Built environment for physical activity-An urban barometer, surveillance, and monitoring.

The Lancet Commission on Obesity (LCO), also known as the "syndemic commission," states that radical changes are required to harness the common drivers of "obesity, undernutrition, and climate change." Urban design, land use, and the built environment are few such drivers. Holding individuals responsible for obesity detracts from the obesogenic built environments. Pedestrian priority and dignity, wide pavements with tree canopies, water fountains with potable water, benches for the elderly at regular intervals, access to open-green spaces within 0.5-km radius and playgrounds in schools are required. Facilities for physical activity at worksite, prioritization of staircases and ramps in building construction, redistribution of land use, and access to quality, adequate capacity, comfortable, and well-networked public transport, which are elderly and differently abled sensitive with universal design are some of the interventions that require urgent implementation and monitoring. An urban barometer consisting of valid relevant indicators aligned to the sustainable development goals (SDGs), UN-Habitat-3 and healthy cities, should be considered a basic human right and ought to be mounted for purposes of surveillance and monitoring. A "Framework Convention on Built Environment and Physical Activity" needs to be taken up by WHO and the UN for uptake and implementation by member countries.

Microeconomic Costs, Insurance, and Catastrophic Health Spending Among Patients With Acute Myocardial Infarction in India: Substudy of a Randomized Clinical Trial.

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

Rationale and protocol for estimating the economic value of a multicomponent quality improvement strategy for diabetes care in South Asia.

BACKGROUND: Economic dimensions of implementing quality improvement for diabetes care are understudied worldwide. We describe the economic evaluation protocol within a randomised controlled trial that tested a multi-component quality improvement (QI) strategy for individuals with poorly-controlled type 2 diabetes in South Asia. METHODS/DESIGN: This economic evaluation of the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) randomised trial involved 1146 people with poorly-controlled type 2 diabetes receiving care at 10 diverse diabetes clinics across India and Pakistan. The economic evaluation comprises both a within-trial cost-effectiveness analysis (mean 2.5 years follow up) and a microsimulation model-based cost-utility analysis (life-time horizon). Effectiveness measures include multiple risk factor control (achieving HbA1c < 7% and blood pressure < 130/80 mmHg and/or LDL-cholesterol< 100 mg/dl), and patient reported outcomes including quality adjusted life years (QALYs) measured by EQ-5D-3 L, hospitalizations, and diabetes related complications at the trial end. Cost measures include direct medical and non-medical costs relevant to outpatient care (consultation fee, medicines, laboratory tests, supplies, food, and escort/accompanying person costs, transport) and inpatient care (hospitalization, transport, and accompanying person costs) of the intervention compared to usual diabetes care. Patient, healthcare system, and societal perspectives will be applied for costing. Both cost and health effects will be discounted at 3% per year for within trial cost-effectiveness analysis over 2.5 years and decision modelling analysis over a lifetime horizon. Outcomes will be reported as the incremental cost-effectiveness ratios (ICER) to achieve multiple risk factor control, avoid diabetes-related complications, or QALYs gained against varying levels of willingness to pay threshold values. Sensitivity analyses will be performed to assess uncertainties around ICER estimates by varying costs (95% CIs) across public vs. private settings and using conservative estimates of effect size (95% CIs) for multiple risk factor control. Costs will be reported in US$ 2018. DISCUSSION: We hypothesize that the additional upfront costs of delivering the intervention will be counterbalanced by improvements in clinical outcomes and patient-reported outcomes, thereby rendering this multi-component QI intervention cost-effective in resource constrained South Asian settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01212328.

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.

Availability, Sales, and Affordability of Tobacco Cessation Medicines in Kerala, India.

BACKGROUND: India is the world's second largest consumer of tobacco, but tobacco cessation remains uncommon due, at least in part, to underutilization of cessation pharmacotherapy. We evaluated the availability, sales, and affordability of nicotine replacement therapy, bupropion, and varenicline in the South Indian state of Kerala to understand potential reasons for underutilization. METHODS AND RESULTS: From November 2016 to April 2017, we collected data on availability, inventory, and pricing of cessation medication through a cross-sectional survey of 199 public, semiprivate (Karunya), and private pharmacies across 5 districts in Kerala using World Health Organization/Health Action International methodology. Revenue and sales data were obtained from the latest Pharmatrac medication database. We assessed affordability using individual- and household-level income and expenditure data collected from November 2014 to November 2016 through the Acute Coronary Syndrome Quality Improvement in Kerala randomized trial. Cessation medications were not available in public hospitals (0%, n=58) nor in public specialty centers (0%, n=10) including those designated to provide cessation services. At least 1 cessation medicine was available at 63% of private pharmacies (n=109) and 27% of Karunya (semiprivate) pharmacies (n=22). Among the 75 pharmacies that stocked cessation medications, 96% had nicotine replacement therapy, 28% had bupropion, and 1% had varenicline. No outlets had sufficient inventory for a patient to purchase a 12-week treatment regimen. There were an estimated 253 270 treatment regimens sold throughout India and 14 092 in Kerala in 2013 to 2014. Treatment regimens cost 1.9 to 13.0× the median amount spent on smoked tobacco and between 8% and 52% of nonsubsistence income. CONCLUSIONS: Tobacco cessation medications are unavailable in the Kerala public sector and have limited availability in the private and semiprivate sectors. When available, medications are unaffordable for most patients. Addition of tobacco cessation medication onto national and state essential medicines lists may help increase access. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02256657.