Improving Assessment of Vaccine Effectiveness by Coupling Test-Negative Design Studies with Survival Models.

ABSTRACT: The test-negative design (TND) has become a widely used observational study design for evaluating vaccine effectiveness (VE), especially during the COVID-19 pandemic. Traditionally, TND has often been viewed as a variant of the case-control study, with its analysis largely limited to logistic regression models. In this paper, we first establish that TND can be framed as a special case of a cohort study, thereby opening the door to a wider range of analytical approaches. We then introduce the Prentice, Williams, and Peterson gap-time (PWP-GT) frailty model as a novel method for analyzing TND data, accounting for recurrent infections and time-dependent vaccination status. Through extensive simulation studies, we demonstrate that the proposed model outperforms conventional models commonly app

SUBMITTER: Song S 

PROVIDER: S-EPMC12706598 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature