管制如何影响烟草使用者?

挑战

In an effort to protect the nation’s 健康 from the harmful effects of tobacco products, the 2009 Family Smoking Prevention and 烟草 Control Act authorized the 食物 and 药品监督管理局 (FDA) to regulate the manufacturing, 市场营销, 以及这些产品的分布. This task would require the Center for 烟草 Products (CTP) at FDA to amass a solid evidence base to inform its regulatory activities. A longitudinal cohort study was considered to be the best way to provide that evidence, 2011年9月, the 美国国立卫生研究院 (NIH) and CTP initiated the Population Assessment of 烟草 and Health (PATH) Study.

这项研究的目的是评估烟草使用行为, 的态度, 和信仰, and tobacco-related 健康 outcomes across the nation using interview data and biospecimen data. 通过这些测量, 该研究提供了发展所需的循证信息, 实现, 评估烟草法规. 我们需要的是一家充满活力的研究公司——长期从事纵向研究, 大规模的调查, 烟草管理科学专家, 访谈技巧和技术的使用, 股本推动, and possessing a reputation for staff continuity and flexibility—to develop and 实现 the study. 美国国家药物滥用研究所(NIDA)和CTP聘请韦斯特担任这项工作. The PATH Study is the premier national tobacco study and 趣赢平台 has conducted it from its inception in 2011 to the present day.

解决方案

与NIDA和CTP合作, we set to work applying our tobacco regulatory science knowledge to the construction of the overall study design, 抽样和加权程序, 问卷的开发, 以及生物标本采集方案的设计. We also designed and developed the PATH Study’s complex systems for survey processing and management, 可视化跟踪可, 自动化仪器设计和测试, 数据处理, 和分析.

下一个, we enrolled a nationally representative sample of tobacco users and nonusers—approximately 34,000名成年人和15,000名12-17岁的青少年. 大多数参与者从一开始就一直坚持这项研究. 根据需要，我们补充了样品.

我们使用调查访谈的黄金标准系统- blaise. This powerful system offers state-of-the-art audio computer-assisted self-interviewing (ACASI), 计算机辅助个人面试(CAPI), 计算机辅助电话采访(CATI), 计算机辅助网络面试(CAWI), 以及各种平台的其他面试能力.

收集数据, 我们严格培训现场数据采集人员, 服务台工作人员, 抽血者, 以及其他与参与者进行面对面交流的人, 面试技巧, 生物标本的收集, 以及研究的目标和重要性.

每次周年调查, we revamp the questionnaire to reflect NIDA’s and CTP’s current needs for scientific data, 不断变化的烟草制品市场, 以及公众对产品的使用和认知的转变. 调查问卷包括关于行为的细粒度问题, 的态度, 以及对12种不同烟草产品的信仰. Questions not only focus on tobacco use behavior but also on substance use and abuse, 心理健康问题, 卫生和医疗保健, 社会因素.

Blood and urine samples are collected from study participants to assess exposure to tobacco products and potential harms. 趣赢平台 coordinates the shipping of specimens to the Centers for Disease Control and Prevention (CDC) and other laboratories for analysis; processes and conducts quality control reviews of the biomarker data from laboratory analysis; and produces technical documentation. 我们还管理PATH研究生物标本获取计划, which allows the research community to use these biospecimens for their own studies.

趣赢平台’s efforts on the PATH Study include collaborating with NIDA and CTP to examine 健康 inequities related to tobacco use—a topic we presented on with other researchers at the 2023 Society for Research on Nicotine and 烟草’s conference.

对于每个纵向测量波, 趣赢平台生产了大量的数据文件供NIDA使用, CTP, 和韦斯特团队, 以及外部研究界的限制和公共使用文件. 这些数据文件包括调查问卷和生物标志物数据, 以及广泛的技术和方法文档.

与NIDA和CTP工作人员合作, 趣赢平台进行了专门的分析, 报告, 以及领先医学领域的同行评议出版物, 健康, 以及社会科学期刊. 目前, we have jointly produced more than 100 such 出版物; PATH Study data has resulted in more than 700 additional 出版物 by outside researchers and hundreds of presentations at scientific meetings.

卓越的研究成果加强了我们的研究, 临床, 以及我们领导的学术合作伙伴，他们为研究的设计做出了贡献, 出版物, 以及其他科学成果. 其中包括罗斯威尔公园综合癌症中心, 达特茅斯大学, 南卡罗来纳医科大学, 纽约大学, 罗格斯大学, 加州大学圣地亚哥分校, 明尼苏达大学, 和滑铁卢大学.

We have collected PATH Study data continuously since 2013 with the exception of a 3-month pause when the COVID-19 pandemic halted in-person interviews in 2020. 通过转向不同的面试方式, “雪克隆”, 自行管理的问卷调查, 还有一种不同的收集生物标本的方法, we were able to complete that year’s survey on time—making the PATH Study the only nationally representative tobacco study to collect data on adults in 2020.

结果

The PATH Study is providing a wealth of evidence to further NIDA’s and CTP’s understanding of tobacco use behaviors and how use affects 健康 over time. This intelligence informs CTP’s regulatory decisions and actions regarding the manufacture, 分布, and 市场营销 of tobacco products in an effort to reduce the public 健康 burden of tobacco use on Americans and create a 健康ier future for our society.