The S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.

OBJECTIVES: The S-REAL study aimed to assess the effectiveness of durvalumab as consolidation therapy after definitive chemoradiotherapy (CRT) in a real-world cohort of patients with locally advanced, unresectable stage III non-small cell lung cancer (LA-NSCLC) included in a Spanish early access program (EAP). METHODS: In this multicentre, observational, retrospective study we analysed data from patients treated in 39 Spanish hospitals, who started intravenous durvalumab (10 mg/kg every 2 weeks) between September 2017 and December 2018. The primary endpoint was progression-free survival (PFS). Secondary endpoints included patient characterization and adverse events of special interest (AESI). RESULTS: A total of 244 patients were followed up for a median of 21.9 months [range 1.2-34.7]. Median duration of durvalumab was 45.5 weeks (11.4 months) [0-145]. Median PFS was 16.7 months (95% CI 12.2-25). No remarkable differences in PFS were observed between patients with programmed cell death-ligand 1 (PD-L1) expression ≥ 1% or < 1% (16.7 versus 15.6 months, respectively). However, PFS was higher in patients who had received prior concurrent CRT (cCRT) versus sequential CRT (sCRT) (20.6 versus 9.4 months). AESIs leading to durvalumab discontinuation were registered in 11.1% of patients. CONCLUSIONS: These results are in line with prior published evidence and confirm the benefits of durvalumab in the treatment of LA-NSCLC patients in a real-world setting. We also observed a lower incidence of important treatment-associated toxicities, such as pneumonitis, compared with the pivotal phase III PACIFIC clinical study.

Validation of an instrument to measure knowledge, attitudes and skills towards Evidence-Based Practice in nursing students in Colombia.

BACKGOUND: Evidence-Based Practice (EBP) is crucial for the nursing profession, as it helps professionals make informed clinical decisions based on the best available evidence. Most EBP competency assessment tools focus on specific technical knowledge or skill components, and most have been tested on medical students. The Evidence-Based Practice Competence Questionnaire (EBP-COQ-E) is an instrument that assesses the competence in EBP in nursing students. The objective of the article was to evaluate the psychometric properties of the EBP-COQ-E instrument in final year nursing students in Colombia. DESIGN: A validation study was conducted using a cross-sectional design. METHODS: The population included nursing students from 19 programs in Colombia, who were selected during the years 2020 and 2021 based on their university enrollment in the last year of training in nursing programs with current qualified registration by the Ministry of Education and who had attended the least one subject related to research. The data were collected through a virtual platform and the researchers consolidated it into a general database. The EBP-COQ-E instrument consists of 25 items grouped into three factors: attitude towards EBP, skills for EBP and knowledge about EBP. The items were answered on a Likert-type scale from 1 to 5. An exploratory factor analysis was performed and an internal consistency analysis of the instrument. RESULTS: A total of 1021 final year students from 19 university nursing programs participated, with a mean age of 23 years and where 83% identified themselves as female. The results showed good internal consistency and construct validity for the instrument, with a Cronbach's alpha of 0.89. In the exploratory factor analysis, 3 factors were found that explained 51% of the variance of the data. Together these three factors had statistically significant positive correlations. CONCLUSION: The study contributes to the validation of the Evidence-Based Practice Competence Questionnaire (EBP-COQ-E) which is a valid and reliable tool to assess knowledge, attitudes and skills in EBP in nursing students in the Colombian context. Training in EBP is crucial to guarantee the quality of performance of future professionals in care practice and the EBP-COQ-E can be useful and applicable where it is necessary to evaluate this competence in training processes.

Comprehensive approach to the protection and controlled release of extremely oxygen sensitive probiotics using edible polysaccharide-based coatings.

The human intestinal system is a complex of various anaerobes including extremely oxygen-sensitive (EOS) bacteria, some of which have been credited with significant health benefits. Among these, Faecalibacterium prausnitzii, which is one of the most abundant anaerobic bacterial strains in the human intestinal tract, has been proved to be a promising probiotic for the treatment of inflammatory bowel diseases. However, because of its extremely sensitive nature, there are many difficulties when passing through the harsh environment of the gastrointestinal tract. Hence, in this study, a comprehensive physicochemical characterization was performed for the use of polysaccharides from several origins (hydroxypropyl methyl cellulose, methyl cellulose, hydroxypropyl cellulose, chitosan, low-methoxylated pectin, kappa-carrageenan, sodium alginate and pullulan) as encapsulating agents to protect and deliver this bacterium. First, the apparent viscosity and surface tension of the polymer solutions were tested. Then, the mechanical properties, water vapor and oxygen barrier properties of these biopolymers as self-standing films were investigated. Lastly, in vitro release profiles of small molecules and bacterial cells from these biopolymer matrices in contact with a simulated gastrointestinal tract were evaluated. The results showed that chitosan, low-methoxylated pectin, kappa-carrageenan, sodium alginate and pullulan films exhibited good oxygen barrier properties to protect EOS probiotics. Among all the biopolymers tested, sodium alginate exhibited the best oxygen barrier properties and release profile. The release kinetics can be modulated by several factors including biopolymer type, plasticizer concentration and active molecules or bacteria to be encapsulated. On that basis and integrating the other parameters analyzed, a multicriteria strategy for probiotic encapsulation was proposed.

Contribución de la obra social femenina de Nuestra Señora de los Desamparados al desarrollo de la enfermería en la Valencia de los años cuarenta / Obra social femenina de nuestra señora de los desamparados contribution to the development of nursing in the forties

Atender a las particularidades de las diversas disciplinas profesionales contribuye a enriquecer el corpus de conocimientos que las integran. Las aportaciones que se realizan desde el ámbito local ayudan a completar este conocimiento y ponen de manifiesto la singularidad de unos acontecimientos que, desencadenados por diversos condicionantes, explican el hecho histórico. El objetivo perseguido con la redacción de este artículo se centra en dar a conocer la influencia que, la iniciativa llevada a cabo por la Obra Social Femenina de Nuestra Señora de los Desamparados de Valencia (OSF) tuvo en la promoción personal y profesional de la mujer valenciana. Concretamente centramos nuestra atención en la tarea llevada a cabo desde la OSF en la promoción de la mujer enfermera. Siguiendo el modelo de investigación histórico basado en la obtención de los datos de forma organizada y sistemática, consultamos fuentes primarias que aportan datos relevantes y hasta hoy desconocidos al estudio y consultamos también bibliografía especializada que nos ayuda a situar, analizar y comprender las circunstancias en las que acontecen los hechos. Enfatizando en el rol social que jugaría la mujer durante las primeras décadas del franquismo y justificando la necesidad de profesionales sanitarios que velaran por poner en práctica las medidas eugenésicas propuestas por el Nuevo Régimen, procuraremos una visión general de la profesión enfermera en aquellos años. Para terminar, y en el contexto de una de las instituciones privadas, que al amparo de la orden de 21 de mayo de 1941 ofrecía la posibilidad de dar validez oficial a los estudios de enfermera, llegamos a descubrir la presencia de una agrupación local de enfermeras que impulsada desde las filas del asociacionismo confesional de principios de siglo XX, contribuyó a la formación de las enfermeras valencianas.(AU)

Attending to the particularities of the various professional disciplines helps to enrich the body of knowledge that integrates them. The contributions made from the local level help complete this knowledge and highlight the uniqueness of some events that, triggered by various conditions, explain the historical fact. The objective pursued with the writing of this article focuses on making known the influence that the initiative carried out by the Obra Social Femenina de Ntra. Sra. de los Desamparados de Valencia (OSF) had on the personal and professional promotion of women Valencian. Specifically, we focus our attention on the task carried out by the OSF in the promotion of women nurses. Following the historical research model based on obtaining the data in an organized and systematic way, we consult primary sources that provide relevant data and until now unknown to the study and also consult specialized bibliography that helps us locate, analyze and understand the circumstances in the that the events happen. Emphasizing the social role that women would play during the first decades of Franquismo and justifying the need for health professionals to ensure the implementation of the eugenic measures proposed by the new Regime, we will seek an overview of the nursing profession in those years. Finally, and in the context of one of the private institutions, which under the order of May 21, 1941 offered the possibility of giving official validity to nursing studies, we discovered the presence of a local group of nurses which, promoted from the ranks of the confessional association of the early twentieth century, contributed to the training of Valencian nurses.(AU)

COVID-19 en pacientes trasplantados renales, en lista de espera y en evaluación para trasplante. Experiencia en un hospital público en Argentina / COVID-19 in renal transplant patients, on the waiting list and under evaluation for transplantation. Experience in a public hospital in Argentina

RESUMEN Objetivos: Evaluar frecuencia de hisopado, casos positivos y tasa de letalidad por SARS-CoV-2 en pacientes trasplantados, en lista de espera o en evaluación en un Hospital Público de la Argentina. Material y métodos: Se realizó un análisis retrospectivo de los pacientes de la unidad (trasplantados, en lista de espera o en evaluación para trasplante) hasta el 30 de septiembre de 2020. Se buscó en forma individualizada cada paciente en el SINTRA, en bases de datos de pacientes de una unidad de trasplante y en el sistema SISA, para buscar: realización de hisopados, porcentaje de positividad de los mismos, mortalidad general y aquella vinculada a SARS-CoV-2. Se consideró edad, sexo, tiempo en diálisis, condición de diabético, hipertensión y enfermedad pulmonar obstructiva crónica. Se realizó análisis estadístico mediante Student, Mann Whitney y Chi cuadrado según correspondiere. Resultados: Durante 2020, estuvieron en seguimiento, en la Unidad de Trasplante Renal, un total de 1513 pacientes entre trasplantados renales en seguimiento (n=515), pacientes en lista de espera renal (n= 413) y pacientes en evaluación para trasplante (n=585). Se registraron un total de 103 casos positivos de COVID-19, sobre 477 hisopados realizados (positividad del 32,51%). La tasa de letalidad global fue del 21,88%, variando según el paciente estuviera en lista de espera (22,73%), en evaluación de trasplante (30%) o trasplantado (35,48%). Estas diferencias no alcanzaron significación estadística. Conclusiones: Se presenta un análisis descriptivo de los efectos de la pandemia sobre nuestra población. Es importante notar que nuestro centro atiende un porcentaje elevado de pacientes de bajos recursos y un área geográfica extensa, por lo cual los resultados pueden haber sido sesgados por estas características. En nuestra población trasplantada se observó un incremento de 10 veces la letalidad observada en la población general. La presencia de un mayor grado de inmunosupresión y factores de riesgo (diabetes, edad, hipertensión) podrían explicar lo observado.

ABSTRACT Objectives: Assess frequency of swabbing, positive and lethality rate cases of SARS-CoV-2 in transplant patients on the waiting list or evaluation in a Public Hospital of Argentina. Methods: A retrospective analysis was carried out of the patients in the unit (transplanted, on the waiting list or under evaluation for transplantation) until September 30, 2020. Each patient was searched individually in the SINTRA, in databases of patients of a transplant unit and in the SISA system, to find: swabbing, percentage of tests positivity, general mortality and that related to SARS-CoV-2. Age, sex, time on dialysis, diabetic condition, hypertension and chronic obstructive pulmonary disease were considered. Statistical analysis was performed using Student, Mann Whitney and Chi square as appropriate. Results: During 2020, a total of 1,513 patients were under follow-up in the Kidney Transplant Unit, including kidney transplants under follow-up (n=515), patients on the renal waiting list (n=413) and patients under evaluation for transplantation (n=585). A total of 103 positive cases of COVID-19 were registered, out of 477 swabs performed (positivity of 32.51%). The overall case fatality rate was of the 21.88%, varying according to the patient was on the waiting list (22.73%) in transplant evaluation (30%) or transplanted (35.48%). These differences did not reach statistical significance. Conclusions: A descriptive analysis of the effects of the pandemic on our population is presented. It is important to note that our center cares for a high percentage of low-income patients and a large geographic area, so the results may have been biased by these characteristics. In our transplanted population, a 10-fold increase in mortality observed in the general population was observed. The presence of a higher degree of immunosuppression and risk factors (diabetes, age, hypertension) could explain what was observed.

Physical Fitness, Exercise Self-Efficacy, and Quality of Life in Adulthood: A Systematic Review.

Background: The aim of the present work is the elaboration of a systematic review of existing research on physical fitness, self-efficacy for physical exercise, and quality of life in adulthood. Method: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement guidelines, and based on the findings in 493 articles, the final sample was composed of 37 articles, which were reviewed to show whether self-efficacy has previously been studied as a mediator in the relationship between physical fitness and quality of life in adulthood. Results: The results indicate that little research exists in relation to healthy, populations with the majority being people with pathology. Physical fitness should be considered as a fundamental aspect in determining the functional capacity of the person. Aerobic capacity was the most evaluated and the 6-min walk test was the most used. Only one article shows the joint relationship between the three variables. Conclusions: We discuss the need to investigate the mediation of self-efficacy in relation to the value of physical activity on quality of life and well-being in the healthy adult population in adult life.

Extravasation accidents with liposomal/liposomal pegylated anthracyclines treated with dexrazoxane: an overview and outcomes.

The extravasation of chemotherapeutic agents is a challenge for oncologic care teams. The management of nonliposomal (conventional) anthracyclines is well established in clinical practice guidelines, including general measures and specific antidotes, such as dexrazoxane. However, there is little scientific evidence on the management of liposomal and pegylated liposomal anthracyclines. The aim of this paper was to review the scientific literature on the extravasation of liposomal and pegylated liposomal anthracyclines and determine the clinical impact of this type of extravasation, focusing on dexrazoxane. The literature was searched using two databases: PubMed and Embase. Three searches were conducted, using liposomal anthracycline extravasation, pegylated liposomal anthracycline extravasation, and liposomal doxorubicin extravasation as keywords, respectively. Seven articles fulfilled the study eligibility criteria and included seventeen cases in humans. Extravasation occurred with three drugs: liposomal doxorubicin in nine (53%) patients, liposomal daunorubicin in four (23.5%) patients, and pegylated liposomal doxorubicin in four (23.5%) patients. General measures for extravasations were applied in all patients, but only three patients received dexrazoxane. All cases were completely resolved at 2-3 months, except for one patient, in whom dexrazoxane was not used. In animals, dexrazoxane decreased both the frequency of wounds produced by pegylated liposomal doxorubicin and their extent. The pharmacokinetic profiles of liposomal and pegylated liposomal anthracyclines differ from those of conventional anthracyclines, modifying their effectiveness and safety. General measures may be inadequate to heal areas affected by extravasation, which may require the administration of dexrazoxane. However, each case should be evaluated individually for the administration of dexrazoxane in off-label use until scientific evidence is available on its effectiveness and safety as an antidote for these formulations of anthracyclines.

Nasoalveolar Molding Therapy for the Treatment of Unilateral Cleft Lip and Palate Improves Nasal Symmetry and Maxillary Alveolar Dimensions.

OBJECTIVE: The aim of this study is to assess the esthetic and morphologic outcomes before surgery using nasoalveolar molding (NAM) therapy in children with unilateral cleft lip and palate. DESIGN: A prospective analysis was performed. SETTING: The study was carried out in the Congenital Malformations Craniofacial and Cleft Lip and Palate Unit, Hospital Virgen de las Nieves, Andalusian Health Service, Granada (Spain). PATIENTS: Twenty consecutively enrolled infants ranging in age from 7 to 30 days with nonsyndromic unilateral cleft lip and palate treated from 2008 to 2012. INTERVENTIONS: All patients were treated with NAM appliances to align the alveolar segments and reduce severity of the nasal deformity. MAIN OUTCOME MEASURE: The extraoral nasal measurements were performed on casts and nasal photographs. The measurements consisted of bialar width (BAW), columellar deviation (CD), cleft nostril height (CNH), cleft nostril width (CNW), non-CNH, non-CNW, and the deviation of the columella to the horizontal line represented by bilateral pupil line (BIA). The authors have made the measurements following Barilla method. Also 2 intraoral measurements were taken. RESULTS: Following NAM the extraoral records showed a statistically significant decrease in CD (P < 0.0001), CNW (P < 0.0001), and BAW (P < 0.001). Furthermore, statistically significant increases in CNH (P < 0.05) and BIA (P < 0.0001) were observed.Following Barilla measurements, the authors have found a high percentage of symmetry in all the nasal measurements after the NAM therapy.Intraoral results showed a statistically significant decrease in the gap between the greater and lesser alveolar segments and a statistically significant increase in maxillary arch width. CONCLUSIONS: Nasoalveolar molding improves nasal symmetry and achieves an improvement of all maxillary alveolar dimensions, increasing alveolar rim width, reducing the size of alveolar cleft gap, and improving shape of the maxillary dental arch. As a consequence of reducing the alveolar and nasal deformities before surgery, it is expected that the primary repair will be easier for the surgeon and more successful.

Recurrence of liver metastases from colorectal cancer and repeat liver resection.

OBJECTIVE: The purpose of this study was to assess the resectability and effectiveness of repeat hepatectomy for relapsing liver metastases of colorectal origin in terms of morbidity, mortality, overall survival, and disease-free survival. METHODS: A retrospective study was performed on a prospective cohort of patients with colorectal liver metastases who underwent repeat surgery at Hospital Universitario San Cecilio, Granada (Spain), from March 2003 to June 2013. Primary outcome variables included survival and morbidity within 30 days post-surgery. RESULTS: A total of 147 patients with colorectal liver metastases underwent surgical excision during the study period; 61 patients had liver recurrence, and 34 of these received repeat surgery. The overall survival rate at 5 and 10 years for resected patients (n=27/34) was 48% and 48%. Mean hospital stay was 8.9 ± 3.5 days, morbidity was 9%, and mortality was 0%. CONCLUSION: Repeat liver resection for colorectal liver metastases is a safe, effective surgical procedure whose results are similar to those obtained after initial liver resection.

Recurrencia de la cirugía de las metástasis hepáticas de cáncer colorrectal y repetición de la resección / Recurrence of liver metastases from colorectal cancer and repeat liver resection

OBJETIVO: el objetivo de este estudio es evaluar la resecabilidad efectividad de las rehepatectomías en metástasis hepáticas de origen colorrectal recidivadas en términos de morbimortalidad, supervivencia global y libre de enfermedad. MÉTODOS: se realizó un estudio retrospectivo de una cohorte prospectiva de pacientes con metástasis hepáticas de origen colorrectal con cirugía de repetición en el Hospital Universitario San Cecilio de Granada de marzo de 2003 hasta junio de 2013. Las variables principales de resultado fueron la supervivencia y la morbilidad antes de los 30 días del postoperatorio. RESULTADOS: un total de 147 pacientes con metástasis hepáticas de origen colorrectal se sometieron a la extirpación quirúrgica durante el periodo de estudio; 61 pacientes presentaron una recidiva hepática de los cuales 34 se sometieron a una cirugía de repetición. La tasa global de supervivencia a 5 y 10 años para los pacientes resecados fue del 48 y el 48%. La estancia media hospitalaria fue de 8,9 ± 3,5 días, la morbilidad del 9% y la mortalidad del 0%. CONCLUSIÓN: las resecciones hepáticas repetidas para las metástasis hepáticas de origen colorrectal constituyen una operación segura y eficaz, con resultados similares a los obtenidos tras una primera resección hepática

OBJECTIVE: The purpose of this study was to assess the resectability and effectiveness of repeat hepatectomy for relapsing liver metastases of colorectal origin in terms of morbidity, mortality, overall survival, and disease-free survival. METHODS: A retrospective study was performed on a prospective cohort of patients with colorectal liver metastases who underwent repeat surgery at Hospital Universitario San Cecilio, Granada (Spain), from March 2003 to June 2013. Primary outcome variables included survival and morbidity within 30 days post-surgery. RESULTS: A total of 147 patients with colorectal liver metastases underwent surgical excision during the study period; 61 patients had liver recurrence, and 34 of these received repeat surgery. The overall survival rate at 5 and 10 years for resected patients (n=27/34) was 48% and 48%. Mean hospital stay was 8.9 ± 3.5 days, morbidity was 9%, and mortality was 0%. CONCLUSION: Repeat liver resection for colorectal liver metastases is a safe, effective surgical procedure whose results are similar to those obtained after initial liver resection

An Activin Receptor IA/Activin-Like Kinase-2 (R206H) Mutation in Fibrodysplasia Ossificans Progressiva.

Fibrodysplasia ossificans progressiva (FOP) is an exceptionally rare genetic disease that is characterised by congenital malformations of the great toes and progressive heterotopic ossification (HO) in specific anatomical areas. This disease is caused by a mutation in activin receptor IA/activin-like kinase-2 (ACVR1/ALK2). A Mexican family with one member affected by FOP was studied. The patient is a 19-year-old female who first presented with symptoms of FOP at 8 years old; she developed spontaneous and painful swelling of the right scapular area accompanied by functional limitation of movement. Mutation analysis was performed in which genomic DNA as PCR amplified using primers flanking exons 4 and 6, and PCR products were digested with Cac8I and HphI restriction enzymes. The most informative results were obtained with the exon 4 flanking primers and the Cac8I restriction enzyme, which generated a 253 bp product that carries the ACVR1 617G>A mutation, which causes an amino acid substitution of histidine for arginine at position 206 of the glycine-serine (GS) domain, and its mutation results in the dysregulation of bone morphogenetic protein (BMP) signalling that causes FOP.

Anorexia y bulimia: caracterización y sistematización de la experiencia de intervención de una Clínica de Adolescentes / Anorexy and bulimia: characterization of the experience of intervention of a Clinic of Adolescents

Objetivo: Caracterizar la población de adolescentes con trastornos de la alimentación y presentar el modelo de intervenvión de la Clínica de Adolescentes del Hospital Nacional de Niños. Pacientes: 22 adolescentes seleccionados con el diagnóstico de anorexia o bulimia. Resultados: Se encontraron los siguientes aspectos relevantes: dinámica familiar disfuncional donde sobresale conflictos a nivel del subsistema parental, adolescentes con rendimiento escolar alto previo a la enfermedad, síntomas ansiosos y enfermedad, síntomas ansiosos y preocupación por la imagen corporal desde la infancia, como antecedentes premórbidos. Se da una asociación significativa de la enfermedad con trastornos afectivos, trastornos ansiosos y con conductas de riesgo de los adolescentes. Los trastornos más frecuentemente encontrados a través de exámenes de laboratorio son: anemia, enfermnedad eutiroidea, alteraciones del sodio y de las gonadotropinas hipofisiarias. El modelo de intervención plantado enfatiza sobre el abordaje interdisciplinario y de la necesidad de complementar la intervención con opciones adecuadas para el internamiento. Palabras claves: anorexia, bulimia, equipo interdisciplinario, conductas de riesgo, disfución familiar.