Locally Prepared Therapeutic Food for Treatment of Severely Underweight Children in Rural India: An Interventional Prospective Controlled Community-Based Study with Long Follow-Up:-'SAMMAN' Trial.

BACKGROUND: Severely underweight (SUW) children contribute significantly to under-five mortality and morbidity. There are WHO guidelines for the management of severe acute malnutrition but no specific guidelines for SUW management. OBJECTIVE: The objectives were to achieve a recovery rate of 30% at 90 days of treatment for severe underweight (SUW) children aged 6-60 months, compare changes in weight-for-age Z (WAZ) scores, growth patterns, and case fatality rates between intervention and reference arms (RA), and reduce the prevalence of SUW in the intervention arm (IA). The target of a 30% recovery rate was achievable and significant based on our past research conducted in similar settings. METHODS: Design: A prospective controlled community-based, longitudinal, two arms (IA, RA), intervention study with long follow-up was conducted between January 2011 and October 2023. SETTING: Primary care for participants from 14 villages in rural Melghat, India. PARTICIPANTS: The study participants included SUW children aged 6-60 months and age-matched (±2 weeks) normal controls. The SAMMAN (Acronym for SAM-Management) intervention was comprised of local therapeutic food-micronutrient (LTF-MN) therapy for 90 days, intensive behavior change communication, infection treatment, and quarterly anthropometric records. SUW recovery, growth patterns, case fatality rate, prevalence at 90 days of therapy and at 60 months of age, and survival until early adolescence were assessed. ANCOVA analysis was used to obtain changes in Z-scores. RESULTS: In the IA, the recovery rate was 36.8% at 90 days and 78.2% at 60 months of age. The mean difference in change in WAZ scores between the intervention arm and the reference arm was statistically significant (p < 0.0001). Growth patterns were similar between the two arms up to early adolescence. The SUW case fatality rate was significantly lower in the IA (0.9%) as compared to 4.62% in the RA at 60 months (p = 0.022). The reduction in SUW prevalence in intervention villages was higher than in the control villages (p < 0.001). The cost of management per SUW child was 3888 INR (47 USD) less than RUTF. CONCLUSION: The SAMMAN intervention is safe and cost-effective for significantly improving WAZ scores, sustainable, and hence replicable in resource-limited areas.

Indexing of Left Atrial Volume by various body size parameters in the Indian non-obese normal subjects: Is there an incremental value ?

BACKGROUND: Left atrial (LA) volume indexing for body surface area (BSA) is the common practice. Since LA volume index is of cardiovascular pathophysiologic significance, it is suggested that indexing for other body size parameters be explored to evaluate a more appropriate alternative method. The aims of this study were to find normal and the best cutoff values for LA volume indexed for multiple body size parameters in normal Indian subjects. METHODS: Data from the multicentric prospective INDEA study conducted through 2018 to 2020 was reviewed and subjects without known cardiac disease and completely normal echocardiograms that had the left atrial volume (LAV) measured by biplane Simpson's method were included. LAV was indexed by BSA (ml/m2), by height (LAV/m), by height raised to exponent 1.72 (mL/m 1.72 and 2.7 (ml/m2.7), by body weight, by ideal body weight (IBW), by ideal body surface area (IBSA) and by height squared (ml/h2). RESULTS: A total of 1046 healthy volunteers (382 female, 38%), mean age 38 ± 10.4 years (range 30-48 years) and body mass index 23.6 kg/m2 (22-25 kg/m2) were analyzed. Mean and normal values were: LAV/BSA 18.7 + 3.15 ml/m2 (range 15-21 ml/m2), LAV/ht 26.0 ± 4.5 ml/m, (range 17-35 ml/m), LAV/ht2 16 ± 2.8 ml/m2 (range 10.4-21.6 ml/m2) and LAV/ht2.7 8.71 ± 2.2 ml/m2.7 (range 6.98-13.58 ml/m2.7). Using ROC curve analysis, LAV/h 1.72 had the highest AUC and the best predictive value to identify LA enlargement but not very different from LAV/BSA. Ideal BSA and ideal body weight as a denominator did not provide any incremental value. CONCLUSION: Normal values for LAV indexed for height, weight, body surface area by three different methods of height as an allometric parameter are described in normal Indian individuals. We reinforce that LA volume indexation for BSA is an acceptable and robust method in non-obese Indian subjects. Indexing for height 1.72 is probably slightly superior method to evaluate LAV.

Real-world experience of brolucizumab in nAMD.

PURPOSE: To evaluate real-world outcomes with neovascular age-related macular degeneration (nAMD) in relation to anatomical success, visual outcomes, and safety of intravitreal brolucizumab (IVBr) injection at 1.5 years. METHODS: Prospective, randomized, single-center study between December 2020 and December 2022 that included 71 eyes of 62 patients with nAMD, who received IVBr. Patients were divided into three groups, i.e., naïve choroidal neovascular membrane (CNVM), switched therapy (st) CNVM, and st polypoidal choroidal vasculopathy (stPCV). They were subdivided into dry, minimal fluid (fluid <50 microns)/pigment epithelial detachment (PED) and persistent fluid (fluid >100 microns)/PED subgroups depending upon the fluid level at the end of 1.5 years. Best-corrected visual acuity (BCVA), central macular thickness (CMT), status of fluid, and number of injections at 1.5 years were evaluated. From the beginning, patients were treated on pro re nata (PRN) basis. RESULTS: Of the 71 eyes, 27 eyes (38%) were naïve CNVM, 35 eyes (49.3%) were stCNVM, and 9 (12.7%) were stPCV cases. Significant vision improvement after 1.5 years was seen in the stCNVM category (P = 0.001), while CMT reduction was significant in all three groups (P < 0.05). The mean number of injections required in naïve CNVM and stCNVM groups was significantly less as compared to the stPCV group (P = 0.017). Further, vision improvement was significant in the "Minimal fluid" subgroup (P = 0.002), while the CMT improvement was significant in the "Minimal fluid" and "Dry" subgroups each with P < 0.0001. No ocular/systemic adverse events including intraocular inflammation (IOI) were noted. CONCLUSION: In a real-world scenario, with 203 procedures and 1.5-year follow-up, brolucizumab is found to be efficacious and safe with the need for a lesser number of injections and more interval-free period in the management of naïve CNVM, stCNVM, and stPCV patients.

Verbal autopsy to assess causes of mortality among the economically productive age group in the tribal region of Melghat, central India.

Background & Objectives: Verbal autopsy (VA) is the systematic and retrospective inquiry (from relatives) about the symptoms of an illness prior to death. In tribal India, 67-75 per cent of deaths occur at home with an unknown cause of death (CoD). Hence, the aim of this study was to determine the CoD in the 16-60 yr age group utilizing VA. Methods: A prospective, community based longitudinal study was conducted in 32 tribal villages in the Melghat region of Maharashtra, between 2004 and 2020. Number of deaths and VAs in 16-60 yr age group were collected by village health workers (VHWs) and supervisors, verified by five different persons (internal-external) and cross-checked by three VA interpretation trained physicians. A modified version of WHO VA was used. Cause-specific mortality fractions were calculated. Results: Of the 1011 deaths recorded, mortality in males was significantly higher than females (P<0.001). A total of 763 VAs were conducted which revealed that tuberculosis was the leading CoD, followed by jaundice, heart diseases, diarrhoea, central nervous system infections and suicide. Suicides were significantly more common among males than in females (P=0.046). Significantly, more deaths occurred during the monsoon (P=0.002), especially diarrhoeal deaths (P=0.024). Interpretation & conclusions: The findings of this study suggest that, in Indian tribal areas, infectious diseases are the leading causes of morbidity and one of the major causes of deaths in economically productive age group. Intensified VHW-mediated interventions are required to reduce the premature deaths.

Vessel density changes in choroid, chorio-capillaries, deep and superficial retinal plexues on OCTA in normal ageing and various stages of age-related macular degeneration.

PURPOSE: To study vessel density (VD) on optical coherence tomography angiography at choroid, chorio-capillaries (CC) and various retinal levels in normal population and various stages of dry AMD and how these changes progress with increase in severity of the disease. METHODS: Prospective, observational, cross-sectional study was done on 252 eyes of 132 patients (males: 61, females: 71) presenting to tertiary-care centre in Central India between February 2021 and January 2022. For study purpose, eyes were divided into five groups according to the size and number of the drusen, viz, Group 1: No AMD (< 50 years), Group 2: No AMD (> 50 years), Group 3: Early AMD, Group 4: Intermediate AMD and Group 5: Advanced AMD. In all eyes, VD was measured at choroid, CC, deep capillary plexus (DCP) of retina and superficial capillary plexus (SCP) of retina. RESULTS: The mean age in case cohort is 61.90 ± 7.97 years. The mean vascular density differed significantly across diagnosis types in all the quadrants (p < 0.05) at choroid, CC and DCP level. At SCP level, the differences were significant across the groups except at the central quadrant. Vessel density was found to be more in early AMD cohort when compared to No AMD (> 50 years) cohort at SCP and DCP level, while it showed continuous reduction later in intermediate and advanced AMD cohort. CONCLUSION: With increase in the severity of disease, significant reduction in VD is also seen in retinal plexuses, along with the changes in choroid and CC. These VD maps may play a role as non-invasive biomarkers for healthy and diseased ageing.

Community-Minimal Invasive Tissue Sampling (cMITS) using a modified ambulance for ascertaining the cause of death: A novel approach piloted in a remote inaccessible rural area in India.

BACKGROUND: Melghat in India is a hilly, forested, difficult to access, impoverished rural area in northeast part of Maharashtra (Central India) with difficult healthcare access. Melghat has very high Mortality rates, because of grossly inadequate medical facilities. (1) Home deaths contribute to 67% of deaths,(2) which are difficult to track and where cause of death is mostly unknown. METHODS: A feasibility study was carried out in 93 rural villages and 5 hospitals to assess feasibility of tracking real-time community mortality and to ascertain cause of death in 0-60 months and 16-60 years age group using Minimal Invasive Tissue Sampling (MITS) in purpose-modified ambulance. We used the network of village health workers (VHW)s, to establish real-time community mortality tracking. Upon receipt of reports of home death, we performed MITS within 4 h of death in the vicinity of the village. RESULTS: We conducted 16 MITS. Nine, in MITS ambulance in community and seven at MAHAN hospital. The acceptance rate of MITS was 59.26%. Standard operating procedure (SOP) of conducting community MITS in an ambulance, is established. Major challenges were, Covid19 lockdown, reluctance of tribal parents for consent for MITS due to illiteracy, superstitions and fear of organ removal. Ambulance was an easy to reach transport means in remote area, provided a well-designed and discrete facility to perform MITS in community, winning the confidence of bereaved family. This has reduced time interval between time of death and performing MITS. CONCLUSIONS: MITS in purpose-modified Ambulance can be used worldwide for community MITS especially in areas which are remote and lack healthcare access. This solution needs to be assessed in different cultural settings to document culture specific issues.

Enlargement of the Pancreas in Children Diagnosed with Acute Pancreatitis: An Approach Based on P/V Ratio.

Background Acute pancreatitis is a reversible inflammation of the pancreatic parenchyma. Enlargement of the pancreas is often envisaged in such conditions. This study evaluates P/V ratio, as a marker to decide pancreatic enlargement in disease condition. Purpose The aim of this study was to develop imaging-based diagnostic criterion for acute pancreatitis in children based on P/V ratio. Material and Methods This study included 37 children with acute pancreatitis and 283 children asymptomatic for pancreatic disorders, from a single hospital center. The age of children ranged between 2 and 18 years. P/V ratio, which is the ratio of greatest anteroposterior dimension of the head, body, and tail of the pancreas relative to the transverse lumbar vertebral body, was obtained for each child through ultrasonographic examination. Age-adjusted receiver operating characteristics (AROC) analysis was performed on P/V ratio at presentation for each pancreatic region, and the sensitivity at 90% specificity, the threshold errors, and the corresponding cutoffs were obtained. The enlargement assessment was also done after clinical recovery by referring to the cutoffs of respective regions. Results AROC analysis for males and females resulted into a maximum sensitivity of 83.33 and 81.67%, respectively, at 90% specificity for head. The error thresholds for both the groups were same, i.e., 0.098, indicating that 90% of the observations had errors less than the threshold. The corresponding P/V ratio cutoff for males and females was 0.43 and 0.42, respectively. Conclusion Radiologists and clinicians can refer a cutoff value of 0.4 for each region, along with hypoechogenicity, to decide about enlargement of the pancreas in acute pancreatitis condition.

Effect of Short-Term Practice of Left Nostril Breathing on Various Sleep Parameters in the Medical Students.

Background: Various recent studies have reported that exclusive right nostril breathing (RNB) and left nostril breathing (LNB) has an immediate and sustained effect under various medical conditions. In the present study, we evaluated the effect of short-term left nostril breathing on various sleep parameters in medical students. Methods: We hypothesized that the increase in vagal tone because of LNB can help in improving the quality of sleep. The baseline sleep quality was documented before the start of study in the case and the control group using the 'Pittsburgh Sleep Quality Index' (PSQI) questionnaire. A PSQI global score of more than 5 indicates poor sleep quality. The case group practiced LNB in a graduated manner for a period of 4 weeks. Thereafter, sleep quality was documented for both the groups using the PSQI questionnaire. Results: Practicing LNB significantly lowered all the seven component scores (p < 0.05) and the global PSQI score in the case group (p-value < 0.0001), suggesting that this practice effectively improved the sleep quality in the individuals of this group. Conclusions: Overall, this study suggested that exclusive LNB practice could serve as an important lifestyle modification that can be incorporated in the routine of medical students for improving their sleep quality.

Effect of home-based childcare on childhood mortality in rural Maharashtra, India: a cluster randomised controlled trial.

BACKGROUND: Melghat, an impoverished rural area in Maharashtra state, India; has scarce hospital services and low health-seeking behaviour. At baseline (2004) the under-five mortality rate (U5MR) (number of deaths in children aged 0-5 years/1000 live births) was 147.21 and infant mortality rate (IMR) (number of deaths of infants aged under 1 year/1000 live births) was 106.6 per 1000 live births. We aimed at reducing mortality rates through home-based child care (HBCC) using village health workers (VHWs). METHODS: A cluster-randomised control trial was conducted in 34 randomly assigned clusters/villages of Melghat, Maharashtra state, between 2004 and 2009. Participants included all under-five children and their parents. Interventions delivered through VHWs were patient-public involvement, newborn care, disease management and behaviour change communications. Primary outcome indicators were U5MR and IMR. Secondary outcome indicators were neonatal mortality rate (NMR) (number of neonatal deaths aged 0-28 days/1000 live births) and perinatal mortality rate (PMR) (number of stillbirths and early neonatal deaths/1000 total births). Analysis was by intention-to-treat at the individual level. This trial was extended to a service phase (2010-2015) in both arms and a government replication phase (2016-2019) only for the intervention clusters/areas (IA). FINDINGS: There were 18 control areas/clusters (CA) allocated and analysed with 4426 individuals, and 16 of 18 allocated IA, analysed with 3230 individuals. The IMR and U5MR in IA were reduced from 106.60 and 147.21 to 32.75 and 50.38 (reduction by 69.28% and 65.78%, respectively) compared with increases in CA from 67.67 and 105.3 to 86.83 and 122.8, respectively, from baseline to end of intervention. NMR and PMR in IA showed reductions from 50.76 to 22.67 (by 55.34%) and from 75.06 to 24.94 (by 66.77%) respectively. These gains extended to villages in the service and replication phases. INTERPRETATION: This socio-culturally contextualised model for HBCC through VHWs backed up with institutional support is effective for significant reduction of U5MR, IMR and NMR in impoverished rural areas. This reduction was maintained in the study area during the service phase, indicating feasibility of implementation in large-scale public health programmes. Replicability of the model was demonstrated by a linear decline in all the mortality rates in 20 new villages during the government phase. TRIAL REGISTRATION NUMBER: NCT02473796.

Pre-operative optical coherence tomography predictors: Do they hold any relevance in the era of inverted internal limiting membrane flap in large macular holes?

Purpose: To study the relevance of preoperative OCT predictors in large macular holes (MH) treated using the inverted ILM peel technique. Methods: Prospective study of 95 patients undergoing vitrectomy for large MH between January 2019 and December 2020 was performed by dividing the patients into groups depending on various quantitative parameters and indices of MH such as base diameter (BD), hole form factor (HFF), macular hole index (MHI), diameter hole index (DHI), and tractional hole index (THI) by using parameters such as minimal hole diameter, hole height, nasal and temporal arm lengths. Depending upon the duration of symptoms, patients were divided into three groups: <3 months, 3-6 months, and >6 months. Anatomical success rate, type of closure, and postoperative vision gain were analyzed in relation to the abovementioned diameters, indices, and duration to see if any significance existed. Results: The mean age of patients included in the study was 60.48 ± 13.88 years, with female preponderance (males: females = 37:58). Change in logMAR was statistically significant individually with all studied parameters (P < 0.0001) without influence of size of hole and other indices. BD and DHI levels showed significant association with type of closure as indicated by P values of 0.017 and 0.048, respectively. Duration of symptoms showed no significance in terms of anatomical and functional success. Conclusion: OCT predictors of MH success seem to have lost relevance with inverted flap surgeries as 100% anatomical success is achieved with this technique, with 95.78% (91/95) achieving type 1 closure with statistically significant equivalent functional gain across the indices with no effect of duration of symptoms.