Cohort study on association between catastrophic costs and unfavorable tuberculosis treatment outcomes among TB-HIV and TB-diabetes comorbid patients in India.

BACKGROUND: India grapples with an alarming burden of tuberculosis (TB), reporting 2.6 million incident cases in 2023, necessitating intensified efforts toward TB elimination. The prevalence of catastrophic costs, defined as expenses exceeding 20% of annual household income, varies widely. Our objective was to determine the association between catastrophic costs from TB-HIV and TB-diabetes care and unfavorable TB treatment outcomes. METHODS: We conducted a cohort study in Bhavnagar, India, from July 2019 to January 2021, involving 234 TB-HIV and 304 TB-diabetes patients. Catastrophic costs were assessed using the World Health Organization's tool. Unfavorable TB treatment outcomes included positive results from sputum smear, nucleic acid amplification, or culture tests at treatment completion, death during treatment, or treatment cessation for a month (for drug-sensitive TB) or two months (for drug-resistant TB). Firth regression was employed to address quasi-separation issues and identify predictors. RESULTS: Among TB-HIV patients, 12% faced catastrophic costs, with 20% experiencing unfavorable TB outcomes. In this group, significant predictors included weight (OR: 0.93, 95% CI: 0.89-0.98), family type (OR: 2.5, 95% CI: 1.2-5.5), and initial hospitalization (OR: 2.6, 95% CI: 1.1-6.3). For TB-diabetes patients, 5% faced catastrophic costs, and 14% had unfavorable outcomes, with significant predictors being below the poverty line (BPL) (OR: 2.9, 95% CI: 1.5-5.9) and initial hospitalization (OR: 3.4, 95% CI: 1.1-11.1). Catastrophic cost incidence was higher in TB-HIV (12% vs. 4% in TB only) and TB-diabetes (5% vs. 4% in TB only) patients. However, catastrophic costs did not show a direct association with unfavorable outcomes in either group. CONCLUSIONS: Our study found no direct association between catastrophic costs and unfavorable TB outcomes among TB-HIV/TB-diabetes patients. Instead, factors such as weight, family type, BPL status, and initial hospitalization were significant predictors. These findings underscore the importance of socio-economic conditions and initial hospitalization, advocate for enhanced support mechanisms including nutritional and financial aid, especially for BPL families.

Capacity Building, Knowledge Enhancement, and Consultative Processes for Development of a Digital Tool (Ni-kshay SETU) to Support the Management of Patients with Tuberculosis: Exploratory Qualitative Study.

BACKGROUND: Achieving the target for eliminating tuberculosis (TB) in India by 2025, 5 years ahead of the global target, critically depends on strengthening the capacity of human resources as one of the key components of the health system. Due to the rapid updates of standards and protocols, the human resources for TB health care suffer from a lack of understanding of recent updates and acquiring necessary knowledge. OBJECTIVE: Despite an increasing focus on the digital revolution in health care, there is no such platform available to deliver the key updates in national TB control programs with easy access. Thus, the aim of this study was to explore the development and evolution of a mobile health tool for capacity building of the Indian health system's workforce to better manage patients with TB. METHODS: This study involved two phases. The first phase was based on a qualitative investigation, including personal interviews to understand the basic requirements of staff working in the management of patients with TB, followed by participatory consultative meetings with stakeholders to validate and develop the content for the mobile health app. Qualitative information was collected from the Purbi Singhbhum and Ranchi districts of Jharkhand and Gandhinagar, and from the Surat districts of Gujarat State. In the second phase, a participatory design process was undertaken as part of the content creation and validation exercises. RESULTS: The first phase collected information from 126 health care staff, with a mean age of 38.4 (SD 8.9) years and average work experience of 8.9 years. The assessment revealed that more than two-thirds of participants needed further training and lacked knowledge of the most current updates to TB program guidelines. The consultative process determined the need for a digital solution in easily accessible formats and ready reckoner content to deliver practical solutions to address operational issues for implementation of the program. Ultimately, the digital platform named Ni-kshay SETU (Support to End Tuberculosis) was developed to support the knowledge enhancement of health care workers. CONCLUSIONS: The development of staff capacity is vital to the success or failure of any program or intervention. Having up-to-date information provides confidence to health care staff when interacting with patients in the community and aids in making quick judgments when handling case scenarios. Ni-kshay SETU represents a novel digital capacity-building platform for enhancing human resource skills in achieving the goal of TB elimination.

Costs incurred by patients with tuberculosis co-infected with human immunodeficiency virus in Bhavnagar, western India: a sequential explanatory mixed-methods research.

BACKGROUND: India reports the highest number of tuberculosis (TB) and second-highest number of the human immunodeficiency virus (HIV) globally. We hypothesize that HIV might increase the existing financial burden of care among patients with TB. We conducted this study to estimate the costs incurred by patients with TB co-infected with HIV and to explore the perspectives of patients as well as program functionaries for reducing the costs. METHODS: We conducted a descriptive cross-sectional study among 234 co-infected TB-HIV patients notified in the Bhavnagar region of western India from 2017 to 2020 to estimate the costs incurred, followed by in-depth interviews among program functionaries and patients to explore the solutions for reducing the costs. Costs were estimated in Indian rupees (INR) and expressed as median (interquartile range IQR). The World Health Organization defines catastrophic costs as when the total costs incurred by patients exceed 20% of annual household income. The in-depth interviews were audio-recorded, transcribed, and analyzed as codes grouped into categories. RESULTS: Among the 234 TB-HIV co-infected patients, 78% were male, 18% were sole earners in the family, and their median (IQR) monthly family income was INR 9000 (7500-11,000) [~US$ 132 (110-162)]. The total median (IQR) costs incurred for TB were INR 4613 (2541-7429) [~US$ 69 (37-109)], which increased to INR 7355 (4337-11,657) [~US$ 108 (64-171)] on adding the costs due to HIV. The catastrophic costs at a 20% cut-off of annual household income for TB were 4% (95% CI 2-8%), which increased to 12% (95% CI 8-16%) on adding the costs due to HIV. Strengthening health systems, cash benefits, reducing costs through timely referral, awareness generation, and improvements in caregiving were some of the solutions provided by program functionaries and the patients. CONCLUSION: We conclude that catastrophic costs due to TB-HIV co-infection were higher than that due to TB alone in our study setting. Bringing care closer to the patients would reduce their costs. Strengthening town-level healthcare facilities for diagnostics as well as treatment might shift the healthcare-seeking of patients from the private sector towards the government and thereby reduce the costs incurred.

Diagnostic and treatment delay among new pulmonary tuberculosis patients in Southern India: A cross-sectional study.

Background: Delay in diagnosis and treatment enhances tuberculosis (TB) transmission and mortality. Understanding causes for delay can help in TB elimination by 2025, the stated goal of India. Objectives: Estimate diagnostic and treatment delay in Ernakulam district of Kerala, identify associated factors, and determine health-seeking behavior and knowledge regarding TB among new pulmonary TB patients. Materials and Methods: Community-based cross-sectional study among the new pulmonary TB patients registered under Revised National TB Control Program. Patients interviewed in-person and data collected using pretested semi-structured questionnaire. Descriptive statistics expressed as frequency, percent, interquartile range, median, and mean. The Chi-square test was used to assess statistical significance (P < 0.05) of association. Backward conditional method logistic regression done using variables with P < 0.2 in univariate analysis and adjusting for possible confounders. Results: Two hundred and twenty-nine patients interviewed and the median patient, health-care system, and treatment delay were 25 days, 22 days, and 1 day, respectively. While the patient delay (>30 days) and treatment delay (>2 days) were seen in 47.6% and 41% of patients, respectively, health-care system delay was seen in 79.9% of the patients. Choosing pharmacy for initial treatment (adjusted odds ratio [aOR] = 5.217), unskilled occupation (aOR = 3.717), female gender (aOR = 3.467), previously not heard about TB (aOR = 3.410), and lower education level (aOR = 2.774) were the independent predictors of the patient delay. Visiting two or more doctors (aOR = 5.855) and initially visiting a doctor of undergraduate qualification (aOR = 3.650) were the independent predictors of health-care system delay. The diagnosis in private sector (aOR = 8.989), not being admitted (aOR = 3.441), and age above 60 years (aOR = 0.394) was the independent predictors of treatment delay. Conclusion: Initial treatment from pharmacy, consulting multiple physicians, and diagnosis by private sector cause significant delay in diagnosis and treatment of pulmonary TB.

Framework for implementing collaborative TB-silicosis activities in India: insights from an expert panel.

Tuberculosis (TB) treatment is more challenging for patients with silicosis, as it complicates the diagnosis of both diseases and increases mortality risk. Silicosis, an incurable occupational disease, confounds the diagnosis of TB and vice versa, making it more difficult to accurately identify and treat either condition. Moreover, TB appears to accelerate the progression of silicosis. Exposure to silica dust, a common cause of silicosis, can also trigger latent TB to become active TB. This correspondence outlines a proposed framework for implementing collaborative TB-silicosis activities in India, aimed at improving early diagnosis and management for both diseases. An expert panel of medical professionals developed this framework through online consultations in October and November 2022. The panel's goal was to establish a consensus on integrating TB-silicosis activities, with a focus on early detection and proper management. The framework suggests testing all patients with silicosis for active TB and screening workers exposed to silica dust for latent TB infection. It also recommends that patients with TB who have a history of occupational exposure to silica dust should be tested for silicosis. Reliable diagnostic tools, such as chest X-rays, are emphasized, providing guidance on their use for both diseases. The proposed collaborative TB-silicosis framework offers a structured approach to identifying and managing these two diseases, contributing to the global goal of eliminating silicosis by 2030 and aligning with the World Health Organization's targets for reducing TB incidence and mortality. It recommends specific strategies for implementation, including testing, referral systems, and workplace-based interventions. The framework also underscores the need for coordinated efforts among stakeholders, including the ministries of health, labor, industry, and environment. This correspondence provides valuable insights into how India can successfully implement collaborative TB-silicosis activities, serving as a model for other regions with similar challenges.

Knowledge, Attitude, and Practices Among Healthcare Practitioners in the Context of Multidrug Resistance Tuberculosis: An Appraisal to Disease Elimination.

INTRODUCTION: Tuberculosis (TB) remains one of the leading infectious causes of death worldwide, and India is among the countries with the highest TB burden. TB control is facing several roadblocks in our country with the rapid development of multidrug-resistant (MDR) as well as extensively drug-resistant TB (XDR) and as an after-effect of the global COVID-19 pandemic. With the target of TB elimination by 2025 (National Tuberculosis Elimination Program, NTEP), there is a need that treating physicians in our country be well aware of MDR-TB and be able to diagnose and treat it at an appropriate time. The present study is conducted to explore the knowledge levels, attitudes, and practices concerning MDR-TB amongst healthcare professionals working in different healthcare sectors. METHODS: A total of 250 allopathic medical practitioners (Bachelor of Medicine and Bachelor of Surgery [MBBS], specialists, and superspecialists) working in any sector (private or government), who are directly involved in managing any form of TB patient and are willing to undertake the assessment, were included in this online questionnaire-based survey that was circulated using various social media platforms like WhatsApp, Facebook, Linked In, and Gmail. Responses to the questionnaires created in Google Forms were analyzed by capturing data in a Microsoft Excel® spreadsheet for further statistical analysis. The data were analyzed using multiple measures of dispersion and cross-tabulations. RESULTS: Among the 250 participants, most of the participants had encountered MDR-TB in their clinical practice, and the majority believe that MDR-TB is a rising problem. Although 88% of the participants did a GeneXpert assay before the start of anti-tubercular therapy (ATT), three-fourths of the participants knew that the assay detects the MTB genome and rifampicin resistance. MDR-TB was suspected in participants after no clinical improvement was observed after 3-6 weeks of a trial of ATT. Two-thirds of the participants knew that linezolid is currently being used as a second-line drug for the treatment of MDR- TB. The respondents in our survey mostly do not themselves treat MDR-TB and refer the patients to an MDR-TB center or a pulmonary medicine specialist. CONCLUSION: Healthcare practitioners (HCPs) with good knowledge levels can diagnose and treat TB patients appropriately, thus decreasing the rising MDR-TB problem, and they can educate patients and the general population about TB and the emerging MDR-TB situation. With the current level of knowledge about MDR-TB management, there is certainly an urgent need for educational and persuasive measures for the training of doctors in both the public and private sectors so as to achieve TB elimination by 2025.

Plasma drug concentrations of 4-drug fixed-dose combination regimen and its efficacy for treatment of pulmonary tuberculosis under National Tuberculosis Elimination Programme: A prospective pilot study.

BACKGROUND: The thrice weekly dosing regimen of DOTS has shown low rifampicin plasma concentrations as an independent risk factor for unfavourable tuberculosis (TB) outcome. With introduction of daily regimen using fixed dose combinations (FDC) under National Tuberculosis Elimination Programme (NTEP) the existence of suboptimal plasma levels of first-line antitubercular drugs and its clinical significance remain poorly understood. METHOD: We included a prospective cohort of newly diagnosed pulmonary tuberculosis (PTB) patients receiving 4-FDC daily regimen under NTEP. Plasma concentration at 2 hours (C2h) of each drug was determined after two weeks of treatment using liquid chromatography (LCMS/MS) developed by us. TB card and laboratory reports were reviewed for baseline characteristics and clinical status at 2, 4 and 6 months after the initiation of treatment. At a 1 year follow-up, therapy failure was defined as death or a relapse of tuberculosis. RESULTS: Among 40 PTB patients, the C2h post dose plasma concentrations of H, R and E were suboptimal in 25%, 60% and 10% respectively. The C2h of H, R, Z and E were respectively 4.2 ± 2.0, 7.3 ± 2.8, 39.2 ± 8.8 and 3.5 ± 1.2 µg/ml; 60% of the patients had suboptimal plasma concentrations and commonly it was observed with H and R. C2h were lower than expected for at least two drugs i.e. H and R in 25% (10/40) of the patients. Plasma concentration of isoniazid and rifampicin has always been considered important for microbiological response and treatment outcome and low concentrations has been associated with poor treatment response. These patients may require a two year follow up and critical evaluation for prevention of MDR-TB. However, all the TB patients were cured and none of them had recurrence within one year follow up. CONCLUSIONS: All the pulmonary TB patients administering 4-FDC daily regimen under programmatic settings were cured despite the suboptimal levels of isoniaizd and rifampicin. All the patients achieved pyrazinamide plasma levels and probably this could be the reason behind favourable outcome. Further study is required on large sample size with various subset of population to understand the need of therapeutic drug monitoring.

Quality of Life Amongst Multidrug-Resistant TB Patients: An Exploratory Study About Distributive Dimensions and Interactions.

BACKGROUND: Multidrug-resistant (MDR)-TB has emerged as a major challenge to eliminate TB as envisioned at policy level. Distinctive traits associated with the disease such as physical, psychosocial and environmental dimensions may influence the treatment outcome in both directions. Quality of life (QoL) indicators may capture these traits distinctively. OBJECTIVE: To quantify the differential effect of MDR-TB on specific QoL domains, their distributions across the strata and to check for possible interactions. METHOD:  This community-based cross-sectional study was conducted on 98 MDR-TB patients registered in the calendar year 2017 under National Tuberculosis Elimination Programme (NTEP) in a central Indian district using the WHO-QoL BREF Scale by patients in their vicinity. The transformed domain scores were descriptively summarized, stratified and exploratory visualised. Likert mapping for each item was done. A two-way ANOVA test was applied to check differences across strata and interaction effects were calculated. RESULT: Participants perceived a higher QoL in the social domain (median score 69, IQR 56-75) while the psychological health domain (median 31 IQR 20.5-44) was professed as most negotiated by disease. More than 50% of participants were found to be dissatisfied with their assumed physical status in item-wise analysis. A statistically significant interaction (p=0.008) was detected with education strata to income tertile most evident in the physical domain while psychological domain alone (p=0.017) without significant interaction with treatment duration (p=0.316) was associated with the type of TB. Overall QoL scores were tilted in favour of an urban setting, male gender and towards a relatively younger population. CONCLUSION:  The overall deficits in QoL are evident in the study, per se in the psychological and physical domains. Moreover there is an inequitable distribution of these scores as revealed in the study. Inclusion of an additional parameter of periodical QoL assessment may thus predict the outcome at individual level and may address this inequity at policy level.

The Characteristics and Patterns of Drug-Resistant Pulmonary Tuberculosis in Eastern India.

BACKGROUND: Drug-resistant tuberculosis is a major public health problem throughout the world and accounts for substantial morbidity and mortality rates in India, too. Early diagnosis is the corner stone of tuberculosis treatment. State-level and cluster-wise variations in drug resistance is a possibility and should be regularly checked in from time to time. MATERIALS AND METHODS: The present prospective cohort study (January 2019 to May 2022) was conducted in Darbhanga Medical College and Hospital on drug-resistant pulmonary tuberculosis patients. Sputum specimens were collected from designated centers. Rapid molecular drug-resistance testing (genotypic tests) and growth-based drug-susceptibility testing (DST) (phenotypic tests) were performed in the National Tuberculosis Elimination Program certified Laboratory. RESULTS: A total of 268 patients with drug-resistant pulmonary tuberculosis were included in the study group. The treatment outcomes revealed as cured in 100 (37.31%); treatment completed in 43 (16.04%); died in 56 (20.89%); treatment failed in 22 (8.21%); loss of follow up in 34 (12.69%); and transferred out in 13 (4.85%) drug-resistant pulmonary tuberculosis patients. Adverse events were recorded in 199 (74.25%) of the drug-resistant pulmonary tuberculosis patients. CONCLUSIONS: Drug-resistant pulmonary tuberculosis patients are a matter of concern and need to be addressed.

Costs incurred by patients with drug-susceptible pulmonary tuberculosis in semi-urban and rural settings of Western India.

BACKGROUND: India reports the highest number of tuberculosis (TB) cases worldwide. Poverty has a dual impact as it increases the risk of TB and exposes the poor to economic hardship when they develop TB. Our objective was to estimate the costs incurred by patients with drug-susceptible TB in Bhavnagar (western India) using an adapted World Health Organization costing tool. METHODS: We conducted a descriptive cross-sectional study of adults, notified in the public sector and being treated for drug-susceptible pulmonary TB during January-June 2019, in six urban and three rural blocks of Bhavnagar region, Gujarat state, India. The direct and indirect TB-related costs, as well as patients' coping strategies, were assessed for the overall care of TB till treatment completion. Catastrophic costs were defined as total costs > 20% of annual household income (excluding any amount received from cash transfer programs or borrowed). Median and interquartile range (IQR) was used to summarize patient costs. The median costs between any two groups were compared using the median test. The association between any two categorical variables was tested by the Pearson chi-squared test. All costs were described in US dollars (USD). During the study period, on average, one USD equalled 70 Indian Rupees. RESULTS: Of 458 patients included, 70% were male, 62% had no formal education, 71% lived in urban areas, and 96% completed TB treatment. The median (IQR) total costs were USD 8 (5-28), direct medical costs were USD 0 (0-0), direct non-medical costs were USD 3 (2-4) and indirect costs were USD 6 (3-13). Among direct non-medical costs, travel cost (median = USD 3, IQR: 2-4) to attend health facilities were the most prominent, whereas the indirect costs were mainly contributed by the patient's loss of wages (median = USD 3, IQR: 0-6). Four percent of patients faced catastrophic costs, 11% borrowed money to cover costs and 7% lost their employment; the median working days lost to TB was 30 (IQR: 15-45). A majority (88%) of patients received a median USD 43 (IQR: 41-43) as part of a cash transfer program for TB patients. CONCLUSIONS: Treatment completion was high and the costs incurred by TB patients were low in this setting. However, negative financial consequences occur even in low-cost settings. The role of universal cash transfer programs in such settings requires further study.