Alastair Canaway

Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: cluster randomised controlled trial (WAVES study)

Abstract Objective To assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity. Design Cluster randomised controlled trial. Setting UK primary schools from the West Midlands. Participants 200 schools were randomly selected from all state run primary schools within 35 miles of the study centre (n=980), oversampling those with high minority ethnic populations. These schools were randomly ordered and sequentially invited to participate. 144 eligible schools were approached to achieve the target recruitment of 54 schools. After baseline measurements 1467 year 1 pupils aged 5 and 6 years (control: 28 schools, 778 pupils) were randomised, using a blocked balancing algorithm. 53 schools remained in the trial and data on 1287 (87.7%) and 1169 (79.7%) pupils were available at first follow-up (15 month) and second follow-up (30 month), respectively. Interventions The 12 month intervention encouraged healthy eating and physical activity, including a daily additional 30 minute school time physical activity opportunity, a six week interactive skill based programme in conjunction with Aston Villa football club, signposting of local family physical activity opportunities through mail-outs every six months, and termly school led family workshops on healthy cooking skills. Main outcome measures The protocol defined primary outcomes, assessed blind to allocation, were between arm difference in body mass index (BMI) z score at 15 and 30 months. Secondary outcomes were further anthropometric, dietary, physical activity, and psychological measurements, and difference in BMI z score at 39 months in a subset. Results Data for primary outcome analyses were: baseline, 54 schools: 1392 pupils (732 controls); first follow-up (15 months post-baseline), 53 schools: 1249 pupils (675 controls); second follow-up (30 months post-baseline), 53 schools: 1145 pupils (621 controls). The mean BMI z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference −0.075 (95% confidence interval −0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was −0.027 (−0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm). Conclusions The primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments. Trial registration Current Controlled Trials ISRCTN97000586.

Measuring and Valuing Outcomes for Care at the End of Life: The Capability Approach

The capability approach is concerned with evaluating interventions in terms of their impact on a person’s well-being assessed as their ability to do and be things in life – their ‘capability’. It is increasingly being adopted to evaluate health and social care interventions in cases where the QALY would provide a partial assessment of outcomes. It is argued here that the case for incorporating broader outcomes is even more compelling in the context of care at the end of life. This chapter advocates a new framework for evaluating end-of-life care. It starts with the normative base of Amartya Sen’s capability approach and is influenced by evidence from the health and psychology literatures, as well as more intuitive ‘human’ experience from pioneers such as Cecily Saunders. It includes elements relating to both a good life and a good death and is unique in incorporating outcomes for persons close to the patient, acknowledging the emotional and physical demands and distress experienced both in the dying stage and through bereavement. This integrated capability-based framework aims to cope with the complexity of outcomes associated with health care, social care and supportive care. The result is a broad and pragmatic solution for evaluation, which can claim conceptual and ethical legitimacy.

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.

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).

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

PurposeThe 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.MethodsThe 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.ResultsThere 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.ConclusionsThe 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.

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.

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.