Uptake of self-management education programmes for people with type 2 diabetes in primary care through the embedding package: a cluster randomised control trial and ethnographic study.

BACKGROUND: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. METHODS: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months - 3-0), step one (months 1-9), step 2 (months 10-18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. RESULTS: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit. CONCLUSIONS: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted. TRIAL REGISTRATION: ISRCTN23474120, registered 05/04/2018.

Cost-effectiveness analysis of two interventions to promote physical activity in a multiethnic population at high risk of diabetes: an economic evaluation of the 48-month PROPELS randomized controlled trial.

INTRODUCTION: Physical activity (PA) is protective against type 2 diabetes (T2D). However, data on pragmatic long-term interventions to reduce the risk of developing T2D via increased PA are lacking. This study investigated the cost-effectiveness of a pragmatic PA intervention in a multiethnic population at high risk of T2D. MATERIALS AND METHODS: We adapted the School for Public Health Research diabetes prevention model, using the PROPELS trial data and analyses of the NAVIGATOR trial. Lifetime costs, lifetime quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for each intervention (Walking Away (WA) and Walking Away Plus (WA+)) versus usual care and compared with National Institute for Health and Care Excellence's willingness-to-pay of £20 000-£30 000 per QALY gained. We conducted scenario analyses on the outcomes of the PROPELS trial data and a threshold analysis to determine the change in step count that would be needed for the interventions to be cost-effective. RESULTS: Estimated lifetime costs for usual care, WA, and WA+ were £22 598, £23 018, and £22 945, respectively. Estimated QALYs were 9.323, 9.312, and 9.330, respectively. WA+ was estimated to be more effective and cheaper than WA. WA+ had an ICER of £49 273 per QALY gained versus usual care. In none of our scenario analyses did either WA or WA+ have an ICER below £20 000 per QALY gained. Our threshold analysis suggested that a PA intervention costing the same as WA+ would have an ICER below £20 000/QALY if it were to achieve an increase in step count of 500 steps per day which was 100% maintained at 4 years. CONCLUSIONS: We found that neither WA nor WA+ was cost-effective at a limit of £20 000 per QALY gained. Our threshold analysis showed that interventions to increase step count can be cost-effective at this limit if they achieve greater long-term maintenance of effect. TRIAL REGISTRATION NUMBER: ISRCTN registration: ISRCTN83465245: The PRomotion Of Physical activity through structuredEducation with differing Levels of ongoing Support for those with pre-diabetes (PROPELS)https://doi.org/10.1186/ISRCTN83465245.

The paradox of haemodialysis: the lived experience of the clocked treatment of chronic illness.

Studies exploring the relationship between time and chronic illness have generally focused on measurable aspects of time, also known as linear time. Linear time follows a predictable, sequential order of past, present and future; measured using a clock and predicated on normative assumptions. Sociological concepts addressing lifecourse disruption following diagnosis of chronic illness have served to enhance the understanding of lived experience. To understand the nuanced relationship between time and chronic illness, however, requires further exploration. Here, we show how the implicit assumptions of linear time meet in tension with the lived experience of chronic illness. We draw on interviews and photovoice work with people with end-stage kidney disease in receipt of in-centre-daytime haemodialysis to show how the clocked treatment of chronic illness disrupts experiences of time. Drawing on concepts of 'crip' and 'chronic' time we argue that clocked treatment and the lived experience of chronic illness converge at a paradox whereby clocked treatment allows for the continuation of linear time yet limits freedom. We use the concept of 'crip time' to challenge the normative assumptions implicit within linear concepts of time and argue that the understanding of chronic illness and its treatment would benefit from a 'cripped' starting point.

Understanding the quality-of-life experiences of older or frail adults following a new dens fracture: Nonsurgical management in a hard collar versus early removal of collar.

INTRODUCTION: In the United Kingdom, fractures of the cervical dens process in older and/or frail patients are usually managed nonsurgically in a hard collar. However, hard collars can lead to complications and this management approach is now being questioned, with growing interest in maximising patients' short-term quality-of-life. It is vital that patients' perspectives are considered; yet, there is a dearth of literature examining the aspect. To help inform wider decision-making about use of collar/no collar management of dens fractures in older/frail people, we explored older/frail people's experience of the two management approaches and how they affected their perceived quality-of-life. METHODS: We interviewed older and/or frail adults with a recent dens fracture (aged ≥65 years or with a clinical frailty score of ≥5) or their caregiver. Participants were recruited from both arms of a clinical trial comparing management using a hard collar for 12 weeks (SM) with early removal of the collar (ERC) and were interviewed following randomisation and again, 12-16 weeks later. Data were analysed using a framework approach. RESULTS: Both participant groups (SM/ERC) reported substantial, negative quality-of-life (QoL) experiences, with the fall itself and lack of access to care services and information being frequent major contributory factors. Many negative experiences cut across both participant groups, including pain, fatigue, diminished autonomy and reduced involvement in personally meaningful activities. However, we identified some subtle, yet discernible, ways in which using SM/ERC reinforced or alleviated (negative) QoL impacts, with the perceived benefits/burdens to using SM/ERC varying between different individuals. CONCLUSION: Study findings can be used to support informed decision-making about SM/ERC management of dens fractures in older/frail patients. PATIENT OR PUBLIC CONTRIBUTION: Public and patient involvement contributors were involved in the study design, development of interview topic guides and interpretation of study findings.

Participant and workplace champion experiences of an intervention designed to reduce sitting time in desk-based workers: SMART work & life.

BACKGROUND: A cluster randomised controlled trial demonstrated the effectiveness of the SMART Work & Life (SWAL) behaviour change intervention, with and without a height-adjustable desk, for reducing sitting time in desk-based workers. Staff within organisations volunteered to be trained to facilitate delivery of the SWAL intervention and act as workplace champions. This paper presents the experiences of these champions on the training and intervention delivery, and from participants on their intervention participation. METHODS: Quantitative and qualitative feedback from workplace champions on their training session was collected. Participants provided quantitative feedback via questionnaires at 3 and 12 month follow-up on the intervention strategies (education, group catch ups, sitting less challenges, self-monitoring and prompts, and the height-adjustable desk [SWAL plus desk group only]). Interviews and focus groups were also conducted at 12 month follow-up with workplace champions and participants respectively to gather more detailed feedback. Transcripts were uploaded to NVivo and the constant comparative approach informed the analysis of the interviews and focus groups. RESULTS: Workplace champions rated the training highly with mean scores ranging from 5.3/6 to 5.7/6 for the eight parts. Most participants felt the education increased their awareness of the health consequences of high levels of sitting (SWAL: 90.7%; SWAL plus desk: 88.2%) and motivated them to change their sitting time (SWAL: 77.5%; SWAL plus desk: 85.77%). A high percentage of participants (70%) reported finding the group catch up session helpful and worthwhile. However, focus groups highlighted mixed responses to the group catch-up sessions, sitting less challenges and self-monitoring intervention components. Participants in the SWAL plus desk group felt that having a height-adjustable desk was key in changing their behaviour, with intrinsic as well as time based factors reported as key influences on the height-adjustable desk usage. In both intervention groups, participants reported a range of benefits from the intervention including more energy, less fatigue, an increase in focus, alertness, productivity and concentration as well as less musculoskeletal problems (SWAL plus desk group only). Work-related, interpersonal, personal attributes, physical office environment and physical barriers were identified as barriers when trying to sit less and move more. CONCLUSIONS: Workplace champion and participant feedback on the intervention was largely positive but it is clear that different behaviour change strategies worked for different people indicating that a 'one size fits all' approach may not be appropriate for this type of intervention. The SWAL intervention could be tested in a broader range of organisations following a few minor adaptations based on the champion and participant feedback. TRIAL REGISTRATION: ISCRCTN registry (ISRCTN11618007).

A multicomponent intervention to reduce daily sitting time in office workers: the SMART Work & Life three-arm cluster RCT.

Background: Office workers spend 70-85% of their time at work sitting. High levels of sitting have been linked to poor physiological and psychological health. Evidence shows the need for fully powered randomised controlled trials, with long-term follow-up, to test the effectiveness of interventions to reduce sitting time. Objective: Our objective was to test the clinical effectiveness and cost-effectiveness of the SMART Work & Life intervention, delivered with and without a height-adjustable workstation, compared with usual practice at 12-month follow-up. Design: A three-arm cluster randomised controlled trial. Setting: Councils in England. Participants: Office workers. Intervention: SMART Work & Life is a multicomponent intervention that includes behaviour change strategies, delivered by workplace champions. Clusters were randomised to (1) the SMART Work & Life intervention, (2) the SMART Work & Life intervention with a height-adjustable workstation (i.e. SMART Work & Life plus desk) or (3) a control group (i.e. usual practice). Outcome measures were assessed at baseline and at 3 and 12 months. Main outcome measures: The primary outcome was device-assessed daily sitting time compared with usual practice at 12 months. Secondary outcomes included sitting, standing, stepping time, physical activity, adiposity, blood pressure, biochemical measures, musculoskeletal issues, psychosocial variables, work-related health, diet and sleep. Cost-effectiveness and process evaluation data were collected. Results: A total of 78 clusters (756 participants) were randomised [control, 26 clusters (n = 267); SMART Work & Life only, 27 clusters (n = 249); SMART Work & Life plus desk, 25 clusters (n = 240)]. At 12 months, significant differences between groups were found in daily sitting time, with participants in the SMART Work & Life-only and SMART Work & Life plus desk arms sitting 22.2 minutes per day (97.5% confidence interval -38.8 to -5.7 minutes/day; p = 0.003) and 63.7 minutes per day (97.5% confidence interval -80.0 to -47.4 minutes/day; p < 0.001), respectively, less than the control group. Participants in the SMART Work & Life plus desk arm sat 41.7 minutes per day (95% confidence interval -56.3 to -27.0 minutes/day; p < 0.001) less than participants in the SMART Work & Life-only arm. Sitting time was largely replaced by standing time, and changes in daily behaviour were driven by changes during work hours on workdays. Behaviour changes observed at 12 months were similar to 3 months. At 12 months, small improvements were seen for stress, well-being and vigour in both intervention groups, and for pain in the lower extremity and social norms in the SMART Work & Life plus desk group. Results from the process evaluation supported these findings, with participants reporting feeling more energised, alert, focused and productive. The process evaluation also showed that participants viewed the intervention positively; however, the extent of engagement varied across clusters. The average cost of SMART Work & Life only and SMART Work & Life plus desk was £80.59 and £228.31 per participant, respectively. Within trial, SMART Work & Life only had an incremental cost-effectiveness ratio of £12,091 per quality-adjusted life-year, with SMART Work & Life plus desk being dominated. Over a lifetime, SMART Work & Life only and SMART Work & Life plus desk had incremental cost-effectiveness ratios of £4985 and £13,378 per quality-adjusted life-year, respectively. Limitations: The study was carried out in one sector, limiting generalisability. Conclusions: The SMART Work & Life intervention, provided with and without a height-adjustable workstation, was successful in changing sitting time. Future work: There is a need for longer-term follow-up, as well as follow-up within different organisations. Trial registration: Current Controlled Trials ISRCTN11618007.

Office workers spend a large proportion of their day sitting. High levels of sitting have been linked to diseases, such as type 2 diabetes, heart disease and some cancers. The SMART Work & Life intervention is designed to reduce office workers' sitting time inside and outside work. The SMART Work & Life intervention involves organisational, environmental, group and individual strategies to encourage a reduction in sitting time and was designed to be delivered with and without a height-adjustable workstation (which allows the user to switch between sitting and standing while working). To test whether or not the SMART Work & Life intervention worked, we recruited 756 office workers from councils in Leicester/Leicestershire, Greater Manchester and Liverpool, UK. Participants were from 78 office groups. One-third of the participants received the intervention, one-third received the intervention with a height-adjustable workstation and one-third were a control group (and carried on as usual). Workplace champions in each office group were given training and resources to deliver the intervention. Data were collected at the start of the study, with follow-up measurements at 3 and 12 months. We measured sitting time using a small device worn on the thigh and collected data on weight, body fat, blood pressure, blood sugar and cholesterol levels. We asked participants about their health and work and spoke to participants to find out what they thought of the intervention. Our results showed that participants who received the intervention without workstation sat for 22 minutes less per day, and participants who received the intervention with workstation sat for 64 minutes less per day, than participants in the control group. Levels of stress, well-being, vigour (i.e. personal and emotional energy and cognitive liveliness) and pain in the lower extremity appeared to improve in the intervention groups. Participants viewed the intervention positively and reported several benefits, such as feeling more energised, alert, focused and productive; however, the extent to which participants engaged with the intervention varied across groups.

Progressing the understanding of chronic illness and its treatment: A post-human, ethological understanding of haemodialysis.

Haemodialysis is a common treatment option offered internationally for people requiring kidney replacement therapy. Research exploring haemodialysis is predominantly clinical and quantitative, and improvements to its provision and receipt tends also to be clinically focused. In recent years, however, a number of studies have sought to explore the lived experience of haemodialysis. These studies tend to use semi-structured interviews and present descriptive findings. Such findings serve to raise the profile of patient perspectives and encourage thinking beyond the clinical gaze. To progress this, we apply a post-humanism approach to the understanding of the receipt of haemodialysis. Drawing on findings from a study to explore the experience and impact of in-centre, daytime, haemodialysis we follow Fox and Alldred's ethological toolkit to provide a post-human analysis of haemodialysis. In doing so we argue that haemodialysis exists as a heterogenous and changeable assemblage of multiple and fluid, human and non-human factors that has the capacity to affect. Here we outline this post-human approach and the impact it has for understanding not just haemodialysis but also the receipt of treatment for other chronic illnesses.

The NightLife study - the clinical and cost-effectiveness of thrice-weekly, extended, in-centre nocturnal haemodialysis versus daytime haemodialysis using a mixed methods approach: study protocol for a randomised controlled trial.

BACKGROUND: In-centre nocturnal haemodialysis (INHD) offers extended-hours haemodialysis, 6 to 8 h thrice-weekly overnight, with the support of dialysis specialist nurses. There is increasing observational data demonstrating potential benefits of INHD on health-related quality of life (HRQoL). There is a lack of randomised controlled trial (RCT) data to confirm these benefits and assess safety. METHODS: The NightLife study is a pragmatic, two-arm, multicentre RCT comparing the impact of 6 months INHD to conventional haemodialysis (thrice-weekly daytime in-centre haemodialysis, 3.5-5 h per session). The primary outcome is the total score from the Kidney Disease Quality of Life tool at 6 months. Secondary outcomes include sleep and cognitive function, measures of safety, adherence to dialysis and impact on clinical parameters. There is an embedded Process Evaluation to assess implementation, health economic modelling and a QuinteT Recruitment Intervention to understand factors that influence recruitment and retention. Adults (≥ 18 years old) who have been established on haemodialysis for > 3 months are eligible to participate. DISCUSSION: There are 68,000 adults in the UK that need kidney replacement therapy (KRT), with in-centre haemodialysis the treatment modality for over a third of cases. HRQoL is an independent predictor of hospitalisation and mortality in individuals on maintenance dialysis. Haemodialysis is associated with poor HRQoL in comparison to the general population. INHD has the potential to improve HRQoL. Vigorous RCT evidence of effectiveness is lacking. The NightLife study is an essential step in the understanding of dialysis therapies and will guide patient-centred decisions regarding KRT in the future. TRIAL REGISTRATION: Trial registration number: ISRCTN87042063. Registered: 14/07/2020.

Reducing the carbon footprint of research: experience from the NightLife study.

BACKGROUND: As set out in the Climate Change Act (2008), the UK National Health Service (NHS) has made a commitment to halve greenhouse gas emissions by 2025 and reach net zero by 2050. Research forms a core part of NHS activity and reducing the carbon footprint of clinical trials is a core element of the National Institute for Health and Care Research Carbon Reduction Strategy (2019). KEY ARGUMENTS: However, support from funding organisations on how to achieve these targets is lacking. This brief communication article reports the reduction in the carbon footprint of the NightLife study, an ongoing multicentre randomised controlled trial assessing the impact of in-centre nocturnal haemodialysis on quality of life. CONCLUSION: By using remote conferencing software and innovative data collection methods, we demonstrated a total saving of 136 tonnes of carbon dioxide equivalent over three workstreams during the first 18 months of the study, following grant activation on 1 January 2020. In addition to the environmental impact, there were additional benefits seen to cost as well as increased participant diversity and inclusion. This work highlights ways in which trials could be made less carbon intensive, more environmentally sustainable and better value for money.

Biographical dialectics: The ongoing and creative problem solving required to negotiate the biographical disruption of chronic illness.

Here we propose the term 'biographical dialectics' as a sister term to 'biographical disruption' to capture the ongoing problem solving that characterises the lives of many people living with life limiting chronic illnesses. The paper is based on the experiences of 35 adults with end-stage kidney disease (ESKD) in receipt of haemodialysis. Photovoice and semi-structured interviews showed that ESKD and the use of haemodialysis was widely agreed to be biographically disruptive. In talking about and showing disruption through photographs the participants' ongoing problem solving was universal across their diverse experiences. 'Biographical disruption' and Hegalian dialectical logic, are drawn on to make sense of these actions and to further understand the personal and disruptive experience of chronic illness. Based on this, 'biographical dialectics' captures the work that is required to account for and manage the enduring and biographical impact of chronic illness that follows the initial disruption of diagnosis and continues as life progresses.

"I have travelled along on my own"-Experiences of seeking help for serious non-COVID health problems during the COVID-19 pandemic: A qualitative study.

OBJECTIVES: During COVID-19 the UK general population has been given strong messages to stay at home. Concurrently unprecedented changes occurred in healthcare access with moves to remote/triage systems. Data have shown that the number of people accessing healthcare services decreased and there are significant concerns that the pandemic has negatively affected help-seeking for serious conditions, with potentially increased morbidity and mortality. An understanding of help-seeking is urgently needed to inform public campaigns. We aimed to develop an in-depth, theory-based understanding of how, when and why people sought help for potentially serious symptoms (e.g., related to major cardiovascular events or cancer diagnoses) during the pandemic, and what influenced their decisions. DESIGN: Qualitative semi-structured interviews. METHODS: We interviewed 25 adults recruited through a targeted social media campaign. Interviews were conducted via telephone or online platform. Our topic guide was informed by the Model of Pathways to Treatment and the Capability-Opportunity-Motivation-Behaviour model. RESULTS: The analysis identified four main themes: Delay in recognition, Holding on to concerns, Weighing it up and Long-term impacts. Multiple societal and environmental factors influenced participants' help-seeking and motivation, capability and opportunity to seek help, with long-term impacts on well-being and future help-seeking. CONCLUSIONS: There is a need for clear guidance about pathways to raise concerns about symptoms and gain advice while usual healthcare contacts are paused or stopped. Recommendations for future interventions to support help-seeking during pandemics include clearer messaging, co-produced with end-users, on when, where and how to seek help.

The Cost-Effectiveness of the SMART Work & Life Intervention for Reducing Sitting Time.

Sedentary behaviours continue to increase and are associated with heightened risks of morbidity and mortality. We assessed the cost-effectiveness of SMART Work & Life (SWAL), an intervention designed to reduce sitting time inside and outside of work, both with (SWAL-desk) and without (SWAL-only) a height-adjustable workstation compared to usual practice (control) for UK office workers. Health outcomes were assessed in quality-adjusted life-years (QALY) and costs in pound sterling (2019-2020). Discounted costs and QALYs were estimated using regression methods with multiply imputed data from the SMART Work & Life trial. Absenteeism, productivity and wellbeing measures were also evaluated. The average cost of SWAL-desk was £228.31 and SWAL-only £80.59 per office worker. Within the trial, SWAL-only was more effective and costly compared to control (incremental cost-effectiveness ratio (ICER): £12,091 per QALY) while SWAL-desk was dominated (least effective and most costly). However, over a lifetime horizon, both SWAL-only and SWAL-desk were more effective and more costly than control. Comparing SWAL-only to control generated an ICER of £4985 per QALY. SWAL-desk was more effective and costly than SWAL-only, generating an ICER of £13,378 per QALY. Findings were sensitive to various worker, intervention, and extrapolation-related factors. Based on a lifetime horizon, SWAL interventions appear cost-effective for office-workers conditional on worker characteristics, intervention cost and longer-term maintenance in sitting time reductions.

Using Normalisation Process Theory (NPT) to develop an intervention to improve referral and uptake rates for self-management education for patients with type 2 diabetes in UK primary care.

BACKGROUND: Referral and uptake rates of structured self-management education (SSME) for Type 2 diabetes (T2DM) in the UK are variable and relatively low. Research has documented contributing factors at patient, practitioner and organisational levels. We report a project to develop an intervention to improve referral to and uptake of SSME, involving an integrative synthesis of existing datasets and stakeholder consultation and using Normalisation Process Theory (NPT) as a flexible framework to inform the development process. METHODS: A three-phase mixed-methods development process involved: (1) synthesis of existing evidence; (2) stakeholder consultation; and (3) intervention design. The first phase included a secondary analysis of data from existing studies of T2DM SSME programmes and a systematic review of the literature on application of NPT in primary care. Influences on referral and uptake of diabetes SSME were identified, along with insights into implementation processes, using NPT constructs to inform analysis. This gave rise to desirable attributes for an intervention to improve uptake of SSME. The second phase involved engaging with stakeholders to prioritise and then rank these attributes, and develop a list of associated resources needed for delivery. The third phase addressed intervention design. It involved translating the ranked attributes into essential components of a complex intervention, and then further refinement of components and associated resources. RESULTS: In phase 1, synthesised analysis of 64 transcripts and 23 articles generated a longlist of 46 attributes of an embedded SSME, mapped into four overarching domains: valued, integrated, permeable and effectively delivered. Stakeholder engagement in phase 2 progressed this to a priority ranked list of 11. In phase 3, four essential components attending to the prioritised attributes and forming the basis of the intervention were identified: 1) a clear marketing strategy for SSME; 2) a user friendly and effective referral pathway; 3) new/amended professional roles; and 4) a toolkit of resources. CONCLUSIONS: NPT provides a flexible framework for synthesising evidence for the purpose of developing a complex intervention designed to increase and reduce variation in uptake to SSME programmes in primary care settings.

Effectiveness of an intervention for reducing sitting time and improving health in office workers: three arm cluster randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness of an intervention, with and without a height adjustable desk, on daily sitting time, and to investigate the relative effectiveness of the two interventions, and the effectiveness of both interventions on physical behaviours and physical, biochemical, psychological, and work related health and performance outcomes. DESIGN: Cluster three arm randomised controlled trial with follow-up at three and 12 months. SETTING: Local government councils in Leicester, Liverpool, and Greater Manchester, UK. PARTICIPANTS: 78 clusters including 756 desk based employees in defined offices, departments, or teams from two councils in Leicester, three in Greater Manchester, and one in Liverpool. INTERVENTIONS: Clusters were randomised to one of three conditions: the SMART Work and Life (SWAL) intervention, the SWAL intervention with a height adjustable desk (SWAL plus desk), or control (usual practice). MAIN OUTCOMES MEASURES: The primary outcome measure was daily sitting time, assessed by accelerometry, at 12 month follow-up. Secondary outcomes were accelerometer assessed sitting, prolonged sitting, standing and stepping time, and physical activity calculated over any valid day, work hours, workdays, and non-workdays, self-reported lifestyle behaviours, musculoskeletal problems, cardiometabolic health markers, work related health and performance, fatigue, and psychological measures. RESULTS: Mean age of participants was 44.7 years, 72.4% (n=547) were women, and 74.9% (n=566) were white. Daily sitting time at 12 months was significantly lower in the intervention groups (SWAL -22.2 min/day, 95% confidence interval -38.8 to -5.7 min/day, P=0.003; SWAL plus desk -63.7 min/day, -80.1 to -47.4 min/day, P<0.001) compared with the control group. The SWAL plus desk intervention was found to be more effective than SWAL at changing sitting time (-41.7 min/day, -56.3 to -27.0 min/day, P<0.001). Favourable differences in sitting and prolonged sitting time at three and 12 month follow-ups for both intervention groups and for standing time for the SWAL plus desk group were observed during work hours and on workdays. Both intervention groups were associated with small improvements in stress, wellbeing, and vigour, and the SWAL plus desk group was associated with improvements in pain in the lower extremity, social norms for sitting and standing at work, and support. CONCLUSIONS: Both SWAL and SWAL plus desk were associated with a reduction in sitting time, although the addition of a height adjustable desk was found to be threefold more effective. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11618007.

Living with frailty and haemodialysis: a qualitative study.

BACKGROUND: Frailty is highly prevalent in people receiving haemodialysis (HD) and is associated with poor outcomes. Understanding the lived experiences of this group is essential to inform holistic care delivery. METHODS: Semi-structured interviews with N = 25 prevalent adults receiving HD from 3 HD units in the UK. Eligibility criteria included a Clinical Frailty Scale (CFS) score of 4-7 and a history of at least one fall in the last 6 months. Sampling began guided by maximum variation sampling to ensure diversity in frailty status; subsequently theoretical sampling enabled exploration of preliminary themes. Analysis was informed by constructivist grounded theory; later we drew upon the socioecological model. RESULTS: Participants had a mean age of 69 ± 10 years, 13 were female, and 13 were White British. 14 participants were vulnerable or mildly frail (CFS 4-5), and 11 moderately or severely frail (CFS 6-7). Participants characterised frailty as weight loss, weakness, exhaustion, pain and sleep disturbance arising from multiple long-term conditions. Participants' accounts revealed: the consequences of frailty (variable function and psychological ill-health at the individual level; increasing reliance upon family at the interpersonal level; burdensome health and social care interactions at the organisational level; reduced participation at the community level; challenges with financial support at the societal level); coping strategies (avoidance, vigilance, and resignation); and unmet needs (overprotection from family and healthcare professionals, transactional health and social care exchanges). CONCLUSIONS: The implementation of a holistic needs assessment, person-centred health and social care systems, greater family support and enhancing opportunities for community participation may all improve outcomes and experience. An approach which encompasses all these strategies, together with wider public health interventions, may have a greater sustained impact. TRIAL REGISTRATION: ISRCTN12840463 .

Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar.

INTRODUCTION: Fractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing does not always occur in older adults, and bony healing is not associated with quality of life, functional, or pain outcomes. Further, hard collars can cause complications such as skin pressure ulcers, swallowing difficulties and difficulties with personal care. We hypothesise that management with no immobilisation may be superior to management in a hard collar for older or frail adults with odontoid fractures. METHODS AND ANALYSES: This is the protocol for the Duration of External Neck Stabilisation (DENS) trial-a non-blinded randomised controlled trial comparing management in a hard collar with management without a collar for older (≥65 years) or frail (Rockwood Clinical Frailty Scale ≥5) adults with a new odontoid fracture. 887 neurologically intact participants with any odontoid process fracture type will be randomised to continuing with a hard collar (standard care) or removal of the collar (intervention). The primary outcome is quality of life measured using the EQ-5D-5L at 12 weeks. Secondary outcomes include pain scores, neck disability index, health and social care use and costs, and mortality. ETHICS AND DISSEMINATION: Informed consent for participation will be sought from those able to provide it. We will also include those who lack capacity to ensure representativeness of frail and acutely unwell older adults. Results will be disseminated via scientific publication, lay summary, and visual abstract. The DENS trial received a favourable ethical opinion from the Scotland A Research Ethics Committee (21/SS/0036) and the Leeds West Research Ethics Committee (21/YH/0141). TRIAL REGISTRATION NUMBER: NCT04895644.

The Impact of Falls: A Qualitative Study of the Experiences of People Receiving Haemodialysis.

The prevalence of falls is high in people receiving haemodialysis (HD). This study aimed to explore the experiences of people receiving HD who had fallen in the last six months. A qualitative study, informed by constructivist grounded theory, used semi-structured interviews in combination with falls diaries. Twenty-five adults (mean age of 69 ± 10 years, 13 female, 13 White British) receiving HD with a history of at least one fall in the last six months (median 3, IQR 2-4) participated. Data were organised within three themes: (a) participants' perceptions of the cause of their fall(s): poor balance, weakness, and dizziness, exacerbated by environmental causes, (b) the consequences of the fall: injuries were disproportionate to the severity of the fall leading to loss of confidence, function and disruptions to HD, (c) reporting and coping with falls: most did not receive any specific care regarding falls. Those who attended falls services reported access barriers. In response, personal coping strategies included avoidance, vigilance, and resignation. These findings indicate that a greater focus on proactively identifying falls, comprehensive assessment, and timely access to appropriate falls prevention programmes is required to improve care and outcomes.

Patient and practitioner views on a combined face-to-face and digital intervention to support medication adherence in hypertension: a qualitative study within primary care.

OBJECTIVES: To explore patients' and healthcare practitioners' (HCPs) views about non-adherence to hypertension medication and potential content of a combined very brief face-to-face discussion (VBI) and digital intervention (DI). METHODS: A qualitative study (N=31): interviews with patients with hypertension (n=6) and HCPs (n=11) and four focus groups with patients with hypertension (n=14). Participants were recruited through general practices in Eastern England and London. Topic guides explored reasons for medication non-adherence and attitudes towards a potential intervention to support adherence. Stimuli to facilitate discussion included example SMS messages and smartphone app features, including mobile sensing. Analysis was informed methodologically by the constant comparative approach and theoretically by perceptions and practicalities approach. RESULTS: Participants' overarching explanations for non-adherence were non-intentional (forgetting) and intentional (concerns about side effects, reluctance to medicate). These underpinned their views on intervention components: messages that targeted forgetting medication or obtaining prescriptions were considered more useful than messages providing information on consequences of non-adherence. Tailoring the DI to the individuals' needs, regarding timing and number of messages, was considered important for user engagement. Patients wanted control over the DI and information about data use associated with any location sensing. While the DI was considered limited in its potential to address intentional non-adherence, HCPs saw the potential for a VBI in addressing this gap, if conducted in a non-judgemental manner. Incorporating a VBI into routine primary care was considered feasible, provided it complemented existing GP practice software and HCPs received sufficient training. CONCLUSIONS: A combined VBI-DI can potentially address intentional and non-intentional reasons for non-adherence to hypertension medication. For optimal engagement, recommendations from this work include a VBI conducted in a non-judgmental manner and focusing on non-intentional factors, followed by a DI that is easy-to-use, highly tailored and with provision of data privacy details about any sensing technology used.

A systematic review of interventions to increase physical activity and reduce sedentary behaviour following bariatric surgery.

BACKGROUND: Bariatric surgery promotes weight loss and improves co-morbid conditions, with patients who are more physically active having better outcomes. However, levels of physical activity and sedentary behaviour often remain unchanged following surgery. OBJECTIVES: To identify interventions and components thereof that are able to facilitate changes in physical activity and sedentary behaviour. ELIGIBILITY: Physical activity and/or sedentary behaviour must have been measured, pre and post intervention, in patients who have undergone bariatric surgery. STUDY APPRAISAL AND SYNTHESIS METHODS: Four databases were searched with key-words. Two researchers conducted paper screening, data extraction and risk-of-bias assessment. RESULTS: Twelve studies were included; eleven were randomised. Two were delivered presurgery and ten postsurgery; five found positive effect. Moderate to vigorous physical activity increased in three studies, two of which also found a significant increase in step count. The fourth found a significant increase in strenuous activity and the fifth a significant increase in metabolic equivalent of task/day and reduced time spent watching television. LIMITATIONS: Meta-analysis could not be conducted due to heterogeneity of outcomes and the tools used. CONCLUSION AND IMPLICATIONS OF KEY FINDINGS: This review has identified interventions and components thereof that were able to provoke positive effect. However, intervention and control conditions were not always well described particularly in terms of behaviour change techniques and the rationale for their use. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO (CRD42019121372).

PARIS: protocol for a prospective single arm, theory-based, group-based feasibility intervention study to increase Physical Activity and reduce sedentary behaviouR after barIatric Surgery.

INTRODUCTION: Increased physical activity and reduced sedentary behaviour can encourage favourable outcomes after bariatric surgery. However, there is a lack of evidence as to how to support patients with behaviour change. The aim of this study is to assess the feasibility of a physiotherapist led, online group-based behaviour change intervention to increase physical activity and reduce sedentary behaviour following bariatric surgery. METHODS AND ANALYSIS: Single arm feasibility study of a theory and evidence-based group behaviour change intervention based on the Behaviour Change Wheel and Theoretical Domains Framework using behaviour change techniques from the Behaviour Change Technique Taxonomy v1. The intervention has eight objectives and specifies behaviour change techniques that will be used to address each of these. Groups of up to eight participants who have had surgery within the previous 5 years will meet weekly over 6 weeks for up to 1½ hours. Groups will be held online led by a physiotherapist and supported by an intervention handbook. Feasibility study outcomes include: rate of recruitment, retention, intervention fidelity, participant engagement and acceptability. Secondary outcomes include: physical activity, sedentary behaviour, body composition, self-reported health status and will be analysed descriptively. Change in these outcomes will be used to calculate the sample size for a future evaluation study. Qualitative interviews will explore participants' views of the intervention including its acceptability. Data will be analysed according to the constant comparative approach of grounded theory. ETHICS AND DISSEMINATION: This study has National Health Service Research Ethics Committee approval; Haydock 20/NW/0472. All participants will provide informed consent and can withdraw at any point. Findings will be disseminated through peer-reviewed journals, conference and clinical service presentations. TRIAL REGISTRATION NUMBER: ISRCTN31524689.