Clinico-epidemiological profiles & outcome of severe malaria in children under-five in the tribal area of Kalahandi, Odisha.

BACKGROUND OBJECTIVES: Severe malaria is a cause of excess mortality and morbidity in children in malaria-endemic areas where indigenous people live. Currently, available reports are all from secondary or tertiary care hospitals across India and some African countries. The objective of this study was to assess the clinical and epidemiological profiles of children under five years in two primary care health centres located in tribal-dominant Thuamul Rampur Block of Kalahandi district, Odisha. The outcome of management of severe malaria in these children was also assessed. METHODS: A retrospective review of case records of children under five years of age diagnosed and admitted with severe malaria in two non-governmental primary care facilities between 2017 and 2022, was undertaken. RESULTS: There was a declining trend in malaria cases documented in primary care health facilities between January 2017 and June 2022. Of the 4858 cases recorded, 242 (4.9%) had severe malaria, of whom 70.7 per cent (n=171) were children under 5 yr. The median age of the study children was 24 months (16-36). Children aged 1-2 yr had a significantly higher risk of malaria. The majority were tribals (87%), more than half the children presented with neurological manifestations (64.4%), and 49.6 per cent had respiratory manifestations, while 20.5 per cent had severe anaemia (Hb <5 g/dl). Most, 167 (97.7%) severe malaria was due to Plasmodium falciparum. Thirty-two percent of children were severely wasted (WHZ < -3 SD) and 28 per cent were moderately wasted (WHZ <-2 SD). There was no fatality among the 171 children who were managed for severe malaria in the two primary care facilities. INTERPRETATION CONCLUSIONS: In high endemic areas severe malaria is predominantly a disease of under-five children and is caused by P. falciparum. Clinical manifestations of severe malaria in children can be varied and life-threatening. Primary health facilities can manage severe malaria successfully, thereby reducing child mortality. Effective collaboration between malaria control and nutrition intervention programmes is essential for appropriate case management.

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.

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.

Evolution of community health workers: the fourth stage.

Introduction: Comprehensive primary care is a key component of any good health system. Designers need to incorporate the Starfield requirements of (i) a defined population, (ii) comprehensive range, (iii) continuity of services, and (iv) easy accessibility, as well as address several related issues. They also need to keep in mind that the classical British GP model, because of the severe challenges of physician availability, is all but infeasible for most developing countries. There is, therefore, an urgent need for them to find a new approach which offers comparable, possibly even superior, outcomes. The next evolutionary stage of the traditional Community health worker (CHW) model may well offer them one such approach. Methods: We suggest that there are potentially four stages in the evolution of the CHW - the health messenger, the physician extender, the focused provider, and the comprehensive provider. In the latter two stages, the physician becomes much more of an adjunct figure, unlike in the first two, where the physician is at the center. We examine the comprehensive provider stage (stage 4) with the help of programs that have attempted to explore this stage, using Qualitative Comparative Analysis (QCA) developed by Ragin. Starting with the 4 Starfield principles, we first arrive at 17 potential characteristics that could be important. Based on a careful reading of the six programs, we then attempt to determine the characteristics that apply to each program. Using this data, we look across all the programs to ascertain which of these characteristics are important to the success of these six programs. Using a truth table, we then compare the programs which have more than 80% of the characteristics with those that have fewer than 80%, to identify characteristics that distinguish between them. Using these methods, we analyse two global programs and four Indian ones. Results: Our analysis suggests that the global Alaskan and Iranian, and the Indian Dvara Health and Swasthya Swaraj programs incorporate more than 80% (> 14) of the 17 characteristics. Of these 17, there are 6 foundational characteristics that are present in all the six stage 4 programs discussed in this study. These include (i) close supervision of the CHW; (ii) care coordination for treatment not directly provided by the CHW; (iii) defined referral pathways to be used to guide referrals; (iv) medication management which closes the loop with patients on all the medicines that they need both immediately and on an ongoing basis (the only characteristic which needs engagement with a licensed physician); (v) proactive care: which ensures adherence to treatment plans; and (vi) cost-effectiveness in the use of scarce physician and financial resources. When comparing between programs, we find that the five essential added elements of a high-performance stage 4 program are (i) the full empanelment of a defined population; (ii) their comprehensive assessment, (iii) risk stratification so that the focus can be on the high-risk individuals, (iv) the use of carefully defined care protocols, and (v) the use of cultural wisdom both to learn from the community and to work with them to persuade them to adhere to treatment regimens.

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.