Manual de simulación clínica en especialidades médicas

Manual sobre técnicas y modos de simulación clínica en diversas especialidades médicas.La enseñanza y formación en medicina necesita el uso de la simulación. Existen evidencias de su uso desde hace cientos de años, pero, en los últimos años se ha incrementado y diseminado. La simulación clínica está validada científicamente en múltiples contextos médicos y de otras áreas profesionales de la salud. Y es considerada de gran importancia como proceso de entrenamiento y de mejora de las competencias y adquisición de habilidades médicas en campos que incluye desde la historia clínica, comunicación con el paciente, exploración, diagnóstico terapéutica médica-farmacológica y quirúrgica y seguridad al tratar al paciente. Hoy en día, para muchas técnicas y situaciones clínicas es inaceptable llegar junto a los pacientes sin un dominio adquirido en simulación. La simulación puede ocurrir sin el uso de recursos adicionales, solo las personas, o utilizando pocos o muchos recursos de baja hasta alta tecnología y se puede adaptar a los recursos disponibles, abarcando todas las áreas de conocimiento, y dentro de ellas competencias técnicas o actitudes, solas o en conjunto. El uso racional y basado en evidencia de la simulación es de la mayor importancia por la necesidad de una mayor efectividad y eficiencia en la transformación de los profesionales de la salud para que puedan mejorar su capacidad de atender a los pacientes. La simulación es también una buena herramienta de evaluación de competencias y habilidades en Medicina y otras disciplinas de las Ciencias de la Salud Este manual incluye técnicas y modos de simulación clínica en diversas especialidades médicas, útiles, para quien busque un manual práctico y actualizado.Cátedra de Mecenazgo de la Universidad de Málaga. Cátedra de Terapias Avanzadas en Patología Cardiovascular Cátedra de Mecenazgo de la Universidad de Málaga. Cátedra de Investigación Biomédica Quirón Salu

Trends in Targeted Therapy Usage in Inflammatory Bowel Disease: TRENDY Study of ENEIDA

Markers that allow for the selection of tailored treatments for individual patients with inflammatory bowel diseases (IBD) are yet to be identified. Our aim was to describe trends in real-life treatment usage. For this purpose, patients from the ENEIDA registry who received their first targeted IBD treatment (biologics or tofacitinib) between 2015 and 2021 were included. A subsequent analysis with Machine Learning models was performed. The study included 10,009 patients [71% with Crohn’s disease (CD) and 29% with ulcerative colitis (UC)]. In CD, anti-TNF (predominantly adalimumab) were the main agents in the 1st line of treatment (LoT), although their use declined over time. In UC, anti-TNF (mainly infliximab) use was predominant in 1st LoT, remaining stable over time. Ustekinumab and vedolizumab were the most prescribed drugs in 2nd and 3rd LoT in CD and UC, respectively. Overall, the use of biosimilars increased over time. Machine Learning failed to identify a model capable of predicting treatment patterns. In conclusion, drug positioning is different in CD and UC. Anti-TNF were the most used drugs in IBD 1st LoT, being adalimumab predominant in CD and infliximab in UC. Ustekinumab and vedolizumab have gained importance in CD and UC, respectively. The approval of biosimilars had a significant impact on treatment

Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

Summary: Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols