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Background Using the World Health Organization’s ‘Guide to Tailoring Immunization Programmes’ (TIP), a three-step program was developed by health services in partnership with a marginalised community in New South Wales, Australia. The aim was to improve immunisation rates of 1-year-old children. For Step 1, nurses identified and monitored local children overdue for immunisation from a national register, and sent parents or family doctors reminders by mail or telephone. For Step 2, parents were offered appointments at a local health centre; and for Step 3, they were offered home visits. Methods An economic costing study was undertaken to examine the program’s resource use. Costs were collected between 1 June 2020 and 31 May 2021. Case records were obtained for 139 children. Results A total of 56 children became up to date after receiving TIP services; most after receiving Step 1 services (n = 37). Total annual costs (A$) for the program were $34 250 or $246 per case; or $612 per case becoming up to date. At $44 per case and $98 per case becoming up to date, Step 1B: personalised reminders, was the lowest costing step. Sensitivity analysis showed a possible 8% program savings through employment of nurses with a lower salary and use of video conference meetings. Conclusion This study provides information to the local health provider on the cost of TIP alongside their community-based programs. It also identified ways in which TIP could be made more cost-effective. Decision-makers can use this information to consider whether the investment in TIP is recommended.

Individualised music listening has been shown to reduce agitation and improve mood in people with dementia. However, there is a paucity of research describing the cost of implementing such interventions in residential care settings for older people.To determine the cost of implementing an individualised music intervention for older people with dementia in residential aged care in Australia.A simple cost analysis was undertaken to determine the cost of delivering the individualised music intervention to 32 older people with dementia at two residential aged care facilities in New South Wales. The analysis took into consideration the operating, training and delivery costs, as well as the costs of purchasing the music equipment and downloads.The cost of delivering the individualised music intervention was found to be AU$6,623.76 per year - or AU$3.98 per resident per week, at 2017 values. At 2022 values, this equates to an annual cost of AU$7,130.07 (£4,031.85) for 32 residents and a weekly cost of AU$4.28 (£2.42) per resident per week.The cost of implementing the individualised music intervention was relatively low compared with the overall cost of residential aged care for older people with dementia.

Background Research impact is an emerging measure of research achievement alongside traditional academic outputs such as publications. We present the results of applying the Framework to Assess the Impact from Translational health research (FAIT) to the Centre for Research Excellence (CRE) in Stroke Rehabilitation and Brain Recovery (CRE-Stroke, 2014–2019) and report on the feasibility and lessons from the application of FAIT to a CRE rather than a discrete research project. Methods Data were gathered via online surveys, in-depth interviews, document analysis and review of relevant websites/databases to report on the three major FAIT methods: the modified Payback Framework, an assessment of costs against monetized consequences, and a narrative account of the impact generated from CRE-Stroke activities. FAIT was applied during the last 4 years of CRE-Stroke operation. Results With an economic investment of AU$ 3.9 million over 5 years, CRE-Stroke delivered a return on investment that included AU$ 18.8 million in leveraged grants, fellowships and consultancies. Collectively, CRE-Stroke members produced 354 publications that were accessed 470,000 times and cited over 7220 times. CRE-Stroke supported 26 PhDs, 39 postdocs and seven novice clinician researchers. There were 59 capacity-building events benefiting 744 individuals including policy-makers and consumers. CRE-Stroke created research infrastructure (including a research register of stroke survivors and a brain biobank), and its global leadership produced international consensus recommendations to influence the stroke research landscape worldwide. Members contributed to the Australian Living Stroke Guidelines: four researchers’ outputs were directly referenced. Based only on the consequences that could be monetized, CRE-Stroke returned AU$ 4.82 for every dollar invested in the CRE. Conclusion This case example in the developing field of impact assessment illustrates how researchers can use evidence to demonstrate and report the impact of and returns on research investment. The prospective application of FAIT by a dedicated research impact team demonstrated impact in broad categories of knowledge-gain, capacity-building, new infrastructure, input to policy and economic benefits. The methods can be used by other research teams to provide comprehensive evidence to governments and other research funders about what has been generated from their research investment but requires dedicated resources to complete.

Introduction: The VALID BP project was initiated to increase the availability of validated blood pressure measuring devices (BPMDs). The goal is to eliminate non validated BPMDs and minimise over- and underdiagnosis of hypertension caused by inaccurate readings. This study was undertaken to assess the potential return on investment in the VALID BP project. Methods: The Framework to Assess the Impact of Translational health research was applied to the VALID BP project. One of the three methods used included a cost benefit analysis to monetise past research investment and model future research costs, implementation costs and benefits. Analysis was based on reasoned assumptions about potential impacts from availability and use of validated BPMDs (assuming an end goal of 100% validated BPMDs available in Australia by 2028) and improved skills leading to more accurate BP measurement. Results: After five years, with 20% attribution of benefits, there is a potential $1.29 return for every dollar spent if the proportion of validated BPMDs and staff trained in proper BP measurement technique increased from 20–60%. After eight years (2020–2028) and assuming universal validation and training coverage, the returns would be $3.20 per dollar spent (not including cost of side-effects of unnecessary medication or downstream patient impacts from unmanaged hypertension). Conclusion: This modelled economic analysis indicates there will be positive downstream economic benefits if the availability of validated BPMDs is increased. The findings support ongoing efforts toward a universal regulatory framework for BPMDs and can be considered within more detailed future economic analyses.

BackgroundFrom 2014 to 2019, the Centre for Research Excellence in Integrated Quality Improvement (CRE-IQI) was evaluated as an innovation platform focusing on continuous quality improvement in Indigenous Australian primary healthcare. Although social network analysis (SNA) is a recognized method for evaluating the functioning, collaboration and effectiveness of innovation platforms, applied research is limited. This study applies SNA to evaluate the CRE-IQI’s functioning as an innovation platform.MethodsTwo surveys (2017, 2019) were conducted using social survey and network methods. Survey items covered respondent characteristics, their perceptions of the CRE-IQI’s performance, and its impact and sociometric relationships. Members’ relationship information was captured for the CRE-IQI at three time points, namely start (retrospectively), midpoint and final year, on three network types (knew, shared information, collaborated). SNA software was used to compute standard network metrics including diameter, density and centrality, and to develop visualizations. Survey and network results were addressed in a workshop held by members to develop improvement strategies.ResultsThe response rate was 80% in 2017 and 65% in 2019 (n = 49 and 47, respectively). Between 2017 and 2019, respondents’ mean ratings of the CRE-IQI’s functioning and achievements in meeting its goals were sustained. They perceived the CRE-IQI as multidisciplinary, having effective management and governance, and incorporating Indigenous research leadership, representation and ways of working. Respondents recognized high levels of trust amongst members, rated “good communication and coordination with participants” highly, and “facilitating collaboration” as the CRE’s most strongly recognized achievement. In collaboration and information-sharing networks, average path length remained low in 2017 and 2019, indicating good small-world network properties for relaying information. On average, respondents shared information and collaborated with more CRE members in 2017 than 2019. However, in both 2017 and 2019 there were new collaborations and information-sharing outside of direct collaborations. CRE-IQI outcomes included: evidence generation; knowledge transfer and skills development in quality improvement; research capacity-building, career development; mentoring; grant support; development of new projects; health service support; and policy impact.ConclusionsThis study shows the utility of network analysis in evaluating the functioning, and collaboration, at the individual, organizational and health system levels, of an innovation platform, and adds to our understanding of factors enabling successful innovation platforms.

BACKGROUND AND AIMS: Opioid agonist treatment is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings world-wide. This study assessed the safety of subcutaneous slow-release depot buprenorphine in custody. SETTING: This is an open-label, non-randomized trial conducted in correctional centres in New South Wales, Australia. Sixty-seven men and women, aged ≥ 18 years of various security classifications with a diagnosis of moderate to severe DSM-5 opioid use disorder currently serving a custodial sentence of ≥ 6 months were recruited between November 2018 and July 2019. Patients not in opioid agonist treatment at recruitment commenced depot buprenorphine; patients already stable on oral methadone treatment were recruited to the comparison arm. INTERVENTION AND COMPARATOR: Depot buprenorphine (CAM2038 weekly for 4 weeks then monthly) and daily oral methadone. Safety was assessed by adverse event (AE) monitoring and physical examinations at every visit. Participants were administered a survey assessing self-reported diversion and substance use at baseline and weeks 4 and 16. FINDINGS: Retention in depot buprenorphine treatment was 92.3%. Ninety-four per cent of patients reported at least one adverse event, typically mild and transient. No diversion was identified. The prevalence of self-reported non-prescribed opioid use among depot buprenorphine patients decreased significantly between baseline (97%) and week 16 (12%, odds ratio = 0.0035, 95% confidence interval = 0.0007-0.018, P

BackTrack is a multi-component, community-based program designed to build capacity amongst high-risk young people. The aim of this study was to conduct a benefit-cost analysis of BackTrack, which was implemented in Armidale, a rural town in New South Wales, Australia. Costs and benefits were identified, measured and valued in 2016 Australian dollars. Costs were estimated from program financial and administrative records. Benefits were estimated using a pre-post design and conservative economic assumptions. Benefits included education attendance or completion; employment; engagement with health service providers; reduced homelessness; economic productivity; reduced vandalism to local infrastructure; reduced youth crime; reduced engagement with the justice system; and program income generated by participants. The counterfactual baseline was zero educational outcome, based on discussions with BackTrack staff and expert informants. We tested this assumption compared to the assumption that participants had a Year 8 education. There was evidence of significant quantifiable improvements in several outcomes: high school attendance or completion, vocational education attendance or completion, unskilled or vocationally qualified employment and economic productivity. Reduced homelessness, engagement with health services and acquisition of job readiness skills, as well as reduced local infrastructure vandalism and reduced crime were further quantifiable improvements. The net social benefit of BackTrack was estimated at $3,267,967 with a benefit-cost ratio of 2.03, meaning that every dollar invested in BackTrack would return $2.03 in benefits. BackTrack represents a viable funding option for a government interested in addressing the needs of high-risk young people.

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.

Background A regional Australian Primary Health Network (PHN) has been subsidising administrative staff from local general practices to undertake the Medical Practice Assisting (MPA) course as part of its MPA Program. The MPA Program aimed to upskill administrative staff to undertake clinical tasks and fill in for busy or absent Practice Nurses (PNs), freeing up PNs to increase revenue-generating activity, avoiding casual replacement staff wages, and increasing patient throughput. An impact assessment was undertaken to evaluate the impact and estimate the economic costs of the MPA program to the PHN, general practices, and students to inform future uptake of the intervention. Methods The Framework to Assess the Impact of Translational Health Research (FAIT) was utilised. Originally designed to assess the impact of health research, this was its first application to a health services project. FAIT combines three validated methods of impact assessment—Payback, economic analysis and narratives underpinned by a program logic model. Quantified metrics describe the impacts of the program within various “domains of benefit”, the economic model costs the intervention and monetises potential consequences, and the narrative tells the story of the MPA Program and the difference it has made. Data were collected via online surveys from general practitioners (GPs), PNs, practice managers; MPA graduates and PHN staff were interviewed by phone and on Zoom. Results FAIT was effective in evidencing the impacts and economic viability of the MPA Program. GPs and PNs reported greater work satisfaction, PNs reported less stress and reduced workloads and MPA graduates reported higher job satisfaction and greater confidence performing a range of clinical skills. MPA Program economic costs for general practices during candidature, and 12 month post-graduation was estimated at $69,756. With effective re-integration planning, this investment was recoverable within 12 months through increased revenue for practices. Graduates paid appropriately for their new skills also recouped their investment within 24 months. Conclusion Utilisation of MPA graduates varied substantially between practices and COVID-19 impacted on their utilisation. More strategic reintegration of the MPA graduate back into the practice to most effectively utilise their new skillset could optimise potential benefits realised by participating practices.

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).

Background Health organisations are increasingly implementing ‘embedded researcher’ models to translate research into practice. This paper examines the impact of an embedded researcher model known as the embedded Economist (eE) Program that was implemented in an Australian Primary Health Network (PHN) located in regional New South Wales, Australia. The site, participants, program aims and design are described. Insights into the facilitators, challenges and barriers to the integration of economic evaluation perspectives into the work of the PHN are provided. Methods The eE Program consisted of embedding a lead health economist on site, supported by offsite economists, part-time, for fifteen weeks to collaborate with PHN staff. Evaluation of the eE at the PHN included qualitative data collection via semi-structured interviews (N= 34), observations (N=8) and a field diary kept by the embedded economists. A thematic analysis was undertaken through the triangulation of this data. Results The eE Program successfully met its aims of increasing PHN staff awareness of the value of economic evaluation principles in decision-making and their capacity to access and apply these principles. There was also evidence that the program resulted in PHN staff applying economic evaluations when commissioning service providers. Evaluation of the eE identified two key facilitators for achieving these results. First, a highly receptive organisational context characterised by a work ethic, and site processes and procedures that were dedicated to improvement. Second was the development of trusted relationships between the embedded economist and PHN staff that was enabled through: the commitment of the economist to bi-directional learning; facilitating access to economic tools and techniques; personality traits (likeable and enthusiastic); and because the eE provided ongoing support for PHN projects beyond the fifteen-week embedding period. Conclusions This study provides the first detailed case description of an embedded health economics program. The results demonstrate how the process, context and relational factors of engaging and embedding the support of a health economist works and why. The findings reinforce international evidence in this area and are of practical utility to the future deployment of such programs.

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.

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).

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.

IntroductionAsthma exacerbations in pregnancy are associated with adverse perinatal outcomes. We aimed to determine whether fractional exhaled nitric oxide (FENO)-based asthma management improves perinatal outcomes compared to usual care.MethodsThe Breathing for Life Trial was a multicentre, parallel-group, randomised controlled trial conducted in six hospital antenatal clinics, which compared asthma management guided byFENO(adjustment of asthma treatment according to exhaled nitric oxide and symptoms each 6–12 weeks) to usual care (no treatment adjustment as part of the trial). The primary outcome was a composite of adverse perinatal events (preterm birth, small for gestational age (SGA), perinatal mortality or neonatal hospitalisation) assessed using hospital records. Secondary outcomes included maternal asthma exacerbations. Concealed random allocation, stratified by study site and self-reported smoking status was used, with blinded outcome assessment and statistical analysis (intention to treat).ResultsPregnant 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).ConclusionFENO-guided asthma pharmacotherapy delivered by a nurse or midwife in the antenatal clinic setting did not improve perinatal outcomes.

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.

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 ‘Physical Activity 4 Everyone’ (PA4E1) was an efficacious multi-component school-based physical activity (PA) program targeting adolescents. PA4E1 has seven PA practices. It is essential to scale-up, evaluate effectiveness and assess implementation of such programs. Therefore, the aim is to assess the impact of implementation support on school practice uptake of the PA4E1 program at 12 and 24 months. Methods A cluster randomised controlled trial, utilising a type III hybrid implementation-effectiveness design, was conducted in 49 randomly selected disadvantaged Australian Government and Catholic secondary schools. A blinded statistician randomly allocated schools to a usual practice control (n = 25) or the PA4E1 program group (n = 24), with the latter receiving seven implementation support strategies to support school PA practice uptake of the seven practices retained from the efficacy trial. The primary outcome was the proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers and analysed using exact logistic regression modelling. This paper reports the 12-month outcomes. Results Schools were recruited from May to November 2017. At baseline, no schools implemented four of the seven practices. At 12 months significantly more schools in the program group had implemented four of the seven practices (16/24, 66.7%) than the control group (1/25, 4%) (OR = 33.0[4.15–1556.4], p p 80%). Conclusions Through the application of multiple implementation support strategies, secondary schools were able to overcome commonly known barriers to implement evidence based school PA practices. As such practices have been shown to result in an increase in adolescent PA and improvements in weight status, policy makers and practitioners responsible for advocating PA in schools should consider this implementation approach more broadly when working with schools. Follow-up is required to determine whether practice implementation is sustained. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017.

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 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

Background The aim of this trial was to evaluate the effectiveness of an online health behaviour change intervention—Prevent 2nd Stroke (P2S)—at improving health-related quality of life (HRQoL) amongst stroke survivors at 6 months of follow-up. Methods and findings A prospective, blinded-endpoint randomised controlled trial, with stroke survivors as the unit of randomisation, was conducted between March 2018 and November 2019. Adult stroke survivors between 6 and 36 months post-stroke with capacity to use the intervention (determined by a score of ≥4 on the Modified Rankin Scale) and who had access and willingness to use the internet were recruited via mail-out invitations from 1 national and 1 regional stroke registry. Participants completed baseline (n = 399) and 6-month follow-up (n = 356; 89%) outcome assessments via computer-assisted telephone interviewing (CATI). At baseline the sample had an average age of 66 years (SD 12), and 65% were male. Randomisation occurred at the end of the baseline survey; CATI assessors and independent statisticians were blind to group allocation. The intervention group received remote access for a 12-week period to the online-only P2S program (n = 199; n = 28 lost at follow-up). The control group were emailed and posted a list of internet addresses of generic health websites (n = 200; n = 15 lost at follow-up). The primary outcome was HRQoL as measured by the EuroQol Visual Analogue Scale (EQ-VAS; self-rated global health); the outcome was assessed for differences between treatment groups at follow-up, adjusting for baseline measures. Secondary outcomes were HRQoL as measured by the EQ-5D (descriptive health state), diet quality, physical activity, alcohol consumption, smoking status, mood, physical functioning, and independent living. All outcomes included the variable ‘stroke event (stroke/transient ischaemic attack/other)’ as a covariate, and analysis was intention-to-treat. At 6 months, median EQ-VAS HRQoL score was significantly higher in the intervention group than the control group (85 vs 80, difference 5, 95% CI 0.79–9.21, p = 0.020). The results were robust to the assumption the data were missing at random; however, the results were not robust to the assumption that the difference in HRQoL between those with complete versus missing data was at least 3 points. Significantly higher proportions of people in the intervention group reported no problems with personal care (OR 2.17, 95% CI 1.05–4.48, p = 0.0359) and usual activities (OR 1.66, 95% CI 1.06–2.60, p = 0.0256) than in the control group. There were no significant differences between groups on all other secondary outcomes. The main limitation of the study is that the sample comprises mostly ‘well’ stroke survivors with limited to no disability. Conclusions The P2S online healthy lifestyle program improved stroke survivors’ self-reported global ratings of HRQoL (as measured by EQ-VAS) at 6-month follow-up. Online platforms represent a promising tool to engage and support some stroke survivors. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12617001205325.

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 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. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336 International Registered Report Identifier (IRRID) RR2-10.2196/15113

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.

BackgroundA priority area in the field of substance dependence treatment is reducing the rates of relapse. Previous research has demonstrated that telephone delivered continuing care interventions are both clinically and cost effective when delivered as a component of outpatient treatment. This protocol describes a NSW Health funded study that assesses the effectiveness of delivering a telephone delivered continuing care intervention for people leaving residential substance treatment in Australia.Methods/designAll participants will be attending residential alcohol and other drug treatment provided by The Salvation Army or We Help Ourselves. The study will be conducted as a randomised controlled trial, where participants will be randomised to one of three treatment arms. The treatment arms will be: (i) 12-session continuing care telephone intervention; (ii) 4-session continuing care telephone intervention, or (iii) continuing care plan only. Baseline assessment batteries and development of the participants’ continuing care plan will be completed prior to participants being randomised to a treatment condition. Research staff blind to the treatment condition will complete follow-up assessments with participants at 3-months and 6-months after they have been discharged from their residential service.DiscussionThis study will provide comprehensive data on the effect of delivering the continuing care intervention for people exiting residential alcohol and other drug treatment. If shown to be effective, this intervention can be disseminated to improve the rates of relapse among people leaving residential alcohol and other drug treatment.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001231235. Registered on 23rd July 2018.https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375621&isReview=true

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 At a population level, small reductions in energy intake have the potential to contribute to a reduction in the prevalence of childhood obesity. In many school systems, there is the potential to achieve a reduction in energy intake through modest improvements in foods packed in children’s school lunchboxes. This study will assess the effectiveness and cost-effectiveness of a multi-component intervention that uses an existing school-based communication application to reduce the kilojoule content from discretionary foods and drinks consumed by children from school lunchboxes whilst at school. Methods A Type I hybrid effectiveness-implementation cluster randomised controlled trial will be conducted in up to 36 primary schools in the Hunter New England, Central Coast and Mid North Coast regions of New South Wales, Australia. Designed using the Behaviour Change Wheel, schools will be randomly allocated to receive either a 5-month (1.5 school terms) multi-component intervention that includes: 1) school lunchbox nutrition guidelines; 2) curriculum lessons; 3) information pushed to parents via an existing school-based communication application and 4) additional parent resources to address common barriers to packing healthy lunchboxes or a control arm (standard school practices). The study will assess both child level dietary outcomes and school-level implementation outcomes. The primary trial outcome, mean energy (kJ) content of discretionary lunchbox foods packed in children’s lunchboxes, will be assessed at baseline and immediately post intervention (5 months or 1.5 school terms). Analyses will be performed using intention to treat principles, assessing differences between groups via hierarchical linear regression models. Discussion This study will be the first fully powered randomised controlled trial internationally to examine the impact of an m-health intervention to reduce the mean energy from discretionary food and drinks packed in the school lunchbox. The intervention has been designed with scalability in mind and will address an important evidence gap which, if shown to be effective, has the potential to be applied at a population level. Trial registration Australian Clinical Trials Registry ACTRN:12618001731280 registered on 17/10/2018. Protocol Version 1.

Background The implementation of interventions at-scale is required to maximise population health benefits. ‘Physical Activity 4 Everyone (PA4E1)’ was a multi-component school-based program targeting adolescents attending secondary schools in low socio-economic areas. An efficacy trial of the intervention demonstrated an increase in students’ mean minutes of moderate-to-vigorous physical activity (MVPA) per day and lower weight gain at low incremental cost. This study aims to assess the effectiveness and cost effectiveness of a multi-component implementation support intervention to improve implementation, at-scale, of the evidence based school physical activity (PA) practices of the PA4E1 program. Impact on student PA levels and adiposity will also be assessed, in addition to the cost of implementation. Methods A cluster randomised controlled trial, utilising an effectiveness-implementation hybrid design, will be conducted in up to 76 secondary schools located in lower socio-economic areas across four health districts in New South Wales (NSW), Australia. Schools will be randomly allocated to a usual practice control arm or a multi-component implementation support intervention to embed the seven school PA practices of the PA4E1 program. The implementation support intervention incorporates seven strategies including executive support, in-School Champion, teacher training, resources, prompts, audit and feedback and access to an external Support Officer. The primary trial outcome will be the proportion of schools meeting at least four of the seven physical activity practices of the program, assessed via surveys with Head Physical Education teachers at 12 and 24-months. Secondary outcomes will be assessed via a nested evaluation of student PA and adiposity at 12-months (Grade 8 students) and 24 months (Grade 9 students) undertaken in 30 schools (15 per group). Resource use associated with the implementation intervention will be measured prospectively. Linear mixed effects regression models will assess program effects on the primary outcome at each follow-up period. Discussion This study is one of few evidence-based multi-component PA programs scaled-up to a large number of secondary schools and evaluated via randomised controlled trial. The use of implementation science theoretical frameworks to implement the evidence-based program and the rigorous evaluation design are strengths of the study. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017. Protocol Version 1. Electronic supplementary material The online version of this article (10.1186/s12889-019-6965-0) contains supplementary material, which is available to authorized users.

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 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.

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 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.

Background Urinary tract infection (UTI) as the most common healthcare-associated infection accounts for up to 36% of all healthcare-associated infections. Catheter-associated urinary tract infection (CAUTI) accounts for up to 80% of these. In many instances indwelling urinary catheter (IDC) insertions may be unjustified or inappropriate, creating potentially avoidable and significant patient distress, embarrassment, discomfort, pain and activity restrictions, together with substantial care burden, costs and hospitalisation. Multifaceted interventions combining best practice guidelines with staff engagement, education and monitoring have been shown to be more effective in bringing about practice change than those that focus on a single intervention. This study builds on a nurse-led initiative that identified that significant benefits could be achieved through a systematic approach to implementation of evidence-based practice. Methods The primary aim of the study is to reduce IDC usage rates by reducing inappropriate urinary catheterisation and duration of catheterisation. The study will employ a multiple pre-post control intervention design using a phased mixed method approach. A multifaceted intervention will be implemented and evaluated in four acute care hospitals in NSW, Australia. The study design is novel and strengthened by a phased approach across sites which allows for a built-in control mechanism and also reduces secular effects. Feedback of point prevalence data will be utilised to engage staff and improve compliance. Ward-based champions will help to steward the change and maintain focus. Discussion This study will improve patient safety through implementation and robust evaluation of clinical practice and practice change. It is anticipated that it will contribute to a significant improvement in patient experiences and health care outcomes. The provision of baseline data will provide a platform from which to ensure ongoing improvement and normalisation of best practice. This study will add to the evidence base through enhancing understanding of interventions to reduce CAUTI and provides a prototype for other studies focussed on reduction of hospital acquired harms. Study findings will inform undergraduate and continuing education for health professionals. Trial registration ACTRN12617000090314. Registered 17 January 2017. Retrospectively registered. Electronic supplementary material The online version of this article (doi:10.1186/s12913-017-2268-2) contains supplementary material, which is available to authorized users.

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.

IntroductionDepression is a common and debilitating condition. In Australia, general practitioners (GPs) are the key providers of depression care. However, available evidence suggests that case finding for depression in primary care is poor. This study will examine whether a systematic approach to screening for depression and assessing patient preferences for depression care improves depression outcomes among primary care patients.Methods and analysisA cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12). Patients who are aged 18 and older, presenting for general practice care, will be eligible to participate. Eighty-three participants will be recruited at each clinic. Participants will be asked to complete a baseline survey administered on a touch screen computer at their GP clinic, and then a follow-up survey at 3, 6 and 12 months. Those attending usual care practices will receive standard care. GPs at intervention practices will complete an online Clinical e-Audit, and will be provided with provider and patient-directed resources for depression care. Patients recruited at intervention practices who score 10 or above on the Patient Health Questionnaire-9 will have feedback regarding their depression screening results and preferences for care provided to their GP. The primary analysis will compare the number of cases of depression between the intervention and control groups.Ethics and disseminationThe study has been approved by the University of Newcastle Human Research Ethics Committee, and registered with Human Research Ethics Committees of the University of Wollongong, Monash University and University of New South Wales. Results will be disseminated through peer-reviewed journal publications and conference presentations.Trial registration numberACTRN12618001139268; Pre-results.

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 Population-based registries are increasingly used to recruit patient samples for research, however, they have several limitations including low consent and participation rates, and potential selection bias. To improve access to samples for research, the utility of a new model of recruitment termed the ‘Consumer Register’, that allows for direct patient recruitment from hospitals, was examined. This paper reports: (i) consent rates onto the register; (ii) preferred methods and frequency of contact; and (iii) the feasibility of establishing the register, including: (a) cost per person recruited to the register; (b) the differential cost and consent rates of volunteer versus paid data collectors; and (c) participant completion rates. Methods A cross-sectional survey was conducted in five outpatient clinics in Australia. Patients were approached by volunteers or paid data collectors and asked to complete a touch-screen electronic survey. Consenting individuals were asked to indicate their willingness and preferences for enrolment onto a research register. Descriptive statistics were used to examine patient preferences and linear regression used to model the success of volunteer versus paid data collectors. The opportunity and financial costs of establishing the register were calculated. Results A total of 1947 patients (80.6 %) consented to complete the survey, of which, 1486 (76.3 %) completed the questionnaire. Of the completers, the majority (69.4 %, or 1032 participants) were willing to be listed on the register and preferred to be contacted by email (50.3 %). Almost 39 % of completers were willing to be contacted three or more times in a 12 month period. The annual opportunity cost of resources consumed by the register was valued at $37,187, giving an opportunity cost per person recruited to the register of $36. After amortising fixed costs, the annual financial outlay was $23,004 or $22 per person recruited to the register. Use of volunteer data collectors contributed to an annual saving of $14,183, however paid data collectors achieved significantly higher consent rates. Successful enrolment onto the register was completed for 42 % of the sample. Conclusions A Consumer Register is a promising and feasible alternative to population-based registries, with the majority of participants willing to be contacted multiple times via low-resource methods such as email. There is an effectiveness/cost trade off in the use of paid versus volunteer data collectors.

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.