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Position statement on longitudinal cracks and fractures of teeth.
Int Endod J
January 2025
Centre for Oral, Clinical & Translational Sciences, King's College London, London, UK.
This position statement is a consensus view of an expert committee convened by the European Society of Endodontology (ESE). The statement is based on current clinical and scientific evidence as well as the collective reflective practice of the committee. The aim is to provide clinicians with evidence-based, authoritative information on the aetiology, clinical presentation, and management of cracks and fractures that typically manifest along the long axis of the crown and/or root.
View Article and Find Full Text PDFGaps in the ethical governance of pharmaceutical clinical trials in Europe.
Front Med (Lausanne)
January 2025
Gispen4Regulatory Science Consultancy, Bilthoven, Netherlands.
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.
View Article and Find Full Text PDFTowards a sustainable set of European Core Health Indicators (ECHI).
J Health Monit
December 2024
National Institute for Public Health and the Environment (RIVM), Centre for Public Health, Healthcare and Society, Bilthoven, The Netherlands.
Background: The European Core Health Indicators (ECHI) are a set of 88 indicators that provide a compact overview of the extensive field of European public health and healthcare. The ECHI set adds value to European Union health information systems (HIS) for both Member States and EU-associated countries and the European Commission by providing a solid, comparable information base on national public health and healthcare trends and developments. The indicators allow for learning by comparison and the list supports the organisation of national health information systems.
View Article and Find Full Text PDFSupplemental Screening With MRI in Women With Dense Breasts: The European Perspective.
J Breast Imaging
January 2025
Department of Radiology, University of Cambridge School of Clinical Medicine, Cambridge Biomedical Campus, Cambridge, UK.
Breast cancer is the most prevalent cancer in women in Europe, and while all European countries have some form of screening for breast cancer, disparities in organization and implementation exist. Breast density is a well-established risk factor for breast cancer; however, most countries in Europe do not have recommendations in place for notification of breast density or additional supplementary imaging for women with dense breasts. Various supplemental screening modalities have been investigated in Europe, and when comparing modalities, MRI has been shown to be superior in cancer detection rate and in detecting small invasive disease that may impact long-term survival, as demonstrated in the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial in the Netherlands.
View Article and Find Full Text PDFPrevalence of lymphedema symptoms across cancer diagnoses and association with depression, pain interference and health-related quality of life.
Acta Oncol
January 2025
Danish Cancer Society National Cancer Survivorship and Late Effects Research Center (CASTLE), Department of Oncology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Background And Purpose: Lymphedema is a debilitating late effect of cancer treatments, yet its prevalence beyond breast cancer remains understudied. This study examined the prevalence of lymphedema symptoms across cancer diagnoses and their association with depression, pain interference, and health-related quality of life (HRQoL).
Patients/material And Methods: This cross-sectional study was conducted at the Department of Oncology, Copenhagen University Hospital, from February to April 2021, as part of a broader investigation into cancer-related late effects.
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