Background In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov ( NCT04381936 ). Findings Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001). Interpretation In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding UK Research and Innovation (Medical Research Council) and National Institute of Health Research.
Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...
Supported Wellbeing Centres have been set up in UK hospital trusts in an effort to mitigate the psychological impact of COVID-19 on healthcare workers, although the extent to which these are utilised and the barriers and facilitators to access are not known. The aim of the study was to determine facility usage and gather insight into employee wellbeing and the views of employees towards this provision. The study included (i) 17-week service use monitoring, (ii) employee online survey with measures of wellbeing, job stressfulness, presenteeism, turnover intentions, job satisfaction, and work engagement, as well as barriers and facilitators to accessing the Wellbeing Centres. Over 17 weeks, 14,934 facility visits were recorded across two sites (peak attendance in single week n = 2605). Facilities were highly valued, but the service model was resource intensive with 134 wellbeing buddies supporting the centres in pairs. 819 hospital employees completed an online survey (88% female; 37.7% working in COVID-19 high risk areas; 52.4% frontline workers; 55.2% had accessed a wellbeing centre). There was moderate-to-high job stress (62.9%), low wellbeing (26.1%), presenteeism (68%), and intentions to leave (31.6%). Wellbeing was higher in those that accessed a wellbeing centre. Work engagement and job satisfaction were high. Healthcare organisations are urged to mobilise access to high-quality rest spaces and psychological first aid, but this should be localised and diversified. Strategies to address presenteeism and staff retention should be prioritised, and the high dedication of healthcare workers should be recognised.
Supported wellbeing centres were set up in UK hospital trusts as an early intervention aimed at mitigating the psychological impact of COVID-19 on healthcare workers. These provided high quality rest spaces with peer-to-peer psychological support provided by National Health Service (NHS) staff volunteers called ‘wellbeing buddies’, trained in psychological first aid. The aim of the study was to explore the views of centre visitors and operational staff towards this COVID-19 workforce wellbeing provision. Qualitative semi-structured interviews were undertaken with twenty-four (20F, 4M) employees from an acute hospital trust in the UK. Interviews were digitally recorded and transcribed, data were handled and analysed using thematic analysis. Interviews generated 3 over-arching themes, and 13 sub-themes covering ‘exposure and job roles’, ‘emotional impacts of COVID-19 and ‘the wellbeing centres’. Supported wellbeing centres were viewed as critical for the wellbeing of hospital employees during the first surge of COVID-19 in the UK. Wellbeing initiatives require managerial advocacy and must be inclusive. Job-related barriers to work breaks and accessing staff wellbeing provisions should be addressed. High quality rest spaces and access to peer-to-peer support are seen to benefit individuals, teams, organisations and care quality. Training NHS staff in psychological first aid is a useful approach to supporting the wellbeing of the NHS workforce during and beyond the COVID-19 pandemic.
Background: Global challenges in the development of a highly skilled and motivated nursing workforce jeopardise the delivery of high-quality care. Flexible and innovative workforce solutions are required to overcome these challenges. Aims: To describe the implementation and present the preliminary evaluation of the 'Chief Nurse Excellence in Care Junior' bespoke Fellowship initiative designed to develop the foundational clinical and academic skills of front-line junior clinical staff. Methods: This initiative was developed and piloted at a large, inner-city, acute NHS trust. The initiative involved two main components: a bespoke development programme and an improvement project that was supported by clinical and academic mentors. The initiative was evaluated using structured feedback, case studies and data on dissemination activities. Results: Six front-line nurses completed the first cohort of the initiative that commenced in spring 2016. Results showed a positive impact on professional development relating to the acquisition of new knowledge and skills. Case studies of projects had a demonstrable impact
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