Adult flu hospitalizations: evaulating diagnostic methods & vaccine effectiveness

成人流感住院：评估诊断方法

• 批准号: 7471749
• 负责人: HELEN Keipp TALBOT
• 金额: $ 12.55万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2012-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7471749
• 关键词: Acute; Address; Adult; Age; Age-Years; Antigens; Cardiac; Cercopithecine Herpesvirus 1; Cessation of life; Chills; Clinical Research; Clinical Trials; Coughing; Data; Databases; Detection; Diagnosis; Diagnostic Procedure; Disease; Effectiveness; Elderly; End Point; Family; Fever; Funding; Gold; Headache; Hospitalization; Individual; Influenza; Influenza vaccination; Investigation; Laboratories; Malaise; Measures; Medical Surveillance; Mentors; Methods; Morbidity - disease rate; Mortality Decline; Myalgia; Neuraminidase inhibitor; Observational Study; Older Population; Orthomyxoviridae; Outcome; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pneumonia; Polymerase Chain Reaction; Population; Public Health; Purpose; RNA; Randomized; Randomized Clinical Trials; Rate; Recommendation; Recording of previous events; Reverse Transcriptase Polymerase Chain Reaction; Risk Factors; Secondary to; Sensitivity and Specificity; Serologic tests; Standards of Weights and Measures; Study of serum; Surveillance Program; Testing; United States; Vaccination; Viral; Virus; age group; aged; anti-influenza; base; day; diagnosis standard; flu; influenza virus vaccine; member; mortality; respiratory; trivalent influenza vaccine; vaccine effectiveness; vaccine efficacy; virology

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.

描述（由申请人提供）：流感，每年在美国造成约36，000人死亡。许多死亡是继发于肺炎或心脏并发症，老年人比年轻人更常见。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P& I死亡率上升的问题越来越受到关注。2005年，Simonsen的一篇文章引起了公众的讨论，该文章声称，对疫苗接种的观察性研究高估了疫苗接种的益处。由于> 65岁人群的流感发病率和死亡率不成比例，美国公共卫生官员建议65岁以下的人群每年进行常规流感疫苗接种，最近又将所有50岁以上的成年人纳入建议范围。这些决定旨在降低流感的发病率和死亡率，但并非基于老年人疫苗功效的随机临床研究。只有三项随机临床试验（RCT）在老年人中进行了三价灭活流感疫苗的有效性测试，只有一项使用实验室确认的流感作为终点。尽管疫苗有效性（VE）为56%，但该研究不足以检查70岁以上成年人的VE，仅观察健康老年人。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。本申请是由塔尔博特博士的导师Kathryn Edwards博士进行的更大监测项目的子研究。这项监测研究将前瞻性地用培养、抗原和PCR检测住院患者的流感。利用这些信息，将实现以下目标： 1.评估三价灭活流感疫苗（TIV）对年龄> 50岁人群中实验室确诊流感相关住院的有效性。 2.在年龄> 50岁因急性呼吸道疾病住院的患者中，使用流感病毒培养阳性或逆转录-聚合酶链反应（RT-PCR）阳性的金标准诊断，确定CDC定义的流感样疾病（ILI）和快速流感抗原检测的灵敏度和特异性。 3.使用前瞻性收集的基于人群的数据，描述50岁以下人群中与流感住院发作相关的发病率。