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OBJECTIVE: To describe the natural history of diabetes in Indians. RESEARCH DESIGN AND METHODS: Data are from participants older than 20 years in the Centre for Cardiometabolic Risk Reduction in South Asia longitudinal study. Glycemic states were defined per American Diabetes Association criteria. Markov models were used to estimate annual transition probabilities and sojourn time through states. RESULTS: Among 2,714 diabetes-free participants, 641 had isolated impaired fasting glucose (iIFG), and 341 had impaired glucose tolerance (IGT). The annual transition to diabetes for those with IGT was 13.9% (95% CI 12.0, 15.9) versus 8.6% (7.3, 9.8) for iIFG. In the normoglycemia ↔ iIFG → diabetes model, mean sojourn time in normoglycemia was 40.3 (34.6, 48.2) years, and sojourn time in iIFG was 9.7 (8.4, 11.4) years. For the normoglycemia ↔ IGT → diabetes model, mean sojourn time in normoglycemia was 34.5 (29.5, 40.8) years, and sojourn time in IGT was 6.1 (5.3, 7.1) years. CONCLUSIONS: Individuals reside in normoglycemia for 35–40 years; however, progression from prediabetes to diabetes is rapid. [ABSTRACT FROM AUTHOR]

Background: Cornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The role of phaco tip position during phacoemulsification on corneal endothelial damage is ambiguous, and there is no consensus regarding the most cornea-friendly phaco tip position (bevel-up or bevel-down). The objective of the trial is to compare the effect of phaco tip position (bevel-up vs. bevel-down) during phacoemulsification using direct chop technique on corneal endothelial cell count. Methods and design: TIPS is a randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio. A total of 480 eligible participants, aged > 18 years with immature cataract, will be randomly allocated into bevel-up and bevel-down groups at two centres. Randomisation will be stratified according to the cataract grade. The primary outcome is postoperative endothelial cell count at 1 month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30 and difference in intraoperative complications. Conclusion: In this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year. SAP Version 0.1 (dated: 28 April 2023) Protocol version:2.0 Trial registration: Clinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464 [ABSTRACT FROM AUTHOR]

Background: Low concentrations of docosahexaenoic acid (DHA) or high n-6 (ω-6):n-3 ratio in pregnant women is associated with poor fetal growth velocity and suboptimal neurodevelopment. However, there is a lack of data on levels of important n-6 and n-3 fatty acids (FAs) at different time points during pregnancy and lactation from India. Data on how much DHA is transferred during actual supplementation are also scarce. Objectives: We report the concentrations of n-6 and n-3 FAs in maternal and infant blood and in breast milk following maternal supplementation with DHA or placebo. Methods: A total of 957 pregnant women (≤20 wk) from Belagavi, Karnataka, were randomly assigned to receive either 400 mg/d of algal DHA or placebo through 6 mo postpartum. Blood samples were collected from the mother at recruitment/baseline, delivery, and 6 mo postpartum and from the infant at birth (cord) and 12 mo (venous). Breast milk samples were collected from a subsample at delivery, 1 mo and 6 mo postpartum. The FA profile was analyzed using gas chromatography. Results: The concentration of DHA appeared to be higher in erythrocyte and breast milk samples of the DHA-supplemented group at all sequent time points. The n-6:n-3 ratio was lower among women in the DHA group at delivery [DHA: 4.08 (1.79); placebo: 5.84 (3.57); P < 0.001] and at 6 mo postpartum [DHA: 5.34 (2.64); placebo: 7.69 (2.9); P < 0.001]. Infants of DHA-supplemented mothers also had a lower n-6:n-3 ratio at delivery and 12 mo. The n-6:n-3 ratio of breast milk increased from delivery through 1 to 6 mo but remained lower in the DHA-supplemented group than in the placebo. Conclusions: Maternal DHA supplementation with 400 mg/d from early pregnancy through 6 mo postpartum significantly increased circulating DHA in breast milk and infant erythrocyte, whereas decreased erythrocyte and breast milk n-6:n-3 ratio. However, maternal supplementation did not get the ratio to the recommended levels. [ABSTRACT FROM AUTHOR]

Objectives: To assess the cost‐effectiveness of a multicomponent strategy versus usual care in people with type 2 diabetes in South Asia. Design: Economic evaluation from healthcare system and societal perspectives. Setting: Ten diverse urban clinics in India and Pakistan. Participants: 1146 people with type 2 diabetes (575 in the intervention group and 571 in the usual care group) with mean age of 54.2 years, median diabetes duration: 7 years and mean HbA1c: 9.9% (85 mmol/mol) at baseline. Intervention: Multicomponent strategy comprising decision‐supported electronic health records and non‐physician care coordinator. Control group received usual care. Outcome Measures: Incremental cost‐effectiveness ratios (ICERs) per unit achievement in multiple risk factor control (HbA1c <7% (53 mmol/mol) and SBP <130/80 mmHg or LDLc <2.58 mmol/L (100 mg/dL)), ICERs per unit reduction in HbA1c, 5‐mmHg unit reductions in systolic BP, 10‐unit reductions in LDLc (mg/dl) (considered as clinically relevant) and ICER per quality‐adjusted life years (QALYs) gained. ICERs were reported in 2020 purchasing power parity–adjusted international dollars (INT$). The probability of ICERs being cost‐effective was considered depending on the willingness to pay (WTP) values as a share of GDP per capita for India (Int$ 7041.4) and Pakistan (Int$ 4847.6). Results: Compared to usual care, the annual incremental costs per person for intervention group were Int$ 1061.9 from a health system perspective and Int$ 1093.6 from a societal perspective. The ICER was Int$ 10,874.6 per increase in multiple risk factor control, $2588.1 per one percentage point reduction in the HbA1c, and $1744.6 per 5 unit reduction in SBP (mmHg), and $1271 per 10 unit reduction in LDLc (mg/dl). The ICER per QALY gained was $33,399.6 from a societal perspective. Conclusions: In a trial setting in South Asia, a multicomponent strategy for diabetes care resulted in better multiple risk factor control at higher costs and may be cost‐effective depending on the willingness to pay threshold with substantial uncertainty around cost‐effectiveness for QALYs gained in the short term (2.5 years). Future research needs to confirm the long‐term cost‐effectiveness of intensive multifactorial intervention for diabetes care in diverse healthcare settings in LMICs. [ABSTRACT FROM AUTHOR]

Google Scholar Crossref Search ADS PubMed WorldCat 11 Enas EA, Mohan V, Deepa M, Farooq S, Pazhoor S, Chennikkara H. The metabolic syndrome and dyslipidemia among Asian Indians: a population with high rates of diabetes and premature coronary artery disease. Tablet-based questionnaires facilitate the easier acquisition of data (eliminates the transfer of data from paper forms to electronic databases), execution of skip patterns and application of instant data-checking rules. [Extracted from the article]

Background: Diabetes control is poor globally and leads to burdensome microvascular and macrovascular complications. We aimed to assess post hoc between-group differences in sustained risk factor control and macrovascular and microvascular endpoints at 6.5 years in the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomized trial. Methods and findings: This parallel group individual randomized clinical trial was performed at 10 outpatient diabetes clinics in India and Pakistan from January 2011 through September 2019. A total of 1,146 patients with poorly controlled type 2 diabetes (HbA1c ≥8% and systolic BP ≥140 mm Hg and/or LDL-cholesterol ≥130 mg/dl) were randomized to a multicomponent quality improvement (QI) strategy (trained nonphysician care coordinator to facilitate care for patients and clinical decision support system for physicians) or usual care. At 2.5 years, compared to usual care, those receiving the QI strategy were significantly more likely to achieve multiple risk factor control. Six clinics continued, while 4 clinics discontinued implementing the QI strategy for an additional 4-year follow-up (overall median 6.5 years follow-up). In this post hoc analysis, using intention-to-treat, we examined between-group differences in multiple risk factor control (HbA1c <7% plus systolic BP <130 mm Hg and/or LDL-cholesterol <100 mg/dl) and first macrovascular endpoints (nonfatal myocardial infarction, nonfatal stroke, death, revascularization [angioplasty or coronary artery bypass graft]), which were coprimary outcomes. We also examined secondary outcomes, namely, single risk factor control, first microvascular endpoints (retinopathy, nephropathy, neuropathy), and composite first macrovascular plus microvascular events (which also included amputation and all-cause mortality) by treatment group and whether QI strategy implementation was continued over 6.5 years. At 6.5 years, assessment data were available for 854 participants (74.5%; n = 417 [intervention]; n = 437 [usual care]). In terms of sociodemographic and clinical characteristics, participants in the intervention and usual care groups were similar and participants at sites that continued were no different to participants at sites that discontinued intervention implementation. Patients in the intervention arm were more likely to exhibit sustained multiple risk factor control than usual care (relative risk: 1.79; 95% confidence interval [CI], 1.45, 2.20), p < 0.001. Cumulatively, there were 233 (40.5%) first microvascular and macrovascular events in intervention and 274 (48.0%) in usual care patients (absolute risk reduction: 7.5% [95% CI: −13.2, −1.7], p = 0.01; hazard ratio [HR] = 0.72 [95% CI: 0.61, 0.86]), p < 0.001. Patients in the intervention arm experienced lower incidence of first microvascular endpoints (HR = 0.68 [95% CI: 0.56, 0.83), p < 0.001, but there was no evidence of between-group differences in first macrovascular events. Beneficial effects on microvascular and composite vascular outcomes were observed in sites that continued, but not sites that discontinued the intervention. Conclusions: In urban South Asian clinics, a multicomponent QI strategy led to sustained multiple risk factor control and between-group differences in microvascular, but not macrovascular, endpoints. Between-group reductions in vascular outcomes at 6.5 years were observed only at sites that continued the QI intervention, suggesting that practice change needs to be maintained for better population health of people with diabetes. Trial registration: ClinicalTrials.govNCT01212328. Nikhil Tandon and colleagues explore the impact of a quality improvement strategy for patients with type 2 diabetes 6.5 years after its implementation for the CARRS randomised trial. Author summary: Why was this study done?: Data on whether improvements in diabetes care goal achievement can be sustained (>5 years) with quality improvement (QI) strategies are lacking from low- and middle-income countries (LMICs). Prior studies of QI strategies to improve care goal achievement among people with diabetes from high-income countries reported modest benefits in blood glucose, blood pressure, and lipids, but the effects of these improvements on reducing vascular complications and deaths related to diabetes are unknown. What did the researchers do and find?: In the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomised trial of 1,146 patients with type 2 diabetes attending 10 diverse diabetes clinics in India and Pakistan, the QI strategy was associated with benefits on diabetes care goals (HbA1c <7% plus systolic BP <130 mm Hg and/or LDL-cholesterol <100 mg/dl) at 2.5 years after randomization. Four clinics discontinued implementation, while 6 clinics continued to implement the QI strategy for an additional 4 years. This report assesses whether benefits were sustained and reduced vascular complications and deaths associated with diabetes at 6.5 years. Patients receiving the QI strategy, compared to those receiving usual care, experienced sustained benefits on diabetes care goals and less microvascular endpoints (eye, kidney, and nerve diseases) at 6.5 years after randomization. Total macrovascular and microvascular events were also lower in those receiving the QI strategy, and this was only observed at sites that continued implementation of the QI strategy for 6.5 years. What do these findings mean?: These findings add to our knowledge of the long-term effects of multicomponent QI strategies in sustaining multiple risk factor control and reducing combined vascular events compared to usual care in resource-limited settings. In view of these findings, clinical decision support and trained nonphysician health workers may be important QI strategies to consider integrating into India's healthcare system to improve diabetes care quality and reduce morbidity and mortality. One limitation of the study is that the tertiary care facilities included in the CARRS trial may not be generalizable across LMICs. [ABSTRACT FROM AUTHOR]

Aims: To study the association of pro-inflammatory markers with incident diabetes in India. Methods: We did a nested case–control study within the CARRS (Centre for Ardiometabolic Risk Reduction in South Asia) cohort. Of the 5739 diabetes-free individuals at the baseline, 216 participants with incident diabetes and 432 age-, gender- and city-matched controls at 2-year follow-up were included. We measured high sensitive C-reactive protein (hsCRP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), monocyte chemoattractant protein-1 (MCP-1), adiponectin, leptin and fetuin-A in the stored baseline blood samples. We did multivariate conditional logistic regression to estimate association of inflammatory markers (as quartiles) and incident diabetes. Covariates were baseline fasting plasma glucose (FPG) and lipids, body mass index (BMI), family history of diabetes, smoking and alcohol use. Results: Baseline hsCRP and TNF-α were higher, and IL-6 and adiponectin were lower among cases vs. controls. In multivariate conditional logistic regression models, only quartile-3 (odds ratio [OR]: 2.96 [95% CI:1.39, 6.30]) and quartile-4 (OR: 2.58 [95% CI: 1.15, 5.79]) of TNF-α and quartile-4 of MCP-1 (OR: 2.55 [95% CI: 1.06, 6.16]) were positively associated with diabetes after adjusting for baseline FPG and BMI. These associations did not remain after adjusting for family history. High level (quartile-4) of IL-6 was negatively associated with diabetes after adjusting for all factors (OR: 0.18 [95% CI: 0.06, 0.55]). Conclusions: Higher TNF-α and MCP-1 levels and lower IL-6 were associated with higher risk of developing diabetes. Better understanding and potential methods of addressing these biomarkers, especially in relation to family history, are needed to address diabetes in South Asians. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: While data from the latter part of the twentieth century consistently showed that immigrants to high-income countries faced higher cardio-metabolic risk than their counterparts in low- and middle-income countries, urbanization and associated lifestyle changes may be changing these patterns, even for conditions considered to be advanced manifestations of cardio-metabolic disease (e.g., chronic kidney disease [CKD]). Methods and findings: Using cross-sectional data from the Center for cArdiometabolic Risk Reduction in South Asia (CARRS, n = 5294) and Mediators of Atherosclerosis in South Asians Living in America (MASALA, n = 748) studies, we investigated whether prevalence of CKD is similar among Indians living in Indian and U.S. cities. We compared crude, age-, waist-to-height ratio-, and diabetes- adjusted CKD prevalence difference. Among participants identified to have CKD, we compared management of risk factors for its progression. Overall age-adjusted prevalence of CKD was similar in MASALA (14.0% [95% CI 11.8–16.3]) compared with CARRS (10.8% [95% CI 10.0–11.6]). Among men the prevalence difference was low (prevalence difference 1.8 [95% CI -1.6,5.3]) and remained low after adjustment for age, waist-to-height ratio, and diabetes status (-0.4 [-3.2,2.5]). Adjusted prevalence difference was higher among women (prevalence difference 8.9 [4.8,12.9]), but driven entirely by a higher prevalence of albuminuria among women in MASALA. Severity of CKD—-i.e., degree of albuminuria and proportion of participants with reduced glomerular filtration fraction-—was higher in CARRS for both men and women. Fewer participants with CKD in CARRS were effectively treated. 4% of CARRS versus 51% of MASALA participants with CKD had A1c < 7%; and 7% of CARRS versus 59% of MASALA participants blood pressure < 140/90 mmHg. Our analysis applies only to urban populations. Demographic—-particularly educational attainment—-differences among participants in the two studies are a potential source of bias. Conclusions: Prevalence of CKD among Indians living in Indian and U.S. cities is similar. Persons with CKD living in Indian cities face higher likelihood of experiencing end-stage renal disease since they have more severe kidney disease and little evidence of risk factor management. [ABSTRACT FROM AUTHOR]

There is a dearth of psychological interventions for self-harm that have been tested and found acceptable by youth in low- and middle income countries. ĀTMAN (Sanskrit word meaning "self" or "self-existent essence") is one such contextually adapted psychological intervention developed in India. It has three key elements; problem-solving, emotion regulation, and social network strengthening skills. We delivered ATMAN in a series of young people who self-harm to optimize the content, structure and delivery mechanisms, and to assess their experiences of therapy and engagement. ATMAN was delivered sequentially by a psychiatrist and non-specialist counselor in 16 participants between 14 to 24 years who presented to a tertiary level public hospital in Mumbai with self-harm. Quantitative measurement tools included Beck's Scale for Suicidal Ideation (BSI), the Patient Health Questionnaire −9 (PHQ-9), Functional Assessment of Self-Mutilation, and session feedback form. Qualitative tools included PSYCHLOPS and exit interviews. Eight female and four male participants completed therapy with a mean of five sessions and an average duration of 50 min. There were no differences in module wise feedback ratings of the psychiatrist and counselor. There were significant differences in the pre- and post-therapy scores on BSI (mean difference (confidence interval)) (−16.8 (−20.2, −13.3)) and PHQ-9 (−10.8 (−14.5, −7.04)). Various content modifications were undertaken during this phase. ATMAN was acceptable to youth in India who self-harm. Modifications introduced during pilot trial phase make ATMAN better suited to the needs of the youth. ATMAN has the potential to be delivered by non- specialist counselors and to be integrated at all levels of health care settings including primary health care to reduce the burden of suicide in young people. However, an extended randomized controlled trial of ATMAN treatment with multiple counselors will help in identifying key competencies that should be developed during training and supervision, and various quality assurance measures that can be undertaken for effective implementation of ATMAN. [ABSTRACT FROM AUTHOR]

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. 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. 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). 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. • Contemporary data on long term outcomes in patients with RF/RHD is limited. • The incidence of adverse outcomes is variable across countries with different socioeconomic states. • India contributes to about 40% of the global burden of RF/RHD. • The long term outcome in patients with RF/RHD have not been reported from India. • The HP-RF/RHD registry data of long term outcomes bridges this knowledge gap. [ABSTRACT FROM AUTHOR]

Populations in economic transition have a high diabetes prevalence even at lower body mass indices (BMI). We compared diabetes incidence in South Asians ≥45 years in urban India (Delhi and Chennai) and Pakistan (Karachi) with blacks and whites in U.S. Prospective analyses were done using data from the Center for Cardiometabolic Risk Reduction in South Asia Study (CARRS, South Asians, n=3,136), and the Atherosclerosis Risk in Communities Study (ARIC, blacks, n=3,059; whites, n=9,924). We defined diabetes as fasting glucose ≥126 mg/dl, HbA1c ≥ 6.5%, or medication use. South Asians were less obese than blacks and whites (BMI, kg/m2: 24.9 vs. 28.2 vs. 26.0; Waist, cms 87.5 vs.97.5 vs. 95.2). Age-standardized diabetes incidence (cases/1000 person-years, 95% CI) in South Asian men was similar to blacks and 1.6 times than whites (26.0, 22.2-29.8 vs. 26.2, 22.7-29.7 vs. 16.1, 14.8-17.4); and in South Asian women slightly higher than blacks and 3 times than whites (31.9, 27.5-36.2 vs. 28.6, 25.7-31.6 vs. 11.3, 10.2-12.3). In those with BMI <25 kg/m2, the diabetes risk was 2.6 times higher in South Asian men, and 5.3 times in women than in whites. In those with BMI ≥30 kg/m2, diabetes incidence in South Asian men and women were 2.6 and 2.1 times higher than in whites. Adults in urban India/Pakistan have higher diabetes incidence than U.S. whites. Even nonobese South Asian adults have markedly higher risk of diabetes compared to whites. Disclosure: K. Narayan: None. D. Kondal: None. N.R. Daya: None. S.A. Patel: None. M. Deepa: None. R. Anjana: None. L.R. Staimez: None. U. Gujral: None. S. Kobes: None. R. Shivashankar: None. M.K. Ali: None. M. Kadir: None. D. Prabhakaran: None. R.L. Hanson: None. V. Mohan: None. E. Selvin: None. N. Tandon: None. Funding: National Heart, Lung, and Blood Institute; Department of Health and Human Services (HHSN268200900026C); United Health Group, Minneapolis, MN; National Institute of Diabetes and Digestive and Kidney Diseases (P30DK111024) [ABSTRACT FROM AUTHOR]

South Asians have a high burden of diabetes at younger ages. We compared diabetes risk in South Asians aged 20-44 years living in India (Delhi and Chennai) and Pakistan (Karachi) with Pima Indians, a population with the world's highest incidence of diabetes. We analyzed prospective cohort data from the Pima Indian Study (Pima, n=1852), and the Center for Cardiometabolic Risk Reduction in South Asia Study (CARRS, South Asians, n=6676). We defined diabetes as fasting glucose ≥126 mg/dl, HbA1c ≥ 6.5%, or medication use. At baseline, on average, the South Asians were less obese than Pima (BMI, kg/m2: 24.4 vs. 33.8; Waist, cms 82.5 vs.107). Age-standardized diabetes incidence (cases/1000 person-years, 95% CI) was lower in South Asians than in Pima (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). Incidence among 20-24 year old were 80% and 87% lower, respectively, among South Asian men and women, but the risk differential narrowed at older ages (Table). In those with BMI <25 kg/m2, the risk of diabetes was over five times higher in South Asian men than in Pima. Among those with BMI ≥30 kg/m2, diabetes incidence in South Asians was nearly as high as in Pima. Intriguingly, diabetes incidence is higher in nonobese South Asian than in Pima men but not in women. In obese South Asians, diabetes incidence is perilously close to that in the Pima, and is a cause for major concern, as obesity levels continue to rise in South Asia. Disclosure: K. Narayan: None. D. Kondal: None. S. Kobes: None. M. Deepa: None. N.R. Daya: None. S.A. Patel: None. R. Anjana: None. L.R. Staimez: None. M.K. Ali: None. U. Gujral: None. D. Prabhakaran: None. R. Shivashankar: None. M. Kadir: None. E. Selvin: None. V. Mohan: None. R.L. Hanson: None. N. Tandon: None. Funding: National Heart, Lung, and Blood Institute; Department of Health and Human Services (HHSN268200900026C); United Health Group, Minneapolis, MN; National Institute of Diabetes and Digestive and Kidney Diseases (P30DK111024) [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. • No quality improvement interventions for acute heart failure have been studied in low- or middle-income country settings. • A quality improvement toolkit increased rates of guideline-directed medical therapy in patients with heart failure in Kerala. • Broader implementation of this quality improvement toolkit may improve heart failure care in low- and middle-income countries. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Non-alcoholic fatty liver disease and non-alcoholic steatohepatitis (NASH) are prevalent in the community, especially among those with metabolic syndrome. Patients with fibrotic NASH are at increased risk of liver-related-events. Currently available non-invasive tests have not been utilized for screening for fibrotic NASH among the community. We aimed to develop a screening tool for fibrotic NASH among community members. We included two large cohorts aimed at assessing cardiovascular disease among community members. Fibrotic NASH was defined using the FibroScan-aspartate aminotransferase score of ≥0.67 that identifies ≥F2 fibrosis and a non-alcoholic fatty liver disease activity score ≥4 with a specificity of 90%. Metabolic parameters, biochemical tests and anthropometry were used to develop a multivariate model. The derivation cohort (n = 1660) included a population with a median age 45 years, 42.5% males, metabolic syndrome in 66% and 2.7% (n = 45) with fibrotic NASH. Multivariate analysis identified the four significant variables (Age, body mass index , Diabetes and alanine aminotransferas levels) used to derive an ABDA score. The score had high diagnostic accuracy (the area under receiver-operating characteristic curve, 0.952) with adequate internal validity. An ABDA score ≥−3.52 identified fibrotic NASH in the derivation cohort with a sensitivity and specificity of 88.9% and 88.3%. The score was validated in a second cohort (n = 357) that included 21 patients (5.9%) with fibrotic NASH, where it demonstrated a high area under receiver-operating characteristic curve (0.948), sensitivity (81%) and specificity (89.3%). ABDA score utilizes four easily available parameters to identify fibrotic NASH with high accuracy in the community. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The household is a potentially important but understudied unit of analysis and intervention in chronic disease research. We sought to estimate the association between living with someone with a chronic condition and one's own chronic condition status.Methods and Findings: We conducted a cross-sectional analysis of population-based household- and individual-level data collected in 4 socioculturally and geographically diverse settings across rural and urban India in 2013 and 2014. Of 10,703 adults ages 18 years and older with coresiding household members surveyed, data from 7,522 adults (mean age 39 years) in 2,574 households with complete covariate information were analyzed. The main outcome measures were diabetes (fasting plasma glucose ≥ 126 mg/dL or taking medication), common mental disorder (General Health Questionnaire score ≥ 12), hypertension (blood pressure ≥ 140/90 mmHg or taking medication), obesity (body mass index ≥ 30 kg/m2), and high cholesterol (total blood cholesterol ≥ 240 mg/dL or taking medication). Logistic regression with generalized estimating equations was used to model associations with adjustment for a participant's age, sex, education, marital status, religion, and study site. Inverse probability weighting was applied to account for missing data. We found that 44% of adults had 1 or more of the chronic conditions examined. Irrespective of familial relationship, adults who resided with another adult with any chronic condition had 29% higher adjusted relative odds of having 1 or more chronic conditions themselves (adjusted odds ratio [aOR] = 1.29; 95% confidence interval [95% CI] 1.10-1.50). We also observed positive statistically significant associations of diabetes, common mental disorder, and hypertension with any chronic condition (aORs ranging from 1.19 to 1.61) in the analysis of all coresiding household members. Associations, however, were stronger for concordance of certain chronic conditions among coresiding household members. Specifically, we observed positive statistically significant associations between living with another adult with diabetes (aOR = 1.60; 95% CI 1.23-2.07), common mental disorder (aOR = 2.69; 95% CI 2.12-3.42), or obesity (aOR = 1.82; 95% CI 1.33-2.50) and having the same condition. Among separate analyses of dyads of parents and their adult children and dyads of spouses, the concordance between the chronic disease status was striking. The associations between common mental disorder, hypertension, obesity, and high cholesterol in parents and those same conditions in their adult children were aOR = 2.20 (95% CI 1.28-3.77), 1.58 (95% CI 1.15-2.16), 4.99 (95% CI 2.71-9.20), and 2.57 (95% CI 1.15-5.73), respectively. The associations between diabetes and common mental disorder in husbands and those same conditions in their wives were aORs = 2.28 (95% CI 1.52-3.42) and 3.01 (95% CI 2.01-4.52), respectively. Relative odds were raised even across different chronic condition phenotypes; specifically, we observed positive statistically significant associations between hypertension and obesity in the total sample of all coresiding adults (aOR = 1.24; 95% CI 1.02-1.52), high cholesterol and diabetes in the adult-parent sample (aOR = 2.02; 95% CI 1.08-3.78), and hypertension and diabetes in the spousal sample (aOR = 1.51; 95% CI 1.05-2.17). Of all associations examined, only the relationship between hypertension and diabetes in the adult-parent dyads was statistically significantly negative (aOR = 0.62; 95% CI 0.40-0.94). Relatively small samples in the dyadic analysis and site-specific analysis call for caution in interpreting qualitative differences between associations among different dyad types and geographical locations. Because of the cross-sectional nature of the analysis, the findings do not provide information on the etiology of incident chronic conditions among household members.Conclusions: We observed strong concordance of chronic conditions within coresiding adults across diverse settings in India. These data provide early evidence that a household-based approach to chronic disease research may advance public health strategies to prevent and control chronic conditions.Trial Registration: Clinical Trials Registry India CTRI/2013/10/004049; http://ctri.nic.in/Clinicaltrials/login.php. [ABSTRACT FROM AUTHOR]

Background: Achievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia.Objective: To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes.Design: Parallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328).Setting: Diabetes clinics in India and Pakistan.Patients: 1146 patients (575 in the intervention group and 571 in the usual care group) with type 2 diabetes and poor cardiometabolic profiles (glycated hemoglobin [HbA1c] level ≥8% plus systolic blood pressure [BP] ≥140 mm Hg and/or low-density lipoprotein cholesterol [LDLc] level ≥130 mg/dL).Intervention: Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records.Measurements: Proportions achieving HbA1c level less than 7% plus BP less than 130/80 mm Hg and/or LDLc level less than 100 mg/dL (primary outcome); mean risk factor reductions, health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes).Results: Baseline characteristics were similar between groups. Median diabetes duration was 7.0 years; 6.8% and 39.4% of participants had preexisting cardiovascular and microvascular disease, respectively; mean HbA1c level was 9.9%; mean BP was 143.3/81.7 mm Hg; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months, a greater percentage of intervention participants achieved the primary outcome (18.2% vs. 8.1%; relative risk, 2.24 [95% CI, 1.71 to 2.92]). Compared with usual care, intervention participants achieved larger reductions in HbA1c level (-0.50% [CI, -0.69% to -0.32%]), systolic BP (-4.04 mm Hg [CI, -5.85 to -2.22 mm Hg]), diastolic BP (-2.03 mm Hg [CI, -3.00 to -1.05 mm Hg]), and LDLc level (-7.86 mg/dL [CI, -10.90 to -4.81 mg/dL]) and reported higher HRQL and treatment satisfaction.Limitation: Findings were confined to urban specialist diabetes clinics.Conclusion: Multicomponent QI improves achievement of diabetes care goals, even in resource-challenged clinics.Primary Funding Source: National Heart, Lung, and Blood Institute and UnitedHealth Group. [ABSTRACT FROM AUTHOR]

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

Objective: Diabetes prevalence is increasing rapidly in rural areas of low- and middle-income countries (LMICs), but there are limited data on the performance of health systems in delivering equitable and effective care to rural populations. We therefore assessed rural-urban differences in diabetes care and control in LMICs.Research Design and Methods: We pooled individual-level data from nationally representative health surveys in 42 countries. We used Poisson regression models to estimate age-adjusted differences in the proportion of individuals with diabetes in rural versus urban areas achieving performance measures for the diagnosis, treatment, and control of diabetes and associated cardiovascular risk factors. We examined differences across the pooled sample, by sex, and by country.Results: The pooled sample from 42 countries included 840,110 individuals (35,404 with diabetes). Compared with urban populations with diabetes, rural populations had ∼15-30% lower relative risk of achieving performance measures for diabetes diagnosis and treatment. Rural populations with diagnosed diabetes had a 14% (95% CI 5-22%) lower relative risk of glycemic control, 6% (95% CI -5 to 16%) lower relative risk of blood pressure control, and 23% (95% CI 2-39%) lower relative risk of cholesterol control. Rural women with diabetes had lower achievement of performance measures relating to control than urban women, whereas among men, differences were small.Conclusions: Rural populations with diabetes experience substantial inequities in the achievement of diabetes performance measures in LMICs. Programs and policies aiming to strengthen global diabetes care must consider the unique challenges experienced by rural populations. [ABSTRACT FROM AUTHOR]

Aim: To assess the level of adherence to diabetes care processes, and associated clinic and patient factors at general practices in Delhi, India. Methods: We interviewed physicians (n = 23) and patients with diabetes (n = 406), and reviewed patient charts at general practices (government = 5; private = 18). We examined diabetes care processes, specifically measurement of weight, blood pressure (BP), glycated hemoglobin (HbA1c), lipids, electrocardiogram, dilated eye, and a foot examination in the last one year. We analyzed clinic and patient factors associated with a number of care processes achieved using multilevel Poisson regression model. Results: The average number of clinic visits per patient was 8.8/year (standard deviation = 5.7), and physicians had access to patient's previous records in only 19.7% of patients. Dilated eye exam, foot exam, and electrocardiogram were completed in 7.4%, 15.1%, and 29.1% of patients, respectively. An estimated 51.7%, 88.4%, and 28.1% had ≥1 measurement of HbA1c, BP, and lipids, respectively. Private clinics, physician access to patient's previous records, use of nonphysicians, patient education, and the presence of diabetes complication were positively associated with a number of care processes in the multivariable model. Conclusion: Adherence to diabetes care processes was suboptimal. Encouraging implementation of quality improvement strategies like Chronic Care Model elements at general practices may improve diabetes care. [ABSTRACT FROM AUTHOR]

Background: Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed.Methods: DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district. The study included a representative baseline cross-sectional survey, development of a structured intervention model, delivery of intervention for a minimum period of 18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques.Discussion: Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction.Trial Registration: CTRI/2013/10/004049 . Registered 7 October 2013. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 HbA1c <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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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/m2, 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract 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. Highlights • Yoga-CaRe trial is one of the largest trials which provides information on much needed data on CR from LMICs • The study is sufficiently powered to address research questions on policy relevant clinical outcomes • Yoga-CaRe programme, if proven to be beneficial may reduce the unmet needs of cardiac rehabilitation across the globe [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

India is experiencing an alarming rise in the burden of noncommunicable diseases, but data on the incidence of chronic kidney disease (CKD) are sparse. Using the Center for Cardiometabolic Risk Reduction in South Asia surveillance study (a population-based survey of Delhi and Chennai, India) we estimated overall, and age-, sex-, city-, and diabetes-specific prevalence of CKD, and defined the distribution of the study population by the Kidney Disease Improving Global Outcomes (KDIGO) classification scheme. The likelihood of cardiovascular events in participants with and without CKD was estimated by the Framingham and Interheart Modifiable Risk Scores. Of the 12,271 participants, 80% had complete data on serum creatinine and albuminuria. The prevalence of CKD and albuminuria, age standardized to the World Bank 2010 world population, was 8.7% (95% confidence interval: 7.9-9.4%) and 7.1% (6.4-7.7%), respectively. Nearly 80% of patients with CKD had an abnormally high hemoglobin A1c (5.7 and above). Based on KDIGO guidelines, 6.0, 1.0, and 0.5% of study participants are at moderate, high, or very high risk for experiencing CKD-associated adverse outcomes. The cardiovascular risk scores placed a greater proportion of patients with CKD in the high-risk categories for experiencing cardiovascular events when compared with participants without CKD. Thus, 1 in 12 individuals living in two of India's largest cities have evidence of CKD, with features that put them at high risk for adverse outcomes. [ABSTRACT FROM AUTHOR]

Background: Tobacco burdens in India and Pakistan require continued efforts to quantify tobacco use and its impacts. We examined the prevalence and sociodemographic and health-related correlates of tobacco use in Delhi, Chennai (India), and Karachi (Pakistan). Methods: Analysis of representative surveys of 11,260 participants (selected through multistage cluster random sampling; stratified by gender and age) in 2011 measured socio-demographics, tobacco use history, comorbid health conditions, and salivary cotinine. We used bivariate and multivariate regression analyses to examine factors associated with tobacco use. Results: Overall, 51.8 % were females, and 61.6 % were below the age of 45 years. Lifetime (ever) tobacco use prevalence (standardized for world population) was 45.0 %, 41.3 %, and 42.5 % among males, and 7.6 %, 8.5 %, and 19.7 % among females in Chennai, Delhi, and Karachi, respectively. Past 6 month tobacco use prevalence (standardized for world population) was 38.6 %, 36.1 %, and 39.1 % among males, and 7.3 %, 7.1 %, and 18.6 % among females in Chennai, Delhi, and Karachi, respectively. In multivariable regression analyses, residing in Delhi or Karachi versus Chennai; older age; lower education; earning less income; lower BMI; were each associated with tobacco use in both sexes. In addition, semi-skilled occupation versus not working and alcohol use were associated with tobacco use in males, and having newly diagnosed dyslipidemia was associated with lower odds of tobacco use among females. Mean salivary cotinine levels were higher among tobacco users versus nonusers (235.4; CI: 187.0-283.8 vs. 29.7; CI: 4.2, 55.2, respectively). Conclusion: High prevalence of tobacco use in the South Asian region, particularly among men, highlights the urgency to address this serious public health problem. Our analyses suggest targeted prevention and cessation interventions focused on lower socioeconomic groups may be particularly important. [ABSTRACT FROM AUTHOR]

Background: To our knowledge, no estimates of lifetime risk of diabetes have been produced for India, a country with a high propensity to developing diabetes and a low overall body weight compared to high-income countries. Data: We estimated the lifetime risk of diabetes in metropolitan India, and its variation by sex, age and BMI. We used government mortality statistics, diabetes prevalence from the Indian Council for Medical Research INdia DIABetes study (2008-15) and incidence from the Centre for Cardiometabolic Risk Reduction in South Asia (2010-2018). We limited estimates Indians aged 20 or more years. Results: Overall lifetime risk of diabetes in women in metropolitan cities aged 20 was 74.7% (95%CI: 65.4-83.3%), and 69.0% (95%CI: 58.9-78.7%) in men. Remaining risk is highest among the obese (92.9% (95%CI: 88.0-96.0%) in women and 92.4% (95%CI: 86.6-96.1%) in men aged 20) and is lowest among underweight/normal weight people (56.4% (95%CI: 46.9-66.3%) in women and 54.2% (95%CI: 44.5-64.6%) in men). Lifetime risk declines with age (to 67.3% (95%CI: 57.4-77.1%) in women aged 40 to 42.5% (95%CI: 33.8-52.9%) at age 60). Conclusion: In metropolitan India, 1 in 2 underweight/normal weight, and 9 in 10 obese, people aged 20 are projected to develop diabetes during their life. This portends a serious epidemic and indicates what may develop elsewhere in India in the absence of urgent action. Table. Lifetime risk of diabetes by sex, age and BMI Disclosure: S. Luhar: None. S. Kinra: None. V. Mohan: None. D. Kondal: None. R. Anjana: None. S.A. Patel: None. M.K. Ali: Research Support; Self; Merck & Co., Inc. D. Prabhakaran: None. N. Tandon: None. K. Narayan: None. Funding: Economic and Social Research Council (ES/J500021/1) [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

Background: Tobacco burdens in India and Pakistan require continued efforts to quantify tobacco use and its impacts. We examined the prevalence and sociodemographic and health-related correlates of tobacco use in Delhi, Chennai (India), and Karachi (Pakistan).Methods: Analysis of representative surveys of 11,260 participants (selected through multistage cluster random sampling; stratified by gender and age) in 2011 measured socio-demographics, tobacco use history, comorbid health conditions, and salivary cotinine. We used bivariate and multivariate regression analyses to examine factors associated with tobacco use.Results: Overall, 51.8 % were females, and 61.6 % were below the age of 45 years. Lifetime (ever) tobacco use prevalence (standardized for world population) was 45.0 %, 41.3 %, and 42.5 % among males, and 7.6 %, 8.5 %, and 19.7 % among females in Chennai, Delhi, and Karachi, respectively. Past 6 month tobacco use prevalence (standardized for world population) was 38.6 %, 36.1 %, and 39.1 % among males, and 7.3 %, 7.1 %, and 18.6 % among females in Chennai, Delhi, and Karachi, respectively. In multivariable regression analyses, residing in Delhi or Karachi versus Chennai; older age; lower education; earning less income; lower BMI; were each associated with tobacco use in both sexes. In addition, semi-skilled occupation versus not working and alcohol use were associated with tobacco use in males, and having newly diagnosed dyslipidemia was associated with lower odds of tobacco use among females. Mean salivary cotinine levels were higher among tobacco users versus nonusers (235.4; CI: 187.0-283.8 vs. 29.7; CI: 4.2, 55.2, respectively).Conclusion: High prevalence of tobacco use in the South Asian region, particularly among men, highlights the urgency to address this serious public health problem. Our analyses suggest targeted prevention and cessation interventions focused on lower socioeconomic groups may be particularly important. [ABSTRACT FROM AUTHOR]