Powered by open-source tools, state-of-the-art analytical methods and global collaboration within the OHDSI community, these findings provide robust and reproducible real-world evidence. The study design was specifically cited by the European Medicines Agency in the foreword of latest version of The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology following its release on a preprint server:
Morales et al. supported the reproducibility of their study by publishing the study protocol in the EU PAS Register ahead of time, providing a start-to-finish executable code, facilitating the sharing and exploration of the complete result set with an interactive web application and asking clinicians and epidemiologists to perform a blinded evaluation of propensity score diagnostics for the treatment comparisons.
“By comparing people exposed to ACE inhibitor and ARBs against people taking other antihypertensives, either alone or in combination, using two methods across three database the study generated 1280 comparisons to assess the safety of these drugs, producing highly consistent results,” says lead author Daniel Morales, Wellcome Trust Clinical Research Fellow at the University of Dundee.
The International COVID-ACE Receptor Inhibition Utilization and Safety (ICARIUS) protocol, code, and results are all available for further exploration at https://github.com/ohdsi-studies/Covid19Icarius.
“Open science and collaboration are tenets of the OHDSI community, and they were never more important than early in this pandemic, when we all knew very little about critical questions like antihypertensive risks around COVID-19,” said George Hripcsak, Chair of the Columbia Department of Biomedical Informatics, the coordinating center for OHDSI. “Our community collaborated for years to develop the high-level analytics which set the course for these studies, and our belief in international collaboration through open science allowed us to generate this reliable, reproducible COVID patient data that can inform and support critical decision-making to this and other issues challenging our healthcare community.”
OHDSI is a multi-stakeholder, interdisciplinary collaborative to bring out the value of health data through large-scale analytics. All solutions are open-source. OHDSI has established an international network of researchers and observational health databases with a central coordinating center housed at Columbia University.
About This Study
The study “Renin–angiotensin system blockers and susceptibility to COVID-19: an international, open science, cohort analysis” was published Dec. 17, 2020, in The Lancet Digital Health.