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Growing evidence exists about the pivotal role of immune mechanisms in the physiopathology of atrial fibrillation (AF). Drugs that modulate the immune system (immunomodulators) may contribute to the development of AF. We aimed to identify immunomodulators that are associated with AF to better define their safety profile, and elucidating their mechanisms of action could yield novel insights into AF’s immune physiopathology.
A descriptive and disproportionality analysis of claims data.
World pharmacovigilance database VigiBase until 1 March 2025.
First, we ascertained the association of immunomodulators with AF over-reporting with a disproportionality analysis evaluating the multivariable-adjusted reporting odds ratio (aROR) for AF reporting performed for 141 immunomodulators in VigiBase. Then, a literature review was done to explore the underlying mechanisms of AF through immunomodulator mechanisms.
A total of 6 148 556 reports encompassing at least one of the 141 immunomodulators were identified in Vigibase. Our primary analysis revealed 20 immunomodulators associated with AF over-reporting. The three immunomodulators with the greatest signal were: recombinant interleukin-11 with an aROR=20.91 (99.96% CI 12.08 to 36.17), efgartigimod alfa with an aROR=6.75 (99.96% CI 3.96 to 11.52) and recombinant interleukin-2 with an aROR=6.15 (99.96% CI 3.62 to 10.45). A derivative literature review posited a hypothetical immune ‘vicious circle’ promoting AF, involving T helper cells, macrophages and natural killer cells which could lead to electrophysiologic and histologic atrial remodelling.
Twenty Food and Drug Administration (FDA)-labelled immunomodulators are associated with AF overreporting in Vigibase with a substantial signal on recombinant IL-11. These data contribute substantively to the prevailing understanding of the safety profile of these immunomodulators. Moreover, these findings support a multidirectional interaction between the immune system and AF development and might lead to considering future therapeutic targets.
To examine the conceptual ambiguity of nursing leadership, particularly in relation to management roles, and to propose a multilevel competency framework that redefines leadership as a core dimension of nursing practice. The paper introduces an innovative hybrid Iceberg–Alles model that integrates observable competencies with deeper motivational, ethical and personality-based attributes.
Integrative review.
Two-stage evidence identification process informed by theoretical reflection and existing evidence on nursing leadership and management.
A literature search was conducted in targeted databases such as PubMed, Scopus, Web of Science, CINAHL and extended to Google Scholar and grey literature.
Current understandings of nursing leadership are fragmented and often limited to managerial skills, overlooking crucial aspects such as ethical commitment, personal values, interpersonal skills and relational capacities. The hybrid Iceberg–Alles model reconceptualizes leadership as a multidimensional construct that balances visible skills with underlying drivers such as motivation, self-awareness and value alignment, offering a more comprehensive basis for leadership development.
Nursing leadership should be understood as a relational and value-based process embedded across all levels of practice, not confined to formal administrative positions. The proposed model enhances conceptual clarity and provides a transferable framework that can be adapted across diverse health systems, roles and organisational structures.
Broadening the scope of nursing leadership can reduce role ambiguity, highlight the unique contribution of nurses to healthcare systems, and strengthen the profession's influence in policy and decision-making. The hybrid model provides concrete guidance for educational programmes, competency-based curricula and organisational strategies aimed at preparing future nurse leaders to manage complexity, promote collaboration and improve patient care.
This manuscript followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines (PRISMA-ScR).
This study did not include patient or public involvement in its design, conduct or reporting.
Vital signs such as heart rate (HR) and respiratory rate (RR), crucial for clinical assessment, are often challenging to measure in paediatric populations. Remote photoplethysmography (rPPG), a video-based measurement tool, has demonstrated accuracy in adults. The objective of this study is to compare HR and RR measurements obtained using rPPG with those from standard clinical monitoring in a paediatric population.
This is a monocentric, prospective study enrolling 600 paediatric participants. Each participant will have standard monitoring electrodes (ECG/impedance) placed on the chest while seated facing a camera for rPPG recording. Simultaneous HR and RR measurements will be recorded over periods of 30 and 60 s using both the standard monitor and the rPPG device. The intraclass correlation coefficient will be calculated to assess agreement between the rPPG and standard monitor measurements.
The study protocol has been approved by the French Agency for the Safety of Health Products (ANSM (Agence nationale de sécurité du médicament) registration no. IDRCB 2023-A02524-41) and by a French ethics committee (CPP Sud Méditerranée III at 29 August 2024, n°2024-A01324-43). The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences and through press releases.
Clinical Trials Registry (NCT06231654).
Early childhood caries (ECC) continues to be a public health problem. The application of silver diamine fluoride (SDF) is a simple, non-invasive procedure. This study aims to evaluate SDF’s effectiveness, acceptability and oral health-related quality of life (OHRQoL) compared with atraumatic restorative treatment in managing ECC.
An open-label parallel superiority randomised clinical trial will be conducted involving children aged 2–5 years. Participants will include children with at least one active cavitated lesion (ICDAS 5+) of their primary teeth, with no signs of pulp involvement. The trial will occur at preschools in the La Araucanía and Metropolitan Regions of Chile from 2025 to 2027. The primary outcome variable will be the caries lesion arrest, acceptability and OHRQoL. We will also determine the presence of any adverse effects. Evaluations will be carried out at 6 and 12 months. A sample of 234 teeth with carious lesions per group is estimated. The primary inferential analysis will be performed on an intention-to-treat basis; a per-protocol analysis will be conducted for adverse effects. For caries lesion arrest, a multilevel logistic regression model adjusted for significant covariates will be used to account for within-child clustering. The acceptability will be assessed through quantitative and qualitative methods. The magnitude of change in OHRQoL between baseline and follow-up will be quantified using effect size estimates derived from the early childhood health impact scale survey data.
This study’s implementation benefits the study population, and the ethical principles of research have been considered and approved by the Science Committee of the University, Resolution N°049_19. The results and conclusions of the clinical trial will be published in academic conferences and peer-reviewed journals.
by John Paul G. Kolcun, Ricky M. Ditzel Jr, Bradley L. Kolb, Ricardo B. V. Fontes, P. B. Raksin
Study designRetrospective chart review.
ObjectiveDescribe safety/feasibility of implementing a novel clinical protocol for acute spinal cord injury (SCI) management.
Summary of background dataSpinal cord perfusion pressure (SCPP) has emerged as a promising target for the medical management of SCI patients. We report our early experience implementing a pragmatic SCPP-driven clinical protocol to supplant conventional mean arterial pressure (MAP) monitoring in the setting of acute SCI.
MethodsWe retrospectively reviewed charts of all SCI patients managed by our SCPP protocol since its adoption at two clinical sites as of 2/1/2023. The SCPP protocol was applied for all adult SCI patients of any injury grade, at any injury level with cord tissue involvement. Intrathecal pressure (ITP) was transduced by lumbar drain (LD). MAP was determined from invasive blood pressure recordings. SCPP was calculated as the difference between MAP and ITP, with an SCPP goal of >65mmHg.
ResultsEighteen patients have been treated since our SCPP protocol was adopted. Patients were predominately male (77.8%); the average age was 52.0 ± 16.2 years. Most injuries involved the cervical segment (72.2%), all of which were manifest clinically as central cord syndrome. The most common presenting injury severity was ASIA Impairment Scale D (44.4%).All patients underwent surgical intervention. There were no complications related to surgery, LD placement, or LD maintenance/ITP transduction during hospitalization. The SCPP protocol was continued for an average 5.2 ± 1.8 days. Eight patients required vasopressor support (44.4%) during that period, for an average 3.1 ± 2.1 days. Five patients underwent therapeutic CSF drainage to augment SCPP (27.8%). All patients maintained an average SCPP above goal for the duration of monitoring.
ConclusionsThis study further establishes the safety and feasibility of monitoring SCPP via LD measurement of ITP in acute SCI patients treated by clinical protocol at two clinical sites. There were no complications related to LD placement/maintenance or SCPP monitoring.
Yoga has been shown to improve pain and function compared with no exercise in people with chronic low back pain (LBP), but treatment effects are small. Given that yoga is a mind–body intervention that addresses physical as well as psychological factors, it may be more effective for patients with chronic LBP who are at high risk of poor prognosis. The study aims to investigate the efficacy of a 12-week yoga programme combined with education in reducing pain and disability for individuals with chronic LBP at high risk of poor prognosis at short (12 weeks) and intermediate (24 weeks) terms, compared with a control group receiving education only.
A randomised controlled trial will include 110 adults with chronic non-specific LBP reporting an average pain intensity of 3 points or more on a 0–10 scale over the past week and classified as high risk of poor prognosis (ie, scoring 50 points or above) on the Orebro Musculoskeletal Pain Questionnaire short-form. Participants in the control group will receive an educational booklet and attend three face-to-face lectures over a 3-month period. In the intervention group, in addition to the booklet and lectures, participants will attend group yoga sessions twice a week for 12 weeks, totalling 24 yoga sessions. The primary outcome is disability assessed at 12 weeks, measured using the Roland-Morris Disability Questionnaire.
The study was approved by the Human Research Ethics Committee of Universidade Federal de Minas Gerais (Protocol number CAAE: 57028022.0.0000.5149). Findings will be disseminated to trial participants, clinicians and the broader public and scientific community.
The study aimed to translate the PUKAT 2.0 tool from English to Italian. This was an adaptation and validation study; the validity of the Italian version was determined through content validity, item validity and construct validity. The reliability of the instrument was assessed by conducting a test–retest analysis on a sample of 62 nurses. The I-CVI indices were above the threshold of 0.78 for 91% of the questions, and according to the S-CVI index, 96% of the evaluators agreed that the questionnaire was highly relevant. The overall values for item difficulty were good, with two items being too difficult and none being too easy. The item discriminant index was overall good and reasonable, low for four items. The overall ICC was poor to moderate with a value of 0.48 (95% CI 0.26–0.65). The instrument has proven to be a good starting point although not yet completely reliable, as it clearly requires more basic preparation on the part of the staff, further modifications regarding the reliability and clarity of the questions and more training of the nursing staff if it is to be used in the Italian context.
Epidermolysis bullosa (EB) is a group of rare genetic skin disorders characterised by skin and mucosal fragility, leading to painful blisters and erosions. Among its subtypes, the severe form of EB simplex (EBS-sev, OMIM 131760) is associated with widespread blistering from birth, mucosal involvement and increased neonatal mortality due to infections. EBS is primarily caused by dominant mutations in the KRT5 or KRT14 genes.
There is currently no curative treatment for EBS; management is symptomatic and multidisciplinary. Our recent data indicate that EBS-sev is associated with an inflammatory profile involving elevated levels of Th17-polarising cytokines (TGF-β, IL-6, IL-21), suggesting a role for the Th17 immune response in disease pathogenesis.
EBULO is an open-label, multicentre phase 2 study, over a 20-week period, to evaluate the oral daily intake of apremilast (dosage depending on the age and the weight of patients) based on a challenge/dechallenge/rechallenge design. Patients are evaluated during five on-site visits, and apremilast is administered for 16 weeks during two treatment periods, with a 4-week treatment interruption in between. The primary outcome will be to assess the efficacy of apremilast in the treatment of patients with EBS-sev evaluated by counting the number of new blisters, a method specifically developed for this protocol to overcome the lack of reliable assessment tools in EBS-sev. The secondary outcome will include assessing the safety and tolerability of apremilast treatment through the description of the specific events occurring during the treatment periods of the study.
The French Ethical Review Authority has approved the EBULO trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.
Despite having more medical and social vulnerabilities than men with substance use disorder (SUD), women with SUD are underrepresented in addiction healthcare structures. This is because they experience double stigma—from society (including the medical community) and from themselves—which hinders them from accessing healthcare.
Using a mixed-methods approach, the main objective of the Calliope study is to explore and compare healthcare satisfaction among women with SUD according to the category of healthcare structure they attend: specialised addiction centres versus primary care centres called ‘microstructures’. A total of 240 women receiving care for SUD will be included in the study, with equal representation from specialised addiction centres and ‘microstructures’. All participants will complete a standardised questionnaire to collect quantitative data. Additionally, a subsample of 40 women will be selected to participate in in-depth, semistructured interviews to gather qualitative data. Additionally, focus groups will be conducted with healthcare professionals to explore their perspectives and practices.
Calliope was reviewed and approved by the institutional ethics committee of Paris Cité University (IRB: 00012024–02). The study’s findings will provide a greater understanding of the characteristics, needs and satisfaction with healthcare of women with SUD living in France. Moreover, they will help guide the development of tailored therapeutic interventions for this population.
Objetivo principal: Evaluar la factibilidad de la aplicación de la técnica de canalización eco-guiada por enfermería en el servicio de neonatología. Metodología: Estudio observacional descriptivo prospectivo realizado entre mayo de 2018 y enero de 2020 en una UCI Neonatal. Resultados principales: Se registraron 55 canalizaciones, con tasa de éxito del 94,55%. La media de edad gestacional, peso y días de vida fue de 32+3SG (24-41), 2410gr (560-4450) y 19días (0-124), respectivamente. No encontramos diferencias significativas en relación con el éxito de la canalización y las características del neonato. Conclusión principal: La técnica eco-guiada ha demostrado ser útil en el paciente neonatal con acceso venoso complejo. El desarrollo de esta técnica es de interés para la enfermería neonatal y justifica la creación de un equipo de enfermería especializado.
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