Adherence to a priori dietary indexes and baseline prevalence of cardiovascular risk factors in the PREDIMED-Plus randomised trial.

PURPOSE: Cardiovascular disease remains the global leading cause of death. We evaluated at baseline the association between the adherence to eight a priori high-quality dietary scores and the prevalence of individual and clustered cardiovascular risk factors (CVRF) in the PREDIMED-Plus cohort. METHODS: All PREDIMED-Plus participants (6874 men and women aged 55-75 years, with overweight/obesity and metabolic syndrome) were assessed. The prevalence of 4 CVRF (hypertension, obesity, diabetes, and dyslipidaemia), using standard diagnoses criteria, were considered as outcomes. The adherence to eight a priori-defined dietary indexes was calculated. Multivariable models were fitted to estimate differences in mean values of factors and prevalence ratios for individual and clustered CVRF. RESULTS: Highest conformity to any dietary pattern did not show inverse associations with hypertension. The modified Mediterranean Diet Score (PR = 0.95; 95% CI 0.90-0.99), Mediterranean Diet Adherence Score (MEDAS) (PR = 0.94; 95% CI 0.89-0.98), the pro-vegetarian dietary pattern (PR = 0.95; 95% CI 0.90-0.99) and the Alternate Healthy Eating Index 2010 (PR = 0.92; 95% CI 0.87-0.96) were inversely associated with prevalence of obesity. We identified significant inverse trend among participants who better adhered to the MEDAS and the Prime Diet Quality Score (PDQS) in the mean number of CVRF across categories of adherence. Better adherence to several high-quality dietary indexes was associated with better blood lipid profiles and anthropometric measures. CONCLUSIONS: Highest adherence to dietary quality indexes, especially Mediterranean-style and PDQS scores, showed marginal associations with lower prevalence of individual and clustered CVRF among elderly adults with metabolic syndrome at high risk of cardiovascular disease.

La pandemia por SARS-CoV-2 y la tercera revolución sanitaria de Sir Muir Gray / No disponible

No disponible

Prevention of type 2 diabetes in prediabetic patients by using functional olive oil enriched in oleanolic acid: The PREDIABOLE study, a randomized controlled trial.

AIM: To assess whether the regular intake of an oleanolic acid (OA)-enriched olive oil is effective in the prevention of diabetes. METHODS: In the PREDIABOLE study, prediabetic individuals (impaired fasting glucose and impaired glucose tolerance) of both sexes (176 patients, aged 30-80 years) were randomized to receive 55 mL/day of OA-enriched olive oil (equivalent dose 30 mg OA/day) [intervention group (IG)] or the same oil not enriched [control group (CG)]. The main outcome was the incidence of new-onset type 2 diabetes in both groups. RESULTS: Forty-eight new diabetes cases occurred, 31 in the CG and 17 in the IG. The multivariate-adjusted hazard ratio was 0.45 (95% CI, 0.24-0.83) for the IG compared with the CG. Intervention-related adverse effects were not reported. CONCLUSIONS: The intake of OA-enriched olive oil reduces the risk of developing diabetes in prediabetic patients. The results of the PREDIABOLE study promote the use of OA in new functional foods and drugs for the prevention of diabetes in individuals at risk of developing it.

Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials.

INTRODUCTION: Many studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits-healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted. METHOD AND ANALYSIS: MEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression. PROSPERO REGISTRATION NUMBER: CRD42018100253; Pre-results.

Mediterranean diet and quality of life: Baseline cross-sectional analysis of the PREDIMED-PLUS trial.

We assessed if a 17-item score capturing adherence to a traditional Mediterranean diet (MedDiet) was associated with better health-related quality of life among older Spanish men and women with overweight or obesity harboring the metabolic syndrome. We analyzed baseline data from 6430 men and women (age 55-70 years) participating in the PREDIMED-Plus study. PREDIMED-Plus is a multi-centre randomized trial testing an energy-restricted MedDiet combined with promotion of physical activity and behavioral therapy for primary cardiovascular prevention compared to a MedDiet alone. Participants answered a 36-item questionnaire about health-related quality of life (HRQoL) and a 17-item questionnaire that assessed adherence to an MedDiet. We used ANCOVA and multivariable-adjusted linear regression models to compare baseline adjusted means of the quality of life scales according to categories of adherence to the MedDiet. Higher adherence to the MedDiet was independently associated with significantly better scores in the eight dimensions of HRQoL. Adjusted differences of > = 3 points between the highest and the lowest dietary adherence groups to the MedDiet were observed for vitality, emotional role, and mental health and of > = 2 points for the other dimensions. In conclusion, this study shows a positive association between adherence to a MedDiet and several dimensions of quality of life.

Mediterranean Diet Improves High-Density Lipoprotein Function in High-Cardiovascular-Risk Individuals: A Randomized Controlled Trial.

BACKGROUND: The biological functions of high-density lipoproteins (HDLs) contribute to explaining the cardioprotective role of the lipoprotein beyond quantitative HDL cholesterol levels. A few small-scale interventions with a single antioxidant have improved some HDL functions. However, to date, no long-term, large-scale, randomized controlled trial has been conducted to assess the effects of an antioxidant-rich dietary pattern (such as a traditional Mediterranean diet [TMD]) on HDL function in humans. METHODS: This study was performed in a random subsample of volunteers from the PREDIMED Study (Prevención con Dieta Mediterránea; n=296) after a 1-year intervention. We compared the effects of 2 TMDs, one enriched with virgin olive oil (TMD-VOO; n=100) and the other enriched with nuts (TMD-Nuts; n=100), with respect to a low-fat control diet (n=96). We assessed the effects of both TMDs on the role of HDL particles on reverse cholesterol transport (cholesterol efflux capacity, HDL ability to esterify cholesterol, and cholesteryl ester transfer protein activity), HDL antioxidant properties (paraoxonase-1 arylesterase activity and total HDL antioxidant capacity on low-density lipoproteins), and HDL vasodilatory capacity (HDL ability to induce the release of nitric oxide in endothelial cells). We also studied the effects of a TMD on several HDL quality-related characteristics (HDL particle oxidation, resistance against oxidative modification, main lipid and protein composition, and size distribution). RESULTS: Both TMDs increased cholesterol efflux capacity relative to baseline (P=0.018 and P=0.013 for TMD-VOO and TMD-Nuts, respectively). The TMD-VOO intervention decreased cholesteryl ester transfer protein activity (relative to baseline, P=0.028) and increased HDL ability to esterify cholesterol, paraoxonase-1 arylesterase activity, and HDL vasodilatory capacity (relative to control, P=0.039, P=0.012, and P=0.026, respectively). Adherence to a TMD induced these beneficial changes by improving HDL oxidative status and composition. The 3 diets increased the percentage of large HDL particles (relative to baseline, P<0.001). CONCLUSIONS: The TMD, especially when enriched with virgin olive oil, improved HDL atheroprotective functions in humans. CLINICAL TRIAL REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN35739639.

Desarrollo de un modelo predictivo para el índice de esfuerzo del cuidador / Developing a predictive model for the caregiver strain index

Fundamentos. La atención al paciente pluripatológico en el hogar es un hecho cada vez más frecuente. El índice de esfuerzo del cuidador es un instrumento en forma de cuestionario que está diseñado para medir la carga percibida en aquellas personas que cuidan a sus familiares. El objetivo fue la construcción de un nomograma diagnóstico de sobrecarga en el cuidador informal mediante el cuestionario del índice de esfuerzo del cuidador con los datos de un modelo predictivo. Métodos. El modelo se confeccionó mediante regresión logística binaria, siendo incluidos los ítems del cuestionario del índice de esfuerzo del cuidador como variables predictoras dicotómicas. La variable dependiente fue la puntuación final obtenida mediante el cuestionario realizándose la categorización referenciada por la bibliografía: valores entre 0 y 6 fueron considerados como no existencia de estrés del cuidador y los iguales o superiores a 7 como existencia de estrés del cuidador. Se utilizó el programa estadístico R versión 3.1.1. Para construir los intervalos de confianza de la curva ROC se utilizaron 2.000 repeticiones bootstrap. Resultados. Sobre una muestra de 67 cuidadores se confeccionó un nomograma diagnóstico, con su gráfica de calibración (índice de Brier escalado = 0,686; R2 de Nagelkerke=0,791) y con la correspondiente curva ROC (área bajo la curva de 0,962). Conclusiones. El modelo predictivo generado mediante regresión logística binaria y su nomograma contienen cuatro variables predictoras (los ítems 1, 4, 5 y 9 del cuestionario). El área bajo la curva ROC (0,96; IC al 95%: 0,994-0,941) muestra un valor alto y discriminativo. La calibración del nomograma también presenta valores altos de bondad de ajuste por lo que estimamos que puede tener utilidad clínica en la consultas de enfermería comunitaria, de gestión de casos, de medicina de familia y de geriatría (AU)

Background. Patient homecare with multiple morbidities is an increasingly common occurrence. The caregiver strain index is tool in the form of questionnaire that is designed to measure the perceived burden of those who care for their families. The aim of this study is to construct a diagnostic nomogram of informal caregiver burden using data from a predictive model. Methods. The model was drawn up using binary logistic regression and the questionnaire items as dichotomous factors. The dependent variable was the final score obtained with the questionnaire but categorised in accordance with that in the literature. Scores between 0 and 6 were labelled as 'no' (no caregiver stress) and at or greater than 7 as 'yes'. The version 3.1.1R statistical software was used. To construct confidence intervals for the ROC curve 2000 boot strap replicates were used. Results. A sample of 67 caregivers was obtained. A diagnosing nomogram was made up with its calibration graph (Brier scaled = 0.686, Nagelkerke R2=0.791), and the corresponding ROC curve (area under the curve=0.962). Findings. The predictive model generated using binary logistic regression and the nomogram contain four items (1, 4, 5 and 9) of the questionnaire. R plotting functions allow a very good solution for validating a model like this. The area under the ROC curve (0.96; 95% CI: 0.994-0.941) achieves a high discriminative value. Calibration also shows high goodness of fit values, suggesting that it may be clinically useful in community nursing and geriatric establishments (AU)

[Developing a predictive model for the caregiver strain index]. / Desarrollo de un modelo predictivo para el índice de esfuerzo del cuidador.

BACKGROUND: Patient homecare with multiple morbidities is an increasingly common occurrence. The caregiver strain index is tool in the form of questionnaire that is designed to measure the perceived burden of those who care for their families. The aim of this study is to construct a diagnostic nomogram of informal caregiver burden using data from a predictive model. METHODS: The model was drawn up using binary logistic regression and the questionnaire items as dichotomous factors. The dependent variable was the final score obtained with the questionnaire but categorised in accordance with that in the literature. Scores between 0 and 6 were labelled as "no" (no caregiver stress) and at or greater than 7 as "yes". The version 3.1.1R statistical software was used. To construct confidence intervals for the ROC curve 2000 boot strap replicates were used. RESULTS: A sample of 67 caregivers was obtained. A diagnosing nomogram was made up with its calibration graph (Brier scaled = 0.686, Nagelkerke R2=0.791), and the corresponding ROC curve (area under the curve=0.962). FINDINGS: The predictive model generated using binary logistic regression and the nomogram contain four items (1, 4, 5 and 9) of the questionnaire. R plotting functions allow a very good solution for validating a model like this. The area under the ROC curve (0.96; 95% CI: 0.994-0.941) achieves a high discriminative value. Calibration also shows high goodness of fit values, suggesting that it may be clinically useful in community nursing and geriatric establishments.

Polymorphism of the Transcription Factor 7-Like 2 Gene (TCF7L2) Interacts with Obesity on Type-2 Diabetes in the PREDIMED Study Emphasizing the Heterogeneity of Genetic Variants in Type-2 Diabetes Risk Prediction: Time for Obesity-Specific Genetic Risk Scores.

Nutrigenetic studies analyzing gene-diet interactions of the TCF7L2-rs7903146 C > T polymorphism on type-2 diabetes (T2D) have shown controversial results. A reason contributing to this may be the additional modulation by obesity. Moreover, TCF7L2-rs7903146 is one of the most influential variants in T2D-genetic risk scores (GRS). Therefore, to increase the predictive value (PV) of GRS it is necessary to first see whether the included polymorphisms have heterogeneous effects. We comprehensively investigated gene-obesity interactions between the TCF7L2-rs7903146 C > T polymorphism on T2D (prevalence and incidence) and analyzed other T2D-polymorphisms in a sub-sample. We studied 7018 PREDIMED participants at baseline and longitudinally (8.7 years maximum follow-up). Obesity significantly interacted with the TCF7L2-rs7903146 on T2D prevalence, associations being greater in non-obese subjects. Accordingly, we prospectively observed in non-T2D subjects (n = 3607) that its association with T2D incidence was stronger in non-obese (HR: 1.81; 95% CI: 1.13-2.92, p = 0.013 for TT versus CC) than in obese subjects (HR: 1.01; 95% CI: 0.61-1.66; p = 0.979; p-interaction = 0.048). Accordingly, TCF7L2-PV was higher in non-obese subjects. Additionally, we created obesity-specific GRS with ten T2D-polymorphisms and demonstrated for the first time their higher strata-specific PV. In conclusion, we provide strong evidence supporting the need for considering obesity when analyzing the TCF7L2 effects and propose the use of obesity-specific GRS for T2D.

A Brief Overview of English Primary Care in the Last Half Century. / Breve visión de los principales protagonistas de la Escuela Inglesa de Atención Primaria durante el último medio siglo.

Key hefts, the hard core of clinical profile, scientific nursing and nowadays of the English School of Primary Care in the last sixty years are revisited. We understand that the most profound intellectual influence has been to Archie Cochrane, among family physicians hard core components we include John Fry (1922-1994), David Metcalfe and Julian Tudor Hart. On the other hand, Lisbeth Hockey (1918-2004), PhD in Nursing, was responsible for several years of Nursing Research Unit at the University of Edinburgh. The internet sources of English nursing historical research are very noticeable. Finally, Trisha Greenhalgh, family physician, researcher and Professor at the University of Oxford, is launching the old English School of Primary Care towards the middle of the XXI century.

Association between dietary fibre intake and fruit, vegetable or whole-grain consumption and the risk of CVD: results from the PREvención con DIeta MEDiterránea (PREDIMED) trial.

Prospective studies assessing the association between fibre intake or fibre-rich food consumption and the risk of CVD have often been limited by baseline assessment of diet. Thus far, no study has used yearly repeated measurements of dietary changes during follow-up. Moreover, previous studies included healthy and selected participants who did not represent subjects at high cardiovascular risk. We used yearly repeated measurements of diet to investigate the association between fibre intake and CVD in a Mediterranean cohort of elderly adults at high cardiovascular risk. We followed-up 7216 men (55-80 years) and women (60-80 years) initially free of CVD for up to 7 years in the PREvención con DIeta MEDiterránea study (registered as ISRCTN35739639). A 137-item validated FFQ was repeated yearly to assess diet. The primary end point, confirmed by a blinded ad hoc Event Adjudication Committee, was a composite of cardiovascular death, myocardial infarction and stroke. Time-dependent Cox's regression models were used to estimate the risk of CVD according to baseline dietary exposures and to their yearly updated changes. We found a significant inverse association for fibre (P for trend=0·020) and fruits (P for trend=0·024) in age-sex adjusted models, but the statistical significance was lost in fully adjusted models. However, we found a significant inverse association with CVD incidence for the sum of fruit and vegetable consumption. Participants who consumed in total nine or more servings/d of fruits plus vegetables had a hazard ratio 0·60 (95 % CI 0·40, 0·96) of CVD in comparison with those consuming <5 servings/d.

Una concepción topológica del ‘bootstrap’ permite la demostración del sesgo de Berkson en epidemiología nutricional / A topological conception of ‘bootstrap’ proofs Berkson bias in nutritional epidemiology

Introducción: El núcleo semántico común para todos los usos del término ‘bootstrap’ es la realización de una tarea compleja mediante la práctica de un gesto sencillo (un individuo y su caballo pueden dar un gran salto después de que tan sólo el jinete se haya tirado de los cordones de las botas). El ‘bootstrapping’ es un método estadístico diseñado para la estimación de la distribución muestral de un estimador mediante remuestreo con reemplazamiento. Metodología: Intentando compensar las debilidades epistemológicas del cálculo del tamaño muestral, se deben obtener por parte de los investigadores, los valores más pequeños posibles del error relativo muestral o de efecto diseño. Por otro lado, nosotros podemos también crear un universo virtual (UV) ubicando topológicamente las muestras obtenidas mediante ‘bootstrap’. Resultados: El tamaño de UV será aproximadamente igual al número de repeticiones multiplicado por el tamaño de la muestra original. En términos frecuentistas podemos emitir una hipótesis de igualdad (H0) y otra de desigualdad (H1) entre nuestro UV y la población real (PR) de donde proviene la muestra primitiva. Para sustentar estas hipótesis hemos desarrollado un ejercicio práctico de demostración del sesgo de Berkson en un diseño de casos y controles mediante bootstrap. Conclusión: Nosotros defendemos una concepción topológica del remuestreo con ‘bootstrap’ que permite ampliar el esquema jerárquico de validación externa propuesta por Justice y cols. a un nivel 0.1 tan sólo con la realización del efecto simulador en el paquete de datos del estudio primitivo. Este concepto permite la demostración del sesgo de Berkson en epidemiología nutricional (AU)

Introduction: The common semantic core for all uses of ‘bootstrapping’ is the realization of a complex task by practicing a simple gesture (an individual and his horse can take a big leap after only rider has been thrown the bootlaces). The ‘bootstrapping’ is a statistical method designed to estimate the sampling distribution of an estimator by re-sampling with replacement. Methodology: Trying to compensate for epistemological weaknesses of sample size calculations should be obtained by the researchers the smallest possible values of the sampling relative error or design effect. On the other hand, we can also create a virtual universe (VU) by a topological placing of samples obtained by ‘bootstrap’. Results: VU size will be approximately equal to the number of repeats multiplied by the size of the original sample. In frequentist terms we can issue an equality hypothesis (H0) and another of inequality (H1) between our VU and the actual population (AP) from which comes the sample. To support these hypotheses we have developed a practical demonstration of Berkson bias in a case-control design by bootstrap resampling. Conclusion: We stand for a topological concept of resampling with ‘the bootstrap’ that can extend the hierarchic external validation scheme proposed by Justice et al. to a 0.1 level just to the embodiment of the simulator effect on the original data package study (AU)

Breve visión de los principales protagonistas de la Escuela Inglesa de Atención Primaria durante el último medio siglo / A brief overview of English Primary Care in the last half century

El objetivo es hacer un breve repaso de las influencias, el núcleo duro de perfil clínico, la enfermería científica y el presente de la Escuela Inglesa de Atención Primaria durante los últimos sesenta años. Entendemos que la influencia intelectual más profunda fue la de Archie Cochrane. Entre los médicos de familia componentes del núcleo duro destacamos a John Fry (1922- 1994), David Metcalfe y Julian Tudor Hart. Por otra parte, Lisbeth Hockey (1918-2004), doctora en enfermería, fue la responsable durante varios años de la Unidad de Investigación en Cuidados de la Universidad de Edimburgo. Las fuentes de investigación historiográfica de la enfermería inglesa en internet son notables. Finalmente, Trisha Greenhalgh, médica de familia, investigadora y docente en la Universidad de Oxford, está lanzando a la vieja Escuela Inglesa de Atención Primaria hacia la mediana del siglo XXI (AU)

Key hefts, the hard core of clinical profile, scientific nursing and nowadays of the English School of Primary Care in the last sixty years are revisited. We understand that the most profound intellectual influence has been to Archie Cochrane, among family physicians hard core components we include John Fry (1922-1994), David Metcalfe and Julian Tudor Hart. On the other hand, Lisbeth Hockey (1918-2004), PhD in Nursing, was responsible for several years of Nursing Research Unit at the University of Edinburgh. The internet sources of English nursing historical research are very noticeable. Finally, Trisha Greenhalgh, family physician, researcher and Professor at the University of Oxford, is launching the old English School of Primary Care towards the middle of the XXI century (AU)

Mediterranean Diet and Invasive Breast Cancer Risk Among Women at High Cardiovascular Risk in the PREDIMED Trial: A Randomized Clinical Trial.

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 0.32 (95% CI, 0.13-0.79) for the Mediterranean diet with extra-virgin olive oil group and 0.59 (95% CI, 0.26-1.35) 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.

La evaluación axiológica de los proyectos en los comités de ética de la investigación / The axiological assessment of projects into research ethics committees

El objetivo de este trabajo es demostrar que la existencia de los Comités de Ética de la Investigación (CEIs) es congruente con el tiempo histórico que nos ha tocado vivir. La idea de una ciencia neutra se remonta a la creación de la Royal Society. Putnam y otros investigadores propusieron el término de valores epistémicos para los valores propios de la ciencia. A esta transformación axiológica se le ha denominado de varias formas: modo 2 de conocimiento, ciencia postnormal, ciencia postacadémica y también tecnociencia. No hay innovación sin valoración previa, e incluso sin múltiples valoraciones previas. La existencia actual de los Comités de Ética de la Investigación (CEIs) es un hecho congruente con el desarrollo histórico de la epistemología durante el siglo XX. Una de las funciones más importantes de los CEIs, es la evaluación axiológica (valores epistémicos) de los proyectos de investigación

The aim of this paper is to show that the existence of Ethics Research Committees is consistent with the historical time in which we reside. The idea of a neutral science dates back to the creation of the Royal Society. Putnam and other researchers proposed the term "epistemic values" to the values of science. This axiological transformation has been called in several ways: knowledge mode 2, post-normal science, post-academic science and technoscience. There is no innovation without evaluation, even without multiple previous assessments. The actual existence of the Research Ethics Committees (RECs) is a fact consistent with the historical development of epistemology in the twentieth century. One of the most important functions of RECs, is the axiological evaluation (epistemic values) of research projects

Modelos lineales de temperatura corporal en el paciente postquirúrgico / Body temperature linear models in postsurgical patients

Introducción y objetivos: La hipotermia no intencionada es una situación ante la cual la enfermería ha de estar entrenada para su reconocimiento y control. Nuestros objetivos han sido: evaluar la proporción de pacientes que llegaban en situación de hipotermia (temperatura <36ºC) y estudiar el comportamiento de la temperatura corporal en la Unidad de Recuperación Postanestésica (URPA). Material y métodos: La medición se llevó a cabo mediante un termómetro timpánico electrónico infrarrojo. El contraste de medias aritméticas se realizó mediante pruebas T. Cuando las variables contenían más de dos categorías se empleó la ANOVA de un factor. Se construyeron modelos con regresión lineal y logística. Resultados: El 85,26% de los pacientes presentaron hipotermia. La temperatura media de ingreso de los pacientes tratados con anestesia combinada fue significativamente más baja que la de los tratados con local o general. Tanto en los modelos univariantes como en los multivariantes con regresión lineal, la temperatura medida a los 90 minutos fue la que más se correlacionó con la temperatura al alta (coeficiente de determinación R2 = 0.69; p<0.001). Discusión: Hemos encontrado una proporción elevada de pacientes con hipotermia (temperatura corporal menor de 36ºC) a su ingreso en la URPA (85,26%). No hemos encontrado ninguna variable predictora para la hipotermia de llegada a pesar de que los pacientes anestesiados de manera combinada ingresaban con una temperatura media menor que aquellos tratados con local o con general (ANOVA de un factor p<0.05). Consideramos una estancia mínima de 90 minutos para un control adecuado de la variable temperatura en un entorno de recalentamiento empírico no protocolizado (AU)

Introduction and objectives: unintentional hypothermia is a situation in which nursing has to be trained for recognition and control. Our objectives were to evaluate the proportion of patients arriving in situations of hypothermia (temperature <36 ° C) and to study the behavior of body temperature in the post-anesthesia care unit. Methods: the measurement was carried out by infrared electronic tympanic thermometer. The contrast arithmetic test was performed by T tests. When variables contained more than two categories, we used the one-way ANOVA. Models were constructed with linear and logistic regression. Results: 85.26% of patients had hypothermia. The average admission temperature of patients treated with combined anesthesia was significantly lower than that of those treated with local or general. Both in the univariate and in multivariate models using linear regression, the temperature measured at 90 minutes was the most correlated with the temperature at discharge (coefficient of determination R2 = 0.69, P <0.001). Discussion: we found a high proportion of patients with hypothermia (body temperature below 36 ° C) on admission (85.26%). We found no predictor for arrival hypothermia despite combined anesthetized patients were admitted with an average temperature measuring less than those treated with local or general (one-way ANOVA p <.05). We consider a minimum stay of 90 minutes for proper control of the temperature variable in a non docketed empirical overheating (AU)

Triangulación de un estudio cualitativo mediante regresión logística / Triangulation of a qualitative research by logistic regression

Fundamento y Objetivo: La investigación cualitativa complementa su visión de la realidad mediante la triangulación. La regresión logística binaria es un instrumento de predicción de riesgo en epidemiología analítica. Nuestro objetivo ha sido triangular una investigación cualitativa de tipo pedagógico con modelos de regresión logística. Material y Método: Sobre la información recogida por un grupo focal, organizamos los datos en tres variables: Aforismo / Frase corta (variable dependiente), Profesor y Tipo (variables predictoras) y construimos dos modelos con regresión logística binaria. El error alfa fue del 5 y del 10%. El tamaño muestral venía impuesto por el grupo focal anterior (saturación cualitativa). Se diseñaron rutinas para trabajar con los datos en el programa R. Resultados: Con 127 elementos (44 aforismos y 83 frases cortas) se obtuvieron significaciones crudas del 10% para dos de los diez profesores con información relevante para el grupo focal (odds ratios de 0.42 y 2.33 respectivamente; índice de Brier escalado = 0.06 y área bajo curva ROC = 0.63) y significaciones menores del 5% para cuatro de los cinco epígrafes en que habíamos dividido la variable tipo (epidemiológicos, epistemológicos, estadísticos y pragmáticos o heurísticos). El epígrafe "Estadístico" fue significativo con respecto a "Epistemológico" (OR=5,00; IC al 95% = 14.431-1.743) y con respecto a "Pragmático" (OR=4.80; IC al 95%=14.602-1.577). El epígrafe "Difusión Científica" no resultó significativo. Conclusiones: En un entorno de investigación cualitativo-pedagógica sobre aforismos y frases cortas, la regresión logística binaria se ha mostrado eficaz, dentro de una estrategia de triangulación, para identificar docentes originales para el grupo focal (p<0.10) y señalar epígrafes con interés clasificatorio (p<0.05). La capacidad predictiva de los modelos ha sido baja y la capacidad discriminativa aceptable

Background and objectives: Qualitative research seeks to enrich its vision of reality through triangulation. Binary logistic regression is a prediction tool in analytical epidemiology. Our aim was to complement a qualitative study by logistic regression models. Methods: On gathered information by a previous focus group, we organized the data into three variables: Aphorism / short phrase (dependent), Professor and Type (predictive) and built two models with binary logistic regression. The alpha error was 5 and 10%. The sample size was imposed by the previous focus group task (qualitative saturation). Routines were implemented to work with the program R. Results: With 127 elements (44 aphorisms and 83 short sentences) we obtained a 10% raw signification for two of the ten teachers with relevant information for the focus group (odds ratios of 0.42 and 2.33 respectively; Brier scaled =0.06 and area under ROC curve = 0.63) and significations less than 5% for four the five sections in which we divided the variable "Type" (epidemiological, epistemological, statistical, pragmatic or heuristic). The heading "Statistics" was significant with respect to "Epistemological" (OR = 5.00, CI 95% = 14.431-1.743) and with respect to "Pragmatic" (OR = 4.80, CI 95% = 14.602-1.577). The label "Scientific Spread" was not significant. Conclusions: In an environment of qualitative and pedagogical research on aphorisms and short phrases, binary logistic regression has been shown effective in identifying original teachers for focus group (p<0.1) and to identify qualifying entries with interest (p<0.05). The predictive capability of models has been low and acceptable the discriminative capacity

White blood cell counts as risk markers of developing metabolic syndrome and its components in the PREDIMED study.

BACKGROUND: The Metabolic Syndrome (MetS) is a cluster of metabolic abnormalities that includes hyperglucemia, hypertension, dyslipidemia and central obesity, conferring an increased risk of cardiovascular disease. The white blood cell (WBC) count has been proposed as a marker for predicting cardiovascular risk. However, few prospective studies have evaluated the relationship between WBC subtypes and risk of MetS. METHODS: Participants were recruited from seven PREDIMED study centers. Both a baseline cross-sectional (n = 4,377) and a prospective assessment (n = 1,637) were performed. Participants with MetS at baseline were excluded from the longitudinal analysis. The median follow-up was 3.9 years. Anthropometric measurements, blood pressure, fasting glucose, lipid profile and WBC counts were assessed at baseline and yearly during the follow-up. Participants were categorized by baseline WBC and its subtype count quartiles. Adjusted logistic regression models were fitted to assess the risk of MetS and its components. RESULTS: Of the 4,377 participants, 62.6% had MetS at baseline. Compared to the participants in the lowest baseline sex-adjusted quartile of WBC counts, those in the upper quartile showed an increased risk of having MetS (OR, 2.47; 95%CI, 2.03-2.99; P-trend<0.001). This association was also observed for all WBC subtypes, except for basophils. Compared to participants in the lowest quartile, those in the top quartile of leukocyte, neutrophil and lymphocyte count had an increased risk of MetS incidence. Leukocyte and neutrophil count were found to be strongly associated with the MetS components hypertriglyceridemia and low HDL-cholesterol. Likewise, lymphocyte counts were found to be associated with the incidence of the MetS components low HDL-cholesterol and high fasting glucose. An increase in the total WBC during the follow-up was also associated with an increased risk of MetS. CONCLUSIONS: Total WBC counts, and some subtypes, were positively associated with MetS as well as hypertriglyceridemia, low HDL-cholesterol and high fasting glucose, all components of MetS. TRIAL REGISTRATION: Controlled-Trials.comISRCTN35739639.

Sobrecarga sentida en personas cuidadoras informales de pacientes pluripatológicos en una zona urbana / Overload in the informal caregivers of patients with multiple comorbidities in an urban area

Objetivos: Determinar el perfil de la persona cuidadora familiar de pacientes pluripatológicos, identificar factores asociados a la sobrecarga sentida y manifestaciones de cansancio. Construir modelos predictivos mediante los ítems del Índice de Esfuerzo del Cuidador (IEC). Método Estudio descriptivo transversal. Población de estudio: personas cuidadoras de pacientes pluripatológicos de centro de salud urbano. Recogida de datos desde la historia clínica y mediante cuestionarios (índice de Barthel, índice de Pfeiffer, IEC). Análisis estadístico mediante medidas de centralización, de dispersión y mediante la construcción de modelos multivariantes con regresión logística binaria (RLB) con los ítems del IEC como predictoras (programa R versión 2.14.0). Resultados Muestra total de 67 personas cuidadoras, con una edad media de 64,69 años (desviación estándar=12,71; mediana 62 años); un 74,6% mujeres, un 35,8% esposas e hijas un 32,8%. El nivel de dependencia de las personas cuidadas fue total/severa del 77,6% y moderada del 12% (Barthel); un 47,8% tenían algún nivel de deterioro cognitivo (Pfeiffer). IEC>7 en el 47,8% de cuidadoras, identificándose en >40% inconvenientes para la vida, restricción de vida social, esfuerzo físico, molestias ante cambios, comportamientos molestos, cambios emocionales personales y familiares, y trastornos del sueño. El ítem n.° 4 del IEC que analiza la restricción social fue el que mostró una mayor significación en el modelo predictivo del estrés del cuidador. El ítem n.° 12 (sobrecarga económica) fue el más significativo en los pacientes con deterioro cognitivo. Conclusiones Las mujeres suelen adoptar el rol de cuidadora a una edad más temprana que los hombres en el entorno urbano estudiado, y con relación al IEC, son los ítems n.° 4 (restricción social) y n.° 12 (sobrecarga económica) los que tienen más significación en los modelos predictivos construidos con RLB (AU)

Objectives: The aim of the study was, to determine the profile of the family caregiver of patients with multiple pathologies, identify factors associated with overload, and construct predictive models using items from the Caregiver Strain Index (CSI). Method: A cross-sectional study of caregivers of patients with multiple comorbidities who attended an urban health centre. Data were collected from health records and questionnaires (Barthel index, Pfeiffer index, and CSI). Statistical analysis was performed using measures of central tendency and dispersion, and by building multivariate models with binary logistic regression with the CSI items as predictors (program R version 2.14.0). Results: The sample included 67 caregivers, with a mean age of 64.69 years (standard deviation = 12.71, median 62 years), of whom 74.6% were women, 35.8% were wives, and 32.8% were daughters. The level of dependence of the patients cared for was total/severe in 77.6%, and moderate in 12% (Barthel), and 47.8% had some level of cognitive impairment (Pfeiffer). A CSI equal or greater than 7 was seen in 47.8% of caregivers, identifying life problems in more than 40% of them such as, restriction of social life, physical exertion, discomfort with change, bad behaviour, personal and family emotional changes, and sleep disturbances. Item 4 of the CSI, analysing the social restriction, was the one that showed a greater significance in the predictive multivariate model. Item 12 (economic burden) was the most signifi can't with age in patients with cognitive impairment. Conclusions: Women tend to take the role of caregiver at an earlier age than men in the urban environment studied, and items from CSI showed that items 4 (social restrictions) and 12 (economic burden) have more significance in the predictive models constructed with Binary Logistic Regression (AU)

[Overload in the informal caregivers of patients with multiple comorbidities in an urban area]. / Sobrecarga sentida en personas cuidadoras informales de pacientes pluripatológicos en una zona urbana.

OBJECTIVES: The aim of the study was, to determine the profile of the family caregiver of patients with multiple pathologies, identify factors associated with overload, and construct predictive models using items from the Caregiver Strain Index (CSI). METHOD: A cross-sectional study of caregivers of patients with multiple comorbidities who attended an urban health centre. Data were collected from health records and questionnaires (Barthel index, Pfeiffer index, and CSI). Statistical analysis was performed using measures of central tendency and dispersion, and by building multivariate models with binary logistic regression with the CSI items as predictors (program R version 2.14.0). RESULTS: The sample included 67 caregivers, with a mean age of 64.69 years (standard deviation=12.71, median 62 years), of whom 74.6% were women, 35.8% were wives, and 32.8% were daughters. The level of dependence of the patients cared for was total/severe in 77.6%, and moderate in 12% (Barthel), and 47.8% had some level of cognitive impairment (Pfeiffer). A CSI equal or greater than 7 was seen in 47.8% of caregivers, identifying life problems in more than 40% of them such as, restriction of social life, physical exertion, discomfort with change, bad behaviour, personal and family emotional changes, and sleep disturbances. Item 4 of the CSI, analysing the social restriction, was the one that showed a greater significance in the predictive multivariate model. Item 12 (economic burden) was the most significant with age in patients with cognitive impairment. CONCLUSIONS: Women tend to take the role of caregiver at an earlier age than men in the urban environment studied, and items from CSI showed that items 4 (social restrictions) and 12 (economic burden) have more significance in the predictive models constructed with Binary Logistic Regression.