Research Project 1: Comparative Modeling of the Impact of E-cigarettes 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案，FDA被要求证明任何新的规定 对烟草产品的销售、销售或含量进行管制是“为了保护公众的利益”。 健康。“为了向FDA提供一个评估烟草法规对健康的潜在影响的框架， 该TCORS项目将协调和扩展四个已建立的烟草控制模拟模型，以检查 FDA可能采取的不同监管行动对香烟和电子烟使用的未来趋势的影响，以及 相关的健康结果。该项目将侧重于影响分析(目标3、4和5)和健康影响。 (目标2和3)，其次强调行为(目标1)。 使用通用的减少危害框架和统计方法来区分实验和 长期使用烟草产品，我们将制定模型的初始流行率；一系列看似合理的 未来按年龄和性别划分的香烟和电子烟开始和停止的现状转变；以及 香烟和电子烟之间一系列看似合理的转换率。使用文献综述和专家 为了开发特定健康结果的相对风险估计，我们将把模型从 全因死亡率也预计与烟草有关的心血管和慢性梗阻死亡率 肺部疾病和不良的妇幼健康后果。我们还将把这些模型扩展到 考虑与香烟和电子烟使用有关的具体政策的影响，例如规定 关于健康影响的信息，使用文献综述和专家小组来制定政策影响估计。 在纳入香烟和电子烟使用的共同初始普及率和过渡率后， 关于健康结果和政策参数的扩展，我们将使用四个模型和它们的 不同的结构，以检查目前和预计未来电子烟使用对总体危害的影响。我们 还将预测FDA具体的潜在法规单独和组合可能会如何影响 未来50年内香烟和电子烟的使用率和相关的健康结果。比较 将对四个模型的预测进行分析，以进一步细化可能的最好情况、最坏情况和 最有可能的是预测情景，并更好地评估监管影响。此外，这些型号将拥有 快速使用来自国家监控队列的新数据并纳入新数据的能力和灵活性 随着这些政策的出现，监管政策选项应运而生。我们的模型也将变得足够灵活，以便进一步考虑 替代无烟的其他替代尼古丁输送产品，包括雪茄 烟草和不灼热产品。

PROJECT 1 Abstract Under the Family Smoking Prevention and Tobacco Control Act, the 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, this TCORS Project will harmonize and extend four established tobacco control simulation models to examine the impact of different possible FDA regulatory actions on future trends in cigarette and e-cigarette use, and associated health outcomes. The Project will focus on Impact Analysis (Aim 3, 4, and 5) and Health Effects (Aims 2 and 3), with a secondary emphasis on Behavior (Aim 1). Using a generalized harm reduction framework and statistical approaches to distinguish experimentation from long-term tobacco product use, we will develop initial prevalence rates for the models; a range of plausible future status quo transitions by age and gender for initiation and cessation for cigarettes and e-cigarettes; and a range of plausible switching rates between cigarettes and e-cigarettes. Using literature reviews and expert elicitation panels to develop relative risk estimates for specific health outcomes, we will extend the models from all-cause mortality to also project tobacco-related mortality due to cardiovascular and chronic obstructive pulmonary disease, and adverse maternal and child health outcomes. We will also extend the models to consider the impact of specific policies related to cigarette and e-cigarette use, such as the provision of information about health effects, using literature reviews and expert panels to develop policy effect estimates. Upon incorporating the common initial prevalence and transition rates for cigarette and e-cigarette use, the extensions regarding health outcomes, and the policy parameters, we will use the four models with their different structures to examine the impact of current and projected future e-cigarette use on overall harms. We will also project how specific potential FDA regulations individually and in combination will likely impact cigarette and e-cigarette use rates and associated health outcomes over a 50-year future period. Comparative analyses of the four models’ predictions will be conducted to further refine the likely best-case, worst-case, and most likely projected scenarios and better assess regulatory impacts. In addition, the models will have the capacity and flexibility to rapidly use new data from national surveillance cohorts and incorporate new regulatory policy options as these emerge. Our models will also be made flexible enough to further consider substitution into and away from other alternative nicotine delivery products, including cigars, smokeless tobacco and heat-not-burn products.