基于智能手机的视频观察治疗与社区为基础的直接观察治疗下的结核病治疗依从性：集群随机对照试验。
Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Cluster Randomized Controlled Trial.
机构信息
Department of Epidemiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.
出版信息
JMIR Mhealth Uhealth. 2024 Jun 3;12:e53411. doi: 10.2196/53411.
BACKGROUND
There are no recent studies comparing the compliance rates of both patients and observers in tuberculosis treatment between the video-observed therapy (VOT) and directly observed therapy (DOT) programs.
OBJECTIVE
This study aims to compare the average number of days that patients with pulmonary tuberculosis and their observers were compliant under VOT and DOT. In addition, this study aims to compare the sputum conversion rate of patients under VOT with that of patients under DOT.
METHODS
Patient and observer compliance with tuberculosis treatment between the VOT and DOT programs were compared based on the average number of VOT and DOT compliance days and sputum conversion rates in a 60-day cluster randomized controlled trial with patients with pulmonary tuberculosis (VOT: n=63 and DOT: n=65) with positive sputum acid-fast bacilli smears and 38 observers equally randomized into the VOT and DOT groups (19 observers per group and n=1-5 patients per observer). The VOT group submitted videos to observers via smartphones; the DOT group followed standard procedures. An intention-to-treat analysis assessed the compliance of both the patients and the observers.
RESULTS
The VOT group had higher average compliance than the DOT group (patients: mean difference 15.2 days, 95% CI 4.8-25.6; P=.005 and observers: mean difference 21.2 days, 95% CI 13.5-28.9; P<.001). The sputum conversion rates in the VOT and DOT groups were 73% and 61.5%, respectively (P=.17).
CONCLUSIONS
Smartphone-based VOT significantly outperformed community-based DOT in ensuring compliance with tuberculosis treatment among observers. However, the study was underpowered to confirm improved compliance among patients with pulmonary tuberculosis and to detect differences in sputum conversion rates.
TRIAL REGISTRATION
Thai Clinical Trials Registry (TCTR) TCTR20210624002; https://tinyurl.com/3bc2ycrh.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/38796.
背景
目前尚无研究比较视频观察治疗（VOT）和直接观察治疗（DOT）方案下结核病治疗中患者和观察者的遵医率。
目的
本研究旨在比较 VOT 和 DOT 方案下肺结核患者及其观察者的平均遵医天数，并比较 VOT 组和 DOT 组患者的痰培养转阴率。
方法
对 60 天的 VOT 和 DOT 方案治疗肺结核患者的痰涂片抗酸杆菌阳性患者（VOT：n=63，DOT：n=65）及 38 名观察者进行了一项基于 VOT 和 DOT 平均遵医天数及痰培养转阴率的 60 天集群随机对照试验。该试验将观察者随机等分为 VOT 组和 DOT 组（每组 19 名观察者，每名观察者 1-5 名患者），VOT 组通过智能手机向观察者提交视频，DOT 组遵循标准程序。意向治疗分析评估了患者和观察者的遵医情况。
结果
VOT 组的平均遵医率高于 DOT 组（患者：平均差异 15.2 天，95%CI 4.8-25.6；P=.005；观察者：平均差异 21.2 天，95%CI 13.5-28.9；P<.001）。VOT 组和 DOT 组的痰培养转阴率分别为 73%和 61.5%（P=.17）。
结论
基于智能手机的 VOT 在确保观察者遵医治疗结核病方面明显优于基于社区的 DOT。然而，该研究的效力不足以确认肺结核患者的遵医率得到改善，也无法检测痰培养转阴率的差异。
临床试验注册
泰国临床试验注册中心（TCTR）TCTR20210624002；https://tinyurl.com/3bc2ycrh。
国际标准报告标识符（IRRID）：RR2-10.2196/38796。
Zotero 插件