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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

Determining whether vaccine efficacy wanes is important for individual and public decision making. Yet, quantification of waning is a subtle task. The classical approaches cannot be interpreted as measures of declining efficacy unless we…

统计方法学 · 统计学 2026-05-21 Gellért Perényi , Matias Janvin , Mats J. Stensrud

In order to meet regulatory approval, pharmaceutical companies often must demonstrate that new vaccines reduce the total risk of a post-infection outcome like transmission, symptomatic disease, severe illness, or death in randomized,…

统计方法学 · 统计学 2024-09-23 Rob Trangucci , Yang Chen , Jon Zelner

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

The test-negative design has become popular for evaluating the effectiveness of post-licensure vaccines using observational data. In addition to its logistical convenience on data collection, the design is also believed to control for the…

统计方法学 · 统计学 2026-05-15 Soumyabrata Kundu , Peng Ding , Jingshu Wang , Xinran Li

While conducting probabilistic surveys is the gold standard for assessing vaccine coverage, implementing these surveys poses challenges for global health. There is a need for more convenient option that is more affordable and practical.…

应用统计 · 统计学 2026-03-30 Nathaniel Dyrkton , Shomoita Alam , Susan Shepherd , Ibrahim Sana , Kevin Phelan , Jay JH Park

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

The test-negative design (TND) is widely used to evaluate vaccine effectiveness in real-world settings. In a TND study, individuals with similar symptoms who seek care are tested, and effectiveness is estimated by comparing vaccination…

统计方法学 · 统计学 2025-09-19 Christopher B. Boyer , Kendrick Qijun Li , Xu Shi , Eric J. Tchetgen Tchetgen

The demand for improved efficiency and accuracy in vaccine safety assessments is increasing. Here, we explore the application of computer vision technologies to automate the monitoring of experimental mice for potential side effects after…

计算机视觉与模式识别 · 计算机科学 2024-04-05 Chuang Li , Shuai Shao , Willian Mikason , Rubing Lin , Yantong Liu

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

Network-based interventions against epidemic spread are most powerful when the full network structure is known. However, in practice, resource constraints require decisions to be made based on partial network information. We investigated…

应用统计 · 统计学 2019-03-19 Yingrui Yang , Ashley McKhann , Sixing Chen , Guy Harling , Jukka-Pekka Onnela

In vaccine studies for infectious diseases such as human immunodeficiency virus (HIV), the frequency and type of contacts between study participants and infectious sources are among the most informative risk factors, but are often not…

应用统计 · 统计学 2012-08-27 Yang Yang , Peter Gilbert , Ira M. Longini, , M. Elizabeth Halloran

Background: The Cox model and its extensions assuming proportional hazards is widely used to estimate vaccine efficacy (VE). In the typical situation that VE wanes over time, the VE estimates are not only sensitive to study duration and…

应用统计 · 统计学 2025-09-10 Ziwei Zhao , Xiangmei Ma , Paul Milligan , Yin Bun Cheung

Cluster-randomized trials are often conducted to assess vaccine effects. Defining estimands of interest before conducting a trial is integral to the alignment between a study's objectives and the data to be collected and analyzed. This…

统计方法学 · 统计学 2019-10-10 Kayla W. Kilpatrick , Michael G. Hudgens , M. Elizabeth Halloran

Real-world vaccine effectiveness has increasingly been studied using matching-based approaches, particularly in observational cohort studies following the target trial emulation framework. Although matching is appealing in its simplicity,…

统计方法学 · 统计学 2026-04-07 Emily Wu , Elizabeth Rogawski McQuade , Mats Stensrud , Razieh Nabi , David Benkeser

Developing accurate and reliable methods to estimate vaccine protection is a key goal in immunology and public health. While several statistical methods have been proposed, their potential inaccuracy in capturing fast intra-seasonal waning…

定量方法 · 定量生物学 2022-05-26 Ariel Nikas , Hasan Ahmed , Veronika I. Zarnitsyna

Results from randomized controlled trials (RCTs) help determine vaccination strategies and related public health policies. However, defining and identifying estimands that can guide policies in infectious disease settings is difficult, even…

统计方法学 · 统计学 2023-01-24 Mats J. Stensrud , Louisa H. Smith

The effectiveness of vaccination highly depends on the choice of individuals to vaccinate, even if the same number of individuals are vaccinated. Vaccinating individuals with high centrality measures such as betweenness centrality (BC) and…

物理与社会 · 物理学 2021-12-30 Bukyoung Jhun

Background: External validations are essential to assess clinical prediction models (CPMs) before deployment. Apart from model misspecification, differences in patient population and other factors influence a model's AUC (c-statistic). We…

Understanding vaccine effects on post-infection outcomes is critical for evaluating the full value proposition of a vaccine. However, defining appropriate causal effects on such outcomes is challenging because infection is affected by…

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