title: Application of a temporal reasoning framework tool in analysis of medical device adverse events.
abstract: The Clinical Narrative Temporal Relation Ontology (CNTRO)1 project offers a semantic-web based reasoning framework, which represents temporal events and relationships within clinical narrative texts, and infer new knowledge over them. In this paper, the CNTRO reasoning framework is applied to temporal analysis of medical device adverse event files. One specific adverse event was used as a test case: late stent thrombosis. Adverse event narratives were obtained from the Food and Drug Administration's (FDA) Manufacturing and User Facility Device Experience (MAUDE) database2. 15 adverse event files in which late stent thrombosis was confirmed were randomly selected across multiple drug eluting stent devices. From these files, 81 events and 72 temporal relations were annotated. 73 temporal questions were generated, of which 65 were correctly answered by the CNTRO system. This results in an overall accuracy of 89%. This system should be pursued further to continue assessing its potential benefits in temporal analysis of medical device adverse events.
authors.affiliation: Department of Biomedical Engineering, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Kimberly K
authors.initials: KK
authors.lastname: Clark
authors.forename: Deepak K
authors.initials: DK
authors.lastname: Sharma
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Chute
authors.forename: Cui
authors.initials: C
authors.lastname: Tao
mesh_terms: D054855:Drug-Eluting Stents / Q000009:adverse effects*; D004868:Equipment Failure; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011475:Prosthesis Failure; D012660:Semantics; D013927:Thrombosis / Q000209:etiology; D013995:Time; D014481:United States; D014486:United States Food and Drug Administration; D018875:Vocabulary, Controlled