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.

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.

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.

Globally optimal trial design and risk sharing arrangements are key to avoiding opportunity costs of delay and enabling equitable, feasible and effective global vaccine research and implementation in current or future pandemics.

Global vaccination in the face of pandemics such as COVID-19 and new variants is a race against time. Avoiding the opportunity costs of delay and the associated health, social, and downstream economic impacts is a challenge and an imperative. Failures to address the global challenges posed by COVID-19 have become increasingly evident as waves of vaccine-evading mutations have emerged, facilitated by unequal vaccination coverage and diminishing immunity against new variants worldwide. To address these challenges, societal decision-makers (governments) and industry manufacturer interests must be better aligned for rapid, globally optimal trial design, ideally with research coverage, implementation, and accessibility of effective vaccines across joint research, implementation, and distribution cycles to address pandemic evolution in real time. Value of information (VoI) methods for optimal global trial design and risk-sharing arrangements align the research, distribution, and implementation interests and efforts globally to meet head-on the imperative of avoiding opportunity costs of delay and enabling consistent global solutions with maximizing local and global net benefits. They uniquely enable feasible early adoption of the most promising strategies in real time while the best globally translatable evidence is collected and interests are aligned for global distribution and implementation. Furthermore, these methods are generally shown to be imperative for feasible, fast, and optimal solutions across joint research, reimbursement, and regulatory processes for current and future pandemics and other global existential threats. Establishing pathways for globally optimal trial designs, risk-sharing agreements, and efficient translation to practice is urgent on many fronts.

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.

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.

Is urban green space associated with lower mental healthcare expenditure?

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.

More green, less lonely? A longitudinal cohort study.

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) (<400, <800 and <1600 m) were adjusted for age, sex, disability, cohabitation status, children and socio-economic variables. Results were translated into absolute risk reductions in loneliness per 10% increase in urban greening. 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 <10% green space, the ORs for cumulative incident loneliness were 0.833 (95% CI = 0.695 to 0.997), 0.790 (95% CI = 0.624 to 1.000) and 0.736 (95% CI = 0.549 to 0.986) for 10-20%, 20-30% and >30% green space, respectively. Compared with the <10% green-space reference group with 13.78% incident loneliness over 4 years and conservatively assuming no impact on incident loneliness, associations translated into absolute risk reductions of 1.70%, 2.26% and 2.72% within populations with 10-20%, 20-30% and >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.

Active Lives South Australia health economic analysis: an evidence base for the potential of health promotion strategies supporting physical activity guidelines to reduce public health costs while improving wellbeing.

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.

Translation of Two Healthy Eating and Active Living Support Programs for Parents of 2-6-Year-Old Children: Outcomes of the 'Time for Healthy Habits' Parallel Partially Randomised Preference Trial.

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 < 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.

Multiple effects health economic evaluation of the Ahead of The Game Study for mental health promotion in sporting club communities.

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 < 1% level) and global measures (significant at 0.001% level), while mean AOTG implementation costs were conservatively estimated as $37.47 per participant. 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.

The effect of omega-3 long chain polyunsaturated fatty acids on aggressive behaviour in adult male prisoners: a structured study protocol for a multi-centre, double-blind, randomised placebo-controlled trial and translation into policy and practice.

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.

An Intervention for Mental Health Literacy and Resilience in Organized Sports.

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.

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).

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).

'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.

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.