Collaboration For Leadership In Applied Health Research And Care Research Articles

Body mass index and survival in people with heart failure

Abstract Background People with obesity are twice as likely to develop heart failure (HF) compared to people with a healthy body mass index (BMI) [1]. However, among people with HF a higher BMI has been linked to a reduced risk of all-cause mortality, a concept known as the “obesity paradox” [2]. Purpose To examine the association between BMI and survival in patients with chronic HF among a large primary care cohort. Methods We extracted data from the Clinical Practice Research Datalink of primary care records from 1st January 2000 to 31st December 2017 and included 47,531 patients with an incident diagnosis of HF, who were aged 45 years and over and who had a recorded BMI. Patients were stratified into categories of baseline BMI as underweight (BMI <18.5 kg/m2), healthy weight (BMI 18.5 to 24.9 kg/m2), overweight (BMI 25.0 to 29.9 kg/m2) or obese, with obesity split into class I (30.0–34.9 kg/m2), class II (35.0–39.9 kg/m2) and class III (40 kg/m2 and over). The primary outcome was all-cause mortality. We used Kaplan-Meier curves and log rank tests to compare survival in people with HF, based on baseline BMI. We also report a Cox regression model for risk of all-cause mortality among people with HF comparing BMI categories. Results There were 25,013 deaths during the study follow-up. The average age of participants was 77.1 years (SD 10.6) and mean BMI was 27.9 (SD 6.1). In an age- and sex-adjusted analysis, people who were underweight were at increased risk of all-cause mortality compared to people with healthy weight (HR 1.52, 95% CI 1.41 to 1.64). People with overweight (HR 0.81, 95% CI 0.79 to 0.84), obesity class I (HR 0.79, 95% CI 0.76 to 0.82) and obesity class II (HR 0.78, 95% CI 0.74 to 0.82) were at decreased risk of all-cause mortality. People with obesity class III had no difference in risk of death compared to people with healthy weight (HR 0.95, 95% CI 0.88 to 1.02). In a Kaplan-Meier analysis, there was an inverse relationship between body weight and risk of death, even within the first year of follow-up. Conclusion In our large community cohort of people with HF, we found an inverse relationship between BMI and survival. Underweight people with HF have the poorest prognosis and should be identified as high-risk. Conversely, people with HF who are overweight or obese (class I and II) are at lower risk of death confirming the obesity paradox in a real-world primary care population. These findings suggest a more cautious approach to weight management in overweight and obese patients may be needed for people with HF in primary care. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The SurviveHF study was funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Oxford at Oxford Health NHS Foundation Trust and the Wellcome Institutional Strategic Fund. The funders did not have any role in the design of the study, analysis and interpretation of the data, or writing of the results for publication.

Reporting on patient and public involvement (PPI) in research publications: using the GRIPP2 checklists with lay co-researchers

BackgroundPatient and public involvement (PPI) in health and social care research is considered important internationally, with increasing evidence that PPI improves the quality, relevance and outcomes of research. There has been a growth in research publications that describe PPI in the research process, but the frequency and detail of PPI reporting varies considerably. This paper reports on a collaborative study that aimed to describe the extent of PPI in publications from research funded by the Collaboration for Leadership in Applied Health Research and Care (CLAHRC) in the East of England (EoE), part of the National Institute of Health Research (NIHR) in England (2014–2019).MethodsA descriptive study of all research publications (1st January 2014 to 31st October 2017) funded by the NIHR CLAHRC EoE. Members of the Public Involvement in Research group (PIRg), at the University of Hertfordshire, were actively involved, with four PIRg co-researchers. We used an internationally recognised reporting checklist for PPI called the GRIPP2 (Guidance for Reporting Involvement of Patients and the Public, Version 2) to guide the reviewing process.ResultsOut of 148 research papers identified, 16 (14%) reported some aspect of PPI activity and were included for review. Ten of the publications (63%) acknowledged the contributions of PPI individuals and/or groups and five had PPI co-authors. There was considerable variation in the PPI reported in the publications, with some ‘missed opportunities’ to provide detail of PPI undertaken. The perspectives of the co-researchers shaped the reporting of the results from this study. The co-researchers found the GRIPP2-SF (short form) to be useful, but the GRIPP2-LF (long form) was considered over complicated and not user-friendly.ConclusionsThis is one of the first studies to involve lay co-researchers in the review of PPI reporting using the GRIPP2 reporting checklists (GRIPP2-SF and GRIPP2-LF). We make recommendations for a revised version of the GRIPP2-SF, with clearer instructions and three additional sections to record whether PPI is reported in the abstract or key words, in the acknowledgements section, and whether there are PPI co-authors. We also recommend the provision of training and support for patient and public peer reviewers.

Pharmacologic Interventions for Kawasaki Disease in Children: A Network Meta-Analysis of 56 Randomized Controlled Trials

Background: Although the current consensus recommends a standard treatment of high-dose intravenous immunoglobulin with high-dose aspirin to manage Kawasaki disease (KD), the use of different adjunctive therapies remains controversial. The aim of current network meta-analysis (NMA) was to compare the efficacy and tolerability of different existing interventions for the initial stage and the refractory stage of KD. Methods: The current NMA of randomized controlled trials (RCTs) was conducted under the frequentist model. Findings: Total fifty-six RCTs with 6,486 participants were included. The NMA demonstrated that the medium intravenous immunoglobulin (IVIG) + aspirin + infliximab [mean difference=−1.76 days (95% confidence intervals (95%CIs): −3.65 to 0.13 days) compared to high IVIG + aspirin] had the shortest fever duration; likewise, the medium IVIG + aspirin + infliximab [odds ratio (OR)=0.50, 95%CIs: 0.18 to 1.37 compared to high IVIG + aspirin] had the least CAL incidence in the initial-stage KD. The high IVIG + pulse steroid therapy (OR=0.04, 95%CIs: 0.00 to 0.43 compared to the high IVIG only) had the best fever subsided rate; likewise, the high IVIG + ciclosporin [OR=0.05 (95%CIs: 0.00 to 1.21) compared to the high IVIG only] had the least CAL incidence in the refractory-stage KD. Interpretation: The current NMA demonstrates that the addition of infliximab plus current standard therapy might be the best treatment for acute KD. Conversely, ciclosporin plus IVIG serves as the best choice for lower the CAL incidence in refractory KD. Further controlled trials are warranted to confirm these findings. Funding Statement: The authors of this work did not receive any grant supports. Brendon Stubbs is supported by a Clinical Lectureship (ICA-CL-2017-03-001) jointly funded by Health Education England (HEE) and the National Institute for Health Research (NIHR). Brendon Stubbs is part funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust. Brendon Stubbs is also supported by the Maudsley Charity, King’s College London and the NIHR South London Collaboration for Leadership in Applied Health Research and Care (CLAHRC) funding. This paper presents independent research. The views expressed in this publication are those of the authors and not necessarily those of the acknowledged institutions. Declaration of Interests: The authors report no financial interests or potential conflicts of interest.

Editorial introductions

Editorial introductions

Effect of antihypertensive medication reduction vs usual care on short-term blood pressure control in patients aged ≥ 80 years with hypertension The OPTiMISE randomized clinical trial

This work received joint funding from the National Institute for Health Research (NIHR) Oxford Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust (ref: P2-501) and the NIHR School for Primary Care Research (SPCR; ref 335).

Hormonal and Pharmacologic Interventions for Depressive Symptoms in Peri- And/Or Post-Menopausal Women: A Network Meta-Analysis of Randomized Controlled Trials

Background: Although various pharmacological interventions and hormone replacement therapies for depressive symptoms in menopausal women have been investigated, their relative efficacies and safety remain unclear. Methods: Based upon literature search on PubMed, Cochrane Library, and ScienceDirect, randomized controlled trials (RCTs) examining all the pharmacological interventions or hormone replacement therapy for depressive symptoms in menopausal women had been included. Data that met inclusion criteria were extracted from RCTs. The current network meta-analysis was conducted under the frequentist model. Findings: Seventy RCTs in total were included with a total of 18,530 women (mean age = 62.5). The network meta-analysis (NMA) demonstrated that fluoxetine plus oral combined therapy [standardized mean difference (SMD) = -1.59, 95% confidence interval (CI) = -2.69 to -0.50], transdermal estradiol (SMD = -0.67, 95% CIs= -1.15 to -0.19), tibolone only (SMD = -0.64, 95% CIs= -1.18 to -0.09), and oral estrogen therapy (SMD = -0.55, 95% CIs= -0.92 to -0.18) were associated with significantly better overall improvement in depressive symptoms than that for placebos in menopausal women. Fluoxetine plus oral combined therapy was ranked the best among all the interventions. Similar findings were also noted in the subgroup of participants with definite diagnosis of depression; while for patients without diagnosis of depression, no pharmacological or hormone replacement therapy was better than placebo. Finally, most medications showed good tolerability with drop-out rate and rate of discontinuation due to adverse events comparable to those in placebo groups. Interpretation: This NMA demonstrated that fluoxetine plus oral combined therapy was associated with the best improvement in menopausal depressive symptoms among the investigated interventions. Future large-scale RCTs on pharmacologic relief of depressive symptoms in menopausal women, especially in aspect of antidepressant regimens, are warranted to support or refute the results of the current study. Funding Statement: The authors of this work were supported by the following grants: Brendon Stubbs is supported by a Clinical Lectureship (ICA-CL-2017-03-001) jointly funded by Health Education England (HEE) and the National Institute for Health Research (NIHR). Brendon Stubbs was partly funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust. Brendon Stubbs is also supported by the Maudsley Charity, King’s College London and the NIHR South London Collaboration for Leadership in Applied Health Research and Care (CLAHRC) funding. Declaration of Interests: The authors report no financial interests or potential conflicts of interest.

Designing high-quality implementation research: development, application, feasibility and preliminary evaluation of the implementation science research development (ImpRes) tool and guide

BackgroundDesigning implementation research can be a complex and daunting task, especially for applied health researchers who have not received specialist training in implementation science. We developed the Implementation Science Research Development (ImpRes) tool and supplementary guide to address this challenge and provide researchers with a systematic approach to designing implementation research.MethodsA multi-method and multi-stage approach was employed. An international, multidisciplinary expert panel engaged in an iterative brainstorming and consensus-building process to generate core domains of the ImpRes tool, representing core implementation science principles and concepts that researchers should consider when designing implementation research. Simultaneously, an iterative process of reviewing the literature and expert input informed the development and content of the tool. Once consensus had been reached, specialist expert input was sought on involving and engaging patients/service users; and economic evaluation. ImpRes was then applied to 15 implementation and improvement science projects across the National Institute of Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South London, a research organisation in London, UK. Researchers who applied the ImpRes tool completed an 11-item questionnaire evaluating its structure, content and usefulness.ResultsConsensus was reached on ten implementation science domains to be considered when designing implementation research. These include implementation theories, frameworks and models, determinants of implementation, implementation strategies, implementation outcomes and unintended consequences. Researchers who used the ImpRes tool found it useful for identifying project areas where implementation science is lacking (median 5/5, IQR 4–5) and for improving the quality of implementation research (median 4/5, IQR 4–5) and agreed that it contained the key components that should be considered when designing implementation research (median 4/5, IQR 4–4). Qualitative feedback from researchers who applied the ImpRes tool indicated that a supplementary guide was needed to facilitate use of the tool.ConclusionsWe have developed a feasible and acceptable tool, and supplementary guide, to facilitate consideration and incorporation of core principles and concepts of implementation science in applied health implementation research. Future research is needed to establish whether application of the tool and guide has an effect on the quality of implementation research.

Clinical effectiveness of the START (STrAtegies for RelaTives) psychological intervention for family carers and the effects on the cost of care for people with dementia: 6-year follow-up of a randomised controlled trial

The START (STrAtegies for RelaTives) intervention reduced depressive and anxiety symptoms of family carers of relatives with dementia at home over 2 years and was cost-effective. To assess the clinical effectiveness over 6 years and the impact on costs and care home admission. We conducted a randomised, parallel group, superiority trial recruiting from 4 November 2009 to 8 June 2011 with 6-year follow-up (trial registration: ISCTRN 70017938). A total of 260 self-identified family carers of people with dementia were randomised 2:1 to START, an eight-session manual-based coping intervention delivered by supervised psychology graduates, or to treatment as usual (TAU). The primary outcome was affective symptoms (Hospital Anxiety and Depression Scale, total score (HADS-T)). Secondary outcomes included patient and carer service costs and care home admission. In total, 222 (85.4%) of 173 carers randomised to START and 87 to TAU were included in the 6-year clinical efficacy analysis. Over 72 months, compared with TAU, the intervention group had improved scores on HADS-T (adjusted mean difference -2.00 points, 95% CI -3.38 to -0.63). Patient-related costs (START versus TAU, respectively: median £5759 v. £16 964 in the final year; P = 0.07) and carer-related costs (median £377 v. £274 in the final year) were not significantly different between groups nor were group differences in time until care home (intensity ratio START:TAU was 0.88, 95% CI 0.58-1.35). START is clinically effective and this effect lasts for 6 years without increasing costs. This is the first intervention with such a long-term clinical and possible economic benefit and has potential to make a difference to individual carers. G.L., Z.W. and C.C. are supported by the UCLH National Institute for Health Research (NIHR) Biomedical Research Centre. G.L. and P.R. were in part supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart's Health NHS Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Z.W. reports during the conduct of the study; personal fees from GE Healthcare, grants from GE Healthcare, grants from Lundbeck, other from GE Healthcare, outside the submitted work.

Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson’s: the PDSAFE RCT

People with Parkinson's disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life. To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson's disease. A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses. Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions. A total of 474 people with Parkinson's disease (i.e. Hoehn and Yahr scale stages 1-4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50 : 50. All participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE. The primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson's Disease Questionnaire. PDSAFE is the largest RCT of falls management among people with Parkinson's disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. Of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98; p = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67; p = 0.009), functional strength (CST: p = 0.041) and falls efficacy (Falls Efficacy Scale - International: mean difference 1.6, 95% CI -3.0 to -0.19; p = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86; p = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG. All participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding. PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson's disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation. Further trials of falls prevention on targeted groups of people with Parkinson's disease are recommended. Current Controlled Trials ISRCTN48152791. 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. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria A Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.

Local radio to promote mental health awareness: a public health initiative

Public health strategies have focused largely on physical health. However, there is increasing recognition that raising mental health awareness and tackling stigma is crucial to reduce disease burden. National campaigns have had some success but tackling issues locally is particularly important. To assess the public's awareness and perception of the monthly BBC Cornwall mental health phone-in programmes that have run for 8.5 years in Cornwall, UK (population 530 000). A consultation, review and feedback process involving a multiagency forum of mental and public health professionals, people with lived experience and local National Health Service trust's media team was used to develop a brief questionnaire. This was offered to all attendees at two local pharmacies covering populations of 27 000 over a 2-week period. In total, 14% (95% CI 11.9-16.5) were aware of the radio show, 11% (95% CI 9.0-13.1) have listened and the majority (76%) of those who listened did so more than once. The estimated reach is 70 000 people in the local population, of whom approximately 60 000 listen regularly. The show is highly valued among respondents with modal and median scores of 4 out of 5. Local radio is a successful, cost-effective and impactful way to reach a significant proportion of the population and likely to raise awareness, reduce stigma and be well received. The format has been adopted in other regions thus demonstrating easy transferability. It could form an essential part of a public health strategy to improve a population's mental well-being. W.H. received support from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula UK. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. L.R. and D.S. were involved in delivering the programmes but had no role in their evaluation.

Holistic services for people with advanced disease and chronic or refractory breathlessness: a mixed-methods evidence synthesis

BackgroundBreathlessness is a common and distressing symptom of many advanced diseases, affecting around 2 million people in the UK. Breathlessness increases with disease progression and often becomes chronic or refractory. Breathlessness-triggered services that integrate holistic assessment and specialist palliative care input as part of a multiprofessional approach have been developed for this group, offering tailored interventions to support self-management and reduce distress.ObjectivesThe aim was to synthesise evidence on holistic breathlessness services for people with advanced disease and chronic or refractory breathlessness. The objectives were to describe the structure, organisation and delivery of services, determine clinical effectiveness, cost-effectiveness and acceptability, identify predictors of treatment response, and elicit stakeholders’ evidence-based priorities for clinical practice, policy and research.DesignThe mixed-methods evidence synthesis comprised three components: (1) a systematic review to determine the clinical effectiveness, cost-effectiveness and acceptability of holistic breathlessness services; (2) a secondary analysis of pooled individual data from three trials to determine predictors of clinical response; and (3) a transparent expert consultation (TEC), comprising a stakeholder workshop and an online consensus survey, to identify stakeholders’ priorities.ResultsThirty-seven papers reporting on 18 holistic breathlessness services were included in the systematic review. Most studies enrolled people with thoracic cancer, were delivered over 4–6 weeks, and included breathing training, relaxation techniques and psychological support. Meta-analysis demonstrated significant reductions in the Numeric Rating Scale (NRS) distress due to breathlessness, significant reductions in the Hospital Anxiety and Depressions Scale (HADS) depression scores, and non-significant reductions in the Chronic Respiratory Disease Questionnaire (CRQ) mastery and HADS anxiety, favouring the intervention. Recipients valued education, self-management interventions, and expertise of the staff in breathlessness and person-centred care. Evidence for cost-effectiveness was limited and inconclusive. The responder analysis (n = 259) revealed baseline CRQ mastery and NRS distress to be strong predictors of the response to breathlessness services assessed by these same measures, and no significant influence from baseline breathlessness intensity, patient diagnosis, lung function, health status, anxiety or depression. The TEC elicited 34 priorities from stakeholders. Seven priorities received high agreement and consensus, reflecting stakeholders’ (n = 74) views that services should be person-centred and multiprofessional, share their breathlessness management skills with others, and recognise the roles and support needs of informal carers.LimitationsThe evidence synthesis draws predominantly from UK services and may not be generalisable to other settings. Some meta-analyses were restricted by reporting biases and statistical heterogeneity.ConclusionsDespite heterogeneity in composition and delivery, holistic breathlessness services are highly valued by recipients and can lead to significant improvements in the distress caused by breathlessness and depression. Outcomes of improved mastery and reduced distress caused by breathlessness are not influenced by patient diagnosis, lung function or health status. Stakeholders highlighted the need for improved access to person-centred, multiprofessional breathlessness services and support for informal carers.Future workOur research suggests that key therapeutic components of holistic breathlessness services be considered in clinical practice and models of delivery and educational strategies to address stakeholders’ priorities tested.Study registrationThis study is registered as PROSPERO CRD42017057508.FundingThe National Institute for Health Research (NIHR) Health Services and Delivery programme. Matthew Maddocks, Wei Gao and Irene J Higginson are supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South London; Matthew Maddocks is supported by a NIHR Career Development Fellowship (CDF-2017-009), William D-C Man is supported by the NIHR CLAHRC Northwest London and Irene J Higginson holds a NIHR Emeritus Senior Investigator Award.

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Re: The Effect of Moving to East Village (the Former London 2012 Olympic and Paralympic Games Athletes' Village) on Physical Activity and Adiposity Levels: The Enable London Study

Objective: There is considerable interest in whether the built environment influences health behaviours, but longitudinal evidence is limited. We examined the effect of moving into East Village (the former London 2012 Olympic Games Athletes Village, repurposed on active design principles), on levels of physical activity (PA) and adiposity among adults. Design: A natural experiment. Participants: A cohort of 1278 adults seeking to move into social, intermediate, and market-rent East Village accommodation was recruited in 2013-2015, and followed up after two years. Intervention: Moving to East Village. Main outcome: Change in objectively measured daily steps (ActiGraph GT3X+). Methods: Change in environmental exposures associated with physical activity were assessed using Geographic Information System derived measures. Individual objective measures of PA using accelerometry, body mass index (BMI) and bioelectrical impedance (fat mass %) were obtained, as were perceptions of change in the built environment. We examined change in levels of PA and adiposity, using multilevel models adjusting for sex, age group, ethnic group, housing sector (fixed effects) and household (random effect), comparing those who moved to East Village (intervention group) with those who did not (control group). Effects of housing sector as an effect modifier were also examined. Results: 877 adults (69%) were followed-up, of whom 50% had moved to East Village. Moving to East Village was associated with only a small non-significant increase in mean daily steps (154, 95% CI -231, 539), despite sizeable improvements in walkability and neighbourhood perceptions of crime and quality. There were no appreciable effects on time spent in moderate-to-vigorous PA (MVPA) or sedentary time, BMI or percentage fat mass, overall or by housing sector. Conclusion: Despite strong evidence of large improvements in neighbourhood perceptions and walkability there was no clear evidence that moving to East Village was associated with increased physical activity. Improving the physical activity environment on its own may be insufficient to increase population physical activity. Funding: This research is being supported by project grants from the Medical Research Council National Prevention Research Initiative (MR/J000345/1) and National Institute for Health Research (12/211/69). Diabetes and obesity prevention research at St George’s, University of London is supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South London. BR is supported by a St George’s, University of London, PhD Studentship. AE is funded by the UK Medical Research Council as part of the Neighbourhoods and Communities Programme (MC_UU_12017-10). BG-C is supported by an NHMRC Principal Research Fellowship (#1107672). ARC and ASP are supported by NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. Declaration of Interest: We declare that we have no competing interests. Ethical Approval: Full ethical approval was obtained from the relevant Multi-Centre Research Ethics Committee (REC Reference 12/LO/1031). All participants provided written informed consent.

Building capacity to use and undertake applied health research: establishing a training programme for the health workforce in the West of England.

Increasing research capacity is important for health services as part of improving the conduct of high-quality research, which addresses the needs of patients and the public. It is a core function of the 13 Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) established in England between 2008 and 2013. This article reports on the development of an innovative capacity building programme in CLAHRC West over an 18-month period (May 2015 to December 2016). It aims to disseminate the learning from the initiative and share our experience with other CLAHRCs. The study design was an evaluation of a training programme to build research capacity. We carried out a training needs assessment among local stakeholders and scoped existing provision of research-related training. This informed the development of a programme of free short courses, which were targeted at health and social care professionals including those working in local authorities and the voluntary sector. We aimed to engage professionals working at all levels in these organisations and to promote interprofessional education, to build a research culture. We engaged a variety of educators to provide a range of 1-day courses at an introductory level, which were accessible to practitioners. During the first 18 months of the training programme, we delivered 31 courses and trained 350 participants. Attendees came from secondary care (20%), voluntary sector (18%) and local authorities (18%). Professionals working in the mental health sector comprised 11% and commissioning 6%. Less well represented were primary care (3%) and community care (4%). The largest professional group was public health, followed by medical, nursing and allied health professionals in approximately equal proportions. Courses were evaluated on a scale of 1 (poor) to 4 (excellent) with the mean being 3.6 (range 3.3-4.0). The training programme has been highly successful with many courses oversubscribed, and all courses being well evaluated by participants. It has met the needs of local professionals for brief, applied training in research, as well as attracting those from other parts of the United Kingdom, suggesting the courses are both appropriate and helping to fill a gap in provision. We are building on this work to further engage audiences working in areas such as the wider determinants of health and commissioning, as well as primary and community sectors. CLAHRCs are uniquely placed to drive a culture change in the use, understanding and application of research across the healthcare community.

Extent and Predictors of Enduring Mental Health in Childhood (Up to 14 Years): Learning from the Millennium Cohort Study

Background: Enduring mental health (EMH) is a new concept introduced by Schaefer et al and refers to a long-term state of not experiencing a mental illness (i.e. enduring mental wellness). No analysis using this concept has been undertaken on UK data nor specifically in the childhood years. Methods: The present study seeks to consider the extent and predictors of EMH in children aged 9 months to 14 years who were part of the UK-wide Millennium Cohort Study (MCS). Data from 13,310 children (49.4% girls) from children at ages 9 months 3, 5, 7, 11, 14 years. Outcomes: Less than half of children (41%) fell into the category of EMH, the rest had at least some periods of mental health problems. Factors associated with EMH included high income, home ownership, positive parent-child interaction and maternal mental health. Of particular note was the high association between good emotion regulation and intellectual capacity, enjoyment of school and EMH status. Interpretation: This suggests that EMH is not the norm during childhood. Identification of the high association between both economic wellbeing and emotional regulation with EMH offer the opportunity for a potentially powerful combination of community and individual initiatives. These might include: tackling social inequalities, supporting positive mental health of the primary care giver, supporting positive caregiver-child interactions in the early years, enhancing school engagement, and strengthening the child's social and emotional skills, including independence, cooperation and self-regulation to prevent later mental health problems. Funding Statement: The research was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart’s Health NHS Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Declaration of Interests: The authors have no conflicts of interest to declare. Ethics Approval Statement: Ethical approval for the MCS was received from a Research Ethics Committee at each sweep.

South Gloucestershire Opioid Pain Review Pilot study: a mixed methods evaluation

BackgroundPrimary care can be an appropriate setting to address opioid analgesic dependence among patients with chronic non-cancer pain. This study evaluated the South Gloucestershire Opioid Pain Review Pilot which aims to help patients understand their relationship with opioids and to develop alternative, non-drug-based, pain management strategies. MethodsPatients from two general practices in South Gloucestershire, UK, were invited to take part in the pilot (September 2016-October 2018). They were given an individually tailored intervention, based on the shared care model, and social prescribing including pain management, and referred to external services. Experiences of the pilot were explored with semi-structured interviews. Routine quantitative data were collected on demographics; opioid use and dose; wellbeing and quality of life; and pain intensity, pain relief, and interference with life. A mixed-methods approach supported a comprehensive evaluation of the pilot. Interviews were analysed thematically. Quantitative and qualitative data were integrated using “following a thread” and triangulation. The study was given ethics approval by West Midlands – Coventry and Warwickshire Research Ethics Committee, and participants gave written or verbal informed consent. FindingsOf 59 invited patients, 34 (58%) enrolled into the service and contributed quantitative data. 18 of the 34 service-users and seven service providers were interviewed. On average, service-users showed improvement in all outcomes except pain relief from medication. Baseline opioid dose (median 90, IQR 60-240)]reduced at follow-up (median 90 mg, IQR 60–240 vs 72 mg, 30–160, Wilcoxon signed-rank test p=0·00013). Service-users received the pilot positively, valuing their relationship with the project worker, time to discuss pain management, and individually tailored support. Individual needs and readiness to change shaped responses to the intervention. Perceived benefits related to understanding of pain, wellbeing, and quality of life; pain management strategies; and medication changes. InterpretationThis novel pilot has shown promise. We recommend that future initiatives within primary care are individually tailored. Project worker and service-user relationships are important. A randomised controlled trial is needed to test the impact of this care-pathway. FundingThis research was funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) West. The pain review pilot was funded by the Public Health and Wellbeing Division at South Gloucestershire Council.

Editorial introductions

Editorial introductions

Knowledge exchange in the UK CLAHRCs

PurposeThe purpose of this paper is to examine how knowledge exchange between academics and clinicians in Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) is influenced by their social position based on their symbolic and social capitals, that is, their personal professional status and connections to high-status professional peers, knowledge brokers, and unfamiliar professional peers.Design/methodology/approachUsing an online survey, the author triangulates the cross-sectional measurement of the effects of academic and clinicians’ social position in the initial and later phases of CLAHRCs with the longitudinal measurement of these effects over a two-year period.FindingsFirst, academics and clinicians with a higher personal professional status are more likely to develop joint networks and decision making both in the early and later phases of a CLAHRC. Second, academics and clinicians who are more connected to higher status occupational peers are more likely to develop joint networks in the early phase of a knowledge exchange partnership but are less likely to become engaged in joint networks over time. Third, involvement of knowledge brokers in the networks of academics and clinicians is likely to facilitate their inter-professional networking only in the later partnership phase.Practical implicationsAcademics and clinicians’ capitals have a distinctive influence on knowledge exchange in the early and later phases of CLAHRCs and on a change in knowledge exchange over a two-year period.Originality/valuePrior research on CLAHRCs has examined how knowledge exchange between academics and clinicians can be encouraged by the creation of shared governance mechanisms. The author advances this research by highlighting the role of their social position in facilitating knowledge exchange.

Why was a judicial review required to allow the English National Health Service to commission pre-exposure prophylaxis for HIV?

BackgroundFollowing research trial evidence, pre-exposure prophylaxis (PrEP), consisting of the drug combination tenofovir disoproxil and emtricitabine taken daily or episodically, was licensed to prevent HIV in high-risk individuals. In 2014, an NHS England (NHSE) HIV Clinical Reference Group outlined the position for commissioning PrEP. Despite stakeholders' belief that NHSE would adopt PrEP as a prevention strategy, NHSE announced in March 2016, that it did not have the legal authority to do so owing to the 2012 Health and Social Care Act, which devolved sexual health services to local authorities. This decision was met with criticism, and a judicial review was brought against NHSE by activists, which NHSE lost. This interview study explored the reasons for NHSE's original decision not to commission PrEP and the implications this has for commissioning prevention strategies. The transparency of NHSE's decision-making process, and the effect of recent health-care reforms were also explored. MethodsPurposive and snowball sampling methods were used to invite individuals to take part in semi-structured interviews. 15 interviewees (commissioners, activists, and individuals from national health bodies) were recruited. The interviews were anonymised and transcribed verbatim. Data saturation was reached, and two coders analysed the data using content analysis. FindingsParticipants cited the cost of PrEP as the reason behind NHSE's decision, especially in the context of austerity. Although NHSE's decision-making process was viewed positively, the final decision lacked transparency, highlighting a disconnect between the decision process and decision outcome. The Health and Social Care Act was viewed negatively with respect to deprioritisation of public health. InterpretationThe commissioning of prevention strategies is unclear while local authorities face budgetary cuts. This could mean future tensions leading to judicial reviews. However, NHSE losing the judicial review and the level of criticism may act as a deterrent to prevent future cases. Improved communication about roles and responsibilities, not least on the part of policy makers, are needed to help overcome tensions arising from the Health and Social Care Act. FundingKing's College London provided funds for expenses. PL and KK are supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South London at King's College Hospital NHS Foundation Trust. The views expressed are not necessarily those of the NHS, the NIHR or the Department of Health.

Patients and professionals learning together: an evaluation of an integrated change management fellowship programme for healthcare improvement

Improving the quality of healthcare involves collaboration between many different stakeholders to lead change. However, individuals are rarely taught to develop the skills to lead change effectively across professional boundaries. Collaborative learning theory suggests that teaching professionals alongside each other may enable them develop those skills, but there is little literature on how this works in practice. Additionally, though it is recognised that patients play a crucial role in improving healthcare, there are few examples of where they learn together alongside professionals. This study contributes to addressing this gap. Using the lens of collaborative learning, we report on a qualitative evaluation of an educational programme (the Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Northwest London (NWL) Improvement Leader Fellowship) which is designed to build capacity to lead change through quality improvement methods in healthcare. This year long programme is a local case study as it enables patients/service users and healthcare professionals to learn together, as equals. Qualitative data were collected across six cohorts of the programme, through online evaluation forms and 34 semi-structured interviews with participants, data were analysed using a grounded theory approach. The overall finding was that the skills and capacity to lead change was valued and was enabled by the processes of learning together, discussing real world problems. The potential struggle Fellows faced to make sense of new concepts and work with new, unexpected methods and people within the Fellowship became a productive struggle, encouraging them to try new things, take a new perspective and step beyond their comfort zone. The integration of patients into the Fellowship appeared to enrich the experience for all fellows, with a clear exchange of learning with professionals and patients benefitting from the new perspectives brought into the group. The flattened hierarchy enabled a range of professions and patients to join as equal voices. This was achieved by faculty facilitation ensuring clear set ground rules and management to prevent one voice (patient or professional) from dominating the group. Fellows project's demonstrated a number of change outputs, from the implementation of patient booklet in mental health wards, to the increased use of co-production in a GP surgery.