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Effect of reporting bias in the analysis of spontaneous reporting data
Author(s) -
Ghosh Palash,
Dewanji Anup
Publication year - 2014
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.1657
Subject(s) - bayesian probability , population , computer science , confidence interval , econometrics , statistics , reporting bias , sample (material) , sampling bias , data mining , sample size determination , medicine , medline , mathematics , artificial intelligence , environmental health , chemistry , chromatography , political science , law
It is well‐known that a spontaneous reporting system suffers from significant under‐reporting of adverse drug reactions from the source population. The existing methods do not adjust for such under‐reporting for the calculation of measures of association between a drug and the adverse drug reaction under study. Often there is direct and/or indirect information on the reporting probabilities. This work incorporates the reporting probabilities into existing methodologies, specifically to Bayesian confidence propagation neural network and DuMouchel's empirical Bayesian methods, and shows how the two methods lead to biased results in the presence of under‐reporting. Considering all the cases to be reported, the association measure for the source population can be estimated by using only exposure information through a reference sample from the source population. Copyright © 2014 John Wiley & Sons, Ltd.