Cluster-Randomized Test-Negative Design Trials: A Novel and Efficient Method to Assess the Efficacy of Community-Level Dengue Interventions.

摘要: Cluster-randomized controlled trials are the gold standard for assessing efficacy of community-level interventions, such as vector-control strategies against dengue. We describe a novel cluster-randomized trial methodology with test-negative design (CR-TND), which offers advantages over traditional approaches. This method uses outcome-based sampling patients presenting syndrome consistent disease interest, who subsequently classified test-positive cases or controls on basis diagnostic testing. used simulations cluster to demonstrate validity estimates under approach. demonstrated that, provided study arms balanced both and illness at baseline that other assumptions met, closely match true efficacy. Analytical considerations an odds ratio-based effect estimate arising from clustered data potential approaches analysis also discussed briefly. concluded application certain could increase their efficiency ease implementation.