Programme theories to describe how different general practitioner service models work in different contexts in or alongside emergency departments (GP-ED): realist evaluation.

BACKGROUND: Addressing increasing patient demand and improving ED patient flow is a key ambition for NHS England. Delivering general practitioner (GP) services in or alongside EDs (GP-ED) was advocated in 2017 for this reason, supported by £100 million (US$130 million) of capital funding. Current evidence shows no overall improvement in addressing demand and reducing waiting times, but considerable variation in how different service models operate, subject to local context. METHODS: We conducted mixed-methods analysis using inductive and deductive approaches for qualitative (observations, interviews) and quantitative data (time series analyses of attendances, reattendances, hospital admissions, length of stay) based on previous research using a purposive sample of 13 GP-ED service models (3 inside-integrated, 4 inside-parallel service, 3 outside-onsite and 3 with no GPs) in England and Wales. We used realist methodology to understand the relationship between contexts, mechanisms and outcomes to develop programme theories about how and why different GP-ED service models work. RESULTS: GP-ED service models are complex, with variation in scope and scale of the service, influenced by individual, departmental and external factors. Quantitative data were of variable quality: overall, no reduction in attendances and waiting times, a mixed picture for hospital admissions and length of hospital stay. Our programme theories describe how the GP-ED service models operate: inside the ED, integrated with patient flow and general ED demand, with a wider GP role than usual primary care; outside the ED, addressing primary care demand with an experienced streaming nurse facilitating the 'right patients' are streamed to the GP; or within the ED as a parallel service with most variability in the level of integration and GP role. CONCLUSION: GP-ED services are complex . Our programme theories inform recommendations on how services could be modified in particular contexts to address local demand, or whether alternative healthcare services should be considered.

Evaluation of different models of general practitioners working in or alongside emergency departments: a mixed-methods realist evaluation.

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.

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 practitioner­emergency 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 practitioner­emergency 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 practitioner­emergency 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 practitioner­emergency department services and we have written easy-to-read summaries of all the articles we published.

The Effectiveness and Cost-Effectiveness of Community Diagnostic Centres: A Rapid Review.

Objectives: To examine the effectiveness of community diagnostic centres as a potential solution to increasing capacity and reducing pressure on secondary care in the UK. Methods: A comprehensive search for relevant primary studies was conducted in a range of electronic sources in August 2022. Screening and critical appraisal were undertaken by two independent reviewers. There were no geographical restrictions or limits to year of publication. A narrative synthesis approach was used to analyse data and present findings. Results: Twenty primary studies evaluating twelve individual diagnostic centres were included. Most studies were specific to cancer diagnosis and evaluated diagnostic centres located within hospitals. The evidence of effectiveness appeared mixed. There is evidence to suggest diagnostic centres can reduce various waiting times and reduce pressure on secondary care. However, cost-effectiveness may depend on whether the diagnostic centre is running at full capacity. Most included studies used weak methodologies that may be inadequate to infer effectiveness. Conclusion: Further well-designed, quality research is needed to better understand the effectiveness and cost-effectiveness of community diagnostic centres.

Effectiveness and safety of asynchronous telemedicine consultations in general practice: a systematic review.

BACKGROUND: There is a focus on increasing asynchronous telemedicine use, which allows medical data to be transmitted, stored, and interpreted later; however, limited evidence of the quality of care it allows in general practice hinders its use. AIM: To investigate uses and effectiveness of asynchronous telemedicine in general practice, according to the domains of healthcare quality, and describe how the COVID-19 pandemic changed its use. DESIGN & SETTING: Systematic review in general practice. METHOD: A systematic search was carried out across four databases using terms related to general practice, asynchronous telemedicine, uses, and effectiveness, and supported by citation searching. This was followed by screening according to pre-defined criteria, data extraction, and critical appraisal. Narrative synthesis was then undertaken guided by the six domains of healthcare quality and exploring differences in use before and following the COVID-19 pandemic. RESULTS: Searches yielded 6864 reports; 27 reports from 23 studies were included. Asynchronous telemedicine is used by a range of staff and patients across many countries. Safety and equity are poorly reported but there were no major safety concerns. Evidence from other domains of healthcare quality show effectiveness in making diagnoses, prescribing medications, replacing other consultations, providing timely care, and increased convenience for patients. Efficiency is impacted by negative effects on workflow, through poor implementation and patient non-adherence, limiting usability and requiring new administrative approaches from healthcare staff. Asynchronous telemedicine use increased rapidly from March 2020, following the COVID-19 pandemic outbreak. CONCLUSION: Asynchronous telemedicine provides quality care for patients but is limited by reports of increased workload and inefficient workflow compared with face-to-face consultations. Limits of evidence include heterogeneity and small-scale studies. Further research into cost-effectiveness, equity, safety, and sustained implementation will influence future policy and practice.

An Evaluation of Contingent Gum Chewing on Rumination Exhibited by an Adolescent with Autism Spectrum Disorder.

Rumination is defined as repeated regurgitation of food, not attributed to other medical conditions. Some individuals with autism or other developmental disabilities engage in rumination, and it can lead to multiple health issues. Previous research demonstrated that noncontingent presentation of chewing gum could be an effective treatment for reducing ruminations. The current study evaluated the effects of noncontingent chewing gum and contingent gum on rumination of an adolescent boy with autism and the results suggest that both treatments were effective, but contingent gum resulted in the lowest rate of rumination. • Rumination can cause multiple health issues including malnutrition, weight loss, esophagitis, tooth decay, and abnormal gastrointestinal symptoms. • Rumination in individuals with autism is often automatically maintained. • Continuous noncontingent gum and contingent gum may be viable treatments for rumination. • Contingent gum may be a more practical intervention for rumination relative to continuous noncontingent gum.

Dimensions of equality in uptake of COVID-19 vaccination in Wales, UK: A multivariable linked data population analysis.

Vaccination has proven to be effective at preventing severe outcomes of COVID-19 infection, and uptake in the population has been high in Wales. However, there is a risk that high-level vaccination coverage statistics may mask hidden inequalities in under-served populations, many of whom may be at increased risk of severe outcomes of COVID-19 infection. The study population included 1,436,229 individuals aged 18 years and over, alive and residence in Wales as at 31st July 2022, and excluded immunosuppressed or care home residents. We compared people who had received one or more vaccinations to those with no vaccination using linked data from nine datasets within the Secure Anonymised Information Linkage (SAIL) databank. Multivariable analysis was undertaken to determine the impact of a range of sociodemographic characteristics on vaccination uptake, including ethnicity, country of birth, severe mental illness, homelessness and substance use. We found that overall uptake of first dose of COVID-19 vaccination was high in Wales (92.1 %), with the highest among those aged 80 years and over and females. Those aged under 40 years, household composition (aOR 0.38 95 %CI 0.35-0.41 for 10+ size household compared to two adult household) and being born outside the UK (aOR 0.44 95 %CI 0.43-0.46) had the strongest negative associations with vaccination uptake. This was followed by a history of substance misuse (aOR 0.45 95 %CI 0.44-0.46). Despite high-level population coverage in Wales, significant inequalities remain across several underserved groups. Factors associated with vaccination uptake should not be considered in isolation, to avoid drawing incorrect conclusions. Ensuring equitable access to vaccination is essential to protecting under-served groups from COVID-19 and further work needs to be done to address these gaps in coverage, with focus on tailored vaccination pathways and advocacy, using trusted partners and communities.

Analysis of applying a patient safety taxonomy to patient and clinician-reported incident reports during the COVID-19 pandemic: a mixed methods study.

BACKGROUND: The COVID-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. We aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context. METHODS: We conducted a mixed-methods study integrating two phases in an exploratory, sequential design. This included a comparative secondary analysis of patient safety incident reports from two studies conducted during the first wave of the pandemic, where we coded patient-reported incidents from the UK and clinician-reported incidents from France. The findings were presented to a focus group of experts in classification systems and patient safety, and a thematic analysis was conducted on the resultant transcript. RESULTS: We identified five key themes derived from the data analysis and expert group discussion. These included capitalising on the unique perspective of safety concerns from different groups, that existing frameworks do identify priority areas to investigate further, the objectives of a study shape the data interpretation, the pandemic spotlighted long-standing patient concerns, and the time period in which data are collected offers valuable context to aid explanation. The group consensus was that no COVID-19-specific codes were warranted, and the PISA classification system was fit for purpose. CONCLUSIONS: We have scrutinised the meaningful use of the PISA classification system's application during a period of systemic healthcare constraint, the COVID-19 pandemic. Despite these constraints, we found the framework can be successfully applied to incident reports to enable deductive analysis, identify areas for further enquiry and thus support organisational learning. No new or amended codes were warranted. Organisations and investigators can use our findings when reviewing their own classification systems.

Communication to promote and support physical distancing for COVID-19 prevention and control.

BACKGROUND: This review is an update of a rapid review undertaken in 2020 to identify relevant, feasible and effective communication approaches to promote acceptance, uptake and adherence to physical distancing measures for COVID-19 prevention and control. The rapid review was published when little was known about transmission, treatment or future vaccination, and when physical distancing measures (isolation, quarantine, contact tracing, crowd avoidance, work and school measures) were the cornerstone of public health responses globally. This updated review includes more recent evidence to extend what we know about effective pandemic public health communication. This includes considerations of changes needed over time to maintain responsiveness to pandemic transmission waves, the (in)equities and variable needs of groups within communities due to the pandemic, and highlights again the critical role of effective communication as integral to the public health response. OBJECTIVES: To update the evidence on the question 'What are relevant, feasible and effective communication approaches to promote acceptance, uptake and adherence to physical distancing measures for COVID-19 prevention and control?', our primary focus was communication approaches to promote and support acceptance, uptake and adherence to physical distancing. SECONDARY OBJECTIVE: to explore and identify key elements of effective communication for physical distancing measures for different (diverse) populations and groups. SEARCH METHODS: We searched MEDLINE, Embase and Cochrane Library databases from inception, with searches for this update including the period 1 January 2020 to 18 August 2021. Systematic review and study repositories and grey literature sources were searched in August 2021 and guidelines identified for the eCOVID19 Recommendations Map were screened (November 2021). SELECTION CRITERIA: Guidelines or reviews focusing on communication (information, education, reminders, facilitating decision-making, skills acquisition, supporting behaviour change, support, involvement in decision-making) related to physical distancing measures for prevention and/or control of COVID-19 or selected other diseases (sudden acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), influenza, Ebola virus disease (EVD) or tuberculosis (TB)) were included. New evidence was added to guidelines, reviews and primary studies included in the 2020 review. DATA COLLECTION AND ANALYSIS: Methods were based on the original rapid review, using methods developed by McMaster University and informed by Cochrane rapid review guidance. Screening, data extraction, quality assessment and synthesis were conducted by one author and checked by a second author. Synthesis of results was conducted using modified framework analysis, with themes from the original review used as an initial framework. MAIN RESULTS: This review update includes 68 studies, with 17 guidelines and 20 reviews added to the original 31 studies. Synthesis identified six major themes, which can be used to inform policy and decision-making related to planning and implementing communication about a public health emergency and measures to protect the community. Theme 1: Strengthening public trust and countering misinformation: essential foundations for effective public health communication Recognising the key role of public trust is essential. Working to build and maintain trust over time underpins the success of public health communications and, therefore, the effectiveness of public health prevention measures. Theme 2: Two-way communication: involving communities to improve the dissemination, accessibility and acceptability of information Two-way communication (engagement) with the public is needed over the course of a public health emergency: at first, recognition of a health threat (despite uncertainties), and regularly as public health measures are introduced or adjusted. Engagement needs to be embedded at all stages of the response and inform tailoring of communications and implementation of public health measures over time. Theme 3: Development of and preparation for public communication: target audience, equity and tailoring Communication and information must be tailored to reach all groups within populations, and explicitly consider existing inequities and the needs of disadvantaged groups, including those who are underserved, vulnerable, from diverse cultural or language groups, or who have lower educational attainment. Awareness that implementing public health measures may magnify existing or emerging inequities is also needed in response planning, enactment and adjustment over time. Theme 4: Public communication features: content, timing and duration, delivery Public communication needs to be based on clear, consistent, actionable and timely (up-to-date) information about preventive measures, including the benefits (whether for individual, social groupings or wider society), harms (likewise) and rationale for use, and include information about supports available to help follow recommended measures. Communication needs to occur through multiple channels and/or formats to build public trust and reach more of the community. Theme 5: Supporting behaviour change at individual and population levels Supporting implementation of public health measures with practical supports and services (e.g. essential supplies, financial support) is critical. Information about available supports must be widely disseminated and well understood. Supports and communication related to them require flexibility and tailoring to explicitly consider community needs, including those of vulnerable groups. Proactively monitoring and countering stigma related to preventive measures (e.g. quarantine) is also necessary to support adherence. Theme 6: Fostering and sustaining receptiveness and responsiveness to public health communication Efforts to foster and sustain public receptiveness and responsiveness to public health communication are needed throughout a public health emergency. Trust, acceptance and behaviours change over time, and communication needs to be adaptive and responsive to these changing needs. Ongoing community engagement efforts should inform communication and public health response measures. AUTHORS' CONCLUSIONS: Implications for practice Evidence highlights the critical role of communication throughout a public health emergency. Like any intervention, communication can be done well or poorly, but the consequences of poor communication during a pandemic may mean the difference between life and death. The approaches to effective communication identified in this review can be used by policymakers and decision-makers, working closely with communication teams, to plan, implement and adjust public communications over the course of a public health emergency like the COVID-19 pandemic. Implications for research Despite massive growth in research during the COVID-19 period, gaps in the evidence persist and require high-quality, meaningful research. This includes investigating the experiences of people at heightened COVID-19 risk, and identifying barriers to implementing public communication and protective health measures particular to lower- and middle-income countries, and how to overcome these.

Impact of COVID-19 pandemic on incidence of long-term conditions in Wales: a population data linkage study using primary and secondary care health records.

BACKGROUND: The COVID-19 pandemic has directly and indirectly had an impact on health service provision owing to surges and sustained pressures on the system. The effects of these pressures on the management of long-term or chronic conditions are not fully understood. AIM: To explore the effects of COVID-19 on the recorded incidence of 17 long-term conditions. DESIGN AND SETTING: This was an observational retrospective population data linkage study on the population of Wales using primary and secondary care data within the Secure Anonymised Information Linkage (SAIL) Databank. METHOD: Monthly rates of new diagnosis between 2000 and 2021 are presented for each long-term condition. Incidence rates post-2020 were compared with expected rates predicted using time series modelling of pre-2020 trends. The proportion of annual incidence is presented by sociodemographic factors: age, sex, social deprivation, ethnicity, frailty, and learning disability. RESULTS: A total of 5 476 012 diagnoses from 2 257 992 individuals are included. Incidence rates from 2020 to 2021 were lower than mean expected rates across all conditions. The largest relative deficit in incidence was in chronic obstructive pulmonary disease corresponding to 343 (95% confidence interval = 230 to 456) undiagnosed patients per 100 000 population, followed by depression, type 2 diabetes, hypertension, anxiety disorders, and asthma. A GP practice of 10 000 patients might have over 400 undiagnosed long-term conditions. No notable differences between sociodemographic profiles of post- and pre-2020 incidences were observed. CONCLUSION: There is a potential backlog of undiagnosed patients with multiple long-term conditions. Resources are required to tackle anticipated workload as part of COVID-19 recovery, particularly in primary care.

Household Composition and Inequalities in COVID-19 Vaccination in Wales, UK.

The uptake of COVID-19 vaccination in Wales is high at a population level but many inequalities exist. Household composition may be an important factor in COVID-19 vaccination uptake due to the practical, social, and psychological implications associated with different living arrangements. In this study, the role of household composition in the uptake of COVID-19 vaccination in Wales was examined with the aim of identifying areas for intervention to address inequalities. Records within the Wales Immunisation System (WIS) COVID-19 vaccination register were linked to the Welsh Demographic Service Dataset (WDSD; a population register for Wales) held within the Secure Anonymised Information Linkage (SAIL) databank. Eight household types were defined based on household size, the presence or absence of children, and the presence of single or multiple generations. Uptake of the second dose of any COVID-19 vaccine was analysed using logistic regression. Gender, age group, health board, rural/urban residential classification, ethnic group, and deprivation quintile were included as covariates for multivariable regression. Compared to two-adult households, all other household types were associated with lower uptake. The most significantly reduced uptake was observed for large, multigenerational, adult group households (aOR 0.45, 95%CI 0.43-0.46). Comparing multivariable regression with and without incorporation of household composition as a variable produced significant differences in odds of vaccination for health board, age group, and ethnic group categories. These results indicate that household composition is an important factor for the uptake of COVID-19 vaccination and consideration of differences in household composition is necessary to mitigate vaccination inequalities.

Real-world effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab on preventing hospital admission among higher-risk patients with COVID-19 in Wales: A retrospective cohort study.

OBJECTIVE: To compare the effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab with no treatment in preventing hospital admission or death in higher-risk patients infected with SARS-CoV-2 in the community. DESIGN: Retrospective cohort study of non-hospitalized adult patients with COVID-19 using the Secure Anonymised Information Linkage (SAIL) Databank. SETTING: A real-world cohort study was conducted within the SAIL Databank (a secure trusted research environment containing anonymised, individual, population-scale electronic health record (EHR) data) for the population of Wales, UK. PARTICIPANTS: Adult patients with COVID-19 in the community, at higher risk of hospitalization and death, testing positive for SARS-CoV-2 between 16th December 2021 and 22nd April 2022. INTERVENTIONS: Molnupiravir, nirmatrelvir-ritonavir, and sotrovimab given in the community by local health boards and the National Antiviral Service in Wales. MAIN OUTCOME MEASURES: All-cause admission to hospital or death within 28 days of a positive test for SARS-CoV-2. STATISTICAL ANALYSIS: Cox proportional hazard model with treatment status (treated/untreated) as a time-dependent covariate and adjusted for age, sex, number of comorbidities, Welsh Index of Multiple Deprivation, and vaccination status. Secondary subgroup analyses were by treatment type, number of comorbidities, and before and on or after 20th February 2022, when omicron BA.1 and omicron BA.2 were the dominant subvariants in Wales. RESULTS: Between 16th December 2021 and 22nd April 2022, 7013 higher-risk patients were eligible for inclusion in the study. Of these, 2040 received treatment with molnupiravir (359, 17.6%), nirmatrelvir-ritonavir (602, 29.5%), or sotrovimab (1079, 52.9%). Patients in the treatment group were younger (mean age 53 vs 57 years), had fewer comorbidities, and a higher proportion had received four or more doses of the COVID-19 vaccine (36.3% vs 17.6%). Within 28 days of a positive test, 628 (9.0%) patients were admitted to hospital or died (84 treated and 544 untreated). The primary analysis indicated a lower risk of hospitalization or death at any point within 28 days in treated participants compared to those not receiving treatment. The adjusted hazard rate was 35% (95% CI: 18-49%) lower in treated than untreated participants. There was no indication of the superiority of one treatment over another and no evidence of a reduction in risk of hospitalization or death within 28 days for patients with no or only one comorbidity. In patients treated with sotrovimab, the event rates before and on or after 20th February 2022 were similar (5.0% vs 4.9%) with no significant difference in the hazard ratios for sotrovimab between the time periods. CONCLUSIONS: In higher-risk adult patients in the community with COVID-19, those who received treatment with molnupiravir, nirmatrelvir-ritonavir, or sotrovimab were at lower risk of hospitalization or death than those not receiving treatment.

Additional consensus recommendations for conducting complex innovative trials of oncology agents: a post-pandemic perspective.

In our 2020 consensus paper, we devised ten recommendations for conducting Complex Innovative Design (CID) trials to evaluate cancer drugs. Within weeks of its publication, the UK was hit by the first wave of the SARS-CoV-2 pandemic. Large CID trials were prioritised to compare the efficacy of new and repurposed COVID-19 treatments and inform regulatory decisions. The unusual circumstances of the pandemic meant studies such as RECOVERY were opened almost immediately and recruited record numbers of participants. However, trial teams were required to make concessions and adaptations to these studies to ensure recruitment was rapid and broad. As these are relevant to cancer trials that enrol patients with similar risk factors, we have added three new recommendations to our original ten: employing pragmatism such as using focused information sheets and collection of only the most relevant data; minimising negative environmental impacts with paperless systems; and using direct-to-patient communication methods to improve uptake. These recommendations can be applied to all oncology CID trials to improve their inclusivity, uptake and efficiency. Above all, the success of CID studies during the COVID-19 pandemic underscores their efficacy as tools for rapid treatment evaluation.

"Code Green Active" Curriculum: Implementation of an Educational Initiative to Increase Awareness of Active Shooter Protocols Among Emergency Department Staff.

BACKGROUND: There has been an increase in violent acts against hospital employees, including active shooter events. Emergency department (ED) staff must be able to respond to these events efficiently to ensure the safest possible outcome. However, few in our ED were aware of our hospital's active shooter protocol. We aimed to increase staff knowledge of and confidence in these guidelines. METHODS: We developed and implemented a 7-week spiral curriculum using the Kern model of curriculum development. Each week, a segment of the hospital active shooter protocol was featured. Multimodal instructional methods including posters, instruction at daily team huddles, descriptions in the weekly division newsletter, and email summaries were used.A 10-question assessment was administered to ED staff both before and after the implementation of our curriculum. During both assessments, staff were asked to rate their confidence in both knowledge of and ability to follow hospital active shooter guidelines. RESULTS: There were 95 and 102 participants in the preintervention and postintervention periods, respectively.The median proportion of correct answers on the knowledge assessment increased when comparing preintervention with postintervention performances (P < 0.05).Staff confidence in both knowledge of and ability to follow active shooter protocols increased after the implementation of our curriculum (P < 0.05). CONCLUSIONS: Our 7-week curriculum resulted in improved knowledge of and confidence in hospital active shooter protocols among ED staff. Given that our sample was an unpaired convenience sample, inferences from our analysis were limited. Tabletop simulations are currently underway to further reinforce and clarify concepts.

Implementing public involvement throughout the research process-Experience and learning from the GPs in EDs study.

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.

The effectiveness of primary care streaming in emergency departments on decision-making and patient flow and safety - A realist evaluation.

Primary care streaming was implemented in UK Emergency Departments (EDs) to manage an increasing demand for urgent care. We aimed to explore its effectiveness in EDs with different primary care models and identify contexts and mechanisms that influenced outcomes: streaming patients to the most appropriate clinician or service, ED flow and patient safety. METHOD: We observed streaming and interviewed ED and primary care staff during case study visits to 10 EDs in England. We used realist methodology, synthesising a middle-range theory with our qualitative data to refine and create a set of theories that explain relationships between contexts, mechanisms and outcomes. RESULTS: Mechanisms contributing to the effectiveness of primary care streaming were: quality of decision-making, patient flow, redeploying staff, managing patients across streams, the implementation of governance protocols, guidance, training, service evaluation and quality improvement efforts. Experienced nurses and good teamworking and strategic and operational management were key contextual factors. CONCLUSION: We recommend service improvement strategies, operational management, monitoring, evaluation and training to ensure that ED nurses stream patients presenting at an ED seeking urgent care to the most appropriate clinicians for their needs in a safe and efficient manner.

Patients' experiences of attending emergency departments where primary care services are located: qualitative findings from patient and clinician interviews from a realist evaluation.

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.

Effect of the COVID-19 pandemic on incidence of long-term conditions in Welsh residents: a population linkage study.

BACKGROUND: The COVID-19 pandemic had direct and indirect effects on health. Indirect effects on long term medical conditions (LTCs) are unclear. We examined trends in recorded incidences of LTCs and quantified differences between expected rates and observed rates from 2020 onwards. METHODS: This is a population data linkage study using primary and secondary care data within the Secure Anonymised Information Linkage Databank. We included data of Welsh residents diagnosed with any of 17 identified LTCs for the first time between Jan 1, 2000, and Dec 31, 2021. LTC's include mental health conditions, respiratory diseases, and heart conditions among others, generally chosen in line with the Quality and Outcomes Framework. The primary outcome was incidence rates (monthly number of new cases per 100 000 population). For each LTC, we did interrupted time series analysis of incidence rates from 2015 to 2021. Expected rates from between Jan 1, 2020, to Dec 31, 2021, were predicted using overall trends and seasonal patterns from the preceding 5 years and compared with observed rates. FINDINGS: We included 5 476 012 diagnoses from 2 257 992 individuals diagnosed with at least one LTC between Jan 1, 2000, to Dec 31, 2021. Across multiple long-term conditions, there was an abrupt reduction in observed incidence of new diagnoses from March to April 2020, followed by a general increase in incidence towards prepandemic rates. The conditions with the largest percentage difference between the observed and expected incidence rates in 2020 and 2021 were chronic obstructive pulmonary disease (38·4% lower than expected), depression (28·3% lower), hypertension (25·5% lower), and anxiety disorders (24·9% lower). The condition with the largest absolute difference between observed and expected incidence rates was anxiety disorders, with 830 per 100 000 less in 2020 and 2021 compared with observed rates. INTERPRETATION: The reduction in incidence rates of LTCs suggests an underreporting of LTCs, especially during 2020 and early 2021. The emergence of these yet undiagnosed cases could result in a surge of new patients in the near future. FUNDING: This work was supported by the Wales COVID-19 Evidence Centre, funded by Health and Care Research Wales.

Learning from diagnostic errors to improve patient safety when GPs work in or alongside emergency departments: incorporating realist methodology into patient safety incident report analysis.

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.

Identifying safe care processes when GPs work in or alongside emergency departments: a realist evaluation.

BACKGROUND: Increasing pressure on emergency services has led to the development of different models of care delivery including GPs working in or alongside emergency departments (EDs), but with a lack of evidence for patient safety outcomes. AIM: This study aimed to explore how care processes work and how patient safety incidents associated with GPs working in ED settings may be mitigated. DESIGN AND SETTING: Realist methodology with a purposive sample of 13 EDs in England and Wales with different GP service models. The study sought to understand the relationship between contexts, mechanisms, and outcomes to develop theories about how and why patient safety incidents may occur, and how safe care was perceived to be delivered. METHOD: Qualitative data were collected (observations, semi-structured audio-recorded staff interviews, and local patient safety incident reports). Data were coded using 'if, then, because' statements to refine initial theories developed from an earlier rapid realist literature review and analysis of a sample of national patient safety incident reports. RESULTS: The authors developed a programme theory to describe how safe patient care was perceived to be delivered in these service models, including: an experienced streaming nurse using local guidance and early warning scores; support for GPs' clinical decision making, with clear governance processes relevant to the intended role (traditional GP approach or emergency medicine approach); and strong clinical leadership to promote teamwork and improve communication between services. CONCLUSION: The findings of this study can be used as a focus for more in-depth human factors investigations to optimise work conditions in this complex care delivery setting.

A classification of primary care streaming pathways in UK emergency departments: Findings from a multi-methods study comprising cross-sectional survey; site visits with observations, semi-structured and informal interviews.

BACKGROUND: Variation in initial assessment methods at emergency departments in with primary care service models and a conflated terminology causes difficulties in assessing relative performance, improving quality or gathering evidence about safety and clinical effectiveness. We aim to describe and classify streaming pathways in emergency departments in different models of emergency department primary care services in England and Wales. METHODS: We used a multi-stage method, including an online survey completed by 77 emergency departments across England & Wales, interviews with 21 clinical leads, and in-depth case studies of 13 emergency departments. All qualitative data were triangulated and analysed using a framework approach. RESULTS: Common emergency department pathways to primary care services were: front door streaming; streaming inside the emergency department; or primary care staff selecting patients. Pathways were also in place to redirect patients with non-urgent primary care problems to community primary care services. Streaming and redirection pathways were often adapted, with variation in protocols based on local circumstances. CONCLUSION: Clinical leads should consider which pathway(s) best suit their local context. Consistency of terminology used to describe pathways between emergency departments and primary care services is necessary for performance measurement, quality improvement and rigorous future multi-site evaluative and descriptive research.