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Understanding how vaccine effectiveness (VE) changes over time can provide evidence-based guidance for public health decision making. While commonly reported by practitioners, time-varying VE estimates obtained using Cox regression are vul-…

Unmeasured confounding bias threatens the validity of observational studies. While sensitivity analyses and study designs have been proposed to address this issue, they often overlook the growing availability of auxiliary data. Using…

统计方法学 · 统计学 2024-10-22 Jie Kate Hu , Dafne Zorzetto , Francesca Dominici

Knowing the true effect size of clinical interventions in randomised clinical trials is key to informing the public health policies. Vaccine efficacy is defined in terms of the relative risk or the ratio of two disease risks. However, only…

统计方法学 · 统计学 2021-02-03 Yasin Memari

Optimization of vaccine allocations among different segments of a heterogeneous population is important for enhancing the effectiveness of vaccination campaigns in reducing the burden of epidemics. Intuitively, it would seem that…

定量方法 · 定量生物学 2022-12-01 Nir Gavish , Guy Katriel

The proximal causal inference framework enables the identification and estimation of causal effects in the presence of unmeasured confounding by leveraging two disjoint sets of observed strong proxies: negative control treatments and…

统计方法学 · 统计学 2025-12-16 Antonio Olivas-Martinez , Peter B. Gilbert , Andrea Rotnitzky

Evaluating causal effects in the presence of interference is challenging in network-based studies of hard-to-reach populations. Like many such populations, people who inject drugs (PWID) are embedded in social networks and often exert…

The test-negative design (TND) has become a standard approach to evaluate vaccine effectiveness against the risk of acquiring infectious diseases in real-world settings, such as Influenza, Rotavirus, Dengue fever, and more recently…

统计方法学 · 统计学 2023-03-09 Kendrick Qijun Li , Xu Shi , Wang Miao , Eric Tchetgen Tchetgen

When assessing the causal effect of a binary exposure using observational data, confounder imbalance across exposure arms must be addressed. Matching methods, including propensity score-based matching, can be used to deconfound the causal…

统计方法学 · 统计学 2024-10-01 Ernesto Ulloa-Pérez , Marco Carone , Alex Luedtke

Understanding how the causal effect of a treatment evolves over time, including the potential for waning, is important for informed decisions on treatment discontinuation or repetition. For example, waning vaccine protection influences…

统计方法学 · 统计学 2025-11-25 Eni Musta , Joris Mooij

Inferring causal effects of continuous-valued treatments from observational data is a crucial task promising to better inform policy- and decision-makers. A critical assumption needed to identify these effects is that all confounding…

The interpretation of vaccine efficacy estimands is subtle, even in randomized trials designed to quantify immunological effects of vaccination. In this article, we introduce terminology to distinguish between different vaccine efficacy…

应用统计 · 统计学 2023-11-15 Mats Stensrud , Daniel Nevo , Uri Obolski

Causal mediation analysis provides techniques for defining and estimating effects that may be endowed with mechanistic interpretations. With many scientific investigations seeking to address mechanistic questions, causal direct and indirect…

Knowledge of the protection afforded by vaccines might, in some circumstances, modify a vaccinated individual's behaviour, potentially increasing exposure to pathogens and hindering effectiveness. Although vaccine studies typically do not…

统计方法学 · 统计学 2026-02-18 Bronner P. Gonçalves , Piero L. Olliaro , Sheena G. Sullivan , Benjamin J. Cowling

Given a collection of features available for inclusion in a predictive model, it may be of interest to quantify the relative importance of a subset of features for the prediction task at hand. For example, in HIV vaccine trials, participant…

统计方法学 · 统计学 2025-03-27 Charles J. Wolock , Peter B. Gilbert , Noah Simon , Marco Carone

Causal mediation analysis has become an important and increasingly used framework for evaluating candidate immune response biomarkers in vaccine research. A controlled effects approach has been proposed to estimate controlled risk curves…

统计方法学 · 统计学 2026-04-09 Qijia He , Bo Zhang

Observational data are often used to estimate real-world effectiveness and durability of vaccines. A sequence of trials can be emulated to draw inference from such data while minimizing selection bias, immortal time bias, and confounding.…

统计方法学 · 统计学 2025-09-03 Justin B. DeMonte , Bonnie E. Shook-Sa , Michael G. Hudgens

Data from both a randomized trial and an observational study are sometimes simultaneously available for evaluating the effect of an intervention. The randomized data typically allows for reliable estimation of average treatment effects but…

统计方法学 · 统计学 2021-12-01 David Cheng , Tianxi Cai

We provide an approach to exploratory data analysis in matched observational studies with a single intervention and multiple endpoints. In such settings, the researcher would like to explore evidence for actual treatment effects among these…

统计方法学 · 统计学 2025-12-10 Mengqi Lin , Colin Fogarty

Identifying causal treatment (or exposure) effects in observational studies requires the data to satisfy the unconfoundedness assumption which is not testable using the observed data. With sensitivity analysis, one can determine how the…

统计方法学 · 统计学 2023-01-31 Yang Ou , Lu Tang , Chung-Chou H. Chang

The human papillomavirus (HPV) vaccine is the most effective way to prevent HPV-related cancers. Integrating provider vaccine counseling is crucial to improving HPV vaccine completion rates. Automating the counseling experience through a…