Signal Detection Based on Time to Onset Algorithm in Spontaneous Reporting System of China

Abstract

TTO can detect signals missed by traditional DPAs and could be an important complementary tool to the currently used DPAs in the SRS of China. We recommend a significance level of 0.2 and no restrictions on time windows for TTO.

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

“…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.…”

“…Spontaneous reporting system (SRS) is one of the main methods to collect adverse drug reaction (ADR) reports and is of great importance to pharmacovigilance . In recent years, the SRS has developed rapidly in China, which received 1 430 000 ADR reports in 2016, representing an increase of 2.3% since 2015 .…”

“…Spontaneous reporting system (SRS) is one of the main methods to collect adverse drug reaction (ADR) reports and is of great importance to pharmacovigilance. 1 In recent years, the SRS has developed rapidly in China, which received 1 430 000 ADR reports in 2016, representing an increase of 2.3% since 2015. 2 In order to detect ADR signals from vast amounts of data and to improve the efficiency of ADR signal Tiantian Zhu, Yuan Zhang, Xiaofei Ye, and Yongfang Hou contributed equally and are cofirst authors of this article.…”

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

“…In the last three decades, a series of signal detection methods have been developed to detect ADR signals in spontaneous reporting system, such as reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), gamma Poisson shrinker (GPS), 3 random forests (RF), 4 time‐to‐onset method (TTO), 5 Poisson–Dirichlet process method, 6 Monte Carlo expectation maximization (MCEM), 7 logistic regression (LR), 8 Monte Carlo logistic regression (MCLR), 9 and so on. However, different signal detection methods yield quite different signal detection results, 10 and we do not know the result of which method is more accurate and reliable.…”