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Prospective, randomised, placebo-controlled, phase 2 clinical trial assessing the efficacy and safety of oral vancomycin in patients with primary sclerosing cholangitis with/out inflammatory bowel disease in Italy: study protocol of VanC-IT trial

Por: Cristoferi · L. · DAmato · D. · Maino · C. · Bernasconi · D. · Dinelli · M. E. · Malandrin · S. M. I. · Facciotti · F. · Festa · M. M. · Gerussi · A. · Rossi · E. · Malinverno · F. · Tettamanti · P. · Cazzaniga · M. E. · Corso · R. · Ippolito · D. · Galimberti · S. · Invernizzi · P. · Ca
Background

Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). No therapy currently halts disease progression. The strong gut–liver axis implicated in PSC pathogenesis supports the investigation of microbiome-targeted treatments. Oral vancomycin (OV), an antibiotic with potential immunomodulatory properties, has shown encouraging results in improving clinical symptoms and liver biochemistry in PSC. However, prospective data on its safety and efficacy remain limited.

Methods and analysis

Oral Vancomycin for primary sclerosing Cholangitis in ITaly (VanC-IT) is a phase II, dose-finding, randomised, placebo-controlled, trial designed to evaluate the efficacy and safety of OV in patients with PSC, with or without underlying IBD. Adults and adolescents aged 15–75 years will be enrolled following a 10-week screening and run-in period and randomised in a 1:1:1 ratio to receive either placebo, OV 750 mg/day or OV 1500 mg/day for 24 weeks. Randomisation will be stratified by baseline liver stiffness (

Ethics and dissemination

The protocol has been approved by the Ethics Committee CE Brianza on 10 February 2023, number 4017. Trial registration number NCT05876182. Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

NCT05876182.

Adjunctive bright light therapy to enhance continuous positive airway pressure adherence in patients with comorbid major depressive disorder and obstructive sleep apnoea syndrome: study protocol for a randomised sham-controlled trial

Por: El Azzaoui · H. · Catoire · S. · Lecharpentier · H. · Felician · J. · Grasset · O. · Gronfier · C. · Vallet · W. · Damato · T. · Brunelin · J.
Introduction

Obstructive sleep apnoea syndrome (OSAS) co-occurs with major depressive disorder (MDD) in approximately 50% of cases, and this comorbidity is associated with greater severity of depressive symptoms, sleep disturbances and poorer clinical outcomes. Although continuous positive airway pressure (CPAP) therapy is effective in treating OSAS and alleviating symptoms of MDD, poor adherence during the initial weeks of treatment remains a major clinical challenge. Bright light therapy has been shown to rapidly improve sleep, wakefulness, cognitive function and mood in patients with MDD. Given these complementary mechanisms, we propose that combining CPAP with bright light therapy may enhance patient adherence during the critical initial phase of CPAP treatment, ultimately leading to better clinical and sleep-related outcomes.

Methods and analysis

In a single-centre, double-blind, sham-controlled study with two parallel arms, 130 patients with both MDD and OSAS requiring CPAP therapy will be randomly assigned to receive either 14 sessions of 30 min active bright light therapy (n=65, 1200 Lux, peak wavelength at 500 nm) or 14 sessions of 30 min sham bright light therapy (n=65, 33 Lux, peak wavelength at 600 nm) during the first 2 weeks, following CPAP initiation at home. The primary outcome will be adherence to CPAP (in hours per 24 hours during the 14 days of investigation). Secondary clinical outcomes will include changes in depressive and anxiety symptoms. Secondary sleep-related outcomes will include both objective sleep parameters (polysomnography, melatonin and actimetry) and standardised psychometric scales. The persistence of treatment effects at 1-month follow-up will also be evaluated.

Ethics and dissemination

The study was approved by an ethics committee (CPP Nord Ouest IV, Lille, France), and the French National Agency for Medicines and Health Products Safety registration number 2024-A01551-46. The findings will be disseminated through international peer-reviewed publications, presentations at scientific conferences and outreach at public conferences.

Trial registration number

NCT06781593.

Access to maternal health services for young women with disabilities in Sub-Saharan Africa: a scoping review protocol

Por: Pebolo · P. F. · Kimera · E. · Nkulu Kalengayi · F. K. · Namatovu · F.
Introduction

Young women with disabilities (WWDs) face multiple barriers in accessing maternal healthcare services in low-resource settings. Consequently, they are at an increased risk of adverse maternal health outcomes due to young age and having a disability. This review focuses on synthesising evidence regarding the extent of access to maternal healthcare services and the barriers faced by young WWDs in Sub-Saharan Africa.

Methods and analysis

We will conduct a scoping review guided by the updated Joanna Briggs Institute methodology for scoping reviews. A systematic search of MEDLINE, EMBASE, Scopus, CINAHL, Web of Science Core Collection, Global Health, African Journal Online and Women’s Studies International will be performed to identify relevant articles published in English from 2007 to 2025. A team of two reviewers will independently screen the retrieved articles for relevancy based on the inclusion criteria, and a thematic synthesis will be undertaken to develop a descriptive analysis.

Ethics and dissemination

Since this review will only involve the analysis of published data, it does not require ethical approval. The results will be published in a peer-reviewed journal.

Registration

This review has been registered with the Open Science Framework DOI; https://doi.org/10.17605/OSF.IO/Q7Y8S.

Co‐Designing a Model of Brilliant Care for Older People

ABSTRACT

Aim

This study aimed to co-design a model of brilliant care for older people that provides clear, actionable principles to guide how brilliant care for older people can be realised.

Background

As the demand for and international importance of care for older people grows, so too does the negative discourse about care for older people. This ongoing focus on deficiencies can have implications for patients, carers, clinicians, health services, and policymakers, overshadowing opportunities for innovation and positive change.

Design

Experience-based co-design informed this study, grounded in the lived experiences of key stakeholders.

Methods

Three scaffolded co-design workshops were facilitated, involving lived experience experts, managers, professionals, clinicians, and an academic (n= 13). The data collected during these workshops were analysed using a qualitative descriptive method and documented according to COREQ guidelines to optimise rigour and transparency.

Results

The participants co-designed a model of brilliant care for older people, comprising principles to promote connection and innovation. To promote connection, the model includes protecting staff member time to deliver meaningful care and demonstrating that everyone matters. To promote innovation, it encourages role flexibility, curiosity, small improvements, and the recognition of brilliant practices.

Conclusions

This article presents a co-designed model of brilliant care for older people, incorporating principles of connection and innovation that can be enacted through simple, resource-efficient practices.

Relevance to Clinical Practice

For those who manage and deliver care for older people, the model encompasses simple, accessible, and cost-effective principles to: positively deviate from norms within the sector, offering care to older people; and to deliver brilliant care for older people. Furthermore, given that the model was co-designed with lived experience experts, managers, professionals, and clinicians, its principles are imbued with their experiential insights, which served to bring particular priorities to the fore.

Patient or Public Contribution

The co-designers, who included lived experience experts, were invited to participate in workshops to co-design a model of brilliant care for older people, during which they discussed and critiqued the findings constructed from the data and co-designed the model.

Exploring the use of low-cost simulation in nursing education: a scoping review

Por: Frangi · D. · Bardacci · Y. · Magi · C. E. · El Aoufy · K. · Longobucco · Y. · Iovino · P. · Amato · C. · Balestri · C. · Forciniti · C. · Rasero · L. · Iozzo · P. · Lucchini · A. · Bambi · S.
Objectives

This scoping review aims to assess low-cost simulation methods used in nursing education, evaluating how they balance educational effectiveness with budget constraints.

Design

Scoping review conducted in accordance with Arksey and O’Malley’s methodological framework and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews reporting guidelines.

Data sources

PubMed, Embase and CINAHL were systematically searched for relevant studies published between January 2000 and October 2023.

Eligibility criteria

We included peer-reviewed primary studies involving nurses or nursing students, focused on the use of low-cost simulation in any healthcare setting. Studies had to describe the simulation strategy and its educational application.

Data extraction and synthesis

Two reviewers independently screened titles, abstracts and full texts and extracted data using a standardised form. Findings were synthesised narratively and categorised by type of simulation, educational context and competencies addressed.

Results

Out of 3332 records, 39 studies met the inclusion criteria. The reviewed studies covered various clinical areas, including critical care, emergency, neonatal, paediatric and obstetric nursing, as well as transversal competencies such as communication and clinical reasoning. Low-cost methods included task trainers, mannequins, computer-based tools, hybrid models and serious games. Only 38% of studies reported detailed cost information.

Conclusions

Low-cost simulation offers promising opportunities in nursing education but suffers from inconsistent cost reporting and a lack of standardisation. Further research is needed to evaluate its long-term effectiveness and support broader implementation.

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