WHO Collaborating Centre for Reference and Research on Influenza, Peter Doherty Institute for Infection and Immunity , 792 Elizabeth St, Melbourne VIC 3000 , Australia.
Expert Rev Vaccines. 2014 Dec;13(12):1571-91. doi: 10.1586/14760584.2014.966695. Epub 2014 Oct 28.
The test-negative design is a variant of the case-control study being increasingly used to study influenza vaccine effectiveness (VE). In these studies, patients with influenza-like illness are tested for influenza. Vaccine coverage is compared between those testing positive versus those testing negative to estimate VE.
We reviewed features in the design, analysis and reporting of 85 published test-negative studies.
Studies were identified from PubMed, reference lists and email updates. Study eligibility: All studies using the test-negative design reporting end-of-season estimates were included.
Design features that may affect the validity and comparability of reported estimates were reviewed, including setting, study period, source population, case definition, exposure and outcome ascertainment and statistical model.
There was considerable variation in the analytic approach, with 68 unique statistical models identified among the studies.
Harmonization of analytic approaches may improve the potential for pooling VE estimates.
病例对照研究是一种越来越多地用于研究流感疫苗有效性（VE）的变体。在这些研究中，对流感样疾病患者进行流感检测。通过比较检测阳性者和检测阴性者的疫苗覆盖率来估计 VE。
我们回顾了 85 篇已发表的病例对照研究在设计、分析和报告方面的特点。
从 PubMed、参考文献列表和电子邮件更新中确定了研究。研究入选标准：所有使用病例对照设计报告季节性末估计值的研究均被纳入。
审查了可能影响报告估计值的有效性和可比性的设计特征，包括设置、研究期间、源人群、病例定义、暴露和结果确定以及统计模型。
分析方法存在很大差异，研究中确定了 68 种独特的统计模型。
分析方法的协调统一可能会提高 VE 估计值的汇总潜力。
