Contextual Knowledge Core

项目摘要。烟草产品研究中心(CSTP)开发了一个模型，用于 使用加热液体的电子烟(ECIG)作为样本来评估新型烟草产品 通常含有尼古丁，形成一种气雾剂，使用者可以吸入。现在，CSTP利用其方法和 ECig的专业知识将从产品评估转向影响分析的综合主题。具体地说， CSTP提出了FDA可以对潜在法规的影响进行预测的方法， 然后，可以检验预测的影响是否在人群中发生。CSTP的模式 评估潜在的法规如何影响产品毒性(项目1)、用户行为(项目2)和 产品成瘾/滥用责任(项目3)。项目1-3的结果用于生成预测 关于人口水平的现象，我们使用前瞻性的方法测试这些人口水平的预测 队列调查(项目4)。因为所有项目都涉及操纵ECIG设备/液体特性和/或 收集ECIG用户的数据，所有人都将受益于有关ECIG用户的详细和最新知识 行为以及ECIG特征、影响和不断变化的消费者和ECIG制造商/经销商 行为。由于变化很快，使用每年的数据通常很难获得这些信息 全国性的调查。在这种情况下，背景知识核心(CKC)的首要目标是支持 每个项目通过使用概念图和在线数据源的组合来通知项目1-4，以便 测试条件和数据收集仪器反映了当前的真实条件。 该团队之前的研究使用了几种方法来了解ECIG效应以及用户和制造商 行为，使用诸如成本和时间高效的参与式在线方法之类的策略 地图“；对一个流行的在线视频分享网站(YouTube)的内容分析；以及对在线视频的系统分析 论坛和制造商/经销商零售网点，以了解ECIG使用行为、消费者参与度、 和行业标签实践。这些研究随后提供了正在进行的随机对照试验、急性实验室研究，以及 在一号工程S气溶胶研究实验室工作。总而言之，这些方法论方法可以为 CSTP研究设计、测量工具和假设。长江基建公司是在这项工作及其目标的基础上发展起来的 为项目1-4提供信息，使用：(1)概念图，(2)系统和纵向在线监测 数据来源，如YouTube和ECIG表格，以及(3)对ECIG在线进行系统和纵向监控 零售网站。总而言之，长江基建利用团队成熟的专业知识，确保项目1-4使用详细的、更高的- 指导设备/液体操作和评估仪器的最新信息。与之前的研究一样， CKC将产生关于真实世界ECIG用户体验的新颖、可发布的信息，以及用户和 制造商/经销商的行为，将向FDA通报未来的监管行动。

Project Summary. The Center for the Study of Tobacco Products (CSTP) has developed a model for evaluating novel tobacco products using, as exemplars, electronic cigarettes (ECIGs) that heat a liquid that often contains nicotine, forming an aerosol that users inhale. Now, CSTP leverages its methodological and ECIG expertise to pivot from product evaluation to an integrative theme of impact analysis. Specifically, the CSTP proposes methods with which FDA can generate predictions regarding a potential regulation’s effects, and then whether or not the predicted effects occur in the population can be tested. The CSTP’s model assesses how potential regulation might influence product toxicity (Project 1), user behavior (Project 2), and product addiction/abuse liability (Project 3). Results from Projects 1-3 are used to generate predictions regarding population-level phenomena, and we test those population-level predictions using a prospective cohort survey (Project 4). Because all Projects involve manipulating ECIG device/liquid characteristics and/or collecting data from ECIG users, all would benefit from detailed and up-to-date knowledge of ECIG user behavior as well as ECIG characteristics, effects, and changing consumer and ECIG manufacturer/distributor behaviors. Because changes are rapid, this information is often difficult to attain using data from annual national surveys. In this context, the overarching goal of the Contextual Knowledge Core (CKC) is to support each project by using a combination of concept mapping and online data sources to inform Projects 1-4 so that testing conditions and data collection instruments reflect current, real-world conditions. The team’s prior studies used several methods to understand ECIG effects and user and manufacturer behavior, using strategies such as a cost- and time-efficient participatory online method known as “concept mapping”; content analysis of a popular online video sharing site (YouTube); and systematic analyses of online forums, and manufacturer/distributor retail outlets to understand ECIG use behaviors, consumer engagement, and industry labeling practices. These studies then informed an ongoing RCT, an acute laboratory study, and work in Project 1’s aerosol research laboratory. Collectively, these methodological approaches can inform CSTP study designs, measurement instruments, and hypotheses. The CKC builds on this work and its aims are to inform Projects 1-4 using: (1) concept mapping, (2) systematic and longitudinal surveillance of online data sources like YouTube and ECIG forms, and (3) systematic and longitudinal surveillance of ECIG online retail sites. In sum, the CKC draws on the team’s proven expertise to ensure that Projects 1-4 use detailed, up- to-date information to guide device/liquid manipulations and assessment instruments. As with prior studies, the CKC will produce novel, publishable information about real-world ECIG user experience as well as user and manufacturer/distributor behavior that will inform FDA about future regulatory action.