使用数字依从性技术作为药物敏感型肺结核成人患者和医疗服务提供者干预保真度的衡量指标:对五个国家整群随机试验数据的描述性分析
Engagement With Digital Adherence Technologies as Measures of Intervention Fidelity Among Adults With Drug-Susceptible Tuberculosis and Health Care Providers: Descriptive Analysis Using Data From Cluster-Randomized Trials in Five Countries.
作者信息
Alacapa Jason, Tadesse Amare Worku, Deyanova Natasha, Dube Tanyaradzwa, Mganga Andrew, Powers Rachel, van Rest Job, Madden Norma, Efo Egwuma, Charalambous Salome, van Kalmthout Kristian, Jerene Degu, Fielding Katherine
机构信息
KNCV Tuberculosis Plus, Manila, Philippines.
TB Centre and Department of Infectious Disease Epidemiology and International Health, London School of Hygiene & Tropical Medicine, Keppel St, London, WC1E 7HT, United Kingdom, 44 20 7636 8636, 44 20 7636 8636.
出版信息
JMIR Public Health Surveill. 2025 Jul 28;11:e62881. doi: 10.2196/62881.
BACKGROUND
Digital adherence technologies (DATs) are promising tools for supporting tuberculosis (TB) treatment. DATs can serve as reminders for people with TB to take their medication and act as proxies for adherence monitoring. Strong engagement with DATs, from both the person with TB and health care provider (HCP) perspectives, is essential for ensuring intervention fidelity. The Adherence Support Coalition to End TB (ASCENT) project evaluated 2 types of DATs, pillboxes and medication labels (99DOTS), in cluster-randomized trials across 5 countries.
OBJECTIVE
This study aims to investigate participant and HCP engagement with DATs for TB treatment, stratified by DAT type and country.
METHODS
This study is a subanalysis of data generated through the ASCENT trials, which enrolled adults with drug-susceptible TB. A digital dose was defined as either a pillbox opening (for pillbox users) or a dosing confirmation SMS text message sent by the participant (for label users), both of which were recorded on the adherence platform. Descriptive analysis was used to provide an overview of dose-day outcomes. DAT engagement was assessed from both participant and HCP perspectives. To enhance participant engagement, we summarized the frequency of digital engagement overall and by treatment phase, as well as the frequency of consecutive days without engagement. For HCP engagement, we summarized the frequency of doses added manually, the number of days between the actual dose day and when a manual dose was added, and instances of consecutive manual dosing lasting more than 3 and more than 7 days, where doses were added more than 1 week after the dose day.
RESULTS
Of the 9511 participants included, 6719 (70.64%) were using the pillbox, 3544 (37.26%) were female, and the median age was 40 years. Across DAT types, there were 1,384,879 dose days, with 973,876 (70.32%) contributed by pillbox users. Of all dose days, 1,165,195 (84.14%) were recorded as digital, 156,664 (11.31%) as manual, 59,045 (4.26%) had no information, and 3975 (0.29%) were confirmed as missed. Digital dosing decreased slightly from the intensive to the continuation phase. The percentage of digital dose days was higher among pillbox users (851,496/973,876, 87.43%) compared with label users (313,699/411,003, 76.33%). Among label users, manual dosing was most common in the Philippines (37,919/171,786, 22.07%) and least common in Tanzania (11,108/76,231, 14.57%). Among pillbox users, manual dosing was most common in the Philippines (24,015/208,130, 11.54%) and Ukraine (13,209/111,901, 11.80%). Overall, 512 out of 2792 (18.34%) label users and 588 out of 6719 (8.75%) pillbox users experienced a run of more than 7 consecutive nondigital dose days that were resolved more than 1 week after the dose day. The highest occurrence was observed in the Philippines (368/1142, 32.22%, for label users and 224/1351, 16.58%, for pillbox users).
CONCLUSIONS
There was considerable variation in DAT engagement across countries and DAT types, reflecting differences in how the intervention was implemented. Further refinement of the intervention and improvements in its delivery may be necessary to enhance outcomes.
背景
数字依从技术(DATs)是支持结核病(TB)治疗的有前景的工具。DATs可以作为提醒结核病患者服药的工具,并充当依从性监测的代理。从结核病患者和医疗服务提供者(HCP)的角度来看,与DATs的密切参与对于确保干预的保真度至关重要。终止结核病依从性支持联盟(ASCENT)项目在5个国家的整群随机试验中评估了2种DATs,药盒和药物标签(99DOTS)。
目的
本研究旨在按DAT类型和国家分层,调查参与者和HCP对用于结核病治疗的DATs的参与情况。
方法
本研究是对ASCENT试验产生的数据进行的子分析,该试验纳入了患有药物敏感型结核病的成年人。数字剂量被定义为药盒打开(对于药盒使用者)或参与者发送的给药确认短信(对于标签使用者),两者均记录在依从性平台上。描述性分析用于提供剂量日结果的概述。从参与者和HCP的角度评估DAT参与情况。为了提高参与者的参与度,我们总结了总体和按治疗阶段的数字参与频率,以及连续无参与天数的频率。对于HCP的参与情况,我们总结了手动添加剂量的频率、实际给药日与添加手动剂量之间的天数,以及连续手动给药持续超过3天和超过7天的情况,即给药日之后超过1周添加剂量的情况。
结果
在纳入的9511名参与者中,6719名(70.64%)使用药盒,3544名(37.26%)为女性,中位年龄为40岁。在不同的DAT类型中,共有1384879个剂量日,其中药盒使用者贡献了973876个(占70.32%)。在所有剂量日中,1165195个(84.14%)被记录为数字剂量,156664个(11.31%)为手动剂量,59045个(4.26%)无信息,3975个(0.29%)被确认为漏服。从强化期到延续期,数字给药略有下降。药盒使用者的数字剂量日百分比(851496/973876, 87.43%)高于标签使用者(313699/411003, 76.33%)。在标签使用者中,手动给药在菲律宾最为常见(37919/171786, 22.07%),在坦桑尼亚最不常见(11108/76231, 14.57%)。在药盒使用者中手动给药在菲律宾(24015/208130, 11.54%)和乌克兰(13209/111901, 11.80%)最为常见。总体而言,2792名标签使用者中有512名(18.34%)和6719名药盒使用者中有588名(8.75%)经历了连续7天以上的非数字剂量日,且在给药日之后超过1周得到解决。最高发生率出现在菲律宾(标签使用者为368/1142, 32.22%,药盒使用者为224/1351, 16.58%)。
结论
不同国家和DAT类型的DAT参与情况存在相当大的差异,这反映了干预实施方式的不同。可能需要进一步完善干预措施并改进其实施,以提高效果。