Contextual Knowledge Core

情境知识核心

• 批准号: 10477278
• 负责人: Pebbles Fagan
• 金额: $ 37.67万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477278
• 关键词: Acute; Adverse event; Aerosols; Assessment tool; Behavior; Categories; Characteristics; Clinical; Cross-Sectional Studies; Data; Data Collection; Data Sources; Dependence; Devices; Electronic cigarette; Ensure; Evaluation; Evolution; Future; Geographic state; Goals; Health; Industry; Inhalation; Knowledge; Label; Laboratory Research; Laboratory Study; Learning; Liquid substance; Manufacturer Name; Measurement; Measures; Methodology; Methods; Modeling; Monitor; Nicotine; Participant; Population; Prospective cohort; Publications; Publishing; Regulation; Reporting; Research; Research Design; Respiratory Signs and Symptoms; Risk; Sales; Sensory; Series; Site; Source; Sum; Surveys; Testing; Time; Tobacco use; Toxic effect; Work; abuse liability; addiction; concept mapping; cost; electronic cigarette use; electronic cigarette user; experience; instrument; liquid nicotine; longitudinal design; novel; recruit; response; tobacco products; tobacco user

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.

项目摘要。烟草制品研究中心 (CSTP) 开发了一个模型 以电子烟（ECIG）为例评估新型烟草产品，该电子烟加热液体， 通常含有尼古丁，形成用户吸入的气雾剂。现在，CSTP 利用其方法和原理。 ECIG 的专业知识从产品评估转向影响分析的综合主题。 CSTP 提出了 FDA 可以对潜在监管影响进行预测的方法， 然后可以测试 CSTP 的模型是否会出现预测的效果。 评估潜在监管如何影响产品毒性（项目 1）、用户行为（项目 2）以及 产品成瘾/滥用倾向（项目 3）。项目 1-3 的结果用于生成预测。 关于人口层面的现象，我们使用前瞻性的方法来测试这些人口层面的预测 因为所有项目都涉及操纵 ECIG 设备/液体特性和/或 从 ECIG 用户收集数据，所有人都将从 ECIG 用户的详细和最新知识中受益 行为以及 ECIG 特征、影响以及不断变化的消费者和 ECIG 制造商/分销商 由于变化很快，因此通常很难使用年度数据来获取这些信息。 在此背景下，背景知识核心（CKC）的总体目标是支持 每个项目都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现实条件。 该团队之前的研究使用了多种方法来了解 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（称为“概念”）等策略 流行的在线视频共享网站（YouTube）的内容分析和在线系统分析； 论坛和制造商/分销商零售店，以了解 ECIG 使用行为、消费者参与度、 这些研究随后为正在进行的随机对照试验（一项急性实验室研究）提供了信息。 总的来说，这些方法可以为项目 1 的气溶胶研究实验室提供信息。 CSTP 研究设计、测量工具和假设建立在这项工作及其目标的基础上。 将使用以下方式为项目 1-4 提供信息：(1) 概念图，(2) 系统和纵向在线监测 YouTube 和 ECIG 表格等数据源，以及 (3) ECIG 在线系统和纵向监控 总之，CKC 利用团队经过验证的专业知识来确保项目 1-4 使用详细的、最新的信息。 与之前的研究一样，指导设备/液体操作和评估仪器的最新信息。 CKC 将制作有关真实世界 ECIG 用户体验以及用户和 制造商/分销商的行为将向 FDA 通报未来的监管行动。