Patients with tuberculosis who used a digital medication reminder monitor had better health-related quality of life (HRQOL) and lower catastrophic costs compared with patients who used a standard therapy.
A digital medication event reminder monitor (MERM)–observed therapy was associated with better health-related quality of life (HRQOL) and lower catastrophic costs for patients with tuberculosis (TB), compared with standard directly observed therapy (DOT).
These findings were published in JAMA Network Open, where the authors cited the lack of data on whether digital adherence technologies, such as MERMs, are economical for patients with TB in settings with limited resources as the reason for their research.
The current study served as a secondary analysis of a randomized, 2-arm, open-label trial conducted among 10 health care facilities in Ethiopia.
A total of 109 participants with pulmonary TB were included in this analysis, with 57 participants randomly assigned to the control group and 52 to the intervention group. All participants were adults with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who were eligible to start first-line anti-TB therapy.
The mean (SD) age was 33.1 (11.1) years and most participants (66.1%) were men. The study authors also noted that 15 (13.9%) participants had HIV coinfection.
Participants in the intervention group received a 15-day course of TB medication dispensed via a MERM device to self-administer and return every 15 days. Meanwhile those in the control group received standard or the standard in-person DOT. Both groups were observed over a 2-month treatment phase.
The authors discovered HRQOL was significantly better in patients with pulmonary TB who used the MERM device compared with patients who used standard DOT. The EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) overall median (IQR) index value was 0.964 (0.907-1), with a median index value of 1 (0.974-1) in the treatment group and .908 (0.891-0.964) in the control group (P < .001).
Additionally, the EQ-5D-5L minimum and maximum health state utility values were 0.906 and 1 in the MERM group, and 0.832 and 1 in the DOT group.
Patients with TB using the digital therapy also had significantly lower rates of catastrophic costs compared with patients not using it.
Measured by the Ethiopian birr (ETB), the median (IQR) postdiagnosis cost for patients using MERM was ETB 24 (16-48), while the cost for patients using DOT was significantly higher at ETB 432 (210-1980). Converted to the US dollar, this amounts to median possible cost savings of $6.44 for patients using MERM-observed therapy.
“If patients in the control arm followed the intervention procedure, they would have the possibility of saving about 92.6% of their current expenditure on TB treatment,” the authors noted.
Further, 42 of the 109 participants faced catastrophic costs. This number was significantly lower in the intervention group, with 11 (21.2%) participants who used the digital therapy facing catastrophic costs, compared with 31 (54.4%) participants from the DOT group.
The authors also found the risk for lower HRQOL was 49% more likely in the DOT trial arm compared with the MERM trial arm.
“This indicates that this intervention has the potential to maintain the economic, psychological, and social well-being of patients with TB as compared with the standard DOT,” the authors wrote. “The main explanation is that, unlike in-person daily DOT, patients who used the MERM device visited the health care facility every 15 days and this significantly reduced vulnerability of patients to the underlying barriers including costs for travel, food, and accommodation for daily in-person DOT."
The most important factor for low HRQOL was trial arm. Meanwhile, trial arm, occupation, number of cohabitants, and smoking were all the most important factors in catastrophic cost.
Limitations include the small sample size from a single city, potential recall bias, and lack of data on other TB-related costs such as pain and nausea medications. Additionally, the EQ-5D-5L was completed once after the treatment period, but did not demonstrate changes in participant health status throughout the 2-month period.
“Despite these limitations, this study clearly compared the effects of MERM-observed self-administered therapy on HRQoL and costs for patients with TB vs the standard DOT in Ethiopia, one of the countries with the highest burden of TB but poorly represented in such clinical trials,” the authors said.
Manyazewal T, Woldeamanuel Y, Fekadu A, Holland DP, Marconi VC. Effect of digital medication event reminder and monitor-observed therapy vs standard directly observed therapy on health-related quality of life and catastrophic costs in patients with tuberculosis. JAMA Netw Open. 2022;5(9):e2230509. doi:10.1001/jamanetworkopen.2022.30509