Evaluating automated approaches to anaphylaxis case classification using unstructured data from the FDA Sentinel System

Pharmacoepidemiology and Drug Safety
R BallTaxiarchis Botsis

Abstract

In May 2008, the Food and Drug Administration launched the Sentinel Initiative, a multi-year program for the establishment of a national electronic monitoring system for medical product safety that led, in 2016, to the launch of the full Sentinel System. Under the Mini-Sentinel pilot, several algorithms for identifying health outcomes of interest, including one for anaphylaxis, were developed and evaluated using data available from the Sentinel common data model. To evaluate whether features extracted from unstructured narrative data using natural language processing (NLP) could be used to classify anaphylaxis cases. Using previously developed methods, we extracted features from unstructured narrative data using NLP and applied rule-based and similarity-based algorithms to identify anaphylaxis among 62 potential cases previously classified by human experts as anaphylaxis (N = 33), not anaphylaxis (N = 27), and unknown (N = 2). The rule-based and similarity-based approaches demonstrated almost equal performance (recall 100% vs 100%, precision 60.3% vs 57.4%, F-measure: 0.753 vs 0.729). Reasons for misclassification included the inability of the algorithms to make the same clinical judgments as human experts about the timing, sev...Continue Reading

References

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Citations

Mar 17, 2019·American Journal of Epidemiology·Susan M ShortreedJennifer C Nelson
Aug 28, 2019·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Shirley V WangAndrew Bate
Jun 28, 2019·The Journal of Allergy and Clinical Immunology·Rachel L MillerAleena Banerji
Aug 22, 2021·Pharmacoepidemiology and Drug Safety·Dominik de SordiAntje Timmer
Nov 17, 2021·Experimental Biology and Medicine·Elke AnklamWilliam Slikker

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Anaphylaxis

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.