Contextual Knowledge Core

项目摘要。烟草制品研究中心（CSTP）开发了一个模型， 使用电子香烟（ECIG）作为范例评估新型烟草产品，所述电子香烟加热液体， 通常含有尼古丁，形成使用者吸入的气雾剂。现在，CSTP利用其方法和 ECIG专业知识从产品评估转向影响分析的综合主题。具体而言是 CSTP提出了FDA可以预测潜在法规影响的方法， 然后可以检验预测的效应是否发生在群体中。CSTP模型 评估潜在法规如何影响产品毒性（项目1）、用户行为（项目2），以及 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来测试这些人口水平的预测。 群组调查（项目4）。因为所有项目都涉及操纵ECIG装置/液体特性和/或 从ECIG用户收集数据，所有人都将受益于ECIG用户的详细和最新知识 行为以及ECIG特性、影响和不断变化的消费者和ECIG制造商/分销商 行为。由于变化迅速，使用年度数据往往很难获得这一信息。 国家调查。在这种情况下，上下文知识核心（CKC）的首要目标是支持 通过使用概念图和在线数据源的组合为项目1-4提供信息， 测试条件和数据收集工具反映了当前的实际情况。 该团队先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有效的参与式在线方法（称为“概念”）等策略 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/分销商零售店，以了解ECIG使用行为，消费者参与， 和行业标签实践。这些研究随后通知了正在进行的RCT，一项急性实验室研究， 在项目1的气溶胶研究实验室工作。总的来说，这些方法可以为 CSTP研究设计，测量工具和假设。CKC建立在这项工作及其目标的基础上 为项目1-4提供信息，使用：（1）概念图，（2）在线的系统和纵向监督 数据来源，如YouTube和ECIG表格，以及（3）对ECIG在线的系统和纵向监控 零售网站。总而言之，CKC利用团队成熟的专业知识，确保项目1-4使用详细的、最新的 指导器械/液体操作和评估仪器的最新信息。与先前的研究一样， CKC将产生关于现实世界ECIG用户体验以及用户和 制造商/经销商行为，将告知FDA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.