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.

Phase Ib/II Study of the Efficacy and Safety of Binimetinib (MEK162) Plus Panitumumab for Mutant or Wild-Type RAS Metastatic Colorectal Cancer.

INTRODUCTION: Activating RAS gene mutations occur in approximately 55% of patients with metastatic colorectal cancer (mCRC) and are associated with poorer clinical outcomes due to epidermal growth factor receptor (EGFR) blockade resistance. Combined EGFR and mitogen-activated protein kinase (MEK) inhibition may extend response to EGFR inhibition and overcome acquired resistance. This phase Ib/II dose escalation trial evaluated the safety and activity of dual inhibition with binimetinib (MEK1/2 inhibitor) and panitumumab (EGFR inhibitor [EGFRi]) in patients with RAS mutant or BRAF wild type (WT)/RAS WT mCRC. METHODS: Phase Ib dose escalation started with binimetinib 45 mg twice daily plus panitumumab 6 mg/kg administered every 2 weeks. In the phase II study, patients with measurable mCRC were enrolled into 4 groups based on previous anti-EGFR monoclonal antibody therapy and RAS mutational status. RESULTS: No patients in the phase Ib portion (n = 10) had a response; 70% of patients had stable disease. In the phase II portion (n = 43), overall response rate (ORR, confirmed) was 2.3% with one partial response in the RAS WT group, DCR was 30.2%, and median progression-free survival was 1.8 months (95%CI, 1.6-3.3). All patients experienced ≥1 adverse event, with the most common being diarrhea (71.7%), vomiting (52.8%), nausea (50.9%), fatigue (49.1%), dermatitis acneiform (43.4%), and rash (41.5%). Most patients required treatment interruption or dose reduction due to difficulties tolerating treatment. CONCLUSIONS: The combination of binimetinib and panitumumab had substantial toxicity and limited clinical activity for patients with mutant or WT RAS mCRC, independent of EGFRi treatment history (Trial registration: NCT01927341).

Understanding how shared decision-making approaches and patient aids influence patients with advanced cancer when deciding on palliative treatments and care: A realist review.

BACKGROUND: Patients with advanced incurable cancer face difficult decisions about palliative treatment options towards their end of life. However, they are often not provided with the appropriate information and support that is needed to make informed decisions. This review aimed to identify contexts and mechanisms associated with communication tools, patient decision-aids and shared decision-making (SDM) approaches that influence patient outcomes. METHODS: We used a realist review method to search for published studies of patients (adults > 18) with advanced cancer who were expected to make a decision about palliative treatment and/or supportive care in consultation with healthcare practitioners. We appraised and synthesised literature describing the contexts of (when and how) decision aids and SDM approaches are used, and how these contexts interact with mechanisms (resources and reasoning) which impact patient outcomes. Stakeholders including academics, palliative healthcare professionals (HCPs) and people with lived experience of supporting people with advanced incurable cancer contributed to identifying explanatory accounts. These accounts were documented, analysed and consolidated to contribute to the development of a programme theory. RESULTS: From the 33 included papers, we consolidated findings into 20 explanatory accounts to develop a programme theory that explains key contexts and mechanisms that influence patient and SDM. Contexts include underlying patients' and HCPs' attitudes and approaches. These need to be understood in relation to key mechanisms, including presenting information in multiple formats and providing adequate time and opportunities to prepare for and revisit decisions. Contexts influenced mechanisms which then influence the levels of patient decisional satisfaction, conflict and regret. CONCLUSIONS: Our programme theory highlights mechanisms that are important in supporting shared treatment decisions for advanced noncurative cancer. The findings are informative for developing and evaluating interventions to improve understanding and involvement in SDM for patients with advanced incurable cancer. PATIENT AND PUBLIC CONTRIBUTION: We included patient and public involvement (PPI) representatives in four stakeholder meetings. PPI helped to define the scope of the review, identify their unique experiences and perspectives, synthesise their perspectives with our review findings, make decisions about which theories we included in our programme theory and develop recommendations for policy and practice and future research.

COLUMBUS 5-year update: a randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF.

WHAT IS THIS SUMMARY ABOUT?: Here, we summarize the 5-year results from part 1 of the COLUMBUS clinical study, which looked at the combination treatment of encorafenib plus binimetinib in people with a specific type of skin cancer called melanoma. Encorafenib (BRAFTOVI®) and binimetinib (MEKTOVI®) are medicines used to treat a type of melanoma that has a change in the BRAF gene, called advanced or metastatic BRAF V600-mutant melanoma. Participants with advanced or metastatic BRAF V600-mutant melanoma took either encorafenib plus binimetinib together (COMBO group), compared with encorafenib alone (ENCO group) or vemurafenib (ZELBORAF®) alone (VEMU group). WHAT WERE THE RESULTS?: In this 5-year update, more participants in the COMBO group were alive for longer without their disease getting worse after 5 years than those in the VEMU and ENCO groups. Patients in the COMBO group were alive for longer without their disease getting worse when they: Had less advanced cancer Were able to do more daily activities Had normal lactate dehydrogenase (LDH) levels Had fewer organs with tumors before treatment After treatment, fewer participants in the COMBO group received additional anticancer treatment than participants in the VEMU and ENCO groups. The number of participants who reported severe side effects was similar for each treatment. The side effects caused by the drugs in the COMBO group decreased over time. WHAT DO THE RESULTS MEAN?: Overall, this 5-year update confirmed that people with BRAF V600-mutant melanoma that has spread to other parts of the body and who took encorafenib plus binimetinib were alive for longer without their disease getting worse than those who took vemurafenib or encorafenib alone. Clinical Trial Registration: NCT01909453 (ClinicalTrials.gov).

Evaluating a Telephone and Home Blood Pressure Monitoring Intervention to Improve Blood Pressure Control and Self-Care Behaviors in Adults with Low-Socioeconomic Status.

Hypertension (HTN) affects nearly 75 million in the United States, and percentages increase with low socioeconomic status (SES) due to poor access to, and quality of, care, and poor self-care behaviors. Federally Qualified Health Centers (FQHCs) employ evidence-based strategies, such as telehealth interventions, to improve blood pressure (BP) control in under-resourced communities, yet a southeastern FQHC could achieve a BP control rate of only 27.6%, well below the Health People 2020 goal of 61.2%. This pilot project used a pre/post, matched-cohort design to evaluate the effect of a telehealth intervention on BP control and self-care behaviors. Secondary outcomes included self-efficacy and perceived stress. Frequency and percentage, Wilcoxon signed-rank, and McNemar tests were used for statistical analysis of results from a convenience sample of 27 participants. Baseline HTN management guidance that incorporated home blood pressure monitoring (HBPM) was reinforced through telephone counseling every two weeks. Although BP control was not achieved, average scores for systolic and diastolic blood pressures decreased significantly: 13 mm Hg (p = 0.0136) and 5 mm Hg (p = 0.0095), respectively. Statistically significant differences were also seen in select self-care behaviors. Greater BP reduction aligned with higher self-efficacy scores and call engagement. Overall, telephone counseling and HBPM were feasible and effective in reducing BP and increasing self-care behaviors. The inability to control BP may be attributable to under-recognition of stress, lack of medication adherence/reconciliation, and underutilization of guideline-based prescribing recommendations. Findings elucidate the potential effectiveness of a sustainable telehealth intervention to improve BP in low-SES populations.

A Phase Ib/II Study of WNT974 + Encorafenib + Cetuximab in Patients With BRAF V600E-Mutant KRAS Wild-Type Metastatic Colorectal Cancer.

BACKGROUND: WNT974 is a small molecule inhibitor of Wnt signaling that specifically inhibits porcupine O-acyltransferase. This phase Ib dose--escalation study evaluated the maximum tolerated dose of WNT974 in combination with encorafenib and cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer with RNF43 mutations or RSPO fusions. PATIENTS AND METHODS: Patients received once-daily encorafenib and weekly cetuximab, in addition to once-daily WNT974, in sequential dosing cohorts. In the first cohort, patients received 10-mg WNT974 (COMBO10), which was reduced in subsequent cohorts to 7.5-mg (COMBO7.5) or 5-mg (COMBO5) after dose-limiting toxicities (DLTs) were observed. Primary endpoints were incidence of DLTs and exposure to WNT974 and encorafenib. Secondary endpoints were anti-tumor activity and safety. RESULTS: Twenty patients were enrolled (COMBO10, n = 4; COMBO7.5, n = 6; COMBO5, n = 10). DLTs were observed in 4 patients, including grade 3 hypercalcemia (COMBO10, n = 1; COMBO7.5, n = 1), grade 2 dysgeusia (COMBO10, n = 1), and lipase increased (COMBO10, n = 1). A high incidence of bone toxicities (n = 9) was reported, including rib fracture, spinal compression fracture, pathological fracture, foot fracture, hip fracture, and lumbar vertebral fracture. Serious adverse events were reported in 15 patients, most frequently bone fracture, hypercalcemia, and pleural effusion. The overall response rate was 10% and disease control rate 85%; most patients achieved stable disease as their best response. CONCLUSION: Concerns surrounding the safety and lack of preliminary evidence of improved anti-tumor activity of WNT974 + encorafenib + cetuximab, compared with previous encorafenib + cetuximab data, ultimately led to study discontinuation. Phase II was not initiated. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02278133.

Detection of numerous phycotoxins in young bull sharks (Carcharhinus leucas) collected from an estuary of national significance.

Florida's Indian River Lagoon (IRL) has experienced large-scale, frequent blooms of toxic harmful algae in recent decades. Sentinel, or indicator, species can provide an integrated picture of contaminants in the environment and may be useful to understanding phycotoxin prevalence in the IRL. This study evaluated the presence of phycotoxins in the IRL ecosystem by using the bull shark (Carcharhinus leucas) as a sentinel species. Concentrations of phycotoxins were measured in samples collected from 50 immature bull sharks captured in the IRL between 2018 and 2020. Ultra-performance liquid chromatography/tandem mass spectrometry was used to measure toxins in shark gut contents, plasma, and liver. Analysis of samples (n = 123) demonstrated the presence of multiple phycotoxins (microcystin, nodularin, teleocidin, cylindrospermopsin, domoic acid, okadaic acid, and brevetoxin) in 82 % of sampled bull sharks. However, most detected toxins were in low prevalence (≤25 % of samples, per sample type). This study provides valuable baseline information on presence of multiple phycotoxins in a species occupying a high trophic position in this estuary of national significance.

COLUMBUS 5-Year Update: A Randomized, Open-Label, Phase III Trial of Encorafenib Plus Binimetinib Versus Vemurafenib or Encorafenib in Patients With BRAF V600-Mutant Melanoma.

PURPOSE: Combination treatment with BRAF and MEK inhibitors has demonstrated benefits on progression-free survival (PFS) and overall survival (OS) and is a standard of care for the treatment of advanced BRAF V600-mutant melanoma. Here, we report the 5-year update from the COLUMBUS trial (ClinicalTrials.gov identifier: NCT01909453). METHODS: Patients with locally advanced unresectable or metastatic BRAF V600-mutant melanoma, untreated or progressed after first-line immunotherapy, were randomly assigned 1:1:1 to encorafenib 450 mg once daily plus binimetinib 45 mg twice daily, vemurafenib 960 mg twice daily, or encorafenib 300 mg once daily. An updated analysis was conducted 65 months after the last patient was randomly assigned. RESULTS: Five hundred seventy-seven patients were randomly assigned: 192 to encorafenib plus binimetinib, 191 to vemurafenib, and 194 to encorafenib. The 5-year PFS and OS rates with encorafenib plus binimetinib were 23% and 35% overall and 31% and 45% in those with normal lactate dehydrogenase levels, respectively. In comparison, the 5-year PFS and OS rates with vemurafenib were 10% and 21% overall and 12% and 28% in those with normal lactate dehydrogenase levels, respectively. The median duration of response with encorafenib plus binimetinib was 18.6 months, with disease control achieved in 92.2% of patients. In comparison, the median duration of response with vemurafenib was 12.3 months, with disease control achieved in 81.2% of patients. Long-term follow-up showed no new safety concerns, and results were consistent with the known tolerability profile of encorafenib plus binimetinib. Interactive visualization of the data presented in this article is available at COLUMBUS dashboard. CONCLUSION: In this 5-year update of part 1 of the COLUMBUS trial, encorafenib plus binimetinib treatment demonstrated continued long-term benefits and a consistent safety profile in patients with BRAF V600-mutant melanoma.

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 Behavioural Impact on Cats during a Transition from a Clay-Based Litter to a Plant-Based Litter.

Current guidelines recommend transitioning cats from one litter product to another over 6 days to minimize stress. The study objective was therefore to test these guidelines using 16 adult domestic cats (2 cohorts of 8) by observing behavioural changes associated with elimination throughout the litter transition. Cats were transitioned from a clay-based litter (CLAY) to a plant-based litter product (PLANT) over 6 days (period 1) via an incremental replacement of CLAY with PLANT. All cats then remained on PLANT for 8 days (period 2). This same transition process was executed for both cohorts, and litter box behaviours were observed via remote recording. Urination, defecation, cover, and dig behaviours were not different between periods 1 and 2 (p > 0.05). Sniffing frequency was greater in period 2 than period 1 (p < 0.05); however, during the litter transition (period 1), cats sniffed the litter boxes being transitioned from CLAY to PLANT more often and for longer than they did for the boxes consisting of only PLANT (p < 0.05). These data suggest that 6 days may be an adequate amount of time to transition a cat to a new litter, although successful transition may also be specific to the types of litters investigated.

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.

Examining science communication on Reddit: From an "Assembled" to a "Disassembling" approach.

This study examines science communication within Ask Me Anything sessions hosted by US National Oceanic and Atmospheric Administration scientists on Reddit. In addition to considering a unique social media platform, our work makes an important contribution in revealing the limitations of a traditional approach to studying science communication and modeling an alternative. First, using an "assembled" approach, we qualitatively explore themes in National Oceanic and Atmospheric Administration scientists' posts and consider how they reflect the goals of "deficit" and "dialogue" models. Second, using a "disassembling" approach, inspired by Davies and Horst and actor-network theory, we more deeply examine our experiences studying the Ask Me Anything sessions. We then demonstrate how this alternative approach identifies "hidden" human and non-human actants that may have shaped science communication as "mediators." We use these insights to reject the common assumption that science communication on social media occurs solely and directly between scientists and publics.

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.

A lived experience co-designed study protocol for a randomised control trial: the Attempted Suicide Short Intervention Program (ASSIP) or Brief Cognitive Behavioural Therapy as additional interventions after a suicide attempt compared to a standard Suicide Prevention Pathway (SPP).

BACKGROUND: Despite being preventable, suicide is a leading cause of death and a major global public health problem. For every death by suicide, many more suicide attempts are undertaken, and this presents as a critical risk factor for suicide. Currently, there are limited treatment options with limited underpinning research for those who present to emergency departments with suicidal behaviour. The aim of this study is to assess if adding one of two structured suicide-specific psychological interventions (Attempted Suicide Short Intervention Program [ASSIP] or Brief Cognitive Behavioural Therapy [CBT] for Suicide Prevention) to a standardised clinical care approach (Suicide Prevention Pathway [SPP]) improves the outcomes for consumers presenting to a Mental Health Service with a suicide attempt. METHODS: This is a randomised controlled trial with blinding of those assessing the outcomes. People who attempt suicide or experience suicidality after a suicide attempt, present to the Gold Coast Mental Health and Specialist Services, are placed on the Suicide Prevention Pathway (SPP), and meet the eligibility criteria, are offered the opportunity to participate. A total of 411 participants will be recruited for the study, with 137 allocated to each cohort (participants are randomised to SPP, ASSIP + SPP, or CBT + SPP). The primary outcomes of this study are re-presentation to hospitals with suicide attempts. Presentations with suicidal ideation will also be examined (in a descriptive analysis) to ascertain whether a rise in suicidal ideation is commensurate with a fall in suicide attempts (which might indicate an increase in help-seeking behaviours). Death by suicide rates will also be examined to ensure that representations with a suicide attempt are not due to participants dying, but due to a potential improvement in mental health. For participants without a subsequent suicide attempt, the total number of days from enrolment to the last assessment (24 months) will be calculated. Self-reported levels of suicidality, depression, anxiety, stress, resilience, problem-solving skills, and self- and therapist-reported level of therapeutic engagement are also being examined. Psychometric data are collected at baseline, end of interventions, and 6,12, and 24 months. DISCUSSION: This project will move both ASSIP and Brief CBT from efficacy to effectiveness research, with clear aims of assessing the addition of two structured psychological interventions to treatment as usual, providing a cost-benefit analysis of the interventions, thus delivering outcomes providing a clear pathway for rapid translation of successful interventions. TRIALS REGISTRATION: ClinicalTrials.gov NCT04072666 . Registered on 28 August 2019.

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.

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.

Senior clinical and business managers' perspectives on the influence of different funding mechanisms, and barriers and enablers to implementing models of employing General Practitioners in or alongside emergency departments: Qualitative study.

PURPOSE: Health policy in England has advocated the use of primary care clinicians at emergency departments to address pressures from rising attendances. This study explored senior managers' perspective son funding mechanisms used to implement the policy and experiences of success or challenges in introducing GPs in or alongside emergency departments. METHODS: The perspectives of senior clinical, business and finance managers with responsibility for emergency department services and on-site primary care service implementation were investigated in semi-structured interviews with 31 managers at 12 type-1 emergency departments in England and Wales (February 2018 - September 2019). Emergency departments operated one of three GP models or had prior experience of implementing a GP model. Interviews were thematically analysed. RESULTS: Perceived successful GPs models in emergency departments were reliant on well-organised and unified funding mechanisms, appropriate staffing and governance, and consideration of population demands and needs. Funding mechanisms and the flow of funds were reported as complex, especially in Inside-parallel GP models. The most efficient mechanisms were described at departments where funding was unified, in collaboration with health and community care services. Staffing with local, experienced GPs was important. There were cautions from experiences with private locum providers. CONCLUSION: Our findings contribute to debates about implementing policy on how primary care clinicians are effectively and safely deployed in emergency departments and how local context should be considered.

Cardiac Autonomic and Blood Pressure Responses to an Acute Bout of Kettlebell Exercise.

ABSTRACT: Wong, A, Nordvall, M, Walters-Edwards, M, Lastova, K, Francavillo, G, Tripken, J, Summerfield, L, and Sanchez-Gonzalez, M. Cardiac autonomic and blood pressure responses to an acute bout of kettlebell exercise. J Strength Cond Res 35(2S): S173-S179, 2021-Kettlebell (KB) training has become an extremely popular exercise program for improving both muscle strength and aerobic fitness. However, the cardiac autonomic modulation and blood pressure (BP) responses induced by an acute KB exercise session are currently unknown. Understanding the impact of this exercise modality on the postexercise autonomic modulation and BP would facilitate appropriate exercise prescription in susceptible populations. This study evaluated the effects of an acute session of KB exercise on heart rate variability and BP responses in healthy individuals. Seventeen (male = 10 and female = 7) healthy subjects completed either a KB or nonexercise control trial in randomized order. Heart rate variability and BP measurements were collected at baseline, 3, 10, and 30 minutes after each trial. There were significant increases (p < 0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (nLF/nHF) for 30 minutes after the KB trial, whereas no changes from baseline were observed after the control trial. There were also significant decreases (p < 0.01) in markers of vagal tone (RMMSD and nHF) for 30 minutes as well as (p < 0.01) systolic BP and diastolic BP at 10 and 30 minutes after the KB trial, whereas no changes from baseline were observed after the control trial. Our findings indicate that KB exercise increases sympathovagal balance for 30 minutes postintervention, which is concurrent with an important hypotensive effect. Further research is warranted to evaluate the potential clinical application of KB training in populations that might benefit from postexercise hypotension, such as hypertensives.