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AIM: Improvement and harmonization of European clinical pharmacology and therapeutics (CPT) education is urgently required. Because digital educational resources can be easily shared, adapted to local situations and re-used widely across a variety of educational systems, they may be ideally suited for this purpose. METHODS: With a cross-sectional survey among principal CPT teachers in 279 out of 304 European medical schools, an overview and classification of digital resources was compiled. RESULTS: Teachers from 95 (34%) medical schools in 26 of 28 EU countries responded, 66 (70%) of whom used digital educational resources in their CPT curriculum. A total of 89 of such resources were described in detail, including e-learning (24%), simulators to teach pharmacokinetics and/or pharmacodynamics (10%), virtual patients (8%), and serious games (5%). Together, these resources covered 235 knowledge-based learning objectives, 88 skills, and 13 attitudes. Only one third (27) of the resources were in-part or totally free and only two were licensed open educational resources (free to use, distribute and adapt). A narrative overview of the largest, free and most novel resources is given. CONCLUSION: Digital educational resources, ranging from e-learning to virtual patients and games, are widely used for CPT education in EU medical schools. Learning objectives are based largely on knowledge rather than skills or attitudes. This may be improved by including more real-life clinical case scenarios. Moreover, the majority of resources are neither free nor open. Therefore, with a view to harmonizing international CPT education, more needs to be learned about why CPT teachers are not currently sharing their educational materials.
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Farmacologia Clínica , Estudos Transversais , Currículo , Humanos , Aprendizagem , Farmacologia Clínica/educação , Faculdades de MedicinaRESUMO
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.
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OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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.
OBJETIVO: 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. RESULTADOS: 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. CONCLUSIONES: 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.