Predictors of transitioning to adult mental health services and associated costs: a cross-country comparison.

BACKGROUND: Young people are at risk of falling through the care gap after leaving child and adolescent mental health services (CAMHS) despite an ongoing need for mental health support. Currently, little is known about the predictors of transitioning to adult mental health services (AMHS), and associated healthcare and societal costs as young people cross the transition boundary. OBJECTIVE: To conduct a secondary data analysis exploring predictors of transitioning or falling through the gap and associated costs. METHODS: Data were used from a longitudinal study, which followed young people from seven European countries for 2 years after reaching their CAMHS boundary. Predictors of transitioning (including sociodemographic and clinical variables) and longitudinal resource use were compared for 488 young people who transitioned to AMHS versus those who fell through the gap. FINDINGS: Young people were more likely to transition to AMHS if they were severely ill. Those from Italy, the Netherlands and the UK were more likely to fall through the gap than transition to AMHS. Healthcare costs fell for all young people over the study, with a sharper decrease for those who fell through the gap. CONCLUSIONS: Total healthcare costs fell for all participants, indicating that the intensity of mental health support reduces for all young people as they cross the CAMHS boundary, regardless of clinical need. CLINICAL IMPLICATIONS: It is important that alternative forms of mental health support are available for young people who do not meet the AMHS care threshold but still have mental health needs after leaving CAMHS.

Healthcare costs for young people transitioning the boundary between child/adolescent and adult mental health services in seven European countries: results from the MILESTONE study.

BACKGROUND: The boundary between services for children and adolescents and adults has been identified as problematic for young people with mental health problems. AIMS: To examine the use and cost of healthcare for young people engaged in mental healthcare before and after the child/adolescent and adult service boundary. METHOD: Data from 772 young people in seven European countries participating in the MILESTONE trial were analysed. We analysed and costed healthcare resources used in the 6-month period before and after the service boundary. RESULTS: The proportion of young people engaging with healthcare services fell substantially after crossing the service boundary (associated costs €7761 pre-boundary v. €3376 post-boundary). Pre-boundary, the main cost driver was in-patient care (approximately 50%), whereas post-boundary costs were more evenly spread between services; cost reductions were correlated with pre-boundary in-patient care. Severity was associated with substantially higher costs pre- and post-boundary, and those who were engaged specifically with mental health services after the service boundary accrued the greatest healthcare costs post-service boundary. CONCLUSIONS: Costs of healthcare are large in this population, but fall considerably after transition, particularly for those who were most severely ill. In part, this is likely to reflect improvement in the mental health of young people. However, qualitative evidence from the MILESTONE study suggests that lack of capacity in adult services and young people's disengagement with formal mental health services post-transition are contributing factors. Long-term data are needed to assess the adverse long-term effects on costs and health of this unmet need and disengagement.

Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT.

BACKGROUND: Upper limb problems are common after breast cancer treatment. OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. DESIGN: This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis; the unit of randomisation was the individual (allocated ratio 1 : 1). SETTING: Breast cancer centres, secondary care. PARTICIPANTS: Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. INTERVENTIONS: All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). MAIN OUTCOME MEASURES: The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. RESULTS: Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392; 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants' mean age was 58.1 years (standard deviation 12.1 years; range 28-88 years). Most participants had undergone axillary node clearance surgery (327/392; 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of -7.81, 95% confidence interval -12.44 to -3.17; p = 0.001) and complier-average causal effect analyses (adjusted mean difference -8.74, 95% confidence interval -13.71 to -3.77; p ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04; p = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (-£387, 95% CI -£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial. LIMITATIONS: Postal follow-up was lower than estimated; however, the study was adequately powered. No serious adverse events directly related to the intervention were reported. CONCLUSIONS: This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life. FUTURE WORK: Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems. TRIAL REGISTRATION: This trial is registered as ISRCTN35358984. 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. 26, No. 15. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Breast cancer is the most common cancer affecting women. Women now live longer because the detection and treatment of cancer has improved over the last 40 years. The side effects of breast cancer treatments can lead to complications, such as difficulties with arm movements, arm swelling (lymphoedema), pain and poor quality of life. These problems can last for many years after the cancer has been treated. Usual care after breast cancer surgery is to give patients an information leaflet explaining arm exercises that they can undertake after their operation. Offering exercise support from a physiotherapist may be a better way to help those at risk of developing shoulder problems after breast cancer treatment than providing a leaflet only. WHAT DID WE DO?: We compared two strategies to prevent shoulder problems in women having breast cancer treatment: information leaflets and an exercise programme. We invited women with a new diagnosis of breast cancer who were at higher risk of developing shoulder problems than other women with a new diagnosis of breast cancer. We recruited 392 women aged 28­88 years from 17 breast cancer units across England. Women were allocated to one of two groups by chance using a computer. Everyone was given information leaflets that explained what type of exercises to do after surgery. Half of the women (n = 196) were then invited to take part in an exercise programme, supported by a trained physiotherapist. These women followed a programme of shoulder mobility, stretching and strengthening exercises for up to 1 year. We measured changes in arm function, pain, arm swelling (lymphoedema) and physical and mental quality of life, and the cost of treatments during the whole first year of recovery, in everyone. We also spoke to the women and physiotherapists to find out whether or not these treatment strategies were acceptable to them. WHAT DID WE FIND OUT?: Women doing the exercise programme had better arm function, less pain and better quality of life than the women given an information leaflet only. Women said that the exercise programme helped with their recovery during cancer treatment. Exercise was cheap to deliver (£129 per person) and led to improved overall quality of life at 1 year after breast cancer surgery.

Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation.

OBJECTIVE: To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. DESIGN: Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. SETTING: 17 UK National Health Service cancer centres. PARTICIPANTS: 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). INTERVENTIONS: Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. MAIN OUTCOME MEASURES: Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. RESULTS: Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale -0.68, -1.23 to -0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) -2.02, -3.11 to -0.93; P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average -£387 (€457; $533) (95% confidence interval -£2491 to £1718; 2015 pricing) and was cost effective compared with usual care. CONCLUSIONS: The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications. TRIAL REGISTRATION: ISRCTN Registry ISRCTN35358984.

"It is not a scientific number it is just a feeling": Populating a multi-dimensional end-of-life decision framework using deliberative methods.

The capability approach is potentially valuable for economic evaluation at the end of life because of its conceptualization of wellbeing as freedom and the potential for capturing outcomes for those at end of life and those close to persons at the end of life. For decision making, however, this information needs to be integrated into current evaluation paradigms. This research explored weights for an integrated economic evaluation framework using a deliberative approach. Twelve focus groups were held (38 members of the public, 29 "policy makers," seven hospice volunteers); budget pie tasks were completed to generate weights. Constant comparison was used to analyze qualitative data, exploring principles behind individuals' weightings. Average weights elicited from members of the general population and policy makers for the importance that should be given to close persons (vs. patients) were very similar, at around 30%. A "sliding scale" of weights between health gain and the capability for a good death resulted from the policy maker and volunteer groups, with increasing weight given to the capability for a good death as the trajectory got closer to death. These weights can be used in developing a more comprehensive framework for economic evaluation at end of life.

Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting. METHODS: This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions. DISCUSSION: The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH. TRIAL REGISTRATION: ISRCTN no. 10608766, prospectively registered on 18th March 2019.

Economic evaluation of a childhood obesity prevention programme for children: Results from the WAVES cluster randomised controlled trial conducted in schools.

BACKGROUND: Childhood obesity is a serious public health challenge and schools have been identified as an ideal place to implement prevention interventions. The aim of this study was to measure the cost-effectiveness of a multi-faceted school-based obesity prevention intervention targeting children aged 6-7 years when compared to 'usual activities'. METHODS: A cluster randomised controlled trial in 54 schools across the West Midlands (UK) was conducted. The 12-month intervention aimed to increase physical activity by 30 minutes per day and encourage healthy eating. Costs were captured from a public sector perspective and utility-based health related outcomes measured using the CHU-9D. Multiple imputation using chained equations was used to address missing data. The cost effectiveness was measured at 30 months from baseline using a hierarchical net-benefit regression framework, that controlled for clustering and prespecified covariates. Any uncertainty in the results was characterised using cost-effectiveness acceptability curves. RESULTS: At 30 months, the total adjusted incremental mean cost of the intervention was £155 (95% confidence interval [CI]: £139, £171), and the incremental mean QALYs gained was 0.006 (95% CI: -0.024, 0.036), per child. The incremental cost-effectiveness at 30 months was £26,815 per QALY and using a standard willingness to pay threshold of £30,000 per QALY, there was a 52% chance that the intervention was cost-effective. CONCLUSIONS: The cost-effectiveness of the school-based WAVES intervention was subject to substantial uncertainty. We therefore recommend more research to explore obesity prevention within schools as part of a wider systems approach to obesity prevention. TRIAL REGISTRATION: This paper uses data collected by the WAVES trial: Controlled trials ISRCTN97000586 (registered May 2010).

Systematic review of economic evaluations of exercise and physiotherapy for patients treated for breast cancer.

PURPOSE: Treatments for breast cancer can lead to chronic musculoskeletal problems. This study aimed to systematically review the evidence surrounding the cost-effectiveness of exercise and physiotherapy interventions aimed at reducing the risk of physical symptoms and functional limitations due to breast cancer treatment. METHODS: A systematic review of the cost-effectiveness of exercise and physiotherapy interventions during and following treatment for breast cancer was undertaken according to PRISMA guidelines. Literature searches were carried out in Ovid MEDLINE, Ovid Embase, Web of Science, EconLit, CINAHL, PsycINFO, Scopus and the Cochrane Library. Cost-effectiveness evidence was summarised in a descriptive manner and studies were assessed using quality appraisal tools. The review protocol was registered on PROSPERO. RESULTS: A total of 7783 articles were identified and seven were included in the final review. Five studies undertook trial-based economic evaluations, whereas two studies conducted economic evaluation based on decision models. One study was a cost-effectiveness analysis (CEA), three undertook stand-alone cost-utility analyses (CUA) and three studies were combined CEAs and CUAs. Three studies reported favourable cost-effectiveness results for different exercise or physiotherapy interventions. In contrast, four studies found that exercise and physiotherapy interventions were not cost-effective on the basis of quality-adjusted life year outcomes. CONCLUSIONS: The evidence surrounding the cost-effectiveness of exercise and physiotherapy interventions for the treatment of breast cancer remains sparse with contrasting conclusions. Future research should particularly aim to broaden the evidence base by disentangling the contributing effects of frequency, intensity, time and type of exercise and physiotherapy interventions on cost-effectiveness outcomes.

Close-Person Spill-Overs in End-of-Life Care: Using Hierarchical Mapping to Identify Whose Outcomes to Include in Economic Evaluations.

BACKGROUND: Guidelines for economic evaluations often request that costs and outcomes beyond the patient are captured; this can include carers and also other affected parties. End-of-life care is one context where impacts of care spill over onto those other than patients, but there is little evidence about who should be included within economic evaluations. OBJECTIVE: The purpose of this article was to examine (1) how many people are close to those at the end of life (2); their characteristics; and (3) what influences the network size at the end of life. METHODS: In-depth interviews were conducted with 23 participants who were either recently bereaved or had somebody close to them currently receiving end-of-life care. Interviews were used in conjunction with hierarchical mapping to explore the network size and composition and influences upon these networks. Interviews were transcribed verbatim. Descriptive statistics were used to analyse the hierarchical maps and this information was combined with a constant comparative analysis of the qualitative data. RESULTS: On average, close-person networks at the end of life contained eight individuals, three of whom were rated as being 'closest'. These were typically family members, although in a small number of cases non-family members were included amongst the closest individuals. There was variation in terms of network composition. Qualitative analyses revealed two key influences on network size: death trajectory (those with cognitive problems/diseases towards the end of life had smaller networks) and family size (larger families had larger networks). CONCLUSIONS: The findings of this article have important implications for researchers wishing to include those affected by end-of-life care in an economic evaluation. Focussing on the three closest individuals would be a key starting point for economists seeking to capture spill-overs, whilst a truly societal perspective would require looking beyond proximal family members. This article further discusses the implications of including close persons in economic evaluations for decision makers.

Evaluating the effects of community treatment orders (CTOs) in England using the Mental Health Services Dataset (MHSDS): protocol for a national, population-based study.

INTRODUCTION: Supervised community treatment (SCT) for people with serious mental disorders has become accepted practice in many countries around the world. In England, SCT was adopted in 2008 in the form of community treatment orders (CTOs). CTOs have been used more than expected, with significant variations between people and places. There is conflicting evidence about the effectiveness of SCT; studies based on randomised controlled trials (RCTs) have suggested few positive impacts, while those employing observational designs have been more favourable. Robust population-based studies are needed, because of the ethical challenges of undertaking further RCTs and because variation across previous studies may reflect the effects of sociospatial context on SCT outcomes. We aim to examine spatial and temporal variation in the use, effectiveness and cost of CTOs in England through the analysis of routine administrative data. METHODS AND ANALYSIS: Four years of data from the Mental Health Services Dataset (MHSDS) will be analysed using multilevel models. Models based on all patients eligible for CTOs will be used to explore variation in their use. A subset of CTO-eligible patients comprising a treatment group (CTO patients) and a matched control group (non-CTO patients) will be used to examine variation in the association between CTO use and study outcomes. Primary outcome will be total time in hospital. Secondary outcomes will include time to first readmission and mortality. Outputs from these models will be used to populate predictive models of healthcare resource use. ETHICS AND DISSEMINATION: Ethical approval has been granted by the National Health Service Data Access and Advisory Group and Warwick University. To ensure patient confidentiality and to meet data governance requirements, analyses will be carried out in a secure microdata laboratory using de-identified data. Study findings will be disseminated through academic channels and shared with mental health policy-makers and other stakeholders.

Realist Evaluation of the Use of Patient Experience Data to Improve the Quality of Inpatient Mental Health Care (EURIPIDES) in England: study protocol.

INTRODUCTION: Inpatient mental healthcare continues to be an area of high risk and where patients report negative experiences. To ensure the patient voice is heard, National Health Service (NHS) Trusts are required to collect feedback from patients routinely. We do not know what kinds of feedback are most important or what management processes are needed to translate this into effective action plans. Further, we do not know if this makes any difference to the patients themselves. This study seeks to explore which of the many different approaches to collecting and using patient experience data are the most useful for supporting improvements in inpatient mental healthcare. The overarching aim of the study is to arrive at recommendations for best practice in the collection and use of patient experience data in NHS England adult inpatient mental health settings. We present the protocol for Realist Evaluation of the Use of Patient Experience Data to Improve the Quality of Inpatient Mental Health Care study (EURIPIDES). METHODS AND ANALYSIS: The study is composed of five work packages (WPs), including a systematic review of patient experiences (WP1); a telephone survey to assist the selection of case sites (WP2); six indepth case studies involving interviews with service users, carers and staff to enable a realist evaluation of the use of patient experience to improve quality in adult inpatient mental health services (WP3); an economic evaluation of patient experience feedback activity (WP5); and a consensus conference (WP4). We discuss the methodological rationale for the five WPs. ETHICS AND DISSEMINATION: This study has received approval from West Midlands/South Birmingham NHS Research Ethics Committee. The outcome of the consensus conference meeting (WP4) will form the basis of the outputs to be disseminated to NHS providers. Dissemination will also take place through publications and presentations at relevant conferences.

Is an enhanced behaviour change intervention cost-effective compared with physiotherapy for patients with chronic low back pain? Results from a multicentre trial in Israel.

OBJECTIVE: To assess the cost-effectiveness of an enhanced transtheoretical model of behaviour change in conjunction with physiotherapy compared with standard care (physiotherapy) in patients with chronic lower back pain (CLBP). DESIGN: Cost-utility and cost-effectiveness analyses alongside a multicentre controlled trial from a healthcare perspective with a 1-year time horizon. SETTING: The trial was conducted in eight centres within the Sharon district in Israel. PARTICIPANTS: 220 participants aged between 25 and 55 years who suffered from CLBP for a minimum of 3 months were recruited. INTERVENTIONS: The intervention used a model of behaviour change that sought to increase the adherence and implementation of physical activity in conjunction with physiotherapy. The control arm received standard care in the form of physiotherapy. PRIMARY AND SECONDARY MEASURES: The primary outcome was the incremental cost per quality-adjusted life year (QALY) of the intervention arm compared with standard care. The secondary outcome was the incremental cost per Roland-Morris Disability Questionnaire point. RESULTS: The cost per QALY point estimate was 10 645 New Israeli shekels (NIS) (£1737.11). There was an 88% chance the intervention was cost-effective at NIS50 000 per QALY threshold. Excluding training costs, the intervention dominated the control arm, resulting in fewer physiotherapy and physician visits while improving outcomes. CONCLUSIONS: The enhanced transtheoretical model intervention appears to be a very cost-effective intervention leading to improved outcomes for low cost. Given limitations within this study, there is justification for examining the intervention within a larger, long-term randomised controlled trial. TRIAL REGISTRATION NUMBER: NCT01631344; Pre-results.

The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6-7 years.

BACKGROUND: Systematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children. DESIGN: A cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible. SETTING: Primary schools, West Midlands, UK. PARTICIPANTS: Schools within a 35-mile radius of the study centre and all year 1 pupils (aged 5-6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses. INTERVENTIONS: The 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting 'Villa Vitality' (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities. MAIN OUTCOME MEASURES: The primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools. RESULTS: Two groups of schools were randomised: 27 in 2011 (n = 650 pupils) [group 1 (G1)] and another 27 in 2012 (n = 817 pupils) [group 2 (G2)]. Primary outcome data were available at first follow-up (n = 1249 pupils) and second follow-up (n = 1145 pupils) from 53 schools. The mean difference (MD) in BMI-z between the control and intervention arms was -0.075 [95% confidence interval (CI) -0.183 to 0.033] and -0.027 (95% CI -0.137 to 0.083) at 3 and 18 months post intervention, respectively. The main analyses showed no evidence of between-arm differences for any secondary outcomes. Third follow-up included data on 467 pupils from 27 G1 schools, and showed a statistically significant difference in BMI-z (MD -0.20, 95% CI -0.40 to -0.01). The mean cost of the intervention was £266.35 per consented child (£155.53 per child receiving the intervention). The incremental cost-effectiveness ratio associated with the base case was £46,083 per QALY (best case £26,804 per QALY), suggesting that the intervention was not cost-effective. LIMITATIONS: The presence of baseline primary outcome imbalance between the arms, and interschool variation in fidelity of intervention delivery. CONCLUSIONS: The primary analyses show no evidence of clinical effectiveness or cost-effectiveness of the WAVES study intervention. A post hoc analysis, driven by findings at third follow-up, suggests a possible intervention effect, which could have been attenuated by baseline imbalances. There was no evidence of an intervention effect on measures of diet or PA and no evidence of harm. FUTURE WORK: A realist evidence synthesis could provide insights into contextual factors and strategies for future interventions. School-based interventions need to be integrated within a wider societal framework and supported by upstream interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586. 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. 22, No. 8. See the NIHR Journals Library website for further project information.

How does age affect the relationship between weight and health utility during the middle years of childhood?

PURPOSE: The limited literature examining weight status and preference-based health-related quality of life (HRQL) in young children is equivocal. This study aims to examine how the association between weight status and preference-based HRQL changes as children develop between the ages of 6 and 10 years old. METHODS: The Child Health Utility 9D (CHU-9D) was used to determine preference-based HRQL. Height and weight data were also collected and used to calculate z-BMI adjusted for age and gender. 1467 children were recruited from 54 schools across the West Midlands. Data were collected at four time points over 5 years. Impact of weight on dimensions of HRQL was assessed via the distribution of responses to CHU-9D dimensions by weight status. Multi-level regression analysis controlling for ethnicity, deprivation and other relevant co-variates was conducted to examine the relationship between weight and HRQL. RESULTS: There was no evidence to suggest that the weight status impacted upon the distribution of responses to CHU-9D dimensions. Correspondingly, the multi-level regression analysis found no statistically significant differences in CHU-9D scores between underweight, healthy weight, overweight and obese children. CONCLUSIONS: The evidence surrounding the link between preference-based HRQL and weight status in children is limited. This study found no association between weight status and HRQL as measured by the CHU-9D in children between the ages of 5 and 10 years in the UK. Given this, it is recommended that future studies aiming to prevent obesity in children in their middle years do not rely solely on preference-based measures for economic evaluation, and instead focus on capturing clinical or wellbeing outcomes.

Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study).

INTRODUCTION: Disruption of care during transition from child and adolescent mental health services (CAMHS) to adult mental health services may adversely affect the health and well-being of service users. The MILESTONE (Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare) study evaluates the longitudinal course and outcomes of adolescents approaching the transition boundary (TB) of their CAMHS and determines the effectiveness of the model of managed transition in improving outcomes, compared with usual care. METHODS AND ANALYSIS: This is a cohort study with a nested cluster randomised controlled trial. Recruited CAMHS have been randomised to provide either (1) managed transition using the Transition Readiness and Appropriateness Measure score summary as a decision aid, or (2) usual care for young people reaching the TB. Participants are young people within 1 year of reaching the TB of their CAMHS in eight European countries; one parent/carer and a CAMHS clinician for each recruited young person; and adult mental health clinician or other community-based care provider, if young person transitions. The primary outcome is Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) measuring health and social functioning at 15 months postintervention. The secondary outcomes include mental health, quality of life, transition experience and healthcare usage assessed at 9, 15 and 24 months postintervention. With a mean cluster size of 21, a total of 840 participants randomised in a 1:2 intervention to control are required, providing 89% power to detect a difference in HoNOSCA score of 0.30 SD. The addition of 210 recruits for the cohort study ensures sufficient power for studying predictors, resulting in 1050 participants and an approximate 1:3 randomisation. ETHICS AND DISSEMINATION: The study protocol was approved by the UK National Research Ethics Service (15/WM/0052) and equivalent ethics boards in participating countries. Results will be reported at conferences, in peer-reviewed publications and to all relevant stakeholder groups. TRIAL REGISTRATION NUMBER: ISRCTN83240263; NCT03013595 (pre-results).

Development of a measure (ICECAP-Close Person Measure) through qualitative methods to capture the benefits of end-of-life care to those close to the dying for use in economic evaluation.

BACKGROUND: End-of-life care affects both the patient and those close to them. Typically, those close to the patient are not considered within economic evaluation, which may lead to the omission of important benefits resulting from end-of-life care. AIM: To develop an outcome measure suitable for use in economic evaluation that captures the benefits of end-of-life care to those close to the dying. DESIGN: To develop the descriptive system for the outcome measure, in-depth qualitative interviews were conducted with the participants and constant comparative analysis methods were used to develop a descriptive system for the measure. PARTICIPANTS: Twenty-seven individuals bereaved within the last 2 years or with a close-person currently receiving end-of-life care were purposively recruited into the study. Participants were recruited through newsletters, adverts, snowball sampling and a local hospice. RESULTS: Twenty-seven individuals were recruited. A measure of capability with six attributes, each with five levels, was developed based on themes arising from the analysis. Attributes comprise the following: good communication with services, privacy and space to be with the loved one, emotional support, practical support, being able to prepare and cope and being free from emotional distress related to the condition of the decedent. CONCLUSION: This measure is designed to capture the benefits of end-of-life care to close-persons for use in economic evaluation. Further research should value the measure and develop methods for incorporating outcomes for close-persons into economic evaluation.

Measuring preference-based quality of life in children aged 6-7 years: a comparison of the performance of the CHU-9D and EQ-5D-Y--the WAVES pilot study.

PURPOSE: To examine the performance of the child health utility 9D (CHU-9D) and EuroQol 5D-youth (EQ-5D-Y) in children aged 6­7 years. METHOD: The CHU-9D and EQ-5D-Y were interviewer-administered to 160 children aged 6­7 years at six schools across the West Midlands. Missing values, time taken to complete instruments and interviewer ratings were recorded to assess feasibility/acceptability. Construct validity was assessed by testing convergent validity hypotheses. Reliability was examined via a test­retest of a sub-sample. Psychometric properties were further examined by exploring distributions of utility scores, qualitative notes and design of the questionnaires. RESULTS: No missing responses were recorded with over 80% of children's understanding being rated as good/excellent for both questionnaires. The average completion time for both instruments was less than 3 minutes, demonstrating excellent feasibility/acceptability. Evidence of construct validity was recorded with 12 of the 13 convergent hypotheses being supported. Test­retest reliability was relatively poor for both instruments with weighted kappa coefficients ranging from fair to moderate. CONCLUSION: Children aged 6­7 years can feasibly complete utility instruments when interviewer-administered. The reliability of the instruments is of concern and requires further study. With respect to content validity and other psychometric properties, the CHU-9D is favoured to the EQ-5D-Y. Until the EuroQol group produces tariff values for the EQ-5D-Y, we recommend that the EQ-5D-Y is not used for utility elicitation in this age group.