Co-producing an online patient public community research hub : a qualitative study exploring the perspectives of national institute for health research (NIHR) research champions in England

Background: Patient and Public Involvement and Engagement (PPIE) should be embedded as part of researchers’ everyday practice. However, this can be challenging. Creating a digital presence for PPIE as part of Higher Education Institutes’ (HEIs) infrastructure may be one way of supporting this. This can support how information is made available to patients and members of the public, but relatively little is known about how HEIs can best do this. Our aim was to develop a university website for patients and members of the public to learn about ways to get actively involved in research and be able to access the results of health and social care research. Methods: This project involved working as partners with five National Institute for Health and Care Research (NIHR) Research Champions. NIHR Research Champions are volunteers who raise awareness and share experiences about health and social care research. Content of a prototype Patient Public Community Research Hub website was co-produced with the Research Champions, and then 15 NIHR Research Champions from across England were asked for their views about the website. Findings: The information collected told us that the Patient Public Community Research Hub was viewed as being beneficial for increasing visibility of PPIE opportunities and sharing the findings of studies though needs further work: to make the information more user-friendly; to improve the methods for directing people to the site and to create new ways of connecting with people. It provides a foundation for further co-development and evaluation. A set of recommendations has been developed that may be of benefit to other HEIs and organisations who are committed to working with patients and members of the public

Protocol for a cluster randomised controlled feasibility study of Prehospital Optimal Shock Energy for Defibrillation (POSED)

Aims: The Prehospital Optimal Shock Energy for Defibrillation (POSED) study will assess the feasibility of conducting a cluster randomised controlled study of clinical effectiveness in UK ambulance services to identify the optimal shock energy for defibrillation. Methods: POSED is a pragmatic, allocation concealed, open label, cluster randomised, controlled feasibility study. Defibrillators within a single UK ambulance service will be randomised in an equal ratio to deliver one of three shock strategies 120–150–200 J, 150–200–200 J, 200–200–200 J. Consecutive adults (18 years or over) presenting with out of hospital cardiac arrest requiring defibrillation will be eligible. The study plans to enrol 90 patients (30 in each group). Patients (or their relatives for non-survivors) will be informed about trial participation after the initial emergency has resolved. Survivors will be invited to consent to participate in follow-up (i.e., at 30 days or discharge). The primary feasibility outcome is the proportion of eligible patients who receive the randomised study intervention. Secondary feasibility outcomes will include recruitment rate, adherence to allocated treatment and data completeness. Clinical outcomes will include Return of an Organised Rhythm (ROOR) at 2 minutes post-shock, refibrillation rate, Return of Spontaneous Circulation (ROSC) at hospital handover, survival and neurological outcome at 30 days. Conclusion: The POSED study will assess the feasibility of a large-scale trial and explore opportunities to optimise the trial protocol

Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm : a randomised controlled feasibility trial (COMPRESS-RCT)

Background Mechanical chest compression devices consistently deliver high-quality chest compressions. Small very low-quality studies suggest mechanical devices may be effective as an alternative to manual chest compressions in the treatment of adult in-hospital cardiac arrest patients. The aim of this feasibility trial is to assess the feasibility of conducting an effectiveness trial in this patient population. Methods COMPRESS-RCT is a multi-centre parallel group feasibility randomised controlled trial, designed to assess the feasibility of undertaking an effectiveness to compare the effect of mechanical chest compressions with manual chest compressions on 30-day survival following in-hospital cardiac arrest. Over approximately two years, 330 adult patients who sustain an in-hospital cardiac arrest and are in a non-shockable rhythm will be randomised in a 3:1 ratio to receive ongoing treatment with a mechanical chest compression device (LUCAS 2/3, Jolife AB/Stryker, Lund, Sweden) or continued manual chest compressions. It is intended that recruitment will occur on a 24/7 basis by the clinical cardiac arrest team. The primary study outcome is the proportion of eligible participants randomised in the study during site operational recruitment hours. Participants will be enrolled using a model of deferred consent, with consent for follow-up sought from patients or their consultee in those that survive the cardiac arrest event. The trial will have an embedded qualitative study, in which we will conduct semi-structured interviews with hospital staff to explore facilitators and barriers to study recruitment. Discussion The findings of COMPRESS-RCT will provide important information about the deliverability of an effectiveness trial to evaluate the effect on 30-day mortality of routine use of mechanical chest compression devices in adult in-hospital cardiac arrest patients

Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a multi-centre feasibility randomised controlled trial (COMPRESS-RCT).

BACKGROUND Mechanical chest compression devices deliver high-quality chest compressions. Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients. To determine the feasibility of undertaking an effectiveness trial in this population, we undertook a feasibility randomised controlled trial. METHODS We undertook a multi-centre parallel group feasibility randomised controlled trial (COMPRESS-RCT). Adult in-hospital cardiac arrest patients that were in a non-shockable rhythm were randomised in a 3:1 ratio to receive mechanical CPR (Jolfe AB/Stryker, Lund, Sweden) or ongoing manual CPR. Recruitment was led by the clinical cardiac arrest team. The primary study outcome was the proportion of eligible participants randomised in the study during site operational recruitment hours. Patients were enrolled under a model of deferred consent. We report data using descriptive statistics, point estimates and 95% confidence intervals. RESULTS Over a two-year period, we recruited 127 patients across five UK hospitals. We recruited 55.2% (95% CI 48.5% to 61.8%) of eligible study participants in site operational recruitment hours. Most participants were male (n = 76, 59.8%) with a mean age of 72 (95% CI: 69.9 - 74.9) years. Median arrest duration was 18 (IQR 13-29) minutes. In patients randomised to mech-CPR, median time from CPR start to device deployment was 11 (IQR 7-15) minutes. ROSC was achieved in 27.6% (n = 35) participants and 4.7% (n = 6) were alive at 30-days. CONCLUSION COMPRESS-RCT identified important factors that preclude progression to an effectiveness trial of mechanical CPR in the hospital setting in the UK. Findings will inform the design of future in-hospital intra-arrest intervention trials. ISRCTN38139840, date of registration 9 January 2017

“Sugar or Salt” (SOS) trial protocol summary

Objective: Does hyperosmolar therapy (mannitol or hypertonic saline) in traumatic brain injury (TBI) improve neurological function clinically and cost- effectively at 6 months? Design: Multi-centre, open label, randomised controlled clinical and cost effectiveness trial with an internal pilot Setting: Intensive Care Units (ICUs) within NHS hospitals treating patients with TBI Target population: Adult patients (aged >16 years) with severe TBI and raised intracranial pressure (ICP) Inclusion criteria: Patients aged ≥16 years old, admitted to ICU following TBI within 10 days from initial primary head injury, abnormal CT scan consistent with TBI and an ICP >20 mmHg for more than 5 mins despite stage 1 procedures Exclusion criteria: Devastating brain injury with withdrawal of life sustaining treatment anticipated in the next 24 hours, pregnancy and severe hypernatraemia (serum Na > 155 mmol/L) Planned sample size: 319 per group (638 in total) Interventions: 2 ml/kg 20% mannitol intravenous bolus and 2 ml/kg 3% hypertonic saline (HTS) intravenous bolus (or equivalent osmolar dose of HTS using the concentration used locally by participating study centres) Outcome measures: Primary outcome: Extended Glasgow Outcome Scale (GOS-E) measured at 6 months after randomisation. Secondary outcome measures: Efficacy – ICP control (during period of monitoring in ICU, progression to stage 3 therapies and requirement for stage 3 therapies to control ICP, Resource use – organ support requirements during ICU, critical care length of stay and hospital length of stay. Patient outcomes – longer term neurological outcomes (Modified Oxford Handicap Scale (mOHS) at discharge and GOS-E at 12 months), Survival (to hospital discharge – defined as the time at which the patient is discharged from the hospital regardless of neurological status, outcome or destination and at 3 months, 6 months and 12 months) and quality of life (EQ-5D-5L at hospital discharge, 3 months, 6 months and 12 months post-TBI) Blinding: Open label with blinded assessment of primary and secondary outcomes Follow up period: Up to 12 months post-randomisation Planned trial period: From 01/06/2019 to 01/12/2023 (total of 54 months) Trial Registration: ISRCTN16075091 Declaration of conflicting interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: National Institute of Health Research Health Technology Assessment Programme (HTA reference 17/120/01)

Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial.

Importance Continuous positive airway pressure (CPAP) and high-flow nasal oxygen (HFNO) have been recommended for acute hypoxemic respiratory failure in patients with COVID-19. Uncertainty exists regarding the effectiveness and safety of these noninvasive respiratory strategies. Objective To determine whether either CPAP or HFNO, compared with conventional oxygen therapy, improves clinical outcomes in hospitalized patients with COVID-19-related acute hypoxemic respiratory failure. Design, Setting, and Participants A parallel group, adaptive, randomized clinical trial of 1273 hospitalized adults with COVID-19-related acute hypoxemic respiratory failure. The trial was conducted between April 6, 2020, and May 3, 2021, across 48 acute care hospitals in the UK and Jersey. Final follow-up occurred on June 20, 2021. Interventions Adult patients were randomized to receive CPAP (n = 380), HFNO (n = 418), or conventional oxygen therapy (n = 475). Main Outcomes and Measures The primary outcome was a composite of tracheal intubation or mortality within 30 days. Results The trial was stopped prematurely due to declining COVID-19 case numbers in the UK and the end of the funded recruitment period. Of the 1273 randomized patients (mean age, 57.4 [95% CI, 56.7 to 58.1] years; 66% male; 65% White race), primary outcome data were available for 1260. Crossover between interventions occurred in 17.1% of participants (15.3% in the CPAP group, 11.5% in the HFNO group, and 23.6% in the conventional oxygen therapy group). The requirement for tracheal intubation or mortality within 30 days was significantly lower with CPAP (36.3%; 137 of 377 participants) vs conventional oxygen therapy (44.4%; 158 of 356 participants) (absolute difference, -8% [95% CI, -15% to -1%], P = .03), but was not significantly different with HFNO (44.3%; 184 of 415 participants) vs conventional oxygen therapy (45.1%; 166 of 368 participants) (absolute difference, -1% [95% CI, -8% to 6%], P = .83). Adverse events occurred in 34.2% (130/380) of participants in the CPAP group, 20.6% (86/418) in the HFNO group, and 13.9% (66/475) in the conventional oxygen therapy group. Conclusions and Relevance Among patients with acute hypoxemic respiratory failure due to COVID-19, an initial strategy of CPAP significantly reduced the risk of tracheal intubation or mortality compared with conventional oxygen therapy, but there was no significant difference between an initial strategy of HFNO compared with conventional oxygen therapy. The study may have been underpowered for the comparison of HFNO vs conventional oxygen therapy, and early study termination and crossover among the groups should be considered when interpreting the findings. Trial Registration isrctn.org Identifier: ISRCTN16912075