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Abstract Background Adequate maternity care and appropriate clinical interventions during labour and delivery can reduce adverse perinatal outcomes, but unnecessary interventions may cause harm. While studies have shown that refugees and asylum seekers face important barriers when accessing maternity care, there is a lack of high-quality quantitative data on perinatal health interventions, such as induction of labour or caesarean sections, among refugees and asylum seekers and the findings reported in the literature tend to be inconsistent. Our goal was to examine and synthesise the evidence regarding the rates of intrapartum clinical interventions in women who are refugees and asylum seekers in high-income countries compared to other population groups. Methods We conducted a scoping review of peer-reviewed studies published in English since 2011 that report original quantitative findings regarding intrapartum clinical interventions among refugees and asylum seekers in high-income countries compared to those in non refugee, non asylum seeker populations. We examined reported rates of clinical pain relief, labour induction and augmentation, episiotomies, instrumental deliveries, and caesarean sections. Results Twenty-five papers were included in the review. Findings indicate that refugees and asylum seekers were less likely to receive pain relief, with 16 out of 20 data points showing unadjusted ORs ranging from 0.20 (CI: 0.10–0.60) to 0.96 (CI: 0.70–1.32). Similarly, findings indicate lower odds of instrumental delivery among refugees and asylum seekers with 14 of 21 data points showing unadjusted ORs between 0.25 (CI: 0.15–0.39) and 0.78 (CI: 0.47–1.30); the remaining papers report no statistically significant difference between groups. There was no discernable trend in rates of labour induction and episiotomies across studies. Conclusions The studies included in this review suggest that asylum seekers and refugees are less likely to receive clinical pain relief and experience instrumental delivery than non-refugee groups in high-income countries. This review strengthens our understanding of the links between immigration status and maternity care, ultimately informing policy and practice to improve perinatal health and the provision of care for all.

Background Opioids kill more people than any other drug. Naloxone is an opioid antagonist which can be distributed in take-home ‘kits’ for peer administration (take-home naloxone). Aim To determine the feasibility of carrying out a definitive randomised controlled trial of take-home naloxone in emergency settings. Design We used Welsh routine data (2015–21) to test the feasibility of developing a discriminant function to identify people at high risk of fatal opioid overdose. We carried out a cluster randomised controlled trial and qualitative study to examine experiences of service users and providers. We assessed feasibility of intervention and trial methods against predetermined progression criteria related to: site sign-up, staff trained, identification of eligible patients, proportion given kits, identification of people who died of opioid poisoning, data linkage and retrieval of outcomes. Setting This study was carried out in the emergency environment; sites comprised an emergency department and associated ambulance service catchment area. Participants At intervention sites, we invited emergency department clinicians and paramedics to participate. We recruited adult patients who arrived at the emergency department or were attended to by ambulance paramedics for a problem related to opioid use with capacity to consent to receiving the take-home naloxone and related training. Interventions Usual care comprised basic life support plus naloxone by paramedics or emergency department staff. The take-home naloxone intervention was offered in addition to usual care, with guidance for recipients on basic life support, the importance of calling the emergency services, duration of effect, safety and legality of naloxone administration. Results Discriminant function With low numbers of opioid-related deaths (1105/3,227,396) and a high proportion having no contact with health services in the year before death, the predictive link between death and opioid-related healthcare events was weak. Logistic regression models indicated we would need to monitor one-third of the population to capture 75% of the decedents from opioid overdose in 1-year follow-up. Randomised controlled trial Four sites participated in the trial and 299 of 687 (44%) eligible clinical staff were trained. Sixty take-home naloxone kits were supplied to patients during 1-year recruitment. Eligible patients were not offered take-home naloxone kits 164 times: ‘forgot’ (n = 136); ‘too busy’ (n = 15); suspected intentional overdose (n = 3). Qualitative interviews Service users had high levels of knowledge about take-home naloxone. They were supportive of the intervention but noted concerns about opioid withdrawal and resistance to attending hospital for an overdose. Service providers were positive about the intervention but reported barriers including difficulty with consenting and training high-risk opioid users. Health economics We were able to calculate costs to train staff at three sites (£40 per AS and £17 in Site 1 ED). No adverse events were reported. Progression criteria were not met – fewer than 50% of eligible staff were trained, fewer than 50% of eligible patients received the intervention and outcomes were not retrieved within reasonable timescales. Future work The take-home naloxone intervention needs to be developed and evaluated in emergency care settings, with appropriate methods. Limitations The Take-home naloxone Intervention Multicentre Emergency setting study was interrupted by coronavirus disease. Conclusions This study did not meet progression criteria for intervention or trial methods feasibility, so outcomes were not followed up and a fully powered trial is not planned. Trial registration This trial is registered as ISRCTN13232859. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information. Plain language summary Emergency ambulance staff and doctors in the emergency department regularly administer naloxone to people who have overdosed, reversing effects of the opioid – so-called ‘take-home naloxone’ – to administer to others in an emergency. We don’t know whether take-home naloxone saves lives. We carried out this feasibility study to see whether: we could identify a high-risk population to include in a trial to determine whether take-home naloxone reduces deaths from overdose ambulance paramedics and emergency department staff could be trained, and would then give out take-home naloxone kits to drug users they see. We included four areas in the study. We randomly selected two for distribution of take-home naloxone to patients at risk of or following an overdose by emergency department clinicians and local ambulance paramedics. We attempted to identify people at high risk of death from opioid overdose. We collected data about patients that were eligible and received take-home naloxone in the two intervention areas. We carried out interviews to find out about the views of patients and staff who gave out the kits. At the start, we agreed criteria that should be met for us to recommend that a full evaluation be carried out. We could not reliably identify people at high risk of death from opioid overdose, as deaths were rare in the population, and previous health service usage was variable. Less than half of eligible staff were trained to supply take-home naloxone (299/687, 44%), and less than half of eligible patients were given take-home naloxone (60/277, 21.7%) over 1 year. Patients were not offered take-home naloxone because staff forgot, were too busy or suspected an intentional overdose. Other patients left before receiving a kit. Service users liked the idea of take-home naloxone kits being provided in the emergency setting but reported resistance to attending hospital following an overdose. Service providers were supportive of providing take-home naloxone in the emergency setting but reported challenges in consent and training. Conclusion This study found that it was not feasible to deliver or evaluate this form of take-home naloxone, using this study design, in emergency care. Scientific summary Parts of this summary have been reproduced from Jones M, Bell F, Benger J, Black S, Buykx P, Dixon S, et al. Protocol for Take-home naloxone In Multicentre Emergency (TIME) settings: feasibility study. Pilot Feasib Stud 2020;6(1):1–10. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text. Background Opioids, such as heroin, kill more people worldwide by overdose than any other type of drug, and death rates associated with opioid poisoning in the United Kingdom (UK) are at record levels. Naloxone is an opioid antagonist which can be distributed in ‘kits’ for administration by witnesses in an overdose emergency. This intervention is known as take-home naloxone (THN). We know that THN can save lives on an individual level, but there is currently limited evidence about the effectiveness of THN distribution on an aggregate level, in specialist drug service settings or in emergency service (ES) settings. Notably, we do not know whether THN kits reduce deaths from opioid overdose in at-risk populations, if there are unforeseen harms associated with THN distribution or if THN is cost-effective. To address this research gap, we aimed to determine the feasibility of a fully powered cluster randomised controlled trial (RCT) of THN distribution in emergency settings. Aim To determine the feasibility of carrying out a definitive RCT of THN in emergency settings. Objectives To determine: the best form of THN kit, training and delivery whether a trial clustered by emergency department (ED) catchment area and the associated ambulance service (AS) is deliverable, as assessed against predefined progression criteria related to intervention, trial design and methods. Design We assessed feasibility of intervention and trial methods based upon the following predetermined progression criteria. Intervention feasibility Sign-up of four sites, including ≥ 50% eligible staff to complete training in delivering the intervention at each intervention site. Identification of ≥ 75% of people who have presented to ED or AS with opioid overdose or an opioid use-related problem over a 12-month period. THN kits issued to ≥ 50% eligible patients over a 12-month period at intervention sites. Serious adverse event rate [to be defined in agreement with Data Monitoring and Ethics Committee (DMEC)] of no more than 10% difference in intervention sites to control sites at the conclusion of recruitment. Trial methods feasibility Identification and inclusion for follow-up of ≥ 75% of people who died of opioid poisoning in the following year in the study areas according to Office of National Statistics (ONS) mortality data (previous ONS data suggest between 140 and 180 such deaths across the 4 participating sites during the study period). Matching and data linkage in ≥ 90% of cases not dissented at the conclusion of quantitative data collection. Retrieval of primary and secondary outcomes from National Health Service (NHS) Digital and National Welsh Informatics Service within 6 months of projected timeline. As the intervention tested is for administration to recipients of the THN kits and peers who may suffer an overdose, we needed to find a way to identify cohorts to include in outcome comparisons. We therefore analysed Welsh routine data to test the feasibility of developing a discriminant function to identify a high-risk population for fatal opioid overdose. We scoped anonymised routine retrospective data from 1 January 2015 to 30 November 2021, sourced from the Welsh Demographic Service Dataset (WDSD) to define the study population. To categorise death associated with an opioid overdose, the annual district death extract (ADDE) dataset was used in conjunction with the WDSD to calculate an individual-level study end date. Finally, we considered critical care, ED and hospital admissions as well as substance misuse treatment for the 36 months up to the end of the study period. We carried out a RCT clustered by site in the emergency environment with a qualitative study to examine processes of implementation, patient safety, costs of training NHS staff and experiences of service users and providers. Two intervention sites (paired ED and local AS catchment area) were randomly selected from the four participating sites. Usual practice was continued in the other two sites, acting as controls. Alongside the RCT, we collected qualitative data via semistructured interviews with service users from substance use treatment centres and third-sector organisations. The interview questions were guided by literature around opioid overdose experience and emergency naloxone use, with the aim to explore how opioid users interact with the knowledge, behaviour and attitudes towards the use of THN kits and training to use the kits. Focus groups and interviews with service providers (paramedics and ED clinical staff) were conducted to discuss barriers in the provision of THN in the emergency setting as well as facilitators to this implementation. We assessed the feasibility of collecting costs associated with THN provision in the emergency setting by measuring the health service contacts and incorporating healthcare resource groups (HRGs) into the analysis to produce an overall cost. Setting This feasibility study was carried out in the emergency care environment, across study sites each centred on a receiving ED and defined geographically as the local AS catchment area for that receiving ED. Participants At intervention sites, we invited ED clinicians and paramedics to participate in the trial and recruited adult patients who arrived at the ED or were attended by ambulance paramedics for a problem related to opioid use with capacity to consent to receiving the THN and related training. Participants were to be identified for outcome comparison by application of the discriminant function, if completed, to the study site general populations. Interventions Usual care comprised administration of basic life support plus naloxone by paramedics or ED staff. The THN intervention was offered in addition to usual care and included a multi dose THN kit (Prenoxad) containing 2 mg naloxone hydrochloride 1 mg/1 ml solution for intramuscular (IM) injection, and instructions on the correct administration of the naloxone dose. Recipients also received guidance on: BLS; the importance of calling the ES; duration of effect; the safety of naloxone in terms of adverse events and overdose; and the legality of bystander administration of naloxone. Results TABLE S1Assessment against preset progression criteria Criteria Achieved Criteria met Sign-up of four sites, including ≥ 50% eligible staff to complete training in delivering the intervention at each intervention site Site 1: ED trained 81.1%, AS trained 54% of eligible staffSite 2: ED trained 8.1%, AS trained 33.8% of eligible staff No Identification of ≥ 75% of people who have presented to ED or AS with opioid overdose or an opioid use-related problem over a 12-month period Unable to assess Not known THN kits issued to ≥ 50% eligible patients over a 12-month period at intervention sites 21.7% of eligible patients were given kits No Serious adverse event rate (to be defined in agreement with the DMEC) of no more than 10% difference in intervention sites to control sites at the conclusion of recruitment No serious adverse events were reported Yes Identification and inclusion for follow-up of ≥ 75% of people who died of opioid poisoning in the following year in the study areas according to ONS mortality data (previous ONS data suggest between 140 and 180 such deaths across the four participating sites during the study period) We were able to identify decedents from opioid poisoning in Wales but were unable to produce a discriminant function which included this group in a sufficiently small section of the general population, or to test these methods in a second population No Matching and data linkage in ≥ 90% of cases not dissented at the conclusion of quantitative data collection Due to significant delays in permissions processes for routine- linked data retrieval from NHS Digital, and low administration of THN kits, we did not attempt to match and link records for patients recruited to the trial No Retrieval of routinely recorded primary and secondary outcomes from national repositories within six-months of projected timeline Again, due to significant delays in permissions processes for routine- linked data retrieval, and low administration of THN kits, we did not attempt to retrieve routinely recorded primary and secondary outcomes No Discriminant function With low numbers of opioid-related deaths (1105/3,227,396) and a high proportion of them having no contact with health services in the year before death, the predictive link between death and opioid-related healthcare events was weak. Logistic regression models indicated we would need to monitor one-third of the population to capture 75% of the decedents from opioid overdose in 1-year follow-up. RCT In total, 299 of 687 (43.5%) eligible staff were trained to supply THN kits to eligible patients at the two sites (Site 1: ED n = 107, AS n = 121; Site 2: ED n = 25, AS n = 46). Sixty THN kits were supplied to eligible patients during the recruitment period (Site 1: ED n = 36, AS n = 4; Site 2: ED n = 16, AS n = 4). Eligible patients were recorded as not being offered THN kits 164 times, with reasons reported for not offering eligible patients kits: staff forgot (n = 136); staff too busy (n = 15); and suspected intentional overdose (n = 3). Staff recorded 626 people as being considered for inclusion but found not to be eligible, with reasons listed as: uncooperative including being abusive towards staff (n = 55); lack of capacity (n = 35); reduced consciousness level (n = 41); patient in custody (n = 21); and patient absconded (n = 161). Qualitative interviews Service users had high levels of knowledge about THN, with variable previous access to kits. They generally supported the provision of THN kits and training in the emergency setting and felt that it should be expanded further to chemists and needle exchanges. They also noted the importance of including loved ones in training and felt that this gave them a sense of empowerment and motivation to help others in an overdose situation. They noted concerns with regards to opioid withdrawal and resistance to attending hospital for an overdose. The service users reported that the provision of THN kits and training to friends and family of opioid users would possibly be more beneficial and believed that incorporating THN provision into normal practice would help mitigate some of these barriers. Interviews and focus groups with service providers found that they were supportive about the provision of THN kits and training in the emergency setting. However, they also reported barriers including difficulties consenting and training opioid users, a high turnover of staff impacting the cascade of the intervention as well as negative attitudes towards the patient group and the coronavirus disease 2019 (COVID-19) pandemic. No adverse events were reported. Conclusion This study did not meet progression criteria for intervention or trial methods feasibility, so outcomes were not followed up and a fully powered trial is not planned. There does appear to be appetite for THN kit provision and training in the emergency setting. We conclude that the THN intervention as defined and administered in the Take-home naloxone Intervention Multicentre Emergency setting (TIME) study was not feasible and should not therefore go forward to full trial. However, there may be space for further development of this complex intervention in emergency care – for example, for protocols to allow administration to family and friends of opioid users; as well as methods for definition and identification of study cohorts for outcome comparisons. Trial registration This trial is registered as ISRCTN13232859. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information.

Introduction Research has found differences in processes and outcomes of care between people in ethnic minorities and White British populations in some clinical conditions, although findings have been mixed. The Building an understanding of Ethnic minority people’s Service Use Relating to Emergency care for injuries study is investigating differences in presentation, experience and health outcomes between people from ethnic minorities and White British people who seek emergency health care for injury. Objective Our aim was to consult with stakeholders to define measurable outcomes available in routine ambulance and emergency department data; to assess the appropriateness of existing outcome measures for ethnic minorities and White British people; and to identify any gaps. Method Clinicians, public contributors, researchers, people from the third sector, public health, healthcare inclusion were invited to join an online workshop to discuss routine outcomes. Results Twenty participants attended the stakeholder consultation, with only one being a public contributor, a limitation. Eleven were from a minority ethnic background and seven were female. The integrated list of outcomes included 25 items, combining routine outcomes from the Building an understanding of Ethnic minority people's Service Use Relating to Emergency care for injuries protocol and literature (n = 17) with additional outcomes (n = 8). Notably, the initial list lacked provisions for safeguarding referrals and cases of treatment refusal, which were new additions. Safety concerns arose due to the lack of safeguarding referrals, treatment refusal and self-discharge. Factors such as pre-existing health conditions, injury location and experiences of discrimination were identified as possible influences on care quality and waiting times for ethnic minority patients. Conclusion Although the number of stakeholders taking part in our consultation was low, their participation identified outcomes not found in routine data, supporting the adoption of a mixed-methods approach to answer our research questions. A future consultation could look to include more public members and wider range of clinicians including those who work in safeguarding and rehabilitation services. Funding This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR132744. Plain language summary Research has shown that people from ethnic minorities often have less favourable healthcare experiences and outcomes than white British people. Our BE SURE study aims to establish whether there are differences between these groups and whether this can be seen in routinely available health outcome data or through patients’ own words through questionnaires and interviews. Before starting data collection, we wanted to consult with people who may deliver or receive emergency health care for injuries, about what routinely available healthcare measures and outcomes we should include in the study. Twenty stakeholders joined the meeting: clinicians, paramedics, researchers and representatives from healthcare organisations, the third sector and a public contributor. We firstly explained what the study was about, and what we hoped to achieve during the online consultation meeting. We presented examples of measurable outcomes that we had included in our original research proposal for injuries. We broke into small groups to discuss these outcome measures and identify gaps. We also asked for comments and suggestions to check the appropriateness of these measures. Participants agreed that the proposed measures were mostly appropriate; these included tests, treatments, waiting times, referrals to other doctors, leaving the hospital against medical advice and time spent in the emergency department. They identified two new outcomes, which were safeguarding referrals and refusal of treatment. The final agreed list of outcomes was 25. Participants also discussed disparities in medication and treatments provided to ethnic minorities compared to white British people, such as pain relief. Additionally, they explored various factors that could affect care differently across these groups. For instance, ethnic minorities may experience discrimination, have distinct health issues or experience variations in the location, nature and severity of injuries. These factors could influence waiting times, pain management and overall quality of care.

Introduction People seeking sanctuary, including refugees and asylum seekers, face barriers and challenges in accessing high quality healthcare. In maternity care specifically, asylum-seeking and refugee women are less likely to access timely and adequate antenatal care and may be more likely to experience adverse perinatal outcomes. Objectives We aim to describe maternity care service users seeking sanctuary in Wales and determine whether their perinatal health outcomes and use of maternity care services differ from women born in the UK. Methods We will conduct a retrospective cohort study. Linking six datasets held by SAIL Databank, we will identify individuals recorded as refugees or asylum seekers in General Practitioner (GP) records. We will conduct a descriptive analysis of their demographic and health characteristics and conduct a comparative analysis of maternity care service use and perinatal health outcomes between refugees and asylum seekers and UK-born individuals. We will identify statistically significant differences between groups, and where the completeness and quality of the data allow, we will adjust for known covariates. Results This study will enable us to report on the characteristics of maternity care service users seeking sanctuary in Wales, their maternity care service use and perinatal health outcomes compared to UK-born women. Conclusions This data linkage study will enhance our understanding of health inequities in maternity care and perinatal outcomes related to asylum seeker or refugee status. Results will inform policy and practice to improve provision of maternity care to women seeking sanctuary.

Background Emergency healthcare services are under intense pressure to meet increasing patient demands. Many patients presenting to emergency departments could be managed by general practitioners in general practitioner–emergency department service models. Objectives To evaluate the effectiveness, safety, patient experience and system implications of the different general practitioner–emergency department models. Design Mixed-methods realist evaluation. Methods Phase 1 (2017–8), to understand current practice: rapid realist literature review, national survey and follow-up key informant interviews, national stakeholder event and safety data analysis. Phase 2 (2018–21), to collect and analyse qualitative (observations, interviews) and quantitative data (time series analysis); cost–consequences analysis of routine data; and case site data for ‘marker condition’ analysis from a purposive sample of 13 case sites in England and Wales. Phase 3 (2021–2), to conduct mixed-methods analysis for programme theory and toolkit development. Results General practitioners commonly work in emergency departments, but delivery models vary widely in terms of the scope of the general practitioner role and the scale of the general practitioner service. We developed a taxonomy to describe general practitioner–emergency department service models (Integrated with the emergency department service, Parallel within the emergency department, Outside the emergency department on the hospital site) and present a programme theory as principal output of the study to describe how these service models were observed to operate. Routine data were of variable quality, limiting our analysis. Time series analysis demonstrated trends across intervention sites for: increased time spent in the emergency department; increased emergency department attendances and reattendances; and mixed results for hospital admissions. Evidence on patient experience was limited but broadly supportive; we identified department-level processes to optimise the safety of general practitioner–emergency department models. Limitations The quality, heterogeneity and extent of routine emergency department data collection during the study period limited the conclusions. Recruitment was limited by criteria for case sites (time series requirements) and individual patients (with ‘marker conditions’). Pandemic and other pressures limited data collection for marker condition analysis. Data collected and analysed were pre pandemic; new approaches such as ‘telephone first’ and their relevance to our findings remains unexplored. Conclusion Findings suggest that general practitioner–emergency department service models do not meet the aim of reducing the overall emergency department waiting times and improving patient flow with limited evidence of cost savings. Qualitative data indicated that general practitioners were often valued as members of the wider emergency department team. We have developed a toolkit, based on our findings, to provide guidance for implementing and delivering general practitioner–emergency department services. Future work The emergency care data set has since been introduced across England to help standardise data collection to facilitate further research. We would advocate the systematic capture of patient experience measures and patient-reported outcome measures as part of routine care. More could be done to support the development of the general practitioner in emergency department role, including a core set of competencies and governance structure, to reflect the different general practitioner–emergency department models and to evaluate the effectiveness and cost effectiveness to guide future policy. Study registration This study is registered as PROSPERO CRD42017069741. 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: 15/145/04) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 10. See the NIHR Funding and Awards website for further award information. Plain language summary Hospital emergency departments are under huge pressure. Patients are waiting many hours to be seen, some with problems that general practitioners could deal with. To reduce waiting times and improve patient care, arrangements have been put in place for general practitioners to work in or alongside emergency departments (general practitioner–emergency department models). We studied the different ways of working to find out what works well, how and for whom. We brought together a lot of information. We reviewed existing evidence, sent out surveys to 184 emergency departments, spent time in the emergency departments observing how they operated and interviewing 106 staff in 13 hospitals and 24 patients who visited those emergency departments. We also looked at statistical information recorded by hospitals. Two public contributors were involved from the beginning, and we held two stakeholder events to ensure the relevance of our research to professionals and patients. Getting reliable figures to compare the various general practitioner–emergency department set-ups (inside, parallel to or outside the emergency department) was difficult. Our findings suggest that over time more people are coming to emergency departments and overall waiting times did not generally improve due to general practitioner–emergency department models. Evidence that general practitioners might admit fewer patients to hospital was mixed, with limited findings of cost savings. Patients were generally supportive of the care they received, although we could not speak to as many patients as we planned. The skills and experience of general practitioners were often valued as members of the wider emergency department team. We identified how the care provided was kept safe with: strong leaders, good communication between different types of staff, highly trained and experienced nurses responsible for streaming and specific training for general practitioners on how they were expected to work. We have produced a guide to help professionals develop and improve general practitioner–emergency department services and we have written easy-to-read summaries of all the articles we published. Scientific summary Background Emergency healthcare services are under intense pressure to meet the increasing patient demands. Many patients presenting to emergency departments (EDs) could be managed by general practitioners (GPs). We aimed to evaluate the effectiveness, safety, patient experience and system implications of the different models of GPs working in or alongside EDs (GP-ED). Objectives Identify which models are in place. Describe how the models work. Describe the outcomes of each model. Explain the relationships between contexts (C), mechanisms (M) and outcomes (O) to develop a programme theory to help inform service delivery in other settings. Design We conducted a mixed-methods realist evaluation to describe what works, for whom, in what circumstances and how over three phases. Phase 1: understanding current practice and which models are in place Rapid realist review Method We conducted a rapid realist review to develop initial theories about how different GP-ED models operate, supported by our co-applicants as an expert reference group. Results A total of 96 articles contributed to initial theories: how decisions on streaming patients to GP services are influenced; the role of GPs in EDs; patient satisfaction and safety concerns; the risk of provider-induced demand in highly visible services; and whether these services represent value for money. National survey and follow-up clinical director interviews Method We sent an online survey to 184 clinical directors (CDs) from Type 1 EDs in England and Wales to gather information on aims, implementation and delivering the GP-ED services. Thirty CDs who worked in services implemented since 2010 (a range of locations, models and sizes) were invited to take part in semistructured telephone interviews to explore: service operation, perceived successes and challenges. Results We received 77 responses out of 184 invitees (41.3%); 51 (66%) respondents used a GP-ED model. We interviewed 21 CDs. Findings were used to characterise and categorise GP-ED models to create a taxonomy, inform case study site selection and further theory development. National stakeholder event Method We held a National Stakeholder event in Bristol in 2018 (n = 48 attendees), to present findings from the review and survey, gather stakeholder feedback on a taxonomy of GP-ED models (in collaboration with researchers from the GP-ED team at the University of the West of England) and identify ‘marker conditions’ to guide data collection in Phase 2. Results The taxonomy included a description of the ‘form’ of the GP-ED models (inside the ED: Integrated with ED service delivery or a separate Parallel service; or Outside the ED: on or off the hospital site) and a description of how different constructs influence how the service may ‘function’ – as a traditional GP service or emergency medicine service. Five marker conditions were selected, including: child with a fever, cough/shortness of breath, abdominal pain, back pain and chest pain. (We added ‘headache’ as a further condition in Phase 2 of the study to enhance patient interview recruitment.) National patient safety data collection and analysis Method We searched Coroners’ Reports to Prevent Future Deaths (2013–8) and National Reporting and Learning System (NRLS) patient safety incident reports (2005–15) relating to diagnostic errors in GP-ED services. We coded these using the Patient Safety Classification System (PISA) framework and developed initial safety theories to inform data collection in Phase 2. Results We identified 9 relevant Coroners’ Reports and 217 NRLS reports. Initial theories were developed around: difficulty with triage and streaming processes; errors in clinical decision-making; and inadequate referral pathways and communication between services. Phase 2: case study mixed-methods data collection and analysis to describe how the general practitioner–emergency department models work and outcomes Qualitative data analysis Method We selected 13 case study sites reflecting different GP-ED models (3 Integrated, 4 Parallel, 3 Outside and 3 with no GP-ED model), different locations, sizes of ED and experience delivering the service. We visited all sites (2–4 days) and conducted observations and realist interviews with staff to refine initial theories. We requested local patient safety incident reports related to the GP-ED model and invited patients presenting with marker conditions for interviews to describe their experience. We analysed data from the multiple data sources and applied knowledge from conceptual frameworks and formal theories to refine our initial theories. We then mapped context–mechanism–outcome configurations against different GP-ED models to compare across different types of service. We presented findings at a second national event on 3 December 2019 (n = 70 attendees) for stakeholder feedback. Results Across all sites, we interviewed 106 staff members, collected 14 anonymised local patient safety incident reports, invited 748 patients to take part in telephone interviews and subsequently interviewed 24 patients. Theories were refined to describe: how streaming processes were influenced by nurse experience, guidance and overall operational and strategic management; how GPs found working in EDs influenced their clinical decision-making to maintain a usual GP approach or adopt an ED clinician approach, mitigating safety risks; factors that facilitate teamwork and communication between GP-ED services and the ED; how separate, visible GP-ED services are perceived to contribute to provider-induced demand; and patients’ expectations and experiences of using services. Routine data analysis Method We obtained patient-level data relating to ED attendances and subsequent hospital admissions from hospital episode statistics accident and emergency and admitted patient care (APC) data sets, via NHS Digital for study sites located in England; and from emergency department data set and patient episode database for Wales data sets (via secure anonymised information linkage) for one study site located in Wales. We summarised the attendance-level data as time series (per site, aggregating data for each study fortnight) for the following ED variables: Attendances; Reattendances; Hospital admissions (defined by patient record appearing in the APC data set); Investigations and Treatments; Time in ED; length of stay (LOS) of hospital admission. For all variables, we used standard time series analysis methods to assess the nature and extent of linear trends and seasonality in data before and after an intervention point at intervention sites. Results Data from 1 October 2010 to 30 September 2018 were eligible for inclusion and were of variable quality, tending to decrease as the level of integration between to GP-ED model and the ED decreased. We are more confident in the interpretations made about some outcomes (attendances, reattendances, admissions, LOS) than others (investigations, treatments, average time in ED) due to data quality. In general, at the GP-ED model sites, attendances increased over time. Reattendances within 28 days in the post-intervention period increased over that in the pre-intervention period in eight of the nine sites assessed. Overall, intervention sites also demonstrated a consistent trend of increasing average time in the ED across both the pre- and post-intervention phases. A mixed picture was seen in relation to hospital admissions in the Integrated and Parallel sites, with data quality issues at the Outside sites. Average length of hospital stay showed a mixed picture over all intervention sites. Cost–consequences analysis Method We conducted a cost–consequences analysis (CCA) using the routine data described above to consider the costs and resource consequences resulting from, or associated with, the use of the GP-ED model types compared to control sites. Results Negligible incremental ED attendance cost differences were observed between the model types and the control with an extremely small increased cost [£0.70, standard error (SE) £0.07] observed when looking at all models combined over control, though a saving of £72 (SE £3.18) when looking at inpatient admissions. When looking at ED visits by individual models, the Integrated model saw a small cost saving (£8.73, SE £0.07), but small cost increases were seen in the Parallel model (£9.51, SE £0.08) and the Outside model (£16.30, SE £0.16). With respect to inpatient admissions, all models saw small cost savings [£25 (SE £4.16) to £215 (SE £9.05)] with the Outside model showing the largest saving (£215, SE £9.05). Marker condition analysis Method We used a CCA as above to evaluate the management of six marker conditions at a Parallel GP-ED model as a case study site (the only site with data available during the pandemic period). Anonymised patient-level data were used to compare proportions of patients admitted to hospital (Pearson’s chi-squared test), and times (non-parametric Mann–Whitney U-test) for ED clinicians and GPs. A backward enter stepwise approach was taken with non-statistically significant variables (p > 0.05) removed. Results Emergency department clinicians saw most patients and those patients categorised as being more severely unwell. Across all marker conditions, GPs managed patients more quickly – the main driver being the time taken from treatment to discharge. Across all marker conditions, the trend was for GPs to admit fewer patients to inpatient care, compared with ED clinicians. This trend was more evident (and for some reaching statistical significance) among those requiring the lowest levels of intervention. Reattendance rates at 7 days were equal for both GPs and ED clinicians. Phase 3: mixed-method analysis, programme theory and toolkit development Mixed-methods analyses Method We conducted mixed-methods analyses to further refine our theories through two approaches: firstly, to identify questions raised through the qualitative data analysis to support, refute or refine through quantitative data analyses; then to identify noteworthy findings from the statistical analysis and cross-check with both the qualitative and marker conditions analyses. Results Streaming The marker condition and qualitative data analysis indicated the potential for GPs to improve the flow of the least unwell patients through the ED. However, at the whole ED level examined by the routine data, the analysis demonstrated increased time in the ED for patients at most sites. Therefore, our theories related to streaming and patient flow have limited support from quantitative data. General practitioner role Marker condition data from a single Parallel case study site showed that patients spent less time in the department and were less likely to be admitted, with no difference in reattendance rates at 7 days. Data on investigation use were of poor quality and not included in the analysis. Routine data for all intervention sites and three control sites also showed poor quality of investigation data. Any influence on time in the department and hospital admissions described in the marker condition data was not seen consistently in routine data analysis. While the marker conditions analysis supports the theory that a GP approach in an ED setting can be different to an ED clinician approach, it remains unclear whether this is due to individual clinicians’ management behaviours or service level differences in ways of working. The quantitative data did not identify particular GP-ED models associated with favourable outcomes potentially attributable to facilitating the ‘GP role’. Safety The routine data indicated increasing rates of reattendance at 28 days across most intervention and control sites. This may reflect changes in levels of morbidity among the population, public behaviours or service configurations (including availability of services elsewhere, notably in-hours primary care) rather than necessarily representing a change in the quality of the care provided at the ED. The marker condition data suggested that GP care in the ED appeared to be as safe as ED clinician care using reattendances within 7 days as a proxy. We have not identified data to develop our theory about strength of communication and teamworking within the ED. Patient experience While the marker conditions analysis indicated that patients attending ED who required the fewest investigations and treatments might be more satisfied by being seen by a GP due to a shorter ED stay, we could not identify any particular GP-ED model that appeared most likely to consistently decrease department stay. Demand Our theory about provider-induced demand in distinct and visible services is not supported by the data on ED attendances over the study period, but our qualitative findings suggest that there is a perceived additional demand for primary care at an ED in services where the primary care service is visible, easily accessible and more well known in the local area. Programme theory development We developed a programme theory, as the principal out of the research, presented as the patient journey through the three GP-ED models, to highlight similarities and differences. We recognise that each site had unique characteristics, so this represents a high-level summary of key features, rather than a description of every possible variation. At Integrated models, the streaming process is less influential. The ‘invisibility’ of the GP service means its impact on patient expectations is also more limited, but it allows for GPs to take on supervision of junior ED doctors, described positively at some sites. At Outside models, the process of ensuring that the right patient saw the GP was more complex, and open to potential problems. Their high visibility and accessibility were likely to have a greater impact on patients’ expectations and experiences. At these sites, GPs often took on a supervisory role for a wider primary care team. Parallel models showed the most variation in the way services were set up and the clarity of the GP role: some more like Integrated models others, Outside models. Toolkit We worked with study co-applicants and a stakeholder group of CDs to translate the research findings and programme theory into guidance for implementing and delivering GP-ED services. Some key points include: A culture including strong clinical leadership, encouraging mutual respect, interprofessional communication and teamworking is essential. To ensure that patients are efficiently and safely streamed, nurses should be highly trained and experienced; streaming pathways/protocols must be clear with senior oversight and include quality improvement systems. Training for GPs based on the type of GP-ED model in use and their intended role. Patients need to be informed about reasons for being streamed to different clinicians to help manage expectations. Conclusion General practitioners commonly work in EDs, but delivery models vary widely in terms of the scope of the GP role and the scale of the GP service. We developed a taxonomy to describe GP-ED models (Integrated, Parallel, Outside) and present a programme theory to describe how these models were observed to operate. Routine data were heterogeneous and of variable quality limiting analysis, including verification of the proposed theories, but trends were noted across intervention sites for: increased time spent in the ED, increased ED attendances and reattendances and mixed findings for hospital admissions. Findings suggest that GP-ED service models do not meet the aim of reducing ED waiting times and improving patient flow, with limited evidence of cost savings. Qualitative data indicated that GPs were often valued as members of the wider ED team, with significant appetite to utilise their specific skillset to provide care in the ED. We developed a toolkit, based on our findings, to provide guidance for implementing and delivering GP-ED services. Study registration This study is registered as PROSPERO CRD42017069741. 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: 15/145/04) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 10. See the NIHR Funding and Awards website for further award information.

Abstract Background The EVITE Immunity study investigated the effects of shielding Clinically Extremely Vulnerable (CEV) people during the COVID-19 pandemic on health outcomes and healthcare costs in Wales, United Kingdom, to help prepare for future pandemics. Shielding was intended to protect those at highest risk of serious harm from COVID-19. We report the cost of implementing shielding in Wales. Methods The number of people shielding was extracted from the Secure Anonymised Information Linkage Databank. Resources supporting shielding between March and June 2020 were mapped using published reports, web pages, freedom of information requests to Welsh Government and personal communications (e.g. with the office of the Chief Medical Officer for Wales). Results At the beginning of shielding, 117,415 people were on the shielding list. The total additional cost to support those advised to stay home during the initial 14 weeks of the pandemic was £13,307,654 (£113 per person shielded). This included the new resources required to compile the shielding list, inform CEV people of the shielding intervention and provide medicine and food deliveries. The list was adjusted weekly over the 3-month period (130,000 people identified by June 2020). Therefore the cost per person shielded lies between £102 and £113 per person. Conclusion This is the first evaluation of the cost of the measures put in place to support those identified to shield in Wales. However, no data on opportunity cost was available. The true costs of shielding including its budget impact and opportunity costs need to be investigated to decide whether shielding is a worthwhile policy for future health emergencies.

Abstract Background It has long been noted that the chain from identification of need (research gap) to impact in the real world is both long and tortuous. This study aimed to contribute evidence about research ethics and governance arrangements and processes in the UK with a focus on: what works well; problems; impacts on delivery; and potential improvements. Methods Online questionnaire widely distributed 20th May 2021, with request to forward to other interested parties. The survey closed on 18th June 2021. Questionnaire included closed and open questions related to demographics, role, study objectives. Results Responses were received from 252 respondents, 68% based in universities 25% in the NHS. Research methods used by respondents included interviews/focus groups (64%); surveys/questionnaires (63%); and experimental/quasi experimental (57%). Respondents reported that participants in the research they conducted most commonly included: patients (91%); NHS staff (64%) and public (50%). Aspects of research ethics and governance reported to work well were: online centralised systems; confidence in rigorous, respected systems; and helpful staff. Problems with workload, frustration and delays were reported, related to overly bureaucratic, unclear, repetitive, inflexible and inconsistent processes. Disproportionality of requirements for low-risk studies was raised across all areas, with systems reported to be risk averse, defensive and taking little account of the risks associated with delaying or deterring research. Some requirements were reported to have unintended effects on inclusion and diversity, particularly impacting Patient and Public Involvement (PPI) and engagement processes. Existing processes and requirements were reported to cause stress and demoralisation, particularly as many researchers are employed on fixed term contracts. High negative impacts on research delivery were reported, in terms of timescales for completing studies, discouraging research particularly for clinicians and students, quality of outputs and costs. Suggested improvements related to system level changes / overall approach and specific refinements to existing processes. Conclusions Consultation with those involved in Health Services Research in the UK revealed a picture of overwhelming and increasing bureaucracy, delays, costs and demoralisation related to gaining the approvals necessary to conduct research in the NHS. Suggestions for improvement across all three areas focused on reducing duplication and unnecessary paperwork/form filling and reaching a better balance between risks of harm through research and harms which occur because research to inform practice is delayed or deterred.

Abstract 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.

Abstract Background Public involvement in health services research is encouraged. Descriptions of public involvement across the whole research cycle of a major study are uncommon and its effects on research conduct are poorly understood. Aim This study aimed to describe how we implemented public involvement, reflect on process and effects in a large‐scale multi‐site research study and present learning for future involvement practice. Method We recorded public involvement roles and activities throughout the study and compared these to our original public involvement plan included in our project proposal. We held a group interview with study co‐applicants to explore their experiences, transcribed the recorded discussion and conducted thematic analysis. We synthesized the findings to develop recommendations for future practice. Results Public contributors' activities went beyond strategic study planning and management to include active involvement in data collection, analysis and dissemination. They attended management, scrutiny, planning and task meetings. They also facilitated public involvement through annual planning and review sessions, conducted a Public Involvement audit and coordinated public and patient input to stakeholder discussions at key study stages. Group interview respondents said that involvement exceeded their expectations. They identified effects such as changes to patient recruitment, terminology clarification and extra dissemination activities. They identified factors enabling effective involvement including team and leader commitment, named support contact, building relationships and demonstrating equality and public contributors being confident to challenge and flexible to meet researchers' timescales and work patterns. There were challenges matching resources to roles and questions about the risk of over‐professionalizing public contributors. Conclusion We extended our planned approach to public involvement and identified benefits to the research process that were both specific and general. We identified good practice to support effective public involvement in health services research that study teams should consider in planning and undertaking research. Public Contribution This paper was co‐conceived, co‐planned and co‐authored by public contributors to contribute research evidence, based on their experiences of active involvement in the design, implementation and dissemination of a major health services research study.

Introduction Shielding aimed to protect those predicted to be at highest risk from COVID-19 and was uniquely implemented in the UK during the first year of the pandemic from March 2020. As the first stage in the EVITE Immunity evaluation (Effects of shielding for vulnerable people during COVID-19 pandemic on health outcomes, costs and immunity, including those with cancer:quasi-experimental evaluation), we generated a logic model to describe the programme theory underlying the shielding intervention.Design and participants We reviewed published documentation on shielding to develop an initial draft of the logic model. We then discussed this draft during interviews with 13 key stakeholders involved in putting shielding into effect in Wales and England. Interviews were recorded, transcribed and analysed thematically to inform a final draft of the logic model.Results The shielding intervention was a complex one, introduced at pace by multiple agencies working together. We identified three core components: agreement on clinical criteria; development of the list of people appropriate for shielding; and communication of shielding advice. In addition, there was a support programme, available as required to shielding people, including food parcels, financial support and social support. The predicted mechanism of change was that people would isolate themselves and so avoid infection, with the primary intended outcome being reduction in mortality in the shielding group. Unintended impacts included negative impact on mental and physical health and well-being. Details of the intervention varied slightly across the home nations of the UK and were subject to minor revisions during the time the intervention was in place.Conclusions Shielding was a largely untested strategy, aiming to mitigate risk by placing a responsibility on individuals to protect themselves. The model of its rationale, components and outcomes (intended and unintended) will inform evaluation of the impact of shielding and help us to understand its effect and limitations.

Abstract 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.

Introduction Injuries are a major public health problem which can lead to disability or death. However, little is known about the incidence, presentation, management and outcomes of emergency care for patients with injuries among people from ethnic minorities in the UK. The aim of this study is to investigate what may differ for people from ethnic minorities compared with white British people when presenting with injury to ambulance and Emergency Departments (EDs).Methods and analysis This mixed methods study covers eight services, four ambulance services (three in England and one in Scotland) and four hospital EDs, located within each ambulance service. The study has five Work Packages (WP): (WP1) scoping review comparing mortality by ethnicity of people presenting with injury to emergency services; (WP2) retrospective analysis of linked NHS routine data from patients who present to ambulances or EDs with injury over 5 years (2016–2021); (WP3) postal questionnaire survey of 2000 patients (1000 patients from ethnic minorities and 1000 white British patients) who present with injury to ambulances or EDs including self-reported outcomes (measured by Quality of Care Monitor and Health Related Quality of Life measured by SF-12); (WP4) qualitative interviews with patients from ethnic minorities (n=40) and focus groups—four with asylum seekers and refugees and four with care providers and (WP5) a synthesis of quantitative and qualitative findings.Ethics and dissemination This study received a favourable opinion by the Wales Research Ethics Committee (305391). The Health Research Authority has approved the study and, on advice from the Confidentiality Advisory Group, has supported the use of confidential patient information without consent for anonymised data. Results will be shared with ambulance and ED services, government bodies and third-sector organisations through direct communications summarising scientific conference proceedings and publications.

Abstract Background Patient experience is an important outcome and indicator of healthcare quality, and patient reported experiences are key to improving quality of care. While patient experience in emergency departments (EDs) has been reported in research, there is limited evidence about patients’ specific experiences with primary care services located in or alongside EDs. We aim to identify theories about patient experience and acceptability of being streamed to a primary care clinician in an ED. Methods Using theories from a rapid realist review as a basis, we interviewed 24 patients and 106 staff members to generate updated theories about patient experience and acceptability of streaming to primary care services in EDs. Feedback from 56 stakeholders, including clinicians, policymakers and patient and public members, as well as observations at 13 EDs, also contributed to the development of these theories, which we present as a programme theory. Results We found that patients had no expectations or preferences for which type of clinician they were seen by, and generally found being streamed to a primary care clinician in the ED acceptable. Clinicians and patients reported that patients generally found primary care streaming acceptable if they felt their complaint was dealt with suitably, in a timely manner, and when clinicians clearly communicated the need for investigations, and how these contributed to decision-making and treatment plans. Conclusions From our findings, we have developed a programme theory to demonstrate that service providers can expect that patients will be generally satisfied with their experience of being streamed to, and seen by, primary care clinicians working in these services. Service providers should consider the potential advantages and disadvantages of implementing primary care services at their ED. If primary care services are implemented, clear communication is needed between staff and patients, and patient feedback should be sought.

Abstract Background Increasing demand on emergency healthcare systems has prompted introduction of new healthcare service models including the provision of GP services in or alongside emergency departments. In England this led to a policy proposal and £100million (US$130million) of funding for all emergency departments to have co-located GP services. However, there is a lack of evidence for whether such service models are effective and safe. We examined diagnostic errors reported in patient safety incident reports to develop theories to explain how and why they occurred to inform potential priority areas for improvement and inform qualitative data collection at case study sites to further refine the theories. Methods We used a mixed-methods design using exploratory descriptive analysis to identify the most frequent and harmful sources of diagnostic error and thematic analysis, incorporating realist methodology to refine theories from an earlier rapid realist review, to describe how and why the events occurred and could be mitigated, to inform improvement recommendations. We used two UK data sources: Coroners’ reports to prevent future deaths (30.7.13–14.08.18) and National Reporting and Learning System (NRLS) patient safety incident reports (03.01.05–30.11.15). Results Nine Coroners’ reports (from 1347 community and hospital reports, 2013–2018) and 217 NRLS reports (from 13 million, 2005–2015) were identified describing diagnostic error related to GP services in or alongside emergency departments. Initial theories to describe potential priority areas for improvement included: difficulty identifying appropriate patients for the GP service; under-investigation and misinterpretation of diagnostic tests; and inadequate communication and referral pathways between the emergency and GP services. High-risk presentations included: musculoskeletal injury, chest pain, headache, calf pain and sick children. Conclusion Initial theories include the following topics as potential priority areas for improvement interventions and evaluation to minimise the risk of diagnostic errors when GPs work in or alongside emergency departments: a standardised initial assessment with streaming guidance based on local service provision; clinical decision support for high-risk conditions; and standardised computer systems, communication and referral pathways between emergency and GP services. These theories require refinement and testing with qualitative data collection from case study (hospital) sites.

Abstract 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

Introduction Shielding aimed to protect those predicted to be at highest risk from COVID-19 and was uniquely implemented in the UK during the COVID-19 pandemic. Clinically extremely vulnerable people identified through algorithms and screening of routine National Health Service (NHS) data were individually and strongly advised to stay at home and strictly self-isolate even from others in their household. This study will generate a logic model of the intervention and evaluate the effects and costs of shielding to inform policy development and delivery during future pandemics.Methods and analysis This is a quasiexperimental study undertaken in Wales where records for people who were identified for shielding were already anonymously linked into integrated data systems for public health decision-making. We will: interview policy-makers to understand rationale for shielding advice to inform analysis and interpretation of results; use anonymised individual-level data to select people identified for shielding advice in March 2020 and a matched cohort, from routine electronic health data sources, to compare outcomes; survey a stratified random sample of each group about activities and quality of life at 12 months; use routine and newly collected blood data to assess immunity; interview people who were identified for shielding and their carers and NHS staff who delivered healthcare during shielding, to explore compliance and experiences; collect healthcare resource use data to calculate implementation costs and cost–consequences. Our team includes people who were shielding, who used their experience to help design and deliver this study.Ethics and dissemination The study has received approval from the Newcastle North Tyneside 2 Research Ethics Committee (IRAS 295050). We will disseminate results directly to UK government policy-makers, publish in peer-reviewed journals, present at scientific and policy conferences and share accessible summaries of results online and through public and patient networks.

Background: Intravenous thrombolysis and intra-arterial thrombectomy are proven emergency treatments for acute ischaemic stroke, but they require rapid delivery to selected patients within specialist services. National audit data have shown that treatment provision is suboptimal. Objectives: The aims were to (1) determine the content, clinical effectiveness and day 90 cost-effectiveness of an enhanced paramedic assessment designed to facilitate thrombolysis delivery in hospital and (2) model thrombectomy service configuration options with optimal activity and cost-effectiveness informed by expert and public views. Design: A mixed-methods approach was employed between 2014 and 2019. Systematic reviews examined enhanced paramedic roles and thrombectomy effectiveness. Professional and service user groups developed a thrombolysis-focused Paramedic Acute Stroke Treatment Assessment, which was evaluated in a pragmatic multicentre cluster randomised controlled trial and parallel process evaluation. Clinicians, patients, carers and the public were surveyed regarding thrombectomy service configuration. A decision tree was constructed from published data to estimate thrombectomy eligibility of the UK stroke population. A matching discrete-event simulation predicted patient benefits and financial consequences from increasing the number of centres. Setting: The paramedic assessment trial was hosted by three regional ambulance services (in north-east England, north-west England and Wales) serving 15 hospitals. Participants: A total of 103 health-care representatives and 20 public representatives assisted in the development of the paramedic assessment. The trial enrolled 1214 stroke patients within 4 hours of symptom onset. Thrombectomy service provision was informed by a Delphi exercise with 64 stroke specialists and neuroradiologists, and surveys of 147 patients and 105 public respondents. Interventions: The paramedic assessment comprised additional pre-hospital information collection, structured hospital handover, practical assistance up to 15 minutes post handover, a pre-departure care checklist and clinician feedback. Main outcome measures: The primary outcome was the proportion of patients receiving thrombolysis. Secondary outcomes included day 90 health (poor status was a modified Rankin Scale score of > 2). Economic outputs reported the number of cases treated and cost-effectiveness using quality-adjusted life-years and Great British pounds. Data sources: National registry data from the Sentinel Stroke National Audit Programme and the Scottish Stroke Care Audit were used. Review methods: Systematic searches of electronic bibliographies were used to identify relevant literature. Study inclusion and data extraction processes were described using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: The paramedic assessment trial found a clinically important but statistically non-significant reduction in thrombolysis among intervention patients, compared with standard care patients [197/500 (39.4%) vs. 319/714 (44.7%), respectively] (adjusted odds ratio 0.81, 95% confidence interval 0.61 to 1.08; p = 0.15). The rate of poor health outcomes was not significantly different, but was lower in the intervention group than in the standard care group [313/489 (64.0%) vs. 461/690 (66.8%), respectively] (adjusted odds ratio 0.86, 95% confidence interval 0.60 to 1.2; p = 0.39). There was no difference in the quality-adjusted life-years gained between the groups (0.005, 95% confidence interval –0.004 to 0.015), but total costs were significantly lower for patients in the intervention group than for those in the standard care group (–£1086, 95% confidence interval –£2236 to –£13). It has been estimated that, in the UK, 10,140–11,530 patients per year (i.e. 12% of stroke admissions) are eligible for thrombectomy. Meta-analysis of published data confirmed that thrombectomy-treated patients were significantly more likely to be functionally independent than patients receiving standard care (odds ratio 2.39, 95% confidence interval 1.88 to 3.04; n = 1841). Expert consensus and most public survey respondents favoured selective secondary transfer for accessing thrombectomy at regional neuroscience centres. The discrete-event simulation model suggested that six new English centres might generate 190 quality-adjusted life-years (95% confidence interval –6 to 399 quality-adjusted life-years) and a saving of £1,864,000 per year (95% confidence interval –£1,204,000 to £5,017,000 saving per year). The total mean thrombectomy cost up to 72 hours was £12,440, mostly attributable to the consumables. There was no significant cost difference between direct admission and secondary transfer (mean difference –£368, 95% confidence interval –£1016 to £279; p = 0.26). Limitations: Evidence for paramedic assessment fidelity was limited and group allocation could not be masked. Thrombectomy surveys represented respondent views only. Simulation models assumed that populations were consistent with published meta-analyses, included limited parameters reflecting underlying data sets and did not consider the capital costs of setting up new services. Conclusions: Paramedic assessment did not increase the proportion of patients receiving thrombolysis, but outcomes were consistent with improved cost-effectiveness at day 90, possibly reflecting better informed treatment decisions and/or adherence to clinical guidelines. However, the health difference was non-significant, small and short term. Approximately 12% of stroke patients are suitable for thrombectomy and widespread provision is likely to generate health and resource gains. Clinician and public views support secondary transfer to access treatment. Future work: Further evaluation of emergency care pathways will determine whether or not enhanced paramedic assessment improves hospital guideline compliance. Validation of the simulation model post reconfiguration will improve precision and describe wider resource implications. Trial registration: This trial is registered as ISRCTN12418919 and the systematic review protocols are registered as PROSPERO CRD42014010785 and PROSPERO CRD42015016649. Funding: The project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 4. See the NIHR Journals Library website for further project information.

Abstract Background To manage increasing demand for emergency and unscheduled care NHS England policy has promoted services in which patients presenting to Emergency Departments (EDs) with non-urgent problems are directed to general practitioners (GPs) and other primary care clinicians working within or alongside emergency departments. However, the ways that hospitals have implemented primary care services in EDs are varied. The aim of this study was to describe ED clinical leads’ experiences of implementing and delivering ‘primary care services’ and ‘emergency medicine services’ where GPs were integrated into the ED team. Methods We conducted interviews with ED clinical leads in England (n = 19) and Wales (n = 2). We used framework analysis to analyse interview transcripts and explore differences across ‘primary care services’, ‘emergency medicine services’ and emergency departments without primary care services. Results In EDs with separate primary care services, success was reported when having a distinct workforce of primary care clinicians, who improved waiting times and flow by seeing primary care-type patients in a timely way, using fewer investigations, and enabling ED doctors to focus on more acutely unwell patients. Some challenges were: trying to align their service with the policy guidance, inconsistent demand for primary care, accessible community primary care services, difficulties in recruiting GPs, lack of funding, difficulties in agreeing governance protocols and establishing effective streaming pathways. Where GPs were integrated into an ED workforce success was reported as managing the demand for both emergency and primary care and reducing admissions. Conclusions Introducing a policy advocating a preferred model of service to address primary care demand was not useful for all emergency departments. To support successful and sustainable primary care services in or alongside EDs, policy makers and commissioners should consider varied ways that GPs can be employed to manage variation in local demand and also local contextual factors such as the ability to recruit and retain GPs, sustainable funding, clear governance frameworks, training, support and guidance for all staff. Whether or not streaming to a separate primary care service is useful also depended on the level of primary care demand.

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

Background: Asylum seekers and refugees (ASRs) often experience poor health in host countries. The United Nations High Commissioner for Refugees (UNHCR) requires hosts to ensure these sanctuary seekers have access to basic health care. Aim: To identify barriers and facilitators that affect access to health care by ASRs in Wales. Design & setting: Participatory research approach using qualitative focus groups across Wales, which hosts 10 000 refugees. Method: Eight focus groups were undertaken with ASRs, support workers, and volunteers (n = 57). Results: Specialist NHS-funded services and grant-aided non-governmental organisations (NGOs) facilitated access to health care, including primary care. Most ASRs understood the role of general practice in providing and coordinating care, but were unaware of out-of-hours services. Reported barriers included: language difficulties, health literacy, unrecognised needs, and the cost of travel to appointments. Participants recognised the importance of mental health, but were disappointed by the state of mental health care. Some feared seeking support for mental health from their GP, and few were aware they had the right to move practice if they were unhappy. Written information about health care was not as accessible to refugees as to asylum seekers (ASs). While some participants read such material before consulting, others struggled to access information when in need. Few participants were aware of health prevention services. Even when they knew about services, such as smoking cessation, these services’ difficulty in accommodating ASRs was a barrier. Conclusion: The main barriers identified were: availability of interpreters; knowledge about entitlements; and access to specialist services.

Abstract 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.

Abstract Background People experiencing a mental health crisis receive variable and poorer quality care than those experiencing a physical health crisis. Little is known about the epidemiology, subsequent care pathways of mental health and self-harm emergencies attended by ambulance services, and subsequent all-cause mortality, including deaths by suicide. This is the first national epidemiological analysis of the processes and outcomes of people attended by an ambulance due to a mental health or self-harm emergency. The study aimed to describe patient characteristics, volume, case-mix, outcomes and care pathways following ambulance attendance in this patient population. Methods A linked data study of Scottish ambulance service, emergency department, acute inpatient and death records for adults aged ≥16 for one full year following index ambulance attendance in 2011. Results The ambulance service attended 6802 mental health or self harm coded patients on 9014 occasions. This represents 11% of all calls attended that year. Various pathways resulted from these attendances. Most frequent were those that resulted in transportation to and discharge from the emergency department (n = 4566/9014; 51%). Some patients were left at home (n = 1003/9014 attendances, 11%). Others were admitted to hospital (n = 2043/9014, 23%). Within 12 months of initial attendance, 279 (4%) patients had died, 97 of these were recorded as suicide. Conclusions This unique study finds that ambulance service and emergency departments are missing opportunities to provide better care to this population and in potentially avoidable mortality, morbidity and service burden. Developing and testing interventions for this patient group in pre-hospital and emergency department settings could lead to reductions in suicide, patient distress, and service usage.

Abstract Background Public and patient involvement is a routine element of health services research methods to produce better designed and reported studies. Although co-production is recommended when involving people in research, methods for involving people are usually designed and managed by researchers and there is little evidence about methods to co-produce models for effective public and patient involvement. We report the method used by a group of patient and carer service users to develop and implement a model for involving public members in research. Method We recruited people with experience of chronic conditions, as patients and carers, and supported them to develop and implement the involvement model. We collected written records to describe the processes of co-production. Results Sixteen service users were involved through a series of workshop, meeting and email discussions. They specified principles and operating characteristics of the model which concerned an inclusive culture, adequate resources, accessibility, good communication and clarity of purpose and roles. Components of the model included an on-line Panel of members (n = 20), Steering Group meetings, representation and communication system, facilitator, supportive research environment and access to research activities. Over 8 years, members were active in 218 research activities and held 22 Steering Group meetings. The model was named SUCCESS standing for Service Users with Chronic Conditions Encouraging Sensible Solutions. Conclusion We supported patients and carers to co-produce the SUCCESS model of involvement in research. The model’s components, addressing their needs and priorities, led to sustained involvement in research over 8 years. Further work is needed to apply the model in different settings and assess impact of this method of involving people in research.

Abstract Background Despite evidence from clinical trials that intravenous (IV) thrombolysis is a cost-effective treatment for selected acute ischaemic stroke patients, there remain large variations in the rate of IV thrombolysis delivery between stroke services. This study is evaluating whether an enhanced care pathway delivered by paramedics (the Paramedic Acute Stroke Treatment Assessment (PASTA)) could increase the number of patients who receive IV thrombolysis treatment. Methods Study design: Cluster randomised trial with economic analysis and parallel process evaluation. Setting: National Health Service ambulance services, emergency departments and hyper-acute stroke units within three geographical regions of England and Wales. Randomisation: Ambulance stations within each region are the units of randomisation. According to station allocation, paramedics based at a station deliver the PASTA pathway (intervention) or continue with standard stroke care (control). Study intervention: The PASTA pathway includes structured pre-hospital information collection, prompted pre-notification, structured handover of information in hospital and assistance with simple tasks during the initial hospital assessment. Study-trained intervention group paramedics deliver this pathway to adults within 4 h of suspected stroke onset. Study control: Standard stroke care according to national and local guidelines for the pre-hospital and hospital assessment of suspected stroke. Participants: Participants enrolled in the study are adults with confirmed stroke who were assessed by a study paramedic within 4 h of symptom onset. Primary outcome: Proportion of participants receiving IV thrombolysis. Sample size: 1297 participants provide 90% power to detect a 10% difference in the proportion of patients receiving IV thrombolysis. Discussion The results from this trial will determine whether an enhanced care pathway delivered by paramedics can increase thrombolysis delivery rates. Trial registration ISRCTN registry, ISRCTN12418919. Registered on 5 November 2015.

Background Policy throughout the United Kingdom promotes involvement of patients and public members inresearch to benefit patient care and health outcomes. PRIME Centre Wales is a national researchcentre, developing and coordinating research about primary and emergency care which forms 90%of health service encounters. In this paper, we describe our approach to public involvement andengagement in PRIME Centre Wales (hereafter called PRIME), in particular: how this approachhas developed; ways in which public members contribute to PRIME activity; the strengths andlimitations of our approach, challenges and future opportunities. PRIME ensures work is relevantto service users, carers, the public and policy makers by incorporating comprehensive patient andpublic involvement in every phase of our work Approach PRIME has policies and processes to enable and promote successful public involvement andengagement across research activities. This ensures public perspectives and patient experiences areintegrated throughout research development, implementation and dissemination and in managingand delivering PRIME strategy over a 10 year timescale. A public/patient group called SUPER is akey resource providing wide-ranging perspectives via email and face-to-face discussion. We collectinformation on processes and experiences to assess value and impact, to guide ongoing involvementand engagement. A funded post provides leadership and support to staff and to public/patientcontributors to facilitate collaborations. Discussion A stable, well-resourced structure has provided the timescales to build strong relationships andembed diverse approaches to public involvement and engagement within PRIME. Researchers andpublic contributors have committed to collaborations, developed knowledge and skills and sustainedrelationships. Effective approaches incorporate values and actions which, when operating together,strengthen processes and outcomes of public involvement and engagement. Conclusion Supportive context, motivation and time are necessary to foster values and practices that enableeffective public involvement and engagement. PRIME has embedded public involvement andengagement across research activities and structures. Central is the public/patient group SUPERoffering experience-based expertise to add value to the research cycle. This innovative model, alignedwith best practice, enhances relevance and quality of primary and emergency care research to benefitpatients and the general population.

Objectives: We sought to explore the sociodemographics and primary care service utilization among people who died from opioid overdose and to assess the possibility of using this information to identify those at high risk of opioid overdose using routine linked data. Methods: Data related to decedents of opioid overdose between January 1, 2012 and December 31, 2015 were linked with general practitioner (GP) records over a period of 36 months prior to death. Results: Of n = 312 decedents of opioid overdose, 73% were male (n = 228). Average age at death was 40.72 (SD 11.92) years. A total of 63.8% of the decedents were living in the 2 most deprived quintiles according to the Welsh Index of Multiple Deprivation. Over 80% (n = 258) of the decedents were recorded as having at least 1 GP episode during the 36-month observation period prior to death. The median number of episodes per decedent was 75 [38-118]. Overall, 31.8% (n = 82) of decedents with at least 1 GP episode received a prescription for a proton pump inhibitor and 31% (n = 80) were prescribed a broad-spectrum antibiotic. According to their GP records, less than 10% were referred to or receiving specialist drug treatment (n = 24, 9.3%); or were known to be drug dependent (n = 21, 8.14%), or a drug user (n = 5, 1.94%). In all, 81% were recorded as smokers (n = 209) and 10.5% as ex-smokers (n = 27). Conclusions: The majority of decedents of opioid overdose were in contact with GP services prior to death. GPs are either often unaware of high-risk opioid use, or rarely record details of opioid use in patient notes. It is possible that GP awareness of high-risk opioid use could be increased. For example, awareness of the risks associated with opioid use, and the relationship between the sociodemographic and clinical characteristics of opioid overdose decedents could be raised using educational materials prominently displayed in waiting areas. Clinicians in primary care may be in an excellent position to intervene in problematic opioid use.

Background: Ambulance services have a vital role in the shift towards the delivery of health care outside hospitals, when this is better for patients, by offering alternatives to transfer to the emergency department. The introduction of information technology in ambulance services to electronically capture, interpret, store and transfer patient data can support out-of-hospital care. Objective: We aimed to understand how electronic health records can be most effectively implemented in a pre-hospital context in order to support a safe and effective shift from acute to community-based care, and how their potential benefits can be maximised. Design and setting: We carried out a study using multiple methods and with four work packages: (1) a rapid literature review; (2) a telephone survey of all 13 freestanding UK ambulance services; (3) detailed case studies examining electronic health record use through qualitative methods and analysis of routine data in four selected sites consisting of UK ambulance services and their associated health economies; and (4) a knowledge-sharing workshop. Results: We found limited literature on electronic health records. Only half of the UK ambulance services had electronic health records in use at the time of data collection, with considerable variation in hardware and software and some reversion to use of paper records as services transitioned between systems. The case studies found that the ambulance services’ electronic health records were in a state of change. Not all patient contacts resulted in the generation of electronic health records. Ambulance clinicians were dealing with partial or unclear information, which may not fit comfortably with the electronic health records. Ambulance clinicians continued to use indirect data input approaches (such as first writing on a glove) even when using electronic health records. The primary function of electronic health records in all services seemed to be as a store for patient data. There was, as yet, limited evidence of electronic health records’ full potential being realised to transfer information, support decision-making or change patient care. Limitations: Limitations included the difficulty of obtaining sets of matching routine data for analysis, difficulties of attributing any change in practice to electronic health records within a complex system and the rapidly changing environment, which means that some of our observations may no longer reflect reality. Conclusions: Realising all the benefits of electronic health records requires engagement with other parts of the local health economy and dealing with variations between providers and the challenges of interoperability. Clinicians and data managers, and those working in different parts of the health economy, are likely to want very different things from a data set and need to be presented with only the information that they need. Future work: There is scope for future work analysing ambulance service routine data sets, qualitative work to examine transfer of information at the emergency department and patients’ perspectives on record-keeping, and to develop and evaluate feedback to clinicians based on patient records. Study registration: This study is registered as Health and Care Research Wales Clinical Research Portfolio 34166. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 10. See the NIHR Journals Library website for further project information.

Abstract 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.

Abstract 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

Abstract Background We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. Methods A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Conclusions Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Background The use of anonymised routine linked data in designing and conducting randomised controlled trials (RCTs) has great potential. Sample sizes can be large, inclusion rates high and follow up periods prolonged, while the disruption to participants’ usual routines may be minimised. However, challenges and limitations in using routine linked data in RCTs remain. Aims To describe, in primary and emergency settings, challenges and opportunities associated with designing and conducting RCTs using anonymised linked routine data to identify study participants and gather outcomes. Methods In each of these trials we have used routine linked data as a key part of the research study design: PRISMATIC (a stepped wedge trial of predictive risk stratification in primary care) utilised linked data outcomes related to emergency admissions to hospital, GP activity and outpatient appointments. Outcomes were included for 230,000 people registered to participating GP practices in the Swansea area SAFER 2: a cluster randomised trial of referral to falls services by ambulance paramedics included linked data outcomes related to subsequent emergency episodes for 4,655 patients across three UK regions TIME: feasibility trial of Take Home Naloxone randomised by city; routine linked data used to identify population for inclusion in follow up and outcomes Regulatory processes - ethics, research and information governance permissions - have caused delay in each trial; inclusion rates have been much higher than is usual in RCTs (outcomes for >80% of eligible patients); large trials have been achievable at reasonable cost (each trial

Background People who frequently call the 999 ambulance service present an operational challenge to providers and their needs are inadequately met by current service provision. Aim of research To understand patterns and health outcomes of frequent calling and to work with stakeholders to co-produce guidance for formal testing in a future evaluation. Methods In this mixed methods study I will carry out a scoping review of national and international literature, including grey literature. I will identify two cohorts of patients 12 months retrospectively who meet the frequent caller threshold. Twelve month health outcomes for both cohorts will be explored through anonymised linked data outcomes using general linear model. I will examine the views of patients using qualitative Bio-photographic interview method with a follow up interview at six months. This will be supported with provider focus groups. All interviews will be thematically analysed. I plan to use information collected from this study to work with two public members, patients and stakeholders to co-produce guidance for optimal care. Results Findings will include follow up of eligible patients (n=400); successful data matching and data linkage; retrieval of outcomes within 12 months. Outcomes will include: adverse events, deaths, emergency admissions; 999 attendances. Bio-photographic interviews with completed scrap books and interviews based on the books (n=34). Care provider focus groups (n= 22). Output Co-produced guidance developed with stakeholders. Conclusion Frequent callers with high needs represent a significant policy challenge to emergency ambulance services. This study will inform on the characteristics of frequent callers and how to address their care supported with a co-produced guidance for care providers.

Introduction Routine linkage of emergency ambulance records with those from the emergency department is uncommon in the UK. Our study, known as the Pre-Hospital Emergency Department Data Linking Project (PHED Data), aimed to link records of all patients conveyed by a single emergency ambulance service to thirteen emergency departments in the UK from 2012-2016. Objectives We aimed to examine the feasibility and resource requirements of collecting de-identified emergency department patient record data and, using a deterministic matching algorithm, linking it to ambulance service data. Methods We used a learning log to record contacts and activities undertaken by the research team to achieve data linkage. We also conducted semi-structured interviews with information management/governance staff involved in the process. Results We found that five steps were required for successful data linkage for each hospital trust. The total time taken to achieve linkage was a mean of 65 weeks. A total of 958,057 emergency department records were obtained and, of these, 81% were linked to a corresponding ambulance record. The match rate varied between hospital trusts (50%-94%). Staff expressed strong enthusiasm for data linkage. Barriers to successful linkage were mainly due to inconsistencies between and within acute trusts in the recording of two ambulance event identifiers (CAD and call sign). Further data cleaning was required on emergency department fields before full analysis could be conducted. Ensuring the data was not re-identifiable limited validation of the matching method. Conclusion We conclude that deterministic record linkage based on the combination of two event identifiers (CAD and call sign) is possible. There is an appetite for data linkage in healthcare organisations but it is a slow process. Developments in standardising the recording of emergency department data are likely to improve the quality of the resultant linked dataset. This would further increase its value for providing evidence to support improvements in health care delivery.

Background: Ambulance service quality measures have focused on response times and a small number of emergency conditions, such as cardiac arrest. These quality measures do not reflect the care for the wide range of problems that ambulance services respond to and the Prehospital Outcomes for Evidence Based Evaluation (PhOEBE) programme sought to address this. Objectives: The aim was to develop new ways of measuring the impact of ambulance service care by reviewing and synthesising literature on prehospital ambulance outcome measures and using consensus methods to identify measures for further development; creating a data set linking routinely collected ambulance service, hospital and mortality data; and using the linked data to explore the development of case-mix adjustment models to assess differences or changes in processes and outcomes resulting from ambulance service care. Design: A mixed-methods study using a systematic review and synthesis of performance and outcome measures reported in policy and research literature; qualitative interviews with ambulance service users; a three-stage consensus process to identify candidate indicators; the creation of a data set linking ambulance, hospital and mortality data; and statistical modelling of the linked data set to produce novel case-mix adjustment measures of ambulance service quality. Setting: East Midlands and Yorkshire, England. Participants: Ambulance services, patients, public, emergency care clinical academics, commissioners and policy-makers between 2011 and 2015. Interventions: None. Main outcome measures: Ambulance performance and quality measures. Data sources: Ambulance call-and-dispatch and electronic patient report forms, Hospital Episode Statistics, accident and emergency and inpatient data, and Office for National Statistics mortality data. Results: Seventy-two candidate measures were generated from systematic reviews in four categories: (1) ambulance service operations (n = 14), (2) clinical management of patients (n = 20), (3) impact of care on patients (n = 9) and (4) time measures (n = 29). The most common operations measures were call triage accuracy; clinical management was adherence to care protocols, and for patient outcome it was survival measures. Excluding time measures, nine measures were highly prioritised by participants taking part in the consensus event, including measures relating to pain, patient experience, accuracy of dispatch decisions and patient safety. Twenty experts participated in two Delphi rounds to refine and prioritise measures and 20 measures scored ≥ 8/9 points, which indicated good consensus. Eighteen patient and public representatives attending a consensus workshop identified six measures as important: time to definitive care, response time, reduction in pain score, calls correctly prioritised to appropriate levels of response, proportion of patients with a specific condition who are treated in accordance with established guidelines, and survival to hospital discharge for treatable emergency conditions. From this we developed six new potential indicators using the linked data set, of which five were constructed using case-mix-adjusted predictive models: (1) mean change in pain score; (2) proportion of serious emergency conditions correctly identified at the time of the 999 call; (3) response time (unadjusted); (4) proportion of decisions to leave a patient at scene that were potentially inappropriate; (5) proportion of patients transported to the emergency department by 999 emergency ambulance who did not require treatment or investigation(s); and (6) proportion of ambulance patients with a serious emergency condition who survive to admission, and to 7 days post admission. Two indicators (pain score and response times) did not need case-mix adjustment. Among the four adjusted indicators, we found that accuracy of call triage was 61%, rate of potentially inappropriate decisions to leave at home was 5–10%, unnecessary transport to hospital was 1.7–19.2% and survival to hospital admission was 89.5–96.4% depending on Clinical Commissioning Group area. We were unable to complete a fourth objective to test the indicators in use because of delays in obtaining data. An economic analysis using indicators (4) and (5) showed that incorrect decisions resulted in higher costs. Limitations: Creation of a linked data set was complex and time-consuming and data quality was variable. Construction of the indicators was also complex and revealed the effects of other services on outcome, which limits comparisons between services. Conclusions: We identified and prioritised, through consensus processes, a set of potential ambulance service quality measures that reflected preferences of services and users. Together, these encompass a broad range of domains relevant to the population using the emergency ambulance service. The quality measures can be used to compare ambulance services or regions or measure performance over time if there are improvements in mechanisms for linking data across services. Future work: The new measures can be used to assess different dimensions of ambulance service delivery but current data challenges prohibit routine use. There are opportunities to improve data linkage processes and to further develop, validate and simplify these measures. Funding: The National Institute for Health Research Programme Grants for Applied Research programme.

Background: With a higher proportion of older people in the UK population, new approaches are needed to reduce emergency hospital admissions, thereby shifting care delivery out of hospital when possible and safe. Study aim: To evaluate the introduction of predictive risk stratification in primary care. Objectives: To (1) measure the effects on service usage, particularly emergency admissions to hospital; (2) assess the effects of the Predictive RIsk Stratification Model (PRISM) on quality of life and satisfaction; (3) assess the technical performance of PRISM; (4) estimate the costs of PRISM implementation and its effects; and (5) describe the processes of change associated with PRISM. Design: Randomised stepped-wedge trial with economic and qualitative components. Setting: Abertawe Bro Morgannwg University Health Board, south Wales. Participants: Patients registered with 32 participating general practices. Intervention: PRISM software, which stratifies patients into four (emergency admission) risk groups; practice-based training; and clinical support. Main outcome measures: Primary outcome – emergency hospital admissions. Secondary outcomes – emergency department (ED) and outpatient attendances, general practitioner (GP) activity, time in hospital, quality of life, satisfaction and costs. Data sources: Routine anonymised linked health service use data, self-completed questionnaires and staff focus groups and interviews. Results: Across 230,099 participants, PRISM implementation led to increased emergency admissions to hospital [ΔL = 0.011, 95% confidence interval (CI) 0.010 to 0.013], ED attendances (ΔL = 0.030, 95% CI 0.028 to 0.032), GP event-days (ΔL = 0.011, 95% CI 0.007 to 0.014), outpatient visits (ΔL = 0.055, 95% CI 0.051 to 0.058) and time spent in hospital (ΔL = 0.029, 95% CI 0.026 to 0.031). Quality-of-life scores related to mental health were similar between phases (Δ = –0.720, 95% CI –1.469 to 0.030); physical health scores improved in the intervention phase (Δ = 1.465, 95% CI 0.774 to 2.157); and satisfaction levels were lower (Δ = –0.074, 95% CI – 0.133 to –0.015). PRISM implementation cost £0.12 per patient per year and costs of health-care use per patient were higher in the intervention phase (Δ = £76, 95% CI £46 to £106). There was no evidence of any significant difference in deaths between phases (9.58 per 1000 patients per year in the control phase and 9.25 per 1000 patients per year in the intervention phase). PRISM showed good general technical performance, comparable with existing risk prediction tools (c-statistic of 0.749). Qualitative data showed low use by GPs and practice staff, although they all reported using PRISM to generate lists of patients to target for prioritised care to meet Quality and Outcomes Framework (QOF) targets. Limitations: In Wales during the study period, QOF targets were introduced into general practice to encourage targeting care to those at highest risk of emergency admission to hospital. Within this dynamic context, we therefore evaluated the combined effects of PRISM and this contemporaneous policy initiative. Conclusions: Introduction of PRISM increased emergency episodes, hospitalisation and costs across, and within, risk levels without clear evidence of benefits to patients. Future research: (1) Evaluation of targeting of different services to different levels of risk; (2) investigation of effects on vulnerable populations and health inequalities; (3) secondary analysis of the Predictive Risk Stratification: A Trial in Chronic Conditions Management data set by health condition type; and (4) acceptability of predictive risk stratification to patients and practitioners. Trial and study registration: Current Controlled Trials ISRCTN55538212 and PROSPERO CRD42015016874. Funding: The National Institute for Health Research Health Services Delivery and Research programme.

ABSTRACT Background Studies demonstrate TIA patients are at risk of further TIAs, stroke and death. TIA incidence is unknown, however estimated at 35 per 100,000 people annually in the UK, costing approximately £7 billion. Many TIA patients call 999, are assessed, stabilised and conveyed to Emergency Department (ED). Rapid assessment of TIA severity and risk and intervention is emerging as the new standard for TIA care leading to alternative pathways with direct referral to specialist services. However, uncertainties exist over this new model of care. We will develop and assess feasibility of paramedic assessment and referral of low-risk TIA patients directly to TIA clinic for early review, thus providing timely specialist review without: adverse consequences; inconvenience of ED attendance; unnecessary cost to the NHS. Methods This feasibility trial is designed to test the methods of a pragmatic cluster randomised trial, utilising data linkage for capturing outcome data, but with a qualitative component. To develop the treatment protocol, training and referral processes, working with clinicians/stakeholders, we will conduct: • survey across UK ambulance services to find referral pathways for low-risk TIA patients • systematic review of TIA prehospital care • paramedic focus groups pre-implementation Then: • randomise paramedics (intervention/control) • recruit patients • interview patients, key clinicians and service managers • collect routine data via data linkage using the SAIL databank • hold paramedic focus groups post-implementation We will: • measure uptake and compliance with treatment protocols • validate TIA assessment tool • analyse qualitative data • pilot recruitment processes • test data collection methods • estimate key outcomes effect size to inform full trial sample size calculation Results Will inform full trial development using criteria: intervention acceptability to practitioners and patients; trial design feasibility; outcome data completeness. Conclusions • If indicated, full trial conducted • If not, but positive results - advise intervention development for immediate implementation • If not, but negative results – advise delivery of intervention should cease.

ABSTRACT Objectives • To present an efficient privacy-protecting model (PRIDAL) for linking routine and identifiable patient-reported research data. • To describe the application of the PRIDAL model with within a major portfolio trial linking a range of health and demographic datasets pertaining to >230,000 patients, alongside >2,300 questionnaires. • To summarise the lessons learned from the application of the PRIDAL model. Approach The rise in availability, quality and use of routine health data has resulted in well-developed methods for anonymised linkage of data from multiple sources. However methods for combining identifiable data (e.g. patient-reported questionnaires) with routine anonymised data are not yet tried and tested. Linking these data presents opportunities to improve the feasibility and effectiveness of observational and experimental studies, but emerging data linkage processes must address the appropriate balance between data security and usability. The Process for Routine and Identifiable Data Linkage (PRIDAL) was devised to efficiently link routine hospital data and patient-reported quality of life and quality of care questionnaire data as part of the PRISMATIC trial (http://www.trialsjournal.com/content/14/1/301). This is a mixed methods progressive cluster randomised trial of the efficacy of an emergency admission risk prediction tool in primary care, funded by the NIHR HS&DR programme. PRIDAL was conceived by a group of specialists in e-trials, health informatics, information governance and process mapping who reviewed data sources, flows, owners, and security to develop a practical and intuitive process model. Results We will present the PRIDAL process model and describe its application in relation to the PRISMATIC study. We will demonstrate that the model achieves high data matching rates (>99%), and consider the lessons learnt from its application. Conclusions The linking of routine health and patient self-reported data presents a valuable opportunity in health research, but clear, replicable models, are needed to support ethical and practical data linkage. We present the fully tested PRIDAL model as a potential solution.