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）：每年的流感在美国造成约36,000人死亡。许多死亡是继发于肺炎或心脏并发症的继发性死亡，在老年人中比在年轻人中更为常见。在过去的几年中，尽管疫苗接种率高于以往，但人们对老年人损失率上升的率越来越大。西蒙森（Simonsen）的文章在2005年成为公开辩论，他断言，疫苗接种的观察性研究高估了疫苗接种的好处。由于年龄在65岁以上的人群中流感的发病率和死亡率不成比例，美国的公共卫生官员建议对个人进行常规的年度流感疫苗= 65岁，并且最近在该建议中增加了50岁以上的所有成年人。这些决定旨在降低流感的发病率和死亡率，但不是基于老年人疫苗疗效的随机临床研究。在老年人中，仅进行了三项随机临床试验（RCT），用于测试三价灭活流感疫苗的功效，只有一项使用实验室确认的流感作为终点。即使疫苗功效（VE）为56％，但这项研究没有足够的动力来检查成人> 70岁的成年人，只看健康的老年人。因此，关于流感疫苗接种在老年人中的有效性仍然存在许多问题。该申请是塔尔伯特（Talbot）的导师凯瑟琳·爱德华兹（Kathryn Edwards）博士进行的更大监视计划的子研究。这项监视研究将前瞻性地测试住院的患者，培养，抗原和PCR的流感。通过此信息，将解决以下目标： 1。估计三价灭活流感疫苗（TIV）对实验室确认的流感相关的住院治疗的有效性。 2。使用CDC定义的流感样疾病（I LI）和快速流感抗原检测的敏感性和特异性，使用阳性流感培养的金标准诊断或对50岁患者的患者患者的流感型阳性逆转录酶 - 聚合酶 - 聚合酶链链反应（RT-PCR）。 3。使用前瞻性收集的基于人群的数据，描述50岁的个体流感发作相关的发病率。