Remote Methods to Biochemically Verify Smoking Status

摘要 NCI有近50个正在进行的赠款，以开发和测试远程交付，基于技术的戒烟 干预（例如，应用程序、网站、文本消息）。远程戒烟试验面临一个关键的方法 破坏严谨性的限制：需要对吸烟状态进行生化验证，以准确评估 干预效果资助机构现在强烈鼓励，如果不是要求，生化验证 在所有戒烟试验中，无论干预是面对面还是远程进行。 纳入吸烟状况的生化指标是至关重要的，因为不准确的评估 吸烟状况可能导致无效治疗的传播和人口水平的停滞率 停止远程收集净化空气中的一氧化碳（CO）是一种非侵入性方法， 检查吸烟状况。远程CO提供了告知吸烟的情景评估的可能性（例如，在1处， 3个月或6个月），如通常针对临床试验终点所做的那样。除了临床试验，远程CO还提供了 通过提供日常波动的生态颗粒评估来增强人类实验室方法， smoking.然而，已经实施远程方法来评估CO的现有试验已经利用CO监测器 将其纳入大规模远程审判的成本太高（700至1 200美元）。支持智能手机的CO 监测器最近已经变得可用，并且可以显著地提高远程CO收集的可行性。 这种显示器的价格比传统显示器低得多（约72美元），可以与任何 iOS或Android兼容的移动终端，并检测0-100 ppm的连续CO浓度。 虽然这些新的监测器扩展了远程捕获CO的方法潜力，但仍存在一些问题， 首先要解决。最关键的是，通过智能手机功能的监测器收集CO必须：1）集成在真实的- 时间与其他研究成果，2）有效时相比，黄金标准的方法，生化 验证，以及3）适用于粒度和情景数据收集的可行性。我们在此提议， 开发和完善一个集成系统，通过该系统，智能手机支持的CO监测器（iCO™ Smokerlyzer） 与通过REDCap进行的安全在线数据采集相结合。该系统将1）启动iCO™阅读，2）视频 记录提供CO阅读的参与者，3）将iCO™的原始信号转换为CO水平，以及4）保存 将国家办事处一级纳入与其他评估相结合的REDCap数据库。接下来，我们将研究：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 和B）符合应用于偶发和颗粒数据收集的远程CO监测。这 项目将开发和验证一种工具，可以填补差距的低成本，可行的方法，以生物化学 在NIH不断增长的远程和/或技术增强的组合的背景下， 戒烟治疗，并有明显的潜力，以提高吸烟行为的远程评估的严格性。

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.