Gaps in the ethical governance of pharmaceutical clinical trials in Europe.

The ethical governance of pharmaceutical clinical trials in Europe, particularly under Regulation 536/2014, is intended to ensure the safety, rights, and well-being of participants. Despite this regulatory framework, significant gaps in ethical oversight remain. This paper identifies five key deficiencies: (1) European regulations only partially address ethical imperatives set by international guidelines, thereby restricting the ethical mandate of relevant entities; (2) the role of research ethics committees is largely limited to pre-approval activities, reducing continuous oversight during trials; (3) GCP inspectors operate within a narrow scope regarding ethical oversight, which limits their ability to identify a broad range of unethical practices; (4) there is insufficient transparency and collaboration between RECs and regulators, specifically GCP inspectorates, leading to fragmented oversight; and (5) there is minimal integration of ethical findings into the marketing authorization decision process by entities such as clinical assessors and the CHMP.

Niche partitioning in a periphyton metacommunity peaks at intermediate species richness in midsized rivers.

The trait-based partitioning of species plays a critical role in biodiversity-ecosystem function relationships. This niche partitioning drives and depends on community structure, yet this link remains elusive in the context of a metacommunity, where local community assembly is dictated by regional dispersal alongside local environmental conditions. Hence, elucidating the coupling of niche partitioning and community structure needs spatially explicit studies.

The organizational challenges of municipal call centers as a health service in Norway-a multiple case study.

Background: To maintain sustainability in the health care system, technology such as social alarms and sensors has been implemented in people's homes with the goal of increasing independent living for elderly and multimorbid health care recipients. When implementing technology, someone needs to monitor and answer the alarms and calls, which is often coined 'telecare'. Many countries have organized telecare service in call centers, which in the health care domain is a service innovation.

Physical activity and content in a variety of physically active learning: an observational case study of real-world practices.

Background: Research on physically active learning (PAL) has mainly been investigated experimentally, where interventions have been introduced to study effects on, for example, physical activity (PA) levels. This might undermine real-world contexts and realistic PA levels when teachers have sustained PAL in their regular teaching practice for several years. The purpose of this study was to observe and describe the organization and content of a variety of teaching where PAL was enacted by experienced teachers and to describe the corresponding PA levels and PA intensity in real-world practices.

Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial.

Objective: This protocol paper describes the rationale and design of a randomised controlled trial (RCT) that aims to evaluate the (cost-)effectiveness of a 12 week e-self-management intervention (Happy Hands app) in people with hand osteoarthritis (HOA).

Methods: In this multicentre RCT, 376 people with HOA will be recruited from all four health regions in Norway. Consenting participants will be randomly allocated to either a control group receiving usual care or an intervention group receiving the Happy Hands app in addition to usual care.

Turning nursing students' mistakes into resources for learning in simulation-based training: facilitators' assumptions about providing feedback in debriefing.

Background: The aim of this study was to investigate how facilitators approach and use nursing students' mistakes in simulation-based training as learning resources in the simulation debriefing phase. Facilitators are responsible for raising students' awareness of their performances during the debriefing and facilitating reflections on their performances, including satisfactory behaviours and performance gaps. Research on facilitators' work during debriefing has highlighted various challenges, such as providing a safe and constructive climate among novice students while simultaneously teaching them the correct procedures, methods, and knowledge of caring practices to become professional nurses.

Navigating the complexity of emergency department care coordination: A qualitative exploration of adaptive strategies using a tabletop sandbox simulation.

Emergency departments accommodate high-acuity patients in complex, high risk environments with high variability in patient flow and resource availability. Strategies for enabling adaptive capacity are necessary for adjusting activities in response to the variability of overall workload and individual patient acuity. This study aims to identify and describe the strategies used by lead-nurses to inform recommendations for training and education.

Prevalence and Regional Variations of Visual and Auditory Impairments Among Elderly Individuals in the Faroe Islands: A Cross-Sectional Study.

Introduction: Aging is associated with the potential onset of vision and hearing problems, affecting the quality of life and functional independence of older adults. This study sought to investigate the prevalence of various vision and hearing problems in 76-year-old Faroese individuals and examine possible regional variations in these health issues.

Materials And Methods: A cross-sectional study design was used, surveying 175 participants, all 76-year-olds, from different regions in the Faroe Islands.

Foucault's Social, Community, and Cultural Psychology.

In today's debate about a user oriented humanistic turn in the field of mental health care, the early Foucault is once again relevant. In his works from 1954 Foucault shows that the root of understanding mental phenomena is not to be found in universal medical concepts and methods, but in the reflection on lived experiences and in the human being itself. In accordance with contemporary social, community, and cultural psychologists, such as Brinkmann, Kinderman and Prilleltensky, Foucault is critical to the psychology's medical foundations.

Correction: Acceptability and Initial Adoption of the Heart Observation App for Infants With Congenital Heart Disease: Qualitative Study.

[This corrects the article DOI: 10.2196/45920.].

Illuminating the hidden cost: A systematic review of cognitive late effects regarding cancer-related fatigue in treated paediatric brain tumors.

Objective: Globally, in 2022, 30,871 children were diagnosed with CNS-tumors. Many have been treated with radiotherapy, and a significant number suffer from chronic late effects, including fatigue. This study aims to investigate previous research on the impact of cancer-related fatigue for neurocognitive function that can be related to radiotherapy in patients who have undergone primary brain radiotherapy before the age of 18.

Steps towards a New Humanism in the Mental Health Disciplines - An Interview with Tim Ingold.

This interview article explores how British anthropologist Tim Ingold's work can inspire innovation in mental health and the psy disciplines. Ingold critiques dominant biomedical and individualistic approaches, arguing for the importance of caring attentiveness and abolishing dichotomies like those between surface and depth, when engaging with people to understand and assist them. Instead, he suggests viewing human existence as correspondences with environmental, social, and relational others.

Human Footprint and Forest Disturbance Reduce Space Use of Brown Bears (Ursus arctos) Across Europe.

Three-quarters of the planet's land surface has been altered by humans, with consequences for animal ecology, movements and related ecosystem functioning. Species often occupy wide geographical ranges with contrasting human disturbance and environmental conditions, yet, limited data availability across species' ranges has constrained our understanding of how human pressure and resource availability jointly shape intraspecific variation of animal space use. Leveraging a unique dataset of 758 annual GPS movement trajectories from 375 brown bears (Ursus arctos) across the species' range in Europe, we investigated the effects of human pressure (i.

Corrigendum: The call for an "educational footprint" in conceptualizing mental health and psychosocial support: the case of Norwegian kindergarten teachers.

[This corrects the article DOI: 10.3389/fpsyg.2024.

The Caregiver Pathway Intervention Can Contribute to Reduced Post-Intensive Care Syndrome Among Family Caregivers of ICU Survivors: A Randomized Controlled Trial.

Objectives: Explore short-term effects of "The Caregiver Pathway," an intervention for family caregiver follow-up, on Post-Intensive Care Syndrome symptoms among families (PICS-F).

Design: A randomized controlled trial.

Setting: A medical ICU at a Norwegian University Hospital.

Multicultural doula support and obstetric and neonatal outcomes: a multi-centre comparative study in Norway.

Background: Migrant women face an increased risk of poor obstetric and neonatal outcomes. Norway implemented a multicultural doula (MCD) program in 2018, which was designed to improve pregnancy care for this group in vulnerable circumstances. This study aimed to assess the impact of MCD support, provided in addition to standard care, on obstetric and neonatal outcomes for selected newly arrived migrants.

Brief Outpatient Rehabilitation Program for Post-COVID-19 Condition: A Randomized Clinical Trial.

Importance: Post-COVID-19 condition (PCC) is emerging as a common and debilitating condition with few treatment options.

Objective: To assess the effectiveness of a brief outpatient rehabilitation program based on a cognitive and behavioral approach for patients with PCC.

Design, Setting, And Participants: Patients with mild to moderate PCC were randomized 1:1 to an established transdiagnostic rehabilitation program or care as usual at a single referral center recruiting from the region of the South-Eastern Norway Regional Health Authority.

Integrating sensory assessments in preventive home visits: a cross-sectional study of the Faroe Islands.

Sensory impairments, including hearing and vision loss, are common in older adults and can affect quality of life. This study examines the integration of hearing and vision assessments in preventive home visits (PHVs) for older adults in the Faroe Islands, comparing outcomes between urban and rural settings. To evaluate the feasibility of including sensory assessments in PHVs and compare sensory measurements between Tórshavn (urban) and rural districts.

Narratives of health-promoting experiences by older husbands and wives providing care to their home-dwelling spouses receiving home-care services in Norway.

Background: In today's healthcare systems, older family caregivers who care for their spouses at home are indispensable providers of healthcare. However, many of these caregivers are at risk of becoming ill themselves. To prevent this and to guide the development of targeted healthcare services, home-care personnel need knowledge on how to promote the health of older family caregivers.

Norwegian adaptation of the Quality in Psychiatric Care - In-Patient instrument: psychometric properties and factor structure.

Background: Validated instruments measuring the quality of mental healthcare from patients' perspectives are scarce, and available instruments have been requested. One of the few instruments measuring the quality of care from a patient's perspective is the Swedish Quality in Psychiatric Care-In-Patient (QPC-IP). This cross-sectional study aimed to translate and adapt the QPC-IP instrument for a Norwegian context and assess its psychometric properties.

Biofilm application for anaerobic digestion: a systematic review and an industrial scale case.

Biofilm is a syntrophic community of microorganisms enveloped by extracellular polymeric substances and displays remarkable adaptability to dynamic environments. Implementing biofilm in anaerobic digestion has been widely investigated and applied as it promotes microbial retention time and enhances the efficiency. Previous studies on anaerobic biofilm primarily focused on application in wastewater treatment, while its role has been significantly extended to accelerate the degradation of lignocellulosic biomass, improve gas-liquid mass transfer for biogas upgrading, or enhance resistance to inhibitors or toxic pollutants.