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Effectiveness and safety of shortened intensive treatment for children with tuberculous meningitis (SURE): a protocol for a phase 3 randomised controlled trial evaluating 6 months of antituberculosis therapy and 8 weeks of aspirin in Asian and African chi

Por: Huynh · J. · Chabala · C. · Sharma · S. · Choo · L. · Singh · V. · Sankhyan · N. · Mujuru · H. · Nguyen · N. · Trinh · T. H. · Phan · P. H. · Nhung · N. V. · Nkole · K. L. · Sirari · T. · Mutata · C. · Frangou · E. · Griffiths · A. · Wobudeya · E. · Muller · C. · Santana · S. · Kestelyn · E.
Introduction

Childhood tuberculous meningitis (TBM) is a devastating disease. The long-standing WHO recommendation for treatment is 2 months of intensive phase with isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E), followed by 10 months of isoniazid and rifampicin. In 2022, WHO released a conditional recommendation that 6 months of intensified antituberculosis therapy (ATT) could be used as an alternative for drug-susceptible TBM. However, this has never been evaluated in a randomised clinical trial. Trials evaluating ATT shortening regimens using high-dose rifampicin and drugs with better central nervous system penetration alongside adjuvant anti-inflammatory therapy are needed to improve outcomes.

Methods and analysis

The Shortened Intensive Therapy for Children with Tuberculous Meningitis (SURE) trial is a phase 3, randomised, partially blinded, factorial trial being conducted in Asia (India and Vietnam) and Africa (Uganda, Zambia and Zimbabwe). It is coordinated by the Medical Research Council Clinical Trial Unit at University College London (MRCCTU at UCL). 400 children (aged 29 days to

Ethics and dissemination

Local ethics committees at all participating study sites and respective regulators approved the SURE protocol. Ethics approval was also obtained from UCL, UK (14935/001). Informed consent from parents/carers and assent from age-appropriate children are required for all participants. Results will be published in international peer-reviewed journals, and appropriate media will be used to summarise results for patients and their families and policymakers.

Trial registration

ISRCTN40829906 (registered 13 November 2018).

Telemedicine models of care: A retrospective review of telehealth in a Melbourne outpatient chronic wound service in 2021

Abstract

To review the application of telehealth guidelines developed by Bondini et al for clinicians to determine patient suitability for telehealth in an outpatient Chronic Wound Service, including the proportion of patients suitable for telehealth, type and mode of telehealth encounters. Retrospective, random convenience sample of patients attending the Chronic Wound Service in 2021. Fifty-six patients were included, most with leg/foot wounds (93%), median age 74 [54–84], 64% male. Four patients at admission and 19 patients at review met criteria for telehealth. Six percent of encounters were telehealth; phone-only (82%), unscheduled nursing reviews (77%) in patients with healing wounds. Thirty patients (54%) received at least one telehealth encounter. Telehealth occurred 35.6 days later in the admission than face-to-face encounters (p < 0.05, 95% CI 14.9–56.3). There was a significant relationship between patients receiving telehealth and meeting telehealth suitability criteria on reviews (X 2 (1) = 19.6*, p < 0.001). Eighteen percent of patients required wound-related hospitalisation during their outpatient admission. Telehealth guidelines identified patients suitable for telehealth, although the proportion of patients was small. Telehealth was mostly utilised for nurse-led telephone calls in patients with improving wounds. Future research into use of telephone review for clinical standards of wound care is warranted.

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