Novel Methods for Evaluating the Association of Electronic Cigarette Use with Cardiovascular Health

项目摘要 这项拟议的5年研究将斯托克斯博士在人口健康方面的培训和对烟草的研究结合起来 在烟草监管科学，心血管（CV）流行病学， 高级生物统计学和应用数据科学。为此，斯托克斯博士组建了一个多学科的 一个导师和顾问团队，以帮助他的培训和学习。K 01将支持一套互补的 培训活动，包括正式课程，参加早期职业教师发展计划， NIH资助的临床和转化科学研究所赞助了K-to-R PRIME项目， 相关领域专家的指导，以帮助他在专业发展和过渡到 独立关于电子烟使用对CV影响的基于人群的证据很少， 电子烟气溶胶中可能导致心血管损害的成分仍不清楚。的 拟议的研究将整合最先进的因果推理方法，调解分析， 无监督的数据聚类方法与电子烟使用的CV影响的研究。申请人将1） 检查电子烟使用和产品转换与CV事件的关联; 2）估计 电子烟使用与CV损伤的风险因素和临床前生物标志物的相关性，并分析 暴露的生物标志物作为潜在的介质;以及3）识别电子烟的独特生物标志物特征 使用数据驱动的聚类方法，将聚类与CV的临床前生物标志物相关联 损伤利用高质量的人口数据和新颖的统计方法来优化控制吸烟 和其他烟草制品的使用，本项目的结果将提供及时和严格的证据， 电子烟使用的影响。同时评估暴露生物标志物和聚集的e- 香烟使用行为模式，结果将告知食品和药物管理局的监管标准， 产品安全和指导旨在减少烟草相关的初级和二级公共卫生干预措施 心血管损害。这些方法和发现也将为未来针对其他非卷烟烟草的研究提供信息。 小雪茄、小雪茄和无烟烟草产品。额外的培训和 K 01提供的受保护的时间将有助于斯托克斯博士过渡到独立调查员 能够获得R系列NIH资助

Project Summary This proposed 5-year study brings together Dr. Stokes’ training in population health and research on tobacco use behaviors with additional training in tobacco regulatory science, cardiovascular (CV) epidemiology, advanced biostatistics, and applied data science. To this end, Dr. Stokes has assembled a multidisciplinary team of mentors and advisors to aid his training and studies. The K01 will support a complementary set of training activities, including formal coursework, participation in the Early Career Faculty Development Program, the NIH-funded Clinical and Translational Science Institute sponsored K-to-R PRIME program, and strong mentorship from experts in relevant fields, to help him in his professional development and transition to independence. Population-based evidence on the CV effects of e-cigarette use is sparse, and the particular components of e-cigarette aerosols that may be responsible for CV harm remain poorly elucidated. The proposed research will integrate state-of-the-art causal inference methods, mediation analyses, and unsupervised data clustering approaches with the study of CV effects of e-cigarette use. The applicant will 1) examine the association of e-cigarette use and product transitions with incident CV events; 2) estimate associations of e-cigarette use with risk factors and preclinical biomarkers of CV injury, and analyze biomarkers of exposure as potential mediators; and 3) identify unique biomarker signatures of e-cigarette exposure using a data-driven clustering approach, and associate clusters with preclinical biomarkers of CV injury. With high quality population data and novel statistical methods to optimally control for cigarette smoking and other tobacco product use, the results of this project will provide timely and rigorous evidence on the CV effects of e-cigarette use. Together with evaluating the mediating role of exposure biomarkers and clustered e- cigarette use behavior patterns, the results will inform Food and Drug Administration regulatory standards for product safety and guide primary and secondary public health interventions that aim to reduce tobacco-related CV harm. The methods and findings will also inform future studies focused on other non-cigarette tobacco products, such as little cigars, cigarillos, and smokeless tobacco products. The additional training and protected time afforded by the K01 will aid Dr. Stokes in making his transition to an independent investigator capable of securing R-series NIH funding.