Outcomes in Children Undergoing Cardiac Catheterization

 描述（由申请人提供）：本提案描述了一个为期五年的培训计划，旨在发展临床研究职业生涯，重点是提高儿童心导管插入术的质量。这一建议将成为发展成为独立调查员的工具。为此，我们制定了一个培训计划，其中包括指导，课程工作，教学教育活动和实践研究。Steven Kawut，MD，MS（主要导师）是医学和流行病学终身副教授。他有成功指导研究员和初级教师的记录，并持有K24支持他的指导活动。已经成立了一个咨询委员会来指导候选人的职业发展。 该申请侧重于三个具体目标。首先，尚未定义比较不同中心导管室结果的指标。我们已经证明死亡和其他灾难性结局与手术量显著相关。然而，手术量和不太严重的不良事件之间的关联性要小得多。我们建议研究手术量与“抢救失败”风险之间的关系（即，在给定不良事件的情况下避免灾难性结果的能力），并在这样做时将其作为该领域的新结果测量引入。我们建议利用多中心临床注册，IMPACT（IMProving Pediatric and Adult Treatment）注册来实现这一目标。 其次，经济成本不仅是临床结果的替代指标，而且是医疗服务效率的独立衡量标准。我们建议建立导管插入术的经济成本基准，并研究影响成本的因素。为了实现这一目标，我们将使用一个多中心的管理数据库，儿科健康信息系统（PHIS）数据库。 第三，患者报告的结局，如健康相关生活质量（HR-QOL）代表了传统医生报告结局中未捕获的健康的重要方面（此外，未纳入多中心登记研究和数据库）。它们也代表了比较有效性研究的一个重要方面（沿着费用）。我们建议进行一项单中心队列研究的儿童接受导管插入术，以确定心脏导管插入术对HR-QOL的影响，并确定影响它的因素（可修改和不可修改），这三个目标一起阐明不同的结果与儿童的心脏导管插入术。通过结合这些新技术，申请人希望开始确定影响接受导管插入术的儿童的健康和福祉的因素，并为测试干预措施以提高需要心导管插入术的儿童的护理质量的研究奠定基础。

 DESCRIPTION (provided by applicant): This proposal describes a five-year training program for the development of a career in clinical research, focused on improving the quality of cardiac catheterization in children. This proposal is will serve as a vehicle to developing into an independent investigator. To that end, we have established a training plan that includes mentoring, course-work, didactic educational activities, and hands-on research. Steven Kawut, MD, MS, (the primary mentor) is a tenured Associate Professor of Medicine and Epidemiology. He has a track record of successfully mentoring fellows and junior faculty and holds a K24 to support his mentoring activities. An advisory committee has been assembled to guide the candidate's career development. The application focuses on three specific aims. First, metrics to compare the outcomes of catheterization laboratories in different centers have not been defined. We have demonstrated that death and other catastrophic outcomes are significantly associated with procedural volume. However, the association between procedural volume and less severe adverse events was much less strong. We propose to study the association between procedural volume and risk of "failure to rescue" (i.e., the ability to avoid catastrophic outcome given an adverse event), and in so doing introduce it to as a novel outcome measure in the field. We propose to leverage a multi-center clinical registry, the IMproving Pediatric and Adult Treatment (IMPACT) registry to accomplish this aim. Second, economic cost is not only a surrogate marker of clinical outcome, but also an independent measure of the efficiency of healthcare delivery. We propose to establish benchmarks for the economic cost of catheterization procedures, and to study the factors influencing cost. To accomplish this aim, we will use a multi-center administrative database, the Pediatric Health Information System (PHIS) database. Third, patient-reported outcomes, such as health-related quality of life (HR-QOL) represent an important aspect of health that is not captured in traditional physician reported outcomes (and moreover are not included in multicenter registries and databases). They also represent an important aspect (along with cost) of comparative effectiveness research. We propose to perform a single center cohort study of children undergoing catheterization to define the effect of cardiac catheterization on HR-QOL, and to determine the factors (modifiable and non-modifiable) that influence it. Together, these three aims illuminate different outcomes associated with cardiac catheterization in children. By combining these novel techniques, the applicant hopes to begin to define the factors that influence health and well-being of children undergoing catheterization and set the groundwork for studies that will test interventions to improve the quality of care for children requiring cardiac catheterization.