Exploration of statistical shrinkage parameters of disproportionality methods in spontaneous reporting system of China

Abstract

When α was around 0.5, the Youden index reached the maximum for each disproportionality methods in this study. The value of 0.6 was suggested as the most appropriate statistical shrinkage parameter for reporting odds ratio and proportional reporting ratio and 0.2 for information component based on the spontaneous reporting system of China.

Adverse drug reaction signal detection methods in spontaneous reporting system: A systematic review

“…A total of 4197 literatures were identified through initial search. After selection, 93 literatures 4–8,11–98 met our inclusion criteria and were included, covering a period from 1998 to 2022. The literature screening process is shown in Figure 1.…”

“…The 93 included literatures contained 27 reviews 19,21,22,30,34,35,40–42,44,47,50,55–57,61,63,67,68,73,77,82,83,85,92,94,98 and 66 methodological studies 4–8,11–18,20,23–29,31–33,36–39,43,45,46,48,49,51–54,58–60,62,64–66,69–72,74–76,78–81,84,86–91,93,95–97 . Among them, 51 were from China, 18 were from America, 6 were from England, and 5 were from France.…”

Application of biclustering algorithm in adverse drug reaction monitoring system of China

“…Information component with a shrinkage parameter of α = 0.05 was employed in this study in order to reduce the false positive signals. A safety signal was identified when the lower limit of the 95% CI exceeds 0 …”

“…Additionally, the disproportional signals were classified as true positives if they corresponded to known ADRs and otherwise classified as false positives. This approach has been used in other studies . Therefore, the product label database collected by the National Center for ADR Monitoring of China was used as a good proxy for a gold standard.…”

“…This approach has been used in other studies. 1,15,[18][19][20] Therefore, the product label database collected by the National Center for ADR Monitoring of China was used as a good proxy for a gold standard. This database listed 45 393 drug-ADR pairs that were considered as true signals.…”