Clinical Outcomes Core

临床结果核心

• 批准号: 8073093
• 负责人: JUSTIN CHARLES. MCARTHUR
• 金额: $ 64.35万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8073093
• 关键词: AIDS Dementia Complex; AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Budgets; Chairperson; Characteristics; Clinical; Clinical Data; Clinical Trials; Cognition; Cognition Disorders; Collection; Data; Data Collection; Development; Devices; Epidemiologic Methods; Epidemiology; Funding; Goals; Grant; Highly Active Antiretroviral Therapy; Human Resources; Impaired cognition; Laboratories; Measurement; Modality; Neurologic; Neurology; Neuropsychological Tests; Outcome; Outcome Measure; Performance; Play; Research; Research Infrastructure; Resources; Role; Testing; Therapeutic Agents; design; individual responsibility; instrument; medication compliance; neuropsychological; novel therapeutics; touchscreen; treatment trial

The Clinical Outcomes Core plays a central role in the proposed center, and will interact with several of the Cores (see Figure 1). The Core is justified by the recognized need to develop new outcome measures for HIVassociated cognitive disorders in the era of highly active antiretroviral therapy (HAART) that are not only robust and well validated, but also sensitive to changes that are expected earlier in the development of HIVassociated cognitive impairment. Also, the statistical power of recent trials for HIV dementia has been limited by excessive variance in the scores of standard neuropsychological test batteries (1). There is currently no funding venue for the kind of outcome measure development proposed in this Core. The individual responsibilities of key personnel are detailed in the Budget Justification. In brief, Dr. Ned Sacktor will direct this Core and oversee the collection of clinical data including neurological assessments. Dr. Ola Seines will oversee the collection of neuropsychological data and assist Dr. Sacktor in subject characterization. Dr. Scott Zeger, Richard Skolasky, and Dr. Kelly Gebo will collaborate with them on the design, data collection and management, statistical analyses, and interpretation of the performance characteristics of the instruments. Dr. Richard Moore, a recognized expert in the development of touch-screen testing devices will supervise these aspects of the Core.

临床结局核心在拟建中心中发挥核心作用，并将与几个 核心（见图1）。核心方案的理由是，人们认识到有必要制定新的艾滋病毒相关成果衡量标准， 在高效抗逆转录病毒疗法（HAART）时代， 并且经过充分验证，但也对 在HIV相关疾病的发展过程中， 认知障碍此外，统计 最近的艾滋病痴呆症试验的力量已经 由于得分差异过大， 标准神经心理学测试组合（1）。那里 目前还没有资金来源 本核心中提出的措施。 关键人员的个人责任 在预算论证中有详细说明。简而言之，博士。 奈德·萨克特将领导核心并监督 收集临床数据，包括神经学数据 评估。奥拉·赛恩斯医生将监督 收集神经心理学数据并协助Dr. Sacktor在主题描述中。斯科特·泽格博士， Richard Skolasky和Kelly Gebo博士将合作 与他们在设计，数据收集和 管理、统计分析和仪器性能特征的解释。博士 理查德摩尔，在触摸屏测试设备的发展公认的专家将监督这些 核心的方面。