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. 2013 Nov;22(11):1205-13.
doi: 10.1002/pds.3505. Epub 2013 Sep 5.

Validation of anaphylaxis in the Food and Drug Administration's Mini-Sentinel

Kathleen E Walsh  1 , Sarah L Cutrona, Sarah Foy, Meghan A Baker, Susan Forrow, Azadeh Shoaibi, Pamala A Pawloski, Michelle Conroy, Andrew M Fine, Lise E Nigrovic, Nandini Selvam, Mano S Selvan, William O Cooper, Susan Andrade
Affiliations

Validation of anaphylaxis in the Food and Drug Administration's Mini-Sentinel

Kathleen E Walsh et al. Pharmacoepidemiol Drug Saf. 2013 Nov.

Abstract

Purpose: We aim to develop and validate the positive predictive value (PPV) of an algorithm to identify anaphylaxis using health plan administrative and claims data. Previously published PPVs for anaphylaxis using International Classification of Diseases, ninth revision, Clinical Modification (ICD-9-CM) codes range from 52% to 57%.

Methods: We conducted a retrospective study using administrative and claims data from eight health plans. Using diagnosis and procedure codes, we developed an algorithm to identify potential cases of anaphylaxis from the Mini-Sentinel Distributed Database between January 2009 and December 2010. A random sample of medical charts (n = 150) was identified for chart abstraction. Two physician adjudicators reviewed each potential case. Using physician adjudicator judgments on whether the case met diagnostic criteria for anaphylaxis, we calculated a PPV for the algorithm.

Results: Of the 122 patients for whom complete charts were received, 77 were judged by physician adjudicators to have anaphylaxis. The PPV for the algorithm was 63.1% (95%CI: 53.9-71.7%), using the clinical criteria by Sampson as the gold standard. The PPV was highest for inpatient encounters with ICD-9-CM codes of 995.0 or 999.4. By combining only the top performing ICD-9-CM codes, we identified an algorithm with a PPV of 75.0%, but only 66% of cases of anaphylaxis were identified using this modified algorithm.

Conclusions: The PPV for the ICD-9-CM-based algorithm for anaphylaxis was slightly higher than PPV estimates reported in prior studies, but remained low. We were able to identify an algorithm that optimized the PPV but demonstrated lower sensitivity for anaphylactic events.

Keywords: Food and Drug Administration; Mini-Sentinel; administrative data; anaphylaxis; pharmacoepidemiology; serious allergic reaction; validation.

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Conflict of interest statement

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

References

    1. US Department of Health and Human Services, editor. The Sentinel Initiative: Access to Electronic Healthcare Data for More than 25 Million Lives; Achieving FDAAA Section 905 Goal One. US Food and Drug Administration, Center for Drug Evaluation and Research;
    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. 2011;364(6):498–9. doi: 10.1056/NEJMp1014427. Epub 2011/01/14. - DOI - PubMed
    1. Sampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF, Jr, Bock SA, Branum A, et al. Second symposium on the definition and management of anaphylaxis: summary report--Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006;117(2):391–7. Epub 2006/02/08. S0091-6749(05)02723-5 [pii] 10.1016/j.jaci.2005.12.1303. - PubMed
    1. Bohlke K, Davis RL, DeStefano F, Marcy SM, Braun MM, Thompson RS. Epidemiology of anaphylaxis among children and adolescents enrolled in a health maintenance organization. J Allergy Clin Immunol. 2004;113(3):536–42. Epub 2004/03/10. 10.1016/j.jaci.2003.11.033 S0091674903027532 [pii] - PubMed
    1. Iribarren C, Tolstykh IV, Miller MK, Eisner MD. Asthma and the prospective risk of anaphylactic shock and other allergy diagnoses in a large integrated health care delivery system. Ann Allergy Asthma Immunol. 2010;104(5):371–7. Epub 2010/05/22. S1081-1206(10)00342-X [pii] 10.1016/j.anai.2010.03.004. - PubMed

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