title: Modeling, building and evaluating an ontology for the automatic characterization of adverse drug effects during pharmacovigilance.
abstract: BACKGROUND
  The characterization of spontaneous reported cases is fundamental for pharmacovigilance. This task is time consuming and its reproducibility is low.
  
  
  OBJECTIVE
  To develop a system founded on an ontology that automatically instantiates spontaneous reported cases as "known" adverse drug effects (ADE) only if the reported ADEs are described in drug compendia.
  
  
  METHODS
  A simple ontology of drugs and their related adverse effects represented in description logics was developed from a drug database. Manual evaluation was carried out on 378 spontaneous reported cases instantiated as "known ADE of a chemical class". The initial manual characterization was reviewed by a pharmacovigilance expert to validate the generated automatic characterization.
  
  
  RESULTS
  The ontology is composed by 57,04 concepts and 5 relations. It was successfully validated thanks to Pellet reasoner and it contains neither inconsistencies nor cycles. In this validation, 86% of the instantiated spontaneous reported cases effectively concerned notorious ADEs, whereas only 75% were initially identified manually as related to notorious ADEs.
  
  
  CONCLUSIONS
  This system can assist characterization by applying a reasoning process similar to that used by experts in the search for ADEs.
authors.affiliation: Laboratoire d'Informatique Médicale et Bioinformatique, Université Paris 13, Bobigny, France. catherine.duclos@avc.aphp.fr
authors.forename: Catherine
authors.initials: C
authors.lastname: Duclos
authors.forename: Lina F
authors.initials: LF
authors.lastname: Soualmia
authors.forename: Sonia
authors.initials: S
authors.lastname: Krivine
authors.forename: Anne
authors.initials: A
authors.lastname: Jamet
authors.forename: Agnes
authors.initials: A
authors.lastname: Lillo-Louët
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced; D006801:Humans