Safety signal detection with control of latent factors

© 2024 John Wiley & Sons Ltd..

Postmarket drug safety database like vaccine adverse event reporting system (VAERS) collect thousands of spontaneous reports annually, with each report recording occurrences of any adverse events (AEs) and use of vaccines. We hope to identify signal vaccine-AE pairs, for which certain vaccines are statistically associated with certain adverse events (AE), using such data. Thus, the outcomes of interest are multiple AEs, which are binary outcomes and could be correlated because they might share certain latent factors; and the primary covariates are vaccines. Appropriately accounting for the complex correlation among AEs could improve the sensitivity and specificity of identifying signal vaccine-AE pairs. We propose a two-step approach in which we first estimate the shared latent factors among AEs using a working multivariate logistic regression model, and then use univariate logistic regression model to examine the vaccine-AE associations after controlling for the latent factors. Our simulation studies show that this approach outperforms current approaches in terms of sensitivity and specificity. We apply our approach in analyzing VAERS data and report our findings.

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - volume:43

Enthalten in:

Statistics in medicine - 43(2024), 7 vom: 30. März, Seite 1397-1418

Sprache:

Englisch

Beteiligte Personen:

Tan, Xianming [VerfasserIn]
Wang, William [VerfasserIn]
Zeng, Donglin [VerfasserIn]
Liu, Guanghan F [VerfasserIn]
Diao, Guoqing [VerfasserIn]
Jafari, Niusha [VerfasserIn]
Alt, Ethan M [VerfasserIn]
Ibrahim, Joseph G [VerfasserIn]

Links:

Volltext

Themen:

Generalized linear mixed models
Journal Article
Multivariate logistic regression model
Signal detection
VAERS
Vaccines
Variational inference (VI) method

Anmerkungen:

Date Completed 18.03.2024

Date Revised 18.03.2024

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1002/sim.10015

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM367867362