Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy.
Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy.
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DOI：
10.1371/journal.pone.0053373
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Reves R
中科院分区：
文献类型：
--
作者：
Belknap R;Weis S;Brookens A;Au-Yeung KY;Moon G;DiCarlo L;Reves R
对结核病（TB）治疗的坚持性差会阻碍个人的康复并威胁公共健康。目前，直接观察治疗（DOT）是护理标准;然而，高维持成本限制了其可用性，需要更实用的依从性确认方法。诸如视频监控和记录药瓶打开时间的设备等技术无法确认实际的药物摄入。Proteus Digital Health，Inc.开发的一种新方法。由一个可摄入传感器和一个身体可穿戴传感器组成;它们一起以电子方式确认独特的摄入并记录摄入的日期/时间。在活动性结核病患者中进行了一项使用早期原型的可行性研究，以确定该系统在确认与传感器共同摄入结核病药物时的准确性和安全性。30例患者完成了10次DOT访视和1，080次共摄入事件;该系统显示出95.0%（95% CI 93.5-96.2%）的阳性检测准确性，定义为检测到的传感器数量除以管理的传输能力传感器数量。基于接收器记录的三个假信号，特异性为99.7% [95% CI 99.2-99.9%]。该系统的识别准确度，定义为正确识别的可摄取传感器的数量除以检测到的传感器的数量，是100%。在11起不良事件中，4起被认为与器械相关或可能相关; 3起轻度皮疹和1起恶心投诉。系统的阳性检测准确性不受试者的体重指数影响（p = 0.7309）。 研究结果表明，该系统能够以高精度正确识别可摄入传感器，对用户构成低风险，并且可能具有较高的患者接受度。该系统有可能逐个剂量地确认药物特定治疗依从性。当与移动的技术相结合时，该系统可以允许无线观察治疗（WOT）来监测结核病治疗，作为DOT的替代品。
Poor adherence to tuberculosis (TB) treatment hinders the individual’s recovery and threatens public health. Currently, directly observed therapy (DOT) is the standard of care; however, high sustaining costs limit its availability, creating a need for more practical adherence confirmation methods. Techniques such as video monitoring and devices to time-register the opening of pill bottles are unable to confirm actual medication ingestions. A novel approach developed by Proteus Digital Health, Inc. consists of an ingestible sensor and an on-body wearable sensor; together, they electronically confirm unique ingestions and record the date/time of the ingestion. A feasibility study using an early prototype was conducted in active TB patients to determine the system’s accuracy and safety in confirming co-ingestion of TB medications with sensors. Thirty patients completed 10 DOT visits and 1,080 co-ingestion events; the system showed 95.0% (95% CI 93.5–96.2%) positive detection accuracy, defined as the number of detected sensors divided by the number of transmission capable sensors administered. The specificity was 99.7% [95% CI 99.2–99.9%] based on three false signals recorded by receivers. The system’s identification accuracy, defined as the number of correctly identified ingestible sensors divided by the number of sensors detected, was 100%. Of 11 adverse events, four were deemed related or possibly related to the device; three mild skin rashes and one complaint of nausea. The system’s positive detection accuracy was not affected by the subjects’ Body Mass Index (p = 0.7309). Study results suggest the system is capable of correctly identifying ingestible sensors with high accuracy, poses a low risk to users, and may have high patient acceptance. The system has the potential to confirm medication specific treatment compliance on a dose-by-dose basis. When coupled with mobile technology, the system could allow wirelessly observed therapy (WOT) for monitoring TB treatment as a replacement for DOT.