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A moderate level of physical activity (PA), such as a daily 30-min walk, reduces cardiovascular risk. There is a lack of evidence about the cardiovascular benefits of PA below this recommendation of minimum PA level.We aimed to study the impact of a lower level of PA on cardiovascular health.Sixty-four overweight/obese men and women were enrolled in a community programme consisting of 4 months of 1h, low-intensity PA two days per week. Before and after the intervention, PA level (METs/h/wk), endogenous antioxidant status (SOD and GPX concentration and activity and oxidised LDL), ADMA concentrations, endothelial function by small artery reactive hyperaemia index (saRHI), and resting heart rate (RHR) were assessed.After the intervention, significant increases in saRHI (P=0.031), SOD and GPX activities, and a decrease in ADMA plasma concentrations, and RHR (P0.001 for all) were observed. Increases in PA were positively associated with increases in saRHI (r=0.341, P=0.022), GPx (r=0.303, P=0.047) and decreases in RHR (r=-0.302, P=0.047). Multivariate analyses showed that independent predictors of saRHI improvement were an increase in PA (2.65, 95%CI: 1.21-4.01), decrease in RHR (1.91, 95%CI: 1.01-4.98), and an increase in GPx (2.61, 95%CI: 1.16-5.01).In obese and overweight men and women, an increase in PA, even below the minimal international recommendations, improves antioxidant capacity, RHR and peripheral small artery reactivity.

Background & aimsMetabolic syndrome (MetS) has become an important public concern due to its increasing prevalence. An altered fatty acid composition has been associated with MetS, but the Mediterranean diet has been shown to have a protective effect. The aim of the present study was to analyze the influence of a Mediterranean dietary pattern, as assessed by the biomarkers of food supplied, on the plasma fatty acid composition and its relation with MetS after 1 year of intervention.MethodsA total of 424 subjects were randomly selected from the PREDIMED randomized dietary trial after completing a 1-year intervention program. Participants aged 55 to 80 years and at high risk of cardiovascular disease were randomly assigned to three dietary interventions: Mediterranean diet supplemented with virgin olive oil or nuts, or a low-fat diet.ResultsAfter 1 year of intervention participants in the virgin olive oil group showed significantly increased plasma concentrations of palmitic and oleic acids, but reduced proportions of margaric, stearic, and linoleic acids. In turn, subjects in the nut group showed significantly increased levels of palmitic, linoleic, and α-linolenic acids, but reduced proportions of myristic, margaric, palmitoleic, and dihommo-γ-linoleic acids. Increases in the biomarkers of foods supplied to the Mediterranean diet groups, i.e., oleic and α-linolenic acids, were beneficially associated with the incidence, reversion and prevalence of MetS. No weight changes were observed among participants.ConclusionsThe nut and olive oil diets induced a fatty acid composition that has been shown to be beneficial in the face of MetS. Therefore, a Mediterranean diet rich in fats of vegetable origin may be a useful tool for the management of MetS without the need for concerns over weight gain due to its high fat content.Trial registrationControlled-Trials.com ISRCTN35739639.

BackgroundBenzodiazepines are extensively used in primary care, but their long-term use is associated with adverse health outcomes and dependence.AimsTo analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use.MethodA multicentre three-arm cluster randomised controlled trial was conducted, with randomisation at general practitioner level (trial registration ISRCTN13024375). A total of 532 patients taking benzodiazepines for at least 6 months participated. After all patients were included, general practitioners were randomly allocated (1:1:1) to usual care, a structured intervention with follow-up visits (SIF) or a structured intervention with written instructions (SIW). The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months.ResultsAt 12 months, 76 of 168 (45%) patients in the SIW group and 86 of 191 (45%) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 (15%) in the control group. After adjusting by cluster, the relative risks for benzodiazepine discontinuation were 3.01 (95% CI 2.03–4.46, PPConclusionsBoth interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity. A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits.

© 2014 Canadian Medical Association or its licensors. Results: Over 4.8 years of follow-up, metabolic syndrome developed in 960 (50.0%) of the 1919 participants who did not have the condition at baseline. The risk of developing metabolic syndrome did not differ between participants assigned to the control diet and those assigned to either of the Mediterranean diets (control v. olive oil HR 1.10, 95% CI 0.94-1.30, p = 0.231; control v. nuts HR 1.08, 95% CI 0.92- 1.27, p = 0.3). Reversion occurred in 958 (28.2%) of the 3392 participants who had metabolic syndrome at baseline. Compared with the control group, participants on either Mediterranean diet were more likely to undergo reversion (control v. olive oil HR 1.35, 95% CI 1.15-1.58, p ≤ 0.001; control v. nuts HR 1.28, 95% CI 1.08-1.51, p ≤ 0.001). Participants in the group receiving olive oil supplementation showed significant decreases in both central obesity and high fasting glucose (p = 0.02); participants in the group supplemented with nuts showed a significant decrease in central obesity. Interpretation: A Mediterranean diet supplemented with either extra virgin olive oil or nuts is not associated with the onset of metabolic syndrome, but such diets are more likely to cause reversion of the condition. An energy-unrestricted Mediterranean diet may be useful in reducing the risks of central obesity and hyperglycemia in people at high risk of cardiovascular disease. Trial registration: ClinicalTrials. gov, no. ISRCTN35739639. Background: Little evidence exists on the effect of an energy-unrestricted healthy diet on metabolic syndrome. We evaluated the long-term effect of Mediterranean diets ad libitum on the incidence or reversion of metabolic syndrome. Methods: We performed a secondary analysis of the PREDIMED trial - a multicentre, randomized trial done between October 2003 and December 2010 that involved men and women (age 55-80 yr) at high risk for cardiovascular disease. Participants were randomly assigned to 1 of 3 dietary interventions: a Mediterranean diet supplemented with extravirgin olive oil, a Mediterranean diet supplemented with nuts or advice on following a low-fat diet (the control group). The interventions did not include increased physical activity or weight loss as a goal. We analyzed available data from 5801 participants. We determined the effect of diet on incidence and reversion of metabolic syndrome using Cox regression analysis to calculate hazard ratios (HRs) and 95% confidence intervals (CIs)., CIBERobn is an initiative of ISCIII, Spain. Supported by the official funding agency for biomedical research of the Spanish government, Instituto de Salud Carlos III (ISCIII), through grants provided to research networks specifically developed for the trial (RTIC G03/140, to Ramón Estruch; RTIC RD 06/0045, to Miguel Martínez-González and through Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición [CIBERobn]), and by grants from Centro Nacional de Investigaciones Cardiovasculares (CNIC 06/2007), Fondo de Investigación Sanitaria–Fondo Europeo de Desarrollo Regional (PI04–2239, PI 05/2584, CP06/00100, PI07/0240, PI07/1138, PI07/0954, PI 07/0473, PI10/01407, PI10/02658, PI11/01647, and P11/02505; PI13/00462), Ministerio de Ciencia e Innovación (AGL-2009–13906-C02 and AGL2010–22319-C03), Fundación Mapfre 2010, Consejería de Salud de la Junta de Andalucía (PI0105/2007), Public Health Division of the Department of Health of the Autonomous Government of Catalonia, Generalitat Valenciana (ACOMP06109, GVA-COMP2010–181, GVACOMP2011–151, CS2010-AP-111, and CS2011-AP-042), and Regional Government of Navarra (P27/2011). None of the funding sources played a role in the design, collection, analysis or interpretation of the data or in the decision to submit the manuscript for publication.

Vitamin K has been related to cardiovascular disease and cancer risk. However, data on total mortality are scarce. The aimof the present study was to assess the association between the dietary intake of different types of vitamin K and mortality in a Mediterranean population at high cardiovascular disease risk. A prospective cohort analysis was conducted in 7216 participants from the PREDIMED (Prevención con Dieta Mediterránea) study (median follow-up of 4.8 y). Energy and nutrient intakes were evaluated using a validated 137-item food frequency questionnaire. Dietary vitamin K intake was calculated annually using the USDA food composition database and other published sources. Deaths were ascertained by an end-point adjudication committee unaware of the dietary habits of participants after they had reviewed medical records and linked up to the National Death Index. Cox proportional hazard models were fitted to assess the RR of mortality. Energy-adjusted baseline dietary phylloquinone intake was inversely associated with a significantly reduced risk of cancer and all-cause mortality after controlling for potential confounders (HR: 0.54; 95% CI: 0.30, 0.96; and HR: 0.64; 95% CI: 0.45, 0.90, respectively). In longitudinal assessments, individuals who increased their intake of phylloquinone or menaquinone during follow-up had a lower risk of cancer (HR: 0.64; 95% CI: 0.43, 0.95; and HR: 0.41; 95% CI: 0.26, 0.64, respectively) and all-cause mortality (HR: 0.57; 95%CI: 0.44, 0.73; and HR: 0.55; 95% CI: 0.42, 0.73, respectively) than individuals who decreased or did not change their intake. Also, individuals who increased their intake of dietary phylloquinone had a lower risk of cardiovascular mortality risk (HR: 0.52; 95% CI: 0.31, 0.86). However, no association between changes in menaquinone intake and cardiovascular mortality was observed (HR: 0.76; 95% CI: 0.44, 1.29). An increase in dietary intake of vitamin K is associated with a reduced risk of cardiovascular, cancer, or all-cause mortality in a Mediterranean population at high cardiovascular disease risk. © 2014 American Society for Nutrition., Supported by National Cardiovascular Research Center grant 06/2007, Health Research Fund grants PI07/0473 and PI1002658, Ministry of Science and Innovation grants AGL-2009-13906-C02 and AGL2010-22319-C03, Ministry of Health–National Drug Plan grant 2010/087, Mapfre Foundation 2010, Government of the Basque Country grant IT386-10, University of the Basque Country grant UFI 11/32, and the Autonomous Government of Catalonia [joint contract with Institute of Health Carlos III (Miguel Servet grant 06/00100)]. CIBER Physiopathology of Obesity and Nutrition and Thematic networks of cooperative health research grant RD 06/0045 are initiatives of the Institute of Health Carlos III.

Resumen Objetivo Describir la producción científica española de atención primaria durante el periodo 2008-2012. Diseño Estudio observacional bibliométrico. Emplazamiento Producción científica española de atención primaria. Participantes Las unidades de estudio fueron las publicaciones indexadas en Medline. Mediciones principales En cada registro se obtuvo revista, año de publicación, primer/último autor, centro de trabajo y comunidad autónoma. Posteriormente los artículos fueron clasificados según su contenido o área de investigación. El factor de impacto fue obtenido a partir de la base de análisis bibliométrico Journal Citation Reports. Resultados Mediante criterios de búsqueda fueron seleccionados 1.048 documentos. El índice de transitoriedad fue del 62,6%. La producción se incrementó desde 170 documentos en 2008 hasta 291 en 2012. La mayoría (65,7%) procedían de centros de salud, observándose un incremento significativo (p = 0,01) de los originados en unidades/institutos de investigación (5,9% en 2008; 12,0% en 2012). El 61,6% se clasificaron como «aspectos clínicos». El 22,5% fueron publicados en la revista Atención Primaria, el 80,5% en revistas con factor de impacto y el 33,49% en revistas extranjeras, siendo esta proporción superior (p

Fundamento Estimar la prevalencia de alteraciones glucidicas ignoradas en la poblacion espanola de altoriesgo contrastando el fenotipo segun la Organizacion Mundial de la Salud (OMS) y la American DiabetesAssociation (ADA). Sujetos y metodo estudio transversal de deteccion selectiva en 10 centros de atencion primaria (230.000 habitantes).Los diagnosticos OMS (normal, intolerancia a la glucosa y diabetes) se basaron en la glucemia a las 2h de una sobrecarga oral con 75 g de glucosa. Los diagnosticos ADA en la glucemia basal (normal, alteraday diabetes). Se compararon la prevalencia, la superposicion diagnostica y 22 parametros clinicobiologicos. Resultados Se evaluaron 580 sujetos (330 mujeres) con una media de 58,1 anos y un indice de masa corporalde 31,2 kg/m2, 292 (50,3%) con un factor de riesgo y 288 (49,7%) con dos o mas. Los diagnosticosOMS fueron: 291 (50,2%) normal (intervalo de confianza [IC] del 95%: 46,2-54,2), 157 (27,1%) intoleranciaa la glucosa (23,5-30,7%) y 132 (22,7%) diabetes (19,3-26,1%). La version ADA fue: 355 (61,2%)glucemia basal normal (57,2-65,2%), 146 (25,2%) glucemia basal alterada (21,7-28,7%) y 79 (13,6%)diabetes (10,9-16,3), descendiendo la prevalencia de diabetes un 9,1% (–11,4 a –6,8%). La superposiciondiagnostica fue un 33,5% para la diabetes y un 19,3% para alteraciones intermedias (intolerancia a la glucosa-glucemia basal alterada). El 50% de diabeticos con glucemia a las 2 h igual o superior a 200 mg/dl(11,1 mM) pero con glucemia basal inferior a 126 mg/dl (7 mM) no se hubiera identificado sin sobrecargaoral. Cambiar el criterio de deteccion (basal por glucemia a las 2 h) redujo el riesgo relacionado con factoresclasicos como la edad y los antecedentes familiares. Conclusiones La prevalencia de trastornos glucemicos ignorados en la poblacion estudiada, aunque elevada,disminuyo aplicando las normas ADA. En la poblacion espanola de mayor riesgo es recomendable retener lasobrecarga oral para la deteccion de diabetes y otras anomalias del metabolismo glucidico.

Introduction and objectives Although it is known that social factors may introduce inequalities in cardiovascular health, data on the role of socioeconomic differences in the prescription of preventive treatment are scarce. We aimed to assess the relationship between the socioeconomic status of an elderly population at high cardiovascular risk and inequalities in receiving primary cardiovascular treatment, within the context of a universal health care system. Methods Cross-sectional study of 7447 individuals with high cardiovascular risk (57.5% women, mean age 67 years) who participated in the PREDIMED study, a clinical trial of nutritional interventions for cardiovascular prevention. Educational attainment was used as the indicator of socioeconomic status to evaluate differences in pharmacological treatment received for hypertension, diabetes, and dyslipidemia. Results Participants with the lowest socioeconomic status were more frequently women, older, overweight, sedentary, and less adherent to the Mediterranean dietary pattern. They were, however, less likely to smoke and drink alcohol. This socioeconomic subgroup had a higher proportion of coexisting cardiovascular risk factors. Multivariate analysis of the whole population found no differences between participants with middle and low levels of education in the drug treatment prescribed for 3 major cardiovascular risk factors (odds ratio [95% confidence interval]): hypertension (0.75 [0.56-1.00] vs 0.85 [0.65-1.10]); diabetic participants (0.86 [0.61-1.22] vs 0.90 [0.67-1.22]); and dyslipidemia (0.93 [0.75-1.15] vs 0.99 [0.82-1.19], respectively). Conclusions In our analysis, socioeconomic differences did not affect the treatment prescribed for primary cardiovascular prevention in elderly patients in Spain. Free, universal health care based on a primary care model can be effective in reducing health inequalities related to socioeconomic status.

© 2013 Massachusetts Medical Society, [Background]: Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events., [Methods]: In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years., [Results]: A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported., [Conclusions]: Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events., Supported by the official funding agency for biomedical research of the Spanish government, Instituto de Salud Carlos III (ISCIII), through grants provided to research networks specifically developed for the trial (RTIC G03/140, to Dr. Estruch; RTIC RD 06/0045, to Dr. Martínez-González and through Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición [CIBERobn]), and by grants from Centro Nacional de Investigaciones Cardiovasculares (CNIC 06/2007), Fondo de Investigación Sanitaria–Fondo Europeo de Desarrollo Regional (PI04-2239, PI 05/2584, CP06/00100, PI07/0240, PI07/1138, PI07/0954, PI 07/0473, PI10/01407, PI10/02658, PI11/01647, and P11/02505), Ministerio de Ciencia e Innovación (AGL-2009-13906-C02 and AGL2010-22319-C03), Fundación Mapfre 2010, Consejería de Salud de la Junta de Andalucía (PI0105/2007), Public Health Division of the Department of Health of the Autonomous Government of Catalonia, Generalitat Valenciana (ACOMP06109, GVACOMP2010-181, GVACOMP2011-151, CS2010-AP-111, and CS2011-AP-042), and Regional Government of Navarra (P27/2011).

INTRODUCTION: Prospective studies have consistently suggested that nut consumption is inversely related to fatal and non-fatal coronary heart disease. Limited data are available on the epidemiological associations between nut intake and cardiometabolic risk factors. OBJECTIVE: To evaluate associations between frequency of nut consumption and prevalence of cardiometabolic risk factors [obesity, metabolic syndrome (MetS), type-2 diabetes, hypertension, and dyslipidemia] in a Mediterranean population at high cardiovascular risk. MATERIALS AND METHODS: Cross-sectional study of 7,210 men and women (mean age, 67 y) recruited into the PREDIMED study. MetS was defined by the harmonized ATPIII and IDF criteria. Diabetes and hypertension were assessed by clinical diagnosis and dyslipidemia (high triglycerides, low HDL-cholesterol, and hypercholesterolemia) by lipid analyses. Nut consumption was assessed using a validated food frequency questionnaire and categorized as 3 servings/wk. Control of confounding was done with multivariate logistic regression. RESULTS: Compared to participants consuming 3 servings/wk had lower adjusted odds ratios (OR) for obesity (0.61, 95% confidence interval 0.54 to 0.68; P-trend

© 2013 Guasch-Ferré et al., [Background]: Prospective studies in non-Mediterranean populations have consistently related increasing nut consumption to lower coronary heart disease mortality. A small protective effect on all-cause and cancer mortality has also been suggested. To examine the association between frequency of nut consumption and mortality in individuals at high cardiovascular risk from Spain, a Mediterranean country with a relatively high average nut intake per person., [Methods]: We evaluated 7,216 men and women aged 55 to 80 years randomized to 1 of 3 interventions (Mediterranean diets supplemented with nuts or olive oil and control diet) in the PREDIMED (‘PREvención con DIeta MEDiterránea’) study. Nut consumption was assessed at baseline and mortality was ascertained by medical records and linkage to the National Death Index. Multivariable-adjusted Cox regression and multivariable analyses with generalized estimating equation models were used to assess the association between yearly repeated measurements of nut consumption and mortality., [Results]: During a median follow-up of 4.8 years, 323 total deaths, 81 cardiovascular deaths and 130 cancer deaths occurred. Nut consumption was associated with a significantly reduced risk of all-cause mortality (P for trend 3 servings/week (32% of the cohort) had a 39% lower mortality risk (hazard ratio (HR) 0.61; 95% CI 0.45 to 0.83). A similar protective effect against cardiovascular and cancer mortality was observed. Participants allocated to the Mediterranean diet with nuts group who consumed nuts >3 servings/week at baseline had the lowest total mortality risk (HR 0.37; 95% CI 0.22 to 0.66)., [Conclusions]: Increased frequency of nut consumption was associated with a significantly reduced risk of mortality in a Mediterranean population at high cardiovascular risk., This study was funded, in part, by the Spanish Ministry of Health (ISCIII), PI1001407, Thematic Network G03/140, RD06/0045, FEDER (Fondo Europeo de Desarrollo Regional), and the Centre Català de la Nutrició de l’Institut d’Estudis Catalans.

ResumenObjetivosDescribir la producción científica internacional en el ámbito de la atención primaria en el período 1985-2004.DiseñoAnálisis bibliométrico.EmplazamientoBase de datos Medline. Acceso mediante WebSPIRS versión 4,3. Se analizan 2 períodos: 2000-2004 (transversal) y 1985-2004 (evolutivo). Búsqueda basada en MesH Major con los descriptores: Primary Care o Primary Health Care, Family Practice, Physicians Family, Nurse Practitioners y los Entry Terms relacionados con ellos.Mediciones principalesSe analizaron los indicadores bibliométricos de producción, circulación, dispersión y visibilidad. Criterios de inclusión: se consideró aquel registro (documento citable) indexado en Medline. Se incluyeron documentos originales y revisiones.ResultadosEn 2000-2004 se publicaron 20.911 artículos, el 0,73% de la producción total. Con una tasa de crecimiento (1985-2004) del 221%, 2,4 veces más que la media. La tasa de transitoriedad fue 83,17%. El idioma inglés es el predominante (88,81%) sobre 34 idiomas, siendo el español el siguiente (2,6%). Dieciséis países producen el 95,67% de los artículos. España ocupa el séptimo lugar. Las universidades (52%) son la institución más productiva. Existen 1.074 revistas diferentes siendo las 10 más productoras: Br J Gen Pract, Adv Nurse Pract, Aust Fam Physician, Fam Pract, Fam Med, BMJ, Aten Primaria, Health Serv J, Can Fam Physician, J Fam Pract. La proporción de ensayos clínicos (5,43%) en atención primaria (AP) es similar a la del resto de disciplinas y ha aumentado el 453% (1985-2004).ConclusionesLa producción de AP supone cerca del 1% del total de la producción científica, con un crecimiento notorio y mayor que la media en 20 años. La proporción de ensayos clínicos es similar a otras disciplinas. Aunque los países y revistas anglosajones son los más productores, España y la revista Aten Primaria se encuentra entre los destacados.AbstractObjectiveTo present an international view of the scientific production in the field of primary care in the period 1985-2004.DesignRetrospective, observational study. Bibliometric analysis.LocationMedline database. WebSPIRS access through version 4.3. We analysed two periods: 2000-2004 (cross-sectional) and 1985-2004 (developmental). Search based on “MeSH Major” with descriptors: Primary Care or Primary Health Care, Family Practice, Family Physicians, Nurse Practitioners, and Entry Terms associated with these.Key MeasuresWe analysed the bibliometric indicators of production, circulation, dispersion, and visibility.ResultsIn 2000-2004, published 20911 articles were published, 0.73% of total production. There was a growth rate (1985-2004) of 221%, which was 2.4 times more than average. Transience rate was 83.17%. The English language is predominant (88.81%) over 34 languages, with Spanish being the next (2.6%). Sixteen countries produce 95.67% of the articles. Spain occupies the 7th place. Universities (52%) are the most productive institutions. There are 1074 different journals with the 10 most productive being: Br J Gen Pract, Adv Nurse Pract, Aust Fam Physician, Fam Pract, Fam Med, BMJ, Aten Primary Health Serv J, Can Fam Physician, J Fam Pract. The proportion of trials (5.43%) in PC is similar to other disciplines and has increased by 453% (1985-2004).ConclusionsThe production of Primary care is about 1% of the total scientific output, with a noticeable and higher than average growth over 20 years. The proportion of clinical trials is similar to other disciplines. Although Anglo-Saxon countries and journals are the highest producers, Spain and the journal Aten Primaria is among those highlighted.

Background There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Methods Design Multicentre randomized clinical trial with an intervention and a control group. Setting 12 primary care centres in the province of Tarragona (Spain). Subjects of study 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Intervention Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Measurements Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Main variables Smoking cessation at 12 months. Analysis Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Expected results Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Discussion Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. Trial registration ClinicalTrial.gov, number NCT01194596.

Background Safety for diabetic patients means providing the most suitable treatment for each type of diabetic in order to improve monitoring and to prevent the adverse effects of drugs and complications arising from the disease. The aim of this study is to analyze the effect of imparting educational interventions to health professionals regarding the safety of patients with Diabetes Mellitus (DM). Methods Design: A cluster randomized trial with a control group. Setting and sample: The study analyzed ten primary healthcare centres (PHC) covering approximately 150,000 inhabitants. Two groups of 5 PHC were selected on the basis of their geographic location (urban, semi-urban and rural), their socio-economic status and the size of their PHC, The interventions and control groups were assigned at random. The study uses computerized patient records to individually assess subjects aged 45 to 75 diagnosed with type 1 and type 2 DM, who met the inclusion conditions and who had the variables of particular interest to the study. Trial: The educational interventions consisted of a standardized teaching course aimed at doctors and nurses. The course lasted 6 hours and was split into three 2-hour blocks with subsequent monthly refresher courses. Measurement: For the health professionals, the study used the Diabetes Attitude Scale (DAS-3) to assess their attitudes and motivation when monitoring diabetes. For the patients, the study assessed factors related to their degree of control over the disease at onset, 6, 12 and 24 months. Main variables: levels of HbA1c. Analysis: The study analyzed the effect of the educational interventions both on the attitudes and motivations of health professionals and on the degree of control over the diabetes in both groups. Discussion Imparting educational interventions to health professionals would improve the monitoring of diabetic patients. The most effective model involves imparting the course to both doctors and nurses. However, these models have not been tested on our Spanish population within the framework of primary healthcare. Trial registration ClinicalTrials.gov: NCT01087541

Background: Although benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepine use in the general population is about 2,2 to 2,6%, is higher in women and increases steadily with age. Interventions performed by General Practitioners may help patients to discontinue long-term benzodiazepine use. We have designed a trial to evaluate the effectiveness and safety of two brief general practitioner-provided interventions, based on gradual dose reduction, and will compare the effectiveness of these interventions with that of routine clinical practice. Methods/Design: In a three-arm cluster randomized controlled trial, general practitioners will be randomly allocated to: a) a group in which the first patient visit will feature a structured interview, followed by visits every 2-3 weeks to the end of dose reduction; b) a group in which the first patient visit will feature a structured interview plus delivery of written instructions to self-reduce benzodiazepine dose, or c) routine care. Using a computerized pharmaceutical prescription database, 495 patients, aged 18-80 years, taking benzodiazepine for at least 6 months, will be recruited in primary care health districts of three regions of Spain (the Balearic Islands, Catalonia, and Valencia). The primary outcome will be benzodiazepine use at 12 months. The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption. Discussion: Although some interventions have been shown to be effective in reducing benzodiazepine consumption by long-term users, the clinical relevance of such interventions is limited by their complexity. This randomized trial will compare the effectiveness and safety of two complex stepped care interventions with that of routine care in a study with sufficient statistical power to detect clinically relevant differences., This study is supported by a grant from the Health Research Funds (Fondos de investigacion sanitaria (FIS)) Carlos III Health Institute (PS09/00947). We are particularly grateful to the Benzored group for the contributions in the recruitment and participation in the study.

OBJECTIVE: To test the effects of two Mediterranean diet (MedDiet) interventions versus a low-fat diet on incidence of diabetes. RESEARCH DESIGN AND METHODS: This was a three-arm randomized trial in 418 nondiabetic subjects aged 55-80 years recruited in one center (PREDIMED-Reus, northeastern Spain) of the Prevención con Dieta Mediterránea [PREDIMED] study, a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk. Participants were randomly assigned to education on a low-fat diet (control group) or to one of two MedDiets, supplemented with either free virgin olive oil (1 liter/week) or nuts (30 g/day). Diets were ad libitum, and no advice on physical activity was given. The main outcome was diabetes incidence diagnosed by the 2009 American Diabetes Association criteria. RESULTS: After a median follow-up of 4.0 years, diabetes incidence was 10.1% (95% CI 5.1-15.1), 11.0% (5.9-16.1), and 17.9% (11.4-24.4) in the MedDiet with olive oil group, the MedDiet with nuts group, and the control group, respectively. Multivariable adjusted hazard ratios of diabetes were 0.49 (0.25-0.97) and 0.48 (0.24-0.96) in the MedDiet supplemented with olive oil and nuts groups, respectively, compared with the control group. When the two MedDiet groups were pooled and compared with the control group, diabetes incidence was reduced by 52% (27-86). In all study arms, increased adherence to the MedDiet was inversely associated with diabetes incidence. Diabetes risk reduction occurred in the absence of significant changes in body weight or physical activity. CONCLUSIONS: MedDiets without calorie restriction seem to be effective in the prevention of diabetes in subjects at high cardiovascular risk.

Pedro Romero-Aroca1, Ramon Sagarra-Alamo2, Josep Basora-Gallisa2, Teresa Basora-Gallisa2, Marc Baget-Bernaldiz2, Angel Bautista-Perez11Ophthalmology Service, Hospital Universitario Sant Joan, IISPV, Universidad Rovira I Virgili, 2Health Primary Care Region Reus-Priorat, Universidad Rovira I Virgili, Reus, SpainPurpose: To compare the results obtained by two screening techniques for diabetic retinopathy.Methods: Patients were assessed in two groups, according to whether the retinal images were analyzed by the general practitioner (Group 1) or by the ophthalmologist (Group 2) in a two-year prospective study using telemedicine.Results: The number of patients referred to the nonmydriatic fundus camera unit was higher in Group 1 than in Group 2 (63.80% versus 17.63%). Greater patient adherence was observed in Group 1 than in Group 2 when patients came to retinography (98.25% versus 87.52%). There were no significant differences in other technique variables. The prevalence of diabetic retinopathy was similar in both groups (8.98% in Group 1 and 9.16% in Group 2), but the prevalence of severe proliferative diabetic retinopathy was higher in Group 2 (1.69% [severe] and 0.45% [proliferative]) than in Group 1 (1.01% and 0.11%, respectively). Diabetic macular edema was more prevalent in Group 2 (2.03%).Conclusions: The inclusion of general practitioners in the screening method seems to be important. A great number of patients with diabetes mellitus were screened, and a higher percentage of patients with diabetic retinopathy or macular edema were detected.Keywords: nonmydriatic fundus camera, diabetic retinopathy, diabetes mellitus, diabetic macular edema, diabetic retinopathy, epidemiology

Background Over the last decade notable progress has been made in developed countries on monitoring smoking although experimenting with cigarettes and smoking in young people remains a serious public health problem. This paper reports a cross-sectional study at the beginning of the 3-year follow-up community study TA_BES. The aim was to study the prevalence of smoking in addition to determining predictive factors for when smoking commences in a representative population of 12-year-old first year compulsory secondary education students. Methods Twenty-nine secondary schools (N = 29) from an area of Catalonia participated in the study. In these schools 2245 students answered a questionnaire to study the attitudes, behaviors, and tobacco consumption in the subject's surrounding circle and family in relation to smoking; carbon monoxide measurements were taken by means of co-oximetry on 2 different occasions. A smoker was defined as a student who had smoked daily or occasionally in the last 30 days. For non-smokers the criteria of not considering was set up for those who answered that in the future they would not be smokers and considering those who answered that they did not rule out becoming a smoker in the future. Results Among the total 2245 students included in the analysis 157(7%) were classified as smokers. Among non-smokers we differentiated between those not considering smoking 1757 (78.3%) and those considering smoking 288 (12.8%). Age is among the factors related to commencing smoking. The risk of becoming a smoker increases 2.27 times/year. The influence of the group of friends with a very high risk for boys OR 149.5 and lower, albeit high, in girls OR 38.1. Tobacco consumption of parents produces different effects in young people. A smoking father does not produce alterations in the smoking behavior of young people. However having a smoking mother or former smoking is a risk factor for boys and a protective factor for girls. We detected a gradual risk of becoming a smoker by means of the co-oximetry test. A boy/girl with a test between 6 p.p.m and 10 p.p.m increased the probability of smoking by 2.29 and co-oximetry values > 10 p.p.m multiplied the risk 4 times over. Conclusions Results indicate that the age of commencing smoking is maintained in spite of prevalence having decreased in the last few years. The risk factors identified should be used to involve families and the educational community by offering them tobacco weaning programmes.

Background and aims Nut intake has been inversely related to body mass index (BMI) in prospective studies. We examined dietary determinants of adiposity in an elderly Mediterranean population with customarily high nut consumption. Methods and results A cross-sectional study was conducted in 847 subjects (56% women, mean age 67 years, BMI 29.7kg/m 2 ) at high cardiovascular risk recruited into the PREDIMED study. Food consumption was evaluated by a validated semi-quantitative questionnaire, energy expenditure in physical activity by the Minnesota Leisure Time Activity questionnaire, and anthropometric variables by standard measurements. Nut intake decreased across quintiles of both BMI and waist circumference ( P -trend P -trend=0.020) and directly to waist ( P -trend=0.011), while meat intake was directly associated with waist circumference ( P -trend=0.018). In fully adjusted multivariable models, independent dietary associations of BMI were the intake of nuts inversely ( P =0.002) and that of meat and meat products directly ( P =0.042). For waist circumference, independent dietary associations were intake of nuts ( P =0.002) and vegetables ( P =0.040), both inversely, and intake of meat and meat products directly ( P =0.009). From the regression coefficients, it was predicted that BMI and waist circumference decreased by 0.78kg/m 2 and 2.1cm, respectively, for each serving of 30g of nuts. Results were similar in men and women. Conclusion Nut consumption was inversely associated with adiposity independently of other lifestyle variables. It remains to be explored whether residual confounding related to a healthier lifestyle of nut eaters might in part explain these results.

Background: Epidemiological studies and feeding trials with supplements suggest that fibre intake is associated with a reduction in cardiovascular risk. However, the effects of changes in dietary fibre on risk factor levels have not been evaluated in free-living individuals. Thus, the effects of changes in dietary fibre intake on cardiovascular risk factors were assessed over 3 months in free-living high-risk subjects. Methods: 772 high-risk subjects (age 69±5 years) were assigned to a low-fat diet or two Mediterranean-style diets. All participants received behavioural and nutritional education, including recommendations for increasing the consumption of vegetables, fruits, and legumes. Changes in food and nutrient intake, body weight, blood pressure, lipid profiles, glucose control and inflammatory markers were evaluated. Results: Most participants increased consumption of vegetable products, but the increase in dietary fibre exhibited wide between-subject variability (6–65 g/day). Body weight, waist circumference, and mean systolic and diastolic blood pressure decreased across quintiles of fibre intake (p, The authors are grateful to grant support by the Spanish Minister of Health (RTIC G03/140 and RD06/0045), the FIS 070473, Centro Nacional de Investigaciones Cardiovasculares (CNIC06) and MADAUS Pharm for their collaboration in the study.

BACKGROUND: Phytosterols in natural foods are thought to inhibit cholesterol absorption. The Mediterranean diet is rich in phytosterol-containing plant foods. AIM OF THE STUDY: To assess whether increasing phytosterol intake from natural foods was associated with a cholesterol-lowering effect in a substudy of a randomized trial of nutritional intervention with Mediterranean diets for primary cardiovascular prevention (PREDIMED study). METHODS: One hundred and six high cardiovascular risk subjects assigned to two Mediterranean diets supplemented with virgin olive oil (VOO) or nuts, which are phytosterol-rich foods, or advice on a low-fat diet. Outcomes were 1-year changes in nutrient intake and serum levels of lipids and non-cholesterol sterols. RESULTS: Average phytosterol intake increased by 76, 158 and 15 mg/day in participants assigned VOO, nuts and low-fat diets, respectively. Compared to participants in the low-fat diet group, changes in outcome variables were observed only in those in the Mediterranean diet with nuts group, with increases in intake of fibre, polyunsaturated fatty acids and phytosterols (P < 0.020, all) and significant (P < 0.05) reductions of LDL-cholesterol (0.27 mmol/l or 8.3%) and the LDL/HDL-cholesterol ratio (0.29 mmol/l or 11.5%). Variations in saturated fat, cholesterol or fibre intake were unrelated to LDL-cholesterol changes. In the whole group, changes in serum sitosterol-to-cholesterol, which reflect those of dietary phytosterol intake and absorption, correlated inversely to LDL-cholesterol changes (r = -0.256; P = 0.008). In multivariate analyses, baseline LDL-cholesterol, increases in serum sitosterol ratios and statin use were independently associated with LDL-cholesterol reductions. CONCLUSIONS: Small amounts of phytosterols in natural foods appear to be bioactive in cholesterol lowering., The PREDIMED study is supported by grants from the Spanish Ministry of Health (FIS) RTIC G03/140, PI04/1828, PI04/1837, PI 04/2239, PI05/1839, PI06/0365, PI 07/240 and RTIC RD06/0045.

OBJECTIVE: To determine the overall prevalence of the chronic use of benzodiazepines and similar drugs in primary care. DESIGN: Observational, cross-sectional study. SETTING: Healthcare centres of the Reus-Altebrat Primary Care Service,Tarragona, Spain. PARTICIPANTS: Patients older than 15 years, on prolonged treatment with benzodiazepines or similar drugs. MEASUREMENTS: The variables studied were age, sex, type of healthcare centre (rural or urban), benzodiazepine, or similar drug administered and duration of treatment. RESULTS: There were 6885 patients who were on prolonged benzodiazepine or similar drug treatment, of which 70.9% were female, 73.4% were 65 years or older, and 73% attended an urban centre. The overall prevalence was 6.9%, and was higher among women than men (9.7% and 4%, respectively), and increased with age up to 27.3% among patients of 75 years or more. The stratified results showed that chronic consumption was higher among women 75 years of age or older attached to urban healthcare centres, with a prevalence of 35.7%. CONCLUSIONS: A high percentage of our population, which includes the most fragile patients, use benzodiazepines or a similar drug in a way that is not consistent with the recommendations of clinical practice guidelines.

Purpose. Wine consumption has been related to a reduced cardiovascular risk. This effect has been attributed partly to the healthier diet of wine drinkers. We compared food habits according to alcoholic beverage preference in a Mediterranean population. Design. A cross-sectional study of a large sample of participants at high risk for cardiovascular disease. Setting. Primary care centers in a Mediterranean country, Spain. Participants. A total of 1675 men aged 55 to 80 years old and 2150 women aged 60 to 80 years old who had no documented cardiovascular disease but had either diabetes or at least three major cardiovascular risk factors. Measures. A food frequency questionnaire, alcoholic beverage consumption, adherence to Mediterranean diet, age, family history of cardiovascular disease, smoking, body mass index, diabetes, dyslipidemia, and educational level were measured. Analysis. We analyzed differences in food consumption according to the type of alcoholic beverage preferentially consumed and adjusted the estimates for age, body mass index, cholesterol level, and total energy intake. Results. We found no substantial differences in adherence to the Mediterranean diet according to the main type of alcoholic beverage consumed, and we found no evidence that Mediterranean wine drinkers at high cardiovascular risk have a healthier diet than other drinkers. However, a better dietary pattern was found among nondrinkers than among drinkers. Conclusion. This large, Mediterranean study does not support an association between wine consumption and healthier dietary habits.

The role of diet in the aetiology of metabolic syndrome (MetS) is not well understood. The aim of the present study was to evaluate the relationship between adherence to the Mediterranean diet (MedDiet) and MetS.A cross-sectional study was conducted with 808 high cardiovascular risk participants of the Reus PREDIMED Centre. MetS was defined by the updated National Cholesterol and Education Program Adult Treatment Panel III criteria. An inverse association between quartiles of adherence to the MedDiet (14-point score) and the prevalence of MetS (P for trend0.001) was observed. After adjusting for age, sex, total energy intake, smoking status and physical activity, participants with the highest score of adherence to the MedDiet (/=9 points) had the lowest odds ratio of having MetS (OR [95% CI] of 0.44 [0.27-0.70]) compared to those in the lowest quartile. Participants with the highest MedDiet adherence had 47 and 54% lower odds of having low HDL-c and hypertriglyceridemia MetS criteria, respectively, than those in the lowest quartile. Some components of the MedDiet, such as olive oil, legumes and red wine were associated with lower prevalence of MetS.Higher adherence to a Mediterranean diet is associated with a significantly lower odds ratio of having MetS in a population with a high risk of cardiovascular disease.

To estimate the prevalence of metabolic syndrome (MS) in a population receiving attention in primary care centers (PCC) we selected a random cohort of ostensibly normal subjects from the registers of 5 basic-health area (BHA) PCC. Diagnosis of MS was with the WHO, NCEP and IDF criteria. Variables recorded were: socio-demographic data, CVD risk factors including lipids, obesity, diabetes, blood pressure and smoking habit and a glucose tolerance test outcome. Of the 720 individuals selected (age 60.3 ± 11.5 years), 431 were female, 352 hypertensive, 142 diabetic, 233 pre-diabetic, 285 obese, 209 dyslipemic and 106 smokers. CVD risk according to the Framingham and REGICOR calculation was 13.8 ± 10% and 8.8 ± 9.8%, respectively. Using the WHO, NCEP and IDF criteria, MS was diagnosed in 166, 210 and 252 subjects, respectively and the relative risk of CVD complications in MS subjects was 2.56. Logistic regression analysis indicated that the MS components (WHO set), the MS components (IDF set) and the female gender had an increased odds ratio for CVD of 3.48 (95CI%: 2.26–5.37), 2.28 (95%CI: 1.84–4.90) and 2.26 (95%CI: 1.48–3.47), respectively. We conclude that MS and concomitant CVD risk is high in ostensibly normal population attending primary care clinics, and this would necessarily impinge on resource allocation in primary care.

The aim of the study was to compare the effect of the administration of a mixture of fibres on body weight-loss, satiety, lipid profile and glucose metabolism. We included 200 overweight or obese patients in a parallel, double-blind, placebo-controlled clinical trial, who were randomised to receive, in the context of an energy-restricted diet for a period of 16 weeks, a mixed fibre dose (3 gPlantago ovatahusk and 1 g glucomannan) twice (b.i.d. group) or three times daily (t.i.d. group) or placebo. Weight change was the primary efficacy endpoint. Satiety, dietary compliance, lipid profile, glucose tolerance, insulin resistance and high-sensitivity C-reactive protein were secondary endpoints. Weight loss tended to be higher after both doses of fibre ( − 4·52 (sd0·56) and − 4·60 (sd0·55) kg) than placebo ( − 0·79 (sd0·58) kg); the differences in changes between groups were not statistically significant. Postprandial satiety increased in both fibre groups compared to the placebo. The differences between groups in LDL-cholesterol levels were significant (P = 0·03), with greater reductions in the two fibre-supplemented groups ( − 0·38 (sd0·10) and − 0·24 (sd0·09) mmol/l in the b.i.d. and t.i.d. groupsv.− 0·06 (sd0·09) mmol/l in placebo group). A similar pattern was observed for changes in total cholesterol:HDL-cholesterol and HDL-cholesterol:LDL-cholesterol ratios. Interventions were well tolerated and had no effects on HDL-cholesterol, glucose and insulin concentrations, glucose tolerance or high-sensitivity C-reactive protein. In conclusion, a 16-week dietary supplement of soluble fibre in overweight or obese patients was well tolerated, induced satiety and had beneficial effects on some CVD risk factors, the most important of which was a significant decrease in plasma LDL-cholesterol concentrations.

BACKGROUND: Epidemiological studies suggest that the Mediterranean diet (MedDiet) may reduce the risk of developing the metabolic syndrome (MetS). We compared the 1-year effect of 2 behavioral interventions to implement the MedDiet vs advice on a low-fat diet on MetS status. METHODS: A total of 1224 participants were recruited from the PREDIMED (Prevención con Dieta Mediterránea) Study, a multicenter, 3-arm, randomized clinical trial to determine the efficacy of the MedDiet on the primary prevention of cardiovascular disease. Participants were older subjects at high risk for cardiovascular disease. Interventions were quarterly education about the MedDiet plus provision of either 1 L/wk of virgin olive oil (MedDiet + VOO) or 30 g/d of mixed nuts (MedDiet + nuts), and advice on a low-fat diet (control diet). All diets were ad libitum, and there was no increase in physical activity for any of the interventions. Lifestyle variables and MetS features as defined by the National Cholesterol Education Program Adult Treatment Panel III criteria were assessed. RESULTS: At baseline, 61.4% of participants met criteria for the MetS. One-year prevalence was reduced by 6.7%, 13.7%, and 2.0% in the MedDiet + VOO, MedDiet + nuts, and control diet groups, respectively (MedDiet + nuts vs control groups, P = .01; MedDiet + VOO vs control group, P = .18). Incident rates of the MetS were not significantly different among groups (22.9%, 17.9%, and 23.4%, respectively). After adjustment for sex, age, baseline obesity status, and weight changes, the odds ratios for reversion of MetS were 1.3 (95% confidence interval, 0.8-2.1) for the MedDiet + VOO group and 1.7 (1.1-2.6) for the MedDiet + nuts group compared with the control diet group. CONCLUSION: A traditional MedDiet enriched with nuts co

Background Most depressed patients are attended at primary care. However, there are significant shortcomings in the diagnosis, management and outcomes of these patients. The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management. Methods/Design Design: A cluster-randomized controlled trial involving two groups, one of which is the control group consisting of patients who are treated for depression in the usual way and the other is the intervention group consisting of patients on a structured programme for treating depression. Setting: 20 primary care centres in the province of Tarragona (Spain) Sample: 400 patients over 18 years of age who have experienced an episode of major depression (DSM-IV) and who need to initiate antidepressant treatment Intervention: A multi-component programme with clinical, educational and organisational procedures that includes training for the health care provider and evidence-based clinical guidelines. It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring. The programme aims to improve the primary care/specialized level interface. Measurements: The patients will be monitored by telephone interviews. The interviewer will not know which group the patient belongs to (blind trial). These interviews will be given at 0, 3, 6 and 12 months. Main variables: Severity of the depressive symptoms, response rate and remission rate. Analysis: Outcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient. This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster. Discussion The effectiveness of caring for depression in primary care can be improved by various strategies. The most effective models involve organisational changes and a greater role of nurses. However, these models are almost exclusively from the USA, and this randomized clinical trial will determine if this approach could be effective to improve the outcomes of depression in primary care in the Spanish health care system. Trial registration ISRCTN16384353

Importance Breast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the Mediterranean diet may reduce the risk of breast cancer. Objective To evaluate the effect of 2 interventions with Mediterranean diet vs the advice to follow a low-fat diet (control) on breast cancer incidence. Design, Setting, and Participants The PREDIMED study is a 1:1:1 randomized, single-blind, controlled field trial conducted at primary health care centers in Spain. From 2003 to 2009, 4282 women aged 60 to 80 years and at high cardiovascular disease risk were recruited after invitation by their primary care physicians. Interventions Participants were randomly allocated to a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Main Outcomes and Measures Breast cancer incidence was a prespecified secondary outcome of the trial for women without a prior history of breast cancer (n = 4152). Results After a median follow-up of 4.8 years, we identified 35 confirmed incident cases of breast cancer. Observed rates (per 1000 person-years) were 1.1 for the Mediterranean diet with extra-virgin olive oil group, 1.8 for the Mediterranean diet with nuts group, and 2.9 for the control group. The multivariable-adjusted hazard ratios vs the control group were 0.31 (95% CI, 0.13-0.77) for the Mediterranean diet with extra-virgin olive oil group and 0.53 (95% CI, 0.23-1.26) for the Mediterranean diet with nuts group. In analyses with yearly cumulative updated dietary exposures, the hazard ratio for each additional 5% of calories from extra-virgin olive oil was 0.72 (95% CI, 0.57-0.90). Conclusions and Relevance This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer. These results come from a secondary analysis of a previous trial and are based on few incident cases and, therefore, need to be confirmed in longer-term and larger studies. Trial Registration ISRCTN.org Identifier: ISRCTN35739639

Background Several epidemiological studies have observed an increased risk of type 2 diabetes mellitus (T2DM) among subjects with a higher consumption of red and processed meat. Heme iron intake has been directly associated with a higher risk of T2DM in healthy adult Chinese and U.S populations. The objective of the present study was to evaluate the association between heme iron intake and the incidence of T2DM in a Mediterranean population at high cardiovascular risk. Methods We assessed a subset of participants in the PREDIMED trial as an observational cohort, followed up for a maximum of eight years. We initially included 1073 non-diabetic subjects (57.1% women) aged 67.3 ± 6.0 years, at high cardiovascular risk. Diet was assessed at the study baseline using a validated, semi-quantitative food frequency questionnaire. Results During the follow-up period 131 diabetics were newly diagnosed. The risk of developing T2DM was assessed using baseline heme iron intake and proportional hazard models, first unadjusted, then adjusted for energy, and finally adjusted for dietary, anthropometric, socio-demographic and lifestyle variables. Significant direct associations with the incidence of T2DM were found for heme iron (Hazard Ratio [HR] 1.30, 95% confidence interval [CI], 1.02 to 1.66). Secondarily, we have also observed that coffee (HR:0.93, 95% CI, 0.89 to 0.98) and alcoholic beverages (HR: 1.02, 95% CI, 1.01 to 1.04) were also found to reduce and increase the risk of T2DM, respectively. Conclusion High dietary intake of heme iron was associated with an increased risk of developing T2DM in a Mediterranean population at high cardiovascular risk. Trial registration Identifier: ISRCTN35739639.

ResumenObjetivoConocer la situación actual del visado de inspección de medicamentos (VIM) en España, desde la perspectiva de los profesionales sanitarios a partir de la introducción de su modalidad electrónica.DiseñoObservacional, transversal, en 2 fases, combinando técnicas cualitativas y cuantitativas.EmplazamientoSistema sanitario público: atención primaria (AP), especializada (AE) y administración.ParticipantesMicrogestores, médicos de AP, endocrinólogos; mesogestores, inspectores médicos, farmacéuticos de AP; macrogestores; responsables de direcciones de farmacia de las consejerías de salud de comunidades autónomas (CCAA).MétodoEntrevistas telefónicas semiestructuradas; saturación de información (fase 1) y Computer Assisted Telephone Interviewing (CATI) (fase 2). Análisis de contenido, comparación con la literatura médica y normativa.ResultadosEl VIM presenta 3 modalidades: manual, electrónica y electrónica vinculada a prescripción electrónica. Los participantes del mismo nivel de gestión perciben de manera similar el fin último del VIM. Existen diferencias en la situación del visado electrónico (VE) entre CCAA. Está más implementado en AP que en AE (63 frente a 37%), con grado similar en ámbitos urbano y rural. Seis de las 17 CCAA presentaron un acceso sencillo y público a la legislación correspondiente.ConclusionesEl VIM se percibe como una herramienta para el control del gasto en medicamentos y como una carga administrativa adicional en AP. El ritmo de implementación del VE difiere entre CCAA así como el acceso a la normativa pertinente.AbstractAimsTo assess the current situation of the inspection validation of prescriptions (IVP) in Spain since the introduction of the electronic procedure (EP) from the healthcare professionals’ perspective.DesignObservational, cross sectional study, in two phases; combining qualitative and quantitative techniques.SettingPrimary Care (PC), Secondary Care (SC) and the health care management sector.ParticipantsPrimary care physicians (PCPs), endocrinologists, medical inspectors, pharmacists and health Authorities of Autonomous Communities (AACC).MethodSemi-structured surveys and Computer Assisted Telephone Interviewing.ResultsThe IVP presents three modalities in Spain: manual, electronics and electronics linked to electronic prescription. The participants of the same level of management perceive in a similar way the purpose of the IVP, and there exist differences between the different levels of interviewed managers. Differences exist in the situation of EP between AACC. It is more implemented in primary care (PC) than in specialized (63% vs 37%), with similar degree in urban and rural areas. Six of 17 AACC presented a public access to the corresponding legislation.ConclusionThe IVP is perceived as a tool for the economic control in expenditure on drugs and as additional administrative load in PC. The rhythm of implementation of EP differs between AACC as well as the access to the regulation.