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.

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.

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.

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.

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.

"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.

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.

Current provision of general practitioner services in or alongside emergency departments in England.

BACKGROUND: In 2017, general practitioners in or alongside the emergency department (GPED), an approach that employs GPs in or alongside the ED to address increasing ED demand, was advocated by the National Health Service in England and supported by capital funding. However, little is known about the models of GPED that have been implemented. METHODS: Data were collected at two time points: September 2017 and December 2019, on the GPED model in use (if any) at 163/177 (92%) type 1 EDs in England. Models were categorised according to a taxonomy as 'inside/integrated', 'inside/parallel', 'outside/onsite' or 'outside/offsite'. Multiple data sources used included: on-line surveys, interviews, case study data and publicly available information. RESULTS: An increase of EDs using GPED was observed from 81% to 95% over the study period. 'Inside/parallel' was the most frequently used model: 30% (44/149) in 2017, rising to 49% (78/159) in 2019. The adoption of 'inside/integrated' models fell from 26% (38/149) to 9% (15/159). Capital funding was received by 87% (142/163) of the EDs sampled. We identified no significant difference between the GPED model adopted and observable characteristics of EDs of annual attendance, 4-hour wait, rurality and deprivation within the population served. CONCLUSION: The majority of EDs in England have now adopted GPED. The availability of capital funding to finance structural changes so that separate GP services can be provided may explain the rise in parallel models and the decrease in integrated models. Further research is required to understand the relative effectiveness of the various models of GPED identified.

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.

Effective delivery of Complex Innovative Design (CID) cancer trials-A consensus statement.

The traditional cancer drug development pathway is increasingly being superseded by trials that address multiple clinical questions. These are collectively termed Complex Innovative Design (CID) trials. CID trials not only assess the safety and toxicity of novel anticancer medicines but also their efficacy in biomarker-selected patients, specific cancer cohorts or in combination with other agents. They can be adapted to include new cohorts and test additional agents within a single protocol. Whilst CID trials can speed up the traditional route to drug licencing, they can be challenging to design, conduct and interpret. The Experimental Cancer Medicine Centres (ECMC) network, funded by the National Institute for Health Research (NIHR), Cancer Research UK (CRUK) and the Health Boards of Wales, Northern Ireland and Scotland, formed a working group with relevant stakeholders from clinical trials units, the pharmaceutical industry, funding bodies, regulators and patients to identify the main challenges of CID trials. The working group generated ten consensus recommendations. These aim to improve the conduct, quality and acceptability of oncology CID trials in clinical research and, importantly, to expedite the process by which effective treatments can reach cancer patients.

CSTI-300 (SMP-100); a Novel 5-HT3 Receptor Partial Agonist with Potential to Treat Patients with Irritable Bowel Syndrome or Carcinoid Syndrome.

The 5-hydroxytryptamine (5-HT) (serotonin) 5-HT3 receptor represents a clinical target for antagonists to deliver symptomatic relief to patients with diarrhea-predominant irritable bowel syndrome (IBS-d) or carcinoid syndrome. Unfortunately, this pharmacological strategy can present side effects (e.g., severe constipation). The present study investigates the potential of a novel 5-HT3 receptor partial agonist, CSTI-300, to treat patients with IBS-d and other conditions associated with discomfort from colonic distension, with a predicted reduced side-effect profile. The in vitro and in vivo preclinical pharmacology of the drug CSTI-300 was investigated to explore the potential to treat patients with IBS-d. CSTI-300 displayed selective high affinity for the human and rat 5-HT3 receptor (Ki approximately 2.0 nM) and acted as a partial agonist (approximately 30%-50% intrinsic efficacy) in vitro. In an in vivo model of IBS-d, the rat colon distension model, CSTI-300 displayed dose-dependent efficacy. In addition, oral administration of CSTI-300 to dogs that achieved plasma levels of the drug exceeding the Ki value for the 5-HT3 receptor failed to either evoke emesis or alter the state of feces. Pharmacokinetics for CSTI-300 in rat and dog identified high levels of oral availability with t 1/2 range of 1.6-4.4 hours. The preclinical pharmacology of the lead candidate drug, CSTI-300, supports the potential of this novel drug to offer symptomatic relief to patients with irritable bowel syndrome and carcinoid syndrome with a rationale for a reduced "on-target" side-effect profile relative to 5-HT3 receptor antagonists, such as alosetron. SIGNIFICANCE STATEMENT: There is a lack of effective current treatment for diarrhea-predominant irritable bowel syndrome and carcinoid syndrome, and in both conditions, overactivity of the 5-hydroxytryptamine (5-HT) 5-HT3 receptor is thought to be implicated in the pathophysiology. Because 5-HT3 receptor blockade with antagonists results in significant side effects, we present evidence that treatment with a suitable 5-HT3 receptor partial agonist will alleviate some symptoms associated with these conditions yet, without fully inhibiting the receptor, predict a less pronounced side-effect profile associated with this therapeutic strategy.

Challenges of recruiting emergency department patients to a qualitative study: a thematic analysis of researchers' experiences.

BACKGROUND: At times of increasing pressure on emergency departments, and the need for research into different models of service delivery, little is known about how to recruit patients for qualitative research in emergency departments. We report from one study which aimed to collect evidence on patients' experiences of attending emergency departments with different models of using general practitioners, but faced challenges in recruiting patients. This paper aims to identify and reflect on the challenges faced at all stages of patient recruitment, from identifying and inviting eligible patients, consenting them for participation and finally to engaging them in interviews, and make recommendations based on our learning. METHODS: A thematic analysis was carried out on field-notes taken during research visits and meeting minutes of discussions to review and improve patient recruitment throughout the study. RESULTS: The following factors influenced the success of patient recruitment in the emergency department setting: complicated or time-consuming electronic health record systems for identifying patients; narrow participant eligibility criteria; limited research nurse support; and lack of face-to-face communication between researchers and eligible patients. CONCLUSIONS: This paper adds to the methodological evidence for improving patient recruitment in different settings, with a focus on qualitative research in emergency departments. Our findings have implications for future studies attempting to recruit patients in similar settings.

Emergency department clinical leads' experiences of implementing primary care services where GPs work in or alongside emergency departments in the UK: a qualitative study.

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.

Health utilities and quality of life in individuals with tuberous sclerosis complex (TSC) who experience epileptic seizures: A web-based survey.

OBJECTIVES: Individuals with tuberous sclerosis complex (TSC) experience a wide range of health impacts, including epileptic seizures, negatively impacting their health-related quality of life (HRQoL). Health state utility values (HSUVs) are index values representing HRQoL and are used as key inputs for health economic analyses. Such data are currently very limited in the TSC population. The objective of this study was to generate HSUVs for TSC health states, defined by the number and type of seizures experienced in the previous week, and to compare with UK normative values. METHODS: This cross-sectional study involved 186 participants (individuals with TSC = 61, caregivers reporting for individuals with TSC = 125) from Europe and North America who completed a web-based survey. Participants completed the [EuroQol - 5 dimensions - 3 levels] (self-report version for individuals with TSC or proxy version 1 for caregivers). RESULTS: The mean age of individuals with TSC was 27.3 years (self-reported: 41.3 years, caregiver-reported: 20.5 years); 56% were males. Most individuals with TSC (71%) reported experiencing between one and ten seizures in the week prior to participating in the study. The most frequently reported type of seizure was focal: simple partial (50%). Across all participants (combined self-report and caregiver-report), the mean HSUV was 0.474 (95% confidence interval [CI]: 0.424-0.524), significantly lower than the UK norm (0.856, 95%CI: 0.848-0.864) [1]. Mean HSUV and HRQoL scores were consistently lower when reported by caregivers than when self-reported by individuals with TSC (HSUV = 0.351 vs. 0.727). This is in part because caregivers reported for individuals with TSC who experienced more frequent and severe seizures than those who were able to self-report. HSUVs incrementally decreased with the experience of more frequent (1-5 per week: HSUV = 0.666 vs. >20: HSUV = 0.290) and more severe seizures (focal: simple partial: HSUV = 0.450 vs. generalized: convulsive: HSUV = 0.194). CONCLUSIONS: The HRQoL and HSUV index scores indicate substantial impairment among individuals with TSC; HSUVs were shown to decrease considerably with increases in seizure frequency or seizure severity, indicating that more burdensome seizure health states are associated with poorer HRQoL.

Identifying 'avoidable harm' in family practice: a RAND/UCLA Appropriateness Method consensus study.

BACKGROUND: Health care-related harm is an internationally recognized threat to public health. The United Kingdom's national health services demonstrate that upwards of 90% of health care encounters can be delivered in ambulatory settings. Other countries are transitioning to more family practice-based health care systems, and efforts to understand avoidable harm in these settings is needed. METHODS: We developed 100 scenarios reflecting a range of diseases and informed by the World Health Organization definition of 'significant harm'. Scenarios included different types of patient safety incidents occurring by commission and omission, demonstrated variation in timeliness of intervention, and conditions where evidence-based guidelines are available or absent. We conducted a two-round RAND / UCLA Appropriateness Method consensus study with a panel of family practitioners in England to define "avoidable harm" within family practice. Panelists rated their perceptions of avoidability for each scenario. We ran a k-means cluster analysis of avoidability ratings. RESULTS: Panelists reached consensus for 95 out of 100 scenarios. The panel agreed avoidable harm occurs when a patient safety incident could have been probably, or totally, avoided by the timely intervention of a health care professional in family practice (e.g. investigations, treatment) and / or an administrative process (e.g. referrals, alerts in electronic health records, procedures for following up results) in accordance with accepted evidence-based practice and clinical governance. Fifty-four scenarios were deemed avoidable, whilst 31 scenarios were rated unavoidable and reflected outcomes deemed inevitable regardless of family practice intervention. Scenarios with low avoidability ratings (1 s or 2 s) were not represented by the categories that were used to generate scenarios, whereas scenarios with high avoidability ratings (7 s 8 s or 9 s) were represented by these a priori categories. DISCUSSION: The findings from this RAND/UCLA Appropriateness Method study define the characteristics and conditions that can be used to standardize measurement of outcomes for primary care patient safety. CONCLUSION: We have developed a definition of avoidable harm that has potential for researchers and practitioners to apply across primary care settings, and bolster international efforts to design interventions to target avoidable patient safety incidents that cause the most significant harm to patients.

Taxonomy of the form and function of primary care services in or alongside emergency departments: concepts paper.

Primary care services in or alongside emergency departments look and function differently and are described using inconsistent terminology. Research to determine effectiveness of these models is hampered by outdated classification systems, limiting the opportunity for data synthesis to draw conclusions and inform decision-making and policy. We used findings from a literature review, a national survey of Type 1 emergency departments in England and Wales, staff interviews, other routine data sources and discussions from two stakeholder events to inform the taxonomy. We categorised the forms inside or outside the emergency department: inside primary care services may be integrated with emergency department patient flow or may run parallel to that activity; outside services may be offered on site or off site. We then describe a conceptual spectrum of integration: identifying constructs that influence how the services function-from being closer to an emergency medicine service or to usual primary care. This taxonomy provides a basis for future evaluation of service models that will comprise the evidence base to inform policy-making in this domain. Commissioners and service providers can consider these constructs in characterising and designing services depending on local circumstances and context.

Diagnostic error in the emergency department: learning from national patient safety incident report analysis.

BACKGROUND: Diagnostic error occurs more frequently in the emergency department than in regular in-patient hospital care. We sought to characterise the nature of reported diagnostic error in hospital emergency departments in England and Wales from 2013 to 2015 and to identify the priority areas for intervention to reduce their occurrence. METHODS: A cross-sectional mixed-methods design using an exploratory descriptive analysis and thematic analysis of patient safety incident reports. Primary data were extracted from a national database of patient safety incidents. Reports were filtered for emergency department settings, diagnostic error (as classified by the reporter), from 2013 to 2015. These were analysed for the chain of events, contributory factors and harm outcomes. RESULTS: There were 2288 cases of confirmed diagnostic error: 1973 (86%) delayed and 315 (14%) wrong diagnoses. One in seven incidents were reported to have severe harm or death. Fractures were the most common condition (44%), with cervical-spine and neck of femur the most frequent types. Other common conditions included myocardial infarctions (7%) and intracranial bleeds (6%). Incidents involving both delayed and wrong diagnoses were associated with insufficient assessment, misinterpretation of diagnostic investigations and failure to order investigations. Contributory factors were predominantly human factors, including staff mistakes, healthcare professionals' inadequate skillset or knowledge and not following protocols. CONCLUSIONS: Systems modifications are needed that provide clinicians with better support in performing patient assessment and investigation interpretation. Interventions to reduce diagnostic error need to be evaluated in the emergency department setting, and could include standardised checklists, structured reporting and technological investigation improvements.

Systematic Approximations to Susceptible-Infectious-Susceptible Dynamics on Networks.

Network-based infectious disease models have been highly effective in elucidating the role of contact structure in the spread of infection. As such, pair- and neighbourhood-based approximation models have played a key role in linking findings from network simulations to standard (random-mixing) results. Recently, for SIR-type infections (that produce one epidemic in a closed population) on locally tree-like networks, these approximations have been shown to be exact. However, network models are ideally suited for Sexually Transmitted Infections (STIs) due to the greater level of detail available for sexual contact networks, and these diseases often possess SIS-type dynamics. Here, we consider the accuracy of three systematic approximations that can be applied to arbitrary disease dynamics, including SIS behaviour. We focus in particular on low degree networks, in which the small number of neighbours causes build-up of local correlations between the state of adjacent nodes that are challenging to capture. By examining how and when these approximation models converge to simulation results, we generate insights into the role of network structure in the infection dynamics of SIS-type infections.

Sources of unsafe primary care for older adults: a mixed-methods analysis of patient safety incident reports.

Background: older adults are frequent users of primary healthcare services, but are at increased risk of healthcare-related harm in this setting. Objectives: to describe the factors associated with actual or potential harm to patients aged 65 years and older, treated in primary care, to identify action to produce safer care. Design and Setting: a cross-sectional mixed-methods analysis of a national (England and Wales) database of patient safety incident reports from 2005 to 2013. Subjects: 1,591 primary care patient safety incident reports regarding patients aged 65 years and older. Methods: we developed a classification system for the analysis of patient safety incident reports to describe: the incident and preceding chain of incidents; other contributory factors; and patient harm outcome. We combined findings from exploratory descriptive and thematic analyses to identify key sources of unsafe care. Results: the main sources of unsafe care in our weighted sample were due to: medication-related incidents e.g. prescribing, dispensing and administering (n = 486, 31%; 15% serious patient harm); communication-related incidents e.g. incomplete or non-transfer of information across care boundaries (n = 390, 25%; 12% serious patient harm); and clinical decision-making incidents which led to the most serious patient harm outcomes (n = 203, 13%; 41% serious patient harm). Conclusion: priority areas for further research to determine the burden and preventability of unsafe primary care for older adults, include: the timely electronic tools for prescribing, dispensing and administering medication in the community; electronic transfer of information between healthcare settings; and, better clinical decision-making support and guidance.