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Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data
Pharmacovigilance is the process of monitoring the emergence of harm from a medicine once it has been licensed and is in use. The aim is to identify new adverse drug reactions (ADRs) or changes in frequency of known ADRs. The last decade has seen increased interest for the use of electronic health r...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9445551/ https://www.ncbi.nlm.nih.gov/pubmed/36081935 http://dx.doi.org/10.3389/fphar.2022.889088 |
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author | Sauzet, Odile Cornelius, Victoria |
author_facet | Sauzet, Odile Cornelius, Victoria |
author_sort | Sauzet, Odile |
collection | PubMed |
description | Pharmacovigilance is the process of monitoring the emergence of harm from a medicine once it has been licensed and is in use. The aim is to identify new adverse drug reactions (ADRs) or changes in frequency of known ADRs. The last decade has seen increased interest for the use of electronic health records (EHRs) in pharmacovigilance. The causal mechanism of an ADR will often result in the occurrence being time dependent. We propose identifying signals for ADRs based on detecting a variation in hazard of an event using a time-to-event approach. Cornelius et al. proposed a method based on the Weibull Shape Parameter (WSP) and demonstrated this to have optimal performance for ADRs occurring shortly after taking treatment or delayed ADRs, and introduced censoring at varying time points to increase performance for intermediate ADRs. We now propose two new approaches which combined perform equally well across all time periods. The performance of this new approach is illustrated through an EHR Bisphosphonates dataset and a simulation study. One new approach is based on the power generalised Weibull distribution (pWSP) introduced by Bagdonavicius and Nikulin alongside an extended version of the WSP test, which includes one censored dataset resulting in improved detection across time period (dWSP). In the Bisphosphonates example, the pWSP and dWSP tests correctly signalled two known ADRs, and signal one adverse event for which no evidence of association with the drug exist. A combined test involving both pWSP and dWSP is reliable independently of the time of occurrence of ADRs. |
format | Online Article Text |
id | pubmed-9445551 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-94455512022-09-07 Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data Sauzet, Odile Cornelius, Victoria Front Pharmacol Pharmacology Pharmacovigilance is the process of monitoring the emergence of harm from a medicine once it has been licensed and is in use. The aim is to identify new adverse drug reactions (ADRs) or changes in frequency of known ADRs. The last decade has seen increased interest for the use of electronic health records (EHRs) in pharmacovigilance. The causal mechanism of an ADR will often result in the occurrence being time dependent. We propose identifying signals for ADRs based on detecting a variation in hazard of an event using a time-to-event approach. Cornelius et al. proposed a method based on the Weibull Shape Parameter (WSP) and demonstrated this to have optimal performance for ADRs occurring shortly after taking treatment or delayed ADRs, and introduced censoring at varying time points to increase performance for intermediate ADRs. We now propose two new approaches which combined perform equally well across all time periods. The performance of this new approach is illustrated through an EHR Bisphosphonates dataset and a simulation study. One new approach is based on the power generalised Weibull distribution (pWSP) introduced by Bagdonavicius and Nikulin alongside an extended version of the WSP test, which includes one censored dataset resulting in improved detection across time period (dWSP). In the Bisphosphonates example, the pWSP and dWSP tests correctly signalled two known ADRs, and signal one adverse event for which no evidence of association with the drug exist. A combined test involving both pWSP and dWSP is reliable independently of the time of occurrence of ADRs. Frontiers Media S.A. 2022-08-23 /pmc/articles/PMC9445551/ /pubmed/36081935 http://dx.doi.org/10.3389/fphar.2022.889088 Text en Copyright © 2022 Sauzet and Cornelius. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Sauzet, Odile Cornelius, Victoria Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data |
title | Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data |
title_full | Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data |
title_fullStr | Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data |
title_full_unstemmed | Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data |
title_short | Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data |
title_sort | generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9445551/ https://www.ncbi.nlm.nih.gov/pubmed/36081935 http://dx.doi.org/10.3389/fphar.2022.889088 |
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