Self-driven solutions and resilience adapted by people with drug-resistant tuberculosis and their caregivers in Bengaluru and Hyderabad, India: a qualitative study.

Background: One-fifth of people with drug-resistance tuberculosis (DR-TB) who were initiated on newer shorter treatment regimen (with injection) had unfavourable treatment outcomes in India as on 2020. Evidence on self-driven solutions and resilience adapted by people with DR-TB (PwDR-TB) towards their multi-dimensional disease and treatment challenges are scarce globally, which we aimed to understand. Methods: In this qualitative study using positive deviance framework, we conducted semi-structured in-depth interviews among consenting adult PwDR-TB (7 women, 13 men) who completed shorter treatment regimen (including injections) with maximum treatment adherence. The study was conducted in the southern districts of Bengaluru and Hyderabad, India between June 2020 and December 2022. Caregivers (14 women, 6 men) and health providers (8 men, 2 women) of PwDR-TB were also interviewed. Interviews were conducted in local language (Kannada, Tamil, Telugu, Urdu and Hindi) and inquired about practices, behaviours, experiences, perceptions and attributes which enabled maximum adherence and resilience of PwDR-TB. Interviews were audio recorded, transcribed, and translated to English and coded for thematic analysis using inductive approach. Findings: Distinctive themes explanatory of the self-driven solutions and resilience exhibited by PwDR-TB and their caregivers were identified: (i) Self-adaptation towards the biological consequences of drugs, by personalised nutritional and adjuvant practices, which helped to improve drug ingestion and therapeutic effects. Also home remedies and self-plans for ameliorating injection pain. (ii) Perceptual adaptation towards drugs aversion and fatigue, by their mind diversion practices, routinisation and normalisation of drug intake process. and constant reinforcement and re-interpretation of bodily signs of disease recovery (iii) Family caregivers intense and participatory care for PwDR-TB, by aiding their essential life activities and ensuring survival, learning and fulfilling special nutritional needs and goal oriented actions to aid drug intake (iv) Health care providers care, marked by swift and timely risk mitigation of side-effects and crisis response (v) Acquired self-efficacy of PwDR-TB, by their decisive family concerns resulting in attitudinal change. Also being sensitised on the detrimental consequences of disease and being motivated through positive examples. Interpretation: Synthesised findings on self-driven solutions and resilience towards the multi-dimensional DR-TB challenges provides opportunity for developing and testing new interventions for its effectiveness in DR-TB care settings globally. Designing and testing personalised cognitive interventions for PwDR-TB: to inculcate attitudinal change and self-efficacy towards medication, developing cognitive reinforcements to address the perception burden of treatment, skill building and mainstreaming the role of family caregivers as therapeutic partners of PwDR-TB, curating self-adaptive behaviours and practices of PwDR-TB to normalise their drug consumptions experiences could be the way forward in building resilience towards DR-TB. Funding: United States Agency for International Development (USAID) through Karnataka Health Promotion Trust (KHPT), Bengaluru, India.

The Predicted Potential Impact of COVID-19 Pandemic on Tuberculosis Epidemic in Tamil Nadu, South India.

OBJECTIVE: To estimate the prevalence and incidence of TB before and during the COVID-19 pandemic in Tamil Nadu, south India. METHODS: In the present study, the effect of COVID-19 epidemiology on the TB epidemic was assessed by the SEIR (Susceptible-Exposed-Infected-Recovered), a compartmental epidemiological model. The model input parameters on compartments of TB and incidence of COVID-19 were collected from the published literature. Based on the data collected, point prevalence and incidence of TB per 100,000 population is calculated with and without COVID-19. A prediction was conducted up to 2025, trend analysis was performed, and a trend chi-square test and chi-square test of independence were used to test the difference between the prevalence with and without COVID-19. R software 2000 (R 4.0.0) was used for analysis. RESULTS: The TB prevalence without and with COVID-19 decreases from 289 in 2020 to 271 in 2025 and from 289 in 2020 to 269 in 2025, respectively. Similarly, the incidence of TB was decreasing from 144 in 2020 to 135 in 2025 without COVID-19 and 143 in 2020 to 134 in 2025 with COVID-19. Though the TB burden is decreasing over the years, the trend was not statistically significant (p > 0.05). With respect to the district level, the prevalence and incidence of TB with and without COVID-19 is also found to be decreasing over the years. It was also found that the difference in the prevalence and incidence of TB with and without COVID-19 was not statically significant. CONCLUSION: The results of our study shows that there was an annual decline of around 2% from 2020 to 2025 in the trend of the prevalence and incidence of TB with and without COVID-19. Overall, there is a reduction, but it was not significant, and there is no significant effect of COVID-19 on TB in Tamil Nadu.

The Prevalence of Self-Reported Tuberculosis in the Andaman and Nicobar Islands, India: Evidence from the NFHS-IV and V.

INTRODUCTION: Since 1992, many rounds of the National Family Health Surveys have produced a significant quantity of data in India. The magnitude of the tuberculosis (TB) burden in Andaman and Nicobar Island can be better understood with this data. The household-level information on self-reported TB may provide useful information on the prevalence and distribution of TB as well as care-seeking behaviour. The primary objective is to analyse the data from the NFHS-IV and NFHS-V to understand the prevalence of self-reported TB as well as healthcare-seeking patterns for TB in the Andaman and Nicobar Islands. METHODOLOGY: We performed secondary data analysis of NFHS-IV and NFHS-V data. After taking into consideration the survey's cluster design and sampling weights, the prevalence was estimated. The association of identified factors with self-reported TB was investigated using the chi-square and logistic regression models. RESULTS: The point prevalence of self-reported TB was 615 (418, 873) and 221 (122, 367) in the NFHS-IV and NFHS-V, respectively (p = 0.012). The elderly, those from rural areas, those belonging to a tribe, and those with a poor wealth index were more likely to report TB. Self-reported TB prevalence was higher in the Nicobar district. There is an increase in a significant proportion of individuals not seeking care. CONCLUSION: The NFHS-IV and NFHS-V show a decline in self-reported TB, which is consistent with national estimates. However, the enhanced TB case detection in individuals at high risk of TB among the Nicobar districts and tribal communities could significantly contribute to the fight against tuberculosis. Improved awareness of TB could improve care seeking for TB.

Cost of screening, out-of-pocket expenditure & quality of life for diabetes & hypertension in India.

Background & objectives: The Government of India has initiated a population based screening (PBS) for noncommunicable diseases (NCDs). A health technology assessment agency in India commissioned a study to assess the cost-effectiveness of screening diabetes and hypertension. The present study was undertaken to estimate the cost of PBS for Type II diabetes and hypertension. Second, out-of-pocket expenditure (OOPE) for outpatient care and health-related quality of life (HRQoL) among diabetes and hypertension patients were estimated. Methods: Economic cost of PBS of diabetes and hypertension was assessed using micro-costing methodology from a health system perspective in two States. A total of 165 outpatients with diabetes, 300 with hypertension and 497 with both were recruited to collect data on OOPE and HRQoL. Results: On coverage of 50 per cent, the PBS of diabetes and hypertension incurred a cost of ₹ 45.2 per person screened. The mean OOPE on outpatient consultation for a patient with diabetes, hypertension and both diabetes and hypertension was ₹ 4381 (95% confidence interval [CI]: 3786-4976), ₹ 1427 (95% CI: 1278-1576) and ₹ 3932 (95% CI: 3614-4250), respectively. Catastrophic health expenditure was incurred by 20, 1.3 and 14.8 per cent of patients with diabetes, hypertension and both diabetes and hypertension, respectively. The mean HRQoL score of patients with diabetes, hypertension and both was 0.76 (95% CI: 0.72-0.8), 0.89 (95% CI: 0.87-0.91) and 0.68 (95% CI: 0.66-0.7), respectively. Interpretations & conclusions: The findings of our study are useful for assessing cost-effectiveness of screening strategies for diabetes and hypertension.

The Cost-Effectiveness of the BEAT-TB Regimen for Pre-Extensively Drug-Resistant TB.

OBJECTIVE: To measure the economic impacts of the longer pre-XDR-TB treatment regimen and the shorter BEAT-TB India regimen. METHODS: In the current study, the economic impacts of the current 18-month pre-XDR-TB treatment regimen and the 6-9 month BEAT-TB regimen were evaluated using an economic model via a decision tree analysis from a societal perspective. The incremental costs and quality-adjusted life years (QALYs) gained from the introduction of the BEAT-TB regimen for pre-XDR-TB patients were estimated. RESULTS: For a cohort of 1000 pre-XDR-TB patients, we found that the BEAT-TB India regimen yielded higher undiscounted life years (40,548 vs. 21,009) and more QALYs gained (27,633 vs. 15,812) than the 18-month regimen. The BEAT-TB India regimen was found to be cost-saving, with an incremental cost of USD -128,651 when compared to the 18-month regimen. The current analysis did not consider the possibility of reduced TB recurrence after use of the BEAT-TB regimen, so it might have under-estimated the benefits. CONCLUSION: As a lower-cost intervention with improved health outcomes, the BEAT-TB India regimen is dominant when compared to the 18-month regimen.

A study on tuberculosis disease disclosure patterns and its associated factors: Findings from a prospective observational study in Chennai.

BACKGROUND: Disclosure of tuberculosis (TB) status by patients is a critical step in their treatment cascade of care. There is a lack of systematic assessment of TB disclosure patterns and its positive outcomes which happens dynamically over the disease period of individual patients with their family and wider social network relations. METHODS: This prospective observational study was conducted in Chennai Corporation treatment units during 2019-2021. TB patients were recruited and followed-up from treatment initiation to completion. Information on disease disclosures made to different social members at different time points, and outcomes were collected and compared. Bivariate and multi variate analysis were used to identify the patients and contact characteristics predictive of TB disclosure status. RESULTS: A total of 466 TB patients were followed-up, who listed a total of 4039 family, extra familial and social network contacts of them. Maximum disclosures were made with family members (93%) and half of the relatives, occupational contacts and friendship contacts (44-58%) were disclosed within 15 days of treatment initiation. Incremental disclosures made during the 150-180 days of treatment were highest among neighbourhood contacts (12%), and was significantly different between treatment initiation and completion period. Middle aged TB patients (31 years and 46-55 years) were found less likely to disclose (AOR 0.56 and 0.46 respectively; p<0.05) and illiterates were found more likely to disclose their TB status (AOR 3.91; p<0.05). Post the disclosure, family contacts have mostly provided resource support (44.90%) and two third of all disclosed contacts have provided emotional support for TB patients (>71%). CONCLUSION: Findings explain that family level disclosures were predominant and disclosures made to extra familial network contacts significantly increased during the latter part of treatment. Emotional support was predominantly received by TB patients from all their contacts post disclosure. Findings could inform in developing interventions to facilitate disclosure of disease status in a beneficial way for TB patients.

Economic evaluation of shortened, bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis (STREAM stage 2): a within-trial analysis of a randomised controlled trial.

BACKGROUND: The STREAM stage 2 trial assessed two bedaquiline-containing regimens for rifampicin-resistant tuberculosis: a 9-month all-oral regimen and a 6-month regimen containing an injectable drug for the first 2 months. We did a within-trial economic evaluation of these regimens. METHODS: STREAM stage 2 was an international, phase 3, non-inferiority randomised trial in which participants with rifampicin-resistant tuberculosis were randomly assigned (1:2:2:2) to the 2011 WHO regimen (terminated early), a 9-month injectable-containing regimen (control regimen), a 9-month all-oral regimen with bedaquiline (oral regimen), or a 6-month regimen with bedaquiline and an injectable for the first 2 months (6-month regimen). We prospectively collected direct and indirect costs and health-related quality of life data from trial participants until week 76 of follow-up. Cost-effectiveness of the oral and 6-month regimens versus control was estimated in four countries (oral regimen) and two countries (6-month regimen), using health-related quality of life for cost-utility analysis and trial efficacy for cost-effectiveness analysis. This trial is registered with ISRCTN, ISRCTN18148631. FINDINGS: 300 participants were included in the economic analyses (Ethiopia, 61; India, 142; Moldova, 51; Uganda, 46). In the cost-utility analysis, the oral regimen was not cost-effective in Ethiopia, India, Moldova, and Uganda from either a provider or societal perspective. In Moldova, the oral regimen was dominant from a societal perspective. In the cost-effectiveness analysis, the oral regimen was likely to be cost-effective from a provider perspective at willingness-to-pay thresholds per additional favourable outcome of more than US$4500 in Ethiopia, $1900 in India, $3950 in Moldova, and $7900 in Uganda, and from a societal perspective at thresholds of more than $15 900 in Ethiopia, $3150 in India, and $4350 in Uganda, while in Moldova the oral regimen was dominant. In Ethiopia and India, the 6-month regimen would cost tuberculosis programmes and participants less than the control regimen and was highly likely to be cost-effective in both cost-utility analysis and cost-effectiveness analysis. Reducing the bedaquiline price from $1·81 to $1·00 per tablet made the oral regimen cost-effective in the provider-perspective cost-utility analysis in India and Moldova and dominate over the control regimen in the provider-perspective cost-effectiveness analysis in India. INTERPRETATION: At current costs, the oral bedaquiline-containing regimen for rifampicin-resistant tuberculosis is unlikely to be cost-effective in many low-income and middle-income countries. The 6-month regimen represents a cost-effective alternative if injectable use for 2 months is acceptable. FUNDING: USAID and Janssen Research & Development.

A national-level analysis of life expectancy associated with the COVID-19 pandemic in India.

Background: From a demographic perspective, the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on life expectancy is not clear. Hence, there is a need to study the number of years of life lost concerning the existing average life expectancy due to COVID-19 in India. Objective: This study aimed to estimate the impact of life expectancy due to the COVID-19 pandemic in India. Methodology: We considered day-wise age-specific mortality due to COVID-19 which was extracted from the COVID-19 data repository from March 11, 2020, to June 30, 2021, in India. All-cause mortality was collected from the United Nations population estimates. An abridged life table technique was utilized for calculating life expectancies based on all-cause mortality and mortality due to COVID-19. MortPak software was used to calculate the life expectancy with and without the COVID-19 pandemic. Life expectancy at birth in different age groups was estimated with respect to with and without COVID-19. Results: A total of 399,459 deaths due to COVID-19 were distributed age wise, and their corresponding life expectancy was calculated. The general mortality was compared with COVID-19 mortality for the various age groups, and it was observed that mortality due to COVID-19 was significantly higher among the elderly age group [i.e., 45 to 60 years (36%) and > 60 years (51%)] when compared with < 25 years (1%) and 26-44 years (11%) (trend Chi-square 7.59; p = 0.001). The life expectancy without and with COVID-19 was 69.28 years and 69.16 years, respectively. Conclusion: Overall, it was estimated that COVID-19 has an impact on life expectancy by 0.12 years during the study period. Even though mortality due to COVID-19 was high, factors such as lockdown, vaccination, and accidents also had an influence on mortality. Thus, there is a need to assess the impact of COVID-19 on life expectancy in future.

A Dual Perspective of Psycho-Social Barriers and Challenges Experienced by Drug-Resistant TB Patients and Their Caregivers through the Course of Diagnosis and Treatment: Findings from a Qualitative Study in Bengaluru and Hyderabad Districts of South India.

Qualitative insights regarding psycho-social barriers and challenges experienced by drug-resistant tuberculosis (DR-TB) patients and their caregivers are understudied in India. We conducted a qualitative study using semi-structured qualitative interviews among treatment-completed DR-TB patients (n = 20) and caregivers (n = 20) in Bengaluru and Hyderabad districts, which represented two different socio-cultural settings in South India. Criterion sampling was used for recruiting the eligible participants who completed treatment with adherence. "Emotional issues and social barriers" were identified to represent a major challenge for patients and caregivers, which occurred acutely after disease diagnosis, characterized by fear and emotional distress due to their perceived loss of life prospects, severity of symptoms, discomfort, and disease denial. Medication intolerance, chronic symptoms, lack of visible signs of treatment progress, loss of weight, and physical concerns caused subsequent fear and distress during the treatment phases for patients along with experiences of stigma. External triggers generated "decisive moments" of hopelessness and life-ending thoughts for patients at the diagnosis and early treatment phase. Medication related challenges included the perceived burden and power of pills which caused emotional distress for patients and intolerance towards caregivers. Pill burden was found as consequential as the side effects of injections. Challenges related to lack of support were another major theme, in which caregivers lacked resources for treatment support and nutrition. Throughout treatment, caregivers and patients expressed concern about a lack of supportive care from family members, sympathy, and intangible social support. Challenges during hospital admission in terms of lack of privacy, quality of services, individual attention, and empathy from health care workers were reported by patients and caregivers. Despite better adherence, DR-TB patients and caregivers experienced considerable emotional and social consequences. Differentiating DR-TB patients and caregivers' issues at different stages of diagnosis and treatment could help improve patient-centered outcomes in India and other high-burden nations.

Cost Effectiveness of a Shorter Moxifloxacin Based Regimen for Treating Drug Sensitive Tuberculosis in India.

Globally efforts are underway to shorten the existing 6-month tuberculosis (TB) treatment regimen for drug-sensitive patients, which would be equally effective and safe. At present, there is a lack of evidence on the cost implications of a shorter 4-month TB regimen in India. This economic modeling study was conducted in the Indian context with a high TB burden. We used a hybrid economic model comprising of a decision tree and Markov analysis. The study estimated the incremental costs, life years (LYs), and quality-adjusted life years (QALYs) gained by the introduction of a Moxifloxacin-based shorter 4-month treatment regimen for pulmonary TB patients. The outcomes are expressed in incremental cost-effectiveness ratios (ICERs) per QALYs gained. The cost per case to be treated under the 4-month regimen was USD 145.94 whereas for the 6-month regimen it was USD 150.39. A shorter 4-month TB regimen was cost-saving with USD 4.62 per LY and USD 5.29 per QALY. One-way sensitivity analysis revealed that the cost of the drugs for the 4-month regimen, hospitalization cost for adverse drug reactions, and human resources incurred for the 6-month regimen had a higher influence on the ICER. The probability sensitivity analysis highlighted that the joint incremental cost and effectiveness using QALY were less costly and more effective for 67% of the iteration values. The cost-effectiveness acceptability curve highlights that the 4-month regimen was dominant to both patients and the National TB Elimination Programme in India as compared to the 6-month regimen at different cost-effectiveness threshold values.

Strategies to detect and manage latent tuberculosis infection among household contacts of pulmonary TB patients in high TB burden countries - a systematic review and meta-analysis.

OBJECTIVE: To summarise latent tuberculosis infection (LTBI) management strategies among household contacts of bacteriologically confirmed pulmonary tuberculosis (TB) patients in high-TB burden countries. METHODS: PubMed/MEDLINE (NCBI) and Scopus were searched (January 2006 to December 2021) for studies reporting primary data on LTBI management. Study selection, data management and data synthesis were protocol-driven (PROSPERO-CRD42021208715). Primary outcomes were the proportions of LTBI, initiating and completing tuberculosis preventive treatment (TPT). Reported factors influencing the LTBI care cascade were qualitatively synthesised. RESULTS: From 3694 unique records retrieved, 58 studies from 23 countries were included. Most identified contacts were screened (median 99%, interquartile range [IQR] 82%-100%; 46 studies). Random-effects meta-analysis yielded pooled proportions for: LTBI 41% (95% confidence interval [CI] 33%-49%; 21,566 tested contacts); TPT initiation 91% (95% CI 79%-97%; 129,573 eligible contacts, 34 studies); TPT completion 65% (95% CI 54%-74%; 108,679 TPT-initiated contacts, 28 studies). Heterogeneity was significant (I2 ≥ 95%-100%) and could not be explained in subgroup analyses. Median proportions (IQR) were: LTBI 44% (28%-59%); TPT initiation 86% (60%-100%); TPT completion 68% (44%-82%). Nine broad themes related to diagnostic testing, health system structure and functions, risk perception, documentation and adherence were considered likely to influence the LTBI care cascade. CONCLUSION: The proportions of household contacts screened, detected with LTBI and initiated on TPT, though variable was high, but the proportions completing TPT were lower indicating current strategies used for LTBI management in high TB burden countries are not sufficient.

Diagnostic accuracy of mercurial versus digital blood pressure measurement devices: a systematic review and meta-analysis.

This study aims to systematically review the diagnostic accuracy of a digital blood pressure measurement device compared to the gold standard mercury sphygmomanometer in published studies. Searches were conducted in PubMed, Cochrane, EBSCO, EMBASE and Google Scholar host databases using the specific search strategy and filters from 1st January 2000 to 3rd April 2021. We included studies reporting data on the sensitivity or specificity of blood pressure measured by digital devices and mercury sphygmomanometer used as the reference standard. Studies conducted among children, special populations, and specific disease groups were excluded. We considered published manuscripts in the English language only. The risk of bias and applicability concerns were assessed based on the author's judgment using the QUADAS2 manual measurement evaluation tool. Based on the screening, four studies were included in the final analysis. Sensitivity, specificity, diagnostic odds ratio (DOR), and 95% confidence interval were estimated. The digital blood pressure monitoring has a moderate level of accuracy and the device can correctly distinguish hypertension with a pooled estimate sensitivity of 65.7% and specificity of 95.9%. After removing one study, which had very low sensitivity and very high specificity, the pooled sensitivity estimate was 79%, and the specificity was 91%. The meta-analysis of DOR suggests that the digital blood pressure monitor had moderate accuracy with a mercury sphygmomanometer. This will provide the clinician and patients with accurate information on blood pressure with which diagnostic and treatment decisions could be made.

An economic evaluation of implementing a decentralized dengue screening intervention under the National Vector Borne Disease Control Programme in Tamil Nadu, South India.

BACKGROUND: Lack of effective early screening is a major obstacle for reducing the fatality rate and disease burden of dengue. In light of this, the government of Tamil Nadu has adopted a decentralized dengue screening strategy at the primary healthcare (PHC) facilities using blood platelet count. Our objective was to determine the cost-effectiveness of a decentralized screening strategy for dengue at PHC facilities compared with the current strategy at the tertiary health facility (THC) level. METHODS: Decision tree analysis followed a hypothetical cohort of 1000 suspected dengue cases entering the model. The cost-effectiveness analysis was performed at a 3% discount rate for the proposed and current strategy. The outcomes are expressed in incremental cost-effectiveness ratios (ICERs) per quality-adjusted life years gained. One-way sensitivity analysis and probabilistic sensitivity analysis were done to check the uncertainty in the outcome. RESULTS: The proposed strategy was found to be cost-saving and ICER was estimated to be -41 197. PSA showed that the proposed strategy had a 0.84 probability of being an economically dominant strategy. CONCLUSIONS: The proposed strategy is cost-saving, however, it is recommended to consider optimal population coverage, costs to economic human resources and collateral benefits of equipment.

Tracing the potential extra-household contacts of TB patients: findings from a personal social network survey in a high TB burden setting in India.

BACKGROUND: Evidence on the extra-household contacts of TB patients who drive disease transmission is scarce. METHODS: We conducted a cross-sectional personal social network survey among 300 newly diagnosed index pulmonary TB patients to identify their first-degree extra-household contacts. RESULTS: A significantly higher proportion of neighbourhood (3.5; 95% CI 1.3 to 7.5), occupational (3.2; 95% CI 1.3 to 9.2) and friendship contacts (2.2; 95% CI 0.8 to 4.5) developed TB within 1 y of the index patient's diagnosis than their household contacts (0.7; 95% CI 0.3 to 1.3). Similarly, a higher proportion of extra-household contacts had TB at different time points before the index patient was diagnosed. CONCLUSION: Extra-household contacts of TB patients could be a potential source of TB or could be at increased risk of TB.

Cost-effectiveness of population-based screening for diabetes and hypertension in India: an economic modelling study.

BACKGROUND: India faces a high burden of diabetes and hypertension. Currently, there is a dearth of economic evidence about screening programmes, affected age groups, and frequency of screening for these diseases in Indian settings. We assessed the cost effectiveness of population-based screening for diabetes and hypertension compared with current practice in India for different scenarios, according to type of screening test, population age group, and pattern of health-care use. METHODS: We used a hybrid decision model (decision tree and Markov model) to estimate the lifetime costs and consequences from a societal perspective. A meta-analysis was done to assess the effectiveness of population-based screening. Primary data were collected from two Indian states (Haryana and Tamil Nadu) to assess the cost of screening. The data from the National Health System Cost Database and the Costing of Health Services in India study were used to determine the health system cost of diagnostic tests and cost of treating diabetes or hypertension and their complications. A total of 962 patients were recruited to assess out-of-pocket expenditure and quality of life. Parameter uncertainty was evaluated using univariate and multivariable probabilistic sensitivity analyses. Finally, we estimated the incremental cost per quality-adjusted life-year (QALY) gained with alternative scenarios of scaling up primary health care through a health and wellness centre programme for the treatment of diabetes and hypertension. FINDINGS: The incremental cost per QALY gained across various strategies for population-based screening for diabetes and hypertension ranged from US$0·02 million to $0·03 million. At the current pattern of health services use, none of the screening strategies of annual screening, screening every 3 years, and screening every 5 years was cost-effective at a threshold of 1-time per capita gross domestic product in India. In the scenario in which health and wellness centres provided primary care to 20% of patients who were newly diagnosed with uncomplicated diabetes or hypertension, screening the group aged between 30 and 65 years every 5 years or 3 years for either diabetes, hypertension, or a comorbid state (both diabetes and hypertension) became cost-effective. If the share of treatment for patients with newly diagnosed uncomplicated diabetes or hypertension at health and wellness centres increases to 70%, from the existing 4% at subcentres and primary health centres, annual population-based screening becomes a cost saving strategy. INTERPRETATION: Population-based screening for diabetes and hypertension in India could potentially reduce time to diagnosis and treatment and be cost-effective if it is linked to comprehensive primary health care through health and wellness centres for provision of treatment to patients who screen positive. FUNDING: Department of Health Research, Government of India.

High incidence of pulmonary tuberculosis in an indigenous Saharia tribe in Madhya Pradesh, central India-A prospective cohort study.

BACKGROUND: Lack of TB incidence data is an important evidence gap among Saharia-a high TB burden indigenous community in Madhya Pradesh, central India. The present study was undertaken to calculate the incidence of pulmonary tuberculosis in this tribe. OBJECTIVE: To calculate the incidence of pulmonary tuberculosis (PTB) among the Saharia tribal population in Madhya Pradesh, central India. METHODS: A prospective cohort study was conducted among the Saharia tribal population (aged 15 years and above) of Shivpuri district in Madhya Pradesh state in central India. A total of 9,756 individuals were screened for TB in the baseline TB prevalence survey during 2012-13. All available household members were screened for symptoms suggestive of pulmonary TB (presumptive TB). Two sputum specimens were collected from persons having symptoms suggestive of TB and examined by smear and culture tests. A cohort of all non-TB individuals in the baseline survey was followed-up for one year and re-screened for the sysmptoms of PTB in the year 2014-15. Based on the data collected, the incidence of TB over one year period was estimated per 100,000 population. RESULTS: A total of 9756 and 9044 individuals (≥ 15 years) were screened for symptoms suggestive of PTB during baseline and endline surveys respectively. The sputum specimens of presumptive TB cases were collected and examined by smear and culture tests. The overall incidence of bacteriologically positive (smear and/or culture) PTB over one year period was 1504 (95% Confidence Interval (CI): 1273-1776) per 100,000 in the study population, the incidence of smear-positive PTB was 1106 (95% CI: 910-1343), and the incidence of culture-positive PTB was 1084 (95% CI: 890-1319) per 100,000 population. The incidence for both smear and culture-positive PTB was 686 (95% CI: 535-878) per 100,000 population in the year 2014-15. The incidence of PTB was 2.8 times higher in males compared to females (2259 vs 807 per 100,000) and was positively correlated with age. CONCLUSION: The findings of the study, the first of its kind in the Saharia tribal population, indicate a high incidence of TB in this tribal community thereby highlighting the urgent need for focused and intensified efforts to achieve the goal of TB elimination in the country.

Cost-effectiveness of incorporating Mycobacterium indicus pranii vaccine to multidrug therapy in newly diagnosed leprosy cases for better treatment outcomes & immunoprophylaxis in contacts as leprosy control measures for National Leprosy Eradication Programme in India.

Background & objectives: The elimination goal for leprosy as a public health problem at the national level was achieved in 2005 in India. However, the number of new cases reporting annually remained nearly the same during the last 10-15 years. Moreover, a substantial number of these new cases reported disabilities for the first time. Therefore, besides multidrug therapy (MDT), newer strategies with focus on effectively decreasing the number of new cases, optimizing the treatment of detected cases, averting disabilities and arresting the transmission of the disease are required. So the objective of this study was to assess the cost-effectiveness of Mycobacterium indicus pranii (MIP) vaccine implementation in National Leprosy Eradication Programme (NLEP) for newly diagnosed leprosy patients as well as their contacts to arrest/decrease the transmission and occurrence of new cases. Methods: This was a model-based estimation of incremental costs, total quality-adjusted life years (QALYs) gained, new cases averted, deaths averted, incremental cost-effectiveness ratio (ICER) and budget impact of the vaccination intervention. This model included the addition of MIP treatment intervention to the newly detected leprosy patients as well as vaccination with MIP to their contacts. Results: Using the societal perspective, discounted ICER was estimated to be ₹73,790 per QALY gained over a five-year time period. Probabilistic sensitivity analysis (PSA) was assessed by varying the values of input parameters. Majority (96%) of simulations fell in North East quadrant of cost-effectiveness plane, which were all below the willingness to pay threshold. Interpretation & conclusions: Introduction of MIP vaccination in the NLEP appears to be a cost-effective strategy for India. Significant health gains were reduction in the number of new leprosy cases, decreased incidence and severity of reactions during treatment, and after release from treatment, prevention of disabilities, thus reducing the cost as well as stigma of the disease.

Bayesian structural equation modeling for post treatment health related quality of life among tuberculosis patients.

BACKGROUND: The use of Bayesian Structural Equation Model (BSEM) to evaluate the impact of TB on self-reported health related quality of life (HRQoL) of TB patients has been not studied. OBJECTIVE: To identify the factors that contribute to the HRQoL of TB patients using BSEM. METHODS: This is a latent variable modeling with Bayesian approach using secondary data. HRQoL data collected after one year from newly diagnosed 436 TB patients who were registered and successfully completed treatment at Government health facilities in Tiruvallur district, south India under the National TB Elimination Programme (NTEP) were used for this analysis. In this study, the four independent latent variables such as physical well-being (PW = PW1-7), mental well-being (MW = MW1-7), social well-being (SW = SW1-4) and habits were considered. The BSEM was constructed using Markov Chain Monte Carlo algorithm for identifying the factors that contribute to the HRQoL of TB patients who completed treatment. RESULTS: Bayesian estimates were obtained using 46,300 observations after convergence and the standardized structural regression estimate of PW, MW, SW on HRQoL were 0.377 (p<0.001), 0.543 (p<0.001) and 0.208 (p<0.001) respectively. The latent variables PW, MW and SW were significantly associated with HRQoL of TB patients. The age was found to be significantly negatively associated with HRQoL of TB patients. CONCLUSIONS: The current study demonstrated the application of BSEM in evaluating HRQoL. This methodology may be used to study precise estimates of HRQoL of TB patients in different time points.

Estimating TB diagnostic costs incurred under the National Tuberculosis Elimination Programme: a costing study from Tamil Nadu, South India.

BACKGROUND: The National Tuberculosis Elimination Programme (NTEP) of India is aiming to eliminate TB by 2025. The programme has increased its services and resources to strengthen the accurate and early detection of TB. It is important to estimate the cost of TB diagnosis in India considering the advancement and implementation of new diagnostic tools under the NTEP. The objective of this study was to estimate the unit costs of providing TB diagnostic services at different levels of public health facilities with different algorithms implemented under the NTEP in Chennai, Tamil Nadu, South India. METHODS: This costing study was conducted from the perspective of the health system. This study used only secondary data and information that were available in the public domain. Data were collected with the approval of health authorities. The patient's diagnostic path from the point of registration until the final diagnosis was considered in the costing exercise. The unit costs of different diagnostic tools used in the NTEP implemented by Chennai Corporation were calculated. RESULTS: We estimated the unit cost of the eight laboratory tests (Ziehl-Neelsen [ZN], fluorescence microscopy [FM], x-ray, digital x-ray, gene Xpert MTB/RIF (cartridge-based nucleic acid amplification test [NAAT] that identifies rifampicin resistant Mycobacterium Tuberculosis) Mycobacterium Tuberculosis/Rifampicin [MTB/RIF], mycobacteria growth indicator tube [MGIT], line probe assay [LPA] and Lowenstein Jensen [LJ] culture) for diagnosis of drug-sensitive and drug-resistant TB. The unit costs included fixed and variable costs for smear examination by ZN microscopy (₹ [Indian Rupee] 326 [US${\$}$4.72], FM (₹104 [US${\$}$1.5]), x-ray (₹218 [US${\$}$3.15]), digital X-ray (₹281 [US${\$}$4.07]), gene Xpert MTB/RIF (₹1137 [US${\$}$16.47]), MGIT (₹7038 [US${\$}$102]), LPA (₹6448 [US${\$}$93.44]) and LJ culture (₹4850 [US${\$}$70.28]). Out of 10 diagnostic algorithms used for TB diagnosis, algorithms using only smear microscopy had the lowest cost, followed by smear microscopy with x-ray for drug-sensitive TB (₹104 [US${\$}$1.5] to ₹544 [US${\$}$7.88]). Diagnostic algorithms for drug-resistant TB involving LPA and gene Xpert MTB/RIF were the most expensive. CONCLUSIONS: Understanding the various costs contributing to TB diagnosis in India provides crucial evidence for policymakers, programme managers and researchers to optimise programme spending and efficiently use resources.