TENNESSEE UNEXPLAINED ENCEPHALITIS SURVEILLANCE PROJECT (TUES STUDY)

田纳西州不明原因脑炎监测项目（周二研究）

• 批准号: 8167300
• 负责人: Roberta Lynn DeBiasi
• 金额: $ 0.2万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-20 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167300
• 关键词: Acute; Algorithms; Area; California; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinical; Collaborations; Computer Retrieval of Information on Scientific Projects Database; Consent; Data Collection; Diagnostic; Diagnostic tests; Encephalitis; Epidemiology; Etiology; Family; Funding; Future; Goals; Grant; Health; Human Resources; Informed Consent; Institution; Journals; Laboratories; Left; Legal; Methods; Neurocognitive; New York; Outcome; Participant; Patients; Peer Review; Physicians; Procedures; Protocols documentation; Publishing; Recruitment Activity; Reporting; Research; Research Ethics Committees; Research Personnel; Resources; Risk Factors; Series; Site; Source; Specimen; Tennessee; Testing; United States; United States National Institutes of Health; improved; interest; meetings; pathogen; prognostic

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is the second of the series of three studies on Unexplained Encephalitis Due to Possible Infectious Causes conducted in collaboration with State Health Departments of California, Tennessee and New York. This series of studies of unexplained encephalitis has been initiated to describe the epidemiology of encephalitis in selected areas of the United States; to characterize the etiologic spectrum of acute encephalitides in the United States; to identify the proportion of encephalitis cases with unexplained etiology; and decrease the proportion of unexplained cases of encephalitis by: developing improved diagnostic strategies, evaluating and implementing newly developed diagnostic tests for agents associated with encephalitis, and identifying new pathogens associated with encephalitis. A secondary goal of the study is to explore long-term neurocognitive outcomes among patients with encephalitis, and identify prognostic features. The study strategies comprise enhanced surveillance for encephalitis cases in study areas; extensive laboratory testing of identified cases, and creating a bank of clinical specimens for future testing as new etiologic agents are discovered. Patients will be referred to the study by their physicians. After patients or their families agree to be contacted, TUES personnel will obtain consent and assent. Participants will then undergo core diagnostic testing for common causes of encephalitis, and, if the results of core testing are negative, their specimens will be further tested for rare and newly identified agents. The left over specimens will be stored to be tested in the future as new pathogens associated with encephalitis are identified. Expected outcomes of the project are reports on the epidemiology of unexplained encephalitis; etiologic spectrum of encephalitides at study sites, as well as on clinical characteristics and risk-factors for encephalitides caused by different pathogens and testing algorithm for encephalitis aimed at minimizing the proportion of unexplained cases. The results of the study will be published in peer-reviewed journals and presented at the scientific meetings. Although the overall objectives, strategies and methods are similar for all three studies, the study protocols have been adapted to reflect established existing practices, local interests, differences in legal/IRB requirements, availability of resources at each of the participating sites and are therefore being submitted for the CDC IRB to review separately for each state. Main differences across study sites lie in the approaches to and procedures of data collection, obtaining informed consent, and applying slightly expanded case-definitions which enables them to recruit patient groups of special local interest. Nevertheless, the study protocol in each instance allows us to identify a core group of patients meeting standard clinical criteria and use comparable testing strategies across study sites.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项研究是与加利福尼亚州、田纳西州和纽约州卫生部门合作进行的关于可能的感染原因引起的不明原因脑炎的三项研究系列中的第二项。 已启动这一系列不明原因脑炎研究，以描述美国选定地区的脑炎流行病学；描述美国急性脑炎的病因谱；确定病因不明的脑炎病例的比例；通过以下方式减少不明原因脑炎病例的比例：制定改进的诊断策略，评估和实施新开发的脑炎相关病原体诊断测试，以及识别与脑炎相关的新病原体。 该研究的第二个目标是探索脑炎患者的长期神经认知结果，并确定预后特征。研究策略包括加强对研究地区脑炎病例的监测；对已发现的病例进行广泛的实验室检测，并创建临床样本库，以便在发现新的病原体后进行进一步的检测。 患者将由其医生转介参加研究。 在患者或其家属同意联系后，TUES 人员将获得同意和同意。 然后，参与者将对脑炎的常见原因进行核心诊断测试，如果核心测试结果为阴性，他们的标本将进一步接受罕见和新发现的病原体检测。 剩下的样本将被储存起来，以便将来在与脑炎相关的新病原体被发现时进行测试。 该项目的预期成果是关于不明原因脑炎流行病学的报告；研究地点脑炎的病因谱，以及不同病原体引起的脑炎的临床特征和危险因素以及旨在最大限度地减少不明原因病例比例的脑炎检测流程。 研究结果将发表在同行评审期刊上并在科学会议上展示。 尽管所有三项研究的总体目标、策略和方法相似，但研究方案已进行了调整，以反映既定的现有实践、当地利益、法律/IRB 要求的差异、每个参与地点的资源可用性，因此正在提交给 CDC IRB 以针对每个州单独进行审查。 不同研究中心的主要差异在于数据收集、获得知情同意以及应用稍微扩展的病例定义的方法和程序，这使得他们能够招募当地特别感兴趣的患者群体。尽管如此，每种情况下的研究方案都使我们能够确定符合标准临床标准的核心患者组，并在研究地点使用可比较的测试策略。