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Related papers: Test-Negative Designs with Multiple Testing Source…

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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…

Methodology · Statistics 2023-03-09 Kendrick Qijun Li , Xu Shi , Wang Miao , Eric Tchetgen Tchetgen

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…

Methodology · Statistics 2025-09-19 Christopher B. Boyer , Kendrick Qijun Li , Xu Shi , Eric J. Tchetgen Tchetgen

Testing of symptomatic persons for infection with SARS-CoV-2 is occurring worldwide. We propose two types of case-control studies that can be carried out jointly in test-settings for symptomatic persons. The first, the test-negative…

Populations and Evolution · Quantitative Biology 2021-06-08 Jan P Vandenbroucke , Elizabeth B Brickley , Christina M J E Vandenbroucke-Grauls , Neil Pearce

The test-negative design (TND) is a resource-efficient observational study design that can assess vaccine effectiveness and exposure-proximal immune correlates of disease. The TND enrolls symptomatic individuals seeking diagnostic testing…

Methodology · Statistics 2026-05-22 Leah I. B. Andrews , Lars van der Laan , Peter B. Gilbert

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…

Methodology · Statistics 2026-05-15 Soumyabrata Kundu , Peng Ding , Jingshu Wang , Xinran Li

The test-negative design (TND), which is routinely used for monitoring seasonal flu vaccine effectiveness (VE), has recently become integral to COVID-19 vaccine surveillance, notably in Qu\'ebec, Canada. Some studies have addressed the…

Methodology · Statistics 2024-12-13 Cong Jiang , Denis Talbot , Sara Carazo , Mireille E Schnitzer

Test-negative designs are widely used for post-market evaluation of vaccine effectiveness, particularly in cases when randomized trials are not feasible. Differing from classical test-negative designs where only healthcare-seekers with…

This paper is a short extension of our previous paper [arXiv:2004.06033] about the use of the Test-Negative design to study risk factors for COVID-19 [See: PubMed and ArXiv reference below] Reason for the extension is that the conditions…

Populations and Evolution · Quantitative Biology 2021-06-08 Jan P Vandenbroucke , Elizabeth B Brickley , Christina M. J. E. Vandenbroucke-Grauls , Neil Pearce

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.…

Methodology · Statistics 2025-09-03 Justin B. DeMonte , Bonnie E. Shook-Sa , Michael G. Hudgens

We discuss some philosophical, methodological and practical problems concerning the use of the test-negative design for COVID-19 vaccines. These problems limit the use of this design considerably.

Applications · Statistics 2022-12-23 Ronald Meester , Jan Bonte

Clinical trials of a vaccine during an epidemic face particular challenges, such as the pressure to identify an effective vaccine quickly to control the epidemic, and the effect that time-space-varying infection incidence has on the power…

Populations and Evolution · Quantitative Biology 2021-05-21 Rob Johnson , Chris Jackson , Anne Presanis , Sofia S. Villar , Daniela De Angelis

Motivated by the increasing number of COVID-19 cases that have been observed in many countries after the vaccination and relaxation of non-pharmaceutical interventions, we propose a mathematical model on time-varying networks for the spread…

Dynamical Systems · Mathematics 2022-03-09 Kathinka Frieswijk , Lorenzo Zino , Ming Cao

Motivated by massive outbreaks of COVID-19 that occurred even in populations with high vaccine uptake, we propose a novel multi-population temporal network model for the spread of recurrent epidemic diseases. We study the effect of human…

Dynamical Systems · Mathematics 2022-09-19 Kathinka Frieswijk , Lorenzo Zino , Ming Cao

Vaccine randomized trials are typically designed to be blinded, ensuring that the estimated vaccine efficacy (VE) reflects the immunological effect of the vaccine. When blinding is broken, however, the estimated VE reflects not only the…

Methodology · Statistics 2026-03-12 Rachel Axelrod , Uri Obolski , Daniel Nevo

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…

Methodology · Statistics 2026-05-21 Gellért Perényi , Matias Janvin , Mats J. Stensrud

The outbreak of the novel coronavirus (COVID-19) is unfolding as a major international crisis whose influence extends to every aspect of our daily lives. Effective testing allows infected individuals to be quarantined, thus reducing the…

Machine Learning · Computer Science 2020-07-28 Rahul Singh , Fang Liu , Ness B. Shroff

With the emergence and spread of infectious diseases with pandemic potential, such as COVID- 19, the urgency for vaccine development have led to unprecedented compressed and accelerated schedules that shortened the standard development…

Applications · Statistics 2025-04-22 Jiayue Wang , Ben Boukai

The Ebola virus in West Africa has infected almost 30,000 and killed over 11,000 people. Recent models of Ebola Virus Disease (EVD) have often made assumptions about how the disease spreads, such as uniform transmissibility and homogeneous…

Populations and Evolution · Quantitative Biology 2016-10-13 Keith Burghardt , Christopher Verzijl , Junming Huang , Matthew Ingram , Binyang Song , Marie-Pierre Hasne

In 2019, the World Health Organization identified dengue as one of the top ten global health threats. For the control of dengue, the Applying Wolbachia to Eliminate Dengue (AWED) study group conducted a cluster-randomized trial in…

Methodology · Statistics 2022-02-08 Bingkai Wang , Suzanne M. Dufault , Dylan S. Small , Nicholas P. Jewell

As of October 12, 2018, 211 cases of Ebola virus disease (EVD) were reported in North Kivu Province, Democratic Republic of Congo. Since the beginning of October the outbreak has largely shifted into regions in which active armed conflict…

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