Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: The COVID-NURSE cluster randomized controlled trial.

AIM: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness. DESIGN: Parallel two-arm, cluster-level randomized controlled trial. METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses. RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the 'other' ethnicity subgroup. CONCLUSION: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required. IMPACT: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care. REPORTING METHOD: CONSORT and CONSERVE. PATIENT OR PUBLIC CONTRIBUTION: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.

The effectiveness of a primary care-based collaborative care model to improve quality of life in people with severe mental illness: PARTNERS2 cluster randomised controlled trial.

BACKGROUND: Individuals living with severe mental illness can have significant emotional, physical and social challenges. Collaborative care combines clinical and organisational components. AIMS: We tested whether a primary care-based collaborative care model (PARTNERS) would improve quality of life for people with diagnoses of schizophrenia, bipolar disorder or other psychoses, compared with usual care. METHOD: We conducted a general practice-based, cluster randomised controlled superiority trial. Practices were recruited from four English regions and allocated (1:1) to intervention or control. Individuals receiving limited input in secondary care or who were under primary care only were eligible. The 12-month PARTNERS intervention incorporated person-centred coaching support and liaison work. The primary outcome was quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). RESULTS: We allocated 39 general practices, with 198 participants, to the PARTNERS intervention (20 practices, 116 participants) or control (19 practices, 82 participants). Primary outcome data were available for 99 (85.3%) intervention and 71 (86.6%) control participants. Mean change in overall MANSA score did not differ between the groups (intervention: 0.25, s.d. 0.73; control: 0.21, s.d. 0.86; estimated fully adjusted between-group difference 0.03, 95% CI -0.25 to 0.31; P = 0.819). Acute mental health episodes (safety outcome) included three crises in the intervention group and four in the control group. CONCLUSIONS: There was no evidence of a difference in quality of life, as measured with the MANSA, between those receiving the PARTNERS intervention and usual care. Shifting care to primary care was not associated with increased adverse outcomes.

What Is the Longitudinal Profile of Impairments and Can We Predict Difficulty Caring for the Profoundly Affected Arm in the First Year Poststroke?

OBJECTIVES: To establish the longitudinal profile of impairments of body functions and activity limitations of the arm, and to evaluate potential predictors of difficulty caring for the profoundly affected arm poststroke. DESIGN: Prospective cohort study. SETTING: Stroke services. PARTICIPANTS: People unlikely to regain functional use of the arm (N=155) were recruited at 2 to 4 weeks poststroke, and followed up at 3, 6, and 12 months. Potential predictors at baseline were hypertonicity, pain, motor control, mood, sensation/perception, age, and stroke severity. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Difficulty caring for the arm (Leeds Arm Spasticity Impact Scale), pain, hypertonicity, range of movement, arm function, and skin integrity. Multivariable linear regression identified the best fitting model for predicting Leeds Arm Spasticity Impact Scale score at 12 months. RESULTS: There were 110 participants (71%) reviewed at 1 year. There was a large variation in the profile of arm functions and activity limitations. Inability or severe difficulty caring for the arm affected 29% of participants. Hypertonicity developed in 77%, with severe hypertonicity present in 25%. Pain was reported by 65%, 94% developed shoulder contracture, and 6% had macerated skin. Difficulty caring for the arm increased with age, greater level of hypertonicity, and stroke classification; collectively, these factors accounted for 33% of the variance in Leeds Arm Spasticity Impact Scale scores. CONCLUSIONS: At 1 year poststroke, there was a high incidence of impairments of body functions and activity limitations in people with a profoundly affected arm. Individual profiles were very variable and although some predisposing factors have been identified, it remains difficult to predict who is at greatest risk.

Children's Compliance With Wrist-Worn Accelerometry Within a Cluster-Randomized Controlled Trial: Findings From the Healthy Lifestyles Programme.

PURPOSE: The purpose of this study was to assess children's compliance with wrist-worn accelerometry during a randomized controlled trial and to examine whether compliance differed by allocated condition or gender. METHODS: A total of 886 children within the Healthy Lifestyles Programme trial were randomly allocated to wear a GENEActiv accelerometer at baseline and 18-month follow-up. Compliance with minimum wear-time criteria (≥10 h for 3 weekdays and 1 weekend day) was obtained for both time points. Chi-square tests were used to determine associations between compliance, group allocation, and gender. RESULTS: At baseline, 851 children had usable data, 830 (97.5%) met the minimum wear-time criteria, and 631 (74.1%) had data for 7 days at 24 hours per day. At follow-up, 789 children had usable data, 745 (94.4%) met the minimum wear-time criteria, and 528 (67%) had complete data. Compliance did not differ by gender (baseline: χ2 = 1.66, P = .2; follow-up: χ2 = 0.76, P = .4) or by group at follow-up (χ2 = 2.35, P = .13). CONCLUSION: The use of wrist-worn accelerometers and robust trial procedures resulted in high compliance at 2 time points regardless of group allocation, demonstrating the feasibility of using precise physical activity monitors to measure intervention effectiveness.

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation.

BACKGROUND: The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. METHODS: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. RESULTS: All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. CONCLUSION: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. TRIAL REGISTRATION: ISRCTN15811706.

Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP) trial.

BACKGROUND: We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial. METHODS: Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months. RESULTS: At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day. CONCLUSION: We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status. TRIAL REGISTRATION: ISRCTN15811706 (1/05/2012).

Frequency, characteristics, and consequences of falls in multiple sclerosis: findings from a cohort study.

OBJECTIVE: To evaluate falls rate and the characteristics of falls (including fall-related injuries) in a multiple sclerosis (MS) cohort. DESIGN: As part of a study evaluating falls risk, a cohort of 150 participants prospectively recorded actual and near fall events using a daily diary over 3 months, as well as the circumstances of each fall including related injuries. SETTING: Community setting. PARTICIPANTS: A population-based sample of people (N=150) with a confirmed diagnosis of MS (Expanded Disability Status Scale, 3.5-6.5) was recruited via a patient-centered longitudinal study database of disease course in people with MS. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Rate of actual and near falls, circumstances and consequences of falls (including rates and type of injury plus follow-up care). RESULTS: The response rate for the falls diary was 92.7%. A total of 672 actual falls and 3785 near falls were recorded, with a moderate correlation between the numbers of actual and near falls per person (ρ=.474; 95% confidence interval, .34-.59). Men recorded significantly more falls than women. Falls were associated with a range of activities, although 27.6% occurred during general mobility activities such as walking, turning, and moving between positions. Injuries occurred in 11.1% of falls, with 6 individuals requiring medical attention. CONCLUSIONS: People with MS experience high numbers of falls, with associated injuries. Falls occur during a wide range of activities, reflecting their potential impact on daily life. Evaluating the characteristics of individuals who experience frequent near falls but few actual falls may be valuable for research and clinical practice.

Lessons from a research partnership in southwest England to understand community palliative care needs in rural, coastal and low-income communities.

Background: The South West Peninsula (Cornwall, Devon, Somerset) has the highest proportion of over 65s (24.2%) and is the only English rural population with greater economic deprivation than in urban areas. Coastal populations have the worst health outcomes in England. Despite innovation among communities to support those with health and care needs in later life, recruitment to palliative care research in the region is low and there has been no evaluation of public health palliative care interventions. Objectives: A new South West Peninsula Palliative Care Research Partnership was funded for 15 months, bringing together four universities, the voluntary and community sector (including hospices) and local National Institute for Health and Care Research networks. The aim was to establish a sustainable multisectoral partnership that would identify community-based support needs for underserved rural and coastal populations by: • conducting a literature scoping review on interventions to enable community members to support the dying; • delivering a research capacity-building programme; • co-creating public and patient involvement capacity; • determining the resources and needs for communities to support dying well; • integrating findings to develop a framework of community-based support and identify future research questions; • establishing a sustainable research network infrastructure for the long-term design and delivery of palliative care research. Design: We convened partners to identify research needs and co-designed activities to meet our objectives. These included a scoping review; a capacity-building programme of training, seminars and a journal club; forming a patient and public involvement group; a multistranded community engagement programme using different creative approaches; four focus groups with members of the public and one with community workers; and producing three 'storytelling' audio recordings. Findings were presented to the partnership at a regional workshop. Results: The scoping review showed that community-engaged palliative care interventions can improve outcomes for individuals but provided little evidence about which approaches work for different communities. Five online seminars and a quarterly journal club to develop research capacity were regularly attended by 15 to 25 participants from across the partnership. While evaluating our engagement methods was beyond the partnership's scope, levels of participation suggested that creative methods of engagement show potential to help researchers and practitioners better understand the needs and priorities of underserved populations. Data showed that rural, coastal and low-income communities face challenges in accessing end-of-life care and support due to issues such as transport to and distance from services, erosion of neighbourhood networks, isolation from family and friends, 'patchiness' of palliative care services and a lack of care providers. Community organisations are well-placed to co-produce and facilitate methodologies for involving communities in palliative care research. Limitations: Although activities took place in diverse areas, it was not possible within the available resources to cover the entire large geographical region, particularly the most isolated rural areas. Conclusions: Partnerships bringing together voluntary and community sector organisations, palliative care providers, health and social care providers, individuals with experience and academics have potential to design future research and public health interventions that better understand local context, involving and supporting communities to address their needs at end of life. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR135312.

England's South West Peninsula (Cornwall, Devon, Somerset) has high levels of poverty and an ageing population. There are some community groups which enable individuals to support each other at the end of life. However there has been little local palliative (i.e. end-of-life) care research to understand people's needs in rural and coastal areas. We created the South West Peninsula Palliative Care Research Partnership including four universities, voluntary and community organisations (including hospices), health research agencies, and a group of individuals interested in palliative care. We wanted to build a sustainable partnership that would identify what communities need to support each other at end of life and help individuals and organisations to plan and participate in research. We reviewed existing research evidence and ran a programme of training events and community activities (an interactive display, focus groups, one-to-one conversations and 'storytelling'). Finally, we came together to discuss the findings and plan next steps. Getting support at the end of life can be difficult in the region because of poor transport, distance from services, isolation from support networks, and patchy palliative and social care services. We found that using creative ways to involve people, like the interactive display, helped clinicians and researchers better understand local needs. Our experience of partnership working showed that palliative care organisations, academics and community organisations working alongside each other can help services reach these areas, and make it easier for people to be involved in research. We hope that continuing this partnership will help communities share and develop expertise in supporting patients and families with palliative care needs, and help clinical services and universities involve people in rural, coastal and low-income areas in planning, delivering and participating in research that addresses their priorities.

How can we improve Comprehensive Geriatric Assessment for older people living with frailty in primary care and community settings? A qualitative study.

OBJECTIVE: With advancing age comes the increasing prevalence of frailty and increased risk of adverse outcomes (eg, hospitalisation). Evidence for comprehensive geriatric assessment (CGA), a multidimensional holistic model of care, is mixed in community settings. Uncertainties remain, such as the key components of CGA, who delivers it, and the use of technology. This study aimed to understand the perspectives, beliefs and experiences, of both older people and health professionals, to improve the current CGA and explore factors that may impact on CGA delivery in community settings. DESIGN: A qualitative interview study was conducted with older people and healthcare professionals (HCPs) identified using a maximum variation strategy. Data were analysed using an abductive analysis approach. The non-adoption, abandonment, scale-up, spread and sustainability framework and the theoretical framework of acceptability guided the categorisation of the codes and identified categories were mapped to the two frameworks. SETTING: England, UK. RESULTS: 27 people were interviewed, constituting 14 older people and 13 HCPs. We identified limitations in the current CGA: a lack of information sharing between different HCPs who deliver CGA; poor communication between older people and their HCPs and a lack of follow-up as part of CGA. When we discussed the potential for CGA to use technology, HCPs and older people varied in their readiness to engage with it. CONCLUSIONS: Viable solutions to address gaps in the current delivery of CGA include the provision of training and support to use digital technology and a designated comprehensive care coordinator. The next stage of this research will use these findings, existing evidence and stakeholder engagement, to develop and refine a model of community-based CGA that can be assessed for feasibility and acceptability.

Risk factors for falls in multiple sclerosis: an observational study.

BACKGROUND: People with multiple sclerosis (MS) experience frequent falls, which are associated with impairments and limitations to activities and participations. OBJECTIVE: The objective of this paper is to evaluate falls risk factors using robust clinical measures. METHODS: A total of 150 individuals (confirmed MS diagnosis, Expanded Disability Status Scale (EDSS) 3.5-6.5) were recruited, with 148 participants included in the final analysis. Demographic data were collected and performance assessed in eight predictor measures (Physiological Profile Assessment (PPA), Brief Ataxia Rating scale, Ashworth scale (Ashworth), Modified Falls Efficacy scale, Symbol Digit Modalities Test, dual-task interference, lying/standing blood pressure, static/dynamic visual acuity). Participants prospectively recorded falls over three months using a daily diary. People were classified as "fallers" based on reports of ≥ two falls. RESULTS: A total of 104 participants recorded 672 falls; 78 (52.7%) reported ≥ two falls. Continence issues, previous falls history and use of prescribed medications were each associated with increased risk of being a "faller". Ashworth and PPA risk score contributed significantly to a logistic regression model predicting faller/non-faller classification. The reduced model (Ashworth, PPA, EDSS) showed fair-to-good predictive ability (ROC c-statistic 0.73, sensitivity 70%, specificity 69%). CONCLUSION: This study confirms the high prevalence of falls in ambulant people with MS. Important potentially modifiable risk factors are identified, suggesting aspects to target in falls interventions.

Engaging with communities in rural, coastal and low-income areas to understand barriers to palliative care and bereavement support: reflections on a community engagement programme in South-west England.

Background: England's South-west Peninsula is largely rural, has a high proportion of over 65s, and has areas of rural and coastal deprivation. Rural and low-income populations face inequities at end of life and little is known about the support needs of rural, coastal and low-income communities. Objectives: To understand how to foster community support for dying and grieving well, a regional, multi-sectoral research partnership developed a community engagement programme to explore experiences of seeking support, issues important to people and the community support they valued. This article shares what people told us about the role that communities can play at end of life, and reflects on learning from our process of engaging communities in conversations about dying. Design and methods: A programme of varied community engagement which included: the use of the 'Departure Lounge' installation and four focus groups with interested individuals in a range of community settings; the co-creation of a 'Community Conversation' toolkit to facilitate conversations with individuals with experience of end-of-life care and their carers with Community Builders; a focus group with Community Builders and a storytelling project with three bereaved individuals. Results: People valued community support at the end of life or in bereavement that offered connection with others, peer support without judgement, responded to their individual needs and helped them to access services. Creative methods of engagement show potential to help researchers and practitioners better understand the needs and priorities of underserved populations. Collaboration with existing community groups was key to engagement, and contextual factors influenced levels of engagement. Conclusion: Local community organizations are well placed to support people at end of life. This work highlighted the potential for partnership with palliative care and bereavement organizations, who could offer opportunities to develop people's knowledge and skills, and together generate sustainable solutions to meet local need.

Effectiveness and cost-effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking (TARS).

AIMS: For smokers unmotivated to quit, we assessed the effectiveness and cost-effectiveness of behavioural support to reduce smoking and increase physical activity on prolonged abstinence and related outcomes. DESIGN: A multi-centred pragmatic two-arm parallel randomised controlled trial. SETTING: Primary care and the community across four United Kingdom sites. PARTICIPANTS: Nine hundred and fifteen adult smokers (55% female, 85% White), recruited via primary and secondary care and the community, who wished to reduce their smoking but not quit. INTERVENTIONS: Participants were randomised to support as usual (SAU) (n = 458) versus multi-component community-based behavioural support (n = 457), involving up to eight weekly person-centred face-to-face or phone sessions with additional 6-week support for those wishing to quit. MEASUREMENTS: Ideally, cessation follows smoking reduction so the primary pre-defined outcome was biochemically verified 6-month prolonged abstinence (from 3-9 months, with a secondary endpoint also considering abstinence between 9 and 15 months). Secondary outcomes included biochemically verified 12-month prolonged abstinence and point prevalent biochemically verified and self-reported abstinence, quit attempts, number of cigarettes smoked, pharmacological aids used, SF12, EQ-5D and moderate-to-vigorous physical activity (MVPA) at 3 and 9 months. Intervention costs were assessed for a cost-effectiveness analysis. FINDINGS: Assuming missing data at follow-up implied continued smoking, nine (2.0%) intervention participants and four (0.9%) SAU participants achieved the primary outcome (adjusted odds ratio, 2.30; 95% confidence interval [CI] = 0.70-7.56, P = 0.169). At 3 and 9 months, the proportions self-reporting reducing cigarettes smoked from baseline by ≥50%, for intervention versus SAU, were 18.9% versus 10.5% (P = 0.009) and 14.4% versus 10% (P = 0.044), respectively. Mean difference in weekly MVPA at 3 months was 81.6 minutes in favour of the intervention group (95% CI = 28.75, 134.47: P = 0.003), but there was no significant difference at 9 months (23.70, 95% CI = -33.07, 80.47: P = 0.143). Changes in MVPA did not mediate changes in smoking outcomes. The intervention cost was £239.18 per person, with no evidence of cost-effectiveness. CONCLUSIONS: For United Kingdom smokers wanting to reduce but not quit smoking, behavioural support to reduce smoking and increase physical activity improved some short-term smoking cessation and reduction outcomes and moderate-to-vigorous physical activity, but had no long-term effects on smoking cessation or physical activity.

Evaluation of the prehospital use of a Valsalva assist device in the emergency treatment of supraventricular tachycardia (EVADE SVT): study protocol for a stepped wedge cluster randomised controlled trial.

INTRODUCTION: Patients with episodes of supraventricular tachycardia (SVT), a common heart arrhythmia, are often attended by ambulance services. International guidelines advocate treatment with the Valsalva manoeuvre (VM), but this simple physical treatment has a low success rate, with most patients requiring conveyance to hospital. The Valsalva Assist Device (VAD) is a simple device that might help practitioners and patients perform a more effective VM and reduce the need for patients to be taken to hospital. METHODS AND ANALYSIS: This stepped wedge cluster randomised controlled trial, conducted within a UK ambulance service, compares the current standard VM with a VAD-delivered VM in stable adult patients presenting to the ambulance service with SVT. The primary outcome is conveyance to hospital; secondary outcomes measures include cardioversion rates, duration of ambulance care and number of subsequent episodes of SVT requiring ambulance service care. We plan to recruit approximately 800 patients, to have 90% power to detect an absolute reduction in conveyance rate of 10% (from 90% to 80%) between the standard VM (control) and VAD-delivered VM (intervention). Such a reduction in conveyance would benefit patients, the ambulance service and receiving emergency departments. It is estimated potential savings would pay for devices for the entire ambulance trust within 7 months. ETHICS AND DISSEMINATION: The study has been approved by the Oxford Research Ethics Committee (reference 22/SC/0032). Dissemination will be through peer-reviewed journal publication, presentation at national and international conferences and by the Arrhythmia Alliance, a patient support charity. TRIAL REGISTRATION NUMBER: ISRCTN16145266.

Motivational support intervention to reduce smoking and increase physical activity in smokers not ready to quit: the TARS RCT.

Background: Physical activity can support smoking cessation for smokers wanting to quit, but there have been no studies on supporting smokers wanting only to reduce. More broadly, the effect of motivational support for such smokers is unclear. Objectives: The objectives were to determine if motivational support to increase physical activity and reduce smoking for smokers not wanting to immediately quit helps reduce smoking and increase abstinence and physical activity, and to determine if this intervention is cost-effective. Design: This was a multicentred, two-arm, parallel-group, randomised (1 : 1) controlled superiority trial with accompanying trial-based and model-based economic evaluations, and a process evaluation. Setting and participants: Participants from health and other community settings in four English cities received either the intervention (n = 457) or usual support (n = 458). Intervention: The intervention consisted of up to eight face-to-face or telephone behavioural support sessions to reduce smoking and increase physical activity. Main outcome measures: The main outcome measures were carbon monoxide-verified 6- and 12-month floating prolonged abstinence (primary outcome), self-reported number of cigarettes smoked per day, number of quit attempts and carbon monoxide-verified abstinence at 3 and 9 months. Furthermore, self-reported (3 and 9 months) and accelerometer-recorded (3 months) physical activity data were gathered. Process items, intervention costs and cost-effectiveness were also assessed. Results: The average age of the sample was 49.8 years, and participants were predominantly from areas with socioeconomic deprivation and were moderately heavy smokers. The intervention was delivered with good fidelity. Few participants achieved carbon monoxide-verified 6-month prolonged abstinence [nine (2.0%) in the intervention group and four (0.9%) in the control group; adjusted odds ratio 2.30 (95% confidence interval 0.70 to 7.56)] or 12-month prolonged abstinence [six (1.3%) in the intervention group and one (0.2%) in the control group; adjusted odds ratio 6.33 (95% confidence interval 0.76 to 53.10)]. At 3 months, the intervention participants smoked fewer cigarettes than the control participants (21.1 vs. 26.8 per day). Intervention participants were more likely to reduce cigarettes by ≥ 50% by 3 months [18.9% vs. 10.5%; adjusted odds ratio 1.98 (95% confidence interval 1.35 to 2.90] and 9 months [14.4% vs. 10.0%; adjusted odds ratio 1.52 (95% confidence interval 1.01 to 2.29)], and reported more moderate-to-vigorous physical activity at 3 months [adjusted weekly mean difference of 81.61 minutes (95% confidence interval 28.75 to 134.47 minutes)], but not at 9 months. Increased physical activity did not mediate intervention effects on smoking. The intervention positively influenced most smoking and physical activity beliefs, with some intervention effects mediating changes in smoking and physical activity outcomes. The average intervention cost was estimated to be £239.18 per person, with an overall additional cost of £173.50 (95% confidence interval -£353.82 to £513.77) when considering intervention and health-care costs. The 1.1% absolute between-group difference in carbon monoxide-verified 6-month prolonged abstinence provided a small gain in lifetime quality-adjusted life-years (0.006), and a minimal saving in lifetime health-care costs (net saving £236). Conclusions: There was no evidence that behavioural support for smoking reduction and increased physical activity led to meaningful increases in prolonged abstinence among smokers with no immediate plans to quit smoking. The intervention is not cost-effective. Limitations: Prolonged abstinence rates were much lower than expected, meaning that the trial was underpowered to provide confidence that the intervention doubled prolonged abstinence. Future work: Further research should explore the effects of the present intervention to support smokers who want to reduce prior to quitting, and/or extend the support available for prolonged reduction and abstinence. Trial registration: This trial is registered as ISRCTN47776579. 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. 27, No. 4. See the NIHR Journals Library website for further project information.

NHS pharmacological and behavioural support helps smokers wanting to quit, and physical activity may also help. It is unclear if behavioural support for those not ready to quit may lead to more quit attempts and abstinence from smoking. A total of 915 smokers who wanted to reduce their smoking, but who had not yet quit, were recruited and randomised to receive an intervention or brief support as usual (brief advice to quit), in Plymouth, London, Oxford and Nottingham. The intervention involved up to eight sessions (by telephone or in person) of motivational support to reduce smoking and increase physical activity (and more sessions to support a quit attempt). Participants self-reported smoking and physical activity information at the start of the trial and after 3 and 9 months. Self-reported quitters confirmed their abstinence with a biochemical test of expired air or saliva. Our main interest was in whether or not the groups differed in the proportion who remained abstinent for at least 6 months. Overall, only 1­2% remained abstinent for 6 months. Although it appeared that a greater proportion did so after receiving the intervention, because few participants were abstinent, the results are not conclusive. However, the intervention had beneficial effects on less rigorous outcomes, including a reduction in the self-reported number of cigarettes smoked, and a greater proportion of intervention than control participants with self-reported and biochemically verified abstinence at 3 months. The intervention also helped participants to reduce, by at least half, the number of cigarettes they smoked at 3 and 9 months, and to report more physical activity, but only at 3 months. Despite reasonable intervention engagement and some short-term changes in smoking and physical activity, the trial does not provide evidence that this intervention would help smokers to quit for at least 6 months nor would it be cost-effective, with an average cost of £239 per smoker.

Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.

BACKGROUND: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AIM: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact. DESIGN & SETTING: A realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across South West and North West England where low-income or ethnic minority populations (for example, South Asian) are represented. Design was informed by patient, public, and professional stakeholder input and phase 1 findings. METHOD: High-volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers, and practitioners. Analyses will comprise the following: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4a) health economic analysis examining costs of delivery; and 4b) realist economic analysis of high-cost events and 'near misses'. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation, and stakeholder co-analysis. CONCLUSION: The realist evaluation will describe how, why, and for whom the intervention does or does not lead to change over time. It will also demonstrate how a non-randomised design can be more appropriate for complex interventions with similar questions or populations.

Periodontitis in non-smoking type 1 diabetic adults: a cross-sectional study.

AIM: To compare levels of periodontitis in non-smoking type 1 diabetic patients and controls. MATERIAL AND METHODS: Type 1 diabetic patients, aged 20-55 years, were recruited from outpatient clinics at five hospitals in Glasgow, UK. Control subjects were recruited from physiotherapy clinics, using the buddy system and through an advertisement in a free newspaper. The primary outcome was severe periodontitis defined by clinical attachment level ≥6 mm on ≥1 tooth. RESULTS: There were 34 well controlled patients (HbA1c ≤ 7.5%), 169 poorly controlled patients and 112 non-diabetic subjects. Prevalence of severe periodontitis was higher in all type 1 diabetic patients [24.1% (95% CI: 18.4-30.6%)] and poorly controlled patients [27.2% (20.7-34.6%)] than in controls [20.5% (13.5-29.2%)]. The fully adjusted odds ratios (ORs) in never smokers comparing the whole diabetic group, and the poorly controlled group, with the control group were 1.35 [0.66-2.8] (p = 0.41) and 1.58 [0.75-3.33] (p = 0.23), respectively. Mean clinical attachment level was higher in all type 1 diabetic and poorly controlled patients than in controls (both p < 0.001). CONCLUSIONS: These results indicate worse periodontal health in type 1 diabetic patients than in control subjects. TRIAL REGISTRATION: This study was registered with the UKCRN, ID: 9314 and Scottish Diabetes Research Network registration number: 128.

Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial.

BACKGROUND: Early mobilisation (> 24 h post-stroke) is recommended for people with stroke. However, there is a paucity of evidence about how to implement early mobilisation for people who have had a severe stroke. Prolonged standing and task-specific training (sit-to-stand repetitions) have separately been evaluated in the literature; however, these functionally linked tasks have not been evaluated in combination for people with severe sub-acute stroke. METHODS: The objective was to determine the feasibility of conducting a randomised controlled trial (RCT) of a functional standing frame programme compared with usual physiotherapy for people with severe sub-acute stroke. An assessor-blinded feasibility RCT with nested qualitative component (interviews and focus group) and process evaluation was adopted. Participants were aged ≥ 18 years with new diagnosis of severe sub-acute stroke (modified Rankin Scale (mRS) 4/5) from four Stroke Rehabilitation Units across South West England. Participants were randomised to receive either: (1) functional standing frame programme (30 min. standing plus sit-to-stand repetitions) plus 15 min of usual physiotherapy daily (intervention); (2) usual physiotherapy (45 min) daily (control). Both programmes were protocolised to be undertaken a minimum of five sessions per week for 3 weeks. Feasibility indicators included process, resource, management, and safety. Adherence, fidelity, and acceptability of the trial and intervention were evaluated using data recorded by therapists, observation of intervention and control sessions, interviews and one focus group. Patient measures of motor impairment, activities/participation, and quality of life were carried out by blinded assessors at baseline, 3, 15, 29, and 55 weeks post-randomisation. RESULTS: Forty-five participants (51-96 years; 42% male, mRS 4 = 80% 5 = 20%) were randomised (n = 22 to intervention). Twenty-seven (60%) participants were followed-up at all time points. Twelve participants (27%) died during the trial; no deaths were related to the trial. Adherence to the minimum number of sessions was low: none of the participants completed all 21 sessions, and only 8 participants (18%) across both groups completed ≥ 15 sessions, over the 3 weeks; 39% intervention; 51% control sessions were completed; mean session duration 39 min (SD 19) control, 37 min intervention (SD 11). Intervention group: mean standing time 13 min (SD 9); mean sit-to-stand repetitions/session 5 (SD 4). Interviews were conducted with 10 participants, four relatives and six physiotherapists. Five physiotherapists attended a focus group. CONCLUSIONS: The majority of progression criteria for this feasibility trial were met. However, adherence to the interventions was unacceptably low. This aspect of the trial design needs to be addressed prior to moving to a definitive RCT of this standing frame intervention in people with severe sub-acute stroke. Solutions have been identified to address these concerns. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ISRCTN15412695 . Registration 19 December 2016.

Brief intervention to reduce fatigue impact in patients with inflammatory arthritis: design and outcomes of a single-arm feasibility study.

OBJECTIVES: Patients with inflammatory arthritis report that fatigue is challenging to manage. We developed a manualised, one-to-one, cognitive-behavioural intervention, delivered by rheumatology health professionals (RHPs). The Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis (FREE-IA) study tested the feasibility of RHP training, intervention delivery and outcome collection ahead of a potential trial of clinical and cost-effectiveness. METHODS: In this single-arm feasibility study, eligible patients were ≥18 years, had a clinician-confirmed diagnosis of an inflammatory arthritis and scored ≥6/10 on the Bristol Rheumatoid Arthritis Fatigue (BRAF) Numerical Rating Scale (NRS) Fatigue Effect. Following training, RHPs delivered two to four sessions to participants. Baseline data were collected before the first session (T0) and outcomes at 6 weeks (T1) and 6 months (T2). The proposed primary outcome was fatigue impact (BRAF NRS Fatigue Effect). Secondary outcomes included fatigue severity and coping, disease impact and disability, and measures of therapeutic mechanism (self-efficacy and confidence to manage health). RESULTS: Eight RHPs at five hospitals delivered 113 sessions to 46 participants. Of a potential 138 primary and secondary outcome responses at T0, T1 and T2, there were 13 (9.4%) and 27 (19.6%) missing primary and secondary outcome responses, respectively. Results indicated improvements in all measures except disability, at either T1 or T2, or both. CONCLUSIONS: This study showed it was feasible to deliver the intervention, including training RHPs, and recruit and follow-up participants with high retention. While there was no control group, observed within-group improvements suggest potential promise of the intervention and support for a definitive trial to test effectiveness.

Evaluation of Simvastatin as a Disease-Modifying Treatment for Patients With Parkinson Disease: A Randomized Clinical Trial.

Importance: Current treatments manage symptoms of Parkinson disease (PD), but no known treatment slows disease progression. Preclinical and epidemiological studies support the potential use of statins as disease-modifying therapy. Objective: To determine whether simvastatin has potential as a disease-modifying treatment for patients with moderate PD. Design, Setting, and Participants: This randomized clinical trial, a double-blind, parallel-group, placebo-controlled futility trial, was conducted between March 2016 and May 2020 within 23 National Health Service Trusts in England. Participants aged 40 to 90 years with a diagnosis of idiopathic PD, with a modified Hoehn and Yahr stage of 3.0 or less while taking medication, and taking dopaminergic medication with wearing-off phenomenon were included. Data were analyzed from May 2020 to September 2020, with additional analysis in February 2021. Interventions: Participants were allocated 1:1 to simvastatin or matched placebo via a computer-generated random sequence, stratified by site and Hoehn and Yahr stage. In the simvastatin arm, participants entered a 1-month phase of simvastatin, 40 mg daily, followed by 23 months of simvastatin, 80 mg daily, before a 2-month washout period. Main Outcomes and Measures: The prespecified primary outcome was 24-month change in Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part III score measured while not taking medication (high scores indicate worse outcome). The primary futility analysis included participants who commenced the 80-mg phase and had valid primary outcome data. The safety analysis included all participants who commenced trial treatment and is reported by dose at time of event. Results: Of 332 patients assessed for eligibility, 32 declined and 65 were ineligible. Of 235 recruited participants, 97 (41%) were female, 233 (99%) were White, and the mean (SD) age was 65.4 (9.4) years. A total of 216 patients progressed to the 80-mg dose. Primary outcome analysis (n = 178) indicated the simvastatin group had an additional deterioration in MDS-UPDRS III score while not taking medication at 24 months compared with the placebo group (1.52 points; 2-sided 80% CI, -0.77 to 3.80; 1-sided futility test P = .006). A total of 37 serious adverse events (AEs), including 3 deaths, and 171 AEs were reported for participants receiving 0-mg simvastatin; 37 serious AEs and 150 AEs were reported for participants taking 40 mg or 80 mg of simvastatin. Four participants withdrew from the trial because of an AE. Conclusions and Relevance: In this randomized clinical trial, simvastatin was futile as a disease-modifying therapy in patients with PD of moderate severity, providing no evidence to support proceeding to a phase 3 trial. Trial Registration: ISRCTN Identifier: 16108482.

Visualising harms in publications of randomised controlled trials: consensus and recommendations.

OBJECTIVE: To improve communication of harm in publications of randomised controlled trials via the development of recommendations for visually presenting harm outcomes. DESIGN: Consensus study. SETTING: 15 clinical trials units registered with the UK Clinical Research Collaboration, an academic population health department, Roche Products, and The BMJ. PARTICIPANTS: Experts in clinical trials: 20 academic statisticians, one industry statistician, one academic health economist, one data graphics designer, and two clinicians. MAIN OUTCOME: measures A methodological review of statistical methods identified visualisations along with those recommended by consensus group members. Consensus on visual recommendations was achieved (at least 60% of the available votes) over a series of three meetings with participants. The participants reviewed and critically appraised candidate visualisations against an agreed framework and voted on whether to endorse each visualisation. Scores marginally below this threshold (50-60%) were revisited for further discussions and votes retaken until consensus was reached. RESULTS: 28 visualisations were considered, of which 10 are recommended for researchers to consider in publications of main research findings. The choice of visualisations to present will depend on outcome type (eg, binary, count, time-to-event, or continuous), and the scenario (eg, summarising multiple emerging events or one event of interest). A decision tree is presented to assist trialists in deciding which visualisations to use. Examples are provided of each endorsed visualisation, along with an example interpretation, potential limitations, and signposting to code for implementation across a range of standard statistical software. Clinician feedback was incorporated into the explanatory information provided in the recommendations to aid understanding and interpretation. CONCLUSIONS: Visualisations provide a powerful tool to communicate harms in clinical trials, offering an alternative perspective to the traditional frequency tables. Increasing the use of visualisations for harm outcomes in clinical trial manuscripts and reports will provide clearer presentation of information and enable more informative interpretations. The limitations of each visualisation are discussed and examples of where their use would be inappropriate are given. Although the decision tree aids the choice of visualisation, the statistician and clinical trial team must ultimately decide the most appropriate visualisations for their data and objectives. Trialists should continue to examine crude numbers alongside visualisations to fully understand harm profiles.