Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy.

BACKGROUND: The World Health Organization recommends 1500 to 2000 mg of calcium daily as supplementation, divided into three doses, for pregnant persons in populations with low dietary calcium intake in order to reduce the risk of preeclampsia. The complexity of the dosing scheme, however, has led to implementation barriers. METHODS: We conducted two independent randomized trials of calcium supplementation, in India and Tanzania, to assess the noninferiority of a 500-mg daily dose to a 1500-mg daily dose of calcium supplementation. In each trial, the two primary outcomes were preeclampsia and preterm birth, and the noninferiority margins for the relative risks were 1.54 and 1.16, respectively. RESULTS: A total of 11,000 nulliparous pregnant women were included in each trial. The cumulative incidence of preeclampsia was 3.0% in the 500-mg group and 3.6% in the 1500-mg group in the India trial (relative risk, 0.84; 95% confidence interval [CI], 0.68 to 1.03) and 3.0% and 2.7%, respectively, in the Tanzania trial (relative risk, 1.10; 95% CI, 0.88 to 1.36) - findings consistent with the noninferiority of the lower dose in both trials. The percentage of live births that were preterm was 11.4% in the 500-mg group and 12.8% in the 1500-mg group in the India trial (relative risk, 0.89; 95% CI, 0.80 to 0.98), which was within the noninferiority margin of 1.16; in the Tanzania trial, the respective percentages were 10.4% and 9.7% (relative risk, 1.07; 95% CI, 0.95 to 1.21), which exceeded the noninferiority margin. CONCLUSIONS: In these two trials, low-dose calcium supplementation was noninferior to high-dose calcium supplementation with respect to the risk of preeclampsia. It was noninferior with respect to the risk of preterm live birth in the trial in India but not in the trial in Tanzania. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT03350516; Clinical Trials Registry-India number, CTRI/2018/02/012119; and Tanzania Medicines and Medical Devices Authority Trials Registry number, TFDA0018/CTR/0010/5).

Assessing association of household diet diversity with mother's time use on productive and reproductive activities: a case for gender sensitive social safety nets.

OBJECTIVE: In South Asia, while women make substantial economic contributions through their participation in agricultural sector, these contributions are undercounted as most of their work is underpaid or unpaid. This paper examines how mothers allocate their time to productive and reproductive activities and its association with a household's ability to achieve high household diet diversity score. DESIGN: The analysis uses data on household consumption and expenditure including food during the kharif (June to October) season (seeds are sown) and a modular time-use survey. SETTING: Two districts of rural Bihar, India. PARTICIPANTS: Mothers with children less than 5 years of age and supported by the head of the household from 2026 households. RESULTS: The estimates indicate that the high household diet diversity (High HDDS ≥ 10) is associated with greater time spent in reproductive activities by all women (OR = 1·12, 95 % CI: 1·06, 1·18). However, with increasing time spent in productive activities by the women the odds of achieving 'High HDDS' reduced (OR = 0·83, 95 % CI: 0·77, 0·89) in adjusted logistic regression analysis. CONCLUSION: The findings highlight propensity to achieve 'High HDDS' in Bihar increased with mothers allocating time towards reproductive activities, while it had an opposing effect with mothers allocating time on productive activities. Our study highlights that the policies that encourage women's participation in agriculture or livestock should acknowledge the unpaid nature of some of the productive activities and design programs to improve economic agency of women to actuate the true potential of agriculture-nutrition pathways.

Predictors of anaemia in mothers and children in Uttar Pradesh, India.

OBJECTIVE: Anaemia affects more than half of Indian women and children, but the contribution of its causes remains unquantified. We examined interrelationships between Hb and nutritional, environmental, infectious and genetic determinants of anaemia in non-pregnant mothers and children in Uttar Pradesh (UP). DESIGN: We conducted a cross-sectional survey of households in twenty-five districts of UP between October and December 2016. We collected socio-demographic data, anthropometry and venous blood in 1238 non-pregnant mothers and their children. We analysed venous blood samples for malaria, Hb, ferritin, retinol, folate, Zn, vitamin B12, C-reactive protein, α1-acid glycoprotein (AGP) and ß-thalassaemia. We used path analysis to examine pathways through which predictors of anaemia were associated with Hb concentration. SETTING: Rural and urban households in twenty-five districts of UP. PARTICIPANTS: Mothers 18-49 years and children 6-59 months in UP. RESULTS: A total of 36·4 % of mothers and 56·0 % of children were anaemic, and 26·7 % of women and 44·6 % of children had Fe deficiency anaemia. Ferritin was the strongest predictor of Hb (ß (95 % CI) = 1·03 (0·80, 1·27) g/dL in women and 0·90 (0·68, 1·12) g/dL in children). In children only, red blood cell folate and AGP were negatively associated with Hb and retinol was positively associated with Hb. CONCLUSIONS: Over 70 % of mothers and children with anaemia had Fe deficiency, needing urgent attention. However, several simultaneous predictors of Hb exist, including nutrient deficiencies and inflammation. The potential of Fe interventions to address anaemia may be constrained unless coexisting determinants are jointly addressed.

The role of dairy consumption in the relationship between wealth and early life physical growth in India: evidence from multiple national surveys.

INTRODUCTION: Prevalence of undernutrition continues to be high in India and low household wealth is consistently associated with undernutrition. This association could be modified through improved dietary intake, including dairy consumption in young children. The beneficial effect of dairy on child growth has not been explored at a national level in India. The present analyses aimed to evaluate the direct and indirect (modifying association of household level per adult female equivalent milk and milk product consumption) associations between household wealth index on height for age (HAZ) and weight for age (WAZ) in 6-59 months old Indian children using data from of nationally representative surveys. METHODS: Two triangulated datasets of two rounds of National Family Health Survey, (NFHS-3 and 4) and food expenditure (National Sample Survey, NSS61 and 68) surveys, were produced by statistical matching of households using Non-Iterative Bayesian Approach to Statistical Matching technique. A Directed Acyclic Graph was constructed to map the pathways in the relationship of household wealth with HAZ and WAZ based on literature. The direct association of wealth index and its indirect association through per adult female equivalent dairy consumption on HAZ and WAZ were estimated using separate path models for each round of the surveys. RESULTS: Wealth index was directly associated with HAZ and WAZ in both the rounds, but the association decreased from NFHS-3 (ßHAZ: 0.145; 95% CI: 0.129, 0.16) to NFHS-4 (ßHAZ: 0.102; 95%CI: 0.093, 0.11). Adult female equivalent milk intake (increase of 10gm/day) was associated with higher HAZ (ß_NFHS-3=0.001;95% CI: 0, 0.002; ß_NFHS-4=0.002;95% CI: 0.002, 0.003) but had no association with WAZ. The indirect association of wealth with HAZ through dairy consumption was 2-fold higher in NFHS-4 compared to NFHS-3. CONCLUSIONS: The analysis of triangulated survey data shows that household level per- adult female equivalent dairy consumption positively modified the association between wealth index and HAZ, suggesting that regular inclusion of milk and milk products in the diets of children from households across all wealth quintiles could improve linear growth in this population.

A longitudinal survey on changes in employment and food consumption during the COVID-19 pandemic in rural Bihar, India.

BACKGROUND: There is a need for empirical evidence on changes in employment and food consumption during pandemic situations in households belonging to the informal economy. OBJECTIVE: To examine changes in food insecurity, household diet diversity, and employment in agriculture during the pre-COVID-19 (2019-early 2020) and COVID-19 pandemic (September 2021) periods. METHODS: A total of 1632 households from a face-to-face pre-COVID-19 survey and 621 of those followed up by a telephonic survey during COVID-19 in Bihar, India, were included in the analyses. Household food insecurity, household diet diversity score (HDDS), and employment change (agriculture or nonagriculture) were assessed during both periods. Food insecurity and diet diversity in the 2 periods were examined by logistic regression. A change in the odds of being food insecure or having low HDDS was examined as an interaction between time and employment status. RESULTS: Prevalence of food insecurity increased from 21% to 55%, and low diet diversity increased from 47% to 69% in households assessed in both surveys. Employment status was not associated with food insecurity or low HDDS during the baseline survey. However, during the pandemic, ∼30% of households changed their employment from agriculture to nonagriculture and were more likely to be food insecure (adjusted odds ratio [aOR]: 2.77; 95% confidence interval [CI] 1. 78-4.32) and have low HDDS (aOR: 1.66; 95%CI: 1.05-2.61), than those who remained in agriculture. Similarly, those who retained nonagricultural employment during the pandemic were more likely to be food insecure (aOR: 2.23; 95%CI: 1.45-3.43) and have low HDDS (aOR: 1.73; 95%CI: 1.11-2.70), compared to those who remained in agriculture. In propensity score-adjusted interaction analysis of time and employment, food insecurity and low HDDS remained significantly associated with nonagricultural employment during the pandemic. CONCLUSIONS: Enhanced support to rural households in agricultural occupations could buffer them from unexpected crises, which may also protect their nutritional intake.

Impact of the COVID-19 lockdown on household diet diversity in rural Bihar, India: a longitudinal survey.

BACKGROUND: The COVID-19 pandemic disrupted livelihoods and diets across the world. This study aimed to assess changes in household diet diversity and food consumption between the pre-COVID-19 period (December 2019-January 2020) and during the lockdown (March-May 2020), and to identify the socio-economic characteristics that determine these changes in rural Bihar, India. METHODS: Households that had provided their phone numbers in the pre-COVID-19 household survey (n = 1797) were contacted for interviews during the lockdown telephonic survey in a longitudinal survey in two districts (Gaya and Nalanda) in Bihar. In total, 939 households were interviewed. Using data on food consumption from both surveys, 876 households were included in the analysis. Food and Agriculture Organization's household diet diversity score (HDDS) was used to compare diet diversity between the pre-COVID-19 period and during the lockdown. Logistic regression was used to identify factors affecting household diet diversity and food consumption in the study households. RESULTS: Low diet diversity increased from 51.6% (95% CI 48.3-54.9) to 75.8% (95% CI 73.0-78.6) from the pre-COVID-19 to the lockdown period. Reduced food consumption was reported across all foods with nearly a quarter of the households reporting reduced consumption of fruits (27%), pulses (25%) and cereals (21%). Nearly 60% and above reported stopping consumption of nutrient-rich foods such as chicken, fish and eggs although the population was predominantly non-vegetarian. Logistic regression analysis revealed that taking a loan from neighbours/relatives (OR = 1.8; 95% CI 1.3-2.5) and belonging to lower social groups (OR = 1.8; 95% CI 1.1-2.9) increased odds of low HDDS. While those possessing ration cards had lower odds of reduced consumption of all food items, it was not associated with stopping consumption of any food item. In an unadjusted analysis, receipt of cash transfer during lockdown was also not associated with diet diversity (OR = 1.2; 95% CI 0.9-1.7). CONCLUSIONS: COVID-19 has impacted the consumption of nutrient-rich foods among already low-income rural households in India. Maintaining diet diversity among socio-economically vulnerable households during periods when food consumption is most threatened by shocks such as COVID-19 would need sustained government support in terms of social protection coverage and benefit transfers in rural communities.

Accelerated scale-up of Kangaroo Mother Care: Evidence and experience from an implementation-research initiative in south India.

AIM: Though Kangaroo Mother Care (KMC) has demonstrated benefits for low birth weight newborns, coverage continues to be low in India. As part of a World Health Organization (WHO) multi-country study, we explored intervention models to accelerate KMC coverage in a high priority district of Karnataka, India. METHODS: We used implementation-research methods, formative assessments and quality improvement approaches to design and scale-up interventions. Evaluation was done using prospective cohort study design; data were collected from facility records, and client interviews during KMC initiation, at discharge and at home after discharge. RESULTS: KMC was initiated at health facilities for 87.6% of LBW babies under 2000 g. At discharge, 85.0% received KMC; 67.9% continued to receive KMC at home on the 7th day post-discharge. The interventions included training, mentoring and constant advocacy at many levels: public health facilities, private sector and the community. Innovations like a KMC case sheet, counselling, peer support group triggered KMC in the facilities; a KMC-link card, a microplanning and communication tool for CHWs helped to sustain practice at homes. CONCLUSION: The study provides a novel approach to designing and scaling up interventions and suggests lessons that are applicable to KMC as well as to broader reproductive, maternal, neonatal and child health programmes.

Fogging of Protective Eyewear in Intensive Care Unit and a Comparative Study of Techniques to Reduce It.

Background: Fogging of protective eyewear (PEW) can hinder routine work in the intensive care unit (ICU). The prevalence of fogging impairing vision (FIV) and the technique that reduces fogging have not been evaluated previously. Methods: After donning personal protective equipment (PPE) with an N95 mask, the healthcare workers (HCWs) sequentially tried plain PEW, soap-coated PEW, PEW worn at a distance over the PPE hood, and the use of tape over a mask. The vision (distant and near) was checked before wearing PEW and with each technique. The prevalence of fogging and FIV, that is, change in vision in either eye was estimated and compared among various techniques. Mixed-effects logistic regression was used to analyze factors affecting fogging and to compare techniques. Room temperature, room humidity, and lens temperature were measured during the study. Results: A total of 125 HCWs participated (151 observations) and the prevalence of FIV was 66.7%. The fogging of PEW, as well as the extent of PEW fogging, was least with soap coating followed by a mask with tape and goggles worn at a distance. The FIV was significantly lesser only with the mask with tape with an odds ratio (OR) [confidence interval CI)] of 0.45 (0.25-0.82). The prevalence of fogging while at work in the COVID ICU was 38%. Conclusion: The prevalence of FIV is 66%. Application of tape over the mask can avoid disturbances in vision best. Soap coating of the PEW and PEW worn at distance from the eyes are potential alternatives. How to cite this article: Ravisankar NP, D'Silva CS, Varma MMKG, Sudarsan TI, Sampath S, Thomas T, et al. Fogging of Protective Eyewear in Intensive Care Unit and a Comparative Study of Techniques to Reduce It. Indian J Crit Care Med 2023;27(1):32-37.

Iron Fortification through Universal Distribution of Double-Fortified Salt Can Increase Wages and Be Cost-Effective: An Ex-Ante Modeling Study in India.

BACKGROUND: The alleviation of iron deficiency through iron supplementation has not effectively reduced anemia in India, mainly due to low compliance. Food fortification with iron is considered a viable alternative, and the provision of double-fortified salt (DFS; with iron and iodine) has been mandated in public health programs. Limited evidence exists on its benefit-cost ratio. OBJECTIVE: In this study we sought to estimate the economic benefit in terms of increased wages in relation to introduction of DFS in reduction of anemia and the cost of doing so. METHODS: The economic benefit of introducing DFS in India was derived using a series of mathematical, statistical, and econometric models using data from national surveys capturing earnings and dietary iron intake of the population. Anemia status was predicted from data on dietary intake, sanitation, and for women, menstrual losses. The impact of iron deficiency anemia (IDA) on wages was estimated using a Heckman Selection model and 2-stage least squares procedure. Benefit of DFS was estimated through increased wages attributed to anemia reduction compared with its cost. RESULTS: Men and women with IDA had lower wages (by 25.9%, 95% CI: 11.3, 38.1; and by 3.9%, 95% CI: 0.0, 7.7, respectively) than those without IDA. Additional iron intake through DFS was predicted to reduce prevalence of IDA (from 10.6% to 0.7% in men and 23.8% to 20.9% in women). The economic benefit-cost ratio of introducing DFS at a national level was estimated to be 4.2:1. CONCLUSIONS: Iron fortification delivered through DFS under a universal program can improve wages and be sufficiently cost-effective for its implementation at scale in India.

Effects of repeated exposures to experimental cold pain stimulus on pain perception in healthy young Indian men.

Background: The influence of repeated exposures to cold pain stimulus, a surrogate of clinical pain, has remained largely unexplored. The study was planned to test the effect of repeated exposures to cold pain through cold pressor task on pain sensitivity and vascular reactivity. Methods: Single-group experimental study. Thirty-seven healthy male volunteers (18-25 years) were exposed to cold pressor tasks for seven consecutive days and on the 14th day on the nondominant hand. The same was repeated on dominant hand on first and seventh days; 31 completed the protocol. Results: Pain threshold and tolerance in the nondominant hand increased from day 1 to day 7 (p < 0.001) and were positively correlated on day 1 ( ρ =0.45, p = 0.011) and day 7 ( ρ =0.38, p = 0.036). Diastolic blood pressure response was found to increase by day 7 (p < 0.0024) and positively correlated with tolerance. On the dominant hand, the threshold reduced from day 1 to day 7, while tolerance increased. Both threshold and tolerance remained lower than that of nondominant hand. Day 14 values of threshold and tolerance were in between day 1 and day 7 values but not significantly different from both. Conclusion: Habituation in pain threshold and tolerance was observed on repeated exposure to cold pain, which was not significantly retained till the 14th day. The same was not observed with subjective feeling of pain perception. The increased diastolic blood pressure response is suggestive of peripheral vasoconstriction. Increased tolerance in the dominant hand by day 7 demonstrates a systemic effect in habituation.

Role of Biomarkers and Its Trend to Predict the Outcome of COVID-19 Patients: A Retrospective Study.

Background: Biomarkers have been extensively studied and used in the diagnosis and management of various diseases. The trend of biomarkers helps in prognosticating and managing critically ill patients. In resource-limited settings, the availability and feasibility of using these biomarkers are challenging.Our study aimed to see the trend of biomarkers and their effect on intensive care unit (ICU) mortality in coronavirus disease-2019 (COVID-19) patients. Materials and methods: A retrospective observational study was done from 1 April 2020 to 30 September 2020. The primary objective was to evaluate the trend of biomarkers in patients with COVID-19 pneumonia and their effect on ICU mortality. The secondary objectives were the duration of mechanical ventilation and length of ICU stay. Results: A total of 380 patients were included. The mean age was 54.9 (SD = 11.1) and 67% were males. The mean age, acute physiology and chronic health evaluation II (APACHE II) score was 29.54 (5.8). Among the biomarkers, total count (TC), ferritin, and procalcitonin (PCT) were higher in non-survivors than in survivors in bivariate analysis. The final multivariable logistic regression model showed age, APACHE II score, length of ICU stay, neutrophil:lymphocyte (NL) ratio, and ferritin as covariates. Among these variables, ferritin was the only biomarker [odds ratio (OR): 1.80, 95% confidence interval (CI) 1.17-2.77] with the APACHE II score (OR: 1.15, 95% CI 1.01-1.30) found to be significant. Conclusion: Ferritin was the only significant biomarker with higher values in non-survivors than in survivors. The trend of biomarkers was not found to be useful in predicting outcome of the patients. How to cite this article: Havaldar AA, Lobo V, Sushmitha EAC, Kumar VM, Raj JM, Thomas T. Role of Biomarkers and Its Trend to Predict the Outcome of COVID-19 Patients: A Retrospective Study. Indian J Crit Care Med 2022;26(9):1031-1035.

Demographics and Clinical Characteristics of COVID-19-vaccinated Patients Admitted to ICU: A Multicenter Cohort Study from India (PostCoVac Study-COVID Group).

Background: Emergency authorization and approval were given for the coronavirus disease-19 (COVID-19) vaccines. The efficacy reported after phase III trials were 70.4% and 78% for Covishield and Covaxin, respectively.In this study, we aim to analyze the risk factors, which were associated with mortality in critically ill COVID-19-vaccinated patients admitted into intensive care unit (ICU). Materials and methods: This study was conducted from April 1, 2021 to December 31, 2021 across five centers in India. Patients who had received either one or two doses of any of the COVID vaccines and developed COVID-19 were included. The ICU mortality was a primary outcome. Results: A total of 174 patients with COVID-19 illness were included in the study. The mean age was 57 years standard deviation (SD 15). Acute physiology, age and chronic health evaluation (APACHE II) score and the sequential organ failure assessment (SOFA) score were 14 (8-24.5) and 6 (4-8), respectively. Multiple variable logistic regression showed patients who have received a single dose [odds ratio (OR): 2.89, confidence interval (CI): 1.18, 7.08], neutrophil:lymphocyte (NL) ratio (OR: 1.07, CI: 1.02,1.11), and SOFA score (OR: 1.18, CI: 1.03,1.36) were associated with higher mortality. Conclusion: The mortality in the vaccinated patients admitted to the ICU was 43.68% due to COVID illness. The mortality was lower in patients who had received two doses. How to cite this article: Havaldar AA, Prakash J, Kumar S, Sheshala K, Chennabasappa A, Thomas RR et al. Demographics and Clinical Characteristics of COVID-19-vaccinated Patients Admitted to ICU: A Multicenter Cohort Study from India (PostCoVac Study-COVID Group). Indian J Crit Care Med 2022;26(11):1184-1191.

Prevalence of Iron Deficiency and its Sociodemographic Patterning in Indian Children and Adolescents: Findings from the Comprehensive National Nutrition Survey 2016-18.

BACKGROUND: Anemia control programs in India focus mainly on the measurement of hemoglobin in response to iron-folic acid supplementation. However, representative national estimates of iron deficiency (ID) are not available. OBJECTIVES: The objective of the present study was to evaluate ID prevalence among children and adolescents (1-19 y) using nationally representative data and to examine the sociodemographic patterning of ID. METHODS: Cross-sectional data from the Comprehensive National Nutrition Survey in children (1-4 y: n = 9635; 5-9 y: n = 11,938) and adolescents (10-19 y; n = 11,507) on serum ferritin (SF) and other biomarkers were analyzed to determine inflammation-adjusted ID prevalence [SF (µg/L): <12 in 1-4 y and <15 in 5-19 y] and its relation to sociodemographic indicators. Multiple-regression analyses were conducted to identify the exposure associations of iron status. In addition, the relation between SF and hemoglobin was assessed as an indicator of iron utilization in different wealth quintiles. RESULTS: ID prevalence was higher in 1- to 4-y-old children (31.9%; 95% CI: 31.0%, 32.8%) and adolescent girls (30.4%; 95% CI: 29.3%, 31.5%) but lower in adolescent boys and 5- to 9-y-old children (11%-15%). In all age groups, ID prevalence was higher in urban than in rural participants (1-4 y: 41% compared with 29%) and in those from richer quintiles (1-4 y: 44% in richest compared with 22% in poorest), despite adjustment for relevant confounders. SF significantly interacted with the wealth index, with declining trends in the strength of association between hemoglobin and SF from the richest to the poorest groups suggesting impaired iron utilization for hemoglobin synthesis in poorer wealth quintiles. CONCLUSIONS: ID prevalence was indicative of moderate (in preschool children and adolescent girls) or mild (in 5- to 9-y-old children and adolescent boys) public health problem with significant variation by state and age. Focusing on increasing iron intake alone, without addressing the multiple environmental constraints related to poverty, may not result in intended benefits.

Association between mustard oil consumption and BMI in India.

OBJECTIVE: This study examined the association between predominant vegetable oil consumed and BMI of adult women and men in India, with emphasis on predominant consumption of mustard oil. DESIGN: Two nationally representative data, the consumer expenditure survey of National Sample Survey Office (NSSO)-68th round (2011-2012) for food consumption and National Family Health Survey-4 (2015-2016) for weight status, were analysed. Data from both surveys were combined by matching households through common matching variables ('family size', 'religion', etc.) using Nearest-Neighbour Hot-Deck matching. The association of overweight/obesity with predominant mustard oil consumption in the household was examined using logistic regression adjusted for confounders. The NSSO reports household consumption of mustard, groundnut, coconut, refined oils (sunflower, safflower, soyabean) and all other edible oils. SETTING: Two nationally representative surveys from India. PARTICIPANTS: Total of 638 445 women and 92 312 men, respectively. RESULTS: Mustard oil was the most predominantly consumed oil (51 %) followed by refined oils (32·4 %). Prevalence of overweight/obesity in women and men was lower in households with predominant mustard oil consumption (17 and 15 %) v. all other refined and other oils combined (27 and 26 %). The adjusted OR for predominant mustard oil use was 0·88 (95 % CI 0·86, 0·87) for women and 0·80 (95 % CI 0·76, 0·83) for men. A similar analysis with predominant groundnut oil consumption showed no association with overweight/obesity. CONCLUSIONS: The data from a large national level survey suggest an inverse association between mustard oil consumption and overweight/obesity which needs to be explored with further research studies.

Blood Cultures and Molecular Diagnostics in Intensive Care Units to Diagnose Sepsis: A Bayesian Latent Class Model Analysis.

BACKGROUND: Confirmation of sepsis by standard blood cultures (STD) is often inconclusive due to slow growth and low positivity. Molecular diagnostics (MOL) are faster and may have higher positivity, but test performance can be inaccurately estimated if STD methods are used as comparators. Bayesian latent class models (LCMs) can evaluate diagnostic methods when there is no "gold standard." Intensive care unit studies that have used LCMs to combine and compare STD and MOL method performance and estimate the prevalence of sepsis have not been described. PATIENTS AND METHODS: Results from an ICU sepsis study that used both tests simultaneously were analyzed. Bayesian LCMs combined prior prevalence of sepsis, prior diagnostic characteristics of the two methods, and the study results to estimate the posterior prevalence and diagnostic characteristics. Sensitivity analyses were performed using objective (published studies) and subjective (expert opinion) prior parameters. Positive predictive values (PPVs) of the prevalence of sepsis were estimated for all combinations of test results. RESULTS: The range of posterior estimates was: sepsis prevalence (0.38-0.88), sensitivities (STD: 0.2-0.35, MOL: 0.56-0.86), and specificities (STD: 0.87-0.99, MOL: 0.72-0.95). The PPV (sepsis) of both tests being positive was (0.72-0.99). CONCLUSION: LCMs combined two imperfect methods to estimate prevalence, PPV, and diagnostic characteristics. The posterior estimates (STD sensitivity < MOL and STD specificity > MOL) seem to reflect the clinical experience appropriately. The high PPV when both methods show positive results can be useful for ruling in disease. HOW TO CITE THIS ARTICLE: Sampath S, Baby J, Krishna B, Dendukuri N, Thomas T. Blood Cultures and Molecular Diagnostics in Intensive Care Units to Diagnose Sepsis: A Bayesian Latent Class Model Analysis. Indian J Crit Care Med 2021;25(12):1402-1407.

Vitamin B-12 Supplementation during Pregnancy and Early Lactation Does Not Affect Neurophysiologic Outcomes in Children Aged 6 Years.

BACKGROUND: Deficiency of vitamin B-12 is common in pregnant Indian women. Assessment of neurophysiological measures using event-related potentials (ERPs) may yield additional information on the effects of maternal B-12 supplementation on child brain function. OBJECTIVES: The objective of the study was to evaluate the effects of vitamin B-12 supplementation (50 µg daily orally) during pregnancy on the childhood ERP measures of positive waveform ∼300 ms after stimulus (P300) and mismatch negativity. METHODS: This study was a follow-up of children born to pregnant women who received oral vitamin B-12 supplements (n = 62) compared with children of pregnant women who received placebo (n = 70) from a randomized controlled trial. The mean ± SD child age was 72 ± 1 mo. We used the Enobio system to assess the ERP measures P300 and mismatch negativity. RESULTS: There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups. We combined the intervention and placebo groups for secondary analyses. On multiple variable regression analysis after adjusting for treatment group, intrauterine growth restriction, and home environment, P300 amplitude in children was significantly higher in the lowest tertile of third-trimester maternal methylmalonic acid (MMA) concentrations (ß = 3034.04; 95% CI: 923.24, 5144.83) compared with the highest MMA tertile (ß = 1612.12; 95% CI: -258.86, 3483.10, P = 0.005). CONCLUSIONS: While no significant effects of maternal vitamin B-12 supplementation on children's ERP measures were seen at 72 mo, elevated maternal MMA concentrations in the third trimester were negatively associated with P300 amplitude in children. It may be worthwhile to study the impact of maternal and infant vitamin B-12 supplementation on childhood brain structure and function in longer and larger trials. The parent trial was registered at clinicaltrials.gov as NCT00641862.

An uncertainty estimate of the prevalence of stunting in national surveys: the need for better precision.

BACKGROUND: Stunting is determined by using the World Health Organization (WHO) child growth standard which was developed using precise measurements. However, it is unlikely that large scale surveys maintain the same level of rigour and precision when measuring the height of children. The population measure of stunting in children is sensitive to over-dispersion, and the high prevalence of stunting observed in surveys in low and middle-income countries (LMIC) could partly be due to lower measurement precison. OBJECTIVES: To quantify the incongruence in the dispersion of height-for-age in national surveys of < 5 y children, in relation to the standard WHO Multicenter Growth Reference Study (MGRS), and propose a measure of uncertainty in population measures of stunting. METHODS: An uncertainty factor was proposed and measured from the observed incongruence in dispersion of the height-for-age of < 5 y children in the MGRS against carefully matched populations from the Demographic Health Survey of 17 countries ('test datasets', based on the availability of data). This also allowed for the determination of uncertainty-corrected prevalence of stunting (height-for-age Z score < - 2) in < 5 y children. RESULTS: The uncertainty factor was estimated for 17 LMICs. This ranged from 0.9 to 2.1 for Peru and Egypt respectively (reference value 1). As an explicit country example, the dispersion of height-for-age in the Indian National Family Health Survey-4 test dataset was 39% higher than the MGRS study, with an uncertainty factor of 1.39. From this, the uncertainty-adjusted Indian national stunting prevalence estimate reduced to 18.7% from the unadjusted estimate of 36.2%. CONCLUSIONS: This study proposes a robust statistical method to estimate uncertainty in stunting prevalence estimates due to incongruent dispersions of height measured in national surveys for children < 5 years in relation to the WHO height-for-age standard. The uncertainty is partly due to population heterogeneity, but also due to measurement precision, and calls for better quality in these measurements.

Age-related differences in height gain with dairy protein and micronutrient supplements in Indian primary school children.

BACKGROUND AND OBJECTIVES: The efficacy of nutrient interventions to prevent/reverse stunting is considered to be restricted to early life. Whether such interventions are equally effective in later childhood is not clear. The present study evaluated the effect of a food-based high-quality protein and micronutrient intervention on the linear growth of Indian primary school children. METHODS AND STUDY DESIGN: A secondary analysis of a one-year milkprotein and micronutrient fortified food product intervention (protein-energy ratio: 12.8%) on the height of 550 children aged 6-10 years, of poor-socioeconomic background, was carried out. Height and weight increments were compared between groups of each year of age using multiple linear regression. Comparisons in prevalence of stunting and underweight between these groups was also made. RESULTS: The overall mean height increment at the end of 1-year was 6.10±1.07 cm, the highest being for 6-year olds (6.38±0.84 cm). The mean height increments in 6, 7 and 8-year-olds were significantly higher (all p<0.05) than the expected median growth. Height-forage score increased across all age-groups (by 0.14±0.18) and was significantly higher in 6-year olds compared to the rest. Stunting reduced by 12% in 6- year olds in comparison to the older age-groups. No significant association was observed between height gain and gender. The increased BMI-for-age scores were significantly lower for the 6-year olds compared to older children. CONCLUSIONS: Food supplements containing high-quality protein (like milk) along with micronutrients, can continue to influence height of children even in primary school, although the most effect is seen in younger children.

Cardiovascular risk factor reduction by community health workers in rural India: A cluster randomized trial.

BACKGROUND: There is a need to identify and test low-cost approaches for cardiovascular disease (CVD) risk reduction that can enable health systems to achieve such a strategy. OBJECTIVE: Community health workers (CHWs) are an integral part of health-care delivery system in lower income countries. Our aim was to assess impact of CHW based interventions in reducing CVD risk factors in rural households in India. METHODS: We performed an open-label cluster-randomized trial in 28 villages in 3 states of India with the household as a unit of randomization. Households with individuals at intermediate to high CVD risk were randomized to intervention and control groups. In the intervention group, trained CHWs delivered risk-reduction advice and monitored risk factors during 6 household visits over 12 months. Households in the non-intervention group received usual care. Primary outcomes were a reduction in systolic BP (SBP) and adherence to prescribed BP lowering drugs. RESULTS: We randomized 2312 households (3261 participants at intermediate or high risk) to intervention (1172 households) and control (1140 households). At baseline prevalence of tobacco use (48.5%) and hypertension (34.7%) were high. At 12 months, there was significant decline in SBP (mmHg) from baseline in both groups- controls 130.3 ±â€¯21 to 128.3 ±â€¯15; intervention 130.3 ±â€¯21 to 127.6 ±â€¯15 (P < .01 for before and after comparison) but there was no difference between the 2 groups at 12 months (P = .18). Adherence to antihypertensive drugs was greater in intervention vs control households (74.9% vs 61.4%, P = .001). CONCLUSION: A 12-month CHW-led intervention at household level improved adherence to prescribed drugs, but did not impact SBP. To be more impactful, a more comprehensive solution that addresses escalation and access to useful therapies is needed.

Revisiting Dietary Iron Requirement and Deficiency in Indian Women: Implications for Food Iron Fortification and Supplementation.

Anemia in Indian women continues to be highly prevalent, and is thought to be due to low dietary iron content. The high risk of dietary iron deficiency is based on the Indian Council of Medical Research recommendation of 21 mg/d, but there is a need for a secure and transparent determination of the Estimated Average Requirement (EAR) of iron in this population. In nonpregnant, nonlactating women of reproductive age (WRA), the EAR of iron was determined to be 15 mg/d. Applying this value to daily iron intakes among WRA in nationally representative Indian state-based data showed that the median risk of dietary iron deficiency was lower than previously thought (65%; IQR: 48-78%), with considerable heterogeneity between states (range: 25-93%). However, in a validation, this risk matched the risk of iron deficiency as defined by blood biomarkers in a recently completed survey. When the risk of dietary iron deficiency was modelled for an increase in iron intake through food fortification of a single dietary staple, that provided 10 mg/d, the median risk reduced substantially (from 65% to 20%), and it virtually disappeared when supplementary iron intakes through the national iron supplementation program were considered. The risk of exceeding the tolerable upper level (TUL) of intake of iron remains low in the population when receiving fortification of 10 mg/d, but is much higher if they consume greater amounts of iron through supplements (range: 0-54%). This newly and transparently defined Indian EAR of iron should be used to evaluate, with precision, the benefits and risks of iron fortification and supplementation policies.