Outcomes in Children Undergoing Cardiac Catheterization

 描述(由申请人提供)：本提案描述了一项为期五年的临床研究职业发展培训计划，重点是提高儿童心导管术的质量。这项提案将作为一种工具，发展成为一名独立的调查者。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。史蒂文·考特，医学博士，硕士，(主要导师)是医学和流行病学的终身副教授。他有成功指导研究员和初级教员的记录，并持有K24证书来支持他的指导活动。已经成立了一个咨询委员会来指导候选人的职业发展。该应用程序侧重于三个具体目标。首先，比较不同中心的导尿实验室结果的指标还没有定义。我们已经证明，死亡和其他灾难性后果与程序量密切相关。然而，程序量和不太严重的不良事件之间的关联要小得多。我们建议研究程序量和“救援失败”风险(即在发生不良事件时避免灾难性后果的能力)之间的联系，并在此过程中将其作为一种新的现场结果衡量标准。我们建议利用多中心临床注册中心，即改进的儿科和成人治疗(IMPACT)注册中心来实现这一目标。第二，经济成本不仅是临床结果的替代标志，也是衡量医疗服务效率的独立指标。我们建议为导尿术的经济成本建立基准，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行政数据库，即儿童健康信息系统(PHIS)数据库。第三，患者报告的结果，如与健康相关的生活质量(HR-QOL)代表了健康的一个重要方面，传统的医生报告的结果中没有包括这一方面(而且也没有包括在多中心登记和数据库中)。它们也代表了比较有效性研究的一个重要方面(以及成本)。我们建议对接受导管术的儿童进行单中心队列研究，以确定导管术对HR-QOL的影响，并确定影响它的因素(可修改的和不可修改的)。这三个目标共同阐明了与儿童心导管术相关的不同结果。通过结合这些新技术，申请人希望开始确定影响接受导管术的儿童的健康和福祉的因素，并为将测试干预措施以提高需要心脏导管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.