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

    Basic Details
    Health Outcome(s)
    acute myocardial infarction (AMI)

    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.


    Sarah L. Cutrona MD, MPH; Sengwee Toh ScD; Aarthi Iyer MPH; Sarah Foy BA; Elizabeth Cavagnaro MPH; Susan Forrow BA; Judith A. Racoosin MD, MPH; Robert Goldberg PhD; Jerry H. Gurwitz MD

    Corresponding Author

    S. L. Cutrona, 377 Plantation St., Biotech 4 Suite 315, Worcester, MA 01605, USA. E-mail: