Socio-economic accounting of inequalities in excess weight: a population-based analysis.

BACKGROUND: The prevalence of excess weight has been increasing globally in the last decades, affecting disproportionally adults from low socio-economic backgrounds and putting undue pressure on health systems and societal resources. In England, tackling unfair and unjust health inequalities is at the heart of national public health policy, and a prerequisite for enabling these decision makers to set policy priorities is an understanding of the prevalence and determinants of excess weight inequalities in their local population. METHODS: We conducted both pooled (England) and regional-level (nine regions: North-East, North-West, Yorkshire and Humber, East Midlands, West Midlands, East of England, London, South East and South West) analyses of individual level data from a nationally representative sample of adults (N = 6,387). We used the Corrected Concentration Index (CCI) to measure absolute inequalities in excess weight across three dimensions of socio-economic deprivation: neighbourhood-level deprivation, occupational status and educational qualification. We used a Shapley decomposition method to evaluate their relative contribution to inequality. RESULTS: At a national level, all three dimensions of socio-economic deprivation were found to be positively associated with excess weight across the adult population, as measured by the CCI, with educational qualification ranking first [CCI: -0.090, p < 0.01], closely followed by neighbourhood-level deprivation [CCI: -0.050, p < 0.01]. Large variation was found between regions and genders, with inequality being either considerably higher or exclusively patterned among women. The strongest independent factor contributing to excess weight inequalities was having a long-lasting limiting illness, especially among women and towards the right tail of the excess weight spectrum. Heterogeneous patterns of contribution across the excess weight spectrum were found, however age played a dominant role toward the left tail of the distribution. CONCLUSIONS: While socio-economic inequalities in excess weight exist in the English adult population, our findings underscore the importance of considering multiple dimensions of deprivation and the unique needs of different populations when developing policies to address overweight and obesity. Targeted interventions for adults with overweight and obesity with long-lasting illnesses and women can generate both short-term and long-term economic benefits, by reducing healthcare costs and increasing workforce productivity.

Assessing the costs and outcomes of control programmes for sexually transmitted infections: a systematic review of economic evaluations.

OBJECTIVE: To identify economic evaluations of interventions to control STIs and HIV targeting young people, and to assess how costs and outcomes are measured in these studies. DESIGN: Systematic review. DATA SOURCES: Seven databases were searched (Medline (Ovid), EMBASE (Ovid), Web of Science, PsycINFO, NHS Economic Evaluation Database, NHS Health Technology Assessment and Database of Abstracts of Reviews of Effects) from January 1999 to April 2019. Key search terms were STIs (chlamydia, gonorrhoea, syphilis) and HIV, cost benefit, cost utility, economic evaluation, public health, screening, testing and control. REVIEW METHODS: Studies were included that measured costs and outcomes to inform an economic evaluation of any programme to control STIs and HIV targeting individuals predominantly below 30 years of age at risk of, or affected by, one or multiple STIs and/or HIV in Organisation for Economic Co-operation and Development countries. Data were extracted and tabulated and included study results and characteristics of economic evaluations. Study quality was assessed using the Philips and BMJ checklists. Results were synthesised narratively. RESULTS: 9530 records were screened and categorised. Of these, 31 were included for data extraction and critical appraisal. The majority of studies assessed the cost-effectiveness or cost-utility of screening interventions for chlamydia from a provider perspective. The main outcome measures were major outcomes averted and quality-adjusted life years. Studies evaluated direct medical costs, for example, programme costs and 11 included indirect costs, such as productivity losses. The study designs were predominantly model-based with significant heterogeneity between the models. DISCUSSION/CONCLUSION: None of the economic evaluations encompassed aspects of equity or context, which are highly relevant to sexual health decision-makers. The review demonstrated heterogeneity in approaches to evaluate costs and outcomes for STI/HIV control programmes. The low quality of available studies along with the limited focus, that is, almost all studies relate to chlamydia, highlight the need for high-quality economic evaluations to inform the commissioning of sexual health services.

An assessment of the construct validity of the Child Health Utility 9D-CHN instrument in school-aged children: evidence from a Chinese trial.

BACKGROUND: Although there is emerging data regarding the psychometric properties of the Child Health Utility-9D instrument, more evidence is required with respect to its validity for use in different country settings. The aim of this study was to examine the construct validity of the CHU-9D-CHN instrument in Chinese children. METHODS: Baseline Health-Related Quality of Life (HRQoL) and demographic data were collected from children recruited to the CHIRPY DRAGON obesity prevention intervention randomised controlled trial in China. HRQoL was measured using the Chinese version of the CHU-9D instrument (CHU-9D-CHN) and the PedsQL instrument. CHU-9D-CHN utility scores were generated using two scoring algorithms [UK and Chinese tariffs]. Discriminant validity, known-group validity and convergent validity were evaluated using non-parametric test for trend, Kruskal-Wallis test and Spearman correlation coefficient analysis respectively. RESULTS: Data was available for 1,539 children (mean age 6 years). The CHU-9D-CHN was sensitive to known group differences determined by the median PedsQL total score. Furthermore, the mean CHU-9D-CHN utility values decreased linearly with increasing levels of severity on each dimension of the PedsQL for emotional and social functioning domains. They decreased monotonically with increasing levels of severity on each dimension of the PedsQL for physical and school functioning domains (p < 0.001). Contrary to studies conducted in Western countries, and although not statistically significant, we found an indication that HRQoL, using both the CHU-9D-CHN and the PedsQL, was higher in children whose parents had lower levels of education, compared to those whose parents were university educated. The correlation between the CHU-9D-CHN utility values using UK and Chinese tariffs, and PedsQL total scores showed a statistically significant moderate positive correlation (Spearman's rho = 0.5221, p < 0.001 and Spearman's rho = 0.5316, p < 0.001), respectively. However, each CHU-9D-CHN dimension was either weakly, or very weakly correlated with each of the predetermined PedsQL domain functioning scores. CONCLUSIONS: Overall, the findings provide some support for the construct validity of the CHU-9D-CHN within a Chinese population aged 6-7 years. However, some uncertainty remains. We recommend future studies continue to test the validity of the CHU-9D in different country settings. TRIAL REGISTRATION: ISRCTN Identifier ISRCTN11867516, Registered on 19/08/2015.

Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.

BACKGROUND: The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness. METHODS: Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained. RESULTS: Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY. CONCLUSIONS: Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.

Micronutrient deficiencies and health-related quality of life: the case of children with vitamin D deficiency.

OBJECTIVE: To explore the extent to which micronutrient deficiencies (MND) affect children's health-related quality of life (HRQoL), using vitamin D deficiency (VDD) as a case study. DESIGN: Proxy valuation study to estimate the impact of VDD on the HRQoL of younger (0-4 years) and older (>4 years) children. We used the Child Health Utility 9 Dimension (CHU9D) questionnaire to estimate HRQoL for children within six VDD-related health states: 'hypocalcaemic cardiomyopathy', 'hypocalcaemic seizures', 'active rickets', 'bone deformities', 'pain and muscle weakness' and 'subclinical VDD'. SETTING: Sampling was not restricted to any particular setting and worldwide experts were recruited. PARTICIPANTS: Respondents were paediatric bone experts recruited through network sampling. RESULTS: Thirty-eight experts completed the survey. The health state with the largest detrimental impact (mean score (se)) on children's HRQoL was hypocalcaemic cardiomyopathy (0·47 (0·02)), followed by hypocalcaemic seizures (0·50 (0·02)) and active rickets (0·62 (0·02) in young children; 0·57 (0·02) in older children). Asymptomatic VDD had a modest but noticeable negative impact on HRQoL, attributed mostly to tiredness in both age groups and pain in the older paediatric population. CONCLUSIONS: Elicitation of HRQoL from clinical experts suggests a negative impact of VDD on HRQoL, even if there is no recognizable clinical manifestation. HRQoL data from populations of patients with MND will inform public health policy decisions. In some settings, routine collection of HRQoL data alongside national nutrition surveys may help capture the full burden of MND and prioritize resources towards effective prevention.

The CHIRPY DRAGON intervention in preventing obesity in Chinese primary-school--aged children: A cluster-randomised controlled trial.

BACKGROUND: In countries undergoing rapid economic transition such as China, rates of increase in childhood obesity exceed that in the West. However, prevention trials in these countries are inadequate in both quantity and methodological quality. In high-income countries, recent reviews have demonstrated that school-based prevention interventions are moderately effective but have some methodological limitations. To address these issues, this study evaluated clinical- and cost- effectiveness of the Chinese Primary School Children Physical Activity and Dietary Behaviour Changes Intervention (CHIRPY DRAGON) developed using the United Kingdom Medical Research Council complex intervention framework to prevent obesity in Chinese primary-school-aged children. METHODS AND FINDINGS: In this cluster-randomised controlled trial, we recruited 40 state-funded primary schools from urban districts of Guangzhou, China. A total of 1,641 year-one children with parent/guardian consent took part in baseline assessments prior to stratified randomisation of schools (intervention arm, 20 schools, n = 832, mean age = 6.15 years, 55.6% boys; control arm n = 809, mean age = 6.14 years, 53.3% boys). The 12-month intervention programme included 4 school- and family-based components delivered by 5 dedicated project staff. We promoted physical activity and healthy eating behaviours through educational and practical workshops, family activities, and supporting the school to improve physical activity and food provision. The primary outcome, assessed blind to allocation, was between-arm difference in body mass index (BMI) z score at completion of the intervention. A range of prespecified, secondary anthropometric, behavioural, and psychosocial outcomes were also measured. We estimated cost effectiveness based on quality-adjusted life years (QALYs), taking a public sector perspective. Attrition was low with 55 children lost to follow up (3.4%) and no school dropout. Implementation adherence was high. Using intention to treat analysis, the mean difference (MD) in BMI z scores (intervention - control) was -0.13 (-0.26 to 0.00, p = 0.048), with the effect being greater in girls (MD = -0.18, -0.32 to -0.05, p = 0.007, p for interaction = 0.015) and in children with overweight or obesity at baseline (MD = -0.49, -0.73 to -0.25, p < 0.001, p for interaction < 0.001). Significant beneficial intervention effects were also observed on consumption of fruit and vegetables, sugar-sweetened beverages and unhealthy snacks, screen-based sedentary behaviour, and physical activity in the intervention group. Cost effectiveness was estimated at £1,760 per QALY, with the probability of the intervention being cost effective compared with usual care being at least 95% at a willingness to pay threshold of £20,000 to 30,000 per QALY. There was no evidence of adverse effects or harms. The main limitations of this study were the use of dietary assessment tools not yet validated for Chinese children and the use of the UK value set to estimate QALYS. CONCLUSIONS: This school- and family-based obesity prevention programme was effective and highly cost effective in reducing BMI z scores in primary-school-aged children in China. Future research should identify strategies to enhance beneficial effects among boys and investigate the transferability of the intervention to other provinces in China and countries that share the same language and cultures. TRIAL REGISTRATION: ISRCTN Identifier ISRCTN11867516.

Methods for public health economic evaluation: A Delphi survey of decision makers in English and Welsh local government.

Standard reference case methods recommended for health technology appraisals do not translate well to a public health setting. This paper reports on a Delphi survey designed to elicit views of public health decision makers in England and Wales, about different methodological elements of economic evaluation. This is important as methods should align with the objective function of decision makers. The Delphi survey comprised two rounds, with round 1 allowing open-ended recommendations in addition to 5-point Likert scale responses. The final survey comprised 36 questions, and levels and strength of agreement were assessed using median values and mean absolute deviation of the median. The Delphi panel (n = 66) achieved high levels of agreement for costs, health, well-being, and productivity impact to be important elements within an economic evaluation. The panel agreed that evaluations should be relevant to the local context and include costs and consequences over a lifetime horizon. There was a call for the transparent reporting of costs and effects for different population subgroups, and for different sectors. Overall, the panel revealed a preference for a flexible approach, understanding that economic evidence fits within a dynamic process of decision making. These results provide empirical evidence to inform guidelines for public health economic evaluation.

Cultural adaptation of a children's weight management programme: Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study.

BACKGROUND: Childhood obesity prevalence continues to be at high levels in the United Kingdom (UK). South Asian children (mainly Pakistani and Bangladeshi origin) with excess adiposity are at particular risk from the cardiovascular consequences of obesity. Many community-based children's weight management programmes have been delivered in the UK, but none have been adapted for diverse cultural communities. The aim of the Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study, was to culturally adapt an existing children's weight management programme for children aged 4-11 years so that the programme was more able to meet the needs of families from South Asian communities. METHODS: The adaptation process was applied to First Steps, an evidence informed programme being delivered in Birmingham (a large, ethnically diverse city). A qualitative study was undertaken to obtain the views of South Asian parents of children with excess weight, who had fully or partially attended, or who had initially agreed but then declined to attend the First Steps programme. The resulting data were integrated with current research evidence and local programme information as part of a cultural adaptation process that was guided by two theoretical frameworks. RESULTS: Interviews or focus groups with 31 parents in their preferred languages were undertaken. Themes arising from the data included the need for convenient timing of a programme in a close familiar location, support for those who do not speak English, the need to focus on health rather than weight, nutritional content that focuses on traditional and Western diets, more physical activity content, and support with parenting skills. The data were mapped to the Behaviour Change Wheel framework and Typology of Cultural Adaptation to develop an intervention programme outline. The research evidence and local programme information was then used in the detailed planning of the programme sessions. CONCLUSIONS: The process of cultural adaptation of an existing children's weight management programme resulted in a theoretically underpinned programme that is culturally adapted at both the surface and deep structural levels. TRIAL REGISTRATION: ISRCTN81798055 , registered: 13/05/2014.

Predicting health-related quality of life (EQ-5D-5 L) and capability wellbeing (ICECAP-A) in the context of opiate dependence using routine clinical outcome measures: CORE-OM, LDQ and TOP.

BACKGROUND: Economic evaluation normally requires information to be collected on outcome improvement using utility values. This is often not collected during the treatment of substance use disorders making cost-effectiveness evaluations of therapy difficult. One potential solution is the use of mapping to generate utility values from clinical measures. This study develops and evaluates mapping algorithms that could be used to predict the EuroQol-5D (EQ-5D-5 L) and the ICEpop CAPability measure for Adults (ICECAP-A) from the three commonly used clinical measures; the CORE-OM, the LDQ and the TOP measures. METHODS: Models were estimated using pilot trial data of heroin users in opiate substitution treatment. In the trial the EQ-5D-5 L, ICECAP-A, CORE-OM, LDQ and TOP were administered at baseline, three and twelve month time intervals. Mapping was conducted using estimation and validation datasets. The normal estimation dataset, which comprised of baseline sample data, used ordinary least squares (OLS) and tobit regression methods. Data from the baseline and three month time periods were combined to create a pooled estimation dataset. Cluster and mixed regression methods were used to map from this dataset. Predictive accuracy of the models was assessed using the root mean square error (RMSE) and the mean absolute error (MAE). Algorithms were validated using sample data from the follow-up time periods. RESULTS: Mapping algorithms can be used to predict the ICECAP-A and the EQ-5D-5 L in the context of opiate dependence. Although both measures can be predicted, the ICECAP-A was better predicted by the clinical measures. There were no advantages of pooling the data. There were 6 chosen mapping algorithms, which had MAE scores ranging from 0.100 to 0.138 and RMSE scores ranging from 0.134 to 0.178. CONCLUSION: It is possible to predict the scores of the ICECAP-A and the EQ-5D-5 L with the use of mapping. In the context of opiate dependence, these algorithms provide the possibility of generating utility values from clinical measures and thus enabling economic evaluation of alternative therapy options. TRIAL REGISTRATION: ISRCTN22608399 . Date of registration: 27/04/2012. Date of first randomisation: 14/08/2012.

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.

A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

BACKGROUND: Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST. METHODS: A two-site, open feasibility trial randomised patients receiving OST for at least 12 months but still reporting illicit opiate use in the past 28 days to one of three treatments: 1) treatment as usual (TAU), 2) Brief Social Behaviour and Network Therapy (B-SBNT) + TAU, or 3) Personal Goal Setting (PGS) + TAU. The two active interventions consisted of 4 sessions. There were 3 aims: 1) test the feasibility of recruiting OST patients to a trial of B-SBNT, and following them up over 12 months; 2) test the feasibility of training clinicians to deliver B-SBNT; 3) test whether B-SBNT reduces heroin use 3 and 12 months after treatment, and to explore potential mediating factors. The primary outcome for aim 3 was number of days of heroin use in the past month, and a range of secondary outcome measures were specified in advance (level of drug dependence, mental health, social satisfaction, therapist rapport, treatment satisfaction, social network size and support). RESULTS: A total of 83 participants were randomised, and 70 (84%) were followed-up at 12 months. Fidelity analysis of showed that B-SBNT sessions were clearly distinguishable from PGS and TAU sessions, suggesting it was possible to train clinical staff to an adequate level of competence. No significant differences were found between the 3 intervention arms in the primary or secondary outcome measures. Attendance at psychosocial treatment intervention sessions was low across all three arms (44% overall). CONCLUSIONS: Patients receiving OST can be recruited into a trial of a social network-based intervention, but poor attendance at treatment sessions makes it uncertain whether an adequate dose of treatment was delivered. In order to achieve the benefits of psychosocial interventions, further work is needed to overcome poor engagement. TRIAL REGISTRATION: ISRCTN Trial Registration Number: ISRCTN22608399 . Date of registration: 27/04/2012. Date of first randomisation: 14/08/2012.

A cluster randomised controlled trial evaluating the effectiveness and cost-effectiveness of the daily mile on childhood obesity and wellbeing; the Birmingham daily mile protocol.

BACKGROUND: Childhood obesity prevention is a public health priority. Children spend a large proportion of their waking time in school; therefore this is an appropriate setting to implement obesity prevention initiatives. Anecdotal reports suggest that implementing The Daily Mile in schools has had positive effects on childhood obesity, academic attainment and wellbeing. This trial aims to measure the effectiveness of The Daily Mile for improving health and wellbeing. METHODS: This protocol describes a cluster randomised controlled trial (RCT) in 40 primary schools located in Birmingham, UK. Eligible participants are children in years 3 (aged 7-8) and 5 (aged 9-10). The study compares The Daily Mile (intervention) to usual practice (control) in relation to health and wellbeing. The Daily Mile intervention involves an additional 15 min of running or walking integrated into the school day, throughout a 12 month study period. The primary clinical outcome is body mass index (BMI) z-scores at 12 months following introduction of the intervention. The cost per Quality Adjusted Life Year (QALY) is the primary outcome of the economic evaluation. Secondary outcomes include wellbeing, physical fitness and teacher reported academic attainment. DISCUSSION: This study is the first RCT investigating the clinical and cost-effectiveness of The Daily Mile. A range of outcomes will be measured to evaluate the broader wellbeing and academic benefits in addition to clinical outcomes typically measured in childhood obesity prevention trials. The intervention is simple and low-cost, therefore if the benefits are demonstrated it has enormous potential to influence future policy. TRIAL REGISTRATION: ISRCTN: 12698269 . Date protocol registered 27th October 2016.

Sensitivity to scale of willingness-to-pay within the context of menorrhagia.

OBJECTIVES: Willingness-to-pay (WTP) provides a broad assessment of well-being, capturing benefits beyond health. However, the validity of the approach has been questioned and the evidence relating to the sensitivity of WTP to changes in health status is mixed. Using menorrhagia (heavy menstrual bleeding) as a case study, this exploratory study assesses the sensitivity to scale of WTP to change in health status as measured by a condition-specific measure, MMAS, which includes both health and non-health benefits. The relationship between EQ-5D and change in health status is also assessed. METHODS: Baseline EQ-5D and MMAS values were collected from women taking part in a randomized controlled trial for pharmaceutical treatment of menorrhagia. Following treatment, these measures were administered along with a WTP exercise. The relationship between the measures was assessed using Spearman's correlation analysis, and the sensitivity to scale of WTP was measured by identifying differences in WTP alongside differences in MMAS and EQ5D values. RESULTS: Our exploratory findings indicated that WTP, and not EQ-5D, was significantly positively correlated with change in MMAS, providing some evidence for convergent validity. These findings suggest that WTP is capturing the non-health benefits within the MMAS measure. Mean WTP also increased with percentage improvements in MMAS, suggesting sensitivity to scale. CONCLUSION: When compared to quality of life measured using the condition-specific MMAS measure, the convergent validity and sensitivity to scale of WTP is indicated. The findings suggest that WTP is more sensitive to change in MMAS, than with EQ-5D.

Preventing vitamin D deficiency (VDD): a systematic review of economic evaluations.

Background: Vitamin D deficiency (VDD) is a public health concern worldwide. If untreated, it can lead to reduced quality of life and escalated costs brought about by ill-health. Preventive programmes to improve population vitamin D status exist but little is known about their cost-effectiveness. This information is vital so that decision-makers adopt efficient strategies and optimise use of public resources. Aims: Systematically review and critically appraise economic evaluations of population strategies to prevent VDD. Methods: The databases reviewed were MEDLINE, EMBASE, Econlit, NHS EED, CEA, and RepEc. All full economic evaluations of VDD prevention strategies were included. Interventions considered were food fortification, supplementation and public health campaigns. Data extracted included type of evaluation, population, setting, measure of benefit and main results. Results: Of the 2492 records screened, 14 studies were included. The majority of studies focused on supplementation within at-risk groups with the primary objective of either preventing fractures or falls in older adults. There was insufficient economic evidence to draw conclusions about the cost-effectiveness of population strategies. No study was identified that offered a direct comparison of the two main alternative population strategies: food fortification vs. supplementation. Conclusions: Whilst there is a growing body of evidence on the cost-effectiveness of micro nutrient programmes, there is a paucity of data on vitamin D fortification and how fortification programmes compare to population supplementation programmes. We highlight research gaps, and offer suggestions of what is required to undertake population-based cost-effectiveness analysis.

Measuring Health and Broader Well-Being Benefits in the Context of Opiate Dependence: The Psychometric Performance of the ICECAP-A and the EQ-5D-5L.

BACKGROUND: Measuring outcomes in economic evaluations of social care interventions is challenging because both health and well-being benefits are evident. The ICEpop CAPability instrument for adults (ICECAP-A) and the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) are measures potentially suitable for the economic evaluation of treatments for substance use disorders. Evidence for their validity in this context is, however, lacking. OBJECTIVES: To assess the construct validity of the ICECAP-A and the EQ-5D-5L in terms of convergent and discriminative validity and sensitivity to change on the basis of standard clinical measures (Clinical Outcomes in Routine Evaluation-Outcome Measure, Treatment Outcomes Profile, Interpersonal Support Evaluation List, Leeds Dependence Questionnaire, and Social Satisfaction Questionnaire). METHODS: A secondary analysis of pilot trial data for heroin users in opiate substitution treatment was conducted. Baseline convergence with clinical measures was assessed using the Pearson correlation coefficient. Discriminative validity was assessed using one-way analysis of variance and stepwise regressions. Sensitivity to changes in clinical indicators was assessed at 3 and 12 months using the standardized response mean statistic and parametric and nonparametric testing. RESULTS: Both measures had the same level of construct validity, except for clinical indicators of well-being, for which the ICECAP-A performed better. The ICECAP-A was sensitive to changes in both health and well-being indicators. The EQ-5D-5L had lower levels of sensitivity to change, and a ceiling effect (27%), particularly evident in the dimensions of self-care (89%), mobility (75%), and usual activities (72%). CONCLUSIONS: The findings support the construct validity of both measures, but the ICECAP-A gives more attention to broader impacts and is more sensitive to change. The ICECAP-A shows promise in evaluating treatments for substance use disorders for which recovery is the desired outcome.

A cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6-7 year old children: the WAVES study protocol.

BACKGROUND: There is some evidence that school-based interventions are effective in preventing childhood obesity. However, longer term outcomes, equity of effects and cost-effectiveness of interventions have not been assessed. The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools, in preventing obesity in 6-7 year old children, compared to usual practice. METHODS: This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a multi-ethnic, socioeconomically diverse population of children aged 6-7 years. The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase time spent doing physical activity within the school day, participation in the 'Villa Vitality' programme (a programme that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents and children, and provision of information to families signposting local leisure opportunities. The primary (clinical) outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC ≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for pre-specified baseline school and child level covariates. DISCUSSION: The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multi-ethnic population, with a sufficient sample size to detect clinically important differences in adiposity. The intervention was developed using the Medical Research Council framework for complex interventions, and outcomes are measured objectively, together with a comprehensive process evaluation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586 (registered May 2010).

Is utility-based quality of life associated with overweight in children? Evidence from the UK WAVES randomised controlled study.

BACKGROUND: Quality-Adjusted Life Years (QALYs) are often used to make judgements about the relative cost-effectiveness of competing interventions and require an understanding of the relationship between health and health-related quality of life (HRQOL) when measured in utility terms. There is a dearth of information in the literature concerning how childhood overweight is associated with quality of life when this is measured using utilities. This study explores how weight is associated with utility-based HRQOL in 5-6 year olds and examines the psychometric properties of a newly developed pediatric utility measure - the CHU9D instrument. METHODS: Weight and HRQOL were examined using data collected from 1334 children recruited within a UK randomised controlled trial (WAVES) (ISRCTN97000586). Utility-based HRQOL was measured using the CHU9D, and general HRQOL measured using the PedsQL instrument. The association between weight and HRQOL was examined through a series of descriptive and multivariate analysis. The construct validity of the CHU9D was further assessed in relation to weight status, in direct comparison to the PedsQL instrument. RESULTS: The HRQOL of children who were either overweight or obese was not statistically different from children who were healthy or underweight. This result was the same for when HRQOL was measured in utility terms using the CHU9D instrument, and in general terms using the PedsQL instrument. Furthermore, the results support the construct validity of the newly developed CHU9D as the PedsQL total HRQOL scores corresponded well with the individual CHU9D dimensions. CONCLUSION: At age 5-6 years, the inverse association between overweight and HRQOL is not being captured by either the utility-based CHU9D instrument nor the PedsQL instrument. This result has implications for how the cost-effectiveness of childhood obesity interventions is measured in children aged 5-6 years. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN97000586 19(th) May 2010.

Is the UK NICE "reference case" influencing the practice of pediatric quality-adjusted life-year measurement within economic evaluations?

OBJECTIVES: To report findings from a systematic review, this article sought to address two related questions. First, how has the practice of UK pediatric cost-utility analyses evolved over time, in particular how are health-related outcomes assessed and valued? Second, how do the methods compare to the limited guidance available, in particular, the National Institute for Health and Care Excellence (NICE) reference case(s)? METHODS: Electronic searches of MEDLINE, Embase, and Cochrane databases were conducted for the period May 2004 to April 2012 and the Paediatric Economic Database Evaluation database for the period May 2004 to December 2010. Identified studies were screened by three independent reviewers. RESULTS: Forty-three studies were identified, 11 of which elicit utility values through primary research. A discrepancy was identified between the methods used for outcome measurement and valuation and the methods advocated within the NICE reference case. Despite NICE recommending the use of preference-based instruments designed specifically for children, most studies that were identified had used adult measures. In fact, the measurement of quality-adjusted life-years is the aspect of economic evaluation with the greatest amount of variability and the area that most digressed from the NICE reference case. CONCLUSIONS: Recommendations stemming from the review are that all studies should specify the age range of childhood and include separate statements of perspective for costs and effects as well as the reallocation of research funding away from systematic review studies toward good quality primary research measuring utilities in children.

Cost-effectiveness of a community-based physical activity programme for adults (Be Active) in the UK: an economic analysis within a natural experiment.

OBJECTIVE: To determine the cost-effectiveness of a physical activity programme (Be Active) aimed at city-dwelling adults living in Birmingham, UK. METHODS: Very little is known about the cost-effectiveness of public health programmes to improve city-wide physical activity rates. This paper presents a cost-effectiveness analysis that compares a physical activity intervention (Be Active) with no intervention (usual care) using an economic model to quantify the reduction in disease risk over a lifetime. Metabolic equivalent minutes achieved per week, quality-adjusted life years (QALYs) gained and healthcare costs were all included as the main outcome measures in the model. A cost-benefit analysis was also conducted using 'willingness-to-pay' as a measure of value. RESULTS: Under base-case assumptions-that is, assuming that the benefits of increased physical activity are sustained over 5 years, participation in the Be Active programme increased quality-adjusted life expectancy by 0.06 years, at an expected discounted cost of £3552, and thus the cost-effectiveness of Be Active is £400 per QALY. When the start-up costs of the programme are removed from the economic model, the cost-effectiveness is further improved to £16 per QALY. The societal value placed on the Be Active programme was greater than the operation cost therefore the Be Active physical activity intervention results in a net benefit to society. CONCLUSIONS: Participation in Be Active appeared to be cost-effective and cost-beneficial. These results support the use of Be Active as part of a public health programme to improve physical activity levels within the Birmingham-wide population.