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Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program.
Pharmacoepidemiol Drug Saf. 2013 Jan; 22(1):40-54.PD

Abstract

PURPOSE

To validate an algorithm based upon International Classification of Diseases, 9(th) revision, Clinical Modification (ICD-9-CM) codes for acute myocardial infarction (AMI) documented within the Mini-Sentinel Distributed Database (MSDD).

METHODS

Using an ICD-9-CM-based algorithm (hospitalized patients with 410.x0 or 410.x1 in primary position), we identified a random sample of potential cases of AMI in 2009 from four Data Partners participating in the Mini-Sentinel Program. Cardiologist reviewers used information abstracted from hospital records to assess the likelihood of an AMI diagnosis based on criteria from the Joint European Society of Cardiology and American College of Cardiology Global Task Force. Positive predictive values (PPVs) of the ICD-9-based algorithm were calculated.

RESULTS

Of the 153 potential cases of AMI identified, hospital records for 143 (93%) were retrieved and abstracted. Overall, the PPV was 86.0% (95% confidence interval; 79.2%, 91.2%). PPVs ranged from 76.3% to 94.3% across the four Data Partners.

CONCLUSIONS

The overall PPV of potential AMI cases, as identified using an ICD-9-CM-based algorithm, may be acceptable for safety surveillance; however, PPVs do vary across Data Partners. This validation effort provides a contemporary estimate of the reliability of this algorithm for use in future surveillance efforts conducted using the Food and Drug Administration's MSDD.

Authors+Show Affiliations

Meyers Primary Care Institute-Fallon Community Health Plan, Reliant Medical Group, and 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 availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.
Validation Study

Language

eng

PubMed ID

22745038

Citation

Cutrona, Sarah L., et al. "Validation of Acute Myocardial Infarction in the Food and Drug Administration's Mini-Sentinel Program." Pharmacoepidemiology and Drug Safety, vol. 22, no. 1, 2013, pp. 40-54.
Cutrona SL, Toh S, Iyer A, et al. Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program. Pharmacoepidemiol Drug Saf. 2013;22(1):40-54.
Cutrona, S. L., Toh, S., Iyer, A., Foy, S., Daniel, G. W., Nair, V. P., Ng, D., Butler, M. G., Boudreau, D., Forrow, S., Goldberg, R., Gore, J., McManus, D., Racoosin, J. A., & Gurwitz, J. H. (2013). Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program. Pharmacoepidemiology and Drug Safety, 22(1), 40-54. https://doi.org/10.1002/pds.3310
Cutrona SL, et al. Validation of Acute Myocardial Infarction in the Food and Drug Administration's Mini-Sentinel Program. Pharmacoepidemiol Drug Saf. 2013;22(1):40-54. PubMed PMID: 22745038.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program. AU - Cutrona,Sarah L, AU - Toh,Sengwee, AU - Iyer,Aarthi, AU - Foy,Sarah, AU - Daniel,Gregory W, AU - Nair,Vinit P, AU - Ng,Daniel, AU - Butler,Melissa G, AU - Boudreau,Denise, AU - Forrow,Susan, AU - Goldberg,Robert, AU - Gore,Joel, AU - McManus,David, AU - Racoosin,Judith A, AU - Gurwitz,Jerry H, Y1 - 2012/06/29/ PY - 2011/12/15/received PY - 2012/05/15/revised PY - 2012/05/29/accepted PY - 2012/6/30/entrez PY - 2012/6/30/pubmed PY - 2013/6/5/medline SP - 40 EP - 54 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 22 IS - 1 N2 - PURPOSE: To validate an algorithm based upon International Classification of Diseases, 9(th) revision, Clinical Modification (ICD-9-CM) codes for acute myocardial infarction (AMI) documented within the Mini-Sentinel Distributed Database (MSDD). METHODS: Using an ICD-9-CM-based algorithm (hospitalized patients with 410.x0 or 410.x1 in primary position), we identified a random sample of potential cases of AMI in 2009 from four Data Partners participating in the Mini-Sentinel Program. Cardiologist reviewers used information abstracted from hospital records to assess the likelihood of an AMI diagnosis based on criteria from the Joint European Society of Cardiology and American College of Cardiology Global Task Force. Positive predictive values (PPVs) of the ICD-9-based algorithm were calculated. RESULTS: Of the 153 potential cases of AMI identified, hospital records for 143 (93%) were retrieved and abstracted. Overall, the PPV was 86.0% (95% confidence interval; 79.2%, 91.2%). PPVs ranged from 76.3% to 94.3% across the four Data Partners. CONCLUSIONS: The overall PPV of potential AMI cases, as identified using an ICD-9-CM-based algorithm, may be acceptable for safety surveillance; however, PPVs do vary across Data Partners. This validation effort provides a contemporary estimate of the reliability of this algorithm for use in future surveillance efforts conducted using the Food and Drug Administration's MSDD. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/22745038/Validation_of_acute_myocardial_infarction_in_the_Food_and_Drug_Administration's_Mini_Sentinel_program_ L2 - https://doi.org/10.1002/pds.3310 DB - PRIME DP - Unbound Medicine ER -