Adult flu hospitalizations: evaulating diagnostic methods & vaccine effectiveness

描述（由申请人提供）：流感每年在美国造成大约36,000人死亡。许多死亡是继发于肺炎或心脏并发症，在老年人中比在年轻人中更常见。在过去的几年里，尽管疫苗接种率比以往任何时候都高，但老年人的死亡率却越来越高，这引起了人们越来越多的关注。2005年，Simonsen的一篇文章断言，疫苗接种的观察性研究高估了疫苗接种的益处，这一担忧成为了一场公开辩论。由于流感在65岁以下人群中的发病率和死亡率不成比例，美国公共卫生官员建议65岁以上的人每年常规接种流感疫苗，最近又将所有50岁以上的成年人纳入建议。这些决定旨在降低流感的发病率和死亡率，但并非基于疫苗对老年人疗效的随机临床研究。仅在老年人中进行了三价灭活流感疫苗有效性的随机临床试验（rct），其中只有一项试验使用实验室确认的流感作为终点。尽管疫苗的有效性（VE）为56%，但这项研究没有足够的证据来检验70岁以下成年人的VE，而且只观察了健康的老年人。因此，关于老年人流感疫苗接种的有效性仍然存在许多问题。这个应用程序是塔尔博特博士的导师凯瑟琳·爱德华兹博士进行的一个更大的监控项目的子研究。本监测研究将采用培养、抗原和PCR对住院患者进行前瞻性流感检测。有了这些资料，将实现下列目标：

DESCRIPTION (provided by applicant): Influenza, yearly, causes approximately 36,000 deaths in the United States. Many of the deaths are secondary to pneumonia or cardiac complications and are much more common in the older than in the younger populations. In the past several years there has been increasing concern over rising rates of P&l deaths in the elderly despite higher vaccination rates than ever before. This concern became a public debate in 2005 with the article by Simonsen that asserted that observational studies of vaccination overestimated the benefits of vaccination. Due to the disproportionate morbidity and mortality of influenza for people > 65 years of age, public health officials in the United States have recommended routine yearly influenza vaccination to individuals = 65 years of age and more recently added all adults over 50 years of age to the recommendation. These decisions were intended to reduce the morbidity and mortality of influenza but were not based on randomized clinical studies of vaccine efficacy in older individuals. Only three randomized clinical trials (RCTs) testing the efficacy of trivalent inactivated influenza vaccines have been conducted in elderly adults and only one used laboratory-confirmed influenza as an endpoint. Even though vaccine efficacy (VE) was 56%, this study was not adequately powered to examine VE in adults > 70 years of age and only looked at healthy elderly. Hence many questions still exist about the effectiveness of influenza vaccination in older adults. This application is a sub-study of a larger surveillance program conducted by Dr. Talbot's mentor, Dr. Kathryn Edwards. This surveillance study will prospectively test hospitalized patients for influenza with culture, antigen and PCR. With this information the following aims will be addressed: 1. To estimate the effectiveness of trivalent inactivated influenza vaccine (TIV) against laboratory-confirmed influenza-associated hospitalizations in individuals aged > 50 years of age. 2. To determine the sensitivity and specificity of both the CDC-defined influenza-like illness (I LI) and rapid influenza antigen detection using the gold standard diagnosis of either a positive influenza culture or a positive reverse transcriptase - polymerase chain reaction (RT-PCR) for influenza in individuals aged > 50 years of age hospitalized for acute respiratory illness. 3. To describe the morbidity associated with hospitalized episodes of influenza in individuals a 50 years of age, using prospectively collected population-based data.