Details:

Alternative Title:
Vaccine
Personal Author:
Jackson, Michael L. ; Rothman, Kenneth J.
Jackson, Michael L. ; Rothman, Kenneth J. Less -
Description:
Background

The recently developed test-negative design is now standard for observational studies of influenza vaccine effectiveness (VE). It is unclear how influenza test misclassification biases test-negative VE estimates relative to VE estimates from traditional cohort or case-control studies.

Methods

We simulated populations whose members may develop acute respiratory illness (ARI) due to influenza and to non-influenza pathogens. In these simulations, vaccination reduces the risk of influenza but not of non-influenza ARI. Influenza test sensitivity and specificity, risks of influenza and non-influenza ARI, and VE were varied across the simulations. In each simulation, we estimated influenza VE using a cohort design, a case-control design, and a test-negative design.

Results

In the absence of influenza test misclassification, all three designs accurately estimated influenza VE. In the presence of misclassification, all three designs underestimated VE. Bias in VE estimates was slightly greater in the test-negative design than in cohort or case-control designs. Assuming the use of highly sensitive and specific reverse-transcriptase polymerase chain reaction tests for influenza, bias in the test-negative studies was trivial across a wide range of realistic values for VE.

Discussion

Although influenza test misclassification causes more bias in test-negative studies than in traditional cohort or case-control studies, the difference is trivial for realistic combinations of attack rates, test sensitivity/specificity, and VE.


Subject:
[+]
Article
Bias (Epidemiology)
Case-Control Studies
Computer Simulation
Human
Humans
Incidence
Influenza
Influenza, Human
Influenza Vaccines
Methodology
Observational Studies As Topic
Sensitivity And Specificity
Vaccine Effectiveness
Vaccine Potency

Source:
Vaccine. 33(11):1313-1316.
Pubmed ID:
25659280
Pubmed Central ID:
PMC5934991
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States ; U01 IP000466/IP/NCIRD CDC HHS/United States
CC999999/Intramural CDC HHS/United States ; U01 IP000466/IP/NCIRD CDC HHS/United States Less -
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:6d669617166475b6cbf176951eeda7a236bbd50ea4aa889b6ba763b27d9d384e
File Type:

Supporting Files

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