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.

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.

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.

Oral melatonin for non-respiratory sleep disturbance in children with neurodisabilities: systematic review and meta-analyses.

AIM: To evaluate the effectiveness of pharmacological interventions for managing non-respiratory sleep disturbances in children with neurodisabilities. METHOD: We performed a systematic review and meta-analyses of randomized controlled trials (RCTs). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017. Data were extracted and assessed for quality by two researchers (B.B., C.M., G.S., A.S., A.P.). RESULTS: Thirteen trials were included, all evaluating oral melatonin. All except one were at high or unclear risk of bias. There was a statistically significant increase in diary-reported total sleep time for melatonin compared with placebo (pooled mean difference 29.6min, 95% confidence interval [CI] 6.9-52.4, p=0.01). Statistical heterogeneity was high (97%). For the single RCT with low risk of bias, the unadjusted mean difference in total sleep time was 13.2 minutes (95% CI -13.3 to 39.7) favouring melatonin, while the mean difference adjusted for baseline total sleep time was statistically significant (22.4min, 95% CI 0.5-44.3, p=0.04). Adverse event profile suggested that melatonin was well-tolerated. INTERPRETATION: There is a paucity of evidence on managing sleep disturbances in children with neurodisabilities, and it is mostly of limited scope and poor quality. There is evidence of the benefit and safety of melatonin compared with placebo, although the extent of this benefit is unclear. WHAT THIS PAPER ADDS: Melatonin for the management of non-respiratory sleep disturbances in children with neurodisabilities was well tolerated with minimal adverse effects. The extent of benefit and which children might benefit most from melatonin use is uncertain. Benefit may be greatest in those with autism spectrum disorder; however, this finding should be interpreted with caution.

Melatonina oral para la alteración del sueño no respiratoria en niños con trastornos del neurodesarrollo: revisión sistemática y metaanálisis OBJETIVO: Evaluar la efectividad de las intervenciones farmacológicas para el tratamiento de los trastornos del sueño no respiratorios en niños con trastornos del neurodesarrollo. MÉTODO: Se realizó una revisión sistemática y un metaanálisis de ensayos controlados aleatorios (ECA). Se realizaron búsquedas en 16 bases de datos, literatura gris y listas de referencias de los artículos incluidos hasta febrero de 2.017. Dos investigadores extrajeron y evaluaron la calidad de la calidad. RESULTADOS: Se incluyeron trece ensayos, todos evaluaron la melatonina oral. Todos excepto uno tenía un riesgo alto o incierto de sesgo. Hubo un aumento estadísticamente significativo en el tiempo total de sueño informado por los registros - usando diarios de datos - para la melatonina en comparación con el placebo (diferencia de medias agrupada 29,6 min, intervalo de confianza [IC] del 95% [IC] 6,9-52,4, p = 0,01). La heterogeneidad estadística fue alta (97%). Para el ECA único con bajo riesgo de sesgo, la diferencia media no ajustada en el tiempo total de sueño fue de 13,2 minutos (IC del 95% −13,3 a 39,7) favoreciendo a la melatonina, mientras que la diferencia media ajustada para el tiempo total de sueño basal fue estadísticamente significativa (22,4 min. IC del 95%: 0,5-44,3, p = 0,04). El perfil de eventos adversos sugirió que la melatonina fue bien tolerada. INTERPRETACIÓN: Existe una escasez de evidencia sobre el manejo de los trastornos del sueño en niños con trastornos del neurodesarrollo, los datos actuales son principalmente de alcance limitado y de mala calidad. Existe evidencia del beneficio y la seguridad de la melatonina en comparación con el placebo, aunque el alcance de este beneficio no está claro.

Melatonina oral para distúrbios não-respiratórios do sono em crianças com neuro-incapacidades: revisão sistemática e metanálise OBJETIVO: Avaliar a efetividade de intervenções farmacológicas para o manejo de distúrbios não-respiratórios do sono em crianças com neuro-incapacidades. MÉTODO: Realizamos uma revisão sistemática e metanálise de ensaios clínicos randomizados (ECRs). Buscamos 16 bases de dados, literatura cinzenta, e listas de referências dos artigos incluídos até fevereiro de 2017. Os dados foram extraídos e avaliados quanto a sua qualidade por dois pesquisadores. RESULTADOS: Treze estudos foram incluídos, todos avaliando a melatonina oral. Todos, com exceção de um, tinham risco de viés alto ou não esclarecido. Houve aumento estatisticamente significativo no tempo total de sono reportado em diário para melatonina comparada com placebo (diferença média agrupada 29,6min, intervalo de confiança [IC] 95% 6,9-52,4, p = 0,01). A heterogeneidade estatística foi alta (97%). Para o único ECR com baixo risco de viés, a diferença média não ajustada no tempo total de sono foi 13,2 minutos (IC 95% −13,3 a 39,7) em favor da melatonina, enquanto a diferença média ajustada para o tempo total de sono na linha de base foi estatisticamente significativa (22,4min, IC 95% 0,5-44,3, p = 0,04). O perfil de eventos adversos sugeriu que a melatonina foi bem tolerada. INTERPRETAÇÃO: Há escassez de evidência sobre o manejo de distúrbios do sono em crianças com neuroincapacidades, e a mesma tem escopo limitado e pouca qualidade. Há evidência do benefício e segurança da melatonina comparada com o placebo, embora e extensão do benefício não esteja clara.

Understanding Public Attitudes Toward Researchers Using Social Media for Detecting and Monitoring Adverse Events Data: Multi Methods Study.

BACKGROUND: Adverse events are underreported in research studies, particularly randomized controlled trials and pharmacovigilance studies. A method that researchers could use to identify more complete safety profiles for medications is to use social media analytics. However, patient's perspectives on the ethical issues associated with using patient reports of adverse drug events on social media are unclear. OBJECTIVE: The objective of this study was to explore the ethics of using social media for detecting and monitoring adverse events for research purposes using a multi methods approach. METHODS: A multi methods design comprising qualitative semistructured interviews (n=24), a focus group (n=3), and 3 Web-based discussions (n=20) with members of the public was adopted. Findings from a recent systematic review on the use of social media for monitoring adverse events provided a theoretical framework to interpret the study's findings. RESULTS: Views were ascertained regarding the potential benefits and harms of the research, privacy expectations, informed consent, and social media platform. Although the majority of participants were supportive of social media content being used for research on adverse events, a small number of participants strongly opposed the idea. The potential benefit of the research was cited as the most influential factor to whether participants would give their consent to their data being used for research. There were also some caveats to people's support for the use of their social media data for research purposes: the type of social media platform and consideration of the vulnerability of the social media user. Informed consent was regarded as difficult to obtain and this divided the opinion on whether it should be sought. CONCLUSIONS: Social media users were generally positive about their social media data being used for research purposes; particularly for research on adverse events. However, approval was dependent on the potential benefit of the research and that individuals are protected from harm. Further study is required to establish when consent is required for an individual's social media data to be used.

Staff expectations for the implementation of an electronic health record system: a qualitative study using normalisation process theory.

BACKGROUND: Global evidence suggests a range of benefits for introducing electronic health record (EHR) systems to improve patient care. However, implementing EHR within healthcare organisations is complex and, in the United Kingdom (UK), uptake has been slow. More research is needed to explore factors influencing successful implementation. This study explored staff expectations for change and outcome following procurement of a commercial EHR system by a large academic acute NHS hospital in the UK. METHODS: Qualitative interviews were conducted with 14 members of hospital staff who represented a variety of user groups across different specialities within the hospital. The four components of Normalisation Process Theory (Coherence, Cognitive participation, Collective action and Reflexive monitoring) provided a theoretical framework to interpret and report study findings. RESULTS: Health professionals had a common understanding for the rationale for EHR implementation (Coherence). There was variation in willingness to engage with and invest time into EHR (Cognitive participation) at an individual, professional and organisational level. Collective action (whether staff feel able to use the EHR) was influenced by context and perceived user-involvement in EHR design and planning of the implementation strategy. When appraising EHR (Reflexive monitoring), staff anticipated short and long-term benefits. Staff perceived that quality and safety of patient care would be improved with EHR implementation, but that these benefits may not be immediate. Some staff perceived that use of the system may negatively impact patient care. The findings indicate that preparedness for EHR use could mitigate perceived threats to the quality and safety of care. CONCLUSIONS: Health professionals looked forward to reaping the benefits from EHR use. Variations in level of engagement suggest early components of the implementation strategy were effective, and that more work was needed to involve users in preparing them for use. A clearer understanding as to how staff groups and services differentially interact with the EHR as they go about their daily work was required. The findings may inform other hospitals and healthcare systems on actions that can be taken prior to EHR implementation to reduce concerns for quality and safety of patient care and improve the chance of successful implementation.

Non-pharmacological interventions for non-respiratory sleep disturbance in children with neurodisabilities: a systematic review.

AIM: To describe existing evidence on non-pharmacological interventions to manage sleep disturbance in children with neurodisabilities. METHOD: We systematically reviewed non-pharmacological interventions aimed at improving non-respiratory sleep disturbance in children with neurodisability. Sixteen databases, grey literature, and reference lists of included papers were searched up to February 2017. Two researchers (B.B., C.M., G.S., A.S., A.P.) undertook screening, data extraction, and quality appraisal. RESULTS: Twenty-five studies were included: 11 randomized controlled trials and 14 before-and-after studies. All studies were at high or unclear risk of bias. Parent-directed interventions were categorized as comprehensive tailored interventions (n=9), comprehensive non-tailored interventions (n=8), and non-comprehensive interventions (n=2). Six 'other' non-pharmacological interventions were included. Seventy-one child and parent sleep-related outcomes were measured across the included studies. We report the two most commonly measured outcomes: the Child Sleep Habits Questionnaire and sleep onset latency. Five studies reported significant improvements on at least one of these outcomes. INTERPRETATION: Various types of non-pharmacological intervention for managing sleep disturbance have been evaluated. Clinical heterogeneity and poor study quality meant we could not draw definitive conclusions on the effectiveness of these interventions. Current clinical guidance recommends parent-directed interventions as the first approach to managing sleep disturbance; prioritizing research in this area is recommended. WHAT THIS PAPER ADDS: Existing evidence on non-pharmacological interventions to manage sleep disturbance in children with neurodisabilities is predominately of poor quality. Most included studies evaluated parent-directed interventions of varying content and intensity. There was very little consistency between studies in the outcome measures used. There is some evidence that parent-directed interventions may improve child outcomes.

Cost-Effectiveness of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People: The REducing Falls with Orthoses and a Multifaceted Podiatry Intervention Trial Findings.

BACKGROUND: Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures. OBJECTIVE: To evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial. METHODS: REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland; 1,010 participants (> 65 years) were randomised to receive either a podiatry intervention (n = 493), including foot and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or usual podiatry treatment plus a falls prevention leaflet (n = 517). PRIMARY OUTCOME: incidence of falls per participant in the 12 months following randomisation. SECONDARY OUTCOMES: proportion of fallers and quality of life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and Clinical Excellence reference case standards, using a regression-based approach with costs expressed in GBP (2015 price). The base case analysis used an intention-to-treat approach on the imputed data set using multiple imputation. RESULTS: There was a small, non-statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73-1.05, p = 0.16). Participants allocated to the intervention group accumulated on average marginally higher QALYs than the usual care participants (mean difference 0.0129, 95% CI -0.0050 to 0.0314). The intervention costs were on average GBP 252 more per participant compared to the usual care participants (95% CI GBP -69 to GBP 589). Incremental cost-effectiveness ratios ranged between GBP 19,494 and GBP 20,593 per QALY gained, below the conventional National Health Service cost-effectiveness thresholds of GBP 20,000 to GBP 30,000 per additional QALY. The probability that the podiatry intervention is cost-effective at a threshold of GBP 30,000 per QALY gained was 0.65. The results were robust to sensitivity analyses. CONCLUSION: The benefits of the intervention justified the moderate cost. The intervention could be a cost-effective option for falls prevention when compared with usual care in the UK.

Mental health training programmes for non-mental health trained professionals coming into contact with people with mental ill health: a systematic review of effectiveness.

BACKGROUND: The police and others in occupations where they come into close contact with people experiencing/with mental ill health, often have to manage difficult and complex situations. Training is needed to equip them to recognise and assist when someone has a mental health issue or learning/intellectual disability. We undertook a systematic review of the effectiveness of training programmes aimed at increasing knowledge, changing behaviour and/or attitudes of the trainees with regard to mental ill health, mental vulnerability, and learning disabilities. METHODS: Databases searched from 1995 onwards included: ASSIA, Cochrane Central Register of Controlled Clinical Trials (CENTRAL), Criminal Justice Abstracts, Embase, ERIC, MEDLINE, PsycINFO, Social Science Citation Index. Courses, training, or learning packages aimed at helping police officers and others who interact with the public in a similar way to deal with people with mental health problems were included. Primary outcomes were change in practice and change in outcomes for the groups of people the trainees come into contact with. Systematic reviews, randomised controlled trials (RCTs) and non- randomised controlled trials (non-RCTs) were included and quality assessed. In addition non-comparative evaluations of training for police in England were included. RESULTS: From 8578 search results, 19 studies met the inclusion criteria: one systematic review, 12 RCTs, three prospective non-RCTs, and three non-comparative studies. The training interventions identified included broad mental health awareness training and packages addressing a variety of specific mental health issues or conditions. Trainees included police officers, teachers and other public sector workers. Some short term positive changes in behaviour were identified for trainees, but for the people the trainees came into contact with there was little or no evidence of benefit. CONCLUSIONS: A variety of training programmes exist for non-mental health professionals who come into contact with people who have mental health issues. There may be some short term change in behaviour for the trainees, but longer term follow up is needed. Research evaluating training for UK police officers is needed in which a number of methodological issues need to be addressed. TRIAL REGISTRATION: Protocol registration number: PROSPERO: CRD42015015981 .

Exploring the implementation of an electronic record into a maternity unit: a qualitative study using Normalisation Process Theory.

BACKGROUND: To explore the benefits, barriers and disadvantages of implementing an electronic record system (ERS). The extent that the system has become 'normalised' into routine practice was also explored. METHODS: Qualitative semi-structured interviews were conducted with 19 members of NHS staff who represented a variety of staff groups (doctors, midwives of different grades, health care assistants) and wards within a maternity unit at a NHS teaching hospital. Interviews were conducted during the first year of the phased implementation of ERS and were analysed thematically. The four mechanisms of Normalisation Process Theory (NPT) (coherence, cognitive participation, collective action and reflexive monitoring) were adapted for use within the study and provided a theoretical framework to interpret the study's findings. RESULTS: Coherence (participants' understanding of why the ERS has been implemented) was mixed - whilst those involved in ERS implementation anticipated advantages such as improved access to information; the majority were unclear why the ERS was introduced. Participants' willingness to engage with and invest time into the ERS (cognitive participation) depended on the amount of training and support they received and their willingness to change from paper to electronic records. Collective action (the extent the ERS was used) may be influenced by whether participants perceived there to be benefits associated with the system. Whilst some individuals reported benefits such as improved legibility of records, others felt benefits were yet to emerge. The parallel use of paper and the lack of integration of electronic systems within and between the trust and other healthcare organisations hindered ERS use. When appraising the ERS (reflexive monitoring) participants perceived the system to negatively impact the patient-clinician relationship, time and patient safety. CONCLUSIONS: Despite expectations that the ERS would have a number of advantages, its implementation was perceived to have a range of disadvantages and only a limited number of 'clinical benefits'. The study highlights the complexity of implementing electronic systems and the associated longevity before they can become 'embedded' into routine practice. Through the identification of barriers to the employment of electronic systems this process could be streamlined with the avoidance of any potential detriment to clinical services.

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.

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/).

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.

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.

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.

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.

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.

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.