Extended multi-item gamma Poisson shrinker methods based on the zero-inflated Poisson model for postmarket drug safety surveillance.

Bayesian signal detection methods, including the multiitem gamma Poisson shrinker (MGPS), assume a Poisson distribution for the number of reports. However, the database of the adverse event reporting system often has a large number of zero-count cells. A zero-inflated Poisson (ZIP) distribution can be more appropriate in this situation than a Poisson distribution. Few studies have considered ZIP-based models for Bayesian signal detection. In addition, most studies on Bayesian signal detection methods include simulation studies conducted assuming a gamma distribution for the prior. Herein, we extend the MGPS method using the ZIP model and apply various prior distributions. We evaluated the extended methods through an extensive simulation using more varied settings for the model and prior than existing methods. We varied the total number of reports, the number of true signals, the relative reporting rate, and the probability of observing a true zero. The results show that as the probability of observing a zero count increased, methods based on the ZIP model outperformed the Poisson model in most cases. We also found that using the mixture log-normal prior resulted in more conservative detection than other priors when the relative reporting rate is high. Conversely, more signals were found when using the mixture truncated normal distributions. We applied the Bayesian signal detection methods to data from the Korea Adverse Event Reporting System from 2012 to 2016.