Search

Abstract Background The SPHERe (Supervised Pulmonary Hypertension Exercise Rehabilitation) trial is a multi-centre, pragmatic, randomised controlled trial assessing the clinical and cost-effectiveness of supervised exercise rehabilitation with psychosocial and motivational support compared to best-practice usual care for people with pulmonary hypertension (PH). The original protocol was published in BMC Pulmonary Medicine (accessible online). We randomised our first participant in January 2020. In response to the COVID-19 pandemic, the trial was stopped in March 2020. In person delivery of the SPHERe intervention to a vulnerable population was not possible during the COVID-19 pandemic. We describe here how trial procedures and intervention delivery were adapted in response to the COVID-19 pandemic. Methods Restrictions imposed by the COVID-19 pandemic on the clinically vulnerable PH population meant that trial delivery was changed from a centre-based rehabilitation programme to remotely delivered group online sessions. This led to minor alterations to the eligibility criteria. These changes followed a consultation process with stakeholders and people with PH and were approved by the funder and independent trial committees. Conclusions We describe the modified SPHERe trial protocol in response to restrictions imposed by the COVID-19 pandemic. SPHERe is the first randomised controlled trial to assess the clinical and cost-effectiveness of an online group rehabilitation programme for people with PH compared to usual care. Trial registration ISRCTN no. 10608766. Prospectively registered on 18th March 2019, updated 16th August 2023.

Abstract Background One in five children with an intellectual disability in the UK display behaviours that challenge. Despite associated impacts on the children themselves, their families, and services, little research has been published about how best to design, organise, and deliver health and care services to these children. The purpose of this study was to describe how services are structured and organised (“service models”) in England for community-based health and care services for children with intellectual disability who display behaviours that challenge. Methods Survey data about services were collected from 161 eligible community-based services in England. Staff from 60 of these services were also interviewed. A combination of latent class and descriptive analysis, coupled with consultation with family carers and professionals was used to identify and describe groupings of similar services (i.e., “service models”). Results The latent class analysis, completed as a first step in the process, supported a distinction between specialist services and non-specialist services for children who display behaviours that challenge. Planned descriptive analyses incorporating additional study variables were undertaken to further refine the service models. Five service models were identified: Child and Adolescent Mental Health Services (CAMHS) (n = 69 services), Intellectual Disability CAMHS (n = 28 services), Children and Young People Disability services (n = 25 services), Specialist services for children who display behaviours that challenge (n = 27 services), and broader age range services for children and/or adolescents and adults (n= 12 services). Conclusions Our analysis led to a typology of five service models for community health and care services for children with intellectual disabilities and behaviours that challenge in England. Identification of a typology of service models is a first step in building evidence about the best provision of services for children with intellectual disabilities who display behaviours that challenge. The methods used in the current study may be useful in research developing service typologies in other specialist fields of health and care. Study registration Trial Registration: Current Controlled Trials ISRCTN88920546, Date assigned 05/07/2022.

Abstract Background Healthcare systems invest in leadership development of surgeons, surgical trainees, and teams. However, there is no agreement on how interventions should be designed, or what components they must contain to be successful. The objective of this realist review was to generate a programme theory explaining in which context and for whom surgical leadership interventions work and why. Methods Five databases were systematically searched, and articles screened against inclusion considering their relevance. Context-mechanism-outcome configurations (CMOCs) and fragments of CMOCs were identified. Gaps in the CMOCs were filled through deliberation with the research team and stakeholder feedback. We identified patterns between CMOCs and causal relationships to create a programme theory. Results Thirty-three studies were included and 19 CMOCs were developed. Findings suggests that interventions for surgeons and surgical teams improve leadership if timely feedback is delivered on multiple occasions and by trusted and respected people. Negative feedback is best provided privately. Feedback from senior-to-junior or peer-to-peer should be delivered directly, whereas feedback from junior-to-senior is preferred when delivered anonymously. Leadership interventions were shown to be most effective for those with awareness of the importance of leadership, those with confidence in their technical surgical skills, and those with identified leadership deficits. For interventions to improve leadership in surgery, they need to be delivered in an intimate learning environment, consider implementing a speak-up culture, provide a variety of interactive learning activities, show a genuine investment in the intervention, and be customised to the needs of surgeons. Leadership of surgical teams can be best developed by enabling surgical teams to train together. Conclusions The programme theory provides evidence-based guidance for those who are designing, developing and implementing leadership interventions in surgery. Adopting the recommendations will help to ensure interventions are acceptable to the surgical community and successful in improving surgical leadership. Trial registration The review protocol is registered with PROSPERO (CRD42021230709).

Introduction Time from symptom onset to treatment initiation in tuberculosis (TB) remains stubbornly prolonged despite reductions in disease incidence. Delays may contribute to increased morbidity, mortality, onward spread of disease and poor patient experiences. Most delays occur prior to hospital referral. The average primary care healthcare provider in England is unlikely to see TB on a regular basis. Little is known about primary care diagnostic and referral challenges.Adults aged 65 years or older are more likely to experience delays. However, little is known about their journey from symptom onset to treatment initiation.Methods and analysis We will carry out a narrative study including adults aged 65 years or older, living in the English Midlands and receiving treatment for active TB. Twelve English and 12 Urdu or Punjabi speakers will be recruited from TB clinics and interviewed. Their primary care records will be accessed, and the primary care story and secondary care letters will be extracted. Each of the data sources will be analysed using dialogical narrative analysis. Data will be triangulated within participants and across the data set.Ethics and dissemination This study received approval from the Health Research Authority and the Research Ethics Committee in April 2022. Risk management and equity considerations have been made a priority. Findings will be disseminated through publication in open access peer-reviewed journals, presentations to policy makers, primary healthcare and secondary healthcare professionals, and through public facing materials developed in conjunction with patients, members of the pubic, TB services and charities.

Background People with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised pulmonary hypertension exercise rehabilitation (SPHERe) programme for people with PH.Methods Development was completed in three phases: (1) systematic review, (2) stakeholder engagement with consensus from patients and experts and (3) prepilot intervention acceptability testing. We completed systematic reviews to identify international cardiopulmonary rehabilitation guidance and trials of exercise-based interventions for people with PH. Evidence from systematic reviews and stakeholder consensus shaped the SPHERe intervention, including addition of individual behavioural support sessions to promote exercise adherence. The draft SPHERe intervention was ratified through discussions with multidisciplinary professionals and people living with PH. We acceptability tested the centre-based intervention with eight participants in a prepilot development phase which identified a number of condition-specific issues relating to safety and fear avoidance of activity. Comprehensive intervention practitioner training manuals were produced to ensure standardised delivery. Participant workbooks were developed and piloted. Trial recruitment began in January 2020 but was subsequently suspended in March 2020 further to COVID-19 pandemic ‘lockdowns’. In response to the pandemic, we undertook further development work to redesign the intervention to be suitable for exclusively home-based online delivery. Recruitment to the revised protocol began in June 2021.Discussion The final SPHERe intervention incorporated weekly home-based online group exercise and behavioural support ‘coaching’ sessions supervised by trained practitioners, with a personalised home exercise plan and the optional loan of a stationary exercise bike. The intervention was fully manualised with clear pathways for assessment and individualised exercise prescription. The clinical and cost-effectiveness of the SPHERe online rehabilitation intervention is currently being tested in a UK multicentre randomised controlled trial.Trial registration number ISCRTN10608766.

Background: Up to half of people hospitalised with COVID-19 report diverse and persistent symptoms affecting quality of life for months and sometimes years after discharge (long-COVID). We describe the development of an online group exercise and behavioural support intervention for people who continue to experience such physical and/or emotional health problems more than three months after hospital discharge. Methods: Intervention development was informed by the Medical Research Council framework for complex interventions. Our multidisciplinary team of academics, clinicians, and people with long-COVID, had collective expertise in the development and testing of complex interventions. We integrated a bio-psycho-social model of care drawing on rehabilitation literature for long-term health conditions and experiences from our pre-pilot study. Multiple stakeholder meetings were held to refine the intervention which was designed to be deliverable within the UK National Health Service. We adhere to TIDieR guidance for transparent and explicit reporting of telehealth interventions. Results: The final REGAIN online exercise and behavioural support intervention consisted of an initial 1:1 consultation with a trained practitioner, followed by eight online group exercise, and six group support, sessions delivered over eight weeks. Participants could also access an online library of on-demand exercise and support videos. Conclusions: The final REGAIN intervention, combining exercise and behavioural support, is fully manualised with clear pathways to delivery and implementation. It is currently being tested in a randomised controlled trial. The intervention, developed with extensive patient and stakeholder engagement, could be incorporated into existing NHS rehabilitation programmes, should it prove to be clinically and cost-effective for people with long-COVID. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) 11466448: Rehabilitation exercise and psychological support after COVID-19 infection: REGAIN.

Objective: Osteoarthritis is the most common joint disease with treatment involving a multidisciplinary approach with pharmacological, physical therapies and surgery as options. Qualitative research can help us to understand the complexity of managing health conditions and this understanding plays a role in good clinical practice. We aimed to systematically search for, identify, and synthesise qualitative research exploring the experience of living with osteoarthritis, including decision making about joint replacement. Methods: We comprehensively searched 4 bibliographic databases and used the methods of meta-ethnography to synthesise qualitative research findings. We screened 10 ​123 titles, 548 abstracts, and 139 full texts. We included findings from 118 reports (105 unique samples) of at least 2534 adults living with osteoarthritis around the world. Results: We developed 7 themes: Becoming your own expert can be hard work; Living has become a careful balancing act; Medication is a double-edged sword; I have other things in my life to consider; You have to weigh up the odds of surgery; Surgery is the only effective option; and Surgery will give me a chance to live now. These findings have been drawn into a conceptual model reflecting a complex balancing act with tensions underpinning treatment decision making. Conclusions: Osteoarthritis is framed as a world where patients become their own expert about their management and healthcare choices. Our conceptual model highlights key tensions underpinning treatment decision-making. These findings provide clinicians with insight of the complex nature of these decisions and how they can help patients through shared decision making.

Background: Improving effective leadership of individuals, groups, and healthcare organisations is essential for improving surgical performance and indirectly improving health outcomes for patients. Numerous systematic reviews have been conducted which seek to determine the effectiveness of specific leadership interventions across a range of disciplines and healthcare outcomes. The purpose of this realist review is to systematically synthesise the literature which examines in which context and for whom leadership interventions improve leadership of surgeons, surgical teams, and trainees. Methods: Several approaches will be used to iteratively search the scientific and grey literature to identify relevant evidence. Selected articles will inform the development of a programme theory that seeks to explain in which context and for whom interventions can improve leadership of surgical trainees, surgeons, and surgical teams. Next, empirical studies will be searched systematically in order to test and, where necessary, refine the theory. Once theoretical saturation has been achieved, recommendations for advancing leadership in surgery will be developed. Stakeholder and patient and public consultations will contribute to the development of the programme theory. The review will be written up according to the Realist And Meta-narrative Evidence Synthesis: Evolving Standards publication standards. No ethical review will be required for the conduct of this realist review. Discussion: The knowledge gained from this review will provide evidence-based guidance for those planning or designing leadership interventions in surgery. The recommendations will help policymakers, educationalists, healthcare providers, and those delivering or planning leadership development programmes across the surgical disciplines to design interventions that are acceptable to the surgical community and successful in improving surgical leadership. PROSPERO registration: CRD42021230709

ObjectivesThis study aimed to explore experiences of women with anal incontinence following a childbirth injury, and to identify areas of missed opportunities within care they received.DesignThis is a qualitative study involving semi-structured interviews.SettingParticipants were recruited via five hospitals in the UK, and via social media adverts and communication from charity organisations.ParticipantsWomen who have experienced anal incontinence following a childbirth injury, either within 7 years of sustaining the injury, or if they identified new, or worsening symptoms of AI at the time of menopause.Main outcome measuresMain outcomes are experiences of women with anal incontinence following childbirth injury, and missed opportunities within the care they received.ResultsThe following main themes were identified: opportunities for diagnosis missed, missed opportunities for information sharing and continuity and timeliness of care.ConclusionsAnal Incontinence following a childbirth injury has a profound impact on women. Lack of information and awareness both amongst women and healthcare professionals contributes to delays in accurate diagnosis and appropriate treatment.

Abstract Background There is little evidence about the lived experience of older people who have completed a falls prevention exercise programme and their life beyond their intervention. Method A phenomenological interview study with 23 participants (12 females), mean age 81 years (range 74–93 years), residing in their own homes across England, who had participated in a falls prevention exercise intervention within the Prevention of Falls Injury Trial (PreFIT). The aims were to explore their experiences of: i. being in a clinical trial involving exercise. ii. exercise once their falls prevention intervention had finished. Interpretative data analysis was informed by van Manen’s (1997) framework for phenomenological data. Results Analysis of interviews about experiences of participating in PreFIT and what happened once the falls intervention ended identified five themes: Happy to help; Exercise behaviours; “It keeps me going”; “It wasn’t a real fall”; and Loss. Participants did not continue their specific exercises after they had completed the intervention. They preferred walking as their main exercise, and none reported preventing falls as a motivator to continue exercising. Participant experiences suggest that they have their own ideas about what constitutes a fall and there is disparity between their interpretation and the definition used by healthcare professionals and researchers. Conclusion Despite good intentions and perceived benefits, on-going participation in falls prevention exercises beyond a structured, supervised intervention was not a priority for these older people. Promoting continuation of falls prevention exercises post-intervention is just as challenging as promoting uptake to and adherence during exercise programmes.

Abstract Background Clinical leadership is fundamental in facilitating service improvements in healthcare. Few studies have attempted to understand or model the different approaches to leadership which are used when promoting the uptake and implementation of evidence-based interventions. This research aims to uncover and explain how distributed clinical leadership can be developed and improved to enhance the use of evidence in practice. In doing so, this study examines implementation leadership in orthopaedic surgery to explain leadership as a collective endeavour which cannot be separated from the organisational context. Methods A mixed-method study consisting of longitudinal and cross-sectional interviews and an embedded social network analysis will be performed in six NHS hospitals. A social network analysis will be undertaken in each hospital to uncover the organisational networks, the focal leadership actors and information flows in each organisation. This will be followed by a series of repeated semi-structured interviews, conducted over 4 years, with orthopaedic surgeons and their professional networks. These longitudinal interviews will be supplemented by cross-sectional interviews with the national established surgical leaders. All qualitative data will be analysed using a constructivist grounded theory approach and integrated with the quantitative data. The participant narratives will enrich the social network to uncover the leadership configurations which exist, and how different configurations of leadership are functioning in practice to influence implementation processes and outcomes. Discussion The study findings will facilitate understanding about how and why different configurations of leadership develop and under what organisational conditions and circumstances they are able to flourish. The study will guide the development of leadership interventions that are grounded in the data and aimed at advancing leadership for service improvement in orthopaedics. The strength of the study lies in the combination of multi-component, multi-site, multi-agent methods to examine leadership processes in surgery. The findings may be limited by the practical challenges of longitudinal qualitative data collection, such as ensuring participant retention, which need to be balanced against the theoretical and empirical insights generated through this comprehensive exploration of leadership across and within a range of healthcare organisations.

Objectives To describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial.Design The I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described.Setting The intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development—to develop an opioid tapering App.Participants The I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month.Outcomes A multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use.Interventions and results Receiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a ‘trade-off to fill the deficit of the effect of the drug’. The final I-WOTCH intervention consists of an 8–10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK.Conclusions We describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial.Trial registration number ISRCTN49470934.

Background There is very limited research exploring the value and impact of qualitative research in chronic pain despite the large volume of research. Aims The aim of this study was to find out whether viewers’ comments in response to a YouTube film, portraying findings from a qualitative evidence synthesis about living with pain, revealed any potential value or impact to viewers. Methods We collected online data posted in response to the film Struggling to Be Me. We used themes from a large review of qualitative research as an a priori analytic framework. We used inductive thematic analysis to distil the essence of data that did not fit this framework. A thematic analysis of online comments to evaluate the impact of an arts-based health research film on people living with chronic pain is presented. Results We developed two inductive themes that explored the value and potential impact of watching the film online: (1) It has given voice to our suffering and (2) it makes me feel that I am not alone. Two subthemes added insight to the a priori framework: First, I have had enough of me added insight to the theme my life is impoverished and confined; second, I am treated like a criminal because I take opioids added insight to the theme lost personal credibility. Conclusions Our findings indicate that watching the YouTube film has potential value and impact, giving voice to suffering and making people feel that they are not alone. There are specific ethical challenges relating to internet-mediated research.

Abstract Background Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting. Methods This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1–5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions. Discussion The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH. Trial registration ISRCTN no. 10608766 , prospectively registered on 18th March 2019.

Abstract Background Working in good jobs is associated with good health. High unemployment rates are reported in those disabled with musculoskeletal pain. Supported employment interventions work well for helping people with mental health difficulties to gain and retain employment. With adaptation, these may be useful for people with chronic pain. We aimed to develop and explore the feasibility of delivering such an adapted intervention. Methods We developed an intervention and recruited unemployed people with chronic pain from NHS pain clinics and employment services. We trained case managers to assess participants and match them to six-week work placements in the Midlands and provide ongoing support to them and their managers. Participants attended a two-day work preparation session prior to placement. Outcome measures included quality of life at baseline, six- weeks, 14-weeks, and six-months, and return to work at 14-weeks and six-months. We held focus groups or interviews with stakeholders to examine acceptability and experiences of the intervention. Results We developed an intervention consisting of work preparation sessions, work experience placements, and individualised employment support. We enrolled 31 people; 27 attended work preparation sessions, and 15 attended placements. Four of our participants started jobs during the study period. We are aware of two others starting jobs shortly after cessation of follow-up. We experienced challenges to recruitment in one area where we had many and diverse placement opportunities and good recruitment in another area where we had a smaller range of placement opportunities. All stakeholders found the intervention acceptable, and it was valued by those given a placement. While there was some disappointment among those not placed, this group still valued the work preparation sessions. Conclusions The developed intervention was acceptable to participants and partners. Trialling the developed intervention could be feasible with attention to three main processes. To ensure advanced availability of a sufficiently wide range of work placements in each area, multiple partners would be needed. Multiple recruitment sites and focus on employment services will yield better recruitment rates than reliance on NHS pain clinics. Maintaining an adequate follow-up response rate will likely require additional approaches with more than the usual effort.

Objectives To identify aspects of the organisation and delivery of acute inpatient services for people with dementia that are associated with shorter length of hospital stay.Design and setting Retrospective cohort study of patients admitted to 200 general hospitals in England and Wales.Participants 10 106 people with dementia who took part in the third round of National Audit of Dementia.Main outcome measure Length of admission to hospital.Results The median length of stay was 12 days (IQR=6–23 days). People with dementia spent less time in hospital when discharge planning was initiated within 24 hours of admission (estimated effect −0.24, 95% CI: −0.29 to −0.18, p

Abstract Objectives The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge. Trial design Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded process evaluation and health economic evaluation. Participants Adults with ongoing COVID-19 sequelae more than three months after hospital discharge Inclusion criteria: 1) Adults ≥18 years; 2) ≥ 3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support; 3) substantial (as defined by the participant) COVID-19 related physical and/or mental health problems; 4) access to, and able/supported to use email and internet audio/video; 4) able to provide informed consent; 5) able to understand spoken and written English, Bengali, Gujarati, Urdu, Punjabi or Mandarin, themselves or supported by family/friends. Exclusion criteria: 1) exercise contraindicated; 2) severe mental health problems preventing engagement; 3) previous randomisation in the present study; 4) already engaged in, or planning to engage in an alternative NHS rehabilitation programme in the next 12 weeks; 5) a member of the same household previously randomised in the present study. Intervention and comparator Intervention 1: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) programme: an eight week, online, home-based, supervised, group rehabilitation programme. Intervention 2: A thirty-minute, on-line, one-to-one consultation with a REGAIN practitioner (best-practice usual care). Main outcomes The primary outcome is health-related quality of life (HRQoL) – PROMIS® 29+2 Profile v2.1 (PROPr) – measured at three months post-randomisation. Secondary outcomes include dyspnoea, cognitive function, health utility, physical activity participation, post-traumatic stress disorder (PTSD) symptom severity, depressive and anxiety symptoms, work status, health and social care resource use, death - measured at three, six and 12 months post-randomisation. Randomisation Participants will be randomised to best practice usual care or the REGAIN programme on a 1:1.03 basis using a computer-generated randomisation sequence, performed by minimisation and stratified by age, level of hospital care, and case level mental health symptomatology. Once consent and baseline questionnaires have been completed by the participant online at home, randomisation will be performed automatically by a bespoke web-based system. Blinding (masking) To ensure allocation concealment from both participant and REGAIN practitioner at baseline, randomisation will be performed only after the baseline questionnaires have been completed online at home by the participant. After randomisation has been performed, participants and REGAIN practitioners cannot be blind to group allocation. Follow-up outcome assessments will be completed by participants online at home. Numbers to be randomised (sample size) A total of 535 participants will be randomised: 263 to the best-practice usual care arm, and 272 participants to the REGAIN programme arm. Trial Status Current protocol: Version 3.0 (27th October 2020) Recruitment will begin in December 2020 and is anticipated to complete by September 2021. Trial registration ISRCTN:11466448 , 23rd November 2020 Full protocol The full protocol Version 3.0 (27th October 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

Abstract Background Rheumatoid arthritis is an autoimmune disease that causes joint inflammation. It affects around 400,000 people in the UK and 1 million adults in the USA. Given the appropriate treatment, many can have relatively few symptoms. It is therefore important to understand what it is like to live with rheumatoid arthritis and gain insight into peoples’ decisions about utilising healthcare. The aims of this study were: (1) to bring together qualitative evidence syntheses that explore patients’ experience of living with rheumatoid arthritis and (2) develop a conceptual understanding of what it is like to live with rheumatoid arthritis. Methods We used the methods of mega-ethnography. The innovation of mega-ethnography is to use conceptual findings from qualitative evidence syntheses as primary data. We searched four bibliographic databases from inception until September 2018 to identify qualitative evidence syntheses that explored patients’ experience of rheumatoid arthritis. Results We identified 373 qualitative evidence syntheses, removed 179 duplicates and screened 194 full text studies. We identified 42 qualitative evidence syntheses that explored the experience of pain or arthritis and 9 of these explored the experience of rheumatoid arthritis. We abstracted ideas into 10 conceptual categories: (1) rheumatoid arthritis is in control of my body (2) rheumatoid arthritis alters reciprocity; (3) rheumatoid arthritis is an emotional challenge; (4) rheumatoid arthritis disrupts my present and future self; (5) the challenge of balancing personal and work life; (6) I am trying to make sense of what is happening; (7) rheumatoid arthritis is variable and unpredictable; (8) rheumatoid arthritis is invisible; (9) I need a positive experience of healthcare, and (10) I need to reframe the situation. We developed a conceptual model underpinned by living life precariously with rheumatoid arthritis. Conclusions This is the second mega-ethnography, or synthesis of qualitative evidence syntheses using the methods of meta-ethnography. Future research should consider the proliferation of qualitative evidence synthesis in order to avoid duplication of research effort. Our model for rheumatoid arthritis has some important clinical implications that might be transferable to other musculoskeletal conditions.

Background: Concerns have repeatedly been expressed about the quality of inpatient care that people with dementia receive. Policies and practices have been introduced that aim to improve this, but their impact is unclear. Aims: To identify which aspects of the organisation and delivery of acute inpatient services for people with dementia are associated with higher-quality care and shorter length of stay. Design: Mixed-methods study combining a secondary analysis of data from the third National Audit of Dementia (2016/17) and a nested qualitative exploration of the context, mechanism and outcomes of acute care for people with dementia. Setting: Quantitative data from 200 general hospitals in England and Wales and qualitative data from six general hospitals in England that were purposively selected based on their performance in the audit. Participants: Quantitative data from clinical records of 10,106 people with dementia who had an admission to hospital lasting ≥ 72 hours and 4688 carers who took part in a cross-sectional survey of carer experience. Qualitative data from interviews with 56 hospital staff and seven carers of people with dementia. Main outcome measures: Length of stay, quality of assessment and carer-rated experience. Results: People with dementia spent less time in hospital when discharge planning was initiated within 24 hours of admission. This is a challenging task when patients have complex needs, and requires named staff to take responsibility for co-ordinating the discharge and effective systems for escalating concerns when obstacles arise. When trust boards review delayed discharges, they can identify recurring problems and work with local stakeholders to try to resolve them. Carers of people with dementia play an important role in helping to ensure that hospital staff are aware of patient needs. When carers are present on the ward, they can reassure patients and help make sure that they eat and drink well, and adhere to treatment and care plans. Clear communication between staff and family carers can help ensure that they have realistic expectations about what the hospital staff can and cannot provide. Dementia-specific training can promote the delivery of person-centred care when it is made available to a wide range of staff and accompanied by ‘hands-on’ support from senior staff. Limitations: The quantitative component of this research relied on audit data of variable quality. We relied on carers of people with dementia to explore aspects of service quality, rather than directly interviewing people with dementia. Conclusions: If effective support is provided by senior managers, appropriately trained staff can work with carers of people with dementia to help ensure that patients receive timely and person-centred treatment, and that the amount of time they spend in hospital is minimised. Future work: Future research could examine new ways to work with carers to co-produce aspects of inpatient care, and to explore the relationship between ethnicity and quality of care in patients with dementia. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 22. See the NIHR Journals Library website for further project information.

ObjectiveTo review qualitative studies on the experience of taking opioid medication for chronic non-malignant pain (CNMP) or coming off them.DesignThis is a qualitative evidence synthesis using a seven-step approach from the methods of meta-ethnography.Data sources and eligibility criteriaWe searched selected databases—Medline, Embase, AMED, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Web of Science and Scopus (Science Citation Index and Social Science Citation Index)—for qualitative studies which provide patients’ views of taking opioid medication for CNMP or of coming off them (June 2017, updated September 2018).Data extraction and synthesisPapers were quality appraised using the Critical Appraisal Skills Programme tool, and the GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation working group - Confidence in Evidence from Reviews of Qualitative research) guidelines were applied. We identified concepts and iteratively abstracted these concepts into a line of argument.ResultsWe screened 2994 unique citations and checked 153 full texts, and 31 met our review criteria. We identified five themes: (1) reluctant users with little choice; (2) understanding opioids: the good and the bad; (3) a therapeutic alliance: not always on the same page; (4) stigma: feeling scared and secretive but needing support; and (5) the challenge of tapering or withdrawal. A new overarching theme of ‘constantly balancing’ emerged from the data.ConclusionsPeople taking opioids were constantly balancing tensions, not always wanting to take opioids, and weighing the pros and cons of opioids but feeling they had no choice because of the pain. They frequently felt stigmatised, were not always ‘on the same page’ as their healthcare professional and felt changes in opioid use were often challenging.Trial registration number49470934; Pre-results.

Abstract Background Facilitation is a promising implementation intervention, which requires theory-informed evaluation. This paper presents an exemplar of a multi-country realist process evaluation that was embedded in the first international randomised controlled trial evaluating two types of facilitation for implementing urinary continence care recommendations. We aimed to uncover what worked (and did not work), for whom, how, why and in what circumstances during the process of implementing the facilitation interventions in practice. Methods This realist process evaluation included theory formulation, theory testing and refining. Data were collected in 24 care home sites across four European countries. Data were collected over four time points using multiple qualitative methods: observation (372 h), interviews with staff (n = 357), residents (n = 152), next of kin (n = 109) and other stakeholders (n = 128), supplemented by facilitator activity logs. A combined inductive and deductive data analysis process focused on realist theory refinement and testing. Results The content and approach of the two facilitation programmes prompted variable opportunities to align and realign support with the needs and expectations of facilitators and homes. This influenced their level of confidence in fulfilling the facilitator role and ability to deliver the intervention as planned. The success of intervention implementation was largely dependent on whether sites prioritised their involvement in both the study and the facilitation programme. In contexts where the study was prioritised (including release of resources) and where managers and staff support was sustained, this prompted collective engagement (as an attitude and action). Internal facilitators’ (IF) personal characteristics and abilities, including personal and formal authority, in combination with a supportive environment prompted by managers triggered the potential for learning over time. Learning over time resulted in a sense of confidence and personal growth, and enactment of the facilitation role, which resulted in practice changes. Conclusion The scale and multi-country nature of this study provided a novel context to conduct one of the few trial embedded realist-informed process evaluations. In addition to providing an explanatory account of implementation processes, a conceptual platform for future facilitation research is presented. Finally, a realist-informed process evaluation framework is outlined, which could inform future research of this nature. Trial registration Current controlled trials ISRCTN11598502.

Abstract Background Health care practice needs to be underpinned by high quality research evidence, so that the best possible care can be delivered. However, evidence from research is not always utilised in practice. This study used the Promoting Action on Research Implementation in Health Services (PARIHS) framework as its theoretical underpinning to test whether two different approaches to facilitating implementation could affect the use of research evidence in practice. Methods A pragmatic clustered randomised controlled trial with embedded process and economic evaluation was used. The study took place in four European countries across 24 long-term nursing care sites, for people aged 60 years or more with documented urinary incontinence. In each country, sites were randomly allocated to standard dissemination, or one of two different types of facilitation. The primary outcome was the documented percentage compliance with the continence recommendations, assessed at baseline, then at 6, 12, 18, and 24 months after the intervention. Data were analysed using STATA15, multi-level mixed-effects linear regression models were fitted to scores for compliance with the continence recommendations, adjusting for clustering. Results Quantitative data were obtained from reviews of 2313 records. There were no significant differences in the primary outcome (documented compliance with continence recommendations) between study arms and all study arms improved over time. Conclusions This was the first cross European randomised controlled trial with embedded process evaluation that sought to test different methods of facilitation. There were no statistically significant differences in compliance with continence recommendations between the groups. It was not possible to identify whether different types and “doses” of facilitation were influential within very diverse contextual conditions. The process evaluation (Rycroft-Malone et al., Implementation Science. doi: 10.1186/s13012-018-0811-0) revealed the models of facilitation used were limited in their ability to overcome the influence of contextual factors. Trial registration Current Controlled Trials ISRCTN11598502. Date 4/2/10. The research leading to these results has received funding from the European Union’s Seventh Framework Programme (FP7/2007–2013) under grant agreement no. 223646.

Abstract Background Mechanical chest compression devices consistently deliver high-quality chest compressions. Small very low-quality studies suggest mechanical devices may be effective as an alternative to manual chest compressions in the treatment of adult in-hospital cardiac arrest patients. The aim of this feasibility trial is to assess the feasibility of conducting an effectiveness trial in this patient population. Methods COMPRESS-RCT is a multi-centre parallel group feasibility randomised controlled trial, designed to assess the feasibility of undertaking an effectiveness to compare the effect of mechanical chest compressions with manual chest compressions on 30-day survival following in-hospital cardiac arrest. Over approximately two years, 330 adult patients who sustain an in-hospital cardiac arrest and are in a non-shockable rhythm will be randomised in a 3:1 ratio to receive ongoing treatment with a mechanical chest compression device (LUCAS 2/3, Jolife AB/Stryker, Lund, Sweden) or continued manual chest compressions. It is intended that recruitment will occur on a 24/7 basis by the clinical cardiac arrest team. The primary study outcome is the proportion of eligible participants randomised in the study during site operational recruitment hours. Participants will be enrolled using a model of deferred consent, with consent for follow-up sought from patients or their consultee in those that survive the cardiac arrest event. The trial will have an embedded qualitative study, in which we will conduct semi-structured interviews with hospital staff to explore facilitators and barriers to study recruitment. Discussion The findings of COMPRESS-RCT will provide important information about the deliverability of an effectiveness trial to evaluate the effect on 30-day mortality of routine use of mechanical chest compression devices in adult in-hospital cardiac arrest patients. Trial registration ISRCTN38139840, date of registration 9th January 2017.

Abstract Background Despite recent guidelines suggesting that patients with chronic non-malignant pain might not benefit, there has been a significant rise in opioid prescription for chronic non-malignant pain. This topic is important because an increasing number of HCPs are prescribing opioids despite very limited evidence for long-term opioid therapy for chronic non-malignant pain outside of end-of-life care. To better understand the challenges of providing effective treatment, we conducted the first qualitative evidence synthesis to explore healthcare professionals’ experience of treating people with chronic non-malignant pain. We report findings that explore healthcare professionals’ experience of prescribing opioids to this group of patients. Methods We searched five electronic bibliographic databases (Medline, Embase, CINAHL, PsychINFO, AMED) from inception to November 2015 and screened titles, abstracts and full texts of potential studies. We included studies in English that explored healthcare professionals’ experience of treating adults with chronic non-malignant pain. Two reviewers quality appraised each paper. We used the methods of meta-ethnography developed and refined for large reviews, and the GRADE-CERQual framework to rate confidence in review findings. Results We screened 954 abstracts and 184 full texts, and included 77 studies in the full review. 17 of these 77 studies included concepts that explored the experience of prescribing opioids. We abstracted these concepts into 6 overarching themes: (1) Should I, shouldn’t I? (2) Pain is Pain; (3) Walking a fine line; (4) Social guardianship; (5) Moral boundary work; (6) Regulations and guidelines. We used the GRADE-CERQual framework to evaluate confidence in findings. A new overarching concept of ‘ambiguity’ explains the balancing required around the factors taken into account when prescribing opioids. Managing this ambiguity is challenging and these findings can inform healthcare professionals dealing with these decisions. Conclusions This conceptual model demonstrates the complexity of making a decision to prescribe opioids to someone with chronic non-malignant pain. Although opioid prescription is underpinned by the therapeutic aim of alleviating pain, this aim may be misplaced. This has implications for education in light of the new regulations for opioid prescription. Findings also demonstrate that the decision is influenced by intra- and interpersonal factors and broader external concerns.

Abstract Background Each year over five million people develop chronic non-malignant pain and can experience healthcare as an adversarial struggle. The aims of this study were: (1) to bring together qualitative evidence syntheses that explore patients’ experience of living with chronic non-malignant pain and develop conceptual understanding of what it is like to live with chronic non-malignant pain for improved healthcare; (2) to undertake the first mega-ethnography of qualitative evidence syntheses using the methods of meta-ethnography. Methods We used the seven stages of meta-ethnography refined for large studies. The innovation of mega-ethnography is to use conceptual findings from qualitative evidence syntheses as primary data. We searched 7 bibliographic databases from inception until February 2016 to identify qualitative evidence syntheses that explored patients’ experience of living with chronic non-malignant pain. Results We identified 82 potential studies from 556 titles, screened 34 full text articles and included 11 qualitative evidence syntheses synthesising a total of 187 qualitative studies reporting more than 5000 international participants living with chronic pain. We abstracted concepts into 7 conceptual categories: (1) my life is impoverished and confined; (2) struggling against my body to be me; (3) the quest for the diagnostic ‘holy grail’; (4) lost personal credibility; (5) trying to keep up appearances; (6) need to be treated with dignity; and (7) deciding to end the quest for the grail is not easy. Each conceptual category was supported by at least 7 of the 11 qualitative evidence syntheses. Conclusions This is the first mega-ethnography, or synthesis of qualitative evidence syntheses using the methods of meta-ethnography. Findings help us to understand that the decision to end the quest for a diagnosis can leave patients feeling vulnerable and this may contribute to the adversarial nature of the clinical encounter. This knowledge demonstrates that treating a patient with a sense that they are worthy of care and hearing their story is not an adjunct to, but integral to health care.

An amendment to this paper has been published and can be accessed via the original article.

Background: People with chronic pain do not always feel that they are being listened to or valued by health-care professionals (HCPs). We aimed to understand and improve this experience by finding out what HCPs feel about providing health care to people with chronic non-malignant pain. We did this by bringing together the published qualitative research. Objectives: (1) To undertake a qualitative evidence synthesis (QES) to increase our understanding of what it is like for HCPs to provide health care to people with chronic non-malignant pain; (2) to make our findings easily available and accessible through a short film; and (3) to contribute to the development of methods for QESs. Design: We used the methods of meta-ethnography, which involve identifying concepts and progressively abstracting these concepts into a line of argument. Data sources: We searched five electronic bibliographic databases (MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO and Allied and Complementary Medicine Database) from inception to November 2016. We included studies that explored HCPs’ experiences of providing health care to people with chronic non-malignant pain. We utilised the Grading of Recommendations Assessment, Development and Evaluation Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) framework to rate our confidence in the findings. Results: We screened 954 abstracts and 184 full texts and included 77 studies reporting the experiences of > 1551 HCPs. We identified six themes: (1) a sceptical cultural lens and the siren song of diagnosis; (2) navigating juxtaposed models of medicine; (3) navigating the patient–clinician borderland; (4) the challenge of dual advocacy; (5) personal costs; and (6) the craft of pain management. We produced a short film, ‘Struggling to support people to live a valued life with chronic pain’, which presents these themes (see Report Supplementary Material 1; URL: www.journalslibrary.nihr.ac.uk/programmes/hsdr/1419807/#/documentation; accessed 24 July 2017). We rated our confidence in the review findings using the GRADE-CERQual domains. We developed a conceptual model to explain the complexity of providing health care to people with chronic non-malignant pain. The innovation of this model is to propose a series of tensions that are integral to the experience: a dualistic biomedical model compared with an embodied psychosocial model; professional distance compared with proximity; professional expertise compared with patient empowerment; the need to make concessions to maintain therapeutic relationships compared with the need for evidence-based utility; and patient advocacy compared with health-care system advocacy. Limitations: There are no agreed methods for determining confidence in QESs. Conclusions: We highlight areas that help us to understand why the experience of health care can be difficult for patients and HCPs. Importantly, HCPs can find it challenging if they are unable to find a diagnosis and at times this can make them feel sceptical. The findings suggest that HCPs find it difficult to balance their dual role of maintaining a good relationship with the patient and representing the health-care system. The ability to support patients to live a valued life with pain is described as a craft learnt through experience. Finally, like their patients, HCPs can experience a sense of loss because they cannot solve the problem of pain. Future work: Future work to explore the usefulness of the conceptual model and film in clinical education would add value to this study. There is limited primary research that explores HCPs’ experiences with chronic non-malignant pain in diverse ethnic groups, in gender-specific contexts and in older people living in the community. Funding: The National Institute for Health Research Health Services and Delivery Research programme.