Evaluation of patient centred digital adherence technology for tuberculosis treatment outcomes: pragmatic randomised controlled trial.

Methods

Pragmatic, two arm, parallel randomised controlled trial.

实用的、双臂、平行随机对照试验。

Four public reference hospitals in Buenos Aires, Argentina.

位于阿根廷布宜诺斯艾利斯的四家公立参考医院。

555 patients aged ≥16 years with newly diagnosed drug susceptible tuberculosis, recruited between November 2020 and July 2023, randomised to standard of care (n=278) or standard of care plus TB-TST (n=277).

招募了555名年龄≥16岁、新诊断为药物敏感性结核病的患者，招募时间为2020年11月至2023年7月，随机分为标准治疗组（n=278）和标准治疗加结核菌素试验（TB-TST）组（n=277）。

intervention

A mobile application that enabled daily adherence reporting, bidirectional messaging with treatment supporters, educational content, and a weekly urine based isoniazid test for verification of adherence.

一种移动应用程序，能够实现每日服药依从性报告、与治疗支持者双向消息交流、提供教育内容以及每周一次的尿液异烟肼测试以验证依从性。

Participants and care givers were aware of their group assignment, but data collectors and data analysts were masked.

参与者和护理人员知道他们的分组情况，但数据收集者和数据分析人员对此是不知情的。

Methods

The primary outcome was treatment success (cure or treatment completion).

主要结果是治疗成功（治愈或完成治疗）。

Secondary outcomes included loss to follow-up.

次要结果包括随访丢失。

Analyses used intention-to-treatand per protocol approaches.

分析采用了意向治疗和按方案处理的方法。

Results

525 participants (94.6% of the enrolled population) were included in the analysis after exclusion of 30 individuals who deviated from the protocol.

在排除了30名偏离方案的个体后，共有525名参与者（占登记人群的94.6%）被纳入分析。

In the intention-to-treatanalysis, treatment success was higher in the intervention group (208/255; 82%) than in the control group (201/270; 74%).

在意向治疗分析中，干预组的治疗成功率（208/255；82%）高于对照组（201/270；74%）。

The risk difference was 7.1% (95% confidence interval1.1% to 14.1%), and the risk ratio was 1.10 (1.00 to 1.20; P=0.04).

风险差异为7.1%（95%置信区间1.1%至14.1%），风险比为1.10（1.00至1.20；P=0.04）。

Loss to follow-up was lower in the intervention group (17% v 24%; risk ratio 0.70, 0.50 to 0.98; P=0.04).

干预组的失访率较低（17%对比24%；风险比为0.70，95%置信区间为0.50至0.98；P=0.04）。

Greater benefit was observed among female participants and those aged under 35 years.

在女性参与者和35岁以下的参与者中观察到更大的益处。

Conclusions

A multifaceted, interactive digital adherence tool improved tuberculosis treatment outcomes, particularly among younger participants and women, showing feasibility and effectiveness in supporting adherence to tuberculosis treatment in low resource settings.

一个多方面、互动的数字依从性工具改善了结核病治疗结果，特别是在年轻参与者和女性中，显示出在支持低资源环境下结核病治疗依从性的可行性和有效性。

Future research should evaluate the impact of app engagement, context factors such as the covid-19 pandemic, cost effectiveness, and use of the tool beyond tuberculosis in the management of chronic diseases.

未来的研究应评估应用程序参与度的影响、包括COVID-19大流行在内的环境因素、成本效益，以及在慢性病管理中除结核病外的工具使用情况。

AI powered features and integrated mental health support may enhance the scalability and personalisation of care.

人工智能驱动的功能和集成的心理健康支持可能会增强护理的可扩展性和个性化。

trial_registration

ClinicalTrials.gov NCT04221789; International Registered Report Identifier DERR1-10.2196/28094.

ClinicalTrials.gov NCT04221789; 国际注册报告标识符 DERR1-10.2196/28094。