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Although it is generally accepted that human tissue biobanks are important to facilitate progress in health and medical research, many academic biobanks face sustainability challenges. We propose that biobank sustainability is challenged by a lack of available data describing the outputs and benefits that are produced by biobanks, as reflected by a dearth of publications that enumerate biobank outputs. We further propose that boosting the available information on biobank outputs and using a broader range of output metrics will permit economic analyses such as cost-consequence analyses of biobank activity. Output metrics and cost-consequence analyses can allow biobanks to achieve efficiencies, and improve the quality and/or quantity of their outputs. In turn, biobank output measures provide all stakeholders with explicit and accountable data on biobank value, which could contribute to the evolution of biobank operations to best match research needs, and mitigate some threats to biobank sustainability.

Asthma exacerbations in pregnancy are associated with adverse perinatal outcomes. We aimed to determine whether fractional exhaled nitric oxide (The Breathing for Life Trial was a multicentre, parallel-group, randomised controlled trial conducted in six hospital antenatal clinics, which compared asthma management guided byPregnant women with current asthma were recruited; 599 to the control group (608 infants) and 601 to the intervention (615 infants). There were no significant group differences for the primary composite perinatal outcome (152 (25.6%) out of 594 control, 177 (29.4%) out of 603 intervention; OR 1.21, 95% CI 0.94-1.56; p=0.15), preterm birth (OR 1.14, 95% CI 0.78-1.68), SGA (OR 1.06, 95% CI 0.78-1.68), perinatal mortality (OR 3.62, 95% CI 0.80-16.5), neonatal hospitalisation (OR 1.24, 95% CI 0.89-1.72) or maternal asthma exacerbations requiring hospital admission or emergency department presentation (OR 1.19, 95% CI 0.69-2.05).

Aims The burden and health costs of Type 2 Diabetes Mellitus continue to increase globally and prevention strategies in at-risk people need to be explored. Previous work, in both animal models and humans, supports the role of zinc in improving glucose homeostasis. We, therefore, aimed to test the effectiveness of zinc supplementation on glycaemic control in pre-diabetic adults. Methods We conducted a randomized, double-blind, placebo-controlled trial across 10 General Practitioner (GP) practices in NSW, Australia. The trial is known as Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD)Study. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7–6.4%, 39–46 mmol/mol) men and women (N = 98) were all assigned to a free state government telephone health coaching service (New South Wales Get Healthy Information and Coaching Service) and then randomised to either daily 30 mg zinc gluconate or placebo. Blood tests were collected at baseline, 1, 6 and 12 months for the primary outcomes (HbA1c, fasting blood glucose (FBG)); secondary outcomes included Homeostasis Model Assessment 2 (HOMA 2) parameters, lipids, body weight, height, waist circumference, blood pressure and pulse. Results The baseline-adjusted mean group difference at 6 months, expressed as treatment–placebo, (95% CI) was −0.02 (−0.14, 0.11, p = 0.78) for HbA1c and 0.17 (−0.07, 0.42; p = 0.17) for FBG, neither of which were statistically significant. There were also no significant differences between groups in any of the secondary outcomes. Zinc was well tolerated, and compliance was high (88%). Conclusion We believe our results are consistent with other Western clinical trial studies and do not support the use of supplemental zinc in populations with a Western diet. There may still be a role for supplemental zinc in the developing world where diets may be zinc deficient. Trial registration Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268. Registered on 6 July 2018.

Refereed/Peer-reviewed Background: About 44% of Indigenous Australian women smoke during pregnancy, compared with 12% of pregnant non-Indigenous women. Health care providers can assist smoking cessation, but they are not typically trained in culturally appropriate methods. Objectives: To determine whether a health care worker training intervention increases smoking cessation rates among Indigenous pregnant smokers compared with usual care. Methods and analysis: Supporting Indigenous Smokers to Assist Quitting (SISTAQUIT) study is a multicentre, hybrid type 1, pragmatic, cluster randomised controlled trial that compares the effects of an intervention for improving smoking cessation by pregnant Indigenous women (16 years or older, 32 weeks’ gestation or less) with usual care. Twenty-one health services caring for Indigenous people in five Australian jurisdictions were randomised to the intervention (ten sites) or control groups (eleven sites). Health care providers at intervention sites received smoking cessation care training based on the ABCD (ask/assess; brief advice; cessation; discuss psychosocial context) approach to smoking cessation for Indigenous women, an educational resource package, free oral nicotine replacement therapy for participating women, implementation support, and trial implementation training. Health care providers in control group services provided usual care. Primary outcome: abstinence from smoking (self-reported abstinence via survey, validated by carbon monoxide breath testing when possible) four weeks after enrolment in the study. Secondary outcomes: health service process evaluations; knowledge, attitudes, and practices of health care providers; and longer term abstinence, perinatal outcomes, and respiratory outcomes for babies (to six months). Ethics approval: The human research ethics committees of the University of Newcastle (H-2015-0438) and the Aboriginal Health and Medical Research Council of NSW (1140/15) provided the primary ethics approval. Dissemination of results: Findings will be disseminated in peer-reviewed publications, at local and overseas conferences, and via public and social media, and to participating health services in art-based formats and reports. Policy briefs will be communicated to relevant government organisations. Trial registration: Australia New Zealand Clinical Trials Registry, ACTRN12618000972224 (prospective).

Background: Achieving system-level, sustainable ‘scale-up’ of interventions is the epitome of successful translation of evidence-based approaches in population health. In physical activity promotion, few evidence-based interventions reach implementation at scale or become embedded within systems for sustainable health impact. This is despite the vast published literature describing efficacy studies of small-scale physical activity interventions. Research into physical activity scale-up (through case-study analysis; evaluations of scale-up processes in implementation trials; and mapping the processes, strategies, and principles for scale-up) has identified barriers and facilitators to intervention expansion. Many interventions are implemented at scale by governments but have not been evaluated or have unpublished evaluation information. Further, few public health interventions have evaluations that reveal the costs and benefits of scaled-up implementation. This lack of economic information introduces an additional element of risk for decision makers when deciding which physical activity interventions should be supported with scarce funding resources. Decision-makers face many other challenges when scaling interventions which do not relate to formal research trials of scale-up; Methods: To explore these issues, a multidisciplinary two-day workshop involving experts in physical activity scale-up was convened by the University of Newcastle, Australia, and the University of Ottawa, Canada (February 2019); Results: In this paper we discuss some of the scale-up tensions (challenges and conflicts) and paradoxes (things that are contrary to expectations) that emerged from this workshop in the context of the current literature and our own experiences in this field. We frame scale-up tensions according to epistemology, methodology, time, and partnerships; and paradoxes as ‘reach without scale’, ‘planned serendipity’ and ‘simple complexity’. We reflect on the implications of these scale-up tensions and paradoxes, providing considerations for future scale-up research and practice moving forward; Conclusions: In this paper, we delve deeper into stakeholders’ assumptions, processes and expectations of scaling up, and challenge in what ways as stakeholders, we all contribute to desired or undesired outcomes. Through a lens of ‘tensions’ and ‘paradoxes’, we make an original contribution to the scale-up literature that might influence current perspectives of scaling-up, provide future approaches for physical activity promotion, and contribute to understanding of dynamic of research-practice partnerships.

Objectives Implementation interventions applied in public health are about using proven strategies to influence the uptake of evidence-based prevention and health promotion initiatives. The decision to invest in implementation has an opportunity cost, which can be overlooked. The purpose of this study was to assess the extent to which economic evaluations have been applied to implementation interventions in public health. Study design We conducted a systematic review of empirical studies examining the costs and consequences, cost-effectiveness or cost-benefit of strategies directed towards enhancing the implementation of public health interventions and policies in developed countries. Methods The following databases were searched for English language publications reporting both effect measures and costs, from 1990 to current: MEDLINE, Embase, PsycINFO, CINAHL, EconLit, EPPI-Centre database of health promotion research, Cost-Effectiveness Analysis Registry, NHS Economic Evaluation Database, Informit and Scopus. Results The search strategy returned 3229 records after duplicate removal, from which we included 14 economic evaluations. All the included evaluations were conducted and published after 2000. Twelve of the 14 evaluations were based on controlled trials and two reported hypothetical modelled scenarios. The methodologic rigour and compliance with reporting guidelines for economic evaluations was highly varied and not related to the publication date. Conclusions Our findings offer the first insight into the application and methodologic rigour of economic evaluations of implementation strategies supporting public health policies and interventions. To usefully inform public health policy and investment decisions, there needs to be greater application of economic evaluation to understand the cost-effectiveness of alternative implementation efforts. This review highlights the great paucity and mixed quality of the evidence on this topic and offers guidance by way of a checklist to improve the quality and reporting of future evaluations.

Background Implementation of antenatal clinical guideline recommendations for addressing maternal alcohol consumption is sub-optimal. There is a complete absence of evidence of the cost and cost-effectiveness of delivering practice change interventions addressing maternal alcohol consumption amongst women accessing maternity services. The study sought to determine the cost, cost-consequence and cost-effectiveness of developing and delivering a multi-strategy practice change intervention in three sectors of a health district in New South Wales, Australia. Methods The trial-based economic analyses compared the costs and outcomes of the intervention to usual care over the 35-month period of the stepped-wedge trial. A health service provider perspective was selected to focus on the cost of delivering the practice change intervention, rather than the cost of delivering antenatal care itself. All costs are reported in Australian dollars ($AUD, 2019). Univariate and probabilistic sensitivity analyses assessed the effect of variation in intervention effect and costs. Results The total cost of delivering the practice change intervention across all three sectors was $367,646, of which $40,871 (11%) were development costs and $326,774 (89%) were delivery costs. Labour costs comprised 70% of the total intervention delivery cost. A single practice change strategy, ‘educational meetings and educational materials’ contributed 65% of the delivery cost. Based on the trial’s primary efficacy outcome, the incremental cost effectiveness ratio was calculated to be $32,570 (95% CI: $32,566–$36,340) per percent increase in receipt of guideline recommended care. Based on the number of women attending the maternity services during the trial period, the average incremental cost per woman who received all guideline elements was $591 (Range: $329 - $940) . The average cost of the intervention per eligible clinician was $993 (Range: $640-$1928). Conclusion The intervention was more effective than usual care, at an increased cost. Healthcare funders’ willingness to pay for this incremental effect is unknown. However, the strategic investment in systems change is expected to improve the efficiency of the practice change intervention over time. Given the positive trial findings, further research and monitoring is required to assess the sustainability of intervention effectiveness and whether economies of scale, or reduced costs of intervention delivery can be achieved without impact on outcomes. Trial registration The trial was prospectively registered with the Australian and New Zealand Clinical Trials Registry, No. ACTRN12617000882325 (date registered: 16/06/2017).

BackTrack is a multi-component, community-based intervention designed to build capacity amongst 14–17-year-old high risk young people. The aim of the current study seeks to explore community value and preferences for reducing youth crime and improving community safety using BackTrack in a rural setting in Armidale, New South Wales, Australia. The study design used discrete choice experiments (DCEs), designed in accordance with the 10-item checklist outlined by the International Society for Pharmacoeconomics and Outcomes Research. The DCE was pilot tested on 43 participants to test feasibility and comprehension. A revised version of the survey was subsequently completed by 282 people over a 12-day period between 30 May 2016 and 10 June 2016, representing a survey response rate of 35%. Ninety per cent of respondents were residents of Armidale, the local rural town where BackTrack was implemented. The DCE generated results that consistently demonstrated a preference for social programs to address youth crime and community safety in the Armidale area. Respondents chose BackTrack over Greater Police Presence 75% of the time with an annual benefit of Australian dollars (AUD) 150 per household, equivalent to a community benefit of AUD 2.04 million. This study estimates a strong community preference for BackTrack relative to more policing (a community willing to pay equivalent to AUD 2.04 million) highlighting the clear value of including community preferences when evaluating community-based programs for high-risk young people.

PurposeThe purpose of this paper is to argue for an improved conceptualisation of health service research, using Stengers' (2018) metaphor of “slow science” as a critical yardstick.Design/methodology/approachThe paper is structured in three parts. It first reviews the field of health services research and the approaches that dominate it. It then considers the healthcare research approaches whose principles and methodologies are more aligned with “slow science” before presenting a description of a “slow science” project in which the authors are currently engaged.FindingsCurrent approaches to health service research struggle to offer adequate resources for resolving frontline complexity, principally because they set more store by knowledge generalisation, disciplinary continuity and integrity and the consolidation of expertise, than by engaging with frontline complexity on its terms, negotiating issues with frontline staff and patients on their terms and framing findings and solutions in ways that key in to the in situ dynamics and complexities that define health service delivery.Originality/valueThere is a need to engage in a paradigm shift that engages health services as co-researchers, prioritising practical change and local involvement over knowledge production. Economics is a research field where the products are of natural appeal to powerful health service managers. A “slow science” approach adopted by the embedded Economist Program with its emphasis on pre-implementation, knowledge mobilisation and parallel site capacity development sets out how research can be flexibly produced to improve health services.

Background In 2017, the NSW Central Coast Local Hospital District (CCLHD) designed and implemented the Outcomes Based Care program to vulnerable older people healthy and at home. Two not for profit providers were commissioned to deliver their own form of care coordination for one year. Provider payments were based on their capacity to reduce unplanned public hospital bed days for an allocated patient cohort. Objectives Our study objectives were to explore how provider and service characteristics, along with patient behaviours, and mediators and moderators of service delivery, may have impacted outcomes. These included hospital utilisation, health outcomes and patient experience with care coordination. Methods The process evaluation explored mechanisms of impact and contextual factors, including the risk stratification approach, frailty of the patient cohort and impact of the funding incentives for care coordination between the CCLHD, community providers and hospitals. Evaluation criteria were developed after a systematic literature review. Information was collected through patient surveys, interviews with patients, providers, the CCLHD and additional program documentation. Results The primary outcomes showed a significant reduction in hospital activity for both the intervention and the control group. While there was an overall decrease in hospital use, modelling results suggest Outcomes Based Care increased ED visits for the intervention group. The risk stratification approach resulted in the selection of a cohort of older patients with more complex patients than anticipated. The funding incentives shifted financial risk to providers, but all allocated unplanned hospital bed days were used within six months with the contract needing to be renegotiated. Survey data suggests providers supported patients in the self-management of their medical conditions but is unclear whether the level of patient engagement was appropriate to achieve intended outcomes. Providers note the lack of General Practitioner and patient engagement hampered efforts to improve health outcomes. Discussion International experience presents similar results for care coordination approaches. A review of 15 randomised trials developed within the US found only three coordinated care programs experienced a significant difference in hospitalisations. One program increased hospitalisations by 19 per cent. Similar findings were identified in the UK with significantly increased ED visits and unplanned hospitalisations compared to control groups, though these weren’t part of a commissioning pilot. Limitations Survey data was intended to be collected at enrolment and again when Outcomes Based Care finished. They were not administered as planned and the timings varied for each survey and between the enrolled and control groups. Response rates also varied by survey type and mode of administration. One provider, in particular did not capture adequate evaluation data. Conclusions The study has important evidence based implications for the development of approaches designed to keep older people healthy and at home and to incentivise the delivery of care. Lessons learned Fourteen evaluation recommendations explore health outcomes, cost effectiveness, patient experience and unintended consequences that specifically relate to outcomes based commissioning designed to keep older people healthy and at home. Suggestions for future research Further models of outcomes based funding should be piloted within the NSW healthcare system.

Background In hospitals, catheter acquired urinary tract infection causes significant resource waste and discomfort among admitted patients. An intervention for reducing indwelling catheterisations - No-CAUTI - was trialled across four hospitals in New South Wales, Australia. No-CAUTI includes: train-the-trainer workshops, site champions, compliance audits, and point prevalence surveys. The trial showed reductions on usual care catheterisation rates at 4- and 9-month post-intervention. This result was statistically non-significant; and post-intervention catheterisation rates rebounded between 4 and 9 months. However, No-CAUTI showed statistically significant catheterisation decreases for medical wards, female patients and for short-term catheterisations. This study presents a budget impact analysis of a projected five year No-CAUTI roll out across New South Wales public hospitals, from the cost perspective of the New South Wales Ministry of Health. Methods Budget forecasts were made for five year roll outs of: i) No-CAUTI; and ii) usual care, among all public hospitals in New South Wales hosting overnight stays (n=180). The roll out design maintains intervention effectiveness with ongoing workshops, quality audits, and hospital surveys. Forecasts of catheterisations, procedures and treatments were modelled on No-CAUTI trial observations. Costs were sourced from trial records, the Medical Benefits Scheme, the Pharmaceutical Benefits Scheme and public wage awards. Cost and parameter uncertainties were considered with sensitivity scenarios. Results The estimated five-year No-CAUTI roll-out cost was $1.5 million. It had an overall budget saving of $640,000 due to reductions of 100,100 catheterisations, 33,300 urine tests and 6,700 antibiotics administrations. Non-Metropolitan hospitals had a net saving of $1.2 million, while Metropolitan hospitals had a net cost of $0.54 million. Conclusions Compared to usual care, NO-CAUTI is expected to realise overall budget savings and decreases in catheterisations over five years. These findings allow a consideration of the affordability of a wide implementation. Trial registration Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000090314). First registered 17 January 2017, retrospectively. First enrolment, 15/11/2016.

ObjectivesTo (1) apply the Framework to Assess the Impact from Translational health research (FAIT) to Lessons from the Best to Better the Rest (LFTB), (2) report on impacts from LFTB and (3) assess the feasibility and outcomes from a retrospective application of FAIT.SettingThree Indigenous primary healthcare (PHC) centres in the Northern Territory, Australia; project coordinating centre distributed between Townsville, Darwin and Cairns and the broader LFTB learning community across Australia.ParticipantsLFTB research team and one representative from each PHC centre.Primary and secondary outcome measuresImpact reported as (1) quantitative metrics within domains of benefit using a modified Payback Framework, (2) a cost-consequence analysis given a return on investment was not appropriate and (3) a narrative incorporating qualitative evidence of impact. Data were gathered through in-depth stakeholder interviews and a review of project documentation, outputs and relevant websites.ResultsLFTB contributed to knowledge advancement in Indigenous PHC service delivery; enhanced existing capacity of health centre staff, researchers and health service users; enhanced supportive networks for quality improvement; and used a strengths-based approach highly valued by health centres. LFTB also leveraged between $A1.4 and $A1.6 million for the subsequent Leveraging Effective Ambulatory Practice (LEAP) Project to apply LFTB learnings to resource development and creation of a learning community to empower striving PHC centres.ConclusionRetrospective application of FAIT to LFTB, although not ideal, was feasible. Prospective application would have allowed Indigenous community perspectives to be included. Greater appreciation of the full benefit of LFTB including a measure of return on investment will be possible when LEAP is complete. Future assessments of impact need to account for the limitations of fully capturing impact when intermediate/final impacts have not yet been realised and captured.

This aim of this paper is to set the scene for the need for impact assessment and return on investment in funded cardiovascular research in Australia, starting with the historical perspective on waste in health and medical research. Recently there has been a substantial move from discussion and policy about the need for research translation, into practice and application via the evolution of funding streams like the Australian Medical Research Future Fund (MRFF). Health and medical research funders play a critical role in both setting the expectations for research translation and impact and helping researchers to meet these expectations. As a leading cause of death, cardiovascular disease is a national health priority, recognised as such with a AUD$220 million MRFF allocation to the Cardiovascular Health Mission. Focussing on cardiovascular research, we address some of the barriers researchers face in prospectively planning for research translation and impact assessment, and call for an ecosystem that supports a return on investment for all stakeholders, especially the community and patient end-users.

Highlights • Over 80% of CMOs are providing preventive care for at least one health behaviour. • Between 16% and 57% of CMOs are providing preventive care for all health behaviours. • Physical activity was most frequently addressed for 50% or more CMO consumers. • Tobacco smoking was least frequently addressed for 50% or more CMO consumers. • Staff training and guidelines were associated with preventive care provision., People living with mental health conditions have a reduced life expectancy of approximately 10 years compared to the general population, largely due to physical chronic diseases and higher rates of tobacco smoking, poor nutrition, harmful alcohol consumption, physical inactivity and poor sleep behaviours. Community managed organisations (CMOs) may play a valuable role in providing preventive care to people with mental health conditions (consumers) to address these health behaviours. This paper reports the findings of a cross-sectional survey undertaken between November 2018 and February 2019 with leaders of CMOs (n = 76) that support people with mental health conditions in the state of New South Wales, Australia to: 1) measure the provision of preventive care (screening, support, and connections to specialist services) for five health behaviours; 2) identify the presence of key organisational features (e.g., data collection, staff training); and 3) explore if these organisational features were associated with the provision of preventive care. Preventive care provision to a majority of consumers (50% or more) was least frequently reported for tobacco smoking and most frequently reported for physical activity. Staff training and guidelines regarding the provision of preventive care were associated with the provision of such care. The results demonstrate that CMOs are already engaged in providing preventive care to some extent, with certain behaviours and preventive care elements addressed more frequently than others. Further research with additional CMO stakeholders, including staff and consumers, is needed to gain a deeper understanding of factors that may underlie CMOs capacity to routinely provide preventive care.

BACKGROUND Mutual support groups are an important source of long-term help for people impacted by addictive behaviors. Routine outcome monitoring (ROM) and feedback are yet to be implemented in these settings. SMART Recovery mutual support groups focus on self-empowerment and use evidence-based techniques (eg, motivational and behavioral strategies). Trained facilitators lead all SMART Recovery groups, providing an opportunity to implement ROM. OBJECTIVE The aim of this stage 1 pilot study is to explore the feasibility, acceptability, and preliminary outcomes of a novel, purpose-built mobile health ROM and feedback app (SMART Track) in mutual support groups coordinated by SMART Recovery Australia (SRAU) over 8 weeks. METHODS SMART Track was developed during phase 1 of this study using participatory design methods and an iterative development process. During phase 2, 72 SRAU group participants were recruited to a nonrandomized, prospective, single-arm trial of the SMART Track app. Four modes of data collection were used: ROM data directly entered by participants into the app; app data analytics captured by Amplitude Analytics (number of visits, number of unique users, visit duration, time of visit, and user retention); baseline, 2-, and 8-week follow-up assessments conducted through telephone; and qualitative telephone interviews with a convenience sample of study participants (20/72, 28%) and facilitators (n=8). RESULTS Of the 72 study participants, 68 (94%) created a SMART Track account, 64 (88%) used SMART Track at least once, and 42 (58%) used the app for more than 5 weeks. During week 1, 83% (60/72) of participants entered ROM data for one or more outcomes, decreasing to 31% (22/72) by the end of 8 weeks. The two main screens designed to provide personal feedback data (Urges screen and Overall Progress screen) were the most frequently visited sections of the app. Qualitative feedback from participants and facilitators supported the acceptability of SMART Track and the need for improved integration into the SRAU groups. Participants reported significant reductions between the baseline and 8- week scores on the Severity of Dependence Scale (mean difference 1.93, SD 3.02; 95% CI 1.12-2.73) and the Kessler Psychological Distress Scale-10 (mean difference 3.96, SD 8.31; 95% CI 1.75-6.17), but no change on the Substance Use Recovery Evaluator (mean difference 0.11, SD 7.97; 95% CI –2.02 to 2.24) was reported. CONCLUSIONS Findings support the feasibility, acceptability, and utility of SMART Track. Given that sustained engagement with mobile health apps is notoriously difficult to achieve, our findings are promising. SMART Track offers a potential solution for ROM and personal feedback, particularly for people with substance use disorders who attend mutual support groups. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336 INTERNATIONAL REGISTERED REPORT RR2-10.2196/15113

BACKGROUND There is significant opportunity to improve the nutritional quality of foods packed in children’s school lunchboxes. Interventions that are effective and scalable targeting the school and home environment are therefore warranted. OBJECTIVE This study aimed to assess the effectiveness of a multicomponent, mobile health–based intervention, SWAP IT, in reducing the energy contribution of discretionary (ie, less healthy) foods and drinks packed for children to consume at school. METHODS A type I effectiveness–implementation hybrid cluster randomized controlled trial was conducted in 32 primary schools located across 3 local health districts in New South Wales, Australia, to compare the effects of a 6-month intervention targeting foods packed in children’s lunchboxes with those of a usual care control. Primary schools were eligible if they were not participating in other nutrition studies and used the required school communication app. The Behaviour Change Wheel was used to co-design the multicomponent SWAP IT intervention, which consisted of the following: school lunchbox nutrition guidelines, curriculum lessons, information pushed to parents digitally via an existing school communication app, and additional parent resources to address common barriers to packing healthy lunchboxes. The primary outcome, mean energy (kilojoules) content of discretionary lunchbox foods and drinks packed in lunchboxes, was measured via observation using a validated school food checklist at baseline (May 2019) and at 6-month follow-up (October 2019). Additional secondary outcomes included mean lunchbox energy from discretionary foods consumed, mean total lunchbox energy packed and consumed, mean energy content of core lunchbox foods packed and consumed, and percentage of lunchbox energy from discretionary and core foods, all of which were also measured via observation using a validated school food checklist. Measures of school engagement, consumption of discretionary foods outside of school hours, and lunchbox cost were also collected at baseline and at 6-month follow-up. Data were analyzed via hierarchical linear regression models, with controlling for clustering, socioeconomic status, and remoteness. RESULTS A total of 3022 (3022/7212, 41.90%) students consented to participate in the evaluation (mean age 7.8 years; 1487/3022, 49.22% girls). There were significant reductions between the intervention and control groups in the primary trial outcome, mean energy (kilojoules) content of discretionary foods packed in lunchboxes (–117.26 kJ; 95% CI –195.59 to –39.83; P=.003). Relative to the control, the intervention also significantly reduced secondary outcomes regarding the mean total lunchbox energy (kilojoules) packed (–88.38 kJ; 95% CI –172.84 to –3.92; P=.04) and consumed (–117.17 kJ; 95% CI –233.72 to –0.62; P=.05). There was no significant difference between groups in measures of student engagement, consumption of discretionary foods outside of school hours, or cost of foods packed in children’s lunchboxes. CONCLUSIONS The SWAP IT intervention was effective in reducing the energy content of foods packed for and consumed by primary school–aged children at school. Dissemination of the SWAP IT program at a population level has the potential to influence a significant proportion of primary school–aged children, impacting weight status and associated health care costs. CLINICALTRIAL Australian Clinical Trials Registry ACTRN12618001731280; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376191&isReview=true INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7725-x

Background: Asthma exacerbations in pregnancy are associated with adverse perinatal outcomes. FENO-based management in pregnancy reduced asthma exacerbations in a previous trial. BLT examined whether FENO-based asthma management would improve perinatal outcomes. Methods: BLT was a multi-centre, parallel group, RCT of asthma management guided by a FENO algorithm versus usual care. 1200 pregnant women with doctor diagnosed asthma and symptoms, or medication use for asthma in the previous year, were randomised to usual care (baseline assessment of asthma and no treatment changes) or FENO-based management. In the intervention group, a modified FENO algorithm was applied each 6-12 weeks (FENO used to adjust ICS dose, long acting beta agonist added when symptoms uncontrolled). A composite adverse perinatal outcome (preterm birth, intrauterine growth restriction, perinatal mortality, neonatal hospitalisation) was assessed from hospital records (primary outcome). Exacerbations in pregnancy (admission, emergency department visit, unscheduled doctor visit or oral steroid course) were assessed postpartum. Results: Baseline characteristics were similar between usual care (n=599) and FENO (n=601) groups. Intention to treat analysis found no significant difference between groups for the composite perinatal outcome (25.6% usual care, 29.4% FENO, OR 1.21 [0.94, 1.56]), all components of the composite outcome, and maternal exacerbations (19.2% usual care, 16.1% FENO, OR 0.80 [0.58, 1.10]). Conclusion: FENO-guided asthma management had no effect on perinatal outcomes. Funding: NHMRC Australia

Objective To evaluate whether a safe medication strategy compared with usual care, provided to people with dementia during an unplanned admission, reduces readmissions to hospital and re-presentation to emergency departments within three months. Methods A prospective, controlled pre-/post-trial conducted at two regional hospitals in New South Wales, Australia. Results No treatment effect was seen for time to first re-presentation or readmission within three months (P = .3). Compliance with six strategies applicable for all participants in the intervention phase was 58%. There was no treatment effect for secondary outcomes including dose administration aid use, home medicines review (HMR) requests by general practitioners and completed HMRs; however, they were significantly higher at the intervention site in both phases. Conclusion A bundle of care to improve medication safety in people with dementia did not reduce re-presentations or readmissions within three months.

Background People with dementia (PWD) are at risk for medication related harm due to their impaired cognition and frequently being prescribed many medications. Few previous studies of PWD inpatients have been focused on medication safety interventions.This study aimed to evaluate an intervention designed to improve medication safety for people with dementia (PWD) and their carers during an unplanned admission to hospital. This article reports the effect of the intervention on potentially inappropriate medications (PIMs), polypharmacy and anticholinergic burden scores for PWD in the study. Methods A quasi-experimental pre-post design using an intervention site and a control site was conducted in 2017-2019, in a regional area in New South Wales, Australia. PIMs, polypharmacy and anticholinergic burden were measured at admission, discharge and three months after discharge. In addition, medication reconciliation at admission and scoring of pharmacists recommendations using severity and relevance scores were measured. Results There were 628 participants including 350 in the post-intervention phase. Polypharmacy for these admissions was high, and there was approximately 30% reduction in the number of medications at discharge. PIMs at admission were also high, and decreased significantly at discharge however there was no treatment effect associated with the intervention. The mean anticholinergic burden score also decreased significantly between admission and discharge, however, no treatment effect was seen. Conclusions High rates of polypharmacy and PIMs in this study indicate this study population was admitted with multiple comorbidities. Reduced PIMs at discharge were correlated with reduced anticholinergic burden. Medication reconciliation resulted in many recommendations that contributed to the reductions in medications. Although the study did not report a treatment effect, reductions in the number of medications and PIMs reduced medication related risk for PWD. Reduced risks associated with inappropriate or unnecessary medications can reduce hospital admissions and adverse events for PWD. This intervention was feasible to implement, and future multisite studies should be designed to recruit larger study samples to evaluate interventions for improving medication safety for PWD. They should also adopt routine screening for cognitive impairment to identify PWD at admission.

Background Despite the importance and popularity of mutual support groups, there have been no systematic attempts to implement and evaluate routine outcome monitoring (ROM) in these settings. Unlike other mutual support groups for addiction, trained facilitators lead all Self-Management and Recovery Training (SMART Recovery) groups, thereby providing an opportunity to implement ROM as a routine component of SMART Recovery groups. Objective This study protocol aims to describe a stage 1 pilot study designed to explore the feasibility and acceptability of a novel, purpose-built mobile health (mHealth) ROM and feedback app (Smart Track) in SMART Recovery groups coordinated by SMART Recovery Australia (SRAU) The secondary objectives are to describe Smart Track usage patterns, explore psychometric properties of the ROM items (ie, internal reliability and convergent and divergent validity), and provide preliminary evidence for participant reported outcomes (such as alcohol and other drug use, self-reported recovery, and mental health). Methods Participants (n=100) from the SMART Recovery groups across New South Wales, Australia, will be recruited to a nonrandomized, prospective, single-arm trial of the Smart Track app. There are 4 modes of data collection: (1) ROM data collected from group participants via the Smart Track app, (2) data analytics summarizing user interactions with Smart Track, (3) quantitative interview and survey data of group participants (baseline, 2-week follow-up, and 2-month follow-up), and (4) qualitative interviews with group participants (n=20) and facilitators (n=10). Feasibility and acceptability (primary objectives) will be analyzed using descriptive statistics, a cost analysis, and a qualitative evaluation. Results At the time of submission, 13 sites (25 groups per week) had agreed to be involved. Funding was awarded on August 14, 2017, and ethics approval was granted on April 26, 2018 (HREC/18/WGONG/34; 2018/099). Enrollment is due to commence in July 2019. Data collection is due to be finalized in October 2019. Conclusions To the best of our knowledge, this study is the first to use ROM and tailored feedback within a mutual support group setting for addictive behaviors. Our study design will provide an opportunity to identify the acceptability of a novel mHealth ROM and feedback app within this setting and provide detailed information on what factors promote or hinder ROM usage within this context. This project aims to offer a new tool, should Smart Track prove feasible and acceptable, that service providers, policy makers, and researchers could use in the future to understand the impact of SMART Recovery groups. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336. International Registered Report Identifier (IRRID) PRR1-10.2196/15113

Background Despite the known benefits of healthy eating in childhood, few Australian childcare services provide food that is consistent with dietary guidelines. The effectiveness of a web-based menu planning intervention to increase childcare service provision of healthy foods and decrease provision of discretionary foods in long day-care services in Australia was assessed in a randomised controlled trial. Here we consider the costs, consequences, cost-effectiveness and budget impact of the intervention using data collected within the trial. Methods The prospective trial-based economic evaluation involved 54 childcare services across New South Wales (NSW), Australia. Services were randomised to a 12-month intervention or usual care. The intervention involved access to a web-based menu planning and decision support tool and online resources. Effectiveness measures included mean number of food groups, overall menu and individual food group compliance with dietary guidelines, and mean servings of food groups at 12 months. Costs (reported in $AUD, 2017/18) were evaluated from both health sector and societal perspectives. The direct cost to support uptake of the intervention was calculated, as were costs to each childcare service. The incremental cost of the intervention was calculated as the net difference in the cost to undertake menu planning and review plus the direct cost of the intervention. Incremental cost-effectiveness ratios (ICERs) including uncertainty intervals were estimated for differences in costs and effects between intervention and control groups. A relative value index was calculated to determine overall value for money. Results Over the 12 months of the trial, we calculated a difference in cost between usual practice and intervention groups of − $482 (95% UI − $859, − $56). While the measured increase in menu and food group compliance within the trial did not reach statistical significance, there were significant improvements in mean servings of fruit and discretionary food, represented in the cost-consequence analysis. The calculated relative value index of 1.1 suggests that the intervention returns acceptable value for money for the outcomes generated. Conclusion Compared to usual practice, web-based programmes may offer an efficient and sustainable alternative for childcare services to improve the provision of healthy foods to children in their care. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12616000974404

Fracture liaison services (FLS) are an accepted approach to lowering rates of osteoporotic refractures. However, resource allocations to FLS are open to challenge, as most relevant cost analyses are based on anticipated, rather than observed, benefits. To support informed decision making, we have estimated the cost of operating an FLS, from the perspective of the Australian health system, with real life costs. On the basis of hospital records, we compared total costs of two cohorts of patients presenting with minimal trauma fractures (MTFs) at two hospital emergency departments (EDs) across a 6‐month period (July to December 2010). The treatment cohort (FLS Cohort, n = 515) attended an ED at a hospital offering FLS post‐fracture care; the Usual Care Cohort (n = 416) attended an ED at a hospital without an FLS. Hospital records were reviewed for further attendance of both groups at their respective hospitals’ EDs with refractures for the subsequent 3 years. Costs were constructed from “bottom up” with a “microcosting” approach. Total costs for both cohorts included any FLS and the costs of refractures. Cohort costs were estimated for every 1000 patients over the 3 observed years. Compared with the Usual Care Cohort, the FLS Cohort had 62 fewer fractures per 1000 patients and $617,275 lower costs over 3 years. In a sensitivity analysis, where 20% of the Usual Care Cohort received FLS preventative treatment, FLS Cohort costs were lower by $880,154. As both hospitals consistently process around 2000 patients per year, the estimated annual saving is $1.2 million to $1.8 million (Australian dollars). From the perspective of the Australian public health system, investment in FLS can be a financially effective way of reducing the cost of osteoporotic fracture management. © 2018 The Authors JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.

Background Depression is highly prevalent yet often poorly detected and treated among cancer patients. In light of the move towards evidence-based healthcare policy, we have developed a simple tool that can assist policy makers, organisations and researchers to logically think through the steps involved in improving patient outcomes, and to help guide decisions about where to allocate resources. Methods The model assumes that a series of filters operate to determine outcomes and cost-effectiveness associated with depression care for cancer patients, including: detection of depression, provider response to detection, patient acceptance of treatment, and effectiveness of treatment provided. To illustrate the utility of the model, hypothetical data for baseline and four scenarios in which filter outcomes were improved by 15% were entered into the model. Results The model provides outcomes including: number of people successfully treated, total costs per scenario, and the incremental cost-effectiveness ratio per scenario compared to baseline. The hypothetical data entered into the model illustrate the relative effectiveness (in terms of the number of additional incremental successes) and relative cost-effectiveness (in terms of cost per successful outcome and total cost) of making changes at each step or filter. Conclusions The model provides a readily accessible tool to assist decision makers to think through the steps involved in improving depression outcomes for cancer patents. It provides transparent guidance about how to best allocate resources, and highlights areas where more reliable data are needed. The filter model presents an opportunity to improve on current practice by ensuring that a logical approach, which takes into account the available evidence, is applied to decision making.

Background The Family Wellbeing (FWB) program applies culturally appropriate community led empowerment training to enhance the personal development of Aboriginal and Torres Strait Islander people in life skills. This study sought to estimate the economic cost required to deliver the FWB program to a child safety workforce in remote Australian communities. Method This study was designed as a retrospective cost description taken from the perspective of a non-government child safety agency. The target population were child protection residential care workers aged 24 or older, who worked in safe houses in five remote Indigenous communities and a regional office during the study year (2013). Resource utilization included direct costs (personnel and administrative) and indirect or opportunity costs of participants, regarded as absence from work. Results The total cost of delivering the FWB program for 66 participants was $182,588 ($2766 per participant), with 45% ($82,995) of costs classified as indirect (i.e., opportunity cost of participants time). Training cost could be further mitigated (∼30%) if offered on-site, in the community. The costs for offering the FWB program to a remotely located workforce were high, but not substantial when compared to the recruitment cost required to substitute a worker in remote settings. Conclusion An investment of $2766 per participant created an opportunity to improve social and emotional wellbeing of remotely located workforce. This cost study provided policy relevant information by identifying the resources required to transfer the FWB program to other remote locations. It also can be used to support future comparative cost and outcome analyses and add to the evidence base around the cost-effectiveness of empowerment programs.

Background: Opioid agonist treatment (OAT) is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings worldwide. Methods: This open-label trial compared depot buprenorphine, CAM2038 (weekly for 4 weeks then monthly) to oral methadone ( https://www.anzctr.org.au ACTRN12618000942257). Modelled treatment costs included a comparison group on sublingual buprenorphine-naloxone. Men and women, aged>18 years of various security classifications with a diagnosis of moderate to severe DSM-5 opioid use disorder and a custodial sentence of at least six months were recruited from correctional centres in New South Wales, Australia. Findings: Between November 2018 and July 2019, 67 patients not in OAT treatment at recruitment commenced depot buprenorphine. Sixty-two patients already stable on oral methadone treatment were recruited to the comparison arm. Patients treated with depot buprenorphine commonly reported at least one adverse event related to study drug (63/67, 94%), typically mild and transient. No diversion of depot buprenorphine was identified. Retention in depot buprenorphine treatment was 92%. Self-reported use of non-prescribed opioids (primarily buprenorphine-naloxone) and injecting drug use decreased significantly among depot buprenorphine patients by 16 weeks (p

BACKGROUND Despite the importance and popularity of mutual support groups, there have been no systematic attempts to implement and evaluate routine outcome monitoring (ROM) in these settings. Unlike other mutual support groups for addiction, trained facilitators lead all Self-Management and Recovery Training (SMART Recovery) groups, thereby providing an opportunity to implement ROM as a routine component of SMART Recovery groups. OBJECTIVE This study protocol aims to describe a stage 1 pilot study designed to explore the feasibility and acceptability of a novel, purpose-built mobile health (mHealth) ROM and feedback app (Smart Track) in SMART Recovery groups coordinated by SMART Recovery Australia (SRAU) The secondary objectives are to describe Smart Track usage patterns, explore psychometric properties of the ROM items (ie, internal reliability and convergent and divergent validity), and provide preliminary evidence for participant reported outcomes (such as alcohol and other drug use, self-reported recovery, and mental health). METHODS Participants (n=100) from the SMART Recovery groups across New South Wales, Australia, will be recruited to a nonrandomized, prospective, single-arm trial of the Smart Track app. There are 4 modes of data collection: (1) ROM data collected from group participants via the Smart Track app, (2) data analytics summarizing user interactions with Smart Track, (3) quantitative interview and survey data of group participants (baseline, 2-week follow-up, and 2-month follow-up), and (4) qualitative interviews with group participants (n=20) and facilitators (n=10). Feasibility and acceptability (primary objectives) will be analyzed using descriptive statistics, a cost analysis, and a qualitative evaluation. RESULTS At the time of submission, 13 sites (25 groups per week) had agreed to be involved. Funding was awarded on August 14, 2017, and ethics approval was granted on April 26, 2018 (HREC/18/WGONG/34; 2018/099). Enrollment is due to commence in July 2019. Data collection is due to be finalized in October 2019. CONCLUSIONS To the best of our knowledge, this study is the first to use ROM and tailored feedback within a mutual support group setting for addictive behaviors. Our study design will provide an opportunity to identify the acceptability of a novel mHealth ROM and feedback app within this setting and provide detailed information on what factors promote or hinder ROM usage within this context. This project aims to offer a new tool, should Smart Track prove feasible and acceptable, that service providers, policy makers, and researchers could use in the future to understand the impact of SMART Recovery groups. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/15113

Background Diabetes is increasing in incidence, morbidity and treatment costs globally, hence prevention strategies need to be explored. Animal studies and some human data have shown that zinc can improve glycaemic control, but the impact of this effect in a pre-diabetic population remains uncertain. This study is designed to investigate whether zinc gluconate and lifestyle coaching can improve glucose handling and ultimately reduce diabetes incidence in an at-risk pre-diabetic population in Australia. Methods/design The study will be a randomised, placebo-controlled, double-blind clinical trial. The study will be conducted at the Hunter New England Local Health District New South Wales (NSW), Australia. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7–6.4) male and female participants (n = 410) aged 40–70 years will be recruited through the Diabetes Alliance Network, a collaboration of diabetes specialists and general practitioner practices. All participants will be given routine care to encourage healthy lifestyle changes using a telephone coaching service (Get Healthy Information and Coaching Service, NSW Health) and then randomised to receive a supplement, either zinc gluconate (equivalent to 30 mg of elemental zinc) or placebo of identical appearance for 12 months. The identity of the supplements will be blinded to both research personnel and the participants. Participants will be asked to complete medical, lifestyle and dietary surveys and will have baseline and final visits at their general practitioner practice. Primary outcomes will be HbA1c and insulin sensitivity collected at baseline and at 1, 6 and 12 months; secondary outcomes will include fasting blood glucose, fasting cholesterol, blood pressure and body mass index. The primary efficacy endpoint will be judged at 6 months. Discussion This study will generate new evidence about the potential for health coaching, with or without zinc supplementation, to improve glucose handling and ultimately to reduce progression from pre-diabetes to diabetes. Trial registration Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268. Registered on 6 July 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3317-4) contains supplementary material, which is available to authorized users.

Background Spirometry is commonly used to assess and monitor lung function. It may also be a useful tool to monitor maternal health during pregnancy. However, large studies examining lung function across gestation are limited. Also, whether spirometry values follow the same pattern during pregnancy in women with and without asthma is unknown. Objective To investigate the effect of advancing gestation, and its interaction with asthma, on lung function in a large well-defined cohort of pregnant women. Methods Data were obtained from prospective cohorts involving women with (n = 770) and without (n = 259) asthma (2004-2017), recruited between 12 and 22 weeks' gestation. Lung function (forced vital capacity [FVC], FEV1, FEV1:FVC%) was assessed periodically during pregnancy using spirometry. Multilevel mixed-effect regression models were used to assess changes in lung function over gestation. Results Asthma had a significant effect on baseline lung function (FEV1%, −9%; FVC%, −3%; FEV1:FVC%, −4%). FVC% decreased with advancing gestation (−0.07%/wk; 95% CI, −0.10 to −0.04]), as did FEV1%, but only among those without asthma (women without asthma: −0.14%/wk, 95% CI, −0.22 to −0.06%; compared with women with asthma: 0.02%/wk, 95% CI, −0.01 to 0.06). FEV1:FVC% remained relatively stable for women without asthma (0.03%/wk; 95% CI, −0.08 to 0.02), but increased for women with asthma (0.06%/wk; 95% CI, 0.04 to 0.16). Conclusions Data suggest that advancing gestation negatively affects FVC% and FEV1%. This is consistent with extrapulmonary restriction from advancing pregnancy. Yet, the presence of asthma altered the trajectories of FEV1% and FEV1:FVC%. Optimal asthma management during pregnancy might have opposed the negative effects of gestation on lung function.

Background The Central Coast Local Health District (CCLHD) implemented the Outcomes Based Commissioning pilot program in 2017 to keep older people with chronic conditions healthy and at home. CCLHD commissioned two not-for-profit organisations to provide care coordination services to an allocated cohort of patients over one year. Payment to providers was based on saved unplanned hospital bed days. Objectives Our study objective was to determine the impact of the CCLHD commissioning process on hospital use, health outcomes, and patient experience of care coordination. We also sought to develop recommendations to improve outcomes based commissioning approaches to keep people healthy and at home within the NSW healthcare system. Methods We developed a commissioning assessment framework by reviewing best practice commissioning approaches for healthcare, and the NSW Government’s commissioning policies and guidelines. We collected information on the CCLHD commissioning process from provider contracts and interviews held with providers and CCLHD. We used the assessment framework to compare CCLHD’s commissioning approach to best practice. Results CCLHD’s commissioning approach was aligned to the NSW Government’s commissioning policies and guidelines. A strong relationship developed between CCLHD and providers helped manage risk, supported by a robust monitoring framework. However, privacy requirements limited providers from using patient data to adequately assess their funding risk before being contracted. Limited access to timely unplanned public hospital data and discharge summaries reduced the ability of providers to manage their ongoing financial risk. Not all funding risk could be transferred to providers by CCLHD due to community obligations. The payment model did not adequately incentivise other desirable activities sought by CCLHD such as GP engagement. Conclusions The Outcomes Based Commissioning program was an innovative but complex approach to funding care coordination. There was little precedent within the NSW healthcare system from which CCLHD could draw upon. CCLHD involved providers in co-designing their commissioning approach. Discussion Providers were incentivised to reduce unplanned hospital bed days. Outcomes Based Commissioning also sought to increase health outcomes and patient and carer satisfaction with the health care system. While providers were asked to collect information on health outcomes through the PROMIS 10 survey, they were not directly incentivised to improve health outcomes nor increase patient and carer satisfaction. This meant there was some potential disconnect between service outcomes desired by CCLHD and provider intentions. Lessons learned Create incentives for providers to undertake other desired behaviours through payment linked to key performance objectives. This could include secondary analysis of process measures alongside primary outcome measures. Limitations Our commissioning results are limited to a 12-month pilot study conducted in one setting involving two providers. In addition, the Outcomes Based Commissioning program was designed to address local needs and conditions and some findings are context specific. These aspects limit transferability of the results. Suggestions for future research Additional evaluation studies are needed on outcomes based commissioning approaches in order to develop greater guidance for policy makers on the powers and pitfalls of using commissioning approaches and outcomes based funding models to achieve integrated care aims.

This study reports carer strain and coping with medications for people with dementia with an unplanned admission to hospital, and it evaluates the impact of a safe medication intervention on carer coping and carer strain. This was a quasi-experimental pre/post-controlled trial that included a survey of carers about managing medications for people with dementia after discharge. For 88 carers who completed surveys, 33% were concerned about managing medications, and 40% reported difficulties with medication management, including resistive behaviours by people with dementia. Dose administration aids were used by 72% of carers, however, only 15% reported receiving a recent home medicines review by a community pharmacist. High carer strain was reported by 74% of carers. Carer comments described many issues that contributed to high carer stress, as well as their engagement in vigilant activities to maintain medication safety. Strategies that can contribute to carers managing medications and reducing their strain include an increased use of dose administration aids, increased provision of home medicines reviews, and increased education of health professionals to provide adequate support and education about managing medications.

In an attempt to improve children’s physical activity levels governments have introduced policies specifying the minimum time schools are to schedule physical activity each week. Despite this, the majority of schools in many jurisdictions fail to implement these policies. This study will assess the effectiveness of a multi-component implementation strategy on increasing the minutes of planned physical activity scheduled by primary school teachers each week. A cluster randomised controlled trial will be conducted in 62 primary schools in the Hunter New England region of New South Wales, Australia. Schools will be randomly allocated to receive either a multi-component implementation strategy that includes; obtaining executive support, training in-school champions, provision of tools and resources, implementation prompts, reminders and feedback; or usual practice. The study will employ an effectiveness-implementation hybrid design, assessing both policy implementation and individual (student) behavioural outcomes. The primary trial outcome of mean minutes of physical activity scheduled by classroom teachers across the school week will be measured via teacher log-book at baseline and approximately 12 and 18 months post baseline. A nested evaluation of the impact of policy implementation on child physical activity will be undertaken of students in Grades 2 and 3. Analyses will be performed using an intention to treat framework. Linear mixed effects regression models will be used to assess intervention effects on the primary outcome at both follow-up periods. This study will be the one of the first well powered randomised trials internationally to examine the impact of an implementation strategy for a physical activity policy in primary schools and will address a fundamental research translation gap. Given the dearth of research, the findings will be important in informing future implementation efforts in this setting. ANZCTR ACTRN12617001265369 version 1 registered 1st September 2017.

The push to identify low value care has led to scrutiny of pathology test re-ordering. The objective of this study was to identify the patterns of ordering pathology tests among inpatients in teaching hospitals and model strategies to reduce unnecessary testing. This was a retrospective cohort study of all adult medical and surgical inpatients admitted to one major teaching hospital and one rural hospital in the same health district over 2 years. Obstetric, gynaecological, intensive care, elective/day procedures and dialysis admissions were excluded. Orders for electrolytes, urea and creatinine (EUC), full blood count (FBC), thyroid stimulating hormone (TSH), glycated haemoglobin (HbA1c), vitamin D, and troponin, date of order, and value of the resulting test, were obtained from a health district data warehouse. Pathology results were mapped to each inpatient day. EUC and FBC constituted over 90% of all inpatient pathology requests for these six tests. Between 40-45% of inpatients had EUC and/or FBC performed daily. After the first couple of tests, the retest interval was consistently around 24 hours, regardless of the previous value of the test, consistent with a culture of routine ordering. This was less pronounced in the rural hospital compared to the urban teaching hospital. Lockouts (applied when previous tests normal) or minimum retest intervals (applied to previously normal and abnormal tests) of various lengths were tested on the data to find optimal combinations that reduced unnecessary tests without missing too many very abnormal tests. A lockout of 48 hours for EUC and 48 hour lockout combined with a 12 hour minimum retest interval for FBC appear optimal to reduce over ordering and could save approximately AU$400/inpatient bed per year at a single teaching hospital. There is evidence of low value re-ordering of EUC and FBC pathology tests. Implementation of a computerised physician order entry system with inbuilt prompts to restrict unnecessary re-ordering of pathology tests may be a practical solution.

Background The aim of this systematic literature review is to identify and critique full economic evaluations of interventions for high risk young people with the purpose of informing the design of future rigorous economic evaluations of such intervention programs. Methods A PRISMA compliant search of the literature between 2000 and April 2018 was conducted to identify full economic evaluations of youth focussed interventions for at risk young people. Duplicates were removed and two researchers independently screened the article titles and abstracts according to PICOS criteria for exclusion and inclusion. The remaining full text articles were assessed for eligibility and a quality assessment of the included articles was conducted using the Drummond checklist. Results The database, grey literature and hand searches located 488 studies of interventions for at risk young people. After preliminary screening of titles and abstracts, 104 studies remained for full text examination and 29 empirical studies containing 32 separate economic evaluations were judged eligible for inclusion in the review. These comprised 13 cost-benefit analyses (41%), 17 cost-effectiveness analyses (53%), one cost-utility analysis (3%) and a social return on investment (3%). Three main methodological challenges were identified: 1. attribution of effects; 2. measuring and valuing outcomes; and 3. identifying relevant costs and consequences. Conclusions A cost-benefit analysis would best capture the dynamic nature of a multi-component intervention for high risk young people, incorporating broader intersectoral outcomes and enabling measurement of more domains of risk. Prospective long-term data collection and a strong study design that incorporates a control group contribute to the quality of economic evaluation. Extrapolation of impact into the future is important for this population, in order to account for the time lag in effect of many impacts and benefits arising from youth interventions. Electronic supplementary material The online version of this article (10.1186/s12913-018-3450-x) contains supplementary material, which is available to authorized users.

Background There is growing recognition that the wider benefits of research (economic, social and health impacts) should be assessed and valued alongside traditional research performance metrics such as peer-reviewed papers. Translation of findings into policy and practice needs to accelerate and pathways to impact need to be better understood. This research protocol outlines a mixed methods study to apply the Framework to Assess the Impact from Translational health research (FAIT) to the Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery (CRE-Stroke). FAIT is purpose-designed to encourage research translation and assess research impact but lacks validation. Methods/Design Phase 1 involves application of the FAIT-modified programme logic model to each CRE-Stroke research stream including identifying process, output and impact metrics, as well as end users of the research. A scoping review will inform potential impacts anticipated from CRE-Stroke. In Phase 2, audit and feedback on achievements against plans will track and encourage research translation. Logic models will be updated to account for changes in the research pathways over time. In Phase 3, three proven methods for measuring research impact – Payback, economic assessment and narratives – will be applied to each research stream and the data triangulated and reported in Phase 4. The feasibility of applying FAIT will also be assessed as part of Phase 3. Discussion Use of prospective, comprehensive research impact frameworks for large interdisciplinary programmes of research is rare. FAIT’s application to CRE-Stroke will provide opportunity for the impact of CRE-Stroke to be assessed and a range of impacts beyond standard academic achievements to be reliably reported. The feasibility of FAIT’s application will also be assessed and, if necessary, refined. The usefulness of FAIT for encouraging research translation will also be described and may prove useful for other programmes looking to implement a research impact framework.

There are increasing concerns that research regulatory requirements exceed those required to manage risks, particularly for low- and negligible-risk research projects. In particular, inconsistent documentation requirements across research sites can delay the conduct of multi-site projects. For a one-year, negligible-risk project examining biobank operations conducted at three separate Australian institutions, we found that the researcher time required to meet regulatory requirements was eight times greater than that required for the approved research activity (60 hours versus 7.5 hours respectively). In total, 76 business days (almost four months) were required to obtain the necessary approvals, and site-specific processes required twice as long (52 business days/approximately 10 weeks) as primary Human Research Ethics Committee and Research Governance Office processes (24 business days/ approximately five weeks). We describe the impact of this administrative load on the conduct of a one-year, externally-funded research project, and identify a shared set of application requirements that could be used to streamline and harmonise research governance review of low- and negligible-risk research projects.

Background Real-time video communication technology (e.g. Skype) may be an effective mode for delivering smoking cessation treatment to regional and remote residents. This randomised trial examines the effectiveness of real-time video counselling compared to: 1) telephone counselling; and 2) written materials (control) in achieving smoking abstinence in regional and remote residents. Design A three-arm, parallel group, randomised trial will be conducted with smokers residing in regional and remote areas of New South Wales, Australia. Potential participants will complete an online screening survey and if eligible an online baseline survey. Participants will be randomly allocated into: 1) real-time video counselling; 2) telephone counselling; or 3) written materials (control). In the video counselling intervention an advisor will deliver up to six video sessions (e.g. via Skype) to participants. Those who nominate a quit date within a month during the initial video session will be offered sessions on the quit date, 3-, 7-, 14- and 30-days after the quit date. Those not ready to set a quit date within a month during the initial video session will be offered sessions 2-, 4- and 6-weeks later. Other than delivery mode, the video counselling and telephone counselling will be identical in content and callback schedules. Control group participants will be mailed one-off written materials. Follow-up surveys will occur at 4-months, 7-months and 13-months post-baseline. The primary outcome will be 7-day point prevalence abstinence at 13-months post-baseline. Discussion Real-time video counselling may be an effective strategy for smoking cessation that could be integrated into quitlines globally.

Obstructive airways diseases (OAD) represent a huge burden of illness world-wide, and in spite of the development of effective therapies, significant morbidity and mortality related to asthma and COPD still remains. Over the past decade, our understanding of OAD has improved vastly, and novel treatments have evolved. This evolution is the result of successful translational research, which has connected clinical presentations of OAD and underlying disease mechanisms, thereby enabling the development of targeted treatments. The next challenge of translational research will be to position these novel treatments for OAD for optimal clinical use. At the same time, there is great potential in these treatments providing even better insights into disease mechanisms in OAD by studying the effects of blocking individual immunological pathways. To optimize this potential, there is a need to ensure that translational aspects are added to randomized clinical trials, as well as real-world studies, but also to use other trial designs such as platform studies, which allow for simultaneous assessment of different interventions. Furthermore, demonstrating clinical impact, that is research translation, is an increasingly important component of successful translational research. This review outlines concepts of translational research, exemplifying how translational research has moved management of obstructive airways diseases into the next century, with the introduction of targeted, individualized therapy. Furthermore, the review describes how these therapies may be used as research tools to further our understanding of disease mechanisms in OAD, through translational, mechanistic studies. We underline the current need for implementing basic immunological concepts into clinical care in order to optimize the use of novel targeted treatments and to further the clinical understanding of disease mechanisms. Finally, potential barriers to adoption of novel targeted therapies into routine practice and how these may be overcome are described.

Fracture liaison services (FLS) are an accepted approach to lowering rates of osteoporotic refractures. However, resource allocations to FLS are open to challenge, as most relevant cost analyses are based on anticipated, rather than observed, benefits. To support informed decision making, we have estimated the cost of operating an FLS, from the perspective of the Australian health system, with real life costs. On the basis of hospital records, we compared total costs of two cohorts of patients presenting with minimal trauma fractures (MTFs) at two hospital emergency departments (EDs) across a 6‐month period (July to December 2010). The treatment cohort (FLS Cohort, n = 515) attended an ED at a hospital offering FLS post‐fracture care; the Usual Care Cohort (n = 416) attended an ED at a hospital without an FLS. Hospital records were reviewed for further attendance of both groups at their respective hospitals’ EDs with refractures for the subsequent 3 years. Costs were constructed from “bottom up” with a “microcosting” approach. Total costs for both cohorts included any FLS and the costs of refractures. Cohort costs were estimated for every 1000 patients over the 3 observed years. Compared with the Usual Care Cohort, the FLS Cohort had 62 fewer fractures per 1000 patients and $617,275 lower costs over 3 years. In a sensitivity analysis, where 20% of the Usual Care Cohort received FLS preventative treatment, FLS Cohort costs were lower by $880,154. As both hospitals consistently process around 2000 patients per year, the estimated annual saving is $1.2 million to $1.8 million (Australian dollars). From the perspective of the Australian public health system, investment in FLS can be a financially effective way of reducing the cost of osteoporotic fracture management. © 2018 The Authors JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.

IntroductionThere is growing recognition among health researchers and funders that the wider benefits of research such as economic, social and health impacts ought to be assessed and valued alongside academic outputs such as peer-reviewed papers. Research translation needs to increase and the pathways to impact ought to be more transparent. These processes are particularly pertinent to the Indigenous health sector given continued concerns that Indigenous communities are over-researched with little corresponding improvement in health outcomes. This paper describes the research protocol of a mixed methods study to apply FAIT (Framework to Assess the Impact from Translational health research) to the Centre for Research Excellence in Integrated Quality Improvement (CRE-IQI). FAIT will be applied to five selected CRE-IQI Flagship projects to encourage research translation and assess the wider impact of that research.Methods and analysisPhase I will develop a modified programme logic model for each Flagship project including identifying process, output and impact metrics so progress can be monitored. A scoping review will inform potential benefits. In phase II, programme logic models will be updated to account for changes in the research pathways over time. Audit and feedback will be used to encourage research translation and collect evidence of achievement of any process, output and interim impacts. In phase III, three proven methodologies for measuring research impact—Payback, economic assessment and narratives—will be applied. Data on the application of FAIT will be collected and analysed to inform and improve FAIT’s performance.Ethics and disseminationThis study is funded by a nationally competitive grant (ID 1078927) from the Australian National Health and Medical Research Council. Ethics approval was obtained from the University of Newcastle’s Human Research Ethics Committee (ID: H-2017–0026). The results from the study will be presented in several peer-reviewed publications, through conference presentations and via social media.

Background Realising the economic potential of research institutions, including medical research institutes, represents a policy imperative for many Organisation for Economic Co-operation and Development nations. The assessment of research impact has consequently drawn increasing attention. Research impact assessment frameworks (RIAFs) provide a structure to assess research translation, but minimal research has examined whether alternative RIAFs realise the intended policy outcomes. This paper examines the objectives presented for RIAFs in light of economic imperatives to justify ongoing support for health and medical research investment, leverage productivity via commercialisation and outcome–efficiency gains in health systems, and ensure that translation and impact considerations are embedded into the research process. This paper sought to list the stated objectives for RIAFs, to identify existing frameworks and to evaluate whether the identified frameworks possessed the capabilities necessary to address the specified objectives. Methods A scoping review of the literature to identify objectives specified for RIAFs, inform upon descriptive criteria for each objective and identify existing RIAFs. Criteria were derived for each objective. The capability for the existing RIAFs to realise the alternative objectives was evaluated based upon these criteria. Results The collated objectives for RIAFs included accountability (top-down), transparency/accountability (bottom-up), advocacy, steering, value for money, management/learning and feedback/allocation, prospective orientation, and speed of translation. Of the 25 RIAFs identified, most satisfied objectives such as accountability and advocacy, which are largely sufficient for the first economic imperative to justify research investment. The frameworks primarily designed to optimise the speed of translation or enable the prospective orientation of research possessed qualities most likely to optimise the productive outcomes from research. However, the results show that few frameworks met the criteria for these objectives. Conclusion It is imperative that the objective(s) for an assessment framework are explicit and that RIAFs are designed to realise these objectives. If the objectives include the capability to pro-actively drive productive research impacts, the potential for prospective orientation and a focus upon the speed of translation merits prioritisation. Frameworks designed to optimise research translation and impact, rather than simply assess impact, offer greater promise to contribute to the economic imperatives compelling their implementation.

Objective To estimate the cost of resources required to deliver a program to assess international medical graduates (IMGs) in Newcastle, Australia, known as the Workplace Based Assessment (WBA) Program. Design and setting A costing study to identify and evaluate the resources required and the overheads of delivering the program for a cohort of 15 IMGs, based on costs in 2012. Main outcome measures Labour-related costs. Results The total cost in 2012 for delivering the program to a typical cohort of 15 candidates was $243,384. This equated to an average of $16,226 per IMG. After allowing for the fees paid by IMGs, the WBA Program had a deficit of $153,384, or $10,226 per candidate, which represents the contribution made by the health system. Conclusion The cost per candidate to the health system of this intensive WBA program for IMGs is small.

Background The Baby Basket initiative was developed by Apunipima Cape York Health Council (ACYHC) to address poor maternal and child health (MCH) in Cape York, the northernmost region of Queensland. While positive outcomes for Indigenous MCH programs are reported in the literature, few studies have a strong evidence base or employ a sound methodological approach to evaluation. The aim of the cost study is to identify the resources required to deliver the Baby Basket program in the remote communities of Cape York. It represents an initial step in the economic evaluation of the Apunipima Baby Basket program. The aim of this study was to report whether the current program represents an effective use of scarce resources. Method The cost study was conducted from the perspective of the health providers and reflects the direct resources required to deliver the Baby Basket program to 170 women across 11 communities represented by ACYHC. A flow diagram informed by interviews with ACYHC staff, administrative documents and survey feedback was used to map the program pathway and measure resource use. Monetary values, in 2013 Australian dollars, were applied to the resources used to deliver the Baby Basket program for one year. Results The total cost of delivering the Baby Basket progam to 170 participants in Cape York was $148,642 or approximately, $874 per participant. The analysis allowed for the cost of providing the Baby Baskets to remote locations and the time for health workers to engage with women and thereby encourage a relationship with the health service. Routinely collected data showed improved engagement between expectant women and the health service during the life of the program. Conclusion The Apunipima Baby Basket cost study identifies the resources required to deliver this program in remote communities of Cape York and provides a framework that will support prospective data collection of more specific outcome data, for future cost-effectiveness analyses and cost-benefit analyses. An investment of $874 per Baby Basket participant was associated with improved engagement with the health service, an important factor in maternal and child health.

Background Research translation, particularly in the biomedical area, is often discussed but there are few methods that are routinely used to measure it or its impact. Of the impact measurement methods that are used, most aim to provide accountability – to measure and explain what was generated as a consequence of funding research. This case study reports on the development of a novel, conceptual framework that goes beyond measurement. The Framework To Assess the Impact from Translational health research, or FAIT, is a platform designed to prospectively measure and encourage research translation and research impact. A key assumption underpinning FAIT is that research translation is a prerequisite for research impact. Methods The research impact literature was mined to understand the range of existing frameworks and techniques employed to measure and encourage research translation and research impact. This review provided insights for the development of a FAIT prototype. A Steering Committee oversaw the project and provided the feedback that was used to refine FAIT. Results The outcome of the case study was the conceptual framework, FAIT, which is based on a modified program logic model and a hybrid of three proven methodologies for measuring research impact, namely a modified Payback method, social return on investment, and case studies or narratives of the process by which research translates and generates impact. Conclusion As funders increasingly seek to understand the return on their research investments, the routine measurement of research translation and research impact is likely to become mandatory rather than optional. Measurement of research impact on its own is insufficient. There should also be a mechanism attached to measurement that encourages research translation and impact – FAIT was designed for this task.

Background The provision of smoking cessation support in Australian drug and alcohol treatment services is sub-optimal. This study examines the cost-effectiveness of an organisational change intervention to reduce smoking amongst clients attending drug and alcohol treatment services. Methods/design A cluster-randomised controlled trial will be conducted with drug and alcohol treatment centres as the unit of randomisation. Biochemically verified (carbon monoxide by breath analysis) client 7-day-point prevalence of smoking cessation at 6 weeks will be the primary outcome measure. The study will be conducted in 33 drug and alcohol treatment services in four mainland states and territories of Australia: New South Wales, Australian Capital Territory, Queensland, and South Australia. Eligible services are those with ongoing client contact and that include pharmacotherapy services, withdrawal management services, residential rehabilitation, counselling services, and case management services. Eligible clients are those aged over 16 years who are attending their first of a number of expected visits, are self-reported current smokers, proficient in the English language, and do not have severe untreated mental illness as identified by the service staff. Control services will continue to provide usual care to the clients. Intervention group services will receive an organisational change intervention, including assistance in developing smoke-free policies, nomination of champions, staff training and educational client and service resources, and free nicotine replacement therapy in order to integrate smoking cessation support as part of usual client care. Discussion If effective, the organisational change intervention has clear potential for implementation as part of the standard care in drug and alcohol treatment centres. Trial registration Australian and New Zealand Clinical Trials Registry, ACTRN12615000204549. Registered on 3 March 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1401-6) contains supplementary material, which is available to authorized users.

Asthma exacerbations are common during pregnancy and associated with an increased risk of adverse perinatal outcomes. Adjusting asthma treatment based on airway inflammation rather than symptoms reduces the exacerbation rate by 50 %. The Breathing for Life Trial (BLT) will test whether this approach also improves perinatal outcomes. BLT is a multicentre, parallel group, randomised controlled trial of asthma management guided by fractional exhaled nitric oxide (FENO, a marker of eosinophilic airway inflammation) compared to usual care, with prospective infant follow-up. Women with physician-diagnosed asthma, asthma symptoms and/or medication use in the previous 12 months, who are 12–22 weeks gestation, will be eligible for inclusion. Women randomised to the control group will have one clinical assessment of their asthma, including self-management education. Any treatment changes will be made by their general practitioner. Women randomised to the intervention group will have clinical assessments every 3–6 weeks during pregnancy, and asthma treatments will be adjusted every second visit based on an algorithm which uses FENO to adjust inhaled corticosteroid (ICS) dose (increase in dose when FENO >29 parts per billion (ppb), decrease in dose when FENO

Bronchiolitis is the most common lung infection in infants and treatment focuses on management of respiratory distress and hypoxia. High-flow warm humidified oxygen (HFWHO) is increasingly used, but has not been rigorously studied in randomised trials. We aimed to examine whether HFWHO provided enhanced respiratory support, thereby shortening time to weaning off oxygen.In this open, phase 4, randomised controlled trial, we recruited children aged less than 24 months with moderate bronchiolitis attending the emergency department of the John Hunter Hospital or the medical unit of the John Hunter Children's Hospital in New South Wales, Australia. Patients were randomly allocated (1:1) via opaque sealed envelopes to HFWHO (maximum flow of 1 L/kg per min to a limit of 20 L/min using 1:1 air-oxygen ratio, resulting in a maximum FiOFrom July 16, 2012, to May 1, 2015, we randomly assigned 202 children to either HFWHO (101 children) or standard therapy (101 children). Median time to weaning was 24 h (95% CI 18-28) for standard therapy and 20 h (95% CI 17-34) for HFWHO (hazard ratio [HR] for difference in survival distributions 0·9 [95% CI 0·7-1·2]; log rank p=0·61). Fewer children experienced treatment failure on HFWHO (14 [14%]) compared with standard therapy (33 [33%]; p=0·0016); of these children, those on HFWHO were supported for longer than were those on standard therapy before treatment failure (HR 0·3; 95% CI 0·2-0·6; p0·0001). 20 (61%) of 33 children who experienced treatment failure on standard therapy were rescued with HFWHO. 12 (12%) of children on standard therapy required transfer to the intensive care unit compared with 14 (14%) of those on HFWHO (difference -1%; 95% CI -7 to 16; p=0·41). Four adverse events occurred (oxygen desaturation and condensation inhalation in the HFWHO group, and two incidences of oxygen tubing disconnection in the standard therapy group); none resulted in withdrawal from the trial. No oxygen-related serious adverse events occurred. Secondary effectiveness outcomes are reported in the Results section.HFWHO did not significantly reduce time on oxygen compared with standard therapy, suggesting that early use of HFWHO does not modify the underlying disease process in moderately severe bronchiolitis. HFWHO might have a role as a rescue therapy to reduce the proportion of children requiring high-cost intensive care.Hunter Children's Research Foundation, John Hunter Hospital Charitable Trust, and the University of Newcastle Priority Research Centre GrowUpWell.

Objective To compare annual costs of an intervention for acutely unwell older residents in residential age care facilities (RACFs) with usual care. The intervention, the Aged Care Emergency (ACE) program, includes telephone clinical support aimed to reduce avoidable emergency department (ED) presentations by RACF residents. Methods This costing of the ACE intervention examines the perspective of service providers: RACFs, Hunter Medicare Local, the Ambulance Service of New South Wales, and EDs in the Hunter New England Local Health District. ACE was implemented in 69 RACFs in the Hunter region of NSW, Australia. Analysis used 14 weeks of ACE and ED service data (June–September 2014). The main outcome measure was the net cost and saving from ACE compared with usual care. It is based on the opportunity cost of implementing ACE and the opportunity savings of ED presentations avoided. Results Our analysis estimated that 981 avoided ED presentations could be attributed to ACE annually. Compared with usual care, ACE saved an estimated A$921214. Conclusions The ACE service supported a reduction in avoidable ED presentations and ambulance transfers among RACF residents. It generated a cost saving to health service providers, allowing reallocation of healthcare resources. What is known about the topic? Residents from RACFs are at risk of further deterioration when admitted to hospital, with high rates of delirium, falls, and medication errors. For this cohort, some conditions can be managed in the RACF without hospital transfer. By addressing avoidable presentations to EDs there is an opportunity to improve ED efficiency as well as providing care that is consistent with the resident’s goals of care. RACFs generate some avoidable ED presentations for residents who may be more appropriately treated in situ. What does this paper add? Telephone triaging with nursing support and training is a means by which ED presentations from RACFs can be reduced. One of the consequences of this intervention is ‘cost avoided’, largely through savings on ambulance costs. What are the implications for practitioners? Unnecessary transfer from RACFs to ED can be avoided through a multicomponent program that includes telephone support with cost-saving implications for EDs and ambulance services.