| アブストラクト | 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. |
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| ジャーナル名 | Statistics in medicine |
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| 投稿日 | 2024/2/1 |
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| 投稿者 | Tan, Xianming; Wang, William; Zeng, Donglin; Liu, Guanghan F; Diao, Guoqing; Jafari, Niusha; Alt, Ethan M; Ibrahim, Joseph G |
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| 組織名 | Department of Biostatistics at Gillings School of Global Public Health,;University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.;Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel;Hill, Chapel Hill, North Carolina, USA.;Merck and Co., Inc., North Wales, Pennsylvania, USA.;Department of Biostatistics and Bioinformatics, Milken Institute School of Public;Health, George Washington University, Washington, DC, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38297431/ |
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