Association of pro-inflammatory cytokines, adipokines and hepatokine with incident diabetes in India: a nested case-control study within CARRS cohort.

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.

Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial.

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.

Household cooking fuel and gallbladder cancer risk: a multi-centre case-control study in India.

PURPOSE: Gallbladder cancers (GBC), unique to certain geographical regions, are lethal digestive tract cancers, disproportionately affecting women, with limited information on risk factors. METHODS: We evaluated the association between household cooking fuel and GBC risk in a hospital-based case-control study conducted in the North-East and East Indian states of Assam and Bihar. We explored the potential mediation by diet, fire-vents, 'daily exposure duration' and parity (among women). We recruited biopsy-confirmed GBC (n = 214) men and women aged 30-69 years between 2019 and 2021, and controls frequency-matched by age, sex and region (n = 166). Information about cooking fuel, lifestyle, personal and family history, female reproductive factors, socio-demographics, and anthropometrics was collected. We tested associations using multivariable logistic regression analyses. RESULTS: All participants (73.4% women) were categorised based on predominant cooking fuel use. Group-1: LPG (Liquefied Petroleum Gas) users in the previous 20 years and above without concurrent biomass use (26.15%); Group-2: LPG users in the previous 20 years and above with concurrent secondary biomass use (15.9%); Group-3: Biomass users for ≥ 20 years (57.95%). Compared to group-1, accounting for confounders, GBC risk was higher in group-2 [OR: 2.02; 95% CI: 1.00-4.07] and group-3 [OR: 2.01; 95% CI: 1.08-3.73] (p-trend:0.020). These associations strengthened among women that attenuated with high daily consumption of fruits-vegetables but not with fire-vents, 'daily exposure duration' or parity. CONCLUSION: Biomass burning was associated with a high-risk for GBC and should be considered as a modifiable risk factor for GBC. Clean cooking fuel can potentially mitigate, and a healthy diet can partially reduce the risk among women.

Linking population-based cohorts with cancer registries in LMIC: a case study and lessons learnt in India.

OBJECTIVES: In resource-constrained settings, cancer epidemiology research typically relies on self-reported diagnoses. To test a more systematic alternative approach, we assessed the feasibility of linking a cohort with a cancer registry. SETTING: Data linkage was performed between a population-based cohort in Chennai, India, with a local population-based cancer registry. PARTICIPANTS: Data set of Centre for Cardiometabolic Risk Reduction in South-Asia (CARRS) cohort participants (N=11 772) from Chennai was linked with the cancer registry data set for the period 1982-2015 (N=140 986). METHODS AND OUTCOME MEASURES: Match*Pro, a probabilistic record linkage software, was used for computerised linkages followed by manual review of high scoring records. The variables used for linkage included participant name, gender, age, address, Postal Index Number and father's and spouse's name. Registry records between 2010 and 2015 and between 1982 and 2015, respectively, represented incident and all (both incident and prevalent) cases. The extent of agreement between self-reports and registry-based ascertainment was expressed as the proportion of cases found in both data sets among cases identified independently in each source. RESULTS: There were 52 self-reported cancer cases among 11 772 cohort participants, but 5 cases were misreported. Of the remaining 47 eligible self-reported cases (incident and prevalent), 37 (79%) were confirmed by registry linkage. Among 29 self-reported incident cancers, 25 (86%) were found in the registry. Registry linkage also identified 24 previously not reported cancers; 12 of those were incident cases. The likelihood of linkage was higher in more recent years (2014-2015). CONCLUSIONS: Although linkage variables in this study had limited discriminatory power in the absence of a unique identifier, an appreciable proportion of self-reported cases were confirmed in the registry via linkages. More importantly, the linkages also identified many previously unreported cases. These findings offer new insights that can inform future cancer surveillance and research in low-income and middle-income countries.

Chronic Exposure to Drinking Water Arsenic and Gallbladder Cancer Risk: Preliminary Evidence from Endemic Regions of India.

BACKGROUND: Evidence linking arsenic in drinking water to digestive tract cancers is limited. We evaluated the association between arsenic levels in groundwater and gallbladder cancer risk in a case-control study (2019-2021) of long-term residents (≥10years) in two arsenic-impacted and high gallbladder cancer risk states of India-Assam and Bihar. METHODS: We recruited men and women aged 30 to 69 years from hospitals (73.4% women), with newly diagnosed, biopsy-confirmed gallbladder cancer (N = 214) and unrelated controls frequency-matched for 5-year age, sex, and state (N = 166). Long-term residential history, lifestyle factors, family history, socio-demographics, and physical measurements were collected. Average-weighted arsenic concentration (AwAC) was extrapolated from district-level groundwater monitoring data (2017-2018) and residential history. We evaluated gallbladder cancer risk for tertiles of AwAC (µg/L) in multivariable logistic regression models adjusted for important confounders [Range: 0-448.39; median (interquartile range), T1-0.45 (0.0-1.19); T2-3.75 (2.83-7.38); T3-17.6 (12.34-20.54)]. RESULTS: We observed a dose-response increase in gallbladder cancer risk based on AwAC tertiles [OR = 2.00 (95% confidence interval, 1.05-3.79) and 2.43 (1.30-4.54); Ptrend = 0.007]. Participants in the highest AwAC tertile consumed more tubewell water (67.7% vs. 27.9%) and reported more sediments (37.9% vs. 18.7%) with unsatisfactory color, odor, and taste (49.2% vs. 25.0%) than those in the lowest tertile. CONCLUSIONS: These findings suggest chronic arsenic exposure in drinking water at low-moderate levels may be a potential risk factor for gallbladder cancer. IMPACT: Risk factors for gallbladder cancer, a lethal digestive tract cancer, are not fully understood. Data from arsenic-endemic regions of India, with a high incidence of gallbladder cancer, may offer unique insights. Tackling 'arsenic pollution' may help reduce the burden of several health outcomes.

Time intervals and patient-level factors in oral cancer diagnostic pathways: An application of the WHO framework in India.

BACKGROUND: Oral cancer, a leading cancer-site in India, is often detected at advanced stages. We evaluated the time intervals from first symptom to help-seeking and diagnosis among oral cancer patients. METHODOLOGY: In this cross-sectional study, we recruited 226 consecutive oral cancer patients (mean age ( ± SD) 51.9 years ( ± 10.9); 81.9% men; 70.3% advanced stage) registered for diagnosis and treatment, between 2019 and 2021 at a cancer care centre in South India. We used WHO framework and previously standardized tools to record time intervals (appraisal, help-seeking and diagnostic) and baseline characteristics. We utilized multivariable logistic regression models to test the associations between 'prolonged (i.e., over 1 month) time intervals') and patient-level factors to estimate odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Over a half of patients presented with prolonged appraisal (60%) and help-seeking intervals (57%), and a third (34%) reported prolonged diagnostic interval. Patients with no formal education, no routine healthcare visits, no self-reported risk factors, and those who did not perceive initial symptoms to be serious were 2-4 times more likely to have prolonged appraisal and help-seeking than the rest. High travel costs and self-decision for visiting healthcare facility prolonged help-seeking. Diagnostic interval was prolonged only among women OR= 2.7 (95% CI: 1.2-6.1)) and in patients whose first doctor's opinion was 'nothing to worry' OR (=7.3 (95% CI: 2.6-20.5)). 'Correct knowledge of cancer' shortened appraisal and help-seeking intervals and 'incorrect knowledge and negative beliefs' prolonged diagnostic interval. CONCLUSION: Our findings highlight that interventions targeting sociocultural and economic determinants, symptom awareness, sensitizing persons at risk (especially women) and primary care providers might reduce overall time to diagnosis. Further, patients without any known risk factors for oral cancer might be at-risk for prolonged appraisal interval. These might help inform 'pull' strategies for cancer control in India and similar settings.

Cardiovascular Health in India - a Report Card from Three Urban and Rural Surveys of 22,144 Adults.

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/m2, 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.

Association of family history of cardiometabolic diseases (CMDs) and individual health behaviours: Analysis of CARRS study from South Asia.

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.

Standardization and validation of assay of selected omega-3 and omega-6 fatty acids from phospholipid fraction of red cell membrane using gas chromatography with flame ionization detector.

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.

Diagnostic Accuracy of a Two-Stage Sequential Screening Strategy Implemented by Community Health Workers (CHWs) to Identify Individuals with COPD in Rural India.

PURPOSE: Undiagnosed Chronic Obstructive Pulmonary Disease (COPD) results in high morbidity, disability and mortality in India. Effective strategies for active COPD screening in community settings are needed to increase early identification, risk reduction and timely management. The objective of this study was to test the diagnostic accuracy of a sequential two-step screening strategy to detect COPD, implemented by community health workers (CHWs), among adults aged ≥40 years in a rural area of North India. PATIENTS AND METHODS: Trained CHWs screened all consenting (n=3256) eligible adults in two villages using the Lung Function Questionnaire (LFQ) to assess their COPD risk and conducted pocket spirometry on 268 randomly selected (132 with high risk ie LFQ score ≤18 and 136 with low risk ie LFQ score >18) individuals. Subsequently, trained researchers conducted post-bronchodilator spirometry on these randomly selected individuals using a diagnostic quality spirometer and confirmed the COPD diagnosis according to the Global Initiative for Obstructive Lung Disease (GOLD) criteria (FEV1/FVC ratio <0.7). RESULTS: This strategy of using LFQ followed by pocket spirometry was sensitive (78.6%) and specific (78.8%), with a positive predictive value of 66% and negative predictive value of 88%. It could accurately detect 67% of GOLD Stage 1, 78% of GOLD Stage 2, 82% of GOLD Stage 3 and 100% of GOLD Stage 4 individuals with airflow limitation. CONCLUSION: COPD can be accurately detected by trained CHWs using a simple sequential screening strategy. This can potentially contribute to accurate assessment of COPD and thus its effective management in low-resource settings.

Temporal changes in diabetes prevalence and achievement of care goals in urban South Asia from 2010 to 2016 - The Center for Cardio-metabolic Risk Reduction in South Asia Study.

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.

Yoga-Based Cardiac Rehabilitation After Acute Myocardial Infarction: A Randomized Trial.

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).

Potassium Intake in India: Opportunity for Mitigating Risks of High-Sodium Diets.

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.

Prevalence of dyslipidaemia and factors associated with dyslipidaemia among South Asian adults: The Center for Cardiometabolic Risk Reduction in South Asia Cohort Study.

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.

Effect of workplace physical activity interventions on the cardio-metabolic health of working adults: systematic review and meta-analysis.

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.

Association between socioeconomic position and cardiovascular disease risk factors in rural north India: The Solan Surveillance Study.

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.

Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: Study rationale and design of a multi-center randomized controlled trial.

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.

Effectiveness of an mHealth-Based Electronic Decision Support System for Integrated Management of Chronic Conditions in Primary Care: The mWellcare Cluster-Randomized Controlled Trial.

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.

Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial.

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.