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Objective: To perform a cost-effectiveness analysis of high-intensity interval training (HIIT) compared with moderate intensity steady-state (MISS) training in people with coronary artery disease (CAD) attending cardiac rehabilitation (CR)., Design: Secondary cost-effectiveness analysis of a prospective, assessor-blind, parallel group, multi-center RCT., Setting: Six outpatient National Health Service cardiac rehabilitation centers in England and Wales, UK., Participants: 382 participants with CAD (N=382)., Interventions: Participants were randomized to twice-weekly usual care (n=195) or HIIT (n=187) for 8 weeks. Usual care was moderate intensity continuous exercise (60%-80% maximum capacity, MISS), while HIIT consisted of 10 × 1-minute intervals of vigorous exercise (>85% maximum capacity) interspersed with 1-minute periods of recovery., Main Outcome Measures: We conducted a cost-effectiveness analysis of the HIIT or MISS UK trial. Health related quality of life was measured with the EQ-5D-5L to estimate quality-adjusted life years (QALYs). Costs were estimated with health service resource use and intervention delivery costs. Cost-utility analysis measured the incremental cost-effectiveness ratio (ICER). Bootstrapping assessed the probability of HIIT being cost-effective according to the UK National Institute for Health and Care Excellence (NICE) threshold value (£20,000 per QALY). Missing data were imputed. Uncertainty was estimated using probabilistic sensitivity analysis. Assumptions were tested using univariate/1-way sensitivity analysis., Results: 124 (HIIT, n=59; MISS, n=65) participants completed questionnaires at baseline, 8 weeks, and 12 months. Mean combined health care use and delivery cost was £676 per participant for HIIT, and £653 for MISS. QALY changes were 0.003 and -0.013, respectively. For complete cases, the ICER was £1448 per QALY for HIIT compared with MISS. At a willingness-to-pay threshold of £20,000 per QALY, the probability of HIIT being cost-effective was 96% (95% CI, 0.90 to 0.95)., Conclusion: For people with CAD attending CR, HIIT was cost-effective compared with MISS. These findings are important to policy makers, commissioners, and service providers across the health care sector., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: There is a lack of international consensus regarding the prescription of high-intensity interval training (HIIT) for people with coronary artery disease (CAD) attending cardiac rehabilitation (CR)., Aims: To assess the clinical effectiveness and safety of low-volume HIIT compared with moderate-intensity steady-state (MISS) exercise training for people with CAD., Methods and Results: We conducted a multi-centre RCT, recruiting 382 patients from 6 outpatient CR centres. Participants were randomized to twice-weekly HIIT (n = 187) or MISS (n = 195) for 8 weeks. HIIT consisted of 10 × 1 min intervals of vigorous exercise (>85% maximum capacity) interspersed with 1 min periods of recovery. MISS was 20-40 min of moderate-intensity continuous exercise (60-80% maximum capacity). The primary outcome was the change in cardiorespiratory fitness [peak oxygen uptake (VO2 peak)] at 8 week follow-up. Secondary outcomes included cardiovascular disease risk markers, cardiac structure and function, adverse events, and health-related quality of life. At 8 weeks, VO2peak improved more with HIIT (2.37 mL.kg-1.min-1; SD, 3.11) compared with MISS (1.32 mL.kg-1.min-1; SD, 2.66). After adjusting for age, sex, and study site, the difference between arms was 1.04 mL.kg-1.min-1 (95% CI, 0.38 to 1.69; P = 0.002). Only one serious adverse event was possibly related to HIIT., Conclusions: In stable CAD, low-volume HIIT improved cardiorespiratory fitness more than MISS by a clinically meaningful margin. Low-volume HIIT is a safe, well-tolerated, and clinically effective intervention that produces short-term improvement in cardiorespiratory fitness. It should be considered by all CR programmes as an adjunct or alternative to MISS., Trial Registration: ClinicalTrials.gov: NCT02784873. https://clinicaltrials.gov/ct2/show/NCT02784873., Competing Interests: Conflict of interest: G.M., L.I., P.B., and S.W.E. have received research grants from the National Institute for Health Research and/or the British Heart Foundation. G.M. and S.E. are Directors of Atrium Health Ltd., a provider of rehabilitation services for the NHS., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: We evaluated the safety, efficacy, and acceptability of a new device designed to facilitate uterine compression in women with postpartum haemorrhage (PPH)., Methods: A prospective, phase two clinical device trial with concurrent qualitative study, conducted in a UK consultant obstetric unit. The device was used in addition to standard care in women unresponsive to initial oxytocin therapy. The primary effectiveness outcome was additional blood loss of over 1000mls, whilst safety was assessed through adverse events. Interviews assessed device feasibility and acceptability, and were analysed using framework analysis., Results: We recruited 57 women with clinical PPH after vaginal birth; 67% were primiparous and 47% had undergone operative birth. All but two (96%) had atony as a cause of the haemorrhage; in addition, 30% also had bleeding from lacerations and 11% had retained tissue. After device use, only one woman had additional blood loss over 1000mls, although 3 women (7%) needed a Bakri balloon and 14% received a blood transfusion. All but one clinician felt that the device was easy to use. Clinicians stated that the device assisted management in 85% of cases. All 56 women who responded stated that if they bled in a future birth they would want the device to be used again. There were no serious adverse events related to the device. However, 3 events were judged as 'possibly' being caused by the device - 2 minor vaginal grazes and one postnatal episiotomy infection and breakdown. Lax vaginal tissue complicated the use of the device in three women. In 47 interviews, participants, birth partners, clinician users and attending midwives viewed the device positively. Clinicians found it useful as a way of stopping blood loss and as an aid to diagnose the source of bleeding., Conclusions: The PPH Butterfly may provide a rapid, acceptable and effective treatment for postpartum haemorrhage. Clinical Trial Registration prospective with ISRCTN15452399 11/09/2017 (www.isrctn.com/ISRCTN15452399)., Competing Interests: Declaration of Competing Interest ADW and PW are co-inventors of the PPH Butterfly. The patent is held by the University of Liverpool, but ADW and PW could in future receive a share of any profits generated from commercialization. The remaining authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: To explore the cost-effectiveness of a novel PPH device as compared with usual care., Design: A decision analytical model was used to explore the cost-effectiveness of the PPH Butterfly device compared with usual care. This was part of a United Kingdom, UK, clinical trial ISRCTN15452399 using a matched historical cohort who had standard PPH management without the use of the PPH Butterfly device. The economic evaluation was conducted from a UK National Health Service (NHS) perspective., Setting: Liverpool Women's Hospital, UK., Participants: 57 women with 113 matched controls., Intervention: The PPH Butterfly is a novel device that has been invented and developed in the UK to facilitate bimanual compression of the uterus in the treatment of PPH., Main Outcome Measures: Main outcome measures included healthcare costs, blood loss, and maternal morbidity events., Results: Mean treatment costs in the Butterfly cohort were £3,459.66 as compared with standard care £3,223.93. Treatment with the Butterfly device resulted in decreased total blood loss in comparison with standard care. The Butterfly device had an incremental cost-effectiveness ratio of £3,795.78 per PPH progression avoided (defined as ≤ 1000 ml additional blood loss from device insertion point). If the NHS is prepared to pay £8,500 per PPH progression avoided, then the Butterfly device is cost-effective with a probability of 87 percent. In the PPH Butterfly treatment arm there were 9% fewer cases of massive obstetric haemorrhage (severe PPH of more than 2000mls or more than 4 units of blood transfusion required) recorded as compared with the standard care historical cohort. As a low-cost device, the PPH Butterfly device is cost-effective but can be cost-saving to the NHS., Conclusion: The PPH pathway can result in high-cost resource use such as blood transfusion or high dependence unit hospital stays. The Butterfly device is a relative low-cost device in a UK NHS setting with a high probability of being cost-effective. The National Institute for Health and Care Excellence (NICE) can use this evidence in considering the adoption of innovative technologies such as the Butterfly device in the NHS. Extrapolation on an international scale to lower and middle-income countries could prevent mortality associated with PPH., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ADW is the co-inventor of the PPH Butterfly, whose patent is held by the University of Liverpool (with a royalty-sharing agreement with the inventors). None of the other authors declare any conflict of interest., (Copyright © 2023. Published by Elsevier B.V.)

Background: The percentage of people in Wales experiencing severe mental health issues more than doubled during the COVID-19 pandemic. Additionally, hundreds of people in Wales wait more than a year for help with their mental health. The EmotionMind Dynamic (EMD) programme is a six-session programme over 3 months involving self-reflective introspection, self-analysis, problem solving, goal setting, and action taking. Furthermore, this programme challenges negative self-perception and increases self-awareness, self-confidence, and self-esteem. We aimed to estimate the social return on investment of EMD lifestyle coaching, both face-to-face and online formats, by comparing the costs of running the programme with the social value generated from clients as measured by improvement in self-confidence and mental wellbeing., Methods: We included 15 clients from previous face-to-face EMD coaching and 17 clients from a new online version of EMD. For face-to-face clients, quantitative data were collected retrospectively with a one-time only questionnaire. For new online clients, quantitative data were collected from baseline and follow-up questionnaires. Qualitative data were collected after intervention from interviews with both groups. Outcomes from questionnaires for both groups included changes in mental wellbeing measured with the Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS) and self-efficacy assessed with the General Self-Efficacy Scale (GSES)., Findings: For every £1 invested, lifestyle coaching generated social values ranging from £4·12 to £7·08 for face-to-face clients compared with £2·37 to £3·35 for online participants. Quantitative and qualitative data from questionnaires and interviews indicated that many clients had improved mental wellbeing and self-efficacy. All 15 face-to-face clients and 11 (65%) of 17 online clients reported an increase of 5 points or more on the SWEMWBS questionnaire. Similarly, all 15 face-to-face clients and ten (59%) of 17 online clients reported an increase of 5 points or more on the GSES questionnaire., Interpretation: The results showed that both face-to-face and online formats of the EMD lifestyle coaching generated a positive social return on investment ratios. With continued long waiting lists for people with mental health challenges, face-to-face and online lifestyle coaching might become more essential across statutory, private, and third sectors to meet the growing demand for mental health support., Funding: Accelerate: the Welsh Health Innovation and Technology Accelerator., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

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).)

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: 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: 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.

Purpose: To determine the incremental cost-effectiveness of portable electronic vision enhancement system (p-EVES) devices compared with optical low vision aids (LVAs), for improving near vision visual function, quality of life and well-being of people with a visual impairment., Methods: An AB/BA randomized crossover trial design was used. Eighty-two participants completed the study. Participants were current users of optical LVAs who had not tried a p-EVES device before and had a stable visual impairment. The trial intervention was the addition of a p-EVES device to the participant's existing optical LVA(s) for 2 months, and the control intervention was optical LVA use only, for 2 months. Cost-effectiveness and cost-utility analyses were conducted from a societal perspective., Results: The mean cost of the p-EVES intervention was £448. Carer costs were £30 (4.46 hr) less for the p-EVES intervention compared with the LVA only control. The mean difference in total costs was £417. Bootstrapping gave an incremental cost-effectiveness ratio (ICER) of £736 (95% CI £481 to £1525) for a 7% improvement in near vision visual function. Cost per quality-adjusted life year (QALY) ranged from £56 991 (lower 95% CI = £19 801) to £66 490 (lower 95% CI = £23 055). Sensitivity analysis varying the commercial price of the p-EVES device reduced ICERs by up to 75%, with cost per QALYs falling below £30 000., Conclusion: Portable electronic vision enhancement system (p-EVES) devices are likely to be a cost-effective use of healthcare resources for improving near vision visual function, but this does not translate into cost-effective improvements in quality of life, capability or well-being., (© 2016 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation and European Association for Vision & Eye Research.)

Background: Proximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking., Objectives: To develop an enhanced community-based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation., Design: Phase I - realist review, survey and focus groups to develop the rehabilitation package. Phase II - parallel-group, randomised (using a dynamic adaptive algorithm) feasibility study with focus groups and an anonymised cohort study., Setting: Recruitment was from orthopaedic wards of three acute hospitals in the Betsi Cadwaladr University Health Board, North Wales. The intervention was delivered in the community following hospital discharge., Participants: Older adults (aged ≥ 65 years) who had received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by the clinical team) and received rehabilitation in the North Wales area., Interventions: Participants received usual care (control) or usual care plus an enhanced rehabilitation package (intervention). Usual care was variable and consisted of multidisciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients' self-efficacy and increasing the amount and quality of patients' practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, a goal-setting diary and six additional therapy sessions., Main Outcome Measures: The primary outcome measure was the Barthel Activities of Daily Living (BADL) index. The secondary outcome measures included the Nottingham Extended Activities of Daily Living (NEADL) scale, EuroQol-5 Dimensions, ICEpop CAPability measure for Older people, General Self-Efficacy Scale, Falls Efficacy Scale - International (FES-I), Self-Efficacy for Exercise scale, Hospital Anxiety and Depression Scale (HADS) and service use measures. Outcome measures were assessed at baseline and at 3-month follow-up by blinded researchers., Results: Sixty-two participants were recruited (23% of those who were eligible), 61 were randomised (control, n  = 32; intervention, n  = 29) and 49 (79%) were followed up at 3 months. Compared with the cohort study, a younger, healthier subpopulation was recruited. There were minimal differences in most outcomes between the two groups, including the BADL index, with an adjusted mean difference of 0.5 (Cohen's d  = 0.29). The intervention group showed a medium-sized improvement on the NEADL scale relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d  = 0.63). There was a trend for greater improvement in FES-I and HADS in the intervention group, but with small effect sizes, with an adjusted mean difference of 4.2 (Cohen's d  = 0.31) and 1.3 (Cohen's d  = 0.20), respectively. The cost of delivering the intervention was £231 per patient. There was a possible small relative increase in quality-adjusted life-years in the intervention group. No serious adverse events relating to the intervention were reported., Conclusions: Trial methods were feasible in terms of eligibility, recruitment and retention, although recruitment was challenging. The NEADL scale was more responsive than the BADL index, suggesting that the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT. There were two main limitations of the study: the feasibility study lacked power to test for differences between the groups and a ceiling effect was observed in the primary measure., Trial Registration: Current Controlled Trials ISRCTN22464643., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 44. See the NIHR Journals Library for further project information.

Purpose: To compare the performance of near vision activities using additional portable electronic vision enhancement systems (p-EVES), to using optical magnifiers alone, by individuals with visual impairment., Methods: A total of 100 experienced optical aid users were recruited from low vision clinics at Manchester Royal Eye Hospital, Manchester, UK, to a prospective two-arm cross-over randomised controlled trial. Reading, performance of near vision activities, and device usage were evaluated at baseline; and at the end of each study arm (Intervention A: existing optical aids plus p-EVES; Intervention B: optical aids only) which was after 2 and 4 months., Results: A total of 82 participants completed the study. Overall, maximum reading speed for high contrast sentences was not statistically significantly different for optical aids and p-EVES, although the critical print size and threshold print size which could be accessed with p-EVES were statistically significantly smaller (p < 0.001 in both cases). The optical aids were used for a larger number of tasks (p < 0.001), and used more frequently (p < 0.001). However p-EVES were preferred for leisure reading by 70% of participants, and allowed longer duration of reading (p < 0.001). During the study arm when they had a p-EVES device, participants were able to carry out more tasks independently (p < 0.001), and reported less difficulty with a range of near vision activities (p < 0.001)., Conclusions: The study provides evidence that p-EVES devices can play a useful role in supplementing the range of low vision aids used to reduce activity limitation for near vision tasks., (© 2017 The Authors Ophthalmic & Physiological Optics © 2017 The College of Optometrists.)

Objective: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture., Setting: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community., Participants: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area., Intervention: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary., Primary and Secondary Outcome Measures: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers., Results: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported., Conclusions: The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT., Trial Registration Number: ISRCTN22464643; Results., Competing Interests: NHW, JLR, NUD, MW, NT, JMC, CAH, VM, ZH, SA, AL, RTW, CS, PL, RTE and CW report a grant from NIHR HTA programme, for the conduct of the study. CS reports being a member of the NIHR HSDR board. 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., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Purpose: The purpose of this study was to compare two interventions for depression, problem solving treatment (PST) and referral to the patient's physician, with a waiting-list control group in people with sight loss and depressive symptoms., Methods: This was an assessor-masked, exploratory, multicenter, randomized clinical trial, with concurrent economic analysis. Of 1008 consecutive attendees at 14 low-vision rehabilitation centers in Britain, 43% (n = 430) screened positive for depressive symptoms on the Geriatric Depression Scale and 85 of these attendees participated in the trial. Eligible participants were randomized in the ratio 1:1:1 to PST, referral to their physician, or a waiting-list control arm. PST is a manualized talking intervention delivered by a trained therapist who teaches people over six to eight sessions to implement a seven-step method for solving their problems. Referral to the physician involved sending a referral letter to the person's physician, encouraging him or her to consider treatment according to the stepped care protocol recommended by the U.K.'s National Institute of Health and Care Excellence. The primary outcome was change in depressive symptoms (6 months after baseline) as determined by the Beck Depression Inventory., Results: At 6 months, Beck Depression Inventory scores reduced by 1.05 (SD 8.85), 2.11 (SD 7.60), and 2.68 (SD 7.93) in the waiting-list control, referral, and PST arms, respectively. The cost per patient of the PST intervention was £1176 in Wales and £1296 in London., Conclusions: Depressive symptoms improved most in the PST group and least in the control group. However, the change was small and the uncertainty of the measurements relatively large.

Background: Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care., Methods: This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point), usually in the person's home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV), who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5)were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control). The intervention evaluated was joint reminiscence groups (with up to 12 dyads) weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD), psychological distress for the carer (General Health Questionnaire, GHQ-28). Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both., Results: The intention to treat analysis (ANCOVA) identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes (self-reported QoL-AD mean difference 0.07 (-1.21 to 1.35), F = 0.48, p = 0.53). Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a General Health Questionnaire-28 sub-scale at the ten month end-point (mean difference 1.25 (0.25 to 2.26), F = 8.28, p = 0.04). Compliance analyses suggested improved autobiographical memory, quality of life and relationship quality for people with dementia attending more reminiscence sessions, however carers attending more groups showed increased care-giving stress. Economic analyses from a public sector perspective indicated that joint reminiscence groups are unlikely to be cost-effective. There were no significant adverse effects attributed to the intervention. Potential limitations of the study include less than optimal attendance at the group sessions--only 57% of participants attended at least half of the intervention sessions over the 10 month period, and a higher rate of study withdrawal in the control group., Conclusions: This trial does not support the clinical effectiveness or cost-effectiveness of joint reminiscence groups. Possible beneficial effects for people with dementia who attend sessions as planned are offset by raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions., Trial Registration: ISRCTN Registry ISRCTN42430123.

Background: Proximal femoral fracture is a common, major health problem in old age resulting in loss of functional independence and a high-cost burden on society, with estimated health and social care costs of £2.3 billion per year in the UK. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness is lacking. Usual rehabilitation care is delivered by a multi-disciplinary team in the hospital and in the community. An 'enhanced rehabilitation' intervention has been developed consisting of a workbook, goal-setting diary and extra therapy sessions, designed to improve self-efficacy and increase the amount and quality of the practice of physical exercise and activities of daily living., Methods/design: This paper describes the design of a phase II study comprising an anonymous cohort of all proximal femoral fracture patients admitted to the three acute hospitals in Betsi Cadwaladr University Health Board over a 6-month period with a randomised feasibility study comparing the enhanced rehabilitation intervention with usual care. These will assess the feasibility of a future definitive randomised controlled trial and concurrent economic evaluation in terms of recruitment, retention, outcome measure completion, compliance with the intervention and fidelity of delivery, health service use data, willingness to be randomised and effect size for a future sample size calculation. Focus groups will provide qualitative data to contribute to the assessment of the acceptability of the intervention amongst patients, carers and rehabilitation professionals and the feasibility of delivering the planned intervention. The primary outcome measure is function assessed by the Barthel Index. Secondary outcomes measure the ability to perform activities of daily living, anxiety and depression, potential mediators of outcomes such as hip pain, self-efficacy and fear of falling, health utility, health service use, objectively assessed physical function and adverse events. Participants' preference for rehabilitation services will be assessed in a discrete choice experiment., Discussion: Phase II studies are an opportunity to not only assess the feasibility of trial methods but also to compare different methods of outcome measurement and novel methods of obtaining health service use data from routinely collected patient information., Trial Registration: Current Controlled Trials ISRCTN22464643, UKCRN16677.

Aim: To undertake the pre-clinical and modelling phases of the Medical Research Council complex intervention framework to underpin development of child-centred 'keep-fit', exercise and physical activity interventions for children and young people who use wheelchairs., Background: Children who use wheelchairs face many barriers to participation in physical activity, which compromises fitness, obesity, well-being and health. 'Keep-fit' programmes that are child-centred and engaging are urgently required to enhance participation of disabled children and their families as part of a healthy lifestyle. Nurses will likely be important in promoting and monitoring 'keep-fit' intervention(s) when implemented in the community., Design: Mixed-method (including economic analysis) feasibility study to capture child and family preferences and keep-fit needs and to determine outcome measures for a 'keep-fit' intervention., Methods: The study comprises three stages. Stage 1 includes a mixed-method systematic review of effectiveness, cost effectiveness and key stakeholder views and experiences of keep-fit interventions, followed by qualitative interviews with children, young people and their parents to explore preferences and motivations for physical activity. Stage 2 will identify standardized outcome measures and test their application with children who use wheelchairs to obtain baseline fitness data. Options for an exercise-based keep-fit intervention will then be designed based on Stage 1 and 2 findings. In stage 3, we will present intervention options for feedback and further refinement to children and parents/carers in focus groups. (Project funded October 2012)., Discussion: At completion, this study will lead to the design of the intervention and a protocol to test its efficacy., (© 2014 John Wiley & Sons Ltd.)

Aim: This mixed-method systematic review aims to establish the current evidence base for 'keep fit', exercise or physical activity interventions for children and young people who use wheelchairs., Background: Nurses have a vital health promotion, motivational and monitoring role in optimizing the health and well-being of disabled children. Children with mobility impairments are prone to have low participation levels in physical activity, which reduces fitness and well-being. Effective physical activity interventions that are fun and engaging for children are required to promote habitual participation as part of a healthy lifestyle. Previous intervention programmes have been trialled, but little is known about the most effective types of exercise to improve the fitness of young wheelchair users., Design: Mixed-method design using Cochrane systematic processes. Evidence regarding physiological and psychological effectiveness, health economics, user perspectives and service evaluations will be included and analysed under distinct streams., Methods: The project was funded from October 2012. Multiple databases will be searched using search strings combining relevant medical subheadings and intervention-specific terms. Articles will also be identified from ancestral references and by approaching authors to identify unpublished work. Only studies or reports evaluating the effectiveness, participation experiences or cost of a physical activity programme will be included. Separate analyses will be performed for each data stream, including a meta-analysis if sufficient homogeneity exists and thematic analyses. Findings across streams will be synthesized in an overarching narrative summary., Discussion: Evidence from the first systematic review of this type will inform development of effective child-centred physical activity interventions and their evaluation., (© 2014 John Wiley & Sons Ltd.)

Background: Wheelchairs for disabled children (≤ 18 years) can provide health, developmental and social benefits. World Health Organisation and United Kingdom Government reports demonstrate the need for improved access to wheelchairs both locally and internationally. The use of health economics within this field is lacking. Provision of wheelchairs based on cost-effectiveness evidence is not currently possible. We conducted the first systematic review in this field to incorporate evidence of effectiveness, service user perspectives, policy intentions and cost-effectiveness in order to develop a conceptual framework to inform future research and service development., Methods: We used an adapted EPPI-Centre mixed-method systematic review design with narrative summary, thematic and narrative synthesis. 11 databases were searched. Studies were appraised for quality using one of seven appropriate tools. A conceptual framework was developed from synthesised evidence., Results: 22 studies and 14 policies/guidelines were included. Powered wheelchairs appear to offer benefits in reduced need for caregiver assistance; improved communicative, personal-social and cognitive development; and improved mobility function and independent movement. From 14 months of age children can learn some degree of powered wheelchair driving competence. However, effectiveness evidence was limited and low quality. Children and parents placed emphasis on improving social skill and independence. Participation in wider society and development of meaningful relationships were key desired outcomes. Policy intentions and aspirations are in line with the perspectives of children and parents, although translation of policy recommendations into practice is lacking., Conclusions: There is a distinct lack of high quality effectiveness and economic evidence in this field. Social and health needs should be seen as equally important when assessing the mobility needs of disabled children. Disabled children and parents placed highest priority on independence and psychosocial outcomes of wheelchair interventions. Translation of policy and guidelines into practice is lacking and more effective implementation strategies are required to improve services and outcomes. Future research should focus on outcome measure development, developing economic evaluation tools and incorporating these into high quality studies to address known research gaps. The novel conceptual framework maps current gaps in evidence and outlines areas for development.

The relatively high rate of suicide among UK farmers suggests that they may suffer greater mental health problems than the general population. This paper provides a comparison of the psychological morbidity of farmers and their partners/spouses with non-farmers. The General Health Questionnaire (GHQ-12) was administered using face-to-face interviews with 784 attendees of agricultural shows in the UK. Results show that GHQ-12 scores for farmers and their partners/spouses were significantly higher (P < 0.001) than those for the non-farming population, indicating higher psychological morbidity among farmer families. Approximately 35% of farmers had scores 12 and higher (recommended cut-off for psychiatric disorders), compared to 27% of non-farmers. Within the farmers group, male respondents, those aged from 45 to 64, self-employed or not in paid employment, having a non-supervisory position and living in a rural area were characterized by higher mean GHQ-12 scores compared to correspondent subgroups from the non-farming population.

Background: There has been little rigorous economic analysis of the relationship between asthma and improved housing., Aim: To evaluate the cost-effectiveness of installing ventilation systems, and central heating if necessary, in homes of children with 'moderate' or 'severe' asthma., Design and Setting: An incremental cost-effectiveness analysis alongside a pragmatic randomised controlled trial of a tailored package of housing modifications designed to improve ventilation and household heating in homes within Wrexham County Borough, Wales, UK., Method: A total of 177 children aged between 5 and 14 years, identified from general practice registers, were studied. Parents reported on the quality of life of their children over a 12-month period. General practices reported on health-service resources used by those children, and their asthma-related prescriptions, over the same period., Results: The tailored package shifted 17% of children in the intervention group from 'severe' to 'moderate' asthma, compared with a 3% shift in the control group. The mean cost of these modifications was £1718 per child treated or £12300 per child shifted from 'severe' to 'moderate'. Healthcare costs over 12 months following randomisation did not differ significantly between intervention and control groups. Bootstrapping gave an incremental cost-effectiveness ratio (ICER) of £234 per point improvement on the 100-point PedsQL™ asthma-specific scale, with 95% confidence interval (CI) = £140 to £590. The ICER fell to £165 (95% CI = £84 to £424) for children with 'severe' asthma., Conclusion: This novel and pragmatic trial, with integrated economic evaluation, reported that tailored improvement of the housing of children with moderate to severe asthma is likely to be a cost-effective use of public resources. This is a rare example of evidence for collaboration between local government and the NHS.

Background: Few robust studies have tested whether enhancing housing also improves health., Aim: To evaluate the effectiveness of installing ventilation systems, and central heating where necessary, in the homes of children with moderate or severe asthma., Design and Setting: Pragmatic randomised controlled trial (RCT) in homes within Wrexham County Borough, Wales, UK., Method: A pragmatic RCT was carried out, of a tailored package of housing improvements providing adequate ventilation and temperature, following inspection by a housing officer. One hundred and ninety-two children with asthma aged 5 to 14 years, identified from general practice registers, were randomised to receive this package, either immediately or a year after recruitment. At baseline, and after 4 and 12 months, parents reported their child's asthma-specific and generic quality of life, and days off school., Results: The package improved parent-reported asthma-specific quality of life significantly at both 4 and 12 months. At 12 months, this showed an adjusted mean difference between groups of 7.1 points (95% confidence interval [CI] = 2.8 to 11.4, P= 0.001): a moderate standardised effect size of 0.42. The generic quality-of-life scale showed reported physical problems were significantly reduced at 4 months, but not quite at 12 months, when the mean difference was 4.5 (95% CI = -0.2 to 9.1, P= 0.061). The improvement in psychosocial quality of life at 12 months was not significant, with a mean difference of 2.2 (95% CI = -1.9 to 6.4, P= 0.292). Parent-reported school attendance improved, but not significantly., Conclusion: This novel and pragmatic trial, with integrated economic evaluation, found that tailored improvement of the housing of children with moderate to severe asthma significantly increases parent-reported asthma-related quality of life and reduces physical problems. Collaborative housing initiatives have potential to improve health.

Background: The Hip & Knee Book: Helping you cope with osteoarthritis was developed to change disadvantageous beliefs and encourage physical activity in people with hip or knee osteoarthritis., Aim: To assess the feasibility of conducting a definitive randomised controlled trial (RCT) of this evidence-based booklet in people with hip or knee osteoarthritis., Design: Phase II feasibility randomised controlled trial (RCT)., Method: Computerised searches of patients' record databases identified people with osteoarthritis of the hip or knee, who were invited to participate in the RCT comparing the new booklet with a control booklet. Outcomes were measured at baseline, 1 month, and 3 months, and included: beliefs about hip and knee pain, exercise, and fear avoidance; level of physical activity; and health service use., Results: The trial methods were feasible in terms of recruitment, randomisation, and follow-up, but most participants recruited had longstanding established symptoms. After one and 3 months, there was a small relative improvement in illness, exercise, and fear-avoidance beliefs and physical activity level in The Hip & Knee Book group (n = 59) compared with the control group (n = 60), which provides some proof of principle for using these outcomes in future trials., Conclusion: This feasibility study provided proof of principle for testing The Hip & Knee Book in a larger definitive RCT.

Significant environmental benefits are claimed for local food systems, but these biophysical indicators are increasingly recognised as inadequate descriptors of supply chain ethics. Social factors such as health are also important indicators of good practice, and are recognised by the organic and local food movements as important to the development of rounded sustainable agricultural practices. This study compared the self-reported health status of farm workers in the United Kingdom, Spain, Kenya and Uganda who were supplying distant markets with fresh vegetables. Workers on Kenyan export horticulture farms reported significantly higher levels of physical health than did Kenyan non-export farm workers and workers in the other study countries. Mean health levels for farm workers in the United Kingdom were significantly lower than relevant population norms, indicating widespread levels of poor health amongst these workers. These results suggest that globalised supply chains can provide social benefits to workers, while local food systems do not always provide desirable social outcomes. The causal mechanisms of these observations probably relate more to the social conditions of workers than directly to income.

Background: Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity., Methods/design: This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months., Discussion: We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial., Trial Registration: Current Controlled Trials ISRCTN24554946.

Background: The growing number of people with dementia, and the increasing cost of care, provides a major incentive to develop and test methods of supporting them in the community for longer. Most attention has been given to pharmacological interventions, but there is increasing recognition that psychosocial interventions may be equally effective, even preferable where medication has negative side-effects. Reminiscence groups, run by professionals and volunteers, which use photographs, recordings and other objects to trigger personal memories are probably the most popular therapeutic approach to working with people with dementia, but there is little evidence for their effectiveness and cost-effectiveness. The recent inclusion of family carers in groups with people with dementia, notably in our own pilot studies, has generated informal evidence that this joint approach improves relationships between people with dementia and their carers, and benefits both., Design and Methods: This multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family care-givers has two parallel arms--an intervention group and a control group who receive care as usual. The intervention consists of joint reminiscence groups held weekly for twelve consecutive weeks, followed by monthly maintenance sessions for a further seven months.The primary outcome measures are the quality of life of people with dementia, as assessed by QoL-AD, and their care-givers' mental health as assessed by the GHQ-28. Secondary outcomes include: the autobiographical memories of people with dementia; the quality of the relationship between them and their care-givers; and the levels of depression and anxiety felt by them and their care-giver. Using a 5% significance level, comparison of 200 pairs attending joint reminiscence groups with 200 pairs receiving usual treatment will yield 80% power to detect a standardised difference of 0.38 in the QoL-AD rated by the person with dementia and 0.28 in the GHQ-28 or carer-rated QoL-AD. The trial will include a cost-effectiveness analysis from a public sector perspective., Discussion: Our Cochrane review (2005) on reminiscence therapy for people with dementia did not identify any rigorous trials or economic analyses in this field., Trial Registration: ISRCTN42430123.

The export of vegetables from African countries to European markets presents consumers with an ethical dilemma: should they support local, but relatively well-off farmers, or poorer farmers from distant countries? This paper considers the issue of farm worker health in the U.K. and Uganda, and considers the dilemma facing U.K. consumers if Uganda achieves their aim of exporting more vegetables to the U.K. Self-reported health scores of 1,200 farm workers in the U.K. and Uganda were measured with the internationally recognised SF-36 questionnaire and compared to an international population norm. The age-corrected health status of U.K. farm workers was significantly lower than the population norm, whereas Ugandans scored significantly higher (indicating good health) for physical health and lower for mental health. If Ugandan produce enters U.K. markets, then consumers may wish to consider both the potential benefits that enhanced trade could offer Ugandan farmers compared with its impacts on U.K. workers.

Background: There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials., Methods: A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis., Results: Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP., Conclusion: We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.

This study describes the self-reported health and well-being status of field and packhouse workers in UK vegetable horticulture, and tests the null hypothesis that there is no difference in the self-reported health of workers on organic and conventional horticultural farms. The majority of those sampled were migrant workers (93%) from Bulgaria, Latvia, Lithuania, Poland, Russia and the Ukraine. More than 95% of the respondents were aged 18-34 and recruited through university agricultural faculties in East European or employed via UK agencies. The health of 605 farm workers (395 males and 210 females) was measured through the use of four standard health instruments. Farm workers' health was significantly poorer than published national norms for three different health instruments (Short Form 36, EuroQol EQ-5D and the Visual Analogue Scale). There were no significant differences in the health status of farm workers between conventional and organic farms for any of these three instruments. However, organic farm workers scored higher on a fourth health instrument the Short Depression Happiness Scale (SDHS) indicating that workers on organic farms were happier than their counterparts working on conventional farms. Multiple regression analysis suggested that the difference in the SDHS score for organic and conventional farms is closely related to the range and number of tasks the workers performed each day. These findings suggest that a great deal of improvement in the self-reported health of farmers will need to occur before organic farms meet the requirements of the 'Principle of Health' as described by IFOAM. Ensuring that farm workers have a varied range of tasks could be a cost effective means of improving self-reported health status in both organic and conventional farming systems.

Objective: To investigate the cost effectiveness of a parenting programme., Design: An incremental cost effectiveness analysis alongside a pragmatic randomised controlled trial of the effectiveness of a group parenting programme delivered through Sure Start in the community., Setting: Sure Start areas in north and mid Wales., Participants: Parents of 116 children aged 36-59 months (87% of the clinical sample) at risk of developing conduct disorders defined by scoring over the clinical cut off on the Eyberg child behaviour inventory). Children were identified by health visitors and recruited by the research team., Intervention: The Webster-Stratton Incredible Years basic parenting programme or a six month waiting list control., Main Outcome Measure: Incremental cost per unit of improvement on the intensity score of the Eyberg child behaviour inventory., Results: The bootstrapped incremental cost effectiveness ratio point estimate was 73 pounds sterling (109 euros, $142) per one point improvement on the intensity score (95% confidence interval 42 pounds sterling to 140 pounds sterling ). It would cost 5486 (8190 euros, $10,666) to bring the child with the highest intensity score to below the clinical cut-off point and 1344 (2006 euros, $2618) to bring the average child in the intervention group within the non-clinical limits on the intensity score (below 127). For a ceiling ratio of 100 pounds sterling (149 euros, $194) per point increase in intensity score, there is an 83.9% chance of the intervention being cost effective. The mean cost per child attending the parenting group was 1934 pounds sterling (2887 euros, $3760) for eight children and 1289 pounds sterling (1924 euros, $2506) for 12 children, including initial costs and materials for training group leaders. When we categorised the sample into relatively mild, moderate, and severe behaviour groups based on intensity scores at baseline the intervention seemed more cost effective in those with the highest risk of developing conduct disorder., Conclusion: This parenting programme improves child behaviour as measured by the intensity score of the Eyberg child behaviour inventory at a relatively low cost and was cost effective compared with the waiting list control. This parenting programme involves modest costs and demonstrates strong clinical effect, suggesting it would represent good value for money for public spending.

Objective: To evaluate the effectiveness of a parenting programme as a preventive intervention with parents of preschool children considered to be at risk of developing conduct disorder., Design: Pragmatic randomised controlled trial using a block design with allocation by area., Setting: Eleven Sure Start areas in north and mid-Wales., Participants: 153 parents from socially disadvantaged areas, with children aged 36-59 months at risk of conduct disorder defined by scoring over the clinical cut off on the Eyberg child behaviour inventory. Participants were randomised on a 2:1 basis, 104 to intervention and 49 to remaining on the wait listing (control). Twenty (13%) were lost to follow-up six months later, 18 from the intervention group., Intervention: The Webster-Stratton Incredible Years basic parenting programme, a 12 week group based intervention., Main Outcome Measures: Problem behaviour in children and parenting skills assessed by self reports from parents and by direct observation in the home. Parents' self reported parenting competence, stress, and depression. Standardised and well validated instruments were used throughout., Results: At follow-up, most of the measures of parenting and problem behaviour in children showed significant improvement in the intervention group. The intention to treat analysis for the primary outcome measure, the Eyberg child behaviour inventory, showed a mean difference between groups of 4.4 points (95% confidence interval 2.0 to 6.9, P<0.001) on the problem scale with an effect size of 0.63, and a mean difference of 25.1 (14.9 to 35.2, P<0.001) on the intensity scale with an effect size of 0.89., Conclusion: This community based study showed the effectiveness of an evidence based parenting intervention delivered with fidelity by regular Sure Start staff. It has influenced policy within Wales and provides lessons for England where, to date, Sure Start programmes have not been effective., Trial Registration: ISRCTN46984318.

This study aimed to examine housing-related difficulties, the relationship with housing tenure and the subsequent influences on health status in a population sample of older people in Wales. Comparisons with health status normative data were undertaken to determine any geographical differences. A random sample of respondents were interviewed in their own homes (N=423). Data included demographic information, self-reported health status, housing problems, tenure and factors relating to energy efficiency. Univariate analysis found that owner occupiers reported the least housing difficulties and the best health status. Those in public rented properties experienced the most difficulties and the poorest health. The health status of the sample was generally poorer than the norms. Multivariate analysis found that housing difficulties, being cold with current heating and hours spent at home predicted poorer health status. This suggests that characteristics of the home environment may help to explain the differences between tenure and health. Considerable financial outlay may be required to meet policy initiatives that support older people remaining independent, autonomous and able to 'age in place'.

Background: Spinal pain is common and costly to health services and society. Management guidelines have encouraged primary care referral for spinal manipulation, but the evidence base is weak. More economic evaluations alongside pragmatic trials have been recommended., Objective: Our aim was to assess the cost-utility of a practice-based osteopathy clinic for subacute spinal pain., Methods: A cost-utility analysis was performed alongside a pragmatic single-centre randomized controlled trial in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. Patients with back pain of 2-12 weeks duration were randomly allocated to treatment with osteopathy plus usual GP care or usual GP care alone. Costs were measured from a National Health Service (NHS) perspective. All primary and secondary health care interventions recorded in GP notes were collected for the study period. We calculated quality adjusted life year (QALY) gains based on EQ-5D responses from patients in the trial, and then cost per QALY ratios. Confidence intervals (CIs) were estimated using non-parametric bootstrapping., Results: Osteopathy plus usual GP care was more effective but resulted in more health care costs than usual GP care alone. The point estimate of the incremental cost per QALY ratio was 3560 pounds (80% CI 542 pounds-77,100 pounds). Sensitivity analysis examining spine-related costs alone and total costs excluding outliers resulted in lower cost per QALY ratios., Conclusion: A primary care osteopathy clinic may be a cost-effective addition to usual GP care, but this conclusion was subject to considerable random error. Rigorous multi-centre studies are needed to assess the generalizability of this approach.

Background: Spinal pain is common and frequently disabling. Management guidelines have encouraged referral from primary care for spinal manipulation. However, the evidence base for these recommendations is weak. More pragmatic trials and economic evaluations have been recommended., Objectives: Our aim was to assess the effectiveness and health care costs of a practice-based osteopathy clinic for subacute spinal pain., Methods: A pragmatic randomized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. A total of 201 patients with neck or back pain of 2-12 weeks duration were allocated at random between usual GP care and an additional three sessions of osteopathic spinal manipulation. The primary outcome measure was the Extended Aberdeen Spine Pain Scale (EASPS). Secondary measures included SF-12, EuroQol and Short-form McGill Pain Questionnaire. Health care costs were estimated from the records of referring GPs., Results: Outcomes improved more in the osteopathy group than the usual care group. At 2 months, this improvement was significantly greater in EASPS [95% confidence interval (CI) 0.7-9.8] and SF-12 mental score (95% CI 2.7-10.7). At 6 months, this difference was no longer significant for EASPS (95% CI -1.5 to 10.4), but remained significant for SF-12 mental score (95% CI 1.0-9.9). Mean health care costs attributed to spinal pain were significantly greater by 65 UK pounds in the osteopathy group (95% CI 32-155 UK pounds). Though osteopathy also cost 22 UK pounds more in mean total health care cost, this was not significant (95% CI - 159 to 142 UK pounds)., Conclusion: A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach.