title: A knowledge based approach for automated signal generation in pharmacovigilance.
abstract: BACKGROUND
  Pharmacovigilance experts detect new adverse drug reactions (ADR) by manually reviewing spontaneous reporting systems. Automated signal generation aims to focus the attention of experts on drug-adverse event associations which are disproportionally present in the database. Although adverse events are coded by means of controlled vocabularies such as the MedDRA dictionary, this semantic information is not taken into account for signal generation.
  
  
  OBJECTIVE
  To improve the performance of current signal detection algorithms using knowledge based approach.
  
  
  METHODS
  We developed a formal ontology of ADRs and built a data mining tool that uses description logic representations of MedDRA terms to group medically related case reports.
  
  
  RESULTS
  This knowledge based approach increased the sensitivity of signal detection with no decrease in specificity.
  
  
  CONCLUSIONS
  A knowledge based approach improved the performance of signal detection tools. However, the huge work-load involved in the knowledge engineering step limits the use of this approach for machine learning.
authors.affiliation: Laboratoire de Santé Publique et d'Informatique Médicale, INSERM ERM 202, Faculté de médecine Broussais Hôtel Dieu, 15 rue de l'Ecole de Médecine, 75006 Paris, France. corneliu.henegar@spim.jussieu.fr
authors.forename: Corneliu
authors.initials: C
authors.lastname: Henegar
authors.forename: Cédric
authors.initials: C
authors.lastname: Bousquet
authors.forename: Agnès
authors.initials: A
authors.lastname: Lillo-Le Louët
authors.forename: Patrice
authors.initials: P
authors.lastname: Degoulet
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Jaulent
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000465:Algorithms; D001185:Artificial Intelligence; D001499:Bayes Theorem; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D001330:Electronic Data Processing; D005602:France; D006801:Humans; D009626:Terminology as Topic; D018875:Vocabulary, Controlled