Design for validation of acute myocardial infarction cases in Mini-Sentinel
Authors
Cutrona, Sarah L.Toh, Sengwee
Iyer, Aarthi
Foy, Sarah
Cavagnaro, Elizabeth
Forrow, Susan
Racoosin, Judith A.
Goldberg, Robert J.
Gurwitz, Jerry H.
UMass Chan Affiliations
Department of Quantitative Health SciencesDepartment of Medicine, Division of Geriatric Medicine
Meyers Primary Care Institute
Document Type
Journal ArticlePublication Date
2012-01-19Keywords
Myocardial InfarctionOutcome and Process Assessment (Health Care)
Validation Studies
UMCCTS funding
Cardiovascular Diseases
Health Services Research
Primary Care
Metadata
Show full item recordAbstract
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.Source
Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:274-81. doi: 10.1002/pds.2314.
DOI
10.1002/pds.2314Permanent Link to this Item
http://hdl.handle.net/20.500.14038/37143PubMed ID
22262617Related Resources
ae974a485f413a2113503eed53cd6c53
10.1002/pds.2314