title: Decision support environment for medical product safety surveillance.
abstract: We have developed a Decision Support Environment (DSE) for medical experts at the US Food and Drug Administration (FDA). The DSE contains two integrated systems: The Event-based Text-mining of Health Electronic Records (ETHER) and the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA). These systems assist medical experts in reviewing reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and the FDA Adverse Event Reporting System (FAERS). In this manuscript, we describe the DSE architecture and key functionalities, and examine its potential contributions to the signal management process by focusing on four use cases: the identification of missing cases from a case series, the identification of duplicate case reports, retrieving cases for a case series analysis, and community detection for signal identification and characterization.
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States. Electronic address: Taxiarchis.Botsis@fda.hhs.gov.
authors.forename: Taxiarchis
authors.initials: T
authors.lastname: Botsis
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Christopher
authors.initials: C
authors.lastname: Jankosky
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Deepa
authors.initials: D
authors.lastname: Arya
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Kory
authors.initials: K
authors.lastname: Kreimeyer
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Matthew
authors.initials: M
authors.lastname: Foster
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Abhishek
authors.initials: A
authors.lastname: Pandey
authors.affiliation: Engility Corporation, United States.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Engility Corporation, United States.
authors.forename: Guangfan
authors.initials: G
authors.lastname: Zhang
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Richard
authors.initials: R
authors.lastname: Forshee
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Ravi
authors.initials: R
authors.lastname: Goud
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: David
authors.initials: D
authors.lastname: Menschik
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Mark
authors.initials: M
authors.lastname: Walderhaug
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Emily Jane
authors.initials: EJ
authors.lastname: Woo
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: John
authors.initials: J
authors.lastname: Scott
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D057225:Data Mining; D003661:Decision Support Techniques; D004777:Environment; D006801:Humans; D058028:Research Report; D014481:United States; D014486:United States Food and Drug Administration
keywords: Information retrieval; Natural language processing; Network analysis; Post-marketing surveillance; Text mining