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一项前瞻性单臂干预性试点研究,旨在评估一种基于智能手机的用于测量和支持药物依从性的系统。

Prospective single-arm interventional pilot study to assess a smartphone-based system for measuring and supporting adherence to medication.

作者信息

Molton James S, Pang Yan, Wang Zhuochun, Qiu Boqin, Wu Pei, Rahman-Shepherd Afifah, Ooi Wei Tsang, Paton Nicholas I

机构信息

University Medicine Cluster, National University Health System, Singapore, Singapore.

Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.

出版信息

BMJ Open. 2016 Dec 20;6(12):e014194. doi: 10.1136/bmjopen-2016-014194.

Abstract

OBJECTIVES

Suboptimal medication adherence for infectious diseases such as tuberculosis (TB) results in poor clinical outcomes and ongoing infectivity. Directly observed therapy (DOT) is now standard of care for TB treatment monitoring but has a number of limitations. We aimed to develop and evaluate a smartphone-based system to facilitate remotely observed therapy via transmission of videos rather than in-person observation.

DESIGN

We developed an integrated smartphone and web-based system (Mobile Interactive Supervised Therapy, MIST) to provide regular medication reminders and facilitate video recording of pill ingestion at predetermined timings each day, for upload and later review by a healthcare worker. We evaluated the system in a single arm, prospective study of adherence to a dietary supplement. Healthy volunteers were recruited through an online portal. Entry criteria included age ≥21 and owning an iOS or Android-based device. Participants took a dietary supplement pill once, twice or three-times a day for 2 months. We instructed them to video each pill taking episode using the system.

OUTCOME

Adherence as measured by the smartphone system and by pill count.

RESULTS

42 eligible participants were recruited (median age 24; 86% students). Videos were classified as received-confirmed pill intake (3475, 82.7% of the 4200 videos expected), received-uncertain pill intake (16, <1%), received-fake pill intake (31, <1%), not received-technical issues (223, 5.3%) or not received-assumed non-adherence (455, 10.8%). Overall median estimated participant adherence by MIST was 90.0%, similar to that obtained by pill count (93.8%). There was a good relationship between participant adherence as measured by MIST and by pill count (Spearmans r 0.66, p<0.001).

CONCLUSIONS

We have demonstrated the feasibility, acceptability and accuracy of a smartphone-based adherence support and monitoring system. The system has the potential to supplement and support the provision of DOT for TB and also to improve adherence in other conditions such as HIV and hepatitis C.

摘要

目的

对于结核病等传染病,药物依从性欠佳会导致临床疗效不佳且持续具有传染性。直接观察治疗(DOT)目前是结核病治疗监测的标准护理方式,但存在一些局限性。我们旨在开发并评估一种基于智能手机的系统,通过视频传输而非亲自观察来促进远程观察治疗。

设计

我们开发了一个集成的智能手机和基于网络的系统(移动交互式监督治疗,MIST),以提供定期用药提醒,并便于在每天预定时间记录吞服药物的视频,供医护人员上传并随后查看。我们在一项单组前瞻性研究中评估了该系统在服用膳食补充剂方面的依从性。通过在线门户网站招募健康志愿者。入选标准包括年龄≥21岁且拥有基于iOS或安卓的设备。参与者每天服用一次、两次或三次膳食补充剂药丸,持续2个月。我们指示他们使用该系统对每次服药过程进行录像。

结果

通过智能手机系统和药丸计数来衡量依从性。

结果

招募了42名符合条件的参与者(中位年龄24岁;86%为学生)。视频被分类为已接收 - 确认吞服药物(3475个,占预期的4200个视频的82.7%)、已接收 - 不确定吞服药物(16个,<1%)、已接收 - 假吞服药物(31个,<1%)、未接收 - 技术问题(223个,5.3%)或未接收 - 假定不依从(455个,10.8%)。MIST估计的参与者总体中位依从性为90.0%,与通过药丸计数获得的结果(93.8%)相似。MIST测量的参与者依从性与药丸计数之间存在良好的相关性(斯皮尔曼相关系数r为0.66,p<0.001)。

结论

我们已经证明了基于智能手机的依从性支持和监测系统的可行性、可接受性和准确性。该系统有可能补充并支持结核病的DOT提供,也有可能提高在其他疾病如艾滋病毒和丙型肝炎中的依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf0a/5223626/dd7757ee008e/bmjopen2016014194f01.jpg

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