Core_plus_Option_A_B_Proposal for Influenza Vaccine Effectiveness Research

描述(由申请人提供)：由于几乎普遍推荐每年接种疫苗(均为6个月大)，出于伦理原因，只能对流感疫苗有效性进行观察性研究。然而，观察性研究的结果可能会受到未被认识到的选择偏差的影响，因此有必要制定研究设计策略来识别和调整这些偏差。我们建议评估流感疫苗在两个卫生系统中预防医疗护理流感的有效性，以及在密歇根州一组有孩子的家庭中预防所有严重程度的流感。在流感季节，我们将在多个门诊卫生中心、三家医院和约300户登记家庭进行监测，并将纳入符合各种病例定义的成人和儿科患者和家庭成员。疫苗接种状态将被报告和验证，并与实验室确认的流感结果一起考虑，以分别评估针对门诊、住院和家庭人口的疫苗有效性，并将不同研究的估计进行比较。分析将采用检测-阴性对照方法--流感检测呈阳性的为病例，检测为阴性的为对照。将在分析模型中评估和考虑疫苗有效性的影响因素和混杂因素，如年龄、健康状况、家庭规模和构成、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.