Related Experiment Video
Updated: Apr 28, 2026

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
A comparison of disproportionality analysis methods in national adverse drug reaction databases of China
Yongfang Hou1, Xiaofei Ye, Guizhi Wu
1National Center for ADR Monitoring , Beijing , China duxiaoxi@cdr.gov.cn.
Objective:
Several disproportionality analysis methods are widely used for signal detection. The goal of this study was to compare the concordance of the performance characteristics of these methods in spontaneous reporting system of China.
Methods:
Algorithms including reporting odds ratio (ROR), proportional reporting ratio (PRR) and information component (IC), a composite criterion previously used by Medicines and Healthcare Products Regulatory Agency (MHRA) were compared. Kappa coefficient was used as the gauge to test the concordance. Reports received in the year 2004 and 2005 were extracted for analysis in this study.
Results:
After data processing, 361,872 reports representing 52,769 combinations were analysed. The analysis generated 24,022, 22,646, 5637 and 5302 signals of disproportionality by PRR, ROR, MHRA and IC, respectively. The kappa coefficient increased with the threshold of number of drug-adverse drug reactions (ADR) combination, and the coefficient exceeded 0.7 when the number of suspected drug-ADR exceeded 2.
Conclusion:
This study shows that different measures used are broadly comparable in spontaneous reporting system in China when two or more cases per combination have been collected.
Related Concept Videos
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Analysis of Population Pharmacokinetic Data
Drug Toxicity: Risk factors
Bioequivalence Data: Statistical Interpretation
Measurement of Bioavailability: Pharmacodynamic Methods
Dosage Regimens: Partial Pharmacokinetic Parameters
