TY - JOUR
T1 - Decision support environment for medical product safety surveillance
AU - Botsis, Taxiarchis
AU - Jankosky, Christopher
AU - Arya, Deepa
AU - Kreimeyer, Kory
AU - Foster, Matthew
AU - Pandey, Abhishek
AU - Wang, Wei
AU - Zhang, Guangfan
AU - Forshee, Richard
AU - Goud, Ravi
AU - Menschik, David
AU - Walderhaug, Mark
AU - Woo, Emily Jane
AU - Scott, John
N1 - Publisher Copyright:
© 2016
PY - 2016/12/1
Y1 - 2016/12/1
N2 - 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.
AB - 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.
KW - Information retrieval
KW - Natural language processing
KW - Network analysis
KW - Post-marketing surveillance
KW - Text mining
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U2 - 10.1016/j.jbi.2016.07.023
DO - 10.1016/j.jbi.2016.07.023
M3 - Article
C2 - 27477839
AN - SCOPUS:84994291850
SN - 1532-0464
VL - 64
SP - 354
EP - 362
JO - Journal of Biomedical Informatics
JF - Journal of Biomedical Informatics
ER -