Effectiveness of a Comprehensive Package Based on Electronic Medication Monitors at Improving Treatment Outcomes Among Tuberculosis Patients in Tibet: A Multi-Centre Randomised Controlled Trial

Wei, Xiaolin; Hicks, Joseph Paul; Zhang, Zhitong; Haldane, Victoria; Pasang, Pande; Li, Linhua; Zhang, Bei; Li, Yinlong; Pan, Qidong; Liu, Xiaoqiu; Walley, John; Hu, Jun

doi:10.2139/ssrn.4387313

Cited by 8 publications

(10 citation statements)

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“…Examples include medication reminders, [19,22,25,28,40,[48][49][50][51] encouraging adverse event reporting [19,20,22,24,40,48] and/or escalation via SMS, phone calls, or home visits if expected video observation was missed. Some VOT interventions were coupled with motivational SMS, reimbursement of mobile data costs, payment for visit attendance, or nutritional allowances.…”

Section: Discussionmentioning

confidence: 99%

The Impact of Digital Adherence Technologies on Health Outcomes in Tuberculosis: A Systematic Review and Meta-Analysis

Mohamed,

Zary,

Kafie

et al. 2024

Preprint

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Background: Suboptimal tuberculosis (TB) treatment adherence may lead to unsuccessful treatment and relapse. Digital adherence technologies (DATs) may allow more person-centric approaches for supporting treatment. We conducted a systematic review (PROSPERO- CRD42022313166) to evaluate the impact of DATs on health outcomes in TB. Methods: We searched MEDLINE, Embase, CENTRAL, CINAHL, Web of Science and preprints from medRxiv, Europe PMC, and clinicaltrials.gov for relevant literature from January 2000 to April 2023. We considered experimental or cohort studies reporting quantitative comparisons of clinical outcomes between a DAT and the standard of care in each setting. Results: Seventy studies (total 58,950 participants) met inclusion criteria. They reported SMS-based interventions (k=18 studies), feature phone-based interventions (k=7), medication sleeves with phone calls (branded as “99DOTS,” k=5), video-observed therapy (VOT; k=17), smartphone-based interventions (k=5), digital pillboxes (k=18), ingestible sensors (k=1), and interventions combining 2 DATs (k=1). Overall, the use of DATs was associated with more frequent treatment success in TB disease (OR = 1.18 [1.06, 1.33]; I2 = 66%, k = 46), a decrease in loss to follow up (OR = 0.71 [0.53, 0.94]; I2 = 80%, k = 36) and an increase in adverse event reporting (OR = 1.53 [1.26, 1.86]; I2 = 0%, k = 9). VOT was associated with an increased likelihood of treatment success in TB disease (OR 1.54 [1.09; 2.19]; I2 = 0%, k = 8) and treatment completion in TB infection (OR 4.69 [2.08; 10.55]; I2 = 0%, k = 2) as well as an increased frequency of adverse event reporting (OR = 1.79 [1.27; 2.52]; I2 = 34%, k = 4). Other interventions involving smartphone technologies were associated with increased treatment success in TB disease (OR 1.98 [1.07; 3.65]; I2 =56%, k = 5) and a decreased frequency of loss to follow up(OR = 0.31 [0.13; 0.77]; I2 = 36%, k = 5). Digital pillboxes were also associated with an improvement in treatment success (OR = 1.32 [1.00; 1.73]; I2 = 71%, k = 11). However, improved treatment success was only seen in high- and upper middle-income countries. SMS-based interventions, feature-phone interventions and 99DOTS were not associated with improvements in short-term clinical outcomes. Conclusion: Certain DATs--notably VOT and smartphone-based interventions, in higher income settings and sometimes combined with other supportive measures—may be associated with improvements in treatment success and losses to follow-up, compared to standard care. However, evidence remains highly variable, and generalizability limited. Higher quality data are needed.

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Section: Discussionmentioning

confidence: 99%

The Impact of Digital Adherence Technologies on Health Outcomes in Tuberculosis: A Systematic Review and Meta-Analysis

Mohamed,

Zary,

Kafie

et al. 2024

Preprint

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“…This intervention improved treatment success primarily by reducing loss to follow-up. Recent findings from a trial in Tibet (16), conducted in a very rural setting, where 25% of participants had microbiologically confirmed TB and the median age of 56 years, reported improved treatment outcomes among participants in the intervention arm versus standard of care. The intervention included a comprehensive package of interventions using medication monitors with voice reminders, health education and personalised support to use the DAT.…”

Section: Discussionmentioning

confidence: 99%

“…Recent DAT trials have reported mixed results on the effectiveness of DATs in improving TB treatment and health outcomes (12), including large-scale trials (13-15). Many trials have shown an impact on treatment adherence (13, 16-23) but few have demonstrated an impact on improving end of treatment outcomes(16, 24, 25). Including TB recurrence in the endpoint definition, as is standard for DS-TB treatment trials, provides a more sensitive measure of the success of the intervention, though few DAT trials have attempted to do so (13, 14).…”

Section: Introductionmentioning

confidence: 99%

Cluster-randomized trial of digital adherence technologies and differentiated care to reduce poor end-of-treatment outcomes and recurrence among adults with drug-sensitive pulmonary TB in Ethiopia

Tadesse,

Sahile,

Foster

et al. 2024

Preprint

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Background The impact of Digital Adherence Technologies (DATs) on long-term tuberculosis treatment outcomes remains unclear. We aimed to assess the effectiveness of DATs and differentiated care in improving tuberculosis treatment outcomes and recurrence. Methods We conducted a pragmatic cluster-randomised trial in Ethiopia. Seventy-eight health facilities (clusters) were randomised to three arms (1:1:1): smart pillbox, medication labels, or standard of care. Adults (≥18 years) with drug-sensitive pulmonary tuberculosis on a fixed-dose combination tuberculosis treatment regimen were enrolled and followed-up for 12 months after treatment initiation. Those in the pillbox arm received a pillbox with customisable audio-visual reminders, while participants in the label arm received their TB medication with a weekly unique code label. Opening the box or texting the code prompted real-time dose logging on the adherence platform, facilitating differentiated response by a healthcare worker. The primary outcome comprised death, loss to follow-up, treatment failure, switch to drug-resistant tuberculosis treatment, or recurrence; secondary outcomes included loss to follow-up. Analysis accounted for clustered design with multiple imputation for the primary outcome. The trial is complete and registered with PACTR202008776694999. Findings From 24/05/2021-08/08/2022, 8477 individuals undergoing tuberculosis treatment were assessed for eligibility, and 3885 participants enrolled, of whom 3858 were included in the intention-to-treat population. The median age was 30 years and 41% were female. At 12 months, using multiple imputation, neither the pillbox (adjusted OR 1.04, 95% CI: 0.74-1.45; adjusted risk difference, 1.0 percentage points, 95% CI -1.2 to 3.1) nor the label (adjusted OR 1.14, 95%CI: 0.83-1.61; adjusted risk difference, 0.4 percentage points, 95% CI -1.8 to 2.6) interventions reduced the risk of the primary composite outcome. Results were similar in complete case and per-protocol analyses. Interpretation The DAT interventions showed no reduction in unfavourable outcomes. This emphasizes the necessity to optimise DATs to enhance TB management strategies and treatment outcomes.

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“…Previous studies employed the CFIR to identify and leverage barriers and motivators in TB control, such as disease texting, screening, triage, diagnosis, prescription, treatment, preventative and care improvement [ 53 – 56 , 64 – 69 ]. Furthermore, it examined the challenges and enablers of implementing electronic monitors, other similar mobile health applications and electronic monitoring systems in diverse settings, including China, Uganda, North America and Africa, and South Africa [ 70 – 74 ]. These studies have illuminated the utility of the CFIR in exploring factors related to TB, electronic monitors and other digital health technologies and elucidating valuable insights into TB management and diverse healthcare settings.…”

Section: Discussionmentioning

confidence: 99%

Barriers and facilitators of implementing electronic monitors to improve adherence and health outcomes in tuberculosis patients: protocol for a systematic review based on the Consolidated Framework for Implementation Research

Li,

Su,

Zhang

et al. 2023

Health Res Policy Sys

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Background Tuberculosis (TB) has been regarded as ‘a relentless scourge’, increasing morbidity and mortality and burdening vulnerable populations. Poor adherence to TB treatment and ineffective traditional interventions hinders TB control. A novel TB approach called ‘electronic monitors’, equipping medication boxes with daily audio or visual reminders for electronically monitoring medication intake, seems promising in improving adherence and health outcomes and overcoming the weaknesses of traditional interventions. However, no review has systematically examined and synthesized the influencing factors of implementing electronic monitors. Implementation research offers the means to analyse the influencing factors of the implementation and its process, fitting well with the aim of this review. Therefore, the widely recognized Consolidated Framework for Implementation Research (CFIR), which offers a common taxonomy for evaluating intervention implementation, will be adopted to systematically identify barriers and facilitators of the electronic monitors for improving adherence and health outcomes in patients with TB. Methods and analysis The systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Literature research will be conducted in five electronic databases (Ovid MEDLINE, CINAHL, EMBASE, Cochrane Library and Web of Science) to identify the barriers and facilitators of implementing electronic monitors in patients with TB. The CFIR will be used as a guide for categorizing and synthesizing the barriers and facilitators. Study screening, data extraction, quality appraisal and data analysis will be conducted by two independent reviewers. The use of additional reviewers will solve any disagreements between the two reviewers. Discussion Given the increased prominence of TB epidemiology and the adherence problem of electronic monitors, there is a solid rationale for synthesizing the existing studies via the CFIR. The findings and conclusion of this review will lay bare the achievements and effectiveness of implementing electronic monitors, as well as the attendant gaps and limitations. Further strategies for facilitating the implementation of electronic monitors will also be explored. This review will be of essential significance for research and practice, supporting future academic research initiatives centred on patients with TB and aiding electronic monitor design in lowering the morbidity and mortality associated with TB disease. Trial registration number: PROSPERO: CRD42023395747.

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Effectiveness of a Comprehensive Package Based on Electronic Medication Monitors at Improving Treatment Outcomes Among Tuberculosis Patients in Tibet: A Multi-Centre Randomised Controlled Trial

Cited by 8 publications

References 0 publications

The Impact of Digital Adherence Technologies on Health Outcomes in Tuberculosis: A Systematic Review and Meta-Analysis

The Impact of Digital Adherence Technologies on Health Outcomes in Tuberculosis: A Systematic Review and Meta-Analysis

Cluster-randomized trial of digital adherence technologies and differentiated care to reduce poor end-of-treatment outcomes and recurrence among adults with drug-sensitive pulmonary TB in Ethiopia

Barriers and facilitators of implementing electronic monitors to improve adherence and health outcomes in tuberculosis patients: protocol for a systematic review based on the Consolidated Framework for Implementation Research

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