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Aim The COVID-19 pandemic has threatened individual and population wellbeing and strategies to jointly address these challenges within budget constraints are required. The aim of our research is to analyse evidence from the Active Lives South Australia study to consider the potential of physical activity (PA) health promotion strategies to be health-system cost saving while addressing wellbeing challenges. Methods The Active Lives South Australia study compares adult populations who meet and do not meet physical activity (PA) guidelines (150+ minutes of weekly physical activity) with respect to their subjective wellbeing and health care utilisation. Subject and results Adults who met PA guidelines had better wellbeing across all aspects with and without adjustment for age, sex and income covariates. Analysis showed significant associations between meeting guidelines and lower probabilities of visiting and utilisation of GPs, specialist doctors, other health professionals, hospital inpatient admissions, outpatient clinic and emergency department visits, and an overall A$1760 lower cost per person annually. Controlling for age, sex and income, health expenditure for adults who met PA guidelines was significantly lower by A$1393 per person annually. That translated to A$804 million potential annual SA health system cost saving by shifting all adults to meeting PA guidelines. Conclusion There is significant potential for effective health promotion strategies to be net cost saving while addressing wellbeing challenges of COVID-19 recovery where they can shift target populations from not meeting to meeting PA guidelines.

Aim International comparisons of public health measures relative to observed best practice are increasingly important for evaluating community health promotion strategies and policies such as meeting or not meeting public health guidelines. This study aimed to identify methods enabling robust evaluation with such binary effect measures at a population level. Subject and methods Conventional efficiency comparisons of binary effect proportions are problematic due to a lack of consistency with alternate framing of resulting relative risks. In this paper, we illustrate such inconsistent efficiency measures comparing the proportion of school age children (9–11 years) meeting or not meeting integrated movement guidelines (IMGs) across the 12 countries from the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) study. IMGs jointly consider physical activity, sleep and sedentary behaviours. An odds method is developed to enable consistent efficiency comparison with alternative framing of binary effects. Results A novel odds solution to relative risk problems arising with conventional efficiency comparison of binary effects with alternative framing is shown to provide consistent efficiency measures relative to best practice. Furthermore, this technical advancement is shown to extend to consistent indirect comparison and evidence translation. Conclusion Robust methods for international cross-country comparison of binary effect measures such as meeting or not meeting guidelines are identified with a novel odds ratio method. This novel solution is particularly important for health promotion evaluation of IMGs given the need for consistent comparison in evaluating practice evidence of what works now and consistent evidence translation of treatment effects as and when they emerge.

Relational continuity, 'a therapeutic relationship between a patient and provider/s that spans health care events', has been associated with improved patient outcomes.To evaluate whether an intervention incorporating patient enrolment and a funding model for higher-risk patients influenced patient-reported experience measures, particularly relational continuity.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.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 were90%. 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.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 2018–31 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 Tool—Short Form at baseline and completion. 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. 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.

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 p = 0.02) and pain scores (octreotide p 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)

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 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.

Background Urban greening may reduce loneliness by offering opportunities for solace, social reconnection and supporting processes such as stress relief. We (i) assessed associations between residential green space and cumulative incidence of, and relief from, loneliness over 4 years; and (ii) explored contingencies by age, sex, disability and cohabitation status. Methods Multilevel logistic regressions of change in loneliness status in 8049 city-dwellers between 2013 (baseline) and 2017 (follow-up) in the Household, Income and Labour Dynamics in Australia study. Associations with objectively measured discrete green-space buffers (e.g. parks) ( Results The absolute risk of loneliness rose from 15.9% to 16.9% over the 4 years; however, a 10% increase in urban greening within 1.6 km was associated with lower cumulative incident loneliness [odds ratio (OR) = 0.927, 95% confidence interval (CI) = 0.862 to 0.996; absolute risk reduction = 0.66%]. Stronger association was observed for people living alone (OR = 0.828, 95% CI = 0.725 to 0.944). In comparison to people with 30% green space, respectively. Compared with the 30% green space, respectively. These associations were stronger again for people living alone, with 10–20% (OR = 0.608, 95% CI = 0.448 to 0.826), 20–30% (OR = 0.649, 95% CI = 0.436 to 0.966) and >30% (OR = 0.480, 95% CI = 0.278 to 0.829) green space within 1600 m. No age, sex or disability-related contingencies, associations with green space within 400 or 800 m or relief from loneliness reported at baseline were observed. Conclusions A lower cumulative incidence of loneliness was observed among people with more green space within 1600 m of home, especially for people living alone. Potential biopsychosocial mechanisms warrant investigation.

Background This study evaluates the Ahead Of The Game (AOTG) mental health promotion strategy for adolescent males relative to usual practice in team based sporting club community settings, allowing for joint incremental effects across 13 dimensions and 5 domains alongside intervention implementation costs. Methods Analysis is undertaken between matched communities with difference in differences analysis of joint multiple pre-post effect changes alongside implementation costs employing radar plots in cost-disutility space. A robust bootstrapping method allowed including all observed change in effect data from 343 AOTG and 273 control arm participants across 13 effect dimensions. Results Triangulation across joint evidence shows mean incremental effects favoured AOTG in all dimensions (10/13 significantly at 5% level) and in simple aggregation to each of five pre-specified 5 domains (each significant at Conclusion The AOTG strategy was found to represent an effective mental health promotion strategy across all domains and globally with associated significant potential for downstream health system cost savings to offset against modest implementation costs. Evaluation methods extend conventional cost-effectiveness analysis to enable robust joint presentation and triangulation under uncertainty of multiple effect dimensions alongside costs. Trial registration ANZCTR, ACTRN12617000709347. Registered 17th May 2017.

Background Interventions to better manage aggressive behaviour and reduce recidivism are a primary concern for corrective services. Nutritional interventions to correct prisoner behaviour have been largely overlooked in the literature. Emerging evidence suggests that dietary intake influences aggressive behaviours and that nutritional supplementation with omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) could attenuate both the severity and frequency of aggressive behaviour. Methods Adult male prisoners who have a history of aggressive behaviour (n = 600) will be recruited from at least 6 Correctional Centres and randomised to receive either n-3 LCPUFA or placebo supplementation for a 16-week duration. Treatment will be with either 1 g/day of n-3 LCPUFA (694 mg DHA and 397 mg EPA) or placebo capsules, which are a corn/soy oil blend and are identical in size and colour. The primary outcome measure is the Inmate Behavioural Observation Scale (IBOS): an objective measure of aggressive behaviour. Secondary outcome measures include questionnaires (including aggression, attention deficit disorder, impulsivity, depression/anxiety/stress scales), engagement in programmes, recidivism and quality of life. Baseline and post-intervention assessments include the IBOS, questionnaires and blood to measure the levels of n-3 LCPUFA. Discussion To conclusively test the potential that increasing n-3 LCPUFA intakes can improve rates of prisoner aggression and associated mental health and violence-related social system management costs, we propose an adequately powered multi-centre, double-blind, randomised controlled trial, examining the effects of n-3 LCPUFA supplementation on aggressive behaviour in adult male prisoners. If successful, this study will inform prisoner policy with respect to nutrition and by inference contribute to a broader community approach to preventative mental health practices. Trial registration Australian New Zealand Clinical Trial Registry (ANZCTR) ACTRN12618001665224. Registered on 10 October 2018.

Purpose In this study, we tested the effectiveness of a multicomponent sports-based program aimed at promoting early intervention, help seeking, and resilience among a sample of adolescent male sport participants. Methods The Ahead of the Game program comprised four intervention components and a messaging campaign. Two components targeted mental health literacy, intentions to seek and provide help, and resilience among adolescent boys. A mental health literacy program for parents and a coach education program to assist in the support of athletes’ psychological needs were also included. We evaluated the program using a nonrandomized controlled trial matching two regional communities. In total, 350 sport participants (mean, 14.53 yr) were included in an intervention group, whereas 466 (mean, 14.66 yr) received usual practice in a matched control community. One hundred and eighty parents or caregivers and eight coaches also participated in the intervention components. Between-group mean differences on the primary and secondary outcomes were analyzed using linear mixed models, adjusted for clustering at club level, participant age, and socioeconomic status. Results Significant positive group–time interactions were found for the primary outcomes of depression and anxiety literacy, intentions to seek help from formal sources, confidence to seek mental health information, and resilience. We also found a significant positive group–time interaction for the secondary outcome of well-being. There were no group–time interactions for social distance (stigma), intentions to seek help from informal sources, implicit beliefs about adversity, perceived familial support, or psychological distress. Conclusions Given the high rates of sport participation worldwide and the increasing focus on mental health in this domain, translation and dissemination of the program may be warranted after replication.

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.

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).

Introduction While the evidence of mental health benefits from investing in green space accumulates, claims of reduced healthcare expenditure are rarely supported by evidence from analyses of actual healthcare data. Additionally, the question of ‘who pays?’ has been ignored. We addressed these gaps using person-level data in three Australian cities. Methods 55,339 participants with a mean follow-up time of 4.97 years in the Sax Institute's 45 and Up Study (wave 2, collected 2012–2015) were linked to fee-for-service records of antidepressant prescriptions and talking therapy subsidised by the Australian Government (including data on per unit fee, state subsidy, and individual co-payment). Total green space, tree canopy and open grass within 1.6 km road network distances were linked to each participant. Multilevel logistic, negative binomial, and generalised linear models with gamma distribution adjusted for demographic and socioeconomic confounders were used to assess association between each green space variable and prescribing/referral and costs of antidepressants and talking therapy. Results Prescription of at least one course of antidepressants occurred for 20.01% (n = 11,071). Referral for at least one session of talking therapy occurred in 8.95% (n = 4954). 13,482 participants (24.4%) had either a prescription or a referral. A 10% increase in green space was associated with higher levels of antidepressant prescribing (e.g. incident rate ratio (IRR) = 1.06, 95%CI = 1.04–1.08). Tree canopy was not associated with antidepressant prescribing or referrals for talking therapy. Open grass was associated with higher odds (OR = 1.17, 95%CI = 1.13–1.20) and counts (IRR = 1.05, 95%CI = 1.02–1.08) of antidepressant prescriptions. Open grass was also associated with lower odds (OR = 0.87, 95%CI = 0.82–0.92) and counts (IRR = 0.93, 95%CI = 0.90–0.96) of talking therapy referrals. Open grass was associated with higher total and mean per-person levels of expenditure on antidepressant prescriptions. Conclusion Although green space supports mental health, these unexpected results provide pause for reflection on whether greening strategies will always result in purported reductions in mental healthcare expenditure.

This translation study assessed the effectiveness of two remotely delivered healthy eating and active living interventions for parents of 2- to 6-year-old children in improving child fruit and vegetable intake, non-core food intake, body mass index (BMI), physical activity, screen time, and sleep. Parents (n = 458) were recruited to a partially randomised preference trial comprising three intervention groups. Healthy Habits Plus comprised six telephone calls, Time2bHealthy comprised six online modules, and the active control comprised ten information sheets and a summary booklet. Data were collected from parents via a telephone questionnaire at baseline and nine months post-baseline. Data were analysed for randomised participants alone (n = 240), preference participants alone (n = 218), and all participants combined (n = 458). There was no significant improvement in fruit and vegetable intake (primary outcome) when comparing the telephone and online interventions to the control. In both the randomised only and all participants combined analyses, there was a significant improvement in non-core food intake for the telephone intervention compared to the control (p &lt, 0.001). Differences between interventions for other outcomes were small. In conclusion, the telephone and online interventions did not improve child fruit and vegetable intake relative to written materials, but the telephone intervention did improve non-core food intake.

Background: Treating chronic, uncontrolled, cancer pain with subcutaneous ketamine in patients unresponsive to opioids and co-analgesics remains controversial, especially in light of recent evidence demonstrating ketamine does not have net clinical benefit in this setting. Aim: To evaluate the cost-effectiveness of subcutaneous ketamine versus placebo in this patient population. Design and setting: A within-trial cost-effectiveness analysis of the Australian Palliative Care Clinical Studies Collaborative’s randomised, double-blind, placebo-controlled trial of ketamine was conducted from a healthcare provider perspective. Mean costs and outcomes were estimated from participant-level data over 5 days including positive response, health-related quality of life (HrQOL) measured with the Functional Assessment of Chronic Illness Therapy–Palliative Care (FACIT-Pal), ketamine costs, medication usage and in-patient stays. Results: There was no statistically significant difference in responder rates, but higher toxicity and worse HrQOL for ketamine participants (mean change −3.10 (standard error (SE) 1.76), ketamine n = 93; 4.53 (SE 1.38), placebo n = 92). Estimated total mean costs were AU$706 higher per ketamine participant (AU$6608) compared with placebo (AU$5902), attributable to the cost of higher in-patient costs as well as costs of ketamine administration. The results were robust to sensitivity analyses accounting for different medication use costing methods and removal of cost outliers. Conclusion: The findings suggest subcutaneous ketamine in conjunction with opioids and standard adjuvant therapy is neither an effective nor cost-effective treatment for refractory pain in advanced cancer patients.

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. 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. 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. Australian and New Zealand Clinical Trials Registry No: ACTRN12614000597695 , first received: June 5, 2014.

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. 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. 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. Australian New Zealand Clinical Trials Registry ACTRN12617000709347 . Date registered 17 May 2017. Retrospectively registered.

School garden and kitchen-based activities have potential as health-promoting school initiatives but lack well-designed evaluation frameworks. This article outlines an evaluation of a national kitchen garden program conducted in Australian primary schools. The aim was to evaluate the implementation and impact of a national garden and kitchen program in Australia, including child and health-related impacts of the program, and program implementation factors. The evaluation was undertaken using a multi-component, hierarchical evaluation framework that incorporated a modified case-control design and mixed methods. A cross-section of initiative (N=28) and comparison (N=14) schools was included. The Stephanie Alexander Kitchen Garden model achieved overall improvements in students’ food choices (as reported by students; t=2.26, p=0.024) and kitchen lifestyle behaviours (as reported by parents; t=2.35, p=0.019); female students and students from provincial schools had statistically greater improvements in food choices than other students and girls showed higher scores than boys (t=6.19, p The evaluation framework generated data that addressed the evaluation questions. Program integrity was maintained. Factors related to the program's implementation, sustainability, generalisability and return on investment were reported. Factors impacting the evaluation included lack of baseline data, specific data collection methods and time issues. The main conclusion drawn from the study is that structured hierarchical, multi-component evaluation is needed to provide practical insights into effective health promotion initiatives in schools.

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 inAustralia, the Consensus Panel agreed to adopt the Canadian recommendations and, apart from some minorchanges to the wording of good practice statements, keep the wording of the guidelines, preamble and title ofthe 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(

Within a jurisdiction adopting and trialling (AT) where a new therapy has positive, while uncertain net clinical benefit and overall net benefit is usually infeasible and unethical, as informed patients prefer certainty of treatment outside trial to chance of new therapy in a trial setting. Hence, ‘within jurisdiction’ feasible options as considered in Chap. 5 for such promising therapies or strategies will often be restricted to delaying and trialling (DT) or adopting now (AN) in optimising joint research and reimbursement decisions. However, in designing optimal trials across jurisdictions, trials don’t need to be undertaken within jurisdiction, and hence adopting and trialling in another jurisdiction becomes a feasible (and often valuable) option for promising therapies or strategies of interest with expected positive while uncertain INB. That is, a jurisdiction can adopt and translate trial evidence from other jurisdictions as part of optimising joint research and reimbursement decision and trial design across jurisdictions, and ideally globally, as this chapter considers following Eckermann and Willan (2009).

Faced with making a decision under uncertainty given current evidence of expected positive while uncertain INB such as the distribution for incremental net benefit in Fig. 5.2, what is the expected value of additional information? Given costs of obtaining additional evidence or information, is it worth undertaking further research or not? If it is optimal to undertake further research, how much research is optimal?

In this chapter, we consider optimal processes for joint reimbursement and research decisions between societal decision makers and manufacturers while also allowing for the role of uncertainty in pricing of new technologies, interventions or strategies. This forms the basis for robust risk-sharing arrangements as part of global trials, where it is feasible to adopt and trial. Consequently global trials with appropriately explicit coverage of evidence translation are shown to allow feasibly undertaking robust risk-sharing arrangements in jurisdictions who adopt and trial as part of optimal joint research and reimbursement processes. Such arrangements can mitigate against potential impacts of cost of reversal with adopting and trialling while avoiding opportunity costs of delay for promising new therapies for societal decision makers and manufacturers alike, while having appropriate incentives to create globally sufficient evidence and prices supporting early adoption.

Importance Antipsychotics are widely used for distressing symptoms of delirium, but efficacy has not been established in placebo-controlled trials in palliative care. Objective To determine efficacy of risperidone or haloperidol relative to placebo in relieving target symptoms of delirium associated with distress among patients receiving palliative care. Design, Setting, and Participants A double-blind, parallel-arm, dose-titrated randomized clinical trial was conducted at 11 Australian inpatient hospice or hospital palliative care services between August 13, 2008, and April 2, 2014, among participants with life-limiting illness, delirium, and a delirium symptoms score (sum of Nursing Delirium Screening Scale behavioral, communication, and perceptual items) of 1 or more. Interventions Age-adjusted titrated doses of oral risperidone, haloperidol, or placebo solution were administered every 12 hours for 72 hours, based on symptoms of delirium. Patients also received supportive care, individualized treatment of delirium precipitants, and subcutaneous midazolam hydrochloride as required for severe distress or safety. Main Outcome and Measures Improvement in mean group difference of delirium symptom score (severity range, 0-6) between baseline and day 3. Five a priori secondary outcomes: delirium severity, midazolam use, extrapyramidal effects, sedation, and survival. Results Two hundred forty-seven participants (mean [SD] age, 74.9 [9.8] years; 85 women [34.4%]; 218 with cancer [88.3%]) were included in intention-to-treat analysis (82 receiving risperidone, 81 receiving haloperidol, and 84 receiving placebo). In the primary intention-to-treat analysis, participants in the risperidone arm had delirium symptom scores that were significantly higher than those among participants in the placebo arm (on average 0.48 Units higher; 95% CI, 0.09-0.86;P = .02) at study end. Similarly, for those in the haloperidol arm, delirium symptom scores were on average 0.24 Units higher (95% CI, 0.06-0.42;P = .009) than in the placebo arm. Compared with placebo, patients in both active arms had more extrapyramidal effects (risperidone, 0.73; 95% CI, 0.09-1.37;P = .03; and haloperidol, 0.79; 95% CI, 0.17-1.41;P = .01). Participants in the placebo group had better overall survival than those receiving haloperidol (hazard ratio, 1.73; 95% CI, 1.20-2.50;P = .003), but this was not significant for placebo vs risperidone (hazard ratio, 1.29; 95% CI, 0.91-1.84;P = .14). Conclusions and Relevance In patients receiving palliative care, individualized management of delirium precipitants and supportive strategies result in lower scores and shorter duration of target distressing delirium symptoms than when risperidone or haloperidol are added. Trial Registration anzctr.org.au Identifier:ACTRN12607000562471.

Chapter 2 highlighted how satisfying decision analytic principles of coverage and comparability with joint consideration of cost and effects are fundamental to allowing unbiased trial-based cost effectiveness analysis for two-strategy comparisons. In this chapter, we extend these principles to identify methods for robust cost effectiveness analysis relevant to decision making in any given jurisdiction of interest (e.g. Australia with a PBAC remit, the UK with a NICE remit), while highlighting common biases, pitfalls and fallacies that should be avoided. Satisfying coverage and comparability principles for unbiased analysis in a jurisdiction of interest is shown to usually require robust methods for evidence synthesis and translation and potentially extrapolation. In particular, methods are required which avoid common inferential fallacies and selection biases associated with partialisation of analysis (O’Brien 1996; Briggs and O’Brien 2001) and alternative framing of binary outcomes (Eckermann and Willan 2009, 2011).