In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence: A Randomized Noninferiority Trial.
In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence: A Randomized Noninferiority Trial.
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DOI：
10.1001/jamanetworkopen.2021.44210
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发表时间：
2022-01-04
影响因子：
13.8
通讯作者：
eDOT Study Team
中科院分区：
文献类型：
--
作者：
Burzynski J;Mangan JM;Lam CK;Macaraig M;Salerno MM;deCastro BR;Goswami ND;Lin CY;Schluger NW;Vernon A;eDOT Study Team
电子直接观察治疗（DOT）越来越多地被用作监测结核病治疗的现场DOT的替代方案。支持其功效的证据有限。确定电子DOT是否可以达到与亲自DOT一样有利的治疗观察水平。这是一项2阶段交叉、非劣效性试验，在门诊结核病治疗开始时，初始随机分配至电子或现场DOT。该试验于2017年7月至2019年10月在纽约市卫生局运营的4家诊所招募了216名医生怀疑或细菌学确诊的结核病参与者。数据分析于二零二零年三月至二零二一年四月期间进行。参与者被要求使用1种DOT方法完成20剂药物，然后切换方法完成另外20剂药物。对于面对面治疗，参与者选择诊所或社区DOT;对于电子DOT，参与者选择现场视频会议或录制视频。观察到参与者使用现场DOT和电子DOT完全摄入的药物剂量百分比之间的差异。如果差异的95%置信上限为10%或更低，则证明非劣效性。我们使用logistic混合效应模型估计完成剂量的百分比，以4种模式运行：修改的意向治疗，符合方案，符合方案且85%或更多剂量符合随机分配，以及经验。通过自举法（1000次重复）估计置信区间。在每个交叉期有173名参与者（中位年龄，40岁[范围，16-86岁]; 140名[66%]男性; 80名[37%]亚洲和太平洋岛民，43名[20%]黑人和71名[33%]西班牙裔个体）在改良的意向治疗分析模式中使用模型进行评估。使用现场DOT完成给药的百分比为87.2%（95% CI，84.6%-89.9%），而使用电子DOT完成给药的百分比为89.8%（95% CI，87.5%-92.1%）。百分比差异为−2.6%（95% CI，−4.8%至−0.3%），与非劣效性结论一致。其他3种分析模式得出了相同的结论，百分比差异在-4.9%到-1.9%之间。在本试验中，电子DOT完成剂量的百分比不劣于亲自DOT。这项试验提供了证据支持这种数字依从性技术的有效性，并将电子DOT纳入标准治疗。ClinicalTrials.gov标识符：NCT 03266003
Electronic directly observed therapy (DOT) is used increasingly as an alternative to in-person DOT for monitoring tuberculosis treatment. Evidence supporting its efficacy is limited. To determine whether electronic DOT can attain a level of treatment observation as favorable as in-person DOT. This was a 2-period crossover, noninferiority trial with initial randomization to electronic or in-person DOT at the time outpatient tuberculosis treatment began. The trial enrolled 216 participants with physician-suspected or bacteriologically confirmed tuberculosis from July 2017 to October 2019 in 4 clinics operated by the New York City Health Department. Data analysis was conducted between March 2020 and April 2021. Participants were asked to complete 20 medication doses using 1 DOT method, then switched methods for another 20 doses. With in-person therapy, participants chose clinic or community-based DOT; with electronic DOT, participants chose live video-conferencing or recorded videos. Difference between the percentage of medication doses participants were observed to completely ingest with in-person DOT and with electronic DOT. Noninferiority was demonstrated if the upper 95% confidence limit of the difference was 10% or less. We estimated the percentage of completed doses using a logistic mixed effects model, run in 4 modes: modified intention-to-treat, per-protocol, per-protocol with 85% or more of doses conforming to the randomization assignment, and empirical. Confidence intervals were estimated by bootstrapping (with 1000 replicates). There were 173 participants in each crossover period (median age, 40 years [range, 16–86 years]; 140 [66%] men; 80 [37%] Asian and Pacific Islander, 43 [20%] Black, and 71 [33%] Hispanic individuals) evaluated with the model in the modified intention-to-treat analytic mode. The percentage of completed doses with in-person DOT was 87.2% (95% CI, 84.6%–89.9%) vs 89.8% (95% CI, 87.5%–92.1%) with electronic DOT. The percentage difference was −2.6% (95% CI, −4.8% to −0.3%), consistent with a conclusion of noninferiority. The 3 other analytic modes yielded equivalent conclusions, with percentage differences ranging from −4.9% to −1.9%. In this trial, the percentage of completed doses under electronic DOT was noninferior to that under in-person DOT. This trial provides evidence supporting the efficacy of this digital adherence technology, and for the inclusion of electronic DOT in the standard of care. ClinicalTrials.gov Identifier: NCT03266003
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DOI：
10.1183/09031936.00193413
发表时间：
2014-06
期刊：
The European respiratory journal
影响因子：
--
作者：
Tanimura T;Jaramillo E;Weil D;Raviglione M;Lönnroth K
通讯作者：
Lönnroth K
影响因子：
158.5
作者：
FRIEDEN, TR;FUJIWARA, PI;HAMBURG, MA
通讯作者：
HAMBURG, MA
影响因子：
168.9
作者：
Story, Alistair;Aldridge, Robert W.;Hayward, Andrew C.
通讯作者：
Hayward, Andrew C.
影响因子：
11.8
作者：
Nahid, Payam;Dorman, Susan E.;Vernon, Andrew
通讯作者：
Vernon, Andrew
影响因子：
4.7
作者：
Guo, Peng;Qiao, Wei;Wang, Chunting
通讯作者：
Wang, Chunting