https://orcid.org/0000-0002-4079-869X
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Abstract
Purpose
The outbreak of COVID-19 has led to a global pandemic with millions of cases and deaths. Many randomized controlled trials (RCTs) were conducted to establish effective therapies. However, the methodological quality of these trials is paramount, as it directly impacts the reliability of results. This systematic review and bibliometric analysis aim to assess the methodological approach, execution diversity, global trends, and distribution of COVID-19 treatment RCTs post-outbreak, covering the period from the second wave and onward up to the present.
Methods
We utilize articles from three electronic databases published from September 1, 2020, to April 1, 2023. Inclusion and exclusion criteria were applied to identify relevant RCTs. Data extraction involved the collection of various study details. Risk of Bias (RoB) 2 tool assessed methodological quality, while implementation variability was evaluated against registration information. Bibliometric analysis, including keyword co-occurrence and country distribution, used VOSviewer and Tableau software.
Results
Initially, 501 studies were identified, but only 22 met the inclusion criteria, of which 19 had registration information. The methodological quality assessment revealed deficiencies in five main domains: randomization process (36%), deviations from intended interventions (9%), missing outcome data (4%), measurement of the outcome (18%), and selection of reported results (4%). An analysis of alignment between research protocols and registration data revealed common deviations in eight critical aspects. Bibliometric findings showcased global collaboration in COVID-19 treatment RCTs, with Iran and Brazil prominently contributing, while keyword co-occurrence analysis illuminated prominent research trends and terms in study titles and abstracts.
Conclusion
This study offers valuable insights into the evaluation of COVID-19 treatment RCTs. The scarcity of high-quality RCTs highlights the importance of enhancing trial rigor and transparency in global health emergencies.
Data Sharing Statement
All the datasets generated during this review are provided within this manuscript.
Ethical Approval
This systematic review and bibliometric analysis incorporated only publicly accessible papers, and as no human subjects were part of the study, there was no necessity for ethics approval.
Disclosure
The authors declare no conflicts of interest.