Modeling the Impact of Novel Tobacco Product use on Smoking and Long-Term Health Outcomes

项目1摘要 根据《家庭吸烟预防和烟草控制法》，食品和药物管理局（FDA） 要求表明，任何新的规则，以规范营销，销售或烟草产品的内容， “适合于保护公众健康”为FDA提供一个评估 烟草法规的潜在健康影响，项目1将协调和扩展完善的中心， 烟草法规评估（CAsToR）烟草控制模拟模型，以检查影响 FDA对卷烟、雪茄、电子尼古丁输送系统（ENDS）未来趋势的监管行动，以及 其他新型烟草制品（ONP）的使用和相关的健康结果。该项目将侧重于行为 (Aim 1）、影响分析（目标2和3）和健康影响（目标2和3）作为科学领域（RFA-OD-22- 04）。项目1有三个目标。目标1.描述使用的纵向模式和 香烟，雪茄，和结束，单独和组合。口服尼古丁，加热烟草制品 一旦获得关于其使用情况的数据，将考虑使用清洁生产技术和清洁生产技术。使用国家代表 健康调查，文献回顾和过渡估计，我们将扩展以前开发的框架 检查常规香烟和ENDS使用之间的过渡，包括雪茄，HTPs和ONP。我们将 制定过渡参数，以区分专用、旧用、两用和转换模式， 每个产品。目标2.开发香烟、雪茄、ENDS和 美国的其他烟草产品及其健康影响。我们将扩展CAsToR模拟 模型（即，SimSmoke、Mendez和Warner、Microsimulation和SAVM）纳入产品使用、健康 结果和雪茄，HTPs和ONP的全因死亡风险。模型中的人口转变将是 通过每种产品的性别和年龄特异性开始和停止率以及转换率建模 产品之间。每个模型将根据以下年龄和性别的流行率进行校准和验证： 对每种产品类型进行调查。目标3.模拟现有和潜在法规对烟草的影响 与香烟、雪茄、ENDS和其他新型烟草相关的使用模式和全因死亡率 产品使用。对于所有模型，我们将创建检查过去和未来FDA政策将如何 影响可燃和新型尼古丁产品使用以及相关的健康结果。我们会发展得最好 政策对每种产品的启动、停止和转换率的影响的估计和可信范围。 我们将考虑不同年龄、性别、种族和社会经济地位的政策效应大小的差异。我们将初步 关注香烟和ENDS使用之间的关系，然后纳入雪茄使用。比较 将对这四种模型的预测进行分析，以确定可能的最佳情况、最坏情况和最坏情况。 可能的预测情景，以更好地评估监管影响。由此产生的模型将具有能力， 灵活地快速整合新数据，并在出现新的监管政策时考虑新的监管政策选择。

PROJECT 1 Abstract Under the Family Smoking Prevention and Tobacco Control Act, the Food and Drug Administration (FDA) is required to show that any new rule to regulate the marketing, sale or content of tobacco products is “appropriate for the protection of the public health.” To provide the FDA with a framework to assess the potential health impacts of tobacco regulations, Project 1 will harmonize and extend well-established Center for the Assessment of Tobacco Regulations (CAsToR) tobacco control simulation models to examine the impact of FDA regulatory actions on future trends in cigarette, cigar, electronic nicotine delivery systems (ENDS), and other novel tobacco product (ONPs) use and associated health outcomes. This project will focus on Behavior (Aim 1), Impact Analysis (Aims 2 and 3) and Health Effects (Aims 2 and 3) as Scientific Domains (RFA-OD-22- 04). Project 1 has three aims. Aim 1. Characterize longitudinal patterns of use and transitions of cigarettes, cigars, and ENDS, individually and in combination. Oral nicotine, heated tobacco products (HTPs), and ONPs will be considered as data on their use become available. Using nationally representative health surveys, literature reviews and transitions estimates, we will extend a previously developed framework to examine transitions between regular cigarette and ENDS use to include cigars, HTPs and ONPs. We will develop transition parameters to distinguish between exclusive, former, dual use and switching patterns for each product. Aim 2. Develop simulation models of the use patterns of cigarettes, cigars, ENDS, and other tobacco products in the US and their health implications. We will expand the CAsToR simulation models (i.e., SimSmoke, Mendez and Warner, Microsimulation and SAVM) to incorporate product use, health outcomes and all-cause mortality risk of cigars, HTPs, and ONPs. Population transitions in the models will be modeled through sex- and age-specific initiation and cessation rates for each product and switching rates between products. Each model will be calibrated and validated against prevalence rates by age and sex from surveys for each product type. Aim 3. Model the impact of existing and potential regulations on tobacco use patterns and all-cause mortality associated with cigarette, cigar, ENDS, and other novel tobacco product use. For all models, we will create the capability to examine how past and future FDA policies will impact combustible and novel nicotine product use and associated health outcomes. We will develop best estimates and credible ranges of the policy effect on each product’s initiation, cessation, and switching rates. We will consider variations in policy effect sizes by age, sex, race, and socioeconomic status. We will initially focus on the relationship between cigarette and ENDS use, and then incorporate cigar use. Comparative analyses of the four models’ predictions will be conducted to refine the likely best-case, worst-case, and most likely projected scenarios to better assess regulatory impacts. The resulting models will have the capacity and flexibility to rapidly incorporate new data and consider new regulatory policy options as they emerge.