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首页> 外文期刊>Journal of the royal statistical society >A hybrid approach for the stratified mark-specific proportional hazards model with missing covariates and missing marks, with application to vaccine efficacy trials
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A hybrid approach for the stratified mark-specific proportional hazards model with missing covariates and missing marks, with application to vaccine efficacy trials

机译：具有缺失协变量和缺失标记的分层标记特异性比例危害模型的混合方法，应用于疫苗疗效试验

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Deployment of the recently licensed tetravalent dengue vaccine based on a chimeric yellow fever virus, CYD-TDV, requires understanding of how the risk of dengue disease in vaccine recipients depends jointly on a host biomarker measured after vaccination (neutralization titre-neutralizing antibodies) and on a 'mark' feature of the dengue disease failure event (the amino acid sequence distance of the dengue virus to the dengue sequence represented in the vaccine). The CYD14 phase 3 trial of CYD-TDV measured neutralizing antibodies via case-cohort sampling and the mark in dengue disease failure events, with about a third missing marks. We addressed the question of interest by developing inferential procedures for the stratified mark-specific proportional hazards model with missing covariates and missing marks. Two hybrid approaches are investigated that leverage both augmented inverse probability weighting and nearest neighbourhood hot deck multiple imputation. The two approaches differ in how the imputed marks are pooled in estimation. Our investigation shows that nearest neighbourhood hot deck imputation can lead to biased estimation without properly selected neighbourhoods. Simulations show that the hybrid methods developed perform well with unbiased nearest neighbourhood hot deck imputations from proper neighbourhood selection.The new methods applied to CYD14 show that neutralizing antibody level is strongly inversely associated with the risk of dengue disease in vaccine recipients, more strongly against dengue viruses with shorter distances.
机译：基于嵌合黄热病病毒，Cyd-TDV部署最近持有的四价登革热疫苗需要了解疫苗接受者中登革热病风险如何在接种后测量的宿主生物标志物（中和滴度中和抗体）和上登革船失败事件的“标记”特征（登革热病毒到疫苗中表示的登革病毒的氨基酸序列距离）。 Cyd14相3试验Cyd-TDV通过病例 - 队列采样测量中和抗体和登革热病失败事件中的标记，大约是第三个缺失的标记。我们通过制定具有缺失的协变量和缺失标记的分层标记特定比例危害模型的推理程序来解决兴趣问题。调查了两种混合方法，可以利用增强逆概率加权和最近的邻域热甲板多重估算。这两种方法在估计中如何汇集算术。我们的调查表明，最近的邻居热躺椅可能导致偏见的估计而没有正确选择的社区。模拟表明，从适当的邻域选择，杂种方法与无偏见的最近邻域热甲板避免表现良好。应用于CYD14的新方法表明，中和抗体水平与疫苗接受者中登革热病的风险相反，更强烈地反对登革热距离短距离的病毒。

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