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Design for validation of acute myocardial infarction cases in Mini-Sentinel

ABSTRACT Purpose To describe the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the US Food and Drug Administration–funded Mini‐Sentinel pilot program. Methods The project consisted of four parts: (i) case identification—developing an algorithm...

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Bibliographic Details
Published in:Pharmacoepidemiology and drug safety 2012-01, Vol.21 (S1), p.274-281
Main Authors: Cutrona, Sarah L., Toh, Sengwee, Iyer, Aarthi, Foy, Sarah, Cavagnaro, Elizabeth, Forrow, Susan, Racoosin, Judith A., Goldberg, Robert, Gurwitz, Jerry H.
Format: Article
Language:English
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Summary:ABSTRACT Purpose To describe the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the US Food and Drug Administration–funded Mini‐Sentinel pilot program. Methods The project consisted of four parts: (i) case identification—developing an algorithm based on the International Classification of Diseases, Ninth Revision, to identify hospitalized AMI patients within the Mini‐Sentinel Distributed Database; (ii) chart retrieval—establishing procedures that ensured patient privacy (collection and transfer of minimum necessary amount of information, and redaction of direct identifiers to validate potential cases of AMI); (iii) ion and adjudication—trained nurse ors gathered key data using a standardized form with cardiologist adjudication; and (iv) calculation of the positive predictive value of the constructed algorithm. Results Key decision points included (i) breadth of the AMI algorithm, (ii) centralized versus distributed ion, and (iii) approaches to maintaining patient privacy and to obtaining charts for public health purposes. We used an algorithm limited to International Classification of Diseases, Ninth Revision, codes 410.x0‐410.x1. Centralized data ion was performed because of the modest number of charts requested (
ISSN:1053-8569
1099-1557
DOI:10.1002/pds.2314