Nutritional supplementation to prevent tuberculosis incidence in household contacts of patients with pulmonary tuberculosis in India (RATIONS): a field-based, open-label, cluster-randomised, controlled trial.

BACKGROUND: In India, tuberculosis and undernutrition are syndemics with a high burden of tuberculosis coexisting with a high burden of undernutrition in patients and in the population. The aim of this study was to determine the effect of nutritional supplementation on tuberculosis incidence in household contacts of adults with microbiologically confirmed pulmonary tuberculosis. METHODS: In this field-based, open-label, cluster-randomised controlled trial, we enrolled household contacts of 2800 patients with microbiologically confirmed pulmonary tuberculosis across 28 tuberculosis units of the National Tuberculosis Elimination Programme in four districts of Jharkhand, India. The tuberculosis units were randomly allocated 1:1 by block randomisation to the control group or the intervention group, by a statistician using computer-generated random numbers. Although microbiologically confirmed pulmonary tuberculosis patients in both groups received food rations (1200 kcal, 52 grams of protein per day with micronutrients) for 6 months, only household contacts in the intervention group received monthly food rations and micronutrients (750 kcal, 23 grams of protein per day with micronutrients). After screening all household contacts for co-prevalent tuberculosis at baseline, all participants were followed up actively until July 31, 2022, for the primary outcome of incident tuberculosis (all forms). The ascertainment of the outcome was by independent medical staff in health services. We used Cox proportional hazards model and Poisson regression via the generalised estimating equation approach to estimate unadjusted hazard ratios, adjusted hazard ratios (aHRs), and incidence rate ratios (IRRs). This study is registered with CTRI-India, CTRI/2019/08/020490. FINDINGS: Between Aug 16, 2019, and Jan 31, 2021, there were 10 345 household contacts, of whom 5328 (94·8%) of 5621 household contacts in the intervention group and 4283 (90·7%) of 4724 household contacts in the control group completed the primary outcome assessment. Almost two-thirds of the population belonged to Indigenous communities (eg, Santhals, Ho, Munda, Oraon, and Bhumij) and 34% (3543 of 10 345) had undernutrition. We detected 31 (0·3%) of 10 345 household contact patients with co-prevalent tuberculosis disease in both groups at baseline and 218 (2·1%) people were diagnosed with incident tuberculosis (all forms) over 21 869 person-years of follow-up, with 122 of 218 incident cases in the control group (2·6% [122 of 4712 contacts at risk], 95% CI 2·2-3·1; incidence rate 1·27 per 100 person-years) and 96 incident cases in the intervention group (1·7% [96 of 5602], 1·4-2·1; 0·78 per 100 person-years), of whom 152 (69·7%) of 218 were patients with microbiologically confirmed pulmonary tuberculosis. Tuberculosis incidence (all forms) in the intervention group had an adjusted IRR of 0·61 (95% CI 0·43-0·85; aHR 0·59 [0·42-0·83]), with an even greater decline in incidence of microbiologically confirmed pulmonary tuberculosis (0·52 [0·35-0·79]; 0·51 [0·34-0·78]). This translates into a relative reduction of tuberculosis incidence of 39% (all forms) to 48% (microbiologically confirmed pulmonary tuberculosis) in the intervention group. An estimated 30 households (111 household contacts) would need to be provided nutritional supplementation to prevent one incident tuberculosis. INTERPRETATION: To our knowledge, this is the first randomised trial looking at the effect of nutritional support on tuberculosis incidence in household contacts, whereby the nutritional intervention was associated with substantial (39-48%) reduction in tuberculosis incidence in the household during 2 years of follow-up. This biosocial intervention can accelerate reduction in tuberculosis incidence in countries or communities with a tuberculosis and undernutrition syndemic. FUNDING: Indian Council of Medical Research-India TB Research Consortium.

Universal health coverage and tuberculosis care in India in the times of Covid-19: Aligning Ayushman Bharat (National Health Assurance Scheme) to improve case detection, reduce deaths and catastrophic health expenditure.

India has the largest global burden of new cases of tuberculosis (TB) and deaths due to TB. These occur predominantly in the poor who suffer catastrophic costs during diagnosis and treatment. The National Tuberculosis Elimination Programme has ambitious goals of 80% reduction of incidence of TB, 90% reduction in mortality due to TB by 2025 and 0% occurrence of catastrophic costs to households affected by TB by 2020. The Covid-19 pandemic and the resulting disruption to TB services are expected to worsen the situation. There are gaps in case finding at the peripheral level and access to care at the higher level for patients with TB. An estimated 32% patients with active TB do not access diagnostic services, while catastrophic costs associated with hospitalization are a barrier to access for seriously ill patients. Deaths due to TB in India occur largely at home and not in medical facilities, and are preventable with appropriate inpatient care. The Ayushman Bharat scheme with its Health and Wellness Centres (HWCs) and coverage for inpatient care under the Pradhan Mantri Jan Arogya Yojana (PM-JAY) can facilitate, the achievement of the goals of TB elimination. The HWCs provide an opportunity to close the case-finding gap as first point of contact by enabling sputum transport services to the designated microscopy centres. This will facilitate case detection, reduce diagnostic delays, and decrease community transmission and the incidence of TB. The benefit package of PM-JAY can cover patients with pulmonary TB, inpatient evaluation for other forms of TB, enhance the allocation for treatment and cover management of comorbid conditions such as severe undernutrition, anaemia, HIV and diabetes.

Rapid appraisal of road-safety environment around educational institutions of Mangaluru city, South India

INTRODUCTION: Road traffic accidents (RTA) are the biggest killers according to the Global Status Report on Road Safety. OBJECTIVE: The objective of the present study was to assess the road safety in the vicinity of the educational institutions in the city of Mangaluru in South India. MATERIAL AND METHODS: Considering the proportion of educational institutions having road safety standards in place as 50%, absolute error as 5%, and z as 1.96 ( 95% confidence level), the required sample size was about 100 institutions. It was decided to sample approximately 100 each of government and private education institutions from a total of about 964 schools and colleges in the city limits of Mangaluru and survey them using a comprehensive checklist prepared based on some previous studies. RESULTS: Of the 200 schools observed for road safety features using a preformed checklist, 124 (62%) were located on the main road, 76 (38%) had an approach road from the main road to reach the school. Of these only 23 (11.5%) of institutions had road sign showing school/college, 14 (7%) had a signage showing children crossing, 37 (18.5) had a speed breaker for slowing of traffic and only 2 (1%) had zebra crossing. Sixty four (32%) institutions had parking space and 12 (6%) had sidewalk/pavement for safety. CONCLUSION: It was found that the road safety features and the safe environment around the schools were inadequate putting children, young adults and the employees of these institutions at risk.

Water, sanitation and hygiene survey - Use of hydrogen sulfide strip at field level as a point-of-care test: A pilot study.

Safe drinking water is a basic element of primary health care. The government of India in its Indian Public Health Standards recommends the hydrogen sulfide (H2S) strip test as a desirable component at primary health centers for screening water for fecal coliforms. The objective of the present study was to conduct a water, sanitation and hygiene (WASH) survey followed by a H2S strip test of drinking water in a village with ninety households. The test was positive in 88% at the source and the point of consumption, with 100% concordance between both the points of test. A subsample of water samples was subjected to testing in microbiology laboratory, and fecal contamination was confirmed in all of them. To conclude, H2S strip test can be conveniently used at field level, and its ease of use and visual nature of results make it a useful point-of-care test of environmental and public health.

Can social interventions prevent tuberculosis?: the Papworth experiment (1918-1943) revisited.

RATIONALE: There is consensus on the need to address social determinants of tuberculosis (TB) to achieve TB control, but evidence based on interventions is lacking. OBJECTIVES: We reanalyzed data from the sociomedical experiment performed at the Papworth Village Settlement in England, where the impact of stable employment and adequate housing and nutrition on the incidence of TB infection and disease in children living with parents with active TB was documented during 1918-1943. METHODS: Information on 315 children of patients, who lived at Papworth, was abstracted from a published monograph. Overall and age-specific occurrence of TB infection, disease, and deaths among children born in the settlement (village-born cohort) were compared with those of children born outside and admitted later (admitted cohort) to Papworth. MEASUREMENTS AND MAIN RESULTS: The annual risks of infection in the village-born and admitted cohorts were 20 and 24%, respectively. Of 24 children who developed TB disease, only one was village-born. Among children 5 years of age or less, there was zero incidence of TB in the village-born, compared with five cases (1,217/100,000 person-years) among children born outside Papworth. In the admitted cohort, among children 13 years of age and older, the incidence of TB before admission to Papworth was 5,263/100,000 person-years, whereas it was 341/100,000 person-years while living in Papworth. CONCLUSIONS: At Papworth social interventions including adequate nutrition did not reduce TB transmission but did reduce the incidence of TB disease in children living with parents with active TB. These results are relevant today for prevention of TB in children of patients with active TB, particularly with multidrug-resistant TB in high-burden settings.

Adverse Events among Beneficiaries who Received a Dose of Sputnik V Vaccine at a Tertiary Care Hospital in Coastal Karnataka, India.

Introduction: Vaccination has played a vital role in containing the COVID-19 pandemic. Sputnik V was the third vaccine approved for emergency use in India. The objectives of the present study were to document the adverse events following Sputnik V vaccination and the factors associated with adverse events. Methodology: This cross-sectional study was conducted during September and October 2021 in a teaching hospital of Karnataka. Ethics approval and CTRI registration were obtained before collecting the data. All persons receiving at least one dose of vaccine were invited to participate and baseline information was collected after written informed consent. They were contacted telephonically to enquire about the adverse events. Data were entered in Microsoft Excel and analyzed using SPSS Version 23 to describe percentages and proportions. Results: The median age of 2532 participants was 31 (IQR 25-39) years and 60.4% were males. Minor adverse events were seen among 29.4% participants. Most common symptoms with first dose were fever, vaccination site tenderness, myalgia and headache, and with second dose were fever, myalgia, headache, and vaccination site tenderness. No severe adverse events were reported in our study. The adverse events were seen more among females (P < 0.05) and with the first dose (P < 0.05). Conclusion: Most common adverse events were similar to symptoms suggested by the vaccine manufacturers with fever being the most common one. A follow-up after a longer lag time may be recommended to enquire whether the vaccinees developed serious adverse events.

Integrating Narrative Medicine Through Story-Telling: A Feasibility Study in a Community Medicine Curriculum for Undergraduate and Postgraduate Students.

Introduction The routine curriculum of community medicine includes clinico-social case-taking with a focus on the physical, biological, and psychosocial determinants of health. There is an opportunity to integrate narrative medicine with this for undergraduate and postgraduate medical students using story-telling. The objective of the current study was to assess its feasibility, challenges, and opportunities. Methods We conducted a need assessment cross-sectional survey of the teaching faculty of community medicine across India using Google Forms. Considering an 80% positive response in a pilot within the department, a relative error of 10%, and a 20% non-response rate, the sample size was 120. The questionnaire included closed-ended questions with a Likert scale that dealt with affective, cognitive, and communication domains and open-ended questions for insights into opportunities and challenges. The results of the former were expressed as descriptive statistics, in frequencies and proportions. Open-ended questions were summarized to guide the refinement of further implementation. Results Of the 120 participants, 92 (77%) quoted low/medium empathy quotient in students, and 107 (89.2%) felt that the listening skills of students can improve with the introduction of story-telling. A hundred and twelve (93.4%) participants felt that their history-taking skills can improve with story-telling, and all agreed that the language of medicine can be improved. One hundred nine (90.8%) felt that it will lead to better student-patient interaction. Opportunities included a better understanding of social determinants, patient-/family-centered care, improved communication skills, and better mental health. The key challenges included time, motivation, the need for training/capacity building, and streamlining of assessment metrics. Conclusion We conclude that story-telling may help medical students investigate various social determinants of health, disease, and lived environments that create vulnerabilities.

Nutritional support for adult patients with microbiologically confirmed pulmonary tuberculosis: outcomes in a programmatic cohort nested within the RATIONS trial in Jharkhand, India.

BACKGROUND: Undernutrition is a common comorbidity of tuberculosis in countries with a high tuberculosis burden, such as India. RATIONS is a field-based, cluster-randomised controlled trial evaluating the effect of providing nutritional support to household contacts of adult patients with microbiologically confirmed pulmonary tuberculosis in Jharkhand, India, on tuberculosis incidence. The patient cohort in both groups of the trial was provided with nutritional support. In this study, we assessed the effects of nutritional support on tuberculosis mortality, treatment success, and other outcomes in the RATIONS patient cohort. METHODS: We enrolled patients (aged 18 years or older) with microbiologically confirmed pulmonary tuberculosis across 28 tuberculosis units. Patients received nutritional support in the form of food rations (1200 kcal and 52 g of protein per day) and micronutrient pills. Nutritional support was for 6 months for drug-susceptible tuberculosis and 12 months for multidrug-resistant tuberculosis; patients with drug-susceptible tuberculosis could receive an extension of up to 6 months if their BMI was less than 18·5 kg/m2 at the end of treatment. We recorded BMI, diabetes status, and modified Eastern Cooperative Oncology Group (ECOG) performance status at baseline. Clinical outcomes (treatment success, tuberculosis mortality, loss to follow-up, and change in performance status) and weight gain were recorded at 6 months. We assessed the predictors of tuberculosis mortality with Poisson and Cox regression using adjusted incidence rate ratios (IRRs) and adjusted hazard ratios (HRs). The RATIONS trial is registered with the Clinical Trials Registry of India (CTRI/2019/08/020490). FINDINGS: Between Aug 16, 2019, and Jan 31, 2021, 2800 patients (mean age 41·5 years [SD 14·5]; 1979 [70·7%] men and 821 [29·3%] women) were enrolled. At enrolment, 2291 (82·4%) patients were underweight (BMI <18·5 kg/m2), and 480 (17·3%) had a BMI of less than 14 kg/m2. The mean weight and BMI were 42·6 kg (SD 7·8) and 16·4 kg/m2 (2·6) in men and 36·1 kg (7·3) and 16·2 kg/m2 (2·9) in women. During the 6-month follow-up, treatment was successful in 2623 (93·7%) patients, 108 (3·9%) tuberculosis deaths occurred, 28 (1·0%) patients were lost to follow-up, and treatment failure was experienced by five (0·2%) patients. The median weight gain was 4·6 kg (IQR 2·8-6·8), but 1441 (54·8%) of 2630 patients remained underweight. At 2 months, 1444 (54·0%) of 2676 patients gained at least 5% of baseline weight. Baseline weight (adjusted IRR 0·95, 95% CI 0·90-0·99), BMI (0·88, 0·76-1·01), poor performance status (ECOG categories 3-4; 5·33, 2·90-9·79), diabetes (3·30, 1·65-6·72), and haemoglobin (0·85, 0·71-1·00) were predictors of tuberculosis mortality. A reduced hazard of death (adjusted HR 0·39, 95% CI 0·18-0·86) was associated with a 5% weight gain at 2 months. INTERPRETATION: In this study, nutritional support was provided to a cohort with a high prevalence of severe undernutrition. Weight gain, particularly in the first 2 months, was associated with a substantially decreased hazard of tuberculosis mortality. Nutritional support needs to be an integral component of patient-centred care to improve treatment outcomes in such settings. FUNDING: India Tuberculosis Research Consortium, Indian Council of Medical Research.

Mid-upper arm circumference and neck circumference to screen for overweight-obesity in young adults in South India.

Introduction: There are many anthropometric techniques to screen for overweight-obesity like the body mass index (BMI), waist circumference (WC), and waist-hip ratio (WHR). These may be difficult or less acceptable in community and outpatient settings. We determine the cut-offs of mid-upper arm circumference (MUAC) and neck-circumference (NC) to screen overweight (BMI ≥25 kg/m2), abdominal obesity by waist circumference (WC; men: ≥90 cm; women: ≥80 cm) and high percent body fat (PBF) (men: ≥20%; women: ≥30%) and explore participant preference for various anthropometric methods. Method: ology: We enrolled 282 medical students in South India and performed anthropometry (height, weight, WC, MUAC and NC), bio-impedance analysis (BIA, Inbody 770) to detect PBF. Receiver operator curves were generated and best cut-offs derived using highest Youden Index (sensitivity + specificity-1). Results: Of the 282 participants, 83 (29.4%) were overweight, 113 (38.7%) had abdominal obesity and 186 (66%) had higher PBF. The MUAC cut-off was 31.3cm for men (sensitivity: 86%; specificity: 74%) to detect overweight and 31.2 cm (sensitivity: 85%; specificity: 73%) to detect abdominal obesity. The corresponding cut-offs in women were 28.5 cm (sensitivity:88%; specificity: 83%) to detect overweight and 28.3 cm (sensitivity: 74%; specificity: 92%) for abdominal obesity. For NC, the proposed cut-off in men was 36.6 cm (sensitivity: 81%; specificity: 82%) for overweight and 37.1 cm (sensitivity:78%; specificity:82%) for abdominal obesity. In women, this was 31.4 cm for both overweight as per BMI (sensitivity: 88%; specificity: 71%) and for abdominal obesity (sensitivity: 75%; specificity: 81%). Neck circumference was preferred by 225 (79.8%) participants. Conclusion: Both MUAC and NC can be considered for screening overweight and abdominal obesity with good sensitivity and specificity but their sensitivity and specificity for screening high PFB were not very good. Neck circumference was the most preferred anthropometric method.

Attributable is preventable: Corrected and revised estimates of population attributable fraction of TB related to undernutrition in 30 high TB burden countries.

Introduction: The Global TB Report 2020 estimated the population attributable fractions (PAF) for the major risk factors of TB. Undernourishment emerged as the leading risk factor accounting for 19% of the cases. The WHO however used the terms undernourishment and undernutrition interchangeably in its computation of PAF. Undernourishment is an indirect model derived estimate of decreased per capita energy availability, while undernutrition is defined by direct anthropometric measurements of nutritional status. An estimate of PAF for a risk factor should use the prevalence and the risk ratio of the same risk factor, which is not the case with the current methodology. Methods: We re- estimated the PAF of undernutrition (instead of undernourishment) in 30 high TB burden countries as defined by WHO for the period 2016-2020, using the prevalence of undernutrition (age standardized estimate of BMI < 18.5 kg/m2 in adults for both sexes), and the relative risk (RR) of 3.2. Further, we revised PAF estimates of undernutrition with an RR of 4.49 (95% CI: 2.28, 8.86), in light of recent evidence. Findings: In 30 high TB burden countries, 24.1% (95% CI: 17.6,30.0) of incident TB is attributable to undernutrition. The PAF of undernutrition was highest in Asian countries, unlike the PAF of undernourishment that was highest in Africa. The corrected estimate led up to 65% increase in number of cases attributable to undernutrition in Asian countries. If a revised relative risk was used, 33.0% (95% CI: 10.1, 60.1) of incident TB cases in the selected countries could be attributable to undernutrition. More than one-third to nearly half of incident TB cases in India could be attributable to undernutrition. Interpretation: Estimation of the PAF of TB related to undernutrition is methodologically valid and operationally relevant, rather than PAF related to undernourishment, and should be used for future Global TB reports by WHO. Addressing undernutrition, the leading driver of TB in high TB burden countries (especially Asia) could enable achievement of END TB milestones of TB incidence for 2025.

Screening for Severe Illness at Diagnosis Has the Potential to Prevent Early TB Deaths: Programmatic Experience From Karnataka, India.

Due to the coronavirus disease (COVID-19) pandemic and its associated response, TB deaths increased for the first time in a decade. In any potentially fatal illness, an assessment of severity is essential. This is not systematically done for adults with TB, mostly due to a lack of policy and/or limited availability of diagnostic and clinical capacity. We developed a screening tool using simple and easily measurable indicators that can be used by paramedical TB program staff to quickly identify people with severe illness. During October-November 2020 in Karnataka, India, the paramedical program staff from 16 districts screened people with TB (aged ≥15 years) notified by public facilities for "high risk of severe illness," which was defined as the presence of any of the following indicators: (1) body mass index (BMI) ≤14.0 kg/m2; (2) BMI ≤16.0 kg/m2 with bilateral leg swelling; (3) respiratory rate >24/minute; (4) oxygen saturation <94%; (5) inability to stand without support. In this cohort study, we determined the incidence of program-recorded early deaths (within 2 months) and its association with high risk of severe illness. Of 3,010 people with TB, 1,529 (50.8%) were screened at diagnosis/notification, of whom 537 (35.1%) had a high risk of severe illness. There were 195 (6.5%, 95% CI=5.7, 7.4) early deaths: 59 (30.2%) within a week and 100 (51.3%) within 2 weeks of treatment initiation. The incidence of early deaths was significantly higher among those with high risk of severe illness (8.9%) at diagnosis compared to those without (3.8%) [adjusted relative risk: 2.36 (95% confidence interval=1.57, 3.55)]. To conclude, early deaths were especially high during the first 2 weeks and strongly associated with a high risk of severe illness at diagnosis/notification. Screening for severe illness should be explored as a potential strategy to end TB deaths.

Are Primary Health Centers Prepared for Noncommunicable Disease Management? A Facility-Based Mapping of Gaps in Coastal Karnataka, India.

BACKGROUND: India is in the middle of epidemiological and demographic transitions, with an estimated 63% of the deaths attributed to noncommunicable diseases (NCDs). Primary health centers (PHCs) can deliver a package of services to prevent and control NCDs. OBJECTIVE: The aim of this sudy is to assess the status of health promotion activities and availability of resources for screening and the treatment of NCDs in PHCs of Dakshina Kannada district, Karnataka. MATERIALS AND METHODS: A cross-sectional facility-based assessment of all the 65 functioning PHCs (2016-2017) was conducted for the status of health promotion activities, and availability of resources using a checklist evolved from the World Health Organization Package of Essential NCD Interventions framework and Indian Public Health Standards. RESULTS: Forty-eight (74%) PHCs had displayed materials on the intake of healthy foods and avoiding junk food. Warning signs of cancer were displayed at 43 (66%) PHCs. The availability of drugs for the management of hypertension (Atenolol and Amlodepine) and diabetes mellitus (Metformin) were seen in all the PHCs. Insulin was available in 64 (98%) PHCs. Sorbitrate and Nifedefine were found in 11 (17%) and 7 (11%) PHCs. More than a quarter of the PHCs were not having the medical officer and other health-care professionals to manage NCDs. CONCLUSIONS: Preparedness of the PHCs in the health promotion domain was good. The availability of human resources, laboratory support and emergency drugs for the management of NCDs needs improvement.

Social determinants of tuberculosis: context, framework, and the way forward to ending TB in India.

INTRODUCTION: Social determinants are involved in the causation of TB and its adverse outcomes. This review was conducted to evolve a framework for action on social determinants with special reference to India in the context of the new END TB strategy. AREAS COVERED: We reviewed the social context of TB in India as a neglected disease of the poor, its emergence in epidemic form in the colonial period, and the factors that resulted in its perpetuation and expansion in post-independence India. We examined the role of social determinants in two key pathways - the pathway of TB causation and its outcomes, and the care cascade for patients with TB, and its consequences. We reviewed the most important social determinants of TB including poverty, membership of certain castes and indigenous population, undernutrition and poor access to healthcare, especially in rural areas. EXPERT OPINION: We suggest that TB elimination will require an optimal mix of enhanced biomedical and social interventions. TB elimination strategy in India needs a pro-poor model of patient - centered care inclusive of nutritional, psycho-social and financial support, universal health coverage, and social protection; and convergence with multi-sectoral efforts to address poverty, undernutrition, unsafe housing, and indoor pollution.

Screening People with Tuberculosis for High Risk of Severe Illness at Notification: Programmatic Experience from Karnataka, India.

Due to limited availability of diagnostics and capacity, people with tuberculosis do not always undergo systematic assessment for severe illness (requiring inpatient care). In Karnataka (south India), para-medical programme staff used a screening tool to identify people at 'high risk of severe illness', defined using indicators of very severe undernutrition, abnormal vital signs and poor performance status (any one): (i) body mass index (BMI) ≤ 14.0 kg/m2 (ii) BMI ≤ 16.0 kg/m2 with bilateral leg swelling (iii) respiratory rate > 24/min (iv) oxygen saturation < 94% (v) inability to stand without support. Of 3020 adults notified from public facilities (15 October to 30 November 2020) in 16 districts, 1531 (51%) were screened (district-wise range: 13-90%) and of them, 538 (35%) were classified as 'high risk of severe illness'. Short median delays in screening from notification (five days), and all five indicators being collected for 88% of patients, suggests the feasibility of using this tool in programme settings. However, districts with poor screening coverage require further attention. To end tuberculosis deaths, screening should be followed by referral to higher facilities for comprehensive clinical evaluation, to assess the need for inpatient care. Future studies should assess the validity (especially sensitivity in picking severely ill patients) of this screening tool.