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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]

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]

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]