Test-negative Design: Basic Principles, Methods of Implementation, Types of Derivatives, Advantages, Limitations, and Applications

Abstract

As a simple, rapid and effective research method, test-negative design (TND) has been widely used to support the evaluation of post-marketing effectiveness of vaccines and efficacies of interventions in healthcare institutions, showing a magnificent prospect of application. With the emergence of new derivative types such as real-time TND and cluster-randomized TND, TND has also been gradually applied to the exploration of disease risk factors and effectiveness evaluation of interventions. However, there are still few related research reports in China. We introduced the basic principles, methods and essentials of implementation, newly derivative types such as real-time TND and cluster-randomized TND, advantages and limitations of TND, as well as its applications in assessing post-marketing effectiveness for vaccines and efficacies of interventions, providing a theoretical and practical basis for researchers in China to carry out relevant research.

Keywords

• test-negative design|vaccine|effectiveness evaluation|research method