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/).

Can routine assessment of older people's mental health lead to improved outcomes: A regression discontinuity analysis.

OBJECTIVE: To assess whether case finding for depression among people aged 65 and above improves mental health. DESIGN: Opportunistic evaluation using a regression discontinuity analysis with data from a randomised controlled trial. SETTING: The REFORM trial, a falls prevention study that recruited patients from NHS podiatry clinics. PARTICIPANTS: 1010 community-dwelling adults over the age of 65 with at least one risk factor for falling (recent previous fall or fear of falling). INTERVENTION: Letter sent to patient's General Practitioner if they scored 10 points or above on the 15-item Geriatric Depression Scale (GDS-15) informing them of the patient's risk of depression. MAIN OUTCOME MEASURE: GDS-15 score six months after initial completion of GDS-15. RESULTS: 895 (88.6%) of the 1010 participants randomised into REFORM had a valid baseline and six-month GDS-15 score and were included in this study. The mean GDS-15 baseline score was 3.5 (SD 3.0, median 3.0, range 0-15); 639 (71.4%) scored 0-4, 204 (22.8%) scored 5-9 indicating mild depression, and 52 (5.8%) scored 10 or higher indicating severe depression. At six months follow-up, those scoring 10 points or higher at baseline had, on average, a reduction of 1.08 points on the GDS-15 scale (95% confidence interval -1.83 to -0.33, p = 0.005) compared to those scoring less than 10, using the simplest linear regression model. CONCLUSION: Case finding of depression in podiatry patients based on a GDS-15 score of 10 or more followed by a letter to their General Practitioner significantly reduced depression severity. Whether this applies to all older patients in primary care is unknown. Further research is required to confirm these findings. Regression discontinuity analyses could be prespecified and embedded within other existing research studies.

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.

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.

Priorities for research to support local authority action on health and climate change: a study in England.

BACKGROUND: Evidence is needed to support local action to reduce the adverse health impacts of climate change and maximise the health co-benefits of climate action. Focused on England, the study identifies priority areas for research to inform local decision making. METHODS: Firstly, potential priority areas for research were identified from a brief review of UK policy documents, and feedback invited from public and policy stakeholders. This included a survey of Directors of Public Health (DsPH) in England, the local government officers responsible for public health. Secondly, rapid reviews of research evidence examined whether there was UK evidence relating to the priorities identified in the survey. RESULTS: The brief policy review pointed to the importance of evidence in two broad areas: (i) community engagement in local level action on the health impacts of climate change and (ii) the economic (cost) implications of such action. The DsPH survey (n = 57) confirmed these priorities. With respect to community engagement, public understanding of climate change's health impacts and the public acceptability of local climate actions were identified as key evidence gaps. With respect to economic implications, the gaps related to evidence on the health and non-health-related costs and benefits of climate action and the short, medium and longer-term budgetary implications of such action, particularly with respect to investments in the built environment. Across both areas, the need for evidence relating to impacts across income groups was highlighted, a point also emphasised by the public involvement panel. The rapid reviews confirmed these evidence gaps (relating to public understanding, public acceptability, economic evaluation and social inequalities). In addition, public and policy stakeholders pointed to other barriers to action, including financial pressures, noting that better evidence is insufficient to enable effective local action. CONCLUSIONS: There is limited evidence to inform health-centred local action on climate change. More evidence is required on public perspectives on, and the economic dimensions of, local climate action. Investment in locally focused research is urgently needed if local governments are to develop and implement evidence-based policies to protect public health from climate change and maximise the health co-benefits of local action.

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.

A scoping review of the outcome reporting following surgery for chronic osteomyelitis of the lower limb.

Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy. A total of 3,303 records were screened, of which 99 studies were included. Most studies were case series (77/99; 78%) and assessed one method of reconstruction (68/99; 69%). A total of 511 outcomes were reported, which were grouped into 58 distinct outcomes. Overall, 143/511 of all outcomes (28%) were provided with a clear, in-text definition, and 231 outcomes (45%) had details reported of how and when they were measured. The most commonly reported outcome was 'recurrence of osteomyelitis' (62; 12%). The single-most patient-reported outcome measure was 'pain'. This study has highlighted significant inconsistencies in the defining, reporting, and measuring of outcomes across studies investigating surgical management for chronic osteomyelitis of the lower limb in adults. Future studies should clearly report complete details of how outcomes are defined and measured, including timing. The development of a standardized core outcome set would be of significant benefit in order to allow evidence synthesis and comparison across studies.

Medication work among nonagenarians: a qualitative study of the Newcastle 85+ cohort participants at 97 years old.

BACKGROUND: People aged ≥85 years are the fastest growing section of our population across most high-income countries. A majority live with multiple long-term conditions and frailty, but there is limited understanding of how the associated polypharmacy is experienced by this group. AIM: To explore the experiences of medication management among nonagenarians and the implications for primary care practice. DESIGN AND SETTING: Qualitative analysis of medication work in nonagenarians from a purposive sample of survivors of the Newcastle 85+ study (a longitudinal cohort study). METHOD: Semi-structured interviews (n = 20) were conducted, transcribed verbatim, and analysed using a thematic approach. RESULTS: In most cases, although considerable work is associated with self-management of medication use, it is generally not experienced as problematic by the older people themselves. Taking medications is habitualised into everyday routines and practices, and is experienced in much the same way as other activities of daily living. For some, the work associated with medications has been relinquished (either partially or wholly) to others, minimising the burden experienced by the individual. Exceptions to this were found when disruptions to these steady states occurred, for example, following a new medical diagnosis with associated medication changes or a major life event. CONCLUSION: This study has shown a high level of acceptance of the work associated with medications among this group and trust in the prescribers to provide the most appropriate care. Medicines optimisation should build on this trust and be presented as personalised, evidence-based care.

Attitudes towards hearing difficulties, health-seeking behaviour, and hearing aid use among older adults in Thailand.

Introduction: This qualitative study explores older adults' attitudes towards hearing difficulties, health-seeking behaviour and hearing aid use in Samutprakarn, Thailand. Method: Three focus groups (n=25), with adults aged 60-88 years, were conducted within a residential complex for older adults. Qualitative data analysis, employing a phenomenological approach was completed. Results: Four themes are presented: (1) Perception of hearing difficulties, (2) Experience of receiving care, (3) Attitudes towards wearing hearing aids, and (4) Raising awareness of hearing difficulties in older adults. Findings indicate that Thai older adults may not be aware or accepting of their hearing difficulties, due to the stigma associated hearing loss, older age, and disability. The consequential impact of these unacknowledged issues manifest in communication challenges and the adoption of avoidance behaviours across diverse situational contexts. Conclusion: This study enhances our understanding of how Thai older adults perceive hearing problems and ear care. Findings underscore the potential pivotal role of familial and social networks in mitigating barriers associated with hearing difficulties among older adults in Thailand. These insights can raise awareness and inform effective management for older adults and their families. Additionally, the findings could guide healthcare providers, researchers, and policy makers, fostering improved care for this demographic.

Identity construction in the very old: A qualitative narrative study.

People are living longer internationally, with a growing number experiencing very old age (≥95 years). Physical, psychological and social changes can challenge one's sense of self and disrupt existing identities. However, experiences of the very old in society are seldom researched and how they construct identity and negotiate a sense of self is little understood. Our study focuses on participants aged >95 years to understand how identity is conceptualised to negotiate a continued place in society. Qualitative interviews with 23 people were thematically analysed, underpinned by Positioning Theory. Five themes were generated: A contented life; reframing independence; familial positioning; appearance and physical wellbeing; reframing ill health. Participants saw themselves as largely content and, despite their world becoming smaller, found pleasure in small routines. Perceptions of self were reframed to maintain autonomy within narrow parameters. Past relationships and experiences/events were drawn on to make sense of ongoing ways of living. There were tensions around feelings of loss of autonomy and independence, with some valuing these over issues such as safety. This sometimes conflicted with views of others and small acts of resistance and subversion were acted out to maintain some sense of control. However, participants minimised progressive ill health. Findings provide insight into how the very old may utilise identity to negotiate, acquiesce, resist and challenge the world around them.

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

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

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

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

Current practice in the measurement and interpretation of intervention adherence in randomised controlled trials: A systematic review.

BACKGROUND: Ideally all participants in a randomised controlled trial (RCT) should fully receive their allocated intervention; however, this rarely occurs in practice. Intervention adherence affects Type II error so influences the interpretation of trial results and subsequent implementation. We aimed to describe current practice in the definition, measurement, and reporting of intervention adherence in non-pharmacological RCTs, and how this data is incorporated into a trial's interpretation and conclusions. METHODS: We conducted a systematic review of phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams. RESULTS: Of 237 reports published, 76 met the eligibility criteria and were included. Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis. Adherence measures varied between intervention types: behavioural change (n = 10, 43.5%), psychological therapy (n = 5, 83.3%) and physiotherapy/rehabilitation (n = 8, 66.7%) interventions predominately measured adherence based on session attendance. Whereas medical device and surgical interventions (n = 17, 73.9%) primarily record the number of participants receiving the allocated intervention, a third (n = 33, 67.3%) of studies reported a difference in findings between primary and sensitivity analyses. CONCLUSIONS: Although most trials report elements of adherence, terminology was inconsistent, and there was no systematic approach to its measurement, analyses, interpretation, or reporting. Given the importance of adherence within clinical trials, there is a pressing need for a standardised approach or framework.

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.

Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus.

BACKGROUND: Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions. METHODS: We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice. RESULTS: In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice. CONCLUSIONS: Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.

Exploring online identity construction for the caregivers of adults living with dementia and the value of interactions with health and social care professionals.

Becoming an informal caregiver for an adult living with dementia has been shown to have a significant impact upon the conception of identity. This study aimed to identify how identity is constructed online amongst caregivers of individuals living with dementia and how healthcare interactions can influence identity development through the analysis of online web blogs. Sixteen online blogs (172 entries) were selected through purposive and snowball sampling, and discourse analysis was used to analyse online identity construction for informal caregivers of adults living with dementia. Six areas of online identity construction were identified: changing family role; powerful expert social campaigner; being an advocate; guardian of their relative's selfhood; sustaining creative and spiritual individuality and wider community member in online and real life. Further to this, the importance of health and social care service interactions in the development of caregiver identity revealed that professionals must ensure person-centred service contacts for caregivers. This is a challenging task in the pandemic climate where interactions between health and social care professionals and caregivers are limited due to isolation measures. It is evident that the blog format can provide a forum through which the identity of the caregiver of an adult living with dementia can evolve. The six areas of identity construction reveal the multifaceted nature of identity for the caregiver and the value of belonging to an online community both in relation to identity construction and support. This finding is especially applicable in the current pandemic when accessing a face-to-face community is challenging for caregivers who may be shielding or living in isolation. The findings of this research can aid health and social care professionals in understanding the development of caregiver identity and in providing appropriate support during service interactions, on accessing virtual and face to face community support.

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

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

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

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

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

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

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

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