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Background: Almost 2 million people in the UK live with sight loss, and this number is predicted to double by 2050. There is increasing recognition of the need to provide counselling services to people living with sight loss. Aim: The aim of this research was to assess whether there is an unmet need for counselling services for people living with sight loss in North Wales and to estimate the social value and budget impact of the potential roll‐out of counselling services to this population. Method: Between December 2020 and May 2021, a telephone survey was completed by 192 people living with sight loss in North Wales, UK. The survey instrument was a 19‐item questionnaire, which included the Short Warwick–Edinburgh Mental Well‐being Scale (SWEMWBS). Using data from the SWEMWBS and published statistics, a social return on investment (SROI) and budget impact analysis were conducted. Results: Most respondents (84%, n = 161) had never been offered counselling in relation to sight loss. Thirty‐nine per cent (n = 74) stated that they would use a new counselling service if it were available. Fifty‐one per cent (n = 97) indicated that counselling could be especially beneficial for people who have recently been registered or diagnosed with sight loss (the timely window). Of those who completed the SWEMWBS, approximately 25% reported low mental well‐being or probable depression. Social return on investment analysis estimated that providing counselling services for people with sight loss in North Wales could generate a social value of £3.42 for every £1 invested. Conclusion: Timely counselling may improve an individual's ability to cope with sight loss and improve their quality of life over time. [ABSTRACT FROM AUTHOR]

Short breaks help maintain caring relationships, enabling people to remain living in their own homes and contributing significant economic benefit to public services. However, relatively little is known about the added social value generated by community-based short breaks. To address this evidence gap, we explored the feasibility of using a social return on investment (SROI) evaluation to explore a day support service in North Wales for people living with dementia and their unpaid carers. Following good practice for evaluating complex interventions, we developed a logic model based on the literature and interviews to understand the mechanisms and outcomes of the day support service. Using questionnaires, we quantified outcomes for the current service cohort, which included people living with dementia, unpaid carers, and paid companions. Seven people living with dementia, three unpaid carers, and four companions completed questionnaires. By following the SROI analysis approach, three key learning points were identified. The first was around ways to capture outcomes from all stakeholder subgroups expected to experience material change. The second concerned the importance of collecting longitudinal data. This included the need to consider how to adapt the SROI method to work with small populations. The third concerned how to value "maintenance" of wellbeing as well as improved wellbeing. [ABSTRACT FROM AUTHOR]

Abstract 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

Abstract 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

Abstract 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.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract: 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. [Copyright &y& Elsevier]

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. [Copyright &y& Elsevier]

Abstract: Adoption rates of any new technology or policy are impacted by a wide range of factors including: farmer characteristics, household characteristics, farm structure, the wider social milieu, and the characteristics of the innovation to be adopted. The aim of this paper is to explore the possibility that the previously ignored issue of farmer health is an important variable in the adoption process. A survey of the physical and mental health of a representative sample of farmers was conducted across Wales, UK. Relationships between self-reported physical and mental health, age, marital status, language (English or Welsh), farm size, farm type, farm tenancy, financial situation and involvement in agri-environmental schemes were examined using logistic regression analysis. Variables relating to farmer health were identified as significantly affecting the odds of agri-environmental schemes being adopted by farmers. In particular, the self-reported mental health of farmers adopting agri-environmental schemes in Wales was significantly better than non-adopters. Although correlation was shown, rather than causation, interpretation of the results suggest that poor mental health of farmers may be one cause of non-adoption of agri-environment schemes. This would suggest that one way to improve biodiversity conservation in agricultural landscapes may be to target rural health services in order to enhance support of the physical and mental health of farmers. [Copyright &y& Elsevier]

The article discusses a study of the feasibility of conducting a larger definitive randomised controlled trial (RCT) of the booklet "The Hip & Knee Book: Helping You Cope With Osteoarthritis." The study involved individuals more than 50 years of age with hip or knee osteoarthritis in North East Wales. Fourteen percent of patients in the control group demonstrate improved their physical activity level. Results showed the feasibility of the trial methods in terms of recruitment and follow-up.

Advocates of ‘local food’ claim it serves to reduce food miles and greenhouse gas emissions, improve food safety and quality, strengthen local economies and enhance social capital. We critically review the philosophical and scientific rationale for this assertion, and consider whether conventional scientific approaches can help resolve the debate. We conclude that food miles are a poor indicator of the environmental and ethical impacts of food production. Only through combining spatially explicit life cycle assessment with analysis of social issues can the benefits of local food be assessed. This type of analysis is currently lacking for nearly all food chains. [Copyright &y& Elsevier]

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.

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.

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: 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.

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.