Core_RT-PCR based Case-Control: Apt Measure of Influenza Vaccine Effectiveness

流感病毒在不断变化，疫苗每年都会重新配制。准确估计 流感疫苗预防流感感染的有效性是评估保护效果的关键 由一年一度的全国疫苗接种计划提供。发现更高级的战略来衡量 疫苗的有效性可能会减轻流感的总体负担，同时改善人们的健康 人口。我们计划与ACIP一起系统地评估流感疫苗的效果 为斯科特和怀特地区6个月或以上儿童推荐的普遍免疫战略 保健-寺庙人口研究区(SWH-TPRA)来源人口。我们的目标是利用我们的 独特的研究经验，探索当前针对实验室衡量疫苗有效性的方法- 确认流感(VE-LCI)，并确定、实施和评估创新、可行和可持续的 在门诊急性护理环境中测量6个月或以上所有人的VE-LCI的策略。我们的 核心假设是，在美国，及时有效地测量VE-LCI是可行和可持续的。 这一假设将通过追求三个具体目标来检验：1)确定创新、可行和可持续的 为6个月或以上寻求的人及时有效地衡量VE-LCI的战略 在门诊急性护理环境中对急性呼吸道疾病(ARI)的护理，2)实施创新、可行 为6个月或以上的人及时、有效地衡量VE-LCI的可持续战略 在门诊急诊环境中寻求急性呼吸窘迫综合征的治疗，以及3)评估创新性、可行性和可持续性 为6个月或以上寻求护理的人及时有效地衡量VE-LCI的战略 急性呼吸窘迫综合征(ARI)在门诊急诊环境中。为了实现这些目标，将在儿童中确定VE-LCI 6个月-18岁，19-49岁的成年人和50岁或以上的人出席SWH-TPRA 具有明确的急性呼吸道感染聚集性且RT-PCR检测甲型或乙型流感呈阳性的门诊急性护理环境 通过比较他们接种流感疫苗的几率和年龄匹配的对照组 在调整混杂因素后，RT-PCR检测结果为阴性。2011-2012至2015-2016年间， 来自SWH-TPRA来源人群的人，他们在SWH有PCP，并存在ARI聚集性 在流感流行期间，在SWH-TPRA门诊、急救或急诊科， 将有资格参与CDC VE-LCI研究，采用滚动4小时整体招聘策略 最大限度地减少选择偏差。采用RT-PCR确证病例对照设计，对所有受试者进行VE-LCI测量 年龄在6个月或以上的人。经RT-PCR确认的流感疫苗接种率将计算 病例和RT-PCR阴性对照，调整VE-LCI混杂因素。这项拟议的研究具有创新性， 因为它将极大地帮助理解VE-LCI的及时和有效的措施，并将定义有效的 扩大和增加流感疫苗接种对疾病负担的公共卫生影响的措施。

Influenza viruses are constantly changing and vaccines are reformulated every year. Accurately estimating influenza vaccine effectiveness to prevent influenza infection is critical in order to evaluate the protection provided by annual, nationwide vaccination programs. The discovery of more advanced strategies to measure vaccine effectiveness will potentially reduce the overall burden of influenza while improving the health of the population. We plan to systematically evaluate the effectiveness of influenza vaccines with the ACIP recommended universal immunization strategy for persons ages 6 months or older in the Scott and White Healthcare-Temple Population Research Area (SWH-TPRA) source population. Our objective is to use our singular research experience to explore current methodologies to measure vaccine effectiveness against lab- confirmed influenza (VE-LCI), and identify, implement and evaluate innovative, feasible, and sustainable strategies for measuring VE-LCI in all persons ages 6 months or older in outpatient acute care settings. Our central hypothesis is that timely and efficient measurement of VE-LCI is feasible and sustainable in the U.S. This hypothesis will be tested by pursuing three specific aims: 1) Identify innovative, feasible, and sustainable strategies to measure VE-LCI in a timely and efficient manner for persons of ages 6 months or older seeking care for an acute respiratory illness (ARI) in outpatient acute care settings, 2) Implement innovative, feasible and sustainable strategies to measure VE-LCI in a timely and efficient manner for persons 6 months or older seeking care for an ARI in outpatient acute care settings, and 3) Evaluate innovative, feasible and sustainable strategies to measure VE-LCI in a timely and efficient manner for persons 6 months or older seeking care for an ARI in outpatient acute care settings. To accomplish these goals, VE-LCI will be determined in children ages 6 months - 18 years, adults ages 19-49 years and those 50 years or older who present at SWH-TPRA outpatient acute care setting with a well-defined ARI cluster and test positive for influenza A or B by RT-PCR assay, by comparing their odds of being vaccinated against influenza with age-matched controls who had a negative influenza RT-PCR assay, after adjusting for confounders. During 2011-2012 through 2015-2016, persons from the SWH-TPRA source population, who have a PCP at SWH, and present with an ARI cluster during the influenza epidemic period at a SWH-TPRA outpatient clinic, urgent care or emergency department, will be eligible to participate in this CDC VE-LCI study, using a rolling 4 hour block recruitment strategy minimizing selection bias. Using RT-PCR confirmed case-control design, we will measure VE-LCI in all persons ages 6 months or older. Influenza immunization rates will be calculated for the RT-PCR confirmed cases and RT-PCR negative controls, adjusting VE-LCI for confounders. The proposed research is innovative, because it will greatly help understand timely and efficient measures of VE-LCI and will also define effective measures of the public health impact of expanded and increasing influenza immunization on burden of illness.