Health Impact and Cost-Effectiveness of Achieving the National Salt and Sugar Reduction Initiative Voluntary Sugar Reduction Targets in the United States: A Microsimulation Study.

BACKGROUND: High intake of added sugar is linked to weight gain and cardiometabolic risk. In 2018, the US National Salt and Sugar Reduction Initiative proposed government-supported voluntary national sugar reduction targets. This intervention's potential effects and cost-effectiveness are unclear. METHODS: A validated microsimulation model, CVD-PREDICT (Cardiovascular Disease Policy Model for Risk, Events, Detection, Interventions, Costs, and Trends), coded in C++, was used to estimate incremental changes in type 2 diabetes, cardiovascular disease (CVD), quality-adjusted life-years (QALYs), costs, and cost-effectiveness of the US National Salt and Sugar Reduction Initiative policy. The model was run at the individual level, incorporating the annual probability of each person's transition between health statuses on the basis of risk factors. The model incorporated national demographic and dietary data from the National Health and Nutrition Examination Survey across 3 cycles (2011 through 2016), added sugar-related diseases from meta-analyses, and policy costs and health-related costs from established sources. A simulated nationally representative US population was created and followed until age 100 years or death, with 2019 as the year of intervention start. Findings were evaluated over 10 years and a lifetime from health care and societal perspectives. Uncertainty was evaluated in a 1-way analysis by assuming 50% industry compliance and probabilistic sensitivity analyses through a second-order Monte Carlo approach. Model outputs included averted diabetes cases, CVD events and CVD deaths, QALYs gained, and formal health care cost savings, stratified by age, race, income, and education. RESULTS: Achieving the US National Salt and Sugar Reduction Initiative sugar reduction targets could prevent 2.48 million CVD events, 0.49 million CVD deaths, and 0.75 million diabetes cases; gain 6.67 million QALYs; and save $160.88 billion net costs from a societal perspective over a lifetime. The policy became cost-effective (<150 000/QALYs) at 6 years, highly cost-effective (<50 000/QALYs) at 7 years, and cost-saving at 9 years. Results were robust from a health care perspective, with lower (50%) industry compliance, and in probabilistic sensitivity analyses. The policy could also reduce disparities, with greatest estimated health gains per million adults among Black or Hispanic individuals, lower income, and less educated Americans. CONCLUSIONS: Implementing and achieving the US National Salt and Sugar Reduction Initiative sugar reformation targets could generate substantial health gains, equity gains, and cost savings.

Health Impact and Cost-Effectiveness of Volume, Tiered, and Absolute Sugar Content Sugar-Sweetened Beverage Tax Policies in the United States: A Microsimulation Study.

BACKGROUND: Sugar-sweetened beverage taxes are a rapidly growing policy tool and can be based on absolute volume, sugar content tiers, or absolute sugar content. Yet, their comparative health and economic impacts have not been quantified, in particular, tiered or sugar content taxes that provide industry incentives for sugar reduction. METHODS: We estimated incremental changes in diabetes mellitus and cardiovascular disease, quality-adjusted life-years, costs, and cost-effectiveness of 3 sugar-sweetened beverage tax designs in the United States, on the basis of (1) volume ($0.01/oz), (2) tiers (<5 g of added sugar/8 oz: no tax; 5-20 g/8 oz: $0.01/oz; and >20 g/8 oz: $0.02/oz), and (3) absolute sugar content ($0.01 per teaspoon added sugar), each compared with a base case of modest ongoing voluntary industry reformulation. A validated microsimulation model, CVD-PREDICT (Cardiovascular Disease Policy Model for Risk, Events, Detection, Interventions, Costs, and Trends), incorporated national demographic and dietary data from the National Health and Nutrition Examination Survey, policy effects and sugar-sweetened beverage-related diseases from meta-analyses, and industry reformulation and health-related costs from established sources. RESULTS: Over a lifetime, the volume, tiered, and absolute sugar content taxes would generate $80.4 billion, $142 billion, and $41.7 billion in tax revenue, respectively. From a healthcare perspective, the volume tax would prevent 850 000 cardiovascular disease (95% CI, 836 000-864 000) and 269 000 diabetes mellitus (265 000-274 000) cases, gain 2.44 million quality-adjusted life-years (2.40-2.48), and save $53.2 billion net costs (52.3-54.1). Health gains and savings were approximately doubled for the tiered and absolute sugar content taxes. Results were robust for societal and government perspectives, at 10 years follow-up, and with lower (50%) tax pass-through. Health gains were largest in young adults, blacks and Hispanics, and lower-income Americans. CONCLUSIONS: All sugar-sweetened beverage tax designs would generate substantial health gains and savings. Tiered and absolute sugar content taxes should be considered and evaluated for maximal potential gains.

Cardiometabolic disease costs associated with suboptimal diet in the United States: A cost analysis based on a microsimulation model.

BACKGROUND: Poor diet is a leading risk factor for cardiometabolic disease (CMD) in the United States, but its economic costs are unknown. We sought to estimate the cost associated with suboptimal diet in the US. METHODS AND FINDINGS: A validated microsimulation model (Cardiovascular Disease Policy Model for Risk, Events, Detection, Interventions, Costs, and Trends [CVD PREDICT]) was used to estimate annual cardiovascular disease (fatal and nonfatal myocardial infarction, angina, and stroke) and type 2 diabetes costs associated with suboptimal intake of 10 food groups (fruits, vegetables, nuts/seeds, whole grains, unprocessed red meats, processed meats, sugar-sweetened beverages, polyunsaturated fats, seafood omega-3 fats, sodium). A representative US population sample of individuals aged 35-85 years was created using weighted sampling from National Health And Nutrition Examination Surveys (NHANES) 2009-2012 cycles. Estimates were stratified by cost type (acute, chronic, drug), sex, age, race, education, BMI, and health insurance. Annual diet-related CMD costs were $301/person (95% CI $287-$316). This translates to $50.4 billion in CMD costs (18.2% of total) for the whole population, of which 84.3% are attributed to acute care ($42.6 billion). The largest annual per capita costs are attributed to low consumption of nuts/seeds ($81; 95% CI $74-$86) and seafood omega-3 fats ($76; 95% CI $70-$83), and the lowest are attributed to high consumption of red meat ($3; 95% CI $2.8-$3.5) and polyunsaturated fats ($20; 95% CI $19-$22). Individual costs are highest for men ($380), those aged ≥65 years ($408), blacks ($320), the less educated ($392), and those with Medicare ($481) or dual-eligible ($536) insurance coverage. A limitation of our study is that dietary intake data were assessed from 24-hour dietary recall, which may not fully capture a diet over a person's life span and is subject to measurement errors. CONCLUSIONS: Suboptimal diet of 10 dietary factors accounts for 18.2% of all ischemic heart disease, stroke, and type 2 diabetes costs in the US, highlighting that timely implementation of diet policies could address these health and economic burdens.

Cost-effectiveness of financial incentives for improving diet and health through Medicare and Medicaid: A microsimulation study.

BACKGROUND: Economic incentives through health insurance may promote healthier behaviors. Little is known about health and economic impacts of incentivizing diet, a leading risk factor for diabetes and cardiovascular disease (CVD), through Medicare and Medicaid. METHODS AND FINDINGS: A validated microsimulation model (CVD-PREDICT) estimated CVD and diabetes cases prevented, quality-adjusted life years (QALYs), health-related costs (formal healthcare, informal healthcare, and lost-productivity costs), and incremental cost-effectiveness ratios (ICERs) of two policy scenarios for adults within Medicare and Medicaid, compared to a base case of no new intervention: (1) 30% subsidy on fruits and vegetables ("F&V incentive") and (2) 30% subsidy on broader healthful foods including F&V, whole grains, nuts/seeds, seafood, and plant oils ("healthy food incentive"). Inputs included national demographic and dietary data from the National Health and Nutrition Examination Survey (NHANES) 2009-2014, policy effects and diet-disease effects from meta-analyses, and policy and health-related costs from established sources. Overall, 82 million adults (35-80 years old) were on Medicare and/or Medicaid. The mean (SD) age was 68.1 (11.4) years, 56.2% were female, and 25.5% were non-whites. Health and cost impacts were simulated over the lifetime of current Medicare and Medicaid participants (average simulated years = 18.3 years). The F&V incentive was estimated to prevent 1.93 million CVD events, gain 4.64 million QALYs, and save $39.7 billion in formal healthcare costs. For the healthy food incentive, corresponding gains were 3.28 million CVD and 0.12 million diabetes cases prevented, 8.40 million QALYs gained, and $100.2 billion in formal healthcare costs saved, respectively. From a healthcare perspective, both scenarios were cost-effective at 5 years and beyond, with lifetime ICERs of $18,184/QALY (F&V incentive) and $13,194/QALY (healthy food incentive). From a societal perspective including informal healthcare costs and lost productivity, respective ICERs were $14,576/QALY and $9,497/QALY. Results were robust in probabilistic sensitivity analyses and a range of one-way sensitivity and subgroup analyses, including by different durations of the intervention (5, 10, and 20 years and lifetime), food subsidy levels (20%, 50%), insurance groups (Medicare, Medicaid, and dual-eligible), and beneficiary characteristics within each insurance group (age, race/ethnicity, education, income, and Supplemental Nutrition Assistant Program [SNAP] status). Simulation studies such as this one provide quantitative estimates of benefits and uncertainty but cannot directly prove health and economic impacts. CONCLUSIONS: Economic incentives for healthier foods through Medicare and Medicaid could generate substantial health gains and be highly cost-effective.

Cost-Effectiveness of a US National Sugar-Sweetened Beverage Tax With a Multistakeholder Approach: Who Pays and Who Benefits.

OBJECTIVES: To estimate the health impact and cost-effectiveness of a national penny-per-ounce sugar-sweetened beverage (SSB) tax, overall and with stratified costs and benefits for 9 distinct stakeholder groups. METHODS: We used a validated microsimulation model (CVD PREDICT) to estimate cardiovascular disease reductions, quality-adjusted life years gained, and cost-effectiveness for US adults aged 35 to 85 years, evaluating full and partial consumer price pass-through. RESULTS: From health care and societal perspectives, the SSB tax was highly cost-saving. When we evaluated health gains, taxes paid, and out-of-pocket health care savings for 6 distinct consumer categories, incremental cost-effectiveness ratios ranged from $20 247 to $42 662 per quality-adjusted life year for 100% price pass-through (incremental cost-effectiveness ratios similar with 50% pass-through). For the beverage industry, net costs were $0.92 billion with 100% pass-through (largely tax-implementation costs) and $49.75 billion with 50% pass-through (largely because of partial industry coverage of the tax). For government, the SSB tax positively affected both tax revenues and health care cost savings. CONCLUSIONS: This stratified analysis improves on unitary approaches, illuminating distinct costs and benefits for stakeholders with political influence over SSB tax decisions.

Cost-effectiveness of financial incentives and disincentives for improving food purchases and health through the US Supplemental Nutrition Assistance Program (SNAP): A microsimulation study.

BACKGROUND: The Supplemental Nutrition Assistance Program (SNAP) provides approximately US$70 billion annually to support food purchases by low-income households, supporting approximately 1 in 7 Americans. In the 2018 Farm Bill, potential SNAP revisions to improve diets and health could include financial incentives, disincentives, or restrictions for certain foods. However, the overall and comparative impacts on health outcomes and costs are not established. We aimed to estimate the health impact, program and healthcare costs, and cost-effectiveness of food incentives, disincentives, or restrictions in SNAP. METHODS AND FINDINGS: We used a validated microsimulation model (CVD-PREDICT), populated with national data on adult SNAP participants from the National Health and Nutrition Examination Survey (NHANES) 2009-2014, policy effects from SNAP pilots and food pricing meta-analyses, diet-disease effects from meta-analyses, and policy, food, and healthcare costs from published literature to estimate the overall and comparative impacts of 3 dietary policy interventions: (1) a 30% incentive for fruits and vegetables (F&V), (2) a 30% F&V incentive with a restriction of sugar-sweetened beverages (SSBs), and (3) a broader incentive/disincentive program for multiple foods that also preserves choice (SNAP-plus), combining 30% incentives for F&V, nuts, whole grains, fish, and plant-based oils and 30% disincentives for SSBs, junk food, and processed meats. Among approximately 14.5 million adults on SNAP at baseline with mean age 52 years, our simulation estimates that the F&V incentive over 5 years would prevent 38,782 cardiovascular disease (CVD) events, gain 18,928 quality-adjusted life years (QALYs), and save $1.21 billion in healthcare costs. Adding SSB restriction increased gains to 93,933 CVD events prevented, 45,864 QALYs gained, and $4.33 billion saved. For SNAP-plus, corresponding gains were 116,875 CVD events prevented, 56,056 QALYs gained, and $5.28 billion saved. Over a lifetime, the F&V incentive would prevent approximately 303,900 CVD events, gain 649,000 QALYs, and save $6.77 billion in healthcare costs. Adding SSB restriction increased gains to approximately 797,900 CVD events prevented, 2.11 million QALYs gained, and $39.16 billion in healthcare costs saved. For SNAP-plus, corresponding gains were approximately 940,000 CVD events prevented, 2.47 million QALYs gained, and $41.93 billion saved. From a societal perspective (including programmatic costs but excluding food subsidy costs as an intra-societal transfer), all 3 scenarios were cost-saving. From a government affordability perspective (i.e., incorporating food subsidy costs, including for children and young adults for whom no health gains were modeled), the F&V incentive was of low cost-effectiveness at 5 years (incremental cost-effectiveness ratio: $548,053/QALY) but achieved cost-effectiveness ($66,525/QALY) over a lifetime. Adding SSB restriction, the intervention was cost-effective at 10 years ($68,857/QALY) and very cost-effective at 20 years ($26,435/QALY) and over a lifetime ($5,216/QALY). The combined incentive/disincentive program produced the largest health gains and reduced both healthcare and food costs, with net cost-savings of $10.16 billion at 5 years and $63.33 billion over a lifetime. Results were consistent in probabilistic sensitivity analyses: for example, from a societal perspective, 1,000 of 1,000 iterations (100%) were cost-saving for all 3 interventions. Due to the nature of simulation studies, the findings cannot prove the health and cost impacts of national SNAP interventions. CONCLUSIONS: Leveraging healthier eating through SNAP could generate substantial health benefits and be cost-effective or cost-saving. A combined food incentive/disincentive program appears most effective and may be most attractive to policy-makers.

Cardiometabolic risk in a population of older adults with multiple co-morbidities in rural south africa: the HAALSI (Health and Aging in Africa: longitudinal studies of INDEPTH communities) study.

BACKGROUND: A consequence of the widespread uptake of anti-retroviral therapy (ART) is that the older South African population will experience an increase in life expectancy, increasing their risk for cardiometabolic diseases (CMD), and its risk factors. The long-term interactions between HIV infection, treatment, and CMD remain to be elucidated in the African population. The HAALSI cohort was established to investigate the impact of these interactions on CMD morbidity and mortality among middle-aged and older adults. METHODS: We recruited randomly selected adults aged 40 or older residing in the rural Agincourt sub-district in Mpumalanga Province. In-person interviews were conducted to collect baseline household and socioeconomic data, self-reported health, anthropometric measures, blood pressure, high-sensitivity C-reactive protein (hsCRP), HbA1c, HIV-status, and point-of-care glucose and lipid levels. RESULTS: Five thousand fifty nine persons (46.4% male) were enrolled with a mean age of 61.7 ± 13.06 years. Waist-to-hip ratio was high for men and women (0.92 ± 0.08 vs. 0.89 ± 0.08), with 70% of women and 44% of men being overweight or obese. Blood pressure was similar for men and women with a combined hypertension prevalence of 58.4% and statistically significant increases were observed with increasing age. High total cholesterol prevalence in women was twice that observed for men (8.5 vs. 4.1%). The prevalence of self-reported CMD conditions was higher among women, except for myocardial infarction, and women had a statistically significantly higher prevalence of angina (10.82 vs. 6.97%) using Rose Criteria. The HIV- persons were significantly more likely to have hypertension, diabetes, or be overweight or obese than HIV+ persons. Approximately 56% of the cohort had at least 2 measured or self-reported clinical co-morbidities, with HIV+ persons having a consistently lower prevalence of co-morbidities compared to those without HIV. Absolute 10-year risk cardiovascular risk scores ranged from 7.7-9.7% for women and from 12.5-15.3% for men, depending on the risk score equations used. CONCLUSIONS: This cohort has high CMD risk based on both traditional risk factors and novel markers like hsCRP. Longitudinal follow-up of the cohort will allow us to determine the long-term impact of increased lifespan in a population with both high HIV infection and CMD risk.

Healthcare Professional Shortage and Task-Shifting to Prevent Cardiovascular Disease: Implications for Low- and Middle-Income Countries.

Cardiovascular diseases (CVD) account for 18 million of annual global deaths with more than three quarters of these deaths occurring in low- and middle-income countries (LMIC). In LMIC, the distribution of risk factors is heterogeneous, with urban areas being the worst affected. Despite the availability of effective CVD interventions in developed countries, many poor countries still struggle to provide care due to lack of resources. In addition, many LMIC suffer from staff shortages which pose additional burden to the healthcare system. Regardless of these challenges, there are potentially effective strategies such as task-shifting which have been used for chronic conditions such as HIV to address the human resource crisis. We propose that through task-shifting, certain tasks related to prevention be shifted to non-physician health workers as well as non-nurse health workers such as community health workers. Such steps will allow better coverage of segments of the underserved population. We recognise that for task-shifting to be effective, issues such as clearly defined roles, evaluation, on-going training, and supervision must be addressed.

Managing high cardiovascular disease risk among adults in Argentina using a multicomponent strategy linking key aspects of care: A two-arm cluster-randomized clinical trial (PRIMECare) protocol.

BACKGROUND: Cardiovascular disease (CVD) imposes a significant burden on the Argentinian population. Management of its leading risk factors can significantly reduce the CVD burden in high-resource settings, but there is insufficient evidence for effective implementation of evidence-based interventions in lower-resource settings like Argentina. METHODS: In this two-arm cluster-randomized trial we seek to compare the effective implementation, of a multicomponent intervention, versus usual care, to improve the management of high CVD risk across the care continuum in three provinces of Argentina. The multicomponent intervention strategy links five primary components of the CVD care continuum to improve its management: (1) a data management system linking a digital mHealth (mobile health) screening tool used by community health workers (CHWs), (2) an electronic appointment scheduler that is integrated with the primary care center electronic appointment system, (3) point of care testing for lipid profiles, (4) a clinical decision support (CDS) system for medication initiation, and (5) a text message (SMS) reminder system to improve treatment adherence and life-style changes. The primary outcome is the mean change in Framingham laboratory-based, 10-year absolute CVD risk score between the study arms from baseline to twelve months after enrollment. CONCLUSIONS: This protocol describes the development of a multicomponent intervention to implement effective management of CVD, developed with partners at the National and provincial Departments of Health in Argentina, with the goal of understanding its effective implementation in a primary health care system strengthened by universal health coverage, provision of free health care services, and provision of free medication.

Improvements in Hypertension Control in the Rural Longitudinal HAALSI Cohort of South African Adults Aged 40 and Older, From 2014 to 2019.

BACKGROUND: Over half of the South African adults aged 45 years and older have hypertension but its effective management along the treatment cascade (awareness, treatment, and control) remains poorly understood. METHODS: We compared the prevalence of all stages of the hypertension treatment cascade in the rural HAALSI cohort of older adults at baseline and after four years of follow-up using household surveys and blood pressure data. Hypertension was a mean systolic blood pressure >140 mm Hg or diastolic pressure >90 mm Hg, or current use of anti-hypertension medication. Control was a mean blood pressure <140/90 mm Hg. The effects of sex and age on the treatment cascade at follow-up were assessed. Multivariate Poisson regression models were used to estimate prevalence ratios along the treatment cascade at follow-up. RESULTS: Prevalence along the treatment cascade increased from baseline (B) to follow-up (F): awareness (64.4% vs. 83.6%), treatment (49.7% vs. 73.9%), and control (22.8% vs. 41.3%). At both time points, women had higher levels of awareness (B: 70.5% vs. 56.3%; F: 88.1% vs. 76.7%), treatment (B: 55.9% vs. 41.55; F: 79.9% vs. 64.7%), and control (B: 26.5% vs. 17.9%; F: 44.8% vs. 35.7%). Prevalence along the cascade increased linearly with age for everyone. Predictors of awareness included being female, elderly, or visiting a primary health clinic three times in the previous 3 months, and the latter two also predicted hypertension control. CONCLUSIONS: There were significant improvements in awareness, treatment, and control of hypertension from baseline to follow-up and women fared better at all stages, at both time points.

Significant Improvement in Blood Pressure Levels Among Older Adults With Hypertension in Rural South Africa.

BACKGROUND: Sub-Saharan Africa is undergoing an epidemiologic transition from infectious diseases to cardiovascular diseases. From 2014 to 2019, sociodemographic surveillance was performed in a large cohort in rural South Africa. METHODS: Disease prevalence and incidence were calculated using inverse probability weights. Poisson regression was used to identify disease predictors. The percentage of individuals with controlled (<140/90 mm Hg) versus uncontrolled hypertension was compared between 2014 and 2019. RESULTS: Compared with 2014 (n=5059), study participants in 2019 (n=4176) had similar rates of obesity (mean body mass index, 27.5±10.0 versus 27.0±6.5) but higher smoking (9.1% versus 11.5%) and diabetes (11.1% versus 13.9%). There was no significant increase in hypertension prevalence (58.4% versus 59.8%; age adjusted, 64.3% versus 63.3%), and there was a significant reduction in mean systolic blood pressure (138.0 versus 128.5 mm Hg; P<0.001). Among hypertensive individuals who reported medication use in 2014 and 2019 (n=796), the proportion with controlled hypertension on medication increased from 44.5% to 62.3%. Hypertension incidence was 6.2 per 100 person-years, and age was the only independent predictor. Among normotensive individuals in 2014 (n=2257), 15.2% developed hypertension by 2019, with the majority already controlled on medications by 2019. CONCLUSIONS: The hypertension prevalence and incidence are plateauing in this aging cohort. There was a statistically and clinically significant decline in mean blood pressure and a substantial increase in individuals with controlled hypertension on medication. The prevalence of cardiometabolic risk factors did not decrease over time, suggesting that the blood pressure decrease is likely due to increased medication access and adherence, promoted by local health systems.

Estimating population level 24-h sodium excretion using spot urine samples in older adults in rural South Africa.

BACKGROUND: South Africa has introduced regulations to reduce sodium in processed foods. Assessing salt consumption with 24-h urine collection is logistically challenging and expensive. We assess the accuracy of using spot urine samples to estimate 24-h urine sodium (24hrUNa) excretion at the population level in a cohort of older adults in rural South Africa. METHODS: 24hrUNa excretion was measured and compared to that estimated from matched spot urine samples in 399 individuals, aged 40-75 years, from rural Mpumalanga, South Africa. We used the Tanaka, Kawasaki, International Study of Sodium, Potassium, and Blood Pressure (INTERSALT), and Population Mean Volume (PMV) method to predict 24hrUNa at the individual and population level. RESULTS: The population median 24hrUNa excretion from our samples collected in 2017 was 2.6 g (interquartile range: 1.53-4.21) equal to an average daily salt intake of 6.6 g, whereas 65.4% of participants had a salt excretion above the WHO recommended 5 g/day. Estimated population median 24hrUNa derived from the INTERSALT, both with and without potassium, showed a nonsignificant difference of 0.25 g (P = 0.59) and 0.21 g (P = 0.67), respectively. In contrast, the Tanaka, Kawasaki, and PMV formulas were markedly higher than the measured 24hrUNa, with a median difference of 0.51 g (P = 0.004), 0.99 g (P = 0.00), and 1.05 g (P = 0.00) respectively. All formulas however performed poorly when predicting an individual's 24hrUNa. CONCLUSION: In this population, the INTERSALT formulas are a well suited and cost-effective alternative to 24-h urine collection for the evaluation of population median 24hrUNa excretion. This could play an important role for governments and public health agencies in evaluating local salt regulations and identifying at-risk populations.

Protocol: Implementation evaluation of a combination intervention for sustainable blood pressure control in rural KwaZulu-Natal, South Africa (IMPACT BP): A three-arm, unblinded, parallel group individually randomized clinical trial.

BACKGROUND: Hypertension is the primary risk factor for stroke and heart disease, which are leading causes of death in South Africa. Despite the availability of treatments, there is an implementation gap in how best to deliver hypertension care in this resource-limited region. METHODS: We describe a three-arm parallel group individually randomized control trial to evaluate the effectiveness and implementation of a technology-supported, community-based intervention to improve blood pressure control among people with hypertension in rural KwaZulu-Natal. The study will compare three strategies: 1) standard of care (SOC arm) clinic-based management, 2) home-based blood pressure management supported by community blood pressure monitors (CBPM arm) and a mobile health application to record blood pressure readings and enable clinic-based nurses to remotely manage care, and 3) an identical strategy to the CBPM arm, except that participants will use a cellular blood pressure cuff, which automatically transmits completed readings over cellular networks directly to clinic-based nurses (eCBPM+ arm). The primary effectiveness outcome is change in blood pressure from enrollment to 6 months. The secondary effectiveness outcome is the proportion of participants with blood pressure control at 6 months. Acceptability, fidelity, sustainability, and cost-effectiveness of the interventions will also be assessed. CONCLUSIONS: In this protocol, we report the development of interventions in partnership with the South Africa Department of Health, a description of the technology-enhanced interventions, and details of the study design so that our intervention and evaluation can inform similar efforts in rural, resource-limited settings. PROTOCOL: Version 3 November 9th, 2022. CLINICALTRIALS: gov Trial Registration: NCT05492955 SAHPRA Trial Number: N20211201. SANCTR Number: DOH-27-112,022-4895.

Implementing federal food service guidelines in federal and private worksite cafeterias in the United States leads to improved health outcomes and is cost saving.

Poor diet increases cardiometabolic disease risk, yet the impact of food service guidelines on employee health and its cost effectiveness is poorly understood. Federal food service guidelines (FFSG) aim to provide United States (U.S.) government employees with healthier food options. Using microsimulation modeling, we estimated changes in the incidence of cardiometabolic disease, related mortality, and the cost effectiveness of implementing FFSG in nationally representative model populations of government and private company employees across 5 years and lifetime. We based estimates on changes in workplace intake of six FFSG dietary targets and showed lifetime reductions of heart attacks (- 107/million), strokes (- 30/million), diabetes (- 134/million), ischemic heart disease deaths (- 56/million), and stroke deaths (- 8/million). FFSG is cost saving overall, with total savings in discounted healthcare costs from $4,611,026 (5 years) to $539,809,707 (lifetime) $U.S. This study demonstrates that FFSG improves health outcomes and is cost saving.

Echocardiographic and Electrocardiographic Abnormalities Among Elderly Adults With Cardiovascular Disease in Rural South Africa.

BACKGROUND: Sub-Saharan Africa is undergoing an epidemiological transition fueled by the interaction between infectious and cardiovascular diseases. Our cross-sectional study aimed to characterize the spectrum of abnormalities suggesting end-organ damage on ECG and transthoracic echocardiograms (TTE) among older adults with cardiovascular diseases in rural South Africa. METHODS: The prevalence of ECG and TTE abnormalities was estimated; χ2 analyses and multivariable logistic regressions were performed to test their association with sex, hypertension, and other selected comorbidities. RESULTS: Overall, 729 ECGs and 155 TTEs were completed, with 74 participants completing both. ECG evaluation showed high rates of left ventricular hypertrophy (LVH, 36.5%) and T wave abnormalities (13.6%). TTE evaluation showed high rates of concentric LVH (31.6%), with moderate-severe (56.8%) diastolic dysfunction. Participants with hypertension showed more cardiac remodeling on ECG by LVH (45.4% versus 22.1%, P<0.01), and TTE by concentric LVH (42.5% versus 8.2%, P<0.01) and increased left ventricular mass (58.5% versus 20.4%, P<0.0001). In multivariable logistic regression, systolic blood pressure remained significantly associated with LVH on ECG (adjusted odds ratio, 1.03 per mm Hg [95% CI, 1.03-1.04], P<0.0001) and increased left ventricular mass on TTE (adjusted odds ratio, 1.04 per mm Hg [95% CI, 1.01-1.06], P=0.001). Male participants (n=326, 40.2%) were more likely than females (n=484, 59.8%) to show ECG abnormalities like LVH (45% versus 30.8%, P<0.01), whereas females were more likely to show TTE abnormalities like concentric LVH (40.8% versus 13.5%, P<0.01) and increased left ventricular mass (58.4% versus 23.1%, P<0.0001). Similar results were confirmed in multivariable models. CONCLUSIONS: Our findings suggest that cardiovascular diseases are widespread in rural South Africa, with a larger burden of hypertensive heart disease than previously appreciated, and define the severity of end-organ damage that is already underway. Local health systems must adapt to face the growing burden of hypertension, as suboptimal rates of hypertension diagnosis and treatment may dramatically increase the heart failure burden.

Concordance between fasting plasma glucose and HbA1c in the diagnosis of diabetes in black South African adults: a cross-sectional study.

OBJECTIVES: We investigated concordance between haemoglobin A1c (HbA1c)-defined diabetes and fasting plasma glucose (FPG)-defined diabetes in a black South African population with a high prevalence of obesity. DESIGN: Cross-sectional study. SETTING: Rural South African population-based cohort. PARTICIPANTS: 765 black individuals aged 40-70 years and with no history of diabetes. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was concordance between HbA1c-defined diabetes and FPG-defined diabetes. Secondary outcome measures were differences in anthropometric characteristics, fat distribution and insulin resistance (measured using Homoeostatic Model Assessment of Insulin Resistance (HOMA-IR)) between those with concordant and discordant HbA1c/FPG classifications and predictors of HbA1c variance. RESULTS: The prevalence of HbA1c-defined diabetes was four times the prevalence of FPG-defined diabetes (17.5% vs 4.2%). Classification was discordant in 15.7% of participants, with 111 individuals (14.5%) having HbA1c-only diabetes (kappa 0.23; 95% CI 0.14 to 0.31). Median body mass index, waist and hip circumference, waist-to-hip ratio, subcutaneous adipose tissue and HOMA-IR in participants with HbA1c-only diabetes were similar to those in participants who were normoglycaemic by both biomarkers and significantly lower than in participants with diabetes by both biomarkers (p<0.05). HOMA-IR and fat distribution explained additional HbA1c variance beyond glucose and age only in women. CONCLUSIONS: Concordance was poor between HbA1c and FPG in diagnosis of diabetes in black South Africans, and participants with HbA1c-only diabetes phenotypically resembled normoglycaemic participants. Further work is necessary to determine which of these parameters better predicts diabetes-related morbidities in this population and whether a population-specific HbA1c threshold is necessary.

Health and Economic Impacts of the National Menu Calorie Labeling Law in the United States: A Microsimulation Study.

BACKGROUND: Excess caloric intake is linked to weight gain, obesity, and related diseases, including type 2 diabetes mellitus and cardiovascular disease (CVD). Obesity incidence is rising, with nearly 3 in 4 US adults being overweight or obese. In 2018, the US federal government finalized the implementation of mandatory labeling of calorie content on all menu items across major chain restaurants nationally as a strategy to support informed consumer choice, reduce caloric intake, and potentially encourage restaurant reformulations. Yet, the potential health and economic impacts of this policy remain unclear. METHODS AND RESULTS: We used a validated microsimulation model (CVD-PREDICT) to estimate reductions in CVD events, diabetes mellitus cases, gains in quality-adjusted life years, costs, and cost-effectiveness of the menu calorie labeling intervention, based on consumer responses alone, and further accounting for potential industry reformulation. The model incorporated nationally representative demographic and dietary data from National Health and Nutrition Examination Surveys 2009 to 2016; policy effects on consumer diets and body mass index-disease effects from published meta-analyses; and policy effects on industry reformulation, policy costs (policy administration, industry compliance, and reformulation), and health-related costs (formal and informal healthcare costs, productivity costs) from established sources or reasonable assumptions. We modeled change in calories to change in weight using an established dynamic weight-change model, assuming 50% of expected calorie reductions would translate to long-term reductions. Findings were evaluated over 5 years and a lifetime from healthcare and societal perspectives, with uncertainty incorporated in both 1-way and probabilistic sensitivity analyses. Between 2018 and 2023, implementation of the restaurant menu calorie labeling law was estimated, based on consumer response alone, to prevent 14 698 new CVD cases (including 1575 CVD deaths) and 21 522 new type 2 diabetes mellitus cases, gaining 8749 quality-adjusted life years. Over a lifetime, corresponding values were 135 781 new CVD cases (including 27 646 CVD deaths), 99 736 type 2 diabetes mellitus cases, and 367 450 quality-adjusted life years. Assuming modest restaurant item reformulation, both health and economic benefits were estimated to be about 2-fold larger than based on consumer response alone. The consumer response alone was estimated to be cost-saving by 2023, with net lifetime savings of $10.42B from a healthcare perspective and $12.71B from a societal perspective. Findings were robust in a range of sensitivity analyses. CONCLUSIONS: Our national model suggests that the full implementation of the US calorie menu labeling law will generate significant health gains and healthcare and societal cost-savings. Industry responses to modestly reformulate menu items would provide even larger additional benefits.

Using mH ealth Tools to Improve Access and Coverage of People With Public Health Insurance and High Cardiovascular Disease Risk in Argentina: A Pragmatic Cluster Randomized Trial.

Background Control of cardiovascular disease ( CVD ) risk factors is suboptimal in Argentina, despite the government's provision of free blood pressure and cholesterol-lowering medications for people without private insurance. We assessed whether community health workers' use of an integrated mH ealth tool encourages patients to attend visits at primary care clinics to improve CVD risk management in 2 provinces of Argentina. Methods and Results We conducted a pragmatic cluster randomized trial, with primary care clinics randomly assigned to intervention or control. Eligible people were aged 40 to 79 years, lived in the catchment area of primary care clinics, possessed a mobile phone for personal use, had public health coverage, and a 10-year CVD risk ≥10%. In the control arm, community health workers screened for CVD risk using a paper-based tool and encouraged high-risk people to present to the primary care clinics for care. In the intervention arm, community health workers used the mH ealth tool to calculate CVD risk and confirm a scheduled physician appointment. Primary outcomes were the proportion of participants who attended a baseline visit and completed at least 1 follow-up, respectively. We enrolled 755 people (376 interventions; 379 controls). Intervention participants were significantly more likely to complete baseline visits (49.4% versus 13.5%, P value 0.0008) and follow-up visits (31.9% versus 7.7%; P value 0.0041). The use of chronic medication and current smoking were significant predictors of primary outcomes. Conclusions Use of mH ealth tools identifies patients at high CVD risk in their home, increases the likelihood of participating in chronic CVD risk factor management, and strengthens referrals. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 02913339.

Cardiovascular Disease Profile of the Oldest Adults in Rural South Africa: Data from the HAALSI Study (Health and Aging in Africa: Longitudinal Studies of INDEPTH Communities).

OBJECTIVES: To characterize the cardiovascular disease (CVD) profile of individuals aged 80 and older in rural South Africa. DESIGN: First wave of population-based longitudinal cohort. SETTING: Agincourt subdistrict (Mpumalanga Province) in rural South Africa. PARTICIPANTS: Adults residents (N = 5,059). MEASUREMENTS: In-person interviews were conducted to obtain social, behavioral, economic, and clinical data. Prevalence of hypertension, diabetes, dyslipidemia, high waist-to-hip ratio, overweight and obesity, high-risk high-sensitivity C-reactive protein, smoking, stroke, myocardial infarction, angina pectoris, and heart failure in individuals younger than 65, aged 65 to 79, and aged 80 and older were compared. Associations between self-reported treatments and determinants of hypertension treatment in those aged 80 and older were assessed using multivariable regression. RESULTS: Of 5,059 individuals included, 549 (10.8%) were aged 80 and older, and their CVD prevalence was 17.9% (stroke 3.8%, myocardial infarction 0.5%, angina pectoris 13.5%, heart failure 0.7%). Hypertension prevalence in this group was 73.8%, and along with angina pectoris, it increased with age (p<.001), whereas overweight and obesity (46.4%), dyslipidemia (39.1%), and smoking prevalences (3.1%) decreased (p<.001). Hypertension treatment was significantly associated with being aged 80 and older (odds ratio (OR)=1.48; 95% confidence interval (CI)=1.14-1.92, p=.003). Male sex (OR=0.73, 95% CI=0.66-0.88, p=.001), being an immigrant (OR=0.80, 95% CI=0.65-0.98; p=.03), higher socioeconomic status (OR=1.28, 95% CI=1.06-1.53, p=.009), and higher depression score (OR=1.12, 95% CI=1.05-1.19, p<.001) were associated with hypertension treatment in those aged 80 and older. CONCLUSION: This is the first study to characterize the CVD profile of individuals aged 80 and older in sub-Saharan Africa and provides baseline data for comparison with future studies in this rapidly growing age group. J Am Geriatr Soc 66:2151-2157, 2018.

Self-rated health status and illiteracy as death predictors in a Brazilian cohort.

Cohort studies assessing predictive values of self-rated health (SRH) and illiteracy on mortality in low-to-middle income countries are missing in the literature. Aiming to determine if these two variables were death predictors, an observational prospective population-based cohort study was conducted in a Brazilian small city. The cohort was established in 2002 with a representative sample of adults living in the city, and re-assessed in 2015. Sociodemographic (including illiteracy), anthropometric, lifestyle, previous CVD, and SRH data were collected. Cox proportional hazard models were designed to assess SRH and illiteracy in 2002 as death (all causes, CVD and non-CVD) predictors in 2015. From a total of 1066 individuals included in this study, 95(9%) died of non-CVD causes and 53(5%) from CVD causes. Mortality rates were higher among those with worse SRH in comparison to better health status categories for all causes of death, CVD and non-CVD deaths (p<0.001 for all outcomes). Similarly, illiterate individuals had higher mortality rates in comparison to non-illiterate for all causes of death (p<0.001), CVD (p = 0.004) and non-CVD death (p<0.001). Higher SRH negatively predicted CVD death (HR 0.44; 95%CI 0.44-0.95; p = 0.027) and all causes of death (OR 0.40; 95%CI 0.20-0.78; p = 0.008) while illiteracy positively predicted Non-CVD death (OR 1.59; 95%CI 1.03-2.54; p = 0.046). In conclusion, we found in this large Brazilian cohort followed for 13 years that better health perception was a negative predictor of death from all causes and CVD deaths, while illiteracy was a positive predictor of non-CVD deaths.