Liliana Pérez

Decentralised clinical trial (DCT) approaches are characterised by moving operational procedures from the traditional on-site setting to the participant’s immediate surroundings through the use of digital tools. DCTs have received increased interest in recent years. In this article, a SWOT analysis was carried out to identify the strengths, weaknesses, opportunities, and threats for DCT approaches from an ethical, legal, regulatory and operational perspective, as compared to conventional clinical trials (CCTs). During a two-day workshop organised on 5 and 6 April 2022 at Utrecht University, a group of 10 experts from the IMI project Trials@Home identified 8 key trial activities (KTAs) which operational procedures differ between DCTs and CCTs and carried out a SWOT analysis for each activity separately: implementation of decentralised/remote (electronic) informed consent; decentralised screening of potential trial participants; home health visits; telemedicine visits; participant’s self-monitoring; delivery and return of investigational product; clinical trial oversight; and remote safety monitoring. These analyses were categorised to form an overall SWOT analysis for DCTs. The analysis revealed 48 strengths, 62 weaknesses, 5 opportunities, and 13 threats across the eight KTAs. Categorisation distilled these into 11 strengths, 13 weaknesses, 2 opportunities, and 4 threats for DCTs. The use of digital technologies, lack of face-to-face contact and harmonisation of regulation were the most targeted issues. DCTs offer potential advantages, such as remote participation, greater autonomy in decision-making, simplified monitoring and access to diverse populations. However, challenges include digital technology barriers, reduced face-to-face contact, difficulties in identity verification and privacy issues. Addressing these challenges requires adequate training of participants and healthcare professionals, robust identity verification methods, strong security measures, and adaptation of communication and procedures. A hybrid approach combining traditional and decentralised elements seems feasible at this stage. Future research should explore the identified strengths and weaknesses of DCTs, propose ethical solutions to remaining challenges and ensure the inclusion of diverse stakeholders.

This article explores the ethical and legal challenges of death by neurological criteria (DNC) in a 20‐week pregnant patient, focusing on the tension between patient autonomy and fetal well‐being. Through an educational clinical case, it analyzes the clinical, bioethical, and legal aspects, considering advance directives, family expectations, and biomedical possibilities. The case raises ethical concerns about the instrumentalization of the woman's body when prolonging life support during pregnancy. The analysis emphasizes the importance of respecting the patient's autonomy and ensuring posthumous dignity. It also highlights the role of interdisciplinary teams in balancing clinical, ethical, and emotional factors in decision‐making. The discussion underscores principles such as autonomy, best interests, and proportionality, promoting ethical management aligned with individual values. Finally, it offers practical tools for healthcare professionals facing similar situations, fostering comprehensive family support and informed bioethical deliberation.

En el presente trabajo se indaga sobre la concepción ciceroniana del lenguaje en la relación gramática-retórica. El abordaje toma como un punto de partida las concepciones estoicas referentes al lenguaje, para marcar el distanciamiento de la retórica latina y la constitución de una estética de la palabra en vistas a la persuasión. Conformada esta perspectiva, se avanza en el estudio de la relación entre dialéctica y retórica y la consiguiente definición de elocuencia, en la concepción de oratio como elaboración artística y como artificio que concluye en el oyente.

© 2015, Springer Science+Business Media Dordrecht.Planted woodland islets act as sources of seed that may accelerate woodland development in extensive agricultural landscapes. We assessed a 1-ha plot that was planted with 16 100-m2 islets of holm oak Quercus ilex subsp. ballota seedlings near Toledo in 1993. In spring 2014 we measured acorn predation and seedling emergence from seeded acorns at different distances from and orientations around the islets with half of the acorns protected to prevent predation, survival of emerged seedlings, and natural tree establishment outside of the planted islets. Most unprotected acorns were removed or predated. Seedling emergence from protected acorns ranged from 42.9 % on the northern side of the islets to 13.2 % on the southern side, suggesting a less stressful microclimate on the northern side. Survival of naturally established seedlings was 28.6 % by the end of first summer; seedling mortality was chiefly due to drought and herbivory. Density of emerged seedlings, surviving seedlings after first dry season, and established oaks >1-year old was similar at different distances from the islets. Over the 21 year time period, 58 new oak individuals >1-year old have established at an average distance of 6.3 ± 5.4 m away from the closest islet. We conclude that initial oak regeneration triggered by small planted islets in Mediterranean abandoned farmland is slowed down by high acorn predation, seedling herbivory, and stressful microclimatic conditions. Regardless, these islets are a viable tool for regeneration of Mediterranean oak woodland.