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Design for validation of acute myocardial infarction cases in Mini-Sentinel.
Pharmacoepidemiol Drug Saf. 2012 Jan; 21 Suppl 1:274-81.PD

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 (<155). The project's public health status accelerated chart retrieval in most instances.

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.

Authors+Show Affiliations

Fallon Community Health Plan and Fallon Clinic, Meyers Primary Care Institute, University of Massachusetts Medical School, Worcester, MA, USA. Sarah.cutrona@umassmemorial.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

22262617

Citation

Cutrona, Sarah L., et al. "Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel." Pharmacoepidemiology and Drug Safety, vol. 21 Suppl 1, 2012, pp. 274-81.
Cutrona SL, Toh S, Iyer A, et al. Design for validation of acute myocardial infarction cases in Mini-Sentinel. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:274-81.
Cutrona, S. L., Toh, S., Iyer, A., Foy, S., Cavagnaro, E., Forrow, S., Racoosin, J. A., Goldberg, R., & Gurwitz, J. H. (2012). Design for validation of acute myocardial infarction cases in Mini-Sentinel. Pharmacoepidemiology and Drug Safety, 21 Suppl 1, 274-81. https://doi.org/10.1002/pds.2314
Cutrona SL, et al. Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:274-81. PubMed PMID: 22262617.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Design for validation of acute myocardial infarction cases in Mini-Sentinel. AU - Cutrona,Sarah L, AU - Toh,Sengwee, AU - Iyer,Aarthi, AU - Foy,Sarah, AU - Cavagnaro,Elizabeth, AU - Forrow,Susan, AU - Racoosin,Judith A, AU - Goldberg,Robert, AU - Gurwitz,Jerry H, PY - 2012/1/21/entrez PY - 2012/1/25/pubmed PY - 2012/5/10/medline SP - 274 EP - 81 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 21 Suppl 1 N2 - 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 (<155). The project's public health status accelerated chart retrieval in most instances. 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. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/22262617/Design_for_validation_of_acute_myocardial_infarction_cases_in_Mini_Sentinel_ L2 - https://doi.org/10.1002/pds.2314 DB - PRIME DP - Unbound Medicine ER -