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    Date Issued2011 (1)AuthorCavagnaro, Elizabeth (1)Cutrona, Sarah L (1)Forrow, Susan (1)Foy, Sarah (1)Goldberg, Robert J. (1)View MoreDocument TypePoster (1)KeywordBiostatistics (1)Systems Biology (1)View More

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    Validation of Acute Myocardial Infarction (AMI) in the FDA’s Mini-Sentinel Distributed Database

    Cutrona, Sarah L; Toh, Darren; Iyer, Aarthi; Foy, Sarah; Cavagnaro, Elizabeth; Forrow, Susan; Goldberg, Robert J.; Gurwitz, Jerry H. (2011-05-20)
    The Food and Drug Administration’s (FDA) Mini-Sentinel is a pilot program that aims to conduct active surveillance to detect and refine safety signals that emerge for marketed medical products. The purpose of this Mini-Sentinel AMI Validation project was to: (a) develop and design an abstraction and adjudication process to use when full text medical record review is required to confirm a coded diagnosis; and (b) to test this approach by validating a code algorithm for acute myocardial infarction (AMI).
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