Career Development in Outcomes Assessment in Congenital Heart Surgery

描述(由申请人提供)：这份职业发展提案将提供一个有专家指导的结构化环境，使Sara Pasqui医生能够发展成为儿科心血管结果研究的独立研究员。先天性心脏病很常见，也是导致儿童发病率和死亡率的主要原因。虽然手术是治疗管理的基石，但关于先天性心脏病手术患者的最佳结果评估策略的数据有限，指导最佳护理的证据也有限。管理数据集经常被用于评估结果和比较儿科心脏中心的质量。然而，行政数据中病例确定、风险分层和结果评估的准确性尚不清楚。帕斯夸里博士将利用一种新的方法来评估管理数据库和临床数据库在先天性心脏病手术患者的结果和质量评估中的使用，以解决这些知识差距。这将涉及将大型临床数据库(胸外科学会先天性心脏病手术数据库；STS-CHS)和管理数据库(儿科健康信息系统数据库；PHIS)连接起来，以临床数据库为金标准，比较这两个数据集中的病例确定和术后结果评估。这些数据，以及我们小组以前开发的经验风险分层方法，将用于开发和验证基于证据的算法，以准确地确定病例和风险分层，以便在未来的分析中使用。除了这些高级研究技能外，帕斯夸里博士还将完成杜克大学临床研究培训计划中的流行病学和生物静力学方面的正式培训，以获得硕士学位。她还将完成领导力和科学写作方面的高级培训。这些职业发展活动将得到一个多学科指导团队的支持，该团队拥有成功的心血管结果研究历史。指导团队在临床和管理数据集的分析和链接方面拥有丰富的经验，最近获得了NHLBI ARRA挑战补助金，使用链接的STS-CHS和PHIS数据库进行比较有效性研究，该数据库也将用于这个拟议的项目。项目导师埃里克·彼得森博士是国际知名的心血管结局研究专家。其他团队成员将提供多中心儿科研究(LI)、结果分析(O‘Brien，DeLong)以及STS-CHS(M Jacobs，J Jacobs)和PHIS(Hall)数据的链接和分析方面的专业知识。该项目将在世界上最大的学术研究机构杜克临床研究所进行。帕斯夸里博士的长期目标是成为儿科心血管结果评估方面的专家，总体目标是确定最佳实践并提高这类患者的护理质量。在一支杰出的导师团队的指导下完成这项职业发展计划后，她将拥有实现这些目标所需的额外正式培训和高级研究技能。 公共卫生相关性：先天性心脏病是最常见的出生缺陷，也是导致儿童发病率和死亡率的主要原因。然而，指导这一人群最佳护理的证据是有限的。这项建议将利用一种新的方法将大量的临床和管理数据集联系起来，以评估接受先天性心脏病手术的患者的最佳结果评估策略。

DESCRIPTION (provided by applicant): This Career Development proposal will provide a structured environment with expert mentorship that will allow Dr. Sara Pasquali to develop into an independent investigator in pediatric cardiovascular outcomes research. Congenital heart defects are common, and a leading cause of morbidity and mortality in children. Although surgery is the cornerstone of therapeutic management, there are limited data regarding optimal strategies for outcomes assessment in patients undergoing congenital heart surgery, and limited evidence to guide optimal care. Administrative datasets are often utilized to evaluate outcomes and compare quality at pediatric heart centers. However, accuracy of case ascertainment, risk stratification, and outcomes assessment in administrative data is unknown. Dr. Pasquali will utilize a novel methodology to evaluate the use of administrative vs. clinical databases in outcomes and quality assessment for patients undergoing congenital heart surgery to address these knowledge gaps. This will involve linking a large clinical (Society of Thoracic Surgeons Congenital Heart Surgery Database; STS-CHS) and administrative (Pediatric Health Information Systems Database; PHIS) database to compare case ascertainment and post-operative outcomes assessment in these two datasets, using the clinical database as the gold standard. These data, along with empiric risk stratification methodology previously developed by our group, will be used to develop and validate an evidence-based algorithm for accurate case ascertainment and risk stratification for use in future analyses. In addition to these advanced research skills, Dr. Pasquali will complete formal training in epidemiology and biostatics in the Duke Clinical Research Training Program toward a Masters degree. She will also complete advanced training in leadership and scientific writing. These career development activities will be supported by a multidisciplinary mentorship team with a successful history of conducting cardiovascular outcomes research. The mentoring team has extensive experience in the analysis and linkage of clinical and administrative datasets, and was recently awarded an NHLBI ARRA Challenge Grant to conduct comparative effectiveness research using the linked STS-CHS and PHIS Databases which will also be used for this proposed project. Dr. Eric Peterson, project mentor, is an internationally renowned expert in cardiovascular outcomes research. Other team members will provide expertise in multicenter pediatric research (Li), outcomes analysis (O'Brien, DeLong), and linking and analysis of STS-CHS (M Jacobs, J Jacobs) and PHIS (Hall) data. The project will be conducted at the Duke Clinical Research Institute, the world's largest academic research organization. Dr. Pasquali's long-term goal is to become an expert in pediatric cardiovascular outcomes assessment, with an overall aim of defining best practices and improving quality of care in this patient population. Upon completion of this Career Development proposal under the guidance of an exceptional team of mentors, she will have the additional formal training and advanced research skills necessary to achieve these goals. PUBLIC HEALTH RELEVANCE: Relevance Congenital heart defects are the most common birth defects, and a leading cause of morbidity and mortality in children. However, evidence to guide optimal care in this population is limited. This proposal will utilize a novel approach to link a large clinical and administrative dataset in order to evaluate optimal strategies for outcomes assessment in patients undergoing congenital heart surgery.