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.
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.
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