Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data
Sauzet O, Cornelius V (2022)
Frontiers in Pharmacology 13: 889088.
Zeitschriftenaufsatz
| Veröffentlicht | Englisch
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Autor*in
Sauzet, OdileUniBi;
Cornelius, Victoria
Einrichtung
Abstract / Bemerkung
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. Copyright © 2022 Sauzet and Cornelius.
Erscheinungsjahr
2022
Zeitschriftentitel
Frontiers in Pharmacology
Band
13
Art.-Nr.
889088
Urheberrecht / Lizenzen
eISSN
1663-9812
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Open-Access-Publikationskosten wurden durch die Universität Bielefeld gefördert.
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https://pub.uni-bielefeld.de/record/2965669
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Sauzet O, Cornelius V. Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data. Frontiers in Pharmacology . 2022;13: 889088.
Sauzet, O., & Cornelius, V. (2022). Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data. Frontiers in Pharmacology , 13, 889088. https://doi.org/10.3389/fphar.2022.889088
Sauzet, Odile, and Cornelius, Victoria. 2022. “Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data”. Frontiers in Pharmacology 13: 889088.
Sauzet, O., and Cornelius, V. (2022). Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data. Frontiers in Pharmacology 13:889088.
Sauzet, O., & Cornelius, V., 2022. Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data. Frontiers in Pharmacology , 13: 889088.
O. Sauzet and V. Cornelius, “Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data”, Frontiers in Pharmacology , vol. 13, 2022, : 889088.
Sauzet, O., Cornelius, V.: Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data. Frontiers in Pharmacology . 13, : 889088 (2022).
Sauzet, Odile, and Cornelius, Victoria. “Generalised weibull model-based approaches to detect non-constant hazard to signal adverse drug reactions in longitudinal data”. Frontiers in Pharmacology 13 (2022): 889088.
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