Nigel Rees

Epidemiology and outcomes from out-of-hospital cardiac arrests in England

INTRODUCTION This study reports the epidemiology and outcomes from out-of-hospital cardiac arrest (OHCA) in England during 2014. METHODS Prospective observational study from the national OHCA registry. The incidence, demographic and outcomes of patients who were treated for an OHCA between 1st January 2014 and 31st December 2014 in 10 English ambulance service (EMS) regions, serving a population of almost 54 million, are reported in accordance with Utstein recommendations. RESULTS 28,729 OHCA cases of EMS treated cardiac arrests were reported (53 per 100,000 of resident population). The mean age was 68.6 (SD=19.6) years and 41.3% were female. Most (83%) occurred in a place of residence, 52.7% were witnessed by either the EMS or a bystander. In non-EMS witnessed cases, 55.2% received bystander CPR whilst public access defibrillation was used rarely (2.3%). Cardiac aetiology was the leading cause of cardiac arrest (60.9%). The initial rhythm was asystole in 42.4% of all cases and was shockable (VF or pVT) in 20.6%. Return of spontaneous circulation at hospital transfer was evident in 25.8% (n=6302) and survival to hospital discharge was 7.9%. CONCLUSION Cardiac arrest is an important cause of death in England. With less than one in ten patients surviving, there is scope to improve outcomes. Survival rates were highest amongst those who received bystander CPR and public access defibrillation.

Pre-hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration In Cardiac arrest (PARAMEDIC-2): Trial protocol

Despite its use since the 1960s, the safety or effectiveness of adrenaline as a treatment for cardiac arrest has never been comprehensively evaluated in a clinical trial. Although most studies have found that adrenaline increases the chance of return of spontaneous circulation for short periods, many studies found harmful effects on the brain and raise concern that adrenaline may reduce overall survival and/or good neurological outcome. The PARAMEDIC-2 trial seeks to determine if adrenaline is safe and effective in out-of-hospital cardiac arrest. This is a pragmatic, individually randomised, double blind, controlled trial with a parallel economic evaluation. Participants will be eligible if they are in cardiac arrest in the out-of-hospital environment and advanced life support is initiated. Exclusions are cardiac arrest as a result of anaphylaxis or life threatening asthma, and patient known or appearing to be under 16 or pregnant. 8000 participants treated by 5 UK ambulance services will be randomised between December 2014 and August 2017 to adrenaline (intervention) or placebo (control) through opening pre-randomised drug packs. Clinical outcomes are survival to 30 days (primary outcome), hospital discharge, 3, 6 and 12 months, health related quality of life, and neurological and cognitive outcomes (secondary outcomes). Trial registration (ISRCTN73485024).

A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest

BACKGROUND Concern about the use of epinephrine as a treatment for out‐of‐hospital cardiac arrest led the International Liaison Committee on Resuscitation to call for a placebocontrolled trial to determine whether the use of epinephrine is safe and effective in such patients. METHODS In a randomized, double‐blind trial involving 8014 patients with out‐of‐hospital cardiac arrest in the United Kingdom, paramedics at five National Health Service ambulance services administered either parenteral epinephrine (4015 patients) or saline placebo (3999 patients), along with standard care. The primary outcome was the rate of survival at 30 days. Secondary outcomes included the rate of survival until hospital discharge with a favorable neurologic outcome, as indicated by a score of 3 or less on the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). RESULTS At 30 days, 130 patients (3.2%) in the epinephrine group and 94 (2.4%) in the placebo group were alive (unadjusted odds ratio for survival, 1.39; 95% confidence interval [CI], 1.06 to 1.82; P = 0.02). There was no evidence of a significant difference in the proportion of patients who survived until hospital discharge with a favorable neurologic outcome (87 of 4007 patients [2.2%] vs. 74 of 3994 patients [1.9%]; unadjusted odds ratio, 1.18; 95% CI, 0.86 to 1.61). At the time of hospital discharge, severe neurologic impairment (a score of 4 or 5 on the modified Rankin scale) had occurred in more of the survivors in the epinephrine group than in the placebo group (39 of 126 patients [31.0%] vs. 16 of 90 patients [17.8%]). CONCLUSIONS In adults with out‐of‐hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30‐day survival than the use of placebo, but there was no significant between‐group difference in the rate of a favorable neurologic outcome because more survivors had severe neurologic impairment in the epinephrine group. (Funded by the U.K. National Institute for Health Research and others; Current Controlled Trials number, ISRCTN73485024.)

Post-admission outcomes of participants in the PARAMEDIC trial : a cluster randomised trial of mechanical or manual chest compressions

BACKGROUND The PARAMEDIC cluster randomised trial evaluated the LUCAS mechanical chest compression device, and did not find evidence that use of mechanical chest compression led to an improvement in survival at 30 days. This paper reports patient outcomes from admission to hospital to 12 months after randomisation. METHODS Information about hospital length of stay and intensive care management was obtained through linkage with Hospital Episode Statistics and the Intensive Care National Audit and Research Centre. Patients surviving to hospital discharge were approached to complete questionnaires (SF-12v2, EQ-5D, MMSE, HADS and PTSD-CL) at 90days and 12 months. The study is registered with Current Controlled Trials, number ISRCTN08233942. RESULTS 377 patients in the LUCAS arm and 658 patients in the manual chest compression were admitted to hospital. Hospital and intensive care length of stay were similar. Long term follow-up assessments were limited by poor response rates (53.7% at 3 months and 55.6% at 12 months). Follow-up rates were lower in those with worse neurological function. Among respondents, long term health related quality of life outcomes and emotional well-being was similar between groups. Cognitive function, measured by MMSE, was marginally lower in the LUCAS arm mean 26.9 (SD 3.7) compared to control mean 28.0 (SD 2.3), adjusted mean difference -1.5 (95% CI -2.6 to -0.4). CONCLUSION There were no clinically important differences identified in outcomes at long term follow-up between those allocated to the mechanical chest compression compared to those receiving manual chest compression.

Rapid analgesia for prehospital hip disruption (RAPID): protocol for feasibility study of randomised controlled trial

BackgroundAdequate pain relief at the point of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilise and whose long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia iliaca compartment block (FICB) is a procedure routinely undertaken by doctors and nurses in the emergency department for patients with hip fracture but not yet evaluated for use by paramedics at the scene of emergency calls.In this feasibility study, we aim to test whether FICB administered by paramedics at the scene of participants’ hip fractures is feasible, safe and acceptable. This will enable us to decide whether to proceed to a fully powered, multi-centre pragmatic randomised trial to evaluate whether the procedure is effective for patients and worthwhile for the NHS.Methods/designIn this study, we propose to recruit ten paramedics in an urban area of South Wales. We will train them to carry out FICB when they attend patients with hip fracture. We will randomly allocate eligible patients to FICB or usual care using audited scratch cards. We will follow up participants to assess measurability of key outcomes including quality of life, pain scores, adverse events, length of stay in hospital, acceptability to patients and compliance of paramedics. We will assess whether the findings meet specified feasibility criteria and, if so, plan a full trial.DiscussionThis study will enable us to recommend whether to undertake a definitive trial of FICB by paramedics for hip fracture.Trial registrationISRCTN60065373

SNAPSHOT OF INITIATIVES TO SUPPORT TIMELY PATIENT HANDOVER FROM AMBULANCES TO THE EMERGENCY DEPARTMENT

Background Increasing pressure on the emergency care system contributes to delays in patient handover from ambulances to emergency departments. The impact of these delays includes ambulance queues, sub-optimal care for patients, staffing and operational challenges, and (in England) financial penalties. New models of care have the potential to reduce handover delay. We surveyed ambulance services across England and Wales to produce a snapshot of initiatives under development or being trialled in order to address problems associated with handover delay. Methods During 2014, we carried out semi-structured telephone interviews with R&D leads in all 11 independent ambulance service trusts in England and Wales. We asked respondents about initiatives taking place within their area, what evaluation was taking place, and what they believed to be the challenges to evaluation. Interviews were recorded and transcribed, and analysed using the Framework approach. Results Initiatives fell into three groups: prehospital; at the ED; and whole system. Prehospital initiatives comprised clinical decision support tools (n=6); alternative pathways (n=6); hospital capacity monitoring (n=3); automated data transfer (n=3). Initiatives at ED included handover screens (n=8); rapid access models (n=7); hospital ambulance liaison officers (n=6); corridor care (n=3). Whole system approaches included new models of collaborative working (n=2); service review (n=2). Challenges to implementing and evaluating change included the lack of standardised approaches to handover across multiple hospital trusts within an ambulance service area; many of the reported initiatives took place only in a small part of the ambulance services operational area. Only five respondents reported evaluation of handover initiatives, and of these two were described as informal evaluation only. The need to report and comply with performance targets was reported as a more immediate pressure than evaluation of new developments. Conclusions While there is a range of activity taking place across England and Wales to address handover delays, there is little formal evaluation and there are missed opportunities for transferable learning.

Paramedics’ perceptions of the care they provide to people who self-harm: A qualitative study using evolved grounded theory methodology

Background Self-harm (SH) accounts for over 5% of the workload of emergency ambulance services, and therefore Paramedics are often the first health professional in contact with people who SH. The authors of this paper have reported elsewhere the significant gaps in our understandings which exist surrounding this early care interaction, and some of the challenges paramedics and opportunities in paramedic care for people who SH. This study aimed to explore paramedics’ perceptions of caring for those who SH using Evolved Grounded Theory Methodology. Methods This study took place between 2014–2016 in one UK ambulance service covering a population of three million people. Semi structured interviews were conducted, purposively sampling paramedics until saturation was reached. Interviews were recorded, transcribed verbatim, and coded through open, axial, and selective levels of coding, identifying the Basic Social Process (BSP) and developing a Grounded Theory. A second researcher (SH) independently reviewed early results, which were also member-checked with participants. Results Eleven paramedics were interviewed. The following six categories emerged: Context; Judgements and values; Isolation and system failure; Managing risk; Competence at the boundary of mental and physical health needs; Professional, legal and ethical tensions. The BSP Decision making in a context of risk was identified. The final Grounded Theory that emerged was one of ‘Wicked Complexity of paramedic care for people who SH, which includes usual factors such as tiredness and frequent callers, heightened factors including lack of support and pathways, and factors specific to SH such assessing mental health and suicide risk. Conclusions This study builds on a very small body of literature to have explored paramedic care for people who SH and has found that this care interaction provides uniquely complex challenges. The multiple influences within the categories defined in this study need considering conjointly when making improvements to care.

Use of scratchcards for allocation concealment in a prehospital randomised controlled trial

Background Rapid Analgesia for Prehospital Hip Disruption was a small study designed to determine the feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics administering Fascia Iliaca Compartment Block as early prehospital pain relief to patients with a fractured hip. The objective was to devise a simple and effective method of random allocation concealment suitable for use by paramedics while in the emergency prehospital setting. Methods Scratchcards were produced using scratch-off silver stickers which concealed the trial arm allocation. Paramedics were each allocated a unique range of consecutive numbers, used as both the scratchcard number and the patient’s study ID. The cards were designed to allow the paramedic to write on the incident number, date and signature. A small envelope holding the cards was prepared for each paramedic. The study took place between 28 June 2016 and 31 July 2017 in the Swansea area. Results Nineteen trial paramedics used 71 scratchcards throughout the study and reported no problems randomly allocating patients using the scratchcards. Five protocol deviations were reported in relation to scratchcard use. On auditing the scratchcards, all unused cards were located, and no evidence of tampering with the silver panel was found. Conclusion Paramedics can use scratchcards as a method of randomly allocating patients in trials in prehospital care. In the future, a method that allows only the top card to be selected and a more protective method of storing the cards should be used. Scratchcards can be considered for wider use in RCTs in the emergency prehospital setting. Trial registration number ISRCTN60065373; Post-results.

Feasibility of data linkage in the PARAMEDIC trial : a cluster randomised trial of mechanical chest compression in out of hospital cardiac arrest

Objectives There is considerable interest in reducing the cost of clinical trials. Linkage of trial data to administrative datasets and disease-specific registries may improve trial efficiency, but it has not been reported in resuscitation trials conducted in the UK. To assess the feasibility of using national administrative and clinical datasets to follow up patients transported to hospital following attempted resuscitation in a cluster randomised trial of a mechanical chest compression device in out-of-hospital cardiac arrest. Methods Hospital data on trial participants were requested from Hospital Episode Statistics (HES), the Intensive Care National Audit and Research Centre, and Myocardial Ischaemia National Audit Project and National Audit of Percutaneous Coronary Interventions, using unique patient identifiers. Linked data were received between June 2014 and June 2015. Results Of 4471 patients randomised in the pre-hospital randomised assessment of a mechanical compression device in cardiac arrest (PARAMEDIC) trial, 2398 (53.6%) were not known to be deceased at emergency department arrival and were eligible for linkage. We achieved an overall match rate of 86.7% in the combined HES accident and emergency, inpatient and critical care dataset, with variable match rates (4.2%–80.4%) in individual datasets. Patient demographics, cardiac arrest-related characteristics and major outcomes were predominantly similar between HES matched and unmatched groups, in the linkage apart from location, response time and return of spontaneous circulation (ROSC) at handover. Conclusions This study shows that it is feasible to track patients from the prehospital setting through to hospital admission using routinely available administrative datasets with a moderate to high degree of success. This approach has the potential to complement the trial data with the demographic and clinical management information about the studied cohort, as well as to improve the efficiency and reduce the costs of follow-up in cardiac arrest trials. Clinical trial registration ISRCTN08233942; Post-results.

8 Rapid analgesia for prehospital hip disruption (rapid)

Aim Pain relief in prehospital care is a challenge in trauma, especially for those with hip fractures, whose injuries are difficult to immobilise and whose long term outcomes may be adversely affected by administration of opiates. Fascia Iliaca Compartment Block (FICB) is routinely undertaken by hospital clinicians, but has not been fully evaluated for use by paramedics in prehospital care. Method Nineteen paramedics were trained; they randomly allocated eligible patients to trial arms using audited scratchcards. Patients were followed up to assess availability of outcomes including quality of life, length of admission, pain scores, and adverse events. Findings were analysed against pre-specified progression criteria. Results Seventy-one patients were randomised by paramedics (28/6/16 – 31/7/17); 57 consented to follow up. The only outcome which reached a statistically significant difference between groups was the proportion of participants who received morphine (38% difference between groups 95% CI: −61.88 to −15.79). There was a difference of approximately nine days in the length of admission between trial arms (mean difference 9.12 (95% CI: −20.51 to 2.27). Conclusion RAPID met its pre-specified progression criteria; a funding application for a fully-powered RCT will therefore be submitted. We will consider the use of length of stay as the primary outcome, as findings indicated a difference between groups without reaching statistical significance. Conflict of interest None Funding Health and Care Research Wales, Research for Patient and Public Benefit.