Совместная работа в виртуальных средах с помощью проблемно-ориентированного обучения

El objetivo es potenciar una competencia crucial como es el trabajo colaborativo y en equipo de los alumnos mediante la utilización de entornos virtuales en el aprendizaje en las enseñanzas universitarias basado en problemas Resulta innegable que el trabajo en equipo y colaborativo fomenta la motivación de los estudiantes y favorece el aprendizaje, debido al propio efecto social que genera la pertenencia a un grupo. Contribuyendo, asimismo, al desarrollo de la capacidad de debate y argumentación, el razonamiento crítico y creativo o la organización de procesos de trabajo complejos, entre otras muchas competencias esenciales. El proyecto pone el foco en el trabajo colaborativo en entornos digitales dentro del aprendizaje basado en problemas y persigue favorecer un modelo de aprendizaje más participativo, mediante el uso de los recursos que nos ofrecen las nuevas tecnologías de la comunicación, aumentando la interacción de los estudiantes, incluso en entornos digitales. El trabajo colaborativo supone la creación de grupos integrados por varios estudiantes con, a priori, el mismo nivel formativo, y con una asunción compartida del liderazgo y la responsabilidad en el proceso de aprendizaje. El trabajo colaborativo se basa, además, en la autonomía de trabajo de sus integrantes que presentan funcionalidades y competencias heterogéneas, y que tienen que desarrollar y fortalecer elementos como la confianza, la comunicación, la gestión de conflictos y solución de problemas y la adopción de decisiones.The aim is to enhance a crucial competence such as collaborative and teamwork of students through the use of virtual environments in problem-based learning in university education. It is undeniable that team and collaborative work fosters students' motivation and favours learning, due to the very social effect that belonging to a group generates. It also contributes to the development of debate and argumentation skills, critical and creative reasoning or the organisation of complex work processes, among many other essential competences. The project focuses on collaborative work in digital environments within problem-based learning and aims to promote a more participatory learning model, through the use of the resources offered by new communication technologies, increasing student interaction, even in digital environments. Collaborative work involves the creation of groups made up of several students with, a priori, the same level of training, and with a shared assumption of leadership and responsibility in the learning process. Collaborative work is also based on the working autonomy of its members, who have heterogeneous functionalities and competences, and who have to develop and strengthen elements such as trust, communication, conflict management and problem solving and decision-making.L'obiettivo è quello di migliorare una competenza cruciale come il lavoro collaborativo e di gruppo degli studenti attraverso l'uso di ambienti virtuali nell'apprendimento basato su problemi nell'istruzione universitaria. È innegabile che il lavoro di gruppo e collaborativo promuova la motivazione degli studenti e favorisca l'apprendimento, proprio per l'effetto sociale che l'appartenenza a un gruppo genera. Contribuisce inoltre allo sviluppo delle capacità di discussione e argomentazione, del ragionamento critico e creativo o dell'organizzazione di processi di lavoro complessi, oltre a molte altre competenze essenziali. Il progetto si concentra sul lavoro collaborativo in ambienti digitali nell'ambito dell'apprendimento basato su problemi e mira a promuovere un modello di apprendimento più partecipativo, attraverso l'uso delle risorse offerte dalle nuove tecnologie di comunicazione, aumentando l'interazione degli studenti, anche in ambienti digitali. Il lavoro collaborativo prevede la creazione di gruppi composti da più studenti con, a priori, lo stesso livello di formazione e con un'assunzione condivisa di leadership e responsabilità nel processo di apprendimento. Il lavoro collaborativo si basa anche sull'autonomia di lavoro dei suoi membri, che hanno funzionalità e competenze eterogenee e devono sviluppare e rafforzare elementi come la fiducia, la comunicazione, la gestione dei conflitti, la risoluzione dei problemi e il processo decisionale.L'objectif est d'améliorer une compétence cruciale telle que le travail collaboratif et d'équipe des étudiants par l'utilisation d'environnements virtuels dans l'apprentissage par problème dans l'enseignement universitaire. Il est indéniable que le travail en équipe et en collaboration stimule la motivation des élèves et favorise l'apprentissage, en raison de l'effet social même que génère l'appartenance à un groupe. Elle contribue également au développement des capacités de débat et d'argumentation, du raisonnement critique et créatif ou de l'organisation de processus de travail complexes, parmi de nombreuses autres compétences essentielles. Le projet se concentre sur le travail collaboratif dans les environnements numériques dans le cadre de l'apprentissage par problèmes et vise à promouvoir un modèle d'apprentissage plus participatif grâce à l'utilisation des ressources offertes par les nouvelles technologies de communication, en augmentant l'interaction des étudiants, même dans les environnements numériques. Le travail collaboratif implique la création de groupes composés de plusieurs étudiants ayant, a priori, le même niveau de formation, et assumant ensemble le leadership et la responsabilité du processus d'apprentissage. Le travail collaboratif repose également sur l'autonomie de travail de ses membres, qui ont des fonctionnalités et des compétences hétérogènes, et qui doivent développer et renforcer des éléments tels que la confiance, la communication, la gestion des conflits, la résolution de problèmes et la prise de décision.Ziel ist es, durch den Einsatz virtueller Umgebungen beim problembasierten Lernen in der Hochschulbildung eine entscheidende Kompetenz wie die Zusammenarbeit und die Teamarbeit von Studierenden zu fördern. Es ist unbestreitbar, dass Team- und Kooperationsarbeit die Motivation der Schüler fördert und das Lernen begünstigt, und zwar aufgrund des sozialen Effekts, den die Zugehörigkeit zu einer Gruppe bewirkt. Sie trägt auch zur Entwicklung von Diskussions- und Argumentationsfähigkeiten, kritischem und kreativem Denken oder der Organisation komplexer Arbeitsprozesse bei, neben vielen anderen wichtigen Kompetenzen. Das Projekt konzentriert sich auf die kollaborative Arbeit in digitalen Umgebungen im Rahmen des problembasierten Lernens und zielt darauf ab, ein partizipativeres Lernmodell zu fördern, indem die von den neuen Kommunikationstechnologien gebotenen Ressourcen genutzt werden und die Interaktion zwischen den Studierenden auch in digitalen Umgebungen verstärkt wird. Bei der Zusammenarbeit werden Gruppen gebildet, die sich aus mehreren Studenten zusammensetzen, die von vornherein das gleiche Ausbildungsniveau haben und die gemeinsam die Leitung und Verantwortung für den Lernprozess übernehmen. Die Zusammenarbeit beruht auch auf der Arbeitsautonomie ihrer Mitglieder, die über heterogene Funktionen und Kompetenzen verfügen und Elemente wie Vertrauen, Kommunikation, Konfliktmanagement, Problemlösung und Entscheidungsfindung entwickeln und stärken müssen.O objectivo é reforçar uma competência crucial como a colaboração e o trabalho de equipa dos estudantes através da utilização de ambientes virtuais na aprendizagem baseada em problemas no ensino universitário. É inegável que o trabalho em equipa e em colaboração promove a motivação dos estudantes e favorece a aprendizagem, devido ao próprio efeito social que a pertença a um grupo gera. Também contribui para o desenvolvimento de capacidades de debate e argumentação, de raciocínio crítico e criativo ou para a organização de processos de trabalho complexos, entre muitas outras competências essenciais. O projecto centra-se no trabalho colaborativo em ambientes digitais no âmbito da aprendizagem baseada em problemas e visa promover um modelo de aprendizagem mais participativo através da utilização dos recursos oferecidos pelas novas tecnologias de comunicação, aumentando a interacção dos estudantes, mesmo em ambientes digitais. O trabalho colaborativo envolve a criação de grupos compostos por vários estudantes com, a priori, o mesmo nível de formação, e com uma assunção partilhada de liderança e responsabilidade no processo de aprendizagem. O trabalho colaborativo baseia-se também na autonomia de trabalho dos seus membros, que têm funcionalidades e competências heterogéneas, e que têm de desenvolver e reforçar elementos tais como confiança, comunicação, gestão de conflitos e resolução de problemas e tomada de decisões.Цель - повысить такую важную компетенцию, как совместная и командная работа студентов посредством использования виртуальных сред в проблемно-ориентированном обучении в университетском образовании. Неоспоримо, что командная и совместная работа повышает мотивацию учащихся и способствует обучению, благодаря тому самому социальному эффекту, который порождает принадлежность к группе. Она также способствует развитию навыков ведения дискуссий и аргументации, критического и творческого мышления или организации сложных рабочих процессов, а также многих других важных компетенций. Проект сосредоточен на совместной работе в цифровой среде в рамках проблемно-ориентированного обучения и направлен на продвижение модели обучения с более широким участием, посредством использования ресурсов, предлагаемых новыми коммуникационными технологиями, увеличивая взаимодействие студентов даже в цифровой среде. Совместная работа предполагает создание групп, состоящих из нескольких студентов, имеющих априори одинаковый уровень подготовки, и совместно принимающих на себя руководство и ответственность в процессе обучения. Совместная работа также основана на рабочей автономии ее членов, которые обладают разнородными функциональными возможностями и компетенциями, и которые должны развивать и укреплять такие элементы, как доверие, коммуникация, управление конфликтами, решение проблем и принятие решений.Depto. de Derecho del Trabajo y Seguridad SocialFac. de DerechoFALSEUniversidad Complutense de Madridsubmitte

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics

Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial

BackgroundSparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.MethodsPROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850.FindingsBetween Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals.InterpretationOver 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function

Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial

Background Sparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis. Methods PROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850. Findings Between Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals. Interpretation Over 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function.</p