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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/1.73m 2 ( 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/1.73m 2 . 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/1.73m 2 . 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., Competing Interests: Nothing to disclose., (© 2022 The Author(s).)

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) <25 Kg/m 2 , blood pressure (BP) <120/80 mm Hg, fasting plasma glucose (FPG) <100 mg/dl, and total cholesterol (TC) <200 mg/dL. We estimated (1) age-and sex-standardized prevalence of ideal CVH and (2) prevalence of good (≥6 markers), moderate (4-5), and poor CVH (≤3) adjusted for age, sex, education, and stratified by setting and asset tertiles., Results: Of the total 22,144 participants, the prevalence of ideal CVH markers were: not smoking (76.7% [95% CI 76.1, 77.2]), consumed ≥5 F&V (4.2% [3.9, 4.5]), high PA (67.5% [66.8, 68.2]), optimum BMI (59.6% [58.9, 60.3]), ideal BP (34.5% [33.9, 35.2]), FPG (65.8% [65.1, 66.5]) and TC (65.4% [64.7, 66.1]). The mean number of ideal CVH metrics was 3.7(95% CI: 3.7, 3.8). Adjusted prevalence of good, moderate, and poor CVH, varied across settings: metropolitan (3.9%, 41.0%, and 55.1%), smaller cities (7.8%, 49.2%, and 43%), and rural (10.4%, 60.9%, and 28.7%) and across asset tertiles: Low (11.0%, 55.9%, 33.1%), Middle (6.3%, 52.2%, 41.5%), and High (5.0%, 46.4%, 48.7%), respectively., Conclusion: Achievement of ideal CVH varied, with higher prevalence in rural and lower asset tertiles. Multi-sectoral and targeted policy and program actions are needed to improve CVH in diverse contexts in India., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2022 The Author(s).)

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., Competing Interests: Declaration of conflicting interest The Authors declare that there is no conflict of interest., (Copyright © 2022 Cardiological Society of India. Published by Elsevier, a division of RELX India, Pvt. Ltd. All rights reserved.)

Background and Aims: Limited data exist on the cardiovascular manifestations and risk factors in people hospitalized with COVID-19 from low- and middle-income countries. This study aims to describe cardiovascular risk factors, clinical manifestations, and outcomes among patients hospitalized with COVID-19 in low, lower-middle, upper-middle- and high-income countries (LIC, LMIC, UMIC, HIC)., Methods: Through a prospective cohort study, data on demographics and pre-existing conditions at hospital admission, clinical outcomes at hospital discharge (death, major adverse cardiovascular events (MACE), renal failure, neurological events, and pulmonary outcomes), 30-day vital status, and re-hospitalization were collected. Descriptive analyses and multivariable log-binomial regression models, adjusted for age, sex, ethnicity/income groups, and clinical characteristics, were performed., Results: Forty hospitals from 23 countries recruited 5,313 patients with COVID-19 (LIC = 7.1%, LMIC = 47.5%, UMIC = 19.6%, HIC = 25.7%). Mean age was 57.0 (±16.1) years, male 59.4%, pre-existing conditions included: hypertension 47.3%, diabetes 32.0%, coronary heart disease 10.9%, and heart failure 5.5%. The most frequently reported cardiovascular discharge diagnoses were cardiac arrest (5.5%), acute heart failure (3.8%), and myocardial infarction (1.6%). The rate of in-hospital deaths was 12.9% (N = 683), and post-discharge 30 days deaths was 2.6% (N = 118) (overall death rate 15.1%). The most common causes of death were respiratory failure (39.3%) and sudden cardiac death (20.0%). The predictors of overall mortality included older age (≥60 years), male sex, pre-existing coronary heart disease, renal disease, diabetes, ICU admission, oxygen therapy, and higher respiratory rates (p < 0.001 for each). Compared to Caucasians, Asians, Blacks, and Hispanics had almost 2-4 times higher risk of death. Further, patients from LIC, LMIC, UMIC versus. HIC had 2-3 times increased risk of death., Conclusions: The LIC, LMIC, and UMIC's have sparse data on COVID-19. We provide robust evidence on COVID-19 outcomes in these countries. This study can help guide future health care planning for the pandemic globally., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2022 The Author(s).)

This study aims to provide evidence on how the COVID-19 pandemic has impacted chronic disease care in diverse settings across Asia. Cross-sectional surveys were conducted to assess the health, social, and economic consequences of the pandemic in India, China, Hong Kong, Korea, and Vietnam using standardized questionnaires. Overall, 5672 participants with chronic conditions were recruited from five countries. The mean age of the participants ranged from 55.9 to 69.3 years. A worsened economic status during the COVID-19 pandemic was reported by 19% to 59% of the study participants. Increased difficulty in accessing care was reported by 8% to 24% of participants, except Vietnam: 1.6%. The worsening of diabetes symptoms was reported by 5.6% to 14.6% of participants, except Vietnam: 3%. In multivariable regression analyses, increasing age, female participants, and worsened economic status were suggestive of increased difficulty in access to care, but these associations mostly did not reach statistical significance. In India and China, rural residence, worsened economic status and self-reported hypertension were statistically significantly associated with increased difficulty in access to care or worsening of diabetes symptoms. These findings suggest that the pandemic disproportionately affected marginalized and rural populations in Asia, negatively affecting population health beyond those directly suffering from COVID-19.

Poor infant young child feeding (IYCF) practices result in malnutrition, poor psychosocial development, poor school performance and less productivity in later life, thereby perpetuating a vicious cycle. The current study aims to characterize the IYCF practices during the first year of life in a maternal-child birth cohort (DHANI) in Belagavi, Karnataka, India. We collected data from the dyad at birth, 6 and 12 months postpartum. We examined dietary diversity among these infants at 12 months using WHO criteria. A total of 902 live births were recorded, and 878 mother-child pairs completed the 12-month follow up. The overall prevalence of early (within 1 h of delivery) initiation of breastfeeding (EIBF) was 77.9%, and that of exclusive breastfeeding (EBF) at 6 months was 52.4%. At 12 months, most (90%) infants were breastfed, while 39% also received formula. The large majority (94.4%) of infants met minimum meal frequency (MMF), but only 55% of infants were receiving a minimum acceptable diet (MAD). The mean dietary diversity (DD) score was 4.7 ± 1.1. Only 21.9% of infants consumed egg and/or flesh food. A large proportion (33.8%) of infants received no vegetables and/or fruits till 12 months of age. Consumption of sweet beverage was 4.8%, but consumption of ultra-processed foods high in trans-fats, sugars and salt was high (85.8%). High-quality, sustainable and scalable interventions to enhance knowledge and support positive behaviour change for adopting and implementing better IYCF practices may be urgently needed in low- and middle-income group settings to improve diet diversity and overall nutritional intake amongst young children.

Background Population-wide reduction in mean blood pressure is proposed as a key strategy for primary prevention of cardiovascular disease. We evaluated the effectiveness of a task-sharing strategy involving frontline health workers in the primary prevention of elevated blood pressure. Methods and Results We conducted DISHA (Diet and lifestyle Interventions for Hypertension Risk reduction through Anganwadi Workers and Accredited Social Health Activists) study, a cluster randomized controlled trial involving 12 villages each from 4 states in India. Frontline health workers delivered a custom-made and structured lifestyle modification intervention in the selected villages. A baseline survey was conducted in 23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively. The baseline characteristics were similar between control and intervention clusters. In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross-sectional survey conducted immediately after the intervention phase of 18-months. The mean (SD) systolic blood pressure increased from 125.7 (18.1) mm Hg to 126.1 (16.8) mm Hg in the control clusters, and it increased from 124.4 (17.8) mm Hg to 126.7 (17.5) mm Hg in the intervention clusters. The population average adjusted mean difference in difference in systolic blood pressure was 1.75 mm Hg (95% CI, -0.21 to 3.70). Conclusions Task-sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India. Expanding the scope of task sharing and intensive training of health workers such as nurses, nutritionists, or health counselors in management of cardiovascular risk at the population level may be more effective in primary prevention of cardiovascular disease. Registration URL: https://www.ctri.nic.in; Unique identifier: CTRI/2013/10/004049.

Background: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of disease ranging from simple steatosis, non-alcoholic steatohepatitis (NASH), through to advanced fibrosis and cirrhosis. We assessed the prevalence, spectrum, and determinants of NAFLD among adults in urban and rural North India., Methods: A representative sample of adults aged 30-60 years were recruited from urban Delhi and rural Ballabhgarh during 2017-2019. Participants underwent abdominal ultrasonography (USG) and vibration controlled transient elastography (VCTE) with FibroScan to assess fatty liver and fibrosis, respectively. We estimated the age- and sex-standardised prevalence of NAFLD and its spectrum. The factors associated with 'ultrasound-diagnosed NAFLD' were identified using multivariate logistic regression., Results: A total of 828 urban (mean ± SD age: 45.5 ± 8.0 years; women: 52.7%) and 832 rural (mean ± SD age: 45.1 ± 7.9 years; women: 62.4%) participants were recruited. The age- and sex-standardized prevalence of ultrasound-diagnosed NAFLD was 65.7% (95%CI: 60.3-71.2) in the urban and 61.1% (55.8-66.5) in the rural areas, respectively. The prevalence of NAFLD with elevated alanine transaminase (≥40IU/L) was 23.2% (19.8-26.6), and 22.5% (19.0-26.0) and any fibrosis by liver stiffness measurement on transient elastography (≥6.9 kPa) was 16.5% (13.8-19.8) and 5.2% (3.8-6.7) in urban and rural participants, respectively. In both urban and rural areas, diabetes, central obesity and insulin resistance were significantly associated with NAFLD., Conclusion: NAFLD prevalence was high among rural and urban North Indian adults, including fibrosis or raised hepatic enzymes. The strong association of metabolic determinants confirms its linkage with metabolic syndrome., Competing Interests: The authors have declared that no competing interests exist.

Background: The long-term outcome data in patients with rheumatic fever/rheumatic heart disease (RF/RHD) is limited. We report the cumulative incidence of adverse outcomes in a cohort of RHD patients from a northern state of India at a median follow-up of 5.4 years., Methods: 1714 patients with RF/RHD diagnosed using clinical and echocardiographic criteria were registered from 2011 to 2018, and their baseline clinical characteristics and treatment practices were recorded. Patients were followed up annually for a median of 5.4 years (range 1-8 years) for incident adverse outcomes. The cumulative incidence of adverse composite outcomes, all-cause mortality, hospitalization for heart failure, stroke, and/or peripheral embolism was estimated. The baseline clinical characteristics were explored to identify the potential risk predictors using a multivariate cox proportional hazard model., Results: The cumulative incidence of adverse composite outcomes was 17.1% (15.3%-19.0%) at a median follow-up of 5.4 years. The predictors for the adverse composite outcomes (hazard ratio, 95% confidence interval) were age (1.03, 1.02-1.04), education status below primary level (1.60, 1.23-2.05), severe valvular heart disease (1.74, 1.36-2.23), NYHA class III/IV at enrollment (1.56, 1.18-2.07), right heart failure (4.48, 2.85-6.95), history of stroke and/or peripheral embolism (3.7, 1.5-9.2) and mitral balloon valvuloplasty (0.62, 0.40-0.96)., Conclusions: The incidence of adverse outcomes is substantial in patients with RF/RHD. Thus, early detection of high-risk patients and their risk management is needed to improve outcomes., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Sex differences in presentation, management, and outcomes of heart failure (HF) have been observed, but it is uncertain whether these differences exist in South India., Objective: We describe sex differences in presentation, management, and in-hospital outcomes in patients hospitalized with HF in South India and explore sex-based differences in the effect of the quality improvement intervention in a secondary analysis of a prospective, interrupted time series study., Methods: The Heart Failure Quality Improvement in Kerala (HF QUIK) study evaluated the effect of a quality improvement toolkit on process of care measures and clinical outcomes in patients hospitalized with HF in eight hospitals in Kerala using an interrupted time series design from February 2018 to August 2018. The primary outcome was guideline-directed medical therapy (GDMT) at hospital discharge for patients with HF with reduced ejection fraction (HFrEF). We performed sex-stratified analyses using mixed effect logistic regression models., Results: Among 1,400 patients, 536 (38.3%) were female. Female patients were older (69.6 vs. 65 years, p < 0.001), were less likely to have an ischemic etiology of HF (control period: 78.2% vs. 87.5%; intervention period: 83.6% vs. 91.5%; p < 0.05 for both) and were less likely to undergo coronary angiography or percutaneous coronary intervention. The quality improvement intervention had similar effects on the odds of GDMT at discharge in females with HFrEF (adjusted OR 1.79, 95% CI 0.92, 3.47) and males with HFrEF (adjusted OR 1.68, 95% CI 1.07, 2.64, p interaction = 0.69)., Conclusions: We observed sex-specific differences in presentation and procedural management of patients with HF but no differences in the effect of the quality improvement intervention on discharge GDMT rates. Both male and female patients with HFrEF remained undertreated in the study intervention period, demonstrating the need for implementation strategies to close the HFrEF treatment gap in South India., Competing Interests: In the past three years, MDH received funding from the World Heart Federation to serve as its senior program advisor for the Emerging Leaders program, which has been supported by Boehringer Ingelheim, Novartis, Bupa, and AstraZeneca. MDH also received support from the American Heart Association, Verily, and AstraZeneca and American Medical Association for work unrelated to this research. The George Institute for Global Health’s wholly owned enterprise, George Health Enterprises, has received investment funds to develop fixed-dose combination products containing aspirin, statin and blood pressure lowering drugs. MDH and AA plan to submit patents for heart failure polypills., (Copyright: © 2021 The Author(s).)

Objective: People with chronic conditions are known to be vulnerable to the COVID-19 pandemic. This study aims to describe patients' lived experiences, challenges faced by people with chronic conditions, their coping strategies, and the social and economic impacts of the COVID-19 pandemic., Design, Setting and Participants: We conducted a qualitative study using a syndemic framework to understand the patients' experiences of chronic disease care, challenges faced during the lockdown, their coping strategies and mitigators during the COVID-19 pandemic in the context of socioecological and biological factors. A diverse sample of 41 participants with chronic conditions (hypertension, diabetes, stroke and cardiovascular diseases) from four sites (Delhi, Haryana, Vizag and Chennai) in India participated in semistructured interviews. All interviews were audio recorded, transcribed, translated, anonymised and coded using MAXQDA software. We used the framework method to qualitatively analyse the COVID-19 pandemic impacts on health, social and economic well-being., Results: Participant experiences during the COVID-19 pandemic were categorised into four themes: challenges faced during the lockdown, experiences of the participants diagnosed with COVID-19, preventive measures taken and lessons learnt during the COVID-19 pandemic. A subgroup of participants faced difficulties in accessing healthcare while a few reported using teleconsultations. Most participants reported adverse economic impact of the pandemic which led to higher reporting of anxiety and stress. Participants who tested COVID-19 positive reported experiencing discrimination and stigma from neighbours. All participants reported taking essential preventive measures., Conclusion: People with chronic conditions experienced a confluence (reciprocal effect) of COVID-19 pandemic and chronic diseases in the context of difficulty in accessing healthcare, sedentary lifestyle and increased stress and anxiety. Patients' lived experiences during the pandemic provide important insights to inform effective transition to a mixed realm of online consultations and 'distanced' physical clinic visits., 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.)

Cardiovascular disease (CVD) is the leading cause of mortality in South Asia, with rapidly increasing prevalence of hypertension, type 2 diabetes (T2DM) and hyperlipidemia over the last two decades. Atherosclerotic CVD (ASCVD) affects South Asians earlier in life and at lower body weights, which is not fully explained by differential burden of conventional risk factors. Heart failure (HF) is a complex clinical syndrome of heterogeneous structural phenotypes including two major clinical subtypes, HF with preserved (HFpEF) and reduced ejection fraction (HFrEF). The prevalence of HF in South Asians is also rising with other metabolic diseases, and HFpEF develops at younger age and leaner body mass index in South Asians than in Whites. Recent genome-wide association studies, epigenome-wide association studies and metabolomic studies of ASCVD and HF have identified genes, metabolites and pathways associated with CVD traits. However, these findings were mostly driven by samples of European ancestry, which may not accurately represent the CVD risk at the molecular level, and the unique risk profile of CVD in South Asians. Such bias, while formulating hypothesis-driven research studies, risks missing important causal or predictive factors unique to South Asians. Importantly, a longitudinal design of multi-omic markers can capture the life-course risk and natural history related to CVD, and partially disentangle putative causal relationship between risk factors, multi-omic markers and subclinical and clinical ASCVD and HF. In conclusion, combining high-resolution untargeted metabolomics with epigenomics of rigorous, longitudinal design will provide comprehensive unbiased molecular characterization of subclinical and clinical CVD among South Asians. A thorough understanding of CVD-associated metabolomic profiles, together with advances in epigenomics and genomics, will lead to more accurate estimates of CVD progression and stimulate new strategies for improving cardiovascular health., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Sun YV et al.)

Background: Although quality improvement interventions for acute heart failure have been studied in high-income countries, none have been studied in low- or middle-income country settings where quality of care can be lower. We evaluated the effect of a quality improvement toolkit on process of care measures and clinical outcomes in patients hospitalized for acute heart failure in 8 hospitals in Kerala, India utilizing an interrupted time series design from February 2018 to August 2018., Methods: The quality improvement toolkit included checklists, audit-and-feedback reports, and patient education materials. The primary outcome was rate of discharge guideline-directed medical therapy for patients with heart failure with reduced ejection fraction. We used mixed effect logistic regression and interrupted time series models for analysis., Results: Among 1400 participants, mean (SD) age was 66.6 (12.2) years, and 38% were female. Mean (SD) left ventricular ejection fraction was 35.2% (9.7%). The primary outcome was observed in 41.3% of participants in the intervention period and 28.1% of participants in the control period (difference 13.2%; 95% CI 6.8, 19.0; adjusted OR = 1.70; 95% CI 1.17, 2.48). Interrupted time series model demonstrated highest rate of guideline-directed medical therapy at discharge in the initial weeks following intervention delivery with a concomitant decline over time. Improvements were observed in discharge process of care measures, including diet counseling, weight monitoring instructions, and scheduling of outpatient clinic follow-up but not hospital length of stay nor inpatient mortality., Conclusions: Higher rates of guideline-directed medical therapy at discharge were observed in Kerala. Broader implementation of this quality improvement intervention may improve heart failure care in low- and middle-income countries., (Copyright © 2020 Elsevier B.V. All rights reserved.)

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.

Introduction: South Asians (SA) and Pima Indians have high prevalence of diabetes but differ markedly in body size. We hypothesize that young SA will have higher diabetes incidence than Pima Indians at comparable body mass index (BMI) levels., Research Design and Methods: We used prospective cohort data to estimate age-specific, sex, and BMI-specific diabetes incidence in SA aged 20-44 years living in India and Pakistan from the Center for Cardiometabolic Risk Reduction in South Asia Study (n=6676), and compared with Pima Indians, from Pima Indian Study (n=1852)., Results: At baseline, SA were considerably less obese than Pima Indians (BMI (kg/m 2 ): 24.4 vs 33.8; waist circumference (cm): 82.5 vs 107.0). Age-standardized diabetes incidence (cases/1000 person-years, 95% CI) was lower in SA than in Pima Indians (men: 14.2, 12.2-16.2 vs 37.3, 31.8-42.8; women: 14.8, 13.0-16.5 vs 46.1, 41.2-51.1). Risk of incident diabetes among 20-24-year-old Pima men and women was six times (relative risk (RR), 95% CI: 6.04, 3.30 to 12.0) and seven times (RR, 95% CI: 7.64, 3.73 to 18.2) higher as compared with SA men and women, respectively. In those with BMI <25 kg/m 2 , however, the risk of diabetes was over five times in SA men than in Pima Indian men. Among those with BMI ≥30 kg/m 2 , diabetes incidence in SA men was nearly as high as in Pima men. SA and Pima Indians had similar magnitude of association between age, sex, BMI, and insulin secretion with diabetes. The effect of family history was larger in SA, whereas that of insulin resistance was larger in Pima Indians CONCLUSIONS: In the background of relatively low insulin resistance, higher diabetes incidence in SA is driven by poor insulin secretion in SA men. The findings call for research to improve insulin secretion in early natural history of diabetes., 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.)

Introduction: We compared diabetes incidence in South Asians aged ≥45 years in urban India (Chennai and Delhi) and Pakistan (Karachi), two low-income and middle-income countries undergoing rapid transition, with blacks and whites in the US, a high-income country., Research Design and Methods: We computed age-specific, sex-specific and body mass index (BMI)-specific diabetes incidence from the prospective Center for Cardiometabolic Risk Reduction in South Asia Study (n=3136) and the Atherosclerosis Risk in Communities Study (blacks, n=3059; whites, n=9924). We assessed factors associated with incident diabetes using Cox proportional hazards regression., Results: South Asians have lower BMI and waist circumference than blacks and whites (median BMI, kg/m 2 : 24.9 vs 28.2 vs 26.0; median waist circumference, cm 87.5 vs 96.0 vs 95.0). South Asians were less insulin resistant than blacks and whites (age-BMI-adjusted homeostatic model assessment of insulin resistance, µIU/mL/mmol/L: 2.30 vs 3.45 vs 2.59), and more insulin deficient than blacks but not whites (age-BMI-adjusted homeostasis model assessment of β-cell dysfunction, µIU/mL/mmol/L: 103.7 vs 140.6 vs 103.9). Age-standardized diabetes incidence (cases/1000 person-years (95% CI)) in South Asian men was similar to black men and 1.6 times higher (1.37 to 1.92) than white men (26.0 (22.2 to 29.8) vs 26.2 (22.7 to 29.7) vs 16.1 (14.8 to 17.4)). In South Asian women, incidence was slightly higher than black women and 3 times (2.61 to 3.66) the rate in white women (31.9 (27.5 to 36.2) vs 28.6 (25.7 to 31.6) vs 11.3 (10.2 to 12.3)). In normal weight (BMI <25 kg/m 2 ), diabetes incidence adjusted for age was 2.9 times higher (2.09 to 4.28) in South Asian men, and 5.3 times (3.64 to 7.54) in South Asian women than in white women., Conclusions: South Asian adults have lower BMI and are less insulin resistant than US blacks and whites, but have higher diabetes incidence than US whites, especially in subgroups without obesity. Factors other than insulin resistance (ie, insulin secretion) may play an important role in the natural history of diabetes in South Asians., 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.)

Aims/hypothesis: We aimed to estimate the lifetime risk of diabetes and diabetes-free life expectancy in metropolitan cities in India among the population aged 20 years or more, and their variation by sex, age and BMI., Methods: A Markov simulation model was adopted to estimate age-, sex- and BMI-specific lifetime risk of developing diabetes and diabetes-free life expectancy. The main data inputs used were as follows: age-, sex- and BMI-specific incidence rates of diabetes in urban India taken from the Centre for Cardiometabolic Risk Reduction in South Asia (2010-2018); age-, sex- and urban-specific rates of mortality from period lifetables reported by the Government of India (2014); and prevalence of diabetes from the Indian Council for Medical Research INdia DIABetes study (2008-2015)., Results: Lifetime risk (95% CI) of diabetes in 20-year-old men and women was 55.5 (51.6, 59.7)% and 64.6 (60.0, 69.5)%, respectively. Women generally had a higher lifetime risk across the lifespan. Remaining lifetime risk (95% CI) declined with age to 37.7 (30.1, 46.7)% at age 60 years among women and 27.5 (23.1, 32.4)% in men. Lifetime risk (95% CI) was highest among obese Indians: 86.0 (76.6, 91.5)% among 20-year-old women and 86.9 (75.4, 93.8)% among men. We identified considerably higher diabetes-free life expectancy at lower levels of BMI., Conclusions/interpretation: Lifetime risk of diabetes in metropolitan cities in India is alarming across the spectrum of weight and rises dramatically with higher BMI. Prevention of diabetes among metropolitan Indians of all ages is an urgent national priority, particularly given the rapid increase in urban obesogenic environments across the country. Graphical abstract.

Long-chain omega-3 fatty acid status during pregnancy may influence newborn anthropometry and duration of gestation. Evidence from high-quality trials from low- and middle-income countries (LMICs) is limited. We conducted a double-blind, randomized, placebo-controlled trial among 957 pregnant women (singleton gestation, 14-20 weeks' gestation at enrollment) in India to test the effectiveness of 400 mg/day algal docosahexaenoic acid (DHA) compared to placebo provided from enrollment through delivery. Among 3379 women who were screened, 1171 were found eligible; 957 were enrolled and were randomized. The intervention was two microencapsulated algal DHA (200 × 2 = 400 mg/day) or two microencapsulated soy and corn oil placebo tablets to be consumed daily from enrollment (≤20 weeks) through delivery. The primary outcome was newborn anthropometry (birth weight, length, head circumference). Secondary outcomes were gestational age and 1 and 5 min Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score. The groups (DHA; n = 478 and placebo; n = 479) were well balanced at baseline. There were 902 live births. Compliance with the intervention was similar across groups (DHA: 88.5%; placebo: 87.1%). There were no significant differences between DHA and placebo groups for birth weight (2750.6 ± 421.5 vs. 2768.2 ± 436.6 g, p = 0.54), length (47.3 ± 2.0 vs. 47.5 ± 2.0 cm, p = 0.13), or head circumference (33.7 ± 1.4 vs. 33.8 ± 1.4 cm, p = 0.15). The mean gestational age at delivery was similar between groups (DHA: 38.8 ± 1.7 placebo: 38.8 ± 1.7 wk, p = 0.54) as were APGAR scores at 1 and 5 min. Supplementing mothers through pregnancy with 400 mg/day DHA did not impact the offspring's birthweight, length, or head circumference.

Inappropriate antimicrobial prescribing is considered to be the leading cause of high burden of antimicrobial resistance (AMR) in resource-constrained lower- and middle-income countries. Under its global action plan, the World Health Organization has envisaged tackling the AMR threat through promotion of rational antibiotic use among prescribers. Given the lack of consensus definitions and other associated challenges, we sought to devise and validate an Antimicrobial Rationality Assessment Tool-AmRAT-for standardizing the assessment of appropriateness of antimicrobial prescribing. A consensus algorithm was developed by a multidisciplinary team consisting of intensivists, internal medicine practitioners, clinical pharmacologists, and infectious disease experts. The tool was piloted by 10 raters belonging to three groups of antimicrobial stewardship (AMS) personnel: Master of Pharmacology (M.Sc.) ( n = 3, group A), Doctor of Medicine (MD) residents ( n = 3, group B), and DM residents in clinical pharmacology ( n = 4, group C) using retrospective patient data from 30 audit and feedback forms collected as part of an existing AMS program. Percentage agreement and the kappa (κ) coefficients were used to measure inter-rater agreements amongst themselves and with expert opinion. Sensitivity and specificity estimates were analyzed comparing their assessments against the gold standard. For the overall assessment of rationality, the mean percent agreement with experts was 76.7% for group A, 68.9% for group B, and 77.5% for group C. The kappa values indicated moderate agreement for all raters in group A (κ 0.47-0.57), and fair to moderate in group B (κ 0.22-0.46) as well as group C (κ 0.37-0.60). Sensitivity and specificity for the same were 80% and 68.6%, respectively. Though evaluated by raters with diverse educational background and variable AMS experience in this pilot study, our tool demonstrated high percent agreement and good sensitivity and specificity, assuring confidence in its utility for assessing appropriateness of antimicrobial prescriptions in resource-constrained healthcare environments.

Aim: Achievement of treatment targets among individuals with diabetes remains suboptimal in many parts of the globe. We aimed to assess changes in diabetes prevalence and achievement of diabetes care goals in South Asia using two consecutive cross-sectional population-based surveys., Methods: Two representative samples of South Asian adults were recruited using identical methods from Chennai, Delhi, and Karachi in 2010-11 (n = 16,288; response rate-94.7%) and 2015-16 (n = 14,587; response rate-94.0%) through the Center for Cardio-metabolic Risk Reduction in South Asia (CARRS) Study. Quality of care goals were defined as HbA 1c <53 mmol/mol (7.0%), blood pressure (BP) control: <140/90 mmHg, lipid control: LDL cholesterol <2.56 mmol/l (100 mg/dl), and self-reported non-smoking., Results: Weighted prevalence of self-reported diabetes increased by 9.0% [13% (95%CI: 13-14) to 15% (14-15)] while that of newly diagnosed diabetes decreased by 16% [6.1% (5.7-6.6) to 5.1% (4.6-5.6)]. There were improvements in achieving glycaemic (25% to 30%, p = 0.002) and lipid (34% to 45%, p < 0.001) goals, but no notable improvements in BP control or smoking status. The proportion of individuals with self-reported diabetes meeting more than one target also increased., Conclusions: Diabetes prevalence continues to grow among urban South Asians and large gaps still exist in the attainment of treatment targets. Concerted policy, systemic, clinical and individual efforts are needed to close these care gaps., (© 2020 Diabetes UK.)

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., Competing Interests: Competing interestsAll authors declare that they have no competing interest., (© The Author(s) 2021.)

Objective: To assess the predictors of achieving and maintaining guideline-recommended glycemic control in people with poorly controlled type 2 diabetes., Methods: We analyzed data from the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) Trial (n = 1146), to identify groups that achieved guideline-recommended glycemic control (HbA1c < 7%) and those that remained persistently poorly controlled (HbA1c > 9%) over a median of 28 months of follow-up. We used generalized estimation equations (GEE) analysis for each outcome i.e. achieving guideline-recommended control and persistently poorly controlled and constructed four regression models (demographics, disease-related, self-care, and other risk factors) separately to identify predictors of HbA1c < 7% and HbA1c > 9% at the end of the trial, adjusting for trial group assignment and site., Results: In the final multivariate model, adherence to prescribed medications (RR: 1.46, 95%CI: 1.09, 1.95), adherence to diet plans (RR: 1.79, 95% CI: 1.43, 2.23) and middle-aged: 50-64 years (RR: 1.32; 95% CI: 1.02-1.71) were associated with achieving guideline-recommended control (HbA1c < 7%). Presence of microvascular complications (RR: 0.70; 95%CI: 0.53-0.92) reduced the probability of achieving guideline-recommended glycemic control (HbA1c 7%). Further, longer duration of diabetes (>15 years), RR: 1.41; 95% CI: 1.15, 1.72, hyperlipidemia, RR: 1.19; 95% CI: 1.06, 1.34 and younger age group (35-49 years vs. >64 years: RR: 0.61; 95% CI: 0.47-0.79) were associated with persistently poor glycemic control (HbA1c > 9%)., Conclusion: To achieve and maintain guideline-recommended glycemic control, care delivery models must put additional emphasis and effort on patients with longer disease duration, younger people and those having microvascular complications and hyperlipidemia., Competing Interests: Declaration of Competing Interest None of the authors have any potential conflict of interest to declare., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Cardiovascular disease (CVD) is the leading cause of mortality in South Asia, with rapidly increasing prevalence of hypertension, type 2 diabetes and hyperlipidemia over the last two decades. Atherosclerotic CVD (ASCVD) affects South Asians earlier in life and at lower body weights, which is not fully explained by differential burden of conventional risk factors. Heart failure (HF) is a complex clinical syndrome of heterogeneous structural phenotypes including two major clinical subtypes, HF with preserved (HFpEF) and reduced ejection fraction (HFrEF). The prevalence of HF in South Asians is also rising with other metabolic diseases, and HFpEF develops at younger age and leaner body mass index in South Asians than in Whites. Recent genome-wide association studies, epigenome-wide association studies and metabolomic studies of ASCVD and HF have identified genes, metabolites and pathways associated with CVD traits. However, these findings were mostly driven by samples of European ancestry, which may not accurately represent the CVD risk at the molecular level, and the unique risk profile of CVD in South Asians. Such bias, while formulating hypothesis-driven research studies, risks missing important causal or predictive factors unique to South Asians. Importantly, a longitudinal design of multi-omic markers can capture the life-course risk and natural history related to CVD, and partially disentangle putative causal relationship between risk factors, multi-omic markers and subclinical and clinical ASCVD and HF. In conclusion, combining high-resolution untargeted metabolomics with epigenomics of rigorous, longitudinal design will provide comprehensive unbiased molecular characterization of subclinical and clinical CVD among South Asians. A thorough understanding of CVD-associated metabolomic profiles, together with advances in epigenomics and genomics, will lead to more accurate estimates of CVD progression and stimulate new strategies for improving cardiovascular health., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 Sun YV et al.)

Intake of dietary docosahexaenoic acid (DHA 22:6n-3) is very low among Indian pregnant women. Maternal supplementation during pregnancy and lactation may benefit offspring neurodevelopment. We conducted a double-blind, randomized, placebo-controlled trial to test the effectiveness of supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg/d algal DHA compared to placebo on neurodevelopment of their offspring at 12 months. Of 3379 women screened, 1131 were found eligible; 957 were randomized. The primary outcome was infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII). Both groups were well balanced on sociodemographic variables at baseline. More than 72% of women took >90% of their assigned treatment. Twenty-five serious adverse events (SAEs), none related to the intervention, (DHA group = 16; placebo = 9) were noted. Of 902 live births, 878 were followed up to 12 months; the DASII was administered to 863 infants. At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60). Supplementing mothers through pregnancy and lactation with 400 mg/d DHA did not impact offspring neurodevelopment at 12 months of age in this setting.

Ambient air pollution, specifically particulate matter of diameter <2.5 μm, is reportedly associated with cardiovascular disease risk. However, evidence linking particulate matter of diameter <2.5 μm and blood pressure (BP) is largely from cross-sectional studies and from settings with lower concentrations of particulate matter of diameter <2.5 μm, with exposures not accounting for myriad time-varying and other factors such as built environment. This study aimed to study the association between long- and short-term ambient particulate matter of diameter <2.5 μm exposure from a hybrid spatiotemporal model at 1-km×1-km spatial resolution with longitudinally measured systolic and diastolic BP and incident hypertension in 5342 participants from urban Delhi, India, within an ongoing representative urban adult cohort study. Median annual and monthly exposure at baseline was 92.1 μg/m 3 (interquartile range, 87.6-95.7) and 82.4 μg/m 3 (interquartile range, 68.4-107.0), respectively. We observed higher average systolic BP (1.77 mm Hg [95% CI, 0.97-2.56] and 3.33 mm Hg [95% CI, 1.12-5.52]) per interquartile range differences in monthly and annual exposures, respectively, after adjusting for covariates. Additionally, interquartile range differences in long-term exposures of 1, 1.5, and 2 years increased the risk of incident hypertension by 1.53× (95% CI, 1.19-1.96), 1.59× (95% CI, 1.31-1.92), and 1.16× (95% CI, 0.95-1.43), respectively. Observed effects were larger in individuals with higher waist-hip ratios. Our data strongly support a temporal association between high levels of ambient air pollution, higher systolic BP, and incident hypertension. Given that high BP is an important risk factor of cardiovascular disease, reducing ambient air pollution is likely to have meaningful clinical and public health benefits.

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., Competing Interests: Conflicts of interest All authors have none to declare., (Copyright © 2020 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.)

Background: . The pattern of dyslipidaemia in South Asia is believed to be different from that in other parts of the world. Nonetheless, limited population-based data are available from the region. We assessed the prevalence, types of, and factors associated with dyslipidaemia among South Asians., Methods: . We used baseline data (2010-11) of the Center for Cardiometabolic Risk Reduction in South Asia (CARRS) cohort of 16 287 representative urban adults aged ≥20 years from Chennai and Delhi in India and Karachi in Pakistan. Total cholesterol (TC) was measured by the enzymatic-cholesterol oxidase peroxidase method, high-density lipoprotein-cholesterol (HDL-C) by the direct homogeneous method and triglycerides (TG) by enzymatic methods. Low-density lipoprotein-cholesterol (LDL-C) was calculated using Friedewald's formula. We defined high TC ≥200 mg/dl or on medication; hypertriglyceridaemia ≥150 mg/dl, high LDL-C ≥130 mg/dl or on medication and low HDL-C <40 mg/dl for males, <50 mg/dl for females. Multivariate logistic regression was carried out to assess the factors associated with dyslipidaemia., Results: . The prevalence of any dyslipidaemia was 76.4%, 64.3% and 68.5% among males and 89.3%, 74.4% and 79.4% among females in Chennai, Delhi and Karachi, respectively. The prevalence of elevated TC was higher in Chennai compared to Delhi and Karachi (31.3%, 28.8% and 22.9%, respectively); males had a significantly greater prevalence of high TG, whereas females had a greater prevalence of low HDL-C in all the three cities. The most common lipid abnormality in all three cities was low HDL-C, which was seen in 67.1%, 49.7% and 61.3% in Chennai, Delhi and Karachi, respectively. Only 2% of the participants were on lipid-lowering drugs. Adjusted for other factors, dyslipidaemia was positively associated with age, female sex, obesity, hypertension, diabetes and tobacco use., Discussion: . Overall, almost seven in ten adults in urban South Asia have some form of dyslipidaemia, and the predominant subtypes were low HDL-C and high TG., Competing Interests: None

Air pollution is a growing public health concern in developing countries and poses a huge epidemiological burden. Despite the growing awareness of ill effects of air pollution, the evidence linking air pollution and health effects is sparse. This requires environmental exposure scientist and public health researchers to work more cohesively to generate evidence on health impacts of air pollution in developing countries for policy advocacy. In the Global Environmental and Occupational Health (GEOHealth) Program, we aim to build exposure assessment model to estimate ambient air pollution exposure at a very fine resolution which can be linked with health outcomes leveraging well-phenotyped cohorts which have information on geolocation of households of study participants. We aim to address how air pollution interacts with meteorological and weather parameters and other aspects of the urban environment, occupational classification, and socioeconomic status, to affect cardiometabolic risk factors and disease outcomes. This will help us generate evidence for cardiovascular health impacts of ambient air pollution in India needed for necessary policy advocacy. The other exploratory aims are to explore mediatory role of the epigenetic mechanisms (DNA methylation) and vitamin D exposure in determining the association between air pollution exposure and cardiovascular health outcomes. Other components of the GEOHealth program include building capacity and strengthening the skills of public health researchers in India through variety of training programs and international collaborations. This will help generate research capacity to address environmental and occupational health research questions in India. The expertise that we bring together in GEOHealth hub are public health, clinical epidemiology, environmental exposure science, statistical modeling, and policy advocacy., Competing Interests: Declaration of conflicting interests:The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2020.)

Background: Given the shortage of cardiac rehabilitation (CR) programs in India and poor uptake worldwide, there is an urgent need to find alternative models of CR that are inexpensive and may offer choice to subgroups with poor uptake (e.g., women and elderly)., Objectives: This study sought to evaluate the effects of yoga-based CR (Yoga-CaRe) on major cardiovascular events and self-rated health in a multicenter randomized controlled trial., Methods: The trial was conducted in 24 medical centers across India. This study recruited 3,959 patients with acute myocardial infarction with a median and minimum follow-up of 22 and 6 months. Patients were individually randomized to receive either a Yoga-CaRe program (n = 1,970) or enhanced standard care involving educational advice (n = 1,989). The co-primary outcomes were: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the European Quality of Life-5 Dimensions-5 Level visual analogue scale at 12 weeks., Results: MACE occurred in 131 (6.7%) patients in the Yoga-CaRe group and 146 (7.4%) patients in the enhanced standard care group (hazard ratio with Yoga-CaRe: 0.90; 95% confidence interval [CI]: 0.71 to 1.15; p = 0.41). Self-rated health was 77 in Yoga-CaRe and 75.7 in the enhanced standard care group (baseline-adjusted mean difference in favor of Yoga-CaRe: 1.5; 95% CI: 0.5 to 2.5; p = 0.002). The Yoga-CaRe group had greater return to pre-infarct activities, but there was no difference in tobacco cessation or medication adherence between the treatment groups (secondary outcomes)., Conclusions: Yoga-CaRe improved self-rated health and return to pre-infarct activities after acute myocardial infarction, but the trial lacked statistical power to show a difference in MACE. Yoga-CaRe may be an option when conventional CR is unavailable or unacceptable to individuals. (A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom; CTRI/2012/02/002408)., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Most Indians are vegetarian or eat very little meat, which could imply high potassium intake. Because a high-potassium diet could counterbalance the adverse health effects of high-sodium intake, this study aimed to describe potassium relative to sodium intake and investigate the relationship between blood pressure and potassium intake relative to sodium intake in rural and urban India., Methods: Investigators collected 24-hour urines from 1,445 participants in a subset of 2 population-based surveys in North India in 2012-2013. Standardized questionnaires were used to collect information on demography, behaviors (tobacco, alcohol consumption, physical activity, and diet [food frequency and 24-hour recall]), and medical history. After evaluating expected versus measured creatinine excretion, the authors calculated median urine potassium excretion and sodium/potassium ratio, according to sex and urban or rural residence, and estimated least square means for the urine measures by participant demographics and comorbidities, after accounting for caloric intake. Two-year blood pressure follow-up data were available in the urban study, and ANCOVA regression was used to determine the association with urine measures. All the statistical analyses of the data were done in January 2019., Results: Acceptable 24-hour urine collections were available in 1,397 participants (rural, n=730). Median urine potassium excretions were 1,492 (IQR=1,012-2,063) and 975 (615-1,497) mg/day; sodium/potassium ratios met the recommended target of <1 in 2.9% rural and 6.6% urban participants. Rural participants did not have higher potassium or lower (better) sodium/potassium ratios when diagnosed with hypertension or other cardiovascular conditions. Higher potassium excretion was associated with lower blood pressure during follow-up among the urban participants (mean systolic blood pressure, 129 vs 133 mm Hg in highest vs lowest potassium excretion tertiles; p=0.029)., Conclusions: Low potassium intake in India warrants dietary policies promoting intake of potassium-rich foods to improve heart health. This approach may be more acceptable than programs focused on sodium reduction alone., (Copyright © 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Adults in urban areas spend almost 77% of their waking time being inactive at workplaces, which leaves little time for physical activity. The aim of this systematic review and meta-analysis was to synthesize evidence for the effect of workplace physical activity interventions on the cardio-metabolic health markers (body weight, waist circumference, body mass index (BMI), blood pressure, lipids and blood glucose) among working adults., Methods: All experimental studies up to March 2018, reporting cardio-metabolic worksite intervention outcomes among adult employees were identified from PUBMED, EMBASE, COCHRANE CENTRAL, CINAHL and PsycINFO. The Cochrane Risk of Bias tool was used to assess bias in studies. All studies were assessed qualitatively and meta-analysis was done where possible. Forest plots were generated for pooled estimates of each study outcome., Results: A total of 33 studies met the eligibility criteria and 24 were included in the meta-analysis. Multi-component workplace interventions significantly reduced body weight (16 studies; mean diff: - 2.61 kg, 95% CI: - 3.89 to - 1.33) BMI (19 studies, mean diff: - 0.42 kg/m 2 , 95% CI: - 0.69 to - 0.15) and waist circumference (13 studies; mean diff: - 1.92 cm, 95% CI: - 3.25 to - 0.60). Reduction in blood pressure, lipids and blood glucose was not statistically significant., Conclusions: Workplace interventions significantly reduced body weight, BMI and waist circumference. Non-significant results for biochemical markers could be due to them being secondary outcomes in most studies. Intervention acceptability and adherence, follow-up duration and exploring non-RCT designs are factors that need attention in future research. Prospero registration number: CRD42018094436.

Introduction: Although deaths due to chronic kidney disease (CKD) have doubled over the past two decades, few data exist to inform screening strategies for early detection of CKD in low-income and middle-income countries., Methods: Using data from three population-based surveys in India, we developed a prediction model to identify a target population that could benefit from further CKD testing, after an initial screening implemented during home health visits. Using data from one urban survey (n=8698), we applied stepwise logistic regression to test three models: one comprised of demographics, self-reported medical history, anthropometry and point-of-care (urine dipstick or capillary glucose) tests; one with demographics and self-reported medical history and one with anthropometry and point-of-care tests. The 'gold-standard' definition of CKD was an estimated glomerular filtration rate <60 mL/min/1.73 m 2 or urine albumin-to-creatinine ratio ≥30 mg/g. Models were internally validated via bootstrap. The most parsimonious model with comparable performance was externally validated on distinct urban (n=5365) and rural (n=6173) Indian cohorts., Results: A model with age, sex, waist circumference, body mass index and urine dipstick had a c-statistic of 0.76 (95% CI 0.75 to 0.78) for predicting need for further CKD testing, with external validation c-statistics of 0.74 and 0.70 in the urban and rural cohorts, respectively. At a probability cut-point of 0.09, sensitivity was 71% (95% CI 68% to 74%) and specificity was 70% (95% CI 69% to 71%). The model captured 71% of persons with CKD and 90% of persons at highest risk of complications from untreated CKD (ie, CKD stage 3A2 and above)., Conclusion: A point-of-care CKD screening strategy using three simple measures can accurately identify high-risk persons who require confirmatory kidney function testing., Competing Interests: Competing interests: None declared.

Often a single blood pressure (BP) measurement is used to diagnose and manage hypertension in busy clinics. However, repeated BP measurements have been shown to be more representative of the true BP status of the individual. Improper measurement of office BP can lead to inaccurate classification, overestimation of a patient's true BP, unnecessary treatment, and misinterpretation of the true prevalence of hypertension. There is no consensus among major guidelines on the number of recommended measurements at a single visit or the method of arriving at final clinic BP reading. The participants of the National Family Health Survey (NFHS-4), a nationwide survey conducted in India from 2015 to 2016, were used for the analysis. The prevalence and median difference in systolic blood pressure (SBP) and diastolic blood pressure (DBP) for single as well as combinations of two or more readings were calculated. Cross-tabulation was used to assess classification of individuals based on first BP reading compared with the mean of two or more BP measurements. There was a 63% higher prevalence of hypertension when only the first reading was considered for diagnosis in comparison to the mean of the second and third readings. A decrease of 3.6 mmHg and 2.4 mm Hg in mean SBP and DBP, respectively, was observed when the mean of the second and third readings was compared to the first reading. In those who are identified to have grade 1 or higher categories of hypertension, we recommend three BP measurements, with the mean of the second and third measurements being the clinic BP.

Background: Although most Indians live in rural settings, data on cardiovascular disease risk factors in these groups are limited. We describe the association between socioeconomic position and cardiovascular disease risk factors in a large rural population in north India., Methods: We performed representative, community-based sampling from 2013 to 2014 of Solan district in Himachal Pradesh. We used education, occupation, household income, and household assets as indicators of socioeconomic position. We used tobacco use, alcohol use, low physical activity, obesity, hypertension, and diabetes as risk factors for cardiovascular disease. We performed hierarchical multivariable logistic regression, adjusting for age, sex and clustering of the health sub-centers, to evaluate the cross-sectional association of socioeconomic position indicators and cardiovascular disease risk factors., Results: Among 38,457 participants, mean (SD) age was 42.7 (15.9) years, and 57% were women. The odds of tobacco use was lowest in participants with graduate school and above education (adjusted OR 0.11, 95% CI 0.09, 0.13), household income >15,000 INR (adjusted OR 0.35, 95% CI 0.29, 0.43), and highest quartile of assets (adjusted OR 0.28, 95% CI 0.24, 0.34) compared with other groups but not occupation (skilled worker adjusted OR 0.93, 95% CI 0.74, 1.16). Alcohol use was lower among individuals in the higher quartile of income (adjusted OR 0.75, 95% CI 0.64, 0.88) and assets (adjusted OR 0.70, 95% CI 0.59, 0.82). The odds of obesity was highest in participants with graduate school and above education (adjusted OR 2.33, 95% CI 1.85, 2.94), household income > 15,000 Indian rupees (adjusted OR 1.89, 95% CI 1.63, 2.19), and highest quartile of household assets (adjusted OR 2.87, 95% CI 2.39, 3.45). The odds of prevalent hypertension and diabetes were also generally higher among individuals with higher socioeconomic position., Conclusions: Individuals with lower socioeconomic position in Himachal Pradesh were more likely to have abnormal behavioral risk factors, and individuals with higher socioeconomic position were more likely to have abnormal clinical risk factors., Competing Interests: MDH received grant funding from the World Heart Federation to serve as its senior program advisor for the Emerging Leaders program, which is supported by Boehringer Ingelheim and Novartis with previous support from BUPA and AstraZeneca. MDH also received grant support from the American Heart Association, Verily, and AstraZeneca for work unrelated to this research and personal fees from the American Medical Association for editorial duties for JAMA Cardiology. There are no patents, products in development, or marketed products to declare. This does not alter the authors’ adherence to all PLOS ONE policies on sharing data and materials.

Objective: Trans-fat, an invariable component of industrial fat is considered as one of the major dietary factors associated with CVD. Although the use of trans-fat is completely banned in some of the high-income countries where the CVD epidemic is declining, it is widely used in LMIC. We aimed to investigate the association of trans fatty acid in serum with risk markers of CVD in an industrial population in India. Participants were randomly selected from a study conducted in an industrial setting among employees and their family members. Information related to their demographic profile, anthropometric measurements, oil intake were recorded. Fasting samples were collected and stored at - 80 °C for analysis. Their lipid profile and hs CRP were measured and fatty acids analyzed using gas chromatography (GC) with flame ionization detector (FID)., Results: Complete data was available for 176 participants. Among trans fatty acids, mono trans fatty acid was significant predictor of serum triglycerides [Unadjusted β (95% CI) 22.9 (2.6, 43.2); Adjusted β (95% CI) 20.4 (3.5, 37.3)]. None of the other trans fatty acids either individually or in group correlated with any of the biochemical markers studied.

Objective: To assess the knowledge, attitudes and practices related to salt consumption among adults in rural and urban North India., Design: Data for the study were obtained from a community-based cross-sectional survey using an interviewer-administered questionnaire and 24 h urine samples., Setting: Data collection was conducted during March-October 2012 in rural Haryana and urban Delhi in North India., Participants: Adults (n 1635) aged ≥20 years (701 in rural Haryana; 934 in urban Delhi)., Results: Twenty-four per cent of rural and 40·5 % of urban participants knew that a high-salt diet causes high blood pressure. Nearly one-fifth of both rural and urban participants knew that there should be a maximum daily limit for consumption of salt. In rural and urban areas, 46·6 and 45·1 %, respectively, perceived it important to reduce the salt content of their diet; however, only 3·7 and 10·2 %, respectively, reported taking some actions. Participants reported they were consuming 'too little salt', 'just the right amount of salt' or 'too much salt', but their corresponding mean (95 % CI) actual salt consumption (g/d; as measured by 24 h urinary Na excretion) was higher, especially among rural participants (rural: 9·2 (8·13, 10·22), 8·5 (8·19, 8·77) or 8·4 (7·72, 8·99); urban: 5·6 (4·67, 6·57), 5·7 (5·32, 6·01) or 4·6 (4·10, 5·14), respectively)., Conclusions: Knowledge about the deleterious health impact of excess salt consumption is low in this population. Tailored public education for salt reduction is warranted with a particular focus on rural residents.

Importance: Ischemic heart disease is the leading cause of death in India, and treatment can be costly., Objective: To evaluate individual- and household-level costs and impoverishing effects of acute myocardial infarction among patients in Kerala, India., Design, Setting, and Participants: This investigation was a prespecified substudy of the Acute Coronary Syndrome Quality Improvement in Kerala study, a stepped-wedge, cluster randomized clinical trial conducted between November 2014 and November 2016 across 63 hospitals in Kerala, India. In this cross-sectional substudy, individual- and household-level cost data were collected 30 days after hospital discharge from a sample of 2114 respondents from November 2014 to July 2016. Data were analyzed from July through October 2018 and in March 2019., Exposures: Health insurance status., Main Outcomes and Measures: The primary outcomes were detailed direct and indirect cost data associated with acute myocardial infarction and respondent ability to pay as well as catastrophic health spending and distress financing. Catastrophic health spending was defined as 40% or more of household expenditures minus food costs spent on health, and distress financing was defined as borrowing money or selling assets to cover health costs. Hierarchical regression models were used to evaluate the association between health insurance and measures of financial risk. Costs were converted from Indian rupees to international dollars (represented herein as "$")., Results: Among 2114 respondents, the mean (SD) age was 62.3 (12.7) years, 1521 (71.9%) were men, 1144 (54.1%) presented with an ST-segment elevation myocardial infarction, and 1600 (75.7%) had no health insurance. The median (interquartile range) expenditure among respondents was $480.4 ($112.5-$1733.0) per acute myocardial infarction encounter, largely driven by in-hospital expenditures. There was greater than 15-fold variability between the 25th and 75th percentiles. Individuals with or without health insurance had similar monthly incomes and annual household expenditures, yet individuals without health insurance had approximately $400 higher out-of-pocket cardiovascular health care costs (median [interquartile range] total cardiovascular expenditures among uninsured, $560.3 [$134.1-$1733.6] vs insured, $161.4 [$23.2-$1726.9]; P < .001). Individuals without health insurance also had a 24% higher risk of catastrophic health spending (adjusted risk ratio, 1.24; 95% CI, 1.07-1.43) and 3-fold higher risk of distress financing (adjusted risk ratio; 3.05; 95% CI, 1.45-6.44)., Conclusions and Relevance: The results of this study indicate that acute myocardial infarction carries substantial financial risk for patients in Kerala. Expansion of health insurance may be an important strategy for financial risk protection to disrupt the poverty cycle associated with cardiovascular diseases in India.

Elevated blood pressure (BP) is a growing burden worldwide, leading to over 10 million deaths each year. May Measurement Month (MMM) is a global initiative aimed at raising awareness of high BP and to act as a temporary solution to the lack of screening programmes worldwide. A recently conducted study on 1.3 million adults in India showed the prevalence of hypertension to be 25.3%. Raised BP is responsible for 8.5% of the total Disability Adjusted Life Years and is also an important contributor to cardiovascular disease which is the leading cause of deaths in the country. An opportunistic cross-sectional survey of volunteers aged ≥18 was carried out in May 2017. Blood pressure measurement, the definition of hypertension and statistical analysis followed the standard MMM protocol. The study was conducted in over 500 screening sites across the country and involved over 5000 volunteers. Screening sites included health facilities such as hospitals and clinics, as well as a variety of public spaces. A total of 240 376 individuals were screened during MMM17. Out of the 122 685 screenees for whom all three BP readings were available, 38 974 (31.8%) had hypertension based on the mean of second and third reading. Of individuals not receiving antihypertensive medication, 21 679 (17.7%) were hypertensive. Of individuals receiving antihypertensive medication, 14 203 (82.6%) had uncontrolled BP. MMM17 was the largest collaborative BP screening campaign undertaken in India with involvement of the public as well as the private sector. Over two-thirds of the individuals on antihypertensive treatment had uncontrolled BP. Approximately one-fifth of the participants had raised BP and were not on antihypertensive treatment prior to the study. These results suggest that opportunistic screening can identify significant numbers with raised BP.

Background: Cardiac rehabilitation (CR) is a standard treatment for secondary prevention of acute myocardial infarction (AMI) in high income countries (HICs), but it is inaccessible to most patients in India due to high costs and skills required for multidisciplinary CR teams. We developed a low-cost and scalable CR program based on culturally-acceptable practice of yoga (Yoga-CaRe). In this paper, we report the rationale and design for evaluation of its effectiveness and cost-effectiveness., Methods: This is a multi-center, single-blind, two-arm parallel-group randomized controlled trial across 22 cardiac care hospitals in India. Four thousand patients aged 18-80 years with AMI will be recruited and randomized 1:1 to receive Yoga-CaRe program (13 sessions supervised by an instructor and encouragement to self-practice daily) or enhanced standard care (3 sessions of health education) delivered over a period of three months. Participants will be followed 3-monthly till the end of the trial. The co-primary outcomes are a) time to occurrence of first cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and emergency cardiovascular hospitalization), and b) quality of life (Euro-QoL-5L) at 12 weeks. Secondary outcomes include need for revascularization procedures, return to pre-infarct activities, tobacco cessation, medication adherence, and cost-effectiveness of the intervention., Conclusion: This trial will alone contribute >20% participants to existing meta-analyses of randomized trials of CR worldwide. If Yoga-CaRe is found to be effective, it has the potential to save millions of lives and transform care of AMI patients in India and other low and middle income country settings., (Copyright © 2019. Published by Elsevier B.V.)

Background: Economic dimensions of implementing quality improvement for diabetes care are understudied worldwide. We describe the economic evaluation protocol within a randomised controlled trial that tested a multi-component quality improvement (QI) strategy for individuals with poorly-controlled type 2 diabetes in South Asia., Methods/design: This economic evaluation of the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) randomised trial involved 1146 people with poorly-controlled type 2 diabetes receiving care at 10 diverse diabetes clinics across India and Pakistan. The economic evaluation comprises both a within-trial cost-effectiveness analysis (mean 2.5 years follow up) and a microsimulation model-based cost-utility analysis (life-time horizon). Effectiveness measures include multiple risk factor control (achieving HbA1c < 7% and blood pressure < 130/80 mmHg and/or LDL-cholesterol< 100 mg/dl), and patient reported outcomes including quality adjusted life years (QALYs) measured by EQ-5D-3 L, hospitalizations, and diabetes related complications at the trial end. Cost measures include direct medical and non-medical costs relevant to outpatient care (consultation fee, medicines, laboratory tests, supplies, food, and escort/accompanying person costs, transport) and inpatient care (hospitalization, transport, and accompanying person costs) of the intervention compared to usual diabetes care. Patient, healthcare system, and societal perspectives will be applied for costing. Both cost and health effects will be discounted at 3% per year for within trial cost-effectiveness analysis over 2.5 years and decision modelling analysis over a lifetime horizon. Outcomes will be reported as the incremental cost-effectiveness ratios (ICER) to achieve multiple risk factor control, avoid diabetes-related complications, or QALYs gained against varying levels of willingness to pay threshold values. Sensitivity analyses will be performed to assess uncertainties around ICER estimates by varying costs (95% CIs) across public vs. private settings and using conservative estimates of effect size (95% CIs) for multiple risk factor control. Costs will be reported in US$ 2018., Discussion: We hypothesize that the additional upfront costs of delivering the intervention will be counterbalanced by improvements in clinical outcomes and patient-reported outcomes, thereby rendering this multi-component QI intervention cost-effective in resource constrained South Asian settings., Trial Registration: ClinicalTrials.gov: NCT01212328., Competing Interests: Institutional ethics committees at each participating site and the research coordinating centres (Public Health Foundation of India and Emory University, USA) approved the study and all physicians and patients gave written informed consent prior to participating in this study.Not applicable.The authors declare that they have no competing interests.

Objectives: To assess whether chronic kidney disease of unknown aetiology (CKDu) is present in India and to identify risk factors for it using population-based data and standardised methods., Design: Secondary data analysis of three population-based cross-sectional studies conducted between 2010 and 2014., Setting: Urban and rural areas of Northern India (states of Delhi and Haryana) and Southern India (states of Tamil Nadu and Andhra Pradesh)., Participants: 12 500 individuals without diabetes, hypertension or heavy proteinuria., Outcome Measures: Mean estimated glomerular filtration rate (eGFR) and prevalence of eGFR below 60 mL/min per 1.73 m 2 (eGFR <60) in individuals without diabetes, hypertension or heavy proteinuria (proxy definition of CKDu)., Results: The mean eGFR was 105.0±17.8 mL/min per 1.73 m 2 . The prevalence of eGFR <60 was 1.6% (95% CI=1.4 to 1.7), but this figure varied markedly between areas, being highest in rural areas of Southern Indian (4.8% (3.8 to 5.8)). In Northern India, older age was the only risk factor associated with lower mean eGFR and eGFR <60 (regression coefficient (95% CI)=-0.94 (0.97 to 0.91); OR (95% CI)=1.10 (1.08 to 1.11)). In Southern India, risk factors for lower mean eGFR and eGFR <60, respectively, were residence in a rural area (-7.78 (-8.69 to -6.86); 4.95 (2.61 to 9.39)), older age (-0.90 (-0.93 to -0.86); 1.06 (1.04 to 1.08)) and less education (-0.94 (-1.32 to -0.56); 0.67 (0.50 to 0.90) for each 5 years at school)., Conclusions: CKDu is present in India and is not confined to Central America and Sri Lanka. Identified risk factors are consistent with risk factors previously reported for CKDu in Central America and Sri Lanka., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: We report the prevalence, risk factors and mortality associated with multimorbidity in urban South Asian adults., Methods: Hypertension, diabetes, heart disease, stroke and chronic kidney disease were measured at baseline in a sample of 16 287 adults ages ≥20 years in Delhi, Chennai and Karachi in 2010-11 followed for an average of 38 months. Multimorbidity was defined as having ≥2 chronic conditions at baseline. We identified correlates of multimorbidity at baseline using multinomial logistic models, and we assessed the prospective association between multimorbidity and mortality using Cox proportional hazards models., Results: The adjusted prevalence of multimorbidity was 9.4%; multimorbidity was highest in adults who were aged ≥60 years (37%), consumed alcohol (12.3%), body mass index ≥25 m/kg2 (14.1%), high waist circumference (17.1%) and had family history of a chronic condition (12.4%). Compared with adults with no chronic conditions, the fully adjusted relative hazard of death was twice as high in adults with two morbidities (hazard ratio [HR] = 2.3; 95% confidence interval [CI]: 1.6, 3.3) and thrice as high in adults with ≥3 morbidities (HR = 3.1; 95% CI: 1.9, 5.1)., Conclusion: Multimorbidity affects nearly 1 in 10 urban South Asians, and each additional morbidity carries a progressively higher risk of death. Identifying locally appropriate strategies for prevention and coordinated management of multimorbidity will benefit population health in the region., (© The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The ACS QUIK trial showed that a multicomponent quality improvement toolkit intervention resulted in improvements in processes of care for patients with acute myocardial infarction in Kerala but did not improve clinical outcomes in the context of background improvements in care. We describe the development of the ACS QUIK intervention and evaluate its implementation, acceptability, and sustainability., Methods: We performed a mixed methods process evaluation alongside a cluster randomized, stepped-wedge trial in Kerala, India. The ACS QUIK intervention aimed to reduce the rate of major adverse cardiovascular events at 30 days compared with usual care across 63 hospitals (n = 21,374 patients). The ACS QUIK toolkit intervention, consisting of audit and feedback report, admission and discharge checklists, patient education materials, and guidelines for the development of code and rapid response teams, was developed based on formative qualitative research in Kerala and from systematic reviews. After four or more months of the center's participation in the toolkit intervention phase of the trial, an online survey and physician interviews were administered. Physician interviews focused on evaluating the implementation and acceptability of the toolkit intervention. A framework analysis of transcripts incorporated context and intervening mechanisms., Results: Among 63 participating hospitals, 22 physicians (35%) completed online surveys. Of these, 17 (77%) respondents reported that their hospital had a cardiovascular quality improvement team, 18 (82%) respondents reported having read an audit report, admission checklist, or discharge checklist, and 19 (86%) respondents reported using patient education materials. Among the 28 interviewees (44%), facilitators of toolkit intervention implementation were physicians' support and leadership, hospital administrators' support, ease-of-use of checklists and patient education materials, and availability of training opportunities for staff. Barriers that influenced the implementation or acceptability of the toolkit intervention for physicians included time and staff constraints, Internet access, patient volume, and inadequate understanding of the quality improvement toolkit intervention., Conclusions: Implementation and acceptability of the ACS QUIK toolkit intervention were enhanced by hospital-level management support, physician and team support, and usefulness of checklists and patient education materials. Wider and longer-term use of the toolkit intervention and its expansion to potentially other cardiovascular conditions or other locations where the quality of care is not as high as in the ACS QUIK trial may be useful for improving acute cardiovascular care in Kerala and beyond., Trial Registration: NCT02256657.

Background: Despite a high cardiovascular disease burden, data on patient-reported health status outcomes among individuals with cardiovascular disease in India are limited., Methods and Results: Between November 2014 and November 2016, we collected health-related quality of life data among 1261 participants in the ACS QUIK trial (Acute Coronary Syndrome Quality Improvement in Kerala). We used a translated, validated version of the Seattle Angina Questionnaire administered 30 days after discharge for acute myocardial infarction, wherein higher scores represent better health status. We compared results across sex, myocardial infarction type, and randomization status using regression models that account for clustering and temporal trends. Mean (SD) age was 60.8 (13.7) years, 62% were men, and 63% presented with ST-segment-elevation myocardial infarction. More than 2 out of 5 respondents (44%) experienced angina 30 days after hospitalization, but most (68% of respondents with angina; 27% of the total sample) experienced it less than once per week (Seattle Angina Questionnaire angina frequency score 60). Respondents rated high median (interquartile range [IQR]) scores for angina frequency (100.0 [80.0-100.0]) overall with similar unadjusted scores by sex, but between-hospitality variability was high. Median (IQR) physical limitation scale response was 58.3 (41.7-77.8), which is consistent with limitations in moderate- and high-intensity activities at 30-day follow-up. Older respondents had more angina frequency and physical limitations and lower treatment satisfaction and quality of life. Women had greater physical limitations (median [IQR], 52.8 [38.9-72.2] for women versus median [IQR], 61.1 [44.4-80.6] for men; P<0.01). Overall treatment satisfaction was high with median (IQR) score, 81.3 (75.0-93.8), but overall quality of life was lower with median (IQR) score, 66.7 (50.0-83.3). Allocation to the quality improvement intervention group had the strongest direct association with higher quality of life (difference, 4.2; P=0.03), but overall effects were modest., Conclusions: This study represents the largest report of quality of life among myocardial infarction survivors in India with variability across age, sex, and quality improvement intervention status. Wide variability demonstrated across hospitals warrants further study., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02256657.

Background: The burden of noncommunicable diseases and their risk factors has rapidly increased worldwide, including in India. Innovative management strategies with electronic decision support and task sharing have been assessed for hypertension, diabetes mellitus, and depression individually, but an integrated package for multiple chronic condition management in primary care has not been evaluated., Methods: In a prospective, multicenter, open-label, cluster-randomized controlled trial involving 40 community health centers, using hypertension and diabetes mellitus as entry points, we evaluated the effectiveness of mWellcare, an mHealth system consisting of electronic health record storage and an electronic decision support for the integrated management of 5 chronic conditions (hypertension, diabetes mellitus, current tobacco and alcohol use, and depression) versus enhanced usual care among patients with hypertension and diabetes mellitus in India. At trial end (12-month follow-up), using intention-to-treat analysis, we examined the mean difference between arms in change in systolic blood pressure and glycated hemoglobin as primary outcomes and fasting blood glucose, total cholesterol, predicted 10-year risk of cardiovascular disease, depression score, and proportions reporting tobacco and alcohol use as secondary outcomes. Mixed-effects regression models were used to account for clustering and other confounding variables., Results: Among 3698 enrolled participants across 40 clusters (mean age, 55.1 years; SD, 11 years; 55.2% men), 3324 completed the trial. There was no evidence of difference between the 2 arms for systolic blood pressure (Δ=-0.98; 95% CI, -4.64 to 2.67) and glycated hemoglobin (Δ=0.11; 95% CI, -0.24 to 0.45) even after adjustment of several key variables (adjusted differences for systolic blood pressure: - 0.31 [95% CI, -3.91 to 3.29]; for glycated hemoglobin: 0.08 [95% CI, -0.27 to 0.44]). The mean within-group changes in systolic blood pressure in mWellcare and enhanced usual care were -13.65 mm Hg versus -12.66 mm Hg, respectively, and for glycated hemoglobin were -0.48% and -0.58%, respectively. Similarly, there were no differences in the changes between the 2 groups for tobacco and alcohol use or other secondary outcomes., Conclusions: We did not find an incremental benefit of mWellcare over enhanced usual care in the management of the chronic conditions studied., Clinical Trial Registration: URL: https://www., Clinicaltrials: gov. Unique identifier: NCT02480062.

Background: The proportion of patients with controlled hypertension (< 140/90 mmHg) is very low in India. Thus, there is a need to improve blood pressure management among patients with uncontrolled hypertension through innovative strategies directed at health system strengthening., Methods: We designed an intervention consisting of two important components - an electronic decision support system (EDSS) used by a trained nurse care coordinator (NCC). Based on preliminary data, we hypothesized that this intervention will be able to reduce mean systolic blood pressure by 6.5 mmHg among those with uncontrolled blood pressure in the intervention arm compared to the standard treatment arm (paper-based hypertension treatment guidelines). The study will adopt a cluster randomized trial design with the community health center (CHC) as the unit of randomization. The trial will be conducted in Visakhapatnam district (southern India). A total of 1876 participants aged ≥30 years with high blood pressure - systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg will be enrolled from 12 CHCs. The intervention consists of trained NCCs equipped with an evidence-based hypertension treatment algorithm in the form of the EDSS with regular SMSs to patients with hypertension to promote hypertension treatment and blood pressure control for 12 months. The primary outcome will be difference in the mean change of SBP, from baseline to 12 months, between the intervention and the standard treatment arm. The secondary outcomes are the difference in mean change of DBP; difference in the proportion of patients with controlled blood pressure (< 140/90 mmHg); difference in mean change of fasting blood sugar, HbA1C, eGFR, and albumin to creatinine ratio; difference in the proportion of patients visiting the CHC regularly (number of actual visits to the CHC/number of visits suggested by the EDSS > 80%); difference in proportion of patients compliant to anti-hypertensive medication/s; cost-effectiveness of intervention versus enhanced care. All the outcomes will be assessed at 12 months., Discussion: The study is expected to provide evidence on the effectiveness of NCC-led, EDSS-based hypertension management in India and can likely offer an exemplar for improving cardiovascular disease (CVD) management in India within the resource-constrained public healthcare system., Trial Registration: ClinicalTrials.gov, ID: NCT03164317 ). Registered retrospectively on 23 May 2017 (first patient enrolled on 6 April 2017) because the authors did not receive a response to their original registration submission (5 January 2017) to the Clinical Trial Registry - India (CTRI).

Background: Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is a structural component of human brain and retina, and can be derived from marine algae, fatty fish and marine oils. Since Indian diets are largely devoid of such products, plasma DHA levels are low. We are testing the effect of pre- and post-natal DHA maternal supplementation in India on infant motor and mental development, anthropometry and morbidity patterns., Methods: DHANI is a double-blinded, parallel group, randomized, placebo controlled trial supplementing 957 pregnant women aged 18-35 years from ≤20 weeks gestation through 6 months postpartum with 400 mg/d algal-derived DHA or placebo. Data on the participant's socio-demographic profile, anthropometric measurements and dietary intake are being recorded at baseline. The mother-infant dyads are followed through age 12 months. The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII). Secondary outcomes are gestational age, APGAR scores, and infant anthropometry. Biochemical indices (blood and breast-milk) from mother-child dyads are being collected to estimate changes in DHA levels in response to supplementation. All analyses will follow the intent-to-treat principle. Two-sample t test will be used to test unadjusted difference in mean DASII score between placebo and DHA group. Adjusted analyses will be performed using multiple linear regression., Discussion: Implications for maternal and child health and nutrition in India: DHANI is the first large pre- and post-natal maternal dietary supplementation trial in India. If the trial finds substantial benefit, it can serve as a learning to scale up the DHA intervention in the country., Trial Registration: The trial is retrospectively registered at clinicaltrials.gov ( NCT01580345 , NCT03072277 ) and ctri.nic.in ( CTRI/2013/04/003540 , CTRI/2017/08/009296 ).

Importance: Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India., Objective: To evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state., Design, Setting, and Participants: Cluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016. During 5 predefined steps over the study period, hospitals were randomly selected to move in a 1-way crossover from the control group to the intervention group. Consecutively presenting patients with acute myocardial infarction were offered participation., Interventions: Hospitals provided either usual care (control group; n = 10 066 participants [step 0: n = 2915; step 1: n = 2649; step 2: n = 2251; step 3: n = 1422; step 4; n = 829; step 5: n = 0]) or care using a quality improvement tool kit (intervention group; n = 11 308 participants [step 0: n = 0; step 1: n = 662; step 2: n = 1265; step 3: n = 2432; step 4: n = 3214; step 5: n = 3735]) that consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training., Main Outcomes and Measures: The primary outcome was the composite of all-cause death, reinfarction, stroke, or major bleeding using standardized definitions at 30 days. Secondary outcomes included the primary outcome's individual components, 30-day cardiovascular death, medication use, and tobacco cessation counseling. Mixed-effects logistic regression models were used to account for clustering and temporal trends., Results: Among 21 374 eligible randomized participants (mean age, 60.6 [SD, 12.0] years; n = 16 183 men [76%] ; n = 13 689 [64%] with ST-segment elevation myocardial infarction), 21 079 (99%) completed the trial. The primary composite outcome was observed in 5.3% of the intervention participants and 6.4% of the control participants. The observed difference in 30-day major adverse cardiovascular event rates between the groups was not statistically significant after adjustment (adjusted risk difference, -0.09% [95% CI, -1.32% to 1.14%]; adjusted odds ratio, 0.98 [95% CI, 0.80-1.21]). The intervention group had a higher rate of medication use including reperfusion but no effect on tobacco cessation counseling. There were no unexpected adverse events reported., Conclusions and Relevance: Among patients with acute myocardial infarction in Kerala, India, use of a quality improvement intervention compared with usual care did not decrease a composite of 30-day major adverse cardiovascular events. Further research is needed to understand the lack of efficacy., Trial Registration: clinicaltrials.gov Identifier: NCT02256657.