Cellulitis is a common bacterial skin infection causing significant pain, swelling and impact on daily activities, frequently leading to emergency department presentations and hospital admissions. While antibiotics are the mainstay of treatment, they do not directly address inflammation, often resulting in persisting or worsening symptoms in the initial days. Corticosteroids, with their potent anti-inflammatory effects, have shown benefit in other acute infections but are not currently standard care for patients with cellulitis. This trial aims to determine if adjunctive oral dexamethasone can reduce pain and improve outcomes in adults with cellulitis presenting to UK urgent secondary care settings.
This is a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial, with an internal pilot and parallel health economic evaluation. Adult patients (≥16 years) with a clinical diagnosis of cellulitis (at any body site except the orbit) presenting to urgent secondary care will be screened for eligibility. 450 participants will be randomised (1:1) to receive either two 8 mg doses of oral dexamethasone or matched placebo, administered approximately 24 hours apart, in addition to standard antibiotic therapy. The primary outcome is total pain experienced over the first 3 days postrandomisation, calculated using the standardised area under the curve from pain scores (Numerical Rating Scale 0–10) across up to seven timepoints. Secondary outcomes include health-related quality of life (EuroQol 5 Dimension 5 Level), patient global impression of improvement, analgesia and antibiotic usage, hospital (re)admissions, complications, unscheduled healthcare use, cellulitis recurrence and cost-effectiveness at 90 days. The primary estimand will apply a treatment policy approach to intercurrent events.
The trial has received ethical approval from South Central—Oxford B Research Ethics Committee (reference: 24/SC/0289) and will be conducted in compliance with Good Clinical Practice and applicable regulations. Informed consent will be obtained from all participants. A model consent form can be seen in . Findings will be disseminated through peer-reviewed publications and conference presentations, and to patient groups and relevant clinical guideline committees.
Patient involvement in healthcare has become increasingly important, not only as an expression of respect for autonomy but also as a means of empowering individuals to safeguard their care. In blood transfusion, informed consent is a critical tool for shared decision-making. This protocol outlines a scoping review to map how transfusion consent processes and forms are used globally and to characterise their key features. We aim to identify technologies used to obtain consent, evaluate compliance with international recommendations, describe practices in special populations and examine patients’ and families’ understanding of the consent process.
Following the Joanna Briggs Institute methodology, we will search PubMed, Embase, LILACS, Web of Science and Scopus; grey literature will be explored via Google Scholar and the Open Access Theses and Dissertations platform. No language or date restrictions will be applied. Reference lists of included studies will also be screened. Two reviewers will independently screen studies and chart data; disagreements will be resolved by a third reviewer. Synthesis will be diagrammatic/tabular with structured narrative, reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses: extension for Scoping Reviews. Where data allow, findings will be stratified by clinical setting. A stakeholder consultation with two transfusion medicine experts and two patient representatives will be undertaken to validate and refine interpretations.
Only publicly available sources will be used; research ethics approval is not required. Findings will be submitted to a peer-reviewed journal and presented at scientific meetings.
10.17605/OSF.IO/NU69J.
In Tanzania, the problem of early sexual initiation among adolescent girls and adolescent girls and young women has remained a persistent public health and human rights challenge that continues to draw the attention of policymakers. Evidence suggests that in some parts of the country, as much as 70% of women had their sexual debut as minors, underscoring the urgency to understand all drivers of early sexual debut among this population. While scholars have pointed to addressing a range of factors that work to expose adolescent girls and young women to early sexual initiation, the role of coercion at first sex has been less explored.
We used cross-sectional data from the 2022 Tanzania Demographic and Health Survey.
A total sample of 1242 sexually active unmarried adolescent girls and young women aged 15–24.
Our study relied on logistic regression models to examine the role of coerced sex on early sexual initiation among sexually active unmarried adolescent girls and young women aged 15–24 years in Tanzania.
We found that 31% and 14% of sexually active unmarried adolescent girls and young women experienced early sexual initiation and coerced first sex, respectively. At the bivariate level, we discovered that those who indicated that they willingly wanted to have their first sex were less likely to initiate sex early (OR=0.44, 95% CI 0.27 to 0.72). At the multivariate level, the significance of these relationships largely holds, even after sequentially accounting for sociodemographic (OR=0.50, 95% CI 0.30 to 0.82) and HIV-related characteristics (OR=0.50, 95% CI to 0.30 to 0.83).
We recommend re-examination of policy addressing early sexual initiation in Tanzania by incorporating coerced sex as one of the major determinants needing urgent attention. Intensifying awareness creation on the risk of early sexual initiation through coerced sex, especially among adolescent girls and boys, will go a long way to help reduce the incidence of early sexual initiation.
The evidence for the optimal duration of psychotherapy for borderline personality disorder (BPD) is scarce. Two previous trials have compared different durations of psychotherapy. The first compared 6 months versus 12 months of dialectical behaviour therapy for BPD (the FASTER trial). The second compared 5 months versus 14 months of mentalisation-based therapy for BPD (the MBT-RCT trial). The primary objective of the present study will be to provide an individual patient data pooled analysis of two randomised clinical trials by combining the two short-term groups and the two long-term groups from the FASTER and MBT-RCT trials, thereby providing greater statistical power than the individual trials. Accordingly, we will evaluate the overall evidence on the effects of short-term versus long-term psychotherapy for BPD and investigate whether certain subgroups might benefit from short-term versus long-term psychotherapy.
An individual patient data pooled analysis of the FASTER trial and the MBT-RCT trial will be conducted. The primary outcome will be a composite of the proportion of participants with a suicide, a suicide attempt or a psychiatric hospitalisation. The secondary outcome will be the proportion of participants with self-harm. Exploratory outcomes will be BPD symptoms, symptom distress, level of functioning and quality of life. We will primarily assess outcomes at 15 months after randomisation for the FASTER trial and at 16 months after randomisation for the MBT-RCT trial. Predefined subgroups based on the design variables in the original trials will be tested for interaction with the intervention as follows: trial, sex (male compared with female), age (below or at 30 years compared with above 30 years) and baseline level of functioning (Global Assessment of Functioning baseline score at 0–49 compared with 50–100).
The statistical analyses will be performed on anonymised trial data that have already been approved by the respective ethical committees that originally assessed the included trials. The final analysis will be published in a peer-reviewed scientific journal and the results will be presented at national seminars and international conferences.
CRD42024612840.