Developing a multi-center clinical data mart of ACEI and ARB for real-world evidence (RWE)

Abstract

Background Randomized controlled trials can be expensive and time-consuming, leading to medical researchers utilizing real-world evidence (RWE) based on already-collected data. We aimed to conduct various RWE studies on angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor blocker (ARB), commonly used as first-line therapy for blood pressure, and to develop a multi-center clinical data mart (CDM) of ACEI/ARB for various clinical purposes.

Methods Data from electronic medical records of St. Marys Hospital and the Seoul National University Hospital were collected. We obtained blood and urine test results of patients within the 30 days prior to their first prescription of ACEI or ARB, as well as the first date of diagnosis and presence of various chronic and cardiovascular diseases using the International Classification of Diseases-10 classification. One researcher managed data quality and collation for each hospital in order to facilitate patient anonymity. When results were unclear, the responsible investigator for each hospital attempted to resolve ambiguities by direct chart review.

Results A total of 102,333 patients who were prescribed ACEI or ARB for the first time were included (21,481 ACEI, 80,551 ARB, and 301 both). Our ACEI/ARB-CDM included short-term studies (within 12 months) to observe changes in various blood or urinary laboratory test values after the initial prescription of ACEI or ARB and long-term studies to confirm the incidence of various diseases.

Conclusion We established a CDM of RWE for ACEI/ARB prescription, which included various clinical studies. As we accumulate experience in this process, we expect that the use of RWE research will grow and develop.