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ObjectivesThe Manchester Acute Coronary Syndromes ECG (MACS-ECG) prediction model calculates a score based on objective ECG measurements to give the probability of a non-ST elevation myocardial infarction (NSTEMI). The model showed good performance in the emergency department (ED), but its accuracy in the pre-hospital setting is unknown. We aimed to externally validate MACS-ECG in the pre-hospital environment.MethodsWe undertook a secondary analysis from the Pre-hospital Evaluation of Sensitive Troponin (PRESTO) study, a multi-centre prospective study to validate decision aids in the pre-hospital setting (26 February 2019 to 23 March 2020). Patients with chest pain where the treating paramedic suspected acute coronary syndrome were included. Paramedics collected demographic and historical data and interpreted ECGs contemporaneously (as ‘normal’ or ‘abnormal’). After completing recruitment, we analysed ECGs to calculate the MACS-ECG score, using both a pre-defined threshold and a novel threshold that optimises sensitivity to differentiate AMI from non-AMI. This was compared with subjective ECG interpretation by paramedics. The diagnosis of AMI was adjudicated by two investigators based on serial troponin testing in hospital.ResultsOf 691 participants, 87 had type 1 AMI and 687 had complete data for paramedic ECG interpretation. The MACS-ECG model had a C-index of 0.68 (95% CI: 0.61 to 0.75). At the pre-determined cut-off, MACS-ECG had 2.3% (95% CI: 0.3% to 8.1%) sensitivity, 99.5% (95% CI: 98.6% to 99.9%) specificity, 40.0% (95% CI: 10.2% to 79.3%) positive predictive value (PPV) and 87.6% (87.3% to 88.0%) negative predictive value (NPV). At the optimal threshold for sensitivity, MACS-ECG had 50.6% sensitivity (39.6% to 61.5%), 83.1% specificity (79.9% to 86.0%), 30.1% PPV (24.7% to 36.2%) and 92.1% NPV (90.4% to 93.5%). In comparison, paramedics had a sensitivity of 71.3% (95% CI: 60.8% to 80.5%) with 53.8% (95% CI: 53.8% to 61.8%) specificity, 19.7% (17.2% to 22.45%) PPV and 93.3% (90.8% to 95.1%) NPV.ConclusionNeither MACS-ECG nor paramedic ECG interpretation had a sufficiently high PPV or NPV to ‘rule in’ or ‘rule out’ NSTEMI alone.

Background England operates a National Data Opt-Out (NDOO) for the secondary use of confidential health data for research and planning. We hypothesised that public awareness and support for the secondary use of health data and the NDOO would vary by participant demography and healthcare experience. We explored patient/public awareness and perceptions of secondary data use, grouping potential researchers into National Health Service (NHS), academia or commercial. We assessed awareness of the NDOO system amongst patients, carers, healthcare staff and the public. We co-developed recommendations to consider when sharing unconsented health data for research. Methods A patient and public engagement program, co-created and including patient and public workshops, questionnaires and discussion groups regarding anonymised health data use. Results There were 350 participants in total. Central concerns for health data use included unauthorised data re-use, the potential for discrimination and data sharing without patient benefit. 94% of respondents were happy for their data to be used for NHS research, 85% for academic research and 68% by health companies, but less than 50% for non-healthcare companies and opinions varied with demography and participant group. Questionnaires showed that knowledge of the NDOO was low, with 32% of all respondents, 53% of all NHS staff and 29% of all patients aware of the NDOO. Recommendations to guide unconsented secondary health data use included that health data use should benefit patients; data sharing decisions should involve patients/public. That data should remain in close proximity to health services with the principles of data minimisation applied. Further, that there should be transparency in secondary health data use, including publicly available lists of projects, summaries and benefits. Finally, organisations involved in data access decisions should participate in programmes to increase knowledge of the NDOO, to ensure public members were making informed choices about their own data. Conclusion The majority of participants in this study reported that the use of healthcare data for secondary purposes was acceptable when accessed by NHS. Academic and health-focused companies. However, awareness was limited, including of the NDOO. Further development of publicly-agreed recommendations for secondary health data use may improve both awareness and confidence in secondary health data use. Supplementary Information The online version contains supplementary material available at 10.1186/s40900-021-00281-2., Plain English summary Health data from routine care can be pseudonymised (with a link remaining to the patient but identifying features removed) or anonymised (with identifying features removed and the link to the patient severed) and used for research and health planning; termed “secondary use”. The National Health Service (NHS) is a single publicly-funded health service for the United Kingdom (UK). The NHS supports secondary data use with a National Data opt-out system. The potential benefits of data secondary use are clear but concerns have been raised. Although the Data Opt-Out is publicised, it is unclear how much public awareness there is of this scheme. We report a patient and publicly created and delivered series of activities including > 350 people; with young adults, patients, NHS staff and the public; to assess concerns, knowledge and acceptance of data sharing. Perceptions of and support for secondary health data use varied depending on who was asked (by age, gender) and their experience of health services (Staff member, patient, member of the public). Knowledge of schemes to limit secondary data use (such as the UK National Data Op-Out) was low, even among NHS staff. The main concerns of sharing health data included onward data use, the potential for discrimination and exploitation and commercial gain from data use with no benefit to patients. Despite this, most participants agreed with health data sharing with NHS, academic and commercial health-based entities. Agreed, co-created themes to increase the acceptability of health data secondary use included education about ‘Opt-out’ schemes, health service oversight of data use (as the most trusted partner), public and patient involvement in data sharing decisions and public transparency. Supplementary Information The online version contains supplementary material available at 10.1186/s40900-021-00281-2.

Introduction Good quality basic life support (BLS) is associated with improved outcome from cardiac arrest. Chest compression fraction (CCF) is a BLS quality indicator, which may be influenced by the type of airway used. We aimed to assess CCF according to the airway strategy in the PARAMEDIC2 study: no advanced airway, supraglottic airway (SGA), tracheal intubation, or a combination of the two. Our hypothesis was that tracheal intubation was associated with a decrease in the CCF compared with alternative airway management strategies. Methods PARAMEDIC2 was a multicentre double-blinded placebo-controlled trial of adrenaline vs placebo in out-of-hospital cardiac arrest. Data showing compression rate and ratio from patients recruited by London Ambulance Service (LAS) as part of this study was collated and analysed according to the advanced airway used during the resuscitation attempt. Results CPR process data were available from 286/ 2058 (13.9%) of the total patients recruited by LAS. The mean compression rate for the first 5 min of data recording was the same in all groups (P = 0.272) and ranged from 104.2 (95% CI of mean: 100.5, 107.8) min−1 to 108.0 (95% CI of mean: 105.1, 108.3) min−1. The mean compression fraction was also similar across all groups (P = 0.159) and ranged between 74.7% and 78.4%. There was no difference in the compression rates and fractions across the airway management groups, regardless of the duration of CPR. Conclusion There was no significant difference in the compression fraction associated with the airway management strategy.

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.

Purpose:\ud To compare the effectiveness of the intravenous (IV) and intraosseous (IO) routes for drug administration in adults with a cardiac arrest enrolled in the Pre-Hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest (PARAMEDIC2) randomised, controlled trial.\ud \ud Methods:\ud Patients were recruited from five National Health Service Ambulance Services in England and Wales from December 2014 through October 2017. Patients with an out-of-hospital cardiac arrest who were unresponsive to initial resuscitation attempts were randomly assigned to 1 mg adrenaline or matching placebo. Intravascular access was established as soon as possible, and IO access was considered if IV access was not possible after two attempts.\ud \ud Results:\ud Among patients with out-of-hospital cardiac arrest, 3631 received adrenaline and 3686 received placebo. Amongst these, 1116 (30.1%) and 1121 (30.4%) received the study drug via the IO route. The odds ratios were similar in the IV and IO groups for return of spontaneous circulation (ROSC) at hospital handover [adjusted odds ratio (aOR) 4.07 (95% CI 3.42–4.85) and (aOR 3.98 (95% CI 2.86–5.53), P value for interaction 0.90]; survival to 30 days [aOR 1.67 (1.18–2.35) versus 0.9 (0.4–2.05), P = 0.18]; and favourable neurological outcome [aOR 1.39 (0.93–2.06) versus 0.62 (0.23–1.67), P = 0.14].\ud \ud Conclusion:\ud There was no significant difference in treatment effect (adrenaline versus placebo) on ROSC at hospital handover between drugs administered by the intraosseous route or by the intravenous route. We could not detect any difference in the treatment effect between the IV and IO routes on the longer term outcomes of 30-day survival or favourable neurological outcome at discharge (ISRCTN73485024).

IntroductionUK ambulance services have identified a concern with high users of the 999 service and have set up ‘frequent callers’ services, ranging from within-service management to cross-sectoral multidisciplinary case management approaches. There is little evidence about how to address the needs of this patient group.AimTo evaluate effectiveness, safety and efficiency of case management approaches to the care of people who frequently call the emergency ambulance service, and gain an understanding of barriers and facilitators to implementation.Objectives(1) Develop an understanding of predicted mechanisms of change to underpin evaluation. (2) Describe epidemiology of sustained high users of 999 services. (3) Evaluate case management approaches to the care of people who call the 999 ambulance service frequently in terms of: (i) Further emergency contacts (999, emergency department, emergency admissions to hospital) (ii) Effects on other services (iii) Adverse events (deaths, injuries, serious medical emergencies and police arrests) (iv) Costs of intervention and care (v) Patient experience of care. (4) Identify challenges and opportunities associated with using case management models, including features associated with success, and develop theories about how case management works in this population.Methods and analysisWe will conduct a multisite mixed-methods evaluation of case management for people who use ambulance services frequently by using anonymised linked routine data outcomes in a ‘natural experiment’ cohort design, in four regional ambulance services. We will conduct interviews and focus groups with service users, commissioners and emergency and non-acute care providers. The planned start and end dates of the study are 1 April 2019 and 1 September 2022, respectivelyEthics and disseminationThe study received approval from the UK Health Research Authority (Confidentiality Advisory Group reference number: 19/CAG/0195; research ethics committee reference number: 19/WA/0216).We will collate feedback from our Lived Experience Advisory Panel, the Frequent Caller National Network and Research Management Group for targeted dissemination activities.

BackgroundTRIM is an evaluation of the models used to triage and manage emergency ambulance service care for patients with suspected Covid-19 during the first wave of the pandemic in 2020. We aimed to understand experiences and concerns of clinical and managerial staff about implementation of triage protocols in call centre and on-scene.MethodsResearch paramedics in four study sites across England interviewed purposively selected stakeholders from ambulance services (call handlers, clinical advisors in call centres, clinicians providing emergency response, managers) and ED clinical staff from one hospital per site. Interviews (n=23) were conducted remotely using MS Teams, recorded, and transcribed in full. Analysis generated themes from the implicit and explicit ideas within participants’ accounts, following the six stages of analysis described by Braun and Clarke, conducted by a group of researchers and PPI partners working together.ResultsWe identified the following themes:Constantly changing guidelines– at some points, updates several times a dayThe ambulance service as part of the wider healthcare system- changes in other parts of the healthcare system left ambulance services as the default optionPeaks and troughs of demand- demand fluctuated greatly over time, with workload varying across the ambulance service, including an increased role for clinical advisorsA stretched system -resources to respond to patient demand were stretched thinner by staff sickness and isolation, longer job times, and increased handover delays at EDEmotional load of responding to the pandemic -particularly for call centre staffDoing the best they can in the face of uncertainty -in the face of a rapidly evolving situation unlike any which ambulance services had faced beforeDiscussionImplementing triage protocols in response to the Covid-19 pandemic was a complex and process which had to be actively managed by a range of front line staff, dealing with external pressures and a heavy emotional load.

BackgroundAmbulance clinicians use pre-alert calls to inform receiving emergency departments (EDs) of the arrival of a critically unwell patient that will require a specialised response. Little is known about how a decision to pre-alert is made and how this is communicated and acted upon in the receiving ED. Whilst appropriate use of pre-alerts benefits patient care, their overuse carries a risk of harm or opportunity costs. The impact of pre-alerts on ambulance clinicians, ED staff and patients is not currently well understood.MethodsWe are conducting a mixed methods study with five inter-related work packages. We will analyse 12 months of routine data from ambulance pre-alerts in three regions to identify factors in the variation of pre-alert use, including pre-hospital decision-making. We will undertake a national online Qualtrics survey of ambulance clinician perspectives and experience of pre-alerts. We will explore the impacts of a pre-alert on staff, ED facilities and the patient using semi-structured interviews with ambulance clinicians, ED staff, patients and carers and undertake non-participant observation of ED pre-alert response.Expected ResultsWe will describe current pre-alert practice using 12 months’ data for 3 Ambulance Services, including volume and types of pre-alerts. We will identify specific conditions or patient groups for whom pre-alerts are most likely to lead to change in clinical practice, or for whom action is unlikely to provide benefit. We will hold a feedback workshop in which we will share and discuss our findings with key stakeholders.ConclusionsCurrent variation in pre-alert processes, both pre-hospital and in-hospital and the impact on patient care is not understood. The outputs of this study will establish an evidence base to update national guidance for pre-alert practice and identify areas of good pre-alert practice for both ambulance service and Emergency Department staff.

Background Adrenaline has been used as a treatment for cardiac arrest for many years, despite uncertainty about its effects on long-term outcomes and concerns that it may cause worse neurological outcomes. Objectives The objectives were to evaluate the effects of adrenaline on survival and neurological outcomes, and to assess the cost-effectiveness of adrenaline use. Design This was a pragmatic, randomised, allocation-concealed, placebo-controlled, parallel-group superiority trial and economic evaluation. Costs are expressed in Great British pounds and reported in 2016/17 prices. Setting This trial was set in five NHS ambulance services in England and Wales. Participants Adults treated for an out-of-hospital cardiac arrest were included. Patients were ineligible if they were pregnant, if they were aged Interventions Participants were randomised to either adrenaline (1 mg) or placebo in a 1 : 1 allocation ratio by the opening of allocation-concealed treatment packs. Main outcome measures The primary outcome was survival to 30 days. The secondary outcomes were survival to hospital admission, survival to hospital discharge, survival at 3, 6 and 12 months, neurological outcomes and health-related quality of life through to 6 months. The economic evaluation assessed the incremental cost per quality-adjusted life-year gained from the perspective of the NHS and Personal Social Services. Participants, clinical teams and those assessing patient outcomes were masked to the treatment allocation. Results From December 2014 to October 2017, 8014 participants were assigned to the adrenaline (n = 4015) or to the placebo (n = 3999) arm. At 30 days, 130 out of 4012 participants (3.2%) in the adrenaline arm and 94 out of 3995 (2.4%) in the placebo arm were alive (adjusted odds ratio for survival 1.47, 95% confidence interval 1.09 to 1.97). For secondary outcomes, survival to hospital admission was higher for those receiving adrenaline than for those receiving placebo (23.6% vs. 8.0%; adjusted odds ratio 3.83, 95% confidence interval 3.30 to 4.43). The rate of favourable neurological outcome at hospital discharge was not significantly different between the arms (2.2% vs. 1.9%; adjusted odds ratio 1.19, 95% confidence interval 0.85 to 1.68). The pattern of improved survival but no significant improvement in neurological outcomes continued through to 6 months. By 12 months, survival in the adrenaline arm was 2.7%, compared with 2.0% in the placebo arm (adjusted odds ratio 1.38, 95% confidence interval 1.00 to 1.92). An adjusted subgroup analysis did not identify significant interactions. The incremental cost-effectiveness ratio for adrenaline was estimated at £1,693,003 per quality-adjusted life-year gained over the first 6 months after the cardiac arrest event and £81,070 per quality-adjusted life-year gained over the lifetime of survivors. Additional economic analyses estimated incremental cost-effectiveness ratios for adrenaline at £982,880 per percentage point increase in overall survival and £377,232 per percentage point increase in neurological outcomes over the first 6 months after the cardiac arrest. Limitations The estimate for survival with a favourable neurological outcome is imprecise because of the small numbers of patients surviving with a good outcome. Conclusions Adrenaline improved long-term survival, but there was no evidence that it significantly improved neurological outcomes. The incremental cost-effectiveness ratio per quality-adjusted life-year exceeds the threshold of £20,000–30,000 per quality-adjusted life-year usually supported by the NHS. Future work Further research is required to better understand patients’ preferences in relation to survival and neurological outcomes after out-of-hospital cardiac arrest and to aid interpretation of the trial findings from a patient and public perspective. Trial registration Current Controlled Trials ISRCTN73485024 and EudraCT 2014-000792-11. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 25. See the NIHR Journals Library website for further project information.

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.

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.

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.

BackgroundThere has been little research into the prehospital management of cardiac arrest following hanging despite it being among the most prevalent methods of suicide worldwide. The aim of this study was to report the characteristics, resuscitative treatment and outcomes of patients managed in the prehospital environment for cardiac arrest secondary to hanging and compare these with all-cause out-of-hospital cardiac arrest (OHCA).MethodsData from a UK ambulance service cardiac arrest registry were extracted for all cases in which treatment was provided for OHCA due to hanging between 1 January 2013 and 30 June 2018. Cases were linked to outcome data obtained from the Trauma Audit and Research Network. Comparison of the cohort was made to previously published data from a UK study of all-cause OHCA with 95% CIs calculated for the proportional difference between the studies in selected presentation and outcome variables.Results189 cases were identified. 95 patients were conveyed to hospital and four of these survived to discharge. 40 patients were conveyed despite absence of a spontaneous circulation and none of these patients survived. While only three patients were initially in a shockable rhythm, DC shocks were administered in 20 cases. There was one case of failed ventilation prompting front-of-neck access for oxygenation. By comparison with all-cause OHCA the proportion of patients with a spontaneous circulation at hospital handover was similar (27.0% vs 27.5%; 0.5% difference, 95% CI −5.9% to 6.8%, p=0.882) but survival to hospital discharge was significantly lower (2.2% vs 8.4%; 6.2% difference, 95% CI 4.1% to 8.3%, p=0.002).ConclusionClinical outcomes following OHCA due to hanging are poor, particularly when patients are transported while in cardiac arrest. Failure to ventilate was uncommon, and clinicians should be alert to the possibility of shockable rhythms developing during resuscitation.

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 £5,685 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 £1,522), than standard care. The mean ICER, estimated as prehospital CPAP compared to standard care, was £9,712 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.

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.

Recurrent tuberculosis (TB), defined as TB that recurs after a patient has been considered cured, constitutes a challenge to TB control. In low TB burden countries, the underlying causes and consequences of recurrent TB are poorly understood. We conducted a literature review to summarise the evidence of recurrent TB in low-burden settings and to address current gaps in knowledge. We included peer-reviewed publications on studies conducted in countries with an estimated TB incidence of

BackgroundMulti-agency case management is being introduced by ambulance services and their partners in the UK to try to identify and address the needs of those who call 999 ambulance services frequently. However, there is a lack of evidence about what works well in this setting and how. Based on current nationally agreed definitions, calling frequently is defined as 5 or more times in a month, or 12 or more times in a three-month period. The STRETCHED study (STRategies to manage Emergency ambulance Telephone Callers with sustained High needs – an Evaluation using linked Data) study seeks to evaluate clinical and cost-effectiveness, safety, and efficiency of case management for people who frequently call the emergency ambulance service.We developed a logic model to describe key components, mechanisms of change and expected impacts of cross-sectoral case management approaches to the management of people who call 999 frequently.MethodWe conducted a stakeholder event with 37 people from Wales, England and Northern Ireland including patient representatives and professional staff involved in commissioning, planning and delivering case management for people who call 999 services frequently. The aggregated responses from the participants was used as the basis for developing a logic model.ResultsComponents: dedicated staff time for case management, availability and knowledge of relevant services for referral, multidisciplinary collaboration, organisational support, and clear information sharing protocolsMechanisms: provision of space for a clear understanding of reasons for calling, tailoring of multi–sectoral management to individual needs, offering therapeutic support and assistance in development of self–efficacyImpacts: improvement in access to appropriate and timely care, increase in efficiency and accessibility of the healthcare system, reduction in emergency calls, costs and mortalityConclusionCase management is a developing area of provision in prehospital emergency care for people who call ambulance services frequently. Our logic model provides a firm foundation for evaluation to build the urgently needed evidence base for case management of people who call ambulance services frequently.

BackgroundUse of the Pre-Hospital 12-lead Electrocardiogram (PHECG) is recommended in patients presenting to emergency medical services (EMS) with suspected acute coronary syndrome (ACS).ObjectivesTo investigate differences in mortality between those who did/did not receive PHECG.MethodsPopulation-based, linked cohort study using Myocardial Ischaemia National Audit Project (MINAP) data from 2010-2017.ResultsOf 330,713 patients, 263,420 (79.6%) had PHECG, 67,293 (20.3%) did not. 30-day mortality was 7.8% overall, 7.1% with PHECG vs 10.9% without PHECG (adjusted Odds Ratio [aOR] 0.772, 95% confidence interval [CI] 0.748-0.795, pConclusionPHECG was associated with lower mortality at 30 days and 1 year in both STEMI and non-STEMI patients.

Introduction Use of the prehospital 12-lead ECG (PHECG) is recommended in patients presenting to emergency medical services (EMS) with suspected acute coronary syndrome (ACS). Prior research found that although PHECG use was associated with improved 30-day survival, a third of patients (typically women, the elderly and those with comorbidities) under EMS care did not receive a PHECG. The overall aim of the PHECG2 study is to update evidence on care and outcomes for patients eligible for PHECG, specifically addressing the following research questions: (1) Is there a difference in 30-day mortality, and in reperfusion rate, between those who do and those who do not receive PHECG? (2) Has the proportion of eligible patients who receive PHECG changed since the introduction of primary percutaneous coronary intervention networks? (3) Are patients that receive PHECG different from those that do not in terms of social and demographic factors, or prehospital clinical presentation? (4) What factors influence EMS clinicians’ decisions to perform PHECG? Methods and analysis This is an explanatory, mixed-method study comprising four work packages (WPs). WP1 is a population-based, linked-data analysis of a national ACS registry (Myocardial Ischaemia National Audit Project). WP2 is a retrospective chart review of patient records from three large regional EMS. WP3 comprises focus groups of EMS personnel. WP4 will synthesise findings from WP1–3 to inform the development of an intervention to increase PHECG uptake. Ethics and dissemination The study has been approved by the London-Hampstead Research Ethics Committee (ref: 18LO1679). Findings will be disseminated through feedback to participating EMS, conference presentations and publication in peer-reviewed journals. Trial registration number NCT03699137

BackgroundEmergency ambulance services are integral to providing a service for those with unplanned urgent and life-threatening health conditions. However, high use of the service by a small minority of patients is a concern.Aims and ObjectivesTo describe: service-wide and local policies or pathways for people classified as Frequent Caller; call volume; and results of any audit or evaluation.MethodsWe conducted a national survey of current practice in ambulance services in relation to the management of people who call the emergency ambulance service frequently using a structured questionnaire, for completion by email and telephone interview. We analysed responses using a descriptive and thematic approach.ResultsTwelve of 13 UK ambulance services responded. Most services used nationally agreed definitions for ‘Frequent Caller’, with 600 – 900 people meeting this classification each month. Service-wide policies were in place, with local variations. Models of care varied from within-service care where calls are flagged in the call centre, contact made with callers and their GP with an aim of discouraging further calls; to case management through cross-service, multi-disciplinary team meetings aiming to resolve callers’ needs. No formal audits or evaluations were reported.ConclusionsAmbulance services are under pressure to meet challenging response times for high acuity patients. Tensions are apparent in the provision of care to patients who have complex needs and call frequently. Within service care focused mainly on reducing calls whilst multi-disciplinary case management aimed to resolve clinical and emotional needs of patients. However, there is currently inadequate evidence to inform commissioning, policy or practice development.

IntroductionAmbulance services are facing increased demand to provide both urgent and emergency care. Details of a paramedic’s case load, patient mix and interventions delivered during patient encounters within contemporary practice are rarely described within the literature. This paper provides insight into the work of paramedics within an NHS ambulance service within the UK; the frequency of low, medium and high acuity clinical presentations, amongst patients they care for and the utilisation of clinical interventions in practice.MethodsA single site, retrospective service evaluation to describe the case load of 45 operational paramedics within a large regional English NHS ambulance service, over a full calendar year.ResultsA combined caseload of 33649 patients were attended by 45 paramedics. Paramedics attend 748 patients per year (95% CI, 705 – 790), 91.6% are adults. Aetiology of clinical presentations of patients attended by paramedics are 76.2% medical and 23.8% traumatic. 34.8% of patients receive a clinical intervention or administration of a medicine during their clinical management. Conveyance to hospital occurs in 63% of face to face interactions. Most patient interactions by paramedics are for low acuity clinical presentations. National Early Warning Score calculations of 25678 clinical records demonstrate that 74.1% of patients are LOW RISK, 16.5% are MEDIUM RISK and only 9.4% of patients are categorised as HIGH RISK. The distribution of NEWS seems not to be affected by rurality of the paramedic’s operational base. Musculoskeletal injury is the most common clinical impression with 7.0% of attendances.ConclusionParamedics attend an extremely varied patient case mix; across the full life cycle. Most patients have low acuity clinical presentations. Patients with high acuity illness and in need of life saving critical interventions are seen infrequently, which may have implications for the education, exposure and skill retention in the management of this patient group.

BackgroundAcute respiratory failure (ARF) is a common and life-threatening medical emergency. Continuous positive airway pressure (CPAP) is a potentially beneficial prehospital treatment, but it is uncertain whether this could improve important outcomes in NHS ambulance services.MethodsAn individually randomised, external pilot study was conducted to test the feasibility of a definitive pragmatic trial. Adults with respiratory distress and peripheral oxygen saturations below British Thoracic Society target levels were recruited from the West Midlands Ambulance Service between August 2017 and July 2018. Participants were randomised 1:1 to prehospital CPAP or standard oxygen therapy. Feasibility objectives estimated the: incidence of eligible patients; proportion recruited and allocated to treatment appropriately; adherence to allocated treatment; retention and data completeness; and 30-day mortality, as a potential primary outcome for a definitive trial.ResultsOver 12 months, 77 patients were enrolled (CPAP arm 42, standard oxygen arm 35 cases, target 120). CPAP was fully delivered as planned in 74% (target 75%). There were no major protocol violations/non-compliances (target 0%). Full data were available for key outcomes (target ≥90%). Mortality was higher than expected (overall 27.3%, CPAP arm 28.6% n=12/42, standard care arm 25.7% n=9/35). Of deceased patients, 14/21 (68%) either did not have a respiratory condition or had ceiling of treatment decisions excluding hospital non-invasive ventilation and critical care. Two patients required emergency department treatment for a pneumothorax, neither having received prehospital CPAP. There were no other serious adverse events.ConclusionsThe lower than expected recruitment rate, limited compliance with CPAP, and the difficulty in identifying patients who could benefit from CPAP, indicate limited potential for prehospital CPAP to reduce mortality. A definitive effectiveness trial is therefore not recommended. These findings also argue against routine implementation of CPAP into NHS ambulance services.

BackgroundMechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA).ObjectiveEvaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA.DesignPragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression.SettingFour UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR.ParticipantsPatients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged InterventionsPatients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene.Main outcome measuresSurvival at 30 days following cardiac arrest; survival without significant neurological impairment [Cerebral Performance Category (CPC) score of 1 or 2].ResultsWe enrolled 4471 eligible patients (1652 assigned to the LUCAS-2 device and 2819 assigned to control) between 15 April 2010 and 10 June 2013. A total of 985 (60%) patients in the LUCAS-2 group received mechanical chest compression and 11 (LimitationsThere was substantial non-compliance in the LUCAS-2 arm. For 272 out of 1652 patients (16.5%), mechanical chest compression was not used for reasons that would not occur in clinical practice. We addressed this issue by using complier average causal effect analyses. We attempted to measure CPR quality during the resuscitation attempts of trial participants, but were unable to do so.ConclusionsThere was no evidence of improvement in 30-day survival with LUCAS-2 compared with manual compressions. Our systematic review of recent randomised trials did not suggest that survival or survival without significant disability may be improved by the use of mechanical chest compression.Future workThe use of mechanical chest compression for in-hospital cardiac arrest, and in specific circumstances (e.g. transport), has not yet been evaluated.TriaI registrationCurrent Controlled Trials ISRCTN08233942.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 11. See the NIHR Journals Library website for further project information.