AimWe aimed to achieve consensus among NHS and community stakeholders to identify and prioritise innovations in Community First Responder (CFR) schemes.MethodsWe conducted a mixed-methods study, adopting a modified nominal group technique with participants from ambulance services, CFR schemes and community stakeholders. The 1-day consensus workshop consisted of four sessions: introduction of innovations derived from primary research; round-robin discussions to generate new ideas; discussion and ranking of innovations; feedback of ranking, re-ranking and concluding statements. Innovations were ranked on a 5-point Likert scale and descriptive statistics of median and interquartile range calculated. Discussions were recorded, transcribed, and analysed thematically.ResultsThe innovations found were classified into two categories: process innovations and technological innovations. The process innovations included six types of innovations: roles, governance, training, policies and protocols, recruitment, and awareness. The technological innovations included three aspects: information and communication; transport; and health technology. The descriptive statistics revealed that innovations such as counselling and support for CFRs (median: 5 IQR 5,5), peer support [5 (4,5)], and enhanced communication with control room [5 (4,5)] were essential priorities. Contrastingly, innovations such as the provision of dual CFR crew [1.5 (1,3)], CFR responsibilities in patient transport to hospital [1 (1,2)], and CFR access to emergency blue light [1 (1,1.5)] were deemed non-priorities.ConclusionsThis article established consensus on innovations in the CFR schemes and their ranking for improving the provision of care delivered by CFRs in communities. The consensus-building process also informed policy- and decision-makers on the potential future change agenda for CFR schemes.

Background:Community First Responders are trained volunteers dispatched by ambulance services to potentially life-threatening emergencies such as cardiac arrest in the first vital minutes to provide care until highly skilled ambulance staff arrive. Community First Responder schemes were first introduced to support ambulance services in rural communities, where access to prehospital emergency care is more likely to be delayed. Evidence is lacking on their contribution to rural healthcare provision, how care is provided and how this might be improved. Objectives:We aimed to describe Community First Responder activities, organisation, costs of provision and outcomes of care together with perceptions and views of patients, public, Community First Responders, ambulance service staff and commissioners of their current and future role including innovations in the rural health and care workforce. Design:We used a mixed-methods design, using a lens of pragmatism and the 'actor', 'behaviour change' and 'causal pathway' framework to integrate quantitative routine and qualitative (policy, guideline and protocol documents with stakeholder interview) data from 6 of 10 English ambulance services. We identified potential innovations in Community First Responder provision and prioritised these using a modified nominal group technique. Patients and public were involved throughout the study. Results:In 4.5 million incidents from six English regional ambulance services during 2019, pre COVID-19 pandemic, Community First Responders attended first a higher proportion of calls in rural areas (almost 4% of calls) than in urban areas (around 1.5%). They were significantly more likely to be called out to rural (vs. urban) areas and to attend older (vs. younger), white (vs. minority ethnic) people in more affluent (vs. deprived) areas with cardiorespiratory and neurological (vs. other emergency) conditions for higher-priority emergency or urgent (category 1 and 2 compared with category 3, 4 or 5) calls but did also attend lower-category calls for conditions such as falls. We examined 10 documents from seven ambulance services. Ambulance policies and protocols integrated Community First Responders into ambulance service structures to achieve the safe and effective operation of volunteers. Costs, mainly for training, equipment and support, varied widely but were not always clearly delineated. Community First Responders enabled a faster prehospital response time. There was no clear benefit in out-of-hospital cardiac arrest outcomes. A specific Community First Responder falls response reduced ambulance attendances and was potentially cost saving. We conducted semistructured interviews with 47 different stakeholders engaged in Community First Responder functions. This showed the trajectory of becoming a Community First Responder, the Community First Responder role, governance and practice, and the positive views of Community First Responders from stakeholders despite public lack of understanding of their role. Community First Responders' scope of practice varied between ambulance services and had developed into new areas. Innovations prioritised at the consensus workshop were changes in processes and structures and an expanded scope of practice supported by training, which included counselling, peer support, better communication with the control room, navigation and communication technology, and specific mandatory and standardised training for Community First Responders. Limitations:Missing data and small numbers of interviews in some stakeholder groups (patients, commissioners) are sources of bias. Future research:Future research should include a robust evaluation of innovations involving Community First Responders. Trial registration:This trial is registered as ClinicalTrials.gov, NCT04279262. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR127920) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 18. See the NIHR Funding and Awards website for further award information.

Background Falls involve around 13% of 999 Emergency Medical Service (EMS) attendances in the East Midlands, UK. The Falls Response Partnership (FRP) between LIVES, Lincolnshire and East Midlands Ambulance Service (EMAS) was commissioned to provide a safe response using vehicles fitted with mobile lifting equipment to adult patients who fall and staffed by two Community First Responders (CFRs) from LIVES. A model-based economic evaluation of the FRP over the pilot period of December 2018-June 2019 reported improvements in effectiveness and cost-effectiveness of FRP versus standard care linked inversely to the ambulance back up rate following FRP attendance. The FRP was recommissioned in February 2020, where 3 vehicles operated 8 am-8 pm daily throughout areas of Lincolnshire, urban and rural. We aimed to examine the operation of the recommissioned FRP against the benchmarks established in the pilot. Methods Descriptive statistics were applied to routine data collected, and linked, from EMAS and LIVES over the period April 2020-December 2021. Information included incident location, timing of response and treatment, ambulance backup, and conveyance. Results Overall, the recommissioned FRP service attended 2090 incidents. Most (1,793, 85.8%) were falls in urban (57.2%) and rural (42.8%) areas, the remainder were non-protocol attendances at non-fall emergencies and life-threatening episode falls. 1,517 falls patients were treated per FRP protocol, an average work rate of 24.1 patients per month per CFR team. Of these, the ambulance backup rate was 51.9% (split 60.2% urban, 39.8% rural). Where backup was sent, 75.4% of patients were conveyed to hospital. Model projections set to 51.9% backup rate suggest that the recommissioned FRP has become cost saving to the National Health Services (NHS). Including benefit arising from auxiliary use only serves to add further value to the NHS. Conclusion The recommissioned CFR falls response service was potentially cost saving to the NHS. A CFR falls scheme responding to people who had fallen at home, led to fewer ambulances attending and likely financial savings. They were distributed in both rural and urban areas to different extents across different service regions. Costs of providing CFR schemes were incompletely recorded and reported by ambulance services but reported figures varied considerably, around 20-fold from £40,000 to over £800,000 per year, between ambulance services so true costs, may have been even higher. Costs reported were attributed to staff providing management and training, together with reimbursement of out-of-pocket costs of volunteering including fuel and vehicle use. Smith et al (2020) report on a model-based economic evaluation in which when patient circumstances dictate that ambulance backup is required, in particular, estimates of the average intervention cost are £195 without backup, but £440 when backup is required. The recommissioned CFR falls response service had the potential to save costs for the NHS. The implementation of a CFR falls scheme, resulted in a decrease in ambulance usage and likely led to financial savings. These schemes were implemented to varying extents in both rural and urban areas across different service regions. However, the costs associated with providing CFR schemes were not consistently recorded or reported by ambulance services. The reported figures varied significantly, ranging from £40,000 to over £800,000 per year, among different ambulance services. Therefore, the true costs may have been even higher. The reported costs included expenses related to staff management and training, as well as reimbursement for out-of-pocket costs incurred by volunteers, such as fuel and vehicle use. According to a study by Smith et al. (2020), a model-based economic evaluation indicated that when patient circumstances necessitate ambulance backup, the estimated average intervention cost is £195 without backup, but increases to £440 when backup is required.

STUDY OBJECTIVE:We aimed to investigate community first responders' contribution to emergency care provision in terms of number, rate, type, and location of calls and characteristics of patients attended.METHODS:We used a retrospective observational design analyzing routine data from electronic clinical records from 6 of 10 ambulance services in the United Kingdom during 2019. Descriptive statistics, including numbers and frequencies, were used to illustrate characteristics of incidents and patients that the community first responders attended first in both rural and urban areas.RESULTS:The data included 4.5 million incidents during 1 year. The community first responders first attended a higher proportion of calls in rural areas compared with those in urban areas (3.90% versus 1.48 %). In rural areas, the community first responders also first attended a higher percentage of the most urgent call categories, 1 and 2. The community first responders first attended more than 9% of the total number of category 1 calls and almost 5% of category 2 calls. The community first responders also attended a higher percentage of the total number of cardiorespiratory and neurological/endocrine conditions. They first attended 6.5% of the total number of neurological/endocrine conditions and 5.9% of the total number of cardiorespiratory conditions. Regarding arrival times in rural areas, the community first responders attended higher percentages (more than 6%) of the total number of calls that had arrival times of less than 7 minutes or more than 60 minutes.CONCLUSION:In the United Kingdom, community first responders contribute to the delivery of emergency medical services, particularly in rural areas and especially for more urgent calls. The work of community first responders has expanded from their original purpose-to attend to out-of-hospital cardiac arrests. The future development of community first responders' schemes should prioritize training for a range of conditions, and further research is needed to explore the contribution and potential future role of the community first responders from the perspective of service users, community first responders' schemes, ambulance services, and commissioners.

"'Hypos' can strike twice" (HS2) is a pragmatic, leaflet-based referral intervention designed for administration by clinicians of the emergency medical services (EMS) to people they have attended and successfully treated for hypoglycaemia. Its main purpose is to encourage the recipient to engage with their general practitioner or diabetic nurse in order that improvements in medical management of their diabetes may be made, thereby reducing their risk of recurrent hypoglycaemia. Herein we build a de novo economic model for purposes of incremental analyses to compare, in 2018-19 prices, HS2 against standard care for recurrent hypoglycaemia in the fortnight following the initial attack from the perspective of the UK National Health Service (NHS). We found that per patient NHS costs incurred by people receiving the HS2 intervention over the fortnight following an initial hypoglycaemia average £49.79, and under standard care costs average £40.50. Target patient benefit assessed over that same period finds the probability of no recurrence of hypoglycaemia averaging 42.4% under HS2 and 39.4% under standard care, a 7.6% reduction in relative risk. We find that implementing HS2 will cost the NHS an additional £309.36 per episode of recurrent hypoglycaemia avoided. Contrary to the favourable support offered in Botan et al., we conclude that in its current form the HS2 intervention is not a cost-effective use of NHS resources when compared to standard NHS care in reducing the risk of hypoglycaemia recurring within a fortnight of an initial attack that was resolved at-scene by EMS ambulance clinicians.

AimTo model optimum proportions of dual-crewed ambulances (DCAs) and rapid-response vehicles (RRVs) in Ambulance Trusts with a view to generating a policy brief for one Ambulance Trust and a modelling tool for other Trusts on the strategic procurement and allocation of emergency vehicle (EV) resources. MethodsHistorical EV assignments for 12 months of emergency calls in 2019 were provided by an NHS Ambulance Trust and analysed for backup, see and treat, and patient to hospital conveyance. Unit costs were derived for paramedics and technicians using Agenda for Change pay rates. Time cycles were assigned for RRV and DCA attendances and unit costs assigned to these. Information was put into a decision analytical model to estimate the costs and numbers of vehicles attending incidents based on relative proportions of available RRVs and DCAs. ResultsOf 711 992 calls attended by 837 107 EVs, 514 766 (72.3%) required at least one emergency department conveyance. The rate of conveyance was significantly lower when RRVs arrived first on the scene. 27 883 out of 529 693 (5.3%) DCAs first arriving at an incident required some backup, and this was also factored into the model. Modelling demonstrated high conveyance rates were counterproductive when increasing the relative proportions of RRVs to DCAs. For example, with conveyance rates of 65%, increasing the RRVs increased the cost and numbers of vehicles attending per incident. At lower conveyance rates, however, there was a levelling around 30% where it could become cost-effective to increase the relative proportions of RRVs to DCAs. ConclusionAt current overall conveyance rates, there is no benefit in increasing the relative proportions of RRVs to DCAs unless additional benefits can be realised that bring the conveyance rates down.

BACKGROUND:Community First Responder (CFR) schemes are a long-established service supplementing ambulance trusts in their local community in the United Kingdom. CFRs are community members who volunteer to respond to people with life-threatening conditions. Previous studies highlighted the motivations for becoming CFRs, their training, community (un)awareness and implications of their work on themselves and others. The practices of CFRs in prehospital care remain underexplored. Therefore, we aimed to explore real-world practice of Community First Responders and their contribution to prehospital emergency care.METHODS:We conducted 47 interviews with CFRs (21), CFR leads (15), ambulance clinicians (4), commissioners (2) and patients and relatives (5) from six ambulance services and regions of England, United Kingdom. Thematic analysis enabled identification of themes and subthemes, with subsequent interpretation built on the theory of practice wisdom.RESULTS:Our analysis revealed the embeddedness of the concept of doing the right thing at the right time in CFR practice. CFRs' work consisted of a series of sequential and interconnected activities which included: identifying patients' signs, symptoms and problems; information sharing with the ambulance control room on the patient's condition; providing a rapid emergency response including assessment and care; and engaging with ambulance clinicians for patient transfer. The patient care sequence began with recognising patients' signs and symptoms, and validation of patient information provided by the ambulance control room. The CFRs shared patient information with ambulance control who in turn notified the ambulance crew en-route. The practices of CFRs also included delivery of emergency care before ambulance clinicians arrived. Following the delivery of a rapid emergency response, CFRs engaged with the ambulance crew to facilitate patient transfer to the nearest medical facility.CONCLUSION:The sequential CFR practices supported ambulance services in delivering prehospital and emergency care in rural areas. CFR practices were founded on the principle of practice wisdom where CFRs constructed their practice decisions based on the patient's condition, their training, availability of equipment and medications and their scope of practice.

Background Community First Responder (CFR) schemes provide important and growing contributions to the Emergency Medical Services response, particularly in rural areas. Ambulance services have sought to improve the function of CFRs through various innovations, but these remain under-studied. This consensus study aimed to identify and prioritise innovations in CFR schemes. Methods A modified-nominal group technique was adopted recruiting participants from regional and national stakeholders and a patient and public involvement panel. The consensus workshop consisted of four hybrid (face-to-face and online) sessions on one day: introduction and research findings; round-robin introduction of additional innovations; discussion and ranking; and concluding statement. Participants identified innovations and scored them on a 5-point Likert scale. Discussions were recorded, transcribed, and thematically analysed. The findings of the survey were analysed using descriptive statistics. Results The meeting included 17 participants from across England including patient contributors, ambulance leads, commissioners and research staff. Innovations were classified into two broad categories: process innovations and technological innovations. Process innovations included six categories: roles, governance, training, policies and protocols, recruitment, and awareness. There were three categories of technological innovations: information and communication technology, transport technology, and health technology. Ranking of innovations was done independently with an online survey using a 1-5 scale showed that counselling and support for CFRs (median: 5 IQR: 5,5), peer support [5 (4,5)], and enhanced communication with the control room [5 (4,5)] were essential priorities. In contrast, innovations such as the provision of dual CFR crew [1.5 (1,3)], CFR responsibilities in patient transport to hospital [1 (1,2)], and CFR access to emergency blue light [1 (1,1.5)] were not deemed priorities. Conclusions This study established consensus on innovations in the CFR schemes and their ranking for improving the functions of CFR schemes. The consensus exercise also informed policy- and decision- makers on the potential future change agenda.

AIM:To measure the cost-effectiveness of adding text message (TMB), exercise (EB) and abstinent-contingent financial incentive-based (CFIB) stop smoking interventions to standard smoking cessation support for pregnant women in England.DESIGN:Modelling cost-effectiveness outcomes by separately adding three cessation interventions to standard cessation care offered to pregnant women in England. English National Health Service Stop Smoking Services (NHS SSS) statistics from 2019 to 2020 were used for estimating the base quit rate. Intervention effectiveness and cost data for interventions were taken from trial reports. Cost-effectiveness was derived using the economics of smoking in pregnancy (ESIP) model from a health service and personal social services perspective. Interventions were compared with each other as well as against standard cessation care.SETTING:English NHS SSS.PARTICIPANTS/CASES:A total of 13 799 pregnant women who accessed NHS SSS. Interventions and comparator; comparator: standard stop smoking support comprising behavioural intervention and an offer of nicotine replacement therapy (NRT). Three additive interventions were TMB, EB and CFIB.MEASUREMENTS:Incremental cost-effectiveness ratios per quality-adjusted life-years gained for both mothers and offspring over their life-times; return on investment (ROI); and cost-effectiveness acceptability curves (CEACs).FINDINGS:The addition of any of the interventions compared with standard care alone was preferred, but only significant for the addition of CFIB, with the CEAC suggesting an at least 90% chance of being favoured to standard care alone. When compared against each other CFIB appeared to yield the largest returns, but this was not significant. The estimated ROI for CFIB was £2 [95% confidence interval (CI) = £1-3] in health-care savings for every £1 spent by the NHS on the cessation intervention.CONCLUSIONS:For a health system which currently provides behavioural support and an offer of nicotine replacement therapy as standard stop smoking support for pregnant women, the greatest economic gains would be provided by operating an abstinent-contingent financial incentives scheme alongside this.

Background We aimed to investigate clinical benefits and economic costs of inhaled methoxyflurane when used by ambulance staff for prehospital emergency patients with trauma. Comparison is to usual analgesic practice (UAP) in the UK in which patient records were selected if treatment had been with Entonox® or intravenous morphine or intravenous paracetamol. Methods Over a 12-month evaluation period, verbal numerical pain scores (VNPS) were gathered from adults with moderate to severe trauma pain attended by ambulance staff trained in administering and supplied with methoxyflurane. Control VNPS were obtained from ambulance database records of UAP in similar patients for the same period. Statistical modelling enabled comparisons of methoxyflurane to UAP, where we employed an Ordered Probit panel regression model for pain, linked by observational rules to VNPS. Results Overall, 96 trained paramedics and technicians from the East Midlands Ambulance Service NHS Trust (EMAS) prepared 510 doses of methoxyflurane for administration to a total of 483 patients. Comparison data extracted from the EMAS database of UAP episodes involved: 753 patients using Entonox®, 802 patients using intravenous morphine, and 278 patients using intravenous paracetamol. Modelling results included demonstration of faster pain relief with inhaled methoxyflurane (all p-values < 0.001). Methoxyflurane’s time to achieve maximum pain relief was estimated to be significantly shorter: 26.4 min (95%CI 25.0–27.8) versus Entonox® 44.4 min (95%CI 39.5–49.3); 26.5 min (95%CI 25.0–27.9) versus intravenous morphine 41.8 min (95%CI 38.9–44.7); 26.5 min (95%CI 25.1–28.0) versus intravenous paracetamol 40.8 (95%CI 34.7–46.9). Scenario analyses showed that durations spent in severe pain were significantly less for methoxyflurane. Costing scenarios showed the added benefits of methoxyflurane were achieved at higher cost, eg versus Entonox® the additional cost per treated patient was estimated to be £12.30. Conclusion When administered to adults with moderate or severe pain due to trauma inhaled methoxyflurane reduced pain more rapidly and to a greater extent than Entonox® and parenteral analgesics. Inclusion of inhaled methoxyflurane to the suite of prehospital analgesics provides a clinically useful addition, but one that is costlier per treated patient.

Introduction Helicobacter pylori (H. pylori) may be pivotal in the pathogenesis of upper gastrointestinal (UGI) ulcer bleeding from aspirin therapy. The Helicobacter Eradication Aspirin Trial (HEAT) investigated whether H. pylori eradication reduces the risk of UGI ulcer bleeding in aspirin users. Methods HEAT was conducted using novel real-world methodology developed by the Simple Trials for Academic Research (STAR) group. Participants aged over 60 and taking aspirin ≤325mg daily for at least 4 months were recruited from primary care between 2012 and 2017. H. pylori positive participants were randomised to receive 7 days of eradication treatment (lansoprazole 30mg bd, clarithromycin 500mg bd and metronidazole 400mg bd) or matching placebos. Recruitment was managed using a bespoke web-based database that communicated directly with a programmed search tool downloaded at participating practices. It identified all suitable patients and automatically sent trial information and an invitation to participate. Effectiveness of H. pylori eradication was evaluated in a prospectively selected 10% sample by end of trial breath testing. Electronic follow up identified events in Hospital Episodes Statistics (HES), GP databases and patient reports. All episodes mentioning GI bleeding or peptic ulcer were evaluated by a blinded adjudication committee. The primary endpoint was a first hospitalisation due to definite or probable peptic ulcer bleeding, analysed using a Cox proportional hazards model. Data are still blinded and presented as Group A and B. Results In total, 1,208 GP practices across the UK sent 188,875 invitation letters; 30,166 patients were consented to the trial, of whom 5,353 H. pylori positive participants (17.8%) were randomised. Mean age at consent was 73.6 ± 7.0 (SD) years and 72.1% of participants were male. In the 10% retest subjects 90.7% had become H. pylori negative in Group A vs 24.3% in Group B. The rate of presentation of UGI ulcer bleeding varied significantly by time. The rate of presentation varied significantly by time. Events occurred most frequently in the first 2–3 years of follow up in Group B when there appeared to be a significant difference between the groups. Fully analysed data will be available for presentation to the meeting Conclusions Very large-scale real-world trials of clinical importance, such as H. pylori eradication in aspirin users can be successfully conducted in primary care using STAR methodology.

BackgroundCommunity First Responders (CFRs) are volunteers dispatched by Emergency Medical Services (EMS) to potentially life-threatening emergencies to provide care until the ambulance staff arrive. Previous qualitative research described CFRs’ role, perceptions, and motivations, but quantitative evidence on their contribution to rural healthcare provision is lacking. We aimed to investigate the number, types, and location of calls (rural or urban), and characteristics of patients attended.MethodsWe used a retrospective observational design analysing routine data from six of ten ambulance services in England during 2019. Descriptive statistics were used to directly compare incidents where CFRs attended first with attendances from ambulance staff. A multiple logistic regression model was used to identify the main predictors of CFR attendance.ResultsThe data included 4.5 million incidents over one year. CFRs attended first a significantly higher proportion of calls in rural areas compared to urban areas (3.90% vs 1.48%, p<0.05). The main predictors of CFR presence were rurality (Odds Ratio [OR] 2.05, 95% Confidence Interval [CI] 1.99-2.11, p<0.001), conditions including cardiorespiratory (OR 9.20, 95%CI 5.08-16.64, p<0.001) or neurological/endocrine (OR 9.26, 95%CI 5.12-16.77, p<0.001) and the most urgent call category 1 (OR 5.19, 95%CI 3.86-6.99, p<0.001) and call category 2 (OR 4.44, 95%CI 3.31-5.96 p<0.001). CFRs were also less likely to attend patients from minority ethnic backgrounds, those younger than 39 years, and incidents in more deprived areas.ConclusionsCFRs play an important role in EMS delivery, supporting the work of ambulance services, especially in rural areas. The work of CFRs has expanded from its original purpose to attend out-of-hospital cardiac arrest to more types of emergencies. Future development of CFR schemes should prioritise training for a range of conditions, and access to more deprived and ethnically diverse areas.

BackgroundHypoglycaemia is a potentially serious condition, characterised by lower-than-normal blood glucose levels, common in people with diabetes (PWD). It can be prevented and self-managed if expert support (e.g., education on lifestyle and treatment) is provided. Our aim was to conduct a process evaluation to investigate how ambulance staff and PWD perceived the ‘Hypos can strike twice’ booklet-based ambulance clinician intervention.MethodsWe used an explanatory sequential design with a self-administered questionnaire study followed by interviews of PWD and ambulance staff. We followed the Medical Research Council framework for process evaluations of complex interventions to guide data collection and analysis. Following descriptive analysis and exploratory factor analysis, multiple regression models were fitted to identify demographic predictors of overall and subscale scores.Results113 ambulance staff members and 46 PWD completed the survey. We conducted interviews with four ambulance staff members and five PWD who had been attended by an ambulance for a hypoglycaemic event. Overall, there were positive attitudes to the intervention from both ambulance staff and PWD. Although the intervention was not always implemented, most staff members and PWD found the booklet informative, easy to read and to use/explain. PWD who completed the survey reported that receiving the booklet reminded and/or encouraged them to test their blood glucose more often, adjust their diet, and have a chat/check up with their diabetes consultant. Interviewed PWD felt that the booklet intervention would be more valuable to less experienced patients or those who cannot manage their diabetes well. Participants felt that the intervention could be beneficial but were uncertain about whether it can prevent a second hypoglycaemic event and/or reduce the number of repeat ambulance attendances.ConclusionsThe ‘Hypos may strike twice’ intervention was found to be feasible, acceptable to PWD and staff, prompting reported behaviour change and help-seeking from primary care.

Abstract Background The Helicobacter Eradication Aspirin Trial (HEAT) is a multicentre, double blind, randomised controlled trial investigating whether Helicobacter (H.) pylori eradication reduces hospitalisation for peptic ulcer bleeding. Recruited participants were aged 60 and over and taking aspirin (≤325 mg daily) for at least four months prior to consent. Based on results of a pilot study, a sample size calculation predicted 6600 H. pylori-positive randomised participants would be required, from 33,000 volunteers, recruited from 170,000 invited patients. Methodology was therefore designed for recruitment of large numbers of patients from primary care using a novel electronic search tool, automated mail-out and electronic follow-up. Recruitment started in 2012 and completed in 2017. Methods All participants were recruited from GP practices, with assistance from the UK Clinical Research Network (UKCRN). H. pylori-positive participants were randomised to one week of eradication treatment or placebo. Recruitment was managed using a bespoke web-based database that communicated directly with a programmed search tool downloaded at participating practices. The primary endpoint is hospitalisation due to peptic ulcer bleeding. The trial will end when 87 adjudicated events have occurred, identified from searches of GP databases, review of secondary care admission data and mortality data, and reported events from randomised participants and GPs. Results HEAT has recruited participants from 1208 GP practices across the UK. Of the 188,875 invitation letters sent, 38,771 returned expressions of interest. Of these, 30,166 patients were consented to the trial, of whom 5355 H. pylori-positive participants (17.8% of those consented) were randomised. Mean age at consent was 73.1 ± 6.9 (SD) years and 72.2% of participants were male. Of the randomised (H. pylori-positive) participants, 531 have died (as of 17 Sep 2020); none of the deaths was due to trial treatment. Conclusion The HEAT trial methodology has demonstrated that recruitment of large numbers of patients from primary care is attainable, with the assistance of the UKCRN, and could be applied to other clinical outcomes studies. Trial registration ClinicalTrials.gov ; registration number NCT01506986 . Registered on 10 Jan 2012.

BackgroundCommunity first responders (CFRs) are volunteers delivering emergency medical assistance and maintaining a patient’s condition until an ambulance arrives. Previous research has highlighted the CFR role and relationships, motivations, practice and perceptions, and need for mental health support. However, factors influencing CFR practise in the field are a relatively underexplored area. We aimed to explore the factors embedded in CFR implementation processes that either facilitated or hindered CFRs’ activities and practice in the UK.MethodIn a qualitative study, we conducted interviews with CFRs and CFR leads, paramedics and ambulance clinicians, commissioners, patients and relatives across six English ambulance service regions. Thematic analysis, supported by NVivo, enabled the identification codes and themes.ResultOverall, 47 participants were interviewed including CFR leads (15), CFRs (21), ambulance staff (4), and commissioners (2) from six ambulance services with patients and relatives (5) from the same regions. The findings revealed multi-layered factors influencing effective CFR functioning at three levels, namely individual, institutional, and societal. CFRs’ local expertise helped them to navigate operational challenges. Use of a personal vehicle and navigation software aided CFRs’ ability to respond promptly. Continuing training improved CFRs’ skills. CFR functioning was facilitated by positive relationships with ambulance crews. Identification and recognition by patients were important and aided by wearing uniforms. Community support was a facilitator for CFR activities in rural areas. In contrast, limited communication in remote regions, long waits for an ambulance, and reliance on community donations impeded CFRs’ care function. Volunteer shortages and lack of access to a blue light while using trusts’ car hindered CFRs’ ability to respond quickly. Negative relationships with ambulance crews also hampered CFRs’ involvement.ConclusionThis study highlights factors associated with effective CFR functioning and the requirement for supportive institutional and societal contexts for CFRs to assist patients in medical emergencies.

BACKGROUND:Peptic ulcers in patients receiving aspirin are associated with Helicobacter pylori infection. We aimed to investigate whether H pylori eradication would protect against aspirin-associated ulcer bleeding. METHODS:We conducted a randomised, double-blind, placebo-controlled trial (Helicobacter Eradication Aspirin Trial [HEAT]) at 1208 primary care centres in the UK, using routinely collected clinical data. Eligible patients were aged 60 years or older who were receiving aspirin at a daily dose of 325 mg or less (with four or more 28-day prescriptions in the past year) and had a positive C13 urea breath test for H pylori at screening. Patients receiving ulcerogenic or gastroprotective medication were excluded. Participants were randomly assigned (1:1) to receive either a combination of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg (active eradication), or oral placebo (control), twice daily for 1 week. Participants, their general practitioners and health-care providers, and the research nurses, trial team, adjudication committee, and analysis team were all masked to group allocation throughout the trial. Follow-up was by scrutiny of electronic data in primary and secondary care. The primary outcome was time to hospitalisation or death due to definite or probable peptic ulcer bleeding, and was analysed by Cox proportional hazards methods in the intention-to-treat population. This trial is registered with EudraCT, 2011-003425-96. FINDINGS:Between Sept 14, 2012, and Nov 22, 2017, 30 166 patients had breath testing for H pylori, 5367 had a positive result, and 5352 were randomly assigned to receive active eradication (n=2677) or placebo (n=2675) and were followed up for a median of 5·0 years (IQR 3·9-6·4). Analysis of the primary outcome showed a significant departure from proportional hazards assumptions (p=0·0068), requiring analysis over separate time periods. There was a significant reduction in incidence of the primary outcome in the active eradication group in the first 2·5 years of follow-up compared with the control group (six episodes adjudicated as definite or probable peptic ulcer bleeds, rate 0·92 [95% CI 0·41-2·04] per 1000 person-years vs 17 episodes, rate 2·61 [1·62-4·19] per 1000 person-years; hazard ratio [HR] 0·35 [95% CI 0·14-0·89]; p=0·028). This advantage remained significant after adjusting for the competing risk of death (p=0·028) but was lost with longer follow-up (HR 1·31 [95% CI 0·55-3·11] in the period after the first 2·5 years; p=0·54). Reports of adverse events were actively solicited; taste disturbance was the most common event (787 patients). INTERPRETATION:H pylori eradication protects against aspirin-associated peptic ulcer bleeding, but this might not be sustained in the long term. FUNDING:National Institute for Health and Care Research Health Technology Assessment.

Aims: Inhaled methoxyflurane, newly licensed in Europe for acute trauma pain in adults, has limited evidence of effectiveness in the pre-hospital setting. We aimed to investigate the clinical effectiveness and costs of methoxyflurane delivered when administered by ambulance staff compared with usual analgesic practice (UAP) for adults with trauma. Methods: A non-randomised control group design was used to compare methoxyflurane versus Entonox® or parenteral analgesics. Verbal numerical pain scores (VNPS) were gathered over time in adults with moderate to severe trauma pain attended by ambulance staff trained in administering and supplied with methoxyflurane. Comparator VNPS were obtained from database records of UAP in similar patients. Clinical efficacy was tested using an Ordered Probit panel regression model of pain intensity linked by observational rules to VNPS. Scenario analyses were used to compare durations under analgesia spent in severe pain, and costs. Results: Over the 12-month evaluation period, 96 trained paramedics and technicians prepared 510 doses of methoxyflurane for administration to a grand total of 483 patients. Thirty-two patients reported side effects, 19 of whom discontinued early. Thirteen patients, 10 aged over 75 years, were nonadherent to instructions given on inhaler use. Modelling results included demonstration of statistically significant clinical effectiveness of methoxyflurane over each comparator (all p-values <0.001). Methoxyflurane’s time to achieve maximum pain relief was significantly faster (all p-values <0.001): 25.7 mins (95%CI 24.4–27.0) versus Entonox® 44.4 (39.5–49.3); 25.8 (24.5–27.1) versus IV paracetamol 40.7 (34.6–46.9); 25.7 (24.4–27.0) versus IV morphine sulfate 41.9 (38.9–44.8). Scenario analyses of time spent in severe pain (VNPS on administration just scoring 10 reducing to a score of 7) were significantly less for methoxyflurane (all difference p-values <0.001): 7.6 mins (95%CI 6.5–8.7) versus Entonox® 24.6 (20.1–29.0); 6.7 (5.6–7.7) versus IV paracetamol 23.0 (17.9–28.0); 6.9 (5.9–7.9) versus IV morphine sulfate 14.9 (13.3–16.6). Costing scenarios compared single-dose use of methoxyflurane versus Entonox® and versus parenteral analgesics (80–20% weighted episode mix of morphine sulfate and paracetamol). In both scenarios, the benefits of methoxyflurane were achieved at higher cost: the additional cost per treated patient was £8.77 versus Entonox® and £9.69 versus parenteral analgesics. The BNF list price for one vial containing a 3 mL dose of methoxyflurane for vaporisation in a Penthrox® inhaler is £17.89 per pack. Conclusion: Methoxyflurane administered by ambulance clinicians reduced moderate or severe pain due to trauma in adults more rapidly compared to Entonox® or parenteral drugs. Methoxyflurane provides a useful addition to pre-hospital analgesia.

Background: Active Steps, guided by the Behaviour Change Wheel, was developed to support inactive adults with lung conditions. Aim: To conduct a mixed-methods process evaluation of Active Steps. Methods: Active Steps comprised of 1:1 telephone health coaching, printed and digital resources for 12 months to increase physical activity. Implementation data (reach, dose and fidelity) were collected and summarised. Paired t tests were used to assess changes (mean, 95% CI) in mechanisms of impact (Capability, Opportunity, Motivation-Behaviour and Sport England self-efficacy scales) at 12 months. Interviews were completed with service users (n=10), service withdrawals (n=8) and British Lung Foundation (BLF) staff (n=10) and analysed thematically. Results: Of those screened (n=553), 30% (n=166) were eligible for the service and consented for the evaluation. Service users were mostly Female (71%), White (95%), with COPD (67%). 88% (n=883) of intervention calls were completed. The number and duration of intervention calls (mean±SD) were 6 (±4) and 31 minutes (±7) respectively. There were statistically significant (p<0.05) increases in self-efficacy (0.6,0.2–1.0), physical capability (0.6,0.2–1.0), overcoming barriers (0.8,0.4-1.2), making plans (0.8,0.5–1.1) and daily routine (1.1,0.6–1.5). Interviews revealed facilitators (e.g. staff training) and barriers (e.g. health coach workload) to implementation as well as positive (e.g. encouragement, goals) and negative (e.g. ill health, facility access) factors influencing physical activity. Conclusion: Active Steps was delivered as intended to support physical activity, but further consideration of staff workload and integration with local services may improve implementation.

Background Acute pain is often inadequately treated in adults with traumatic injury. Inhaled methoxyflurane, newly licensed in Europe for this indication, has limited evidence of clinical effectiveness in the prehospital setting. We aimed to investigate clinical effectiveness and costs of methoxyflurane administered by ambulance staff compared with usual analgesic practice (UAP) for patients with trauma. Methods We used a non-randomised control group pragmatic design comparing methoxyflurane versus Entonox® and parenteral analgesics. Verbal numerical pain scores (VNPS) were gathered over time in adults with moderate to severe trauma pain attended by ambulance staff trained in administering and supplied with methoxyflurane. Comparator VNPS were obtained from database records of UAP in similar patients. Clinical efficacy was tested using an Ordered Probit panel regression model of pain linked by observational rules to VNPS. Scenario analyses were used to compare durations under analgesia spent in severe pain, and costs. Results Over 12 months, 96 trained paramedics and technicians prepared 510 doses of methoxyflurane for administration to 483 patients. 32 patients reported side-effects, 19 of whom discontinued early. 13 patients, 10 aged over 75 years, were nonadherent to inhaler use instructions. Modelling results showed statistically significant clinical effectiveness of methoxyflurane over each comparator (all p-values<0.001). Methoxyflurane’s time to achieve maximum pain relief was significantly faster (all p-values<0.001): 26.4 mins (95%CI 25.0-27.8) versus Entonox® 44.4 (39.5-49.3); 26.5 (25.0-27.9) versus IV morphine sulfate 41.8 (38.9-44.7); 26.5 (25.1-28.0) versus IV paracetamol 40.8 (34.7-46.9). Scenario analyses of durations spent in severe pain were significantly less for methoxyflurane to comparators. Benefits of methoxyflurane were achieved at higher cost to comparators. Conclusions Methoxyflurane reduced pain more rapidly and to a greater extent than Entonox® and more quickly than parenteral analgesics in adults with moderate or severe pain due to trauma attended by ambulance clinicians. Methoxyflurane provides a useful addition to prehospital analgesia.