ABSTRACT
BACKGROUND: Commercialized since 2019, emicizumab (Hemlibra) was available only in French hospital pharmacies for prophylaxis of hemophilia A with or without inhibitors. Since June 15, 2021, patients can choose between a hospital and community pharmacy. These changes in the care pathway have important organizational consequences for patients, their relatives, and health professionals. Two training programs are available for community pharmacists: the "HEMOPHAR" training program proposed by the national reference center for hemophilia and the Roche training program proposed by the laboratory that markets the product. OBJECTIVE: The PASODOBLEDEMI study aims to evaluate the direct impact of the training programs provided to community pharmacists in the context of the dispensing of emicizumab, and to evaluate patients' satisfaction with their treatment whether they choose dispensation from a community pharmacy or retained dispensation from the hospital pharmacy. METHODS: We designed a cross-sectional study based on the 4-level Kirkpatrick evaluation model: the immediate reaction of community pharmacists following training (Reaction), the knowledge acquired during the training (Learning), the professional practice of community pharmacists during dispensing of the product (Behavior), and patients' satisfaction related to the treatment whether it is dispensed from a hospital or from a community pharmacy (Results). RESULTS: Considering that single outcome measures cannot adequately reflect the complexity of this new organization, the Kirkpatrick evaluation model provides 4 distinct outcomes: the immediate reaction after the HEMOPHAR training program, the level of knowledge acquired after the HEMOPHAR training program, the impact of training on professional practice, and patient satisfaction with access to emicizumab. We developed specialized questionnaires for each of the 4 levels of the Kirkpatrick evaluation model. All community pharmacists involved in dispensing emicizumab, whether they have followed the HEMOPHAR or the Roche training program or neither, were eligible for inclusion. All patients with severe hemophilia A were eligible, irrespective of inhibitor use, age, treatment with emicizumab, and whether they chose dispensation from a community pharmacy or retained dispensation from a hospital pharmacy. CONCLUSIONS: The new organization for dispensing emicizumab to patients with hemophilia A in French community pharmacies must be accompanied by optimal safety and quality conditions due to the risk of serious and urgent bleeding situations in the management of rare bleeding diseases. The elaboration of the PASODOBLEDEMI protocol has already a positive impact with the commitment of all health professionals, physicians, hospital and community pharmacists, and the patient community. The results will be disseminated among the French authorities and will enable, if necessary, proposing this access model to other rare diseases. TRIAL REGISTRATION: ClinicalTrials.gov NCT05449197, https://clinicaltrials.gov/ct2/show/NCT05449197?term=NCT05449197; ClinicalTrials.gov NCT05450640, https://clinicaltrials.gov/ct2/show/NCT05450640?term=NCT05450640. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43091.
ABSTRACT
Para iniciar la enseñanza de anatomía la nueva Escuela de Medicina de la Universidad de Tarapacá (UTA) adquirió innovadores recursos tecnológicos según el estado del arte en medios digitales y 3D. La primera cohorte de estudiantes de medicina utilizó estos recursos tecnológicos el año 2016, valoró positivamente la asignatura cursada y su metodología didáctica mediante un enfoque combinado (B-Learn). Estos resultados fueron publicados el año 2018, siendo un exitoso modelo local de enseñanza hasta el año 2019. La pandemia COVID-19 golpeó fuertemente a Chile desde el inicio del año 2020 y las universidades debieron adaptar su modelo de enseñanza. En nuestro caso se realizó impartiendo las asignaturas mediante un enfoque de total aprendizaje en línea a través de internet (E-Learn). Se impartió el primer y segundo semestre de anatomía a 36 estudiantes del primer año de medicina 2020. Además de los recursos tradicionales como textos de estudio y guías de laboratorio, para migrar a un modelo de curso E-Learn totalmente en línea, se utilizaron los recursos digitales y 3D almacenados en la base de datos local de la mesa de disección digital SECTRA® y su plataforma RIS/PACS portal IDS7 SECTRA®, para ser enseñados mediante internet vía Zoom® en tiempo real y vía plataformas Intranet-UTA en conjunto con Moodle® para las tareas y posteriores evaluaciones. La transición desde un modelo B-Learn a uno E-Learn se realizó en forma exitosa gracias a la experiencia conseguida los años anteriores en cuanto a diseño y uso de recursos didácticos, además de la base de datos local con recursos anatómicos previamente almacenados en formato digital. El rendimiento de los alumnos fue sobresaliente durante la pandemia, mostrando la versatilidad y adaptación de los nuevos estudiantes nativos digitales a las emergentes condiciones de aprendizaje.
SUMMARY: To start teaching anatomy, the recently established medical school of the University of Tarapacá (UTA) acquired innovative and state of the art technological resources in digital and 3D media. The first cohort of medical students used these resources in 2016 and positively assessed the subject studied and its didactic methodology through a combined approach (B- Learn). These results were published in 2018, and it was deemed a successful local teaching model until 2019. Since the beginning of 2020 the COVID-19 pandemic impacted Chile particularly hard, and universities had to adapt their teaching model. In our case, we carried it out by teaching the subjects using a comprehensive online learning approach through the Internet (E-Learn). The first and second semester of anatomy were taught to 36 students in the first year of medicine 2020. In addition to traditional resources such as study texts and laboratory guides, to migrate to a fully online E- Learn course model, the digital and 3D resources stored in the local database of the SECTRA® digital dissection table and its RIS/ PACS portal IDS7 SECTRA® platform were used to be taught via the internet through Zoom® in real-time and via Intranet UTA platforms in conjunction with Moodle® for the tasks and subsequent evaluations. The transition from a B-Learn model to an E-Learn model was carried out successfully thanks to the experience gained in previous years in terms of design and use of teaching resources, in addition to the local database with previously stored anatomical resources in digital format. Student performance was outstanding during the pandemic, showing the versatility and adaptation of new digital native students to emerging learning conditions.