This study provides robust evidence that integrating VOT into standard TB treatment protocols significantly enhances patients’ QoL and reduces the overall disease burden.
Tuberculosis (TB) persists as a significant global public health concern despite the identification of its causative agent a century ago. According to the Global TB Report of 2023, TB ranks among the top 10 causes of mortality worldwide. In 2022, approximately 10.6 million individuals were infected with TB globally, comprising 5.8 million men, 3.5 million women, and 1.3 million children. TB negatively impacts the patient’s quality of life (QoL) and the effectiveness of treatment due to the physical, emotional, and social challenges during the disease. The impact on QoL has become a significant research focus over the last decade.
QoL is a broad and intricate concept that covers many aspects of life, including physical health, social connections, psychological well-being, economic stability, spirituality, and more. Due to its complexity, defining and measuring QoL is challenging. However, it can generally be understood as how individuals perceive their position in life, shaped by the culture and values they live in, and in relation to their personal goals, expectations, standards, and concerns. QoL varies among TB patients at different treatment stages. Poor QoL among patients at the start of treatment, and even at the end of treatment among those with unfavorable outcomes, calls for urgent attention from care providers at all stages. Besides the disease itself, the treatment involves prolonged use of multiple drugs, which can cause temporary adverse reactions that further affect the QoL, despite the ultimate benefits of the treatment.
Effective management of TB necessitates rigorous adherence to treatment regimens, typically achieved through directly observed treatment short course (DOTs). This traditional approach mandates that healthcare providers directly supervise patients as they take their medication, ensuring compliance and reducing the risk of drug resistance.
Recent advancements in digital technology have transformed healthcare, particularly in enhancing treatment outcomes for TB patients. Innovations such as video-observed therapy (VOT) and mobile health applications have revolutionized disease management. These digital health tools not only improve treatment efficacy but also facilitate real-time monitoring and personalized care, thereby enhancing patient QoL. By harnessing digital technology, VOT enables remote monitoring of patients as they take their medication, ensuring a high level of treatment adherence. This innovative approach involves two methods: synchronous VOT, where a healthcare worker observes the patient in real-time via video call, and asynchronous VOT, where the patients record and submit videos of themselves taking their medication, which are then reviewed by healthcare providers. This technology provides an enhanced opportunity to engage, counsel, and support patients.
As digital technologies continue to evolve, assessing their impact on TB patients’ QoL becomes increasingly important. Understanding how these innovations affect patient well-being can provide valuable insights for optimizing TB care and improving treatment outcomes. The World Health Organization recommends that VOT can serve as an alternative to DOTs if video communication technology is accessible and manageable by both healthcare providers and patients. However, the use of VOT in TB patients has not yet been explored in India. This study therefore aims to compare the QoL in TB patients using treatment observation by DOTs versus VOT in Northern India.
SUBJECTS AND METHODS
Setting study and design
This 6-month duration study was carried out at a TB hospital in India. It was prospective and observational in nature.
Ethical considerations
Ethical clearance was obtained from the institutional ethics committee, registered by DHR according to GCP guidelines. As the study was observational in nature, the patients were not subjected to any additional risk or harm during the study. Written informed consent was taken from the patients before participating in the study. The purpose and the details of the study were explained to the patients using a patient information sheet. The patient information sheet and informed consent were prepared in English as well as in Hindi.
Patient characteristics
A total of 110 TB patients were enrolled in the study and equally divided into two groups based on their observed therapy method: VOT and DOTs. The patients were randomly assigned into two equal groups: VOT and DOTs. For the DOTs group, patients visited the DOTs center, where they took their medicine under the observation of a healthcare worker. For the VOT group, both synchronous and asynchronous video calls were used to observe patients taking their medication.
Patients with pulmonary or extrapulmonary TB, of both genders, from age group 18 till 60 years, with or without comorbid conditions, and on a therapeutic regimen of isoniazid, rifampicin, pyrazinamide, and ethambutol were included. To participate in the VOT group, patients needed to have access to a smartphone or PC or laptop, or tablet with Internet connectivity. Drug-resistant TB patients and those with HIV as a comorbidity were excluded. In addition, TB patients who refused to participate in the study were excluded too.
Data collection
Demographic information for each patient was recorded at the beginning of the study. The QoL was assessed at three key points: at baseline (start of treatment), after 2 months (completion of the intensive phase), and at the end of 6 months (completion of treatment). Data were collected by in-person interviews with the help of the SF-36 questionnaire. This questionnaire, which has been previously translated, validated, and standardized, assesses various dimensions of health, including physical functioning, bodily pain, general health, energy, social functioning, emotional well-being, and mental health.
Statistical analysis
All statistical analyses were carried out using SPSS software. To compare variables, the ANOVA test and t-test were used. All hypotheses were considered significant if P < 0.05. Data were presented as mean ± standard deviation for normally distributed variables and median (interquartile range [IQR]) for skewed data.
RESULTS
Patients' characteristics
In this study, 55 patients each were enrolled in DOTs group and VOT group and observed for 6 months following the initiation of their treatment. Among the 55 patients in the VOT group, 18 (3.27%) were aged 18-24, 31 (56.36%) were aged 25-44, and 6 (10.90%) were aged 45-60. In comparison, the DOTs group included 37 (67.27%) patients aged 18-24, 24 (43.63%) patients aged 25-44, and 12 (21.81%) patients aged 45-60. In addition, the VOT group comprised 31 (56.36%) males and 24 (43.63%) females, while the DOTs group included 34 (61.81%) males and 21 (38.18%) females. The baseline characteristics of patients of both the groups have been compared in Table 1 to assess their similarity at the start of treatment. Most variables showed no significant difference, indicating that both groups were well-matched, except for the weight (P = 0.004), with lighter patients in DOTs and heavier in VOT.
Quality of life in tuberculosis patients using directly observed treatment short course
Table 2 demonstrates the change in QoL of patients over the various stages of treatment in the DOTs group. Significant improvement in the average scores for all the dimensions of QoL in the DOTs group was observed after the completion of the intensive phase and at the end of the treatment. The boxplot compares QoL scores before and after treatment, showing high QoL scores in patients observed by DOTs [Figure 1]. Initially, scores ranged from 0.19 to 14.64, with a median of 7.78 with IQR of 14.45. After the completion of the treatment, scores increased, ranging from 21.53 to 51.41, with a median of 45.19 and IQR of 29.88.
Quality of life in tuberculosis patients using video-observed therapy
Table 3 shows significant improvement in the average scores for all the dimensions of QoL in the VOT group as the treatment progressed. The boxplot highlights the treatment's effectiveness in improving QoL in the VOT group by comparing QoL scores before and after the treatment [Figure 2]. The initial treatment scores range from 10.06 to 28.81, with a median of 18.00 and IQR of 18.75. After treatment, scores increased, ranging from about 47.58 to 68.50 with a median of 58.82, and IQR of 20.92.
The total mean change in QoL score of TB patients in VOT was compared with those in DOTs group at various stages of treatment. It was found that the QoL of patients was significantly higher in the VOT group as compared to the DOTs group after completing the intensive phase and the continuous phase of the treatment (P < 0.05 was considered significant at a 95% confidence level) [Table 4].
DISCUSSION
DOT has been the standard approach to manage TB treatment, involving healthcare workers observing patients taking their medication. However, it is resource-intensive and can be burdensome for both patients and healthcare systems. Our results show that as the treatment progressed, the patients in DOTs group experienced improvement in QoL for all domains, with the most substantial improvement in the physical functioning dimension. These findings align with studies carried out in the past on Indian TB patients with significant improvement of QoL in the physical domain. Another DOTs-based study reflected an overall increase in physical, mental, and total summary score from 46.5, 37.6, and 43.1, respectively, to 70.1, 65.9, and 69.6, respectively, after continuous phase in TB patients. The boxplot graphs of DOTs group of our study reflected that the initial treatment scores were more tightly clustered compared to the final treatment, suggesting greater variability in outcomes after the treatment. Greater variability reflects that the treatment outcome may not be universally effective as observed by DOTs, leading to uneven results, which could be a concern for the healthcare providers.
VOT is facilitated by technological advancements and offers a potentially more flexible and less intrusive alternative, allowing patients to record and submit videos of themselves taking their medication. Our findings show that as the treatment progressed, QoL improved for all the domains, with the most notable improvement observed in the physical functioning dimension for the patients in the VOT group. The improved outcomes in the VOT group were significantly higher than the DOTs group patients. Furthermore, the boxplot graph for the VOT group shows less variability in the scores, which became consistently high after the final treatment, highlighting the effectiveness of VOT in improving QoL. Consistency in outcomes indicates that the treatment observed by VOT was effective across different patient groups and conditions.
DOTs require patients to travel to DOTs centers which increases the cost burden of the treatment and associated social stigma on the patients, thus affecting their QoL. Literature shows that patients in the DOTs group often experienced a reduction in work hours, achieved less in their jobs, and participated less in other activities, resulting in a decreased sense of vitality, thus adversely impacting their QoL. Conversely, the convenience and the flexibility of taking the medication at home and recording video of the same in the VOT group reduces the need for frequent healthcare facility visits. The reduction in travel expenses contributes to the overall cost savings in the VOT group, positively impacting their QoL scores. In addition, video recording reduced the stigma and the anxiety associated with TB, allowing patients to feel more comfortable and autonomous, thus improving their psychological well-being. This became more evident when a cross-sectional study carried out in Southern and Central India reported that majority of TB patients (62%) preferred video-observed treatment over directly observed treatment. The significant QoL score improvements observed in the VOT group suggest that VOT could be a viable alternative to DOTs, particularly in settings where frequent clinic visits are challenging. Furthermore, a recent systematic review and meta-analysis corroborates that VOT can be better linked with improvements in treatment success and losses to follow-up, in comparison to DOTs.
Limitations of the study
Our study has some limitations which must be considered. Notably, patients with multidrug-resistant TB were excluded from the study because their treatment regimens varied widely and often included injectable medications or multiple scheduled doses to be observed per day. In addition, the sample size was small, which could affect the robustness and generalizability of the results. The exclusion of hospital-admitted patients may also introduce biases, as these individuals might have different medication adherence and QoL compared to those treated in outpatient settings.
CONCLUSION
The impact of TB on the QoL of patients is profound, affecting their physical, emotional, and social well-being. The present study provides strong evidence supporting the integration of digital technology such as VOT as a standard practice in the treatment protocol of TB to enhance patient outcomes and reduce the overall burden of the disease. The convenience, flexibility, and reduced need for physical interaction in VOT make it particularly advantageous, especially in remote or resource-limited settings. Further evaluation of VOT implementation in a wider range of settings and among diverse populations will help fill evidence gaps and broaden the existing knowledge base.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
