{"title":"基于智能手机的视频观察疗法与基于社区的直接观察疗法下的结核病治疗依从性：群组随机对照试验。","authors":"Ponlagrit Kumwichar, Tagoon Prappre, Virasakdi Chongsuvivatwong","doi":"10.2196/53411","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>Thai Clinical Trials Registry (TCTR) TCTR20210624002; https://tinyurl.com/3bc2ycrh.</p><p><strong>International registered report identifier (irrid): </strong>RR2-10.2196/38796.</p>","PeriodicalId":14756,"journal":{"name":"JMIR mHealth and uHealth","volume":"12 ","pages":"e53411"},"PeriodicalIF":5.4000,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184266/pdf/","citationCount":"0","resultStr":"{\"title\":\"Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Cluster Randomized Controlled Trial.\",\"authors\":\"Ponlagrit Kumwichar, Tagoon Prappre, Virasakdi Chongsuvivatwong\",\"doi\":\"10.2196/53411\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>Thai Clinical Trials Registry (TCTR) TCTR20210624002; https://tinyurl.com/3bc2ycrh.</p><p><strong>International registered report identifier (irrid): </strong>RR2-10.2196/38796.</p>\",\"PeriodicalId\":14756,\"journal\":{\"name\":\"JMIR mHealth and uHealth\",\"volume\":\"12 \",\"pages\":\"e53411\"},\"PeriodicalIF\":5.4000,\"publicationDate\":\"2024-06-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184266/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JMIR mHealth and uHealth\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2196/53411\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JMIR mHealth and uHealth","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2196/53411","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
摘要
背景：最近还没有研究对肺结核治疗中患者和观察者的依从率进行比较：最近还没有研究对肺结核患者和观察者在视频观察治疗（VOT）和直接观察治疗（DOT）项目中的依从率进行比较：本研究旨在比较肺结核患者及其观察者在视频观察疗法和直接观察疗法中的平均达标天数。此外，本研究还旨在比较 VOT 患者与 DOT 患者的痰转阴率：在一项为期 60 天的分组随机对照试验中，根据 VOT 和 DOT 的平均达标天数和痰液转化率，比较了 VOT 和 DOT 项目中患者和观察者的结核病治疗依从性，试验对象为痰液酸性ast 杆菌涂片呈阳性的肺结核患者（VOT：63 人，DOT：65 人），38 名观察者被平均随机分为 VOT 组和 DOT 组（每组 19 名观察者，每名观察者负责 1-5 名患者）。VOT 组通过智能手机向观察员提交视频；DOT 组遵循标准程序。意向治疗分析评估了患者和观察员的依从性：结果：VOT 组的平均依从性高于 DOT 组（患者：平均相差 15.2 天，95% CI 4.8-25.6；P=.005；观察者：平均相差 21.2 天，95% CI 13.5-28.9；P=.005）：在确保观察者遵守结核病治疗方面，基于智能手机的 VOT 明显优于基于社区的 DOT。然而，这项研究的力量不足，无法证实肺结核患者的依从性有所提高，也无法检测出痰液转化率的差异：泰国临床试验注册中心（TCTR）TCTR20210624002；https://tinyurl.com/3bc2ycrh.International 注册报告标识符（irrid）：RR2-10.2196/38796。
Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Cluster Randomized Controlled Trial.
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.
期刊介绍：
JMIR mHealth and uHealth (JMU, ISSN 2291-5222) is a spin-off journal of JMIR, the leading eHealth journal (Impact Factor 2016: 5.175). JMIR mHealth and uHealth is indexed in PubMed, PubMed Central, and Science Citation Index Expanded (SCIE), and in June 2017 received a stunning inaugural Impact Factor of 4.636.
The journal focusses on health and biomedical applications in mobile and tablet computing, pervasive and ubiquitous computing, wearable computing and domotics.
JMIR mHealth and uHealth publishes since 2013 and was the first mhealth journal in Pubmed. It publishes even faster and has a broader scope with including papers which are more technical or more formative/developmental than what would be published in the Journal of Medical Internet Research.
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