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有将近50份持续的赠款来开发和测试以技术为基础的吸烟戒烟 干预措施（例如，应用程序，网站，文本消息传递）。远程戒烟试验面对一个关键的方法论 破坏严格严格的限制：对吸烟状况的生化验证需要准确评估 干预效率。资金机构现在强烈鼓励（如果不需要）生化验证 在所有戒烟试验中吸烟，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至关重要，因为评估不准确 吸烟状况可能导致传播无效的治疗方法和人口水平的停滞率 停止。远程收集过期的空气一氧化碳（CO）是一种无创的方法，可以使用 验证吸烟状况。 Remote Co提供了通知吸烟情节评估的潜力（例如，1，1， 通常为临床试验终点所做的3个或6个月）。除临床试验之外，Remote Co提供了潜力 通过提供对日常波动的生态颗粒状评估来增强人类LAB方法 吸烟。但是，已实施评估CO的远程方法的额外试验已使用CO监视 这将是过于良好的（$ 700- $ 1,200），其中包括大规模远程试验。支持智能手机的CO 显示器最近已获得，并且可以大大提高远程CO收集的可行性。 此类监视器的成本比传统监视器的成本低得多（约72美元），可与任何人一起使用 iOS或Android兼容的移动设备，并检测到每百万份0-100份的连续CO浓度。 尽管这些新显示器扩大了远程捕获CO的方法学潜力，但必须有几个问题 首先要解决。最重要的是，通过智能手机的监视器收集的CO收集必须是：1）集成 与生化的金色标准方法相比，有其他研究结果的时间，2）有效 验证，以及3）可行的，如粒状和情节数据收集。我们在这里提出的建议 开发并完善了一个启用智能手机的CO监视器（ICO™sumperlyzer）的集成系统 与安全的在线数据通过RedCap配对。该系统将1）启动ICO™阅读，2）视频 记录提供CO读数的参与者，3）将ICO™的原始信号转换为CO级别，4）保存 与其他评估集成在一起的REDCAP数据库的CO级别。随后，我们将检查：a） 与金化学验证的金标准方法相比，远程CO数据捕获系统的有效性 b）遵守远程CO监视，同时适用于情节和颗粒数据收集。这 项目将开发和验证一个可以填补空白的工具 在NIH不断增长的远程和/或技术增强的投资组合中验证吸烟状况 停止治疗，并具有明确的潜力，可以改善对吸烟行为的远程评估的严格评估。