RESUMO
Statistical algorithms for detecting safety signals are beginning to be applied to Animal Health Pharmacovigilance (PV) databases. How these signal detection algorithms (SDAs) perform in an animal health PV database is the subject of this report. Statistical methods and SDAs were assessed against a set of known signals in order to identify which SDAs were most appropriate for signal detection using the Elanco Animal Health PV database. A reference set of adverse events that should signal was created for 31 products across four species. Nine SDAs based on five disproportionality statistical methods were evaluated against the reference set. The performance metrics were sensitivity, precision, specificity, accuracy, and F score. For bovine and porcine products, the Observed-to-Expected (O/E) SDA was the closest in terms of geometric distance to 100% sensitivity and 100% precision. For canine and feline products, the Information Component (IC) SDA was geometrically closest to 100% sensitivity and 100% precision. Principal Component Analysis confirmed that the O/E and IC SDAs were unique performers with respect to one another and other SDAs. The performance of the SDAs was dependent on the choice of the statistical method with differences seen between animal species.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Algoritmos , Interpretação Estatística de Dados , Bases de Dados de Produtos Farmacêuticos , Farmacovigilância , Animais , Animais Domésticos , Análise de Componente Principal , Especificidade da EspécieRESUMO
The Vetscan Imagyst system (Zoetis) is a novel, artificial intelligence-driven detection tool that can assist veterinarians in the identification of enteric parasites in dogs and cats. This system consists of a sample preparation device, an automated digital microscope scanner, and a deep-learning algorithm. The EasyScan One scanner (Motic) has had good diagnostic performance compared with manual examinations by experts; however, there are drawbacks when used in veterinary practices in which space for equipment is often limited. To improve the usability of this system, we evaluated an additional scanner, the Ocus 40 (Grundium). Our objectives were to 1) qualitatively evaluate the performance of the Vetscan Imagyst system with the Ocus 40 scanner for identifying Ancylostoma, Toxocara, and Trichuris eggs, Cystoisospora oocysts, and Giardia cysts in canine and feline fecal samples, and 2) expand the assessment of the performance of the Vetscan Imagyst system paired with either the Ocus 40 or EasyScan One scanner to include a larger dataset of 2,191 fecal samples obtained from 4 geographic regions of the United States. When tested with 852 canine and feline fecal samples collected from different geographic regions, the performance of the Vetscan Imagyst system combined with the Ocus 40 scanner was correlated closely with manual evaluations by experts. Sensitivities were 80.0â97.0% and specificities were 93.7â100.0% across the targeted parasites. When tested with 1,339 fecal samples, the Vetscan Imagyst system paired with the EasyScan One scanner successfully identified the targeted parasite stages; sensitivities were 73.6â96.4% and specificities were 79.7â100.0%.