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首页> 美国卫生研究院文献>American Journal of Epidemiology >Cluster-Randomized Test-Negative Design Trials: A Novel and Efficient Method to Assess the Efficacy of Community-Level Dengue Interventions
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Cluster-Randomized Test-Negative Design Trials: A Novel and Efficient Method to Assess the Efficacy of Community-Level Dengue Interventions

机译：集群随机化测试阴性设计试验：一种评估社区一级登革热干预效果的新颖有效方法

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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 a test-negative design (CR-TND), which offers advantages over traditional approaches. This method uses outcome-based sampling of patients presenting with a syndrome consistent with the disease of interest, who are subsequently classified as test-positive cases or test-negative controls on the basis of diagnostic testing. We used simulations of a cluster trial to demonstrate validity of efficacy estimates under the test-negative approach. We demonstrated that, provided study arms are balanced for both test-negative and test-positive illness at baseline and that other test-negative design assumptions are met, the efficacy estimates closely match true efficacy. Analytical considerations for an odds ratio–based effect estimate arising from clustered data and potential approaches to analysis are also discussed briefly. We concluded that application of the test-negative design to certain cluster-randomized trials could increase their efficiency and ease of implementation.
机译：集群随机对照试验是评估社区级干预措施（例如针对登革热的媒介控制策略）有效性的金标准。我们描述了一种新型的带有测试阴性设计（CR-TND）的集群随机试验方法，它比传统方法更具优势。此方法使用基于结果的样本，对表现出与所关注疾病相符的综合征的患者进行分类，随后根据诊断测试将其分类为测试阳性病例或测试阴性对照。我们使用集群试验的模拟来证明在测试阴性方法下有效性评估的有效性。我们证明，只要研究组在基线时对测试阴性和测试阳性的疾病均处于平衡状态，并且满足其他测试阴性设计假设，则功效估算值与真实功效非常匹配。还简要讨论了从聚集数据和潜在分析方法得出的基于比值比的效果估计的分析注意事项。我们得出的结论是，将阴性试验设计应用于某些聚类随机试验可以提高其效率和易实施性。

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