Diagnóstico y tratamiento del paciente varón con síntomas del tracto urinario inferior en España - Estudio MERCURY. ¿Seguimos los urólogos las recomendaciones de las guías europeas? / Diagnosis and treatment of male patients with lower urinary tract symptoms in Spain - The MERCURY Study. Do urologists follow the recommendations of the European guidelines?

Objetivos: Conocer el manejo de pacientes varones con síntomas del tracto urinario inferior (STUI) y evaluar el seguimiento de las recomendaciones de las guías de la Asociación Europea de Urología en España. Material y métodos: El estudio MERCURY, epidemiológico y transversal, con 227 unidades de urología participantes en España, evaluó a pacientes varones con STUI mixtos predominantemente de llenado, de los cuales se recogió información sociodemográfica, clínica y de consumo de recursos de los 6 meses anteriores. Adicionalmente, mediante un caso clínico teórico, los investigadores describieron su actitud sobre el manejo de los STUI mixtos con predominio de llenado persistentes tras un tratamiento inicial, en cuanto a pruebas diagnósticas y aproximación terapéutica en la primera y la segunda visita. Las opciones proporcionadas para el manejo de los STUI estaban alineadas con las recomendaciones de la Asociación Europea de Urología. Resultados: Se evaluaron 610 pacientes, de los cuales el 87,7% consumió algún recurso sanitario debido a: visitas al urólogo (79,7%), determinación del PSA (76,6%) y tratamiento con alfabloqueante (37,5%) y alfabloqueante más antimuscarínico (37,2%). En el caso clínico teórico, la actitud del urólogo en la elección de pruebas diagnósticas y tratamiento farmacológico fue principalmente: determinación del PSA (97,7%), tacto rectal (91,4%) y tratamiento con alfabloqueantes en monoterapia (56,6%) en la primera visita; flujometría (48,9%), diario miccional (40,3%) y tratamiento con alfabloqueante más antimuscarínico (70,6%) en la segunda visita. Conclusiones: La actitud de los urólogos en España para el manejo del paciente varón con STUI mixtos predominantemente de llenado se ajusta a las recomendaciones de las guías clínicas europeas

Objectives: To explore the management of lower urinary tract symptoms (LUTS) in men in Spain and assess the compliance with recommendations established in the European Association of Urology (EAU) guidelines. Material and methods: MERCURY was an epidemiological and cross-sectional study which involved 227 Urology Units across Spain assessing adult male patients with mixed LUTS and persisting storage symptoms. Sociodemographic, clinical and resource use data for the 6 months prior to study inclusion were collected. Additionally, through a theoretical clinical case, clinicians described their attitude toward the diagnostic and therapeutic management of males with mixed LUTS and persisting storage symptoms during the first and second visits. Answer options given to clinicians about LUTS management were aligned with those recommended by EAU guidelines. Result: 610 patients included in the study were evaluated. 87.7% of them consumed some health resource mainly due to: urologist visits (79.7%), PSA determination (76.6%) and treatment with alpha-blockers (37.5%) and alpha-blockers plus antimuscarinics (37.2%). According to the theoretical clinical case, urologists preference toward diagnostic tools and pharmacological treatment in first visit were mainly PSA determination (97.7%), digital rectal examination (91.4%) and treatment with alphablockers as monotherapy (56.6%), whereas in the second visit uroflowmetry (48.9%), voiding diary (40.3%) and treatment with alpha-blockers plus antimuscarinics (70.6%) were mainly preferred. Conclusions: Urologists attitude toward management of male patients with mixed LUTS and persisting storage symptoms is aligned with that recommended in the EAU guidelines

Impacto de los síntomas de vejiga hiperactiva sobre la actividad laboral: estudio ACTIVHA / Impact of overactive bladder symptoms on work activity: The ACTIVHA study

Objetivos: Analizar el impacto de los síntomas de vejiga hiperactiva (VH) sobre la actividad laboral de pacientes en España. Método: Estudio observacional, multicéntrico y transversal con 149 urólogos y 131 ginecólogos de España que incluyeron pacientes diagnosticados de VH según criterio clínico, en edad laboral (18-65 años). Se recogieron datos sociodemográficos, clínicos y de actividad laboral. Los pacientes cumplimentaron el Cuestionario de Autoevaluación del Control de la Vejiga (CACV) y el Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH). Se evaluó el impacto de cada síntoma sobre la actividad diaria y laboral. Los resultados se estratificaron según género y presencia de urgencia e incontinencia urinaria (IU) según el CACV. Resultados: Se evaluaron 768 pacientes (89% mujeres), con una media (DE) de edad de 52,5 (9,3) años y 2,6 (2,6) años de evolución de VH. La sintomatología más frecuente según el paciente fue urgencia (89,8%), seguida de nicturia (75,7%), incontinencia urinaria de urgencia (68,5%) y frecuencia (68,2%). El 96% adoptaron medidas adaptativas para la VH. Según el CACV, 543 pacientes (71%) presentaban urgencia y de estos, 294 (54%) presentaban IU. El síntoma que más afectaba la actividad laboral fue la frecuencia (59,8%). Según el WPAI-GH, los pacientes refirieron un impacto del 32% durante la jornada laboral (41% en pacientes con urgencia e IU) y una pérdida de tiempo de trabajo del 6,5% (un 9,9% en pacientes con urgencia e IU). Conclusiones: Los síntomas de VH impactan negativamente sobre la actividad laboral, especialmente en pacientes que presentan urgencia e IU

Objectives: To analyse the impact of overactive bladder (OAB) symptoms on the work activity of patients in Spain. Method: An observational, multicentre cross-sectional study was conducted with 149 urologists and 131 gynaecologists of Spain and included patients diagnosed with OAB, according to clinical judgment, who were of working age (18-65 years). We collected sociodemographic, clinical and work activity data. The patients filled out the Bladder Control Self-Assessment Questionnaire (B-SAQ) and the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH). The effect of each symptom on the daily and occupational activity was assessed. The results were stratified according to sex and the presence of emergency and urinary incontinence (UI) according to the B-SAQ. Results: We assessed 768 patients (89% women), with a mean (SD) age of 52.5 (9.3) years and 2.6 (2.6) years of OAB progression. The most common symptoms according to the patients were urgent urination (89.8%), nocturia (75.7%), urge incontinence (68.5%) and frequent urination (68.2%). Ninety-six percent of the patients adopted adaptive measures for their OAB. According to the B-SAQ, 543 patients (71%) presented urgent urination; of these, 294 (54%) showed UI. The symptom that most affected work activity was frequent urination (59.8%). According to the WPAI-GH, the patients reported an impact of 32% during the workday (41% in patients with urgent urination and UI) and a loss of work time of 6.5% (9.9% in patients with urgent urination and UI). Conclusions: The symptoms of OAB negatively affect work activity, especially in patients who have urgent urination and UI

Diagnosis and treatment of male patients with lower urinary tract symptoms in Spain - The MERCURY Study. Do urologists follow the recommendations of the European guidelines? / Diagnóstico y tratamiento del paciente varón con síntomas del tracto urinario inferior en España - Estudio MERCURY. ¿Seguimos los urólogos las recomendaciones de las guías europeas?

OBJECTIVES: To explore the management of lower urinary tract symptoms (LUTS) in men in Spain and assess the compliance with recommendations established in the European Association of Urology (EAU) guidelines. MATERIAL AND METHODS: MERCURY was an epidemiological and cross-sectional study which involved 227 Urology Units across Spain assessing adult male patients with mixed LUTS and persisting storage symptoms. Sociodemographic, clinical and resource use data for the 6 months prior to study inclusion were collected. Additionally, through a theoretical clinical case, clinicians described their attitude toward the diagnostic and therapeutic management of males with mixed LUTS and persisting storage symptoms during the first and second visits. Answer options given to clinicians about LUTS management were aligned with those recommended by EAU guidelines. RESULT: 610 patients included in the study were evaluated. 87.7% of them consumed some health resource mainly due to: urologist visits (79.7%), PSA determination (76.6%) and treatment with alpha-blockers (37.5%) and alpha-blockers plus antimuscarinics (37.2%). According to the theoretical clinical case, urologists preference toward diagnostic tools and pharmacological treatment in first visit were mainly PSA determination (97.7%), digital rectal examination (91.4%) and treatment with alphablockers as monotherapy (56.6%), whereas in the second visit uroflowmetry (48.9%), voiding diary (40.3%) and treatment with alpha-blockers plus antimuscarinics (70.6%) were mainly preferred. CONCLUSIONS: Urologists attitude toward management of male patients with mixed LUTS and persisting storage symptoms is aligned with that recommended in the EAU guidelines.

Impact of overactive bladder symptoms on work activity: The ACTIVHA study. / Impacto de los síntomas de vejiga hiperactiva sobre la actividad laboral: estudio ACTIVHA.

OBJECTIVES: To analyse the impact of overactive bladder (OAB) symptoms on the work activity of patients in Spain. METHOD: An observational, multicentre cross-sectional study was conducted with 149 urologists and 131 gynaecologists of Spain and included patients diagnosed with OAB, according to clinical judgment, who were of working age (18-65 years). We collected sociodemographic, clinical and work activity data. The patients filled out the Bladder Control Self-Assessment Questionnaire (B-SAQ) and the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH). The effect of each symptom on the daily and occupational activity was assessed. The results were stratified according to sex and the presence of emergency and urinary incontinence (UI) according to the B-SAQ. RESULTS: We assessed 768 patients (89% women), with a mean (SD) age of 52.5 (9.3) years and 2.6 (2.6) years of OAB progression. The most common symptoms according to the patients were urgent urination (89.8%), nocturia (75.7%), urge incontinence (68.5%) and frequent urination (68.2%). Ninety-six percent of the patients adopted adaptive measures for their OAB. According to the B-SAQ, 543 patients (71%) presented urgent urination; of these, 294 (54%) showed UI. The symptom that most affected work activity was frequent urination (59.8%). According to the WPAI-GH, the patients reported an impact of 32% during the workday (41% in patients with urgent urination and UI) and a loss of work time of 6.5% (9.9% in patients with urgent urination and UI). CONCLUSIONS: The symptoms of OAB negatively affect work activity, especially in patients who have urgent urination and UI.

Iron-dependent reconfiguration of the proteome underlies the intracellular lifestyle of Brucella abortus.

Brucella ssp. is a facultative intracellular pathogen that causes brucellosis, a worldwide zoonosis that affects a wide range of mammals including humans. A critical step for the establishment of a successful Brucella infection is its ability to survive within macrophages. To further understand the mechanisms that Brucella utilizes to adapt to an intracellular lifestyle, a differential proteomic study was performed for the identification of intracellular modulated proteins. Our results demonstrated that at 48 hours post-infection Brucella adjusts its metabolism in order to survive intracellularly by modulating central carbon metabolism. Remarkably, low iron concentration is likely the dominant trigger for reprogramming the protein expression profile. Up-regulation of proteins dedicated to reduce the concentration of reactive oxygen species, protein chaperones that prevent misfolding of proteins, and proteases that degrade toxic protein aggregates, suggest that Brucella protects itself from damage likely due to oxidative burst. This proteomic analysis of B. abortus provides novel insights into the mechanisms utilized by Brucella to establish an intracellular persistent infection and will aid in the development of new control strategies and novel targets for antimicrobial therapy.

Aberrant gene methylation and bronchial dysplasia in high risk lung cancer patients.

INTRODUCTION: The risk for lung cancer is incremented in high degree dysplasia (HGD) and in subjects with hypermethylation of multiple genes. We sought to establish the association between them, as well as to analyze the DNA aberrant methylation in sputum and in bronchial washings (BW). METHODS: Cross sectional study of high risk patients for lung cancer in whom induced sputum and autofluorescence bronchoscopy were performed. The molecular analysis was determined on DAPK1, RASSF1A and p16 genes using Methylation-specific PCR. RESULTS: A total of 128 patients were enrolled in the study. Dysplasia lesions were found in 79 patients (61.7%) and high grade dysplasia in 20 (15.6%). Ninety eight patients out of 128 underwent molecular analysis. Methylation was observed in bronchial secretions (sputum or BW) in 60 patients (61.2%), 51 of them (52%) for DAPK1, in 20 (20.4%) for p16 and in three (3.1%) for RASSF1A. Methylated genes only found in sputum accounted for 38.3% and only in BW in 41.7%, and in both 20.0%. In the 11.2% of the patients studied, HGD and a hypermethylated gene were present, while for the 55.1% of the sample only one of both was detected and for the rest of the subjects (33.6%), none of the risk factors were observed. CONCLUSIONS: Our data determines DNA aberrant methylation panel in bronchial secretions is present in a 61.2% and HGD is found in 15.6%. Although both parameters have previously been identified as risk factors for lung cancer, the current study does not find a significative association between them. The study also highlights the importance of BW as a complementary sample to induced sputum when analyzing gene aberrant methylation.

Does the COPD assessment test (CAT(TM)) questionnaire produce similar results when self- or interviewer administered?

PURPOSE: The COPD assessment test (CAT) is a questionnaire that assesses the impact of chronic obstructive pulmonary disease (COPD) on health status, but some patients have difficulties filling it up by themselves. We examined whether the mode of administration of the Spanish version of CAT (self vs. interviewer) influences its scores and/or psychometric properties. METHODS: Observational, prospective study in 49 Spanish centers that includes clinically stable COPD patients (n = 153) and patients hospitalized because of an exacerbation (ECOPD; n = 224). The CAT was self-administered (CAT-SA) or administered by an interviewer (CAT-IA) based on the investigator judgment of the patient's capacity. To assess convergent validity, the Saint George's Respiratory Disease Questionnaire (SGRQ) and the London Chest Activity of Daily Living (LCADL) instrument were also administered. Psychometric properties were compared across modes of administration. RESULTS: A total of 118 patients (31 %) completed the CAT-SA and 259 (69 %) CAT-IA. Multiple regression analysis showed that mode of administration did not affect CAT scores. The CAT showed excellent psychometric properties in both modes of administration. Internal consistency coefficients (Cronbach's alpha) were high (0.86 for CAT-SA and 0.85 for CAT-IA) as was test-retest reliability (intraclass correlation coefficients of 0.83 for CAT-SA and CAT-IA). Correlations with SGRQ and LCADL were moderate to strong both in CAT-SA and CAT-IA, indicating good convergent validity. Similar results were observed when testing longitudinal validity. CONCLUSIONS: The mode of administration does not influence CAT scores or its psychometric properties. Hence, both modes of administration can be used in clinical practice depending on the physician judgment of patient's capacity.

Patterns of systemic lupus erythematosus expression in Europe.

OBJECTIVES: To analyse the differences in disease expression of European SLE patients based on gender, age at diagnosis, and ethnicity. METHODS: A two-year, retrospective, multicentre, observational study was carried out in five countries (France, Germany, Italy, Spain and the UK). Patients' clinical manifestations including disease activity, organ involvement, organ damage and flares were analysed. RESULTS: Thirty-one centres enrolled 412 consecutive eligible patients (90.5% of women), with active disease, stratified by disease severity (half severe and half non-severe). Baseline characteristics included; mean (SD) age: 43.3 (13.6) years, SLE duration: 10.7 (8.0) years and age at disease diagnosis: 32.6 (13.0) years old. The mean (SD) SELENA-SLEDAI and SLICC/ACR scores were: 8.1 (6.7) and 0.82 (1.36), respectively. Over half of patients experienced flares (54.9%). The average number of annual flares was 1.01 (0.71) flares/year. In males compared to females, the renal system was more frequently active (53.8% vs 30.0%, p=0.002), the mean SLICC/ACR score was higher (1.15 vs 0.79, p=0.039) and the pulmonary system was more likely to be damaged (12.8% vs 3.8%, p=0.010). Furthermore, patients diagnosed at younger age displayed more renal system activity (young: 56.3% vs adult: 33.4% vs elder: 8.9%, p<0.001) and renal damage (25.0% vs 6.9% vs 2.2%, p=0.018) compared to the others. The annual number of flares (1.13 vs 1.05 vs 0.81 flares/year, p<0.0001), including the occurrence of severe flares (0.58 vs 0.51 vs 0.20, p<0.0001), was also higher in these patients. Conversely, greater organ damage was observed in patients diagnosed at an older age compared to the others. The mean SLICC/ACR score was higher (1.31 vs young: 0.88 and adult: 0.78, p<0.001) in patients diagnosed in the older age groups. The pulmonary (13.3% vs younger: 0% vs adult: 3.7%, p=0.030) and cardiovascular (17.8% vs younger: 0% vs adult: 2.9%, p<0.001) systems were more frequently damaged in these patients. Black African descents showed greater disease activity compared to Caucasian patients. They flared more often (77.1% vs 48.6%, p=0.001) and experienced a greater number of annual flares (1.57 vs 0.89 flares/year, p<0.0001), mainly more severe flares (0.89 vs 0.38/year, p<0.0001). They also were more likely to experience renal system damage. CONCLUSION: The study showed clearly two patient subsets. The disease was the most active in Black African descents, and this phenomenon has never been described before in continental Europe. The disease was also more active in patients diagnosed at a younger or adult. Greater disease damage was observed in males and in patients diagnosed at an older age.

Disease-specific quality of life evaluation and its determinants in Cushing's syndrome: what have we learnt?

Cushing's syndrome (CS) has a considerable negative impact on patient health-related quality of life (HRQoL). Two disease-specific instruments (the CushingQoL and the Tuebingen CD-25 questionnaire) are now available to assess the impact of the disease and its treatment on HRQoL. The purpose of this review was to summarize the characteristics of the studies which have used these two instruments to date and summarize their findings regarding (a) the determinants of disease-specific HRQoL in patients with CS and (b) the impact of treatment for CS on disease-specific HRQoL. A total of 7 studies were identified, 5 with the CushingQoL and 2 with the Tuebingen CD-25. Most were observational studies, though the CushingQoL had been used in one randomized clinical trial. In terms of clinical factors, there was some evidence for an association between UFC levels and disease-specific HRQoL, though the presence and strength of the association varied between studies. There was also some evidence that a more recent diagnosis of CS could lead to poorer HRQoL, and that length of time with adrenal insufficiency may also affect HRQoL. There was no evidence for an impact on disease-specific HRQoL of etiology or of the clinical signs and symptoms associated with CS, such as bruising, rubor, and fat deposits. One factor which did have a significant negative effect on HRQoL was the presence of depression. No clear picture emerged as to the effect of demographic variables such as age and gender on HRQoL scores, though there was some evidence for poorer HRQoL in female patients. As regards treatment, the two interventions studied to date (transsphenoidal surgery and pasireotide) both showed significant gains in HRQoL, with moderate to large effect sizes. This type of review is useful in summarizing knowledge to date and suggesting future research directions.

Mapping CushingQOL scores to EQ-5D utility values using data from the European Registry on Cushing's syndrome (ERCUSYN).

PURPOSE: To construct a model to predict preference-adjusted EuroQol 5D (EQ-5D) health utilities for CS using the disease-specific health-related quality of life measure (CushingQOL). METHODS: Data were obtained from the European Registry on CS (ERCUSYN). ERCUSYN is a web-based, multicenter, observational study that enrolled 508 CS patients from 36 centers in 23 European countries. Patients included in the study completed both the EQ-5D and the disease-specific CushingQOL questionnaire. Socio-demographic and clinical data were also collected. The UK tariff values were used to calculate EQ-5D utility scores. Various predictive models were tested, and the final model was selected based on four criteria: explanatory power (adjusted R-squared), consistency of estimated coefficients (sign and parameter estimation), normality of prediction errors (mean error, mean absolute error, root mean squared error), and parsimony. RESULTS: For the mapping analysis, data were available from a total of 129 patients. Mean (SD) age was 43.1 (13) years, and the sample was predominantly female (84.5 %). Patients had a mean (SD) CushingQOL score of 39.7 (17.1) and a mean (SD) 'tariff' value on the EQ-5D of 0.55 (0.3). The model which best met the criteria for selection included the intercept and 3 CushingQOL's questions and had an R(2) of 0.506 and a root mean square error of 0.216. CONCLUSIONS: It was possible to find a mapping function which successfully predicted the EQ-5D UK utilities from disease-specific CushingQOL scores. The function may be useful in calculating EQ-5D scores when EQ-5D data have not been gathered directly in a study.

Validación de la versión española de la escala de intensidad del picor (Cuestionario Itch Severity Scale, ISS). Estudio PSEDA / Validation of the Spanish Version of the Itch Severity Scale: The PSEDA Study

Introducción y objetivo: El cuestionario Itch Severity Scale (ISS) permite evaluar objetivamente la intensidad del prurito. El presente estudio pretende validar la versión española del cuestionario ISS en pacientes con dermatitis atópica (DA). Materiales y métodos: Estudio epidemiológico prospectivo, incluyendo pacientes con DA de más de un año de evolución y un grupo control sin DA. Los pacientes con DA se estratificaron según actividad de las lesiones (activas/inactivas), realizando una visita basal y dos de seguimiento (3 y 6 meses). Se recogieron variables sociodemográficas, relacionadas con la DA (incluyendo el modified Eczema Area and Severity Index o mEASI), enfermedades concomitantes y medidas del paciente como ISS, Dermatology Life Quality Index (DLQI) o Children's DLQI (cDLQI). Resultados: Se incluyeron 207 pacientes pediátricos (2-17 años): 56 controles, 103 con lesiones activas y 48 inactivas, con una edad media (DE) de 8,1(4,0) años. Los adultos fueron 261 pacientes (≥ 18 años): 89 controles, 124 con lesiones activas y 48 inactivas, con una edad media (DE) de 32,3 (13,4) años.ISS pediátricos: tasa de respuesta > 80% (factibilidad), correlacionándose con mEASI y cDLQI en visita basal (p<0,001) (validez), effect size de 0,988 (sensibilidad al cambio) y alpha de Cronbach de 0,840 (consistencia interna).ISS adultos: tasa de respuesta fue > 95% (factibilidad), correlacionándose con mEASI y DLQI en visita basal (p<0,001) (validez), effect size de 1,0 (sensibilidad al cambio), alpha de Cronbach de 0,825 (consistencia interna). Conclusiones: La versión española del ISS se mostró factible, válida, sensible al cambio y fiable en términos de consistencia interna, tanto en niños como en adultos (AU)

Background and objectives: The Itch Severity Scale (ISS) facilitates objective assessment of the intensity of pruritus. The aim of this study was to validate a Spanish version of the ISS in patients with atopic dermatitis. Material and methods: A prospective epidemiological study was undertaken in patients diagnosed with atopic dermatitis at least 1 year previously and a control group without the disease. Patients with atopic dermatitis were stratified according to the status of the lesions (active or inactive) and questionnaires were completed at baseline and 3-month and 6-month follow-up. Data were collected on sociodemographic variables relating to atopic dermatitis (including the modified Eczema Area and Severity Index [mEASI]), concomitant disease, and patient measures such as ISS, Dermatology Life Quality Index (DLQI), and Children's DLQI (cDLQI). Results: A total of 207 children (2-17 years) were included: 56 control subjects, 103 patients with active lesions, and 48 with inactive lesions. The mean (SD) age of the participants in this age group was 8.1 (4.0) years. A total of 261 adults (≥ 18 years) were included: 89 control subjects, 124 patients with active lesions, and 48 with inactive lesions. The mean age of the adult participants was 32.3 (13.4) years. A response rate of > 80% was obtained on the pediatric ISS (feasibility) and the responses correlated with the mEASI and cDLQI at baseline (P<0.001) as an indicator of validity. An effect size of 0.988 was observed (sensitivity to change) along with a Chronbach α of 0.840 (internal consistency). A response rate of >95% was obtained on the adult ISS (feasibility) and the responses correlated with the mEASI and DLQI at baseline (P<0.001) as an indicator of validity. An effect size of 1.0 was observed (sensitivity to change) along with a Chronbach α of 0.825 (internal consistency). Conclusions: The Spanish version of the ISS is feasible, valid, sensitive to change, and displays good reliability based on internal consistency in both children and adults (AU)

[Validation of the Spanish Version of the Itch Severity Scale: the PSEDA study]. / Validación de la versión española de la escala de intensidad del picor (Cuestionario Itch Severity Scale, ISS). Estudio PSEDA.

BACKGROUND AND OBJECTIVES: The Itch Severity Scale (ISS) facilitates objective assessment of the intensity of pruritus. The aim of this study was to validate a Spanish version of the ISS in patients with atopic dermatitis. MATERIAL AND METHODS: A prospective epidemiological study was undertaken in patients diagnosed with atopic dermatitis at least 1 year previously and a control group without the disease. Patients with atopic dermatitis were stratified according to the status of the lesions (active or inactive) and questionnaires were completed at baseline and 3-month and 6-month follow-up. Data were collected on sociodemographic variables relating to atopic dermatitis (including the modified Eczema Area and Severity Index [mEASI]), concomitant disease, and patient measures such as ISS, Dermatology Life Quality Index (DLQI), and Children's DLQI (cDLQI). RESULTS: A total of 207 children (2-17 years) were included: 56 control subjects, 103 patients with active lesions, and 48 with inactive lesions. The mean (SD) age of the participants in this age group was 8.1 (4.0) years. A total of 261 adults (≥ 18 years) were included: 89 control subjects, 124 patients with active lesions, and 48 with inactive lesions. The mean age of the adult participants was 32.3 (13.4) years. A response rate of > 80% was obtained on the pediatric ISS (feasibility) and the responses correlated with the mEASI and cDLQI at baseline (P<.001) as an indicator of validity. An effect size of 0.988 was observed (sensitivity to change) along with a Chronbach α of 0.840 (internal consistency). A response rate of >95% was obtained on the adult ISS (feasibility) and the responses correlated with the mEASI and DLQI at baseline (P<.001) as an indicator of validity. An effect size of 1.0 was observed (sensitivity to change) along with a Chronbach α of 0.825 (internal consistency). CONCLUSIONS: The Spanish version of the ISS is feasible, valid, sensitive to change, and displays good reliability based on internal consistency in both children and adults.

Treatment of chronic he1patitis C genotype 1 with peginterferon-alpha2a (40 kDa) plus ribavirin under routine clinical practice in Spain: early prediction of sustained virological response rate.

BACKGROUND: Sustained virological response rates of up to 52% have been obtained with peginterferon alpha2a (40 kDa) plus ribavirin in patients suffering from chronic hepatitis C genotype 1 in randomized-controlled trials. AIM: To assess early virological response and its clinical utility in predicting an sustained virological response in patients suffering from chronic hepatitis C genotype 1 in routine clinical practice in Spain. METHODS: Treatment-naïve patients received pegylated interferon alpha2a (40 kDa) 180 microg/week plus ribavirin 1000/1200 mg/day for 48 weeks, and were followed for a further 24 weeks. Overall, 475 patients received at least one dose of medication and were included in the efficacy population. RESULTS: The overall sustained virological response rate was 48%. Of those with week 12 virological data, 83% had an early virological response. The negative predictive value of an early virological response was 93%. CONCLUSION: If sustained virological response is the goal, a treatment-decision based on a 12-week evaluation during routine clinical practice is feasible.

Change over time of bowel habit in irritable bowel syndrome: a prospective, observational, 1-year follow-up study (RITMO study).

BACKGROUND: Evolution of bowel habit in irritable bowel syndrome (IBS) is not well known. AIM: To evaluate the change over time of bowel habit in IBS patients followed-up during 1 year. METHODS: Five hundred and seventeen patients with IBS were prospectively included in an observational study with five evaluations over a 1-year period. Symptoms were recorded daily in diary cards during four 4-week periods along the study. Bristol Stool Scale (BSS) was used to define bowel habit. RESULTS: Four-hundred patients completed the study. Rome II showed low-moderate agreement (42%) with BSS to define bowel habit. Frequency of constipation and diarrhoea showed little changes throughout the study. Over 50% of the patients had the same bowel habit when each diary was compared with the next one. A third of patients maintained the same habit throughout the study. Most changes occurred from/to mixed or unsubtyped IBS. Only 14% of cases changed from constipation to diarrhoea or vice versa. This change was associated to female gender (OR: 2.65). CONCLUSIONS: The frequency of constipation and diarrhoea remains relatively stable over time. Changes in IBS subtypes are common, but changes between constipation and diarrhoea are rare. Alternating IBS is more frequent in women.

Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen.

BACKGROUND: The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancer patients treated with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG). PATIENTS AND METHODS: This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment). RESULTS: The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2-4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P<0.03). CONCLUSIONS: The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.

Predictive factors of irritable bowel syndrome improvement: 1-year prospective evaluation in 400 patients.

BACKGROUND: The natural history of the irritable bowel syndrome is poorly understood. AIM: To assess the clinical course of the irritable bowel syndrome and the factors that might predict it. METHODS: An observational prospective study, involving 400 irritable bowel syndrome patients meeting Rome II criteria. Symptoms were recorded in a diary over four non-consecutive months (1, 4, 7 and 10). Demographic data, associated disorders, psychological status and health-related quality of life were obtained. RESULTS: At 1-year follow-up, half of the patients and half of their physicians considered irritable bowel syndrome to have improved, but improvement was minor. Diary data showed that, according to the type of symptom, improvement was small and quite different: diarrhoea in 19% of patients, abdominal pain frequency in 26%, constipation in 33% and abdominal pain intensity in 60%. Factors related to improvement at one year were: severe symptoms and poor health-related quality of life at first visit, irritable bowel syndrome-constipation, good improvement at 3 months, anxiety/depression, stress, symptoms related to meals and absence of comorbidity. By multivariate logistic regression, predictors were: severe basal symptoms and good improvement at 3 months (OR:CI 95%, 1.32:1.09-1.59 and 4.44:2.81-7.05). CONCLUSIONS: At 1-year follow-up, half the patients and their physicians considered the irritable bowel syndrome to have had some improvement but, symptom diaries demonstrated that improvement was small and heterogeneous. Severe basal symptoms and improvement at 3 months were related to better prognosis.

[Validation of the Spanish version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)]. / Validación de la versión española del cuestionario de calidad de vida para pacientes con rinoconjuntivitis.

OBJECTIVE: Validate the questionnaire Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in conditions of regular clinical practice. METHODS: Two hundred and eighty four adult patients with a diagnosis of rhinoconjunctivitis (RC) cared in 37 centers of specialized health care in allergy or otorhinolaryngology services in Spain were analyzed. Patients with RC were included in two groups: clinically non-stable patients who received treatment with an oral second generation antihistaminic (group A), and clinically stable patients (group B). Sociodemographic and clinical variables were collected and the questionnaires RQLQ and EQ-5D were administered in the initial visit and in the second visit 15 days after. Feasibility, validity, reliability and sensitivity related to the change of the RQLQ were analyzed. RESULTS: The mean period (standard deviation) of administration was 9.67 (6.25) minutes and 85.6% of patients needed assistance in order to fill the RQLQ, especially the selection of the characteristics (62.5%). The dimensions of the RQLQ showed a greater association with the dimensions of the EQ-5D that assessed similar aspects and the symptoms in which a greater relation was expected. The alpha Cronbach coefficient of the scorings of the RQLQ fluctuated between 0.85 and 0.96 and the intraclass correlation coefficient fluctuated between 0.68 and 0.89. The sensitivity to the change of the dimensions of the RQLQ, evaluated through the magnitude of the effect between the two visits, ranged between 0.76 and 1.46. CONCLUSIONS: The Spanish version of the RQLQ proved to be a valid instrument for assessing the Health-Related Quality of Life (HRQL) in adult patients with seasonal or perennial RC.

[Nutrition and dietary recommendations for the elderly "Public Health" Working Group of the Spanish Nutrition Society]. / Nutrición y recomendaciones dietéticas para personas mayores. Grupo de trabajo "Salud pública" de la Sociedad Española de Nutrición (SEN).

With the increase of life expectancy, the desire to maintain good health, functionality and maximum quality of life at advanced ages, for which nutrition plays a critical role, is a priority for the elderly. Though genetic factors are a determinant of life expectancy, there are several extrinsic factors which have a great influence on the quality of life of the elderly. Diet and nutritional status have a great influence, especially in the prevention and treatment of several diseases, which affect this heterogeneous and vulnerable age group. The nutritional status and needs of elderly people are associated with age-related biological, psychological and often socio-economic changes. All of these changes can increase the risk of developing a number of age-related diseases. In developed countries the elderly are the most affected by malnutrition, either because of a deficiency (energy and several nutrients) or an excess, leading to obesity and related diseases. This review highlights the most important factors affecting nutritional status in elderly people and focus on the need to maintain adequate physical activity level and an optimal physic, psychic and social functional capacity. It discusses dietary reference intakes and guidelines to improve and/or maintain adequate nutritional status in older people in order to reduce susceptibility to some illness and disease.