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.

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

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.

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 -amp;#91;OR-amp;#93;: 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 -amp;#91;CI-amp;#93;: 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.

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.

External Validation of Cardiovascular Risk Scores in the Southern Cone of Latin America: Which Predicts Better? / Validación externa de ecuaciones de riesgo cardiovascular en el Cono Sur de Latinoamérica: ¿cuál predice mejor?

ABSTRACT: Background: Inaccurate estimates of demographic cardiovascular risk may lead to an inadequate management of preventive medical interventions such as the use of statins. Objectives: The aim of this study was to evaluate the external validity of cardiovascular risk equations in the general population of the Southern Cone of Latin America. Methods: Equations including variables evaluated in the CESCAS cohort study and that estimate overall cardiovascular mortality (CUORE, Framingham, Globorisk and Pooled Cohort Studies) were assessed. For each equation, an independent analysis was per-formed taking into account the cardiovascular events originally considered. Discrimination of each equation was evaluated through C-statistic and Harrell's C-index. To assess calibration, a graph was built for each equation with the proportion of observed events vs. the proportion of estimated events by risk quintiles and the β slope of the resulting linear regression was calculated. Sensitivity and specificity were determined for the detection of people at high cardiovascular risk. results: The median follow-up time of the cohort at the time of the analysis was 2.2 years, with an interquartile range of 1.9 to 2.8 years. Sixty cardiovascular events were incorporated into the analysis. All C-statistic and Harrell's-C index values were greater than 0.7. The value of the β slope farthest from 1 was that of the Pooled Cohort Studies score. Conclusions: Although the external validation parameters evaluated were similar, CUORE, Globorisk and the Framingham equa-tions showed the best global performance for cardiovascular risk estimation in our population.

RESUMEN: introducción: La estimación inexacta del riesgo cardiovascular poblacional puede llevar a un manejo inadecuado de las intervenciones médicas preventivas, como, por ejemplo, el uso de estatinas. Objetivo: Evaluar la validez externa de ecuaciones de predicción de riesgo cardiovascular en población general del Cono Sur de Latinoamérica. Material y métodos: Se evaluaron ecuaciones que incluyen variables evaluadas en el estudio CESCAS y que predicen tanto morbilidad como mortalidad cardiovascular global (CUORE, Framingham, Globorisk y Pooled Cohort Studies Equations). Para cada ecuación se realizó un análisis independiente en el que se tuvieron en cuenta los eventos cardiovasculares relevados. Se evaluó la discriminación de cada ecuación a través del cálculo del estadístico-C y el índice Harrell C. Para evaluar la calibración se graficó la proporción de riesgos observados vs. estimados por quintilos de riesgo para cada ecuación y se calculó la pendiente β de regresión lineal para las estimaciones. Se calculó sensibilidad y especificidad para la detección de personas con elevado riesgo cardiovascular. resultados: La mediana del tiempo de seguimiento de la cohorte al momento del análisis es de 2,2 años, con un rango intercuartilo de 1,9 a 2,8 años. Se incorporaron a los análisis 60 eventos cardiovasculares. Todos los valores de estadístico-C y del índice de Harrell fueron superiores a 0,7. El valor de la pendiente β más alejado de 1 fue el de Pooled Cohort Studies Euations. Conclusiones: Si bien los parámetros de validación externa evaluados fueron similares, CUORE, Globorisk y el índice de Framing-ham fueron las ecuaciones con mejores indicadores globales de predicción de riesgo cardiovascular.