Egg consumption and cardiovascular disease according to diabetic status: The PREDIMED study.

BACKGROUND: Eggs are a major source of dietary cholesterol and their consumption has been sometimes discouraged. A relationship between egg consumption and the incidence of cardiovascular disease (CVD) has been suggested to be present exclusively among patients with type2 diabetes. AIMS: To assess the association between egg consumption and CVD in a large Mediterranean cohort where approximately 50% of participants had type 2 diabetes. METHODS: We prospectively followed 7216 participants (55-80 years old) at high cardiovascular risk from the PREDIMED (PREvención con DIeta MEDiterránea) study for a mean of 5.8 years. All participants were initially free of CVD. Yearly repeated measurements of dietary information with a validated 137-item food-frequency questionnaire were used to assess egg consumption and other dietary exposures. The endpoint was the rate of major cardiovascular events (myocardial infarction, stroke or death from cardiovascular causes). RESULTS: A major cardiovascular event occurred in 342 participants. Baseline egg consumption was not significantly associated with cardiovascular events in the total population. Non-diabetic participants who ate on average >4 eggs/week had a hazard ratio (HR) of 0.96 (95% confidence interval, 0.33-2.76) in the fully adjusted multivariable model when compared with non-diabetic participants who reported the lowest egg consumption (<2 eggs/week). Among diabetic participants, the HR was 1.33 (0.72-2.46). There was no evidence of interaction by diabetic status. HRs per 500 eggs of cumulative consumption during follow-up were 0.94 (0.66-1.33) in non-diabetics and 1.18 (0.90-1.55) in diabetics. CONCLUSIONS: Low to moderated egg consumption was not associated with an increased CVD risk in diabetic or non-diabetic individuals at high cardiovascular risk. This trial was registered at controlled-trials.com as ISRCTN35739639.

Effects of total dietary polyphenols on plasma nitric oxide and blood pressure in a high cardiovascular risk cohort. The PREDIMED randomized trial.

BACKGROUND AND AIM: Hypertension is one of the main cardiovascular risk factors in the elderly. The aims of this work were to evaluate if a one-year intervention with two Mediterranean diets (Med-diet) could decrease blood pressure (BP) due to a high polyphenol consumption, and if the decrease in BP was mediated by plasma nitric oxide (NO) production. METHODS AND RESULTS: An intervention substudy of 200 participants at high cardiovascular risk was carried out within the PREDIMED trial. They were randomly assigned to a low-fat control diet or to two Med-diets, one supplemented with extra virgin olive oil (Med-EVOO) and the other with nuts (Med-nuts). Anthropometrics and clinical parameters were measured at baseline and after one year of intervention, as well as BP, plasma NO and total polyphenol excretion (TPE) in urine samples. Systolic and diastolic BP decreased significantly after a one-year dietary intervention with Med-EVOO and Med-nuts. These changes were associated with a significant increase in TPE and plasma NO. Additionally, a significant positive correlation was observed between changes in urinary TPE, a biomarker of TP intake, and in plasma NO (Beta = 4.84; 95% CI: 0.57-9.10). CONCLUSIONS: TPE in spot urine sample was positively correlated with plasma NO in Med-diets supplemented with either EVOO or nuts. The statistically significant increases in plasma NO were associated with a reduction in systolic and diastolic BP levels, adding to the growing evidence that polyphenols might protect the cardiovascular system by improving the endothelial function and enhancing endothelial synthesis of NO.

Inverse association between habitual polyphenol intake and incidence of cardiovascular events in the PREDIMED study.

BACKGROUND AND AIMS: Epidemiologic and biological evidence supports an inverse association between polyphenol consumption and the risk of cardiovascular disease (CVD). However, no previous studies have prospectively evaluated the relationship between polyphenol intake and the incidence of CVD in such a comprehensive way. The aim was to evaluate the association between intakes of total polyphenol and polyphenol subgroups, and the risk of major cardiovascular events (myocardial infarction, stroke or death from cardiovascular causes) in the PREDIMED study. METHODS AND RESULTS: The present work is an observational study within the PREDIMED trial. Over an average of 4.3 years of follow-up, there were 273 confirmed cases of CVD among the 7172 participants (96.3%) who completed a validated 137-item food frequency questionnaire (FFQ) at baseline. Polyphenol consumption was calculated by matching food consumption data from the FFQ with the Phenol-Explorer database on polyphenol content of each reported food. After multivariate adjustment, a 46% reduction in risk of CVD risk was observed comparing Q5 vs. Q1 of total polyphenol intake (HR = 0.54; 95% confidence interval [CI] = 0.33-0.91; P-trend = 0.04). The polyphenols with the strongest inverse associations were flavanols (HR = 0.40; CI 0.23-0.72; P-trend = 0.003), lignans (HR = 0.51; CI 0.30-0.86; P-trend = 0.007), and hydroxybenzoic acids (HR = 0.47; CI 0.26-0.86; P-trend 0.02). CONCLUSION: Greater intake of polyphenols, especially from lignans, flavanols, and hydroxybenzoic acids, was associated with decreased CVD risk. Clinical trials are needed to confirm this effect and establish accurate dietary recommendations.

Dietary intake and major food sources of polyphenols in a Spanish population at high cardiovascular risk: the PREDIMED study.

BACKGROUND AND AIMS: Epidemiological data have shown an inverse association between the consumption of polyphenol-rich foods and the risk of cardiovascular disease or overall mortality. A comprehensive estimation of individual polyphenol intake in nutritional cohorts is needed to gain a better understanding of this association. The aim of this study was to estimate the quantitative intake of polyphenols and the major dietary sources in the PREDIMED (PREvención con DIeta MEDiterránea) cohort using individual food consumption records. METHODS AND RESULTS: The PREDIMED study is a large, parallel-group, multicentre, randomised, controlled 5-year feeding trial aimed at assessing the effects of the Mediterranean diet on the primary prevention of cardiovascular disease. A total of 7200 participants, aged 55-80 years, completed a validated 1-year food frequency questionnaire (FFQ) at baseline. Polyphenol consumption was calculated by matching food consumption data from the FFQ with the recently developed Phenol-Explorer database on polyphenol content in foods. The mean total polyphenol intake was 820 ± 323 mg day⁻¹ (443 ± 218 mg day⁻¹ of flavonoids and 304 ± 156 mg day⁻¹ of phenolic acids). Hydroxycinnamic acids were the phenolic group with the highest consumption and 5-caffeoylquinic acid was the most abundantly ingested individual polyphenol. The consumption of olives and olive oil was a differentiating factor in the phenolic profile of this Spanish population compared with other countries. CONCLUSION: In Mediterranean countries, such as Spain, the main dietary source of polyphenols is coffee and fruits, but the most important differentiating factor with respect to other countries is the consumption of polyphenols from olives and olive oil.

Gazpacho consumption is associated with lower blood pressure and reduced hypertension in a high cardiovascular risk cohort. Cross-sectional study of the PREDIMED trial.

BACKGROUND AND AIM: Hypertension is a major public health problem and a leading cause of death and disability in both developed and developing countries, affecting one-quarter of the world's adult population. Our aim was to evaluate whether the consumption of gazpacho, a Mediterranean vegetable-based cold soup rich in phytochemicals, is associated with lower blood pressure (BP) and/or reduced prevalence of hypertension in individuals at high cardiovascular risk. METHODS AND RESULTS: We selected 3995 individuals (58% women, mean age 67 y) at high cardiovascular risk (81% hypertensive) recruited into the PREDIMED study. BP, weight, and dietary and physical activity data were collected. In multivariate linear regression analyses, after adjustment, moderate and high gazpacho consumption categories were associated with reduced mean systolic BP of -1.9 mm Hg [95% confidence interval (CI): -3.4; -0.6] and -2.6 mm Hg (CI: -4.2; -1.0), respectively, and reduced diastolic BP of -1.5 mm Hg (CI: -2.3; -0.6) and -1.9 mm Hg (CI: -2.8; -1.1). By multiple-adjusted logistic regression analysis, gazpacho consumption was associated with a lower prevalence of hypertension, with OR = 0.85 (CI: 0.73; 0.99) for each 250 g/week increase and OR = 0.73 (CI: 0.55; 0.98) for high gazpacho consumption groups compared to the no-consumption group. CONCLUSIONS: Gazpacho consumption was inversely associated with systolic and diastolic BP and prevalence of hypertension in a cross-sectional Mediterranean population at high cardiovascular risk. The association between gazpacho intake and reduction of BP is probably due to synergy among several bioactive compounds present in the vegetable ingredients used to make the recipe.

Changes in bread consumption and 4-year changes in adiposity in Spanish subjects at high cardiovascular risk.

The effects of bread consumption change over time on anthropometric measures have been scarcely studied. We analysed 2213 participants at high risk for CVD from the PREvención con DIeta MEDiterránea (PREDIMED) trial to assess the association between changes in the consumption of bread and weight and waist circumference gain over time. Dietary habits were assessed with validated FFQ at baseline and repeatedly every year during 4 years of follow-up. Using multivariate models to adjust for covariates, long-term weight and waist circumference changes according to quartiles of change in energy-adjusted white and whole-grain bread consumption were calculated. The present results showed that over 4 years, participants in the highest quartile of change in white bread intake gained 0·76 kg more than those in the lowest quartile (P for trend = 0·003) and 1·28 cm more than those in the lowest quartile (P for trend < 0·001). No significant dose-response relationships were observed for change in whole-bread consumption and anthropometric measures. Gaining weight (>2 kg) and gaining waist circumference (>2 cm) during follow-up was not associated with increase in bread consumption, but participants in the highest quartile of changes in white bread intake had a reduction of 33 % in the odds of losing weight (>2 kg) and a reduction of 36 % in the odds of losing waist circumference (>2 cm). The present results suggest that reducing white bread, but not whole-grain bread consumption, within a Mediterranean-style food pattern setting is associated with lower gains in weight and abdominal fat.

Total polyphenol excretion and blood pressure in subjects at high cardiovascular risk.

BACKGROUND AND AIMS: Dietary factors are critical for the prevention and treatment of hypertension, but data on the effects of specific nutrients on blood pressure (BP) are scarce. The aim of this study was to assess the relationship between total polyphenol excretion (TPE) in urine, as an objective measurement of total polyphenol intake and BP in an elderly population at high cardiovascular risk. METHODS AND RESULTS: Cross-sectional substudy of 589 high-risk participants entering in the PREDIMED trial. BP was measured and TPE was determined in urine by Folin-Ciocalteu assay. A significant positive association was observed between TPE in urine and daily intake of fruit and vegetables (F&V), coffee or wine after adjusting for potential confounders. The intake of 100 g of F&V (Beta=0.150;P<0.001) had a greater contribution to TPE than 100 mL of coffee (Beta=0.141;P=0.001), and the latter two foods contributed more than the consumption of 100 mL of wine (Beta=0.120;P=0.019). An inverse association was observed between urinary TPE and the prevalence of hypertension. Participants in the highest quartile of urinary TPE had a reduced prevalence of hypertension compared to those in the lowest quartile (Odds Ratio=0.64; 95% confidence interval 0.45 to 0.92; P=0.015). Systolic and diastolic BP were inversely associated with urinary TPE after adjustment for potential confounders (P=0.024 and P=0.003, respectively). CONCLUSIONS: Polyphenol intake, assessed via TPE in urine, was negatively associated with BP levels and prevalence of hypertension in an elderly Mediterranean population at high cardiovascular risk. Participants with the highest intake of polyphenol-rich foods showed the lowest BP measurements.

Effects of dietary fibre intake on risk factors for cardiovascular disease in subjects at high risk.

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<0.005; all). Reductions in fasting glucose and total cholesterol levels, and increments in HDL cholesterol were highest among participants in the upper 20% of fibre intake (p = 0.04 and 0.02 respectively). Plasma concentrations of C-reactive protein, but not those of inflammatory cytokines, decreased in parallel with increasing dietary fibre (p = 0.04). Significant reductions in LDL cholesterol were observed only among participants with the greatest increases in soluble fibre intake (p = 0.04). CONCLUSIONS: Increasing dietary fibre intake with natural foods is associated with reductions in classical and novel cardiovascular risk factors in a high-risk cohort.

Role of vegetables and fruits in Mediterranean diets to prevent hypertension.

BACKGROUND/OBJECTIVES: Several studies support the effectiveness of increasing the consumption of fruits and vegetables (F&V) to prevent hypertension. However, none of them have been conducted in a Mediterranean setting. The aim of this study was to assess the association between F&V consumption and the risk of hypertension. SUBJECTS/METHODS: A prospective Mediterranean study (the SUN cohort), including 8594 participants aged 20-95 years (mean, 41.1) with median follow-up of 49 months. RESULTS: Analyses according to the joint classification by olive oil and F&V consumption showed a significant inverse relation between F&V consumption and the risk of hypertension only among participants with a low olive oil consumption (<15 g per day). Also, tests for trend were significant only in the low olive oil intake stratum. CONCLUSIONS: We found a statistically significant interaction (P=0.01) between olive oil intake and F&V consumption. These data suggest a sub-additive effect of both food items.

[NUTRISOL: a computer programme for communitary and hospital nutritional evaluation of free access]. / NUTRISOL: un programa informático para la evaluación nutricional comunitaria y hospitalaria de acceso libre.

We have developed the computer programme NUTRISOL, a nutritional programme destined to analysis of dietary intake by means of the food transformation to nutrient. It has been performed under Windows operative system, using Visual Basic 6.0. It is presented in a CD-Rom. We have used the Spanish CSIC Food Composition Table and domestic food measures commonly used in Spain which could be modified and updated. Diverse kind of diets and reference anthropometric data are also presented. The results may be treated using various statistical programmes. The programme contains three modules: 1) Nutritional epidemiology, which allows to create or open a data base, sample management, analyse food intake, consultation of nutrient content and exportation of data to statistical programmes. 2) Analyses of diets and recipes, creation or modification of new ones. 3) To ask different diets for prevalent pathologies. Independent tools for modifying the original tables, calculate energetic needs, recommend nutrient intake and anthropometric indexes are also offered. In conclusion, NUTRISOL Programme is an application which runs in PC computers with minimal equipment in a friendly interface, of easy use, freeware, which may be adapted to each country, and has demonstrated its usefulness and reliability in different epidemiologic studies. Furthermore, it may become an efficient instrument for clinical nutrition and health promotion.

NUTRISOL: un programa informático para la evaluación nutricional comunitaria y hospitalaria de acceso libre / Nutrisol: A computer programme for communitary and hospital nutritional evaluation of free access

Hemos desarrollado el programa NUTRISOL, un programa informático destinado al análisis de la ingesta alimentaria mediante la transformación de alimentos a nutrientes. Ha sido elaborado bajo el sistema operativo Windows®, usando el entorno Visual Basic® 6.0. En su elaboración se han usado las tablas de composición de alimentos del CSIC y medidas domésticas de alimentos de uso común en España, siendo posible modificarlas y actualizarlas. También se presentan diversas dietas y datos antropométricos de referencia. Los resultados que aporta pueden procesarse con la mayoría de los programas estadísticos. El programa ofrece tres módulos: 1) Epidemiología nutricional, en el que se pueden crear o abrir bases de datos, gestionar muestras, gestionar la ingesta, consultar contenido de nutrientes y exportar datos para tratarlos con programas estadísticos. 2) Análisis de dietas y recetas, en el que además se pueden crear o modificar las existentes y exportarlas. 3) Solicitud de distintas dietas para patologías prevalentes. También se ofrece un apartado de herramientas independientes en el que se pueden modificar las tablas originales, calcular las necesidades energéticas, las ingestas recomendadas e índices antropométricos. En conclusión, el programa NUTRISOL es una aplicación que funciona en ordenadores tipo PC-compatibles con mínimo equipamiento, con una interfaz "amigable", de uso sencillo, que se puede adaptar a cualquier región, de acceso gratuito y que ha demostrado su utilidad y fiabilidad en distintos estudios epidemiológicos. Además, puede ser un instrumento eficiente para la educación nutricional, la nutrición hospitalaria y la promoción de la salud (AU)

We have developed the computer programme NUTRISOL, a nutritional programme destined to analysis of dietary intake by means of the food transformation to nutrient. It has been performed under Windows® operative system, using Visual Basic® 6.0. It is presented in a CD-Rom. We have used the Spanish CSIC Food Composition Table and domestic food measures commonly used in Spain which could be modified and updated. Diverse kind of diets and reference anthropometric data are also presented. The results may be treated using various statistical programmes. The programme contains three modules: 1) Nutritional epidemiology, which allows to create or open a data base, sample management, analyse food intake, consultation of nutrient content and exportation of data to statistical programmes. 2) Analyses of diets and recipes, creation or modification of new ones. 3) To ask different diets for prevalent pathologies. Independent tools for modifying the original tables, calculate energetic needs, recommend nutrient intake and anthropometric indexes are also offered. In conclusion, NUTRISOL Programme is an application which runs in PC computers with minimal equipment in a friendly interface, of easy use, freeware, which may be adapted to each country, and has demonstrated its usefulness and reliability in different epidemiologic studies. Furthermore, it may become an efficient instrument for clinical nutrition and health promotion (AU)

Components of the Mediterranean-type food pattern and serum inflammatory markers among patients at high risk for cardiovascular disease.

OBJECTIVE: To evaluate associations between components of the Mediterranean diet and circulating markers of inflammation in a large cohort of asymptomatic subjects at high risk for cardiovascular disease. SUBJECTS/METHODS: A total of 339 men and 433 women aged between 55 and 80 years at high cardiovascular risk because of presence of diabetes or at least three classical cardiovascular risk factors, food consumption was determined by a semi-quantitative food frequency questionnaire. Serum concentrations of high-sensitivity C-reactive protein (CRP) were measured by immunonephelometry and those of interleukin-6 (IL-6), intracellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) by enzyme-linked immunosorbent assay. RESULTS: After adjusting for age, gender, body mass index, diabetes, smoking, use of statins, non-steroidal antiinflammatory drugs and aspirin, a higher consumption of fruits and cereals was associated with lower concentrations of IL-6 (P for trend 0.005;both). Subjects with the highest consumption of nuts and virgin olive oil showed the lowest concentrations of VCAM-1, ICAM-1, IL-6 and CRP; albeit only for ICAM-1 was this difference statistically significant in the case of nuts (for trend 0.003) and for VCAM-1 in the case of virgin olive oil (P for trend 0.02). Participants with higher adherence to the Mediterranean-type diet did not show significantly lower concentrations of inflammatory markers (P<0.1 for VCAM-1 and ICAM-1). CONCLUSIONS: The consumption of some typical Mediterranean foods (fruits, cereals, virgin olive oil and nuts) was associated with lower serum concentrations of inflammatory markers especially those related to endothelial function, in subjects with high cardiovascular risk living in a Mediterranean country.

[Quality of life in patients treated for early laryngeal cancer, in healthy people and in those with other associated pathologies]. / Calidad de vida en pacientes tratados por un cáncer de laringe inicial y en personas sanas y con otras patologías.

Nowadays there are different non aggressive treatment options for early laryngeal cancer. However, they are not free of undesirable effects. We have studied this patients' quality of life, by comparing it with that obtained from healthy population and other illness groups (post-AMI patients, Chronic Kidney patients). We have studied 62 T1-T2NoMo laryngeal carcinoma diagnosed at the "Virgen de la Victoria" clinical hospital from Malaga, Spain, between 1990 and 1998. We used the Quality of Life in Málaga (QLM), general QL questionnaire which was developed and validated at the Department of Preventive Medicine of the University of Málaga, Spain. The results were compared with those obtained from ramdom samples in healthy population from Málaga and from various pathology groups. The global QOL of our patients treated for an early glottic cancer (Index Quality of life 29.4%) was better than almost all the other ones.

Calidad de vida en pacientes tratados por un cáncer de laringe inicial y en personas sanas y con otras patologías / Quality of life in patients treated for early laryngeal cancer and healthy people and in those with other associated diseases

Hoy dia existen múltiples tratamientos, poco agresivos, para un cáncer de laringe inicial, pero ninguno está exento de efectoos secundarios. Pretendemos comparar la calidad de vida global de estos pacientes con la población sana y otros grupos de enfermedad (IAM y nefrópatas crónicos). hemos estudiado a 62 pacientes que constituyen la totalidad de los casos diagnosticados de un carcinoma laringeo inicial T1-T2NoMo en el Hospital Clinico Virgen de la Victoriade Málaga entre 1990 y 1998. Hemos aplicado el Cuestinario general de Calidad de Vida en Málaga (QLM) desarrollado por el departamento de Medicina Preventiva de la Universidad de Málaga, de propiedades psicometricas demostradas. Comparamos los resultados de nuestros pacientes con los obtenidso con muestras aleatorias de población de málaga sanas y con diversas patologias. Nuestros pacientes con un indice de Pérdida de la calidad de vida del 29,4% superaban a casi todos los grupos de comparación (AU)

Nowadays there are different non aggressive treatment options for early laryngeal cancer. However, they are not free of undesirable effects. We have studied this patients' quality of life, by comparing it with that obtained from healthy population and other illness groups (post-AMI patients, Chronic Kidney patients). We have studied 62 T1-T2NoMo laryngeal carcinoma diagnosed at the "Virgen de la Victoria" clinical hospital from Malaga, Spain, between 1990 and 1998. We used the Quality of Life in Málaga (QLM), general QL questionnaire which was developed and validated at the Department of Preventive Medicine of the University of Málaga, Spain. The results were compared with those obtained from ramdom samples in healthy population from Málaga and from various pathology groups. The global QOL of our patients treated for an early glottic cancer (Index Quality of life 29.4%) was better than almost all the other ones (AU)

Development of a short dietary intake questionnaire for the quantitative estimation of adherence to a cardioprotective Mediterranean diet.

Our objective was to develop a short questionnaire that can be easily used to estimate quantitatively the level of adherence to cardioprotective Mediterranean diets. The short questionnaire assessed the consumption of cardioprotective elements included in the Mediterranean diet (olive oil, wine, fruits, vegetables, fish, legumes and whole-grain intake). A low consumption of meat or meat-products was also included in the composite score. The relative risk of myocardial infarction for each category of the composite score obtained (range 0-9) was computed using data from a case-control study that included 171 cases of first myocardial infarction and 171 matched controls. We found an adjusted odds ratio=0.18 (95% confidence interval (CI): 0.03-0.97; P=0.04) for those scoring 7-9 points when comparing them with those scoring 1-2 points. An increment of one point in the score was associated with an 18% reduction in the relative risk of myocardial infarction (P=0.05).

Calidad de vida en pacientes tratados por un cáncer de cabeza y cuello / Quality of life in patients treated of a head and neck cancer

En este trabajo pretendemos comparar la calidad de vida global de pacientes que recibieron tratamiento por un carcinoma laríngeo inicial con la de otros pacientes tratados de un cáncer de cabeza y cuello avanzado. Hemos estudiado a 62 pacientes que constituyen la totalidad de los casos diagnosticados de un carcinoma laríngeo inicial T1, T2-N0M0 en el Hospital Clínico Virgen de la Victoria de Málaga entre 1990 y 1998. Hemos aplicado el Cuestionario EORTC QLQ C-30 y su módulo de cabeza y cuello H&N 35. Comparamos los resultados con los de un grupo heterogéneo de 48 pacientes con cánceres avanzados de cabeza y cuello. La calidad de vida de nuestros pacientes fue mejor en muchas escalas funcionales del EORTC y en varios síntomas específicos del H&N 35, pero no en los síntomas generales del cáncer (AU)

In this paper we have studied the quality of life of patients that underwent treatment for an early laryngeal carcinoma in comparison to others with an advanced head and neck cancer. We have studied 62 patients (T1N0M0, T2N0M0) with laryngeal carcinoma diagnosed between 1990 and 1998. We have applied the European EORTC QOL C-30 questionnaire, and more specifically its head and neck module (H&N 35). The results were compared with a heterogeneous group of 48 patients with different degrees of head and neck cancers. The quality of life of our patients who were treated for an early glottic cancer was better in many functional scales of the EORTC and in many specific symptom scales of the H&N 35, but not in global cancer symptoms (AU)

[Quality of life in patients treated for head and neck cancer]. / Calidad de vida en pacientes tratados por un cáncer de cabeza y cuello.

In this paper we have studied the quality of life of patients that underwent treatment for an early laryngeal carcinoma in comparison to others with an advanced head and neck cancer. We have studied 62 patients (T1N0M0, T2N0M0) with laryngeal carcinoma diagnosed between 1990 and 1998. We have applied the European EORTC QOL C-30 questionnaire, and more specifically its head and neck module (H&N 35). The results were compared with a heterogeneous group of 48 patients with different degrees of head and neck cancers. The quality of life of our patients who were treated for an early glottic cancer was better in many functional scales of the EORTC and in many specific symptom scales of the H&N 35, but not in global cancer symptoms.

Methodological quality and reporting of ethical requirements in clinical trials.

OBJECTIVES: To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. DESIGN: Systematic review using a standardised checklist. MAIN MEASURES: Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published by at least one Spanish author during the same period in any other journal were also included. RESULTS: We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groups. CONCLUSION: Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects.

Flexible flat feet in children: a real problem?

OBJECTIVES: To estimate the prevalence of flexible flat feet in the provincial population of 4- to 13-year-old schoolchildren and the incidence of treatments considered unnecessary. SETTING: Province of Málaga, Spain. METHODS: We examined and graded by severity a sample of 1181 pupils taken from a total population of 198 858 primary schoolchildren (CI: 95%; margin of error: 5%). The sample group was separated into three 2-year age groups: 4 and 5 years, 8 and 9 years, and 12 and 13 years. The plantar footprint was classified according to Denis1 into three grades of flat feet: grade 1 in which support of the lateral edge of the foot is half that of the metatarsal support; grade 2 in which the support of the central zone and forefoot are equal; and grade 3 in which the support in the central zone of the foot is greater than the width of the metatarsal support. The statistical analysis for the evaluation of the differences between the groups was performed with Student's t and chi2 tests as appropriate. RESULTS: The prevalence of flat feet was 2.7%. Of the 1181 children sampled, 168 children (14.2%) were receiving orthopedic treatment, but only 2.7% had diagnostic criteria of flat feet. When we inspected the sample, we found that a number of children were being treated for flat feet with boots and arch supports. Most of them did not have a flat plantar footprint according to the criteria that we used for this work. Furthermore, in the group of children that we diagnosed as having flat feet, only 28.1% were being treated. We found no significant differences between the number of children receiving orthopedic treatments and the presence or absence of a flat plantar footprint. Children who were overweight in the 4- and 5-year-old group showed an increased prevalence for flat feet as diagnosed by us. CONCLUSION: The data suggest that an excessive number of orthopedic treatments had been prescribed in the province. When extrapolated to the 1997 population of schoolchildren within the age groups studied the figures suggested that approximately 28 167 children in Málaga province probably would have been receiving orthopedic treatments with boots and insoles at the time of our study. Consequently, the total expenditure on orthopedic boots and insoles that year could be estimated as 676 008 000 pesetas ($4 447 422 in US currency).