Outcomes and patterns of use of Radium-223 in metastatic castration-resistant prostate cancer.

Introduction: Radium-223 dichloride (Ra-223) is recommended as a treatment option for metastatic castration-resistant prostate cancer (mCRPC) patients with symptomatic bone metastases and no visceral disease, after docetaxel failure, or in patients who are not candidates to receive it. In this study, we aimed to ambispectively analyze overall survival (OS) and prognostic features in mCRPC in patients receiving Ra-223 as per clinical routine practice and identify the most suitable treatment sequence. Patients and methods: This study is observational, multicentric, and ambispective. Eligibility criteria included mCRPC patients treated with Ra-223, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, without visceral metastases, and no more than three cm involved lymph nodes. Results: A total of 145 patients were included; the median age was 73.97 years, and a Gleason score of more than or equal to 7 in 61 (48%) patients; 73 (81%) had previously received docetaxel. The most important benefit was reached by those patients who received Ra-223 in the second-line setting, with a median OS of 17 months (95% CI, 12-21), and by patients who received six cycles of treatment, with a median OS of 19 months (95% CI, 14-21). An alkaline phosphatase (ALP) decrease was also identified as a prognosis marker. When performing the multivariate analysis, the time to develop castration-resistant disease longer than 24 months was the most important prognostic factor to predict the evolution of the patients receiving Ra-223. Ra-223 was well tolerated, with thrombocytopenia, anemia, and diarrhea being the main adverse events. Conclusion: There is a benefit for those patients who received Ra-223 in the second-line setting, regardless of prior use of docetaxel. In addition, a survival benefit for patients presenting with a decline in ALP was observed.

Limitación de tratamientos de soporte vital en Unidades de Cuidados Intensivos españolas: análisis del estudio ETHICUS II / Limitation of life support treatments in Spanish Intensive Care Units: Analysis of the ETHICUS II study

Objetiv Describir los resultados obtenidos en UCI españolas en el estudio ETHICUS II. Diseño Subestudio planificado de pacientes del ETHICUS II. Ámbito 12 UCI españolas. Pacientes o participantes Pacientes que fallecieron o en los que se decidió una limitación de tratamiento de soporte vital (LTSV) durante un periodo de reclutamiento de 6 meses. Intervenciones Se realizó seguimiento hasta el alta de la UCI y 2 meses tras la decisión de LTSV o fallecimiento. Variables de interés principales Características demográficas, clínicas, tipo de decisión de LTSV. Se clasificaron en 4 categorías: omisión o retirada de tratamientos de soporte, acortar el proceso de morir, resucitación cardiopulmonar ineficaz y muerte cerebral. Resultados Un total de 12 UCI participaron en el ETHICUS II. Incluyeron 795 pacientes; 129 fallecieron tras realizarse RCP, 129 desarrollaron muerte encefálica. Se decidió LTSV en 537, fallecieron en UCI 485, el 90,3%. La edad media fue 66,19 años±14,36, el 63,8% fueron hombres. En un 41% se decidió retirada de tratamientos de soporte total y en un 59% se procedió a no iniciar medidas. Diecinueve pacientes (2,38%) disponían de documento de voluntades vitales anticipadas. Conclusiones El perfil clínico predominante cuando se estableció una LTSV fue el de pacientes varones mayores de 65 años con comorbilidad mayoritariamente cardiovascular. La supervivencia fue mayor en las decisiones de LTSV que comprendían la omisión de tratamientos respecto a aquellas en las que se decidió la retirada. España ha ocupado un papel destacado en este estudio multicéntrico de ámbito mundial. (AU)

Objective The aim of this study is to describe the results of Spanish ICUs in ETHICUS II study. Design Planned substudy of patients from ETHICUS II study. Setting 12 Spanish ICU. Patients or participants Patients admitted to Spanish ICU who died or in whom a limitation of life-sustaining treatment (LLST) was decided during a recruitment period of 6 months. Interventions Follow-up of patients was performed until discharge from the ICU and 2 months after the decision of LLST or death. Main variables of interest Demographic characteristics, clinical profile, type of decision of LLST, time and form in which it was adopted. Patients were classified into 4 categories according to the ETHICUS II study protocol: withholding or withdrawing life-sustaining therapy, active shortening of the dying process, failed cardiopulmonary resuscitation and patients with brain death. Results A total of 795 patients were analyzed; 129 patients died after CPR, 129 developed brain death. LLST was decided in 537 patients, 485 died in the ICU, 90.3%. The mean age was 66.19 years±14.36, 63.8% of male patients. In 221 (41%) it was decided to withdraw life-sustaining treatments and in 316(59%) withholding life-sustaining treatments. Nineteen patients (2.38%) had advance living directives. Conclusions The predominant clinical profile when LTSV was established was male patients over 65 years with mostly cardiovascular comorbidity. We observed that survival was higher in LLST decisions involving withholding of treatments compared to those in which withdrawal was decided. Spain has played a leading role in both patient and ICU recruitment participating in this worldwide multicenter study. (AU)

Fístula gastrocólica como causa infrecuente de diarrea persistente en un paciente portador de gastrostomía radiológica percutánea / Gastrocolic fistula as infrequent cause of chronic diarrhea in a patient with percutaneous radiological gastrostomy

Introducción: la fístula gastrocólica supone una complicación infrecuente pero potencialmente grave de las sondas de gastrostomía. La sospecha clínica ante una diarrea de origen incierto que comienza tras el recambio de la sonda es clave para la detección y el tratamiento precoces. Caso clínico: se presenta el caso de un paciente portador de gastrostomía radiológica percutánea (PRG) que comienza con diarrea persistente tras el primer recambio de la sonda y desnutrición grave secundaria. Tras el fracaso de las medidas terapéuticas iniciales se amplían los estudios, con hallazgo de esta complicación en la imagen de TC. Se suspende el uso de esta sonda con resolución de la diarrea y evolución nutricional favorable. Discusión: este caso pone de manifiesto la importancia de incluir la fístula gastrocólica en el diagnóstico diferencial de la diarrea persistente en un paciente portador de sonda de gastrostomía.(AU)

Introduction: gastrocolic fistula is an infrequent but severe complication of percutaneous gastrostomy. Clinical suspicion in the presence of chronic diarrhea of unknown etiology manifesting after percutaneous radiological gastrostomy (PRG) tube replacement is key to early detection and treatment. Case report: we report the case of a patient with PRG that began with chronic diarrhea after tube replacement and developed severe malnutrition. Initial treatment was not effective, studies were extended with the finding of this complication in a CT image. The use of this tube was discontinued with resolution of diarrhea and a favorable nutritional outcome. Discussion: this case report shows the importance of considering gastrocolic fistula in the differential diagnosis of persistent diarrhea in a patient with a gastrostomy tube.(AU)

Limitation of life support treatments in Spanish Intensive Care Units: Analysis of the ETHICUS II study.

OBJECTIVE: The aim of this study is to describe the results of Spanish ICUs in ETHICUS II study. DESIGN: Planned substudy of patients from ETHICUS II study. SETTING: 12 Spanish ICU. PATIENTS OR PARTICIPANTS: Patients admitted to Spanish ICU who died or in whom a limitation of life-sustaining treatment (LLST) was decided during a recruitment period of 6 months. INTERVENTIONS: Follow-up of patients was performed until discharge from the ICU and 2 months after the decision of LLST or death. MAIN VARIABLES OF INTEREST: Demographic characteristics, clinical profile, type of decision of LLST, time and form in which it was adopted. Patients were classified into 4 categories according to the ETHICUS II study protocol: withholding or withdrawing life-sustaining therapy, active shortening of the dying process, failed cardiopulmonary resuscitation and patients with brain death. RESULTS: A total of 795 patients were analyzed; 129 patients died after CPR, 129 developed brain death. LLST was decided in 537 patients, 485 died in the ICU, 90.3%. The mean age was 66.19 years ± 14.36, 63.8% of male patients. In 221 (41%) it was decided to withdraw life-sustaining treatments and in 316 (59%) withholding life-sustaining treatments. Nineteen patients (2.38%) had advance living directives. CONCLUSIONS: The predominant clinical profile when LTSV was established was male patients over 65 years with mostly cardiovascular comorbidity. We observed that survival was higher in LLST decisions involving withholding of treatments compared to those in which withdrawal was decided. Spain has played a leading role in both patient and ICU recruitment participating in this worldwide multicenter study.

[Gastrocolic fistula as infrequent cause of chronic diarrhea in a patient with percutaneous radiological gastrostomy]. / Fístula gastrocólica como causa infrecuente de diarrea persistente en un paciente portador de gastrostomía radiológica percutánea.

Introduction: Introduction: gastrocolic fistula is an infrequent but severe complication of percutaneous gastrostomy. Clinical suspicion in the presence of chronic diarrhea of unknown etiology manifesting after percutaneous radiological gastrostomy (PRG) tube replacement is key to early detection and treatment. Case report: we report the case of a patient with PRG that began with chronic diarrhea after tube replacement and developed severe malnutrition. Initial treatment was not effective, studies were extended with the finding of this complication in a CT image. The use of this tube was discontinued with resolution of diarrhea and a favorable nutritional outcome. Discussion: this case report shows the importance of considering gastrocolic fistula in the differential diagnosis of persistent diarrhea in a patient with a gastrostomy tube.

Introducción: Introducción: la fístula gastrocólica supone una complicación infrecuente pero potencialmente grave de las sondas de gastrostomía. La sospecha clínica ante una diarrea de origen incierto que comienza tras el recambio de la sonda es clave para la detección y el tratamiento precoces. Caso clínico: se presenta el caso de un paciente portador de gastrostomía radiológica percutánea (PRG) que comienza con diarrea persistente tras el primer recambio de la sonda y desnutrición grave secundaria. Tras el fracaso de las medidas terapéuticas iniciales se amplían los estudios, con hallazgo de esta complicación en la imagen de TC. Se suspende el uso de esta sonda con resolución de la diarrea y evolución nutricional favorable. Discusión: este caso pone de manifiesto la importancia de incluir la fístula gastrocólica en el diagnóstico diferencial de la diarrea persistente en un paciente portador de sonda de gastrostomía.

Case-control study assessing the impact of COVID19 in advanced kidney cancer patients treated with antiangiogenics or immunotherapy: the COVID-REN study.

BACKGROUND: Cancer is a risk factor for developing severe COVID19. Additionally, SARS-CoV2 has a special tropism for renal cells and complications like thrombosis or cytokine storm could be enhanced by standard treatments in kidney cancer (i.e., antiangiogenics or immunotherapy). Thus, understanding the impact of COVID19 in patients with this tumor is key for their correct management. METHODS: We designed a retrospective case-control study comparing the outcome of three groups of advanced kidney cancer patients on systemic treatment: cohort A (developed COVID19 while on antiangiogenics), cohort B (developed COVID19 while on immunotherapy) and cohort C (non-infected). Matching factors were age, gender, and treatment. RESULTS: 95 patients were recruited in 16 centers in Spain from September 2020 to May 2021. Finally, 85 were deemed as eligible (23 cohort A, 21 cohort B, 41 cohort C). Patients with COVID required more dose interruptions (25 vs. six) and hospitalizations (10 vs. none) than those without COVID (both p = 0.001). No difference between cohorts A and B was observed regarding hospitalization or length of stay. No ICU admission was registered and one patient in cohort B died due to COVID19. Regarding cancer evolution, three patients in cohort A presented progressive disease after COVID19 compared to two in cohort B. One case in cohort B, initially deemed as stable disease, achieved a partial response after COVID19. CONCLUSIONS: Kidney cancer patients who developed COVID19 while on systemic therapy required more treatment interruptions and hospitalizations than those non-infected. However, no significant impact on cancer outcome was observed. Also, no difference was seen between cases on antiangiogenics or immunotherapy.

Embarazo y ortopedia / Pregnancy and Orthopaedics

Introducción: Son múltiples las afecciones ortopédicas que sufre una mujer embarazada, por ello las demandas de atención por esta causa van en ascenso. Objetivo: Actualizar el tratamiento de las lesiones traumáticas y ortopédicas en la paciente embarazada y coordinar las indicaciones de la cesárea. Métodos: Se utilizan métodos teóricos y empíricos para realizar análisis del conocimiento actualizado sobre estas. Resultados: Se determinó que el parto normal es posible después de una fractura pélvica, siempre que no existan secuelas que dañen el canal del parto. El dolor de espalda fue un síntoma común en las mujeres embarazadas, pero en las que presentaron escoliosis las molestias fueron más frecuentes. La diastasis de la sínfisis del pubis se asoció con la maniobra de McRoberts; y la indicación de cesárea se sugirió a partir de criterios puramente obstétricos, aunque se respetaron las afecciones ortopédicas y traumáticas presentes en las pacientes. Conclusiones: Incrementar los conocimientos del personal que trabaja con la embarazada, a partir de sus factores de riesgo y las posibilidades de mitigación de daño por estas causas.

Introduction: pregnant women suffer from multiple orthopaedic conditions; therefore, care demands for this cause are on the rise. Objective: to update the treatment of traumatic and orthopaedic injuries in pregnant patients and coordinate the indications for cesarean section. Methods: theoretical and empirical methods were used to carry out the analysis of updated knowledge regarding these affections. Results: we determined that normal delivery is possible after a pelvic fracture, as long as there are no sequelae that damage the birth canal. Back pain was a common symptom in pregnant women but in those with scoliosis the discomfort was more frequent. Symphysis pubis diastasis was associated with the McRobert's maneuver; and the indication for cesarean section was suggested based on purely obstetric criteria, although the orthopaedic and traumatic conditions present in the patients were respected. Conclusions: to increase the knowledge of the personnel, who work with the pregnant women, based on their risk factors and the possibilities of mitigating damage due to these causes.

Correction: Personalized Precision Medicine for Health Care Professionals: Development of a Competency Framework.

[This corrects the article DOI: 10.2196/43656.].

Personalized Precision Medicine for Health Care Professionals: Development of a Competency Framework.

BACKGROUND: Personalized precision medicine represents a paradigm shift and a new reality for the health care system in Spain, with training being fundamental for its full implementation and application in clinical practice. In this sense, health care professionals face educational challenges related to the acquisition of competencies to perform their professional practice optimally and efficiently in this new environment. The definition of competencies for health care professionals provides a clear guide on the level of knowledge, skills, and attitudes required to adequately carry out their professional practice. In this context, this acquisition of competencies by health care professionals can be defined as a dynamic and longitudinal process by which they use knowledge, skills, attitudes, and good judgment associated with their profession to develop it effectively in all situations corresponding to their field of practice. OBJECTIVE: This report aims to define a proposal of essential knowledge domains and common competencies for all health care professionals, which are necessary to optimally develop their professional practice within the field of personalized precision medicine as a fundamental part of the medicine of the future. METHODS: Based on a benchmark analysis and the input and expertise provided by a multidisciplinary group of experts through interviews and workshops, a new competency framework that would guarantee the optimal performance of health care professionals was defined. As a basis for the development of this report, the most relevant national and international competency frameworks and training programs were analyzed to identify aspects that are having an impact on the application of personalized precision medicine and will be considered when developing professional competencies in the future. RESULTS: This report defines a framework made up of 58 competencies structured into 5 essential domains: determinants of health, biomedical informatics, practical applications, participatory health, and bioethics, along with a cross-cutting domain that impacts the overall performance of the competencies linked to each of the above domains. Likewise, 6 professional profiles to which this proposal of a competency framework is addressed were identified according to the area where they carry out their professional activity: health care, laboratory, digital health, community health, research, and management and planning. In addition, a classification is proposed by progressive levels of training that would be advisable to acquire for each competency according to the professional profile. CONCLUSIONS: This competency framework characterizes the knowledge, skills, and attitudes required by health care professionals for the practice of personalized precision medicine. Additionally, a classification by progressive levels of training is proposed for the 6 professional profiles identified according to their professional roles.

The Association of HIV-1 Neutralization in Aviremic Children and Adults with Time to ART Initiation and CD4+/CD8+ Ratios.

Broadly neutralizing antibodies (bnAbs) bind and neutralize diverse HIV isolates and demonstrate protective effects in primate models and humans against specific isolates. To develop an effective HIV vaccine, it is widely believed that inducing these antibodies is crucial. However, the high somatic hypermutation in bnAbs and the limited affinity of HIV Env proteins for bnAb germline precursors suggest that extended antigen exposure is necessary for their production. Consequently, HIV vaccine research is exploring complex sequential vaccination strategies to guide the immune response through maturation stages. In this context, the exploration of the factors linked to the generation of these antibodies across diverse age groups becomes critical. In this study, we assessed the anti-HIV-1 neutralization potency and breadth in 108 aviremic adults and 109 aviremic children under 15 years of age who were receiving ART. We used a previously described minipanel of recombinant viruses and investigated the factors associated with neutralization in these individuals. We identified individuals in both groups who were capable of neutralizing viruses from three different subtypes, with greater cross-neutralization observed in the adult group (49.0% vs. 9.2%). In both groups, we observed an inverse association between neutralization breadth and the CD4+/CD8+ ratio, as well as a direct association with the time to ART initiation. However, we found no association with time post-infection, cumulative ART duration, or CD8+ cell levels. The present study demonstrates that children receiving antiretroviral therapy generate broadly neutralizing responses to HIV-1, albeit with lower magnitude compared to adults. We also observed that neutralization breadth is associated with CD4+/CD8+ levels and time to treatment initiation in both children and adults living with HIV-1. Our interpretation of these results is that a delay in ART initiation could have prolonged the antigenic stimulation associated with viral replication and thus facilitate the capacity to elicit long-lasting broadly neutralizing responses. These results corroborate prior findings that show that HIV-1-neutralizing responses can persist for years, even at low antigen levels, implying an HIV-1 vaccine may induce lasting neutralizing antibody response.

Real-world data with afatinib in Spanish patients with treatment-naïve non-small-cell lung cancer harboring exon 19 deletions in epidermal growth factor receptor (Del19 EGFR): Clinical experience of the Galician Lung Cancer Group.

BACKGROUND: In clinical studies, first-line afatinib demonstrated efficacy in Del19-EGFR NSCLC. MATERIALS AND METHODS: This prospective, non-interventional study assessed efficacy and safety of first-line afatinib in patients with advanced/metastatic NSCLC with Del19-EGFR from Galicia (Spain), with a preplanned analysis by age (<70 vs ≥70 years). RESULTS: Median age of 46 patients enrolled was 69.5 years (range 37-87). The objective response rate (ORR) was 78.2%, with median progression-free survival (PFS) of 20.5 months (95% CI 12.7, 28.3) and median overall survival (OS) of 37.5 months (95% CI 19.2-55.8). Outcomes by age (<70 vs ≥70 years) were ORR of 82.6% vs 73.9%, median PFS of 20.2 months (95% CI 14.8-25.6) vs 24.1 (9.8-38.3), and median OS of 45.1 months (95% CI, 17.0-73.1) vs 33.9 (28.7-39.1), respectively. Median treatment duration was 17.2 months (range 0.4-64.1) with 11 patients still on treatment; 14 patients received osimertinib at discontinuation due to T790M. Grade 3 adverse events included mucositis (n = 7, 15.2%), skin toxicity (n = 9, 19.6%), and diarrhea (n = 6, 13.0%) that were manageable with dose reductions. The afatinib dose was reduced in 31 patients (67.4%) and treatment was discontinued in 8 patients (17.4%) due to adverse events. By age (<70 vs ≥70 years), afatinib was dose-reduced in 13 (56.5%) vs 18 patients (78.3%) and discontinued in 3 (13.0%) vs 5 patients (21.7%), respectively. CONCLUSIONS: PFS in our patients was longer than reported in clinical studies with similar response rates and toxicity, even in older patients, reflecting a good risk-benefit from afatinib in patients with Del19-EGFR NSCLC. MICROABSTRACT: This real-world study of first-line afatinib in Caucasian patients with Del19 EGFR NSCLC reported durable efficacy and showed that older patients (> 70 years) benefitted from afatinib as much as younger patients. The safety profile of afatinib was as expected, albeit more dose reductions in older patients. Afatinib may be an option for patients with Del19 EGFR NSCLC, even in those who are older.

Actualización en el tratamiento del hipoparatiroidismo posquirúrgico / Update on management of postoperative hypoparathyroidism

Introducción y objetivo: El hipoparatiroidismo posquirúrgico es una complicación frecuente de la cirugía tiroidea y paratiroidea, con consecuencias significativas sobre la salud y calidad de vida. El objetivo de esta revisión es proporcionar una visión actualizada de su prevención, detección precoz y tratamiento.Síntesis: Tras la tiroidectomía y paratiroidectomía puede aparecer hipoparatiroidismo de forma aguda, especialmente en algunos pacientes de alto riesgo. La determinación de la hormona paratiroidea intacta (PTHi) en el postoperatorio temprano es una herramienta útil en el manejo del paciente. Un nivel de PTHi postoperatoria <10-15 pg/ml, combinado con los niveles de calcemia 24 horas después de la cirugía, ofrece el mejor valor predictivo para hipocalcemia aguda. El hipoparatiroidismo permanente se asocia con morbilidad y deterioro de calidad de vida a largo plazo y debería prevenirse cuando sea posible. El tratamiento convencional incluye calcio oral y metabolitos activos de vitamina D. En caso de hipocalcemia severa o sintomática se precisa calcio intravenoso. El tratamiento debe monitorizarse e incluir educación sanitaria del paciente, para evitar amplias desviaciones de la calcemia. Sin embargo, con la terapia convencional mantener un adecuado control puede representar un desafío. (AU)

Introduction and objective: Surgical hypoparathyroidism is a common complication following thyroid and parathyroid surgery. It has significant consequences for health and quality of life. The objective of this review is to provide an overview of its prevention, early detection, and treatment. Synthesis: Acute hypoparathyroidism can occur after thyroidectomy and parathyroidectomy, especially in high-risk patients. Measurement of early postoperative intact parathyroid hormone (PTHi) can help guide patient management. A postoperative PTHi < 10-15 pg/ml combined with serum calcium assay testing 24 hours after surgery yielded the highest diagnostic accuracy for predicting acute hypocalcemia. Permanent hypoparathyroidism is associated with long-term morbidity and poor quality of life, and should be prevented whenever possible. Conventional treatment consist of oral calcium and active vitamin D analogs. For more severe or symptomatic hypocalcemia it is necessary intravenous calcium. Treatment require monitoring and patient education to avoid wide swings in serum calcium. However, with standard therapy, maintaining an adequate control often presents a therapeutic challenge. Recombinant human parathyroid hormone (rhPTH) replacement can lower the doses of calcium and active vitamin D analogs required, while maintaining serum calcium and phosphate levels within the recommended therapeutic ranges. It may improve bone metabo-lism and quality of life on the long term. Additional data on safety and efficacy are needed. Conclusions: Postoperative hypoparathyroidism is common. It requires early diagnosis, pharmacologic intervention and patient education to achieve optimal control and lower the risk of long-term complications. rhPTH seems to be an effective option for those patients who do not stably mantein their calcium in the target range. (AU)

Emerging Blood-Based Biomarkers for Predicting Immunotherapy Response in NSCLC.

Immunotherapy with Immune Checkpoint Inhibitors (ICIs) has demonstrated a profitable performance for Non-Small Cell Lung Cancer (NSCLC) cancer treatment in some patients; however, there is still a percentage of patients in whom immunotherapy does not provide the desired results regarding beneficial outcomes. Therefore, obtaining predictive biomarkers for ICI response will improve the treatment management in clinical practice. In this sense, liquid biopsy appears as a promising method to obtain samples in a minimally invasive and non-biased way. In spite of its evident potential, the use of these circulating biomarkers is still very limited in the real clinical practice, mainly due to the huge heterogeneity among the techniques, the lack of consensus, and the limited number of patients included in these previous studies. In this work, we review the pros and cons of the different proposed biomarkers, such as soluble PD-L1, circulating non-coding RNA, circulating immune cells, peripheral blood cytokines, and ctDNA, obtained from liquid biopsy to predict response to ICI treatment at baseline and to monitor changes in tumor and tumor microenvironment during the course of the treatment in NSCLC patients.

Spanish Translation and Linguistic Validation of the Glucose Monitoring Experiences Questionnaire (GME-Q) in Continuous Glucose Monitoring Users.

BACKGROUND AND AIMS: The use of continuous glucose monitoring (CGM) has become standard practice in people with type 1 diabetes. The evaluation of user satisfaction is crucial. The Glucose Monitoring Experiences questionnaire (GME-Q) includes 23 items with a 5-point Likert scale to produce a total satisfaction score and three subscale scores. The study aimed to translate the GME-Q from English into Spanish and to validate its use in Spanish-speaking CGM users with type 1 diabetes. METHODS: The linguistic translation and validation process of the GME-Q was established. T1D CGM users were asked to complete the produced Spanish version of the GME-Q and interviewed about difficulties or misunderstandings. Total satisfaction, effectiveness, convenience and intrusiveness subscales and internal consistency reliability were computed. RESULTS: Forward and backward translations and cognitive debriefing produced a final version of the GME-Q in Spanish. Ninety-eight subjects with type 1 diabetes were selected (age: 40 ± 12 years, 63% females, Hb1c: 7.2 ± 0.9% (55 ± 10 mmol/l), pump users: 78%, CGM use: 3.7 ± 2.6 years). The completion rate was 99% and the Cronbach's alpha coefficient was 0.8. The total satisfaction score was 3.9 ± 0.4 (effectiveness: 4.1 ± 0.6, convenience: 3.8 ± 0.6, intrusiveness: 2.2 ± 0.7). CONCLUSION: The GME-Q was translated into Spanish and validated for Spanish-speaking CGM users with type 1 diabetes.

Autoevaluación de la especialidad Ortopedia y Traumatología para su acreditación en un hospital universitario villaclareño / Self-assessment of the Orthopedics and Traumatology specialty for its accreditation in a university hospital in Villa Clara

RESUMEN La calidad es el resultado de una serie de factores internos y del entorno, vinculados a una buena gestión y práctica universitarias, atañe tanto a los procesos que gestiona como a los resultados que obtienen los participantes, por lo que es siempre deseable, relativa y multidimensional. El objetivo del presente artículo es expresar la valoración del proceso de autoevaluación en la especialidad Ortopedia y Traumatología que se desarrolla en el servicio de Ortopedia y Traumatología del hospital docente "Mártires del 9 de Abril", en estrecha relación con el modelo de acreditación vigente. La acreditación de la especialidad de Ortopedia y Traumatología permitirá continuar avanzando hacia la excelencia académica, tan anhelada por todos, elevar la calidad de vida del pueblo y de forma pertinente, consolidarse como institución académica, científica y humanista.

ABSTRACT Quality is the result of a series of internal and environmental factors, linked to good university management and practice; it concerns both the processes it manages and the results obtained by the participants, that´s why it is always desirable, relative and multidimensional. The objective of this article is to express the assessment of the self-assessment process in the Orthopedics and Traumatology specialty that takes place in the Orthopedics and Traumatology service of the "Mártires del 9 de Abril" University Hospital, in close relationship with the current accreditation model. The accreditation of the specialty of Orthopedics and Traumatology will allow continuing to advance towards academic excellence, so desired by all, to raise the quality of life of the people and in a pertinent way, to consolidate itself as an academic, scientific and humanistic institution.

PD-L1 testing and clinical management of newly diagnosed metastatic non-small cell lung cancer in Spain: MOREL study.

AIM: To describe the clinical management and PD-L1 testing of patients with newly diagnosed stage IV non-small cell lung cancer (NSCLC) without driver mutations in Spain. METHODS: Multicenter, retrospective study. RESULTS: Among 297 evaluated patients, 89.2% received systemic treatment for stage IV disease, of whom 53.6% received platinum doublet therapy, 26.8% immunotherapy as monotherapy and 14.7% immunotherapy + chemotherapy, with 9.4% receiving treatment as part of a clinical trial. Treatment was initiated 1 month after histological diagnosis, with PD-L1 test results available in most cases (92.6%). PD-L1 testing was performed in 287 patients, 95.1% by in-house tests, mostly with the 22C3 pharmDx assay. The factor most strongly associated with treatment selection was, as expected, the expression of PD-L1. CONCLUSION: PD-L1 testing is implemented in clinical practice and seems to guide treatment decisions in patients with NSCLC in Spain.

Rotura del tendón largo del bíceps braquial: resultado tras 15 años de evolución / Long tendon rupture of the biceps brachii: result after 15 years of evolution

RESUMEN 15. La rotura de la porción larga del tendón del bíceps produce dificultades para la función del miembro superior y la estética del brazo. Se presenta un paciente con rotura de tendón largo del bíceps, que fue tratado hace 15 años con tratamiento quirúrgico; se muestra desde su lesión y tratamiento hasta la recuperación total y sus condiciones actuales. El siguiente trabajo tiene como objetivo la presentación de un paciente, el cual fue atendido en el Hospital General Provincial Universitario «Mártires del 9 de Abril», en Sagua la Grande, por una rotura de la porción larga de bíceps en el año 2005. Se utilizó una forma de anclaje al hueso diferente a la clásica descrita en la literatura, con excelente resultado. Tras 15 años, se expone el caso y se detalla la evolución posterior, se valora la función actual y se aporta conocimiento interesante para los profesionales que tratan esta afección.

ABSTRACT 19. Rupture of the long head of the biceps tendon causes difficulties for upper limb function and arm aesthetics. We present a male patient with a rupture of the long biceps tendon, who was treated 15 years ago with surgical treatment; he is shown from his injury and treatment to his full recovery and current condition. The aim of the following work is to present a patient who was treated at "Mártires del 9 de Abril" Provincial General University Hospital, in Sagua la Grande, due to a rupture of the long head of the biceps in 2005. A form of bone anchorage, different from the classic one described in the literature, was used with excellent results. After 15 years, the case is presented and the subsequent evolution is detailed, the current function is assessed and interesting knowledge is provided for professionals who treat this condition.

Lesiones de cadera relacionadas con la actividad deportiva / Sports-Related Hip Injuries

Introducción: Las lesiones de la cadera relacionadas con las actividades deportivas han sido poco abordadas; sin embargo, han ido en aumento y su diagnóstico suele ser difícil o retardado. Incluyen múltiples afecciones y su recuperación suele ser larga. Objetivo: Actualizar conocimientos sobre algunas de las afecciones deportivas que afectan la cadera. Métodos: Se realiza una revisión bibliográfica sistemática y detallada sobre el tema, para lo cual se emplearon métodos teóricos, analítico-sintético, histórico-lógico e inductivo-deductivo y el análisis documental como método empírico. Se hizo una búsqueda sistemática sobre la temática en las bases de datos PubMed, Medscape y Google Academics desde junio de 2016 hasta la fecha. Se revisaron 500 artículos referentes al tema, de los cuales se seleccionaron 45 artículos para este trabajo. Análisis y síntesis de la información: Las lesiones de la cadera relacionadas con el deporte ocurren entre 5 y 9 por ciento de atletas adultos. Las actividades con movimientos rápidos, aceleraciones, desaceleraciones, y los cambios direccionales son la principal causa de tales lesiones. Provocan daños corporales provocados por una transferencia de energía, que excede la capacidad para mantener la estructura y/o la función íntegra, durante el entrenamiento o competición. Conclusiones: Las lesiones de la cadera relacionadas con el deporte pueden ser múltiples y son responsables de dolor en un gran número de atletas, fundamentalmente en el fútbol, la gimnasia y el beisbol. El diagnóstico precoz es fundamental para evitar la progresión de la lesión. Las mejoras en el diagnóstico radiológico y las posibilidades del uso de la artroscopia han mejorado la evolución y el pronóstico para los atletas(AU)

Introduction: Sports injuries of the hip have been little addressed; however, they have been increasing and their diagnosis is often difficult or delayed. They include multiple conditions and their recovery is usually long. Objective: To bring up to date knowledge on some of the sports conditions that affect the hip, which is particularly important to improve medical care. Methods: A systematic and detailed bibliographic review is carried out on the subject, for which theoretical, analytical-synthetic, historical-logical and inductive-deductive methods were used, as well as documentary analysis as an empirical method. A systematic search on the subject was carried out in PubMed, Medscape and Google Academics databases from June 2016 to date. Five hundred articles referring to the topic were reviewed. Forty-five articles the total were selected for this paper. Analysis and synthesis of the information: Sports-related hip injuries occur between 5 and 9 percent of adult athletes. Activities with rapid movements, accelerations, decelerations, and directional changes are the main cause of such injuries. They cause bodily harm produced by a transfer of energy, which exceeds the capacity to maintain the entire structure and, or function, during training or competition. Conclusions: Sports injuries of the hip can be multiple and are responsible for pain in a large number of athletes, mainly in soccer, gymnastics and baseball. Early diagnosis is essential to avoid progression of the lesion. Improvements in radiological diagnosis and the possibilities of the use of arthroscopy have improved the evolution and prognosis for athletes(AU)

Pretreatment Tissue TCR Repertoire Evenness Is Associated with Complete Pathologic Response in Patients with NSCLC Receiving Neoadjuvant Chemoimmunotherapy.

PURPOSE: Characterization of the T-cell receptor (TCR) repertoire may be a promising source for predictive biomarkers of pathologic response to immunotherapy in locally advanced non-small cell lung cancer (NSCLC). EXPERIMENTAL DESIGN: In this study, next-generation TCR sequencing was performed in peripheral blood and tissue samples of 40 patients with NSCLC, before and after neoadjuvant chemoimmunotherapy (NADIM clinical trial, NCT03081689), considering their complete pathologic response (CPR) or non-CPR. Beyond TCR metrics, tissue clones were ranked by their frequency and spatiotemporal evolution of top 1% clones was determined. RESULTS: We have found a positive association between an uneven TCR repertoire in tissue samples at diagnosis and CPR at surgery. Moreover, TCR most frequently ranked clones (top 1%) present in diagnostic biopsies occupied greater frequency in the total clonal space of CPR patients, achieving an AUC ROC to identify CPR patients of 0.967 (95% confidence interval, 0.897-1.000; P = 0.001), and improving the results of PD-L1 tumor proportion score (TPS; AUC = 0.767; P = 0.026) or tumor mutational burden (TMB; AUC = 0.550; P = 0.687). Furthermore, tumors with high pretreatment top 1% clonal space showed similar immune cell populations but a higher immune reactive gene expression profile. Finally, the selective expansion of pretreatment tissue top 1% clones in peripheral blood of CPR patients suggests also a peripheral immunosurveillance, which could explain the high survival rate of these patients. CONCLUSIONS: We have identified two parameters derived from TCR repertoire analysis that could outperform PD-L1 TPS and TMB as predictive biomarkers of CPR after neoadjuvant chemoimmunotherapy, and unraveled possible mechanisms of CPR involving enhanced tumor immunogenicity and peripheral immunosurveillance.

[ISAR Score (Identification of Seniors At Risk) predicts mortality in patients older than 75 years admitted in Intensive Care]. / ISAR Score (Identification of Seniors At Risk) predice la mortalidad en mayores de 75 años ingresados en Cuidados Intensivos.

BACKGROUND AND OBJECTIVES: Currently, the patient's baseline situation is a more important prognostic factor than age. The purpose of this study is to estimate the prognostic value of the ISAR score (Identification of Senior at Risk) in patients ≥75 years admitted to intensive care (ICU). PATIENTS AND METHODS: Prospective multicenter study including patients ≥75 years admitted to the ICU > 24hours. On admission, 28 days and 6 months after discharge from the ICU, mortality and baseline were evaluated using the ISAR score, the Lawton and Brody scale (LB) and the Barthel index (BI), the Frail fragility scale. scale (FS), the Charlson comorbidity index (ICC), Dementia rating score (DRC). RESULTS: 38 of 94 patients (40%) were high risk (ISAR ≥ 3) and were characterized by BI 90 (65-100), LB 4 (3-5), and CDR 1 (0-2), ICC 7.5 (6-10). 58% had FS ≥ 3. In the long term, they were in a situation of dependency [BI 50 (2.5-77.5), LB 3 (0-4), CDR 1 (0-1.5)]. The ICU mortality at 28 days and 6 months was 18.4%, 25.7% and 35.3%, respectively, being statistically significant. The area under the ISAR score ROC curve was 0.749 to 0.797, in all the mortality periods studied, although the difference with other predictive variables was not significant, but the p value was the lowest. CONCLUSIONS: The ISAR score predicts mortality in critically elderly patients with a discriminative capacity comparable to other predictive variables.