Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial
Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial
复制标题
DOI：
10.1016/s0140-6736(18)32993-3
复制
发表时间：
2019-03-23
期刊：
影响因子：
168.9
通讯作者：
Hayward, Andrew C.
中科院分区：
文献类型：
--
作者：
Story, Alistair;Aldridge, Robert W.;Hayward, Andrew C.
背景自20世纪90年代初以来，直接观察治疗（DOT）一直是结核病的标准治疗方法，但对患者和服务提供者来说都不方便。视频观察治疗（VOT）已被WHO有条件地推荐作为DOT的替代方案。我们测试了治疗观察水平是否与VOT.Methods改善，我们做了一个多中心，分析盲法，随机对照优效性试验在22个诊所在英格兰（英国）。符合条件的参与者是年龄至少16岁的活动性肺结核或非肺结核患者，根据当地指南，他们有资格接受DOT。排除标准包括无法为智能手机充电的患者。我们将参与者随机分配到VOT（使用智能手机应用程序进行每日远程观察）或DOT（每周在家庭，社区或诊所环境中进行三到五次观察）。随机化由SealedEnvelope服务使用最小化进行。DOT涉及由保健或非专业工作人员进行治疗观察，任何剩余的每日剂量都是自我给药。VOT由伦敦的一个集中服务机构提供。患者接受培训，每周7天使用智能手机应用程序记录和发送每次摄入剂量的视频。经过培训的治疗观察员通过受密码保护的网站查看这些视频。还鼓励患者在视频中报告药物不良事件。研究者免费提供智能手机和数据计划。DOT或VOT观察记录由观察者完成，直至治疗或研究结束。主要结局是入组后前2个月内完成80%或更多的计划治疗观察。进行了意向治疗（ITT）和限制性（仅包括分配组完成至少1周观察的患者）分析。通过主要结局患者比例的15%差异（60% vs 75%）确定优先级。该试验在国际标准随机对照试验编号登记处注册，编号ISRCTN 26184967。结果在2014年9月1日至2016年10月1日期间，我们随机分配了226例患者; 112例接受VOT，114例接受DOT。总体而言，131名（58%）患者有无家可归，监禁，吸毒，酒精问题或精神健康问题的历史。在ITT分析中，VOT组112例患者中有78例（70%）在前2个月内成功完成了>= 80%的计划观察，而DOT组114例患者中有35例（31%）成功完成了计划观察（校正比值比[OR] 5.48，95%CI 3.10-9.68; p
Background Directly observed treatment (DOT) has been the standard of care for tuberculosis since the early 1990s, but it is inconvenient for patients and service providers. Video-observed therapy (VOT) has been conditionally recommended by WHO as an alternative to DOT. We tested whether levels of treatment observation were improved with VOT.Methods We did a multicentre, analyst-blinded, randomised controlled superiority trial in 22 clinics in England (UK). Eligible participants were patients aged at least 16 years with active pulmonary or non-pulmonary tuberculosis who were eligible for DOT according to local guidance. Exclusion criteria included patients who did not have access to charging a smartphone. We randomly assigned participants to either VOT (daily remote observation using a smartphone app) or DOT (observations done three to five times per week in the home, community, or clinic settings). Randomisation was done by the SealedEnvelope service using minimisation. DOT involved treatment observation by a health-care or lay worker, with any remaining daily doses self-administered. VOT was provided by a centralised service in London. Patients were trained to record and send videos of every dose ingested 7 days per week using a smartphone app. Trained treatment observers viewed these videos through a password-protected website. Patients were also encouraged to report adverse drug events on the videos. Smartphones and data plans were provided free of charge by study investigators. DOT or VOT observation records were completed by observers until treatment or study end. The primary outcome was completion of 80% or more scheduled treatment observations over the first 2 months following enrolment. Intention-to-treat (ITT) and restricted (including only patients completing at least 1 week of observation on allocated arm) analyses were done. Superiority was determined by a 15% difference in the proportion of patients with the primary outcome (60% vs 75%). This trial is registered with the International Standard Randomised Controlled Trials Number registry, number ISRCTN26184967.Findings Between Sept 1, 2014, and Oct 1, 2016, we randomly assigned 226 patients; 112 to VOT and 114 to DOT. Overall, 131 (58%) patients had a history of homelessness, imprisonment, drug use, alcohol problems or mental health problems. In the ITT analysis, 78 (70%) of 112 patients on VOT achieved >= 80% scheduled observations successfully completed during the first 2 months compared with 35 (31%) of 114 on DOT (adjusted odds ratio [OR] 5.48, 95% CI 3.10-9.68; p