检测阴性设计：基本原理、方法、衍生设计、优劣势及应用

doi:10.12114/j.issn.1007-9572.2022.0277

摘要/Abstract

摘要： 检测阴性设计是一种简便、快速且有效的研究方法，被广泛应用于疫苗上市后效果评价，有助于国内外基层医疗卫生机构及其他卫生机构评估疫苗上市后效果及其他干预措施效果，其应用前景广阔。随着实时检测阴性设计、整群随机检测阴性设计等新型衍生设计类型的出现，该研究设计被逐步应用于疾病危险因素探索、干预措施效果评估等。然而目前国内相关研究报道较为缺乏。本研究介绍了检测阴性设计的定义、基本原理、方法、设计实施要点，以及实时检测阴性设计、整群随机检测阴性设计等最新衍生设计类型、优势、局限性，在疫苗上市后效果评价以及其他干预措施效果评估等方面的应用，为国内学者开展相关研究提供理论与实践依据。

关键词: 检测阴性设计, 疫苗, 效果评价, 研究方法

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.

Key words: Test-negative design, Vaccine, Effectiveness evaluation, Research method

巫婷,刘珏. 检测阴性设计：基本原理、方法、衍生设计、优劣势及应用[J]. 中国全科医学, 2022, 25(36): 4601-4608. DOI: 10.12114/j.issn.1007-9572.2022.0277.
WU Ting,LIU Jue. Test-negative Design: Basic Principles, Methods of Implementation, Types of Derivatives, Advantages, Limitations, and Applications[J]. Chinese General Practice, 2022, 25(36): 4601-4608. DOI: 10.12114/j.issn.1007-9572.2022.0277.

图/表 3

图1 TND研究流程示意图

Figure 1 Schematic diagram of the test-negative design

表1 TND四格表

Table 1 Fourfold table method for analyzing the test-negative design

分组	检测阳性	检测阴性
暴露	a	b
未暴露	c	d

图2 CR-TND设计示意图

Figure 2 Schematic diagram of the cluster-randomized test-negative design

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