SynthesisEpidemiology (Cambridge, Mass.)2020
The Use of Test-negative Controls to Monitor Vaccine Effectiveness: A Systematic Review of Methodology.
Synthesis in Epidemiology (Cambridge, Mass.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 104 papers, 3 of them syntheses 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
104 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Robustness of reported postacute health outcomes in children with SARS-CoV-2 infection: a systematic review.Archives of disease in childhood · 2023Pooled it
- Effectiveness of SARS-CoV-2 vaccines against Omicron infection and severe events: a systematic review and meta-analysis of test-negative design studies.Frontiers in public health · 2023Pooled it
- Do Rotavirus Strains Affect Vaccine Effectiveness? A Systematic Review and Meta-analysis.The Pediatric infectious disease journal · 2021Pooled it
- Validating and leveraging non-SARS-CoV-2 respiratory infection as a negative control outcome in a phase 3 COVID-19 vaccine trial with extended observational follow-up.American journal of epidemiology · 2026Trial
- The validity of test-negative design for assessment of typhoid conjugate vaccine protection: comparison of estimates by different study designs using data from a cluster-randomised controlled trial.The Lancet. Global health · 2025Trial
- Typhoid conjugate vaccine effectiveness in Malawi: evaluation of a test-negative design using randomised, controlled clinical trial data.The Lancet. Global health · 2023Trial
- An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial.Human vaccines & immunotherapeutics · 2021Trial
- Influenza vaccine protection and contact patterns among outpatients with influenza-like illness during the 2024-2025 season in China: a test-negative case-control study.Journal of global health · 2026Article
- Article
- Influenza vaccination in children with underlying conditions: affirming effectiveness and confronting gaps.Translational pediatrics · 2026Article
- Improving Assessment of Vaccine Effectiveness by Coupling Test-negative Design Studies with Survival Models.Epidemiology (Cambridge, Mass.) · 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
- Real-World Effectiveness of Universal Nirsevimab on Bronchiolitis Incidence: A Regional Hub-Spoke Surveillance Analysis in Liguria, Italy.Pediatric pulmonology · 2026Article
- Effectiveness of Influenza Vaccines in Italy in the 2024/2025 Season: A Nationwide, Test-Negative Design Study Based on Surveillance Records.Influenza and other respiratory viruses · 2026Review
- Improving Assessment of Vaccine Effectiveness by Coupling Test-Negative Design Studies with Survival Models.medRxiv : the preprint server for health sciences · 2026Article
- Age-specific patterns of all-cause mortality across COVID-19 booster dose groups in two Japanese municipalities: an exploratory analysis.Frontiers in public health · 2026Observational
- Evaluation of enterovirus A71 vaccine effectiveness against pediatric hand, foot, and mouth disease caused by enterovirus A71 virus in Tianjin, China, 2016-2023: A test-negative design case-control study.Human vaccines & immunotherapeutics · 2025Article
- Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities.The Journal of infectious diseases · 2025Review
- Nirsevimab Treatment of RSV Bronchiolitis in Pediatric Emergency Departments.JAMA network open · 2025Article
- Rotavirus Vaccine Effectiveness Stratified By National-Level Characteristics: An Introduction to the 24-Country MNSSTER-V Project, 2007-2023.The Journal of infectious diseases · 2025Article
44 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundThe test-negative design is an increasingly popular approach for estimating vaccine effectiveness (VE) due to its efficiency. This review aims to examine published test-negative design studies of VE and to explore similarities and differences in methodological choices for different diseases and vaccines.
methodsWe conducted a systematic search on PubMed, Web of Science, and Medline, for studies reporting the effectiveness of any vaccines using a test-negative design. We screened titles and abstracts and reviewed full texts to identify relevant articles. We created a standardized form for each included article to extract information on the pathogen of interest, vaccine(s) being evaluated, study setting, clinical case definition, choices of cases and controls, and statistical approaches used to estimate VE.
resultsWe identified a total of 348 articles, including studies on VE against influenza virus (n = 253), rotavirus (n = 48), pneumococcus (n = 24), and nine other pathogens. Clinical case definitions used to enroll patients were similar by pathogens of interest but the sets of symptoms that defined them varied substantially. Controls could be those testing negative for the pathogen of interest, those testing positive for nonvaccine type of the pathogen of interest, or a subset of those testing positive for alternative pathogens. Most studies controlled for age, calendar time, and comorbidities.
conclusionsOur review highlights similarities and differences in the application of the test-negative design that deserve further examination. If vaccination reduces disease severity in breakthrough infections, particular care must be taken in interpreting vaccine effectiveness estimates from test-negative design studies.
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What OpenQuestion holds
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.