CONSCIOUS curriculum projects

Rychlickova, J., Batuca, J. R., Nagy, V., Shiely, F., Cechova, Z., Nebeska, K., Souckova, L., Mouly, S., Kovács, G. L., Németh, A., Oliveira, T., Painho, M., Maia, S., & Monteiro, E. C. (2023). Building key competencies clinical trialists of the future: CONSCIOUS curriculum projects. Poster session presented at ORPHEUS2023, "Putting the i’s and o’s in Doctoral Training; International, Intersectoral, Interdisciplinary, and Open Science", Leuven, Belgium. --- This work was supported by the Erasmus+ Programme of the Europe Union (2018-1-HU01-KA203-047811 and 2021-1-CZ01-KA220-HED-000023177).Investigator-initiated clinical trials (IIT) are a broadly interprofessional field that is becoming increasingly relevant to biomedical postgraduate students, especially to validate their research question in clinical practice. Indeed, IIT represent a way to develop individualized treatment and obtain objective evidence to answer questions of day-to-day practice. On the other hand, IIT place greater demands on investigators as they extend their position to include the coordination and management role of the sponsor. At the same time, little formal training in clinical trials is available across European countries in both undergraduate and postgraduate education, and the understanding of biomedical graduates in clinical research organization may not be optimal. A consortium of six European universities was established to fill this gap by preparing a highly practice-based and -oriented curriculum within two consequent projects – CONSCIOUS and CONSCIOUS II. Especially the CONSCIOUS II is focused on postgraduate students and provides them with e-learning lessons of practical guidance on how to design a research question and a clinical trial, the regulatory requirements that need to be met, how to conduct the trial, what activities can be delegated, and how to analyze the results. The second part targets transdisciplinary skills such as leadership, publishing, and teaching. The CONSCIOUS II pedagogical approach moves on to contextualized, case-based exercises allowing to test the acquired skills in simulated situations. Both CONSCIOUS projects thus offer a comprehensive, free-of-charge curriculum for biomedical students but will also open a pilot course with international participation as a further extension of this curriculum.publishersversionpublishersversionpublishe

Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Evaluation of the potential for caesium transfer from contaminated soil to the food chain as a consequence of uptake by edible vegetables

This paper analyzes the effect of caesium (Cs) concentration on seed germination, seedling growth, root uptake, and leaf uptake of Lactuca sativa to understand the potential transfer of the metal from contaminated soil to humans through the food chain. The results of germination experiments show that seed germination and seedling growth strongly depend on increasing Cs concentration, with a decrease in the number of germinated seeds compared to the control up to 13.6% and a reduction in seedling growth up to 10.3% at the highest Cs tested concentration (15 mM). Uptake experiments indicate a low transfer of Cs from soil to leaves and roots of the plants, ranging between 0.06% and 2.2%. The transfer is found to be a not-monotone function of soil potassium (K) content, with highest values corresponding to 1-2 mM K2SO4. Increasing concentrations of K lead to lower translocation of Cs from roots to leaves. Values above the average amount applied (20 and 40 mM K2SO4) almost stop the translocation, suggesting the use of a high amount of K2SO4 protects the food chain from Cs contamination