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: 6535157
• 负责人: RICHARD E ROTHMAN
• 金额: $ 11.28万
• 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/6535157
• 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.

建议（改编自申请人的摘要）：IE是最 与静脉吸毒相关的严重医学并发症， 在未被发现的病例中发生严重的发病率和死亡率。 目前与IE相关的临床特征很难定义。 由于注射吸毒者中近98%的IE病例发生发热， 呼吁所有发热的注射吸毒者住院接受进一步评估。 的 这项研究的总体目标是开发和实施一个安全和成本- 有效的急诊科（艾德）为基础的算法，用于评估 有IE风险的发热IDUs。 研究人员假设， 最新发展的优势，它结合了联合收割机的先进发现， 诊断测试（包括超声心动图）和临床评估， 算法将使艾德医生能够更快速、更可靠地分层 有IE风险的患者。 他们进一步假设， 已排除艾德的患者子集，资源密集程度较低 设置将减少住院次数，而不会增加不良反应 活动，从而促进临床资源的更有效利用。 测试 根据这些假设，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，使艾德医生能够预测 增加的速度和特异性， IE或出现需要住院治疗的IE相关并发症。 标准 临床、实验室和影像学信息以及新的实验室- 的诊断工具将被用来推导算法。 2)到 确定“机会成本”（即，资源的价值， 回收并可用于其他用途） 普遍住院治疗。 3)执行和进行全面的 衍生临床算法的成本效益分析。 这项研究将 采用前瞻性的两阶段设计。 在第一阶段，备选方案 将在根据以下标准治疗的患者中对模型进行比较和评价： 普遍住院的标准做法。 第二阶段，患者 将进行评估，并出院到三个可能的设置： 随访、模拟艾德观察单位或住院治疗（如有指征） 通过临床算法。 他们将估计算法对 成本和患者的结果。 这项研究的结果将提供 可用于指导和改进评价的宝贵信息， 管理越来越多的发热注射吸毒者。