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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.

Examining the Relationship Between Hospital Nurses' Structural Empowerment, Missed Nursing Care and Quality of Care: A Cross‐Sectional Study

ABSTRACT

Aim

To examine relationships between structural empowerment, missed nursing care and quality of care among hospital-based, direct-care nurses.

Design

Cross-sectional study.

Methods

A convenience sample of 161 nurses completed the Conditions for Work Effectiveness-II Questionnaire, the MISSCARE and a single-question rating of quality of care. Correlation, T-tests, regression and ANOVA were used to analyse data.

Results

Nurses reported high structural empowerment (total CWEQ-II = 22.8). Higher empowerment was significantly correlated with less missed care. Most nurses (77.7%) worked at Magnet hospitals; however, no difference in missed care was found between Magnet and non-Magnet nurses. The average number of patients on the last shift was 5.1. The number of patients cared for was not significantly correlated to missed care; however, nurses' perceptions of better staffing adequacy, teamwork and job satisfaction were. Nurses who intended to leave (25.5%) missed more care. Intention to leave and access to resources predicted missed care.

Conclusion

This appears to be the first study examining the relationship between structural empowerment and missed care, demonstrating that higher empowerment was related to greater nurse work effectiveness and improved care delivery. Work environment factors, specifically subjective perceptions of staffing and resource adequacy, were linked to missed care, while nurse–patient ratio was not. Subjective factors may contribute more to missed care than is recognised.

Implications

Creating and sustaining empowering work environments, ensuring resource adequacy and enhancing factors that promote retention may reduce missed care. No patient/public contribution.

Financial Conflicts of Interest

None.

Reporting Method

STROBE checklist for cross-sectional studies.

Randomized Trial of Group Postpartum Care Model Improves Knowledge and Clinical Outcomes

imageBackground In sub-Saharan Africa, the risk of obstetric complications remains high throughout the postpartum period. Objective We developed and tested a novel, integrated model of group postpartum care titled Focused-Postpartum Care (Focused-PPC) to improve outcomes. In this paper, we report clinical outcomes of participants in the intervention arm and differences in knowledge of postbirth warning signs among those in the intervention and control arms. Methods Focused-PPC encompassed recommended clinical assessments, targeted education, and peer support up to 1 year after birth. Focused-PPC was implemented as a parallel randomized controlled trial involving 192 postpartum women across four health centers in Tamale, Ghana, from February 2022 to August 2023. Eligible participants 18 years or older with a live birth were randomly assigned to either the Focused-PPC intervention arm or the control arm at a 1:1 allocation and were not blinded to their allocation. At each health center, 48 participants were allocated to either an intervention or control arm. Focused-PPC groups in the intervention arm consisted of eight participants per group. Participants in the intervention arm received the Focused-PPC integrated group model of care. Participants in the control arm received the standard of postnatal care already administered at each health center. Results Baseline analysis included 96 participants from the control arm and 91 participants from the intervention arm. We found that vital signs and clinical outcomes were relatively stable; however, incidences of hypertension substantially decreased among participants in the intervention arm. By 3 months postbirth, most participants in the intervention arm were able to identify all postbirth warning signs and retain this knowledge compared to the control arm. Those in the intervention arm were also knowledgeable of more warning signs at each time point compared to the control arm. Discussion An integrated, evidence-based approach to postpartum care, such as Focused-PPC, has potential to increase knowledge and improve clinical outcomes among mothers in Ghana.

Sleep deprivation and medication administration errors in registered nurses—A scoping review

Abstract

Aim

To explore whether sleep deprivation contributes to medication errors in registered nurses (RNs).

Background

Sleep deprivation is a potential issue for RNs, particularly those who work shifts. Sleep deprivation has been found to have a negative impact on numerous cognitive processes. Nurses administer several medications to patients a day, potentially while sleep deprived—anecdotal reports suggest that this could result in an increased risk of error occurring.

Design

A scoping review was conducted using the Prisma-ScR extension framework to explore what is known about the effect of RNs' sleep deprivation on medication administration errors.

Methods

A search of databases generated 171 results. When inclusion and exclusion criteria were applied, 18 empirical studies were analysed. Studies included retrospective analysis of errors, surveys of perceptions of causes and observational studies.

Results

Data indicated that RNs consider fatigue, which may be caused by sleep deprivation, to be a contributing factor to medication errors. The search only identified three observer studies, which provided conflicting results as to whether lack of sleep contributes to the error rate. Of the numerous tools used to measure sleep, the Pittsburgh Sleep Quality Index was the most frequently used.

Conclusion

Although RNs anecdotally consider a lack of sleep potentially contributes to medication errors, there is insufficient research to provide robust evidence to confirm this assumption.

No Patient or Public Contributions

Patient or public contributions were not required for this scoping review.

Relevance to Clinical Practice

Sleep deprivation is a potential issue for nurses, especially those who work shifts. Poor sleep impacts cognitive processes that potentially could increase errors. Nurses should be aware of the impact sleep may have on patient safety.

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