[Translated article] Four-year Epidemiological Surveillance of the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy: Current Situation and Trends.

BACKGROUND: The epidemiological surveillance of contact dermatitis is one of the objectives of the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy. Knowing whether the prevalence of positive tests to the different allergens changes over time is important for this monitoring process. OBJECTIVES: To describe the various temporary trends in allergen positivity in the GEIDAC standard series from 2018 through December 31, 2022. METHODS: This was a multicenter, observational trial of consecutive patients analyzed via patch tests as part of the study of possible allergic contact dermatitises collected prospectively within the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy. The data was analyzed using 2 statistical tests: one homogeneity test (to describe the changes seen over time) and one trend test (to see whether the changes described followed a linear trend). RESULTS: A total of 11327 patients were included in the study. Overall, the allergens associated with a highest sensitization were nickel sulfate, methylisothiazolinone, cobalt chloride, methylchloroisothiazolinone/methylisothiazolinone, and fragrance mix i. A statistically significant decrease was found in the percentage of methylisothiazolinone positive tests across the study years with an orderly trend. CONCLUSIONS: Although various changes were seen in the sensitizations trends to several allergens of the standard testing, it became obvious that a high sensitization to nickel, methylchloroisothiazolinone/methylisothiazolinone and fragrances mix i remained. Only a significant downward trend was seen for methylisothiazolinone.

Heterogeneity of sensitization profiles and clinical phenotypes among patients with seasonal allergic rhinitis in Southern European countries-The @IT.2020 multicenter study.

BACKGROUND: Pollen allergy poses a significant health and economic burden in Europe. Disease patterns are relatively homogeneous within Central and Northern European countries. However, no study broadly assessed the features of seasonal allergic rhinitis (SAR) across different Southern European countries with a standardized approach. OBJECTIVE: To describe sensitization profiles and clinical phenotypes of pollen allergic patients in nine Southern European cities with a uniform methodological approach. METHODS: Within the @IT.2020 multicenter observational study, pediatric and adult patients suffering from SAR were recruited in nine urban study centers located in seven countries. Clinical questionnaires, skin prick tests (SPT) and specific IgE (sIgE) tests with a customized multiplex assay (Euroimmun Labordiagnostika, Lübeck, Germany) were performed. RESULTS: Three hundred forty-eight children (mean age 13.1 years, SD: 2.4 years) and 467 adults (mean age 35.7 years SD: 10.0 years) with a predominantly moderate to severe, persistent phenotype of SAR were recruited. Grass pollen major allergenic molecules (Phl p 1 and/or Phl p 5) ranged among the top three sensitizers in all study centers. Sensitization profiles were very heterogeneous, considering that patients in Rome were highly poly-sensitized (sIgE to 3.8 major allergenic molecules per patient), while mono-sensitization was prominent and heterogeneous in other cities, such as Marseille (sIgE to Cup a 1: n = 55/80, 68.8%) and Messina (sIgE to Par j 2: n = 47/82, 57.3%). Co-sensitization to perennial allergens, as well as allergic comorbidities also broadly varied between study centers. CONCLUSIONS: In Southern European countries, pollen allergy is heterogeneous in terms of sensitization profiles and clinical manifestations. Despite the complexity, a unique molecular, multiplex, and customized in-vitro IgE test detected relevant sensitization in all study centers. Nevertheless, this geographical diversity in pollen allergic patients imposes localized clinical guidelines and study protocols for clinical trials of SAR in this climatically complex region.

[Translated article] Descriptive study of spinal instrumentation-related infections in a tertiary hospital.

INTRODUCTION: Spinal instrumentation-related infections (SIRI) are one of the main causes of post-surgical complication and comorbidity. Our objective was to describe the clinical and microbiological characteristics, treatment and prognosis of these infections. MATERIAL AND METHODS: We conducted a retrospective study in our institution (2011-2018) including adult patients undergoing spinal instrumentation who met the diagnostic criteria for confirmed infection. Superficial surgical wound and deep intraoperative samples were processed for microbiological culture. The medical and orthopaedic team was always the same. RESULTS: Forty-one cases were diagnosed of which 39 patients (95.1%) presented early infection (<3 months after initial surgery) with symptoms in the first two weeks, mean CRP at diagnosis was 133mg/dl and 23% associated bacteremia. The remaining two patients (4.8%) were chronic infections (symptoms >3 months after surgery). The treatment of choice in early infections was the Debridement, Antibiotics and Implant Retention (DAIR) strategy without removal of the bone graft, which successfully resolved 84.2% of the infections. The main aetiology was gram-positive (Staphylococcus aureus: 31.7%), followed by gram-negative and polymicrobial flora. Antibiotics were optimised according to cultures with a mean duration of 12 weeks. CONCLUSIONS: In early infections, early diagnosis and DAIR strategy (with bone graft retention) demonstrated a healing rate higher than 80%.

Four-year Epidemiological Surveillance of the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy: Current Situation and Trends. / Vigilancia epidemiológica en los últimos 4 años del Registro Español de Investigación en Dermatitis de Contacto y Alergia Cutánea: situación actual y tendencias.

BACKGROUND: The epidemiological surveillance of contact dermatitis is one of the objectives of the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy. Knowing whether the prevalence of positive tests to the different allergens changes over time is important for this monitoring process. OBJECTIVES: To describe the various temporary trends in allergen positivity in the GEIDAC standard series from 2018 through December 31, 2022. METHODS: This was a multicenter, observational trial of consecutive patients analyzed via patch tests as part of the study of possible allergic contact dermatitises collected prospectively within the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy. The data was analyzed using 2 statistical tests: one homogeneity test (to describe the changes seen over time) and one trend test (to see whether the changes described followed a linear trend). RESULTS: A total of 11327 patients were included in the study. Overall, the allergens associated with a highest sensitization were nickel sulfate, methylisothiazolinone, cobalt chloride, methylchloroisothiazolinone/methylisothiazolinone, and fragrance mix i. A statistically significant decrease was found in the percentage of methylisothiazolinone positive tests across the study years with an orderly trend. CONCLUSIONS: Although various changes were seen in the sensitizations trends to several allergens of the standard testing, it became obvious that a high sensitization to nickel, methylchloroisothiazolinone/methylisothiazolinone and fragrances mix i remained. Only a significant downward trend was seen for methylisothiazolinone.

Descriptive study of spinal instrumentation-related infections in a tertiary hospital. / Estudio descriptivo de las infecciones asociadas con instrumentación de columna en un hospital terciario.

INTRODUCTION: Spinal instrumentation-related infections (SIRI) are one of the main causes of post-surgical complication and comorbidity. Our objective was to describe the clinical and microbiological characteristics, treatment and prognosis of these infections. MATERIAL AND METHODS: We conducted a retrospective study in our institution (2011-2018) including adult patients undergoing spinal instrumentation who met the diagnostic criteria for confirmed infection. Superficial surgical wound and deep intraoperative samples were processed for microbiological culture. The medical and orthopaedic team was always the same. RESULTS: Forty-one cases were diagnosed of which 39 patients (95.1%) presented early infection (<3 months after initial surgery) with symptoms in the first two weeks, mean CRP at diagnosis was 133mg/dl and 23% associated bacteremia. The remaining two patients (4.8%) were chronic infections (symptoms >3 months after surgery). The treatment of choice in early infections was the Debridement, Antibiotics and Implant Retention (DAIR) strategy without removal of the bone graft, which successfully resolved 84.2% of the infections. The main etiology was gram-positive (Staphylococcus aureus: 31.7%), followed by gram-negative and polymicrobial flora. Antibiotics were optimized according to cultures with a mean duration of 12 weeks. CONCLUSIONS: In early infections, early diagnosis and DAIR strategy (with bone graft retention) demonstrated a healing rate higher than 80%.

Transition of Adolescents With Severe Asthma From Pediatric to Adult Care in Spain: The STAR Consensus.

OBJECTIVES: To assess the degree of consensus among a multidisciplinary expert panel on the transition of adolescents with severe asthma from pediatric to adult care. METHODS: A 61-item survey was developed based on guidelines for other chronic diseases, covering transition planning, preparation, effective transfer, and follow-up. A 2-round Delphi process assessed the degree of consensus among 98 experts (49 pediatricians, 24 allergists, and 25 pulmonologists). Consensus was established with ≥70% agreement. RESULTS: Consensus was reached for 42 items (70%). Panelists were unable to agree on an age range for initiation of transition. The main goal during the transition identified by the experts is for adolescents to gain autonomy in managing severe asthma and prescribed treatments. The panelists agreed on the importance of developing an individualized plan, promoting patient autonomy, and identifying factors associated with the home environment. They agreed that the adult health care team should have expertise in severe asthma, biologics, and management of adolescent patients. Pediatric and adult health care teams should share clinical information, agree on the criteria for maintaining biological therapy, and have an on-site joint visit with the patient before the effective transfer. Adult health care professionals should closely follow the patient after the effective transfer to ensure correct inhaler technique, adherence, and attendance at health care appointments. CONCLUSION: This consensus document provides the first roadmap for Spanish pediatric and adult teams to ensure that key aspects of the transition process in severe asthma are covered. The implementation of these recommendations will improve the quality of care offered to the patient.

Transition of Adolescents With Severe Asthma From Pediatric to Adult Care in Spain: The STAR Consensus

Objective: To assess the degree of consensus among a multidisciplinary expert panel on the transition of adolescents with severe asthma from pediatric to adult care. Methods: A 61-item survey was developed based on guidelines for other chronic diseases, covering transition planning, preparation, effective transfer, and follow-up. A 2-round Delphi process assessed the degree of consensus among 98 experts (49 pediatricians, 24 allergists, and 25 pulmonologists). Consensus was established with ≥70% agreement. Results: Consensus was reached for 42 items (70%). Panelists were unable to agree on an age range for initiation of transition. The main goal during the transition identified by the experts is for adolescents to gain autonomy in managing severe asthma and prescribed treatments. The panelists agreed on the importance of developing an individualized plan, promoting patient autonomy, and identifying factors associated with the home environment. They agreed that the adult health care team should have expertise in severe asthma, biologics, and management of adolescent patients. Pediatric and adult health care teams should share clinical information, agree on the criteria for maintaining biological therapy, and have an on-site joint visit with the patient before the effective transfer. Adult health care professionals should closely follow the patient after the effective transfer to ensure correct inhaler technique, adherence, and attendance at health care appointments. Conclusions: This consensus document provides the first roadmap for Spanish pediatric and adult teams to ensure that key aspects of the transition process in severe asthma are covered. The implementation of these recommendations will improve the quality of care offered to the patient (AU)

Objetivo: Evaluar el grado de consenso con un panel multidisciplinar de expertos sobre la transición del adolescente con asma grave de los servicios de pediatría a atención de adultos. Métodos: Se elaboró un cuestionario de 61 ítems basado en recomendaciones de transición para otras patologías crónicas, abarcando la planificación de la transición, preparación, transferencia efectiva y seguimiento. Se evaluó el nivel de consenso entre 98 expertos (49 pediatras, 24 alergólogos y 25 neumólogos) mediante un proceso Delphi de dos rondas. El consenso se estableció con un acuerdo ≥70%. Resultados: Cuarenta y dos ítems (70%) alcanzaron consenso. Los panelistas no alcanzaron consenso en el rango de edad para iniciar la transición. El principal objetivo a conseguir durante la transición según los expertos fue que el adolescente gane autonomía en el manejodel asma grave y tratamientos prescritos. Asimismo, alcanzaron acuerdo en la importancia de desarrollar un plan individualizado, promover la autonomía del paciente e identificar los factores clave en el entorno familiar. Los especialistas de adultos deben tener experiencia en asma grave y tratamientos biológicos, así como en el manejo de pacientes adolescentes. Los equipos sanitarios de pediatría y de adultos deben compartir la información clínica, consensuar los criterios para mantener la terapia biológica y realizar una visita conjunta con el paciente antes de la transferencia. Los especialistas de adultos deben realizar un seguimiento estrecho del paciente tras la transferencia para asegurar una correcta técnica inhalatoria, el cumplimiento del tratamiento y la asistencia a las citas sanitarias. Conclusiones: Este documento de consenso proporciona la primera hoja de ruta en España para que los equipos especialistas de pediatría y adultos garanticen aspectos clave del proceso de transición en pacientes adolescentes con asma grave. La aplicación de estas (AU)

Validez de contenido de un ECOE en el pregrado de fisioterapia para el razonamiento clínico / Validity of content of a ECOE in the physiotherapy undergraduate for clinical reasoning

Introducción: El Examen Clínico Objetivo Estructurado (ECOE) es una metodología de evaluación que permite medir de manera válida las competencias clínicas en estudiantes de fisioterapia a través de estaciones previamente estandarizadas. Objetivo: Determinar la validez de contenido del instrumento ECOE-LM 2017 para la medición de competencias clínicas en el examen, evaluación, diagnóstico, pronóstico e intervención de una persona con lumbalgia mecánica en fisioterapia. Métodos: Se diseñó un instrumento de seis estaciones evaluado con la técnica de juicio de expertos, para posteriormente calcular la confiabilidad interobservador a través de Fleiss’ Kappa, por medio del ReCal; adicionalmente se identificó el índice de aceptabilidad. Resultados: Se obtiene un índice kappa de 0,82 (casi perfecto) que da cuenta de una buena confiabilidad para el instrumento. Conclusiones: Se cuenta con un instrumento con una buena concordancia para su empleo en los procesos educativos. (AU)

Introduction: The Objective Structured Clinical Examination (ECOE) is an evaluation methodology that allows to validly measure clinical competencies in Physiotherapy students through previously standardized stations. Objective: To determine the content validity of the ECOE-LM 2017 instrument for the measurement of clinical competencies in the examination, evaluation, diagnosis, prognosis and intervention of a person with mechanical low back pain in Physiotherapy. Methods: An instrument of six stations evaluated with the expert judgment technique was designed to subsequently calculate the inter-observer reliability, through Fleiss’ Kappa, by means of the ReCal, additionally the acceptability index was identified. Results: A Kappa index of 0.82 (almost perfect) is obtained, which shows good reliability for the instrument. Conclusions: There is an instrument with good agreement for its use in educational processes. (AU)

GABAB Receptor Chemistry and Pharmacology: Agonists, Antagonists, and Allosteric Modulators.

The GABAB receptors are metabotropic G protein-coupled receptors (GPCRs) that mediate the actions of the primary inhibitory neurotransmitter, γ-aminobutyric acid (GABA). In the CNS, GABA plays an important role in behavior, learning and memory, cognition, and stress. GABA is also located throughout the gastrointestinal (GI) tract and is involved in the autonomic control of the intestine and esophageal reflex. Consequently, dysregulated GABAB receptor signaling is associated with neurological, mental health, and gastrointestinal disorders; hence, these receptors have been identified as key therapeutic targets and are the focus of multiple drug discovery efforts for indications such as muscle spasticity disorders, schizophrenia, pain, addiction, and gastroesophageal reflex disease (GERD). Numerous agonists, antagonists, and allosteric modulators of the GABAB receptor have been described; however, Lioresal® (Baclofen; ß-(4-chlorophenyl)-γ-aminobutyric acid) is the only FDA-approved drug that selectively targets GABAB receptors in clinical use; undesirable side effects, such as sedation, muscle weakness, fatigue, cognitive deficits, seizures, tolerance and potential for abuse, limit their therapeutic use. Here, we review GABAB receptor chemistry and pharmacology, presenting orthosteric agonists, antagonists, and positive and negative allosteric modulators, and highlight the therapeutic potential of targeting GABAB receptor modulation for the treatment of various CNS and peripheral disorders.

Incidence of Fatal Anaphylaxis: A Systematic Review of Observational Studies.

BACKGROUND: Fatal anaphylaxis is very rare, with an incidence ranging from 0.5 to 1 deaths per million person-years. OBJECTIVE: Based on a systematic review, we aimed to explain differences in the reported incidence of fatal anaphylaxis based on the methodological and demographic factors addressed in the various studies. METHODS: We searched PubMed/MEDLINE, EMBASE, and the Web of Science for relevant retrospective and prospective cohort studies and registry studies that had assessed the anaphylaxis mortality rate for the population of a country or for an administrative region. The research strategy was based on combining the term "anaphylaxis" with "death", "study design", and "main outcomes" (incidence). RESULTS: A total of 46 studies met the study criteria and included 16,541 deaths. The range of the anaphylaxis mortality rate for all causes of anaphylaxis was 0.002-2.51 deaths per million person-years. Fatal anaphylaxis due to food (range 0.002-0.29) was rarer than deaths due to drugs (range 0.004-0.56) or Hymenoptera venom (range 0.02-0.61). The frequency of deaths due to anaphylaxis by drugs increased during the study period (IRR per year, 1.02; 95%CI, 1.00-1.04). We detected considerable heterogeneity in almost all of the meta-analyses carried out. CONCLUSION: The incidence of fatal anaphylaxis is very low and differs according to the various subgroups analyzed. The studies were very heterogeneous. Fatal anaphylaxis due to food seems to be less common than fatal anaphylaxis due to drugs or Hymenoptera venom.

Incidence of Fatal Anaphylaxis A Systematic Review of Observational Studies

Background: Fatal anaphylaxis is very rare, with an incidence ranging from 0.5 to 1 deaths per million person-years. Objective: Based on a systematic review, we aimed to explain differences in the reported incidence of fatal anaphylaxis based on the methodological and demographic factors addressed in the various studies. Methods: We searched PubMed/MEDLINE, EMBASE, and the Web of Science for relevant retrospective and prospective cohort studies and registry studies that had assessed the anaphylaxis mortality rate for the population of a country or for an administrative region. The research strategy was based on combining the term “anaphylaxis” with “death”, “study design”, and “main outcomes” (incidence). Results: A total of 46 studies met the study criteria and included 16,541 deaths. The range of the anaphylaxis mortality rate for all causes of anaphylaxis was 0.002-2.51 deaths per million person-years. Fatal anaphylaxis due to food (range 0.002-0.29) was rarer than deaths due to drugs (range 0.004-0.56) or Hymenoptera venom (range 0.02-0.61). The frequency of deaths due to anaphylaxis by drugs increased during the study period (IRR per year, 1.02; 95%CI, 1.00-1.04). We detected considerable heterogeneity in almost all of the meta-analyses carried out. Conclusion: The incidence of fatal anaphylaxis is very low and differs according to the various subgroups analyzed. The studies were very heterogeneous. Fatal anaphylaxis due to food seems to be less common than fatal anaphylaxis due to drugs or Hymenoptera venom (AU)

Antecedentes: La muerte por anafilaxia es un evento muy excepcional, con una incidencia que varía de 0,5 a 1 muerte por millón de personas/año. Objetivo: Usando las técnicas de una revisión sistemática, nuestro objetivo ha sido explicar las diferencias en la incidencia informada de la muerte por anafilaxia atendiendo a diversos factores metodológicos y demográficos empleados en los diversos estudios de la revisión. Métodos: Se realizaron búsquedas en PubMed/MEDLINE, EMBASE y Web of Science, con el fin de obtener estudios de cohortes y registros prospectivos y retrospectivos relevantes que hubieran evaluado la tasa de muerte por anafilaxia en la población de un país o una región administrativa. La estrategia de investigación se basó en combinar “anafilaxia” con “muerte”, “diseño del estudio” y “resultados principales” (incidencia). Resultados: Un total de 46 estudios cumplieron con los criterios del estudio. Los estudios incluyeron 16.541 muertes. El rango de la tasa de mortalidad por anafilaxia para todas las causas de anafilaxia fue de 0,002 a 2,51 muertes por millón de personas/año. La anafilaxia mortal debida a los alimentos (rango 0,002-0,29) fue más rara que las muertes debidas a medicamentos (rango 0,004-0,56) o veneno de himenópteros (rango 0,02-0,61). La frecuencia de muertes por anafilaxia por fármacos aumentó durante el período de estudio (IRR por año, 1,02; IC del 95%: 1,00-1,04). Se detectó una heterogeneidad considerable en casi todos los metaanálisis realizados. Conclusión: La incidencia de anafilaxia mortal es muy baja y difiere según los distintos subgrupos analizados. Los estudios fueron muy heterogéneos. La muerte por anafilaxia debida a alimentos parece ser menos común que la anafilaxia mortal debida a fármacos o por veneno de himenópteros (AU)

Efectividad de la fisioterapia respiratoria combinada con higienepostural en niños con afectación neurológica crónica / Effectiveness of respiratory physiotherapy combined with postural education in children with chronic neurological diseases

Fundamento:Los niños con afectación neurológica crónica presentan discapacidad motora y aumento de morbilidad y mortalidad por causa respiratoria. El objetivo fue evaluar si se benefician de fisioterapia respiratoria e higiene postural a corto y medio plazo.Pacientes y métodos:Estudio cuasi-experimental con realización de seis sesiones quincenales de fisioterapia y talleres de higiene postural a niños de 0 a 6 años con afectación neurológica crónica y respiratoria. Se evaluaron variables clínicas respiratorias, secreciones expectoradas, reagudizaciones respiratorias y calidad de vida mediante cuestionario PedsQL. Las evaluaciones fueron realizadas al inicio, al final de la intervención y a los tres meses de la misma.Resultados:Tras la intervención, en los 30 niños se observó una mejora significativa (p<0,001) respecto al inicio en la media de saturación de oxígeno (98,3 vs 94,37%), frecuencia cardiaca (103,6 vs 126,03 latidos/minuto), frecuencia respiratoria (34,27 vs 42,13 respiraciones/minuto) y volumen de secreciones (28,17 vs 45,33 mL). Esta mejoría se mantuvo a los tres meses de finalizada la intervención. La media de reagudizaciones respiratorias disminuyó (p<0,001) respecto a los seis meses previos: hospitalizaciones (0,5 vs 1,6), visitas a urgencias (1,53 vs 2,59) y a pediatría de atención primaria (5,03 vs 7). La puntuación media del cuestionario PedsQL incrementó significativamente (p<0,001) tras la intervención, tanto para salud física (un 27%, hasta 73,43) como mental (un 12% hasta 70,09).Conclusiones:La fisioterapia respiratoria combinada con higiene postural mejora el estado clínico y la calidad de vida en niños con afectación neurológica crónica, por lo que podría recomendarse en la práctica clínica habitual.(AU)

Background: Children with chronic neurological diseases present motor disability and increased respiratory morbidity and mortality. The aim of this study was to assess whether children with chronic neurological impairment benefit from respiratory physiotherapy and postural hygiene. Methods: Quasi-experimental study in which six fortnightly respiratory physiotherapy sessions and workshops on postural hygiene were carried out on children aged 0 to 6 years with chronic neurological disease and respiratory impairment. A PedsQL questionnaire assessed respiratory clinical variables, expectorated secretions, respiratory exacerbations and quality of life. Assessments were performed at baseline, post-intervention, and at a 3-month follow-up. Results: After physiotherapy sessions, all participants (n=30) experienced a significant (p<0.001) improvement in average oxygen saturation (94.37 to 98.3%), heart rate (126.03 to 103.6 beats/minute) and respiratory rate (42.13 to 34.27 breaths/minute), as well as a decrease in secretions (from 45.33 to 28.17 mL). This improvement was maintained after a 3-month follow-up. The average respiratory exacerbations decreased (p<0.001) compared to the previous six months: hospitalizations (from 1.6 to 0.5), visits to the emergency department (from 2.59 to 1.53) and to primary care Pediatric consultations (from 7 to 5.03). The mean score on the PedsQL questionnaire demonstrated a significant increase(p<0.001) in the quality of life after the intervention for physical (27%, to 73.4) and mental health (12%, to 70.09%). Conclusion: Respiratory physiotherapy combined withpostural hygiene is effective for the clinical status andquality of life in children with chronic neurological diseases, and therefore could be introduced in habitual clinicalpractice.(AU)

Spanish translation and validation of the Scale for Contraversive Pushing to measure pusher behaviour.

INTRODUCTION: The aim of this study was to develop and validate a Spanish-language version of the Scale for Contraversive Pushing, used to diagnose and measure pusher behaviour in stroke patients. METHODS: Translation-back translation was used to create the Spanish-language Scale for Contraversive Pushing; we subsequently evaluated its validity and reliability by administering it to a sample of patients. We also analysed its sensitivity to change in patients identified as pushers who received neurological physiotherapy. RESULTS: Experts indicated that the content of the scale was valid. Internal consistency was very good (Cronbach's alpha of 0.94). The intraclass correlation coefficient showed high intra- and interobserver reliability (0.999 and 0.994, respectively). The Kappa and weighted Kappa coefficients were used to measure the reliability of each item; the majority obtained values above 0.9. Lastly, the differences between baseline and final evaluations of pushers were significant (paired sample t test), showing that the scale is sensitive to changes obtained through physical therapy. CONCLUSIONS: The Spanish-language version of the Scale for Contraversive Pushing is valid and reliable for measuring pusher behaviour in stroke patients. In addition, it is able to evaluate the ongoing changes in patients who have received physical therapy.

[Effectiveness of respiratory physiotherapy combined with postural education in children with chronic neurological diseases].

BACKGROUND: Children with chronic neurological diseases present motor disability and increased respiratory morbidity and mortality. The aim of this study was to assess whether children with chronic neurological impairment benefit from respiratory physiotherapy and postural hygiene. METHODS: Quasi-experimental study in which six fortnightly respiratory physiotherapy sessions and workshops on postural hygiene were carried out on children aged 0 to 6 years with chronic neurological disease and respiratory impairment. A PedsQL questionnaire assessed respiratory clinical variables, expectorated secretions, respiratory exacerbations and quality of life. Assessments were performed at baseline, post-intervention, and at a 3-month follow-up. RESULTS: After physiotherapy sessions, all participants (n=30) experienced a significant (p<0.001) improvement in average oxygen saturation (94.37 to 98.3%), heart rate (126.03 to 103.6 beats/minute) and respiratory rate (42.13 to 34.27 breaths/minute), as well as a decrease in secretions (from 45.33 to 28.17 mL). This improvement was maintained after a 3-month follow-up. The average respiratory exacerbations decreased (p<0.001) compared to the previous six months: hospitalizations (from 1.6 to 0.5), visits to the emergency department (from 2.59 to 1.53) and to primary care Pediatric consultations (from 7 to 5.03). The mean score on the PedsQL questionnaire demonstrated a significant increase (p<0.001) in the quality of life after the intervention for physical (27%, to 73.4) and mental health (12%, to 70.09%). CONCLUSION: Respiratory physiotherapy combined with postural hygiene is effective for the clinical status and quality of life in children with chronic neurological diseases, and therefore could be introduced in habitual clinical practice.

Traducción y validación española de la Scale for Contraversive Pushing (SCP) para la valoración del comportamiento empujador / Spanish translation and validation of the Scale for Contraversive Pushing to measure pusher behaviour

Introducción: El objetivo de este estudio es traducir y validar al español la Scale for Contraversive Pushing, usada para diagnosticar y medir el comportamiento empujador en pacientes que han sufrido un ictus.MétodosSe realizó una traducción-retrotraducción de la Scale for Contraversive Pushing para la población española y, posteriormente, se evaluó la validez y fiabilidad de la misma a partir de una muestra de pacientes. Además, se analizó la sensibilidad al cambio en pacientes que resultaron ser empujadores y recibieron tratamiento de fisioterapia neurológica.ResultadosLas respuestas de los expertos indicaron que la escala era válida en cuanto a su contenido. La consistencia interna, medida a través del alfa de Cronbach, obtuvo un resultado de 0,94. La fiabilidad intraobservador e interobservador, calculada por medio del coeficiente de correlación intraclase, presentó un valor de 0,999 y 0,994 respectivamente. Cuando se analizó la fiabilidad de cada ítem, por medio del coeficiente de kappa o kappa ponderado, la mayoría de ellos obtuvo una puntuación superior a 0,9. Por último, las diferencias obtenidas entre la valoración inicial y final de los pacientes empujadores fueron significativas (t de Student pareada), objetivando que la escala era sensible a los cambios obtenidos tras un tratamiento de fisioterapia.ConclusionesLa Scale for Contraversive Pushing es válida y fiable para medir el comportamiento empujador en pacientes que han sufrido un ictus. Además, es capaz de evaluar los cambios ocurridos en los pacientes, tras recibir tratamiento de fisioterapia. (AU)

Introduction: The aim of this study was to develop and validate a Spanish-language version of the Scale for Contraversive Pushing, used to diagnose and measure pusher behaviour in stroke patients.MethodsTranslation–back translation was used to create the Spanish-language Scale for Contraversive Pushing; we subsequently evaluated its validity and reliability by administering it to a sample of patients. We also analysed its sensitivity to change in patients identified as pushers who received neurological physiotherapy.ResultsExperts indicated that the content of the scale was valid. Internal consistency was very good (Cronbach's alpha of 0.94). The intraclass correlation coefficient showed high intra- and interobserver reliability (0.999 and 0.994, respectively). The Kappa and weighted Kappa coefficients were used to measure the reliability of each item; the majority obtained values above 0.9. Lastly, the differences between baseline and final evaluations of pushers were significant (paired sample t test), showing that the scale is sensitive to changes obtained through physical therapy.ConclusionsThe Spanish-language version of the Scale for Contraversive Pushing is valid and reliable for measuring pusher behaviour in stroke patients. In addition, it is able to evaluate the ongoing changes in patients who have received physical therapy. (AU)

Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆.

BACKGROUND: We report results from the phase I dose-finding and phase II expansion part of a multicenter, open-label study of single-agent lenvatinib in pediatric and young adult patients with relapsed/refractory solid tumors, including osteosarcoma and radioiodine-refractory differentiated thyroid cancer (RR-DTC) (NCT02432274). PATIENTS AND METHODS: The primary endpoint of phase I was to determine the recommended phase II dose (RP2D) of lenvatinib in children with relapsed/refractory solid malignant tumors. Phase II primary endpoints were progression-free survival rate at 4 months (PFS-4) for patients with relapsed/refractory osteosarcoma; and objective response rate/best overall response for patients with RR-DTC at the RP2D. RESULTS: In phase I, 23 patients (median age, 12 years) were enrolled. With lenvatinib 14 mg/m2, three dose-limiting toxicities (hypertension, n = 2; increased alanine aminotransferase, n = 1) were reported, establishing 14 mg/m2 as the RP2D. In phase II, 31 patients with osteosarcoma (median age, 15 years) and 1 patient with RR-DTC (age 17 years) were enrolled. For the osteosarcoma cohort, PFS-4 (binomial estimate) was 29.0% [95% confidence interval (CI) 14.2% to 48.0%; full analysis set: n = 31], PFS-4 by Kaplan-Meier estimate was 37.8% (95% CI 20.0% to 55.4%; full analysis set) and median PFS was 3.0 months (95% CI 1.8-5.4 months). The objective response rate was 6.7% (95% CI 0.8% to 22.1%). The patient with RR-DTC had a best overall response of partial response. Some 60.8% of patients in phase I and 22.6% of patients in phase II (with osteosarcoma) had treatment-related treatment-emergent adverse events of grade ≥3. CONCLUSIONS: The lenvatinib RP2D was 14 mg/m2. Single-agent lenvatinib showed activity in osteosarcoma; however, the null hypothesis could not be rejected. The safety profile was consistent with previous tyrosine kinase inhibitor studies. Lenvatinib is currently being investigated in osteosarcoma in combination with chemotherapy as part of a randomized, controlled trial (NCT04154189), in pediatric solid tumors in combination with everolimus (NCT03245151), and as a single agent in a basket study with enrollment ongoing (NCT04447755).