title: Formalizing MedDRA to support semantic reasoning on adverse drug reaction terms.
abstract: Although MedDRA has obvious advantages over previous terminologies for coding adverse drug reactions and discovering potential signals using data mining techniques, its terminological organization constrains users to search terms according to predefined categories. Adding formal definitions to MedDRA would allow retrieval of terms according to a case definition that may correspond to novel categories that are not currently available in the terminology. To achieve semantic reasoning with MedDRA, we have associated formal definitions to MedDRA terms in an OWL file named OntoADR that is the result of our first step for providing an "ontologized" version of MedDRA. MedDRA five-levels original hierarchy was converted into a subsumption tree and formal definitions of MedDRA terms were designed using several methods: mappings to SNOMED-CT, semi-automatic definition algorithms or a fully manual way. This article presents the main steps of OntoADR conception process, its structure and content, and discusses problems and limits raised by this attempt to "ontologize" MedDRA.
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France; Université Paris 13, Sorbonne Paris Cité, LIMICS, (UMR_S 1142), F-93430, Villetaneuse, France; University of Saint Etienne, Department of Public Health and Medical Informatics, Saint-Etienne, France.
authors.forename: Cédric
authors.initials: C
authors.lastname: Bousquet
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France; Université Paris 13, Sorbonne Paris Cité, LIMICS, (UMR_S 1142), F-93430, Villetaneuse, France.
authors.forename: Éric
authors.initials: É
authors.lastname: Sadou
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France; Université Paris 13, Sorbonne Paris Cité, LIMICS, (UMR_S 1142), F-93430, Villetaneuse, France; University of Saint Etienne, Department of Public Health and Medical Informatics, Saint-Etienne, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Souvignet
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France; Université Paris 13, Sorbonne Paris Cité, LIMICS, (UMR_S 1142), F-93430, Villetaneuse, France.
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Jaulent
authors.affiliation: INSERM, U1142, LIMICS, F-75006, Paris, France; Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1142, LIMICS, F-75006, Paris, France; Université Paris 13, Sorbonne Paris Cité, LIMICS, (UMR_S 1142), F-93430, Villetaneuse, France. Electronic address: gunnar.declerck@upmc.fr.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Declerck
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D012660:Semantics; D039061:Systematized Nomenclature of Medicine; D009626:Terminology as Topic
keywords: Adverse drug reaction; MedDRA; Ontology; SNOMED-CT; Semantic reasoning; Terminology