Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial.

Background: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. Methods: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). Discussion: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

Examining the influence of mental health and structural determinants of health on the stage of motivational readiness for health behaviour changes: A path analysis study.

This study explores the influence of mental health and structural determinants of health on motivational readiness for health behaviour change in 1462 Spanish primary healthcare users. Chi-square test and structural equation modelling were performed. Results showed that depression and anxiety were negatively associated with being in the action stages of motivational readiness for a healthy diet and physical activity. This association was statistically significant only for motivational readiness for a healthy diet and depression (ß=-0.076;p=0.046). Furthermore, women and workers were more likely to be in the action stages of motivational readiness for a healthy diet while older adults and adults with higher health-related quality of life were more likely to be in the action stages of motivational readiness for physical activity. The present study suggests that structural (being older, being a woman and being employed) and intermediary (suffering from depression and higher health-related quality of life) determinants of health influence motivational readiness for health behaviour changes.

Role of personal aptitudes as determinants of incident morbidity, lifestyles, quality of life, use of health services, and mortality (DESVELA cohort): quantitative study protocol for a prospective cohort study in a hybrid analysis.

Introduction: The healthcare and well-being of the population depend on multiple factors and should adapt to societal changes. The opposite is also occurring; society has evolved concerning the individuals' approach to their care, which includes participation in decision-making processes. In this scenario, health promotion and prevention become crucial to provide an integrated perspective in the organization and management of the health systems.Health status and well-being depend on many aspects, determinants of health, which in turn may be modulated by individual behavior. Certain models and frameworks try to study the determinants of health and individual human behaviors, separately. However, the interrelation between these two aspects has not been examined in our population.Our main objective is to analyze whether personal aptitudes related to behaviors are independently associated with the incidence of morbidity. A secondary objective will enquire whether these personal aptitudes are independently associated with lower all-cause mortality, enhanced adoption of healthy lifestyles, higher quality of life, and lower utilization of health services during follow-up. Methods: This protocol addresses the quantitative branch of a multicenter project (10 teams) for the creation of a cohort of at least 3,083 persons aged 35 to 74 years from 9 Autonomous Communities (AACC). The personal variables to evaluate are self-efficacy, activation, health literacy, resilience, locus of control, and personality traits. Socio-demographic covariates and social capital will be recorded. A physical examination, blood analysis, and cognitive evaluation will be carried out.Several sets of six Cox models (one for each independent variable) will analyze the incidence of morbidity (objective 1); all-cause mortality and the rest of the dependent variables (objective 2). The models will be adjusted for the indicated covariates, and random effects will estimate Potential heterogeneity between AACC. Discussion: The analysis of the association of certain behavioral patterns and determinants of health is essential and will contribute to improving health promotion and prevention strategies. The description of the individual elements and interrelated aspects that modulate the onset and persistence of diseases will allow the evaluation of their role as prognostic factors and contribute to the development of patient-tailored preventive measures and healthcare.Clinical Trial Registration: ClinicalTrials.gov, NCT04386135. Registered on April 30, 2020.

Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial.

BACKGROUND: The present study describes the effectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD).  METHODS: Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45-75 years who presented at least two of the following criteria were included: smoker, low adherence to the MD or insufficient level of physical activity. The intervention group (IG) had three different levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor's office. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors. RESULTS: Three thousand sixty-two participants were included (IG = 1,481, CG = 1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9-17.5; p < 0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the final visit. Moreover, the effect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p < 0.001) in IG. CONCLUSIONS: A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03136211. Retrospectively registered on 02/05/2017 https://clinicaltrials.gov/ct2/show/NCT03136211.

Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial.

OBJECTIVES: The aim of this research was to evaluate the effects of adding 10 g of cocoa-rich chocolate (99%) to the habitual diet on cognitive performance in postmenopausal women. METHODS: Following a randomised controlled parallel clinical trial, a total of 140 postmenopausal women aged 50-64 were recruited. The intervention group (n = 73) consumed daily 10 g of chocolate (99% cocoa) in addition to their usual food intake for 6 months, whereas the control group (n = 67) did not receive any intervention. Attention and executive functions, verbal memory, working memory, phonological fluency, category fluency and clinical variables were assessed at baseline and 6 months. RESULTS: Trail Making Test B execution time showed a decreased of -12.08 s (95% CI: -23.99, -0.18; p = 0.047) in the intervention group compared to the control group, after adjusting for age, educational level, time elapsed from the beginning of menopause and daily energy consumption (Cohen's d = -0.343). Attention, immediate or delayed verbal memory, phonological or category fluency, and working memory remained unchanged. CONCLUSIONS: The consumption of cocoa-rich (99%) chocolate in addition to the habitual diet could be related to a slight improvement in cognitive performance regarding cognitive flexibility and processing speed in postmenopausal women, with no changes in the rest of the cognitive performance variables evaluated.Trial registration: This clinical trial has been registered at clinicaltrials.gov as NCT03492983.

Vascular target organ damage in patients with Philadelphia negative myeloproliferative syndrome: A propensity score analysis.

PURPOSE: To assess whether subjects with Philadelphia negative myeloproliferative neoplasms (Ph-MPNs) show differences in the presence of vascular, cardiac or renal target organ damage (TOD) and other vascular function parameters as compared to individuals without this condition. METHODS: An observational study was conducted. Fifty-seven subjects diagnosed with Ph-MPNs used as cases and 114 subjects without Ph-MPNs as controls. We matched the subjects with and without Ph-MPNs using the propensity scores in a 1:2 ratio using the variables gender, type 2 diabetes mellitus, high blood pressure, hyperlipidaemia and smoking. Vascular, cardiac and renal TOD were established according to the criteria of the European Society of Hypertension and Cardiology guidelines. Arterial stiffness was also assessed using the cardio-ankle vascular index (CAVI). RESULTS: Mean age was 63.50±11.70 and 62.90±8.32 years in subjects with and without Ph-MPNs, 32 females (56%) in the first group and 62 (54%) in the second. Subjects with Ph-MPNs have a higher percentage of carotid injury than subjects without Ph-MPNs (35.1% vs. 21.1%) and higher albumin/creatinine ratio. In the logistic regression analysis, subjects with Ph-MPNs had an OR=2.382 (IC95% 1.066-5.323) for carotid injury versus those without haematological disease. CONCLUSIONS: Subjects with Ph-MPNs have twice the risk of by carotid injury than those without haematological disease.

Retinal blood vessel calibre and vascular ageing in a general Spanish population: A EVA study.

INTRODUCTION: The aim of this work was to analyse the association of the retinal arteriolar calibre and the arteriole/venule index (AV index) with vascular ageing in a general population without previous cardiovascular disease. MATERIALS AND METHODS: Descriptive cross-sectional study. A total of 482 individuals without cardiovascular disease (mean age: 55.6 ± 14.2 years) were selected by random sampling, stratified by age and sex. The retinal arteriolar calibre was measured using digital fundus images of the back of the eye captured with a validated, semiautomatized and computer-assisted software (Index calculator). Vascular ageing was defined using three criteria based on the values of: (1) Carotid-femoral Pulse Wave Velocity (cfPWV), (2) Brachial-ankle Pulse Wave Velocity (baPWV) and (3) Carotid Intima-Media Thickness. RESULTS: The AV index and arteriolar calibre show a negative correlation with age, arterial pressure, cardiovascular risk and parameters of vascular structure and function (p < 0.001 in all cases). We found lower mean values of the AV index and arteriolar calibre in the individuals with early vascular ageing compared to those with healthy vascular ageing. AV index was negatively correlated with cfPWV ((ß=-2.9; 95% CI (-4.7; -1.1)), baPWV ((ß=-3.2; 95% CI (-5.4; -0.9)) and vascular ageing index ((ß=-1.7; 95% CI (-2.7; -0.7)). Arteriolar calibre showed a negative correlation with baPWV (ß=-0.1; 95% CI (-0.2; -0.1)). In the logistic regression analysis, lower values of AV index ((OR=0.01; 95% CI (0.01-0.10), OR=0.03; 95% CI (0.01-0.11) and OR=0.09; 95% CI (0.01-0.67)) were associated with EVA defined with cfPWV, baPWV and vascular ageing index respectively, and lower values of arteriolar calibre ((OR=0.71; 95% CI (0.55-0.91)) were associated with EVA defined with vascular ageing index. CONCLUSIONS: Lower values of AV index and retinal arteriolar calibre were associated with vascular ageing in a general Spanish population without previous cardiovascular disease.

The Relationship between Adherence to the Mediterranean Diet, Intake of Specific Foods and Depression in an Adult Population (45-75 Years) in Primary Health Care. A Cross-Sectional Descriptive Study.

BACKGROUND: The relationship between the quality of the diet and the adherence to the Mediterranean diet with the presence of persistent or recurrent depressive symptoms have been described. The objective of this study is to analyze the relationship between adherence to the Mediterranean diet and the intake of specific foods in primary care patients aged 45 to 75, having subclinical or major depression. The study also specifically analyzes this relationship in individuals suffering from chronic diseases. METHODS: A cross-sectional descriptive study was conducted. 3062 subjects met the inclusion criteria from the EIRA study. Sociodemographic variables, clinical morbidity, depression symptomatology (PHQ-9) and adherence to Mediterranean diet (MEDAS) were collected. RESULTS: Being female, younger, with a higher BMI, consuming more than 1 serving of red meat a day and drinking more than one carbonated or sugary drink daily, not consuming 3 servings of nuts a week and not eating 2 vegetables cooked in olive oil a week are predictors of having higher depressive symptomatology. CONCLUSIONS: Assessing the type of diet of patients presenting depressive symptoms and promoting adherence to a healthy diet is important, especially in patients with chronic diseases. However, depression is a very complex issue and the relationship between nutrition and depression must be further examined.

Cocoa-rich chocolate and body composition in postmenopausal women: a randomised clinical trial.

During menopause, women undergo a series of physiological changes that include a redistribution of fat tissue. This study was designed to investigate the effect of adding 10 g of cocoa-rich chocolate to the habitual diet of postmenopausal women daily on body composition. We conducted a 6-month, two-arm randomised, controlled trial. Postmenopausal women (57·2 (sd 3·6) years, n 132) were recruited in primary care clinics. Participants in the control group (CG) did not receive any intervention. Those of the intervention group (IG) received 10 g daily of 99 % cocoa chocolate in addition to their habitual diet for 6 months. This quantity comprises 247 kJ (59 kcal) and 65·4 mg of polyphenols. The primary outcomes were the between-group differences in body composition variables, measured by impendancemetry at the end of the study. The main effect of the intervention showed a favourable reduction in the IG with respect to the CG in body fat mass (-0·63 kg (95 % CI -1·15, -0·11), P = 0·019; Cohen's d = -0·450) and body fat percentage (-0·79 % (95 % CI -1·31, -0·26), P = 0·004; Cohen's d = -0·539). A non-significant decrease was also observed in BMI (-0·20 kg/m2 (95 % CI -0·44, 0·03), P = 0·092; Cohen's d = -0·345). Both the body fat mass and the body fat percentage showed a decrease in the IG for the three body segments analysed (trunk, arms and legs). Daily addition of 10 g of cocoa-rich chocolate to the habitual diet of postmenopausal women reduces their body fat mass and body fat percentage without modifying their weight.

Cocoa-Rich Chocolate and Quality of Life in Postmenopausal Women: A Randomized Clinical Trial.

Menopause has a negative impact on quality of life (QoL). The aim of the present study was to analyse the effect on QoL of adding 10 g per day of chocolate with a high concentration of cocoa (99%) to the habitual diet, for 6 months, in a sample of postmenopausal women. Postmenopausal women (n = 140) aged 50-64 years were randomised to either an addition of 10 g per day of cocoa-rich chocolate to their usual diet or no supplement addition. All variables were measured at baseline and after six months of intervention. QoL was evaluated using the 3-level version of EuroQol-5D (EuroQoL-5D-3L), the EuroQol Visual Analogue Scale (EQ-VAS) and the Cervantes scale. Analysis of covariance (ANCOVA) analyses adjusted for the main determinants of QoL considered in this study showed no changes in the global score of QoL evaluated with the EuroQoL-5D-3L. The intervention group showed an increase of 6.0 points (95% confidence interval (CI): 0.4, 11.7) in the EQ-VAS compared to the control group (p = 0.036). No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale. The additional daily contribution of 10 g of cocoa-rich chocolate in postmenopausal women could have a slight impact on their perception toward their health state, although without modifying the health-related QoL or the dimensions that compose it.

The Relationship Between Alcohol Consumption With Vascular Structure and Arterial Stiffness in the Spanish Population: EVA Study.

BACKGROUND: Controversy exists regarding the way alcohol use is associated with vascular structure and arterial stiffness parameters. The purpose of this study is to evaluate the association between alcohol consumption with vascular structure and arterial stiffness in an adult population. METHODS: We conducted a cross-sectional study. Five hundred and one participants were recruited by random sampling from an urban population of 43,946 individuals aged 35 to 75 years, assigned from 5 healthcare centers located in Salamanca, Spain. This was a subanalysis of the EVA study. Arterial stiffness was assessed by measuring cardio-ankle vascular index (CAVI) and brachial-ankle pulse wave velocity (ba-PWV) with the VaSera VS-1500® device, and carotid-femoral pulse wave velocity (cf-PWV) with the Sphygmocor® . Vascular structure was evaluated by measuring the carotid intima-media thickness (c-IMT) with a Sonosite Micromax® ultrasound. Alcohol consumption was calculated using a standardized questionnaire and quantified in g/wk. RESULTS: In the multiple regression analysis adjusted for sex, age, smoking status, and systolic blood pressure, the c-IMT and cf-PWV values of individuals drinking > 70 g/wk were higher than those of the reference group (nondrinkers) by 0.02 mm (p = 0.030) and 0.42 m/s (p = 0.021), respectively. The association between alcohol consumption with vascular structure and arterial stiffness only attains statistical significance for cf-PWV (p = 0.039) and c-IMT (p = 0.019), showing an association which suggests a J-shaped association. This association was not statistically significant for ba-PWV and CAVI (p = 0.446 and p = 0.141, respectively), although a similar trend was observed with ba-PWV. CONCLUSIONS: The results of this study suggest that heavy alcohol consumption (>70 g/wk) is associated with increased c-IMT and cf-PWV. Moreover, we found a J-shaped association between alcohol consumption and c-IMT and cf-PWV values as markers of vascular structure and arterial stiffness, with no association with ba-PWV and CAVI being observed.

Effects of Cocoa-Rich Chocolate on Blood Pressure, Cardiovascular Risk Factors, and Arterial Stiffness in Postmenopausal Women: A Randomized Clinical Trial.

This study aimed to evaluate the effects of the intake of 10 g of cocoa-rich chocolate on blood pressure, other cardiovascular risk factors, and vascular structure and function in postmenopausal women. A total of 140 postmenopausal women participated in this randomized and controlled parallel clinical trial. For six months, the intervention group (IG; n = 73) consumed daily 10 g of chocolate (99% cocoa) added to their usual food intake, whereas the control group (CG; n = 67) did not receive any intervention. Blood pressure, pulse pressure (PP), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), augmentation index, and laboratory variables were measured at baseline and six months. ANCOVA analyses adjusted for baseline values revealed no significant differences for systolic blood pressure (-1.45 mm Hg; 95% confidence interval (CI): -4.79, 1.88; p = 0.391) or baPWV (0.18 m/s; 95% CI: -0.14, 0.50; p = 0.263) between groups. A decrease in PP was observed in the IG compared to the CG (-2.05 mm Hg; 95% CI: -4.08, -0.02; p = 0.048). The rest of the vascular structure and function parameters and other measured variables remained unchanged. The daily intake of 10 g of cocoa-rich chocolate seems to provide little improvement to cardiovascular health, but neither does it cause any adverse effects on the parameters evaluated in postmenopausal women in the long term.

Vascular aging and its relationship with lifestyles and other risk factors in the general Spanish population: Early Vascular Ageing Study.

OBJECTIVES: To describe the prevalence of healthy vascular aging (HVA), normal vascular aging and early vascular aging (EVA) in a sample of Spanish population without cardiovascular disease. The relationship of vascular aging with lifestyle, cardiovascular risk factors, psychological and inflammatory risk factors is also analyzed. METHODS: A total of 501 participants were recruited (49.70% men, aged 55.90 ±â€Š14.24 years) by random sampling. Vascular aging was defined in three steps: Step 1: participants with vascular damage in carotid arteries or peripheral artery disease were classified as EVA. Step 2: with the percentiles of carotid-to-femoral pulse wave velocity (cfPWV) we used three criteria, first, the 10th and 90th cfPWV percentiles of the population studied by age and sex; second, the 10th and 90th percentiles of the European population reference values and third, the 25th and 75th cfPWV percentiles of the population studied by age and sex. Step 3: participants with hypertension or type 2 diabetes mellitus included in HVA were reclassified as normal vascular aging. Arterial stiffness was assessed with cfPWV using a Sphygmocor device. Physical activity was measured with an accelerometer. Psychological factors, lifestyle and other clinical information were obtained by standard questionnaire. RESULTS: The global prevalence of HVA was 8 and 14% (men 8 and 10%, women 9 and 18%), and 22 and 18% (men 26 and 23%, women 17 and 12%) for EVA, using criteria a and b, respectively. In the logistic regression analysis, vascular aging maintains positive associations with more sedentary time [odds ratio (OR) = 2.37 and 4.51], having triglycerides above 150 mg/dl (OR = 6.55 and 4.06), abdominal obesity (OR = 2.73 and 2.90), increased uric acid (OR = 4.63 and 2.98) and insulin resistance index homeostatic model assessment (OR = 4.05 and 6.78), and a negative association with less physical activity (OR = 0.29 and 0.28) using criteria a and b, respectively. CONCLUSION: One in 10 has HVA and one in five EVA. The prevalence of EVA is higher in men. Study results suggest that preventive strategies aimed at increasing physical activity, reducing sedentary time and decreasing obesity and insulin resistance improve vascular aging.

Automatic image analyser to assess retinal vessel calibre (ALTAIR). A new tool to evaluate the thickness, area and length of the vessels of the retina.

BACKGROUND AND OBJECTIVES: The examination of the fundus allows to evaluate retinal the microcirculation in vivo. We assess the reliability and validity of ALTAIR software, and to evaluate its clinical relevance by the association of thickness, area and length of the retinal vessels with other measures of vascular structure and function, target organ damage and cardiovascular risk. METHODS: Cross-sectional study involving a total of 250 subjects aged 62 ±â€¯9 years, 51 % males. In a random subsample of 60 subjects (118 retinographies), we estimated the intraobserver, interobserver and interdevice intraclass correlation coefficients (ICC) of the measurements of retinal vascular thickness, area and length in 3 concentric circles. Concurrent validity was assessed with all 250 subjects (495 retinographies), analysing the relationship to age, blood pressure, target organ damage, vascular structure and function, and cardiovascular risk. RESULTS: Of the sample, 69 % were diagnosed with hypertension and 17 % with diabetes. Intraobserver ICC ranged from 0.640 for venous length to 0.906 for arterial area. Interobserver ICC ranged from 0.809 for arterial length to 0.916 for venous area, and interdevice ICC for arteriovenous ratio (AVR) was 0.887, thickness of arteries 0.590 and vein thickness 0.677. We found a moderate correlation between retinal vascular parameters and vascular structure and function, and target organ damage. In multiple linear regression analysis, the association with blood pressure, albumin/creatinine ratio, carotid intima-media thickness and cardiovascular risk is maintained. CONCLUSION: The ALTAIR tool has been useful for analysing the thickness, area and length of retinal vessels, with adequate reliability and a concomitant association of retinal vessel measurements with other cardiovascular parameters and cardiovascular risk. Therefore, in addition to thickness, the area and length of retinal vessels could also play a role in the prediction of cardiovascular risk.

Reference values of arterial stiffness parameters and their association with cardiovascular risk factors in the Spanish population. The EVA Study.

INTRODUCTION AND OBJECTIVES: To describe, for the first time, reference values for the cardio-ankle vascular index (CAVI), brachial-ankle pulse wave velocity (BA-PWV), carotid-femoral pulse wave velocity (CF-PWV), and the central augmentation index and to establish their association with cardiovascular risk factors in the Spanish adult population aged 35 to 75 years without cardiovascular disease. METHODS: We conducted a cross-sectional study. Through random sampling stratified by age and sex, we included 501 participants without cardiovascular disease. The mean age was 55.9 years and 50.3% were women. The measurements were taken using the SphigmoCor and Vasera VS-1500 devices. RESULTS: Values for all measures, except those for the central augmentation index, were higher in men and increased with age and blood pressure. The mean values were as follows: CAVI, 8.01±1.44; BA-PWV, 12.93±2.68m/s; CF-PWV, 6.53±2.03 m/s, and central augmentation index, 26.84±12.79. On multiple regression analysis, mean blood pressure was associated with the 4 measures, glycated hemoglobin was associated with all measures except the central augmentation index, and body mass index showed an inverse association with CAVI. The explanatory capacity of age, sex, and mean blood pressure was 62% for BA-PWV, 49% for CF-PWV 49%, 54% for the CAVI, and 38% for the central augmentation index. On logistic regression, hypertension was associated with the CAVI (OR=3.45), VOP-BT (OR=3.44), VOP-CF (OR=3.38) and with the central augmentation index (OR=3.73). CONCLUSIONS: All arterial stiffness measures increased with age. The CAVI and CF-PWV were higher in men and the central augmentation index was higher in women, with no differences in BA-PWV. This study is registered at ClinicalTrials.gov. Identifier NCT02623894.

Reclassification by applying the Framingham equation 30 years to subjects with intermediate cardiovascular risk. MARK study.

BACKGROUND AND OBJECTIVE: The estimation of cardiovascular risk (CVR) with scores at 30 years old has a special interest in reclassifying in a suitable way <60 year subjects with intermediate CVR. This study analyzes what percentage of patients with intermediate CVR included in the MARK study is reclassified by applying the 30-year Framingham score (FS30). It also analyzes the degree of agreement between the two equations to classify high risk subjects. PATIENTS AND METHODS: Cross-sectional study of 966 subjects included in the MARK study. The CVR was calculated with the two versions of the FS30 (based on lipids and body mass index) for "hard" cardiovascular events in subjects with intermediate CVR. RESULTS: The 59% and 61% of the subjects with intermediate CVR would be classified as if they had high CVR to undergo a hard event if we used the FS30 in both versions. 70% of men and 35% of women would be classified as high CVR (p<0.01). The agreement percentage, measured with the Kappa index, between the equations FS30L and FS30BMI to classify the high-risk subjects was 67.9% (in men 67.4% and in women 68.7%). CONCLUSIONS: In subjects with intermediate CVR the FS30 reclassifies more than the half as high RCV, 2 out of 3 men and 1 out of 3 women.

EVIDENT Smartphone App, a New Method for the Dietary Record: Comparison With a Food Frequency Questionnaire.

BACKGROUND: More alternatives are needed for recording people's normal diet in different populations, especially adults or the elderly, as part of the investigation into the effects of nutrition on health. OBJECTIVE: The aim of this study was to compare the estimated values of energy intake, macro- and micronutrient, and alcohol consumption gathered using the EVIDENT II smartphone app against the data estimated with a food frequency questionnaire (FFQ) in an adult population aged 18 to 70 years. METHODS: We included 362 individuals (mean age 52 years, SD 12; 214/362, 59.1% women) who were part of the EVIDENT II study. The participants registered their food intake using the EVIDENT app during a period of 3 months and through an FFQ. Both methods estimate the average nutritional composition, including energy intake, macro- and micronutrients, and alcohol. Through the app, the values of the first week of food recording, the first month, and the entire 3-month period were estimated. The FFQ gathers data regarding the food intake of the year before the moment of interview. RESULTS: The intraclass correlation for the estimation of energy intake with the FFQ and the app shows significant results, with the highest values returned when analyzing the app's data for the full 3-month period (.304, 95% CI 0.144-0.434; P<.001). For this period, the correlation coefficient for energy intake is .233 (P<.001). The highest value corresponds to alcohol consumption and the lowest to the intake of polyunsaturated fatty acids (r=.676 and r=.155; P<.001), respectively. The estimation of daily intake of energy, macronutrients, and alcohol presents higher values in the FFQ compared with the EVIDENT app data. Considering the values recorded during the 3-month period, the FFQ for energy intake estimation (Kcal) was higher than that of the app (a difference of 408.7, 95% CI 322.7-494.8; P<.001). The same is true for the other macronutrients, with the exception g/day of saturated fatty acids (.4, 95% CI -1.2 to 2.0; P=.62). CONCLUSIONS: The EVIDENT app is significantly correlated to FFQ in the estimation of energy intake, macro- and micronutrients, and alcohol consumption. This correlation increases with longer app recording periods. The EVIDENT app can be a good alternative for recording food intake in the context of longitudinal or intervention studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02016014; http://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/760i8EL8Q).

Capacity adiposity indices to identify metabolic syndrome in subjects with intermediate cardiovascular risk (MARK study).

BACKGROUND: Obesity increases mortality, and is linked to cardiovascular diseases and metabolic syndrome (MetS). Therefore, the purpose of this study was to analyze the ability of different adiposity indices to identify subjects with MetS among people with intermediate cariovascular risk. MATERIALS AND METHODS: The cross-sectional study involved 2478 subjects, recruited by the MARK study. Adiposity measures: general adiposity by body mass index (BMI), central adiposity by waist-to-height ratio (WHtR), fat mass percent by the Clínica Universidad de Navarra-body adiposity estimator (CUN-BAE), percentage of body fat and of visceral adipose tissue by body roundness index (BRI) and visceral obesity and general adiposity with body shape index (ABSI). The diagnosis of MetS was made in accordance with the criteria established in the international consensus of the Joint Scientific Statement National Cholesterol Education Program III. RESULTS: The highest correlation coefficients were obtained by the glycemic components (HbA1c and FPG) of the MetS and ranged from 0.155 to 0.320. The exception was ABSI, which showed lower values in the global analysis and in the males. Values of the area under the ROC curve with the adiposity indices ranged from 0.773 with the BMI in males to 0.567 with ABSI in males. In the logistic regression analysis, all adiposity factors, except ABSI, showed similar OR values of MetS after adjusting for possible confounding factors. In the global analysis, the adiposity index that showed a highest OR of MetS was CUN-BAE (OR 5.50; 95% CI 4.27-7.09). In the analysis by gender, the highest ORs were BMI in males (OR 5.98; 95% CI 4.70-7.60) and both WHtR and BRI in females (OR 4.15; 95% CI 3.09-5.58). CONCLUSION: All adiposity indices, except for ABSI, show an association with MetS and similar ability to detect subjects with MetS among people with intermediate cariovascular risk.

Combined use of smartphone and smartband technology in the improvement of lifestyles in the adult population over 65 years: study protocol for a randomized clinical trial (EVIDENT-Age study).

BACKGROUND: The increasing use of smartphones by older adults also increases their potential for improving different aspects of health in this population. Some studies have shown promising results in the improvement of cognitive performance through lifestyle modification. All this may have a broad impact on the quality of life and carrying out daily living activities. The objective of this study is to evaluate the effectiveness of combining the use of smartphone and smartband technology for 3 months with brief counseling on life habits, as opposed to providing counseling only, in increasing physical activity and improving adherence to the Mediterranean diet. Secondary objectives are to assess the effect of the intervention on body composition, quality of life, independence in daily living activities and cognitive performance. METHODS: This study is a two-arm cluster-randomized trial that will be carried out in urban health centers in Spain. We will recruit 160 people aged between 65 and 80 without cardiovascular disease or cognitive impairment (score in the Mini-mental State Examination ≥24). On a visit to their center, intervention group participants will be instructed to use a smartphone application for a period of 3 months. This application integrates information on physical activity received from a fitness bracelet and self-reported information on the patient's daily nutritional composition. The primary outcome will be the change in the number of steps measured by accelerometer. Secondary variables will be adherence to the Mediterranean diet, sitting time, body composition, quality of life, independence in daily living activities and cognitive performance. All variables will be measured at baseline and on the assessment visit after 3 months. A telephone follow-up will be carried out at 6 months to collect self-reported data regarding physical activity and adherence to the Mediterranean diet. DISCUSSION: Preventive healthy aging programs should include health education with training in nutrition and lifestyles, while stressing the importance of and enhancing physical activity; the inclusion of new technologies can facilitate these goals. The EVIDENT-AGE study will incorporate a simple, accessible intervention with potential implementation in the care of older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03574480 . Date of trial Registration July 2, 2018.

Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial.

INTRODUCTION: The intake of polyphenols has certain health benefits. This study will aim to assess the effect of adding a daily amount of chocolate high in cocoa content and polyphenols to the normal diet on blood pressure, vascular function, cognitive performance, quality of life and body composition in postmenopausal women. METHODS AND ANALYSIS: Here we plan a randomised clinical trial with two parallel groups involving a total of 140 women between 50 and 64 years in the postmenopausal period, defined by amenorrhoea of ​​at least 12 consecutive months. The main variable will be the change in blood pressure. Secondary variables will be changes in vascular function, quality of life, cognitive performance and body composition. The intervention group will be given chocolate containing 99% cocoa, with instructions to add 10 g daily to their normal diet for 6 months. The daily nutritional contribution of this amount of chocolate is 59 kcal and 65.4 mg of polyphenols. There will be no intervention in the control group. All variables will be measured at the baseline visit and 3 and 6 months after randomisation, except cognitive performance and quality of life, which will only be assessed at baseline and at 6 months. Recruitment is scheduled to begin on 1 June 2018, and the study will continue until 31 May 2019. ETHICS AND DISSEMINATION: This study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca, Spain ('CREC of Health Area of Salamanca'), in February 2018. A SPIRIT checklist is available for this protocol. The clinical trial has been registered at ClinicalTrials.gov provided by the US National Library of Medicine, number NCT03492983. The results will be disseminated through open access peer-reviewed journals, conference presentations, broadcast media and a presentation to stakeholders.