El principio de veracidad biologica y la eleccion del sexo de los hijos segun la Ley espanola de reproduccion humana asistida / The principle of biological veracity and the choice of the sex of the children according to the Spanish Law on Assisted Human Reproduction

Las técnicas de gestación asistida requieren una investigación exhaustiva, buscando proporcionar criterios y argumentos para evaluar los problemas relativos al impacto de la investigación y la práctica de la reproducción humana asistida. La sociedad de nuestros días plantea problemas muy diversos en el campo de la reproducción humana, como el de la elección del sexo de los hijos, sobre los cuales conviene concretar sus posibilidades e inconvenientes. Por ello la Ley 14/2006, sobre Técnicas de Reproducción Humana Asistida (LRHA), tiene como principal objetivo facilitar la descendencia por medio de la manipulación de los gametos y preembriones humanos. Esta norma regula también la aplicación de las técnicas de reproducción asistida en la prevención y tratamiento de enfermedades de origen genético o hereditario y las condiciones en las que podrá autorizarse la utilización de gametos y preembriones humanos con fines de investigación. En tal sentido, comenzaremos exponiendo las técnicas de reproducción asistida, para continuar describiendo el principio de la veracidad biológica paternal y la elección del sexo de los hijos

Assisted gestation techniques require a multidisciplinary research line, seeking to provide criteria and arguments for assessing the problems related to the impact of research and practice in the framework of assisted human reproduction. For today's society poses very diverse problems in the field of human reproduction, on which a fair and current legal regulation will have to be pronounced. Therefore Law 14/2006, on Techniques of Assisted Human Reproduction (LRHA), has as main objective to facilitate the offspring through the therapeutic use of human gametes and preembrions. This standard also regulates the application of assisted reproduction techniques in the prevention and treatment of diseases of genetic origin or hereditary origin and the conditions under which the use of human gametes and preembrions may be authorised for research purposes. To structure our exhibition we will begin by exposing the techniques of assisted reproduction, to continue commenting on the biological truthfulness of the paternal and the choice of the sex of the children

Efficacy and safety of ossein-hydroxyapatite complex versus calcium carbonate to prevent bone loss.

Objective: This study aimed to compare the efficacy and safety of ossein-hydroxyapatite complex (OHC) versus calcium carbonate (CC) for preventing bone loss during perimenopause in current clinical practice.Methods: The prospective, comparative, non-randomized, open-label study included 851 perimenopausal women with basal bone mineral density (BMD) T-score ≥-2 standard deviations (SDs). Participants received either OHC (712 mg calcium/day) or CC (1000 mg calcium/day) over 3 years. BMD was evaluated by dual-energy X-ray absorptiometry at the lumbar spine (L2-L4) at baseline and after 18 and 36 months of follow-up. Adverse drug reactions (ADRs) were also recorded.Results: In women receiving OHC, BMD at the L2-L4 site remained stable over the 3-year follow-up period (mean [SD] change 0.00 [0.11] g/cm2). BMD in the CC arm decreased -3.1% (mean [SD] - 0.03 [0.11] g/cm2). Between-group differences were statistically significant (p < 0.001) and favored OHC. ADRs were more frequent in the CC group (7.7% vs. 2.7% in the OHC group; p = 0.001), affecting primarily the gastrointestinal system.Conclusion: OHC showed greater efficacy and tolerability than CC for bone loss prevention in perimenopausal women in real-world practice. As the daily dose of calcium was higher in the CC group, the differences might be linked to the ossein compound in OHC.

Análisis de los costes asociados al manejo y morbilidad del edema macular diabético y el edema macular secundario a oclusión venosa de la retina / Analysis of costs associated with the management and morbidity of diabetic macular oedema and macular oedema secondary to retinal vein occlusion

OBJETIVO: Analizar el coste de la enfermedad en pacientes con edema macular diabético (EMD) o edema macular secundario a oclusión venosa de la retina (EMOVR), desde la perspectiva de la sociedad. MÉTODOS: Estudio observacional, transversal, multicéntrico. Se incluyó a adultos (>18 años) con EMD uni- o bilateral o EMOVR unilateral. Se recogió el consumo de recursos sanitarios desde el diagnóstico y se evaluó el impacto de la enfermedad en la vida laboral. Los costes fueron anualizados (euros, en enero de 2014). Se adoptó la perspectiva de la sociedad. Las diferencias se contrastaron mediante los estadísticos Chi cuadrado (o test de Fisher), U de Mann Whitney o Kruskal-Wallis (contraste de Dunn). RESULTADOS: Se incluyó a 448 pacientes (EMD 255; EMOVR 193). Se encontraron diferencias significativas en costes de diagnóstico: EMOVR 1.856 €, EMD bilateral 1.661 € y EMD unilateral 1.401 € (p < 0,001) y en los costes médicos agregados: EMOVR 4.639 €, EMD bilateral 6.275 € y EMD unilateral 6.269 € (p < 0,001). El coste por incapacidad laboral permanente fue mayor en EMD bilateral (11.712 €) que en EMD unilateral (4.284 €) y en EMOVR (1.052 €; p < 0,05). En el análisis de regresión lineal, las variables asociadas con los costes sanitarios directos fueron: diagnóstico (EMD bilateral estaba asociado a un mayor coste) así como número de días de hospitalización, número de visitas, tiempo de observación y número de días de baja laboral. CONCLUSIONES: Los pacientes con EMD bilateral suponen un mayor impacto en el coste directo sanitario así como un mayor coste indirecto por afectación en la vida laboral

OBJECTIVE: To analyse the disease burden in patients with diabetic macular oedema (DMO) or with retinal vein occlusion macular oedema (RVOMO) from a societal perspective. METHODS: Observational, cross-sectional, multicentre study conducted on patients >18 years old diagnosed with uni- or bilateral DMO or unilateral RVOMO. Data on the use of health resources from diagnosis was collected, and the impact of disease on work life was assessed. Costs were annualised (euros, January 2014). Differences were contrasted using Chi-squared test (or Fisher Exact test), Mann Whitney-U test or Kruskal-Wallis test (Dunn contrast). RESULTS: A total of 448 patients were included (DMO 255; RVOMO 193). There were significant differences in costs of diagnosis: RVOMO €1856, bilateral DMO €1661, and unilateral DMO €1401 (P < .001) and the aggregate medical costs: RVOMO €4639, bilateral DMO 6275€ and unilateral DMO 6269€ (P < .001). Cost by permanent time off work was higher in bilateral DMO €11712, than in unilateral DMO €4284€, and than in RVOMO €1052 (P < .05). Linear regression analysis showed that variables associated with direct health costs were: Diagnosis (bilateral DMO was associated with higher cost), as well as number of days in hospital, number of visits, time of observation, and number of days of time off work. CONCLUSIONS: Patients with bilateral DMO are associated with a higher direct health cost, as well as a higher indirect cost by impact of the disease on work life

Analysis of costs associated with the management and morbidity of diabetic macular oedema and macular oedema secondary to retinal vein occlusion. / Análisis de los costes asociados al manejo y morbilidad del edema macular diabético y el edema macular secundario a oclusión venosa de la retina.

OBJECTIVE: To analyse the disease burden in patients with diabetic macular oedema (DMO) or with retinal vein occlusion macular oedema (RVOMO) from a societal perspective. METHODS: Observational, cross-sectional, multicentre study conducted on patients >18 years old diagnosed with uni- or bilateral DMO or unilateral RVOMO. Data on the use of health resources from diagnosis was collected, and the impact of disease on work life was assessed. Costs were annualised (euros, January 2014). Differences were contrasted using Chi-squared test (or Fisher Exact test), Mann Whitney-U test or Kruskal-Wallis test (Dunn contrast). RESULTS: A total of 448 patients were included (DMO 255; RVOMO 193). There were significant differences in costs of diagnosis: RVOMO €1856, bilateral DMO €1661, and unilateral DMO €1401 (P<.001) and the aggregate medical costs: RVOMO €4639, bilateral DMO 6275€ and unilateral DMO 6269€ (P<.001). Cost by permanent time off work was higher in bilateral DMO €11712, than in unilateral DMO €4284€, and than in RVOMO €1052 (P<.05). Linear regression analysis showed that variables associated with direct health costs were: Diagnosis (bilateral DMO was associated with higher cost), as well as number of days in hospital, number of visits, time of observation, and number of days of time off work. CONCLUSIONS: Patients with bilateral DMO are associated with a higher direct health cost, as well as a higher indirect cost by impact of the disease on work life.

Investigación biomédica responsable / Responsible Biomedical Research

La gestión de la bioinvestigación reúne unas características y necesidades que deben ser manejadas de forma óptima por la administración hospitalaria y por las instituciones sanitarias. Pues las peculiaridades de la bioinvestigación, sin perjuicio de que ofrezcan ciertas coincidencias con la actuación médica de finalidad principalmente curativa, exigen evitar la aplicación automática e indiscriminada de los criterios que el Derecho positivo ha venido estableciendo, creando un sistema propio y diferenciado. Y, ciertamente, piedra angular del sistema de responsabilidad en esta materia, que en este caso también lo es en la responsabilidad derivada de la actuación de los profesionales sanitarios en general, es la prestación de un consentimiento informado, libre y consciente (trátese de obtención de muestras biológicas, de realización de análisis genéticos con distintos fines o de utilización de preembriones procedentes de tratamiento de reproducción asistida para investigación, por mencionar algunas de las actividades biomédicas). Por lo que cabe preguntarse si este sistema de responsabilidad será aplicable al marco normativo general de la responsabilidad patrimonial de la Administración Sanitaria

The management of the bioinvestigación assembles a few characteristics and needs that they must be handled of ideal form for the hospitable administration and for the sanitary institutions. So the peculiarities of the bioinvestigación, without prejudice that they offer certain coincidences with the medical action of principally curative purpose, demand to avoid the automatic and indiscriminate application of the criteria that the Statute law has come establishing, creating an own and differentiated system. And, certainly, angular stone of the system of responsibility in this matter, which in this case also it is in the responsibility derived from the action of the sanitary professionals in general, is the presentation of an informed, free and conscious assent (( It be a question of obtaining of biological samples, of accomplishment of genetic analyses with different ends or of utilization of preembriones proceeding from treatment of reproduction represented for investigation, for mentioning some of the biomedical activities). For what it is necessary to ask if this system of responsibility will be applicable to the normative general frame of the patrimonial responsibility of the Sanitary Administration

El entrenamiento en tapiz rodante a domicilio mejora la calidad seminal en adultos con diabetes de tipo 2 / Home-based treadmill training improved seminal quality in adults with type 2 diabetes

Objetivo: El presente estudio se diseñó para determinar la influencia de un programa de entrenamiento domiciliario en la calidad seminal de adultos con diabetes tipo 2. Material y método: Participaron un total de 60 adultos varones con diagnóstico de diabetes tipo 2 distribuidos aleatoriamente en un grupo intervención (n = 30) y otro control (n = 30). Los participantes incluidos en el grupo de intervención desarrollaron un programa de entrenamiento domiciliario en tapiz rodante de 14 semanas, 3 sesiones/semana de 40 min a una intensidad del 55-70% FCmáx (incrementando un 2,5% cada 2 semanas). Los parámetros de calidad seminal ensayados fueron: volumen, concentración y porcentaje de movilidad y morfología normal. Asimismo se estudió el nivel de defensas antioxidantes en plasma seminal. Nuestro protocolo fue aprobado por un comité de ética institucional. Resultados: Tras completar el programa de entrenamiento se observó un incremento significativo de la concentración espermática, así como de los porcentajes de movilidad y de morfología normal. Paralelamente, se observó un incremento del estatus total antioxidante en el plasma seminal. No se observaron cambios significativos en ninguna de las variables ensayadas en el grupo control. Conclusiones: El programa de entrenamiento mejoró la calidad seminal en pacientes con diabetes tipo 2. Este hallazgo podría explicarse por una mejora de las defensas antioxidantes seminales inducida por el ejercicio

Objective: This was the first study conducted to determine the influence of home-based treadmill training on seminal quality in adults with type 2 diabetes. Material and methods: Sixty sedentary adults with type 2 diabetes volunteered for the current study. Thirty were randomly allocated to the intervention group and performed a a 14-week, home-based, treadmill training program, 3 sessions per week, consisting of a warm-up (10-15 min), 40 min treadmill exercise at a work intensity of 55-70% of peak heart rate (increasing by 2.5% each two weeks) measured during a maximal treadmill test, and cooling-down (5-10 min). The control group included 30, age and BMI matched adults with type 2 diabetes who did not take part in any training program. Seminal quality analysis included semen volume, sperm concentration, motility and normal morphologic features. Furthermore, total antioxidant status (TAS) as well as glutathione peroxidase (GPX) activity were assessed in seminal plasma. This protocol was approved by an Institutional Ethics Committee. Results: The home-based treadmill training significantly increased sperm concentration as well as percentages of total sperm motility and normal spermatozoa. Furthermore, TAS and GPX activity were increased after the completion of the training program. No significant changes in any of the measured variables were found in the control group. Conclusions: Home-based treadmill training improved seminal quality in adults with type 2 diabetes. A secondary finding was that seminal antioxidant defense system was significantly increased after being exercised

Home-based treadmill training improved seminal quality in adults with type 2 diabetes.

OBJECTIVE: This was the first study conducted to determine the influence of home-based treadmill training on seminal quality in adults with type 2 diabetes. MATERIAL AND METHODS: Sixty sedentary adults with type 2 diabetes volunteered for the current study. Thirty were randomly allocated to the intervention group and performed a a 14-week, home-based, treadmill training program, 3 sessions per week, consisting of a warm-up (10-15min), 40min treadmill exercise at a work intensity of 55-70% of peak heart rate (increasing by 2.5% each two weeks) measured during a maximal treadmill test, and cooling-down (5-10min). The control group included 30, age and BMI matched adults with type 2 diabetes who did not take part in any training program. Seminal quality analysis included semen volume, sperm concentration, motility and normal morphologic features. Furthermore, total antioxidant status (TAS) as well as glutathione peroxidase (GPX) activity were assessed in seminal plasma. This protocol was approved by an Institutional Ethics Committee. RESULTS: The home-based treadmill training significantly increased sperm concentration as well as percentages of total sperm motility and normal spermatozoa. Furthermore, TAS and GPX activity were increased after the completion of the training program. No significant changes in any of the measured variables were found in the control group. CONCLUSIONS: Home-based treadmill training improved seminal quality in adults with type 2 diabetes. A secondary finding was that seminal antioxidant defense system was significantly increased after being exercised.

Ecuación predictora de masa grasa corporal en deportistas con lesión medular crónica: estudio piloto / Predictive equation of body fat percentage in athletes with chronic spinal cord injury: a pilot study

La determinación del porcentaje de masa grasa en pacientes con lesión medular crónica (LMC) resulta de interés por la alta morbimortalidad cardiovascular que presenta este grupo. En el caso de deportistas, además, permitiría optimizar su rendimiento deportivo. Por consiguiente, el presente estudio se planteó como primer objetivo comparar diferentes métodos de estudio del porcentaje de masa grasa de deportistas con LMC. Y como objetivo secundario, identificar alguna ecuación que permita predecir los niveles de masa grasa de manera más económica, sencilla, rápida y no invasiva. Se diseño un estudio observacional y transversal en el que participaron voluntariamente 8 deportistas varones con LMC a nivel o por debajo de T5 que compiten a nivel nacional. El porcentaje de masa grasa corporal de los participantes se determinó mediante tres metodologías: densitometría (DEXA), antropometría convencional (Ecuación de Siri) e impedancia bioeléctrica (BIA). Este protocolo fue aprobado por un Comité de Ética Institucional. El porcentaje de masa grasa presentado por jugadores de baloncesto en silla de ruedas tras someterse al método de referencia (DEXA) fue del 28,76±9,16%. El análisis de concordancia de Bland-Altman entre métodos sugiere que tanto la antropometría convencional como la BIA subestiman el porcentaje de masa grasa de deportistas con LMC. la ecuación de predicción obtenida fue: Masa Grasa (%)= 1,9197 (pliegue tríceps (mm)) + 6,5063. Tanto las técnicas antropométricas convencionales como la propia BIA subestiman la masa grasa en deportistas con LMC. Asimismo se ha identificado una ecuación de regresión para la predicción del porcentaje de masa grasa de bajo coste y aplicable en cualquier entorno.

The assessment of fat mass (FM) is of great interest for people with chronic spinal cord injury (SCI) given that morbidity and mortality from cardiovascular disease are greater and occur earlier in this group. Furthermore, it may play a key role improving physical performance in athletes with SCI. For the reasons already mentioned, the current study was designed to compare different methods for assessing FM in athletes with SCI. A secondary objective was to identify a predictive equation for FM in this group that is easily reproducible elsewhere. A total of 8 male athletes with complete SCI at or below the 5th thoracic level (T5) competing in a national league volunteered for this study. The percentage of FM was assessed by three different methods: conventional anthropometry (Siri equation), bioelectrical impedance analysis (BIA) and densitometry (DEXA). This research was conducted in full accordance with ethical principles, including the World Medical Association Declaration of Helsinki (version, 2002). Furthermore, the present protocol was approved by an Institutional Ethics Committee. Mean percentage of FM assessed by DXA was 28.76±9.16%. Moreover, Bland-Altman plots suggested conventional anthropometry and BIA underestimated fat mass percentage in this group. Lastly, a predictive equation for fat mass was established as follows: FM (%)=1.9197 (triceps skinfold thickness (mm))+6.5063. It was concluded that both conventional anthropometry and BIA underestimated fat mass in athletes with chronic SCI. Furthermore, a predictive equation of fat mass was recommended for this group due to its low cost and wide availability in any clinical setting.

Correlaciones entre marcadores de grasa abdominal obtenidos por densitometría y técnicas antropométricas convencionales en mujeres postmenopausicas con síndrome metabólico / Correlations between markers of abdominal fat obtained by dxa and anthropometric conventional techniques in postmenopausal women with metabolic syndrome

El presente estudio pretende identificar correlaciones estadísticamente significativas entre parámetros de masa grasa abdominal obtenidos por densitometría (DXA) y otros de tipo cineantropométrico (índices de distribución de masa grasa) y bioquímico (perfil lipídico) en mujeres postmenopausicas con síndrome metabólico. Se diseño un estudio de cohortes histórico que incluyó a un total de 1326 mujeres post-menopausicas con edad > 45 años que se habían sometido rutinariamente a DXA para conocer su densidad mineral ósea entre Enero de 2006 y Enero de 2011. Se utilizó un DXA tipo Lunar DPX-L para determinar la masa grasa abdominal en las regiones de interés L1-L4 y L3-L4. Además del DXA, se obtuvo de cada participante la correspondiente anamnesis, bioquímica, tensión arterial e índices de distribución de masa grasa mediante técnicas antropométricas convencionales. Se utilizó la clasificación NCEP-ATP-III para el diagnóstico de síndrome metabólico. Este protocolo fue aprobado por un Comité de Ética Institucional. La mayor fuerza de asociación se estableció entre el porcentaje de masa grasa L1-L4 obtenido por DXA y el perímetro de la cintura (r= 0,77; p= 0,0016) además de con colesterol-HDL (r= -0,58; p= 0,0290). Finalmente se concluye que el perímetro de la cintura y los niveles de colesterol-HDL podrían recomendarse como predictores del comportamiento de la masa grasa abdominal de regiones de interés L1-L4 y L3-L4 obtenidas por DXA en mujeres postmenopausicas con síndrome metabólico.

The current study was conducted to identify potential correlations between abdominal fat mass obtained by DXA and several parameters obtained by anthropometric conventional techniques as well as lipid profile in postmenopausal women with MS. This historical cohort study included a total of 1326 postmenopausal women aged > 45 years old who had routinely undergone DXA to measure their bone mineral density between January 2006 and January 2011. The regions of interest envisaged in our study by using DXA were the lumbar regions L1-L4 and L4-L5. At the same time, they underwent a complete medical examination including personal medical history assessment, biochemical blood analysis, blood pressure measurements and anthropometrical evaluation. Metabolic syndrome was diagnosed attending to the criteria established by National Cholesterol Education Program Adult Treatment Panel III (NECP-ATP-III). This protocol was approved by an Institutional Ethics Committee. Several significant correlations were found between DXA and indices of body fat distribution as well as lipid profile. The strongest correlations were found between fat mass L1-L4 and waist circumference (r= 0.77; p= 0.0016) and levels of HDL-cholesterol (r= -0.58; p= 0.0290). It was concluded that waist circumference and HDL-cholesterol may be recommended to predict fat mass in regions of interest L1-L4 and L3-L4 in postmenopausal women with MS.

Central obesity measurements predict metabolic syndrome in a retrospective cohort study of postmenopausal women / Obesidad abdominal determinada por DEXA como predictor de síndrome metabólico en mujeres postmenopáusicas

Introduction: The various diagnostic classifications in the literature concur as regards the important role of abdominal obesity in the onset and progression of metabolic syndrome. Accordingly, this study was aimed at clarifying whether central obesity measurements assessed by dual X-ray absorptiometry (DXA) may predict metabolic syndrome in Spanish postmenopausal women. Material and methods: This historical cohort study included a total of 1326 postmenopausal women aged > 45 years old who had routinely undergone DXA to measure their bone mineral density between January 2006 and January 2011. The regions of interest (ROI) envisaged in our study by using DXA were the lumbar regions L1-L4 and L4-L5. At the same time, they underwent a complete medical examination including personal medical history assessment, biochemical blood analysis, blood pressure measurement and anthropometrical evaluation. Metabolic syndrome was diagnosed attending to the criteria established by National Cholesterol Education Program Adult Treatment Panel III (NECP-ATP-III). Results: During the observation period, 537 women, representing 40.5% of the total studied, met the diagnostic criteria for metabolic syndrome. L1-L4 and L4-L5 abdominal fat mass determinations were associated with the development of metabolic syndrome in all regression models tested, showing an increasing gradient from the lowest to highest quintile. Conclusion: Central adiposity measurements assessed by DXA, especially L1-L4 region of interest, could be considered a powerful predictor of metabolic syndrome in postmenopausal women (AU)

Introducción: En la actualidad se acepta la importancia de la masa grasa abdominal en la fisiopatología del síndrome metabólico tal y como reconocen las diferentes clasificaciones diagnósticas disponibles. Nuestro objetivo fue analizar la utilidad como predictores de síndrome metabólico de marcadores de grasa abdominal obtenidos por DEXA en mujeres postmenopausicas aprovechando su participación en screening rutinarios para el estudio de la densidad mineral ósea. Material y método: El presente estudio de cohortes histórico incluyó a un total de 1326 mujeres post-menopausicas con edad > 45 años que se habían sometido rutinariamente a DEXA para conocer su densidad mineral ósea entre Enero de 2006 y Enero de 2011. Además del DEXA, se obtuvo de cada participante la correspondiente anamnesis, bioquímica, tensión arterial e índices de distribución de masa grasa mediante técnicas antropométricas convencionales. Se utilizó la clasificación NCEP-ATP-III para el diagnóstico de síndrome metabólico. Este protocolo fue aprobado por un Comité de Ética Institucional. Resultados: Durante el periodo de observación, 537 mujeres, el 40.5% del total de las estudiadas, cumplió los criterios diagnósticos de síndrome metabólico. Los parámetros de masa grasa abdominal obtenidos mediante DEXA fueron significativamente mayores en mujeres postmenopáusicas con síndrome metabólico. Finalmente, la masa grasa abdominal de regiones de interés L1-L4 y L3-L4 obtenidas por DEXA se relacionaron con el desarrollo de síndrome metabólico en los modelos de regresión ensayados. Conclusión: La masa grasa abdominal determinada por DEXA, especialmente la región L1-L4, podría recomendarse como predictor de síndrome metabólico en este grupo (AU)

Manual para la elaboración de documentos basados en la evidencia. Herramientas derivadas del conocimiento científico / Handbook for the preparation of evidence-based documents. Tools derived from scientific knowledge

Objetivo. El manual pretende ser una guía, accesible y fácil de consultar, que oriente a los profesionales en la elaboración o adaptación de documentos basados en la evidencia que ayuden a la estandarización de la práctica clínica y a la toma de decisiones velando siempre por la calidad de la misma de forma que siga unos referentes establecidos. Material y métodos. La Comisión de Atención Sanitaria Basada en la Evidencia (CASBE), perteneciente a la estructura de calidad del Hospital Universitario Virgen del Rocío, propuso elaborar un manual para la elaboración de documentos basados en la evidencia que incorpore la relación de productos, la descripción de sus características, atributos, utilidad, metodología de elaboración y ámbito de aplicación de cada uno de ellos. Resultados. El manual contiene 7 herramientas basadas en la evidencia, un capítulo sobre metodología de análisis crítico de la literatura científica, un capítulo con recursos en Internet y anexos con herramientas de evaluación. Conclusiones. Este manual ofrece grandes oportunidades para la mejora de la calidad a los clínicos como guía de estandarización de la práctica asistencial, a los gestores como estrategia para promover y fomentar la elaboración de documentos que ayuden a reducir la variabilidad de la práctica clínica y a los pacientes la oportunidad de participar en la planificación de sus cuidados(AU)

Objectives. This handbook is intended to be an accessible, easy-to-consult guide to help professionals produce or adapt Evidence-Based Documents. Such documents will help standardize both clinical practice and decision-making, the quality always being monitored in such a way that established references are complied with. Materials and methods. Evidence-Based Health Care Committee, a member of “Virgen del Rocío” University Hospital quality structure, proposed the preparation of a handbook to produce Evidence-Based Documents including: a description of products, characteristics, qualities, uses, methodology of production, and application scope of every one of them. Results. The handbook consists of seven Evidence-Based tools, one chapter on critical analysis methodology of scientific literature, one chapter with internet resources, and some appendices with different assessment tools. Conclusions. This Handbook provides general practitioners with a great opportunity to improve quality and as a guideline to standardize clinical healthcare, and managers with a strategy to promote and encourage the development of documents in an effort to reduce clinical practice variability, as well as giving patients the opportunity of taking part in planning their own care(AU)

[Handbook for the preparation of evidence-based documents. Tools derived from scientific knowledge]. / Manual para la elaboración de documentos basados en la evidencia. Herramientas derivadas del conocimiento científico.

OBJECTIVES: This handbook is intended to be an accessible, easy-to-consult guide to help professionals produce or adapt Evidence-Based Documents. Such documents will help standardize both clinical practice and decision-making, the quality always being monitored in such a way that established references are complied with. MATERIALS AND METHODS: Evidence-Based Health Care Committee, a member of "Virgen del Rocío" University Hospital quality structure, proposed the preparation of a handbook to produce Evidence-Based Documents including: a description of products, characteristics, qualities, uses, methodology of production, and application scope of every one of them. RESULTS: The handbook consists of seven Evidence-Based tools, one chapter on critical analysis methodology of scientific literature, one chapter with internet resources, and some appendices with different assessment tools. CONCLUSIONS: This Handbook provides general practitioners with a great opportunity to improve quality and as a guideline to standardize clinical healthcare, and managers with a strategy to promote and encourage the development of documents in an effort to reduce clinical practice variability, as well as giving patients the opportunity of taking part in planning their own care.

Central obesity measurements predict metabolic syndrome in a retrospective cohort study of postmenopausal women.

INTRODUCTION: The various diagnostic classifications in the literature concur as regards the important role of abdominal obesity in the onset and progression of metabolic syndrome. Accordingly, this study was aimed at clarifying whether central obesity measurements assessed by dual X-ray absorptiometry (DXA) may predict metabolic syndrome in Spanish postmenopausal women. MATERIAL AND METHODS: This historical cohort study included a total of 1326 postmenopausal women aged > 45 years old who had routinely undergone DXA to measure their bone mineral density between January 2006 and January 2011. The regions of interest (ROI) envisaged in our study by using DXA were the lumbar regions L1-L4 and L4-L5. At the same time, they underwent a complete medical examination including personal medical history assessment, biochemical blood analysis, blood pressure measurement and anthropometrical evaluation. Metabolic syndrome was diagnosed attending to the criteria established by National Cholesterol Education Program Adult Treatment Panel III (NECP-ATP-III). RESULTS: During the observation period, 537 women, representing 40.5% of the total studied, met the diagnostic criteria for metabolic syndrome. L1-L4 and L4-L5 abdominal fat mass determinations were associated with the development of metabolic syndrome in all regression models tested, showing an increasing gradient from the lowest to highest quintile. CONCLUSION: Central adiposity measurements assessed by DXA, especially L1-L4 region of interest, could be considered a powerful predictor of metabolic syndrome in postmenopausal women.

Introducción: En la actualidad se acepta la importancia de la masa grasa abdominal en la fisiopatología del síndrome metabólico tal y como reconocen las diferentes clasificaciones diagnósticas disponibles. Nuestro objetivo fue analizar la utilidad como predictores de síndrome metabólico de marcadores de grasa abdominal obtenidos por DEXA en mujeres postmenopausicas aprovechando su participación en screening rutinarios para el estudio de la densidad mineral ósea. Material y método: El presente estudio de cohortes histórico incluyó a un total de 1326 mujeres post-menopausicas con edad > 45 años que se habían sometido rutinariamente a DEXA para conocer su densidad mineral ósea entre Enero de 2006 y Enero de 2011. Además del DEXA, se obtuvo de cada participante la correspondiente anamnesis, bioquímica, tensión arterial e índices de distribución de masa grasa mediante técnicas antropométricas convencionales. Se utilizó la clasificación NCEP-ATP-III para el diagnóstico de síndrome metabólico. Este protocolo fue aprobado por un Comité de Ética Institucional. Resultados: Durante el periodo de observación, 537 mujeres, el 40.5% del total de las estudiadas, cumplió los criterios diagnósticos de síndrome metabólico. Los parámetros de masa grasa abdominal obtenidos mediante DEXA fueron significativamente mayores en mujeres postmenopáusicas con síndrome metabólico. Finalmente, la masa grasa abdominal de regiones de interés L1-L4 y L3-L4 obtenidas por DEXA se relacionaron con el desarrollo de síndrome metabólico en los modelos de regresión ensayados. Conclusión: La masa grasa abdominal determinada por DEXA, especialmente la región L1-L4, podría recomendarse como predictor de síndrome metabólico en este grupo.

Impact of the Spanish Fertility Society guidelines on the number of embryos to transfer.

The multiple pregnancy rate in assisted reproduction treatment cycles depends, fundamentally, on the number of embryos transferred. It is essential that patients and professionals should have good practical guidelines on the best number of embryos to be transferred in each cycle in order to obtain high pregnancy rates with minimal risk of multiple pregnancies. This study analysed the impact made by the Spanish Fertility Society (SEF) guidelines on the number of embryos to be transferred, as regards the policies adopted at clinics in Spain and the resulting financial repercussions. Data were collected from the assisted reproduction treatment register of the SEF and compared over three periods of time: 2002-2003, with no legal regulation and no SEF guidelines; 2004, with only legal regulation; and 2005-2006, with legal regulation and SEF guidelines. The acceptance of SEF guidelines varies according to the IVF technique. The guidelines have led to a reduction in multiple pregnancy rates, especially concerning triplets, in patients' own-egg and with donor-egg cycles. Even without full implantation, these results validate the clinical utility of the SEF guidelines. They constitute a useful tool to reduce the incidence of the principal adverse effect of treatment cycles: multiple pregnancies. The multiple pregnancy rate in assisted reproduction cycles depends fundamentally on the number of embryos transferred. It is essential that patients and professionals should have good practical guidelines on the best number of embryos to be transferred in each cycle in order to obtain high pregnancy rates with minimal risk of multiple pregnancies. The purpose of this study was to analyse the impact made by the Spanish Fertility Society (SEF) guidelines on the number of embryos to be transferred, as regards the policies adopted at clinics in Spain, and the resulting financial repercussions. Data were collected from the assisted reproduction register of the SEF and compared over three periods of time: 2002-2003, when there was no legal regulation and no SEF guidelines; 2004, when there was only legal regulation; and 2005-2006, when there was legal regulation and SEF guidelines. The degree of acceptance of SEF guidelines varies according to the IVF technique employed. The guidelines have led to a reduction in multiple pregnancy rates, especially concerning triplets, using patients' own eggs and with donor eggs. The reduction in the financial cost of deliveries achieved in the years 2005-2006 ranged from 890,187 to 18,593,242 euros, and the incremental cost per percentage point of multiple pregnancy avoided is 2,989,613 euros. In conclusion, even without full implementation, these results validate the clinical utility of the SEF guidelines. They constitute a useful tool to reduce the incidence of the principal adverse effect of assisted reproduction cycles, namely multiple pregnancies.

Safety and effectiveness of ivabradine after cardiac transplantation.

BACKGROUND: Heart denervation is the primary cause of sinus tachycardia in transplant recipients. Drugs are usually needed to treat associated symptoms. OBJECTIVE: To evaluate the safety and effectiveness of the novel I(f) channel antagonist ivabradine to control heart rate after transplantation. METHODS: Of 316 heart transplant recipients at a single center since 1991, ivabradine was administered in 15 patients, in addition to ß-blockers in 4 patients and contraindication to use of ß-blocker therapy in the others. A prospective follow-up study was conducted to identify possible adverse effects, tolerance, and drug effects on heart rate and control of symptoms. RESULTS: Of the 15 patients, 13 were men; overall mean (SD) patient age was 46 (4.6) years. In all patients, treatment was begun after verification of basal heart rate greater than 100 bpm and after other causes of sinus tachycardia had been ruled out. During follow-up of 1.13 (0.3) years, no substantial adverse effects were observed. It was possible to reach the maximum drug dosage in all patients, achieving a reduction in basal heart rate of 33 (6.2) bpm. All patients reported substantial clinical improvement, and demonstrated an increase in functional class. CONCLUSION: Ivabradine is safe, well tolerated, and effective in heart transplant recipients.

[Use of antidepressant treatment. Patients' perception]. / Uso de los tratamientos antidepresivos. La percepción del paciente.

INTRODUCTION: A major determinant of response to antidepressant drugs is how the patients use them. Our objective is to take a look over the antidepressants use in a real sample. METHODS: In determining which factors may be relevant for treatment good use, social, demographic, disease and treatment-related data were gathered from 550 patients, who were currently taking antidepressants for any motive. The questionnaire included two items, the patients' perceived difficulty of following treatment and the level of acknowledged non-compliance by the patient, which may be considered as both an indirect and guiltless way of approximating the patients' real use of treatment. RESULTS: Compliance was poor among the less educated, as well as those living in rural areas and in patients receiving concomitant treatment for organic diseases. Use was good in 61.5% and was particularly good among those with an affective disorder (69.8%). Among patients who did not respond to treatment, the incidence of non-compliance (49.1%) was higher than for those achieving improvement (31.2%). CONCLUSIONS: It's important to explore and reinforce a good use of antidepressants in clinical settings and to be sure this type of treatment is necessary if the indication is not clear.

Uso de los tratamientos antidepresivos. La percepción del paciente / Use of antidepressant treatment. Patients’ perception

Introducción. Un determinante fundamental de la respuesta al tratamiento antidepresivo es cómo el paciente lo toma. Nuestro objetivo es observar el uso de los antidepresivos en una muestra real de pacientes. Métodos. Para determinar que factores pueden ser relevantes para un buen uso del tratamiento se recogieron datos sociales, demográficos, relativos a la enfermedad y al tratamiento de 550 pacientes que estaban siendo tratados con antidepresivos por cualquier motivo. El cuestionario elaborado incluía dos ítems, la dificultad percibida por el paciente para seguir las indicaciones del tratamiento y el nivel de reconocimiento de falta de cumplimiento, lo que puede ser considerado como una forma indirecta y poco culpabilizadora de aproximarse al uso real del medicamento por parte del paciente. Resultados. El cumplimiento fue peor en el grupo con un nivel inferior de educación, así como en aquellos que vivían en zonas rurales y en los que recibían otro tratamiento concomitante para enfermedades orgánicas. El uso era bueno en el 61,5 % y, particularmente bueno, entre aquellos diagnosticados de un trastorno afectivo (69,8%). Entre los pacientes que no respondían al tratamiento, la incidencia del no-cumplimiento (49,1%) era superior a aquellos que sí referían haber mejorado (31,2%).Conclusiones. Es importante explorar y reforzar un buen uso del tratamiento antidepresivo en todos los dispositivos asistenciales y estar seguro de que este tipo de tratamiento es necesario si la indicación no está clara (AU)

Introduction. A major determinant of response to antidepressant drugs is how the patients use them. Our objective is to take a look over the antidepressants use in a real sample. Methods. In determining which factors may be relevant for treatment good use, social, demographic, disease and treatment-related data were gathered from 550 patients, who were currently taking antidepressants for any motive. The questionnaire included two items, the patients’ perceived difficulty of following treatment and the level of acknowledged non-compliance by the patient, which may be considered as both an indirect and guiltless way of approximating the patients’ real use of treatment. Results. Compliance was poor among the less educated, as well as those living in rural areas and in patients receiving concomitant treatment for organic diseases. Use was good in 61.5% and was particularly good among those with an affective disorder (69.8%). Among patients who did not respond to treatment, the incidence of non-compliance (49.1%) was higher than for those achieving improvement (31.2%).Conclusions. It’s important to explore and reinforce a good use of antidepressants in clinical settings and to be sure this type of treatment is necessary if the indication is not clear (AU)

[Therapeutic use and profile of toxicity of the FOLFOX4 regimen]. / Uso terapéutico y perfil de toxicidad del esquema FOLFOX4.

INTRODUCTION: Since the publication of the MOSAIC test results in 2004, the FOLFOX4 regimen has been established as an adjuvant treatment which is recommended in stage III colorectal cancer. The aim of this study is to assess the use of this regimen in our field and to describe its toxicity. METHODS: Descriptive study of treatments with FOLFOX4 prescribed between April 2005 and March 2007. The data was obtained from the Farhos Oncología programme and clinical records. The following data was collected: age, gender, diagnosis, stage of the illness (TNM classification) and adverse reactions, expressing severity according to Common Toxicity Criteria 2.0. RESULTS: The FOLFOX4 regimen was prescribed for 39 patients (24 men and 15 women) with an average age of 59. The diagnoses were: 28 colon cancer (4 stage II, 17 stage III, and 7 stage IV), 10 rectal cancer (1 stage II, 4 stage III, and 5 stage IV) and 1 stage IV gastric cancer. The most frequent adverse reactions were peripheral neuropathy (82 %), neutropenia (56.4 %) and diarrhoea (53.9 %.) When the study was completed, 9 patients continued active treatment with the regimen (average 6.8 cycles.) Of the 30 remaining patients only 16 people completed the 12 planned cycles. 14 patients stopped their treatment (an average of 8.1 cycles) due to toxicity in 10 cases, clinical progression in 3 cases and one patient died. Of the total 368 cycles administered, 68 suffered administration delays and 22 had the dosage reduced. CONCLUSION: The use of the FOLFOX4 regimen has been adjusted to uses with some solid scientific evidence, but its toxicity has limited its use and has made administering the planned dosage levels difficult.

Atypical presentation of acute myeloid leukemia: cardiac myeloid sarcoma.

We present the case of a 52-year-old man with a 2-month history of dyspnea, bilateral pleural effusion and cardiomegaly of rapid onset. A cardiac ultrasound showed pericardial effusion with infiltration of the infero-lateral cardiac wall, right auricle and aortic arch by a mass of unknown origin. Despite 1% blast cells in the peripheral blood, 2 bone marrow biopsies were negative for malignancy. Flow cytometry analysis of the blood and immunohistochemistry study of the pleural liquid showed a blast population of CD34+, CD33+, CD13+ and HLA-DR+ cells; a percutaneous cardiac biopsy showed CD34+ cells in the pericardium which led to the diagnosis of extramedullary acute myeloid leukemia (AML). The patient was treated with induction chemotherapy allowing remission, but unfortunately died of septic shock of fungal origin. This case illustrates a rare presentation of cardiac extramedullary AML.