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. 2013 Jan;22(1):40-54.
doi: 10.1002/pds.3310. Epub 2012 Jun 29.

Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program

Sarah L Cutrona  1 , Sengwee Toh, Aarthi Iyer, Sarah Foy, Gregory W Daniel, Vinit P Nair, Daniel Ng, Melissa G Butler, Denise Boudreau, Susan Forrow, Robert Goldberg, Joel Gore, David McManus, Judith A Racoosin, Jerry H Gurwitz
Affiliations

Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program

Sarah L Cutrona et al. Pharmacoepidemiol Drug Saf. 2013 Jan.

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.

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Conflict of interest statement

COI statement: Authors have no conflicts of interest to report.

Figures

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Mini-Sentinel acute myocardial infarction validation: Abstraction form
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Mini-Sentinel acute myocardial infarction validation: Abstraction form
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Mini-Sentinel acute myocardial infarction validation: Abstraction form
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Mini-Sentinel acute myocardial infarction validation: Abstraction form
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Mini-Sentinel acute myocardial infarction validation: Abstraction form
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Mini-Sentinel acute myocardial infarction validation: Abstraction form
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Mini-Sentinel acute myocardial infarction validation: Abstraction form
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Mini-Sentinel acute myocardial infarction validation: Abstraction form
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Mini-Sentinel acute myocardial infarction validation: Adjudication for
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Mini-Sentinel acute myocardial infarction validation: Adjudication for
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References

    1. Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt R. Developing the Sentinel System--a national resource for evidence development. N Engl J Med. Feb 10;364(6):498–9. - PubMed
    1. Robb MA, Racoosin JA, Sherman RE, Gross TP, Ball R, Reichman ME, et al. The US Food and Drug Administration’s Sentinel Initiative: expanding the horizons of medical product safety. Pharmacoepidemiol Drug Saf. 2012 Jan;21(Suppl 1):9–11. - PubMed
    1. Platt R, Carnahan RM, Brown JS, Chrischilles E, Curtis LH, Hennessy S, et al. The U.S. Food and Drug Administration’s Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf. 2012 Jan;21(Suppl 1):1–8. - PubMed
    1. Goff SL, Feld A, Andrade SE, Mahoney L, Beaton SJ, Boudreau DM, et al. Administrative data used to identify patients with irritable bowel syndrome. J Clin Epidemiol. 2008 Jun;61(6):617–21. - PubMed
    1. Andrade SE, Gurwitz JH, Chan KA, Donahue JG, Beck A, Boles M, et al. Validation of diagnoses of peptic ulcers and bleeding from administrative databases: a multi-health maintenance organization study. J Clin Epidemiol. 2002 Mar;55(3):310–3. - PubMed

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