of Reporting Trials (CONSORT) Harms checklist. We searched MEDLINE and Drug@FDA, and identified four Food and Drug Administration-approved drugs from DOACs class and their relevant clinical trials. The data extraction form was designed using the CONSORT Statement of Harms to include 18 items. Data extraction was conducted by the first three authors independently, and any discrepancies were resolved with a discussion later. Descriptive analysis was employed to measure the rate and percentage of completion of all the items in our revised CONSORT Statement of Harms checklist. Data analysis was performed using the Statistical Package for the Social Sciences version 20.0 software. All included articles were multicentered. The median number of authors was 14.78, and the median impact factor was 26.48. Eligibility criteria, interventions, outcomes, sequence generation, and baseline data were the most reported items whereas estimating the outcomes and explaining any interim analyses and stopping guidelines were the least reported items. All articles from New England Journal of Medicine had a higher percentage of completion of items on the CONSORT checklist compared to the articles from other journals. The quality of reporting adverse effects for DOACs against warfarin in AF was found to be adequate.

Keywords: Adverse effects, atrial fibrillation, consortium, direct oral anticoagulants, warfarin

How to cite this URL:
Alkhuzai F, Almalki H, Althobiani S, Ali M, Elrggal M. Quality of adverse effect reporting in the clinical trials of comparing direct oral anticoagulants versus warfarin in atrial fibrillation. Arch Pharma Pract [Epub ahead of print] [cited 2019 Aug 24]. Available from: http://www.archivepp.com/preprintarticle.asp?id=206662



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