Using publicly available UK datasets to identify recruitment sites to maximise inclusion of under-served groups: three case studies.

Background: There is strong evidence that those recruited into studies are not always representative of the population for whom the research is most relevant. Development of the study design and funding decisions are points in the research process where considerations about inclusion of under-served populations may usefully be made. Current practical guidance focuses on designing and modifying participant recruitment and retention approaches but an area that has not been addressed is recruitment site selection. Methods: We present case studies of three NIHR funded trials to demonstrate how publicly available UK population datasets can be used to facilitate the identification of under-served communities for inclusion in trials. The trials have different designs, address different needs and demonstrate recruitment planning across Trauma centres, NHS Trusts and special educational settings.We describe our use of national freely available datasets, such as those provided by NHS Digital and the Office for National Statistics, to identify potential recruitment sites with consideration of health status, socio-economic status and ethnicity as well as clinical and risk factors to support inclusivity.For all three studies, we produced lists of potential recruitment sites in excess of the number anticipated as necessary to meet the recruitment targets. Discussion: We reflect on the challenges to our approach and some potential future developments. The datasets used are all free to use but each has their limitations. Agreeing search parameters, acceptable proxies and identifying the appropriate datasets, then cross referencing between datasets takes considerable time and particular expertise. The case studies are trials, but the methods are generalisable for various other study types. Conclusion: Through these exemplars, we aim to build on the NIHR INCLUDE project, by providing trialists with a much needed practical approach to embedding EDI into trial design at the grant application stage.

Impact of Social Stories on social and emotional health of autism spectrum primary school children: the ASSSIST2 RCT with economic evaluation.

Background: Differences in the way autistic children experience the world can contribute to anxiety and stress. Carol Gray's Social Stories™ are a highly personalised intervention to support children by providing social information about specific situations in an individual story. Objectives: This randomised controlled trial aimed to establish whether Social Stories are clinically effective and cost-effective in improving social responsiveness and social and emotional health in children on the autism spectrum in schools. Design: A multisite pragmatic cluster randomised controlled trial comparing Social Stories with care as usual. Setting: Eighty-seven schools (clusters) across Yorkshire and the Humber. Participants: Two hundred and forty-nine children were randomised via a bespoke system hosted at York Trials Unit (129 Social Stories and 120 care as usual). Recruitment was completed in May 2021. Participants were children aged 4-11 years with a diagnosis of autism, alongside teachers, interventionists and caregivers. Recruitment was via schools, NHS trusts, support groups and local publicity. Intervention: The intervention included training for educational professionals and caregivers covering psychoeducation and implementation of Social Stories. Stories were written around contextualised goals around the child's need for social information. Interventionists read the Social Story™ with the child at least six times over 4 weeks during school. Main outcome measure: The primary outcome was the Social Responsiveness Scale-2 completed by teachers at 6 months (the primary end point), which measures social awareness, cognition, communication and behaviour. Data were collected from caregivers and educational professionals at 6 weeks and 6 months through questionnaires. Blinding of participants was not possible. Results: At 6 months, the estimated difference in expected teacher-reported Social Responsiveness Scale-2 T-score (the primary end point) was -1.61 (95% confidence interval -4.18 to 0.96, p = 0.220), slightly favouring the intervention group. The estimated differences for the parent-reported secondary outcomes at 6 months were small and generally favoured the control group except the measure of children's quality-adjusted life-year (+ 0.001, 95% confidence interval -0.032 to 0.035) and parental stress (-1.49, 95% confidence interval -5.43 to 2.46, p = 0.460), which favoured the intervention group. Children in the intervention group met their individual goals more frequently than children who received usual care alone (0.97 confidence interval 0.21 to 1.73, p = 0.012). The intervention is likely to save small costs (-£191 per child, 95% confidence interval -767.7 to 337.7) and maintain a similar quality of life compared to usual care. The probability of Social Stories being a preferred option is 75% if the society is willing to pay £20,000 per quality-adjusted life-year gained. Limitations include considerable disruptions during the coronavirus disease 2019 pandemic. Conclusion: Social Stories are used in schools and represent a low-cost intervention. There is no clinically evident impact on social responsiveness, anxiety and/or depression, parental stress or general health. Benefits were observed for specific behavioural goals as assessed by the teacher, and Social Stories may serve as a useful tool for facilitating dialogue between children and school staff to address specific behavioural challenges. Usage should be at the school's discretion. Future work: Given the uncertainty of the results in light of coronavirus disease 2019, further work to establish the impact of Social Stories is merited. Trial registration: This trial is registered as ISRCTN11634810. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/111/91) and is published in full in Health Technology Assessment; Vol. 28, No. 39. See the NIHR Funding and Awards website for further award information.

Autism affects the way children experience the world, and some children find social situations stressful. We wanted to know whether Social Stories™, developed by Carol Gray, helped children with their social skills and behaviour in school and whether they offered value for money. A randomised controlled trial design was used, which gave schools an equal chance of being asked to deliver Social Stories or to continue providing care as usual. Two hundred and forty-nine children from 87 schools took part and we trained school staff and parents to write and deliver Social Stories. We agreed with teachers and parents, what each child needed help with and wrote stories with this in mind. Trained staff read the Social Story with the child at least six times over 4 weeks. Follow-up information was collected from parents and school staff at the start of the study, after 6 weeks and 6 months. After 6 months, teachers completed a questionnaire called the Social Responsiveness Scale-2 which measures the child's social skills. Using these measures, the results suggest that Social Stories do not lead to any significant changes in social skills, mental health, parent stress, general health or quality of life but children in schools allocated to Social Stories met their goal more frequently and incurred less costs than children who did not. Parents and educational professionals found the Social Stories intervention and training beneficial. Based on our findings, Social Stories do not appear to improve general social skills in primary-aged autistic children. Benefits were observed for specific goals, and school-based costs were reduced.

Mixed Methods EvAluation of the high-volume low-complexity Surgical hUb pRogrammE (MEASURE): a mixed methods study protocol.

INTRODUCTION: The waiting list for elective surgery in England recently reached over 7.8 million people and waiting time targets have been missed since 2010. The high-volume low complexity (HVLC) surgical hubs programme aims to tackle the backlog of patients awaiting elective surgery treatment in England. This study will evaluate the impact of HVLC surgical hubs on productivity, patient care and the workforce. METHODS AND ANALYSIS: This 4-year project consists of six interlinked work packages (WPs) and is informed by the Consolidated Framework for Implementation Research. WP1: Mapping current and future HVLC provision in England through document analysis, quantitative data sets (eg, Hospital Episodes Statistics) and interviews with national service leaders. WP2: Exploring the effects of HVLC hubs on key performance outcomes, primarily the volume of low-complexity patients treated, using quasi-experimental methods. WP3: Exploring the impact and implementation of HVLC hubs on patients, health professionals and the local NHS through approximately nine longitudinal, multimethod qualitative case studies. WP4: Assessing the productivity of HVLC surgical hubs using the Centre for Health Economics NHS productivity measure and Lord Carter's operational productivity measure. WP5: Conducting a mixed-methods appraisal will assess the influence of HVLC surgical hubs on the workforce using: qualitative data (WP3) and quantitative data (eg, National Health Service (NHS) England's workforce statistics and intelligence from WP2). WP6: Analysing the costs and consequences of HVLC surgical hubs will assess their achievements in relation to their resource use to establish value for money. A patient and public involvement group will contribute to the study design and materials. ETHICS AND DISSEMINATION: The study has been approved by the East Midlands-Nottingham Research Ethics Committee 23/EM/0231. Participants will provide informed consent for qualitative study components. Dissemination plans include multiple academic and non-academic outputs (eg, Peer-reviewed journals, conferences, social media) and a continuous, feedback-loop of findings to key stakeholders (eg, NHS England) to influence policy development. TRIAL REGISTRATION: Research registry: Researchregistry9364 (https://www.researchregistry.com/browse-the-registry%23home/registrationdetails/64cb6c795cbef8002a46f115/).

The well-being of nurses working in general practice during the COVID-19 pandemic: A qualitative study (The GenCo Study).

AIM: Exploration of experiences of nurses working in general practice during the COVID-19 pandemic to evaluate the impact on nurses' professional well-being. DESIGN: An exploratory qualitative study comprised of case studies of three general practice sites in England and a nationwide interview study of nurses working in general practice and nurse leaders. The study was funded by The General Nursing Council for England and Wales Trust. University of York ethics approval (HSRGC/2021/458/I) and Health Research Authority approval was obtained (IRAS: 30353, Protocol number: R23982, Ref 21/HRA/5132, CPMS: 51834). METHODS: Forty participants took part. Case site data consisted of interviews/focus groups and national data consisted of semi-structured interviews. Data collection took place between April and August 2022. Analysis was underpinned by West et al.'s The courage of compassion. Supporting nurses and midwives to deliver high-quality care, The King's fund, 2020 ABC framework of nurses' core work well-being needs. FINDINGS: The majority of participants experienced challenges to their professional well-being contributed to by lack of recognition, feeling undervalued and lack of involvement in higher-level decision-making. Some participants displayed burnout and stress. Structural and cultural issues contributed to this and many experiences pre-dated, but were exacerbated by, the COVID-19 pandemic. CONCLUSIONS: By mapping findings to the ABC framework, we highlight the impact of the COVID-19 pandemic on the well-being of nurses working in general practice and contributing workplace factors. The issues identified have implications for retention and for the future of nursing in general practice. The study highlights how this professional group can be supported in the future. IMPACT: The study contributes to our understanding of the experiences of nurses working in general practice during the COVID-19 pandemic and beyond. Findings have implications for this skilled and experienced workforce, for retention of nurses in general practice, the sustainability of the profession more broadly and care quality and patient safety. REPORTING METHOD: Standards for Reporting Qualitative Research (O'Brien et al. in Journal of the Association of American Medical Colleges, 89(9), 1245-1251, 2014). PATIENT OR PUBLIC CONTRIBUTION: As this was a workforce study there was no patient or public contribution.

Remote and technology-mediated working during the COVID-19 pandemic: A qualitative exploration of the experiences of nurses working in general practice (the GenCo Study).

AIM: To explore how nurses working in general practice experienced remote and technology-mediated working during the COVID-19 pandemic. DESIGN: Exploratory qualitative study with nursing team members working in general practices in England and national nurse leaders. METHODS: Data were collected between April and August 2022. Forty participants took part in either semi-structured interviews or focus groups. Data were analysed using Framework Analysis informed by the PERCS (Planning and Evaluating Remote Consultation Services) Framework. University of York ethics approval [HSRGC/2021/458/I] and Health Research Authority approval were obtained [IRAS:30353. Protocol number: R23982. Ref 21/HRA/5132. CPMS: 51834]. The study was funded by The General Nursing Council for England and Wales Trust. RESULTS: Participants continued to deliver a significant proportion of patient care in-person. However, remote and technology-mediated care could meet patients' needs and broaden access in some circumstances. When remote and technology-mediated working were used this was often part of a blended model which was expected to continue. This could support some workforce issues, but also increase workload. Participants did not always have access to remote technology and were not involved in decision-making about what was used and how this was implemented. They rarely used video consultations, which were not seen to add value in comparison to telephone consultations. Some participants expressed concern that care had become more transactional than therapeutic and there were potential safety risks. CONCLUSION: The study explored how nurses working in general practice during the COVID-19 pandemic engaged with remote and technology-mediated working. It identifies specific issues of access to technology, workload, hybrid working, disruption to therapeutic relationships, safety risks and lack of involvement in decision-making. Changes were implemented quickly with little strategic input from nurses. There is now an opportunity to reflect and build on what has been learned in relation to remote and technology-mediated working to ensure the future development of safe and effective nursing care in general practice. IMPACT: The paper contributes to understanding of remote and technology-mediated working by nurses working in general practice during the COVID-19 pandemic and indicates to employers and policy makers how this can be supported moving forward. REPORTING METHOD: Standards for Reporting Qualitative Research (O'Brien et al., 2014). PATIENT OR PUBLIC CONTRIBUTION: This was a workforce study so there was no patient or public contribution. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: The paper highlights specific issues which have implications for the development of remote, technology-mediated and blended working for nurses in general practice, care quality and patient safety. These require full attention to ensure the future development of safe and effective nursing care in general practice moving forward.

Why do people take part in vaccine trials? A mixed methods narrative synthesis.

OBJECTIVES: To understand why individuals do or do not take part in vaccine trials, exploring the motivators and barriers to identify effective strategies to optimise recruitment in vaccine research. METHODS: Qualitative studies and quantitative surveys capturing data on reasons for trial participation/decline were included. Six databases were searched from 1996 to October 2021. Two reviewers independently screened and assessed risk of bias. Results were reported narratively and analysed using thematic analysis. RESULTS: We included 32 studies (17 qualitative; 12 quantitative; 3 mixed-methods) that covered a wide range of populations, geographical areas and disease types. Eight themes were identified 1) altruism; 2) potential for personal benefit; 3) perceived risks; 4) trust or distrust; 5) social networks; 6) stigma; 7) practical implications; 8) research vanguard. CONCLUSION: Our findings provide a detailed description of how potential participants weigh up their decisions to participate in vaccine trials, which could inform the planning and implementation of studies to enhance recruitment. PRACTICE IMPLICATIONS: Clinical trial researchers should consider a patient-centered approach to recruitment, tailoring promoting material and attempt to understand fears, stigma and perceived risks. In addition, recognising the importance of trust and the key role friends, communities, family, and those in supervisory positions play in decisions.

What is important to adults after lower limb reconstruction surgery: a conceptual framework.

PURPOSE: Patient-reported outcome measures (PROMs) are used to understand the impact of lower limb reconstruction on patient's Health-Related Quality of Life (HRQL). Existing measures have not involved this group of patients and their experiences during development. This study aimed to develop a conceptual framework to reflect what is important to patients requiring, undergoing or after undergoing reconstructive surgery. METHODS: Our population of interest was people requiring, undergoing or after undergoing reconstructive surgery due to trauma, malunion, nonunion, infection or congenital issues treated by internal or external fixation. We undertook semi-structured interviews with patients and orthopaedic healthcare professionals (surgeons, methodologists and patient contributors) in England. RESULTS: Thirty-two patients and 22 orthopaedic healthcare professionals (surgeons, methodologists and patient contributors) were interviewed between November 2020 and June 2021. Eight domains from a previously developed preliminary conceptual framework were used as a framework around which to code the interviews using thematic analysis. Six domains important to patients (from the perspective of patients and orthopaedic healthcare professionals) were included in the final conceptual framework: pain, perception-of-self, work and finances, daily lifestyle and functioning, emotional well-being, and support. These findings, plus meetings with our advisory panel led to the refinement of the conceptual framework. CONCLUSION: The first five domains relate to important outcomes for patients; they are all inter-related and their importance to patients changed throughout recovery. The final domain-support (from work, the hospital, physiotherapists and family/friends)-was vital to patients and lessened the negative impact of the other domains on their HRQL. These new data strengthen our original findings and our understanding of the domains we identified in the QES. The next step in this research is to ascertain whether current PROMs used with this group of patients adequately capture these areas of importance.

Communication interventions for medically unexplained symptom conditions in general practice: A systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Medically unexplained symptoms (MUS) account for 3-50% of all General Practitioner (GP) consultations and are difficult to diagnose due to their unknown aetiology, symptom overlap between conditions, and lack of effective treatment options. MUS patients' and primary care clinicians frequently face challenges during consultations, with GPs reporting difficulty identifying and classifying MUS, whilst patients report stigma and feeling illegitimised by clinicians. Communication interventions have been proposed as a method to facilitate the doctor-patient relationship and aid the management of MUS. AIM: This systematic review aims to evaluate the effectiveness of primary care based communication interventions at improving MUS patients' and/or clinician outcomes. METHOD: Four electronic databases were searched from inception to November 2021. Two researchers independently undertook screening, data extraction and quality appraisal. Given the heterogeneous nature of the studies identified, narrative syntheses were conducted, along with meta-analyses where possible to pool data. RESULTS: 9 papers from 10 Randomised Controlled Trials were included. The included studies displayed considerable risk of bias and poor reporting. Some limited evidence suggests that communication interventions tailored to MUS and not following a pre-specified model (such as reattribution) could improve pain, mental and physical functioning whilst reattribution training may improve clinician confidence treating MUS. However, methodological limitations mean that these findings should be interpreted with caution. CONCLUSION: A range of interventions for improving communication with MUS patients in primary care have been evaluated. However, the heterogeneous nature of existing evidence and poor study quality mean we cannot conclude whether these interventions are effective. Before considering further randomised controlled trials researchers should focus on developing a new or modified communication intervention for MUS patients and their clinicians. TRAIL REGISTRATION: The systematic review was prospectively registered with PROSPERO (registration record CRD42020206437).

Do general practitioners working in or alongside the emergency department improve clinical outcomes or experience? A mixed-methods study.

OBJECTIVES: To examine the effect of general practitioners (GPs) working in or alongside the emergency department (GPED) on patient outcomes and experience, and the associated impacts of implementation on the workforce. DESIGN: Mixed-methods study: interviews with service leaders and NHS managers; in-depth case studies (n=10) and retrospective observational analysis of routinely collected national data. We used normalisation process theory to map our findings to the theory's four main constructs of coherence, cognitive participation, collective action and reflexive monitoring. SETTING AND PARTICIPANTS: Data were collected from 64 EDs in England. Case site data included: non-participant observation of 142 clinical encounters; 467 semistructured interviews with policy-makers, service leaders, clinical staff, patients and carers. Retrospective observational analysis used routinely collected Hospital Episode Statistics alongside information on GPED service hours from 40 hospitals for which complete data were available. RESULTS: There was disagreement at individual, stakeholder and organisational levels regarding the purpose and potential impact of GPED (coherence). Participants criticised policy development and implementation, and staff engagement was hindered by tensions between ED and GP staff (cognitive participation). Patient 'streaming' processes, staffing and resource constraints influenced whether GPED became embedded in routine practice. Concerns that GPED may increase ED attendance influenced staff views. Our quantitative analysis showed no detectable impact on attendance (collective action). Stakeholders disagreed whether GPED was successful, due to variations in GPED model, site-specific patient mix and governance arrangements. Following statistical adjustment for multiple testing, we found no impact on: ED reattendances within 7 days, patients discharged within 4 hours of arrival, patients leaving the ED without being seen; inpatient admissions; non-urgent ED attendances and 30-day mortality (reflexive monitoring). CONCLUSIONS: We found a high degree of variability between hospital sites, but no overall evidence that GPED increases the efficient operation of EDs or improves clinical outcomes, patient or staff experience. TRIAL REGISTRATION NUMBER: ISCRTN5178022.

Perspectives of GPs working in or alongside emergency departments in England: qualitative findings from the GPs and Emergency Departments Study.

BACKGROUND: Around 43% of emergency department (ED) attendances can be managed in general practice. Strategies to address this include directing appropriate patients to GPs working in or alongside EDs (GPED). Views of GPs choosing to work in GPED roles may inform planning and implementation of GPED services as well as wider general practice provision. AIM: To explore the experiences and motivations of GPs choosing to work in GPED services in England, and to identify factors that may support or hinder GPs working in GPED roles. DESIGN AND SETTING: Thematic analysis of 42 semi-structured interviews of GPs working in 10 GPED case sites across England. METHOD: Qualitative GP interviews from a mixed-methods study of GPs in GPED roles were thematically analysed in relation to research aims. RESULTS: Four themes were generated: the 'pull' of a portfolio career; the 'push' of disillusionment with general practice; professional reciprocity; sustainability of GPED services and core general practice. Flexible, favourable working conditions, collaboration, and professional development made GPED an attractive workplace, often as part of a portfolio career or after retiring from core general practice. Working in GPED services was largely driven by disillusionment with core general practice. Both GPED and core general practice were thought to benefit from GPED GPs' skills. There were concerns about GPED sustainability and destabilisation of core general practice. CONCLUSION: GPED may extend the clinical careers of experienced GPs and support recruitment and retention of more recently qualified GPs. Despite some benefits, GPED may destabilise core general practice and increase pressure on both environments.

General Practice Nurses' experiences of changing care delivery during COVID-19. Implications for future practice: Qualitative study protocol.

AIM: To explore how General Practice Nurses experience implementing change at pace and scale in delivering care during consecutive waves of the COVID-19 pandemic. To evaluate the impact of changes to general practice nurses' working practices on professional wellbeing. BACKGROUND: In response to the COVID-19 pandemic, general practice rapidly and extensively changed care delivery. There has been little exploration of the experiences of General Practice Nurses and care delivery, job satisfaction, workload, stress and professional support. DESIGN: A qualitative case study design of three to five general practice case sites will explore General Practice Nurses' experiences during the Covid-19 pandemic. The study was funded and approved by the General Nursing Council Trust in June 2021. University ethics approval was gained in July 2021. Health Research Authority approval has been obtained [IRAS:30353. Protocol number: R23982. Ref 21/HRA/5132. CPMS: 51834]. METHODS: Data will consist of focus groups and/or semi-structured interviews with General Practice Nurses, primary healthcare team members and other key informants. Business/strategy and nurse team meetings relating to workforce planning/review will be observed. Documents will be analysed and routinely collected general practice data will provide descriptive contextualisation at each site. The study will be theoretically underpinned by the Non-adoption, Abandonment, Scale-up, Spread and Sustainability Framework and data analysed using framework analysis. DISCUSSION: General Practice Nurses have a unique sphere of knowledge and undertake specific work in primary care. This workforce is challenged by recruitment, retention and retirement issues, leading to the loss of highly experienced and knowledgeable professionals. It is important to explore how working practices brought about by Covid-19 affect General Practice Nurses. IMPACT: This study will explore working practices brought about by the Covid-19 pandemic to inform care delivery, patient care and support General Practice Nursing workforce wellbeing and will highlight and mitigate negative aspects of novel and changing care delivery. Key factors in implementing and supporting future practice and change implementation will be developed. TRIAL REGISTRATION: CPMS: 51834.

Surgery versus conservative management of stable thoracolumbar fracture: the PRESTO feasibility RCT.

BACKGROUND: There is informal consensus that simple compression fractures of the body of the thoracolumbar vertebrae between the 10th thoracic vertebra and the second lumbar vertebra without neurological complications can be managed conservatively and that obvious unstable fractures require surgical fixation. However, there is a zone of uncertainty about whether surgical or conservative management is best for stable fractures. OBJECTIVES: To assess the feasibility of a definitive randomised controlled trial comparing surgical fixation with initial conservative management of stable thoracolumbar fractures without spinal cord injury. DESIGN: External randomised feasibility study, qualitative study and national survey. SETTING: Three NHS hospitals. METHODS: A feasibility randomised controlled trial using block randomisation, stratified by centre and type of injury (high- or low-energy trauma) to allocate participants 1 : 1 to surgery or conservative treatment; a costing analysis; a national survey of spine surgeons; and a qualitative study with clinicians, recruiting staff and patients. PARTICIPANTS: Adults aged ≥ 16 years with a high- or low-energy fracture of the body of a thoracolumbar vertebra between the 10th thoracic vertebra and the second lumbar vertebra, confirmed by radiography, computerised tomography or magnetic resonance imaging, with at least one of the following: kyphotic angle > 20° on weight-bearing radiographs or > 15° on a supine radiograph or on computerised tomography; reduction in vertebral body height of 25%; a fracture line propagating through the posterior wall of the vertebra; involvement of two contiguous vertebrae; or injury to the posterior longitudinal ligament or annulus in addition to the body fracture. INTERVENTIONS: Surgical fixation: open spinal surgery (with or without spinal fusion) or minimally invasive stabilisation surgery. Conservative management: mobilisation with or without a brace. MAIN OUTCOME MEASURE: Recruitment rate (proportion of eligible participants randomised). RESULTS: Twelve patients were randomised (surgery, n = 8; conservative, n = 4). The proportion of eligible patients recruited was 0.43 (95% confidence interval 0.24 to 0.63) over a combined total of 30.7 recruitment months. Of 211 patients screened, 28 (13.3%) fulfilled the eligibility criteria. Patients in the qualitative study (n = 5) expressed strong preferences for surgical treatment, and identified provision of information about treatment and recovery and when and how they are approached for consent as important. Nineteen surgeons and site staff participated in the qualitative study. Key themes were the lack of clinical consensus regarding the implementation of the eligibility criteria in practice and what constitutes a stable fracture, alongside lack of equipoise regarding treatment. Based on the feasibility study eligibility criteria, 77% (50/65) and 70% (46/66) of surgeons participating in the survey were willing to randomise for high- and low-energy fractures, respectively. LIMITATIONS: Owing to the small number of participants, there is substantial uncertainty around the recruitment rate. CONCLUSIONS: A definitive trial is unlikely to be feasible currently, mainly because of the small number of patients meeting the eligibility criteria. The recruitment and follow-up rates were slightly lower than anticipated; however, there is room to increase these based on information gathered and the support within the surgical community for a future trial. FUTURE WORK: Development of consensus regarding the population of interest for a trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12094890. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 62. See the NIHR Journals Library website for further project information.

Fractures occurring in the mid- to low back region (or thoracolumbar fractures) are the most common back fractures. When the fracture is stable with no spinal nerve injury, there is uncertainty whether treatment with surgery or non-surgical treatment (e.g. stabilising the spine with a brace) results in the best outcome for patients. The Pragmatic Randomised Evaluation of Stable Thoracolumbar fracture treatment Outcomes (PRESTO) study aimed to explore whether or not it would be feasible to carry out a full-scale study to find out which of these two treatments works best. Adults aged ≥ 16 years being treated for these fractures in three hospitals were invited to take part in the study. Over the course of 1 year, we assessed how many patients were treated, the number who met the study entry criteria and the proportion of eligible patients who agreed to take part. Staff and patients were interviewed about the study processes and their experiences of taking part. Spine surgeons from around the UK were also asked to complete an online survey, which asked questions about the treatment of patients with this fracture. There were fewer patients than expected who met the study entry criteria and, of these, fewer patients who agreed to take part. There were differences among surgeons about the definition of a stable fracture, and we found that surgeons have strong views about whether or not surgery is appropriate when fractures are stable. We also found that more support would be required for the staff involved in inviting patients to take part in a bigger study, and that the format and content of information provided to patients needs to be improved. The findings of the PRESTO study showed that a large trial is unlikely to be successful at this time; however, we have provided important information for future research into the treatment of these fractures.

Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over: the OTIS RCT.

BACKGROUND: Falls and fall-related fractures are highly prevalent among older people and are a major contributor to morbidity and costs to individuals and society. Only one small pilot trial has evaluated the effectiveness of a home hazard assessment and environmental modification in the UK. This trial reported a reduction in falls as a secondary outcome, and no economic evaluation was undertaken. Therefore, the results need to be confirmed and a cost-effectiveness analysis needs to be undertaken. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of a home hazard assessment and environmental modification delivered by occupational therapists for preventing falls among community-dwelling people aged ≥ 65 years who are at risk of falling, relative to usual care. DESIGN: This was a pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and a qualitative study. SETTING: Eight NHS trusts in primary and secondary care in England. PARTICIPANTS: In total, 1331 participants were randomised (intervention group, n = 430; usual-care group, n = 901) via a secure, remote service. Blinding was not possible. INTERVENTIONS: All participants received a falls prevention leaflet and routine care from their general practitioner. The intervention group were additionally offered one home environmental assessment and modifications recommended or provided to identify and manage personal fall-related hazards, delivered by an occupational therapist. MAIN OUTCOME MEASURES: The primary outcome was the number of falls per participant during the 12 months from randomisation. The secondary outcomes were the proportion of fallers and multiple fallers, time to fall, fear of falling, fracture rate, health-related quality of life and cost-effectiveness. RESULTS: The primary analysis included all 1331 randomised participants and indicated weak evidence of a difference in fall rate between the two groups, with an increase in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% confidence interval 0.99 to 1.38; p = 0.07). A similar proportion of participants in the intervention group (57.0%) and the usual-care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the secondary outcomes. The base-case cost-effectiveness analysis from an NHS and Personal Social Services perspective found that, on average per participant, the intervention was associated with additional costs (£18.78, 95% confidence interval £16.33 to £21.24), but was less effective (mean quality-adjusted life-year loss -0.0042, 95% confidence interval -0.0041 to -0.0043). Sensitivity analyses demonstrated uncertainty in these findings. No serious, related adverse events were reported. The intervention was largely delivered as intended, but recommendations were followed to a varying degree. LIMITATIONS: Outcome data were self-reported by participants, which may have led to inaccuracies in the reported falls data. CONCLUSIONS: We found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in this population of community-dwelling participants aged ≥ 65 years deemed at risk of falling. The intervention was more expensive and less effective than usual care, and therefore it does not provide a cost-effective alternative to usual care. FUTURE WORK: An evaluation of falls prevention advice in a higher-risk population, perhaps those previously hospitalised for a fall, or given by other professional staff could be justified. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22202133. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 46. See the NIHR Journals Library website for further project information.

Falling is a common problem among older people. In fact, up to half of people aged over 80 years fall each year, with most falls happening inside the home. Unfortunately, some falls cause serious injuries, such as broken bones. People often think that falls are part of getting older and that little can be done to stop them from falling. However, there are many ways to reduce falls. The Occupational Therapist Intervention Study (OTIS) explored whether or not a home assessment visit by an NHS occupational therapist could reduce falls among older people who are likely to be at risk of falling. In total, 1331 people aged 65 years or older living in England took part in the study. These people were all sent an Age UK leaflet about how to prevent falls, and 430 people were selected at random to receive a visit from an occupational therapist. The occupational therapist assessed their homes for hazards, such as slippery floors or poor lighting, and made suggestions for changes. We collected information from participants using monthly falls calendars and postal questionnaires to ask them about their falls, their quality of life, how often they used NHS services and how often they used paid care workers. We also asked them about whether they had had equipment and adaptations installed as a result of the assessments. We found that the home assessment visits did not reduce the number of falls people had or make any difference to participants' quality of life. However, many of the recommendations made by the occupational therapists were not carried out. The home assessment visits by an occupational therapist were not good value for money.

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.

BACKGROUND: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. DESIGN: Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. SETTING: NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. PARTICIPANTS: Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. RESULTS: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient's circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients' treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. CONCLUSIONS: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. TRIAL REGISTRATION: ACTIVE: ( ISRCTN98152560 ). Registered on 06/03/2018. PRESTO: ( ISRCTN12094890 ). Registered on 22/02/2018.

Factors influencing streaming to General Practitioners in emergency departments: A qualitative study.

BACKGROUND: Emergency Department attendance is increasing internationally, of which a significant proportion could be managed in general practice. In England, policies backed by substantial capital funding require such patients attending Emergency Departments be directed or 'streamed' to General Practitioners working in or parallel to Emergency Departments. However, evidence for streaming is limited and the processes of streaming patients attending Emergency Departments to General Practitioners lacks exploration. OBJECTIVES: This paper explores streaming to General Practitioners in and alongside Emergency Departments at ten sites across England. It highlights positive streaming practice, as well as issues that may contribute to poor streaming practice, in order to inform future service improvement. METHODS: A longitudinal qualitative study was conducted with data collected between October 2017 and December 2019 across 10 case study sites throughout England as part of a broader mixed methods study. 186 non-participant observations and 226 semi-structured interviews with 191 health professionals working in Emergency Departments or related General Practitioner Services were thematically analysed in relation to streaming processes and experiences. RESULTS: Six interconnected themes influencing streaming were identified: implementing and maintaining structural support; developing and supporting streaming personnel; implementing workable and responsive streaming protocols; negotiating primary/secondary care boundaries; developing and maintaining interprofessional relationships and concerns for patient safety. Streaming was considered central to the success of General Practitioners in/parallel to Emergency Departments. The importance of the skills of streaming nurses in delivering an optimal and safety critical service was highlighted, as was the skillset of General Practitioners and interprofessional relationships between streamers and General Practitioners. There was no distinct streaming model or method associated with good streaming practice to General Practitioners in/alongside Emergency Departments, instead factors for success were identified and key recommendations suggested. 'Inappropriate' streaming was identified as a problem, where patients streamed to General Practitioners in or parallel to Emergency Departments required Emergency Department management, or patients suitable for General Practitioner care were kept in the Emergency Department. CONCLUSION: Despite adopting differing methods, commonalities across case sites in the delivery of good streaming practice were identified, leading to identification of key recommendations which may inform development of streaming services. STUDY REGISTRATION: ISRCTN51780222. Tweetable abstract: Workplace culture and the skillset of streamers and General Practitioners is crucial to streaming of patients to General Practitioners in Emergency Departments.

What are the implications for patient safety and experience of a major healthcare IT breakdown? A qualitative study.

INTRODUCTION: To explore the impact of a three-week downtime to an electronic pathology system on patient safety and experience. METHODS: Qualitative study consisting of semi-structured interviews and a focus group at a large NHS teaching hospital in England. Participants included NHS staff (n = 16) who represented a variety of staff groups (doctors, nurses, healthcare assistants) and board members. Data were collected 2-5 months after the outage and were analysed thematically. RESULTS: We present the implications which the IT breakdown had for both patient safety and patient experience. Whilst there was no actual recorded harm to patients during the crisis, there was strong and divided opinion regarding the potential for a major safety incident to have occurred. Formal guidance existed to assist staff to navigate the outage but there was predominantly a reliance on informal workarounds. Junior clinicians seemed to struggle without access to routine blood test results whilst senior clinicians seemed largely unperturbed. Patient experience was negatively affected due to the extensive wait time for manually processed diagnostic tests, increasing logistical problems for patients. CONCLUSION: The potential negative consequences on patient safety and experience relating to IT failures cannot be underestimated. To minimise risks during times of crisis, clear communication involving all relevant stakeholders, and guidance and management strategies that are agreed upon and communicated to all staff are recommended. To improve patient experience flexible approaches to patient management are suggested.

Potential impacts of general practitioners working in or alongside emergency departments in England: initial qualitative findings from a national mixed-methods evaluation.

OBJECTIVES: To explore the potential impacts of introducing General Practitioners into Emergency Departments (GPED) from the perspectives of service leaders, health professionals and patients. These 'expectations of impact' can be used to generate hypotheses that will inform future implementations and evaluations of GPED. DESIGN: Qualitative study consisting of 228 semistructured interviews. SETTING: 10 acute National Health Service (NHS) hospitals and the wider healthcare system in England. Interviews were undertaken face to face or via telephone. Data were analysed thematically. PARTICIPANTS: 124 health professionals and 94 patients and carers. 10 service leaders representing a range of national organisations and government departments across England (eg, NHS England and Department of Health) were also interviewed. RESULTS: A range of GPED models are being implemented across the NHS due to different interpretations of national policy and variation in local context. This has resulted in stakeholders and organisations interpreting the aims of GPED differently and anticipating a range of potential impacts. Participants expected GPED to affect the following areas: ED performance indicators; patient outcome and experience; service access; staffing and workforce experience; and resources. Across these 'domains of influence', arguments for positive, negative and no effect of GPED were proposed. CONCLUSIONS: Evaluating whether GPED has been successful will be challenging. However, despite uncertainty surrounding the direction of effect, there was agreement across all stakeholder groups on the areas that GPED would influence. As a result, we propose eight domains of influence that will inform our subsequent mixed-methods evaluation of GPED. TRIAL REGISTRATION NUMBER: ISRCTN51780222.

A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults.

AIMS: A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. METHODS: A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods. DISCUSSION: The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: Bone Jt Open 2021;2(3):150-163.

Quality of life following a lower limb reconstructive procedure: a protocol for the development of a conceptual framework.

INTRODUCTION: Lower limb conditions requiring reconstructive surgery can be either congenital or acquired from trauma, infection or other medical conditions. Patient-reported outcome measures (PROMs) are often used by healthcare professionals to assess the impact of a patient's condition (and treatment) on quality of life. However, we are not aware of any measures developed specifically for people requiring lower limb reconstructive surgery. Consequently, it is not clear the extent to which current PROMs accurately and specifically measure the outcomes that are important to these patients. METHODS AND ANALYSIS: The 'PROLLIT' (Patient-Reported Outcome Measure for Lower Limb Reconstruction) involves three phases: to explore what is important to patients with regard to quality of life (phase 1), ascertain whether current measures adequately capture these experiences (phase 2) and if not begin, the development of a new PROM (phase 3). The population of interest is people requiring, undergoing or after undergoing reconstructive surgery for a lower limb condition. In this paper, we describe phase 1, which aims to develop a conceptual framework to identify and map what is important to this group with regard to social interactions, employment, perceived health and quality of life after condition onset/injury and throughout recovery. The conceptual framework will be developed through three steps: (step A) a qualitative evidence synthesis, (step B) a qualitative study with patients and staff to explore patient's views and experiences of lower limb reconstructive surgery and (step C) a round table discussion with key stakeholders where findings from step A and step B will be brought together and used to finalise the conceptual framework. ETHICS CONSIDERATION AND DISSEMINATION: Ethical approval has been granted for the qualitative data collection (step B) from South Central Berkshire Research Ethics committee (REF:20/SC/0114). Findings from steps A and B will be submitted for peer-reviewed publication in academic journals, and presented at academic conferences. PROSPERO REGISTRATION NUMBER: CRD42019139587. ISRCTN REGISTRATION NUMBER: ISRCTN75201623.

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention.

BACKGROUND: Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights. DESIGN: Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. SETTING: Seven NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-to-face or over the telephone. PARTICIPANTS: Twenty-one REFORM trial participants and 14 podiatrists who delivered the REFORM intervention. RESULTS: Factors affecting fidelity included: how similar the intervention was to routine practice; the challenges of delivering a multifaceted intervention to a heterogeneous older population; and practical issues with delivery such as time and training. Trial participants' views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial and individual factors such as medical conditions may also have affected intervention fidelity. CONCLUSIONS: Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project-specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed-methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN68240461. Registered on 01/07/2011.