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.

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.

Economic evaluation of deep-brain stimulation for Tourette's syndrome: an initial exploration.

BACKGROUND: Deep-brain stimulation (DBS) can be effective in controlling medically intractable symptoms of Tourette's syndrome (TS). There is no evidence to date, though, of the potential cost-effectiveness of DBS for this indication. OBJECTIVE: To provide the first estimates of the likely cost-effectiveness of DBS in the treatment of severe TS. METHODS: We conducted a cost-utility analysis using clinical data from 17 Australian patients receiving DBS. Direct medical costs for DBS using non-rechargeable and rechargeable batteries and for the alternative best medical treatment (BMT), and health utilities for BMT were sourced from the literature. Incremental cost-effectiveness ratios (ICERs) were estimated using a Markov models with a 10-year time horizon and 5% discount rate. RESULTS: DBS increased quality-adjusted life year (QALY) gained from 2.76 to 4.60 over a 10-year time horizon. The ICER for DBS with non-rechargeable (rechargeable) batteries, compared to BMT, was A$33,838 (A$15,859) per QALY. The ICER estimates are sensitive to DBS costs and selected time horizon. CONCLUSIONS: Our study indicates that DBS may be a cost-effective treatment for severe TS, based on the very limited clinical data available and under particular assumptions. While the limited availability of data presents a challenge, we also conduct sensitivity analyses to test the robustness of the results to the assumptions used in the analysis. We nevertheless recommend the implementation of randomised controlled trials that collect a comprehensive range of costs and the use of a widely accepted health-related quality of life instrument to enable more definitive statements about the cost-effectiveness of DBS for TS.

Cost-Effectiveness of Deep Brain Stimulation With Movement Disorders: A Systematic Review.

BACKGROUND: Movement disorders (MDs) are increasingly being managed with deep brain stimulation (DBS). High-quality economic evaluations (EEs) are necessary to evaluate the cost-effectiveness of DBS. We conducted a systematic review of published EEs of the treatment of MDs with DBS. The review compares and contrasts the reported incremental cost-effectiveness ratios (ICERs) and methodology employed by trial-based evaluations (TBEs) and model-based evaluations (MBEs). METHODS: MeSH and search terms relevant to "MDs," "DBS," and "EEs" were used to search biomedical and economics databases. Studies that used a comparative design to evaluate DBS, including before-after studies, were included. Quality and reporting assessments were conducted independently by 2 authors. Seventeen studies that targeted Parkinson's disease (PD), dystonia, and essential tremor (ET), met our selection criteria. RESULTS: Mean scores for methodological and reporting quality were 73% and 76%, respectively. The ICERs for DBS compared with best medical therapy to treat PD patients obtained from MBEs had a lower mean and range compared with those obtained from TBEs ($55,461-$735,192 per quality-adjusted life-year [QALY] vs. $9,301-$65,111 per QALY). Pre-post ICER for DBS to treat dystonia was $64,742 per QALY. DBS was not cost-effective in treating ET compared with focused-ultrasound surgery. Cost-effectiveness outcomes were sensitive to assumptions in health utilities, surgical costs, battery life-span, model time horizons, and the discount rate. CONCLUSIONS: The infrequent use of randomized, controlled trials to evaluate DBS efficacy, the paucity of data reporting the long-term effectiveness and/or utility of DBS, and the uncertainty surrounding cost data limit our ability to report cost-effectiveness summaries that are robust.