The COVID-19 ambulance response assessment (CARA) study: a national survey of ambulance service healthcare professionals' preparedness and response to the COVID-19 pandemic.

Background: The COVID-19 pandemic placed significant demand on the NHS, including ambulance services, but it is unclear how this affected ambulance service staff and paramedics in other clinical settings (e.g. urgent and primary care, armed services, prisons). This study aimed to measure the self-perceived preparedness and impact of the first wave of the pandemic on paramedics' psychological stress and perceived ability to deliver care. Methods: Ambulance clinicians and paramedics working in other healthcare settings were invited to participate in a three-phase sequential online survey during the acceleration (April 2020), peak (May 2020) and deceleration (September/October 2020) phases of the first wave of COVID-19 in the United Kingdom. Recruitment used social media, Trust internal bulletins and the College of Paramedics' communication channels, employing a convenience sampling strategy. Data were collected using purposively developed open- and closed-ended questions and the validated general health questionnaire-12 (GHQ-12). Data were analysed using multi-level linear and logistic regression models. Results: Phase 1 recruited 3717 participants, reducing to 2709 (73%) by phase 2 and 2159 (58%) by phase 3. Participants were mostly male (58%, n = 2148) and registered paramedics (n = 1992, 54%). Mean (standard deviation) GHQ-12 scores were 16.5 (5.2) during phase 1, reducing to 15.2 (6.7) by phase 3. A total of 84% of participants (n = 3112) had a GHQ-12 score ≥ 12 during the first phase, indicating psychological distress. Participants that had higher GHQ-12 scores were feeling unprepared for the pandemic, and reported a lack of confidence in using personal protective equipment and managing cardiac arrests in confirmed or suspected COVID-19 patients. Conclusions: Most participants reported psychological distress, the reasons for which are multi-factorial. Ambulance managers need to be aware of the risks to staff mental health and take action to mitigate these, to support staff in the delivery of unscheduled, emergency and urgent care under these additional pressures.

Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3).

Aims: The PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest. Methods: PARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model.The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained. Conclusion: The PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest.Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.

An in-depth qualitative interview study of female ambulance staff experiences of the menopause transition (CESSATION phase 3).

Introduction: Menopause is a key workplace issue. Many women will experience symptoms through their later working life. The ambulance service constitutes an employment setting that, dependent on the roles of female staff, can impact on the severity of menopause symptoms and experiences (Prothero et al., 2021). This study aimed to explore female ambulance staff experiences of the menopause transition and suggest ways to improve support offerings. Methods: A qualitative interpretive approach was adopted, involving 12 UK ambulance services. Participants were identified via purposive sampling, and semi-structured interviews were conducted from February to July 2022 via an online platform or telephone. Recordings were transcribed verbatim and analysed using an inductive thematic approach. Results: Twenty-two female participants, aged between 42 and 62 years, were interviewed, and represented all phases of the menopause: peri-menopause (n = 9); menopause (n = 5); post-menopause (n = 3); and unsure (n = 5). Fourteen participants had front-line (patient-facing) or emergency operation centre-based roles, while seven were employed in service support roles. Ten themes were identified: impact on work role; awareness and preparedness for menopause transition; personal impact of symptoms; desired support; appropriate sickness and menopause policy; managerial development; compassion and dignity; impact of working environment; impact on safety; and lack of choice. Lack of understanding and support from colleagues and line managers were identified as the key issues. This is included under the managerial development and compassion and dignity themes. Conclusions: The varying range of menopausal symptoms and their severity impacted on women's performance at work. The experience of working while going through the menopause could be challenging. Employers should adopt a menopause policy which includes training and awareness for all staff, and suitable for front-line as well as service support staff. There is a need to create a culture where the menopause is not taboo, and women feel able to talk about their symptoms.

Experiences and views of people who frequently call emergency ambulance services: A qualitative study of UK service users.

INTRODUCTION: People who call emergency ambulances frequently are often vulnerable because of health and social circumstances, have unresolved problems or cannot access appropriate care. They have higher mortality rates. Case management by interdisciplinary teams can help reduce demand for emergency services and is available in some UK regions. We report results of interviews with people who use emergency ambulance services frequently to understand their experiences of calling and receiving treatment. METHODS: We used a two-stage recruitment process. A UK ambulance service identified six people who were known to them as frequently calling emergency services. Through third-sector organisations, we also recruited nine individuals with healthcare experiences reflecting the characteristics of people who call frequently. We gained informed consent to record and transcribe all telephone interviews. We used thematic analysis to explore the results. RESULTS: People said they make frequent calls to emergency ambulance services as a last resort when they perceive their care needs are urgent and other routes to help have failed. Those with the most complex health needs generally felt their immediate requirements were not resolved and underlying mental and physical problems led them to call again. A third of respondents were also attended to by police and were arrested for behaviour associated with their health needs. Those callers receiving case management did not know they were selected for this. Some respondents were concerned that case management could label frequent callers as troublemakers. CONCLUSION: People who make frequent calls to emergency ambulance services feel their health and care needs are urgent and ongoing. They cannot see alternative ways to receive help and resolve problems. Communication between health professionals and service users appears inadequate. More research is needed to understand service users' motivations and requirements to inform design and delivery of accessible and effective services. PATIENT OR PUBLIC CONTRIBUTION: People with relevant experience were involved in developing, undertaking and disseminating this research. Two public contributors helped design and deliver the study, including developing and analysing service user interviews and drafting this paper. Eight public members of a Lived Experience Advisory Panel contributed at key stages of study design, interpretation and dissemination. Two more public contributors were members of an independent Study Steering Committee.

Clinical and cost-effectiveness of paramedic administered fascia iliaca compartment block for emergency hip fracture (RAPID 2)-protocol for an individually randomised parallel-group trial.

BACKGROUND: Approximately 75,000 people fracture a hip each year in the UK. This painful injury can be devastating-with a high associated mortality rate-and survivors likely to be more dependent and less mobile. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given by paramedics, but opioids are less effective for dynamic pain and can cause serious side effects, including nausea, constipation, delirium and respiratory depression. These may delay surgery, require further treatment and worsen patient outcomes. We completed a feasibility study of paramedic-provided fascia iliaca compartment block (FICB), testing the intervention, trial methods and data collection. The study (RAPID) demonstrated that a full trial was feasible. In this subsequent study, we aim to test safety, clinical and cost-effectiveness of paramedic-provided FICB as pain relief to patients with suspected hip fracture in the prehospital environment. METHODS: We will conduct a pragmatic multi-centre individually randomised parallel-group trial, with a 1:1 allocation between usual care (control) and FICB (intervention). Hospital clinicians in five sites (paired ambulance services and receiving hospitals) in England and Wales will train 220 paramedics to administer FICB. The primary outcome is change in pain score from pre-randomisation to arrival at the emergency department. One thousand four hundred patients are required to find a clinically important difference between trial arms in the primary outcome (standardised statistical effect ~ 0.2; 90% power, 5% significance). We will use NHS Digital (England) and the SAIL (Secure Anonymised Information Linkage) databank (Wales) to follow up patient outcomes using routine anonymised linked data in an efficient study design, and questionnaires to capture patient-reported outcomes at 1 and 4 months. Secondary outcomes include mortality, length of hospital stay, job cycle time, prehospital medications including morphine, presence of hip fracture, satisfaction, mobility, and NHS costs. We will assess safety by monitoring serious adverse events (SAEs). DISCUSSION: The trial will help to determine whether paramedic administered FICB is a safe, clinically and cost-effective treatment for suspected hip fracture in the pre-hospital setting. Impact will be shown if and when clinical guidelines either recommend or reject the use of FICB in routine practice in this context. TRIAL REGISTRATION: ISRCTN15831813 . Registered on 22 September 2021.

STRategies to manage Emergency ambulance Telephone Callers with sustained High needs: an Evaluation using linked Data (STRETCHED) - a study protocol.

INTRODUCTION: UK 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. AIM: To 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 ANALYSIS: We 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, respectively ETHICS AND DISSEMINATION: The 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.

'Menopause affects us all . . .': menopause transition experiences of female ambulance staff from a UK ambulance service.

BACKGROUND: There is limited research regarding the menopause transition in the emergency services; however, all women will experience this life phase, which can have a significant impact on personal well-being, workplace attendance and performance. The aim of this survey was to explore personal and work impacts of the menopause for all female staff in the ambulance setting. METHODS: A purpose-designed, 20-question survey, based on the Menopause Rating Scale and British Menopause Survey, was developed to understand menopausal symptoms and their impact on female staff in one UK ambulance service. Disseminated during 1-31 July 2019, it resulted in a convenience sample of 522 responses, which were analysed using descriptive statistics and thematic approaches. RESULTS: Typically, respondents were either pre-menopausal or peri-menopausal, with approximately a third being menopausal or post-menopausal. Over half worked in emergency operational delivery, and typically worked shifts or unsocial hours. For those who had experienced menopause symptoms, the most commonly reported were tiredness or low energy levels, difficulty sleeping (including insomnia) and mood changes (including anxiety or depression). Symptoms impacted respondents' well-being, work and home life. Most had not expected the symptoms they experienced. The majority of respondents did not feel supported at work, with lack of menopausal symptom awareness and personal impact, working times and patterns, and sense of embarrassment of most concern. Other issues included lack of managerial and peer support, inadequate working environment and uniform, lack of dignity and choice, and no dedicated menopause policy. CONCLUSIONS: It is understood that this is the first survey to explore female ambulance staff menopause experiences. The impact of menopausal symptoms can be significant. Menopause awareness in this ambulance service is lacking and there is clear scope for initiatives for improved staff support and well-being. Further research is warranted to explore how best to support ambulance staff with the menopause transition.

A survey-based evaluation of ambulance staff awareness of vitamin D and risk of deficiency in a UK ambulance service.

BACKGROUND: Healthcare professions, shift-working and indoor-working are risk factors for vitamin D deficiency. The aim of this survey was to investigate ambulance staff awareness of vitamin D, and the risks associated with deficiency, to inform the need for appropriate well-being resources. METHODS: A purpose-designed, 20-question survey was developed, based on a validated vitamin D questionnaire, to explore staff vitamin D knowledge and self-health in one UK ambulance service. Disseminated during June/July 2020, survey completion was voluntary, and responses obtained were analysed using descriptive and thematic approaches. RESULTS: A total of 384 survey responses were received; 41% (n = 156) of respondents were male. Over half worked within emergency operational service delivery (57%; n = 219). Respondents were predominantly 'White British' (92%; n = 352). According to the Fitzpatrick Scale, most described themselves as having a 'Medium, between white to moderate brown: sometimes mild burns, gradual tan' complexion (47%; n = 182). The majority felt they got sufficient sunlight exposure when at home (66%; n = 253), but not at work (58%; n = 222). Almost one fifth (17%; n = 66) had received a diagnosis of vitamin D deficiency. Forty percent took vitamin D supplements: 12% (n = 45) as advised by a medical professional; 28% (n = 107) self-directed to prevent deficiency. The ability of respondents to recognise known factors that affect vitamin D production in the skin, good vitamin D food sources and individuals at risk of vitamin D deficiency were variable. Respondents commented on their lack of vitamin D awareness, vitamin supplementation, COVID-19, work arrangements and access to sunlight. CONCLUSIONS: Ambulance staff are at risk of vitamin D deficiency irrespective of their role: vitamin D awareness, access to sunlight and use of vitamin D supplements are variable. For affected individuals, the impact of vitamin D deficiency can be significant, requiring absence from work. The development of appropriate vitamin D and well-being resources appears to be warranted.

Randomised feasibility study of prehospital recognition and antibiotics for emergency patients with sepsis (PhRASe).

Severe sepsis is a time critical condition which is known to have a high mortality rate. Evidence suggests that early diagnosis and early administration of antibiotics can reduce morbidity and mortality from sepsis. The prehospital phase of emergency medical care may provide the earliest opportunity for identification of sepsis and delivery of life-saving treatment for patients. We aimed to assess the feasibility of (1) paramedics recognising and screening patients for severe sepsis, collecting blood cultures and administering intravenous antibiotics; and (2) trial methods in order to decide whether a fully-powered trial should be undertaken to determine safety and effectiveness of this intervention. Paramedics were trained in using a sepsis screening tool, aseptic blood culture collection and administration of intravenous antibiotics. If sepsis was suspected, paramedics randomly allocated patients to intervention or usual care using scratchcards. Patients were followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We collected self-reported health-related quality of life at 90 days. We pre-specified criteria for deciding whether to progress to a fully-powered trial based on: recruitment of paramedics and patients; delivery of the intervention; retrieval of outcome data; safety; acceptability; and success of anonymised follow-up. Seventy-four of the 104 (71.2%) eligible paramedics agreed to take part and 54 completed their training (51.9%). Of 159 eligible patients, 146 (92%) were recognised as eligible by study paramedics, and 118 were randomised (74% of eligible patients, or 81% of those recognised as eligible). Four patients subsequently dissented to be included in the trial (3%), leaving 114 patients recruited to follow-up. All recruited patients were matched to routine data outcomes in the Secure Anonymised Information Linkage Databank. Ninety of the 114 (79%) recruited patients had sepsis or a likely bacterial infection recorded in ED. There was no evidence of any difference between groups in patient satisfaction, and no adverse reactions reported. There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths). This feasibility study met its pre-determined progression criteria; an application will therefore be prepared and submitted for funding for a fully-powered multi-centre randomised trial.Trial registration: ISRCTN36856873 sought 16th May 2017; https://doi.org/10.1186/ISRCTN36856873.

Mental health, well-being and support interventions for UK ambulance services staff: an evidence map, 2000 to 2020.

BACKGROUND: Prior to COVID-19 there had been a renewed policy focus in the National Health Service on the health and well-being of the healthcare workforce, with the ambulance sector identified as a priority area. This focus is more important than ever as the sector deals with the acute and longer-term consequences of a pandemic. AIM: To systematically identify, summarise and map the evidence regarding mental health, well-being and support interventions for United Kingdom ambulance services staff and to identify evidence gaps. METHOD: Evidence mapping methodology of published and grey original research published in English from 1 January 2000 to 23 May 2020 describing the health risk, mental health and/or well-being of UK ambulance services staff including retired staff, volunteers and students. MEDLINE, EMBASE, PsychINFO, CINAHL and AMED databases, plus EThOS, Zetoc, OpenGrey and Google, were searched, alongside hand-searching of grey literature and bibliographies. Information was extracted on study aims, sample, design and methodology, funding source, country and key findings. Included studies were categorised into seven a priori theme areas. RESULTS: Of 1862 identified articles, 45 peer-reviewed studies are included as well as 24 grey literature documents. Peer-reviewed research was largely observational and focused on prevalence studies, post-traumatic stress disorder or organisational and individual social factors related to health and well-being. Most grey literature reported the development and testing of interventions. Across all study types, underpinning theory was often not cited. CONCLUSION: To date, intervention research has largely been funded by charities and published in the grey literature. Few studies were identified on self-harm, bullying, sleep and fatigue or alcohol and substance use. Theoretically informed intervention development and testing, including adaptation of innovations from other countries and 24-hour workforces, is needed. This evidence map provides important context for planning of staff well-being provision and research as the sector responds to and recovers from the pandemic. PROSPERO REGISTRATION NUMBER: CRD42018104659.

Call volume, triage outcomes, and protocols during the first wave of the COVID-19 pandemic in the United Kingdom: Results of a national survey.

OBJECTIVES: During the first wave of the COVID-19 pandemic in the United Kingdom (UK), to describe volume and pattern of calls to emergency ambulance services, proportion of calls where an ambulance was dispatched, proportion conveyed to hospital, and features of triage used. METHODS: Semistructured electronic survey of all UK ambulance services (n = 13) and a request for routine service data on weekly call volumes for 22 weeks (February 1-July 3, 2020). Questionnaires and data request were emailed to chief executives and research leads followed by email and telephone reminders. The routine data were analyzed using descriptive statistics, and questionnaire data using thematic analysis. RESULTS: Completed questionnaires were received from 12 services. Call volume varied widely between services, with a UK peak at week 7 at 13.1% above baseline (service range -0.5% to +31.4%). All services ended the study period with a lower call volume than at baseline (service range -3.7% to -25.5%). Suspected COVID-19 calls across the UK totaled 604,146 (13.5% of all calls), with wide variation between services (service range 3.7% to 25.7%), and in service peaks of 11.4% to 44.5%. Ambulances were dispatched to 478,638 (79.2%) of these calls (service range 59.0% to 100.0%), with 262,547 (43.5%) resulting in conveyance to hospital (service range 32.0% to 53.9%). Triage models varied between services and over time. Two primary call triage systems were in use across the UK. There were a large number of products and arrangements used for secondary triage, with services using paramedics, nurses, and doctors to support decision making in the call center and on scene. Frequent changes to triage processes took place. CONCLUSIONS: Call volumes were highly variable. Case mix and workload changed significantly as COVID-19 calls displaced other calls. Triage models and prehospital outcomes varied between services. We urgently need to understand safety and effectiveness of triage models to inform care during further waves and pandemics.

Mobile Stroke Unit in the UK Healthcare System: Avoidance of Unnecessary Accident and Emergency Admissions.

BACKGROUND: Acute stroke patients are usually transported to the nearest hospital regardless of their required level of care. This can lead to increased pressure on emergency departments and treatment delay. OBJECTIVE: The aim of the study was to explore the benefit of a mobile stroke unit (MSU) in the UK National Health Service (NHS) for reduction of hospital admissions. METHODS: Prospective cohort audit observation with dispatch of the MSU in the East of England Ambulance Service area in Southend-on-Sea was conducted. Emergency patients categorized as code stroke and headache were included from June 5, 2018, to December 18, 2018. Rate of avoided admission to the accident and emergency (A&E) department, rate of admission directly to target ward, and stroke management metrics were assessed. RESULTS: In 116 MSU-treated patients, the following diagnoses were made: acute stroke, n = 33 (28.4%); transient ischaemic attacks, n = 13 (11.2%); stroke mimics, n = 32 (27.6%); and other conditions, n = 38 (32.8%). Pre-hospital thrombolysis was administered to 8 of 28 (28.6%) ischaemic stroke patients. Pre-hospital diagnosis avoided hospital admission for 29 (25.0%) patients. As hospital treatment was indicated, 35 (30.2%) patients were directly triaged to the stroke unit, 1 patient (0.9%) even directly to the catheter laboratory. Thus, only 50 (43.1%) patients required transfer to the A&E department. Moreover, the MSU enabled thrombolysis with a median dispatch-to-needle time of 42 min (interquartile range, 40-60). CONCLUSION: This first deployment of an MSU in the UK NHS demonstrated improved triage decision-making for or against hospital admission and admission to the appropriate target ward, thereby reducing pressure on strained A&E departments.

A qualitative study on conveyance decision-making during emergency call outs to people with dementia: the HOMEWARD project.

BACKGROUND: Paramedics are increasingly required to make complex decisions as to whether they should convey a patient to hospital or manage their condition at the scene. Dementia can be a significant barrier to the assessment process. However, to our knowledge no research has specifically examined the process of decision-making by paramedics in relation to people with dementia. This qualitative study was designed to investigate the factors influencing the decision-making process during Emergency Medical Services (EMS) calls to older people with dementia who did not require immediate clinical treatment. METHODS: This qualitative study used a combination of observation, interview and document analysis to investigate the factors influencing the decision-making process during EMS calls to older people with dementia. A researcher worked alongside paramedics in the capacity of observer and recruited eligible patients to participate in case studies. Data were collected from observation notes of decision-making during the incident, patient care records and post incident interviews with participants, and analysed thematically. FINDINGS: Four main themes emerged from the data concerning the way that paramedics make conveyance decisions when called to people with dementia: 1) Physical condition; the key factor influencing paramedics' decision-making was the physical condition of the patient. 2) Cognitive capacity; most of the participants preferred not to remove patients with a diagnosis of dementia from surroundings familiar to them, unless they deemed it absolutely essential. 3) Patient circumstances; this included the patient's medical history and the support available to them. 4) Professional influences; participants also drew on other perspectives, such as advice from colleagues or information from the patient's General Practitioner, to inform their decision-making. CONCLUSION: The preference for avoiding unnecessary conveyance for patients with dementia, combined with difficulties in obtaining an accurate patient medical history and assessment, mean that decision-making can be particularly problematic for paramedics. Further research is needed to find reliable ways of assessing patients and accessing information to support conveyance decisions for EMS calls to people with dementia.

What are emergency ambulance services doing to meet the needs of people who call frequently? A national survey of current practice in the United Kingdom.

BACKGROUND: Emergency 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. Our objectives were to describe: service-wide and local policies or pathways for people classified as Frequent Caller; call volume; and results of any audit or evaluation. METHOD: We 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. RESULTS: Twelve 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 General Practitioner (GP) with an aim of discouraging further calls, to case management through cross-service, multi-disciplinary team meetings aiming to resolve callers' needs. Although data were available related to volume of calls and number of callers meeting the threshold for definition as Frequent Caller, no formal audits or evaluations were reported. CONCLUSIONS: Ambulance 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. Multi-disciplinary case management approaches may help to provide appropriate care, and reduce demand on emergency services. However, there is currently inadequate evidence to inform commissioning, policy or practice development.

Patient and clinician factors associated with prehospital pain treatment and outcomes: cross sectional study.

OBJECTIVE: We aimed to identify how patient (age, sex, condition) and paramedic factors (sex, role) affected prehospital analgesic administration and pain alleviation. METHODS: We used a cross-sectional design with a 7-day retrospective sample of adults aged 18 years or over requiring primary emergency transport to hospital, excluding patients with Glasgow Coma Scale below 13, in two UK ambulance services. Multivariate multilevel regression using Stata 14 analysed factors independently associated with analgesic administration and a clinically meaningful reduction in pain (≥2 points on 0-10 numerical verbal pain score [NVPS]). RESULTS: We included data on 9574 patients. At least two pain scores were recorded in 4773 (49.9%) patients. For all models fitted there was no significant relationship between analgesic administration or pain reduction and sex of the patient or ambulance staff. Reduction in pain (NVPS ≥2) was associated with ambulance crews including at least one paramedic (odds ratio [OR] 1.52, 95% confidence interval [CI] 1.14 to 2.04, p < 0.01), with any recorded pain score and suspected cardiac pain (OR 2.2, 95% CI 1.02 to 4.75). Intravenous morphine administration was also more likely where crews included a paramedic (OR 2.82, 95% CI 1.93 to 4.13, P < 0.01), attending patients aged 51 to 64 years (OR 2.04, 95% CI 1.21 to 3.45, p = 0.01), in moderate to severe (NVPS 4-10) compared with lower levels of pain for any clinical condition group compared with the reference condition. CONCLUSION: There was no association between patient sex or ambulance staff sex or grade and analgesic administration or pain reduction.

How do people with dementia use the ambulance service? A retrospective study in England: the HOMEWARD project.

OBJECTIVES: An increasing number of older people are calling ambulances and presenting to accident and emergency departments. The presence of comorbidities and dementia can make managing these patients more challenging and hospital admission more likely, resulting in poorer outcomes for patients. However, we do not know how many of these patients are conveyed to hospital by ambulance. This study aims to determine: how often ambulances are called to older people; how often comorbidities including dementia are recorded; the reason for the call; provisional diagnosis; the amount of time ambulance clinicians spend on scene; the frequency with which these patients are transported to hospital. METHODS: We conducted a retrospective cross-sectional study of ambulance patient care records (PCRs) from calls to patients aged 65 years and over. Data were collected from two ambulance services in England during 24 or 48 hours periods in January 2017 and July 2017. The records were examined by two researchers using a standard template and the data were extracted from 3037 PCRs using a coding structure. RESULTS: Results were reported as percentages and means with 95% CIs. Dementia was recorded in 421 (13.9%) of PCRs. Patients with dementia were significantly less likely to be conveyed to hospital following an emergency call than those without dementia. The call cycle times were similar for patients regardless of whether or not they had dementia. Calls to people with dementia were more likely to be due to injury following a fall. In the overall sample, one or more comorbidities were reported on the PCR in over 80% of cases. CONCLUSION: Rates of hospital conveyance for older people may be related to comorbidities, frailty and complex needs, rather than dementia. Further research is needed to understand the way in which ambulance clinicians make conveyance decisions at scene.

Implementation and use of computerised clinical decision support (CCDS) in emergency pre-hospital care: a qualitative study of paramedic views and experience using Strong Structuration Theory.

BACKGROUND: Computerised clinical decision support (CCDS) has been shown to improve processes of care in some healthcare settings, but there is little evidence related to its use or effects in pre-hospital emergency care. CCDS in this setting aligns with policies to increase IT use in ambulance care, enhance paramedic decision-making skills, reduce avoidable emergency department attendances and improve quality of care and patient experience. This qualitative study was conducted alongside a cluster randomised trial in two ambulance services of the costs and effects of web-based CCDS system designed to support paramedic decision-making in the care of older people following a fall. Paramedics were trained to enter observations and history for relevant patients on a tablet, and the CCDS then generated a recommended course of action which could be logged. Our aim was to describe paramedics' experience of the CCDS intervention and to identify factors affecting its implementation and use. METHODS: We invited all paramedics who had been randomly allocated to the intervention arm of the trial to participate in interviews or focus groups. The study was underpinned by Strong Structuration Theory, a theoretical model for studying innovation based on the relationship between what people do and their context. We used the Framework approach to data analysis. RESULTS: Twenty out of 22 paramedics agreed to participate. We developed a model of paramedic experience of CCDS with three domains: context, adoption and use, and outcomes. Aspects of context which had an impact included organisational culture and perceived support for non-conveyance decisions. Experience of adoption and use of the CCDS varied between individual paramedics, with some using it with all eligible patients, some only with patients they thought were 'suitable' and some never using it. A range of outcomes were reported, some of which were different from the intended role of the technology in decision support. CONCLUSION: Implementation of new technology such as CCDS is not a one-off event, but an ongoing process, which requires support at the organisational level to be effective. TRIAL REGISTRATION: ISRCTN Registry 10538608 . Registered 1 May 2007. Retrospectively registered.

Prehospital recognition and antibiotics for 999 patients with sepsis: protocol for a feasibility study.

BACKGROUND: Sepsis is a common condition which kills between 36,000 and 64,000 people every year in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve the health and well-being of people with sepsis. Paramedics frequently come into contact with patients with sepsis and are well placed to provide early diagnosis and treatment.We aim to determine the feasibility of undertaking a fully powered randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics obtaining blood cultures from and administering IV antibiotics to patients with sepsis, so we can make a decision about whether to proceed to a fully powered randomised controlled trial, which will answer questions regarding safety and effectiveness for patients and benefit to the National Health Service (NHS). METHODS/DESIGN: This is an individually randomised, two-arm feasibility study for a randomised controlled trial with a 1:1 ratio. Sixty paramedics will receive training to assist them to recognise sepsis using a screening tool, obtain blood cultures, and provide IV antibiotics. If sepsis is suspected, paramedics will randomly allocate patients to intervention or usual care using their next sequential individually issued scratch card. Patients will be followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We will also collect self-reported health-related quality of life (using SF-12) at this time. We will interview ten patients by telephone and hold a focus group with paramedics, to find out what they think about the intervention. DISCUSSION: At the end of this study, we will make a recommendation about whether a full randomised controlled trial of paramedics obtaining blood cultures and administering IV antibiotics for sepsis is warranted, and if so, we will develop a proposal for research funding in order to take the work forward. TRIAL REGISTRATION: ISRCTN, ISRCTN36856873.

Expedited Programs for Serious Conditions: An Update on Breakthrough Therapy Designation.

PURPOSE: Our aim was to describe the regulatory pathways made available by the US Food and Drug Administration (FDA) to expedite the drug development and approval process, with a focus on the benefits and limitations of the Breakthrough Therapy Designation (BTD) pathway. METHODS: Published materials consisting of journal articles, press releases, government documents, and news articles from pharmaceutical publishers were identified through online databases (ie, Medline and Scopus), the FDA website, and Internet search engines (eg, Google). FINDINGS: To encourage pharmaceutical innovation and increase the number of products being approved each year, the FDA has introduced 4 expedited regulatory pathways to accelerate the drug development and approval process. The most recent program, enacted in July 2012, was BTD that is given to drugs that treat a serious or life-threatening disease or condition; and preliminary clinical evidence suggests the potential for these drugs to provide a substantial improvement over the current standard of care. The primary basis for the creation of BTD is to provide patients with serious conditions with earlier access to FDA-approved medications. In 2014, 22% of the new molecular entities approved within the Center for Drug Evaluation and Research had BTD status, as opposed to only 11% in 2013, which indicates both the popularity and success of this expedited pathway. Additionally, the creation of BTD has produced a more collaborative working relationship between the pharmaceutical industry and the FDA because both parties have a vested interest in the drug's success. Some of the more notable concerns surrounding these approved breakthrough therapies have been the abbreviated tolerability and efficacy evidence available from accelerated clinical development programs, ensuring the manufacturing aspects keep pace with these accelerated clinical programs, and finally, managing the strain on resources for both the pharmaceutical companies and the FDA. IMPLICATIONS: BTD has already had many positive and negative impacts on various stakeholders, including sponsors, investors, regulatory agencies, third-party payors, and patients. The ultimate goal of the BTD program is to identify promising drug candidates early in the clinical development timeline, expedite the development and review processes via intensive guidance from the FDA, and provide patients access to approved therapies as quickly as possible. With the first few batches of BTD product approvals, the FDA and other stakeholders have been working collaboratively to address the various expected and unexpected challenges that have arisen during the BTD process in order to refine and improve this already successful program.