The Cool Little Kids randomised controlled trial population-level early prevention for anxiety disorders

Background: The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful ‘efficacy’ trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry.
Methods/Design: This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child’s bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (costconsequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms.
Discussion: This trial addresses gaps for internalising problems identified in the 2004 World Health Organization Prevention of Mental Disorders report. If effective and cost-effective, the intervention could readily be applied at a population level. Governments consider mental health to be a priority, enhancing the likelihood that an effective early prevention program would be adopted in Australia and internationally.

Supermarket Healthy Eating for Life (SHELf): protocol of a randomised controlled trial promoting healthy food and beverage consumption through price reduction and skill-building strategies

Background: In the context of rising food prices, there is a need for evidence on the most effective approaches for promoting healthy eating. Individually-targeted behavioural interventions for increasing food-related skills show promise, but are unlikely to be effective in the absence of structural supports. Fiscal policies have been advocated as a means of promoting healthy eating and reducing obesity and nutrition-related disease, but there is little empirical evidence of their effectiveness. This paper describes the Supermarket Healthy Eating for LiFe (SHELf) study, a randomised controlled trial to investigate effectiveness and cost-effectiveness of a tailored skill-building intervention and a price reduction intervention, separately and in combination, against a control condition for promoting purchase and consumption of healthy foods and beverages in women from high and low socioeconomic groups.
Methods/design: SHELf comprises a randomised controlled trial design, with participants randomised to receive either (1) a skill-building intervention; (2) price reductions on fruits, vegetables and low-joule soft drink beverages and water; (3) a combination of skill-building and price reductions; or (4) a control condition. Five hundred women from high and low socioeconomic areas will be recruited through a store loyalty card program and local media. Randomisation will occur on receipt of informed consent and baseline questionnaire. An economic evaluation from a societal perspective using a cost-consequences approach will compare the costs and outcomes between intervention and control groups.
Discussion: This study will build on a pivotal partnership with a major national supermarket chain and the Heart Foundation to investigate the effectiveness of intervention strategies aimed at increasing women’s purchasing and consumption of fruits and vegetables and decreased purchasing and consumption of sugar-sweetened beverages. It will be among the first internationally to examine the effects of two promising approaches - skill-building and price reductions - on diet amongst women.

Exploring potential success factors for procurement of privately financed infrastructure

Australia has joined many governments to adopt public-private partnership (PPP) as a major strategy for procuring infrastructure for decades. However, failures have occurred although the market has been considered to be a mature and sophisticated one. Failures have typically been traced back to inappropriate economic evaluation and a lack of value-for-money. In particular, a literature review has identified that there was no holistic consideration on the evaluation of procurement transactions of PPP projects. The transaction costs of PPPs were not handled properly. In this paper, theories of transaction cost economics are proposed for the purpose of such a holistic institutional economic evaluation. These theories are analysed in order to identify potential critical success factors for a strategic infrastructure procurement framework. The potential critical success factors are identified and grouped into a number of categories that match the theories of transaction cost economics. These categories include (1) Asset Specificity, (2) Organizational Capability, (3) Transaction Frequency, (4) Behavioural Uncertainty, and (5) Environmental Uncertainty. These potential critical success factors may be subject to an empirical test in the future. The proposed framework will offer decision makers with an insight into project life cycle economic outcomes needed to successfully deliver PPPs.

Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer

Background: Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity.

Methods/design: A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention “Living with Prostate Cancer” that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis) and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and healthrelated quality of life (QoL); psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage) will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial.

Discussion: This study will address a critical but as yet unanswered research question: to identify a populationbased way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention.

The population cost-effectiveness of interventions designed to prevent childhood depression

BACKGROUND AND OBJECTIVES: Depression in childhood and adolescence is common and often persists into adulthood. This study assessed the population-level cost-effectiveness of a preventive intervention that screens children and adolescents for symptoms of depression in schools and the subsequent provision of a psychological intervention to those showing elevated signs of depression. The target population for screening comprised 11- to 17-year-old children and adolescents in the 2003 Australian population.

METHODS: Economic modeling techniques were used to assess the incremental cost-effectiveness of the intervention compared with no intervention. The perspective was that of the health sector, and outcomes were measured by using disability-adjusted life-years (DALYs). Multivariate probabilistic and univariate sensitivity testing was applied to quantify variations in the model parameters.

RESULTS: The modeled psychological intervention had an incremental cost-effectiveness ratio of $5400 per DALY averted, with just 2% of iterations falling above a $50 000 per DALY value-for-money threshold. Results were robust to model assumptions.

CONCLUSIONS: After school screening, screening and the psychological intervention represent good value-for-money. Such an intervention needs to be seriously considered in any national package of preventive health services. Acceptability issues, particularly to intervention providers, including schools and mental health professionals, need to be considered before wide-scale adoption.

Preventing mental health problems in children : the families in mind population-based cluster randomised controlled trial.

Background

Externalising and internalising problems affect one in seven school-aged children and are the single strongest predictor of mental health problems into early adolescence. As the burden of mental health problems persists globally, childhood prevention of mental health problems is paramount. Prevention can be offered to all children (universal) or to children at risk of developing mental health problems (targeted). The relative effectiveness and costs of a targeted only versus combined universal and targeted approach are unknown. This study aims to the effectiveness, costs and uptake of two approaches to early childhood prevention of mental health problems ie: a Combined universal-targeted approach, versus a Targeted only approach, in comparison to current primary care services (Usual care).
Design

Three armed, population-level cluster randomised trial (2010-2014) within the universal, well child Maternal Child Health system, attended by more than 80% of families in Victoria, Australia at infant age eight months. Participants: Families of eight month old children from nine participating local government areas. Randomised to one of three groups: Combined, Targeted or Usual care. Intervention: (a) the Combined universal and targeted program where all families are offered the universal Toddlers Without Tears group parenting program followed by the targeted Family Check-Up one-on-one program or (b) the Targeted Family Check-Up program. The Family Check-Up program is only offered to children at risk of behavioural problems. Analysis: Participants will be analysed according to the trial arm to which they were randomised, using logistic and linear regression models to compare primary and secondary outcomes. An economic evaluation (cost consequences analysis) will compare incremental costs to all incremental outcomes from a societal perspective.
Discussion

This trial will inform public health policy by making recommendations about the effectiveness and cost-effectiveness of these early prevention programs. If effective prevention programs can be implemented at the population level, the growing burden of mental health problems could be curbed.

Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

Background
Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional and social support, assist and encourage clinical care and be available when needed.
Methods
A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support to the participants. (1) Trained supporters lead 12 monthly group meetings. Participants are assisted to set goals to improve diabetes self-management, discuss with and encourage each other to strengthen linkages with local clinical services (including allied health services) as well as provide social and emotional support. (2) Support through regular supporter-participant or participant-participant contact, between monthly sessions, is also promoted in order to maintain motivation and encourage self-improvement and confidence in diabetes self-management. (3) Participants receive a workbook containing diabetes information, resources and community support services, key diabetes management behaviors and monthly goal setting activity sheets. (4) Finally, a password protected website contains further resources for the participants. Supporters are mentored and assisted throughout the intervention by other supporters and the research team through attendance at a weekly teleconference. Data, including a self-administered lifestyle survey, anthropometric and biomedical measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective.
Discussion
This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes.

Construction of the descriptive system for the assessment of quality of life AQoL-6D utility instrument

Background
Multi attribute utility (MAU) instruments are used to include the health related quality of life (HRQoL) in economic evaluations of health programs. Comparative studies suggest different MAU instruments measure related but different constructs. The objective of this paper is to describe the methods employed to achieve content validity in the descriptive system of the Assessment of Quality of Life (AQoL)-6D, MAU instrument.

Methods
The AQoL program introduced the use of psychometric methods in the construction of health related MAU instruments. To develop the AQoL-6D we selected 112 items from previous research, focus groups and expert judgment and administered them to 316 members of the public and 302 hospital patients. The search for content validity across a broad spectrum of health states required both formative and reflective modelling. We employed Exploratory Factor Analysis and Structural Equation Modelling (SEM) to meet these dual requirements.

Results and Discussion
The resulting instrument employs 20 items in a multi-tier descriptive system. Latent dimension variables achieve sensitive descriptions of 6 dimensions which, in turn, combine to form a single latent QoL variable. Diagnostic statistics from the SEM analysis are exceptionally good and confirm the hypothesised structure of the model.

Conclusions
The AQoL-6D descriptive system has good psychometric properties. They imply that the instrument has achieved construct validity and provides a sensitive description of HRQoL. This means that it may be used with confidence for measuring health related quality of life and that it is a suitable basis for modelling utilities for inclusion in the economic evaluation of health programs.

ShopSmart 4 Health - protocol of a skills-based randomised controlled trial promoting fruit and vegetable consumption among socioeconomically disadvantaged women

Background
There is a need for evidence on the most effective and cost-effective approaches for promoting healthy eating among groups that do not meet dietary recommendations for good health, such as those with low incomes or experiencing socioeconomic disadvantage. This paper describes the ShopSmart 4 Health study, a randomised controlled trial conducted by Deakin University, Coles Supermarkets and the Heart Foundation, to investigate the effectiveness and cost-effectiveness of a skill-building intervention for promoting increased purchasing and consumption of fruits and vegetables amongst women of low socioeconomic position (SEP).

Methods/design
ShopSmart 4 Health employed a randomised controlled trial design. Women aged 18–60 years, holding a Coles store loyalty card, who shopped at Coles stores within socioeconomically disadvantaged neighbourhoods and met low-income eligibility criteria were invited to participate. Consenting women completed a baseline survey assessing food shopping and eating habits and food-related behaviours and attitudes. On receipt of their completed survey, women were randomised to either a skill-building intervention or a wait-list control condition. Intervention effects will be evaluated via self-completion surveys and using supermarket transaction sales data, collected at pre- and post-intervention and 6-month follow-up. An economic evaluation from a societal perspective using a cost-consequences approach will compare the costs and outcomes between intervention and control groups. Process evaluation will be undertaken to identify perceived value and effects of intervention components.

Discussion
This study will provide data to address the currently limited evidence base regarding the effectiveness and cost-effectiveness of skill-building intervention strategies aimed at increasing fruit and vegetable consumption among socioeconomically disadvantaged women, a target group at high risk of poor diets.

Cost-effectiveness of fiscal policies to prevent obesity

Cost-effective, sustainable strategies are urgently required to curb the global obesity epidemic. To date, fiscal policies such as taxes and subsidies have been driven largely by imperatives to raise revenue or increase supply, rather than to change population behaviours. This paper reviews the economic evaluation literature around the use of fiscal policies to prevent obesity. The cost-effectiveness literature is limited, and more robust economic evaluation studies are required. However, uncertainty and gaps in the effectiveness evidence base need to be addressed first: more studies are needed that collect ‘real-world’ empirical data, and larger studies with more robust designs and longer follow-up timeframes are required. Reliability of cross-price elasticity data needs to be investigated, and greater consideration given to moderators of intervention effects and the sustainability of outcomes. Economic evaluations should adopt a societal perspective, incorporate a broader spectrum of economic costs and consider other factors likely to affect the implementation of fiscal measures. The paucity of recent cost-effectiveness studies means that definitive conclusions about the value for money of fiscal policies for obesity prevention cannot yet be drawn. However, as in other public health areas such as alcohol and tobacco, early indications are that population-level fiscal policies are likely to be potentially effective and cost-saving.

Prevention of common mental disorders: what can we learn from those who have gone before and where do we go next?

Objective:

What's important in defining quality of life for older people? An exploratory study of the views of older South Australians

Background
Cost-effectiveness analyses of interventions for older adults have traditionally focused on health status. There is increasing recognition of the need to develop new instruments to capture quality of life in a broader sense in the face of age-associated increasing frailty and declining health status, particularly in the economic evaluation of aged and social care interventions which may have positive benefits beyond health.