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Caveats regarding the test-negative design to study mpox risk factors and vaccine effectiveness [PDF]

American Journal of Epidemiology
Abstract The test-negative design (TND) has been commonly used to study vaccine effectiveness (notably regarding COVID-19 and influenza vaccines) and recently has been proposed as a valid design to study causal risk factors of diseases during an outbreak.
Isaac Núñez
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Adjustment for Disease Severity in the Test-Negative Study Design

American Journal of Epidemiology, 2021
Abstract The test-negative study design is often used to estimate vaccine effectiveness in influenza studies, but it has also been proposed in the context of other infectious diseases, such as cholera, dengue, or Ebola. It was introduced as a variation of the case-control design, in an attempt to reduce confounding bias due to health ...
Iuliana, Ciocănea-Teodorescu, Martha, Nason, Arvid, Sjölander, Erin E, Gabriel   +3 more
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Immune correlates analysis using vaccinees from test negative designs

Biostatistics, 2020
Summary Determining the effect of vaccine-induced immune response on disease risk is an important goal of vaccinology. Typically, immune correlates analyses are conducted prospectively with immune response measured shortly after vaccination and subsequent disease status regressed on immune response. In outbreaks and rare disease settings,
Dean A, Follmann, Lori, Dodd
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The test-negative design for estimating influenza vaccine effectiveness

Vaccine, 2013
The test-negative design has emerged in recent years as the preferred method for estimating influenza vaccine effectiveness (VE) in observational studies. However, the methodologic basis of this design has not been formally developed.In this paper we develop the rationale and underlying assumptions of the test-negative study.
Michael L, Jackson, Jennifer C, Nelson
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Effectiveness of Pentavalent Rotavirus Vaccine in Shanghai, China: A Test-Negative Design Study

The Journal of Pediatrics, 2023
To evaluate vaccine effectiveness (VE) of a live oral pentavalent rotavirus vaccine (RotaTeq, RV5) among young children in Shanghai, China, via a test-negative design study.We consecutively recruited children visiting a tertiary children's hospital for acute diarrhea from November 2021 to February 2022.
Wenjie, Ma, Zhongqiu, Wei, Jiayin, Guo, Lijuan, Lu, Jingjing, Li, Jiehao, Cai, Xiangshi, Wang, Hailing, Chang, Zhuoying, Huang, Xiang, Guo, Qirong, Zhu, Jin, Xu, Mei, Zeng   +12 more
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Influenza Vaccine Effectiveness and Test-Negative Study Design Within the Department of Defense

Military Medicine, 2023
ABSTRACT Test-negative observational studies are routinely used to assess vaccine effectiveness. This test method consistently shows lower annual vaccine effectiveness in the highly vaccinated U.S. military compared to the general population.
David R Sayers, John K Iskander
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Test-Negative Study Designs for Evaluating Vaccine Effectiveness

JAMA
This JAMA Guide to Statistics and Methods article explains the test-negative study design, an observational study design routinely used to estimate vaccine effectiveness, and examines its use in a study that estimated the performance of messenger RNA boosters against the Omicron variant.
Natalie, Dean, Avnika B, Amin
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The case test-negative design for studies of the effectiveness of influenza vaccine

Vaccine, 2013
A modification to the case-control study design has become popular to assess vaccine effectiveness (VE) against viral infections. Subjects with symptomatic illness seeking medical care are tested by a highly specific polymerase chain reaction (PCR) assay for the detection of the infection of interest.
Ivo M, Foppa, Michael, Haber, Jill M, Ferdinands, David K, Shay   +3 more
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[Application of test-negative design in vaccine efficacy evaluation].

Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi, 2020
Vaccine efficacy can be assessed by a randomized placebo-control trial prior to marketing. However, after the marketing of a vaccine, if a placebo-randomized control trial is used to evaluate the efficacy of the vaccine, ethical issues will arise. Therefore, the evaluation of the efficacy of a vaccine after marketing has become a difficult problem in ...
L, Zhang, P F, Jin, J X, Li, F C, Zhu
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