Adverse Events Reporting Quality of Randomized Controlled Trials of COVID-19 Vaccine Using the CONSORT Criteria for Reporting Harms: A Systematic Review.

ABSTRACT: Assessing the quality of evidence from vaccine clinical trials is essential to ensure the safety and efficacy of the vaccine and further enhance public acceptance. This study aims to summarize and critically evaluate the quality of harm reporting on randomized controlled trials for the COVID-19 vaccine and determine the factors associated with reporting quality. We systematically searched the literature using PRISMA guidelines for randomized controlled trials (RCT) on COVID-19 Vaccine until 30 December 2021. Published articles were searched from electronic databases such as PubMed, Science Direct, Google Scholar, and Bibliovid. Bias analysis was performed using RoB-2 tools. The quality of reporting was assessed by the Consolidated Standards of Reporting Trials (CONSORT) harm extension modi

SUBMITTER: Yuniar CT 

PROVIDER: S-EPMC8875800 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature