Effects of imperfect test sensitivity and specificity on observational studies of influenza vaccine effectiveness
Effects of imperfect test sensitivity and specificity on observational studies of influenza vaccine effectiveness
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DOI：
10.1016/j.vaccine.2015.01.069
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发表时间：
2015-03-10
期刊：
影响因子：
5.5
通讯作者：
Rothman, Kenneth J.
中科院分区：
文献类型：
--
作者：
Jackson, Michael L.;Rothman, Kenneth J.
背景：最近开发的测试阴性设计现在是流感疫苗有效性（VE）观察性研究的标准。目前还不清楚如何流感测试错误分类偏见测试阴性VE估计相对于VE估计从传统的队列或病例对照study.Methods：我们模拟人口的成员可能会发展急性呼吸道疾病（ARI），由于流感和非流感病原体。在这些模拟中，疫苗接种降低了流感的风险，但没有降低非流感ARI的风险。流感检测灵敏度和特异性、流感和非流感ARI的风险以及VE在模拟中各不相同。在每个模拟，我们估计流感VE使用队列设计，病例对照设计，和测试阴性design.Results：在没有流感测试错误分类，所有三个设计准确估计流感VE。在存在错误分类的情况下，所有三种设计都低估了VE。VE估计值的偏倚在测试阴性设计中略大于队列或病例对照设计。假设使用高灵敏度和特异性的逆转录酶聚合酶链反应检测流感病毒，在VE的实际值范围内，检测阴性研究的偏倚微不足道。尽管流感检测错误分类在检测阴性研究中比在传统队列或病例对照研究中导致更多偏倚，但对于实际的发作率、检测灵敏度/特异性、和VE。(C)2015爱思唯尔有限公司版权所有。
Background: The recently developed test-negative design is now standard for observational studies of influenza vaccine effectiveness (VE). It is unclear how influenza test misclassification biases test-negative VE estimates relative to VE estimates from traditional cohort or case-control studies.Methods: We simulated populations whose members may develop acute respiratory illness (ARI) due to influenza and to non-influenza pathogens. In these simulations, vaccination reduces the risk of influenza but not of non-influenza ARI. Influenza test sensitivity and specificity, risks of influenza and non-influenza ARI, and VE were varied across the simulations. In each simulation, we estimated influenza VE using a cohort design, a case-control design, and a test-negative design.Results: In the absence of influenza test misclassification, all three designs accurately estimated influenza VE. In the presence of misclassification, all three designs underestimated VE. Bias in VE estimates was slightly greater in the test-negative design than in cohort or case-control designs. Assuming the use of highly sensitive and specific reverse-transcriptase polymerase chain reaction tests for influenza, bias in the test-negative studies was trivial across a wide range of realistic values for VE.Discussion: Although influenza test misclassification causes more bias in test-negative studies than in traditional cohort or case-control studies, the difference is trivial for realistic combinations of attack rates, test sensitivity/specificity, and VE. (C) 2015 Elsevier Ltd. All rights reserved.