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Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance

There are several different proposed data mining methods for the postmarketing surveillance of drug safety. Adverse events are often classified into a hierarchical structure. Our objective was to compare the performance of several of these different data mining methods for adverse drug events data w...

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Autores principales: Park, Goeun, Jung, Heesun, Heo, Seok-Jae, Jung, Inkyung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460123/
https://www.ncbi.nlm.nih.gov/pubmed/32764444
http://dx.doi.org/10.3390/life10080138
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author Park, Goeun
Jung, Heesun
Heo, Seok-Jae
Jung, Inkyung
author_facet Park, Goeun
Jung, Heesun
Heo, Seok-Jae
Jung, Inkyung
author_sort Park, Goeun
collection PubMed
description There are several different proposed data mining methods for the postmarketing surveillance of drug safety. Adverse events are often classified into a hierarchical structure. Our objective was to compare the performance of several of these different data mining methods for adverse drug events data with a hierarchical structure. We generated datasets based on the World Health Organization’s Adverse Reaction Terminology (WHO-ART) hierarchical structure. We evaluated different data mining methods for signal detection, including several frequentist methods such as reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), the likelihood ratio test-based method (LRT), and Bayesian methods such as gamma Poisson shrinker (GPS), Bayesian confidence propagating neural network (BCPNN), the new IC method, and the simplified Bayesian method (sB), as well as the tree-based scan statistic through an extensive simulation study. We also applied the methods to real data on two diabetes drugs, voglibose and acarbose, from the Korea Adverse event reporting system. Only the tree-based scan statistic method maintained the type I error rate at the desired level. Likelihood ratio test-based methods and Bayesian methods tended to be more conservative than other methods in the simulation study and detected fewer signals in the real data example. No method was superior to the others in terms of the statistical power and sensitivity of detecting true signals. It is recommended that those conducting drug‒adverse event surveillance use not just one method, but make a decision based on several methods.
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spelling pubmed-74601232020-09-02 Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance Park, Goeun Jung, Heesun Heo, Seok-Jae Jung, Inkyung Life (Basel) Article There are several different proposed data mining methods for the postmarketing surveillance of drug safety. Adverse events are often classified into a hierarchical structure. Our objective was to compare the performance of several of these different data mining methods for adverse drug events data with a hierarchical structure. We generated datasets based on the World Health Organization’s Adverse Reaction Terminology (WHO-ART) hierarchical structure. We evaluated different data mining methods for signal detection, including several frequentist methods such as reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), the likelihood ratio test-based method (LRT), and Bayesian methods such as gamma Poisson shrinker (GPS), Bayesian confidence propagating neural network (BCPNN), the new IC method, and the simplified Bayesian method (sB), as well as the tree-based scan statistic through an extensive simulation study. We also applied the methods to real data on two diabetes drugs, voglibose and acarbose, from the Korea Adverse event reporting system. Only the tree-based scan statistic method maintained the type I error rate at the desired level. Likelihood ratio test-based methods and Bayesian methods tended to be more conservative than other methods in the simulation study and detected fewer signals in the real data example. No method was superior to the others in terms of the statistical power and sensitivity of detecting true signals. It is recommended that those conducting drug‒adverse event surveillance use not just one method, but make a decision based on several methods. MDPI 2020-08-05 /pmc/articles/PMC7460123/ /pubmed/32764444 http://dx.doi.org/10.3390/life10080138 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Park, Goeun
Jung, Heesun
Heo, Seok-Jae
Jung, Inkyung
Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance
title Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance
title_full Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance
title_fullStr Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance
title_full_unstemmed Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance
title_short Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance
title_sort comparison of data mining methods for the signal detection of adverse drug events with a hierarchical structure in postmarketing surveillance
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460123/
https://www.ncbi.nlm.nih.gov/pubmed/32764444
http://dx.doi.org/10.3390/life10080138
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