Power and sample size considerations for test-negative design with bias correction: a case study on the world first malaria vaccine.

ABSTRACT:

Background

Test-negative design (TND) studies are increasingly common in evaluating vaccine effectiveness (VE) for various infectious diseases. TND studies are susceptible to bias due to disease outcome misclassification caused by imperfect test sensitivity and specificity. Several bias correction methods have been proposed. However, sample size or power considerations for TND studies incorporating bias correction for such misclassification have not yet been investigated.

Methods

We used Monte Carlo simulations to assess how bias correction affects the statistical power and sample size for VE estimation in TND studies. Simulations were conducted under varying levels of diagnostic test sensitivities (60%, 80%, and 95%). Bias correction was implemented using the multiple over-

SUBMITTER: Ko YK 

PROVIDER: S-EPMC12309064 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature