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The DEXACELL trial--a protocol for a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial to assess the effectiveness and cost-effectiveness of DEXAmethasone as an adjunctive therapy for the manag

Por: Joyce · K. · Lear · R. · Hamilton · F. W. · Arnold · D. · Chaudhuri · E. · Connors · J. · Cook · H. · Creanor · S. · Dawe · P. · Goodwin · E. · Hawton · A. · Hayward · C. · Lasserson · D. S. · Ridd · M. J. · Rowe · D. · Shipley · D. · Taylor · H. · Wainman · H. E. · Williams · O. M. · Carlto
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ISRCTN76873478.

MINMON-J: a hybrid implementation pilot study evaluating a low-barrier hepatitis C treatment model in a jail setting

Por: Berk · J. · Fu · E. S. · Murphy · M. · Akiyama · M. J. · Sulkowski · M. · Rich · J. D. · Frank · H. E.
Introduction

Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.

Methods and analysis

MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.

Ethics and dissemination

This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.

Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.

Trial registration number

NCT06953479.

Randomised controlled trial to measure effectiveness and cost-effectiveness of a digital social intervention promoted by primary care clinicians to adults with asthma to improve asthma control: protocol

Por: Karampatakis · G. D. · Wood · H. E. · Griffiths · C. J. · Taylor · S. J. · Toffolutti · V. · Bird · V. J. · Lea · N. C. · Ashcroft · R. · Coulson · N. S. · Panzarasa · P. · Li · X. · Sheikh · A. · Relton · C. · Sastry · N. · Watson · J. S. · Mant · J. · Marsh · V. · Day · B. · Mihaylova · B
Introduction

In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

Methods and analysis

An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

Ethics and dissemination

The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

Trial registration number

NCT06849245.

Achieving impactful treatment for paediatric endocrine disorders in low- to middle-income countries (LMICs): a scoping review

Por: Olson · H. E. · Dolan · C.
Objectives

Endocrine disorders, such as hypo/hyperthyroidism and diabetes, affect over 5% of the world’s population, with an additional 5% of cases remaining undiagnosed. Despite the increasing prevalence of endocrine disorders, especially in low- to middle-income countries (LMICs), limited research offers comprehensive guidance on treating this complex medical field. This scoping review aims to provide evidence-based recommendations for efficient, effective and accessible treatment of paediatric thyroid conditions and diabetes in LMICs.

Design

Scoping review guidelines outlined by the Preferred Reporting Items for Systematic and Meta-Analysis Extension for Scoping Reviews, using the Joanna Briggs Institute (JBI) methodology to analyse healthcare administration approaches in LMICs.

Data sources

PubMed, Google Scholar, MEDLINE, EconLit, Science Direct and Scopus were searched using a set of search terms from 19 December 2023 to 16 January 2024. An additional high-level search was performed in May 2025.

Eligibility criteria

Selection of a variety of peer-reviewed publications with a setting in LMICs. Articles were included if they described an intervention strategy related to select paediatric chronic diseases, endocrine conditions or non-communicable diseases. The treatment strategies in question were government initiatives, mobile health, specialised programmes and primary care.

Data extraction and synthesis

One reviewer manually reviewed articles and documented findings on Microsoft Excel. In accordance with JBI methodological guidelines, no risk of bias assessment or quality appraisal of included studies was conducted.

Results

After reviewing primary care, specialised care, government intervention programmes and mobile care initiatives within developing countries, primary care with an emphasis on task shifting emerged as the best approach for treating paediatric endocrine disorders.

Conclusion

Despite recommendations favouring specialised care or government interventions, primary care proves to be the optimal method for treating endocrine conditions. Given limited healthcare funding in LMICs, implementing primary care initiatives can achieve significant health outcomes while maximising resources.

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