Is bureaucracy being busted in research ethics and governance for health services research in the UK?:Experiences and perspectives reported by stakeholders through an online survey

Acknowledgements: We would like to thank the Board of Trustees of HSRUK for support and advice throughout study. Thank you to all respondents to the survey for contributing their data and views. The HRA and NIHR are also warmly acknowledged for their continued support throughout the study.Peer reviewedPublisher PD

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients?

Objective To explore patients’ experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury. Design Qualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture. Setting Patients treated by paramedics in the catchment area of one emergency department in South Wales. Participants Six patients and one carer of a patient who received fascia iliaca compartment block (FICB). Intervention FICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB—a local anaesthetic injection directly into the hip region—or usual care—most commonly morphine—using audited scratch cards. Outcomes Acceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants’ consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member. Results Patients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury. Conclusions This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting

Paramedics' experiences of administering fascia iliaca compartment block to patients in South Wales with suspected hip fracture at the scene of injury: results of focus groups

Objectives To explore paramedics’ experience of delivering fascia iliaca compartment block (FICB) to patients with suspected hip fracture at the scene of injury. Design Focus groups within a randomised controlled trial. Setting Paramedics based at ambulance stations in the catchment area of one Emergency Department in South Wales, recruited and trained in a feasibility study about an alternative to routine prehospital pain management for patients with suspected hip fracture. Participants 11 paramedics. Intervention Paramedic-administered FICB to patients with suspected hip fracture. We randomly allocated eligible patients to FICB, a local anaesthetic injection directly into the hip region—or usual care, most commonly morphine - using audited scratch cards. Outcomes Paramedics’ experiences of administering FICB gathered through thematic analysis of interview transcripts by two researchers, one paramedic and one lay member. Results Respondents believed that FICB was a suitable intervention for paramedics to deliver. It aligned with routine practice and was within people’s capabilities. They said it took up to 10 minutes longer than usual care to prepare and deliver, in part due to nervousness and unfamiliarity with a new procedure. They praised the training provided but said they were anxious about causing harm by injecting into the wrong location. Confidence increased after one paramedic team successfully treated a patient for local anaesthetic toxicity. Reported challenges related to the emergency context: patients often waited many hours for ambulance arrival; moving patients exacerbated their pain; family and neighbours were present as paramedics administered treatment. Conclusions Paramedics are willing and able to administer FICB to patients with suspected hip fracture before ambulance transport to hospital. Feasibility study findings will inform further research

Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study

Background In managing hip fracture, effective pain relief before admission to hospital is difficult without risking side effects. Although emergency departments routinely use fascia iliaca compartment block (FICB), there has been little evaluation of its use by paramedics before hospital admission. We aimed to assess whether a multi-centre randomised trial to evaluate FICB was feasible. Methods Volunteer paramedics used scratchcards to allocate patients with hip fracture at random between FICB and pain relief as usual. Primary outcomes were mortality and quality of life. We also measured adverse events, costs, final diagnosis, length of stay in hospital, pain scores and quality of care and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on the recruitment of paramedics and patients, delivery of FICB, retrieval of outcome data, safety, acceptability, and diagnostic accuracy of hip fracture. Results We effectively met all progression criteria: we recruited 19 paramedics who randomly allocated 71 patients between trial arms between 28 June 2016 and 31 July 2017; 57 (31 experimental arm, 26 usual care arm, 80% overall) retrospectively consented to follow-up. Just over half (17/31) of experimental participants received FICB; all others had contraindications, including nine taking anticoagulants. Four of the 31 participants assigned FICB and six of the 26 assigned usual care died within 6 months of hospital admission. Serious adverse events were also similar: 3/35 experimental versus 4/36 in usual care. Paramedics’ recognition of hip fracture had sensitivity of 49/64 (77%) with a positive predictive value of 46/57 (81%). We received quality of life questionnaires for 30 of 49 patients (61%) at 1 month and 12 of 17 (71%) at 6 months. Patient satisfaction was similar: experimental mean 3.4 (n = 20) versus 3.5 (n = 13) for usual care. Conclusions RAPID met all progression criteria within reasonable limits. As equipoise remains, we plan to undertake a fully powered multi-centre trial to test clinical and cost effectiveness of paramedic-administered FICB at the scene of hip fracture

Women’s Perceptions of Journeying Toward an Unknown Future With Breast Cancer: The “Lives at Risk Study”

Breast cancer risk classifications are useful for prognosis, yet little is known of their effect on patients. This study clarified women's understandings of risk as they "journeyed" through the health care system. Breast cancer patients and women undergoing genetic investigation were recruited ( N = 25) from a large UK Health Board, 2014-2015, completing a "Book of Experience," and Bio-photographic elicitation interviews. Stakeholder and Participant Feedback Forums were undertaken with key stakeholders, including patients, oncologists, funders, and policy developers, to inform team understanding. Thematic and visual frameworks from multidisciplinary analysis workshops uncovered two themes: "Subjective Understandings of Risk" and "Journeying Toward an Unknown Future." Breast cancer patients and women undergoing investigation experienced risk intuitively. Statistical formulations were often perplexing, diverting attention away from concrete life-and-death facts. Following risk classification, care must be co-defined to reduce patients' foreboding about an unknown future, taking into consideration personal risk management strategies and aspirations for a cancer-free future

What are emergency ambulance services doing to meet the needs of people who call frequently? A national survey of current practice in the United Kingdom

Background Emergency ambulance services are integral to providing a service for those with unplanned urgent and life-threatening health conditions. However, high use of the service by a small minority of patients is a concern. Our objectives were to describe: service-wide and local policies or pathways for people classified as Frequent Caller; call volume; and results of any audit or evaluation. Method We conducted a national survey of current practice in ambulance services in relation to the management of people who call the emergency ambulance service frequently using a structured questionnaire for completion by email and telephone interview. We analysed responses using a descriptive and thematic approach. Results Twelve of 13 UK ambulance services responded. Most services used nationally agreed definitions for ‘Frequent Caller’, with 600–900 people meeting this classification each month. Service-wide policies were in place, with local variations. Models of care varied from within-service care where calls are flagged in the call centre; contact made with callers; and their General Practitioner (GP) with an aim of discouraging further calls, to case management through cross-service, multi-disciplinary team meetings aiming to resolve callers’ needs. Although data were available related to volume of calls and number of callers meeting the threshold for definition as Frequent Caller, no formal audits or evaluations were reported. Conclusions Ambulance services are under pressure to meet challenging response times for high acuity patients. Tensions are apparent in the provision of care to patients who have complex needs and call frequently. Multi-disciplinary case management approaches may help to provide appropriate care, and reduce demand on emergency services. However, there is currently inadequate evidence to inform commissioning, policy or practice development

STRategies to manage Emergency ambulance Telephone Callers with sustained High needs: an Evaluation using linked Data (STRETCHED) – a study protocol

Introduction UK ambulance services have identified a concern with high users of the 999 service and have set up ‘frequent callers’ services, ranging from within-service management to cross-sectoral multidisciplinary case management approaches. There is little evidence about how to address the needs of this patient group. Aim To evaluate effectiveness, safety and efficiency of case management approaches to the care of people who frequently call the emergency ambulance service, and gain an understanding of barriers and facilitators to implementation. Objectives (1) Develop an understanding of predicted mechanisms of change to underpin evaluation. (2) Describe epidemiology of sustained high users of 999 services. (3) Evaluate case management approaches to the care of people who call the 999 ambulance service frequently in terms of: (i) Further emergency contacts (999, emergency department, emergency admissions to hospital) (ii) Effects on other services (iii) Adverse events (deaths, injuries, serious medical emergencies and police arrests) (iv) Costs of intervention and care (v) Patient experience of care. (4) Identify challenges and opportunities associated with using case management models, including features associated with success, and develop theories about how case management works in this population. Methods and analysis We will conduct a multisite mixed-methods evaluation of case management for people who use ambulance services frequently by using anonymised linked routine data outcomes in a ‘natural experiment’ cohort design, in four regional ambulance services. We will conduct interviews and focus groups with service users, commissioners and emergency and non-acute care providers. The planned start and end dates of the study are 1 April 2019 and 1 September 2022, respectively Ethics and dissemination The study received approval from the UK Health Research Authority (Confidentiality Advisory Group reference number: 19/CAG/0195; research ethics committee reference number: 19/WA/0216). We will collate feedback from our Lived Experience Advisory Panel, the Frequent Caller National Network and Research Management Group for targeted dissemination activities

Association of Diabetes in Pregnancy with Child Weight at Birth, Age 12 Months and 5 Years – A Population-Based Electronic Cohort Study

This study examines the effect of diabetes in pregnancy on offspring weight at birth and ages 1 and 5 years.A population-based electronic cohort study using routinely collected linked healthcare data. Electronic medical records provided maternal diabetes status and offspring weight at birth and ages 1 and 5 years (n = 147,773 mother child pairs). Logistic regression models were used to obtain odds ratios to describe the association between maternal diabetes status and offspring size, adjusted for maternal pre-pregnancy weight, age and smoking status.We identified 1,250 (0.9%) pregnancies with existing diabetes (27.8% with type 1 diabetes), 1,358 with gestational diabetes (0.9%) and 635 (0.4%) who developed diabetes post-pregnancy. Children whose mothers had existing diabetes were less likely to be large at 12 months (OR: 0.7 (95%CI: 0.6, 0.8)) than those without diabetes. Maternal diabetes was associated with high weight at age 5 years in children whose mothers had a high pre-pregnancy weight tertile (gestational diabetes, (OR:2.1 (95%CI:1.25-3.6)), existing diabetes (OR:1.3 (95%CI:1.0 to 1.6)).The prevention of childhood obesity should focus on mothers with diabetes with a high maternal pre-pregnancy weight. We found little evidence that diabetes in pregnancy leads to long term obesity 'programming'

Paediatric frequent use of emergency medical services: A systematic review

BackgroundFrequent use of emergency medical services (EMS) is recognised to be a global phenomenon, although paediatric frequent use is poorly understood. This systematic review aimed to understand how paediatric frequent use of EMS is currently defined, identify factors associated with paediatric frequent use of EMS and determine effectiveness of interventions for paediatric patients who frequently use EMS. MethodsFour electronic databases (Medline, CINAHL, Web of Science and PsycINFO) were searched to September 2022 for primary, peer-reviewed research studies published in English from January 2000. Studies were included that examined frequent use (>1 contact during study period) of EMS or other services with arrival via EMS. Paediatric patients were defined as <18 years of age or otherwise defined by study authors as paediatric/adolescent/children. Data were extracted using a structured proforma, and quality was assessed using the Standard Quality Assessment Criteria for Quantitative Studies but did not influence inclusion decisions. Data were presented using narrative synthesis. ResultsThe search resulted in 4,172 unique references, with 12 papers included in the review from seven countries. Four were EMS studies, and eight Emergency Department (ED) with arrival via EMS. All studies used retrospective designs, with no interventional studies identified. Paediatric frequent EMS users were more likely to use services for medical reasons rather than trauma, including respiratory complaints, mental health, and seizures, but data on gender and ethnicity were inconclusive and silent on socio-economic status. There was no consistency in definitions of either a paediatric patient or of frequent use. ConclusionThe broad range of reasons for frequent use suggests that a single intervention is unlikely to be effective at addressing the causes of frequent use. There is a need for further research to better identify the underlying reasons for frequent EMS use amongst paediatric patients and to develop interventions in this population