National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
International Union against Tuberculosis and Lung Disease (The Union), Paris, France.
PLoS One. 2020 Nov 9;15(11):e0242112. doi: 10.1371/journal.pone.0242112. eCollection 2020.
In China, an indigenously developed electronic medication monitor (EMM) was used. EMM recorded each time the device was opened (no real time data), offering an indirect measure of tuberculosis treatment adherence. Previous study in China showed that the EMM uptake was satisfactory, missing adherence data were common in the information management system (25%) and shift to directly observed therapy (DOT) based on poor adherence documented by EMMs were seldom.
Among people with tuberculosis notified in 30 counties (July-December 2018) where EMM supported self-administered therapy (SAT) was suggested to all eligible (no communication impairment, ambulatory), we assessed the relative differences in unfavourable outcomes and deaths among those started on EMM at baseline (within first month of diagnosis) when compared to SAT alone.
This was a cohort study using secondary data. We employed an intention to treat analysis, and used modified Poisson regression with robust variance estimates to assess the association.
Of 1810 eligible people, 1047 used EMM at baseline and of them, 216 (20.1%) stopped using EMM midway. Of 763 people who did not use EMM at baseline, 267 (35.0%) started using EMM later during the treatment. Among those who started using EMM at baseline, 6.3% [95% CI: 4.9, 8.0] had unfavourable outcomes compared to 6.7% [95% CI: 5.1, 8.8] among those who did not (p = 0.746). Lesser deaths were observed in people who started EMM at baseline when compared to those who did not: 2.5% [95% CI: 1.7, 3.7] versus 3.5% [95% CI: 2.4, 5.2], p = 0.191. The lack of association remained after adjusting for potential confounders (occupation, TB classification and TB category).
Under programmatic settings, we did not find significant differences in the outcomes. Optimization of EMMs by shifting to DOT when indicated, addressing the issue of missing data and ensuring continuous use is required.
在中国，使用了一种自主研发的电子用药监测器（EMM）。EMM 记录每次设备开启的时间（无实时数据），这是对结核病治疗依从性的间接衡量。中国此前的研究表明，EMM 的采用率令人满意，但信息管理系统中经常缺失依从性数据（25%），而且很少根据 EMM 记录的较差依从性转为直接观察治疗（DOT）。
在 30 个县（2018 年 7 月至 12 月）中，所有符合条件的结核病患者（无沟通障碍、可活动）都推荐使用 EMM 支持自我管理治疗（SAT），我们评估了在基线时（诊断后第一个月内）开始使用 EMM 与单独使用 SAT 的人群之间不良结局和死亡的相对差异。
这是一项利用二级数据进行的队列研究。我们采用意向治疗分析，并使用校正后的方差估计量进行修正泊松回归来评估相关性。
在 1810 名符合条件的患者中，有 1047 名患者在基线时使用了 EMM，其中 216 名（20.1%）中途停止使用 EMM。在 763 名基线时未使用 EMM 的患者中，有 267 名（35.0%）在治疗过程中开始使用 EMM。在基线时开始使用 EMM 的患者中，有 6.3%（95%CI：4.9，8.0）出现不良结局，而未使用 EMM 的患者中有 6.7%（95%CI：5.1，8.8）（p = 0.746）。与未使用 EMM 的患者相比，基线时开始使用 EMM 的患者死亡人数较少：2.5%（95%CI：1.7，3.7）与 3.5%（95%CI：2.4，5.2）（p = 0.191）。在调整了职业、结核病分类和结核病类别等潜在混杂因素后，这种关联仍然存在。
在项目实施环境下，我们未发现结局存在显著差异。需要通过转为指示性 DOT 来优化 EMM，解决数据缺失问题，并确保连续使用。
