Remote Methods to Biochemically Verify Smoking Status

生化验证吸烟状况的远程方法

• 批准号: 9884111
• 负责人: Jennifer Renee Dahne
• 金额: $ 24.46万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9884111
• 关键词: Address; Adult; Air; Android; Biochemical; Biological Assay; Carbon Monoxide; Cellular Phone; Clinical Trials; Collection; Communities; Conduct Clinical Trials; Consent; Cotinine; Data; Data Collection; Databases; Enhancement Technology; Enrollment; Ensure; Ethnic Origin; Face; Financial compensation; Funding Agency; Future; Gold; Grant; Health Technology; Human; Infrastructure; Intervention; Lead; Measurement; Methodology; Methods; Monitor; Multi-Institutional Clinical Trial; Outcome; Outcomes Research; Participant; Patient Self-Report; Persons; Population; Race; Randomized; Reading; Research; Research Methodology; Research Personnel; Saliva; Sampling; Sampling Studies; Secure; Signal Transduction; Site; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Smoking Status; Socioeconomic Status; Subgroup; System; Technology; Testing; Text Messaging; Time; Translating; Treatment Efficacy; Tube; United States National Institutes of Health; Visit; arm; base; behavioral/social science; cost; cost effective; feasibility trial; handheld mobile device; improved; ineffective therapies; low socioeconomic status; mHealth; method development; programs; recruit; rurality; sex; smoking cessation; stem; tool; usability; web site

ABSTRACT NCI has nearly 50 ongoing grants to develop and test remotely delivered, technology-based smoking cessation interventions (e.g., apps, websites, text messaging). Remote cessation trials face one key methodological limitation that undermines rigor: the need for biochemical verification of smoking status to accurately assess intervention efficacy. Funding agencies are now strongly encouraging, if not requiring, biochemical verification of smoking in all cessation trials regardless of whether the intervention is delivered in-person or remotely. Incorporation of biochemical indicators of smoking status is critically important as inaccurate assessment of smoking status may lead to dissemination of ineffective treatments and stagnant rates of population-level cessation. Remote collection of expired-air carbon monoxide (CO) is a non-invasive approach that can be used to verify smoking status. Remote CO offers the potential to inform episodic assessment of smoking (e.g., at 1, 3, or 6 months) as is typically done for clinical trial endpoints. Beyond clinical trials, remote CO offers the potential to enhance human-lab methods by providing ecological granular assessment of day-to-day fluctuations in smoking. However, extant trials that have implemented remote methods to assess CO have utilized CO monitors that would be cost-prohibitive ($700-$1,200) to include in large-scale remote trials. Smartphone-enabled CO monitors have recently become available and could dramatically improve the feasibility of remote CO collection. Such monitors are available at substantially lower cost (~$72) than traditional monitors, can be used with any iOS- or Android-compatible mobile device, and detect continuous CO concentrations of 0-100 parts per million. Although these new monitors expand the methodologic potential to capture CO remotely, several issues must first be resolved. Most critically, CO collection via smartphone-enabled monitor must be: 1) integrated in real- time with other research outcomes, 2) valid when compared to gold-standard approaches for biochemical verification, and 3) feasible as applied both to granular and episodic data collection. We herein propose to develop and refine an integrated system through which a smartphone-enabled CO monitor (iCO™ Smokerlyzer) is paired with secure online data capture via REDCap. This system will 1) initiate an iCO™ reading, 2) video record the participant providing a CO reading, 3) translate the iCO™’s raw signal into a CO level, and 4) save the CO level to a REDCap database integrated with other assessments. Subsequently, we will examine: a) validity of the remote CO data capture system as compared to gold-standard methods for biochemical verification and b) compliance with remote CO monitoring as applied both to episodic and granular data collection. This project will develop and validate a tool that could fill the gap for a low-cost, feasible method to biochemically verify smoking status within the context of NIH’s growing portfolio of remote and/or technology-enhanced cessation treatments and has clear potential to improve the rigor of remote assessment of smoking behavior.

抽象的 NCI 拥有近 50 项持续拨款，用于开发和测试基于远程技术的戒烟 远程戒烟试验面临一个关键的方法论。 损害酒精度的限制：需要对吸烟状况进行生化验证以准确评估 资助机构现在强烈鼓励（如果不要求的话）进行生化验证。 所有戒烟试验中吸烟的比例，无论干预是亲自进行还是远程进行。 纳入吸烟状况的生化指标至关重要，因为评估不准确 吸烟状况可能导致无效治疗的传播和人口水平的停滞 远程收集呼出气体一氧化碳 (CO) 是一种可以使用的非侵入性方法。 验证吸烟状况。远程 CO 可以为吸烟情况进行间歇性评估（例如，在 1、 3 或 6 个月），就像临床试验终点通常所做的那样，除了临床试验之外，远程 CO 还提供了潜力。 通过提供日常波动的生态精细评估来增强人类实验室方法 然而，现有的采用远程方法评估 CO 的试验都使用了 CO 监测仪。 将其纳入大规模智能手机远程试验的成本高昂（700-1,200 美元）。 监测器最近已上市，可以极大地提高远程二氧化碳收集的可行性。 此类显示器的成本远低于传统显示器（约 72 美元），可与任何显示器一起使用 兼容 iOS 或 Android 的移动设备，并连续检测百万分之 0-100 的 CO 浓度。 尽管这些新监测仪扩展了远程捕获二氧化碳的方法学潜力，但仍有几个问题必须解决 首先要解决的问题是，通过智能手机监控器收集 CO 必须：1）集成到实时环境中。 与其他研究成果的时间，2) 与生化金标准方法相比有效 验证，3）适用于细粒度和情景数据收集。 开发和完善一个集成系统，通过该系统可实现支持智能手机的 CO 监测仪 (iCO™ Smokerlyzer) 与通过 REDCap 进行的安全在线数据采集配对，该系统将 1) 启动 iCO™ 读取，2) 视频。 记录参与者提供的 CO 读数，3) 将 iCO™ 的原始信号转换为 CO 水平，以及 4) 保存 随后，我们将检查：a) 远程 CO 数据采集系统与生化验证金标准方法相比的有效性 b) 遵守适用于间歇性和精细数据收集的远程 CO 监测。 该项目将开发并验证一种工具，该工具可以填补低成本、可行的生化方法的空白 在 NIH 不断增长的远程和/或技术增强组合的背景下验证吸烟状况 戒烟治疗，并且具有提高吸烟行为远程评估严格性的明显潜力。