title: Evaluation of statistical association measures for the automatic signal generation in pharmacovigilance.
abstract: Pharmacovigilance aims at detecting the adverse effects of marketed drugs. It is generally based on the spontaneous reporting of events thought to be the adverse effects of drugs. Spontaneous Reporting Systems (SRSs) supply huge databases that pharmacovigilance experts cannot exhaustively exploit without data mining tools. Data mining methods; i.e., statistical association measures in conjunction with signal generation criteria, have been proposed in the literature but there is no consensus regarding their applicability and efficiency, especially since such methods are difficult to evaluate on the basis of actual data. The objective of this paper is to evaluate association measures on simulated datasets obtained with SRS modeling. We compared association measures using the percentage of false positive signals among a given number of the most highly ranked drug-event combinations according to the values of the association measures. By considering 150 drugs and 100 adverse events, these percentages of false positives, among the 500 most highly ranked drug-event couples, vary from 1.1% to 53.4% (averages over 1000 simulated datasets). As the measures led to very different results, we could identify which measures appeared to be the most relevant for pharmacovigilance.
authors.affiliation: Laboratory of Image and Signal Processing, Institut National de la Santé et de la Recherche Médicale (INSERM) U.642, Rennes, France. emmanuel.roux@univ-rennes1.fr
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Roux
authors.forename: Frantz
authors.initials: F
authors.lastname: Thiessard
authors.forename: Annie
authors.initials: A
authors.lastname: Fourrier
authors.forename: Bernard
authors.initials: B
authors.lastname: Bégaud
authors.forename: Pascale
authors.initials: P
authors.lastname: Tubert-Bitter
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000465:Algorithms; D001185:Artificial Intelligence; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D003628:Database Management Systems; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D016247:Information Storage and Retrieval / Q000379:methods*; D015233:Models, Statistical; D010363:Pattern Recognition, Automated / Q000379:methods; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D012680:Sensitivity and Specificity