The test-negative design for estimating influenza vaccine effectiveness
The test-negative design for estimating influenza vaccine effectiveness
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DOI：
10.1016/j.vaccine.2013.02.053
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发表时间：
2013-04-19
期刊：
影响因子：
5.5
通讯作者：
Nelson, Jennifer C.
中科院分区：
文献类型：
--
作者：
Jackson, Michael L.;Nelson, Jennifer C.
目的：近年来，阴性试验设计已成为观察性研究中估计流感疫苗有效性（VE）的首选方法。然而，这种设计的方法学基础还没有正式developed.Methods：在本文中，我们开发的测试阴性研究的基本原理和基本假设。在VE流感检测阴性设计下，研究受试者均为因急性呼吸道疾病（ARI）寻求治疗的患者。对所有受试者进行流感感染检测。根据流感病毒检测阳性受试者接种疫苗的几率与流感病毒检测阴性受试者接种疫苗的几率的比值估计流感病毒VE。假设（a）ARI的非流感原因的分布不因流感疫苗接种状况而异，（B）VE不因就医行为而异，样本的VE估计可以推广到产生研究样本的全部源总体。基于我们的推导这种设计，我们表明，测试阴性的研究，流感VE可以产生有偏见的VE估计，如果他们包括人寻求照顾ARI时，流感不流通或不调整日历time.Conclusions：测试阴性的设计是不太容易受到偏见，由于感染的错误分类和混淆的医疗保健寻求行为，相对于传统的病例对照或队列研究。测试阴性设计的成本是额外的、难以测试的假设，即在任何求医行为分层内，接种疫苗组和未接种疫苗组之间的非流感呼吸道感染发生率相似，并且流感VE在求医分层之间没有变化。(C)2013爱思唯尔有限公司保留所有权利。
Objective: The test-negative design has emerged in recent years as the preferred method for estimating influenza vaccine effectiveness (VE) in observational studies. However, the methodologic basis of this design has not been formally developed.Methods: In this paper we develop the rationale and underlying assumptions of the test-negative study. Under the test-negative design for influenza VE, study subjects are all persons who seek care for an acute respiratory illness (ARI). All subjects are tested for influenza infection. Influenza VE is estimated from the ratio of the odds of vaccination among subjects testing positive for influenza to the odds of vaccination among subjects testing negative.Results: With the assumptions that (a) the distribution of non-influenza causes of ARI does not vary by influenza vaccination status, and (b) VE does not vary by health care-seeking behavior, the VE estimate from the sample can generalized to the full source population that gave rise to the study sample. Based on our derivation of this design, we show that test-negative studies of influenza VE can produce biased VE estimates if they include persons seeking care for ARI when influenza is not circulating or do not adjust for calendar time.Conclusions: The test-negative design is less susceptible to bias due to misclassification of infection and to confounding by health care-seeking behavior, relative to traditional case-control or cohort studies. The cost of the test-negative design is the additional, difficult-to-test assumptions that incidence of non-influenza respiratory infections is similar between vaccinated and unvaccinated groups within any stratum of care-seeking behavior, and that influenza VE does not vary across care-seeking strata. (C) 2013 Elsevier Ltd. All rights reserved.