Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Development of the Tiers of Service framework to support system and operational planning for children’s healthcare services

Background Providing access to pediatric healthcare services in British Columbia, Canada, presents unique challenges given low population densities spread across large geographic distances combined with a lack of availability of specialist providers in remote areas, leading to quality of care shortcomings and inequalities in care delivery. The study objective was to develop a framework that provides a common language and methodology for defining and planning child and youth healthcare services across the province. Methods The framework was developed in two phases. In Phase 1, a literature and jurisdictional review was completed using the following inclusion criteria: (i) description of a framework focusing on organizing service delivery systems (ii) that supports health service planning, (iii) includes specialty or subspecialty services and (iv) has been published since 2008. In Phase 2, a series of meetings with key provincial stakeholders were held to receive feedback on the developed Tiers of Service framework versions that were based on the literature and jurisdictional review and adjusted to the British Columbian health care context. The final version was endorsed by the Child Health BC Steering Committee. Results Ten medical articles and thirteen jurisdictional papers met the established selection criteria and were included in this study. Most frameworks were developed by the Australian national or state jurisdictions and published in jurisdictional papers (n = 8). Frameworks identified in the medical literature were mainly developed in Canada (n = 3) and the US (n = 3) and focused on maternity, neonatal, critical care and oncology services. Based on feedback received from the expert group, the framework was expanded to include community-based services, prevention and health determinants. The final version of the Tiers of Service framework describes the specific services to be delivered at each tier, which are categorized as Tier 1 (community services) through Tier 6 (sub-specialized services). Two consecutive steps were identified to effectively use the framework for operational and system planning: (i) development of a ‘module’ outlining the responsibilities and requirements to be delivered at each tier; and (ii) assessment of services provided at the health care facility against those described in the module, alignment to a specific tier, identification of gaps at the local, regional and provincial level, and implementation of quality improvement initiatives to effectively address the gaps. Conclusions The benefits of the Tiers of Service framework and accompanying modules for health service planning are being increasingly recognized. Planning and coordinating pediatric health services across the province will help to optimize flow and improve access to high-quality services for children living in British Columbia.Medicine, Faculty ofPediatrics, Department ofReviewedFacult

Implementation study of a 5-component pediatric early warning system (PEWS) in an emergency department in British Columbia, Canada, to inform provincial scale up

Background: The rapid identification of deterioration in the pediatric population is complex, particularly in the emergency department (ED). A comprehensive multi-faceted Pediatric Early Warning System (PEWS) might maximize early recognition of clinical deterioration and provide a structured process for the reassessment and escalation of care. The objective of the study was to evaluate the implementation fidelity, effectiveness, and utility of a 5-component PEWS implemented in the ED of an urban public general hospital in British Columbia, Canada, and to guide provincial scale up. Methods: We used a before-and-after design to evaluate the implementation fidelity, effectiveness, and utility of a 5-component PEWS (pediatric assessment flowsheet, PEWS score, situational awareness, escalation aid, and communication framework). Sources of data included patient medical records, surveys of direct care staff, and key-informant interviews. Data were analyzed using mixed-methods approaches. Results: The majority of medical records had documented PEWS scores at triage (80%) and first bedside assessment (81%), indicating that the intervention was implemented with high fidelity. The intervention was effective in increasing vital signs documentation, both at first beside assessment (84% increase) and throughout the ED stay (> 100% increase), in improving staff’s self-perceived knowledge and confidence in providing pediatric care, and self-reported communication between staff. Satisfaction levels were high with the PEWS scoring system, flowsheet, escalation aid, and to a lesser extent with the situational awareness tool and communication framework. Reasons for dissatisfaction included increased paperwork and incidence of false-positives. Overall, the majority of providers indicated that implementation of PEWS and completing a PEWS score at triage alongside the Canadian Triage and Acuity Scale (CTAS) added value to pediatric care in the ED. Results also suggest that the intervention is aligned with current practice in the ED. Conclusion: Our study shows that high-fidelity implementation of PEWS in the ED is feasible. We also show that a multi-component PEWS can be effective in improving pediatric care and be well-accepted by staff. Results and lessons learned from this pilot study are being used to scale up implementation of PEWS in ED settings across the province of British Columbia.Other UBCNon UBCReviewedFacult