Mentored Patient-Oriented Research Career Development Aw

指导以患者为中心的研究职业发展Aw

• 批准号: 6160144
• 负责人: RICHARD E ROTHMAN
• 金额: $ 12.78万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-08-01 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6160144
• 关键词: bacterial disease; bacterial endocarditis; career; clinical research; data collection methodology /evaluation; diagnostic tests; disease /disorder proneness /risk; drug abuse; echocardiography; emergency health services; endocarditis; health care cost /financing; hospital length of stay; hospital utilization; human subject; human therapy evaluation; intravenous administration; longitudinal human study; mathematics; medical complication; mycosis; outcomes research; polymerase chain reaction; prognosis; tissue /cell culture

PROPOSAL (Adapted from the applicant's abstract): IE is one of the most serious medical complications associated with intravenous drug use, with significant morbidity and mortality occurring in unrecognized cases. Presenting clinical features associated with IE have been difficult to define. Since fever occurs in nearly 98% of cases of IE in IDUs, current practice calls for hospitalization of all febrile IDUs for further evaluation. The overall goal of this study is to develop and implement a safe and cost- effective emergency department (ED)-based algorithm for the evaluation of febrile IDUs at risk for IE. The investigators hypothesize that, by taking advantage of recent developments which combine findings from advanced diagnostic testing (including echocardiography) and clinical assessment, this algorithm will enable ED physicians to more quickly and reliably stratify patients at risk for IE. They further hypothesize that disposition of the subset of patients in whom ED has been ruled out to less resource-intensive settings will reduce the number of hospitalizations without increasing adverse events, thus promoting more efficient use of clinical resources. To test these hypotheses, they propose a program consisting of three specific aims: 1) To derive an algorithm that will allow ED physicians to predict with increased speed and specificity which febrile IDUs are likely to either have IE or develop IE-related complications that require hospitalization. Standard clinical, laboratory and imaging information as well as a novel laboratory- based diagnostic tool will be utilized to derive the algorithm. 2) To determine the 'opportunity costs' (i.e., the value of resources that would be recovered and available for other uses) associated with the current practice of universal hospitalization. 3) To implement and conduct a comprehensive cost effectiveness analysis of the derived clinical algorithm. The study will employ a prospective, two-phase design. In the first phase, alternative models will be compared and evaluated among patients treated according to the standard practice of universal hospitalization. In the second phase, patients will be evaluated and discharged to three possible settings: home with follow-up, a simulated ED observational unit, or hospitalization, as indicated by the clinical algorithm. They will estimate the impact of the algorithm on costs and patients' outcomes. Findings from this research will provide valuable information that can be used to guide and improve evaluation and management of the growing number of febrile IDUs.

提案(改编自申请人的摘要)：IE是最多的 与静脉吸毒有关的严重医疗并发症， 重大发病率和死亡率发生在未被确认的病例中。 呈现与IE相关的临床特征一直很难定义。 由于注射吸毒者中近98%的IE病例出现发烧，目前的做法是 呼吁所有发烧的注射吸毒者住院接受进一步评估。这个 这项研究的总体目标是开发和实施一种安全且成本低廉的- 基于急诊科(ED)的有效评估算法 发烧的注射吸毒者有患IE的风险。调查人员假设，通过采取 结合了高级研究结果的最新发展的优势 诊断测试(包括超声心动图)和临床评估，这 算法将使急诊医生能够更快、更可靠地分层 有IE风险的患者。他们进一步假设， 排除ED到资源密集度较低的患者的子集 环境将减少住院次数，而不会增加不利因素 活动，从而促进更有效地利用临床资源。为了测试 在这些假设下，他们提出了一个由三个具体目标组成的计划： 1)推导出一种算法，该算法将允许急诊医生通过 更快的速度和更高的特异性，发烧的注射吸毒者可能具有 IE或出现IE相关并发症，需要住院治疗。标准 临床、实验室和影像信息以及一个新的实验室- 将使用基于诊断工具来推导该算法。2)至 确定“机会成本”(即 已回收并可用于其他用途)与当前做法相关 普遍的住院治疗。3)落实和开展全面的 对推导出的临床算法进行成本-效果分析。这项研究将 采用前瞻性的两阶段设计。在第一阶段，替代方案 模型将在根据 全民住院的标准做法。在第二阶段，患者 将被评估并被释放到三个可能的环境中： 随访，模拟ED观察单元，或住院，如所示 由临床算法实现。他们将评估该算法对 成本和患者的结果。这项研究的发现将提供 有价值的信息可用于指导和改进评估和 管理越来越多的发烧注射吸毒者。