Reporting quality and risk of bias in randomized controlled trials of rotavirus vaccines.

Purpose: Although several randomized controlled trials (RCTs) have examined the efficacy of rotavirus vaccines, few have comprehensively assessed their reporting quality and risk of bias. This study aimed to evaluate the reporting quality and methodological rigor of RCTs on rotavirus vaccines using the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist and the Cochrane Risk of Bias 2.0 (RoB 2.0) tool. Materials and Methods: We systematically searched PubMed and Cochrane Central for phase 3 randomized controlled trials of rotavirus vaccines administered as monotherapy. Reporting quality was assessed using the CONSORT 2010 checklist and risk of bias was evaluated with the Cochrane RoB 2.0 tool across five domains to determine overall methodological rigor. Results: A total of 29 phase 3 RCTs were included after screening 1,066 records. Most trials were conducted in Asia and funded by industry. Adherence to the CONSORT 2010 checklist was high for trial design and outcome reporting but poor for protocol availability, allocation concealment, and blinding procedures. Overall, 62% of studies had a low risk of bias, while 34% were rated high. Trials published after 2010 and those with low risk of bias showed significantly higher reporting quality. Conclusion: Adherence to the CONSORT 2025 guidelines is essential for future rotavirus vaccine trials, enhancing the quality of individual studies while reinforcing the broader evidence base that informs immunization strategies and public health policies.