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BackgroundGuidelines for adults presenting to the emergency department (ED) with suspected sepsis recommend protocols and bundles that promote rapid and potentially intensive treatment, but give little consideration of how patient characteristics, such as age, functional status and comorbidities, might influence management. This study aimed to describe the characteristics, management and outcomes of adults attending the ED with suspected sepsis, and specifically describe the prevalence of comorbidities, functional impairment and escalations of care.MethodsWe undertook a single-centre retrospective observational study involving medical record review of a random sample of adults admitted to an ED between February 2018 and January 2019 with suspected sepsis. Descriptive statistics were used with 95% confidence intervals (CIs) for key proportions.ResultsWe included 509 patients (median age 74 years), of whom 49.3% met the Sepsis-3 criteria. Less than half of the patients were living at home independently (42.5%) or could walk independently (41.5%), 19.3% were care home residents and 89.2% of patients had one or more comorbidity. 22% had a pre-existing do not attempt resuscitation order. 6.5% were referred to intensive care, and 34.3% of the 13.2% who died in-hospital had an escalation plan explicitly documented.ConclusionAdults with suspected sepsis have substantial functional limitations, comorbidities and treatment directives that should be considered in guidelines, especially recommendations for escalation of care.

AIMS: We aimed to describe the characteristics and outcomes of adults admitted to hospital with suspected COVID-19 according to their DNACPR decisions, and identify factors associated with DNACPR decisions. METHODS: We undertook a secondary analysis of 13,977 adults admitted to hospital with suspected COVID-19 and included in the Pandemic Respiratory Infection Emergency System Triage (PRIEST) study. We recorded presenting characteristics and outcomes (death or organ support) up to 30 days. We categorised patients as early DNACPR (before or on the day of admission) or late/no DNACPR (no DNACPR or occurring after the day of admission). We undertook descriptive analysis comparing these groups and multivariable analysis to identify independent predictors of early DNACPR. RESULTS: We excluded 1249 with missing DNACPR data, and identified 3929/12748 (31%) with an early DNACPR decision. They had higher mortality (40.7% v 13.1%) and lower use of any organ support (11.6% v 15.7%), but received a range of organ support interventions, with some being used at rates comparable to those with late or no DNACPR (e.g. non-invasive ventilation 4.4% v 3.5%). On multivariable analysis, older age (p < 0.001), active malignancy (p < 0.001), chronic lung disease (p < 0.001), limited performance status (p < 0.001), and abnormal physiological variables were associated with increased recording of early DNACPR. Asian ethnicity was associated with reduced recording of early DNACPR (p = 0.001). CONCLUSIONS: Early DNACPR decisions were associated with recognised predictors of adverse outcome, and were inversely associated with Asian ethnicity. Most people with an early DNACPR decision survived to 30 days and many received potentially life-saving interventions. REGISTRATION: ISRCTN registry, ISRCTN28342533, http://www.isrctn.com/ISRCTN28342533.

Introduction:Acute respiratory failure (ARF) is a common medical emergency. Pre-hospital management includes controlled oxygen therapy, supplemented by specific management options directed at the underlying disease. The aim of the current study was to characterise the accuracy of paramedic diagnostic assessment in acute respiratory failure. Methods:A nested diagnostic accuracy and agreement study comparing pre-hospital clinical impression to the final hospital discharge diagnosis was conducted as part of the ACUTE (Ambulance CPAP: Use, Treatment effect and Economics) trial. Adults with suspected ARF were recruited from the UK West Midlands Ambulance Service. The pre-hospital clinical impression of the recruiting ambulance service clinician was prospectively recorded and compared to the final hospital diagnosis at 30 days. Agreement between pre-hospital and hospital diagnostic assessments was evaluated using raw agreement and Gwets AC1 coefficient. Results:77 participants were included. Chronic obstructive pulmonary disease (32.9%) and lower respiratory tract infection (32.9%) were the most frequently suspected primary pre-hospital diagnoses for ARF, with secondary contributory conditions recorded in 36 patients (46.8%). There was moderate agreement between the primary pre-hospital and hospital diagnoses, with raw agreement of 58.5% and a Gwets AC1 coefficient of 0.56 (95% CI 0.43 to 0.69). In five cases, a non-respiratory final diagnosis was present, including: myocardial infarction, ruptured abdominal aortic aneurysm, liver failure and sepsis. Conclusions:Pre-hospital assessment of ARF is challenging, with limited accuracy compared to the final hospital diagnosis. A syndromic approach, providing general supportive care, rather than a specifically disease-orientated treatment strategy, is likely to be most appropriate for the pre-hospital environment.

BackgroundEmergency Medical Services (EMS) have experienced surges in demand as the COVID-19 pandemic has progressed with ambulances services in the UK declaring major incidents due to the risk of care being compromised. COVID-19 specific EMS telephone triage tools have been introduced to help manage demand. There has been no previous evaluation of the accuracy of EMS telephone triage in identifying patients with suspected COVID-19 at risk of serious adverse outcome.We aimed to assess accuracy of EMS telephone triage in identifying patients who need an EMS response and identify factors which affect triage accuracy.MethodPatients who made an emergency call to Yorkshire Ambulance Service between 2nd April and 29th June 2020 and were assessed using an AMPDS pandemic pathway for suspected COVID-19 were linked to Office for National Statistics death registration data, hospital and general practice electronic health care data collected by NHS Digital.Accuracy of decision to dispatch an ambulance was assessed in terms of death or need for organ support at 30 days from the first 999 call. Multivariable logistic regression was used to identify factors associated with false negative and false positive triage.ResultsOf 12, 653 callers included in the study population, 11.1% experienced the primary composite adverse outcome. Using the triage pathway, 16% of callers did not receive an emergency response and they had a lower risk (3.5%) of the primary outcome. Ambulances were dispatched to 4, 230 callers (33.4%) who were not subsequently conveyed to hospital and did not experience the primary outcome (false positive triage). Multivariable modelling found older age and presence of pre-existing respiratory disease were significant predictors of false positive triage.ConclusionEMS telephone triage avoided 16% of calls receiving an emergency ambulance, of whom 3.5% died or needed organ support by 30 days. Telephone triage can therefore reduce the burden of EMS responses but with the cost of a small proportion of patients who do not receive an initial emergency response deteriorating. Research is needed to identify the appropriate balance between over- and under-triage

Purpose Epilepsy is associated with costly unplanned health service use. The UK’s National Audits of Seizure Management in Hospital found use was often clinically unnecessary, avoidable and typically led to little benefit for epilepsy management. We systematically identified how services have responded to reduce such use. Methods We invited England’s ambulance services, neuroscience and neurology centres and a random sample of Emergency Departments (EDs) to complete a survey. It asked what innovations they (or services they worked with) had made in the past 5 years or were making, the priority afforded to them, user involvement, what comprised usual practice, and barriers to change. Results 72/87 of invited (82.8 %) services responded. EDs ascribed less priority to reducing emergency hospital use for epilepsy and convulsions, than other service types. Overall, 60 % of services reported a change(s) and/or were planning one. Neurology/neuroscience sites (93.8 %) were most likely to report change; EDs (15.4 %) least likely. Eleven types of change were identified; 5 sought to promote proactive epilepsy care and avert the need for emergency care; 3 focused on the care received from emergency services; and 3 focused on follow-up care ED attendees received. Most were for those with established, rather than new epilepsy and targeted known limitations to current care provision. Conclusion Reducing emergency hospital use by PWE is a high priority for most health services in England and a number of new services have been developed. However, they have not been consistently implemented and innovation is lacking in some areas of care.

BackgroundTools proposed to triage patient acuity in COVID-19 infection have only been validated in hospital populations. We estimated the accuracy of five risk-stratification tools recommended to predict severe illness and compared accuracy to existing clinical decision making in a prehospital setting.MethodsAn observational cohort study using linked ambulance service data for patients attended by Emergency Medical Service (EMS) crews in the Yorkshire and Humber region of England between 26 March 2020 and 25 June 2020 was conducted to assess performance of the Pandemic Respiratory Infection Emergency System Triage (PRIEST) tool, National Early Warning Score (NEWS2), WHO algorithm, CRB-65 and Pandemic Medical Early Warning Score (PMEWS) in patients with suspected COVID-19 infection. The primary outcome was death or need for organ support.ResultsOf the 7549 patients in our cohort, 17.6% (95% CI 16.8% to 18.5%) experienced the primary outcome. The NEWS2 (National Early Warning Score, version 2), PMEWS, PRIEST tool and WHO algorithm identified patients at risk of adverse outcomes with a high sensitivity (>0.95) and specificity ranging from 0.3 (NEWS2) to 0.41 (PRIEST tool). The high sensitivity of NEWS2 and PMEWS was achieved by using lower thresholds than previously recommended. On index assessment, 65% of patients were transported to hospital and EMS decision to transfer patients achieved a sensitivity of 0.84 (95% CI 0.83 to 0.85) and specificity of 0.39 (95% CI 0.39 to 0.40).ConclusionUse of NEWS2, PMEWS, PRIEST tool and WHO algorithm could improve sensitivity of EMS triage of patients with suspected COVID-19 infection. Use of the PRIEST tool would improve sensitivity of triage without increasing the number of patients conveyed to hospital.

Background Many health care systems triage injured patients to major trauma centres (MTCs) or local hospitals by using triage tools and paramedic judgement. Triage tools are typically assessed by whether patients with an Injury Severity Score (ISS) ≥ 16 go to an MTC and whether patients with an ISS Methods A patient-level, probabilistic, mathematical model of a UK major trauma system was developed. Patients with an ISS ≥ 16 who were only treated at local hospitals had worse outcomes compared to being treated in an MTC. Nine empirically derived triage tools, from a previous study, were examined so we assessed triage tools with realistic trade-offs between triage tool sensitivity and specificity. Lifetime costs, lifetime quality adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for each tool and compared to maximum acceptable ICERs (MAICERs) in England. Results Four tools had ICERs within the normal range of MAICERs used by English decision makers (£20,000 to £30,000 per QALY gained). A low sensitivity (28.4%) and high specificity (88.6%) would be cost-effective at the lower end of this range while higher sensitivity (87.5%) and lower specificity (62.8%) was cost-effective towards the upper end of this range. These results were sensitive to the cost of MTC admissions and whether MTCs had a benefit for patients with an ISS between 9 and 15. Conclusions The cost-effective triage tool depends on the English decision maker’s MAICER for this health problem. In the usual range of MAICERs, cost-effective prehospital trauma triage involves clinically suboptimal sensitivity, with a proportion of seriously injured patients (at least 10%) being initially transported to local hospitals. High sensitivity trauma triage requires development of more accurate decision rules; research to establish if patients with an ISS between 9 and 15 benefit from MTCs; or, inefficient use of health care resources to manage patients with less serious injuries at MTCs.

ObjectiveTo assess accuracy of telephone triage in identifying patients who need emergency care amongst those with suspected COVID-19 infection and identify factors which affect triage accuracy.DesignObservational cohort studySettingCommunity telephone triage in the Yorkshire and Humber, Bassetlaw, North Lincolnshire and North East Lincolnshire region.Participants40, 261 adults who contacted NHS 111 telephone triage services provided by Yorkshire Ambulance Service NHS Trust between the 18th March 2020 and 29th June 2020 with symptoms indicating possible COVID-19 infection were linked to Office for National Statistics death registration data, hospital and general practice electronic health care data collected by NHS Digital.OutcomeAccuracy of triage disposition (self-care/non-urgent clinical assessment versus ambulance dispatch/urgent clinical assessment) was assessed in terms of death or need for organ support at 30, 7 and 3 days from first contact with the telephone triage service.ResultsCallers had a 3% (1, 200/40, 261) risk of adverse outcome. Telephone triage recommended self-care or non-urgent assessment for 60% (24, 335/40, 261), with a 1.3% (310/24, 335) risk of subsequent adverse outcome. Telephone triage had 74.2% sensitivity (95% CI: 71.6 to 76.6%) and 61.5% specificity (61% to 62%) for adverse outcomes at 30 days from first contact. Multivariable analysis suggested some co-morbidities (such as chronic respiratory disease) may be over-estimated as predictors of adverse outcome, while the association of diabetes with adverse outcome may be under-estimated. Repeat contact with the service appears to be an important under recognised predictor of adverse outcomes with both 2 contacts (OR 1.77 95% CI: 1.14 to 2.75) and 3 or more contacts (OR 4.02 95% CI: 1.68 to 9.65) associated with clinical deterioration when not provided with an ambulance or urgent clinical assessment.ConclusionPatients advised to self-care or receive non-urgent clinical assessment had a small but non-negligible risk of serious clinical deterioration. The sensitivity and specificity of telephone triage was comparable to other tools used to triage patient acuity in emergency and urgent care. Repeat contact with telephone services needs recognition as an important predictor of subsequent adverse outcomes.What is already known on this topicTelephone triage has been used to divert patients with suspected COVID-19 to self care or for non-urgent clinical assessments, and thereby help mitigate the risk of health services being overwhelmed by patients who require no speficic treatment.Concerns have been raised that telephone triage may not be sufficiently accurate in identifying need for emergency care. However, no previous evaluation of accuracy of telephone triage in patients with suspected COVID-19 infection has been completed.What this study addsPatients advised to self care or receive non-urgent clinical assessment had a small but non-negligible risk of deterioration and significant adverse outcomes.Telephone triage has comparable performance to methods used to triage patient acuity in other emergency and urgent care settings.Accuracy of triage may be improved by better recognition of multiple contact with services as a predictor of adverse outcomes.

What you need to know Early recognition and treatment of sepsis is essential to reduce mortality, but this can only be achieved if patients with suspected sepsis receive priority treatment in the emergency care system. One suggested approach for identifying these patients is through the use of early warning scores. These use simple clinical measurements to calculate a score indicating the risk of adverse outcome,1 and several guidelines make recommendations around their use in early recognition of sepsis (see box 1). Box 1 ### Guidelines recommending the use of early warning scores to aid in early recognition of sepsis risk in adultsRETURN TO TEXT

Edited by Dr Gabrielle Prager on behalf of the RCEM COVID-19 CPD team Following from the successful ‘RCEM weekly top five’ series starting in April 2020, this is the third of a monthly format for EMJ readers. We have undertaken a focused search of the PubMed literature using a standardised COVID-19 search string. Our search between 1 December and 31 December 2020 returned 1183 papers limited to human subjects and English language. We also searched high impact journals for papers of interest. Our team have narrowed down the most interesting, relevant and important of the papers and provided a critical snapshot of five of those we felt most deserved EMJ reader attention. Importantly, we have highlighted not only the main findings from the papers but also key limitations and considerations for EM clinicians when interpreting the work. In doing so we have created an accessible window into pertinent research findings for our busy colleagues during this fast-paced and ever-changing COVID-19 landscape. The papers are ranked in one of three categories, allowing you to focus on those that are most vital to your practice: This month’s searches were undertaken by the Centre for Urgent and Emergency Care Research at the University of Sheffield. We look forward to next month’s instalment by our colleagues in Leicester. ### Topic: treatment #### Rating: game changer In March 2020, the WHO recommended randomised trials into potential treatments for COVID-19. Experts agreed on four antiviral drugs that could be repurposed to reduce mortality in this patient group. The four drugs were remdesivir, hydroxychloroquine, lopinavir and interferon beta-1a. Within a month a large international, open-label randomised trial was launched at 405 hospitals in 30 different countries. There was no placebo group; the control group consisted …

IntroductionHospital-acquired thrombosis accounts for a large proportion of all venous thromboembolism (VTE), with significant morbidity and mortality. This subset of VTE can be reduced through accurate risk assessment and tailored pharmacological thromboprophylaxis. This systematic review aimed to determine the comparative accuracy of risk assessment models (RAMs) for predicting VTE in patients admitted to hospital.MethodsA systematic search was performed across five electronic databases (including MEDLINE, EMBASE and the Cochrane Library) from inception to February 2021. All primary validation studies were eligible if they examined the accuracy of a multivariable RAM (or scoring system) for predicting the risk of developing VTE in hospitalised inpatients. Two or more reviewers independently undertook study selection, data extraction and risk of bias assessments using the PROBAST (Prediction model Risk Of Bias ASsessment Tool) tool. We used narrative synthesis to summarise the findings.ResultsAmong 6355 records, we included 51 studies, comprising 24 unique validated RAMs. The majority of studies included hospital inpatients who required medical care (21 studies), were undergoing surgery (15 studies) or receiving care for trauma (4 studies). The most widely evaluated RAMs were the Caprini RAM (22 studies), Padua prediction score (16 studies), IMPROVE models (8 studies), the Geneva risk score (4 studies) and the Kucher score (4 studies). C-statistics varied markedly between studies and between models, with no one RAM performing obviously better than other models. Across all models, C-statistics were often weak (0.8). Similarly, estimates for sensitivity and specificity were highly variable. Sensitivity estimates ranged from 12.0% to 100% and specificity estimates ranged from 7.2% to 100%.ConclusionAvailable data suggest that RAMs have generally weak predictive accuracy for VTE. There is insufficient evidence and too much heterogeneity to recommend the use of any particular RAM.PROSPERO registration numberSteve Goodacre, Abdullah Pandor, Katie Sworn, Daniel Horner, Mark Clowes. A systematic review of venous thromboembolism RAMs for hospital inpatients. PROSPERO 2020 CRD42020165778. Available from https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=165778https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=165778

BackgroundAmbulance service quality measures have focused on response times and a small number of emergency conditions, such as cardiac arrest. These quality measures do not reflect the care for the wide range of problems that ambulance services respond to and the Prehospital Outcomes for Evidence Based Evaluation (PhOEBE) programme sought to address this.ObjectivesThe aim was to develop new ways of measuring the impact of ambulance service care by reviewing and synthesising literature on prehospital ambulance outcome measures and using consensus methods to identify measures for further development; creating a data set linking routinely collected ambulance service, hospital and mortality data; and using the linked data to explore the development of case-mix adjustment models to assess differences or changes in processes and outcomes resulting from ambulance service care.DesignA mixed-methods study using a systematic review and synthesis of performance and outcome measures reported in policy and research literature; qualitative interviews with ambulance service users; a three-stage consensus process to identify candidate indicators; the creation of a data set linking ambulance, hospital and mortality data; and statistical modelling of the linked data set to produce novel case-mix adjustment measures of ambulance service quality.SettingEast Midlands and Yorkshire, England.ParticipantsAmbulance services, patients, public, emergency care clinical academics, commissioners and policy-makers between 2011 and 2015.InterventionsNone.Main outcome measuresAmbulance performance and quality measures.Data sourcesAmbulance call-and-dispatch and electronic patient report forms, Hospital Episode Statistics, accident and emergency and inpatient data, and Office for National Statistics mortality data.ResultsSeventy-two candidate measures were generated from systematic reviews in four categories: (1) ambulance service operations (n = 14), (2) clinical management of patients (n = 20), (3) impact of care on patients (n = 9) and (4) time measures (n = 29). The most common operations measures were call triage accuracy; clinical management was adherence to care protocols, and for patient outcome it was survival measures. Excluding time measures, nine measures were highly prioritised by participants taking part in the consensus event, including measures relating to pain, patient experience, accuracy of dispatch decisions and patient safety. Twenty experts participated in two Delphi rounds to refine and prioritise measures and 20 measures scored ≥ 8/9 points, which indicated good consensus. Eighteen patient and public representatives attending a consensus workshop identified six measures as important: time to definitive care, response time, reduction in pain score, calls correctly prioritised to appropriate levels of response, proportion of patients with a specific condition who are treated in accordance with established guidelines, and survival to hospital discharge for treatable emergency conditions. From this we developed six new potential indicators using the linked data set, of which five were constructed using case-mix-adjusted predictive models: (1) mean change in pain score; (2) proportion of serious emergency conditions correctly identified at the time of the 999 call; (3) response time (unadjusted); (4) proportion of decisions to leave a patient at scene that were potentially inappropriate; (5) proportion of patients transported to the emergency department by 999 emergency ambulance who did not require treatment or investigation(s); and (6) proportion of ambulance patients with a serious emergency condition who survive to admission, and to 7 days post admission. Two indicators (pain score and response times) did not need case-mix adjustment. Among the four adjusted indicators, we found that accuracy of call triage was 61%, rate of potentially inappropriate decisions to leave at home was 5–10%, unnecessary transport to hospital was 1.7–19.2% and survival to hospital admission was 89.5–96.4% depending on Clinical Commissioning Group area. We were unable to complete a fourth objective to test the indicators in use because of delays in obtaining data. An economic analysis using indicators (4) and (5) showed that incorrect decisions resulted in higher costs.LimitationsCreation of a linked data set was complex and time-consuming and data quality was variable. Construction of the indicators was also complex and revealed the effects of other services on outcome, which limits comparisons between services.ConclusionsWe identified and prioritised, through consensus processes, a set of potential ambulance service quality measures that reflected preferences of services and users. Together, these encompass a broad range of domains relevant to the population using the emergency ambulance service. The quality measures can be used to compare ambulance services or regions or measure performance over time if there are improvements in mechanisms for linking data across services.Future workThe new measures can be used to assess different dimensions of ambulance service delivery but current data challenges prohibit routine use. There are opportunities to improve data linkage processes and to further develop, validate and simplify these measures.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

BACKGROUND: Chest pain is the top reason for hospitalization/observation in the USA, but it is unclear if this strategy improves patient outcomes. OBJECTIVE: The objective of this study was to compare 30-day outcomes for patients admitted versus discharged after a negative emergency department (ED) evaluation for suspected acute coronary syndrome. DESIGN: A retrospective, multi-site, cohort study of adult encounters with chest pain presenting to one of 13 Kaiser Permanente Southern California EDs between January 1, 2015, and December 1, 2017. Instrumental variable analysis was used to mitigate potential confounding by unobserved factors. PATIENTS: All adult patients presenting to an ED with chest pain, in whom an acute myocardial infarction was not diagnosed in the ED, were included. MAIN MEASURES: The primary outcome was 30-day acute myocardial infarction or all-cause mortality, and secondary outcomes included 30-day revascularization and major adverse cardiac events. KEY RESULTS: In total, 77,652 patient encounters were included in the study (n=11,026 admitted, 14.2%). Three hundred twenty-two (0.4%) had an acute myocardial infarction (n=193, 0.2%) or death (n=137, 0.2%) within 30 days of ED visit (1.5% hospitalized versus 0.2% discharged). Very few (0.3%) patients underwent coronary revascularization within 30 days (0.7% hospitalized versus 0.2% discharged). Instrumental variable analysis found no adjusted differences in 30-day patient outcomes between the hospitalized cohort and those discharged (risk reduction 0.002, 95% CI −0.002 to 0.007). Similarly, there were no differences in coronary revascularization (risk reduction 0.003, 95% CI −0.002 to 0.007). CONCLUSION: Among ED patients with chest pain not diagnosed with an acute myocardial infarction, risk of major adverse cardiac events is quite low, and there does not appear to be any benefit in 30-day outcomes for those admitted or observed in the hospital compared to those discharged with outpatient follow-up. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-06841-2.

Acute respiratory failure is a life-threatening emergency. Standard prehospital management involves controlled oxygen therapy. Continuous positive airway pressure is a potentially beneficial alternative treatment; however, it is uncertain whether or not this treatment could improve outcomes in NHS ambulance services.To assess the feasibility of a large-scale pragmatic trial and to update an existing economic model to determine cost-effectiveness and the value of further research.(1) An open-label, individual patient randomised controlled external pilot trial. (2) Cost-effectiveness and value-of-information analyses, updating an existing economic model. (3) Ancillary substudies, comprising an acute respiratory failure incidence study, an acute respiratory failure diagnostic agreement study, clinicians perceptions of a continuous positive airway pressure mixed-methods study and an investigation of allocation concealment.Four West Midlands Ambulance Service hubs, recruiting between August 2017 and July 2018.Adults with respiratory distress and peripheral oxygen saturations below the British Thoracic Society's target levels were included. Patients with limited potential to benefit from, or with contraindications to, continuous positive airway pressure were excluded.Prehospital continuous positive airway pressure (O-Two system, O-Two Medical Technologies Inc., Brampton, ON, Canada) was compared with standard oxygen therapy, titrated to the British Thoracic Society's peripheral oxygen saturation targets. Interventions were provided in identical sealed boxes.Feasibility objectives estimated the incidence of eligible patients, the proportion recruited and allocated to treatment appropriately, adherence to allocated treatment, and retention and data completeness. The primary clinical end point was 30-day mortality.Seventy-seven patients were enrolled (target 120 patients), including seven patients with a diagnosis for which continuous positive airway pressure could be ineffective or harmful. Continuous positive airway pressure was fully delivered to 74% of participants (target 75%). There were no major protocol violations/non-compliances. Full data were available for all key outcomes (target ≥ 90%). Thirty-day mortality was 27.3%. Of the 21 deceased participants, 14 (68%) either did not have a respiratory condition or had ceiling-of-treatment decision implemented that excluded hospital non-invasive ventilation and critical care. The base-case economic evaluation indicated that standard oxygen therapy was probably cost-effective (incremental cost-effectiveness ratio £5685 per quality-adjusted life-year), but there was considerable uncertainty (population expected value of perfect information of £16.5M). Expected value of partial perfect information analyses indicated that effectiveness of prehospital continuous positive airway pressure was the only important variable. The incidence rate of acute respiratory failure was 17.4 (95% confidence interval 16.3 to 18.5) per 100,000 persons per year. There was moderate agreement between the primary prehospital and final hospital diagnoses (Gwet's AC1 coefficient 0.56, 95% confidence interval 0.43 to 0.69). Lack of hospital awareness of the Ambulance continuous positive airway pressure (CPAP): Use, Treatment Effect and economics (ACUTE) trial, limited time to complete trial training and a desire to provide continuous positive airway pressure treatment were highlighted as key challenges by participating clinicians.During week 10 of recruitment, the continuous positive airway pressure arm equipment boxes developed a 'rattle'. After repackaging and redistribution, no further concerns were noted. A total of 41.4% of ambulance service clinicians not participating in the ACUTE trial indicated a difference between the control and the intervention arm trial boxes (115/278); of these clinician 70.4% correctly identified box contents.Recruitment rate was below target and feasibility was not demonstrated. The economic evaluation results suggested that a definitive trial could represent value for money. However, limited compliance with continuous positive airway pressure and difficulty in identifying patients who could benefit from continuous positive airway pressure indicate that prehospital continuous positive airway pressure is unlikely to materially reduce mortality.A definitive clinical effectiveness trial of continuous positive airway pressure in the NHS is not recommended.Current Controlled Trials ISRCTN12048261.This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inAcute respiratory failure is a life-threatening medical emergency. It occurs when heart or lung disease suddenly develops, or deteriorates, and leads to the patient being unable to maintain oxygen levels in their blood. Continuous positive airway pressure is a potentially useful treatment that could be used by paramedics. It involves delivering oxygen under increased pressure through a tight-fitting face mask. However, it is uncertain whether or not it could work effectively in NHS ambulance services, or if it represents value for money. The Ambulance continuous positive airway pressure (CPAP): Use, Treatment Effect and economics (ACUTE) trial investigated whether or not it is possible and worthwhile to undertake a full-scale study comparing continuous positive airway pressure with normal paramedic treatment. Paramedics identified adults with acute respiratory failure when attending 999 emergency calls. Half were randomly assigned to receive continuous positive airway pressure, whereas the other half were treated normally. Patients were then followed up to see what happened to them. Fewer patients than expected were entered into the trial, but paramedics were able to provide treatment with continuous positive airway pressure, and most patients were successfully followed up. It therefore seems possible to do a full-scale trial. A cost-effectiveness model also showed that it is uncertain whether or not continuous positive airway pressure represents value for money for the NHS, so further research might be worthwhile, if continuous positive airway pressure is thought to be effective. However, examination of patients recruited to the trial uncovered important doubts about whether or not continuous positive airway pressure would help them. One-quarter of patients were not able to tolerate the tight continuous positive airway pressure mask. Some of the patients had conditions that are not usually treated by continuous positive airway pressure, or had severe underlying disease that could not be helped by this treatment. Others had collapsed lungs that could have been made worse by continuous positive airway pressure. This means that, although a full-scale trial may be possible, it is difficult to see how continuous positive airway pressure could save enough lives to make a trial worthwhile.

Uneven vaccination and less resilient health care systems mean hospitals in LMICs are at risk of being overwhelmed during periods of increased COVID-19 infection. Risk-scores proposed for rapid triage of need for admission from the emergency department (ED) have been developed in higher-income settings during initial waves of the pandemic.Routinely collected data for public hospitals in the Western Cape, South Africa from the 27We analysed 305,564, derivation 140,520 Omicron and 12,610 UK validation cases. Over 100 events per predictor parameter were modelled. Multivariable analyses identified eight predictor variables retained across models. We used these findings and clinical judgement to develop a score based on South African Triage Early Warning Scores and also included age, sex, oxygen saturation, inspired oxygen, diabetes and heart disease. The LMIC-PRIEST score achieved C-statistics: 0.82 (95% CI: 0.82 to 0.83) development cohort; 0.79 (95% CI: 0.78 to 0.80) Omicron cohort; and 0.79 (95% CI: 0.79 to 0.80) UK cohort. Differences in prevalence of outcomes led to imperfect calibration in external validation. However, use of the score at thresholds of three or less would allow identification of very low-risk patients (NPV ≥0.99) who could be rapidly discharged using information collected at initial assessment.The LMIC-PRIEST score shows good discrimination and high sensitivity at lower thresholds and can be used to rapidly identify low-risk patients in LMIC ED settings.Uneven vaccination in low- and middle-income countries (LMICs) coupled with less resilient health care provision mean that emergency health care systems in LMICs may still be at risk of being overwhelmed during periods of increased COVID-19 infection.Risk-stratification scores may help rapidly triage need for hospitalisation. However, those proposed for use in the ED for patients with suspected COVID-19 have been developed and validated in high-income settings.The LMIC-PRIEST score has been robustly developed using a large routine dataset from the Western Cape, South Africa and is directly applicable to existing triage practices in LMICs.External validation across both income settings and COVID-19 variants showed good discrimination and high sensitivity (at lower thresholds) to a composite outcome indicating need for inpatient admission from the ED.Use of the LMIC-PRIEST score at thresholds of three or less would allow identification of very low-risk patients (negative predictive value ≥0.99) across all settings assessedDuring periods of increased demand, this could allow the rapid identification and discharge of patients from the ED using information collected at initial assessment.

Introduction: Acute respiratory failure (ARF) is a common and life-threatening medical emergency. Continuous positive airway pressure (CPAP) is a potentially beneficial alternative treatment; however, it is uncertain whether this could improve important outcomes in NHS ambulance services. The ACUTE study aimed to assess the feasibility of a large-scale pragmatic trial of pre-hospital CPAP.Methods: The study was a pilot randomised controlled trial of the O-Two system CPAP mask versus standard oxygen therapy, with concealed allocation in identical sealed boxes. Feasibility objectives estimated the incidence of eligible patients; the proportion recruited and allocated to treatment appropriately; adherence to allocated treatment; and retention and data completeness. The primary clinical endpoint was 30-day mortality. Ancillary studies included an ARF incidence study, ARF diagnostic agreement study, clinician perceptions of CPAP mixed methods study and investigation of allocation concealment.Results: Over 12 months, 77 patients were enrolled (target 120). CPAP was fully delivered in 74% (target 75%). There were no major protocol violations/non-compliances. Full data were available for all key outcomes (targets ≥ 90%). Thirty-day mortality was 27.3%. Of deceased patients, 14/21 (68%) either did not have a respiratory condition or had ceiling of treatment decisions implemented excluding hospital NIV and critical care.Conclusion: The ACUTE trial recruitment rate was below the target rate and feasibility was not demonstrated. Identification of patients who might benefit from pre-hospital CPAP was challenging. It appeared difficult to exclude conditions where CPAP would not work, or might be harmful, and to select appropriate patients where there was a meaningful chance of success, or where the potential advantages of pre-hospital CPAP would outweigh the burdens of more advanced and aggressive treatment. The limited compliance with CPAP, and the difficulty in identifying patients who could benefit from CPAP, indicate that pre-hospital CPAP is unlikely to materially reduce mortality. A definitive effectiveness trial of CPAP in the NHS is therefore not recommended.

BackgroundWe aimed to estimate the diagnostic accuracy of the VitalScan magnetocardiograph (MCG) for suspected acute coronary syndrome (ACS).MethodsWe undertook a prospective cohort study evaluating the diagnostic accuracy of the MCG in adults with suspected ACS. The reference standard of ACS was determined by an independent adjudication committee based on 30-day investigations and events. The cohort was split into a training sample, to derive the MCG algorithm and an algorithm combining MCG with a modified Manchester Acute Coronary Syndrome (MACS) clinical probability score, and a validation sample, to estimate diagnostic accuracy.ResultsWe recruited 756 participants and analysed data from 680 (293 training, 387 validation), of whom 96 (14%) had ACS. In the training sample, the respective area under the receiver operating characteristic (AUROC) curves were the following: MCG 0.66 (95% CI 0.58 to 0.74), MACS 0.64 (95% CI 0.54 to 0.73) and MCG+MACS 0.70 (95% CI 0.63 to 0.77). MCG specificity was 0.16 (95% CI 0.12 to 0.21) at the threshold achieving acceptable sensitivity for rule-out (>0.98). In the validation sample (n=387), the respective AUROCs were the following: MCG 0.56 (95% CI 0.48 to 0.64), MACS 0.69 (95% CI 0.61 to 0.77) and MCG+MACS 0.64 (95% CI 0.56 to 0.72). MCG sensitivity was 0.89 (95% CI 0.77 to 0.95) and specificity 0.15 (95% CI 0.12 to 0.20) at the rule-out threshold. MCG+MACS sensitivity was 0.85 (95% CI 0.73 to 0.92) and specificity 0.30 (95% CI 0.25 to 0.35).ConclusionThe VitalScan MCG is currently unable to accurately rule out ACS and is not yet ready for use in clinical practice. Further developmental research is required.

Background Standard prehospital management for Acute respiratory failure (ARF) involves controlled oxygen therapy. Continuous positive airway pressure (CPAP) is a potentially beneficial alternative treatment, however, it is uncertain whether this could improve outcomes and provide value for money. This study aimed to evaluate the cost-effectiveness of prehospital CPAP in ARF. Methods A cost-utility economic evaluation was performed using a probabilistic decision tree model synthesising available evidence. The model consisted of a hypothetical cohort of patients in a representative ambulance service with undifferentiated ARF, receiving standard oxygen therapy or prehospital CPAP. Costs and quality adjusted life years (QALYs) were estimated using methods recommended by NICE. Results In the base case analysis, using CPAP effectiveness estimates form the ACUTE trial, the mean expected costs of standard care and prehospital CPAP were £15,201 and £14,850 respectively and the corresponding mean expected QALYs were 1.190 and 1.128, respectively. The mean ICER estimated as standard oxygen therapy compared to prehospital CPAP was £5685 per QALY which indicated that standard oxygen therapy strategy was likely to be cost-effective at a threshold of £20,000 per QALY (67% probability). The scenario analysis, using effectiveness estimates from an updated meta-analysis, suggested that prehospital CPAP was more effective (mean incremental QALYs of 0.157), but also more expensive (mean incremental costs of £1522), than standard care. The mean ICER, estimated as prehospital CPAP compared to standard care, was £9712 per QALY. At the £20,000 per QALY prehospital CPAP was highly likely to be the most cost-effective strategy (94%). Conclusions Cost-effectiveness of prehospital CPAP depends upon the estimate of effectiveness. When based on a small pragmatic feasibility trial, standard oxygen therapy is cost-effective. When based on meta-analysis of heterogeneous trials, CPAP is cost-effective. Value of information analyses support commissioning of a large pragmatic effectiveness trial, providing feasibility and plausibility conditions are met.

Background Opioids, such as heroin, kill more people worldwide by overdose than any other type of drug, and death rates associated with opioid poisoning in the UK are at record levels (World Drug Report 2018 [Internet]. [cited 2019 Nov 19]. Available from: http://www.unodc.org/wdr2018/; Deaths related to drug poisoning in England and Wales - Office for National Statistics [Internet]. [cited 2019 Nov 19]. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2018registrations). Naloxone is an opioid antagonist which can be distributed in ‘kits’ for administration by witnesses in an overdose emergency. This intervention is known as take-home naloxone (THN). We know that THN can save lives on an individual level, but there is currently limited evidence about the effectiveness of THN distribution on an aggregate level, in specialist drug service settings or in emergency service settings. Notably, we do not know whether THN kits reduce deaths from opioid overdose in at-risk populations, if there are unforeseen harms associated with THN distribution or if THN is cost-effective. In order to address this research gap, we aim to determine the feasibility of a fully powered cluster randomised controlled trial (RCT) of THN distribution in emergency settings. Methods We will carry out a feasibility study for a RCT of THN distributed in emergency settings at four sites, clustered by Emergency Department (ED) and catchment area within its associated ambulance service. THN is a peer-administered intervention. At two intervention sites, emergency ambulance paramedics and ED clinical staff will distribute THN to adult patients who are at risk of opioid overdose. At two control sites, practice will carry on as usual. We will develop a method of identifying a population to include in an evaluation, comprising people at risk of fatal opioid overdose, who may potentially receive naloxone included in a THN kit. We will gather anonymised outcomes up to 1 year following a 12-month ‘live’ trial period for patients at risk of death from opioid poisoning. We expect approximately 100 patients at risk of opioid overdose to be in contact with each service during the 1-year recruitment period. Our outcomes will include deaths, emergency admissions, intensive care admissions, and ED attendances. We will collect numbers of eligible patients attended by participating in emergency ambulance paramedics and attending ED, THN kits issued, and NHS resource usage. We will determine whether to progress to a fully powered trial based on pre-specified progression criteria: sign-up of sites (n = 4), staff trained (≥ 50%), eligible participants identified (≥ 50%), THN provided to eligible participants (≥ 50%), people at risk of death from opioid overdose identified for inclusion in follow-up (≥ 75% of overdose deaths), outcomes retrieved for high-risk individuals (≥ 75%), and adverse event rate (< 10% difference between study arms). Discussion This feasibility study is the first randomised, methodologically robust investigation of THN distribution in emergency settings. The study addresses an evidence gap related to the effectiveness of THN distribution in emergency settings. As this study is being carried out in emergency settings, obtaining informed consent on behalf of participants is not feasible. We therefore employ novel methods for identifying participants and capturing follow-up data, with effectiveness dependent on the quality of the available routine data. Trial registration ISRCTN13232859 (Registered 16/02/2018)

BackgroundMeasurement of post-exertion oxygen saturation has been proposed to assess illness severity in suspected COVID-19 infection. We aimed to determine the accuracy of post-exertional oxygen saturation for predicting adverse outcome in suspected COVID-19.MethodsWe undertook a substudy of an observational cohort study across 70 emergency departments during the first wave of the COVID-19 pandemic in the UK. We collected data prospectively, using a standardised assessment form, and retrospectively, using hospital records, from patients with suspected COVID-19, and reviewed hospital records at 30 days for adverse outcome (death or receiving organ support). Patients with post-exertion oxygen saturation recorded were selected for this analysis. We constructed receiver-operating characteristic curves, calculated diagnostic parameters, and developed a multivariable model for predicting adverse outcome.ResultsWe analysed data from 817 patients with post-exertion oxygen saturation recorded after excluding 54 in whom measurement appeared unfeasible. The c-statistic for post-exertion change in oxygen saturation was 0.589 (95% CI 0.465 to 0.713), and the positive and negative likelihood ratios of a 3% or more desaturation were, respectively, 1.78 (1.25 to 2.53) and 0.67 (0.46 to 0.98). Multivariable analysis showed that post-exertion oxygen saturation was not a significant predictor of adverse outcome when baseline clinical assessment was taken into account (p=0.368). Secondary analysis excluding patients in whom post-exertion measurement appeared inappropriate resulted in a c-statistic of 0.699 (0.581 to 0.817), likelihood ratios of 1.98 (1.26 to 3.10) and 0.61 (0.35 to 1.07), and some evidence of additional prognostic value on multivariable analysis (p=0.019).ConclusionsPost-exertion oxygen saturation provides modest prognostic information in the assessment of selected patients attending the emergency department with suspected COVID-19.Trial registration numberISRCTN Registry (ISRCTN56149622) http://www.isrctn.com/ISRCTN28342533.

ObjectivesEmergency departments (EDs) are complex adaptive systems and improving patient flow requires understanding how ED processes work. This study aimed to explore the patient flow process in an ED in Trinidad and Tobago, identifying organisational factors influencing patient flow.MethodsMultiple qualitative methods, including non-participant observations, observational process mapping and informal conversational interviews were used to explore patient flow. The process maps were generated from the observational process mapping. Thematic analysis was used to analyse the data.SettingThe study was conducted at a major tertiary level ED in Trinidad and Tobago.ParticipantsPatient and staff journeys in the ED were directly observed.ResultsSix broad categories were identified: (1) ED organisational work processes, (2) ED design and layout, (3) material resources, (4) nursing staff levels, roles, skill mix and use, (5) non-clinical ED staff and (6) external clinical and non-clinical departments. Within each category there were individual factors that appeared to either facilitate or hinder patient flow. Organisational processes such as streaming, front loading of investigations and the transfer process were pre-existing strategies in the ED while staff actions to compensate for limitations with flow were more intuitive. A conceptual framework of factors influencing ED patient flow is also presented.ConclusionThe knowledge gained may be used to strengthen the emergency care system in the local context. However, the study findings should be validated in other settings.

Background Hospital emergency departments play a crucial role in the initial assessment and management of suspected COVID-19 infection. This needs to be guided by studies of people presenting with suspected COVID-19, including those admitted and discharged, and those who do not ultimately have COVID-19 confirmed. We aimed to characterise patients attending emergency departments with suspected COVID-19, including subgroups based on sex, ethnicity and COVID-19 test results. Methods and findings We undertook a mixed prospective and retrospective observational cohort study in 70 emergency departments across the United Kingdom (UK). We collected presenting data from 22445 people attending with suspected COVID-19 between 26 March 2020 and 28 May 2020. Outcomes were admission to hospital, COVID-19 result, organ support (respiratory, cardiovascular or renal), and death, by record review at 30 days. Mean age was 58.4 years, 11200 (50.4%) were female and 11034 (49.6%) male. Adults (age >16 years) were acutely unwell (median NEWS2 score of 4), frequently had limited performance status (46.9%) and had high rates of admission (67.1%), COVID-19 positivity (31.2%), organ support (9.8%) and death (15.5%). Children had much lower rates of admission (27.4%), COVID-19 positivity (1.2%), organ support (1.4%) and death (0.3%). Similar numbers of men and women presented to the ED, but men were more likely to be admitted (72.9% v 61.4%), require organ support (12.2% v 7.7%) and die (18.2% v 13.0%). Black or Asian adults tended to be younger than White adults (median age 54, 50 and 67 years), were less likely to have impaired performance status (43.1%, 26.8% and 51.6%), be admitted to hospital (60.8%, 57.3%, 69.6%) or die (11.6%, 11.2%, 16.4%), but were more likely to require organ support (15.9%, 14.3%, 8.9%) or have a positive COVID-19 test (40.8%, 42.1%, 30.0%). Adults admitted with suspected and confirmed COVID-19 had similar age, performance status and comorbidities (except chronic lung disease) to those who did not have COVID-19 confirmed, but were much more likely to need organ support (22.2% v 8.9%) or die (32.1% v 15.5%). Conclusions Important differences exist between patient groups presenting to the emergency department with suspected COVID-19. Adults and children differ markedly and require different approaches to emergency triage. Admission and adverse outcome rates among adults suggest that policies to avoid unnecessary ED attendance achieved their aim. Subsequent COVID-19 confirmation confers a worse prognosis and greater need for organ support. Registration ISRCTN registry, ISRCTN56149622, http://www.isrctn.com/ISRCTN28342533.

Background No seizure first aid training intervention exists for people with epilepsy who regularly attend emergency departments and their significant others, despite such an intervention’s potential to reduce clinically unnecessary and costly visits. Objectives The objectives were to (1) develop Seizure first Aid training For Epilepsy (SAFE) by adapting a broader intervention and (2) determine the feasibility and optimal design of a definitive randomised controlled trial to test SAFE’s efficacy. Design The study involved (1) the development of an intervention informed by a co-design approach with qualitative feedback and (2) a pilot randomised controlled trial with follow-ups at 3, 6 and 12 months and assessments of treatment fidelity and the cost of SAFE’s delivery. Setting The setting was (1) third-sector patient support groups and professional health-care organisations and (2) three NHS emergency departments in England. Participants Participants were (1) people with epilepsy who had visited emergency departments in the prior 2 years, their significant others and emergency department, paramedic, general practice, commissioning, neurology and nursing representatives and (2) people with epilepsy aged ≥ 16 years who had been diagnosed for ≥ 1 year and who had made two or more emergency department visits in the prior 12 months, and one of their significant others. Emergency departments identified ostensibly eligible people with epilepsy from attendance records and patients confirmed their eligibility. Interventions Participants in the pilot randomised controlled trial were randomly allocated 1 : 1 to SAFE plus treatment as usual or to treatment as usual only. Main outcome measures Consent rate and availability of routine data on emergency department use at 12 months were the main outcome measures. Other measures of interest included eligibility rate, ease with which people with epilepsy could be identified and routine data secured, availability of self-reported emergency department data, self-reported emergency department data’s comparability with routine data, SAFE’s effect on emergency department use, and emergency department use in the treatment as usual arm, which could be used in sample size calculations. Results (1) Nine health-care professionals and 23 service users provided feedback that generated an intervention considered to be NHS feasible and well positioned to achieve its purpose. (2) The consent rate was 12.5%, with 53 people with epilepsy and 38 significant others recruited. The eligibility rate was 10.6%. Identifying people with epilepsy from attendance records was resource intensive for emergency department staff. Those recruited felt more stigmatised because of epilepsy than the wider epilepsy population. Routine data on emergency department use at 12 months were secured for 94.1% of people with epilepsy, but the application process took 8.5 months. Self-reported emergency department data were available for 66.7% of people with epilepsy, and people with epilepsy self-reported more emergency department visits than were captured in routine data. Most participants (76.9%) randomised to SAFE received the intervention. The intervention was delivered with high fidelity. No related serious adverse events occurred. Emergency department use at 12 months was lower in the SAFE plus treatment as usual arm than in the treatment as usual only arm, but not significantly so. Calculations indicated that a definitive trial would need ≈ 674 people with epilepsy and ≈ 39 emergency department sites. Limitations Contrary to patient statements on recruitment, routine data secured at the pilot trial’s end indicated that ≈ 40% may not have satisfied the inclusion criterion of two or more emergency department visits. Conclusions An intervention was successfully developed, a pilot randomised controlled trial conducted and outcome data secured for most participants. The consent rate did not satisfy a predetermined ‘stop/go’ level of ≥ 20%. The time that emergency department staff needed to identify eligible people with epilepsy is unlikely to be replicable. A definitive trial is currently not feasible. Future work Research to more easily identify and recruit people from the target population is required. Trial registration Current Controlled Trials ISRCTN13871327. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 39. See the NIHR Journals Library website for further project information.

ObjectivesThe World Health Organisation (WHO) and National Institute for Health and Care Excellence (NICE) recommend various triage tools to assist decision-making for patients with suspected COVID-19. We aimed to estimate the accuracy of triage tools for predicting severe illness in adults presenting to the emergency department (ED) with suspected COVID-19 infection.MethodsWe undertook a mixed prospective and retrospective observational cohort study in 70 EDs across the United Kingdom (UK). We collected data from people attending with suspected COVID-19 between 26 March 2020 and 28 May 2020, and used presenting data to determine the results of assessment with the following triage tools: the WHO algorithm, NEWS2, CURB-65, CRB-65, PMEWS and the swine flu adult hospital pathway (SFAHP). We used 30-day outcome data (death or receipt of respiratory, cardiovascular or renal support) to determine prognostic accuracy for adverse outcome.ResultsWe analysed data from 20892 adults, of whom 4672 (22.4%) died or received organ support (primary outcome), with 2058 (9.9%) receiving organ support and 2614 (12.5%) dying without organ support (secondary outcomes). C-statistics for the primary outcome were: CURB-65 0.75; CRB-65 0.70; PMEWS 0.77; NEWS2 (score) 0.77; NEWS2 (rule) 0.69; SFAHP (6-point) 0.70; SFAHP (7-point) 0.68; WHO algorithm 0.61. All triage tools showed worse prediction for receipt of organ support and better prediction for death without organ support.At the recommended threshold, PMEWS and the WHO criteria showed good sensitivity (0.96 and 0.95 respectively), at the expense of specificity (0.31 and 0.27 respectively). NEWS2 showed similar sensitivity (0.96) and specificity (0.28) when a lower threshold than recommended was used.ConclusionCURB-65, PMEWS and NEWS2 provide good but not excellent prediction for adverse outcome in suspected COVID-19, and predicted death without organ support better than receipt of organ support. PMEWS, the WHO criteria and NEWS2 (using a lower threshold than usually recommended) provide good sensitivity at the expense of specificity.RegistrationISRCTN registry, ISRCTN28342533, http://www.isrctn.com/ISRCTN28342533

Background More than half of deaths in low- and middle-income countries (LMICs) result from conditions that could be treated with emergency care - an integral component of universal health coverage (UHC) - through timely access to lifesaving interventions. Methods The World Health Organization (WHO) aims to extend UHC to a further 1 billion people by 2023, yet evidence supporting improved emergency care coverage is lacking. In this article, we explore four phases of a research prioritisation setting (RPS) exercise conducted by researchers and stakeholders from South Africa, Egypt, Nepal, Jamaica, Tanzania, Trinidad and Tobago, Tunisia, Colombia, Ethiopia, Iran, Jordan, Malaysia, South Korea and Phillipines, USA and UK as a key step in gathering evidence required by policy makers and practitioners for the strengthening of emergency care systems in limited-resource settings. Results The RPS proposed seven priority research questions addressing: identification of context-relevant emergency care indicators, barriers to effective emergency care; accuracy and impact of triage tools; potential quality improvement via registries; characteristics of people seeking emergency care; best practices for staff training and retention; and cost effectiveness of critical care – all within LMICs. Conclusions Convened by WHO and facilitated by the University of Sheffield, the Global Emergency Care Research Network project (GEM-CARN) brought together a coalition of 16 countries to identify research priorities for strengthening emergency care in LMICs. Our article further assesses the quality of the RPS exercise and reviews the current evidence supporting the identified priorities.

BackgroundHospital emergency departments play a crucial role in the Initial management of suspected COVID-19 infection. We aimed to characterise patients attending emergency departments with suspected COVID-19, including subgroups based on sex, ethnicity and COVID-19 test results.MethodsWe undertook a mixed prospective and retrospective observational cohort study in 70 emergency departments across the United Kingdom (UK). We collected presenting data from 22446 people attending with suspected COVID-19 between 26 March 2020 and 28 May 2020. Outcomes were admission to hospital, COVID-19 result, organ support (respiratory, cardiovascular or renal), and death, by record review at 30 days.ResultsAdults were acutely unwell (median NEWS2 score 4) and had high rates of admission (67.1%), COVID-19 positivity (31.2%), organ support (9.8%) and death (15.9%). Children had much lower rates of admission (27.4%), COVID-19 positivity (1.2%), organ support (1.4%) and death (0.3%). Adult men and women presented in similar numbers (10210 versus 10506), but men were more likely to be admitted (72.9% v 61.4%), require organ support (12.2% v 7.7%) and die (18.7% v 13.3%). Black or Asian adults tended to be younger than White adults (median age 54, 50 and 67 years), were less likely to be admitted (60.8%, 57.3%, 69.6%) or die (11.9%, 11.2%, 16.8%), but were more likely to require organ support (15.9%, 14.3%, 8.9%) or have a positive COVID-19 test (40.8%, 42.1%, 30.0%). Adults admitted with confirmed COVID-19 had similar age and comorbidities (except chronic lung disease) to those who did not have COVID-19 confirmed, but were much more likely to need organ support (22.2% v 8.9%) or die (32.7% v 15.9%).ConclusionsImportant differences exist between patient groups presenting to the emergency department with suspected COVID-19. People with confirmed COVID-19 have a poor prognosis, compared with similar emergency admissions without confirmed COVID-19.RegistrationISRCTN registry, ISRCTN56149622, http://www.isrctn.com/ISRCTN28342533

BackgroundMeasurement of post-exertion oxygen saturation has been proposed to assess illness severity in suspected COVID-19 infection. We aimed to determine the accuracy of post-exertional oxygen saturation for predicting adverse outcome in suspected COVID-19.MethodsWe undertook an observational cohort study across 70 emergency departments during first wave of the COVID-19 pandemic in the United Kingdom. We collected data prospectively, using a standardised assessment form, and retrospectively, using hospital records, from patients with suspected COVID-19, and reviewed hospital records at 30 days for adverse outcome (death or receiving organ support). Patients with post-exertion oxygen saturation recorded were selected for this analysis.ResultsWe analysed data from 817 patients with post-exertion oxygen saturation recorded after excluding 54 in whom measurement appeared unfeasible. The c-statistic for post-exertion change in oxygen saturation was 0.589 (95% confidence interval 0.465 to 0.713), and the positive and negative likelihood ratios of a 3% or more desaturation were respectively 1.78 (1.25 to 2.53) and 0.67 (0.46 to 0.98). Multivariable analysis showed that post-exertion oxygen saturation was not a significant predictor of adverse outcome when baseline clinical assessment was taken into account (p=0.368). Secondary analysis excluding patients in whom post-exertion measurement appeared inappropriate resulted in a c-statistic of 0.699 (0.581 to 0.817), likelihood ratios of 1.98 (1.26 to 3.10) and 0.61 (0.35 to 1.07), and some evidence of additional prognostic value on multivariable analysis (p=0.019).ConclusionsPost-exertion oxygen saturation provides modest prognostic information in the assessment of patients attending the emergency department with suspected COVID-19.RegistrationISRCTN registry, ISRCTN56149622, http://www.isrctn.com/ISRCTN28342533Key messagesWhat is already known on this subject?Post exertional decrease in oxygen saturation can be used to predict prognosis in chronic lung diseasesPost exertional desaturation has been proposed as a way of predicting adverse outcome in people with suspected COVID-19What this study adds:Post-exertion oxygen saturation provides modest prognostic information in the assessment of patients attending the emergency department with suspected COVID-19

ObjectivesTo determine the feasibility of a large-scale definitive multicentre trial of prehospital continuous positive airway pressure (CPAP) in acute respiratory failure.DesignA single-centre, open-label, individual patient randomised, controlled, external pilot trial.SettingA single UK Ambulance Service, between August 2017 and July 2018.ParticipantsAdults with respiratory distress and peripheral oxygen saturations below British Thoracic Society target levels despite controlled oxygen treatment.InterventionsPatients were randomised to prehospital CPAP (O-Two system) versus standard oxygen therapy in a 1:1 ratio using simple randomisation.Primary and secondary outcome measuresFeasibility outcomes comprised recruitment rate, adherence to allocated treatment, retention and data completeness. The primary clinical outcome was 30-day mortality.Results77 patients were enrolled (target 120), including 7 cases with a diagnosis where CPAP could be ineffective or harmful. CPAP was fully delivered in 74% (target 75%). There were no major protocol violations. Full data were available for all key outcomes (targets ≥90%). Overall 30-day mortality was 27.3%. Of these deceased patients, 14/21 (68%) either did not have a respiratory condition or had ceiling of treatment decisions implemented excluding hospital non-invasive ventilation and critical care.ConclusionsRecruitment rate was below target and feasibility was not demonstrated. Limited compliance with CPAP, and difficulty in identifying patients who could benefit from CPAP, indicate that prehospital CPAP is unlikely to materially reduce mortality. A definitive effectiveness trial of CPAP is therefore not recommended.Trial registration numberISRCTN12048261; Post-results.

BackgroundSepsis is a major cause of morbidity and mortality and many tools exist to facilitate early recognition. This review compares two tools: the quick Sequential Organ Failure Assessment (qSOFA) and Early Warning Scores (National/Modified Early Warning Scores (NEWS/MEWS)) for predicting intensive care unit (ICU) admission and mortality when applied in the emergency department.MethodsA literature search was conducted using Medline, CINAHL, Embase and Cochrane Library, handsearching of references and a grey literature search with no language or date restrictions. Two authors selected studies and quality assessment completed using QUADAS-2. Area under the receiver operating characteristic curve (AUROC), sensitivities and specificities were compared.Results13 studies were included, totalling 403 865 patients. All reported mortality and six reported ICU admission.The ranges for AUROC estimates varied from little better than chance to good prediction of mortality (NEWS: 0.59–0.88; qSOFA: 0.57–0.79; MEWS 0.56–0.75), however, individual papers generally reported higher AUROC values for NEWS than qSOFA. NEWS values demonstrated a tendency towards better sensitivity for ICU admission (NEWS ≥5, 46%-91%; qSOFA ≥2, 12%–53%) and mortality (NEWS ≥5, 51%–97%; qSOFA ≥2, 14%–71%) but lower specificity (ICU: NEWS ≥5, 25%–91%; qSOFA ≥2, 67%–99%; mortality: NEWS ≥5, 22%–91%; qSOFA ≥2, 58%–99%).ConclusionThe wide range of AUROC estimates and high heterogeneity limit our conclusions. Allowing for this, the NEWS AUROC was consistently higher than qSOFA within individual papers. Both scores allow threshold setting, determined by the preferred compromise between sensitivity and specificity. At established thresholds NEWS tended to higher sensitivity while qSOFA tended to a higher specificity.PROSPERO registration numberCRD42019131414.

Background Front-line health-care services are under increased demand when acute alcohol intoxication is most common, which is in night-time environments. Cities have implemented alcohol intoxication management services to divert the intoxicated away from emergency care. Objectives To evaluate the effectiveness, cost-effectiveness and acceptability to patients and staff of alcohol intoxication management services and undertake an ethnographic study capturing front-line staff’s views on the impact of acute alcohol intoxication on their professional lives. Methods This was a controlled mixed-methods longitudinal observational study with an ethnographic evaluation in parallel. Six cities with alcohol intoxication management services were compared with six matched control cities to determine effects on key performance indicators (e.g. number of patients in the emergency department and ambulance response times). Surveys captured the impact of alcohol intoxication management services on the quality of care for patients in six alcohol intoxication management services, six emergency departments with local alcohol intoxication management services and six emergency departments without local alcohol intoxication management services. The ethnographic study considered front-line staff perceptions in two cities with alcohol intoxication management services and one city without alcohol intoxication management services. Results Alcohol intoxication management services typically operated in cities in which the incidence of acute alcohol intoxication was greatest. The per-session average number of attendances across all alcohol intoxication management services was low (mean 7.3, average minimum 2.8, average maximum 11.8) compared with the average number of emergency department attendances per alcohol intoxication management services session (mean 78.8), and the number of patients diverted away from emergency departments, per session, required for services to be considered cost-neutral was 8.7, falling to 3.5 when ambulance costs were included. Alcohol intoxication management services varied, from volunteer-led first aid to more clinically focused nurse practitioner services, with only the latter providing evidence for diversion from emergency departments. Qualitative and ethnographic data indicated that alcohol intoxication management services are acceptable to practitioners and patients and that they address unmet need. There was evidence that alcohol intoxication management services improve ambulance response times and reduce emergency department attendance. Effects are uncertain owing to the variation in service delivery. Limitations The evaluation focused on health service outcomes, yet evidence arose suggesting that alcohol intoxication management services provide broader societal benefits. There was no nationally agreed standard operating procedure for alcohol intoxication management services, undermining the evaluation. Routine health data outcomes exhibited considerable variance, undermining opportunities to provide an accurate appraisal of the heterogenous collection of alcohol intoxication management services. Conclusions Alcohol intoxication management services are varied, multipartner endeavours and would benefit from agreed national standards. Alcohol intoxication management services are popular with and benefit front-line staff and serve as a hub facilitating partnership working. They are popular with alcohol intoxication management services patients and capture previously unmet need in night-time environments. However, acute alcohol intoxication in emergency departments remains an issue and opportunities for diversion have not been entirely realised. The nurse-led model was the most expensive service evaluated but was also the most likely to divert patients away from emergency departments, suggesting that greater clinical involvement and alignment with emergency departments is necessary. Alcohol intoxication management services should be regarded as fledgling services that require further work to realise benefit. Future work Research could be undertaken to determine if a standardised model of alcohol intoxication management services, based on the nurse practitioner model, can be developed and implemented in different settings. Future evaluations should go beyond the health service and consider outcomes more generally, especially for the police. Future work on the management of acute alcohol intoxication in night-time environments could recognise the partnership between health-care, police and ambulance services and third-sector organisations in managing acute alcohol intoxication. Trial registration Current Controlled Trials ISRCTN63096364. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 24. See the NIHR Journals Library website for further project information.

Summary Background Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. Methods We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124. Findings Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). Interpretation We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial. Funding UK National Institute for Health Research Health Technology Assessment Programme.

Background Opioids, such as heroin, kill more people worldwide by overdose than any other type of drug, and death rates associated with opioid poisoning in the UK are at record levels (1, 2). Naloxone is an opioid antagonist which can be distributed in ‘kits’ for administration by witnesses in an overdose emergency. This intervention is known as Take Home Naloxone (THN). We know that THN can save lives on an individual level, but there is currently limited evidence about the effectiveness of THN distribution on an aggregate level, in specialist drug service settings or in emergency service settings. Notably, we do not know whether THN kits reduce deaths from opioid overdose in at-risk populations, if there are unforeseen harms associated with THN distribution or if THN is cost-effective. In order to address this research gap, we aim to determine the feasibility of a fully-powered cluster Randomised Controlled Trial (RCT) of THN distribution in emergency settings. Methods We will carry out a feasibility study for a RCT of THN distributed in emergency settings at four sites, clustered by Emergency Department (ED) and catchment area within its associated ambulance service. THN is a peer-administered intervention. At two intervention sites, emergency ambulance paramedics and ED clinical staff will distribute THN to adult patients who are at risk of opioid overdose. At two control sites, practice will carry on as usual. We will develop a method of identifying a population to include in an evaluation, comprising people at risk of fatal opioid overdose, who may potentially receive naloxone included in a THN kit. We will gather anonymised outcomes up to one year following a 12 month ‘live’ trial period for patients at risk of death from opioid poisoning. We expect approximately 100 patients at risk of opioid overdose to be in contact with each service during the one year recruitment period. Our outcomes will include: deaths; emergency admissions; intensive care admissions; and ED attendances. We will collect numbers of eligible patients attended by participating emergency ambulance paramedics and attending ED; THN kits issued; and NHS resource usage. We will determine whether to progress to a fully-powered trial based on pre-specified progression criteria: sign-up of sites (n = 4); staff trained (>= 50%); eligible participants identified (>= 50%); THN provided to eligible participants (>= 50%); people at risk of death from opioid overdose identified for inclusion in follow up (>= 75% of overdose deaths); outcomes retrieved for high risk individuals (>= 75%); and adverse event rate (Discussion This feasibility study is the first randomised, methodologically robust investigation of THN distribution in emergency settings. The study addresses an evidence gap related to the effectiveness of THN distribution in emergency settings. As this study is being carried out in emergency settings, obtaining informed consent on behalf of participants is not feasible. We therefore employ novel methods for identifying participants and capturing follow up data, with effectiveness dependent on the quality of the available routine data.Trial registration ISRCTN13232859 (Registered 16/02/2018)

ObjectiveTo determine the feasibility and optimal design of a randomised controlled trial (RCT) of Seizure First Aid Training For Epilepsy (SAFE).DesignPilot RCT with embedded microcosting.SettingThree English hospital emergency departments (EDs).ParticipantsPatients aged ≥16 with established epilepsy reporting ≥2 ED visits in the prior 12 months and their significant others (SOs).InterventionsPatients (and their SOs) were randomly allocated (1:1) to SAFE plus treatment-as-usual (TAU) or TAU alone. SAFE is a 4-hour group course.Main outcome measuresTwo criteria evaluated a definitive RCT’s feasibility: (1) ≥20% of eligible patients needed to be consented into the pilot trial; (2) routine data on use of ED over the 12 months postrandomisation needed securing for ≥75%. Other measures included eligibility, ease of obtaining routine data, availability of self-report ED data and comparability, SAFE’s effect and intervention cost.ResultsOf ED attendees with a suspected seizure, 424 (10.6%) patients were eligible; 53 (12.5%) patients and 38 SOs consented. Fifty-one patients (and 37 SOs) were randomised. Routine data on ED use at 12 months were secured for 94.1% patients. Self-report ED data were available for 66.7% patients. Patients reported more visits compared with routine data. Most (76.9%) patients randomised to SAFE received it and no related serious adverse events occurred. ED use at 12 months was lower in the SAFE+TAU arm compared with TAU alone, but not significantly (rate ratio=0.62, 95% CI 0.33 to 1.17). A definitive trial would need ~674 patient participants and ~39 recruitment sites. Obtaining routine data was challenging, taking ~8.5 months.ConclusionsIn satisfying only one predetermined ‘stop/go’ criterion, a definitive RCT is not feasible. The low consent rate in the pilot trial raises concerns about a definitive trial’s finding’s external validity and means it would be expensive to conduct. Research is required into how to optimise recruitment from the target population.Trial registration numberISRCTN13871327

Introduction and Aims\ud \ud Alcohol Intoxication Management Services (AIMS) provide basic care for intoxication and minor injuries, have been increasingly implemented in urban areas characterised by a large number of premises licensed for the sale and on‐site consumption of alcohol, with the goal of reducing alcohol's burden on emergency services, including referrals into hospital emergency departments. The acceptability of new health services to users is a key effectiveness outcome. The aim was to describe patient experiences when attending an AIMS and document the acceptability of AIMS to users.\ud \ud \ud \ud Design and Methods\ud \ud A sequential mixed methods study was undertaken involving semi‐structured interviews with participants from four AIMS followed by a survey of users recruited from six AIMS.\ud \ud \ud \ud Results\ud \ud Interviewees (N = 19) were positive about the care they received in AIMS and appreciated the friendly, non‐judgemental atmosphere. Survey respondents rated their experience in AIMS positively (on a 0 to 10 Likert scale, mean = 9.34, SD = 1.38, n = 188). Frequently given reasons for attendance included drinking alcohol (57%) and minor injury (42%); 24% said they would have attended the emergency department had the AIMS not been available and 6% said they would have preferred to go to the emergency department; 31% indicated they would have felt unsafe without the AIMS.\ud \ud \ud \ud Discussion and Conclusions\ud \ud AIMS are acceptable to users. AIMS are likely to address previously unmet demand for a safe space within the night‐time environment.

Background: Rapid identification of coronary heart disease may improve clinical outcomes in patients presenting with acute chest pain. We aimed to establish whether early CT coronary angiography in intermediate-risk patients presenting to the Emergency Department with acute chest pain could improve one-year clinical outcomes. Methods: In a prospective randomised open blinded-endpoint parallel-group clinical trial, adults with suspected acute coronary syndrome and prior coronary heart disease, elevated cardiac troponin or ischaemic electrocardiogram, were randomised 1:1 to early CT coronary angiography plus standard of care or standard of care alone in 37 UK hospitals. The primary endpoint was one-year all-cause death or subsequent type 1 or 4b myocardial infarction. Findings: Between 23rd March 2015 and 27th June 2019, 1748 participants (mean age 62 (SD 13) years, 64% male, mean GRACE score 115 (SD 35)) were randomised to early CT coronary angiography (n=877) or to standard of care alone (n=871). The primary endpoint occurred in 51 (5·8%) participants randomised to CT coronary angiography and 53 (6·1%) participants with standard of care (adjusted hazard ratio 0·91 (95% confidence interval, 0·62 to 1·35), P=0·65). CT coronary angiography was associated with reduced invasive coronary angiography (adjusted hazard ratio 0·81 (95% confidence interval, 0·72 to 0·92), P=0·001) but no change in coronary revascularisation or preventative therapies. Early CT coronary angiography was associated with longer hospitalisations (median increase 0·21 (95% confidence interval 0·05 to 0·40) days) and higher costs (£561 more per patient). Interpretation: In patients with suspected acute coronary syndrome, CT coronary angiography did not alter overall coronary therapeutic interventions or one-year clinical outcomes but increased length of hospital stay and healthcare costs. These findings do not support the routine use of early CT coronary angiography in intermediate-risk patients with acute chest pain. Trial Registration: ISRCTN19102565 and NCT02284191. Funding Statement: National Institute for Health Research HTA Programme (13/04/108). Declaration of Interests: SG was deputy director of the National Institute for Health Research Health Technology Assessment Programme and chairs the NIHR HTA commissioning committee. NC reports Unrestricted research grants from HeartFlow, Boston Scientific, Haemonetics, Beckmann Coulter Speaker fees and Consultancy from HeartFlow, Boston Scientific, Abbott, Haemonetics Travel sponsorship from Haemonetics, Boston Scientific, HeartFlow, Biosensors, Edwards, Medtronic. DEN reports grant support from Siemens. All other authors report no conflicts of interest. Ethics Approval Statement: The trial was approved by the South East Scotland Research Ethics Committee 01.

There are many clinical decision rules for adults with minor head injury, but it is unclear how they compare in terms of diagnostic accuracy. This study aimed to systematically identify clinical decision rules for adults with minor head injury and compare the estimated diagnostic accuracies for any intracranial injury and injury requiring neurosurgical intervention.Several electronic bibliographic databases covering biomedical, scientific, and gray literature were searched from inception to March 2010. At least two independent reviewers determined the eligibility of cohort studies that described a clinical decision rule to identify adults with minor head injury (Glasgow Coma Scale score, 13-15) at risk of intracranial injury or injury requiring neurosurgical intervention.Twenty-two relevant studies were identified. Differences existed in patient selection, outcome definition, and reference standards used. Nine rules stratified patients into high- and moderate-risk categories (to identify neurosurgical or nonsurgical intracranial lesions). The Canadian Computed Tomography Head Rule (CCHR) high-risk criteria have sensitivity of 99% to 100% with specificity of 48% to 77% for injury requiring neurosurgical intervention. Other rules such as New Orleans criteria, National Emergency X-Radiography Utilization Study II, Neurotraumatology Committee of the World Federation of Neurosurgical Societies, Scandinavian, and Scottish Intercollegiate Guidelines Network produce similar sensitivities for injury requiring neurosurgical intervention but with lower and more variable specificity values.The most widely researched decision rule is the CCHR, which has consistently shown high sensitivity for identifying injury requiring neurosurgical intervention with an acceptable specificity to allow considered use of cranial computed tomography. No other decision rule has been as widely validated or demonstrated as acceptable results, but its exclusion criteria make it difficult to apply universally.

Objectives To establish if the use of early computed tomography (CT) coronary angiography improves one year clinical outcomes in patients presenting to the emergency department with acute chest pain and at intermediate risk of acute coronary syndrome and subsequent clinical events. Design Randomised controlled trial. Setting 37 hospitals in the UK. Participants Adults with suspected or a provisional diagnosis of acute coronary syndrome and one or more of previous coronary heart disease, raised levels of cardiac troponin, or abnormal electrocardiogram. Interventions Early CT coronary angiography and standard of care compared with standard of care only. Main outcome measures Primary endpoint was all cause death or subsequent type 1 or 4b myocardial infarction at one year. Results Between 23 March 2015 and 27 June 2019, 1748 participants (mean age 62 years (standard deviation 13), 64% men, mean global registry of acute coronary events (GRACE) score 115 (standard deviation 35)) were randomised to receive early CT coronary angiography (n=877) or standard of care only (n=871). Median time from randomisation to CT coronary angiography was 4.2 (interquartile range 1.6-21.6) hours. The primary endpoint occurred in 51 (5.8%) participants randomised to CT coronary angiography and 53 (6.1%) participants who received standard of care only (adjusted hazard ratio 0.91 (95% confidence interval 0.62 to 1.35), P=0.65). Invasive coronary angiography was performed in 474 (54.0%) participants randomised to CT coronary angiography and 530 (60.8%) participants who received standard of care only (adjusted hazard ratio 0.81 (0.72 to 0.92), P=0.001). There were no overall differences in coronary revascularisation, use of drug treatment for acute coronary syndrome, or subsequent preventive treatments between the two groups. Early CT coronary angiography was associated with a slightly longer time in hospital (median increase 0.21 (95% confidence interval 0.05 to 0.40) days from a median hospital stay of 2.0 to 2.2 days). Conclusions In intermediate risk patients with acute chest pain and suspected acute coronary syndrome, early CT coronary angiography did not alter overall coronary therapeutic interventions or one year clinical outcomes, but reduced rates of invasive angiography while modestly increasing length of hospital stay. These findings do not support the routine use of early CT coronary angiography in intermediate risk patients with acute chest pain and suspected acute coronary syndrome. Trial registration ISRCTN19102565 , NCT02284191 .

BackgroundThromboprophylaxis can reduce the risk of venous thromboembolism (VTE) during lower-limb immobilisation, but it is unclear whether or not this translates into meaningful health benefit, justifies the risk of bleeding or is cost-effective. Risk assessment models (RAMs) could select higher-risk individuals for thromboprophylaxis.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of different strategies for providing thromboprophylaxis to people with lower-limb immobilisation caused by injury and to identify priorities for future research.Data sourcesTen electronic databases and research registers (MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, the Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluation Database, Science Citation Index Expanded, ClinicalTrials.gov and the International Clinical Trials Registry Platform) were searched from inception to May 2017, and this was supplemented by hand-searching reference lists and contacting experts in the field.Review methodsSystematic reviews were undertaken to determine the effectiveness of pharmacological thromboprophylaxis in lower-limb immobilisation and to identify any study of risk factors or RAMs for VTE in lower-limb immobilisation. Study quality was assessed using appropriate tools. A network meta-analysis was undertaken for each outcome in the effectiveness review and the results of risk-prediction studies were presented descriptively. A modified Delphi survey was undertaken to identify risk predictors supported by expert consensus. Decision-analytic modelling was used to estimate the incremental cost per quality-adjusted life-year (QALY) gained of different thromboprophylaxis strategies from the perspectives of the NHS and Personal Social Services.ResultsData from 6857 participants across 13 trials were included in the meta-analysis. Thromboprophylaxis with low-molecular-weight heparin reduced the risk of any VTE [odds ratio (OR) 0.52, 95% credible interval (CrI) 0.37 to 0.71], clinically detected deep-vein thrombosis (DVT) (OR 0.40, 95% CrI 0.12 to 0.99) and pulmonary embolism (PE) (OR 0.17, 95% CrI 0.01 to 0.88). Thromboprophylaxis with fondaparinux (Arixtra®, Aspen Pharma Trading Ltd, Dublin, Ireland) reduced the risk of any VTE (OR 0.13, 95% CrI 0.05 to 0.30) and clinically detected DVT (OR 0.10, 95% CrI 0.01 to 0.94), but the effect on PE was inconclusive (OR 0.47, 95% CrI 0.01 to 9.54). Estimates of the risk of major bleeding with thromboprophylaxis were inconclusive owing to the small numbers of events. Fifteen studies of risk factors were identified, but only age (ORs 1.05 to 3.48), and injury type were consistently associated with VTE. Six studies of RAMs were identified, but only two reported prognostic accuracy data for VTE, based on small numbers of patients. Expert consensus was achieved for 13 risk predictors in lower-limb immobilisation due to injury. Modelling showed that thromboprophylaxis for all is effective (0.015 QALY gain, 95% CrI 0.004 to 0.029 QALYs) with a cost-effectiveness of £13,524 per QALY, compared with thromboprophylaxis for none. If risk-based strategies are included, it is potentially more cost-effective to limit thromboprophylaxis to patients with a Leiden thrombosis risk in plaster (cast) [L-TRiP(cast)] score of ≥ 9 (£20,000 per QALY threshold) or ≥ 8 (£30,000 per QALY threshold). An optimal threshold on the L-TRiP(cast) receiver operating characteristic curve would have sensitivity of 84–89% and specificity of 46–55%.LimitationsEstimates of RAM prognostic accuracy are based on weak evidence. People at risk of bleeding were excluded from trials and, by implication, from modelling.ConclusionsThromboprophylaxis for lower-limb immobilisation due to injury is clinically effective and cost-effective compared with no thromboprophylaxis. Risk-based thromboprophylaxis is potentially optimal but the prognostic accuracy of existing RAMs is uncertain.Future workResearch is required to determine whether or not an appropriate RAM can accurately select higher-risk patients for thromboprophylaxis.Study registrationThis study is registered as PROSPERO CRD42017058688.FundingThe National Institute for Health Research Health Technology Assessment programme.

BackgroundDrug poisoning deaths in England and Wales have increased by 52% since 2011 with over half involving opioids. Deaths are preventable if naloxone is administered in time. Take Home Naloxone (THN) kits have been distributed through drug services; however, uptake is low and effectiveness unproven. The TIME trial tests the feasibility of conducting a full randomised controlled trial of providing THN administration and basic life support training to high-risk opioid-users in emergency care settings.MethodsA multi-site feasibility trial commenced in June 2019 with two hospitals and their surrounding ambulance services (Bristol Royal Infirmary (BRI) with South Western Ambulance NHS Foundation Trust (SWASFT) and Hull Royal Infirmary with Yorkshire Ambulance Service) randomly allocated to intervention arms; and sites in Wrexham and Sheffield allocated as ‘usual care’ controls. SWASFT began recruiting in October 2019 with the aim of recruiting and training 50% (n=111) of paramedics working within the BRI’s catchment area, to supply THN to at least 100 eligible patients during a 12-month period.ResultsThe trial was suspended between 17.03.2020-06.08.2020 and extended to 01.03.2021 (COVID-19). Despite this, 121 SWASFT paramedics undertook TIME training. TIME trained paramedics attended 30% (n=57) of the n=190 opioid-related emergency calls requiring naloxone administration during the study period. A total of n=29 potentially eligible patients were identified before and n=28 after the COVID-19 suspension. Two patients were supplied with THN during each period. During the COVID-19 suspension, twenty-two potentially eligible patients were missed. The majority of eligible patients presented with a reduced consciousness level, preventing recruitment (73%; n=42/48). These patients were transported to hospital for further treatment (n=39) or died on scene following advanced life support (n=3).ConclusionsThe lowered consciousness levels of prehospital emergency ambulance patients who present with opioid poisoning, often prevent the delivery of training required to enable the supply of THN.

BackgroundAlcohol intoxication management services (AIMS) provide an alternative care pathway for alcohol-intoxicated adults otherwise requiring emergency department (ED) services and at times of high incidence. We estimate the effectiveness and cost-effectiveness of AIMS on ED attendance rates with ED and ambulance service performance indicators as secondary outcomes.MethodsA controlled longitudinal retrospective observational study in English and Welsh towns, six with AIMS and six without. Control and intervention cities were matched by sociodemographic characteristics. The primary outcome was ED attendance rate per night, secondary analyses explored hospital admission rates and ambulance response times. Interrupted time series analyses compared control and matched intervention sites pre-AIMS and post-AIMS. Cost-effectiveness analyses compared the component costs of AIMS to usual care before with results presented from the National Health Service and social care prospective. The number of diversions away from ED required for a service to be cost neutral was determined.ResultsAnalyses found considerable variation across sites, only one service was associated with a significant reduction in ED attendances (−4.89, pConclusionsAIMSs have variable effects on the emergency care system, reflecting variable structures and processes, but may be associated with modest reductions in the burden on ED and ambulance services. The more expensive model, supported by the ED, was the only configuration likely to divert patients away from ED. AIMS should be regarded as fledgling services that require further work to realise benefit.Trial registration numberISRCTN63096364.

IntroductionEmergency department (ED) visits for epilepsy are common, costly, often clinically unnecessary and typically lead to little benefit for epilepsy management. An ‘Alternative Care Pathway’ (ACP) for epilepsy, which diverts people with epilepsy (PWE) away from ED when ‘999’ is called and leads to care elsewhere, might generate savings and facilitate improved ambulatory care. It is unknown though what features it should incorporate to make it acceptable to persons from this particularly vulnerable target population. It also needs to be National Health Service (NHS) feasible. This project seeks to identify the optimal ACP configuration.Methods and analysisMixed-methods project comprising three-linked stages. In Stage 1, NHS bodies will be surveyed on ACPs they are considering and semi-structured interviews with PWE and their carers will explore attributes of care important to them and their concerns and expectations regarding ACPs. In Stage 2, Discrete Choice Experiments (DCE) will be completed with PWE and carers to identify the relative importance placed on different care attributes under common seizure scenarios and the trade-offs people are willing to make. The uptake of different ACP configurations will be estimated. In Stage 3, two Knowledge Exchange workshops using a nominal group technique will be run. NHS managers, health professionals, commissioners and patient and carer representatives will discuss DCE results and form a consensus on which ACP configuration best meets users’ needs and is NHS feasible.Ethics and disseminationEthical approval: NRES Committee (19/WM/0012) and King’s College London ethics Committee (LRS-18/19-10353). Primary output will be identification of optimal ACP configuration which should be prioritised for implementation and evaluation. A pro-active dissemination strategy will make those considering developing or supporting an epilepsy ACP aware of the project and opportunities to take part in it. It will also ensure they are informed of its findings.Project registration numberResearchregistry4723.

ObjectiveRecent studies suggest that combinations of clinical probability assessment (the YEARS algorithm or Geneva score) and D-dimer can safely rule out suspected pulmonary embolism (PE) in pregnant women. We performed a secondary analysis of the DiPEP (Diagnosis of Pulmonary Embolism in Pregnancy) study data to determine the diagnostic accuracy of these strategies.MethodsThe DiPEP study prospectively recruited and collected data and blood samples from pregnant/postpartum women with suspected PE across 11 hospitals and retrospectively collected data from pregnant/postpartum women with diagnosed PE across all UK hospitals (15 February 2015 to 31 August 2016). We selected prospectively recruited pregnant women who had definitive diagnostic imaging for this analysis. We used clinical data and D-dimer results to determine whether the rule out strategies would recommend further investigation. Two independent adjudicators used data from imaging reports, treatments and adverse events up to 30 days to determine the reference standard.ResultsPEs were diagnosed in 12/219 (5.5%) women. The YEARS/D-dimer strategy would have ruled out PE in 96/219 (43.8%) but this would have included 5 of the 12 with PEs. Sensitivity for PE was 58.3% (95% CI 28.6% to 83.5%) and specificity 44.0% (37.1% to 51.0%). The Geneva/D-dimer strategy would have ruled out PE in 46/219 (21.0%) but this would have included three of the 12 with PE. Sensitivity was 75.0% (95% CI 42.8% to 93.3%) and specificity 20.8% (95% CI 15.6% to 27.1%). Administration of anticoagulants prior to blood sampling may have reduced D-dimer sensitivity for small PE.ConclusionStrategies using clinical probability and D-dimer have limited diagnostic accuracy and do not accurately rule out all PE in pregnancy. It is uncertain whether PE missed by these strategies lead to clinically important consequences.

ObjectivesRecent guidance recommended use of high-sensitivity troponin for rapid rule out of myocardial infarction (MI) in the English health service. We aimed to determine the extent of implementation of this guidance across English hospitals.MethodsThis study conducted a cross-sectional questionnaire survey of 131 English acute hospitals with over 10 000 admissions per year.ResultsWe received 125/131 responses (95%), with 110/125 (88%) reporting use of a high-sensitivity troponin assay and responses showing progressive implementation over the last 10 years. High-sensitivity troponin was reported to be used for rapid rule out of MI in 92/110 Trusts (84%). Review of guidelines received from 95/110 Trusts identified that 71/95 (75%) provided guidance for rapid MI rule out with high-sensitivity troponin: 57 recommended testing at 0 and 3 hours, 4 recommended testing at 0 and 2 hours, and 9 recommended testing at 0 and 1 hour, and timing was unclear at one Trust.ConclusionsEnglish acute hospital Trusts report widespread implementation of high-sensitivity troponin for rapid rule out of MI, with most recommending testing at 0 and 3 hours.

Background\ud \ud With millions of pounds spent annually on medical research in the UK, it is important that studies are spending funds wisely. Internal pilots offer the chance to stop a trial early if it becomes apparent that the study will not be able to recruit enough patients to show whether an intervention is clinically effective. This study aims to assess the use of internal pilots in individually randomised controlled trials funded by the Health Technology Assessment (HTA) programme and to summarise the progression criteria chosen in these trials.\ud \ud Methods\ud \ud Studies were identified from reports of the HTA committees’ funding decisions from 2012 to 2016. In total, 242 trials were identified of which 134 were eligible to be included in the audit. Protocols for the eligible studies were located on the NIHR Journals website, and if protocols were not available online then study managers were contacted to provide information.\ud \ud Results\ud \ud Over two-thirds (72.4%) of studies said in their protocol that they would include an internal pilot phase for their study and 37.8% of studies without an internal pilot had done an external pilot study to assess the feasibility of the full study. A typical study with an internal pilot has a target sample size of 510 over 24 months and aims to recruit one-fifth of their total target sample size within the first one-third of their recruitment time. There has been an increase in studies adopting a three-tiered structure for their progression rules in recent years, with 61.5% (16/26) of studies using the system in 2016 compared to just 11.8% (2/17) in 2015. There was also a rise in the number of studies giving a target recruitment rate in their progression criteria: 42.3% (11/26) in 2016 compared to 35.3% (6/17) in 2015.\ud \ud Conclusions\ud \ud Progression criteria for an internal pilot are usually well specified but targets vary widely. For the actual criteria, red/amber/green systems have increased in popularity in recent years. Trials should justify the targets they have set, especially where targets are low.

The 2009 influenza A H1N1 pandemic was responsible for considerable global morbidity and mortality. In 2009, several research studies in the UK were rapidly funded and activated for clinical and public health actions. However, some studies were too late for their results to have an early and substantial effect on clinical care, because of the time required to call for research proposals, assess, fund, and set up the projects. In recognition of these inherent delays, a portfolio of projects was funded by the National Institute for Health Research in 2012. These studies have now been set up (ie, with relevant permissions and arrangements made for data collection) and pilot tested where relevant. All studies are now on standby awaiting activation in the event of a pandemic being declared. In this Personal View, we describe the projects that were set up, the challenges of putting these projects into a maintenance-only state, and ongoing activities to maintain readiness for activation, and discuss how to plan research for a range of major incidents.

IntroductionInadequate pain management in EDs is a worldwide problem, yet there has been little progress in understanding how pain management can be improved. There is only weak evidence and limited rationale to support interventions to improve pain management. We used naturalistic, qualitative methods to understand the factors that influence how pain is managed within the adult ED.MethodsWe used a multiple case study design incorporating 143-hour non-participant observation, documentary analysis and semistructured interviews with 37 staff and 19 patients at three EDs in the North of England between 2014 and 2016. We analysed data using thematic analysis.ResultsOur analysis demonstrated that pain management was not well aligned with the core priorities of the ED and was overlooked when other works took priority. We identified that (1) pain management was not perceived to be a key organisational priority for which staff were held accountable and staff had limited awareness of their performance, (2) pain management was not a core component of ED education and training, (3) ED processes and structures were not aligned with pain management and pain reassessment was overlooked unless staff escalated pain management outside of normal processes and (4) staff held embedded beliefs that conceptualised pain management as distinct from core priorities and limited their capacity to improve. However, EDs were able to improve pain management by aligning processes of pain management with other core works, particularly patient flow (eg, nurse-initiated analgesia at triage).ImplicationsEDs may be able to improve pain management by ensuring pain management processes align with key ED priorities. Undertaking multifaceted changes to structures and processes may enable staff to improve pain management and develop a culture in which pain management can be prioritised more easily. Future interventions need to be compatible with the wider work of the ED and enable patient flow in order to be adopted and maintained.

Background Delirium affects > 15% of hospitalised patients but is grossly underdetected, contributing to poor care. The 4 ‘A’s Test (4AT, www.the4AT.com) is a short delirium assessment tool designed for routine use without special training. The primary objective was to assess the accuracy of the 4AT for delirium detection. The secondary objective was to compare the 4AT with another commonly used delirium assessment tool, the Confusion Assessment Method (CAM). Methods This was a prospective diagnostic test accuracy study set in emergency departments or acute medical wards involving acute medical patients aged ≥ 70. All those without acutely life-threatening illness or coma were eligible. Patients underwent (1) reference standard delirium assessment based on DSM-IV criteria and (2) were randomised to either the index test (4AT, scores 0–12; prespecified score of > 3 considered positive) or the comparator (CAM; scored positive or negative), in a random order, using computer-generated pseudo-random numbers, stratified by study site, with block allocation. Reference standard and 4AT or CAM assessments were performed by pairs of independent raters blinded to the results of the other assessment. Results Eight hundred forty-three individuals were randomised: 21 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome, and 785 were included in the analysis. Mean age was 81.4 (SD 6.4) years. 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT had an area under the receiver operating characteristic curve of 0.90 (95% CI 0.84–0.96). The 4AT had a sensitivity of 76% (95% CI 61–87%) and a specificity of 94% (95% CI 92–97%). The CAM had a sensitivity of 40% (95% CI 26–57%) and a specificity of 100% (95% CI 98–100%). Conclusions The 4AT is a short, pragmatic tool which can help improving detection rates of delirium in routine clinical care. Trial registration International standard randomised controlled trial number (ISRCTN) 53388093. Date applied 30/05/2014; date assigned 02/06/2014. Electronic supplementary material The online version of this article (10.1186/s12916-019-1367-9) contains supplementary material, which is available to authorized users.

Venous thromboembolic disease is a major global cause of morbidity and mortality. An estimated 10 million episodes are diagnosed yearly; over half of these episodes are provoked by hospital admission/procedures and result in significant loss of disability adjusted life years. Temporary lower limb immobilisation after injury is a significant contributor to the overall burden of venous thromboembolism (VTE). Existing evidence suggests that pharmacological prophylaxis could reduce overall VTE event rates in these patients, but the proportional reduction of symptomatic events remains unclear. Recent studies have used different pharmacological agents, dosing regimens and outcome measures. Consequently, there is wide variation in thromboprophylaxis strategies, and international guidelines continue to offer conflicting advice for clinicians. In this review, we provide a summary of recent evidence assessing both the clinical and cost effectiveness of thromboprophylaxis in patients with temporary immobilisation after injury. We also examine the evidence supporting stratified thromboprophylaxis and the validity of widely used risk assessment methods.

Pregnant women are at increased risk for venous thromboembolism, and pulmonary embolism (PE) is among the most common causes of maternal death. Yet, evidence on the evaluation of suspected PE durin...