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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.
Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.
The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.
Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.
The optimal strategy for induction of labour (IOL) in cases of prelabour rupture of membranes (PROM) with an unfavourable cervix is elusive. No study conducted in nulliparous women has shown any one induction method to be superior to any other. In this project, we seek to determine whether IOL with balloon catheter and oxytocin can (1) increase rate of delivery
We are conducting a multicentre, randomised, controlled, open-label therapeutic trial with two parallel arms on nulliparous women with unfavourable cervix showing PROM at term without spontaneous labour.
After 12 hours of PROM, women are randomly assigned to one of two study groups. One group is treated with a balloon catheter for 12 hours, with oxytocin administered after 6 hours. If the balloon is expelled earlier than 6 hours after insertion and the cervix is still unfavourable, another balloon is placed. The other group (control) is treated with 25 µg oral PGE1 every 2 hours until labour starts. After a maximum of eight administrations and a timelapse of 4 hours, if there are no effective uterine contractions, the induction is continued with oxytocin infusion and epidural analgesia if the patient requests it. A total of 520 women will be recruited in five university hospitals in France and randomised at a 1:1 ratio with stratification by study centre.
Main inclusion criteria are nulliparous women with gestational age ≥37 weeks, PROM without labour beyond 12 hours, unfavourable cervix (Bishop score
The hierarchical primary endpoints are: (1) Proportion of patients vaginally delivered
The RUBAPRO2 trial was approved by the French national agency for drug safety and committee for protection of persons involved in biomedical research on 15 September 2022. Informed written consent will be obtained from all participants.
To explore current evidence regarding the provision of palliative care for individuals with very severe to extreme behavioural and psychological symptoms of dementia (BPSD) in a hospital setting.
Scoping review.
The PRISMA-ScR reporting guideline.
The JBI guidelines for scoping reviews were followed. A data extraction form assisted in the identification of key findings via a process of content analysis.
Studies were obtained from bibliographic databases of PubMed, CINAHL, and PsycINFO.
This review included six articles, and nine categories emerged from the findings. Symptom assessment and management, pain assessment challenges, atypical presentation of end-stage dementia, complex prescribing and treatment practices, principles of person-centred care, collaboration; training for health care professionals; emotional impact on staff; and family and caregivers.
This scoping review highlighted a significant gap in the literature regarding palliative care for people living with very severe to extreme BPSD in hospital settings. This review highlighted key differences in the presentation of people with BPSD needing palliative care. There is a need for tailored models of care, specialised training and education for health professionals, families, and carers, and recognition of dementia as a terminal illness.
The results of this review provide valuable insights into the level of understanding about the unique palliative care needs for people experiencing very severe to extreme BPSD, making an important contribution to the planning and development of future models of care.
Mapping the available literature highlights a paucity of research in palliative care for people with very severe to extreme BPSD in hospital settings. There is a need for rigorous research studies and models of care developed and informed by the evidence for this small population necessitating unique care needs.
No patient or public contribution.
Obesity is a prevalent multifactorial disease worldwide that has become a major public health concern. Excess adiposity poses a health risk because it is related to several chronic diseases, which impact the person’s quality of life and present a greater risk of mortality. This study presents a protocol to evaluate the effectiveness of the Energy2MOB programme (Improvement of Obesity) in reducing body weight (between 5%–10%) in adults with obesity with a multicomponent group intervention of food education and physical activity.
Randomised clinical trial with two groups (control and intervention) of 1 year, which includes people from the Berguedà health region between 18 and 65 years old with grade II overweight (body mass index (BMI) between 27–30 kg/m2) or obesity (BMI between 30–40 kg/m2). Accepting an alpha risk of 0.05 and a statistical power >0.8 in a bilateral contrast, 68 subjects in each group are needed to detect a difference equal to or >2.5 kg.
The protocol was approved by the Ethics Committee of the University Institute for Research in Primary Care (IDIAP Jordi Gol) with the CEIm code: 24/303-P. The IDIAPJGol CEIm complies with the standards of Good Clinical Practice and with the current legislation that regulates its operation. The protocol complies with the ethical principles of the Declaration of Helsinki and applicable data protection regulations. All participants will provide written informed consent before participating. The dissemination plan includes presenting the results at national and international scientific conferences, publication in peer-reviewed journals, and sharing a plain-language summary with all participants through their primary care centres. Key findings will also be shared with local health authorities and community health professionals to inform future interventions on obesity prevention and management.
Children with limited access to dental care can be negatively impacted by reduced frequency of oral health monitoring, delays in diagnosis of dental disease and increased waits for dental care, resulting in them experiencing more disease (extent and amount). Smartphone-based intraoral photography has been cited as having the potential to improve oral health monitoring for children through screening; however, it has not been well evaluated, and its limitations are unclear. The picture-perfect study aims to assess diagnostic accuracy, feasibility and acceptability to determine whether remote photographic monitoring can be effectively integrated into pathways of dental care for children aged 6-16 years.
Observational, cross-sectional, mixed-methods study with three workflows: Workflow 1: development of user-friendly, comprehensive guidance to help parent/carers (parents) take high-quality intraoral photographs of their children’s mouths. The guidance will be codesigned with parents and healthcare professionals. Workflow 2: diagnostic accuracy using intraoral photographs taken by a parent of their children will be evaluated by comparing clinicians' diagnoses from the photographs to gold-standard clinical visual-tactile examinations. Parent–child dyads (n=110) will be recruited to capture intraoral photographs using positioning aids, guidance and smartphones provided by the research team. The diagnoses will focus on plaque accumulation, gingival health, restoration status and dental caries. Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value, negative predictive value and area under the curve. Workflow 3: assessment of feasibility and acceptability will be through task completion rates, photograph quality and participant feedback. Qualitative interviews and an online survey will capture parents’ and children’s experiences. Observational data will provide insights into practical challenges.
This study, approved by the National Health Service (NHS) Research Ethics Committee (Integrated Research Application System [IRAS]: 24/EE0137), will be conducted in adherence to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Written informed consent will be obtained from all participating parents, with age-appropriate assent from children prior to enrolment. Participants have the right to withdraw at any time without explanation, and their data will be anonymised to ensure privacy and confidentiality. Study findings will be disseminated through peer-reviewed journals, conference presentations and reports to relevant stakeholders.
The study protocol has been registered on the Open Science Framework: https://doi.org/10.17605/OSF.IO/WX29D.
Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.
The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.
This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.
Rev Enferm;39(6): 56-65, 2016 Jun. . [Artículo]
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