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Article
Design for validation of acute myocardial infarction cases in Mini-Sentinel
Meyers Primary Care Institute Publications and Presentations
  • Sarah L. Cutrona, University of Massachusetts Medical School
  • Sengwee Toh, Harvard Medical School
  • Aarthi Iyer, Harvard Pilgrim Health Care Institute, Boston
  • Sarah Foy, University of Massachusetts Medical School
  • Elizabeth Cavagnaro, Harvard Pilgrim Health Care Institute, Boston
  • Susan Forrow, Harvard Pilgrim Health Care Institute, Boston
  • Judith A. Racoosin, Food and Drug Administration
  • Robert J. Goldberg, University of Massachusetts Medical School
  • Jerry H. Gurwitz, University of Massachusetts Medical School
UMMS Affiliation
Meyers Primary Care Institute; Department of Medicine, Division of Geriatric Medicine; Department of Quantitative Health Sciences
Date
1-19-2012
Document Type
Article
Medical Subject Headings
Myocardial Infarction; Outcome and Process Assessment (Health Care); Validation Studies
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) abstraction and adjudication-trained nurse abstractors 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 abstraction, 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 abstraction was performed because of the modest number of charts requested ( CONCLUSIONS: We have established a process to validate AMI within Mini-Sentinel, which may be used for other health outcomes. Challenges include the following: (i) ensuring that only minimum necessary data are transmitted by Data Partners for centralized chart review, (ii) establishing procedures to maintain data privacy while still allowing for timely access to medical charts, and (iii) securing access to charts for public health uses that do not require approval from an institutional review board while maintaining patient privacy. Copyright © 2012 John Wiley & Sons, Ltd.
Rights and Permissions
Citation: Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:274-81. doi: 10.1002/pds.2314.
Related Resources
Link to article in PubMed
Keywords
  • UMCCTS funding
PubMed ID
22262617
Citation Information
Sarah L. Cutrona, Sengwee Toh, Aarthi Iyer, Sarah Foy, et al.. "Design for validation of acute myocardial infarction cases in Mini-Sentinel" Vol. 21 Iss. Suppl 1 (2012) ISSN: 1099-1557
Available at: http://works.bepress.com/sarah_cutrona/15/