Statistical Signal Detection as a Routine Pharmacovigilance Practice: Effects of Periodicity and Resignalling Criteria on Quality and Workload

摘要

IntroductionThe goal of signal detection in pharmacovigilance (PV) is to detect unknown causal associations between medicines and unexpected events. Statistical methods serve to detect signals and supplement traditional PV methods. Statistical signal detection (SSD) requires decisions about various settings that influence the quality and efficiency of SSD, as shown in several studies. To our knowledge, the effects of SSD periodicity and resignalling criteria on the quality and workload of routine SSD have not been published before.