Core_plus_Option_A_B_Proposal for Influenza Vaccine Effectiveness Research

描述（由申请方提供）：由于每年接种疫苗（所有年龄均为6个月）的建议几乎是普遍的，因此出于伦理原因，只能进行流感疫苗有效性的观察性研究。 然而，观察性研究的结果可能会受到未识别的选择偏倚的影响，因此有必要制定研究设计策略来识别和调整这些偏倚。 我们建议估计流感疫苗在预防两个卫生系统中的医疗流感方面的有效性，以及密歇根州一组有儿童的家庭中所有严重程度的流感。 我们将在流感季节在多个门诊健康中心、三家医院和约300个登记的家庭进行监测，并将登记符合各种病例定义的成人和儿童患者以及家庭成员。将报告和验证疫苗接种状态，并与实验室确认的流感结果一起考虑，以分别估计门诊、住院和家庭人群的疫苗有效性，并在不同研究中比较估计值。 分析将使用测试阴性对照方法-流感测试阳性的为病例，测试阴性的为对照。 将在分析模型中评估和考虑疫苗有效性的修饰因素和混杂因素，如年龄、健康状况、家庭规模和组成、卫生保健利用、主观社会经济状况和卫生系统特征。

DESCRIPTION (provided by applicant): Because of near universal recommendation for annual vaccination (all aged 6 months) only observational studies of influenza vaccine effectiveness can be performed for ethical reasons. However, results from observational studies may be subject to unrecognized selection biases, and study design strategies to identify and adjust for these biases are necessary. We propose estimation of influenza vaccine effectiveness in preventing medically attended influenza in two health systems, and influenza of all severities in a cohort of households with children, in Michigan. We will conduct surveillance at multiple outpatient health centers, three hospitals, and in ~300 enrolled households during the influenza season, and will enroll adult and pediatric patients and household members meeting various case definitions. Vaccination status will be reported and validated, and considered with laboratory-confirmed influenza outcomes to estimate vaccine effectiveness separately for ambulatory, inpatient and household populations, with estimates compared across studies. Analyses will use a test-negative control approach-those testing positive for influenza are cases, those testing negative are controls. Modifiers and confounders of vaccine effectiveness such as age, health status, household size and composition, health care utilization, subjective socio-economic status, and health system characteristics will be assessed and considered in analytic models.