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Introduction: In the UK, National Health Service (NHS) guidelines recommend that informal carers of people living with dementia should be offered training to help them develop care skills and manage their own physical and mental health. The WHO recommends access to affordable, proven, well-designed, online technologies for education, skills training and support for dementia carers. In response to these recommendations, this multisite randomised controlled trial (RCT) is the first study in the UK to evaluate the clinical and cost-effectiveness of an online support programme developed by the WHO called 'iSupport for dementia carers'., Methods and Analysis: 350 informal carers (age 18+ years) living in Britain who self-identify as experiencing stress and depression will be recruited. They will be randomised to receive 'iSupport', or standardised information about caring for someone with dementia (control-comparison). Data will be collected via videoconferencing (eg, Zoom) or telephone interview at baseline, 3 months and 6 months. Intention-to-treat analysis will ascertain effectiveness in the primary outcomes (distress and depression) and combined cost, and quality-adjusted life-year data will be used to assess cost-effectiveness compared with usual care from a public sector and wider societal perspective. A mixed-methods process evaluation with a subgroup of carers in the intervention (~N=50) will explore the barriers and facilitators to implementing 'iSupport'. A non-randomised feasibility study will adapt 'iSupport' for young carers (n=38 participants, age 11-17 years)., Ethics and Dissemination: The research plan was scrutinised by National Institute for Health Research reviewers ahead of funding being awarded. Ethical approval was granted by Bangor University's School of Health and Medical Sciences Academic Ethics Committee, reference number 2021-16915. Dissemination plans include delivering events for stakeholders, social media, a project website, developing policy briefings, presenting at conferences and producing articles for open access publications., Trial Registration Number: ISRCTN17420703., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

The COVID-19 pandemic contributed to longer waiting lists for people seeking to access mental health services. The NHS Five Year Forward View encourages the development of empowerment-based social prescribing interventions to supplement existing mental health programmes. Based in South Wales, EmotionMind Dynamic (EMD) is a lifestyle coaching programme that supports individuals suffering from anxiety or depression. In this evaluation of lifestyle coaching, a mixed-method social return on investment (SROI) methodology was used to value quantitative and qualitative data from face-to-face and online participants. Data collection took place between June 2021 and January 2022. Participants included both self-referred clients and those referred from health services. Mental wellbeing data were collected at baseline and at the end of the programme using the short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) and the General Self-Efficacy Scale (GSES). Baseline and follow-up data were available for 15 face-to-face participants and 17 online clients. Wellbeing valuation quantified and valued outcomes from participants. Results indicated that for every GBP 1 invested, lifestyle coaching generated social values ranging from GBP 4.12-GBP 7.08 for face-to-face clients compared with GBP 2.37-GBP 3.35 for online participants. Overall, lifestyle coaching generated positive social value ratios for both face-to-face and online clients.

Mountain watersheds often contain a mosaic of glacier-, snow-, and rain-fed streams that have distinct hydrologic, temperature, and biogeochemical regimes. However, as glaciers diminish and precipitation shifts from snow to rain, the physical and chemical characteristics that make glacial or snowmelt streams distinct from rain-fed streams will fade. Among the unforeseen consequences of this hydrologic homogenization could be the loss of unique food webs that sustain aquatic consumers. To explore the impacts of a melting cryosphere on stream food webs, we parameterized an aquatic food web model with empirical physicochemical data from glacier-, snow-, and rain-fed streams in southeast Alaska and used the model to simulate the seasonal biomass dynamics of aquatic primary producers and consumers and the growth of juvenile salmon. Model results suggest that glacier-, snow-, and rain-fed streams exhibit seasonal asynchronies in the timing of biofilm and aquatic invertebrate abundance. Although warmer rain-fed streams were more productive during the summer (June through September), colder glacial and snowmelt streams provided enhanced foraging and growth opportunities throughout the remainder of the year. For juvenile salmon that can track peaks in resource abundance within river networks, the loss of meltwater streams strongly constrained modeled growth opportunities by removing spatially and temporally distinct foraging habitats within a watershed. These findings suggest that climate change induced homogenization of high latitude river networks may result in the loss of unique food web dynamics, which could diminish the capacity of watersheds to sustain mobile consumers., (© 2022 The Authors. Global Change Biology published by John Wiley & Sons Ltd. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Background: People living with rarer dementias face considerable difficulty accessing tailored information, advice, and peer and professional support. Web-based meeting platforms offer a critical opportunity to connect with others through shared lived experiences, even if they are geographically dispersed, particularly during the COVID-19 pandemic., Objective: We aim to develop facilitated videoconferencing support groups (VSGs) tailored to people living with or caring for someone with familial or sporadic frontotemporal dementia or young-onset Alzheimer disease, primary progressive aphasia, posterior cortical atrophy, or Lewy body dementia. This paper describes the development, coproduction, field testing, and evaluation plan for these groups., Methods: We describe a 3-phase approach to development. First, information and knowledge were gathered as part of a coproduction process with members of the Rare Dementia Support service. This information, together with literature searches and consultation with experts by experience, clinicians, and academics, shaped the design of the VSGs and session themes. Second, field testing involved 154 Rare Dementia Support members (people living with dementia and carers) participating in 2 rounds of facilitated sessions across 7 themes (health and social care professionals, advance care planning, independence and identity, grief and loss, empowering your identity, couples, and hope and dementia). Third, a detailed evaluation plan for future rounds of VSGs was developed., Results: The development of the small groups program yielded content and structure for 9 themed VSGs (the 7 piloted themes plus a later stages program and creativity club for implementation in rounds 3 and beyond) to be delivered over 4 to 8 sessions. The evaluation plan incorporated a range of quantitative (attendance, demographics, and geography; pre-post well-being ratings and surveys; psycholinguistic analysis of conversation; facial emotion recognition; facilitator ratings; and economic analysis of program delivery) and qualitative (content and thematic analysis) approaches. Pilot data from round 2 groups on the pre-post 3-word surveys indicated an increase in the emotional valence of words selected after the sessions., Conclusions: The involvement of people with lived experience of a rare dementia was critical to the design, development, and delivery of the small virtual support group program, and evaluation of this program will yield convergent data about the impact of tailored support delivered to geographically dispersed communities. This is the first study to design and plan an evaluation of VSGs specifically for people affected by rare dementias, including both people living with a rare dementia and their carers, and the outcome of the evaluation will be hugely beneficial in shaping specific and targeted support, which is often lacking in this population., International Registered Report Identifier (irrid): DERR1-10.2196/35376., (©Claire Waddington, Emma Harding, Emilie V Brotherhood, Ian Davies Abbott, Suzanne Barker, Paul M Camic, Victory Ezeofor, Hannah Gardner, Adetola Grillo, Chris Hardy, Zoe Hoare, Roberta McKee-Jackson, Kirsten Moore, Trish O’Hara, Jennifer Roberts, Samuel Rossi-Harries, Aida Suarez-Gonzalez, Mary Pat Sullivan, Rhiannon Tudor Edwards, Millie Van Der Byl Williams, Jill Walton, Alicia Willoughby, Gill Windle, Eira Winrow, Olivia Wood, Nikki Zimmermann, Sebastian J Crutch, Joshua Stott. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.07.2022.)

Background: The head and neck cancer (HNC) Patient Concerns Inventory (PCI) is a condition-specific prompt list that allows patients to raise concerns to cancer consultants that otherwise might be overlooked., Objective: This is the first economic evaluation of the PCI in patients with HNC investigating the costs and effects to the health service of not prioritising certain treatment pathways in addition to the primary cancer pathway. Additional costs can be accrued due to delayed referral to other appropriate services, e.g. hospital dentist. Economic evidence could influence future policy direction in this area globally., Methods: Alongside a 3-year clustered randomised controlled trial, an economic evaluation was undertaken with Client Service Receipt Inventory data collected at three different time points (baseline and 6 and 12 months post-baseline). Patients were identified by a multidisciplinary team at the trial clinics. This economic analysis compared the PCI intervention versus the non-PCI treatment pathway. A deterministic and probabilistic sensitivity analysis was conducted to investigate the cost per quality-adjusted life-year (QALY) gain of the PCI versus non-PCI intervention treatment pathways. Qualitative data were also collected from seven consultants to triangulate findings from the economic evaluation., Results: The analysis used data from 191 patients (66% of the full trial sample). The PCI inventory was low cost, at just over £13 per participant. The PCI intervention was cost effective and also cost saving, with an incremental cost difference of £295.91 over the 12-month follow-up period. The QALY values were higher in the PCI intervention strategy, with a value of 0.79, whereas the non-PCI group had a value of 0.76, thus the PCI intervention was dominant. The sensitivity analysis showed that, at a willingness-to-pay threshold of £20,000 per QALY gained, the probability of being cost effective was 0.85 (95% confidence interval [CI] 0.80-0.83). Qualitative results showed that consultants using the PCI reported an enhanced awareness of patients' overall post-treatment needs., Discussion: The PCI provided an effective means to conduct clinical consultations by avoiding unnecessary healthcare costs and focussing on aspects of care most important to patients. The cost per QALY gain was within the National Institute for Health and Care Excellence guideline threshold. The economic evaluation showed that the PCI intervention strategy was dominant and therefore cost saving to the national health service (NHS) and was more effective in terms of treatment., Conclusion: The PCI appears to be a low-cost intervention that generates a cost-effective benefit to patients from a NHS perspective if rolled out as part of routine care. Qualitative evidence has shown that the use of the PCI is supported by consultants in routine practice., Trial Registration: Clinical Trials Identifier: NCT03086629., (© 2022. The Author(s).)

Background: Reducing bullying is a public health priority. KiVa, a school-based anti-bullying programme, is effective in reducing bullying in Finland and requires rigorous testing in other countries, including the UK. This trial aims to test the effectiveness and cost-effectiveness of KiVa in reducing child reported bullying in UK schools compared to usual practice. The trial is currently on-going. Recruitment commenced in October 2019, however due to COVID-19 pandemic and resulting school closures was re-started in October 2020., Methods: Design: Two-arm pragmatic multicentre cluster randomised controlled trial with an embedded process and cost-effectiveness evaluation., Participants: 116 primary schools from four areas; North Wales, West Midlands, South East and South West England. Outcomes will be assessed at student level (ages 7-11 years; n = approximately 13,000 students)., Intervention: KiVa is a whole school programme with universal actions that places a strong emphasis on changing bystander behaviour alongside indicated actions that provide consistent strategies for dealing with incidents of bullying. KiVa will be implemented over one academic year., Comparator: Usual practice., Primary Outcome: Student-level bullying-victimisation assessed through self-report using the extensively used and validated Olweus Bully/Victim questionnaire at baseline and 12-month follow-up., Secondary Outcomes: student-level bullying-perpetration; student mental health and emotional well-being; student level of, and roles in, bullying; school related well-being; school attendance and academic attainment; and teachers' self-efficacy in dealing with bullying, mental well-being, and burnout., Sample Size: 116 schools (58 per arm) with an assumed ICC of 0.02 will provide 90% power to identify a relative reduction of 22% with a 5% significance level., Randomisation: recruited schools will be randomised on 1:1 basis stratified by Key-Stage 2 size and free school meal status. Process evaluation: assess implementation fidelity, identify influences on KiVa implementation, and examine intervention mechanisms. Economic evaluation: Self-reported victimisation, Child Health Utility 9D, Client Service Receipt Inventory, frequency of services used, and intervention costs. The health economic analysis will be conducted from a schools and societal perspective., Discussion: This two-arm pragmatic multicentre cluster randomised controlled trial will evaluate the KiVa anti-bullying intervention to generate evidence of the effectiveness, cost-effectiveness and scalability of the programme in the UK. Our integrated process evaluation will assess implementation fidelity, identify influences on KiVa implementation across England and Wales and examine intervention mechanisms. The integrated health economic analysis will be conducted from a schools and societal perspective. Our trial will also provide evidence regarding the programme impact on inequalities by testing whether KiVa is effective across the socio-economic gradient., Trial Registration: Trials ISRCTN 12300853 Date assigned 11/02/2020., (© 2022. The Author(s).)

Research on quality adjusted life year (QALY) has been underway for just over 50 years, which seems like a suitable milestone to review its history. The purpose of this study is to provide a historical overview of why the QALY was developed, the key theoretical work undertaken by Torrance, Bush and Fanshel and how two seminal papers shaped its subsequent development. Moving the QALY forward - there are several historical and reflective exercises. The historical interplay between politics, policy and the challenges facing the National Health Service (NHS) in formulating the QALY concept in the UK has been explored in some depth already, whilst the conceptualization and development of the methodological framework is relatively underexplored. We address this gap by viewing the QALY through the lens of the methodological debates, reflecting upon two key papers underpinning the QALY methodology and how these methods have been developed over time. In part the changes in technology e.g. Google Scholar, and the availability of tools to search for early uses of the QALY allow us to better understand the historical context in which the theoretical development of the QALY has taken place. Here we celebrate two seminal papers that shaped early QALY development. The first section provides a history of these papers, summaries their contributions and explores the uptake of these papers over time. The second section reviews the methodological debates that have surrounded the QALY over the last 50 years and looks at how the QALY has moved to address these challenges. The third section presents the voices of diverse commentators representing the field of health economics who have contributed to the subsequent development of the QALY in both theoretical and empirical capacities and captures their thoughts about future research and policy use of QALYS., (Copyright © 2021. Published by Elsevier Ltd.)

Background: Neovascular (wet) age-related macular degeneration (AMD) can be associated with large submacular haemorrhage (SMH). The natural history of SMH is very poor, with typically marked and permanent loss of central vision in the affected eye. Practice surveys indicate varied management approaches including observation, intravitreal anti-vascular endothelial growth factor therapy, intravitreal gas to pneumatically displace SMH, intravitreal alteplase (tissue plasminogen activator, TPA) to dissolve the clot, subretinal TPA via vitrectomy, and varying combinations thereof. No large, published, randomised controlled trials have compared these management options., Methods: TIGER is a phase 3, pan-European, two-group, active-control, observer-masked, superiority, randomised controlled surgical trial. Eligible participants have large, fovea-involving SMH of no more than 15 days duration due to treatment-naïve or previously treated neovascular AMD, including idiopathic polypoidal choroidal vasculopathy and retinal angiomatous proliferation. A total of 210 participants are randomised in a 1:1 ratio to pars plana vitrectomy, off-label subretinal TPA up to 25 μg in 0.25 ml, intravitreal 20% sulfahexafluoride gas and intravitreal aflibercept, or intravitreal aflibercept monotherapy. Aflibercept 2 mg is administered to both groups monthly for 3 doses, then 2-monthly to month 12. The primary efficacy outcome is the proportion of participants with best-corrected visual acuity (BCVA) gain of ≥ 10 Early Treatment Diabetic Retinopathy (ETDRS) letters in the study eye at month 12. Secondary efficacy outcomes (at 6 and 12 months unless noted otherwise) are proportion of participants with a BCVA gain of ≥ 10 ETDRS letters at 6 months, mean ETDRS BCVA, Radner maximum reading speed, National Eye Institute 25-item Visual Function Questionnaire composite score, EQ-5D-5L with vision bolt-on score, Short Warwick and Edinburgh Mental Wellbeing score, scotoma size on Humphrey field analyser, and presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using independent reading centre multimodal image analysis (12 months only). Key safety outcomes are adverse events, serious adverse events, and important medical events, coded using the Medical Dictionary for Regulatory Activities Preferred Terms., Discussion: The best management of SMH is unknown. TIGER aims to establish if the benefits of SMH surgery outweigh the risks, relative to aflibercept monotherapy., Trial Registration: ClinicalTrials.gov NCT04663750 ; EudraCT: 2020-004917-10., (© 2022. The Author(s).)

Purpose: To examine how mobility and mobility impairment affect quality of life; to develop a descriptive system (i.e., questions and answers) for a novel mobility-related quality of life outcome measure., Materials and Methods: Data were collected through semi-structured interviews. Participants were recruited predominantly from NHS posture and mobility services. Qualitative framework analysis was used to analyse data. In the first stage of analysis the key dimensions of mobility-related quality of life were defined, and in the second stage a novel descriptive system was developed from the identified dimensions., Results: Forty-six interviews were conducted with 37 participants (aged 20-94 years). Participants had a wide range of conditions and disabilities which impaired their mobility, including cerebral palsy, multiple sclerosis, and arthritis. Eleven dimensions of mobility-related quality of life were identified: accessibility, safety, relationships, social inclusion, participation, personal care, pain and discomfort, independence, energy, self-esteem, and mental-wellbeing. A new outcome measure, known as MobQoL, was developed., Conclusions: Mobility and mobility impairment can have significant impacts on quality of life. MobQoL is the first outcome measure designed specifically to measure the impact of mobility on quality of life, and therefore has utility in research and practice to measure patient outcomes related to rehabilitation.Implications for RehabilitationMobility impairment affects many different aspects of health and quality of life.The impact of mobility impairment on quality of life is related to processes of physical, emotional, and behavioural adaptation.MobQoL is the first patient-reported outcome measure designed specifically to measure the quality of life impacts of mobility impairment and assistive mobility technology use.MobQoL has potential to be used by rehabilitation professionals to measure and monitor mobility-related quality of life as part of routine clinical practice.

Purpose: The patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss issues that otherwise might be overlooked. This trial evaluated the effectiveness of using the PCI at routine outpatient clinics for one year after treatment on health-related QOL (HRQOL)., Methods: A pragmatic cluster preference randomised control trial with 15 consultants, 8 'using' and 7 'not using' the PCI intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible., Results: Consultants saw a median (inter-quartile range) 16 (13-26) patients, with 140 PCI and 148 control patients. Of the pre-specified outcomes, the 12-month results for the mean University of Washington Quality of Life (UW-QOLv4) social-emotional subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), p = 0.04 after full adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12 months (primary outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (- 2.9%, 12.9%) but without achieving statistical significance. Other non-a-priori analyses, including all 12 UWQOL domains and at consultant level also suggested better HRQOL with PCI. Consultation times were unaffected and the number of items selected decreased over time., Conclusion: This novel trial supports the integration of the PCI approach into routine consultations as a simple low-cost means of benefiting HNC patients. It adds to a growing body of evidence supporting the use of patient prompt lists more generally., (© 2020. The Author(s).)

Health economists are currently debating, with some suspicion, the relative merits of cost-benefit analysis (CBA), grounded in theoretical welfare economics, and the proliferation of social return on investment (SROI), a pragmatic approach of developing a triple-bottom line (social, environmental and financial), but not grounded in welfare theory. We argue, in rather existential terms, that there is a need to understand the role of heuristics, or prior beliefs, in current 'best practice' in CBA and SROI. A taxonomy of CBA and SROI is presented, which summarises the origins of the methods, reporting guidance, publication checklist of quality of reporting, who is wanting these analytical approaches, and policy decision rule present. We argue that a bottom-up SROI is best thought of as localised CBA, building stakeholder involvement right into the framing of SROI, perhaps addressing or mitigating the effects of prior heuristics in top-down CBA. Behavioural CBA and social CBA recognise that people are not rational and that sources of value other than willingness to pay may best reflect social values. Standardisation of SROI and comparison with CBA may illuminate the role of prior heuristics and seek to better reflect social value in weighing up the costs and benefits of public health interventions at both a local and societal level., (© 2021. The Author(s).)

Background: Selective lamellar corneal transplantation (keratoplasty) has overtaken full thickness penetrating keratoplasty as the graft choice for endothelial failure. Even more recently eye bank prepared tissues are becoming increasing popular as a way to reduce the risks of tissue loss and stress during endothelial keratoplasty preparation in the surgical theatre. This study compares costs between surgeon and eye bank prepared tissues for Descemet's stripping automated endothelial keratoplasty (DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK)., Methods: Retrospective study conducted at the Royal Liverpool University Hospital including endothelial keratoplasties with a minimum of 6 months follow-up time. Cost analysis included surgical expenses, tissue acquisition fees, cost of patient's ward admission and out-patient expenses, including cost of re-bubbling procedures, costs of visits, anterior segment imaging and optometrist visits within the first 6 months follow-up., Results: Ninety-eight eyes of 98 patients were included in the study of which 42 underwent DSAEK surgery and 56 DMEK surgery. Cost analysis of surgical expenses in the DSAEK group showed a significant difference between using surgeon prepared and eye bank prepared tissue (£3866 ± 296 and £4389 ± 360, respectively; p < 0.01) and the same was found in the DMEK group (£3682 ± 167 and £4162 ± 167 for surgeon prepared and eye bank prepared tissues, respectively; p < 0.01). Cost of out-patient visits did not differ significantly in either group., Conclusions: At the Royal Liverpool University Hospital, eye bank prepared tissues had higher surgical expenses compared to those prepared by the surgeon, while the post-operative care expenses were similar between the two groups., (© 2021. The Author(s).)

Background: Compared to the rest of Europe, the UK has relatively poor cancer outcomes, with late diagnosis and a slow referral process being major contributors. General practitioners (GPs) are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored, which is now even more crucial due to the ongoing COVID-19 pandemic and its major impact on cancer referrals. The ThinkCancer! workshop is an educational behaviour change intervention aimed at the whole general practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, the appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan and has been adapted so it can be delivered remotely. This study aims to assess the feasibility of the ThinkCancer! intervention for a future definitive randomised controlled trial., Methods: The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and feasibility economic analysis. Twenty-three to 30 general practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect primary care intervals (PCI), 2-week wait (2WW) referral rates, conversion rates and detection rates at baseline and 6 months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation., Discussion: This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this study will inform the future design of a full-scale definitive phase III trial., Trial Registration: ClinicalTrials.gov NCT04823559 .

Background: Critical limb ischaemia is a severe stage of lower limb peripheral artery disease which can lead to tissue loss, gangrene, amputation and death. FlowOx™ therapy is a novel negative-pressure chamber system intended for home use to increase blood flow, reduce pain and improve wound healing for patients with peripheral artery disease and critical limb ischaemia., Methods: A Markov model was constructed to assess the relative cost-effectiveness of FlowOx™ therapy compared to standard care in lower limb peripheral artery disease patients with intermittent claudication or critical limb ischaemia. The model used data from two European trials of FlowOx™ therapy and published evidence on disease progression. From an NHS analysis perspective, various FlowOx™ therapy scenarios were modelled by adjusting the dose of FlowOx™ therapy and the amount of other care received alongside FlowOx™ therapy, in comparison to standard care., Results: In the base case analysis, consisting of FlowOx™ therapy plus nominal care, the cost estimates were £12,704 for a single dose of FlowOx™ therapy per annum as compared with £15,523 for standard care. FlowOx™ therapy patients gained 0.27 additional quality adjusted life years compared to standard care patients. This equated to a dominant incremental cost-effectiveness ratio per QALY gained. At the NICE threshold WTP of £20,000 and £30,000 per QALY gained, FlowOx™ therapy in addition to standard care had a 0.80 and 1.00 probability of being cost-effectiveness respectively., Conclusions: FlowOx™ therapy delivered as a single annual dose may be a cost-effective treatment for peripheral artery disease. FlowOx™ therapy improved health outcomes and reduced treatment costs in this modelled cohort. The effectiveness and cost-effectiveness of FlowOx™ therapy is susceptible to disease severity, adherence, dose and treatment cost. Research assessing the impact of FlowOx™ therapy on NHS resource use is needed in order to provide a definitive economic evaluation., Competing Interests: HH is employed by Otivio AS with funding from The Research Council of Norway (grant no. 285758). Otivio AS has the commercial rights to the INP technology used in this study. The authors alone are responsible for the content and writing of the paper. We adhere fully to PLOS ONE policies on sharing data and materials.

Background: The National Institute for Health and Care Excellence (NICE) has set out guidance for promoting physical activity (PA) in the physical environment to promote health and well-being. The aim of this selective scoping review was to investigate the influence of gross income on accessing local green spaces to engage in PA and the associated health benefits., Methods: A scoping review was conducted of international literature to facilitate the clarification of the research question., Findings: 15 papers were critically appraised under two themes: (1) environments and well-being and (2) PA and income/socioeconomic status and impact on the frequency, duration and opportunity to engage in PA., Interpretation: Income is related to differential use of green and blue spaces for PA, due mainly to access issues. People who live in lower socioeconomic areas tend to be more sedentary and there are also gender differences related to PA in built environments., Conclusion: There is an effect of income in using green spaces for PA, but the relationship is non-linear, and there is still a lack of knowledge about what kind of green spaces are best for health benefits. The COVID-19 pandemic highlighted the importance of accessing green local spaces to engage in physical exercise to improve well-being among the public., Competing Interests: The authors declare no conflict of interest.

Purpose: The main aim of this paper is to present baseline demographic and clinical characteristics and HRQOL in the two groups of the Patient Concerns Inventory (PCI) trial. The baseline PCI data will also be described., Methods: This is a pragmatic cluster preference randomised control trial with 15 consultant clusters from two sites either 'using' (n = 8) or 'not using' (n = 7) the PCI at a clinic for all of their trial patients. The PCI is a 56-item prompt list that helps patients raise concerns that otherwise might be missed. Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments)., Results: From 511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days. At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment. These exceptions were cluster (consultant) related to Maxillofacial and ENT consultants seeing different types of cases. Consultation times were similar, with PCI group times taking about 1 min longer on average (95% CL for the difference between means was from - 0.7 to + 2.2 min)., Conclusion: Using the PCI in routine post-treatment head and neck cancer clinics do not elongate consultations. Recruitment has finished but 12-month follow-up is still ongoing.

Introduction: Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care., Methods and Analysis: Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme., Ethics and Dissemination: National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication., Trial Registration Number: ISRCTN28376407; Pre-results registered on 23 November 2018., Competing Interests: Competing interests: NHW reports additional grants from NIHR HS&DR outside the submitted work and membership of the NIHR HTA programme funding committee (commissioned research)., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Background: One-fifth of all disabled children have mobility limitations. Early provision of powered mobility for very young children (aged < 5 years) is hypothesised to trigger positive developmental changes. However, the optimum age at which to introduce powered mobility is unknown., Objective: The aim of this project was to synthesise existing evidence regarding the effectiveness and cost-effectiveness of powered mobility for very young children, compared with the more common practice of powered mobility provision from the age of 5 years., Review Methods: The study was planned as a mixed-methods evidence synthesis and economic modelling study. First, evidence relating to the effectiveness, cost-effectiveness, acceptability, feasibility and anticipated outcomes of paediatric powered mobility interventions was reviewed. A convergent mixed-methods evidence synthesis was undertaken using framework synthesis, and a separate qualitative evidence synthesis was undertaken using thematic synthesis. The two syntheses were subsequently compared and contrasted to develop a logic model for evaluating the outcomes of powered mobility interventions for children. Because there were insufficient published data, it was not possible to develop a robust economic model. Instead, a budget impact analysis was conducted to estimate the cost of increased powered mobility provision for very young children, using cost data from publicly available sources., Data Sources: A range of bibliographic databases [Cumulative Index to Nursing and Allied Health Literature (CINHAL), MEDLINE, EMBASE™ (Elsevier, Amsterdam, the Netherlands), Physiotherapy Evidence Database (PEDro), Occupational Therapy Systematic Evaluation of Evidence (OTseeker), Applied Social Sciences Index and Abstracts (ASSIA), PsycINFO, Science Citation Index (SCI; Clarivate Analytics, Philadelphia, PA, USA), Social Sciences Citation Index™ (SSCI; Clarivate Analytics), Conference Proceedings Citation Index - Science (CPCI-S; Clarivate Analytics), Conference Proceedings Citation Index - Social Science & Humanities (CPCI-SSH; Clarivate Analytics), Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), NHS Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA) Database and OpenGrey] was systematically searched and the included studies were quality appraised. Searches were carried out in June 2018 and updated in October 2019. The date ranges searched covered from 1946 to September 2019., Results: In total, 89 studies were included in the review. Only two randomised controlled trials were identified. The overall quality of the evidence was low. No conclusive evidence was found about the effectiveness or cost-effectiveness of powered mobility in children aged either < 5 or ≥ 5 years. However, strong support was found that powered mobility interventions have a positive impact on children's movement and mobility, and moderate support was found for the impact on children's participation, play and social interactions and on the safety outcome of accidents and pain. 'Fit' between the child, the equipment and the environment was found to be important, as were the outcomes related to a child's independence, freedom and self-expression. The evidence supported two distinct conceptualisations of the primary powered mobility outcome, movement and mobility: the former is 'movement for movement's sake' and the latter destination-focused mobility. Powered mobility should be focused on 'movement for movement's sake' in the first instance. From the budget impact analysis, it was estimated that, annually, the NHS spends £1.89M on the provision of powered mobility for very young children, which is < 2% of total wheelchair service expenditure., Limitations: The original research question could not be answered because there was a lack of appropriately powered published research., Conclusions: Early powered mobility is likely to have multiple benefits for very young children, despite the lack of robust evidence to demonstrate this. Age is not the key factor; instead, the focus should be on providing developmentally appropriate interventions and focusing on 'movement for movement's sake'., Future Work: Future research should focus on developing, implementing, evaluating and comparing different approaches to early powered mobility., Study Registration: This study is registered as PROSPERO CRD42018096449., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 50. See the NIHR Journals Library website for further project information., Competing Interests: Niina Kolehmainen is a panel member of the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Prioritisation Committee for Maternal, Child and Mental Health Care (2018 to present) and was a panel member of the NIHR HTA Maternal, Neonatal and Child Health Topic Identification, Development and Evaluation Panel (2015–18). Jane Noyes was a member of the NIHR Dissemination Centre Advisory Group (2015–20) and was a Trustee of Whizz-Kidz (2005–9) (Whizz-Kidz is a not-for-profit organisation and an NHS provider of wheelchairs for children). Dawn Craig is a member of the NIHR Health Services and Delivery Research Researcher-led Prioritisation Committee (2018 to present) and a member of the Health and Care Research Wales Funding Research for Patient & Public Benefit Committee (2017 to present).

Local governments and Health Boards are seeking to develop integrated services to promote well-being. Social participation and physical activity are key in promoting well-being for older people. The Health Precinct is a community hub in North Wales that people with chronic conditions are referred to through social prescribing. To improve community-based assets there is a need to understand and evidence the social value they generate. Data collection took place October 2017-September 2019. Social Return on Investment (SROI) analysis was used to evaluate the Health Precinct. Stakeholders included participants aged 55+, participants' families, staff, the National Health Service and local government. Participants' health and well-being data were collected upon referral and four months later using the EQ-5D-5L, Campaign to End Loneliness Scale and the Rosenberg Self-Esteem Scale. Family members completed questionnaires at four months. Baseline data were collected for 159 participants. Follow-up data were available for 66 participants and 38 family members. The value of inputs was £55,389 (attendance fees, staffing, equipment, overheads), and the value of resulting benefits was £281,010; leading to a base case SROI ratio of £5.07 of social value generated for every £1 invested. Sensitivity analysis yielded estimates of between 2.60:1 and 5.16:1.

Objectives: To test whether providing psychological self-help materials would significantly lower the incidence of post-traumatic stress disorder (PTSD) at 6-12 weeks postnatally., Design: Open-label randomised controlled trial, with blinded outcome assessment., Setting: Community midwifery services in two National Health Service (NHS) trusts in the North West., Sample: A cohort of 2419 women receiving normal NHS postnatal care., Methods: Midwives screened women for traumatic birth experience; 678 women who screened positively (28.1%) were randomly allocated to self-help with usual care (n = 336) or to usual care alone (n = 342). The self-help materials were a leaflet and online film designed to prevent the development of PTSD after trauma exposure through explaining how to manage early psychological responses., Main Outcome Measure: The primary outcome was a composite of diagnostic and subdiagnostic PTSD at 6-12 weeks postnatally using the gold-standard Clinician-Administered PTSD Scale (CAPS-5) interview., Results: Of the 678 women correctly randomised plus the nine women randomised in error, 478 (70.5%) were followed up. Diagnostic or subdiagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (intention-to-treat analysis: RR 1.02, 95% CI 0.68-1.53). Findings remained consistent in the per-protocol analysis (RR 1.04, 95% CI 0.85-1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost., Conclusions: Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced., Tweetable Abstract: Self-help information alone does not reduce the number of women developing PTSD after a traumatic childbirth., (© 2020 Royal College of Obstetricians and Gynaecologists.)

Background: Asylum seekers and refugees (AS&Rs) experience impaired mental health and wellbeing, related to stresses in their country of origin, experiences in transit and reception on arrival, including significant barriers to accessing mainstream services. Their contact with health care is often crisis-driven and mediated through non-governmental organisations (NGOs). Problem Management Plus (PM+) is a psychosocial intervention recommended by the World Health Organisation to address distress experienced by adults affected by humanitarian crises. We are investigating its application for the first time in a high-income country., Methods: In a pilot randomised controlled trial (RCT), PM+ will be delivered to AS&Rs in contact with NGOs in Liverpool City Region, UK by lay therapists who have lived experience of forced migration. Following systematic review and stakeholder engagement, PM+ has been adapted to the local context, and lay therapists have been trained in its delivery. We will assess the feasibility of conducting a three-arm RCT of five 90-min sessions of PM+, delivered individually or in groups by lay therapists to AS&Rs experiencing emotional distress and functional impairment, compared with each other and with usual support offered by local NGOs. Distress and impairment at baseline will be measured by the Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule (WHO-DAS). We aim to recruit 105 participants, 35 per arm. Primary health outcomes are anxiety and depressive symptoms at 3 months, measured by HADS. Secondary outcomes include subjective wellbeing, functional status, progress on identified problems, presence of post-traumatic stress disorder and depressive disorder and service usage. Longer-term impact will be assessed at 6 months post baseline, on the same parameters. We will assess the feasibility of conducting a full RCT in relation to the following elements: recruitment and retention of lay therapists and study participants; fidelity of delivery of PM+; and suitability of the study measures, including any linguistic or cultural barriers., Discussion: We will use these findings to specify the parameters for a full RCT to test the effectiveness and cost-effectiveness of PM+ in reducing emotional distress and health inequalities, and improving functional ability and wellbeing, amongst asylum seekers and refugees., Trial Registration: ISRCTN, ID: ISRCTN15214107. Registered on 10 September 2019.

Introduction: Mobility impairment is the leading cause of disability in the UK. Individuals with congenital mobility impairments have unique experiences of health, quality of life and adaptation. Preference-based outcomes measures are often used to help inform decisions about healthcare funding and prioritisation, however the applicability and accuracy of these measures in the context of congenital mobility impairment is unclear. Inaccurate outcome measures could potentially affect the care provided to these patient groups. The aim of this systematic review was to examine the performance of preference-based outcome measures for the measurement of utility values in various forms of congenital mobility impairment., Methods: Ten databases were searched, including Science Direct, CINAHL and PubMed. Screening of reference lists and hand-searching were also undertaken. Descriptive and narrative syntheses were conducted to combine and analyse the various findings. Results were grouped by condition. Outcome measure performance indicators were adapted from COSMIN guidance and were grouped into three broad categories: validity, responsiveness and reliability. Screening, data extraction and quality appraisal were carried out by two independent reviewers., Results: A total of 31 studies were considered eligible for inclusion in the systematic review. The vast majority of studies related to either cerebral palsy, spina bifida or childhood hydrocephalus. Other relevant conditions included muscular dystrophy, spinal muscular atrophy and congenital clubfoot. The most commonly used preference-based outcome measure was the HUI3. Reporting of performance properties predominantly centred around construct validity, through known group analyses and assessment of convergent validity between comparable measures and different types of respondents. A small number of studies assessed responsiveness, but assessment of reliability was not reported. Increased clinical severity appears to be associated with decreased utility outcomes in congenital mobility impairment, particularly in terms of gross motor function in cerebral palsy and lesion level in spina bifida. However, preference-based measures exhibit limited correlation with various other condition-specific and clinically relevant outcome measures., Conclusion: Preference-based measures exhibit important issues and discrepancies relating to validity and responsiveness in the context of congenital mobility impairment, thus care must be taken when utilising these measures in conditions associated with congenital mobility impairments.

The stable isotope ratios of stream water can be used to trace water sources within river basins; however, drivers of variation in water isotopic spatial patterns across basins must be understood before ecologically relevant and isotopically distinct water sources can be identified and this tool efficiently applied. We measured the isotope ratios of surface-water samples collected during summer low-flow across five basins in Washington and southeast Alaska (Snoqualmie, Green, Skagit, and Wenatchee Rivers, and Cowee Creek) and compared models (isoscapes) describing the spatial variation in surface-water isotope ratios across a range of hydraulic and climatic conditions. We found strong correlations between mean watershed (MWE) elevation and surface-water isotopic ratios on the windward west side of the Cascades and in Alaska, explaining 48-90% of variation in δ 18 O values. Conversely, in the Wenatchee basin, located leeward of the Cascade Range, MWE alone had no predicative power. The elevation relationship and predictive isoscapes varied between basins, even those adjacent to each other. Applying spatial stream network models (SSNMs) to the Snoqualmie and Wenatchee Rivers, we found incorporating Euclidean and flow-connected spatial autocovariance improved explanatory power. SSNMs improved the accuracy of river water isoscapes in all cases; however, their utility was greater for the Wenatchee basin, where covariates explained only a small proportion of total variation. Our study provides insights into why basinscale surface-water isoscapes may vary even in adjacent basins and the importance of incorporating spatial autocorrelation in isoscapes. For determining source water contributions to downstream waters, our results indicate that surface water isoscapes should be developed for each basin of interest.

Objective: To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes., Design: Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation., Setting: 11 diabetes clinics in England and Wales., Participants: Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention., Intervention: We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment. OUTCOME MEASURES AT 3 AND 6 MONTHS: Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use., Results: Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=-4.68; SE=1.74; 95%CI from -8.10 to -1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents., Conclusions: Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes., Trial Registration Number: ISRCTN17551624., Competing Interests: Competing interests: Professor JWG has received payments from Pfizer, Bayer and Ipsen for lectures, development of educational presentations and travel/accommodation to attend scientific meetings and advisory board meetings. His employer (Cardiff University) has also received funding from Novo Nordisk to support the development of patient-support materials used in the Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED) research study., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

The purpose of this study was to determine the efficacy of a dental nurse-delivered intervention-the Dental RECUR Brief Negotiated Interview for Oral Health (DR-BNI)-in reducing the recurrence of dental caries in children who have a primary tooth extracted. It was based on a 2-arm multicenter randomized controlled trial with blinded outcome assessment. Participants were 5- to 7-y-old children ( n = 241) scheduled to have primary teeth extracted in 12 UK centers. Test intervention parents ( n = 119) received DR-BNI led by trained dental nurses. DR-BNI is a 30-min structured conversation informed by motivational interviewing with a forward focus to prevent future caries. Preventive goals are agreed, and a review appointment is made with child's general dental practitioner, who is advised to treat the child as being at high caries risk. The control intervention ( n = 122) was a parent-nurse conversation about child's future tooth eruption, with advice given to visit a general dental practitioner as usual. At baseline, the DR-BNI group's mean dmft was 6.8, and the control group's was 6.3. A median of 5 teeth were extracted, mainly under general anesthesia. Final dental assessments were conducted by a single examiner visiting 189 schools 2 y after intervention; 193 (80%) of 241 children were examined. In the control group, 62% developed new caries in teeth that were caries-free or unerupted at baseline, as compared with 44% in the test group, a significant reduction ( P = 0.021). The odds of new caries experience occurring were reduced by 51% in the DR-BNI group as compared with control. There was a 29% decrease in the relative risk of new caries experience in the DR-BNI group as compared with control. This single low-cost, low-intensity intervention was successful in significantly reducing the risk of recurrence of dental caries in children. This trial has implications for changing pediatric dental practice internationally. Training in and implementation of a motivational interviewing-informed brief intervention provides opportunities for dental nurses to facilitate behavior change improving the oral health of children at high caries risk (ISRCTN 24958829).

Background and Objectives: Arts activities may benefit people living with dementia. Social return on investment (SROI) analysis, a form of cost-benefit analysis, has the potential to capture the value of arts interventions, but few rigorous SROI analyses exist. This article presents a framework for an SROI analysis., Research Design and Methods: One hundred twenty-five people with mild to severe dementia and 146 caregivers were recruited to the Dementia and Imagination study across residential care homes, a hospital and community venues in England and Wales for a 12-week visual arts program. Quantitative and qualitative data on quality of life, support, and program perceptions were obtained through interviews. SROI was undertaken to explore the wider social value of the arts activities., Results: An input of £189,498 ($279,320/€257,338) to deliver the groups created a social value of £980,717 ($1,445,577/€1,331,814). This equates to a base case scenario of £/$/€5.18 of social value generated for every £/$/€1 invested. Sensitivity analysis produced a range from £/$/€3.20 to £/$/€6.62 per £/$/€1, depending on assumptions about benefit materialization; financial value of participants' time; and length of sustained benefit., Discussion: To our knowledge, this is the first study applying SROI to an arts intervention for people with dementia. Arts-based activities appear to provide a positive SROI under a range of assumptions., Implications: Decision makers are increasingly seeking wider forms of economic evidence surrounding the costs and benefits of activities. This analysis is useful for service providers at all levels, from local government to care homes., (© The Author(s) 2018. Published by Oxford University Press on behalf of The Gerontological Society of America.)

Background: Pain is a common experience in adolescence, with up to 44% of adolescents reporting chronic pain. For a significant minority, severe pain becomes an ongoing disabling problem. Treatment of adolescent chronic pain aims to reduce the impact of pain on adolescents' lives. Efficient, accurate assessment of the impact of pain is essential to treatment. The 'Bath Adolescent Pain Questionnaire' (BAPQ) is a psychometrically robust multidimensional self-report measure of adolescent functioning. Whilst widely used, the paper-based format of the BAPQ can present completion difficulties for adolescents experiencing chronic pain. To increase the accessibility and clinical utility of the BAPQ, an electronic version of the measure is needed. This study assesses the usability and feasibility of a computerized version of this measure (BAPQ-C) in an adolescent chronic pain population., Methods: Fourteen adolescents (13 females; 13-16 years) were recruited from a hospital-based residential pain management programme. Participants completed a qualitative 'thinking aloud task' whilst completing the BAPQ-C. and, an acceptability questionnaire regarding the BAPQ-C. Data were analysed using thematic analysis, a widely used qualitative method of data analysis ., Results: Two themes labelled 'engagement and technological appeal' and 'accessibility and independence' were generated. Themes revealed numerous factors contributing to participants' preference for the BAPQ-C compared with the paper version of the BAPQ. Participants reported that the BAPQ-C was 'quicker' and 'easier' to complete than the BAPQ. Functional aspects of the BAPQ-C which included use of a touch screen rather than a pen and paper, font colours/styles, the zoom function and the spellchecker, provided participants with improved access. This subsequently increased participants' independence and confidence when completing the measure., Conclusion: The BAPQ-C is a feasible multidimensional tool for the assessment of functioning in adolescents who experience chronic pain. It was well-received by participants who were able to complete the measure more quickly, independently and confidently than the paper-based BAPQ. Increased speed, ease and accuracy of completion make the BAPQ-C an ideal tool for use in busy clinical and research settings. Findings highlight the potential benefits of adopting the BAPQ-C when assessing the impact of chronic pain on adolescents in clinic and home-based settings.

Background: People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness., Methods: We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13-25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants' homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective., Discussion: We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia., Trial Registration: ISRCTN, ISRCTN15320670. Registered on 4 September 2018.

Background and study aims  The English National Bowel Scope Screening Programme (BSSP) invites 55-year-olds for a one-off, unsedated flexible sigmoidoscopy (FSIG). Data from BSSP participant-reported experience studies shows 1 in 3 participants report moderate or severe discomfort. Water-assisted colonoscopy (WAS) may improve participants' comfort. The primary objective of this study is to ascertain if post-procedural participant-assessed pain is reduced in WAS compared with carbon dioxide (CO 2 ) insufflation, in invitees undergoing FSIG in BSSP. Patients and methods  This is a multicenter, prospective, randomized, two-arm, single-blinded trial designed to evaluate the performance of WAS versus CO 2 insufflation in BSSP. Participants will be randomized to either CO 2 or WAS and will be asked to rate pain post-procedure. Key procedure-related data will be analyzed, including adenoma detection rates (ADR) and degree of sigmoid looping. A cost-effectiveness analysis of WAS versus CO 2 and a discrete choice experiment exploring preferences of participants for attributes of sigmoidoscopy will also be performed. Discussion  This is the first trial in the United Kingdom (UK) to investigate the effects of WAS in a screening setting. If the trial shows WAS either reduces pain or increases ADR, this may result in a practice change to implement WAS in screening and non-screening endoscopic practice directly impacting on 256,000 people a year who will undergo BSSP FSIG by 2020. Trial funding came from National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) supported by the NIHR Clinical Research Network. The trial is actively recruiting. ID: 35866 ISRCTN: 81466870., Competing Interests: Competing interests None

Introduction: Kidney disease is common, affecting up to 1 in 10 of the adult population, and the numbers are expected to rise over the next decade. There are three main treatments that are available to patients with kidney disease: transplantation, dialysis and supportive care without dialysis. Dialysis can occur in a dialysis unit or in a person's home, but unit-based dialysis remains the most common initial treatment for patients in Wales. This is a cause for concern as most studies suggest that it is associated with the lowest quality of life and the highest mortality, and is a more expensive treatment option.This study aims to identify the factors that lead to patients choosing unit-based haemodialysis rather than home-based dialysis with a view to informing future changes in patient education and service commissioning in Wales. A secondary aim is to determine if the co-production of research leads to more sustainable services., Methods and Analysis: This mixed-method study taking place between October 2018 and September 2020 will use a sequential explanatory design whereby the descriptive quantitative cross-sectional analysis of linked health and administrative data sets inform qualitative data collection from patients, carers and health and care professionals. Qualitative findings will be used to interpret or explain quantitative descriptive results. Additional strands to the study include a review of materials and education provided to patients and an economic review of treatment modalities., Ethics and Dissemination: The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from Health and Care Research Wales Research Ethics Committee #5. As a co-productive study involving patients, clinicians, third sector partners and academics, findings from this study will be shared on a continual basis. Study results will be published in peer-reviewed journals and presented at national and international conferences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The sensitivity of endoscopic ultrasound (EUS) in staging gastro-oesophageal cancers (GOCs) has been widely studied. However, the economic evidence of EUS staging in the management of patients with GOCs is scarce. This review aimed to examine all economic evidence (not limited to randomised controlled trials) of the use of EUS staging in the management of GOCs patients, and to offer a review of economic evidence on the costs, benefits (in terms of GOCs patients' health-related quality of life), and economic implications of the use of EUS in staging GOCs patients., Methods: The protocol was registered prospectively with PROSPERO (CRD42016043700; http://www.crd.york.ac.uk/PROSPERO/display&#95;record.php?ID=CRD42016043700 ). MEDLINE (ovid), EMBASE (ovid), The Cochrane Collaboration Register and Library (including the British National Health Service Economic Evaluation Database), CINAHL (EBSCOhost) and Web of Science (Core Collection) as well as reference lists were systematically searched for studies conducted between 1996 and 2018 (search update 28/04/2018). Two authors independently screened the identified articles, assessed study quality, and extracted data. Study characteristics of the included articles, including incremental cost-effectiveness ratios, when available, were summarised narratively., Results: Of the 197 articles retrieved, six studies met the inclusion criteria: three economic studies and three economic modelling studies. Of the three economic studies, one was a cost-effectiveness analysis and two were cost analyses. Of the three economic modelling studies, one was a cost-effectiveness analysis and two were cost-minimisation analyses. Both of the cost-effectiveness analyses reported that use of EUS as an additional staging technique provided, on average, more QALYs (0.0019-0.1969 more QALYs) and saved costs (by £1969-£3364 per patient, 2017 price year) compared to staging strategy without EUS. Of the six studies, only one included GOCs participants and the other five included oesophageal cancer participants., Conclusions: The data available suggest use of EUS as a complementary staging technique to other staging techniques for GOCs appears to be cost saving and offers greater QALYs. Nevertheless, future studies are necessary because the economic evidence around this EUS staging intervention for GOCs is far from robust. More health economic research and good quality data are needed to judge the economic benefits of EUS staging for GOCs., Prospero Registration Number: CRD42016043700 .

Physical inactivity has been identified as a leading risk factor for premature mortality globally, and adolescents, in particular, have low physical activity levels. Schools have been identified as a setting to tackle physical inactivity. Economic evidence of school-based physical activity programmes is limited, and the costs of these programmes are not always collected in full. This paper describes a micro-costing and cost-consequence analysis of the 'Girls Active' secondary school-based programme as part of a cluster randomised controlled trial (RCT). Micro-costing and cost-consequence analyses were conducted using bespoke cost diaries and questionnaires to collect programme delivery information. Outcomes for the cost-consequence analysis included health-related quality of life measured by the Child Health Utility-9D (CHU-9D), primary care General Practitioner (GP) and school-based (school nurse and school counsellor) service use as part of a cluster RCT of the 'Girls Active' programme. Overall, 1,752 secondary pupils were recruited and a complete case sample of 997 participants (Intervention n = 570, Control n = 427) was used for the cost-consequence analysis. The micro-costing analysis demonstrated that, depending upon how the programme was delivered, 'Girls Active' costs ranged from £1,054 (£2 per pupil, per school year) to £3,489 (£7 per pupil, per school year). The least costly option was to absorb 'Girls Active' strictly within curriculum hours. The analysis demonstrated no effect for the programme for the three main outcomes of interest (health-related quality of life, physical activity and service use).Micro-costing analyses demonstrated the costs of delivering the 'Girls Active' programme, addressing a gap in the United Kingdom (UK) literature regarding economic evidence from school-based physical activity programmes. This paper provides recommendations for those gathering cost and service use data in school settings to supplement validated and objective measures, furthering economic research in this field. Trial registration: -ISRCTN, ISRCTN10688342., Competing Interests: MJD has acted as consultant, advisory board member and speaker for Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca and Janssen, an advisory board member for Servier and as a speaker for Mitsubishi Tanabe Pharma Corporation and Takeda Pharmaceuticals International Inc. MJD has received grants in support of investigator and investigator initiated trials from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim and Janssen. This does not alter our adherence to PLOS ONE policies on sharing data and materials. KK has served as a speaker/consultant for Amgen, AstraZeneca, Bayer, NAPP, Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche, Berlin-Chemie AG / Menarini Group, Sanofi-Aventis and Servier. KK has received grants in support of investigator and investigator initiated trials from AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. KK has served on advisory boards for Amgen, AstraZeneca, Bayer, NAPP, Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche, Berlin-Chemie AG / Menarini Group, Sanofi-Aventis and Servier. This does not alter our adherence to PLOS ONE policies on sharing data and materials. Outside of the submitted work, JMC and RTE report funding from Public Health Wales during the conduct of the study. CE reports grants from National Institute for Health Research Public Health Research during the conduct of the study. DHB, TG, DMH, LS and TY all have nothing to declare.

Objective: The impact of impairment and disability on quality of life can be considerable, however advances in assistive technology can help to optimise physical and psychosocial functioning. Little is known about how impairment and subsequent adaptation influences health state perceptions, particularly amongst the general public. The aim of this pilot project was to examine student perceptions of what it would be like to live with a physical or sensory impairment, and how adaptation influences health and quality of life., Results: In total 151 undergraduate Psychology students were invited to participate in a questionnaire-based survey. Ethical approval was granted by an academic ethics committee. The survey included a range of validated outcome measures relating to illness perceptions and quality of life, including the B-IPQ, EQ-5D-3L and ICECAP-O. Surveys were divided into two parts: firstly, participants were asked to self-report their own health; and secondly participants were asked to estimate the health impacts of a range of hypothetical states of impairment. Severe adapted impairments were perceived to have less impact on health status than moderate un-adapted impairments. Hearing impairment was perceived to have the least impact on health status, whilst mobility impairment was perceived to have the largest impact on health status.

Background: Exercise referral schemes (ERSs) are recommended for patients with health conditions or risk factors. Evidence points to the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, but effects often diminish over time. Techniques such as goal setting, self-monitoring, and personalized feedback may support motivation for physical activity and maintenance of effects. Wearable technologies could provide an opportunity to integrate motivational techniques into exercise schemes. However, little is known about acceptability to exercise referral populations or implementation feasibility within exercise referral services., Objective: To determine the feasibility and acceptability of implementing an activity-monitoring device within the Welsh National ERS to inform a decision on whether and how to proceed to an effectiveness trial., Methods: We conducted a feasability randomized controlled trial with embedded mixed-methods process evaluation and an exploratory economic analysis. Adults (N=156) were randomized to intervention (plus usual practice; n=88) or usual practice only (n=68). Usual practice was a 16-week structured exercise program. The intervention group additionally received an accelerometry-based activity monitor (MyWellnessKey) and associated Web platform (MyWellnessCloud). The primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and proposed evaluation. Postal questionnaires were completed at baseline (time 0:T0), 16 weeks (T1), and 12 months after T0 (T2). Routine data were accessed at the same time-points. A subsample of intervention participants and scheme staff were interviewed following the initiation of intervention delivery and at T2., Results: Participants were on average aged 56.6 (SD 16.3) years and mostly female (101/156, 64.7%) and white (150/156, 96.2%). Only 2 of 5 progression criteria were met; recruitment and randomization methods were acceptable to participants, and contamination was low. However, recruitment and retention rates (11.3% and 67.3%, respectively) fell substantially short of target criteria (20% and 80%, respectively), and disproportionally recruited from the least deprived quintile. Only 57.4% of intervention participants reported receipt of the intervention (below the 80% progression threshold). Less than half reported the intervention to be acceptable at T2. Participant and staff interviews revealed barriers to intervention delivery and engagement related to the device design as well as context-specific technological challenges, all of which made it difficult to integrate the technology into the service. Routinely collected health economic measures had substantial missing data, suggesting that other methods for collecting these should be used in future., Conclusions: To our knowledge, this is the first study to evaluate short- and long-term feasibility and acceptability of integrating wearable technologies into community-based ERSs. The findings highlight device- and context-specific barriers to doing this in routine practice, with typical exercise referral populations. Key criteria for progression to a full-scale evaluation were not met., Trial Registration: ISRCTN Registry ISRCTN85785652; http://www.isrctn.com/ISRCTN85785652., (©Jemma Hawkins, Joanna M Charles, Michelle Edwards, Britt Hallingberg, Linda McConnon, Rhiannon Tudor Edwards, Russell Jago, Mark Kelson, Kelly Morgan, Simon Murphy, Emily J. Oliver, Sharon A. Simpson, Graham Moore. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 29.03.2019.)

Objective: The present parallel randomised control trial evaluated the feasibility of a nurse-led psycho-educational intervention aimed at improving the self-management of prostate cancer survivors., Methods: We identified 305 eligible patients from a district general hospital, diagnosed 9-48 months previously, who completed radical treatment, or were monitored clinically (ineligible for treatment). Ninety-five patients were recruited by blinded selection and randomised to Intervention (N = 48) and Control (N = 47) groups. Participant allocation was revealed to patients and researchers after recruitment was completed. For 36 weeks, participants received augmented usual care (Control) or augmented usual care and additional nurse support (Intervention) provided in two community hospitals and a university clinic, or by telephone., Results: Data from 91 participants (Intervention, N = 45; Control, N = 46) were analysed. All feasibility metrics met predefined targets: recruitment rate (31.15%; 95% CI: 25.95%-36.35%), attrition rate (9.47%; 95% CI: 3.58%-15.36%) and outcome measures completion rates (77%-92%). Forty-five patients received the intervention, with no adverse events. The Extended Prostate Cancer Index Composite can inform the minimum sample size for a future effectiveness trial. The net intervention cost was £317 per patient., Conclusions: The results supported the feasibility and acceptability of the intervention, suggesting that it should be evaluated in a fully powered trial to assess its effectiveness and cost-effectiveness., (© 2018 John Wiley & Sons Ltd.)

Objective: To identify the risk factors for significant depressive symptoms in people with visual impairment in England and Wales to provide information on who is most at risk and to whom support services could be targeted in future., Design: A cross-sectional study using baseline data from a pragmatic randomised controlled trial., Setting and Participants: 990 participants aged 18 or over attending 1 of 14 low-vision rehabilitation primary care optometry-based clinics in South Wales or two hospital clinics in London., Outcome Measure: A score of ≥6 on the Geriatric Depression Scale-15 was classed as clinically significant depressive symptoms., Results: In a multivariable logistic regression model, significant depressive symptoms were associated with age (adjusted OR (AOR)=0.82, 95% CI: 0.66 to 0.90, p<0.001), ethnicity (AOR non-white compared with white=1.72, 95% CI: 1.05 to 2.81, p=0.031), total number of eye conditions (AOR for two vs one condition=0.98, 95% CI: 0.67 to 1.43; three or more vs one condition=0.34, 95% CI: 0.15 to 0.75, p=0.026), self-reported health (AOR for excellent vs poor=0.01, 95% CI: 0.00 to 0.12; very good vs poor=0.06, 95% CI: 0.03 to 0.13; good vs poor=0.14, 95% CI: 0.08 to 0.24; fair vs poor=0.28, 95% CI: 0.18 to 0.46, p<0.001) and self-reported visual functioning (AOR=1.45, 95% CI: 1.31 to 1.61, p<0.001)., Conclusion: Younger age, a non-white ethnicity, fewer eye conditions and poorer self-reported health and visual function are risk factors for significant depressive symptoms in this population., Trial Registration Number: ISRCTN46824140; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Diabetic foot ulceration is a considerable cost to the NHS and foot orthotic provision is a core strategy for the management of the people with diabetes and a moderate to high risk of foot ulceration. The traditional process to produce a custom-made foot orthotic device is to use manual casting of foot shape and physical moulding of orthoses materials. Parts of this process can be undertaken using digital tools rather than manual processes with potential advantages. The aim of this trial was to provide the first comparison of a traditional orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar pressure, health status, and health service time and cost data to compare the two supply chains., Methods: Fifty-seven participants with diabetes were randomly allocated to each supply chain. Plantar pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at six-months. The costs for orthoses and clinical services accessed by participants were assessed over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at the site of highest pressure, assessed for non-inferiority to current care. Secondary outcomes were: reduction in plantar pressure at foot regions identified as at risk (> 200 kPa), cost-consequence analysis (supply chain, clinician time, service use) and health status., Results: At point of supply pressure reduction for the digital supply chain was non-inferior to a predefined margin and superior ( p  < 0.1) to the traditional supply chain, but both supply chains were inferior to the margin after 6 months. Custom-made orthoses significantly reduced pressure for at risk regions compared to a flat control (traditional - 13.85%, digital - 20.52%). The digital supply chain was more expensive (+£13.17) and required more clinician time (+ 35 min). There were no significant differences in health status or service use between supply chains., Conclusions: Custom made foot orthoses reduce pressure as expected. Given some assumptions about the cost models we used, the supply chain process adopted to produce the orthoses seems to have marginal impact on overall costs and health status., Trial Registration: Retrospectively registered on ISRCTN registry (ISRCTN10978940, 04/11/2015)., Competing Interests: Ethical approval was provided by the University of Salford, School of Health Sciences ethics committee (HSCR15–89) and national health service committees (REC ref.: 15/YH/0392). Participants gave informed consent prior to data collection.Not applicable.CN is a Director and owns equity in a company (Salfordinsole healthcare Ltd) that manufacturers foot orthoses. The company was a partner in the project that funded this study but provided no direct funding. The company provided access to its insole designs. CN took no part in the design of orthoses, nor data collection and analysis.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Objective: To develop a patient-centred outcome measure (PCOM) for use with children and young people accessing National Health Service (NHS) wheelchair and posture services. Identifying and addressing outcomes of most importance to young wheelchair users (≤ 18 years) will help services maximise the benefits achievable within available resources., Methods: A mixed-methods approach was used, involving questionnaire surveys and qualitative interviews, and building on previous work identifying how young wheelchair users define health-related quality of life (HRQoL). Framework analysis was used to analyse the interview transcripts. Survey questionnaires seeking views on the importance of a range of outcomes were completed by 21 young wheelchair users or their parents. Subsequent face-to-face interviews with 11 parents or dyads of parents and young wheelchair users explored these responses and identified novel outcomes. Interviewees also scored and recorded satisfaction levels for their key outcomes., Results: All outcomes proposed in the survey were rated as 'extremely important' by at least one respondent, as were additional outcomes uncovered in the qualitative data. In consultation with the service providers and service users, the Wheelchair outcomes Assessment Tool for Children (WATCh) was developed to allow service users and providers to identify, score and monitor individual users' most important outcomes. The final WATCh tool comprises 16 outcome options, of which service users select five to be monitored. The tool will be used to measure key outcomes identified by service users before and after wheelchair provision., Competing Interests: The authors have declared that no competing interests exist.

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

Background: GPs can play an important role in achieving earlier cancer diagnosis to improve patient outcomes, for example through prompt use of the urgent suspected cancer referral pathway. Barriers to early diagnosis include individual practitioner variation in knowledge, attitudes, beliefs, professional expectations, and norms., Aim: This programme of work (Wales Interventions and Cancer Knowledge about Early Diagnosis [WICKED]) will develop a behaviour change intervention to expedite diagnosis through primary care and contribute to improved cancer outcomes., Design & Setting: Non-experimental mixed-method study with GPs and primary care practice teams from Wales., Method: Four work packages will inform the development of the behaviour change intervention. Work package 1 will identify relevant evidence-based interventions (systematic review of reviews) and will determine why interventions do or do not work, for whom, and in what circumstances (realist review). Work package 2 will assess cancer knowledge, attitudes, and behaviour of GPs, as well as primary care teams' perspectives on cancer referral and investigation (GP survey, discrete choice experiment [DCE], interviews, and focus groups). Work package 3 will synthesise findings from earlier work packages using the behaviour change wheel as an overarching theoretical framework to guide intervention development. Work package 4 will test the feasibility and acceptability of the intervention, and determine methods for measuring costs and effects of subsequent behaviour change in a randomised feasibility trial., Results: The findings will inform the design of a future effectiveness trial, with concurrent economic evaluation, aimed at earlier diagnosis., Conclusion: This comprehensive, evidence-based programme will develop a complex GP behaviour change intervention to expedite the diagnosis of symptomatic cancer, and may be applicable to countries with similar healthcare systems.

Objective: As part of a wider feasibility study, the feasibility of gaining older patients' views for hip fracture rehabilitation services was tested using a discrete choice experiment in a UK context., Design: Discrete choice experiment is a method used for eliciting individuals' preferences about goods and services., Subjects/patients: The discrete choice experiment was administered to 41 participants who had experienced hip fracture (mean age 79.3 years; standard deviation (SD) 7.5 years), recruited from a larger feasibility study exploring a new multidisciplinary rehabilitation for hip fracture., Methods: Attributes and levels for this discrete choice experiment were identified from a systematic review and focus groups. The questionnaire was administered at the 3-month follow-up., Results: Participants indicated a significant preference for a fully-qualified physiotherapist or occupational therapist to deliver the rehabilitation sessions (β = 0·605, 95% confidence interval (95% CI) 0.462-0.879), and for their rehabilitation session to last less than 90 min (β = -0.192, 95% CI -0.381 to -0.051)., Conclusion: The design of the discrete choice experiment using attributes associated with service configuration could have the potential to inform service implementation, and assist rehabilitation service design that incorporates the preferences of patients.

Background: Health economic evaluations rely on the accurate measurement of health service resource use in order to calculate costs. These are usually measured with patient completed questionnaires using instruments such as the Client Service Receipt Inventory (CSRI). These rely on participants' recall and can be burdensome to complete. Health service activity data are routinely captured by electronic databases.The aim was to test methods for obtaining these data and compare with those data collected using the CSRI, within a feasibility study of an enhanced rehabilitation intervention following hip fracture (Fracture in the Elderly Multidisciplinary Rehabilitation: FEMuR)., Methods: Primary care activity including prescribing data was obtained from the Secure Anonymised Information Linkage (SAIL) Databank and secondary care activity (Emergency Department attendances, out-patient visits and in-patient days) directly from Betsi Cadwaladr University Health Board (BCUHB), North Wales, UK. These data were compared with patient responses from the CSRI using descriptive statistics and the intraclass correlation coefficient (ICC)., Results: It was possible to compare health service resource use data for 49 out of 61 participants in the FEMuR study. For emergency department (ED) attendances, records matched in 23 (47%) cases, 21 (43%) over-reported on electronic records compared with CSRI and five participants (10%) under-reported, with an overall ICC of 0.42. For out-patient episodes, records matched in only six cases, 28 participants over-reported on electronic records compared with CSRI and 15 (12%) under-reported, with an overall ICC of only 0.27. For in-patient days, records matched exactly in only five cases (10%), but if an error margin of 7 days was allowed, then agreement rose to 39 (66%) cases, and the overall ICC for all data was 0.88.It was only possible to compare prescribing data for 12 participants. For prescribing data, the SAIL data reported 117 out of 118 items (99%) and the CSRI only 89 (79%) items., Conclusions: The use of routinely collected data has the potential to improve the efficiency of trials and other studies. Although the methodology to make the data available has been demonstrated, the data obtained was incomplete and the validity of using this method remains to be demonstrated., Trial Registration: Trial registration: ISRCTN22464643 Registered 21 July 2014., Competing Interests: The study received ethical approval from the NHS Wales Research Ethics Committee 5 Ref 13/WA/0402 and NHS Research and Development approval from the Betsi Cadwaladr University Health Board (BCUHB) Internal Review Panel.NHW, JLR, NUD, NT, JMC, ZH and RTE report a grant from NIHR HTA programme, for the conduct of the study. NHW reports additional grants from Public Health Wales, NIHR HTA and BCUHB, outside the submitted work. JMC and RTE report grants from Public Health Wales, outside the submitted work.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Our aim was to compare the efficacy of the Therabite ® jaw motion rehabilitation system (Atos Medical) with that of wooden spatulas to relieve and prevent trismus in patients who have had radiotherapy for stage three and four oral and oropharyngeal cancer. Secondary aims were to assess the feasibility and the impact of exercise on health-related quality of life (QoL), and the use of health services after treatment. We designed a randomised, open-label, controlled, three-centre feasibility study to compare the effectiveness and cost of the Therabite ® and wooden spatulas. We studied compliance with exercises and health-related QoL, assessed cost using three health economics measures, and conducted semistructured interviews with patients. Patients were randomised into two groups: the Therabite ® group (n=37) and the wooden spatula group (n=34). All patients had some sense of jaw tightening before the study started. Mean mouth opening after six months increased in both groups, but the difference between the groups was not significant (p=0.39). Completion rates for the three economic measures were good. There was no significant difference between the two groups in frequency of contact with care services or in QoL. Exercises during and after radiotherapy can ameliorate trismus in patients with stage three and four oral and oropharygeal cancers, but differences between groups in efficacy, compliance, QoL, or use of hospital or community health services, were not significant., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Patients can develop trismus from their head and neck cancer or as a result of treatment. Trismus affects the jaw muscles and makes mouth opening difficult. To potentially combat trismus, patients could undertake proactive jaw stretching exercises prior to, during and after radiotherapy, although currently these are not the standard of care., Methods and Analysis: This is a randomised, open-label, controlled, two-centre feasibility study, to assess the objective and subjective effectiveness and cost-effectiveness of therabite use compared with wooden spatula in ameliorating trismus in patients treated for stage 3 and 4 oral and oropharyngeal cancer, managed either by primary surgery followed by (chemo)radiotherapy or primary (chemo)radiotherapy. The principal objective assessment is measurement of maximum jaw opening. Assessments in all cases will be performed preradiotherapy and again at 3 and 6 months postintervention.Secondary aims of the study will be (1) to assess whether therabite or the wooden spatula intervention improves patients' quality of life, (2) reduce the level of post-treatment clinical management/healthcare use and (3) a nested qualitative study will explore the experience of the patient taking part in the intervention; data will be transcribed verbatim and analysis will be based on content analysis methods using the interview questions as the framework for examination., Ethics and Dissemination: North West Greater Manchester granted ethical approval (REC Reference 11/NW/0744). Good Clinical Practice and the Declaration of Helsinki have been adhered to. The results will be presented internationally and submitted to a peer-reviewed journal. Head and neck cancer charities and information websites will also be approached., Trial Registration Number: NCT01733797., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: People with dementia progressively lose abilities and are prone to falling. Exercise- and activity-based interventions hold the prospect of increasing abilities, reducing falls, and slowing decline in cognition. Current falls prevention approaches are poorly suited to people with dementia, however, and are of uncertain effectiveness. We used multiple sources, and a co-production approach, to develop a new intervention, which we will evaluate in a feasibility randomised controlled trial (RCT), with embedded adherence, process and economic analyses., Methods: We will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics, and a family member or carer. We will randomise participants between a therapy programme with high intensity supervision over 12 months, a therapy programme with moderate intensity supervision over 3 months, and brief falls assessment and advice as a control intervention. The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants. We will measure activities of daily living, falls and a battery of intermediate and distal health status outcomes, including activity, balance, cognition, mood and quality of life. The main aim is to test recruitment and retention, intervention delivery, data collection and other trial processes in advance of a planned definitive RCT. We will also study motivation and adherence, and conduct a process evaluation to help understand why results occurred using mixed methods, including a qualitative interview study and scales measuring psychological, motivation and communication variables. We will undertake an economic study, including modelling of future impact and cost to end-of-life, and a social return on investment analysis., Discussion: In this study, we aim to better understand the practicalities of both intervention and research delivery, and to generate substantial new knowledge on motivation, adherence and the approach to economic analysis. This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia, which will be evaluated in a definitive randomised controlled trial., Trial Registration: ClinicalTrials.gov: NCT02874300; ISRCTN 10550694., Competing Interests: This protocol was approved by the Bradford Leeds Research Ethics Committee (reference 16/YH/0040). All participants give written informed consent.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: Pancreatic cancer diagnosis and staging can be difficult in 10-20% of patients. Positron emission tomography (PET)/computed tomography (CT) adds precise anatomical localisation to functional data. The use of PET/CT may add further value to the diagnosis and staging of pancreatic cancer., Objective: To determine the incremental diagnostic accuracy and impact of PET/CT in addition to standard diagnostic work-up in patients with suspected pancreatic cancer., Design: A multicentre prospective diagnostic accuracy and clinical value study of PET/CT in suspected pancreatic malignancy., Participants: Patients with suspected pancreatic malignancy., Interventions: All patients to undergo PET/CT following standard diagnostic work-up., Main Outcome Measures: The primary outcome was the incremental diagnostic value of PET/CT in addition to standard diagnostic work-up with multidetector computed tomography (MDCT). Secondary outcomes were (1) changes in patients' diagnosis, staging and management as a result of PET/CT; (2) changes in the costs and effectiveness of patient management as a result of PET/CT; (3) the incremental diagnostic value of PET/CT in chronic pancreatitis; (4) the identification of groups of patients who would benefit most from PET/CT; and (5) the incremental diagnostic value of PET/CT in other pancreatic tumours., Results: Between 2011 and 2013, 589 patients with suspected pancreatic cancer underwent MDCT and PET/CT, with 550 patients having complete data and in-range PET/CT. Sensitivity and specificity for the diagnosis of pancreatic cancer were 88.5% and 70.6%, respectively, for MDCT and 92.7% and 75.8%, respectively, for PET/CT. The maximum standardised uptake value (SUV max. ) for a pancreatic cancer diagnosis was 7.5. PET/CT demonstrated a significant improvement in relative sensitivity ( p  = 0.01) and specificity ( p  = 0.023) compared with MDCT. Incremental likelihood ratios demonstrated that PET/CT significantly improved diagnostic accuracy in all scenarios ( p  < 0.0002). PET/CT correctly changed the staging of pancreatic cancer in 56 patients ( p  = 0.001). PET/CT influenced management in 250 (45%) patients. PET/CT stopped resection in 58 (20%) patients who were due to have surgery. The benefit of PET/CT was limited in patients with chronic pancreatitis or other pancreatic tumours. PET/CT was associated with a gain in quality-adjusted life-years of 0.0157 (95% confidence interval -0.0101 to 0.0430). In the base-case model PET/CT was seen to dominate MDCT alone and is thus highly likely to be cost-effective for the UK NHS. PET/CT was seen to be most cost-effective for the subgroup of patients with suspected pancreatic cancer who were thought to be resectable., Conclusion: PET/CT provided a significant incremental diagnostic benefit in the diagnosis of pancreatic cancer and significantly influenced the staging and management of patients. PET/CT had limited utility in chronic pancreatitis and other pancreatic tumours. PET/CT is likely to be cost-effective at current reimbursement rates for PET/CT to the UK NHS. This was not a randomised controlled trial and therefore we do not have any information from patients who would have undergone MDCT only for comparison. In addition, there were issues in estimating costs for PET/CT. Future work should evaluate the role of PET/CT in intraductal papillary mucinous neoplasm and prognosis and response to therapy in patients with pancreatic cancer., Study Registration: Current Controlled Trials ISRCTN73852054 and UKCRN 8166., Funding: The National Institute for Health Research Health Technology Assessment programme.

Objective: This study aimed to evaluate the feasibility of completing a parallel-group randomized controlled trial to compare usual follow-up care for women who have completed treatment of gynecological cancer against a nurse-led telephone intervention, known as Optimal Personalised Care After Treatment-Gynaecological., Methods: The unblinded trial aimed to recruit patients who had completed treatment of cervical, endometrial, epithelial ovarian, or vulval cancer within the previous 3 months at 3 North Wales hospitals. We randomized participants to either usual hospital-based follow-up or specialist nurse-led telephone education, empowerment, and structured needs assessment follow-up. The primary outcomes assessed the feasibility of running a larger trial including patient eligibility, recruitment and retention rates, and outcome measure completion. Secondary outcomes were generic and health-related quality of life and a patient self-report health service use (Client Service Receipt Inventory) data collected at 3 time points (baseline, 3 months, and 6 months)., Results: Of the 58 women screened, 44 were eligible (76%) and 24 (55%) were recruited and randomized (12:12 to control and intervention, respectively). One participant was lost to follow-up. Recruited participants had a mean (SD) age of 60 (11.2) years and were approximately 5 months from their initial diagnosis (mean [SD], 159 [58] days). Seventeen (71%) of the participants had an endometrial cancer diagnosis. All outcome measure completion rates exceeded 96%. Although not a core feasibility objective, analyses of outcome measures indicated positive changes in quality of life and well-being within the Optimal Personalised Care After Treatment-Gynaecological group; exploratory cost consequence analysis indicated that the nurse-led intervention had a mean total service use cost of £27 per patient (bootstrapped 95% confidence interval, -£290 to £240) lower than did the standard care group., Conclusion: Eligibility, recruitment, and retention rates as well as outcome measure completion showed that the trial is feasible.

Background: Access to formal care is not always timely and a better understanding on the impact of untimely access is needed., Objective: To examine, from a societal perspective, the impact of untimely access to formal care in terms of total costs and quality of life over one year in community dwelling people with dementia., Methods: Within the Actifcare study, needs, resource use, and quality of life were observed for one year in a cohort of 451 community dwelling people with dementia in 8 European countries. Untimely access to care was operationalized as having at least one unmet need for care identified by the Camberwell Assessment of Need for the Elderly (CANE) instrument. Two regression models were built for both total costs and quality of life measured by the EQ-5D-5L, one using sum of unmet needs and one using a predefined selection of need items., Results: Unmet needs were not associated with higher total costs but they were associated with a lower quality of life of people with dementia. Of all CANE items, only an unmet need for "company" was significantly related to lower total costs., Conclusion: Total costs did not seem to differ between participants with unmet and met needs. Only few associations between specific unmet needs and costs and quality of life were found. Furthermore, quality of life of people with dementia decreases when multiple unmet needs are experienced, indicating that assessing and meeting needs is important to improve quality of life.

Background: With 10.5 million people with dementia in Europe and $301 billion associated costs, governments face challenges organizing access to care., Objective: To examine the costs related to formal and informal care use and quality of life for people with dementia in eight European countries, and explore the association with unmet needs., Methods: Cross-sectional data from 451 persons with dementia and their informal caregivers of the Actifcare cohort study were obtained. Formal and informal care use was multiplied by country specific unit prices of services. Needs were measured using the CANE and health-related quality of life (HRQOL) of the person with dementia (both self- and proxy-rated) and informal caregiver's quality of life using EQ-5D-5L, ICECAP-O, DEMQOL-U, and CarerQol utility scores. The association between costs and country, European region, and unmet needs was assessed using multi-level linear regression., Results: Self-rated EQ-5D-5L utility score was higher than proxy-rated (0.84 and 0.71, respectively). Informal caregivers' utility score was 0.84. Across eight countries annual mean costs of formal and informal care were approximately € 17,000. Unmet needs were not associated with annual costs of care, nor with proxy-rated HRQOL, but were associated with self-rated HRQOL., Conclusion: We found varying relationships between unmet needs and quality of life, and no association between unmet needs and care costs, although the results were sensitive to various factors. Future research should further investigate the relation between unmet needs, quality of life and costs to generate a better understanding of the effects of (un)timely access to care.