Purpose To describe European legal foundations, governance structures, and quality assurance mechanisms for bioethics committee approvals in multicenter laryngology research, and present a consensus framework to harmonize practice across Europe. Methods An expert panel used the Nominal Group Technique to define scope, review supranational and national regulations (including Regulation (EU) 536/2014 and GDPR considerations), and identify practical barriers in multicenter/multinational laryngology research. Consensus rounds prioritized reproducibility, feasibility, and harmonization of ethics review processes across jurisdictions. Results Regulatory context combines EU Regulation 536/2014 and GDPR with substantial national heterogeneity in REC/IRB structure and procedures. Core challenges include: (i) heterogeneity of documentation and approvals; (ii) ambiguity about single vs. multiple REC approvals in multicenter studies; (iii) limited guidance for registry-based and real-world data designs; and (iv) variable integration of data protection and ethics review. Key recommendations: clarify when single-country versus cross-border REC approvals are required; standardize documentation templates and timelines; align consent and data-handling with ethics review; provide governance for emerging study designs and biobanking; and promote EUlevel coordination to harmonize practices. Conclusions National variation challenges multicenter laryngology research in Europe. The European Laryngological Society provides a consensus framework to guide legal bases and quality assurance of REC approvals, aiming to improve efficiency, consistency, and ethical compliance.
Robot-assisted radical prostatectomy (RARP) is a widely adopted and effective treatment for localized prostate cancer. The Retzius-sparing approach (RS-RARP) has been shown to significantly improve early urinary continence recovery while maintaining comparable long-term oncological outcomes relative to the anterior approach. However, the impact of body mass index (BMI) on RS-RARP outcomes remains insufficiently investigated. The present study aimed to address this gap. A retrospective analysis was conducted on 596 patients who underwent RS-RARP between April 2016 and December 2023, including 197 normal-weight, 287 overweight, and 112 obese individuals. Perioperative, oncological, and functional outcomes were assessed. Estimated blood loss was significantly higher in obese patients. No statistically significant differences in urinary continence rates were observed at any time point. Immediate continence rates were 77
BACKGROUND AND OBJECTIVES:Neuromyelitis optica (NMO) is a CNS inflammatory disease that predominantly affects the optic nerves and the spinal cord. It is more frequent in Asian and African populations than in European ones. Data on epidemiology, clinical presentation, additional investigations, and treatment in the African continent are scarce. We aim to (1) collect and analyze published data on neuromyelitis optica spectrum disorder (NMOSD), (2) indicate challenges in the diagnosis and management, and (3) discuss opportunities for future research, education, and policy making, specifically on the African continent.METHODS:A systematic review was performed in January 2021 with the search terms "Neuromyelitis optica and Africa," "Devic Disease and Africa," and "NMOSD and Africa." We included all study types except case reports, correspondence, or conference abstracts on NMO or NMOSD. Extracted data included study design, country, study period, demographic and clinical characteristics, results of paraclinical investigations, and outcome. Data analysis was performed with descriptive statistics.RESULTS:We retrieved a total of 79 records, of which 19 were included. Ten of 54 African countries reported a total of 410 cases. Almost half of them were from North African countries. The mean age at diagnosis was 33 years (range 7-88 years), and 75% were female. Transverse myelitis followed by optic neuritis were the most frequent symptoms at the time of presentation. One hundred nineteen patients experienced at least 1 previous relapse, and 106 had a relapsing course after diagnosis. Relapses were treated with IV methylprednisolone. Azathioprine and steroids were used most often as maintenance treatments. Outcomes were rarely described.DISCUSSION:The majority of studies on NMOSD from the African continent are retrospective, and most countries do not report any data. Our systemic review shows that data derived from patients living in Africa correspond well to what has been previously published in meta-analyses on patients of African ancestry with NMOSD who live outside of Africa, except for a younger age at onset and a lower proportion of females. We advocate for systematic data collection to adequately capture and monitor the burden of NMOSD, for expansion of research efforts and facilities to perform fundamental and clinical research, and for improved access to health care including diagnostics, treatments, and rehabilitation services for people affected by NMOSD in the African continent.
This update and revision of the international guideline for urticaria was developed in accordance with the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. It is an initiative of the Global Allergy and Asthma Excellence Network (GA(2)LEN) and its Urticaria and Angioedema Centers of Reference and Excellence (UCAREs and ACAREs), with the participation of 210 delegates from 107 national and international societies, from 59 countries. The consensus conference was held on December 6th, 2024. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). Urticaria is a frequent, mast cell-driven disease, defined by a rapid appearance of wheals, angioedema, or both. The lifetime prevalence of acute urticaria is estimated to be approximately 20%. Chronic urticaria, categorized as either chronic spontaneous urticaria or chronic inducible urticaria, is disabling, impairs quality of life, and affects performance at work and school, however, novel therapies are available. This updated version of the international guideline for urticaria covers the definition and classification of urticaria and outlines expert-guided and evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria.
Metabolic dysfunction-associated steatohepatitis (MASH) is a multifactorial metabolic liver disease that occurs in the context of obesity, insulin resistance and cardiometabolic comorbidities. Monotherapy targeting single pathways often provides only partial improvements in histological liver fibrosis and systemic metabolic parameters, prompting growing interest in multitargeted combination therapies. Multitargeted and combination strategies for MASH can modulate multiple and complementary pathogenic processes, potentially improving efficacy, promoting liver fibrosis regression, optimising systemic metabolic outcomes and reducing treatment-related adverse effects. Liver-directed combination therapies, such as thyroid hormone receptor-beta (THR-β) agonists along with acetyl-CoA carboxylase (ACC) inhibitors or peroxisome proliferator-activated receptor agonists, aim to improve histological features of MASH. Regimens combining systemic metabolic and liver-specific agents, such as glucagon-like peptide-1 (GLP-1) receptor agonists with fibroblast growth factor-21 analogues or THR-β agonists, aim to optimise metabolic outcomes, including body weight, insulin resistance and plasma lipids. Thoughtfully designed drug pairings, such as diacylglycerol O-acyltransferase 2 inhibitors combined with ACC inhibitors or GLP-1 and glucagon receptor dual agonists, could improve safety and tolerability by leveraging complementary mechanisms that may mitigate adverse effects. These therapeutic strategies aim to achieve more comprehensive and durable improvements in both liver pathology and systemic health than single-agent therapy alone. This review integrates current knowledge on multitargeted and combination therapies for MASH, examines mechanistic rationales and emerging clinical evidence and addresses practical considerations for patient-centred implementation. Therefore, we aim to provide clinicians and researchers with a comprehensive framework to optimise individualised management and improve both hepatic and systemic outcomes in individuals living with MASH.
