Hypertension in Guatemala's Public Primary Care System: A Needs Assessment Using the Health System Building Blocks Framework.

BACKGROUND: Uncontrolled hypertension represents a substantial and growing burden in Guatemala and other low and middle-income countries. As a part of the formative phase of an implementation research study, we conducted a needs assessment to define short- and long-term needs and opportunities for hypertension services within the public health system. METHODS: We conducted a multi-method, multi-level assessment of needs related to hypertension within Guatemala's public system using the World Health Organization's health system building blocks framework. We conducted semi-structured interviews with stakeholders at national (n = 17), departmental (n = 7), district (n = 25), and community (n = 30) levels and focus groups with patients (3) and frontline auxiliary nurses (3). We visited and captured data about infrastructure, accessibility, human resources, reporting, medications and supplies at 124 health posts and 53 health centers in five departments of Guatemala. We conducted a thematic analysis of transcribed interviews and focus group discussions supported by matrix analysis. We summarized quantitative data observed during visits to health posts and centers. RESULTS: Major challenges for hypertension service delivery included: gaps in infrastructure, insufficient staffing and high turnover, limited training, inconsistent supply of medications, lack of reporting, low prioritization of hypertension, and a low level of funding in the public health system overall. Key opportunities included: prior experience caring for patients with chronic conditions, eagerness from providers to learn, and interest from patients to be involved in managing their health. The 5 departments differ in population served per health facility, accessibility, and staffing. All but 7 health posts had basic infrastructure in place. Enalapril was available in 74% of health posts whereas hydrochlorothiazide was available in only 1 of the 124 health posts. With the exception of one department, over 90% of health posts had a blood pressure monitor. CONCLUSIONS: This multi-level multi-method needs assessment using the building blocks framework highlights contextual factors in Guatemala's public health system that have been important in informing the implementation of a hypertension control trial. Long-term needs that are not addressed within the scope of this study will be important to address to enable sustained implementation and scale-up of the hypertension control approach.

Association between drinking patterns and cardiovascular risk: a population-based study in the Southern Cone of Latin America.

BACKGROUND: Using data from general adult population, this study aims to describe epidemiology of alcohol consumption patterns and their association with cardiovascular risk. METHODS: CESCAS I is a population-based study from four mid-sized cities in Argentina, Chile and Uruguay. Associations between diabetes, hypertension, dyslipidemia, cardiovascular disease (CVD) risk and history of CVD and drinking patterns were assessed using crude prevalence odds ratios (ORs) and adjusted OR. RESULTS: A total of 37.2% of the studied population never drank and 18.3% reported to be former drinkers. Among current drinkers, moderate drinking was the most frequent pattern (24.2%). For women with light and moderate consumption, the odds of having >20% CVD risk was ~40% lower than that of never drinkers. The odds of having a history of CVD was 50% lower in those with moderate consumption. For men with heavy consumption, the odds of having >20% CVD risk was about twice as high as for never drinkers. CONCLUSIONS: A harmful association was observed between heavy drinking and having >20% CVD risk for men. However, for women, an apparently protective association was observed between light and moderate drinking and having >20% CVD risk and between moderate drinking and having a history of CVD.

Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol.

BACKGROUND: Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life. The level of parasitemia is a known risk factor for congenital transmission. Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load. The fear of treatment-related side effects limits the implementation of the Argentine guideline recommending BZN 60d/300 mg (or equivalent) treatment of T. cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy. A short and low dose BZN treatment might reduce major side effects and increase compliance, but its efficacy to reduce T. cruzi parasitic load compared to the standard 60d/300 mg course is not yet established. Clinical trials testing alternative BZN courses among women of reproductive age are urgently needed. METHODS AND DESIGN: We are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short low dose 30-day treatment with BZN 150 mg/day (30d/150 mg) vs. BZN 60d/300 mg. We will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum, and follow them up with the following specific aims: Specific aim 1: to measure the effect of BZN 30d/150 mg compared to 60d/300 mg preconceptional treatment on parasitic load measured by the frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR), immediately and 10 months after treatment. Specific aim 2: to measure the frequency of serious adverse events and/or any adverse event leading to treatment interruption. TRIAL REGISTRATION: ClinicalTrials.gov . Identifier: NCT03672487 . Registered 14 September 2018.

Hypothetical interventions to prevent stroke: an application of the parametric g-formula to a healthy middle-aged population.

The effects of interventions on multiple lifestyle and metabolic risk factors, initiated in midlife or later in a healthy population, on the long-term risk of first-ever stroke is not known. A particular methodological challenge in observational studies is to estimate the unbiased effect of a time-varying exposure in presence of time-varying confounders, if those confounders are affected by prior exposure. In such cases, the parametric g-formula can be applied to estimate an unbiased effect. We applied the parametric g-formula to estimate the 18-years (1994-2012) cumulative stroke risk under different scenarios of hypothetical interventions on levels of blood pressure, cholesterol, weight, physical activity, smoking and alcohol intake; and compared these to the observed scenario, to calculate the population risk ratios and risk differences. Among 14,796 eligible participants in the prospective, population-based Tromsø study (baseline mean age 46.1 years, 51% women), the observed 18-years stroke risk was 5.9%. A feasible joint hypothetical intervention on six lifestyle and metabolic risk factors would reduce the 18-year stroke risk by 32% (95% confidence interval 16, 44). A combination of more intensive interventions reduced the estimated 18-years stroke risk by 64% (95% confidence interval 40, 80). Blood pressure reduction and quitting smoking significantly reduced the risk when applied separately.

Effect of a Community Health Worker-Led Multicomponent Intervention on Blood Pressure Control in Low-Income Patients in Argentina: A Randomized Clinical Trial.

Importance: Despite extensive knowledge of hypertension treatment, the prevalence of uncontrolled hypertension is high and increasing in low- and middle-income countries. Objective: To test whether a community health worker-led multicomponent intervention would improve blood pressure (BP) control among low-income patients with hypertension. Design, Setting, and Participants: A cluster randomized trial was conducted in 18 centers for primary health care within a national public system providing free medications and health care to uninsured patients in Argentina. A total of 1432 low-income adult patients with uncontrolled hypertension were recruited between June 2013 and April 2015 and followed up to October 2016. Interventions: Nine centers (743 patients) were randomized to the multicomponent intervention, which included a community health worker-led home intervention (health coaching, home BP monitoring, and BP audit and feedback), a physician intervention, and a text-messaging intervention over 18 months. Nine centers (689 patients) were randomized to usual care. Main Outcomes and Measures: The coprimary outcomes were the differences in systolic and diastolic BP changes from baseline to the end of follow-up of patients with hypertension. Secondary outcomes included the proportion of patients with controlled hypertension (BP <140/90 mm Hg). Three BP measurements were obtained at each of 2 baseline and 2 termination visits using a standard protocol, the means of which were used for analyses. Results: Of 1432 participants (mean age, 55.8 years [SD, 13.3]; 772 women [53.0%]), 1357 (94.8%) completed the trial. Baseline mean systolic BP was 151.7 mm Hg for the intervention group and 149.8 mm Hg for the usual care group; the mean diastolic BP was 92.2 mm Hg for the intervention group and 90.1 mm Hg for the usual care group. Systolic BP reduction from baseline to month 18 was 19.3 mm Hg (95% CI, 17.9-20.8 mm Hg) for the intervention group and 12.7 mm Hg (95% CI, 11.3-14.2 mm Hg) for the usual care group; the difference in the reduction was 6.6 mm Hg (95% CI, 4.6-8.6; P < .001). Diastolic BP decreased by 12.2 mm Hg (95% CI, 11.2-13.2 mm Hg) in the intervention group and 6.9 mm Hg (95% CI, 5.9-7.8 mm Hg) in the control group; the difference in the reduction was 5.4 mm Hg (95% CI, 4.0-6.8 mm Hg; P < .001). The proportion of patients with controlled hypertension increased from 17.0% at baseline to 72.9% at 18 months in the intervention group and from 17.6% to 52.2% in the usual care group; the difference in the increase was 20.6% (95% CI, 15.4%-25.9%; P < .001). No adverse events were reported. Conclusions and Relevance: Low-income patients in Argentina with uncontrolled hypertension who participated in a community health worker-led multicomponent intervention experienced a greater decrease in systolic and diastolic BP than did patients who received usual care over 18 months. Further research is needed to assess generalizability and cost-effectiveness of this intervention and to understand which components may have contributed most to the outcome. Trial Registration: clinicaltrials.gov Identifier: NCT01834131.

A Multi-Component Intervention to Improve Therapeutic Adherence in Uncontrolled Hypertensive Patients Within the Primary Care Level: A Before-and-After Study.

INTRODUCTION: Non-adherence to medication severely affects chronic disease control. AIM: To assess whether a multi-component intervention implemented at the public primary care level in Argentina improves adherence to antihypertensive medication and helps to reduce blood pressure (BP) levels in uncontrolled hypertensive patients. METHODS: A before-and-after study was conducted in five public primary care clinics located in the city of Almirante Brown, Argentina. One hundred and twenty-five uncontrolled hypertensive patients received a multi-component intervention based on the Chronic Care model and the 5As strategy (Ask, Advise, Agree, Assist, and Arrange). Medication possession ratio (MPR) and BP values were assessed before and after a 6-month period. RESULTS: The follow-up rate was 96.8%. Main baseline characteristics were as follows, male: 44.8%, mean age: 57.1 years (± 8.1), exclusive public healthcare coverage: 83.5%, primary school level or less: 68.8%, and mean systolic/diastolic BP: 157.4 (± 13.6)/97.7 (± 8.2) mmHg. After implementing the intervention, a significant increase in the proportion of adequate adherence (MPR ≥ 80%) was observed, from 16.8% at baseline to 47.2% (p < 0.001). A significant reduction of 16.4 mmHg (CI 95%: 19.6, 13.1) was observed for systolic blood pressure (SBP) and 12.0 mmHg (CI 95%: 14.2, 9.9) for diastolic blood pressure (DBP) (p < 0.001). At 6 months, 51.2% of the population achieved blood pressure control (SBP < 140 mmHg and DBP < 90 mmHg). CONCLUSIONS: The study intervention was associated with an increased adherence rate, achieving a significant reduction in BP values and reaching BP control in more than half of the population.

Compliance with a WHO guideline for cardiovascular disease prevention. A population based cross-sectional study in Argentina.

INTRODUCTION: Current recommendations for cardiovascular disease (CVD) prevention are guided CVD risk classification. This study aims to analyze the level of compliance with pharmacological and non-pharmacological recommendations outlined in the World Health Organization (WHO) CVD prevention clinical practice guideline within the general population of two cities in Argentina. METHODS: We analyzed the compliance with preventive recommendations from the WHO 2007 Guidelines for Management of Cardiovascular Risk in two cities of Argentina participating in the CESCAS population-based study in the Southern Cone of Latin America. RESULTS: 3990 participants were included. Considering the WHO recommendations, the use of antiplatelet medication was 5.6% (95% CI 3.5, 8.9) in primary prevention and 20.5% (95%= CI 16.0, 25.9) in secondary prevention. Regarding lipid-lowering medication, it was 6.7% (CI 95%= 4.4, 10.1) and 15.4% (CI 95%= 11.6, 20.1), respectively. As per non-pharmacological recommendations in the general population: low intake of fruit and vegetables was 78.4% (CI 95%= 76.8, 79.9); low physical activity was 26.9% (CI 95%= 25.3, 28.5), current cigarette smoking was 28.3% (CI 95%= 26.6, 30.0), overweight/obesity was 73.9% (CI 95%= 72.3, 75.6), and excessive alcohol intake was 2.6% (CI 95%= 2.1, 3.4). CONCLUSIONS: It was observed a significantly low compliance with pharmacological and non-pharmacological recommendations for CVD prevention in the general population of two cities in Argentina. Urgent efforts are needed to improve compliance to cardiovascular preventive recommendations promoted by CPG, especially in Low- and Middle- Income Countries.

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.

Risk factor clustering in men and women with CHD in the Southern Cone of Latin America.

Background: Presence of multiple risk factors (RF) increases the risk for cardiovascular morbidity and mortality, and this is especially important in patients with coronary heart disease (CHD). The current study investigates sex differences in the presence of multiple cardiovascular RF in subjects with established CHD in the southern Cone of Latin America. Methods: We analyzed cross-sectional data from the 634 participants aged 35-74 with CHD from the community-based CESCAS Study. We calculated the prevalence for counts of cardiometabolic (hypertension, dyslipidemia, obesity, diabetes) and lifestyle (current smoking, unhealthy diet, low physical activity, excessive alcohol consumption) RF. Differences in RF number between men and women were tested with age-adjusted Poisson regression. We identified the most common RF combinations among participants with ≥4 RF. We performed a subgroup analysis by educational level. Results: The prevalence of cardiometabolic RF ranged from 76.3% (hypertension) to 26.8% (diabetes), and the prevalence of lifestyle RF from 81.9% (unhealthy diet) to 4.3% (excessive alcohol consumption). Obesity, central obesity, diabetes and low physical activity were more common in women, while excessive alcohol consumption and unhealthy diet were more common in men. Close to 85% of women and 81.5% of men presented with ≥4 RF. Women presented with a higher number of overall (relative risk (RR) 1.05, 95% CI 1.02-1.08) and cardiometabolic RF (1.17, 1.09-1.25). These sex differences were found in participants with primary education (RR women overall RF 1.08, 1.00-1.15, cardiometabolic RF 1.23, 1.09-1.39), but were diluted in those with higher educational attainment. The most common RF combination was hypertension/dyslipidemia/obesity/unhealthy diet. Conclusion: Overall, women showed a higher burden of multiple cardiovascular RF. Sex differences persisted in participants with low educational attainment, and women with low educational level had the highest RF burden.

Blood Pressure Association with the 8-Item Morisky Medication Adherence Scale in Hypertensive Adults from Low-Resource Primary Care Settings: Results from a Prospective Cohort Nested within a Randomised Controlled Trial.

INTRODUCTION: One of the self-report adherence scales most widely used is the 8-item Morisky Medication Adherence Scale (MMAS-8). AIM: To evaluate construct validity and reliability of the MMAS-8 in hypertensive adults from low-resource settings within the public primary care level in Argentina. METHODS: Prospective data from hypertensive adults under antihypertensive pharmacological treatment that participated in the "Hypertension Control Program in Argentina" study was analyzed. Participants were followed at baseline, 6, 12 and 18 months. Based on MMAS-8, adherence was defined as low (score < 6), medium (score 6 to < 8) and high (score of 8). RESULTS: 1214 participants were included in the analysis. In comparison to low adherence, high adherence category was associated with a reduction of - 5.6 mmHg (CI 95%: - 7.2; - 4.0) in systolic blood pressure (BP) and - 3.2 mmHg (CI 95%: - 4.2; - 2.2) in diastolic BP; and with a 56% higher likelihood to have controlled BP (p < .0001). Among those participants with baseline score ≤ 6, two points increase in MMAS-8 along follow-up showed a tendency to reduce BP in almost all-time points and a 34% higher likelihood of having controlled BP at the end of the follow-up (p = 0.0039). Cronbach's alpha total-item values in all time-points were higher than 0.70. CONCLUSIONS: Higher MMAS-8 categories were positively associated with BP reduction and higher likelihood of BP control over time. Internal consistency was acceptable and in line with previous studies.

Elevated Lipoprotein(a) prevalence and association with family history of premature cardiovascular disease in general population with moderate cardiovascular risk and increased LDL cholesterol.

Background: Elevated Lipoprotein(a) [Lp(a)] is independently associated with increased cardiovascular disease (CVD) risk. There are discrepancies regarding its epidemiology due to great variability in different populations. This study aimed to evaluate the prevalence of elevated Lp(a) in people with moderate CVD risk and increased LDL-c and to determine the association between family history of premature CVD and elevated Lp(a). Methods: Random subjects from the CESCAS population-based study of people with moderate CVD risk (Framingham score 10-20 %) and LDL-c ≥ 130 mg/dL, were selected to evaluate Lp(a) by immunoturbidimetry independent of the Isoforms variability. The association between family history of premature CVD and elevated Lp(a) was evaluated using multivariate logistic regression models. Elevated Lp(a) was defined as Lp(a) ​​≥ 125 nmol/L. Results: Lp(a) was evaluated in 484 samples; men = 39.5 %, median age = 57 years (Q1-Q3: 50-63), mean CVD risk = 14.4 % (SE: 0.2), family history of premature CVD = 11.2 %, Lp(a) median of 21 nmol/L (Q1-Q3: 9-42 nmol/L), high Lp(a) = 6.1 % (95 % CI = 3.8-9.6). Association between family history of premature CVD and elevated Lp(a) in total population: OR 1.31 (95 % CI = 0.4, 4.2) p = 0.642; in subgroup of people with LDL-c ≥ 160 mg%, OR 4.24 (95 % CI = 1.2, 15.1) p = 0.026. Conclusions: In general population with moderate CVD risk and elevated LDL-c from the Southern Cone of Latin America, less than one over ten people had elevated Lp(a). Family history of premature CVD was significantly associated with the presence of elevated Lp(a) in people with LDL-c ≥ 160 mg/dL.

Monitoring Study Participants and Implementation with Phone Calls to Support Hypertension Control During the COVID-19 Pandemic: The Case of a Multicomponent Intervention Trial in Guatemala.

Background: The COVID-19 pandemic presents a challenge to health care for patients with chronic diseases, especially hypertension, because of the important association and increased risk of these patients with a severe presentation of COVID-19 disease. The Guatemalan Ministry of Health has been implementing a multi-component program aimed at improving hypertension control in rural communities since 2019 as a part of an intervention research cluster randomized trial. When the first cases of COVID-19 were reported (March 13, 2020) in Guatemala, our study paused all study field activities, and began monitoring participants through phone calls. The objective of this paper is to describe the approach used to monitor study participants during the COVID-19 pandemic and compare data obtained during phone calls for intervention and control group participants. Methods: We developed a cross-sectional study within the HyTREC (Hypertension Outcomes for T4 Research within Lower Middle-Income Countries) project 'Multicomponent Intervention to Improve Hypertension Control in Central America: Guatemala' in which phone calls were made to participants from both intervention and control groups to monitor measures important to the study: delivery of antihypertensive medications in both groups, receipt of coaching sessions and use of a home blood pressure monitor by intervention group participants, as well as reasons that they were not implemented. Results: Regarding the delivery of antihypertensive drugs by the MoH to participants, those in the intervention group had a higher level of medication delivery (73%) than the control group (51%), p<0.001. Of the total participants in the intervention group, 62% had received at least one health coaching session in the previous three months and 81% used a digital home blood pressure monitor at least twice a week. Intervention activities were lower than expected due to restricted public transportation on top of decreased availability of health providers. Conclusion: In Guatemala, specifically in rural settings, access to antihypertensive medications and health services during pandemic times was impaired and less than expected, even after accounting for the program's implementation activities and actions.

Adherence to Drinking Guidelines and Reasons for Alcohol Consumption Cessation in the Southern Cone of Latin America - Findings from the CESCAS Study.

Introduction: Alcohol consumption is a risk factor for morbidity and mortality globally. Consumption levels in Southern Latin America are among the highest in the world. Objectives: To describe consumption patterns and adherence to guidelines in the general adult population of Southern Latin America, as well as exploration of reasons for alcohol cessation and the advising role of the health worker in this decision. Methods: In 7,520 participants from the Centro de Excelencia en Salud Cardiovascular para el America del Sur (CESCAS) cohort, consumption patterns were described and the proportion excessive drinkers (i.e. >7 units/week for women and >14 for men or binge drinking: >4 (women) or >5 (men) units at a single occasion) was calculated. Former drinkers were asked if they had quit alcohol consumption on the advice of a health worker and/or because of health reasons. Furthermore, among former drinkers, multivariable logistic regression analysis was performed to assess which participant characteristics were independently associated with the chance of quitting consumption on a health worker's advice. Results: Mean age was 54.8 years (SD = 10.8), 42% was male. Current drinking was reported by 44.6%, excessive drinking by 8.5% of the population. In former drinkers, 23% had quit alcohol consumption because of health reasons, half of them had additionally quit on the advice of a health worker. The majority of former drinkers however had other, unknown, reasons. When alcohol cessation was based on a health worker's advice, sex, country of residence, educational status and frequency of visiting a physician were independent predictors. Conclusion: In this Southern American population-based sample, most participants adhered to the alcohol consumption guidelines. The advising role of the health worker in quitting alcohol consumption was only modest and the motivation for the majority of former drinkers remains unknown. A more detailed assessment of actual advice rates and exploration of additional reasons for alcohol cessation might be valuable for alcohol policy making.

Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial.

BACKGROUND: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback. METHODS: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness. DISCUSSION: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03504124. Registered on 20 April 2018.

Epidemiology of early repolarization pattern in an adult general population.

Background: Early repolarization pattern (ERP) is a frequent finding in asymptomatic subjects with controversial implications regarding to its prognosis. This study aims to estimate the prevalence of ERP and its association with sociodemographic characteristics and cardiovascular risk factors among the adult population in the Southern Cone of Latin America.Methods: A sub-sample of 5398 participants of the CESCAS I study was included in the present analysis. ERP was defined as a J peak ≥0.1 mV in two or more contiguous leads with an end-QRS notch or slur on the downslope of a prominent R-wave.Results: The global prevalence of ERP was 8.1%; 11.1% in men and 5.6% in women. The prevalence in women increased with age (odds ratio [OR] 2.5, 95% confidence interval [CI] 1.5-4.2, at >65 years, p < 0.001), current cigarette smoking (OR 1.4, 95%CI 1.0-2.0, p = 0.045) and hypercholesterolaemia (OR 1.4, 95%CI 1.0-2.0, 0 p = 0.036). Conversely, in men, ERP prevalence decreased with age (OR 0.5, 95%CI 0.3-0.9, at >65 years, p = 0.01) and obesity (OR 0.6, 95%CI 0.4-0.8, p = 0.006). We found an increasing ERP prevalence with a higher Sokolow-Lyon index in both sexes (p < 0.001). Inferior location was found in 67.9% of cases, and the most common ERP type was a "slurring" appearance without ST elevation (76.3%).Conclusions: We found an overall prevalence of ERP of 8.1% and a robust association of ERP with normal BMI and higher Sokolow-Lyon index in men and with hypercholesterolaemia, current cigarette smoking and higher Sokolow-Lyon index in women.

The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk.

BACKGROUND: Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations. AIM: The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older. METHODS: This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer. RESULTS: We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals. CONCLUSIONS: We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.

Cluster Randomized Trial for Hypertension Control: Effect on Lifestyles and Body Weight.

INTRODUCTION: Lifestyle modification, such as healthy diet habits, regular physical activity, and maintaining a normal body weight, must be prescribed to all hypertensive individuals. This study aims to test whether a multicomponent intervention is effective in improving lifestyle and body weight among low-income families. STUDY DESIGN: Cluster randomized trial conducted between June 2013 and October 2016. SETTING/PARTICIPANTS: A total of 1,954 uninsured adult patients were recruited in the study within 18 public primary healthcare centers of Argentina. INTERVENTION: Components targeting the healthcare system, providers, and family groups were delivered by community health workers; tailored text messages were sent for 18 months. MAIN OUTCOME MEASURES: Changes in the proportion of behavioral risk factors and body weight from baseline to end of follow-up. Data were analyzed in 2017. RESULTS: Low fruit and vegetable consumption (fewer than 5 servings per day) decreased from 96.4% at baseline to 92.6% at 18 months in the intervention group, whereas in the control group it increased from 97.0% to 99.9% (p=0.0110). The proportion of low physical activity (<600 MET-minutes/week) decreased from 54.3% at baseline to 46.2% at 18 months in the intervention group and kept constant around 52% (p=0.0232) in the control group. The intervention had no effect on alcohol intake (p=0.7807), smoking (p=0.7607), addition of salt while cooking or at the table (p=0.7273), or body weight (p=0.4000). CONCLUSIONS: The multicomponent intervention was effective for increasing fruit and vegetable intake and physical activity with no effect on alcohol consumption, smoking, addition of salt, or body weight among low-income families in Argentina. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01834131.

An Educational Intervention to Improve Statin Use: Cluster RCT at the Primary Care Level in Argentina.

INTRODUCTION: Statins are essential drugs for high cardiovascular disease (CVD) risk management; however, there is still low adherence to good clinical practice guidelines for statin use at the primary care level in low- and middle-income countries. This study aimed to test whether a complex intervention targeting physicians improves treatment and control of hypercholesterolemia among patients with moderate to high CVD risk in Argentina. STUDY DESIGN: Cluster RCT. SETTING/PARTICIPANTS: Ten primary care centers from the public healthcare system of Argentina. INTERVENTION: Primary care physicians in the intervention group received an educational program with three main components: (1) an intensive 2-day training workshop; (2) educational outreach visits; and (3) a mobile health application installed on the physician's smartphones. MAIN OUTCOME MEASURES: Reduction in mean low-density lipoprotein cholesterol level, reduction in mean Framingham risk score, proportion of patients receiving an appropriate statin dose, and mean annual number of primary care center visits. RESULTS: Data were analyzed in 2017-2018. Between April 2015 and April 2016, a total of 357 participants were enrolled (179 patients in the intervention group and 178 in the control group). The global follow-up rate was 97.2%. At the end of the follow-up period, there was no difference in low-density lipoprotein cholesterol levels in any of the follow-up points among the groups. Mean CVD risk had a significant net difference in the first 6 months in the intervention group versus the control group (-4.0, 95% CI = -6.5, -1.5). At the end of follow-up, there was an absolute 41.5% higher rate of participants receiving an appropriate statin dose in the intervention group versus the control group. CONCLUSIONS: Although the intervention did not reach a reduction in cholesterol levels, it had a significant positive impact on the promotion of adequate use of clinical practice guidelines. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02380911.

Long-term moderately elevated LDL-cholesterol and blood pressure and risk of coronary heart disease.

BACKGROUND: Harmful effects of long-term exposure to moderately elevated low-density lipoprotein (LDL)-cholesterol and blood pressure on coronary heart disease (CHD) have not been rigorously examined. We estimated the risk of CHD under long-term exposure to moderately elevated LDL-cholesterol and blood pressure compared with the risk under shorter exposures to higher levels of the same risk factors. METHODS: Observational study using data from 2,714 adults in Framingham Offspring Study who were free of existing cardiovascular disease and aged <70 years at baseline (1987-1991). We used the parametric g-formula to estimate 16-year CHD risk under different levels and durations of exposure to LDL-cholesterol (low: <130 mg/dL, moderate: 130 to <160 mg/dL, high 160 to <190 mg/dL, and very high: ≥190 mg/dL) and systolic blood pressure (low: <120 mmHg, prehypertension: 120 to <140 mmHg, stage 1 hypertension: 140 to <160 mmHg, and stage 2 hypertension: ≥160 mmHg). RESULTS: The estimated 16-year CHD risk under exposure to low LDL was 8.2% (95% CI = 7.0-9.6). The 16-year CHD risk under exposure to moderate LDL was 8.9% (7.8-10.1) which was similar to CHD risk under 8 years of low LDL followed by 8 years of high LDL at 9.0% (7.7-10.3); and 12 years of low LDL followed by 4 years of very high LDL at 8.8% (7.6-10.1). The results for blood pressure were similar. CONCLUSIONS: Long-term exposure to moderate levels of LDL-cholesterol and blood pressure had a similar impact on CHD risk as shorter exposures to levels considered 'high' per clinical guidelines.

Smoke-Free Adolescents. Effectiveness of an educational intervention. Controlled, before and after study. / Adolescentes Libres de Tabaco. Efectividad de una intervención educativa. Estudio antes-después controlado.

Smoking is considered the main cause of preventable death worldwide. Most smokers start using tobacco at an early age, especially during adolescence. The objective of this study was to identify the determinants of adolescent use of tobacco and assess the impact of an educational intervention on the prevalence of smoking. Methods. Controlled, before and after study conducted between 2010 and 2012 at two secondary schools in the city of La Plata. A baseline survey was administered at both schools followed by two subsequent measurements; an educational intervention aimed at youth aged 12 and 13 years was implemented in one of the schools. Multiple regression models were used to identify the outcome measures associated with smoking and assess the impact of the intervention. Results. A total of 1911 surveys were included (school A: 617; school B: 1294). The outcome measures associated with adolescent smoking were having a sibling who smokes (odds ratio [OR]: 2.55), a mother who smokes (OR: 2.32), age (OR: 1.92), and female sex (OR: 1.75). The OR adjusted for these determinants to be a current smoker at the intervention school versus the control school was 0.54 (95% confidence interval [CI]: 0.35-0.83) in the first year of follow-up and 0.98 (95% CI: 0.60-1.61) in the second year. Conclusions. Having a mother or a sibling who smokes, age, and female sex were strongly correlated to cigarette smoking. The educational intervention had a positive effect in the first year of follow-up, which was not maintained over time

El tabaquismo es considerado la principal causa de muerte prevenible en el mundo. La mayoría de los fumadores inician esta adicción durante edades tempranas, especialmente, durante la adolescencia. El objetivo del estudio fue identificar los determinantes de consumo adolescente y evaluar el impacto de una intervención educativa en la prevalencia del tabaquismo. Métodos. Estudio antes-después controlado, realizado durante los años 2010-2012 en dos colegios secundarios de la ciudad de La Plata. En ambos, se realizó una encuesta basal seguida de dos mediciones posteriores; en uno de ellos, se implementó una intervención educativa dirigida a jóvenes de 12 y 13 años. Se utilizaron modelos de regresión múltiple para identificar las variables asociadas al tabaquismo y evaluar el impacto de la intervención. Resultados. Se incluyeron 1911 encuestas (Colegio A: 617; Colegio B: 1294). Las variables asociadas al tabaquismo adolescente fueron la tenencia de un hermano fumador (odds ratio ­OR­ 2,55), madre fumadora (OR 2,32), años de edad (OR 1,92) y el sexo femenino (OR 1,75). El OR ajustado por dichos determinantes para ser fumador actual en el colegio intervención versus el control fue 0,54 (intervalo de confianza ­IC­ del 95%: 0,35-0,83) en el primer año de seguimiento y 0,98 (IC 95%: 0,60-1,61) en el segundo año. Conclusiones. La tenencia de una madre o un hermano fumador, la edad y el sexo femenino se correlacionaron fuertemente con el consumo de cigarrillos. La intervención educativa tuvo un efecto positivo en el primer año de seguimiento, pero luego no se mantuvo.