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Abstract Background The associations of vegetarian diets with risks for site-specific cancers have not been estimated reliably due to the low number of vegetarians in previous studies. Therefore, the Cancer Risk in Vegetarians Consortium was established. The aim is to describe and compare the baseline characteristics between non-vegetarian and vegetarian diet groups and between the collaborating studies. Methods We harmonised individual-level data from 11 prospective cohort studies from Western Europe, North America, South Asia and East Asia. Comparisons of food intakes, sociodemographic and lifestyle factors were made between diet groups and between cohorts using descriptive statistics. Results 2.3 million participants were included; 66% women and 34% men, with mean ages at recruitment of 57 (SD: 7.8) and 57 (8.6) years, respectively. There were 2.1 million meat eaters, 60,903 poultry eaters, 44,780 pescatarians, 81,165 vegetarians, and 14,167 vegans. Food intake differences between the diet groups varied across the cohorts; for example, fruit and vegetable intakes were generally higher in vegetarians than in meat eaters in all the cohorts except in China. BMI was generally lower in vegetarians, particularly vegans, except for the cohorts in India and China. In general, but with some exceptions, vegetarians were also more likely to be highly educated and physically active and less likely to smoke. In the available resurveys, stability of diet groups was high in all the cohorts except in China. Conclusions Food intakes and lifestyle factors of both non-vegetarians and vegetarians varied markedly across the individual cohorts, which may be due to differences in both culture and socioeconomic status, as well as differences in questionnaire design. Therefore, care is needed in the interpretation of the impacts of vegetarian diets on cancer risk.

Introduction: Region-specific data on individual factors associated with uptake of breast and cervical cancer screening or early testing in diverse Indian populations are limited. Aim: To assess the prevalence and individual determinants of uptake of breast and/or cervical cancer screening or testing among women aged 30–69 years in regionally representative populations of two large Indian cities: New Delhi and Chennai. Methods: We conducted an analysis of the cross-sectional data (2016–2017) nested within the Centre for Cardiometabolic Risk Reduction in South Asia cohort, established in 2010–2011 with 12,271 participants (5365 in New Delhi; 6906 in Chennai). Among 3310 women participants, we evaluated the associations of demographic, socioeconomic, lifestyle, medical, psychosocial, and reproductive factors with breast and/or cervical cancer screening or testing using multivariable logistic regression models with results expressed as adjusted odds ratios (OR) and 95% confidence intervals (CI). Results: At any point prior to 2016–2017, 193 women self-reported having undergone evaluations for breast and/or cervical cancer. The reasons for evaluation were ‘general examination’ or ‘physician’s advice’ (i.e., screening) or ‘being symptomatic’ (i.e., early testing). The overall prevalence was 5.8% for screening or testing and 2.5% for screening alone. Formal education (OR:1.88; 95% CI:1.12–3.15), high monthly household income (OR:2.27; 95% CI:1.59–3.25) and less ‘fear-of-judgement’ (OR:1.65; 95% CI:1.05–2.58) were positively associated with screening or testing uptake. When screening uptake was analysed separately, the results were generally similar. Conclusion: Our findings may have important implications for interventions at community-level (e.g., reducing ‘fear-of-judgement’, increasing awareness to screening programs and early symptoms) and health-system level (e.g., opportunistic screening).

Background: Standard treatment workflows (STWs) indeed play a crucial role in enhancing healthcare delivery by providing structured guidelines for managing prevalent diseases. These guidelines are particularly beneficial in primary and secondary healthcare settings, where they help standardize treatment protocols, streamline referrals, and ultimately improve healthcare efficiency. Methods: Indian Council of Medical Research, in collaboration with the National Health Authority and the World Health Organisation India country office developed the STWs. The broad medical specialities were identified and speciality expert groups each of 5–12 experienced members led by an eminent chairperson were constituted. Priority disease conditions were identified and the speciality experts deliberated on the evidence available for various recommendations and developed the content for the STW. These were then converted to a one-pager infographic. The draft STWs were reviewed by relevant experts for internal and external validation of content. Results: 125 STWs in 23 specialties have been developed. Conclusion: STWs are one-page summaries of clinical guidelines designed to improve healthcare delivery in India. Training healthcare profesionals and collaboration with medical bodies are crucial for successful implementation. This can ensure standardized, evidence-based care throughout India's healthcare system.

Background: Defining lipid goals solely on low-density lipoprotein-cholesterol (LDL-C) levels in Indian population may cause misclassification due to high prevalence of hypertriglyceridemia and small dense LDL-C particles. International guidelines now recommend Apoliporotein-B (Apo-B) and non-high-density lipoprotein-cholesterol (non-HDL-C) levels as alternative targets. In this study, we used a cross-sectional representative population database to determine Apo-B and non-HDL-C cut-offs corresponding to identified LDL-C targets and compared them to international guidelines. Methods: A community-based survey carried out in urban Delhi and adjacent rural Ballabhgarh provided lipid values for 3047 individuals. The Spearman correlation coefficient was used to evaluate the degree of relationship between Apo-B and LDL-C and non-HDL-C. Cut-off values for Apo-B and non-HDL-C were established using receiver operator curve analysis correlating with guideline-recommended LDL-C targets. Results: Spearman's rank correlations between Apo-B and LDL-C (0.82) and non-HDL-C and LDL-C (0.93) were significant (p 150 mg/dl the corresponding Apo-B and non-HDL-C values were 85.1, 92.7, 103.5, 117.5 and 135 mg/dL and 124.5, 126.5, 147.5, 167.5 and 190.5 mg/L respectively. Conclusion: Based on this study we provide Apo-B and non-HDL cut-offs corresponding to target LDL-C values in Indian patients with and without high triglycerides. It is noted that in individuals with triglycerides ≥ 150 mg/dl, the Apo-B levels are much higher than the values recommended by guidelines.

Abstract Background While previously considered a transient condition, with no lasting adverse impact, gestational diabetes mellitus (GDM) is now a well‐established risk factor for developing type 2 diabetes mellitus (T2DM). The risk of developing T2DM appears to be particularly high in the first few years after childbirth, providing a compelling case for early intervention. This review provides an up‐to‐date systematic review and meta‐analysis to assess the effectiveness of interventions to reduce incidence of T2DM in women with a recent history of GDM. Methods The search was conducted on October 20, 2023 with an annual surveillance planned for the next 5 years to maintain a living systematic review. The inclusion criteria were randomized controlled trials of any type in women within 5 years of GDM‐complicated pregnancy that reported outcomes of T2DM diagnosis or measures of dysglycemia with a follow‐up of at least 12 months. Results Seventeen studies met our inclusion criteria and have been included in this review. There were 3 pharmacological and 14 lifestyle interventions. Intervention was not associated with significant reduction in the primary outcome of T2DM (risk ratio, 0.78; 95% confidence interval [CI]: 0.43–1.41; p = 0.41; I2 = 79%) compared with the control group (placebo or usual care). However, meta‐analysis of the four studies reporting hazard ratios suggested a reduction in diabetes incidence (hazard ratio, 0.68; 95% CI: 0.48–0.97; p = 0.03; I2 = 31%). Conclusion This review provides equivocal evidence about the efficacy of interventions to reduce the risk of T2DM in women within 5 years of GDM‐complicated pregnancy and highlights the need for further studies, including pharmacotherapy.

Introduction People with diabetes are at risk of developing chronic kidney disease. However, limited data are available to quantify their risk of kidney function decline in South Asia. This study evaluates the rate and predictors of kidney function decline among people with type 2 diabetes in South Asia.Research design and methods We analyzed data from the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) Trial to quantify the rate of decline in estimated glomerular filtration rate (eGFR) in people with type 2 diabetes (n=1146) over 2.5 years of follow-up. The CARRS Trial evaluated a multicomponent intervention of decision-supported electronic health records and non-physician care coordinator to improve diabetes management at 10 diabetes clinics in India and Pakistan. We used linear mixed models to estimate eGFR slope among all participants and tested the association of eGFR slope with demographic, disease-related, and self-care parameters, accounting for randomization and site.Results The mean age of participants was 54.2 years, with a median duration of diabetes of 7.0 years (IQR: 3.0 - 12.0) and median CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) eGFR of 83.6 (IQR: 67.7 to 97.9) mL/min/1.73 m2. The overall mean eGFR slope was −1.33/mL/min/1.73 m2/year. There were no differences in the eGFR slope by treatment assignment to intervention versus usual care. In the adjusted regression model, pre-existing diabetic retinopathy (slope difference: −2.11; 95% CI: −3.45 to –0.77), previous cardiovascular disease (−1.93; 95% CI: −3.45 to –0.40), and statins use (−0.87; 95% CI: −1.65 to –0.10) were associated with faster eGFR decline.Conclusions People with diabetes receiving care at urban diabetes clinics in South Asia experienced annual eGFR decline at two times higher rate than that reported from other contemporary international diabetes cohorts. Risk factors for faster decline were similar to those previously established, and thus care delivery models must put an additional emphasis on kidney protective therapies among subgroups with microvascular and macrovascular diabetes complications.Trial registration number NCT01212328.

BackgroundDiabetes control is poor globally and leads to burdensome microvascular and macrovascular complications. We aimed to assess post hoc between-group differences in sustained risk factor control and macrovascular and microvascular endpoints at 6.5 years in the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomized trial.Methods and findingsThis parallel group individual randomized clinical trial was performed at 10 outpatient diabetes clinics in India and Pakistan from January 2011 through September 2019. A total of 1,146 patients with poorly controlled type 2 diabetes (HbA1c ≥8% and systolic BP ≥140 mm Hg and/or LDL-cholesterol ≥130 mg/dL) were randomized to a multicomponent quality improvement (QI) strategy (trained nonphysician care coordinator to facilitate care for patients and clinical decision support system for physicians) or usual care. At 2.5 years, compared to usual care, those receiving the QI strategy were significantly more likely to achieve multiple risk factor control. Six clinics continued, while 4 clinics discontinued implementing the QI strategy for an additional 4-year follow-up (overall median 6.5 years follow-up). In this post hoc analysis, using intention-to-treat, we examined between-group differences in multiple risk factor control (HbA1c ConclusionsIn urban South Asian clinics, a multicomponent QI strategy led to sustained multiple risk factor control and between-group differences in microvascular, but not macrovascular, endpoints. Between-group reductions in vascular outcomes at 6.5 years were observed only at sites that continued the QI intervention, suggesting that practice change needs to be maintained for better population health of people with diabetes.Trial registrationClinicalTrials.gov NCT01212328.

Abstract Purpose We aimed to evaluate the prevalence of postpartum diabetes among women with a history of overt diabetes in pregnancy (ODiP) and compare with women having a history of gestational diabetes mellitus (GDM) and normoglycemia in pregnancy. Methods We have an established longitudinal cohort of postpartum women with a history of hyperglycemia (preexisting diabetes [PED] [n = 101], ODiP [n = 92], GDM [n = 643]), and normoglycemia (n = 183) in pregnancy. For this study, we excluded women with PED and invited other eligible women in a fasting state for clinical and biochemical evaluation. Results We evaluated 918 women with a mean (SD) age of 33.6 (5.0) years and at a median (interquartile range) postpartum interval of 31 (20–45) months. Diabetes was diagnosed in 65 (70.7%) women in ODiP compared to 99 (15.4%) in GDM (p 3 years postpartum. Diabetes was more common when ODiP was diagnosed in the first (27/29, 93.1%) compared to the second trimester of pregnancy (35/57, 61.4%). The adjusted odds ratio for diabetes in ODiP was 14.82 (95% confidence interval, 8.49–25.87; p

Abstract Objectives To explore associations between type and number of abnormal glucose values on antenatal oral glucose tolerance test (OGTT) with postpartum diabetes in South Asian women diagnosed with gestational diabetes (GDM) using International Association of the Diabetes and Pregnancy Study Groups criteria. Methods This post‐hoc evaluation of the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, a randomized controlled trial, was conducted among women with GDM in the index pregnancy, across 19 centers in Bangladesh, India, and Sri Lanka. Postpartum diabetes (outcome) was defined on OGTT, using American Diabetes Association (ADA) criteria. Results We report data on 1468 women with GDM, aged 30.9 (5.0) years, and with median (interquartile range) follow‐up period of 1.8 (1.4–2.4) years after childbirth following the index pregnancy. We found diabetes in 213 (14.5%) women with an incidence of 8.7 (7.6–10.0)/100 women‐years. The lowest incidence rate was 3.8/100 women years, in those with an isolated fasting plasma glucose (FPG) abnormality, and highest was 19.0/100 women years in participants with three abnormal values. The adjusted hazard ratios for two and three abnormal values compared to one abnormal value were 1.73 (95% confidence interval [CI], 1.18–2.54; p = .005) and 3.56 (95% CI, 2.46–5.16; p

Abstract Aim We planned this study to identify diabetogenic glutamic acid decarboxylase (GAD65) peptides possibly responsible for human leucocyte antigen (HLA)‐DR3/DQ2‐mediated activation of GAD65‐specific CD4 T cells in type 1 diabetes (T1D). Methods Top 30 GAD65 peptides, found to strongly bind in silico with HLA‐DR3/DQ2 molecules, were selected and grouped into four pools. The peptides were used to stimulate CD4 T cells of study subjects in 16‐h peripheral blood mononuclear cell culture. CD4 T cells' stimulation in terms of interferon‐gamma (IFN‐γ), interleukin (IL)‐17, tumor necrosis factor‐alpha (TNF‐α), and IL‐10 expression was analyzed using flow cytometry. Results Although all four GAD65 peptide pools (PP1‐4) resulted in significantly higher expression of IFN‐γ by CD4 T cells (p = .003, p

Self-stigma-the internalization of negative community attitudes and beliefs about a disease or condition-represents an important barrier to improving patient care outcomes for people living with common mental disorders and diabetes. Integrated behavioral healthcare interventions are recognized as evidence-based approaches to improve access to behavioral healthcare and for improving patient outcomes, including for those with comorbid diabetes, yet their impact on addressing self-stigma remains unclear. Using secondary data from the Integrating Depression and Diabetes Treatment (INDEPENDENT) study-a trial that aimed to improve diabetes outcomes for people with undertreated and comorbid depression in four urban Indian cities via the Collaborative Care Model-we longitudinally analyzed self-stigma scores and evaluated whether change in total self-stigma scores on diabetes outcomes is mediated by depressive symptom severity. Self-stigma scores did not differ longitudinally comparing Collaborative Care Model participants to enhanced standard-of-care participants (mean monthly rate of change in Self-Stigma Scale for Chronic Illness-4 Item scores; B = 0.0087; 95% CI: -0.0018, 0.019, P = .10). Decreases in total self-stigma scores over 12 months predicted diabetes outcomes at 12 months (HbA1c, total effect; B = 0.070 95%CI: 0.0032, 0.14; P < .05), however depressive symptoms did not mediate this relationship (average direct effect; B = 0.064; 95% CI: -0.0043, 0.13, P = .069). Considering the local and plural notions of stigma in India, further research is needed on culturally grounded approaches to measure and address stigma in India, and on the role of integrated care delivery models alongside multi-level stigma reduction interventions. Trial registration : ClinicalTrials.gov, NCT02022111. https://clinicaltrials.gov/study/NCT02022111.

Background: A heavy burden of cardiometabolic conditions on low- and middle-income countries like India that are rapidly undergoing urbanization remains unaddressed. Indians are known to have high levels of triglycerides and low levels of HDL-C along with moderately higher levels of LDL-C. The genome-wide findings from Western populations need to be validated in an Indian context for a better understanding of the underlying etiology of dyslipidemia in India.Objective: We aim to validate 12 genetic variants associated with lipid levels among rural and urban Indian populations and derive unweighted and weighted genetic risk scores (uGRS and wGRS) for lipid levels among the Indian population.Methods: Assuming an additive model of inheritance, linear regression models adjusted for all the possible covariates were run to examine the association between 12 genetic variants and total cholesterol, triglycerides, HDL-C, LDL-C, and VLDL-C among 2,117 rural and urban Indian participants. The combined effect of validated loci was estimated by allelic risk scores, unweighted and weighted by their effect sizes.Results: The wGRS for triglycerides and VLDL-C was derived based on five associated variants (rs174546 at FADS1, rs17482753 at LPL, rs2293889 at TRPS1, rs4148005 at ABCA8, and rs4420638 at APOC1), which was associated with 36.31 mg/dL of elevated triglyceride and VLDL-C levels (β = 0.95, SE = 0.16, p < 0.001). Similarly, every unit of combined risk score (rs2293889 at TRPS1 and rs4147536 at ADH1B) was associated with 40.62 mg/dL of higher total cholesterol (β = 1.01, SE = 0.23, p < 0.001) and 33.97 mg/dL of higher LDL-C (β = 1.03, SE = 0.19, p < 0.001) based on its wGRS (rs2293889 at TRPS1, rs4147536 at ADH1B, rs4420638 at APOC1, and rs660240 at CELSR2). The wGRS derived from five associated variants (rs174546 at FADS1, rs17482753 at LPL, rs4148005 at ABCA8, rs4420638 at APOC1, and rs7832643 at PLEC) was associated with 10.64 mg/dL of lower HDL-C (β = −0.87, SE = 0.14, p < 0.001).Conclusion: We confirm the role of eight genome-wide association study (GWAS) loci related to different lipid levels in the Indian population and demonstrate the combined effect of variants for lipid traits among Indians by deriving the polygenic risk scores. Similar studies among different populations are required to validate the GWAS loci and effect modification of these loci by lifestyle and environmental factors related to urbanization.

Purpose: Emerging lifestyle changes due to rapid urbanization have led to an epidemiological transition and the rising prevalence of obesity is responsible for major non-communicable diseases (NCDs) which have further aggravated due to the COVID-19 pandemic. This study aims to assess the effectiveness of a comprehensive school-based intervention on diet and physical activity-related behavior of adolescents. Methods: In 2019, a cluster-randomized controlled trial was conducted in randomly selected (n = 8) private schools. A 2-year intervention program was implemented over consecutive academic years (2019–2020 and 2020–2021) with students who were in the 6th and 7th grades when the study began. Four schools were randomly assigned to the intervention (n = 794) and four schools to the control group (n = 774). Results: The difference in changes in diet and physical-activity-related behaviors of the students between the intervention and control schools were not significant in the intention to treat analysis probably due to the large drop-out due to COVID-19 measures: 304 students were available for follow-up in the intervention group and 122 in the control group (391 cases were excluded to make data comparable with baseline survey). The intake of vegetables (once a day) [β = 0.35, OR = 1.42, 95% CI (1.03, 1.95)] in the per-protocol analysis has increased among adolescents in the intervention group as compared to the control group. Conclusion: The findings of this study indicated a positive effect of the intervention on diet and physical-activity-related changes in the expected direction and highlights the importance of addressing such behavior to prevent obesity among adolescents and thus NCDs in the later stage of life.

Introduction Measures to address the COVID-19 pandemic in India included a ban on the sale and use of tobacco products during 2020 when stay at home guidance (lockdown) was in place. In this study we examined the extent of reduction in frequency of tobacco consumption across all products. Material and Methods Telephone survey was conducted between July and August 2020 across an existing cohort of tobacco users (n=801) residing in Delhi (55.4%) and Chennai (44.6%), India. The participants were recruited irrespective of their gender and use of any kind of tobacco product(s). The survey questionnaire was based on the STOP (Studying Tobacco users Of Pakistan) survey and adapted to the context of smoking and smokeless tobacco use in India. Results Cigarette consumption declined from a median value of 5.0 (IQR: 2–10) sticks in the pre-lockdown period to 2.0 (IQR: 0.4–5) sticks during the lockdown period. Reductions were reported in the daily use of bidis, from 8 (IQR: 4–12) sticks to 5 (IQR: 2–10) sticks and for smokeless tobacco users from 3.5 (IQR: 2–5) packs to 2 (IQR: 1–4) packs during the lockdown. Furthermore, the number of daily cigarette smokers in our cohort decreased from 32.6% (n=261) in the pre-lockdown period to 27.5% (n=220) during lockdown and smokeless tobacco users decreased from 35.8% (n=287) in pre-lockdown period to 30.3% (n=243) during the lockdown period. Conclusions The decrease in tobacco use can be attributed to various societal and environmental factors. However, the pandemic-linked lockdown provided an opportune condition to reduce the use of tobacco products, which could be due to restricted access and increase in health awareness during the COVID-19 lockdown.

Introduction Exposure to fine particulate matter has been associated with several cardiovascular and cardiometabolic diseases. However, such evidence mostly originates from low-pollution settings or cross-sectional studies, thus necessitating evidence from regions with high air pollution levels, such as India, where the burden of non-communicable diseases is high.Research design and methods We studied the associations between ambient PM2.5 levels and fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c) and incident type 2 diabetes mellitus (T2DM) among 12 064 participants in an adult cohort from urban Chennai and Delhi, India. A meta-analytic approach was used to combine estimates, obtained from mixed-effects models and proportional hazards models, from the two cities.Results We observed that 10 μg/m3 differences in monthly average exposure to PM2.5 was associated with a 0.40 mg/dL increase in FPG (95% CI 0.22 to 0.58) and 0.021 unit increase in HbA1c (95% CI 0.009 to 0.032). Further, 10 μg/m3 differences in annual average PM2.5 was associated with 1.22 (95% CI 1.09 to 1.36) times increased risk of incident T2DM, with non-linear exposure response.Conclusions We observed evidence of temporal association between PM2.5 exposure, and higher FPG and incident T2DM in two urban environments in India, thus highlighting the potential for population-based mitigation policies to reduce the growing burden of diabetes.

Background: This project aimed to assess the impact of yoga on stress, metabolic parameters and cognition (attention & concentration) in adolescents, aged 13–15 years from public and private schools in two cities (Chennai and New Delhi) in India. Methods: The study recruited 2000 adolescents from 24 schools in a cluster randomized controlled trial design. The yoga group participants underwent 17 yoga sessions, which included: pranayama, basic asanas, meditation and relaxation exercises. Yoga sessions, were held in the school premises once a week. A total of five awareness talks on healthy lifestyle were delivered once a month to the education group. ADOlescence Stress Scale (ADOSS), salivary cortisol, metabolic and clinical parameters and Letter Cancellation Test (LCT) score were measured at baseline and post-intervention (5–6 months). Results: The yoga group showed statistically significant differences in the mean ADOSS score, metabolic parameters, salivary cortisol, and LCT scores compared to the education group. In the intention- to- treat analysis, a significant reduction [5.11, 95% CI (4.78, 5.36), p = 0.001] in ADOSS score was seen in the yoga group compared to education. Conclusion: Implementation of a 17-week standardized yoga program at the school level significantly decreased stress, improved attention and concentration, metabolic and clinical parameters in Indian adolescents. Trial registration: This trial was registered at Clinical Trials Registry, India (CTRI/2017/08/009203).

Context: Collaborative care models for depression have been successful in a variety of settings, but their success may differ by patient engagement. We conducted a post-hoc analysis of the INDEPENDENT trial to investigate the role of differential engagement of participants on health outcomes over 3 years. Settings and Design: INDEPENDENT study was a parallel, single-blinded, randomised clinical trial conducted at four socio-economically diverse clinics in India. Participants were randomised to receive either active collaborative care or usual care for 12 months and followed up for 24 months. Method: We grouped intervention participants by engagement, defined as moderate (≤7 visits) or high, (8 or more visits) and compared them with usual care participants. Improvements in composite measure (depressive symptoms and at least one of three cardio-metabolic) were the primary outcome. Statistical Analysis: Mean levels of depression and cardio-metabolic measures were analysed over time using computer package IBM SPSS Statistics 25. Results: The composite outcome was sustained the highest in the moderate engagers [27.5%, 95% confidence interval (CI): 19.5, 36.7] and the lowest in high engagers (15.8%, 95% CI: 8.1, 26.8). This pattern was observed for individual parameters – depressive symptoms and glycosylated haemoglobin. Progressive reductions in mean depressive symptom scores were observed for moderate engagers and usual care group from baseline to 36 months. However, in high engagers of collaborative care, mean depressive symptoms were higher at 36 months compared to 12 months. Conclusion: Sustained benefits of collaborative care were larger in participants with moderate engagement compared with high engagement, although a majority of participants relapsed on one or more outcome measures by 36 months. High engagers of collaborative care for co-morbid depression and diabetes may need light touch interventions for longer periods to maintain health and reduce depressive symptoms.

Background: India has the highest number of prevalent type-1 diabetes (T1D) cases in the under-20-year age population. Data on the anthropometry of underprivileged Indian children with T1D are scarce. In economically disadvantaged countries like India, poor growth in patients with T1D is a major concern due to limited accessibility and affordability. Besides, due to the double burden of malnutrition, the prevalence of obesity is increasing mirroring the global trends, which may lead to the development of insulin resistance. Objectives: This study aims to assess the prevalence of malnutrition in Indian children and youth with T1D and to identify the determinants of short stature. Methods: A registry-based cross-sectional analysis of data collected from various centres across India enrolled in the Changing Diabetes in Children (CDiC) programme. Results: We observed that 6.4% were undernourished (3.4% severe undernutrition) and 17.7% (overweight 13.2%) had combined overweight/obesity. 21.2% of participants had short stature (adjusted for mid-parental height) with 7.4% cases of familial short stature. Longer duration of illness and insulin requirement were significant positive predictors of short stature while glycaemic control, insulin regimen and mid-parental height did not have a significant relationship with short stature. Participants on basal-bolus regimen had significantly higher insulin requirements and better glycaemic control than the ones on mixed-split regimen. Conclusion: We report that around one-fifth of children and youth with T1D were overweight/obese and around a fourth were stunted, especially those with longer duration of diabetes and higher insulin requirements. Close monitoring of anthropometric parameters is necessary for all children with T1D to optimize growth and nutrition.

Context: Pheochromocytomas/paragangliomas (PPGLs) have recently been shown to be associated with lower bone mineral density (BMD) and trabecular bone score as compared to healthy controls suggesting low bone mineral concentration and disrupted bone microarchitecture. There is paucity of data on prevalence and clinical predictors of low BMD/osteoporosis in PPGL from India and the extent of change in BMD post-operatively. Aims: This study aimed to find prevalence of low BMD/osteoporosis and trabecular bone score (TBS)-adjusted FRAX score in subjects with PPGL and to see the post-operative change in BMD and TBS at follow-up. Material and Methods: 32 consecutively diagnosed adult cases with PPGL were enrolled. Although the provisional diagnosis of PPGL was made based on imaging consistent with PPGL supported by biochemical evidence of catecholamine excess, its confirmation was made histopathologically before final analysis. Results: We found significantly low average BMD T-score/Z-score at spine, hip or wrist. Osteoporosis was evident in 87.5% of subjects (nine of 11 post-menopausal women or men >50 years of age) and BMD below the expected range for age in 42.9% of subjects (nine of 21 pre-menopausal women or men

Abstract Background India contributes 15% of the total global maternal mortality burden. An increasing proportion of these deaths are due to Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anaemia. This study aims to evaluate the effectiveness of a tablet-based electronic decision-support system (EDSS) to enhance routine antenatal care (ANC) and improve the screening and management of PIH, GDM, and anaemia in pregnancy in primary healthcare facilities of Telangana, India. The EDSS will work at two levels of primary health facilities and is customized for three cadres of healthcare providers – Auxiliary Nurse Midwifes (ANMs), staff nurses, and physicians (Medical Officers). Methods This will be a cluster randomized controlled trial involving 66 clusters with a total of 1320 women in both the intervention and control arms. Each cluster will include three health facilities—one Primary Health Centre (PHC) and two linked sub-centers (SC). In the facilities under the intervention arm, ANMs, staff nurses, and Medical Officers will use the EDSS while providing ANC for all pregnant women. Facilities in the control arm will continue to provide ANC services using the existing standard of care in Telangana. The primary outcome is ANC quality, measured as provision of a composite of four selected ANC components (measurement of blood pressure, blood glucose, hemoglobin levels, and conducting a urinary dipstick test) by the healthcare providers per visit, observed over two visits. Trained field research staff will collect outcome data via an observation checklist. Discussion To our knowledge, this is the first trial in India to evaluate an EDSS, targeted to enhance the quality of ANC and improve the screening and management of PIH, GDM, and anaemia, for multiple levels of health facilities and several cadres of healthcare providers. If effective, insights from the trial on the feasibility and cost of implementing the EDSS can inform potential national scale-up. Lessons learned from this trial will also inform recommendations for designing and upscaling similar mHealth interventions in other low and middle-income countries. Trial Registration. ClinicalTrials.gov, NCT03700034, registered 9 Oct 2018, https://www.clinicaltrials.gov/ct2/show/NCT03700034 CTRI, CTRI/2019/01/016857, registered on 3 Mar 2019, http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=28627&EncHid=&modid=&compid=%27,%2728627det%27

Abstract Aims/Introduction We aimed to evaluate and compare continuous glucose monitoring system (CGMS)‐based glycemic parameters in women in early pregnancy (

Primary healthcare caters to nearly 70% of the population in India and provides treatment for approximately 80–90% of common conditions. To achieve universal health coverage (UHC), the Indian healthcare system is gearing up by initiating several schemes such as National Health Protection Scheme, Ayushman Bharat, Nutrition Supplementation Schemes, and Inderdhanush Schemes. The healthcare delivery system is facing challenges such as irrational use of medicines, over- and under-diagnosis, high out-of-pocket expenditure, lack of targeted attention to preventive and promotive health services, and poor referral mechanisms. Healthcare providers are unable to keep pace with the volume of growing new scientific evidence and rising healthcare costs as the literature is not published at the same pace. In addition, there is a lack of common standard treatment guidelines, workflows, and reference manuals from the Government of India. Indian Council of Medical Research in collaboration with the National Health Authority, Govt. of India, and the WHO India country office has developed Standard Treatment Workflows (STWs) with the objective to be utilized at various levels of healthcare starting from primary to tertiary level care. A systematic approach was adopted to formulate the STWs. An advisory committee was constituted for planning and oversight of the process. Specialty experts' group for each specialty comprised of clinicians working at government and private medical colleges and hospitals. The expert groups prioritized the topics through extensive literature searches and meeting with different stakeholders. Then, the contents of each STW were finalized in the form of single-pager infographics. These STWs were further reviewed by an editorial committee before publication. Presently, 125 STWs pertaining to 23 specialties have been developed. It needs to be ensured that STWs are implemented effectively at all levels and ensure quality healthcare at an affordable cost as part of UHC.

BackgroundAsian Indians are at higher risk of cardiometabolic disease compared to other ethnic groups, and the age of onset is typically younger. Cardiac structure and function are poorly characterized in this ethnic group. In this study, we describe image-acquisition methods and the reproducibility of measurements and detailed echocardiography characteristics in two large Indian population-based cohorts (the New Delhi and Vellore Birth Cohorts) from India.MethodsThe IndEcho study captured transthoracic echocardiographic measurements of cardiac structure and function from 2,322 men and women aged 43–50 years. M-mode measurements in the parasternal long axis (PLAX) and 2-dimensional (2D) short axis recordings at the mitral valve, mid-papillary and apical level were recorded. Apical 2D recordings of two- three- and four-chamber (2C, 3C and 4C) views and Doppler images (colour, pulsed and continuous) were recorded in cine-loop format. Left ventricular (LV) mass, LV hypertrophy, and indices of LV systolic and diastolic function were derived.ResultsEchocardiographic measurements showed good/excellent technical reproducibility. Hetero-geneity across sites, sex and rural/urban differences in cardiac structure and function were observed. Overall, this cohort of South Asian Indians had smaller LV mass and normal systolic and diastolic function when compared with published data on other Asian Indians and the West, (LV mass indexed for body surface area: Delhi men: 68 g/m2, women 63.9; Vellore men: 65.8, women 61.6) but were within ethnic-specific reference ranges. The higher prevalence of obesity, diabetes and hypertension is reflected by the higher proportion of LV remodelling and lesser hypertrophy.ConclusionsOur study adds to scarce population-based echocardiographic data for mid-life Asian Indians. Compared to published literature on other ethnic groups, the Asian Indian heart is characterised by smaller cardiac dimensions and normal range systolic and diastolic function on a background of a high prevalence of hypertension, diabetes and cardiac disease at a relatively young age. This data will form the basis for further analyses of lifecourse, metabolic and body composition predictors of cardiac structure and function, and echocardiographic predictors of future mortality.ISRCTN registration number13432279

Objectives: Family history is considered as an important predictor of cardiovascular diseases (CVDs) and diabetes. Available research findings suggest that family history of chronic diseases is associated with perceived risk of disease and adoption of healthy behaviours. We examined the association between family history of cardio-metabolic diseases (CMDs) and healthy behaviours among adults without self-reported CMDs. Methods: Cross-sectional data of 12,484 adults, without self-reported CMDs, from the baseline survey of Centre for cArdiometabolic Risk Reduction in South-Asia (CARRS) cohort study were analysed. Results: Family history was positively associated with non-smoking and high fruits & vegetables consumption in the age group of 45–64 years and moderate to high physical activity in the age group ≥65 years after adjusting for sex, education, wealth index, city and body mass index. Conclusions: Understanding perceived risks and cultural or psychological factors related to family history through ethnographic studies may deepen understanding of these associations.

Abstract Aim To estimate the prevalence, socio-demographic determinants, common disease combinations, and health impact of multimorbidity among a young rural population. Methods We conducted a cross-sectional survey among participants aged ≥30 years in rural Punjab, North India, from Jan 2019 to April 2019. Multimorbidity was defined as the coexistence of ≥two conditions using a 14-condition tool validated in India. We also calculated a multimorbidity-weighted index (MWI), which provides a weight to each disease based on its impact on physical functioning. Logistic regression was conducted to evaluate the association with sociodemographic variables, mental health (PHQ-9), physical functioning (ADL scale), and self-rated health (SRH). Results We analyzed data from 3213 adults [Mean age 51.5 (±13), 54% women]. Prevalence of single chronic condition, multimorbidity, and MWI was 28.6, 18% and − 1.9 respectively. Age, higher wealth index and ever use alcohol were significantly associated with multimorbidity. Overall, 2.8% of respondents had limited physical functioning, 2.1% had depression, and 61.5% reported low SRH. Poorer health outcomes were more prevalent among the elderly, women, less educated, and those having lower wealth index and multimorbidity, were found to be significantly associated with poor health outcomes. Conclusions The burden of multimorbidity was high in this young rural population, which portends significant adverse effects on their health and quality of life. The Indian health system should be reconfigured to address this emerging health priority holistically, by adopting a more integrated and sustainable model of care.

Summary: Background: Cardiovascular diseases (CVDs) are the leading cause of death in most low- and middle-income countries (LMICs). CVDs and their metabolic risk factors have historically been concentrated among urban residents with higher socioeconomic status (SES) in LMICs such as India. However, as India develops, it is unclear whether these socioeconomic and geographic gradients will persist or change. Understanding these social dynamics in CVD risk is essential for mitigating the rising burden of CVDs and to reach those with the greatest needs. Methods: Using nationally representative data with biomarker measurements from the fourth (2015–16) and fifth (2019–21) Indian National Family and Health Surveys, we investigated trends in the prevalence of four CVD risk factors: smoking (self-reported), unhealthy weight (BMI ≥25 kgm2), diabetes (random plasma glucose concentration ≥200 mg/dL or self-reported diabetes), and hypertension (one of: average systolic blood pressure ≥140 mmHg, average diastolic blood pressure ≥90 mmHg, self-reported past diagnosis, or self-reported current antihypertensive medication use) among adults aged 15–49 years. We first described changes at the national level and then trends stratified by place of residence (urban versus rural), geographic region (northern, northeastern, central, eastern, western, southern), regional level of development (Empowered Action Group member state or not), and two measures of socioeconomic status: level of education (no education, primary incomplete, primary complete, secondary incomplete, secondary complete, higher) and wealth (quintiles). Findings: Unhealthy weight increased among all social and geographic groups but both the absolute and the relative changes were substantially higher among people with low SES (as measured by education or wealth) and in rural areas. For diabetes and hypertension, the prevalence increased for those from disadvantaged groups while staying constant or even decreasing among the wealthier and more educated. In contrast, smoking consumption declined for all social and geographic groups. Interpretation: In 2015–16, CVD risk factors were higher among more advantaged subpopulations in India. However, between 2015–16 and 2019–21, the prevalence of these risk factors grew more rapidly for less wealthy and less educated subpopulations and those living in rural areas. These trends have resulted in CVD risk becoming far more widespread throughout the population; CVD can no longer be characterized as a wealthy urban phenomenon. Funding: This work was supported by the Alexander von Humboldt Foundation (grant received by NS); the Stanford Diabetes Research Center [grant received by PG] and the Chan Zuckerberg Biohub [grant received by PG].

BackgroundStudies have highlighted a possible influence of gingival and periodontal disease (PD) on COVID-19 risk and severity. However, the evidence is based on hospital-based studies and community-level data are sparse.ObjectivesWe described the epidemiological pattern of SARS-CoV-2 infection in Delhi and evaluated the associations of gingival and PD with incident COVID-19 disease in a regionally representative urban Indian population.MethodsIn a prospective study nested within the Centre for Cardiometabolic Risk Reduction in South-Asia (CARRS) study, participants with clinical gingival and periodontal status available at baseline (2014–16) (n = 1,727) were approached between October 2021 to March 2022. Information on COVID-19 incidence, testing, management, severity was collected as per the WHO case criteria along with COVID-19 vaccination status. Absolute incidence of COVID-19 disease was computed by age, sex, and oral health. Differences in rates were tested using log-rank test. Poisson regression models were used to evaluate independent associations between gingival and PD and incidence of COVID-19, adjusted for socio-demographic and behavioral factors, presence of comorbidity, and medication use.ResultsAmong 1,727 participants, the mean age was 44.0 years, 45.7% were men, 84.5% participants had baseline gingival or PD and 89.4% participants had received at least one dose of COVID-19 vaccine. Overall, 35% (n = 606) participants were tested for COVID-19 and 24% (n = 146/606) tested positive. As per the WHO criteria total number of cases was 210, constituting 12% of the total population. The age and sex-specific rates of COVID-19 were higher among men and older participants, but women aged >60 years had higher rates than men of same age. The incidence rate did not differ significantly between those having gingival or PD and healthy periodontium (19.1 vs. 16.5/1,000 person-years) and there was no difference in risk of COVID-19 by baseline oral disease status.ConclusionGingival and PD were not associated with increased risk of COVID-19.

Abstract Background The growing burden of hypertension and diabetes is one of the major public health challenges being faced by the health system in India. Clinical Decision Support Systems (CDSS) that assist with tailoring evidence-based management approaches combined with task-shifting from more specialized to less specialized providers may together enhance the impact of a program. We sought to integrate a technology “CDSS” and a strategy “Task-shifting” within the Government of India’s (GoI) Non-Communicable Diseases (NCD) System under the Comprehensive Primary Health Care (CPHC) initiative to enhance the program’s impact to address the growing burden of hypertension and diabetes in India. Methods We developed a model of care “I-TREC” entirely calibrated for implementation within the current health system across all facility types (Primary Health Centre, Community Health Centre, and District Hospital) in a block in Shaheed Bhagat Singh (SBS) Nagar district of Punjab, India. We undertook an academic-community partnership to incorporate the combination of a CDSS with task-shifting into the GoI CPHC-NCD system, a platform that assists healthcare providers to record patient information for routine NCD care. Academic partners developed clinical algorithms, a revised clinic workflow, and provider training modules with iterative collaboration and consultation with government and technology partners to incorporate CDSS within the existing system. Discussion The CDSS-enabled GoI CPHC-NCD system provides evidence-based recommendations for hypertension and diabetes; threshold-based prompts to assure referral mechanism across health facilities; integrated patient database, and care coordination through workflow management and dashboard alerts. To enable efficient implementation, modifications were made in the patient workflow and the fulcrum of the use of technology shifted from physician to nurse. Conclusion Designed to be applicable nationwide, the I-TREC model of care is being piloted in a block in the state of Punjab, India. Learnings from I-TREC will provide a roadmap to other public health experts to integrate and adapt their interventions at the national level. Trial registration CTRI/2020/01/022723.

Background: Adrenocortical tumors are rare tumors in children with a paucity of outcome data, especially in a resource-challenged setting. Materials and Methods: A retrospective study was conducted to evaluate the presentation, management, and outcomes of children with adrenocortical tumors who presented to our institute from January 1992 to December 2019. Results: During the study period, 28 children were included. Adenoma was present in nine children and the remaining 19 children had adrenocortical carcinoma. The median age of presentation was 48 months. Nearly half of the children with carcinomas presented with a mass compared to only 10% adenomas (P = 0.049). Virilization was present in 60% of the patients and in most cases was associated with Cushingoid features. Three children (15.7%) had metastasis at presentation. All children underwent surgical excision with a spill in 6 and gross residue in two patients. Recurrence was observed in five patients after a mean duration of 11.8 months. The 4-year overall survival and event-free survival were 100% in patients with adenomas compared to 75% and 44%, respectively, in carcinoma. Children who underwent complete surgical excision without any spill had a relatively favorable outcome. Conclusion: Adrenocortical tumors are uncommon tumors in children. Adenomas have a favorable outcome. There was no disease-free survival in incompletely resected or metastatic tumors. Tumor spill may also have an adverse outcome in completely resected tumors.

BackgroundType 2 diabetes mellitus (T2DM), a common chronic health condition, has major health and socioeconomic consequences. In the Indian subcontinent, it is a health condition for which individuals commonly consult Ayurvedic (traditional medical system) practitioners and use their medicines. However, to date, a good quality T2DM clinical guideline for Ayurvedic practitioners, grounded on the best available scientific evidence, is not available. Therefore, the study aimed to systematically develop a clinical guideline for Ayurvedic practitioners to manage T2DM in adults.MethodsThe development work was guided by the UK’s National Institute for Health and Care Excellence (NICE) manual for developing guidelines, the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, and the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. First, a comprehensive systematic review was conducted which evaluated Ayurvedic medicines’ effectiveness and safety in managing T2DM. In addition, the GRADE approach was used for assessing the certainty of the findings. Next, using the GRADE approach, the Evidence-to-Decision framework was developed, and we focused on glycemic control and adverse events. Subsequently, based on the Evidence-to-Decision framework, a Guideline Development Group of 17 international members made recommendations on Ayurvedic medicines’ effectiveness and safety in T2DM. These recommendations formed the basis of the clinical guideline, and additional generic content and recommendations were adapted from the T2DM Clinical Knowledge Summaries of the Clarity Informatics (UK). The feedback given by the Guideline Development Group on the draft version was used to amend and finalize the clinical guideline.ResultsA clinical guideline for managing T2DM in adults by Ayurvedic practitioners was developed, which focuses on how practitioners can provide appropriate care, education, and support for people with T2DM (and their carers and family). The clinical guideline provides information on T2DM, such as its definition, risk factors, prevalence, prognosis, and complications; how it should be diagnosed and managed through lifestyle changes like diet and physical activity and Ayurvedic medicines; how the acute and chronic complications of T2DM should be detected and managed (including referral to specialists); and advice on topics like driving, work, and fasting including during religious/socio-cultural festivals.ConclusionWe systematically developed a clinical guideline for Ayurvedic practitioners to manage T2DM in adults.

Abstract Background There is substantial interest in leveraging digital health technology to support hypertension management in low- and middle-income countries such as India. The potential for healthcare infrastructure and broader context to support such initiatives in India has not been examined. We evaluated existing healthcare infrastructure to support digital health interventions and examined epidemiologic, socioeconomic, and geographical contextual correlates of healthcare infrastructure in 544 districts covering 29 states and union territories across India. Methods The study was a cross-sectional analysis of India’s Fourth District Level Household and Facility Survey (DLHS-4; 2012–2014), the most up-to-date nationally representative district-level healthcare infrastructure data. Facilities were the unit of analysis, and analyses accounted for clustering within states. The main outcome was healthcare system infrastructural context to implement hypertension management programs. Domains included diagnostics (functional BP instrument), medications (anti-hypertensive medication in stock), essential clinical staff (e.g., staff nurse, medical officer, pharmacist), and IT specific infrastructure (regular power supply, internet connection, computer availability). Descriptive analysis was conducted for infrastructure indicators based on the Indian Public Health Standards, and logistic regression was conducted to estimate the association between epidemiologic and geographical context (exposures) and the composite measure of healthcare system. Results Data from 32,215 government facilities were analyzed. Among lowest-tier subcenters, 30% had some IT infrastructure, while at the highest-tier district hospitals, 92% possessed IT infrastructure. At mid-tier primary health centres and community health centres, IT infrastructure availability was 28 and 51%, respectively. For all but sub-centres, the availability of essential staff was lower than the availability of IT infrastructure. For all but district hospitals, higher levels of blood pressure, body mass index, and urban residents were correlated with more favorable infrastructure. By region, districts in Western India tended towards having the best prepared health facilities. Conclusions IT infrastructure to support digital health interventions is more frequently lacking at lower and mid-tier healthcare facilities compared with apex facilities in India. Gaps were generally larger for staffing than physical infrastructure, suggesting that beyond IT infrastructure, shortages in essential staff impose significant constraints to the adoption of digital health interventions. These data provide early benchmarks for state- and district-level planning.

Summary: Background: Few longitudinal data characterize kidney function decline among South Asians, one of the world's largest population groups. We aimed to identify estimated glomerular filtration rate (eGFR) trajectories in a population-based cohort from India and assess predictors of rapid kidney function decline. Methods: We used 6-year longitudinal data from participants of a population-representative study from Delhi and Chennai, India who had at least two serum creatinine measures and baseline CKD-EPI eGFR> 60 ml/min/1.73m2 (n=7779). We used latent class trajectory modeling to identify patterns of kidney function trajectory (CKD-EPI eGFR) over time. In models accounting for age, sex, education, and city, we tested the association between 15 hypothesized risk factors and rapid kidney function decline. Findings: Baseline mean eGFR was 108 (SD 16); median eGFR was 110 [IQR: 99-119] ml/min/1.73m2. Latent class trajectory modeling and functional characterization identified three distinct patterns of eGFR: class-1 (no decline; 58%) annual eGFR change 0.2 [0.1, 0.3]; class-2 (slow decline; 40%) annual eGFR change −0.2 [−0.4, −0.1], and class-3 (rapid decline; 2%) annual eGFR change −2.7 [−3.4, −2.0] ml/min/1.73m2. Albuminuria (>30 mg/g) was associated with rapid eGFR decline (OR for class-3 vs class-1: 5.1 [95% CI: 3.2; 7.9]; class-3 vs. class-2: 4.3 [95% CI:2.7; 6.6]). Other risk factors including self-reported diabetes, cardiovascular disease, peripheral arterial disease, and metabolic biomarkers such as HbA1c and systolic blood pressure were associated with rapid eGFR decline phenotype but potential ‘non-traditional’ risk factors such as manual labor or household water sources were not. Interpretation: Although mean and median eGFRs in our population-based cohort were higher than those reported in European cohorts, we found that a sizeable number of adults residing in urban India are experiencing rapid kidney function decline. Early and aggressive risk modification among persons with albuminuria could improve kidney health among South Asians. Funding: The CARRS study has been funded with federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, under Contract No. HHSN2682009900026C and P01HL154996. Dr. Anand was supported by NIDDK K23DK101826 and R01DK127138.

Background: Cardiovascular disease (CVD) is highly prevalent in India, and little is known about the perception of patients and providers about a package of collaborative quality improvement (C-QIP) strategies consisting of provider-focused electronic health records-decision support system (EHR-DSS), non-physician health workers (NPHW), and patient-facing text messages to enhance the CVD care. Objective: To explore the barriers and enablers of the C-QIP strategy from the perspective of providers, health administrators, patients, and care givers in India. Methods: We conducted a qualitative study using the consolidated framework for implementation research (CFIR) to understand the challenges and facilitators of implementing C-QIP strategy to enhance CVD care in the Indian context. A diverse sample of 38 physicians, 14 non-physician health workers (nurses, pharmacists), 4 health administrators, and 16 patients and their caregivers participated in semi-structured interviews. All interviews were audio-recorded, transcribed, translated, anonymised, and coded using MAXQDA software. We used the framework method and CFIR domains to analyze the qualitative data. Results: Barriers perceived from providers’ and health administrators’ perspectives in providing quality CVD care were high patient volume, physician burnout, lack of robust communication or referral system, paucity of electronic health records, lack of patient counsellors, polypharmacy, poor patient adherence to medications, and lack of financial incentives. Low health literacy, high cost of treatment, misinformation bias, and difficulty in maintaining lifestyle changes were barriers from patients’ perspectives. The CFIR identified key enablers for the implementation of C-QIP such as standardized treatment protocol, reduced medication errors, improved physician-patient relationships, and enhanced patient self-care through trained and supported NPHW. Barriers included: heterogenous healthcare settings, diverse patient groups and comorbidities, associated costs of care and interoperability, confidentiality, and data privacy issues around the use of EHR-DSS. Conclusion: Strategies to enhance CVD care must be low-cost, culturally acceptable, and integrated into existing care pathways.

This article details a correction to: Shivashankar R, Singh K, Kondal D, Gupta R, Perel P, Kapoor D, et al.. Cardiovascular Health in India – a Report Card from Three Urban and Rural Surveys of 22,144 Adults. Global Heart. 2022; 17(1): 52. DOI: http://doi.org/10.5334/gh.1137

Abstract Background Docosahexaenoic acid (DHA) is an important structural component of human brain and retina. Evidence exists linking nutritional status of pregnant mothers and cognitive functions of their born infants. The DHANI (Maternal DHA Supplementation and Offspring Neurodevelopment in India) trial was implemented to evaluate the effect of maternal supplementation with DHA during pregnancy and for 6 months following delivery on motor and mental development of infants at 1 and 12 months. We describe here the standardization and validation of an assay for measurement of selected omega-3 and omega-6 fatty acids from the phospholipid fraction of red blood cells to assess their status in mothers at baseline, delivery and 6 months post-delivery and for infants in cord blood and at 1 and 12 months of age. The validated method has been used for the analysis of samples for DHANI. Methods Lipids were extracted from a pool of red blood cells, separated using thin layer chromatography. The phospholipid fraction was esterified, and fatty acids were separated by gas chromatography using a flame ionization detector. Result The method accuracy for DHA was between 97 - 98% and between 91 - 95% for arachidonic acid (AA) at three different concentrations. The intra-assay and inter-assay coefficient of variation for the fatty acids ranged from 1.19 to 5.7% and 0.78 to 13.0% respectively. Intraclass correlation (ICC), as a measure of reproducibility, ranged between 0.689 and 0.996. A good linearity was observed for all the fatty acids between concentrations of 0.2–4 μg/ml. Conclusion The standardized and validated method is suitable for implementation in large epidemiological studies for evaluation of fatty acids and in nutritional trials for assessment of fatty acid content of various lipid classes.

BackgroundThe world witnessed a highly contagious and deadly disease, COVID-19, toward the end of 2019. India is one of the worst affected countries. We aimed to assess anxiety and depression levels among adult tobacco users and people who recently quit tobacco during COVID-19 lockdown in India.Materials and methodsThe study was conducted across two Indian cities, Delhi and Chennai (July-August, 2020) among adult tobacco users (n = 801). Telephonic interviews were conducted using validated mental health tools (Patient Health Questionnaire-PHQ-9 and Generalized Anxiety Disorder-GAD-7) to assess the anxiety and depression levels of the participants. Descriptive analysis and multiple logistic regression were used to study the prevalence and correlates of depression and anxiety.ResultsWe found that 20.6% of tobacco users had depression symptoms (3.9% moderate to severe); 20.7% had anxiety symptoms (3.8% moderate to severe). Risk factors associated with depression and anxiety included food, housing, and financial insecurity.ConclusionDuring COVID-19 lockdown, mental health of tobacco users (primarily women) was associated with food, housing and financial insecurity. The Indian Government rightly initiated several health, social and economic measures to shield the most vulnerable from COVID-19, including a ban on the sale of tobacco products. It is also necessary to prioritize universal health coverage, expanded social security net, tobacco cessation and mental health services to such vulnerable populations during pandemic situations.

Background: Markers of ideal cardiovascular health (CVH) predict cardiovascular events. We estimated the prevalence of ideal CVH markers in two levels of cities and villages in India. Methods: We did pooled analysis of individual-level data from three cross sectional surveys of adults ≥ 30 years over 2010–14 (CARRS: Centre for cArdiometabolic Risk Reduction in South Asia; UDAY and Solan Surveillance Study) representing metropolitan cities; smaller cities and rural areas in diverse locations of India. We defined ideal CVH using modified American Heart Association recommendations: not smoking, ≥ 5 servings of fruits and vegetables (F&V), high physical activity (PA), body mass index (BMI)

Objective: Lifestyle preferences are inculcated in childhood and once established, persist into adulthood. The Project PROMoting Health LIteracy in School (i-PROMISe) aims to promote a healthy lifestyle among students for the universal prevention of non-communicable diseases (NCDs) like diabetes. Study design: Qualitative study using focus-group-discussions (FGDs) and In-Depth Interviews (IDI). Method: Project was undertaken in two-phases in two private schools in New Delhi, India. In phase-one, FGDs with students (grades IV to VIII) and IDIs with teachers were conducted to ascertain their perceptions of diabetes prevention and management according to the Health Belief Model. The data was analyzed using a thematic framework method. In phase-two, the resources were pre-tested and participants’ feedback was requested on the duration, quality, and understanding of the resources. Results: In total, 89 students and 17 teachers participated in phase-one (n = 54 [in FGDs] and n = 5 [in IDIs]) and phase-two (n = 35 students and n = 12 teachers in FGDs). In phase-one, themes that emerged included: diabetes was considered a disease of the elderly; misconceptions about susceptibility to these diseases were common; children were largely aware of measures to prevent these diseases, but barriers to adopting a healthy lifestyle existed. Based on the findings, a comprehensive module was developed, which consisted of a teacher's manual with interactive activities and short films. The resources (teacher's manual and short films) were well received and contributed to a better understanding of diabetes and other NCDs; myths/misconceptions were clarified. Conclusion: Development of resources using participatory approach can be effective in promoting and reinforcing healthy behaviours among school going children to prevent and control NCDs in schools.

Introduction: Many Ayurvedic medicines have the potential for managing type 2 diabetes mellitus (T2DM), with previous systematic reviews demonstrating effectiveness and safety for specific Ayurvedic medicines. However, many of the reviews need updating and none provide a comprehensive summary of all the Ayurvedic medicines evaluated for managing T2DM.Objective: The objective of this systematic review was to evaluate and synthesize evidence on the effectiveness and safety of Ayurvedic medicines for managing T2DM.Inclusion criteria: Published and unpublished RCTs assessing the effectiveness and safety of Ayurvedic medicines for managing T2DM in adults.Methods: The JBI systematic review methodology was followed. A comprehensive search of sources (including 18 electronic databases) from inception to 16 January 2021 was made. No language restrictions were applied. Data synthesis was conducted using narrative synthesis and random effects meta-analyses, where appropriate. Pooled results are reported as mean differences (MD) with 95% confidence intervals (CI).Results: Out of 32,519 records identified from the searches, 219 articles were included in the systematic review representing 199 RCTs (21,191 participants) of 98 Ayurvedic medicines. Overall, in the studies reviewed the methodology was not adequately reported, resulting in poorer methodological quality scoring. Glycated hemoglobin (HbA1c) was reduced using Aegle marmelos (L.) Corrêa (MD -1.6%; 95% CI −3 to −0.3), Boswellia serrata Roxb. (−0.5; −0.7 to −0.4), Gynostemma pentaphyllum (Thunb.) Makino (−1; −1.5 to −0.6), Momordica charantia L. (−0.3; −0.4 to −0.1), Nigella sativa L. (−0.4; −0.6 to −0.1), Plantago ovata Forssk. (−0.9; −1.4 to −0.3), Tinospora cordifolia (Willd.) Hook.f. and Thomson (−0.5; −0.6 to −0.5), Trigonella foenum-graecum L. (−0.6; −0.9 to −0.4), and Urtica dioica L. (−1.3; −2.4 to −0.2) compared to control. Similarly, fasting blood glucose (FBG) was reduced by 4–56 mg/dl for a range of Ayurvedic medicines. Very few studies assessed health-related quality of life (HRQoL). Adverse events were not reported in many studies, and if reported, these were mostly none to mild and predominately related to the gastrointestinal tract.Conclusion: The current evidence suggests the benefit of a range of Ayurvedic medicines in improving glycemic control in T2DM patients. Given the limitations of the available evidence and to strengthen the evidence base, high-quality RCTs should be conducted and reported.

Abstract Aims/Introduction This study aims to evaluate the prevalence of and factors associated with non‐alcoholic fatty liver disease (NAFLD) in Indian women with prior gestational diabetes mellitus (GDM) diagnosed using International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria. Materials and Methods This cross‐sectional study (2018–2019) enrolled women with and without prior GDM. Study participants underwent detailed assessments, including relevant medical, obstetric and demographic details; 75‐g oral glucose tolerance test with glucose and insulin estimation at 0, 30 and 120 min; and other relevant biochemical and anthropometric measurements. NAFLD status was defined by ultrasonography. Results We evaluated a total of 309 women (201 and 108 with and without prior GDM, respectively) at a mean age of 31.9 ± 5.0 years and median of 16 months (interquartile range 9–38 months) following the index delivery. The prevalence of NAFLD was significantly higher in women with prior GDM (62.7% vs 50.0%, P = 0.038; grade 2 and 3 disease, 13.9% vs 6.5%). On logistic regression analysis (fully adjusted model), the odds of NAFLD were 2.11‐fold higher in women with prior GDM (95% confidence interval 1.16–3.85, P = 0.014). Overweight/obesity, metabolic syndrome, prediabetes and homeostasis model of assessment of insulin resistance (a measure of insulin resistance) were positively associated with NAFLD, whereas the Matsuda index (a measure of insulin sensitivity) showed a negative association with NAFLD. Conclusions The prevalence of NAFLD is high in women with prior GDM. Such women also have a high burden of cardiometabolic risk factors. Future studies should evaluate the intermediate and long‐term hepatic and cardiovascular risk, and the impact of lifestyle interventions in reducing morbidity in such women.

Abstract Background People with chronic conditions are disproportionately prone to be affected by the COVID-19 pandemic but there are limited data documenting this. We aimed to assess the health, psychosocial and economic impacts of the COVID-19 pandemic on people with chronic conditions in India. Methods Between July 29, to September 12, 2020, we telephonically surveyed adults (n = 2335) with chronic conditions across four sites in India. Data on participants’ demographic, socio-economic status, comorbidities, access to health care, treatment satisfaction, self-care behaviors, employment, and income were collected using pre-tested questionnaires. We performed multivariable logistic regression analysis to examine the factors associated with difficulty in accessing medicines and worsening of diabetes or hypertension symptoms. Further, a diverse sample of 40 participants completed qualitative interviews that focused on eliciting patient’s experiences during the COVID-19 lockdowns and data analyzed using thematic analysis. Results One thousand seven hundred thirty-four individuals completed the survey (response rate = 74%). The mean (SD) age of respondents was 57.8 years (11.3) and 50% were men. During the COVID-19 lockdowns in India, 83% of participants reported difficulty in accessing healthcare, 17% faced difficulties in accessing medicines, 59% reported loss of income, 38% lost jobs, and 28% reduced fruit and vegetable consumption. In the final-adjusted regression model, rural residence (OR, 95%CI: 4.01,2.90–5.53), having diabetes (2.42, 1.81–3.25) and hypertension (1.70,1.27–2.27), and loss of income (2.30,1.62–3.26) were significantly associated with difficulty in accessing medicines. Further, difficulties in accessing medicines (3.67,2.52–5.35), and job loss (1.90,1.25–2.89) were associated with worsening of diabetes or hypertension symptoms. Qualitative data suggest most participants experienced psychosocial distress due to loss of job or income and had difficulties in accessing in-patient services. Conclusion People with chronic conditions, particularly among poor, rural, and marginalized populations, have experienced difficulties in accessing healthcare and been severely affected both socially and financially by the COVID-19 pandemic.

India has the second largest population with diabetes mellitus in the world. Long-term, uncontrolled diabetes is associated with increased microvascular and macrovascular (commonly cardiovascular) complications and death. The large burden of uncontrolled diabetes in India could be because of lack of treatment adherence, limited access to laboratory testing, lack of physical activity, and poor dietary habits. This creates a compelling need for a greater involvement of healthcare professionals (HCPs) in improving societal awareness and regular monitoring of glycemic control, which is limited in patient outreach programs. IMPACT India, launched in November 2018, is a diabetes control program with a three-pronged approach aimed at creating an impact at the level of HCPs, society, and individuals living with diabetes. The India Diabetes Care Index (iDCI®), a quarterly aggregate index of glycated hemoglobin, fasting plasma glucose (FPG), and postprandial plasma glucose (PPG), forms the backbone of IMPACT India. The program uses iDCI® to evaluate glycemic control at periodic intervals, sensitize HCPs about the glycemic control status, and optimize diabetes care by escalating pharmacotherapy including insulin whenever required. Societal awareness will be created by social media to achieve actionable awareness based on the iDCI® reports. At baseline (January 2018 to June 2018), the database (2.39 million) revealed an average glycated hemoglobin of 8.56%, FPG of 172 mg/dL, and PPG of 253 mg/dL. Also, 74% of the patients had HbA1c >7% and FPG >130 mg/dL and >83% of the patients had PPG >160 mg/dL. The IMPACT India program aims to positively impact diabetes care in India by achieving at least 1% glycated hemoglobin reduction in 1000 days.

Context: In view of the rising burden of type 2 diabetes mellitus (DM) cases in India, there is an urgent need for an effective, low-cost, sustainable intervention controlling diabetes thus preventing complications. Aims: This study aimed to assess the effect of structured yoga programs on diabetes. Subjects and Methods: This was a community-based interventional study that was conducted in an urban resettlement colony of Delhi, India. Known diabetes patients with glycated hemoglobin (Hb1Ac) ≥6.5% were enrolled from 12 randomly selected blocks of the community with a sample size of 192 in each intervention and wait-listed control arm. The intervention was structured yoga of 50 min daily, 2 consecutive weeks in a nearby park and health center followed by twice a week home practice up to the 3rd month. The primary outcome measure was HbA1c% and secondary outcome measures were lipid profile and fasting blood glucose. Statistical Analysis Used: Aper-protocol analysis was done. Mean, standard deviation (SD), and 95% confidence interval were estimated. The level of significance was considered for 0.05. Results: There was a significant decrease of Hb1Ac (0.5%, SD = 1.5, P = 0.02), total cholesterol (11.7 mg/dl, SD = 40.5, P < 0.01), and low-density lipoprotein (3.2 mg/dl, SD = 37.4, P < 0.01) from baseline to end line in the intervention group. These changes in intervention group were also significantly different from the change in the wait-listed control group. The other variables did not change significantly. Conclusions: It revealed that structured yoga program improved glycemic outcome and lipid profile of individuals in a community-based setting. Yoga can be a feasible strategy to control hyperglycemia, lipid levels, and can help better control type 2 DM.

Purpose: Comorbid depression and type 2 diabetes are associated with poor glycemic control, increased complications, and poor self-management, compared to either condition alone. The Integrating Depression and Diabetes Treatment (INDEPENDENT) clinical trial demonstrated the effectiveness of an integrated care model in improving diabetes and depression outcomes, in diabetes-specialty clinics in India. The INDEPENDENT model used task sharing to address the shortage of mental health professionals in India. Care coordinators (CCs) who were dietitians or counsellors were a key component of this care model. This article details the training and support provided to the CCs during the INDEPENDENT trial. Materials and Methods: CCs were nonphysician and nonpsychiatrist health specialists who supported patients in self-management of diabetes and depression, helping them set achievable goals and monitored progress. During the clinical trial, the CCs underwent both offsite and on-site trainings. The trainings equipped them with various lifestyle management tools for self-care, including one-on-one education sessions and motivational interviewing for self-monitoring, adherence to medication, diet, exercise regimes, and cessation of smoking, among others. Results: Nine CCs from the four sites were trained effectively during the course of the INDEPENDENT study from 2014 to 2018. Conclusions: Given the paucity of mental health professionals in India, the use of collaborative care and a team of well-trained CCs may be an effective strategy for the management of comorbid depression and diabetes. This model of care could help fill deficiencies in the delivery of care for comorbidity of depression and diabetes care in India.

Abstract Background Hypertension and diabetes are among the most common and deadly chronic conditions globally. In India, most adults with these conditions remain undiagnosed, untreated, or poorly treated and uncontrolled. Innovative and scalable approaches to deliver proven-effective strategies for medical and lifestyle management of these conditions are needed. Methods The overall goal of this implementation science study is to evaluate the Integrated Tracking, Referral, Electronic decision support, and Care coordination (I-TREC) program. I-TREC leverages information technology (IT) to manage hypertension and diabetes in adults aged ≥30 years across the hierarchy of Indian public healthcare facilities. The I-TREC program combines multiple evidence-based interventions: an electronic case record form (eCRF) to consolidate and track patient information and referrals across the publicly-funded healthcare system; an electronic clinical decision support system (CDSS) to assist clinicians to provide tailored guideline-based care to patients; a revised workflow to ensure coordinated care within and across facilities; and enhanced training for physicians and nurses regarding non-communicable disease (NCD) medical content and lifestyle management. The program will be implemented and evaluated in a predominantly rural district of Punjab, India. The evaluation will employ a quasi-experimental design with mixed methods data collection. Evaluation indicators assess changes in the continuum of care for hypertension and diabetes and are grounded in the Reach, Effectiveness, Adoption Implementation, and Maintenance (RE-AIM) framework. Data will be triangulated from multiple sources, including community surveys, health facility assessments, stakeholder interviews, and patient-level data from the I-TREC program’s electronic database. Discussion I-TREC consolidates previously proven strategies for improved management of hypertension and diabetes at single-levels of the healthcare system into a scalable model for coordinated care delivery across all levels of the healthcare system hierarchy. Findings have the potential to inform best practices to ultimately deliver quality public-sector hypertension and diabetes care across India. Trial registration The study is registered with Clinical Trials Registry of India (registration number CTRI/2020/01/022723 ). The study was registered prior to the launch of the intervention on 13 January 2020. The current version of protocol is version 2 dated 6 June 2018.

Objectives: We aimed to measure the change in prevalence of Coronary Heart Disease (CHD) and Cardiovascular Diseases (CVDs) risk among those aged 35–64 years in urban and rural areas of National Capital Region (NCR) of Delhi, between 1991-1994 (survey 1) and 2010–2012 (survey 2). Methods: Both surveys used similar sampling methodology and mean ages of participants were similar. A total of 3048 and 2052 subjects were studied in urban Delhi and 2487 and 1917 participants recruited from rural Ballabgarh in survey 1 and in survey 2 respectively. CHD was diagnosed based on a Minnesota coded ECG and Rose angina questionnaire. Data on behavioural, physical, clinical and biochemical parameters were collected using standard methods. CVD Risk of participants was calculated using the gender specific Framingham risk equation. Results: The age and sex standardised prevalence of CHD in urban Delhi increased from 10.3% (95% CI: 9.2–11.4) to 14.1% (95% CI: 12.6–15.6) between the two surveys as compared to an increase from 6.0% (95% CI: 5.0–6.9) to 7.4% (95% CI: 6.3–8.6) in rural Ballabgarh. The highest increase in the prevalence of CHD was reported among urban women (10.1% to 16.6%).The proportion of population with high 10-year CVD risk increased to 4.1% from 1.2% in rural areas as compared to 4.8% from 2.5% in urban areas. Conclusions: The CHD and CVD risk has increased over 20 years period in and around Delhi and the increase was more in rural population and women, traditionally considered to be at low risk.

Introduction Sleep-related breathing disorders (SRBDs) including obstructive sleep apnea (OSA) and central sleep apnea (CSA) are quite common and are the leading causes of mortality in acromegaly. OSA in acromegaly is generally attributed to changes in oropharyngeal soft tissues. Data on OSA in Indian acromegaly are scant, especially cephalometric findings. The aim of this study is to evaluate the burden of SRBDs in acromegaly and its correlation to cephalometric parameters. Materials and Methods A total of 32 subjects (20 men and 12 women), diagnosed with acromegaly on the basis of standard clinical, biochemical, and hormonal measurements were recruited. In addition to the above parameters, polysomnography and magnetic resonance imaging (MRI) of the pharynx were performed in all subjects. Results The mean age of the subjects was 42.66 ± 11.13 years (range = 26–66) and mean duration of study after first presentation was 7.6 ± 6.3 years (range = 0.25–32). A total of 28 of 32 (93.3%) subjects had sellar MRI documented macroadenomas while 20 (62.5%) patients were treatment naive at the time of assessment. Twenty-nine (90.6%) patients had evidence of SRBD and all of them had OSA subtype. The Apnea–Hypopnea Index (AHI) indicating severity of OSA (mild 21.8%, moderate 34.4%, and severe 34.4%) correlated positively with tongue length, uvula length, and uvula thickness on MRI. However, AHI had no correlation with the severity of GH excess or disease activity or individual parameters such as weight, body mass index, blood pressure, hemoglobin A1c, serum human growth hormone, and insulin-like growth factor-1 level. Conclusion SRBD, the generally overlooked comorbidity, is highly prevalent in subjects with acromegaly and is almost always due to OSA, the severity of which correlates positively with tongue and uvula size. Well-designed, long-term follow-up study on a large cohort of acromegalic patients is required to improve our understanding on the subject.

Introduction: Minimally invasive approaches are the current standard of care for pheochromocytoma/paraganglioma (PC/PG) surgery. However, a number of patients still undergo open surgery for these tumors. We evaluated the current indications and outcomes of open surgery for PC/PG to define the role of this approach. Methods: Data of patients undergoing PC/PG surgery between July 2008 and July 2017 were retrieved from our prospectively maintained electronic database and hospital records. Tumor characteristics, operative and recovery parameters, and complications were evaluated for indications of open procedure and outcomes. Results: During the study period, 106 patients underwent 124 procedures for PC/PG, including 18 simultaneous bilateral procedures. Surgeries included 102 adrenalectomies, 18 PG excisions, one partial adrenalectomy, and three partial cystectomies. Twenty-five (23.6%) patients (mean age 38.2 ± 16.1 years) underwent an open procedure, including four bilateral procedures. This included 16 adrenalectomies and 9 PG excisions. The indications for open surgery were unilateral large tumours (5; size 8–16, mean 11 cm), bilateral large tumours (2; size 6–10, mean 8.2 cm), retrocaval tumour extension (4), inter aortocaval PGs (8), Retro-mesenteric PG (1), concomitant procedures (3), and conversion from laparoscopy (2). Mean operative time was 217 ± 63.8 min, blood loss was 868 ± 734.2 ml, 11 patients required blood transfusion, and hospital stay was 6.44 ± 2.4 days. All these parameters were higher than for minimally invasive surgery (MIS) in this cohort. Three patients (12%) suffered a postoperative complication, and the rate of complications was not higher than MIS cohort (16%). Conclusions: Open surgery was most often indicated for large tumors or those located in the inter-aortocaval region. Most such procedures require large incisions and possible hepatic mobilization on the right side. The procedures can be safely completed with few complications.