The Use of Test-negative Controls to Monitor Vaccine Effectiveness: A Systematic Review of Methodology - PubMed (original) (raw)

The Use of Test-negative Controls to Monitor Vaccine Effectiveness: A Systematic Review of Methodology

Huiying Chua et al. Epidemiology. 2020 Jan.

Abstract

Background: The 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.

Methods: We 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.

Results: We 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.

Conclusions: Our 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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Conflict of interest statement

POTENTIAL CONFLICTS OF INTEREST

BJC has received honoraria from Sanofi Pasteur and Roche. The authors report no other potential conflicts of interest.

Figures

Figure 1.

Figure 1.

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram of the process and results of study screening.

Figure 2.

Figure 2.

Number of included studies by year. Most of the studies identified were of influenza virus. The first eligible study was published in 1980 (16).

Figure 3.

Figure 3.

Study setting by pathogen. Patients could be recruited from outpatient/emergency department, inpatient, or both outpatient and inpatient setting.

Figure 4.

Figure 4.

Choices of clinical case definition by pathogen. Studies that reported recruitment of patients meeting certain clinical case criteria without clarifying specific symptoms were excluded from this figure, including 32 influenza studies (recruited influenza-like illness patients), seven rotavirus studies (recruited gastroenteritis patients), two poliovirus studies (recruited acute flaccid paralysis patients), and one B. pertussis study (recruited pertussis-like-illness patients). Human papillomavirus and N. gonorrhoeae studies which recruited patients from routine testing were also excluded. Panel A: Other respiratory symptoms include wheezing, whooping cough, apnea, dyspnea, shortness of breath, bronchitis, pharyngitis, pneumonia etc. Other symptoms include complications such as sepsis, stroke, acute exacerbations of chronic respiratory conditions, contact history, etc, or for the case of measles virus, rash, dermal eruption etc. Panel B: Clinical case definition by culture-positive include eight studies which recruited patients with invasive pneumococcal disease and one with acute otitis media. DNA detection may include polymerase chain reaction, or multilocus sequence typing wherever specified. Biochemical tests include bile solubility and optochin susceptibility test. Panel D: Other symptoms include neck stiffness, altered consciousness, other meningeal signs.

Figure 5.

Figure 5.

Choices of cases and controls by pathogen. Purple indicates cases and light green indicates controls. If patient samples were tested-positive for pathogen of interest, patient samples may be further tested to identify whether they were infected by vaccine-type or non-vaccine-type. If patients’ samples tested negative for the pathogen of interest, samples may be further tested. Alternative pathogens may be identified or patient samples may be undiagnosed or pan-negative (i.e. negative for all tested pathogen). Studies can be counted more than once when there was more than one choice of cases or controls.

Figure 6.

Figure 6.

Proportion of studies that included age, sex, calendar time, or comorbidities in statistical model to estimate VE.

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