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To analyse the applications for drugs in special situations (compassionate use, off-label use and foreign drugs) for solid tumours, and to assess the level of evidence supporting these applications, as well as the effectiveness and safety of most frequent drugs.We performed a cross-sectional study of all applications for drugs in special situations during 2018 and 2019 in a representative third-level centre. We collected data about generic names of drugs, clinical indications, and level of evidence provided on the application form. Furthermore, tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.1., Progression Free Survival and Overall Survival. Safety was evaluated with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.2,273 drugs in special situations were approved between January 2018 and December 2019. In 431 cases (19%), they were used to treat solid tumours. Out of 431, 291 (67.5%) applications were offlabel drugs, 76 (18%) foreign drugs, and 64 (15%) were compassionate use of drugs. Most of them were supported by phase 3 (47%) or phase 2 (33%) clinical trials. The majority of adverse effects were grade 1 and only in 6/67 cases the treatment was discontinued due to toxicity.A significant number of drugs in special situations are prescribed to Oncology patients. The majority of applications of these drugs was supported by clinical trials. The real-life experience showed an effectiveness and tolerance profile similar to those described in randomised clinical trials.Analizar las solicitudes de medicamentos en situaciones especiales (uso compasivo, uso fuera de indicación y medicamentos extranjeros) para tumores sólidos, y evaluar el nivel de evidencia que avala dichas solicitudes, así como la efectividad y seguridad de los medicamentos más frecuentes.Método: Estudio transversal que incluyó las solicitudes de medicamentos en situaciones especiales durante el período 2018-2019 en un centro representativo español de tercer nivel. Se recogieron datos sobre principios activos, indicaciones clínicas y nivel de evidencia aportado en la solicitud. Asimismo, la respuesta tumoral fue evaluada mediante criterios Response Evaluation Criteria in Solid Tumours versión 1.1, supervivencia libre de progresión y supervivencia global. La seguridad fue evaluada con la versión 5.0 de los criterios de toxicidad Common Terminology Criteria for Adverse Events del National Cancer Institute de Estados Unidos.Un total de 2.273 medicamentos en situaciones especiales fueron aprobados entre enero de 2018 y diciembre de 2019. El 19% (431) se aprobaron para el tratamiento de tumores sólidos. De estos 431, 291 (67,5%) solicitudes fueron de medicamentos fuera de indicación, 76 (18%) extranjeros y 64 (15%) en uso compasivo. La mayoría son avaladas por estudios clínicos aleatorizados en fase III (47%) o fase II (33%). La mayor parte de los efectos adversos fueron de grado 1 y solo en 6/67 casos el tratamiento fue interrumpido por toxicidad.Un porcentaje importante de medicamentos en usos especiales se prescriben a pacientes oncológicos. La mayoría de las solicitudes fueron avaladas por algún estudio clínico aleatorizado. La experiencia en vida real mostró un perfil de efectividad y tolerancia similar al descrito en los estudios clínicos aleatorizados.

Background and objectives: The COVID-19 pandemic has forced universities to move the completion of university studies online. Spain's National Conference of Medical School Deans coordinates an objective, structured clinical competency assessment called the Objective Structured Clinical Examination (OSCE), which consists of 20 face-to-face test sections for students in their sixth year of study. As a result of the pandemic, a computer-based case simulation OSCE (CCS-OSCE) has been designed. The objective of this article is to describe the creation, administration, and development of the test. Materials and methods: This work is a descriptive study of the CCS-OSCE from its planning stages in April 2020 to its administration in June 2020. Results: The CCS-OSCE evaluated the competences of anamnesis, exploration, clinical judgment, ethical aspects, interprofessional relations, prevention, and health promotion. No technical or communication skills were evaluated. The CCS-OSCE consisted of ten test sections, each of which had a 12-minutes time limit and ranged from six to 21 questions (mean: 1.1 minutes/question). The CCS-OSCE used the virtual campus platform of each of the 16 participating medical schools, which had a total of 2,829 students in their sixth year of study. It was jointly held on two dates in June 2020. Conclusions: The CCS-OSCE made it possible to bring together the various medical schools and carry out interdisciplinary work. The CCS-OSCE conducted may be similar to Step 3 of the United States Medical Licensing Examination.

Objectives: Evaluation of the functional status one year after a hip fracture surgery and the influence of sarcopenia and other clinical factors at the time of admission. Method: Prospective observational study with 135 patients over 65 years of age. Functional status of basic (modified Katz) and instrumental activities (Lawton and Brody) and walking ability (Functional Ambulation Classification, FAC) was measured on admission, at discharge, and telephonically one year later. The risk or positive screening of sarcopenia (SARC-F) and cognitive status (Pfeiffer), as well as clinical variables, were evaluated. Results: 72% of patients are women; 36% have a risk of sarcopenia (Sarc-F ≥ 4), and 43% have moderate–severe cognitive impairment (Pfeiffer ≥ 5). Walking capacity at one year was closer to the values at admission more often in women than in men (0.2 ± 1.3 points vs. 0.9 ± 1.6; p = 0.001), as well as in patients without risk of sarcopenia versus sarcopenic patients (0.3 ± 1.2 points vs. 0.7 ± 1.7; p = 0.001), although their evolution did not show significant differences (p = 0.183). Instrumental activities after one year have not been recovered (1.7 ± 2.5 points; p = 0.032), and patients at risk of sarcopenia showed worse values (1.7 ± 1.9 points vs. 3.7 ± 2.7; p < 0.001) and worse evolution (p = 0.012). The evolution of basic activities varied according to the risk of sarcopenia (0.6 ± 1.4 points vs. 1.4 ± 2.1; p = 0.008). Conclusions: Functional status at one year is related to the functional status at admission, the positive screening of sarcopenia, sex, and cognitive impairment of the patient. Knowing at the time of admission an estimate of the functional status at one year will help to reinforce the individual treatment of patients with a worse prognosis.

Resumen Antecedentes y objetivos La pandemia de la COVID-19 ha obligado a completar los estudios universitarios online. La Conferencia Nacional de Decanos de Facultades de Medicina coordina una prueba de evaluacion de competencias clinicas objetiva y estructurada (ECOE) de 20 estaciones presenciales a los estudiantes de sexto del grado. Como consecuencia de la pandemia se ha disenado una ECOE sustitutoria con casos-clinicos computarizados simulados (ECOE-CCS). El objetivo del articulo es describir la elaboracion, la ejecucion y el desarrollo de la prueba. Materiales y metodos Estudio descriptivo de la ECOE-CCS conjunta desde su gestacion en abril 2020 hasta su ejecucion en junio 2020. Resultados La ECOE-CCS evaluo las competencias de anamnesis, exploracion, juicio clinico, aspectos eticos, relaciones interprofesionales, prevencion y promocion de la salud. No se evaluaron habilidades tecnicas ni de comunicacion. La ECOE-CCS consistio en 10 estaciones de 12 minutos de duracion, con un numero de preguntas de seis a 21 (media: 1,1 minutos/pregunta). En la ECOE-CCS se utilizo la plataforma virtual del campus de cada una de las 16 facultades de Medicina que participaron, con un total de 2.829 estudiantes de sexto curso. Se realizo de una forma conjunta en dos fechas de junio del 2020. Conclusiones La experiencia de la ECOE-CCS permitio llevar a cabo una integracion y el trabajo interdisciplinar de las diferentes facultades de Medicina. La ECOE-CCS realizada podria asemejarse al Step 3 CCS de la United States Medical Licensing Examination.