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A Reference Standard for Evaluation of Methods for Drug Safety Signal Detection Using Electronic Healthcare Record Databases

Drug SafetyPublished 23 November 2012
Preciosa M. Coloma, Paul Avillach, Francesco Salvo, Martijn J. Schuemie, Carmen Ferrajolo, Alexandre Pariente
Citations99
SJR quartileQ1
SJR score1.13
SNIP1.34

TL;DR

A surrogate reference standard of drug-adverse event associations based on existing scientific literature and expert opinion is proposed and should be seen as dynamic as knowledge on drug safety evolves over time and new issues in drug safety arise.

Abstract

A strategy for the construction of a reference standard to evaluate signal detection methods that use EHR has been proposed. The resulting reference standard is by no means definitive, however, and should be seen as dynamic. As knowledge on drug safety evolves over time and new issues in drug safety arise, this reference standard can be re-evaluated.

Keywords

MedicinePharmacology, Toxicology and Pharmaceutics