The Marri Gudjaga project: a study protocol for a randomised control trial using Aboriginal peer support workers to promote breastfeeding of Aboriginal babies.

BACKGROUND: Breastfeeding protects against a range of conditions in the infant, including sudden infant death syndrome (SIDS), diarrhoea, respiratory infections and middle ear infections [1, 2]. The World Health Organization (WHO) recommends exclusive breastfeeding until six months of age, with continued breastfeeding recommended for at least two years and other complementary nutritious foods [3]. The 2017-18 National Health Survey (NHS) and 2018-19 National Aboriginal and Torres Strait Islander Health Survey (NATSIHS) reported that the proportion of breastfeeding in Aboriginal and Torres Strait Islander infants (0-2 years) were less than half that of non-Indigenous infants (21.2% vs. 45%, respectively)[4]. There is a lack of research on interventions supporting Aboriginal women to breastfeed, identifying an evaluation gap related to peer support interventions to encourage exclusive breastfeeding in Aboriginal women. METHODS: We will evaluate the effect of scheduled breastfeeding peer support for and by Aboriginal women, on breastfeeding initiation and the prevalence of exclusive breastfeeding. This MRFF (Medical Research Future Fund) funded project is designed as a single-blinded cluster randomised controlled trial recruiting six sites across New South Wales, Australia, with three sites being randomised to employ a peer support worker or undertaking standard care. Forty pregnant women will be recruited each year from each of the six sites and will be surveyed during pregnancy, at six weeks, four and six months postnatally with a single text message at 12 months to ascertain breastfeeding rates. In-depth interviews via an Indigenous style of conversation and storytelling called 'Yarning' will be completed at pre- and post-intervention with five randomly recruited community members and five health professionals at each site" [5]. Yarns will be audio recorded, transcribed, coded and thematic analysis undertaken. Health economic analysis will be completed to assess the health system incremental cost and effects of the breastfeeding intervention relative to usual care. DISCUSSION: Evidence will be given on the effectiveness of Aboriginal peer support workers to promote the initiation and continuation of breastfeeding of Aboriginal babies. The findings of this study will provide evidence of effectiveness and cost-effectiveness of including peer support workers in postnatal care to promote breastfeeding practices. TRIAL REGISTRATION: ACTRN12622001208796 The impact of breastfeeding peer support on nutrition of Aboriginal infants.

A collaborative approach to adopting/adapting guidelines. The Australian 24-hour movement guidelines for children (5-12 years) and young people (13-17 years): An integration of physical activity, sedentary behaviour, and sleep.

BACKGROUND: In 2018, the Australian Government updated the Australian Physical Activity and Sedentary Behaviour Guidelines for Children and Young People. A requirement of this update was the incorporation of a 24-hour approach to movement, recognising the importance of adequate sleep. The purpose of this paper was to describe how the updated Australian 24-Hour Movement Guidelines for Children and Young People (5 to 17 years): an integration of physical activity, sedentary behaviour and sleep were developed and the outcomes from this process. METHODS: The GRADE-ADOLOPMENT approach was used to develop the guidelines. A Leadership Group was formed, who identified existing credible guidelines. The Canadian 24-Hour Movement Guidelines for Children and Youth best met the criteria established by the Leadership Group. These guidelines were evaluated based on the evidence in the GRADE tables, summaries of findings tables and recommendations from the Canadian Guidelines. We conducted updates to each of the Canadian systematic reviews. A Guideline Development Group reviewed, separately and in combination, the evidence for each behaviour. A choice was then made to adopt or adapt the Canadian recommendations for each behaviour or create de novo recommendations. We then conducted an online survey (n=237) along with three focus groups (n=11 in total) and 13 key informant interviews. Stakeholders used these to provide feedback on the draft guidelines. RESULTS: Based on the evidence from the Canadian systematic reviews and the updated systematic reviews in Australia, the Guideline Development Group agreed to adopt the Canadian recommendations and, apart from some minor changes to the wording of good practice statements, maintain the wording of the guidelines, preamble, and title of the Canadian Guidelines. The Australian Guidelines provide evidence-informed recommendations for a healthy day (24-hours), integrating physical activity, sedentary behaviour (including limits to screen time), and sleep for children (5-12 years) and young people (13-17 years). CONCLUSIONS: To our knowledge, this is only the second time the GRADE-ADOLOPMENT approach has been used to develop movement behaviour guidelines. The judgments of the Australian Guideline Development Group did not differ sufficiently to change the directions and strength of the recommendations and as such, the Canadian Guidelines were adopted with only very minor alterations. This allowed the Australian Guidelines to be developed in a shorter time frame and at a lower cost. We recommend the GRADE-ADOLOPMENT approach, especially if a credible set of guidelines that was developed using the GRADE approach is available with all supporting materials. Other countries may consider this approach when developing and/or revising national movement guidelines.

Effectiveness of Quality Incentive Payments in General Practice (EQuIP-GP) cluster randomized trial: impact on patient-reported experience.

BACKGROUND: Relational continuity, 'a therapeutic relationship between a patient and provider/s that spans health care events', has been associated with improved patient outcomes. OBJECTIVES: To evaluate whether an intervention incorporating patient enrolment and a funding model for higher-risk patients influenced patient-reported experience measures, particularly relational continuity. METHODS: Cluster-randomized controlled trial over 12 months (1 August 2018-31 July 2019). Participating patients within intervention practices were offered enrolment with a preferred general practitioner, a minimum of 3 longer appointments, and review within 7 days of hospital admission or emergency department attendance. Intervention practices received incentives for longer consultations (dependent on reducing unnecessary prescriptions and tests), early post-hospital follow-up, and hospitalization reductions. The primary outcome was patient-reported relational continuity, measured by the Primary Care Assessment Tool Short Form. RESULTS: A total of 774 patients, aged 18-65 years with a chronic illness or aged over 65 years, from 34 general practices in metropolitan, regional, and rural Australia across 3 states participated. Response rates for questionnaires were >90%. From a maximum of 4.0, mean baseline scores for relational continuity were 3.38 (SE 0.05) and 3.42 (SE 0.05) in control and intervention arms, respectively, with no significant between-group differences in changes pre-post trial. There were no significant changes in other patient-focussed measures. CONCLUSION: Patient-reported relational continuity was high at baseline and not influenced by the intervention, signalling the need for caution with policies incorporating patient enrolment and financial incentives. Further research is required targeting at-risk patient groups with low baseline engagement with primary care.

Relational continuity, 'a therapeutic relationship between a patient and provider/s that spans health care events', has been associated with improved patient outcomes. This study aimed to evaluate whether patient enrolment with a preferred general practitioner (GP) and a funding model for higher-risk patients influenced patient-reported experience measures, particularly relational continuity. The trial was randomized by practice and ran over 12 months (1 August 2018­31 July 2019). Participating patients within intervention practices were offered enrolment with a preferred GP, a minimum of 3 longer appointments, and review within 7 days of hospital discharge. Intervention practices received incentives for longer consultations (with quality improvements), early post-hospital follow-up, and hospitalization reductions. We measured patient experience using the Primary Care Assessment Tool­Short Form at baseline and completion. A total of 774 patients, aged 18­65 years with a chronic illness or aged over 65 years, from 34 general practices in metropolitan, regional, and rural Australia participated. Patient-reported relational continuity was high at baseline and not influenced by the intervention. There were no significant changes in other patient-focussed measures. We advise caution with policies incorporating patient enrolment and financial incentives. Further research is required targeting at-risk patient groups with low baseline engagement with primary care.

Telephone and Web-Based Delivery of Healthy Eating and Active Living Interventions for Parents of Children Aged 2 to 6 Years: Mixed Methods Process Evaluation of the Time for Healthy Habits Translation Trial.

BACKGROUND: Few translational trials have provided detailed reports of process evaluation results. OBJECTIVE: This study reported on findings from a mixed methods process evaluation of a large translational trial comparing 2 remotely delivered healthy eating and active living interventions with an active control, targeting parents of young children. METHODS: Mixed methods process evaluation data were collected as part of a 3-arm, partially randomized preference trial targeting parents of children aged 2 to 6 years from New South Wales, Australia. Recruitment strategies were assessed through the participant baseline questionnaire and a questionnaire completed by the health promotion staff involved in recruitment. Data on participants' intervention preferences were collected at baseline and after the intervention. Intervention acceptability and demographic data were collected via a postintervention questionnaire (approximately 3 months after baseline), which was supplemented by qualitative participant interviews. Implementation data on intervention fidelity and withdrawal were also recorded. Differences in intervention acceptability, fidelity, and withdrawal rates between telephone and web-based interventions and between randomized and nonrandomized participants were analyzed. The significance level was set at P<.05 for all tests. The interview content was analyzed, key themes were drawn from participant responses, and findings were described narratively. RESULTS: Data were collected from 458 participants in the baseline survey and 144 (31.4%) participants in the 3-month postintervention survey. A total of 30 participants completed the qualitative interviews. A total of 6 health promotion staff members participated in the survey on recruitment strategies. Most participants were recruited from Early Childhood Education and Care services. There was a broad reach of the study; however, better take-up rates were observed in regional and rural areas compared with metropolitan areas. Parents with a university education were overrepresented. Most participants preferred the web-based medium of delivery at baseline. There was high acceptability of the web-based and telephone interventions. Participants found the healthy eating content to be the most useful component of the modules (web-based) and calls (telephone). They regarded text (web-based) or verbal (telephone) information as the most useful component. A high proportion of participants completed the telephone intervention compared with the web-based intervention; however, more participants actively withdrew from the telephone intervention. CONCLUSIONS: This is one of the first studies to comprehensively report on process evaluation data from a translation trial, which demonstrated high acceptability of all interventions but a strong participant preference for the web-based intervention. This detailed process evaluation is critical to inform further implementation and be considered alongside the effectiveness outcomes.

Health-related quality of life in patients with inoperable malignant bowel obstruction: secondary outcome from a double-blind, parallel, placebo-controlled randomised trial of octreotide.

BACKGROUND: This analysis aims to evaluate health-related quality of life (HrQoL) (primary outcome for this analysis), nausea and vomiting, and pain in patients with inoperable malignant bowel obstruction (IMBO) due to cancer or its treatments randomised to standardised therapies plus octreotide or placebo over a maximum of 72 h in a double-blind clinical trial. METHODS: Adults with IMBO and vomiting recruited through 12 services spanning inpatient, consultative and community settings in Australia were randomised to subcutaneous octreotide infusion or saline. HrQoL was measured at baseline and treatment cessation (EORTC QLQ-C15-PAL). Mean within-group paired differences between baseline and post-treatment scores were analysed using Wilcoxon Signed Rank test and between group differences estimated using linear mixed models, adjusted for baseline score, sex, age, time, and study arm. RESULTS: One hundred six of the 112 randomised participants were included in the analysis (n = 52 octreotide, n = 54 placebo); 6 participants were excluded due to major protocol violations. Mean baseline HrQoL scores were low (octreotide 22.1, 95% CI 14.3, 29.9; placebo 31.5, 95% CI 22.3, 40.7). There was no statistically significant within-group improvement in the mean HrQoL scores in the octreotide (p = 0.21) or placebo groups (p = 0.78), although both groups reported reductions in mean nausea and vomiting (octreotide p < 0.01; placebo p = 0.02) and pain scores (octreotide p < 0.01; placebo p = 0.03). Although no statistically significant difference in changes in HrQoL scores between octreotide and placebo were seen, an adequately powered study is required to fully assess any differences in HrQoL scores. CONCLUSION: The HrQoL of patients with IMBO and vomiting is poor. Further research to formally evaluate the effects of standard therapies for IMBO is therefore warranted. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12608000211369 (date registered 18/04/2008).

'Jump start' childcare-based intervention to promote physical activity in pre-schoolers: six-month findings from a cluster randomised trial.

BACKGROUND: Participation in adequate levels of physical activity during the early years is important for health and development. We report the 6-month effects of an 18-month multicomponent intervention on physical activity in early childhood education and care (ECEC) settings in low-income communities. METHODS: A cluster randomised controlled trial was conducted in 43 ECEC settings in disadvantaged areas of New South Wales, Australia. Three-year-old children were recruited and assessed in the first half of 2015 with follow-up 6 months later. The intervention was guided by Social Cognitive Theory and included five components. The primary outcome was minutes per hour in total physical activity during ECEC hours measured using Actigraph accelerometers. Intention-to-treat analysis of the primary outcome was conducted using a generalized linear mixed model. RESULTS: A total of 658 children were assessed at baseline. Of these, 558 (85%) had valid accelerometer data (mean age 3.38y, 52% boys) and 508 (77%) had valid accelerometry data at 6-month follow-up. Implementation of the intervention components ranged from 38 to 72%. There were no significant intervention effects on mins/hr. spent in physical activity (adjusted difference = - 0.17 mins/hr., 95% CI (- 1.30 to 0.97), p = 0.78). A priori sub-group analyses showed a greater effect among overweight/obese children in the control group compared with the intervention group for mins/hr. of physical activity (2.35mins/hr., [0.28 to 4.43], p = 0.036). CONCLUSIONS: After six-months the Jump Start intervention had no effect on physical activity levels during ECEC. This was largely due to low levels of implementation. Increasing fidelity may result in higher levels of physical activity when outcomes are assessed at 18-months. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000597695.

Translation of two healthy eating and active living support programs for parents of 2-6 year old children: a parallel partially randomised preference trial protocol (the 'time for healthy habits' trial).

BACKGROUND: Parents are key decision makers and role models in establishing and maintaining healthy behaviours in their children. Interventions involving parents have been shown to be more effective than those that do not, but there are barriers to participation. Efficacy trials have previously been conducted on two such parent-focussed healthy eating and active living interventions with the potential to overcome these barriers - Healthy Habits (telephone-based) and Time2bHealthy (online) with promising results. Further research is now required to determine the effectiveness of these interventions in a real-world context. The Time for Healthy Habits study is a 3-arm partially randomised preference trial which aims to evaluate the effectiveness and cost-effectiveness of two theory-based programs to promote healthy eating and appropriate levels of movement behaviours (physical activity, sedentary behaviour and sleep) for parents of 2- to 6-year-old children (Healthy Habits Plus telephone-based program and Time2bHealthy online program), when compared to a comparison group receiving written materials. METHODS: Participants will be recruited across five Local Health Districts in New South Wales, Australia. The partially randomised preference design initially allows for participants to decide if they wish to be randomised or opt to select their preferred intervention and has been recommended for use to test effectiveness in a real-world setting. Both interventions incorporate multiple behaviour change techniques and support parents to improve their children's healthy eating, and movement behaviours (physical activity, sedentary behaviour and sleep) and run for 12 weeks, followed by a 3-month and 9-month post-baseline follow-up. Participants will also be asked to complete a process evaluation questionnaire at the completion of the intervention (3-months post-baseline). Outcomes include fruit and vegetable intake (primary outcome), non-core food intake, weight status, physical activity, sedentary behaviour, and sleep habits. DISCUSSION: To our knowledge, this is the first translational research trial evaluating the effectiveness and cost-effectiveness of a healthy eating and active living intervention in the 2- to 6-years age group. The results will build the evidence base in regard to translation of effective childhood obesity prevention interventions and inform the implementation and delivery of community based childhood obesity prevention programs. TRIAL REGISTRATION: UTN: U1111-1228-9748, ACTRN: 12619000396123p.

Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.

We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Secondary outcomes at baseline, 3, 6 and 12 months included carer and patient emotional and physical well-being. No difference between intervention (n = 100) and control (n = 97) patients was found for the composite outcome (hazard ratio (HR) 1.22, 95% confidence interval (CI) = 0.89, 1.68; p = 0.22). Improved fatigue, mastery, vitality and general health occurred in intervention group patients (all p values < 0.05). No benefits were seen in carer outcomes. Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14; p = 0.05; adjusted for Australia-modified Karnofsky Performance Status), with a significant diagnosis-intervention interaction (p = 0.028) showing higher mortality in patients with COPD (HR 4.26; 95% CI = 1.60, 11.35) but not those with interstitial lung disease (HR 0.83; 95% CI = 0.28, 2.46). No difference was detected in the primary outcome, but patient mortality was higher when carers had received the intervention, especially in the most disabled patients. Trials examining behavioural change interventions in severe disease should stratify for functionality, and both risks and benefits should be independently monitored. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12607000177459).

Effectiveness of quality incentive payments in general practice (EQuIP-GP): a study protocol for a cluster-randomised trial of an outcomes-based funding model in Australian general practice to improve patient care.

BACKGROUND: There is international interest in whether improved primary care, in particular for patients with chronic or complex conditions, can lead to decreased use of health resources and whether financial incentives help achieve this goal. This trial (EQuIP-GP) will investigate whether a funding model based upon targeted, continuous quality incentive payments for Australian general practices increases relational continuity of care, and lessens health-service utilisation, for high-risk patients and children. METHODS: We will use a mixed methods approach incorporating a two-arm pragmatic cluster randomised control trial with nested qualitative case studies. We aim to recruit 36 general practices from Practice-Based Research Networks (PBRN) covering urban and regional areas of Australia, randomised into intervention and control groups. Control practices will provide usual care while intervention practices will be supported to implement a new service model incorporating incentives for relational continuity and timely access to appointments. Patients will comprise three groups: older (over 65 years); 18-65 years with chronic and/or complex conditions; and those aged less than 16 years with increased risk of hospitalisation. The funding model includes financial incentives to general practitioners (GPs) for providing longer consultations, same day access and timely follow-up after hospitalisation to enrolled patients. The payments are proportional to expected health system savings associated with improved quality of GP care. An outreach facilitator will work with practices to help incorporate the incentive model into usual work. The main outcome measure is relational continuity of care (Primary Care Assessment Tool short-form survey), with secondary outcomes including health-related quality of life and health service use (hospitalisations, emergency presentations, GP and specialist services in the community, medicine prescriptions and targeted pathology and imaging ordering). Outcomes will be initially evaluated over a period of 12 months, with ongoing data collection for 5 years. DISCUSSION: The trial will provide robust evidence on a novel approach to providing continuous incentives for improving quality of general practice care, which can be compared to block payment incentives awarded at target quality levels of pay-for-performance, both within Australia and also internationally. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000105246. Registered on 23 January 2018.

Correction to: Effectiveness of quality incentive payments in general practice (EQuIP-GP): a study protocol for a cluster-randomised trial of an outcomes-based funding model in Australian general practice to improve patient care.

In the original publication of this article [1], the first name of the 3rd author is wrong.

Ahead of the game protocol: a multi-component, community sport-based program targeting prevention, promotion and early intervention for mental health among adolescent males.

BACKGROUND: There is a recognised need for targeted community-wide mental health strategies and interventions aimed specifically at prevention and early intervention in promoting mental health. Young males are a high need group who hold particularly negative attitudes towards mental health services, and these views are detrimental for early intervention and help-seeking. Organised sports provide a promising context to deliver community-wide mental health strategies and interventions to adolescent males. The aim of the Ahead of the Game program is to test the effectiveness of a multi-component, community-sport based program targeting prevention, promotion and early intervention for mental health among adolescent males. METHODS: The Ahead of the Game program will be implemented within a sample drawn from community sporting clubs and evaluated using a sample drawn from a matched control community. Four programs are proposed, including two targeting adolescents, one for parents, and one for sports coaches. One adolescent program aims to increase mental health literacy, intentions to seek and/or provide help for mental health, and to decrease stigmatising attitudes. The second adolescent program aims to increase resilience. The goal of the parent program is to increase parental mental health literacy and confidence to provide help. The coach program is intended to increase coaches' supportive behaviours (e.g., autonomy supportive behaviours), and in turn facilitate high-quality motivation and wellbeing among adolescents. Programs will be complemented by a messaging campaign aimed at adolescents to enhance mental health literacy. The effects of the program on adolescent males' psychological distress and wellbeing will also be explored. DISCUSSION: Organised sports represent a potentially engaging avenue to promote mental health and prevent the onset of mental health problems among adolescent males. The community-based design, with samples drawn from an intervention and a matched control community, enables evaluation of adolescent males' incremental mental health literacy, help-seeking intentions, stigmatising attitudes, motivation, and resilience impacts from the multi-level, multi-component Ahead of the Game program. Notable risks to the study include self-selection bias, the non-randomised design, and the translational nature of the program. However, strengths include extensive community input, as well as the multi-level and multi-component design. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000709347 . Date registered 17 May 2017. Retrospectively registered.

A collaborative approach to adopting/adapting guidelines - The Australian 24-Hour Movement Guidelines for the early years (Birth to 5 years): an integration of physical activity, sedentary behavior, and sleep.

BACKGROUND: In 2017, the Australian Government funded the update of the National Physical Activity Recommendations for Children 0-5 years, with the intention that they be an integration of movement behaviours across the 24-h period. The benefit for Australia was that it could leverage research in Canada in the development of their 24-h guidelines for the early years. Concurrently, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group published a model to produce guidelines based on adoption, adaption and/or de novo development using the GRADE evidence-to-decision framework. Referred to as the GRADE-ADOLOPMENT approach, it allows guideline developers to follow a structured and transparent process in a more efficient manner, potentially avoiding the need to unnecessarily repeat costly tasks such as conducting systematic reviews. The purpose of this paper is to outline the process and outcomes for adapting the Canadian 24-Hour Movement Guidelines for the Early Years to develop the Australian 24-Hour Movement Guidelines for the Early Years guided by the GRADE-ADOLOPMENT framework. METHODS: The development process was guided by the GRADE-ADOLOPMENT approach. A Leadership Group and Consensus Panel were formed and existing credible guidelines identified. The draft Canadian 24-h integrated movement guidelines for the early years best met the criteria established by the Panel. These were evaluated based on the evidence in the GRADE tables, summaries of findings tables and draft recommendations from the Canadian Draft Guidelines. Updates to each of the Canadian systematic reviews were conducted and the Consensus Panel reviewed the evidence for each behaviour separately and made a decision to adopt or adapt the Canadian recommendations for each behaviour or create de novo recommendations. An online survey was then conducted (n = 302) along with five focus groups (n = 30) and five key informant interviews (n = 5) to obtain feedback from stakeholders on the draft guidelines. RESULTS: Based on the evidence from the Canadian systematic reviews and the updated systematic reviews in Australia, the Consensus Panel agreed to adopt the Canadian recommendations and, apart from some minor changes to the wording of good practice statements, keep the wording of the guidelines, preamble and title of the Canadian Guidelines. The Australian Guidelines provide evidence-informed recommendations for a healthy day (24-h), integrating physical activity, sedentary behaviour (including limits to screen time), and sleep for infants (<1 year), toddlers (1-2 years) and preschoolers (3-5 years). CONCLUSIONS: To our knowledge, this is only the second time the GRADE-ADOLOPMENT approach has been used. Following this approach, the judgments of the Australian Consensus Panel did not differ sufficiently to change the directions and strength of the recommendations and as such, the Canadian recommendations were adopted with very minor alterations. This allowed the Guidelines to be developed much faster and at lower cost. As such, we would recommend the GRADE-ADOLOPMENT approach, especially if a credible set of guidelines, with all supporting materials and developed using a transparent process, is available. Other countries may consider using this approach when developing and/or revising national movement guidelines.

Increasing physical activity among young children from disadvantaged communities: study protocol of a group randomised controlled effectiveness trial.

BACKGROUND: Participation in regular physical activity (PA) during the early years helps children achieve healthy body weight and can substantially improve motor development, bone health, psychosocial health and cognitive development. Despite common assumptions that young children are naturally active, evidence shows that they are insufficiently active for health and developmental benefits. Exploring strategies to increase physical activity in young children is a public health and research priority. METHODS: Jump Start is a multi-component, multi-setting PA and gross motor skill intervention for young children aged 3-5 years in disadvantaged areas of New South Wales, Australia. The intervention will be evaluated using a two-arm, parallel group, randomised cluster trial. The Jump Start protocol was based on Social Cognitive Theory and includes five components: a structured gross motor skill lesson (Jump In); unstructured outdoor PA and gross motor skill time (Jump Out); energy breaks (Jump Up); activities connecting movement to learning experiences (Jump Through); and a home-based family component to promote PA and gross motor skill (Jump Home). Early childhood education and care centres will be demographically matched and randomised to Jump Start (intervention) or usual practice (comparison) group. The intervention group receive Jump Start professional development, program resources, monthly newsletters and ongoing intervention support. Outcomes include change in total PA (accelerometers) within centre hours, gross motor skill development (Test of Gross Motor Development-2), weight status (body mass index), bone strength (Sunlight MiniOmni Ultrasound Bone Sonometer), self-regulation (Heads-Toes-Knees-Shoulders, executive function tasks, and proxy-report Temperament and Approaches to learning scales), and educator and parent self-efficacy. Extensive quantitative and qualitative process evaluation and a cost-effectiveness evaluation will be conducted. DISCUSSION: The Jump Start intervention is a unique program to address low levels of PA and gross motor skill proficiency, and support healthy lifestyle behaviours among young children in disadvantaged communities. If shown to be efficacious, the Jump Start approach can be expected to have implications for early childhood education and care policies and practices, and ultimately a positive effect on the health and development across the life course. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry No: ACTRN12614000597695 , first received: June 5, 2014.

Aligning opportunity cost and net benefit criteria: the health shadow price.

Given constrained healthcare budgets and many competing demands, public health decision-making requires comparing the expected cost and health outcomes of alternative strategies and associated adoption and financing actions. Opportunity cost (comparing outcomes from the best alternative use of budgets or actions in decision making) and more recently net benefit criteria (relative valuing of effects at a threshold value less costs) have been key concepts and metrics applied toward making such decisions. In an ideal world, opportunity cost and net benefit criteria should be mutually supportive and consistent. However, that requires a threshold value to align net benefit with opportunity cost assessment. This perspective piece shows that using the health shadow price as the ICER threshold aligns net benefit and opportunity cost criteria for joint adoption and financing actions that arise when reimbursing any new strategy or technology under a constrained budget. For an investment strategy with ICER at the health shadow price Bc = 1/(1/n + 1/d-1/m), net benefit of reimbursing (adopting and financing) that strategy given an incremental cost-effectiveness ration (ICER) of actual displacement, d, in financing, is shown to be equivalent to that of the best alternative actions, the most cost-effective expansion of existing programs (ICER = n) funded by the contraction of the least cost-effective programs (ICER = m). Net benefit is correspondingly positive or negative if it is below or above this threshold. Implications are discussed for creating pathways to optimal public health decision-making with appropriate incentives for efficient displacement as well as for adoption actions and related research.

Show me the money! Associations between tree canopy and hospital costs in cities for cardiovascular disease events in a longitudinal cohort study of 110,134 participants.

Health benefits from urban greening are assumed to translate into reduced healthcare expenditure, yet few studies have tested this. A total of 110,134 participants in the Sax Institute's 45 and Up Study in the Australian cities of Sydney, Newcastle, or Wollongong were linked with hospital cost data for cardiovascular disease (CVD) events (e.g., acute myocardial infarctions) up to 30 June 2018. Associations between percentages of total green space, tree canopy, and open grass within 1.6 km of participants homes and annual per person measured CVD-related hospital costs were analysed using generalised linear model (GLM) with gamma density as a component of a two-part mixture model, adjusting for confounders. Overall, 26,243 participants experienced a CVD-related hospitalisation. Incidence was lower among participants with 10 % more tree canopy (OR 0.98, 95 %CI 0.96, 0.99), but not with higher total green space or open grass percentages. Total costs of hospitalisations per year were lower with 10 % more tree canopy (means ratio 0.96, 95 %CI 0.95, 0.98), but also higher with 10 % more open grass (means ratio 1.04, 95 %CI 1.02, 1.06). It was estimated that raising tree canopy cover to 30 % or more for individuals with currently less than 10 % could lead to a within-sample annual saving per person of AU$ 193 overall and AU$ 569 for those who experienced one or more CVD-related hospital admissions. This projects to an estimated annual health sector cost reduction of AU$ 19.3 million per 100,000 individuals for whom local tree canopy cover is increased from less than 10 % to 30 % or higher. In conclusion, this longitudinal study is among the first to analyse measured healthcare cost data in relation to urban green space in general, and with differentiation between major types of greenery relevant to urban planning policies in cities around the world. In sum, this study advances an increasingly important and international focus of research by reporting on the lower burden of CVD and fewer associated hospitalisations stemming from upstream investments that protect and restore urban tree canopy, which not only translates into substantial reduced costs for the health sector, but also helps to create regenerative cities and flourishing communities.

Are value of information methods ready for prime time? An application to alternative treatment strategies for NSTEMI patients.

OBJECTIVES: The use of value of information methods to inform trial design has been widely advocated but there have been few empirical applications of these methods and there is little evidence they are widely used in decision making. This study considers the usefulness of value of information models in the context of a real clinical decision problem relating to alternative diagnostic strategies for patients with a recent non-ST elevated myocardial infarction. METHODS: A pretrial economic model is constructed to consider the cost-effectiveness of two competing strategies: coronary angiography alone or in conjunction with fractional flow reserve measurement. A closed-form solution to the expected benefits of information is used with optimal sample size estimated for a range of models reflecting increasingly realistic assumptions and alternative decision contexts. RESULTS: Fractional flow reserve measurement is expected to be cost-effective with an incremental cost-effectiveness ratio of GBP 1,621, however, there is considerable uncertainty in this estimate and consequently a large expected value to reducing this uncertainty via a trial. The recommended sample size is strongly affected by the reality of the assumptions of the expected value of information (EVI) model and the decision context. CONCLUSIONS: Value of information models can provide a simple and flexible approach to clinical trial design and are more consistent with the constraints and objectives of the healthcare system than traditional frequentist approaches. However, the variation in sample size estimates demonstrates that it is essential that appropriate model parameters and decision contexts are used in their application.

Primary care vs specialist sleep center management of obstructive sleep apnea and daytime sleepiness and quality of life: a randomized trial.

IMPORTANCE: Due to increasing demand for sleep services, there has been growing interest in ambulatory models of care for patients with obstructive sleep apnea. With appropriate training and simplified management tools, primary care physicians are ideally positioned to take on a greater role in diagnosis and treatment. OBJECTIVE: To compare the clinical efficacy and within-trial costs of a simplified model of diagnosis and care in primary care relative to that in specialist sleep centers. DESIGN, SETTING, AND PATIENTS: A randomized, controlled, noninferiority study involving 155 patients with obstructive sleep apnea that was treated at primary care practices (n=81) in metropolitan Adelaide, 3 rural regions of South Australia or at a university hospital sleep medicine center in Adelaide, Australia (n = 74), between September 2008 and June 2010. INTERVENTIONS: Primary care management of obstructive sleep apnea vs usual care in a specialist sleep center; both plans included continuous positive airway pressure, mandibular advancement splints, or conservative measures only. MAIN OUTCOME AND MEASURES: The primary outcome was 6-month change in Epworth Sleepiness Scale (ESS) score, which ranges from 0 (no daytime sleepiness) to 24 points (high level of daytime sleepiness). The noninferiority margin was -2.0. Secondary outcomes included disease-specific and general quality of life measures, obstructive sleep apnea symptoms, adherence to using continuous positive airway pressure, patient satisfaction, and health care costs. RESULTS: There were significant improvements in ESS scores from baseline to 6 months in both groups. In the primary care group, the mean baseline score of 12.8 decreased to 7.0 at 6 months (P < .001), and in the specialist group, the score decreased from a mean of 12.5 to 7.0 (P < .001). Primary care management was noninferior to specialist management with a mean change in ESS score of 5.8 vs 5.4 (adjusted difference, -0.13; lower bound of 1-sided 95% CI, -1.5; P = .43). There were no differences in secondary outcome measures between groups. Seventeen patients (21%) withdrew from the study in the primary care group vs 6 patients (8%) in the specialist group. CONCLUSIONS AND RELEVANCE: Among patients with obstructive sleep apnea, treatment under a primary care model compared with a specialist model did not result in worse sleepiness scores, suggesting that the 2 treatment modes may be comparable. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12608000514303.

Cluster-randomised trial of the Effectiveness of Quality Incentive Payments in General Practice (EQuIP-GP): Prescribing of medicines outcomes.

BACKGROUND: The Effectiveness of Quality Incentive Payments in General Practice (EQuIP-GP) study investigated whether targeted financial incentives promoting access to a preferred general practitioner, post-hospitalisation follow-up and longer consultations, increase patient-perceived relational continuity in primary care. Secondary outcomes included the use of medicines. OBJECTIVE: To evaluate whether introducing a general practice-level service model incorporating enrolment and continuous and graded quality improvement incentives influenced the total prescriptions written and potentially inappropriate prescribing of medicines. METHODS: A 12-month cluster-randomised controlled trial, whereby participating patients within intervention practices were offered enrolment with a preferred general practitioner, a minimum of three longer appointments, and review within seven days of hospital admission or emergency department attendance. Control practice patients received usual care. Differences between intervention and control groups pre-post trial for total prescriptions were analysed, as an indicator of polypharmacy, along with prescriptions for four groups of drugs known to have common quality of medicines issues: antibiotics, benzodiazepines, opioids and proton pump inhibitors (PPIs). RESULTS: A total of 774 patients, aged 18-65 years with a chronic illness or aged over 65 years, from 34 general practices in metropolitan, regional and rural Australia participated. The mean number of medicine prescriptions per month at baseline was 4.19 (SD 3.27) and 4.34 (SD 3.75) in the control and intervention arms, respectively, with no significant between-group differences in changes pre-post trial and also no significant between-group or within-group differences of prescription rates for antibiotics, benzodiazepines, opioids or PPIs. CONCLUSIONS: Total prescribing volume and the use of key medicines were not influenced by quality-linked financial incentives for offering longer consultations and early post-hospital review for enrolled patients.

Accounting for between-study variation in incremental net benefit in value of information methodology.

Previous applications of value of information methods for determining optimal sample size in randomized clinical trials have assumed no between-study variation in mean incremental net benefit. By adopting a hierarchical model, we provide a solution for determining optimal sample size with this assumption relaxed. The solution is illustrated with two examples from the literature. Expected net gain increases with increasing between-study variation, reflecting the increased uncertainty in incremental net benefit and reduced extent to which data are borrowed from previous evidence. Hence, a trial can become optimal where current evidence is sufficient assuming no between-study variation. However, despite the expected net gain increasing, the optimal sample size in the illustrated examples is relatively insensitive to the amount of between-study variation. Further percentage losses in expected net gain were small even when choosing sample sizes that reflected widely different between-study variation.