ArticleAmerican journal of epidemiology2018
Measurement of Vaccine Direct Effects Under the Test-Negative Design.
Article in American journal of epidemiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
75 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Use of Test-negative Controls to Monitor Vaccine Effectiveness: A Systematic Review of Methodology.Epidemiology (Cambridge, Mass.) · 2020Pooled it
- An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial.Human vaccines & immunotherapeutics · 2021Trial
- Durability and Seasonal Variation in the Effectiveness of Nirsevimab over Three Seasons in Connecticut.medRxiv : the preprint server for health sciences · 2026Article
- Statistical methods for estimating the protective effects of immune markers using test-negative designs.American journal of epidemiology · 2026Article
- Use of the test-negative design to estimate the protective effect of a scalar immune measure: a simulation analysis.American journal of epidemiology · 2026Article
- Proposed study design for estimating COVID-19 vaccine effectiveness in post-pandemic Taiwan.Journal of the Chinese Medical Association : JCMA · 2026Article
- Influenza vaccine effectiveness among primary and secondary school students in Shenzhen during the 2023/24 influenza season.Emerging microbes & infections · 2025Article
- Influenza vaccine effectiveness and genetic diversity: insights from end-of-season community surveillance, France, 2024-2025.Emerging microbes & infections · 2025Article
- Waning in influenza vaccine effectiveness against influenza A(H1N1)pdm09-associated hospitalization in children in 2012/2013.Epidemiology and infection · 2025Article
- Real-World Effectiveness of Nirsevimab in Preventing RSV Hospitalizations: Evidence of Protection in Southern Italian Infants, 2024-2025.Journal of medical virology · 2025Article
- Atypical Influenza A(H3N2) Activity Patterns in Germany, 2021-2023, and Characterization of Newly Emerged Virus Clades.Journal of medical virology · 2025Article
- The potential bias introduced into COVID-19 vaccine effectiveness studies at primary care level due to the availability of SARS-CoV-2 tests in the general population.International journal of epidemiology · 2025Article
- Impact of unequal testing on vaccine effectiveness estimates across two study designs: a simulation study.Nature communications · 2025Article
- Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data: A Secondary Cross-Protocol Analysis of 5 Randomized Clinical Trials.JAMA network open · 2025Article
- Strength and durability of indirect protection against SARS-CoV-2 infection through vaccine and infection-acquired immunity.Nature communications · 2025Article
- Article
- Balancing the efforts of chart review and gains in PRS prediction accuracy: An empirical study.Journal of biomedical informatics · 2024Article
- Review
- Effectiveness of nirsevimab against RSV-bronchiolitis in paediatric ambulatory care: a test-negative case-control study.The Lancet regional health. Europe · 2024Article
- Severity-dependent test-seeking behaviors and test-negative designs: impact on estimated vaccine effectiveness and utility of analytic and design choices.American journal of epidemiology · 2024Article
15 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
Test-negative designs are commonplace in assessments of influenza vaccination effectiveness, estimating this value from the exposure odds ratio of vaccination among individuals treated for acute respiratory illness who test positive for influenza virus infection. This approach is widely believed to recover the vaccine direct effect by correcting for differential health-care-seeking behavior among vaccinated and unvaccinated persons. However, the relationship of the measured odds ratio to true vaccine effectiveness is poorly understood. We derived the odds ratio under circumstances of real-world test-negative studies. The odds ratio recovers the vaccine direct effect when 2 conditions are met: 1) Individuals' vaccination decisions are uncorrelated with exposure or susceptibility to the test-positive or test-negative conditions, and 2) vaccination confers "all-or-nothing" protection (whereby certain individuals have no protection while others are perfectly protected). Biased effect-size estimates arise if either condition is unmet. Such bias might suggest misleading associations of vaccine effectiveness with time since vaccination or the force of infection of influenza. The test-negative design could also fail to correct for differential health-care-seeking behavior among vaccinated and unvaccinated persons without stringent criteria for enrollment and testing. Our findings demonstrate a need to reassess how data from test-negative studies can inform policy decisions.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.