mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial.

INTRODUCTION: The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuberculosis (MDR-TB) undergoing treatment in Vietnam. This economic evaluation seeks to quantify the cost-effectiveness of this mHealth intervention from a healthcare provider and societal perspective. METHODS AND ANALYSIS: The V-SMART trial will recruit 902 patients treated for MDR-TB across seven participating provinces in Vietnam. Participants in both intervention and control groups will receive standard community-based therapy for MDR-TB. Participants in the intervention group will also have a purpose-designed App installed on their smartphones to report AEs to health workers and to facilitate timely management of AEs. This economic evaluation will compare the costs and health outcomes between the intervention group (mHealth) and the control group (standard of care). Costs associated with delivering the intervention and health service utilisation will be recorded, as well as patient out-of-pocket costs. The health-related quality of life (HRQoL) of study participants will be captured using the 36-Item Short Form Survey (SF-36) questionnaire and used to calculate quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) will be based on the primary outcome (proportion of patients with treatment success after 24 months) and QALYs gained. Sensitivity analysis will be conducted to test the robustness of the ICERs. A budget impact analysis will be conducted from a payer perspective to provide an estimate of the total budget required to scale-up delivery of the intervention. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by the University of Sydney Human Research Ethics Committee (2019/676), the Scientific Committee of the Ministry of Science and Technology, Vietnam (08/QD-HDQL-NAFOSTED) and the Institutional Review Board of the National Lung Hospital, Vietnam (13/19/CT-HDDD). Study findings will be published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: ACTRN12620000681954.

Medication Adherence Assessment and Cost Analysis of COPD Treatment Under Out-Patient Clinic in Vietnam.

Chronic obstructive pulmonary disease (COPD) out-patient clinic is for stable patients but it requires patient's adherence to medicine and medical checkups. Our study aimed to assess COPD out-patient clinics management efficacy with respect to medication adherence and treatment costs at 3 out-patient clinics. Data were collected through 514 patient interviews and from medical records for statistical analysis. The most common comorbidity was hypertension (28.8%), and 52.9% of patients had experienced exacerbations in the past year requiring 75.7% of them to be hospitalized. According to the Morisky scale, 78.8% had high adherence and 82.9% were using inhaled corticosteroids regimens. The mean cost per year among different cohorts varied, with the out-patient cohort at $305.93, the acute exacerbations of COPD non-hospital cohort at $247.39, the standard admission cohort at $1275.3, and the emergency department cohort at $2132.5. Patients with low medication adherence had significantly lower annual costs ($238.25 vs $325.04, P = .001). In Vietnam, economic constraints have made Inhaled corticosteroids/ Long-acting ß-2 agonists the main mode of treatment. However, the exclusion of Long-acting ß-2 agonists/Long-acting anti-muscarinic antagonists drugs from health insurance coverage poses a challenge to Global Initiative for Chronic Obstructive Lung Disease-based prescription practices and increases the importance of monitoring medication adherence, particularly in patients with higher COPD Assessment Test scores.

Open-Source Hardware May Address the Shortage in Medical Devices for Patients with Low-Income and Chronic Respiratory Diseases in Low-Resource Countries.

Respiratory diseases pose an increasing socio-economic burden worldwide given their high prevalence and their elevated morbidity and mortality. Medical devices play an important role in managing acute and chronic respiratory failure, including diagnosis, monitoring, and providing artificial ventilation. Current commercially available respiratory devices are very effective but, given their cost, are unaffordable for most patients in low- and middle-income countries (LMICs). Herein, we focus on a relatively new design option-the open-source hardware approach-that, if implemented, will contribute to providing low-cost respiratory medical devices for many patients in LMICs, particularly those without full medical insurance coverage. Open source reflects a set of approaches to conceive and distribute the comprehensive technical information required for building devices. The open-source approach enables free and unrestricted use of the know-how to replicate and manufacture the device or modify its design for improvements or adaptation to different clinical settings or personalized treatments. We describe recent examples of open-source devices for diagnosis/monitoring (measuring inspiratory/expiratory pressures or flow and volume in mechanical ventilators) and for therapy (non-invasive ventilators for adults and continuous positive airway pressure support for infants) that enable building simple, low-cost (hence, affordable), and high-performance solutions for patients in LMICs. Finally, we argue that the common practice of approving clinical trials by the local hospital ethics board can be expanded to ensure patient safety by reviewing, inspecting, and approving open hardware for medical application to maximize the innovation and deployment rate of medical technologies.

Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial.

INTRODUCTION: Multidrug-resistant tuberculosis (MDR-TB) remains a major public health problem globally. Long, complex treatment regimens coupled with frequent adverse events have resulted in poor treatment adherence and patient outcomes. Smartphone-based mobile health (mHealth) technologies offer national TB programmes an appealing platform to improve patient care and management; however, clinical trial evidence to support their use is lacking. This trial will test the hypothesis that an mHealth intervention can improve treatment success among patients with MDR-TB and is cost-effective compared with standard practice. METHODS AND ANALYSIS: A community-based, open-label, parallel-group randomised controlled trial will be conducted among patients treated for MDR-TB in seven provinces of Vietnam. Patients commencing therapy for microbiologically confirmed rifampicin-resistant or multidrug-resistant tuberculosis within the past 30 days will be recruited to the study. Participants will be individually randomised to an intervention arm, comprising use of an mHealth application for treatment support, or a 'standard care' arm. In both arms, patients will be managed by the national TB programme according to current national treatment guidelines. The primary outcome measure of effectiveness will be the proportion of patients with treatment success (defined as treatment completion and/or bacteriological cure) after 24 months. A marginal Poisson regression model estimated via a generalised estimating equation will be used to test the effect of the intervention on treatment success. A prospective microcosting of the intervention and within-trial cost-effectiveness analysis will also be undertaken from a societal perspective. Cost-effectiveness will be presented as an incremental cost per patient successfully treated and an incremental cost per quality-adjusted life-year gained. ETHICS: Ethical approval for the study was granted by The University of Sydney Human Research Ethics Committee (2019/676). DISSEMINATION: Study findings will be disseminated to participants and published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: ACTRN12620000681954.