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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.
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 (
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.
Evidence-based practice (EBP) is essential for clinical decision-making, integrating the best available evidence, clinical expertise, and stakeholder values. In Italy, interest in EBP is growing, and a key step in its promotion is adopting tools to assess nurses' beliefs and behaviors toward EBP. While the EBP Beliefs Scale has been translated and validated in multiple languages, it has yet to be adapted for the Italian context.
This study aims to adapt EBP measurement tools for the Italian context and evaluate their psychometric properties.
This study used an observational cross-sectional design. The process of cross-cultural translation, adaptation, and validation was adopted. A panel of experts culturally adapted the Beliefs Scales (long and short version) through the item and scale content validity (I-CVI, S-CVI). To test the psychometric properties, 409 nurses were asked to complete the two scales. Confirmatory factor analysis was conducted to validate the factor structure within the Italian context. Convergent validity between the long and short versions of the scale was assessed using the correlation coefficient (r), and the reliability was assessed by computing Cronbach's alpha.
The I-CVI and S-CVI for the long and short version ranged from 0.75 to 1.00. The CFA model performed for the long and short version reported a good fit without the need for further refinements. The Cronbach's alpha was higher than 0.80 for both scales. The correlation of 0.615 (p < 0.01) indicated a moderate to strong positive relationship supporting the convergent validity of the short version in relation to the long version.
In time-constrained settings, the short scale should be utilized for efficient assessments and longitudinal tracking of changes. The long version serves as a complementary tool for in-depth analysis, facilitating a deeper understanding of underlying factors and informing targeted interventions to address specific barriers.
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