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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

Test-negative designs (TNDs), a form of case-cohort study, are widely used to evaluate infectious disease interventions, notably for influenza and, more recently, COVID-19 vaccines. TNDs rely on recruiting individuals who are tested for the…

统计方法学 · 统计学 2025-04-29 Mengxin Yu , Nicholas P. Jewell

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…

统计方法学 · 统计学 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…

统计方法学 · 统计学 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…

统计方法学 · 统计学 2024-12-13 Cong Jiang , Denis Talbot , Sara Carazo , Mireille E Schnitzer

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…

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

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…

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

Two observational methods are currently being used to monitor post-deployment vaccine effectiveness: the obvious crude method comparing rate testing positive per head of vaccinated population with that rate per head of unvaccinated…

统计方法学 · 统计学 2023-07-18 Roger F. Sewell

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…

统计方法学 · 统计学 2022-02-08 Bingkai Wang , Suzanne M. Dufault , Dylan S. Small , Nicholas P. Jewell

COVID-19 vaccines are highly efficacious at preventing symptomatic infection, severe disease, and death. Most of the evidence that COVID-19 vaccines also reduce transmission of SARS-CoV-2 is based on retrospective, observational studies.…

应用统计 · 统计学 2022-06-16 Marlena S. Bannick , Fei Gao , Elizabeth R. Brown , Holly E. Janes

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…

种群与进化 · 定量生物学 2021-05-21 Rob Johnson , Chris Jackson , Anne Presanis , Sofia S. Villar , Daniela De Angelis

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 potential waning of the vaccination immunity to COVID-19 could pose threats to public health, as it is tenable that the timing of such waning would synchronize with the near-complete restoration of normalcy. Should also testing be…

Studies of HPV vaccine efficacy usually record infections with vaccine targeted and nontargeted strains. Contrary to blinded randomized controlled trials, confounding bias can be a threat and risk compensation may occur in observational…

统计方法学 · 统计学 2026-05-13 Lola Etievant

Studies of vaccine efficacy often record both the incidence of vaccine-targeted virus strains (primary outcome) and the incidence of non-targeted strains (secondary outcome). However, standard estimates of vaccine efficacy on targeted…

应用统计 · 统计学 2023-01-02 Lola Etievant , Joshua N. Sampson , Mitchell H. Gail

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

Test-negative designs with added controls have recently been proposed to study COVID-19. An individual is test-positive or test-negative accordingly if they took a test for a disease but tested positive or tested negative. Adding a control…

统计方法学 · 统计学 2020-05-15 Bikram Karmakar , Dylan Small

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…

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