Directly Observed Therapy in TB: Can an Alternative Digital Method Improve QoL?

Patients with tuberculosis (TB) had significantly higher health-related quality of life (HRQoL) and significantly lower catastrophic costs when using digital medication event reminder monitor (MERM)-observed therapy vs standard directly observed therapy (DOT), according to study findings published recently in the Journal of the American Medical Association Network Open.

The current standard care for TB requires patients to take medications at a health care facility where they are directly observed. In response to World health Organization stated TB priorities, efforts are underway to find easier and more cost-effective alternatives to this burdensome 6- to 20-month DOT regimen. Researchers therefore sought to compare standard DOT with digital MERM-observed therapy, evaluating their respective effects on HRQoL and direct and indirect catastrophic health care costs. 

The researchers conducted a secondary analysis of the SELFTB trial, a 2-arm, open-label, randomized trial (ClinicalTrials.gov Identifier: NCT04216420) in 10 health care centers in Ethiopia from June 2020 through mid-June 2021. The study analysis involved 109 participants (mean [SD] age, 33.1 [11.1] years; 66.1% male; 13.9% with HIV coinfection) who were previously treated or new bacteriologically confirmed, drug-sensitive pulmonary TB. Participants were divided into 2 cohorts, with 57 in a control group using standard, in-person, DOT, and 52 in an intervention group in which participants received a 15-day TB medication supply to self-administer and return via a MERM device. HIV status and baseline characteristics were well-balanced between the 2 arms. Observations of both arms lasted through a 2-month intensive treatment phase.

The investigators measured HRQoL using the EuroQoL 5-dimension 5-level (EQ-5D-5L) tool, which measures an individual’s overall HRQoL and health state using a score ranging from 0 to 1, with the higher score indicating better HRQoL/health state. The 5 dimensions of HRQoL considered by the tool include mobility, self-care, usual activities, pain or discomfort, and anxiety or depression.

 For the overall study population, the median (IQR) EQ-5D-5L index value was 0.964 (0.907-1.000). The study analysis found that the median (IQR) was significantly higher in the intervention arm (1.000[0.974-1.000] vs the control arm (0.908[0.891-0.964]) (P <.001). Minimum and maximum values for the health state of participants were 0.832 and 1.000 in the control group and 0.906 and 1.000 in the intervention group. The analysis also found a higher proportion of patients with health problems such as anxiety and depression and pain in the control group vs intervention group, and that 92.3% of participants found to have full health according to the EQ-5D-5L were in the intervention group.

The researchers found that the overall median patient post-diagnosis cost among patients studied was $1.53 US (Ethiopian birr [ETB] 80 [IQR 16 to 480]), and that this cost was significantly lower in the intervention arm (ETB 24 [16 to 48] vs the control arm (ETB 432 [210 to 1980]) (P <.001). The investigators calculated median possible cost savings associated with the intervention to be ETB 336 (156 to 1339). They also found that overall, 42 (38.5%) study participants faced catastrophic costs, and that significantly fewer of these participants were in the intervention arm (11) vs the control arm (31) (P <.001).

The investigators also analyzed of individual factors contributing to the outcomes assessed. The most important factor associated with low HRQoL was receipt of standard care rather than the MERM intervention; the most important factors associated with catastrophic costs were the patient’s number of cohabitants, occupation, and smoking status.

Study limitations included underpowered sample size, limited generalizability, recall bias in the tool used to estimate patient costs, and single-time completion of the EQ-5D-5L.

“MERM device-observed self-administered therapy was associated with higher HRQoL and lower catastrophic costs compared with the standard DOT,” researchers concluded. They added that “The financial burden of treatment remains a critical issue for patients with TB preventing them from being retained in care, which alternative mechanisms including the use of digital health may alleviate.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

This article originally appeared on Pulmonology Advisor