Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel

This article describes the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the FDA’s Mini-Sentinel pilot program. The project consisted of four parts: (i) case identification; (ii) chart retrieval; (iii) abstraction and adjudication; and (iv) calculation of the positive predictive value of the algorithm used to identify cases.