[Automated grouping of terms associated to cardiac valve fibrosis in MedDRA].
OBJECTIVE
To propose an alternative approach for building custom groupings of terms that complements the usual approach based on both hierarchical method (selection of reference groupings in medical dictionary for regulatory activities [MedDRA]) and/or textual method (string search), for case reports extraction from a pharmacovigilance database in response to a safety problem. Here we take cardiac valve fibrosis as an example.


METHODS
The list of terms obtained by an automated approach, based on querying ontology of adverse drug reactions (OntoADR), a knowledge base defining MedDRA terms through relationships with systematized nomenclature of medicine-clinical terms (SNOMED CT) concepts, was compared with the reference list consisting of 53 preferred terms obtained by hierarchical and textual method. Two queries were performed on OntoADR by using a dedicated software: OntoADR query tools. Both queries excluded congenital diseases, and included a procedure or an auscultation method performed on cardiac valve structures. Query 1 also considered MedDRA terms related to fibrosis, narrowing or calcification of heart valves, and query 2 MedDRA terms described according to one of these four SNOMED CT terms: "Insufficiency", "Valvular sclerosis", "Heart valve calcification" or "Heart valve stenosis".


RESULTS
The reference grouping consisted of 53 MedDRA preferred terms. Our automated method achieved recall of 79% and precision of 100% for query 1 privileging morphological abnormalities, and recall of 100% and precision of 96% for query 2 privileging functional abnormalities.


CONCLUSIONS
An alternative approach to MedDRA reference groupings for building custom groupings is feasible for cardiac valve fibrosis. OntoADR is still in development. Its application to other adverse reactions would require significant work for a knowledge engineer to define every MedDRA term, but such definitions could then be queried as many times as necessary by pharmacovigilance professionals.
UMR_S 1142, Inserm, LIMICS, Sorbonne universités, UPMC université Paris 06, 75006 Paris, France; Service de santé publique et d'information médicale, hôpital nord, centre hospitalier universitaire de Saint-Etienne, 42270 Saint-Etienne, France. Electronic address: Hadyl.as@gmail.com.
Hadyl
H
Asfari
UMR_S 1142, Inserm, LIMICS, Sorbonne universités, UPMC université Paris 06, 75006 Paris, France; Service de santé publique et d'information médicale, hôpital nord, centre hospitalier universitaire de Saint-Etienne, 42270 Saint-Etienne, France.
Julien
J
Souvignet
Centre régional de pharmacovigilance, hôpital européen Georges-Pompidou, AP-HP, 75015 Paris, France.
Agnès
A
Lillo-Le Louët
Service de santé publique et d'information médicale, hôpital nord, centre hospitalier universitaire de Saint-Etienne, 42270 Saint-Etienne, France.
Béatrice
B
Trombert
UMR_S 1142, Inserm, LIMICS, Sorbonne universités, UPMC université Paris 06, 75006 Paris, France.
Marie-Christine
MC
Jaulent
UMR_S 1142, Inserm, LIMICS, Sorbonne universités, UPMC université Paris 06, 75006 Paris, France; Service de santé publique et d'information médicale, hôpital nord, centre hospitalier universitaire de Saint-Etienne, 42270 Saint-Etienne, France.
Cédric
C
Bousquet
Heart valve diseases; MedDRA; Pharmacovigilance; SNOMED CT; Semantics; Systematized nomenclature of medicine; Sémantique; Valvulopathies