title: MedDRA® automated term groupings using OntoADR: evaluation with upper gastrointestinal bleedings.
abstract: OBJECTIVE
  To propose a method to build customized sets of MedDRA terms for the description of a medical condition. We illustrate this method with upper gastrointestinal bleedings (UGIB).
  
  
  METHODS
  We created a broad list of MedDRA terms related to UGIB and defined a gold standard with the help of experts. MedDRA terms were formally described in a semantic resource named OntoADR. We report the use of two semantic queries that automatically select candidate terms for UGIB. Query 1 is a combination of two SNOMED CT concepts describing both morphology 'Hemorrhage' and finding site 'Upper digestive tract structure'. Query 2 complements Query 1 by taking into account MedDRA terms associated to SNOMED CT concepts describing clinical manifestations 'Melena' or 'Hematemesis'.
  
  
  RESULTS
  We compared terms in queries and our gold standard achieving a recall of 71.0% and a precision of 81.4% for query 1 (F1 score 0.76); and a recall of 96.7% and a precision of 77.0% for query 2 (F1 score 0.86).
  
  
  CONCLUSIONS
  Our results demonstrate the feasibility of applying knowledge engineering techniques for building customized sets of MedDRA terms. Additional work is necessary to improve precision and recall, and confirm the interest of the proposed strategy.
authors.affiliation: a 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.|b Department of Public Health and medical informatics , CHU University of Saint Etienne , Saint-Etienne , France.
authors.forename: Julien
authors.initials: J
authors.lastname: Souvignet
authors.affiliation: a 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.|b Department of Public Health and medical informatics , CHU University of Saint Etienne , Saint-Etienne , France.
authors.forename: Hadyl
authors.initials: H
authors.lastname: Asfari
authors.affiliation: a 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.|b Department of Public Health and medical informatics , CHU University of Saint Etienne , Saint-Etienne , France.
authors.forename: Jérémy
authors.initials: J
authors.lastname: Lardon
authors.affiliation: c Gastroenterology Department , CHU of Saint-Etienne , Saint-Etienne , France.
authors.forename: Emilie
authors.initials: E
authors.lastname: Del Tedesco
authors.affiliation: d Sorbonne universités, Université de technologie de Compiègne, EA 2223 Costech (Connaissance, Organisation et Systèmes Techniques), Centre Pierre Guillaumat , Compiègne CEDEX , France.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Declerck
authors.affiliation: a 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.|b Department of Public Health and medical informatics , CHU University of Saint Etienne , Saint-Etienne , France.
authors.forename: Cédric
authors.initials: C
authors.lastname: Bousquet
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification*; D005240:Feasibility Studies; D006471:Gastrointestinal Hemorrhage / Q000175:diagnosis*; D006396:Hematemesis / Q000209:etiology; D006801:Humans; D008551:Melena / Q000209:etiology; D009626:Terminology as Topic
keywords: MedDRA; OntoADR; Pharmacovigilance; SNOMED CT; UGIB; ontology; signal detection