The need for a clinical case definition in test-negative design studies estimating vaccine effectiveness.

ABSTRACT: Test negative studies have been used extensively for the estimation of COVID-19 vaccine effectiveness (VE). Such studies are able to estimate VE against medically-attended illness under certain assumptions. Selection bias may be present if the probability of participation is associated with vaccination or COVID-19, but this can be mitigated through use of a clinical case definition to screen patients for eligibility, which increases the likelihood that cases and non-cases come from the same source population. We examined the extent to which this type of bias could harm COVID-19 VE through systematic review and simulation. A systematic review of test-negative studies was re-analysed to identify studies ignoring the need for clinical criteria. Studies using a clinical case definition had a l

SUBMITTER: Sullivan SG 

PROVIDER: S-EPMC10423262 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature