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Background. Ayurveda, the Indian system of medicine, has been practised in India since ages. We evaluated the overall awareness regarding Ayurveda among patients attending two specialty clinics at a tertiary care institute. Methods. We did a cross-sectional study on patients attending the cardiology and neurology clinics at a tertiary care hospital in India. We conducted this paper-based survey using a standardized, validated questionnaire. Statistical analysis was performed using STATA version 14.2. Results. Three hundred and ninety-seven patients agreed to participate in the study. Their mean (SD) age was 45.65 (15.02) years. Among them 68.5% were men and 56.9% were from urban areas. Participants perceived that Ayurveda comprised herbal drugs (77.6%), metallic/herbo-mineral preparations (44.3%), Panchakarma therapy (22.2%) and personalized medicine (37.8%). Principal sources of information were TV promotional programmes (34.7%) and newspaper advertisements (13.9%). Nearly two-thirds (63%) of participants opined that Ayurveda is effective in chronic disorders. Although only 9.1% of participants reported the use of Ayurvedic medicines, 89.2% believed it would be beneficial if the All India Institute of Medical Sciences (AIIMS), New Delhi had Ayurveda services. Three-fourths (75.8%) of respondents were interested to participate in research studies integrating Ayurveda with modern medicine. Conclusion. Imprecise knowledge and awareness towards Ayurveda appears to prevail in addition to the low practice among the patients surveyed. We found imprecise knowledge of Ayurvedic therapies and its low usage among patients attending specialized OPDs in a tertiary care hospital. The major source of information reported was promotional advertisements in the print and electronic media. Our survey shows a need for awareness programmes for general public at various levels. [ABSTRACT FROM AUTHOR]

Background: The immunomodulatory effects of vitamin D are widely recognized and a few studies have been conducted to determine its utility in the treatment of tuberculosis, with mixed results. This study was conducted to see if vitamin D supplementation in patients with active pulmonary tuberculosis (PTB) in the Indian population contributed to sputum smear and culture conversion as well as the prevention of relapse. Methods: This randomized double-blind placebo-controlled trial was conducted in three sites in India. HIV negative participants aged 15–60 years with sputum smear positive PTB were recruited according to the Revised National Tuberculosis Control Program guidelines and were randomly assigned (1:1) to receive standard anti-tubercular treatment (ATT) with either supplemental dose of oral vitamin D3 (60,000 IU/sachet weekly for first two months, fortnightly for next four months followed by monthly for the next 18 months) or placebo with same schedule. The primary outcome was relapse of PTB and secondary outcomes were time to conversion of sputum smear and sputum culture. Results: A total of 846 participants were enrolled between February 1, 2017 to February 27, 2021, and randomly assigned to receive either 60,000 IU vitamin D3 (n = 424) or placebo (n = 422) along with standard ATT. Among the 697 who were cured of PTB, relapse occurred in 14 participants from the vitamin D group and 19 participants from the placebo group (hazard risk ratio 0.68, 95%CI 0.34 to 1.37, log rank p value 0.29). Similarly, no statistically significant difference was seen in time to sputum smear and sputum culture conversion between both groups. Five patients died each in vitamin D and placebo groups, but none of the deaths were attributable to the study intervention. Serum levels of vitamin D were significantly raised in the vitamin D group as compared to the placebo group, with other blood parameters not showing any significant difference between groups. Conclusions: The study reveals that vitamin D supplementation does not seem to have any beneficial effect in the treatment of PTB in terms to the prevention of relapse and time to sputum smear and culture conversion. Trial registration: CTRI/2021/02/030977 (ICMR, Clinical trial registry-India). [ABSTRACT FROM AUTHOR]

Objective: High burden of anaemia exists amongst rural adolescent girls in India. The objective of this study was to characterise anaemia in school going adolescent girls in rural Haryana, India. Design: Linear and multiple logistic regression analysis of data collected prior to an intervention trial was conducted. Participants were classified into anaemic (haemoglobin <12 g/dl) and non-anaemic group and were further classified into deficiencies of Fe, folate or vitamin B12, mixed, anaemia of other causes and inflammation. Setting: Three schools in Ballabgarh block of Faridabad District, Haryana, India. Participants: One hundered and ninety-eight non-anaemic and 202 anaemic adolescent girls (12–19 years). Results: Anaemic girls had 29·6 % Fe deficiency, 28·1 % folate or vitamin B12 deficiency, 15·8 % mixed deficiency and 9·7 % acute inflammation. Anaemia of other causes was found in 16·8 % of the anaemic participants. Girls with Fe and isolated folate deficiency had 2·5 times and four times higher odds of developing anaemia, respectively, as compared with non-anaemic girls. Fe deficiency with no anaemia was found amongst 11 % non-anaemic girls. Non-anaemic girls had a high prevalence of combined deficiency of folate or vitamin B12 (29·5 %) and acute inflammation (14·4 %). Conclusions: The current strategy of Fe and folic acid supplementation alone will not suffice for achieving the desired reduction in the prevalence of anaemia as unknown causes and anaemia of inflammation contribute to a substantial proportion of anaemia. Integrating other nutrition-specific components like improving water, sanitation and hygiene practices with the ongoing micronutrient supplementation program will comprehensively tackle anaemia. Unknown causes of anaemia warrant further research. [ABSTRACT FROM AUTHOR]

Introduction: Hand-foot syndrome (HFS) is a common cutaneous side effect of capecitabine therapy. Apart from oral cyclooxygenase-2 (COX-2) inhibitor (celecoxib), there are no proven strategies for the prevention of HFS. However, celecoxib is associated with significant cardiotoxicity. To date, no study has evaluated the role of topical COX inhibitor, diclofenac. In this study, we aim to compare topical 1% diclofenac gel with placebo in the prevention of capecitabine-induced HFS.Methods: This is a randomized, placebo-controlled, double-blind, parallel-group superiority trial: the Diclofenac Topical in Reducing Capecitabine induced HFS (D-TORCH) study. A total of 264 patients with breast and gastrointestinal malignancies will be randomly allocated (stratified by sex and type of therapy [monotherapy or combination regimen with capecitabine]) to receive either 1% topical diclofenac or placebo that will be applied over the palmar and dorsal surface of the hands twice daily whilst taking capecitabine for 12 weeks. The patients will be followed up until the end of four cycles. The primary objective of this study is to compare the effect of topical diclofenac with placebo in preventing HFS (incidence of NCI CTCAEv5.0 grade 2 or higher HFS). The secondary objective is to compare the effect of topical diclofenac with placebo on preventing all grades of HFS (incidence of NCI CTCv5.0 all grade HFS), time to develop HFS (from the start of capecitabine), patient-reported outcomes (PROs) (HF-HRQoL questionnaire), adherence with the application (self-reported), capecitabine dose changes (number of patients with dose modifications due to HFS) and safety profile (NCICTCv5.0 all grade HFS) DISCUSSION: The D-TORCH study aims to determine if 1% topical diclofenac reduces the incidence of grade 2 or higher HFS in patients receiving capecitabine. To date, there have been a lot of trials for hand-foot syndrome prevention using agents like pyridoxine, vitamin E, carvedilol, and various polyherbal formulations, but none has been found successful. If the trial meets the primary end point, 1% topical diclofenac will be the new standard of care for HFS prevention.Trial Registration: Clinical Trials Registry of India  CTRI/2021/01/030592 . Prospectively registered on January 19, 2021. [ABSTRACT FROM AUTHOR]

Background: India lacks epidemiological information on the disease burden of pediatric HIV. The National AIDS Control Program (NACP) estimates the numbers of HIV-positive children as a proportion of adult persons living with HIV. A third of HIV-positive children die before their first birthday and a half before they reach their second birthday. The early detection of HIV is crucial for the prevention of morbidities, growth delays, and death among HIV-positive children.Methods: The study aimed to estimate the disease burden of pediatric HIV among children in 'A' category district of a high HIV prevalence state. An 'A' category district is defined by the presence of > 1% HIV prevalence among the general population, as estimated by HIV Sentinel Surveillance. The study used an innovative three-pronged strategy combining cross-sectional and longitudinal methods. The overall burden of pediatric HIV was calculated as a product of cases detected multiplied by a net inflation factor, for each of three strategies.Results: The existing pool of HIV infection in the district is estimated to be 3266 (95% CI: 2621-4197) HIV positive children < 15 years of age, in a mid-year (2013) projected child population of about 1.4 million, thus giving an HIV prevalence of 0.23% (CI: 0.19-0.30) among children (0-14 years of age). The proportion of children among all people living with HIV in the district works out to 10.4% (CI: 8.6-13.5%).Conclusions: The study estimate of 0.23% HIV prevalence among children (0-14 years of age) is higher than the NACP estimates (0.02) and is 2.5 higher than the Karnataka state estimate (0.09)22. Similarly, the proportion of children among all persons living with HIV in Belgaum district is 10.4% in this study, as against 6.54% for India. The study methodology is replicable for other settings and other diseases. [ABSTRACT FROM AUTHOR]

Background: Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the Sustainable Development Goal-3. Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising.Methods: A phase III, multicenter, randomized, double-blind, placebo-controlled study is being conducted at six sites in India. A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex, and birth weight, would be done through an interactive web response system (IWRS) using a standard web browser and email service. Vivomixx®, a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1-ml/day dose for 30 days. The follow-up of enrolled infants for 60 days would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, and blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performing sepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. The study would be implemented as per the MRC guideline for the management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A contract research organization would be engaged for comprehensive monitoring and quality assurance. The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes of sepsis, possible serious bacterial infection (PSBI), and secondary outcomes. The codes will be broken after DMC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sites.Discussion: This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low-middle-income countries.Trial Registration: Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197 . Registered on 16 May 2019. [ABSTRACT FROM AUTHOR]

Objective: The objectives of this study were to evaluate ENDIT score and develop a novel outcome prediction score for outcome of pediatric convulsive status epilepticus (CSE) at the hospital and 3 months postdischarge. Methods: Children and adolescents aged 1 month to 14 years, presenting with CSE to a tertiary care teaching center in North India from January 2017 to March 2019, were screened for enrollment. In‐hospital and 3‐month postdischarge outcome were defined as poor if Pediatric Cerebral Performance Category Scale (PCPCS) score dropped by ≥2 levels. Results: Overall, 61 patients were enrolled for final analysis after applying exclusion and inclusion criteria. The area under the receiver operating characteristic (ROC) curve for ENDIT score in predicting mortality and differentiating good from poor outcome at the hospital and at 3 months postdischarge was 0.74 (95% confidence interval [CI] = 0.58‐0.89), 0.7 (95% CI = 0.57‐0.83), and 0.72 (95% CI = 0.6‐0.82), respectively. Based on predictors in the present cohort that were significantly different between good and poor outcome cases at the hospital and 3 months postdischarge, a new six‐point score named PEDSS (pre–status epilepticus PCPCS, background electroencephalographic abnormalities, drug refractoriness, semiology, and critical sickness) was developed. The area under ROC curves for PEDSS score in predicting mortality and differentiating good from poor outcome at the hospital and at 3 months postdischarge were 0.93 (95% CI = 0.87‐0.99), 0.8 (95% CI = 0.7‐0.9), and 0.89 (95% CI = 0.8‐0.96), respectively. The best cutoff PEDSS scores for predicting mortality and poor outcome at the hospital and at 3 months postdischarge were ≥4, ≥3, and ≥3, respectively. Significance: The PEDSS score has high predictive accuracy for mortality and differentiating good from poor outcome at the hospital and 3 months postdischarge in pediatric CSE. Future studies should be planned to validate it in various geographical and health care settings and in adults. [ABSTRACT FROM AUTHOR]

Plasmodium infections are co-endemic with infections caused by other agents of acute febrile illnesses, such as dengue virus (DENV), chikungunya virus, Leptospira spp., and Orientia tsutsugamushi. However, co-infections may influence disease severity, treatment outcomes, and development of drug resistance. When we analyzed cases of acute febrile illness at the All India Institute of Medical Sciences, New Delhi, India, from July 2017 through September 2018, we found that most patients with malaria harbored co-infections (Plasmodium mixed species and other pathogens). DENV was the most common malaria co-infection (44% of total infections). DENV serotype 4 was associated with mild malaria, and Leptospira was associated with severe malaria. We also found the presence of P. knowlesi in our study population. Therefore, in areas with a large number of severe malaria cases, diagnostic screening for all 4 DENV serotypes, Leptospira, and all Plasmodium species should be performed. [ABSTRACT FROM AUTHOR]

Objective: The aim of this systematic review and meta-analysis was to estimate the prevalence of traumatic dental injuries (TDI) in India. The secondary objective was to evaluate the prevalence rate according to the differences in gender, age, regions, type of TDI and risk factors associated with TDI.Methods: The PubMed, LILACS, Web of Science, Cochrane, CINHAL, and Scopus databases, along with the Public Health Electronic Library, TRoPHI and DoPHER were searched from 1st March to 15thApril 2019 without any restriction of language and year of publication. The qualitative synthesis was done regarding the demographics, study methods, cause of trauma, geographic location, increased overjet and inadequate lip coverage. The meta-analysis was undertaken with STATA-14 software (USA). The pooled prevalence of TDI was calculated using data extracted from 48 studies included in qualitative synthesis and meta-analysis. A sub-group meta-analysis was done by extraction of the data for age groups of 6 years and >6 years.Results: The pooled prevalence of TDI in Indian population was 13 cases in 100 individuals. The prevalence of TDI for age groups of ≤6 was 15% (males, 15%; females, 16%) and for >6 years was 12% (males, 13%; females, 8%). The most common cause of TDI was falls, and most frequent location was home. The odds ratio for occurrence of TDI and inadequate lip-coverage was 3.35 and overjet greater than 3 mm was 3.53.Conclusions: The pooled prevalence of TDI was 13% and slightly higher in children less than 6 years of age. Inadequate lip coverage and increased overjet are the risk factors associated with TDI. Heterogeneity was observed among the studies in terms of design, variables recorded, sampling, study methods and statistical methods. Majority of them also suffered from moderate to high risk of bias. [ABSTRACT FROM AUTHOR]

Context: Parkinson's disease (PD) has devastating effects on quality of life (QoL), but there is no instrument that has been developed for Hindi-speaking persons with Parkinson's disease (PWP). Objective: The objective of this study was to develop and validate an instrument in Hindi language to measure health-related QoL (HRQoL) in PWP. Subjects and Methods: Literature review and interviews of stakeholders were done to create a pool of 68 items to develop a questionnaire. Self-rated global QoL item was also included in the questionnaire. Questionnaire was tested on 300 Hindi-speaking PWP. Item reduction was achieved through factor analysis and clinimetrics to finalize the QoL in PD (QLPD) instrument. Validity and reliability of the QLPD were tested. Results: "QLPD" is a 45-item instrument with nine subscales, namely, activities of daily living, mobility, psychological, fear, social, family, treatment, finance, and nonmotor symptom subscales. Internal consistency of QLPD's summary score and all subscales except treatment subscale was high (α = 0.74--0.94). Intraclass correlation coefficient between summary score and global QoL was 0.79. Summary score and subscale scores were significantly different (P < 0.0001) for predefined five categories on global QoL (very good to very bad). QLPD subscales exhibited good convergent and divergent validity with subscales of 39-item PD questionnaire and short form-36 scale. Higher Hoehn and Yahr stage, lower monthly per capita income, and higher levodopa equivalent daily dosage were found to be independently associated with poor HRQoL. Conclusion: QLPD is a valid and reliable instrument to measure HRQoL in Hindi-speaking PWP. [ABSTRACT FROM AUTHOR]

Objective: To assess the prevalence and risk factors of underweight, overweight and obesity among a geriatric population living in a high-altitude region of India.Design: Community-based cross-sectional study. Data were collected on sociodemographic profile and anthropometric parameters. Weight and height measurements were utilized for calculation of BMI. Nutrient intake data were collected using 24 h dietary recall.Setting: High-altitude region of Nainital District, Uttarakhand State, North India.Subjects: Community-dwelling geriatric subjects (n 981) aged 60 years or above.Results: We found that 26·6 % of the elderly subjects were underweight (BMI<18·5 kg/m2). Overweight (BMI 25·0-29·9 kg/m2) and obesity (BMI≥30·0 kg/m2) was seen among 18·0 % and 4·6 %, respectively. After controlling for potential cofounders, risk factors such as low level of education and income, chewing problems and lower number of daily meals were found to be associated with underweight. On the other hand, risk factors for overweight/obesity were lower age, high income and unskilled work.Conclusions: There is a need to develop and implement intervention strategies to prevent underweight, overweight and obesity among the geriatric population of India. [ABSTRACT FROM AUTHOR]

An oral health survey was conducted in 829 individuals in different age groups in Ballabhgarh, Haryana, India, to estimate the prevalence of Dental caries and Periodontal diseases. A survey tool was modified from WHO's STEPwise approach to surveillance and Oral Health Assessment form 2013 from recently released WHO Oral Health Survey: Basic Methods (5th Edition) keeping in mind the South East Asian region. Out of 28 villages, six villages were randomly selected. A random list of study participants (Age-sex specific) was generated from the pooled list of these 6 villages. Local health workes helped in inviting the specific subjects to one centralized location within each village/ locality. The subjects were examined by trained dental surgeons and recordings were done by trained assistants. The prevalence of dental caries in 5-7 year, 12-15 year, 35-44 year and 65-74 year was 33.2%, 31.3%, 64.9% and 50.1% respectively. The prevalence of Periodontal Disease in 35-44 year and 65-74 year found to be 65.2% and 90.4% respectively. Only 37 participants had mucosal lesions, of which leukoplakia and tobacco pouch keratosis was seen in majority. Using the adopted tool, the prevalence of dental caries was found to be highest in 35-44 year (64.9%) age group and the prevalence of periodontal disease was found to be high in 35-44 year (65.2%) age group and highest in 65-74 year (90.4%) age group. Oral health promotion efforts are required to prevent oro-dental diseases in the studied population. [ABSTRACT FROM AUTHOR]

Background. There is lack of reliable predictors of disease severity and mortality in dengue. The present study was carried out to identify these predictors during the 2015 outbreak in India. Methods. This prospective observational study included confirmed adult dengue patients hospitalized between August and November 2015 in a tertiary care centre in New Delhi, India. Appropriate statistical tests were used to compare clinicolaboratory characteristics, derive predictors of severe disease and mortality, and compute a predictive score for mortality. Serotyping was done. Results. Data of 369 patients were analyzed (mean age, 30.9 years; 67% males). Of these, 198 (54%) patients had dengue fever, 125 (34%) had dengue hemorrhagic fever (grade 1 or 2), and 46 (12%) developed dengue shock syndrome (DSS). Twenty-two (6%) patients died. Late presentation to the hospital (≥5 days after onset) and dyspnea at rest were identified as independent predictors of severe disease. Age ≥24 years, dyspnea at rest and altered sensorium were identified as independent predictors of mortality. A clinical risk score was developed (12*age + 14*sensorium + 10*dyspnea), which, if ≥22, predicted mortality with a high sensitivity (81.8%) and specificity (79.2%). The predominant serotypes in Delhi (2015) were dengue virus DENV2 and DENV4. Conclusion. Age ≥24 years, dyspnea at rest, and altered sensorium were identified as independent predictors of mortality. Platelet counts did not determine outcome in dengue patients. Timely referral/access to healthcare is important. The clinical risk score for mortality prediction that was developed in this study can be used in all healthcare settings, after validation in larger cohorts. [ABSTRACT FROM AUTHOR]

Background: Phenytoin, mainly metabolized by cytochrome P450 enzyme system, has a narrow therapeutic index and may have adverse effects due to inter-individual variation in the dose requirement and genetic polymorphisms. This cross-sectional study was done to study the prevalence of cytochrome P450 CYP2C9 polymorphisms in Indian epileptic children and to see the effect of polymorphisms on serum levels in epileptic children on phenytoin monotherapy.Methods: We studied 89 epileptic children of North Indian population, randomly selected, to see the genotypic and allelic frequency of CYP2C9 and its association with drug levels on phenytoin monotherapy. Analysis was done using STATA 9 Software. The results were analyzed as prevalence at 95 % C.I. (Confidence Interval). The difference in mean phenytoin serum levels between wild and mutant alleles was tested using Student`s T test for independent samples. P value less than 0.05 was considered statistically significant.Results: CYP2C9*1, *2 & *3 allelic frequencies were 85.4, 4.5 and 10.1 % respectively. CYP2C9*3 allelic group showed significantly higher serum phenytoin levels compared to the wild variants (P = 0.009). There was no statistically significant difference in the dose received (P = 0.12) and side effects of CYP2C9*2 and CYP2C9*3 genotypes (P = 0.442 and 0.597 respectively) when compared with wild variant.Conclusion: CYP2C9*3 is more common than *2 in the present study. All the polymorphisms demonstrated in our study were heterozygous with no homozygosity. Serum phenytoin levels are higher in polymorphic groups (*3) which suggest their poor metabolizing nature. Genotyping may help to avoid toxicity and concentration-dependent adverse effects. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of a Neurofacilitation of Developmental Reaction (NFDR) approach with that of a Conventional approach in the modulation of tone in children with neurodevelopmental delay. Methods: Experimental control design. A total of 30 spastic children ranging in age from 4 to 7 years with neurodevelopmental delay were included. Baseline evaluations of muscle tone and gross motor functional performance abilities were performed. The children were allocated into two intervention groups of 15 subjects each. In groups A and B, the NFDR and conventional approaches were applied, respectively, for 3 months and were followed by subsequent re-evaluations. Results: Between group analyses were performed using independent t test for tone and primitive reflex intensity and a Mann-Whitney U test for gross motor functional ability. For the within-group analyses, paired t tests were used for tone and primitive reflex intensity, and a Wilcoxon signed-rank test was used for gross motor functional ability. Conclusion: The NFDR approach/technique prepares the muscle to undergo tonal modulation and thereby enhances motor development and improves the motor functional performance abilities of the children with neurodevelopmental delay. [ABSTRACT FROM AUTHOR]

Introduction: The role of heavy metals in the etio-pathogenesis of ASD is controversial. Paucity of studies from Indian subcontinent with different sociocultural and environmental background prompted the present study. Methods: Sixty children aged three to 12 years with Autism Spectrum Disorder (ASD) and 60 age matched controls were enrolled. Detailed history including possible exposure history to various heavy metals was taken. Severity of ASD was assessed using Childhood Autism Rating Scale 2. Blood level of metals was estimated by Inductively coupled plasma - atomic emission spectroscopy (ICP-AES). Results: Mean blood mercury levels in the two groups of ASD and controls was comparable (p = 0.28). Median blood cadmium and arsenic levels were higher in controls possibly due to higher ground water use and insecticide exposure. (7/60 versus 17/60, p = 0.04) and (2/60 versus 7/60, p = 0.08) while mean blood zinc level was lower in controls. Lead was significantly higher in greater proportion of children with ASD. (11/60 vs 1/60, p = 0.002). Children with ASD had significantly higher pica (26/60 versus 10/60, p = 0.001) and higher median number of days of antibiotics during infancy (24.5 (0-120) versus 15 (0-60), p = 0.004). None of the heavy metal tested had significant correlation with the severity of ASD. Conclusions: Mean blood mercury, lead, zinc, arsenic and cadmium did not show significant association with diagnosis of ASD. High levels of toxic metals in both children with ASD and controls points towards an urgent need to contain environmental pollution by heavy metals. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has affected the world, leading to significant morbidity and mortality. Various meteorological parameters are considered essential for the viability and transmission of the virus. Multiple reports from various parts of the world suggest a correlation between the disease spread and air pollution severity. This study was carried out to identify the relationship between meteorological parameters, air pollution, and COVID-19 in New Delhi, one of the worst-affected states in India. We studied air pollution and meteorological parameters in New Delhi, India. We obtained data about COVID-19 occurrence, meteorological parameters, and air pollution indicators from various sources from April 1, 2020, until November 12, 2020. We performed correlational analysis and employed autoregressive distributed lag models to identify the relationship between COVID-19 cases, air pollution and meteorological parameters. We found a significant impact of particulate matter (PM) 2.5, PM10, and meteorological parameters on COVID-19. There was a significant positive correlation between daily COVID-19 cases and COVID-19-related deaths with PM2.5 and PM10 levels. Increasing temperature and wind speed were associated with a reduction in the number of cases, while increasing humidity was associated with increased cases. This study demonstrated a significant association between PM2.5 and PM10 and daily COVID-19 cases and COVID-19-related mortality. This knowledge will likely help us prepare well for the future and implement air pollution control measures for other airborne disease epidemics.

Introduction: The ProSPoNS trial is a multicentre, double-blind, placebo-controlled trial to evaluate the role of probiotics in prevention of neonatal sepsis. The present protocol describes the data and methodology for the cost utility of the probiotic intervention alongside the controlled trial., Methods and Analysis: A societal perspective will be adopted in the economic evaluation. Direct medical and non-medical costs associated with neonatal sepsis and its treatment would be ascertained in both the intervention and the control arm. Intervention costs will be facilitated through primary data collection and programme budgetary records. Treatment cost for neonatal sepsis and associated conditions will be accessed from Indian national costing database estimating healthcare system costs. A cost-utility design will be employed with outcome as incremental cost per disability-adjusted life year averted. Considering a time-horizon of 6 months, trial estimates will be extrapolated to model the cost and consequences among high-risk neonatal population in India. A discount rate of 3% will be used. Impact of uncertainties present in analysis will be addressed through both deterministic and probabilistic sensitivity analysis., Ethics and Dissemination: Has been obtained from EC of the six participating sites (MGIMS Wardha, KEM Pune, JIPMER Puducherry, AIPH, Bhubaneswar, LHMC New Delhi, SMC Meerut) as well as from the ERC of LSTM, UK. A peer-reviewed article will be published after completion of the study. Findings will be disseminated to the community of the study sites, with academic bodies and policymakers., Registration: The protocol has been approved by the regulatory authority (Central Drugs Standards Control Organisation; CDSCO) in India (CT-NOC No. CT/NOC/17/2019 dated 1 March 2019). The ProSPoNS trial is registered at the Clinical Trial Registry of India (CTRI). Registered on 16 May 2019., Trial Registration Number: CTRI/2019/05/019197; Clinical Trial Registry., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background & Objectives: Studies assessing the spatial and temporal association of ambient air pollution with emergency room visits of patients having acute respiratory symptoms in Delhi are lacking. Therefore, the present study explored the relationship between spatio-temporal variation of particulate matter (PM) 2.5 concentrations and air quality index (AQI) with emergency room (ER) visits of patients having acute respiratory symptoms in Delhi using the geographic information system (GIS) approach., Methods: The daily number of ER visits of patients having acute respiratory symptoms (less than or equal to two weeks) was recorded from the ER of four hospitals of Delhi from March 2018 to February 2019. Daily outdoor PM 2.5 concentrations and air quality index (AQI) were obtained from the Delhi Pollution Control Committee. Spatial distribution of patients with acute respiratory symptoms visiting ER, PM 2.5 concentrations and AQI were mapped for three seasons of Delhi using ArcGIS software., Results: Of the 70,594 patients screened from ER, 18,063 eligible patients were enrolled in the study. Winter days had poor AQI compared to moderate and satisfactory AQI during summer and monsoon days, respectively. None of the days reported good AQI (<50). During winters, an increase in acute respiratory ER visits of patients was associated with higher PM 2.5 concentrations in the highly polluted northwest region of Delhi. In contrast, a lower number of acute respiratory ER visits of patients were seen from the 'moderately polluted' south-west region of Delhi with relatively lower PM 2.5 concentrations., Interpretation & Conclusions: Acute respiratory ER visits of patients were related to regional PM 2.5 concentrations and AQI that differed during the three seasons of Delhi. The present study provides support for identifying the hotspots and implementation of focused, intensive decentralized strategies to control ambient air pollution in worst-affected areas, in addition to the general city-wise strategies.

Objective: To develop and validate a simple risk scores chart to estimate the probability of poor outcomes in patients with severe head injury (HI)., Design: Retrospective., Setting: Level-1, government-funded trauma centre, India., Participants: Patients with severe HI admitted to the neurosurgery intensive care unit during 19 May 2010-31 December 2011 (n=946) for the model development and further, data from same centre with same inclusion criteria from 1 January 2012 to 31 July 2012 (n=284) for the external validation of the model., Outcomes: In-hospital mortality and unfavourable outcome at 6 months., Results: A total of 39.5% and 70.7% had in-hospital mortality and unfavourable outcome, respectively, in the development data set. The multivariable logistic regression analysis of routinely collected admission characteristics revealed that for in-hospital mortality, age (51-60, >60 years), motor score (1, 2, 4), pupillary reactivity (none), presence of hypotension, basal cistern effaced, traumatic subarachnoid haemorrhage/intraventricular haematoma and for unfavourable outcome, age (41-50, 51-60, >60 years), motor score (1-4), pupillary reactivity (none, one), unequal limb movement, presence of hypotension were the independent predictors as its 95% confidence interval (CI) of odds ratio (OR)&#95;did not contain one. The discriminative ability (area under the receiver operating characteristic curve (95% CI)) of the score chart for in-hospital mortality and 6 months outcome was excellent in the development data set (0.890 (0.867 to 912) and 0.894 (0.869 to 0.918), respectively), internal validation data set using bootstrap resampling method (0.889 (0.867 to 909) and 0.893 (0.867 to 0.915), respectively) and external validation data set (0.871 (0.825 to 916) and 0.887 (0.842 to 0.932), respectively). Calibration showed good agreement between observed outcome rates and predicted risks in development and external validation data set (p>0.05)., Conclusion: For clinical decision making, we can use of these score charts in predicting outcomes in new patients with severe HI in India and similar settings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background & Objectives: Coronavirus disease 2019 (COVID-19) has so far affected over 41 million people globally. The limited supply of real-time reverse transcription-polymerase chain reaction (rRT-PCR) kits and reagents has made meeting the rising demand for increased testing incompetent, worldwide. A highly sensitive and specific antigen-based rapid diagnostic test (RDT) is the need of the hour. The objective of this study was to evaluate the performance of a rapid chromatographic immunoassay-based test (index test) compared with a clinical reference standard (rRT-PCR)., Methods: A cross-sectional, single-blinded study was conducted at a tertiary care teaching hospital in north India. Paired samples were taken for RDT and rRT-PCR (reference standard) from consecutive participants screened for COVID-19 to calculate the sensitivity and specificity of the RDT. Further subgroup analysis was done based on the duration of illness and cycle threshold values. Cohen's kappa coefficient was used to measure the level of agreement between the two tests., Results: Of the 330 participants, 77 were rRT-PCR positive for SARS-CoV-2. Sixty four of these patients also tested positive for SARS-CoV-2 by RDT. The overall sensitivity and specificity were 81.8 and 99.6 per cent, respectively. The sensitivity of RDT was higher (85.9%) in participants with a duration of illness ≤5 days., Interpretation & Conclusions: With an excellent specificity and moderate sensitivity, this RDT may be used to rule in COVID-19 in patients with a duration of illness ≤5 days. Large-scale testing based on this RDT across the country would result in quick detection, isolation and treatment of COVID-19 patients., Competing Interests: None

Purpose: Psychogenic non-epileptic seizures (PNES) offer an immense diagnostic and therapeutic challenge. We sought to determine socioeconomic, psychological and demographic factors in PNES compared to age and gender matched epilepsy patients as well as healthy controls. We also examined psychiatric co-morbidities in PNES and epilepsy patients., Methods: We conducted a case-control study at a tertiary centre in India with three groups including PNES only, age and gender matched epilepsy only and healthy participants. Factors including marital status, family type, education level and psychiatric comorbidities etc. were compared between the three groups. Details of PNES semiology, duration of event and disease were collected. Psychiatric assessment included MINI International Diagnostic Interview based on DSM-IV criteria and Holmes-Rahe Social Readjustment Scale for stress evaluation. The modified Kuppuswamy scale was used to assess socio-economic status., Results: We enrolled 100 PNES patients (mean age 26.1 ± 10.8 years), 100 epilepsy patients (23.5 ± 9.6 years) and 100 healthy controls (28.9 ± 11.0 years). Ninety per cent of participants were female. Significant factors associated with PNES included family history of epilepsy [OR 20.3 (2.6-155.6) (p = 0.004)], low education including literate/illiterate status [OR 14.1 (2.5-78.9) (p = 0.003)], interpersonal conflict [OR 2.4 (1.1-6.0) (p = 0.05)] and presence of psychiatric comorbidity [OR 60.5 (24.1-152.2) (p < 0.001)] of which major depression was the most common. The current suicide risk was significantly elevated in PNES compared to epilepsy patients (p < 0.001). PNES disease duration correlated with presence of current depression, dysthymia and suicidality but not with other psychiatric comorbidities., Conclusions: Our results highlight that several socio-economic and demographic factors are associated with occurrence of PNES. High rates of psychiatric comorbidities including current suicide risk emphasise the need for a collaborative neuropsychiatric approach., (Copyright © 2020. Published by Elsevier Ltd.)

Background: Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates., Methods: This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters., Findings: A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm., Interpretation: Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births., Trial Registration Number: The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181)., Competing Interests: Competing interests: None declared, (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background & Objectives: Population-based seroepidemiological studies measure the extent of SARS-CoV-2 infection in a country. We report the findings of the first round of a national serosurvey, conducted to estimate the seroprevalence of SARS-CoV-2 infection among adult population of India., Methods: From May 11 to June 4, 2020, a randomly sampled, community-based survey was conducted in 700 villages/wards, selected from the 70 districts of the 21 States of India, categorized into four strata based on the incidence of reported COVID-19 cases. Four hundred adults per district were enrolled from 10 clusters with one adult per household. Serum samples were tested for IgG antibodies using COVID Kavach ELISA kit. All positive serum samples were re-tested using Euroimmun SARS-CoV-2 ELISA. Adjusting for survey design and serial test performance, weighted seroprevalence, number of infections, infection to case ratio (ICR) and infection fatality ratio (IFR) were calculated. Logistic regression was used to determine the factors associated with IgG positivity., Results: Total of 30,283 households were visited and 28,000 individuals were enrolled. Population-weighted seroprevalence after adjusting for test performance was 0.73 per cent [95% confidence interval (CI): 0.34-1.13]. Males, living in urban slums and occupation with high risk of exposure to potentially infected persons were associated with seropositivity. A cumulative 6,468,388 adult infections (95% CI: 3,829,029-11,199,423) were estimated in India by the early May. The overall ICR was between 81.6 (95% CI: 48.3-141.4) and 130.1 (95% CI: 77.0-225.2) with May 11 and May 3, 2020 as plausible reference points for reported cases. The IFR in the surveyed districts from high stratum, where death reporting was more robust, was 11.72 (95% CI: 7.21-19.19) to 15.04 (9.26-24.62) per 10,000 adults, using May 24 and June 1, 2020 as plausible reference points for reported deaths., Interpretation & Conclusions: Seroprevalence of SARS-CoV-2 was low among the adult population in India around the beginning of May 2020. Further national and local serosurveys are recommended to better inform the public health strategy for containment and mitigation of the epidemic in various parts of the country., Competing Interests: None

Conducting population-based serosurveillance for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) will estimate and monitor the trend of infection in the adult general population, determine the socio-demographic risk factors and delineate the geographical spread of the infection. For this purpose, a serial cross-sectional survey would be conducted with a sample size of 24,000 distributed equally across four strata of districts categorized on the basis of the incidence of reported cases of COVID-19. Sixty districts will be included in the survey. Simultaneously, the survey will be done in 10 high-burden hotspot cities. ELISA-based antibody tests would be used. Data collection will be done using a mobile-based application. Prevalence from the group of districts in each of the four strata will be pooled to estimate the population prevalence of COVID-19 infection, and similarly for the hotspot cities, after adjusting for demographic characteristics and antibody test performance. The total number of reported cases in the districts and hotspot cities will be adjusted using this seroprevalence to estimate the expected number of infected individuals in the area. Such serosurveys repeated at regular intervals can also guide containment measures in respective areas. State-specific context of disease burden, priorities and resources should guide the use of multifarious surveillance options for the current COVID-19 epidemic., Competing Interests: None

Vitamin D deficiency may contribute to etiology of type 2 diabetes in Asian Indians. The objectives of this study was to evaluate effect of vitamin D supplementation on glycemic profile and body composition in prediabetic and vitamin D deficient overweight/obese Asian Indian women. In this open-label randomized placebo-controlled trial (78 weeks duration), 121 females (aged 20-60 years) with prediabetes and vitamin D deficiency were randomly allocated in intervention (n, 61) and placebo (n, 60) groups. The primary outcome variables were fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia. In Intention-to-treat analysis, at the end of intervention, we observed significant decrease in FBG [-5.0 (-12.6-2.4), p = 0.04], 2-h blood glucose post OGTT [-11(-49.3-26.9), p = 0.02], hemoglobin A1c [-0.41 (5.89, 6.55), p = 0.05] and increase in 25(OH) D [7.5 (-6.0-20.9), p = 0.002] levels in intervention as compared to the placebo group. Changes in glycemic category based on FBG were as follows; intervention group: normal FBG, 58.6%; impaired fasting glucose (IFG), 39%; and type 2 diabetes mellitus (T2DM), 2.4%; placebo group: normal FBG, 48.8%; IFG, 46.3%; and T2DM, 4.9%. Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%. After intervention, subscapular skinfold (visit I st compared to visit III rd ) and suprailiac skinfold (visit II nd compared to visit III rd ) were significantly lower in intervention group vs. control group. In conclusion, we observed significant reduction in FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia in overweight/obese prediabetic vitamin D deficient Asian Indian women after 78 weeks of vitamin D supplementation.

Background: The coverage of community-based maternal, neonatal, and child health (MNCH) services remains low, especially in hard-to-reach areas. We evaluated the effectiveness of a mobile-phone-and web-based application, Innovative Mobile-phone Technology for Community Health Operations (ImTeCHO), as a job aid to the government's Accredited Social Health Activists (ASHAs) and Primary Health Center (PHC) staff to improve coverage of MNCH services in rural tribal communities of Gujarat, India., Methods and Findings: This open cluster-randomized trial was conducted in 22 PHCs in six tribal blocks of Bharuch and Narmada districts in India. The ImTeCHO mobile-phone-and web-based application included various technology-based job aids to facilitate scheduling of home visits, screening for complications, counseling during home visits, and supportive supervision by PHC staff. Primary outcome indicators were a composite index calculated based on coverage of important MNCH services and coverage of at least two home visitations by ASHA within the first week of birth. Primary analysis was intention to treat (ITT). Generalized Estimating Equation (GEE) was used to account for clustering. Eleven PHCs each were randomly allocated to the intervention (280 ASHAs, population: 234,134) and control (281 ASHAs, population: 242,809) arms. The intervention was implemented from February, 2016 to January, 2017. At the end of the implementation, 6,493 mothers were surveyed. Most of the surveyed women were tribal (5,571, 85.8%), and reported having a government-issued certificate for living below poverty line (4,916, 75.7%). The coverage of at least two home visits within first week of birth was 32.4% in the intervention clusters compared to 22.9% in the control clusters (adjusted effect size 10.2 [95% CI: 6.4, 14.0], p < 0.001). Mean number of home visits within first week of birth was 1.11 and 0.80 for intervention and control clusters, respectively (adjusted effect size 0.34 [95% CI: 0.23, 0.45], p < 0.001). The composite coverage index was 43.0% in the intervention clusters compared to 38.5% (adjusted effect size 4.9 [95% CI: 0.2, 9.5], p = 0.03) in the control clusters. There were substantial improvements in coverage home visits by ASHAs during antenatal period (adjusted effect size 15.7 [95% CI: 11.0, 20.4], p < 0.001), postnatal period (adjusted effect size 6.4, [95% CI: 3.2, 9.6], p <0.001), early initiation of breastfeeding (adjusted effect size 7.8 [95% CI: 4.2, 11.4], p < 0.001), and exclusive breastfeeding (adjusted effect size 13.4 [95% CI: 8.9, 17.9], p < 0.001). Number of infant and neonatal deaths was similar in the two arms in the ITT analysis. The limitations of the study include potential risk of inaccuracies in reporting events that occurred during pregnancy by the mothers and the duration of intervention being 12 months, which might be considered short., Conclusions: In this study, we found that use of ImTeCHO mobile- and web-based application as a job aid by government ASHAs and PHC staff improved coverage and quality of MNCH services in hard-to-reach areas. Supportive supervision, change management, and timely resolution of technology-related issues were critical implementation considerations to ensure adherence to the intervention., Trial Registration: Study was registered at the Clinical Trial Registry of India (www.ctri.nic.in). Trial number: CTRI/2015/06/005847. The trial was registered (prospective) on 3 June, 2015. First enrollment was done on 26 August, 2015., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Argusoft India Ltd is the owner of the core IT platform which was used to develop ImTeCHO application. RG and SV are co-investigators for this study and employed by Argusoft India Ltd. SQ is retired medical officer at the WHO. AS is senior scientist at the ICMR; WHO and ICMR funded the trial.

Objective: To evaluate body fat patterning and phenotype including hepatic fat and pancreatic volume of non-obese (BMI: < 25 kg/m2) Asian Indians with type 2 diabetes residing in North India., Methods: Non-obese patients with type 2 diabetes (n = 93) and non-obese, normo-glycemic subjects (n = 40) were recruited. BMI, waist & hip circumferences, skinfold thickness at 8 sites, body fat, lean mass and detailed abdominal fat evaluation [total abdominal fat, total subcutaneous fat (superficial, deep, anterior, and posterior), total intra-abdominal fat (intra-peritoneal, retroperitoneal)], liver span, grades of fatty liver and pancreatic volume were compared., Results: Waist circumference, subscapular skinfolds and total truncal fat (on DEXA) were higher whereas calf, total peripheral skinfolds and total leg fat (on DEXA) lower in patients. Specifically, the following volumes were higher in cases as compared to controls; total abdominal fat (19.4%), total intra-abdominal fat (49.7%), intra-peritoneal fat (47.7%), retroperitoneal fat (70.7%), pancreatic volume (26.6%), pancreatic volume index (21.3%) and liver span (10.8%). In cases, significant positive correlations were observed for pancreatic volume with BMI, waist and hip circumferences, W-HR, subscapular, abdominal and total truncal skinfolds, truncal, total subcutaneous, total intra-abdominal, intra-peritoneal, retroperitoneal fat depots, liver span and fatty liver., Conclusions: In non-obese Asian Indians with type 2 diabetes, subcutaneous and intra-abdominal obesity, including fatty liver, and pancreatic volume were higher and peripheral subcutaneous adiposity was lower than BMI matched non-diabetic subjects. Importantly, increased pancreatic volume in patients was highly correlated with multiple measures of abdominal obesity and liver fat.