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. 2014 Dec;13(12):1571-91.
doi: 10.1586/14760584.2014.966695. Epub 2014 Oct 28.

Potential of the test-negative design for measuring influenza vaccine effectiveness: a systematic review

Sheena G Sullivan  1 , Shuo Feng, Benjamin J Cowling
Affiliations

Potential of the test-negative design for measuring influenza vaccine effectiveness: a systematic review

Sheena G Sullivan et al. Expert Rev Vaccines. 2014 Dec.

Abstract

Background: The test-negative design is a variant of the case-control study being increasingly used to study influenza vaccine effectiveness (VE). In these studies, patients with influenza-like illness are tested for influenza. Vaccine coverage is compared between those testing positive versus those testing negative to estimate VE.

Objectives: We reviewed features in the design, analysis and reporting of 85 published test-negative studies.

Data sources: Studies were identified from PubMed, reference lists and email updates. Study eligibility: All studies using the test-negative design reporting end-of-season estimates were included.

Study appraisal: Design features that may affect the validity and comparability of reported estimates were reviewed, including setting, study period, source population, case definition, exposure and outcome ascertainment and statistical model.

Results: There was considerable variation in the analytic approach, with 68 unique statistical models identified among the studies.

Conclusion: Harmonization of analytic approaches may improve the potential for pooling VE estimates.

Keywords: case–control; influenza; public health; test-negative study; vaccine effectiveness.

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Figures

Figure 1
Figure 1
Identification of eligible articles
Figure 2
Figure 2
Number of published test-negative studies by year of publication. The bar for 2014 includes nineteen studies published between January and August 2014.
Figure 3
Figure 3
Seasons for which estimates had been published as of August 2014. Influenza seasons are labelled according to the year in which they started, i.e. 2003 includes the 2003 southern hemisphere season as well as the 2003–04 northern hemisphere season.
Figure 4
Figure 4
Vaccine effectiveness (VE) estimates reported in the principal analyses, by year of study. Influenza seasons are labelled according to the year in which they started. E.g. 2003 includes the 2003 southern hemisphere season as well as the 2003/2004 northern hemisphere season. Studies for the 2009 season largely reported estimates against A(H1N1)pdm09 only and are therefore not included in this figure.
See this image and copyright information in PMC

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