Standardizing health outcomes for chronic kidney disease. Adaptation of the international consortium for health outcomes measurement standard set to the Spanish setting / Estandarización de los resultados de salud en la enfermedad renal crónica. Adaptación del conjunto de variables de resultados del International Consortium for Health Outcomes Measurement al entorno español

Background and objectives: We aim to adapt the International Consortium for Health Outcomes Measurements standard set for chronic kidney disease (CKD) patients to the Spanish setting and supplement it with those variables agreed upon through initiatives proposed by the Spanish Society of Nephrologists (S.E.N.). Material and methods: The working group defined a first standard set of variables based on a literature review. The S.E.N. members then assessed the suitability of each variable for inclusion (Consensus≥75%). A second draft of the standard set was generated and evaluated by the Patient advocacy group Federación Nacional de Asociaciones para la Lucha Contra las Enfermedades del Riñón (ALCER). Lastly, the working group established the final standard set of variables (Consensus≥75%). Results: The standard set targets patients with very high-risk CKD (G3a/A3 and G3b/A2-G5) in pre-end-stage kidney disease (pre-ESKD), hemodialysis (HD), peritoneal dialysis (PD), kidney transplantation (KT) or conservative care (CC). The essential follow-up variables agreed for all patients (All) were patient survival, hospitalizations, cardiovascular events, smoking status, health-related quality of life, pain, fatigue, physical function, daily activities, depression, renal function and hemoglobin. Additionally, it was agreed to collect PD survival (in PD patients), peritonitis (PD), infection/bacteremia (PD, HD, KT), vascular access type (HD), vascular access survival (HD), acute rejection (KT), post-transplant cancer (KT), albuminuria (KT) and kidney allograft survival (KT). (AU)

Antecedentes y objetivos: El objetivo del estudio es adaptar el conjunto de variables de resultados del International Consortium for Health Outcomes Measurements para pacientes con enfermedad renal crónica al ámbito español y complementarlo con aquellas variables consensuadas en iniciativas de la Sociedad Española de Nefrología. Material y métodos: El grupo de trabajo definió un primer conjunto de variables a partir de una revisión bibliográfica. Seguidamente, los miembros de la Sociedad Española de Nefrología valoraron la idoneidad de cada variable para su inclusión (consenso≥75%). Posteriormente, se generó un segundo borrador que fue evaluado por la asociación de pacientes Federación Nacional de Asociaciones para la lucha contra las enfermedades del riñón. Por último, el grupo de trabajo estableció el conjunto de variables final (consenso≥75%). Resultados: El conjunto de variables se dirige a pacientes con enfermedad renal crónica y muy alto riesgo de progresión (G3a/A3 y G3b/A2-G5) en estadios previos al tratamiento renal sustitutivo, hemodiálisis (HD), diálisis peritoneal (DP), trasplante renal (TR) o tratamiento conservador. Las variables esenciales de seguimiento acordadas para todos los pacientes fueron la supervivencia del paciente, las hospitalizaciones, los eventos cardiovasculares, el hábito tabáquico, la calidad de vida relacionada con la salud, el dolor, la fatiga, la función física, las actividades diarias, la depresión, la función renal y la hemoglobina. Además, se acordó recoger la supervivencia en DP (en pacientes en DP), peritonitis (DP), infección/bacteriemia (DP, HD, TR), tipo de acceso vascular (HD), supervivencia del acceso vascular (HD), rechazo agudo (TR), cáncer postrasplante (TR), albuminuria (TR) y supervivencia del aloinjerto renal (TR). Las variables opcionales acordadas para todos los pacientes fueron los niveles de fósforo y potasio y el control de la diabetes (en pacientes con diabetes). (AU)

Evaluación poblacional del impacto del nivel socioeconómico en los resultados clínicos en pacientes con insuficiencia cardiaca en entornos de atención integrada / Population-based evaluation of the impact of socioeconomic status on clinical outcomes in patients with heart failure in integrated care settings

Introduction and objectives: Low socioeconomic status (SES) is associated with poor outcomes in patients with heart failure (HF). We aimed to examine the influence of SES on health outcomes after a quality of care improvement intervention for the management of HF integrating hospital and primary care resources in a health care area of 209 255 inhabitants.MethodsWe conducted a population-based pragmatic evaluation of the implementation of an integrated HF program by conducting a natural experiment using health care data. We included all individuals consecutively admitted to hospital with at least one ICD-9-CM code for HF as the primary diagnosis and discharged alive in Catalonia between January 1, 2015 and December 31, 2019. We compared outcomes between patients exposed to the new HF program and those in the remaining health care areas, globally and stratified by SES.ResultsA total of 77 554 patients were included in the study. Death occurred in 37 469 (48.3%), clinically-related hospitalization in 41 709 (53.8%) and HF readmission in 29 755 (38.4%). On multivariate analysis, low or very low SES was associated with an increased risk of all-cause death and clinically-related hospitalization (all Ps <.05). The multivariate models showed a significant reduction in the risk of all-cause death (HR, 0.812; 95%CI, 0.723-0.912), clinically-related hospitalization (HR, 0.886; 95%CI, 0.805-0.976) and HF hospitalization (HR, 0.838; 95%CI, 0.745-0.944) in patients exposed to the new HF program compared with patients exposed to the remaining health care areas and this effect was independent of SES.ConclusionsAn intensive transitional HF management program improved clinical outcomes, both overall and across SES strata. (AU)

Introducción y objetivos: El nivel socioeconómico (NSE) bajo se asocia con malos resultados en pacientes con insuficiencia cardiaca (IC). Nuestro objetivo es examinar la influencia del NSE en los resultados de salud tras una intervención de mejora de la calidad en el abordaje de la IC en un área de salud integrada de 209.255 habitantes.MétodosSe efectuó una evaluación pragmática poblacional utilizando bases de datos administrativas y sanitarias. Se incluyó a todas las personas consecutivas hospitalizadas con un código CIE-9-CM de IC como diagnóstico principal y dadas de alta vivas en Cataluña entre el 1 de enero de 2015 y el 31 de diciembre de 2019. Se compararon los resultados entre los pacientes expuestos al nuevo programa de IC y los de las demás áreas asistenciales, en general y según su NSE.ResultadosSe incluyó a 77.554 pacientes. Los eventos adversos fueron: muerte en 37.469 (48,3%), hospitalización clínicamente relacionada en 41.709 (53,8%) y reingreso por IC en 29.755 (38,4%). El NSE bajo o muy bajo se asoció con un mayor riesgo de eventos clínicos adversos (p <0,05). Se observó una reducción significativa del riesgo de muerte (HR=0,812; IC95%, 0,723-0,912), hospitalización relacionada con la clínica (HR=0,886; IC95%, 0,805-0,976) y por IC (HR=0,838; IC95%, 0,745-0,944) en los pacientes expuestos al nuevo programa frente a los de las demás áreas sanitarias y este efecto fue independiente del NSE.ConclusionesUn programa de atención transicional para la IC mejoró los resultados clínicos, tanto en general como en todos los estratos de NSE. (AU)

Evaluation of the usefulness of the Clavien-Dindo classification of surgical complications / Evaluación de la utilidad de la clasificación de complicaciones quirúrgicas de Clavien-Dindo

The Clavien-Dindo (CD) classification is widely used in the reporting of surgical complications in scientific literature. It groups complications based on the level of intervention required to resolve them, and benefits from simplicity and ease of use, both of which contribute its to high inter-rater reliability. It has been validated for use in many specialties due to strong correlation with key outcome measures including length of stay, postsurgical quality of life and case-related renumeration. Limitations of the classification include concerns over differentiating grade III and IV complications and not classifying intraoperative complications. The Comprehensive Complication Index is an adaptation of the CD classification which generates a morbidity score from 0 to 100. It has been proposed as a more effective method of assessing the morbidity burden of surgical procedures. However, it remains less popular as calculations of morbidity are complicated and time-consuming. In recent years there have been suggestions of adaptations to the CD classification such as the Clavien-Dindo-Sink classification, while in some specialties, completely new classifications have been proposed due to evidence the CD classification is not reliable. Similarly, the Surgical Expertise and Validity Evaluation project aims to determine benchmarks against which surgeons may compare their own practice. (AU)

La clasificación de Clavien-Dindo (CD) es ampliamente utilizada en la notificación de complicaciones quirúrgicas en la literatura científica. Agrupa las complicaciones en función del nivel de intervención necesario para resolverlas y se beneficia de la simplicidad y la facilidad de uso, que contribuyen a su alta fiabilidad entre evaluadores. Ha sido validado para su uso en muchas especialidades debido a la fuerte correlación con las medidas de resultado clave, incluida la duración de la estancia, la calidad de vida posquirúrgica y la remuneración relacionada con el caso. Las limitaciones de la clasificación incluyen la preocupación por diferenciar las complicaciones de grado III y IV y no clasificar las complicaciones intraoperatorias. El Índice Integral de Complicaciones es una adaptación de la clasificación de CD que genera una puntuación de morbilidad de 0 a 100. Se ha propuesto como un método más efectivo para evaluar la carga de morbilidad de los procedimientos quirúrgicos. Sin embargo, sigue siendo menos popular ya que los cálculos de morbilidad son complicados y requieren mucho tiempo. En los últimos años ha habido sugerencias de adaptaciones a la clasificación de CD como la clasificación de Clavien-Dindo-Sink, mientras que en algunas especialidades se han propuesto clasificaciones completamente nuevas debido a la evidencia de que la clasificación de CD no es confiable. De manera similar, el proyecto de Evaluación de Validez y Experiencia Quirúrgica tiene como objetivo determinar puntos de referencia contra los cuales los cirujanos pueden comparar su propia práctica. (AU)

Atención farmacéutica y asma: protocolo de una revisión de revisiones sistemáticas / Pharmaceutical care and asthma: Protocol of an umbrella review of systematic reviews

Introducción las revisiones sistemáticas y metaanálisis recientes sugieren que las intervenciones por parte de farmacéuticos en pacientes asmáticos tienen un impacto positivo en resultados en salud. Sin embargo, la asociación no está bien establecida y el papel de los farmacéuticos clínicos está pobremente representado, así como el de los pacientes con asma grave. El objetivo de esta revisión de revisiones es identificar revisiones sistemáticas publicadas que evalúen el impacto de las intervenciones farmacéuticas en resultados en salud medidos en pacientes asmáticos, así como describir los componentes clave de las intervenciones, los resultados medidos y cualquier asociación entre las intervenciones farmacéuticas y los resultados en salud medidos. Métodos se hará una busqueda en PubMed, Embase, Scopus y la Cochrane Library desde el primer registro hasta diciembre de 2022. Se considerará la inclusión de revisiones sistemáticas de todo tipo de estudios primarios, severidad del asma o nivel asistencial que midan resultados en salud. La calidad metodológica se medirá usando A Measurement Tool to Assess Systematic Reviews 2. Dos investigadores independientes realizarán la selección de los estudios, la evaluación de la calidad y la extracción de datos. Cualquier discrepancia será solventada por un tercer investigador. Ambos resultados, narrativos y metaanálisis, de los estudios primarios incluidos en las revisiones sistemáticas serán sintetizados. Si los datos son apropiados para un análisis cuantitativo, las medidas de asociación se expresarán como cociente de riesgos y diferencia de medias. Discusión los primeros resultados del establecimiento de una red multidisciplinar para el manejo de los pacientes asmáticos mostraron beneficios en integrar los diferentes niveles asistenciales en el control de la enfermedad y la reducción de la morbilidad...(AU)

Introduction Recent systematic reviews and meta-analyses suggest that pharmacists' interventions in asthma patients have a positive impact on health-related outcomes. Nevertheless, the association is not well established and the role of clinical pharmacists is poorly represented, as well as severe asthma patients. The aim of this overview of systematic reviews is to identify published systematic reviews assessing the impact of pharmacists' interventions on health-related outcomes measured in asthma patients, as well as to describe key components of the interventions, the outcomes assessed and any associations between pharmacists' interventions and health-related outcomes. Methods PubMed, Embase, Scopus and the Cochrane Library will be searched from inception to December 2022. Systematic reviews of all study designs, severity of asthma and level of care that measured health-related outcomes will be considered. Methodological quality will be assessed using A Measurement Tool to Assess Systematic Reviews 2. Two independent investigators will perform the study selection, quality assessment and data collection, any discrepancy will be solved by a third investigator. Both narrative findings and meta-analysis of primary study data included in the systematic reviews will be synthesized. If data are appropriate for quantitative synthesis, the measures of association will be expressed as the risk ratio and difference in means. Discussion The first results on the establishment of a multidisciplinary network for the management of asthmatic patients have shown the benefits of integrating different levels of care in disease control and morbidity reduction. Further studies showed benefits in hospital admissions, patients' basal oral corticosteroid dose, exacerbations and quality of life of asthma patients...(AU)

Prevalence and Impact of Asthma and Allergy on Daily Life, Health Outcomes and Use of Healthcare Services in Children: A Population-Based Study

Introduction: Studies on the prevalence of asthma and allergies often lack representation of the pediatric population, and their impact has not been examined using children without these diseases as a reference group. This study aimed to determine the prevalence of asthma and allergies in children under 14 years old in Spain and their impact on health-related quality of life, activities, healthcare utilization, and environmental and household exposure risk factors. Methods: Data came from a Spanish population-based representative survey of children aged <14 years (N=6297). A sample of controls (1:4) from the same survey was matched using propensity score matching. Logistic regression models and population-attributable fractions were calculated to determine the impact of asthma and allergy. Results: The population prevalence of asthma was 5.7% (95% CI: 5.0%, 6.4%), and of allergy was 11.4% (95% CI: 10.5%, 12.4. In children with lower percentiles of health-related quality of life (≤20th), 32.3% (95% CI, 13.6%, 47.0%) was attributed to asthma and 27.7% (95% CI: 13.0%, 40.0%) to allergy. Forty-four percent of restrictions in usual activity were attributed to asthma (OR: 2.0, p-value: <0.001), and 47.9% to allergy (OR: 2.1, p-value: <0.001). 62.3% of all hospital admissions were attributed to asthma (OR: 2.8, p-value: <0.001), and 36.8% (OR: 2.5, p-value: <0.001) of all specialist consults to allergy. Conclusions: The high prevalence of atopic disease and its impact on daily life and healthcare utilization call for an integrated healthcare system focused on children and caregivers’ needs with continuity of care across education and healthcare settings. (AU)

Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in real-life conditions in two Latin American countries / Desenlaces reportados por los pacientes diagnosticados con AR tratados con tofacitinib o FARME biológico bajo condiciones reales en dos países de Latinoamérica

Objective: To describe efficacy, safety, and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions. Methods: A noninterventional study was performed between March 2017 and September 2019 at 13 sites in Colombia and Peru. Outcomes measured at baseline and at the 6-month follow-up were disease activity (RAPID3 [Routine Assessment of Patients Index Data] score), functional status (HAQ-DI [Health Assessment Questionnaire] score), and quality of life (EQ-5D-3L [EuroQol Questionnaire]). The Disease Activity Score-28 (DAS28-ESR) and frequency of adverse events (AEs) were also reported. Unadjusted and adjusted differences from baseline were estimated and expressed as the least squares mean difference (LSMD). Results: Data from 100 patients treated with tofacitinib and 70 patients with bDMARDs were collected. At baseline, the patients’ mean age was 53.53 years (SD 13.77), the mean disease duration was 6.31 years (SD 7.01). The change from baseline at month 6 was not statistically significant different in the adjusted LSMD [SD] for tofacitinib vs. bDMARDs for RAPID3 score (−2.55[.30] vs. −2.52[.26]), HAQ-DI score (−.56[.07] vs. −.50[.08]), EQ-5D-3L score (.39[.04] vs. .37[.04]) and DAS28-ESR (−2.37[.22] vs. −2.77[.20]). Patients from both groups presented similar proportions of nonserious and serious AEs. No deaths were reported.Conclusion: Changes from baseline were not statistically significantly different between tofacitinib and bDMARDs in terms of RAPID3 scores and secondary outcomes. Patients from both groups presented similar proportions of nonserious and serious AEs.(AU)

Objetivo: Describir la eficacia, la seguridad y los desenlaces reportados por los pacientes (PRO) en pacientes con artritis reumatoide (RA) con una respuesta inadecuada a los fármacos antirreumáticos modificadores de la enfermedad sintéticos convencionales (csFARME) tratados con tofacitinib o FARME biológico (bFARME) en condiciones de la vida real. Métodos: Estudio no intervencional realizado entre marzo de 2017 y septiembre de 2019 en 13 centros de Colombia y Perú. Los desenlaces evaluados al inicio y a los seis meses de seguimiento fueron la actividad de la enfermedad (puntaje Routine Assessment of Patients Index Data [RAPID3]), el estado funcional (puntaje Health Assessment Questionnaire [HAQ-DI]) y la calidad de vida (EuroQol Questionnaire [EQ-5D-3L]). El puntaje de actividad de la enfermedad-28 (DAS28-ESR) y la frecuencia de eventos adversos (EA). Se estimaron las diferencias no ajustadas y ajustadas con respecto a los valores basales y se expresaron como diferencia de medias por mínimos cuadrados (LMD). Resultados: Se recolectó información de 100 pacientes tratados con tofacitinib y 70 pacientes con bFARME. Al inicio del estudio, la edad media de los pacientes era de 53,53 años (DE 13,77) y la duración media de la enfermedad de 6,31 años (DE 7,01). El cambio con respecto al valor basal en el mes 6 no fue estadísticamente significativo en la LMD ajustada (SE) para tofacitinib vs. los bFARME para RAPID3 (−2,55 [0,30] vs. −2,52 [0,26]), puntuación HAQ-DI (−0,56 [0,07] vs. −0,50 [0,08]), puntuación EQ-5D-3L (0,39 [0,04] vs. 0,37 [0,04]) y DAS28-ESR (−2,37 [0,22] vs. −2,77 [0,20]). Los pacientes de ambos grupos presentaron proporciones similares de EA no graves y graves. Ninguna muerte fue reportada. Conclusiones: Los cambios desde el inicio no fueron estadísticamente significativos entre tofacitinib y los bFARME en RAPID3 y en los desenlaces secundarios. Los pacientes de ambos grupos presentaron proporciones similares de EA no graves y graves.(AU)

Evolución de la asistencia cardiovascular en el Sistema Nacional de Salud de España. Datos del proyecto RECALCAR 2011-2020 / Trends in cardiovascular care in the National Health System in Spain. Data from the RECALCAR project 2011-2020

Introducción y objetivos: El proyecto RECALCAR (Recursos y Calidad en Cardiología), iniciativa de la Sociedad Española de Cardiología, pretende estandarizar la información para generar evidencia sobre los resultados en salud cardiovascular. Su objetivo es analizar la evolución de los recursos y la actividad de las unidades y los servicios de cardiología y conocer los resultados en la asistencia cardiovascular durante la última década en España. Métodos: Este estudio se basa en las dos fuentes anuales de datos del proyecto RECALCAR: una encuesta sobre recursos y actividad de las unidades y servicios de cardiología (2011-2020) y el conjunto mínimo básico de datos del Sistema Nacional de Salud (2011-2019), referido a insuficiencia cardiaca (IC), infarto agudo de miocardio con (IAMCEST) y sin (IAMSEST) elevación del segmento ST. Resultados: La encuesta incluye el 70% de las unidades y servicios de cardiología de España. Se ha observado una disminución en el número de camas de hospitalización y la estancia media y un incremento notable en el número de estudios de imagen cardiaca y procedimientos terapéuticos percutáneos. Los ingresos por IC ajustados por edad y sexo han disminuido, aunque su mortalidad y el porcentaje de reingresos han ido en aumento. La evolución de la mortalidad y los reingresos ha sido muy favorable en el IAMCEST; en el IAMSEST, aunque positiva, ha sido menos relevante. Conclusiones: La información aportada por el proyecto RECALCAR demuestra una evolución favorable en la última década en recursos, actividad y resultados en determinados procesos cardiovasculares y constituye una fuente esencial para mejoras futuras y facilitar la toma de decisiones en política sanitaria. (AU)

Introduction and objectives: The RECALCAR project (Resources and Quality in Cardiology), an initiative of the Spanish Society of Cardiology, aims to standardize information to generate evidence on cardiovascular health outcomes. The objective of this study was to analyze trends in the resources and activity of cardiology units and/or services and to identify the results of cardiovascular care during the last decade in Spain. Methods: The study was based on the 2 annual data sources of the RECALCAR project: a survey on resources and activity of cardiology units and/or services (2011-2020) and the minimum data set of the National Health System (2011-2019), referring to heart failure (HF), STEMI, and non-STEMI. Results: The survey included 70% of cardiology units and/or services in Spain. The number of hospital beds and length of stay decreased, while there was a notable increase in the number of cardiac imaging studies and percutaneous therapeutic procedures performed. Age- and sex-adjusted admissions for HF tended to decrease, despite an increase in mortality and the percentage of readmissions. In contrast, the trend in mortality and readmissions was highly favorable in STEMI; in non-STEMI, although positive, the trend was less marked. Conclusions: The information provided by the RECALCAR project shows a favorable trend in the last decade in resources, activity and results of certain cardiovascular processes and constitutes an essential source for future improvements and decision-making in health policy. (AU)

Outcomes and impact of multidisciplinary team care on immunologic and hemato-oncologic pediatric patients

Introduction: Immunologic and hemato-oncologic disorders in the pediatric population represent an interrelated and complex group of conditions whose approach, diagnosis, and management could be difficult. Multidisciplinary teams have been proved beneficial in treating such complexities. Methods: We conducted a retrospective observational study at a tertiary hospital in Madrid, Spain, which is a pediatric immunology and onco-hematology referral center. We included all patients of multidisciplinary outpatient consultation, comprising a working group of pediatric oncohematologists and immunologists, between April 2016 and December 2019. Epidemiologic, clinical, and laboratory data were collected. We analyzed these data and established a relationship between age and findings of final diagnosis as well as variance on diagnoses prior to their multidisciplinary assessment and number of visits to the consultation. Results: In all, 93 children and adolescents were included in this study. Laboratory abnormalities were the most frequent reason for being referred to our unit (87.2%); 78% of children had a previously diagnosed comorbidity. Before starting follow-up in the multidisciplinary consultation, 14% of patients were diagnosed, and after the study by the multidisciplinary team, the final diagnosis was reached in 58.1% of patients. No correlation was discovered between final diagnosis and gender (P = 0.29), age (biserial correlation coefficient, r = 0.036, P = 0.70), and number of visits (P = 0.07). Conclusion: A multidisciplinary approach to immunologic, hematologic, and oncologic pediatric diseases is feasible. It can be a powerful and useful tool for diagnosis and treatment, especially in complex pediatric patients (AU)

Importancia del Estudio Piloto en un Proyecto de Intervención / Importance of a Pilot Study in an intervention project

Objetivo: Detallar los elementos básicos de los estudios piloto, sus propósitos y los componentes que evalúan. Desarrollo: Las intervenciones en salud se desarrollan en cuatro fases. Este artículo se enfoca en la segunda fase, que corresponde a los estudios piloto. En términos generales, los estudios piloto son diseñados e implementados para analizar la fidelidad, aceptabilidad y efectos preliminares. La fidelidad se refiere a la relación entre los ingredientes activos de la intervención, sus componentes y actividades (teórica), y el grado en que se implementa la intervención de acuerdo con lo planificado (operacional). La aceptabilidad es un constructo de siete indicadores, e incluye la satisfacción de los participantes hacia la intervención y el intervencionista. Los efectos preliminares hacen referencia a la capacidad de la intervención de inducir cambios en los resultados de una investigación. Conclusiones: Un estudio piloto es uno de los primeros pasos que se lleva a cabo en un proyecto de intervención. El estudio piloto permite tomar decisiones fundamentadas sobre la implementación de una investigación principal. Este artículo pretende ser referencia para el diseño, implementación y evaluación de estudios piloto.(AU)

Objective: To describe the basic elements of the pilot studies, their purpose and their evaluation components. Development: Health interventions are generally developed in four phases. This article focuses on the Second Phase, which corresponds to pilot studies. Generally speaking, pilot studies are designed and implemented to analyze the fidelity, acceptability, and preliminary effects of an intervention. Fidelity refers to the relationship between the intervention’s active ingredients and its components and activities (theoretical), and the degree to which the intervention is delivered according to what was planned (operational). Acceptability includes the participant’s satisfaction towards the intervention and the interventionist. Preliminary effects refer to the ability of the intervention to induce changes in the outcome of an intervention. Conclusions: A Pilot Study is one of the first steps in an intervention project. A pilot study allows informed decisions to be made about the implementation of a larger research project. This article intends to serve as a guide for the design, implementation and evaluation of pilot studies.(AU)

Can adjunctive corticosteroid therapy improve patient-centered outcomesfollowing third molar surgery? A systematic review

Background: Third molar surgery is frequently associated with postoperative discomfort such as pain, edema andtrismus. We aimed to evaluate the current evidence on the efficacy of adjunctive corticosteroid therapy in improving patient-centered outcomes following third molar surgery.Material and Methods: This systematic review assessed and searched PubMed, Google scholar, Scopus, web ofscience, clinicaltrials.gov and Cochrane central for controlled trials, up to May 2021. The primary outcome measures were patient-centered outcomes such as quality of life following the use of adjunctive corticosteroid therapyin third molar removal. Only randomized controlled trials published in English language were included.Results: A total of 355 studies were initially identified, and 12 studies were finally included. The results showedthat both methylprednisolone and dexamethasone decreased postoperative side effects such as pain, trismus, andedema and consequently were improving patient reported outcomes. In this regard, none of the included papersreported any significant statistical difference between these two drugs (p > 0.05). The analysis regarding theroute of administration for the corticosteroids showed that local and intravenous injection of dexamethasone hadequivalent effects, and both methods showed better results as compared to simple oral administration.Conclusions: Adjunctive use of corticosteroid drugs may improve patient-centered outcomes following third molar surgery. However, there is no significant difference between drugs and routs of administration. Comparingvarious administration routs, local submucosal injection of dexamethasone seems to be a straightforward, painlessand cost-effective adjunctive therapy. (AU)

Retrospective cohort study on risk factors for developing ischemic stroke

Background: There is a paucity of studies describing the risk factors for developing ischemic stroke in our region. Objective: The objective of the current study was to delineate the potential risk factors for the development of ischemic stroke. Methods: We have conducted a retrospective cohort hospitalbased study that has enrolled 231 subjects. The subjects have had presented to the emergency department in a tertiary hospital in the United Arab Emirates. Subjects were diagnosed with ischemic stroke within 24 hours of presentation. Outcome measure: The main outcome measure was the development of ischemic stroke during an indexed hospital visit. Results: The mean age was 47.5 ±3.2 with a higher preponderance of males over females (60.9%) and 48.1% were ≥ 65 years. The final logistic regression model for the development of ischemic stroke contains seven variables. In descending order, the seven predictive risk factors for the development of ischemic stroke were: hypertension (OR 6.1, CI 2.4-9.5; P = 0.029), coronary artery disease (OR 4.2, 3.7-9.1; P = 0.038), low physical activity (OR 4.2, CI 2.1-9.1; P = 0.035), history of previous stroke (OR 4.1, 1.4-3.4; P = 0.033), atrial fibrillation (OR 3.2, CI 2.6-8.2; P = 0.017), family history of stroke (OR 3.1, 1.3-6.9; P = 0.042) and diabetes mellitus (OR 2.7, CI 1.25-6.1; P = 0.035). The specificity of the model was 58.1%; the sensitivity was 86.1%, and the overall accuracy was 75.7%. Conclusion: It is prudent to control modifiable risk factors for the development of strokes such as hypertension, diabetes, atrial fibrillation, coronary artery disease, and low physical activity. (AU)

El modelo Clinical outcomes, healthcare resource utilization, and related costs (COHERENT). Aplicación en pacientes con insuficiencia cardiaca / The Clinical outcomes, healthcare resource utilization, and related costs (COHERENT) model. Application in heart failure patients

Introducción y objetivos: Los resultados combinados se utilizan ampliamente, pero tienen diversas limitaciones. El modelo Clinical outcomes, healthcare resource utilization and related costs (COHERENT) es una aproximación nueva para presentar y comparar visualmente todos los componentes de los resultados combinados (incidencia, tiempo, duración) y los costes relacionados. El objetivo es evaluar su utilidad en una cohorte de pacientes. Métodos: Se diseñó un sistema de colores que representa gráficamente el porcentaje de pacientes en cada situación clínica (estado vital y ubicación: domicilio, urgencias, hospital), codificada jerárquicamente, en cada momento del seguimiento. Se aplicó a 1.126 pacientes con insuficiencia cardiaca aguda de 25 hospitales seguidos durante 30 días tras su visita a urgencias, y se calculó el tiempo en cada situación clínica y sus costes sanitarios. Resultados: El modelo ilustra visualmente los componentes del objetivo combinado a los 30 días (el 2,12% en urgencias, el 23,6% en hospitalización índice, el 2,7% en reingresos, el 65,5% vivo en casa y el 6,02% fallecido) y muestra diferencias significativas entre grupos de pacientes, hospitales o sistemas sanitarios. El instrumento también calcula y muestra los costes diarios y acumulados (total, 4.895.070 euros; media, 144,91 euros/paciente/día). Conclusiones: El modelo COHERENT es un nuevo método para mostrar visualmente resultados combinados y sus costes que permite comparar grupos de pacientes y cohortes. El nuevo sistema puede ser útil como un nuevo criterio de valoración para ensayos clínicos o estudios observacionales, y un instrumento para la evaluación comparativa, la planificación clínica, el análisis económico y la implementación de la atención sanitaria basada en valor (AU)

Introduction and objectives: Composite endpoints are widely used but have several limitations. The Clinical outcomes, healthcare resource utilization and related costs (COHERENT) model is a new approach for visually displaying and comparing composite endpoints including all their components (incidence, timing, duration) and related costs. We aimed to assess the validity of the COHERENT model in a patient cohort. Methods: A color graphic system displaying the percentage of patients in each clinical situation (vital status and location: at home, emergency department [ED] or hospital) and related costs at each time point during follow-up was created based on a list of mutually exclusive clinical situations coded in a hierarchical fashion. The system was tested in a cohort of 1126 patients with acute heart failure from 25 hospitals. The system calculated and displayed the time spent in each clinical situation and health care resource utilization-related costs over 30 days. Results: The model illustrated the times spent over 30 days (2.12% in ED, 23.6% in index hospitalization, 2.7% in readmissions, 65.5% alive at home, and 6.02% dead), showing significant differences between patient groups, hospitals, and health care systems. The tool calculated and displayed the daily and cumulative health care-related costs over time (total, €4 895 070; mean, €144.91 per patient/d). Conclusions: The COHERENT model is a new, easy-to-interpret, visual display of composite endpoints, enabling comparisons between patient groups and cohorts, including related costs. The model may constitute a useful new approach for clinical trials or observational studies, and a tool for benchmarking, and value-based health care implementation (AU)

Diseño y usabilidad de ParaSportAPP: una mHealth destinada a promocionar la actividad física en personas con lesión medular / Design e usabilidade do ParaSportAPP: uma mHealth para promover a actividade física em pessoas comlesões da medula espinal / Design and usability of ParaSportAPP: an mHealth aimed at promoting physical activity in people with spinalcord injury

Objetivo: Diseñar y evaluar la usabilidad de una mHealth destinada a aumentar los niveles de actividad física en personas con paraplejia usuarias de sillade ruedas manual. Método: En primer lugar, se diseñó la mHealth ParaSportAPP mediante un comité de expertos en ejercicio físico y lesión medular. Posteriormente, una vezcreada la mHealth, se instaló ParaSportAPP en los teléfonos inteligentes de 15 personas con lesión medular dorsal usuarias de silla de ruedas. 8 mesesdespués de la instalación de la mHealth, se citó de nuevo a los participantes del estudio y cumplimentaron la Escala de Usabilidad del Sistema. Resultados: Se creó una mHealth con 79 ejercicios físicos diferentes y con dos modos distintos de transmitirlos al usuario. Además, la aplicación es capazde registrar los ejercicios físicos realizados al margen de los proporcionados por la misma y ofrece un informe a modo de feedback sobre el ejercicio físicorealizado durante el día. Asimismo, los resultados hallados mostraron una puntuación media de 77.5 (18.85) en la Escala de Usabilidad del Sistema.Conclusiones: Se ha conseguido diseñar y crear una mHealth funcional y con buenos niveles de usabilidad centrada en promocionar la actividad física enpersonas con lesión medular dorsal.(AU)

Aim: To design and evaluate the usability of an mHealth aimed at increasing physical activity levels in people with paraplegia who use manualwheelchairs. Method: Firstly, the ParaSportAPP mHealth was designed by a committee of experts in physical exercise and spinal cord injury. Subsequently, once themHealth was created, ParaSportAPP was installed on the smartphones of 15 wheelchair users with dorsal spinal cord injury. 8 months after theinstallation of the mHealth, the participants were summoned again and completed the System Usability Scale. Results: An mHealth was created with 79 different physical exercises and with two different ways of transmitting them to the user. In addition, theapplication is able to record the physical exercises performed in addition to those provided by the application itself and offers a feedback report on thephysical exercise performed during the day. The results also showed an average score of 77.5 (18.85) on the System Usability Scale. Conclusions: It has been possible to design and create a functional mHealth with good levels of usability focused on promoting physical activity in peoplewith dorsal spinal cord injury.(AU)

Objectivo: Conceber e avaliar a usabilidade de uma mHealth destinada a aumentar os níveis de actividade física em pessoas com paraplegia que utilizamcadeiras de rodas manuais. Método: Primeiro, o ParaSportAPP mHealth foi concebido por um comité de peritos em exercício físico e lesões da medula espinal. Subsequentemente,uma vez criada a mHealth, o ParaSportAPP foi instalado nos smartphones de 15 utilizadores de cadeiras de rodas com lesão da espinal medula dorsal. 8meses após a instalação do mHealth, os participantes do estudo foram novamente convocados e completaram a Escala de Usabilidade do Sistema. Resultados: Foi criada uma mHealth com 79 exercícios físicos diferentes e com duas formas diferentes de os transmitir ao utilizador. Além disso, o pedidoé capaz de registar os exercícios físicos realizados para além dos fornecidos pelo próprio pedido e oferece um relatório como feedback sobre o exercíciofísico realizado durante o dia. Além disso, os resultados encontrados mostraram uma pontuação média de 77.5 (18.85) na Escala de Usabilidade doSistema. Conclusões: Tem sido possível conceber e criar uma mHealth funcional com bons níveis de usabilidade centrada na promoção da actividade física empessoas com lesões da espinal-medula dorsal.(AU)

Evaluación de resultados del proyecto educativo “Alcohol: Conciencia con ciencia del Programa ARGOS-Región de Murcia de prevención del consumo de alcohol en alumnado de 1º de Educación Secundaria Obligatoria / Result’s Evaluation of the educational project Alcohol: conciencia con ciencia of Programa ARGOS-Region de Murcia of alcohol consumption prevention for First Secondary School students

Fundamentos: Alcohol: Conciencia con ciencia es un proyecto educativo-comunitario de prevención universal para alumnado de 12 años (1º ESO) que consta de tres sesiones y se desarrolla desde 2012 cada curso escolar. El objetivo de este trabajo fue evaluar su efecto en el consumo de alcohol, actitudes y conocimientos en cursos posteriores (segundo y tercero), para conocer su durabilidad. Métodos: Estudio observacional transversal en distintas fases (octubre/abril), cuasiexperimental con grupo comparación. Se realizó en centros educativos seleccionados (18 centros, 13 municipios) el curso 2017/2018, completando todo el alumnado de 2º (2.892) y 3º ESO (2.601) un cuestionario de conocimientos, opiniones y consumos. Análisis estadístico: pruebas chi-cuadrado de contingencia y diferencia de las diferencias. Resultados: Fue menor el alumnado que inició el consumo en el grupo intervención durante el curso escolar posterior, con diferencias entre grupos (31,5% frente a 36,6% en octubre y 35,9% frente al 43,4% en abril) (octubre p=0,037, abril p=0,006) y diferencia de las diferencias negativa a favor de la intervención (-2,6%), más acusada en chicas (-8,1%). Aunque trabajó el alcohol, se extendió esta mayor percepción de riesgo al tabaco y el cánnabis. El efecto en conocimientos se mantuvo el siguiente curso, con diferencias estadísticamente significativas. La presión de grupo reconocida por el que la sufrió, fue significativamente mayor durante 2º ESO en grupo comparación (octubre p=0,002, abril p=0,015), más duradera en chicas. Conclusiones: La implementación de este proyecto frena el inicio del consumo de alcohol, borracheras y consumo todas las semanas, durante todo el siguiente curso escolar (2º ESO) a la intervención, en 3º ESO el efecto de la intervención desaparece siendo necesario reforzar con Drogas: ALTACAN en 2º.(AU)

Background: Alcohol: Conciencia con ciencia is an educational-community universal prevention project for 12-year-old students (1st of ESO) which consists of three sessions and it is being implemented every school year since 2012. The objective was to evaluate its effect on alcohol consumption, attitudes and knowledge in the subsequent courses (2nd and 3rd of ESO), in order to know its durability. Methods: It is a cross-sectional observational study in different phases (applied in October and April), quasi-experimental with a comparison group. In the 2017/2018 academic year, all 2nd (n=2,892) and 3rd of ESO (n=2,601) students completed a questionnaire based on knowledge, opinions and consumption patterns in selected educational centers (18 centers in 13 municipalities). Statistical analysis: chi-square tests of contingency and difference of differences. Results: The number of students who started drinking is less in the intervention group during the subsequent school year, with differences between groups (31.5% vs. 36.6% in October, and 35.9% vs. 43.4% in April) (October p=0.037, April p=0.006) and difference in negative differences in favour of the intervention (-2.6%), more pronounced in girls (-8.1%). Although the study includes alcohol, the greatest perception of risk extends to tobacco and cannabis. The effect on knowledge maintained the following year, being the differences statistically significant. The group pressure recognized by those who suffer it was significantly higher during 2nd of ESO in the comparison group (October p=0.002, April p=0.015), being its durability longer in girls. Conclusions: The intervention stops the beginning of consumption, drunkenness and every-week consumption the hole next school year (2nd ESO) after intervention, but in 3rd of ESO the effect of the intervention disappears, being therefore necessary to reinforce it with the implementation of the project Drogas: ALTACAN in 2nd of ESO(AU)

SEVE project (Surgical Expertise Validity Evaluation) risk adjusted quality by standard data

The SEVE project (Surgical Expertise Validity Evaluation) is a collaborative effort of the AEC (Spanish Association of Surgeons) and the Section of Surgery of the European Union of Medical Specialists (UEMS) that aims to develop a model and an on line application that can be used to evaluate surgical complications. The aim is to identify the optimal results that can be obtained in each intervention, in order to present them as a reference for our usual practice (benchmarking)(AU)

El proyecto SEVE, constituye un modelo de colaboración entre la Asociación Española de Cirujanos y la Sección de Cirugía de la Unión Europea de Médicos Especialistas, con el objetivo de establecer en la Unión Europea un modelo de evaluación de las complicaciones quirúrgicas en un proyecto piloto. El objetivo es identificar los mejores resultados que pueden obtenerse en cada intervención, y la posibilidad de presentarlo como referencia de la práctica quirúrgica habitual(AU)

Exclusive 3D-brachytherapy as a good option for stage-I inoperable endometrial cancer: a retrospective analysis in the gynaecological cancer GEC-ESTRO Working Group

PurposeAnalyse outcomes of stage-I inoperable endometrial cancer (EC) patients from seven European centres treated with 3D-image-guided brachytherapy (IGBT) alone.Materials and methodsFrom 2004 to 2018, 62 patients (41 stage-IA and 21 IB) were retrospectively studied, analysing anaesthetic procedure, applicator type, BT-planning imaging, clinical target volume (CTV), BT schedule, overall daily-dose equivalent to 2 Gy (EQD2(α/β=4.5 or 3)) to the CTV(α/β=4.5) and D2 cm3(α/β=3) for organs at risk. Complications were evaluated using CTCAEv4 scores. The 2 and 5 year survival was calculated [cancer-specific survival (CSS), disease-free survival (DFS), local relapse-free survival (LRFS), loco-regional relapse-free survival (LRRFS) and distant metastasis-free survival (DMFS)]. Descriptive analysis and the Kaplan–Meier method were used for survival analysis.ResultsMean follow-up: 32.8 months (SD 33.7). Spinal anaesthesia (38/62) followed by none (16/62) were the most common. Y-shaped Rotte applicators were used in 74% of patients. High-dose rate brachytherapy was administered in 89%. Median D90 to the CTV was 58.9 Gy (8.66–144 Gy). Eight patients presented relapse: four uterine, four nodal and four distant. The 2 and 5 year CSS was 93.3 and 80.5%, DFS 84.8 and 80.5%, LRFS was 93.1 and 88.7%, LRRFS was 91 and 91% and DMFS was 90.2 and 90.2%, respectively, CSS was better in stage-IA vs. IB (p = 0.043). Late vaginal and bladder G3-complication rates were 2.1%, respectively.ConclusionInoperable EC patients can be safely treated by BT with 2 and 5 year CSS of 93 and 80.5%, respectively, with even better results for IA cases. Prospective studies on 3D-IGBT are necessary to better analyse EC patient outcomes based on dose and treated volumes.

Evaluación de los resultados de un programa de servicio responsable de bebidas alcohólicas aplicado en ciclos de formación profesional de hostelería y restauración / Evaluation of the results of a program of Responsible Service of Alcoholic Beverages applied in Professional Training Cycles of Hospitality and Catering

Fundamentos: El consumo abusivo de alcohol es uno de los principales problemas de salud. La formación en un Servicio Responsable de Alcohol (SRA) al personal de hostelería es una forma de minimizar el consumo abusivo en contextos de ocio. Hasta la fecha no se han publicado estudios sobre la efectividad de esta formación en futuros profesionales de la hostelería. En este artículo se presenta la valoración de la efectividad de una intervención de formación en SRA realizada en los Ciclos de Servicios de Restauración de un Centro Integrado de Navarra con estudiantes de Formación Profesional. Métodos: Se formó en SRA a 81 estudiantes, mediante una acción formativa de 4 horas. Para evaluar la efectividad de la intervención se valoraron los conocimientos sobre el alcohol antes y después de la actividad. También se evaluó la actitud, la perspectiva de autoeficacia y las expectativas hacia el SRA. Finalmente, se valoró la satisfacción con la actividad. Para ello se realizó una comparación de medias a partir de un diseño de medidas repetidas test-retest mediante la prueba no paramétrica de Wilcoxon de los rangos con signo. Además, se realizó un análisis individual de la evolución de cada participante. Resultados: Desde una perspectiva grupal, el conocimiento sobre los efectos del alcohol (W=2,91; p=0,04), las actitudes (W=3,52; p<0,001) y las expectativas (W=2,97; p=0,003) hacia el SRA mejoraron. La satisfacción con los diferentes aspectos de la formación osciló entre 3,52 y 4,08 puntos sobre 5. Conclusiones: La formación en SRA con alumnado de Formación Profesional favorece la responsabilización en el servicio de bebidas alcohólicas e incrementa las expectativas hacia el SRA. Asimismo, se recomienda realizar adaptaciones específicas de esta formación para el alumnado de Formación Profesional.(AU)

Background: The abusive consumption of alcohol is a relevant health problem. Training hospitality professionals in Responsible Alcohol Service (RAS) is a way to minimize abusive consumption in leisure contexts. To date, no studies have been published on the effectiveness of this training in future hospitality professionals. This study presents the evaluation of the effectiveness of a training intervention carried out with Vocational Training students. Methods: Eighty-one students were trained in RAS through a 4-hour course. To evaluate the effectiveness of the intervention, knowledge about alcohol was assessed before and after the activity. Attitude, self-efficacy perspective and expectations towards RAS were also evaluated. Finally, satisfaction with the activity was assessed. To do this, a comparison of means was carried out from a testretest repeated measures design using Wilcoxon’s nonparametric test of signed ranges. An individual analysis of the evolution of each participant was also carried out. Results: From a group perspective, knowledge about the effects of alcohol (W=2.91; p=0.04), attitudes (W=3.52; p<0.001) and expectations (W=2.97; p=0.003) towards RAS improved after the intervention. Satisfaction with different aspects of the training ranged between 3.52 and 4.08 points out of 5. Conclusions: RAS training with Vocational Training students favors accountability in the service of alcoholic beverages and increases expectations towards RAS.Likewise, to make specific adaptations for Vocational Training students is recommended.(AU)