The potential role of EHR data in optimizing eligibility criteria definition for cardiovascular outcome trials

Background: Cardiovascular outcome trials (CVOTs) include patients with high risks for cardiovascular events based on specific inclusion criteria. Little is known about the impact of such inclusion criteria on patient accrual and the incidence rate of cardiovascular events. Materials and methods: We evaluated the impact of criteria on the accrual and the number of cardiovascular events in a cohort of 1544 diabetes patients identified from the clinical data warehouse of New York Presbyterian Hospital / Columbia University Irving Medical Center. Results: The highest incidence rate of the composite events (i.e., cardiovascular mortality, stroke, and myocardial infarction) was observed when the inclusion criteria seek patients with underlying cardiovascular diseases or age > 60 with at least two of the risk factors including duration of diabetes, hypertension, dyslipidemia, smoking status, and albuminuria. Conclusion: Our study shows that the electronic health records could be utilized to optimize the inclusion criteria while balancing study inclusiveness and number of events.