The impact of a regionally based translational cancer research collaborative in Australia using the FAIT methodology.

BACKGROUND: Translating research, achieving impact, and assessing impact are important aspirations for all research collaboratives but can prove challenging. The Hunter Cancer Research Alliance (HCRA) was funded from 2014 to 2021 to enhance capacity and productivity in cancer research in a regional centre in Australia. This study aimed to assess the impact and benefit of the HCRA to help inform future research investments of this type. METHOD: The Framework to Assess the Impact from Translational health research (FAIT) was selected as the preferred methodology. FAIT incorporates three validated methodologies for assessing impact: 1) Modified Payback; 2) Economic Analysis; and 3) Narrative overview and case studies. All three FAIT methods are underpinned by a Program Logic Model. Data were collected from HCRA and the University of Newcastle administrative records, directly from HCRA members, and website searches. RESULTS: In addition to advancing knowledge and providing capacity building support to members via grants, fellowships, scholarships, training, events and targeted translation support, key impacts of HCRA-member research teams included: (i) the establishment of a regional biobank that has distributed over 13,600 samples and became largely self-sustaining; (ii) conservatively leveraging $43.8 M (s.a.$20.5 M - $160.5 M) in funding and support from the initial $9.7 M investment; (iii) contributing to clinical practice guidelines and securing a patent for identification of stem cells for endometrial cell regeneration; (iv) shifting the treatment paradigm for all tumour types that rely on nerve cell innervation, (v) development and implementation of the world's first real-time patient treatment verification system (Watchdog); (vi) inventing the effective 'EAT' psychological intervention to improve nutrition and outcomes in people experiencing radiotherapy for head and neck cancer; (vi) developing effective interventions to reduce smoking rates among priority groups, currently being rolled out to disadvantaged populations in NSW; and (vii) establishing a Consumer Advisory Panel and Consumer Engagement Committee to increase consumer involvement in research. CONCLUSION: Using FAIT methodology, we have demonstrated the significant impact and downstream benefits that can be achieved by the provision of infrastructure-type funding to regional and rural research collaboratives to help address inequities in research activity and health outcomes and demonstrates a positive return on investment.

Improving the accuracy of blood pressure measuring devices in Australia: a modelled return on investment study.

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. The Framework to Assess the Impact of Translational Health Research was applied to the VALID BP project. This paper focuses on the implementation of the cost benefit analysis aspect of this framework 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. After 5 years, with 20% attribution of benefits, there is a potential $1.14-$1.30 return for every dollar spent if the proportion of validated BPMDs and staff trained in proper BP measurement technique increased from 20% to 60%. After eight years (2020-2028) and assuming universal validation and training coverage, the returns would be between $2.70 and $3.20 per dollar spent (not including cost of side effects of unnecessary medication or downstream patient impacts from unmanaged hypertension). 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.

Prioritising and incentivising productivity within indicator-based approaches to Research Impact Assessment: a commentary.

Research Impact Assessment (RIA) represents one of a suite of policies intended to improve the impact generated from investment in health and medical research (HMR). Positivist indicator-based approaches to RIA are widely implemented but increasingly criticised as theoretically problematic, unfair, and burdensome. This commentary proposes there are useful outcomes that emerge from the process of applying an indicator-based RIA framework, separate from those encapsulated in the metrics themselves. The aim for this commentary is to demonstrate how the act of conducting an indicator-based approach to RIA can serve to optimise the productive gains from the investment in HMR. Prior research found that the issues regarding RIA are less about the choice of indicators/metrics, and more about the discussions prompted and activities incentivised by the process. This insight provides an opportunity to utilise indicator-based methods to purposely optimise the research impact. An indicator-based RIA framework specifically designed to optimise research impacts should: focus on researchers and the research process, rather than institution-level measures; utilise a project level unit of analysis that provides control to researchers and supports collaboration and accountability; provide for prospective implementation of RIA and the prospective orientation of research; establish a line of sight to the ultimate anticipated beneficiaries and impacts; Include process metrics/indicators to acknowledge interim steps on the pathway to final impacts; integrate 'next' users and prioritise the utilisation of research outputs as a critical measure; Integrate and align the incentives for researchers/research projects arising from RIA, with those existing within the prevailing research system; integrate with existing peer-review processes; and, adopt a system-wide approach where incremental improvements in the probability of translation from individual research projects, yields higher impact across the whole funding portfolio.Optimisation of the impacts from HMR investment represents the primary purpose of Research Impact policy. The process of conducting an indicator-based approach to RIA, which engages the researcher during the inception and planning phase, can directly contribute to this goal through improvements in the probability that an individual project will generate interim impacts. The research project funding process represents a promising forum to integrate this approach within the existing research system.

Evaluation of the Effect of a Safe Medication Strategy on Potentially Inappropriate Medications, Polypharmacy and Anticholinergic Burden for People with Dementia: An Intervention Study.

People with dementia (PWD) are at risk for medication-related harm due to their impaired cognition and frequently being prescribed many medications. This study evaluated a medication safety intervention (including pharmacist medication reconciliation and review) for PWD during an unplanned admission to hospital. This article reports the effect of the intervention on polypharmacy, potentially inappropriate medications (PIMs), and anticholinergic burden scores for PWD. A 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. Polypharmacy, PIMs, and anticholinergic burden were measured at admission, discharge, and three months after discharge. There were 628 participants including 289 at the control site and 339 at the intervention site. Polypharmacy was 95% at admission and 90% at discharge. PIMs at admission were 95-98% across timepoints and decreased significantly at discharge. The mean anticholinergic score decreased significantly between admission (2.40-3.15) and discharge (2.01-2.57). Reduced PIMs at discharge were correlated with reduced anticholinergic burden (rho = 0.48-0.55, p < 0.001). No significant differences were identified between the study and control sites for Polypharmacy, PIMs, and anticholinergic burden rates and scores. High rates of polypharmacy and PIMs in this study indicate a study population with multiple comorbidities. This intervention was feasible to implement but was limited due to difficulty recruiting participants and deaths during the study. Future multisite studies should be designed to recruit larger study samples to evaluate interventions for improving medication safety for PWD and improve outcomes for these vulnerable people.

Task-specific training versus usual care to improve upper limb function after stroke: the "Task-AT Home" randomised controlled trial protocol.

Background: Sixty percent of people have non-functional arms 6 months after stroke. More effective treatments are needed. Cochrane Reviews show low-quality evidence that task-specific training improves upper limb function. Our feasibility trial showed 56 h of task-specific training over 6 weeks resulted in an increase of a median 6 points on the Action Research Arm test (ARAT), demonstrating the need for more definitive evidence from a larger randomised controlled trial. Task-AT Home is a two-arm, assessor-blinded, multicentre randomised, controlled study, conducted in the home setting. Aim: The objective is to determine whether task-specific training is a more effective treatment than usual care, for improving upper limb function, amount of upper limb use, and health related quality of life at 6 weeks and 6 months after intervention commencement. Our primary hypothesis is that upper limb function will achieve a ≥ 5 point improvement on the ARAT in the task-specific training group compared to the usual care group, after 6 weeks of intervention. Methods: Participants living at home, with remaining upper limb deficit, are recruited at 3 months after stroke from sites in NSW and Victoria, Australia. Following baseline assessment, participants are randomised to 6 weeks of either task-specific or usual care intervention, stratified for upper limb function based on the ARAT score. The task-specific group receive 14 h of therapist-led task-specific training plus 42 h of guided self-practice. The primary outcome measure is the ARAT at 6 weeks. Secondary measures include the Motor Activity Log (MAL) at 6 weeks and the ARAT, MAL and EQ5D-5 L at 6 months. Assessments occur at baseline, after 6 weeks of intervention, and at 6 months after intervention commencement. Analysis will be intention to treat using a generalised linear mixed model to report estimated mean differences in scores between the two groups at each timepoint with 95% confidence interval and value of p. Discussion: If the task-specific home-based training programme is more effective than usual care in improving arm function, implementation of the programme into clinical practice would potentially lead to improvements in upper limb function and quality of life for people with stroke. Clinical Trial Registration: ANZCTR.org.au/ACTRN12617001631392p.aspx.

Impact assessment of the Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery.

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.

Impact assessment of the medical practice assisting (MPA) program in general practice in the hunter New England and central coast regions of Australia.

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.

Network evaluation of an innovation platform in continuous quality improvement in Australian Indigenous primary healthcare.

BACKGROUND: From 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. METHODS: Two 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. RESULTS: The 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. CONCLUSIONS: This 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.

Tensions and Paradoxes of Scaling Up: A Critical Reflection on Physical Activity Promotion.

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

Tailoring childhood immunisation services in a socioeconomically disadvantaged community in New South Wales, Australia: a cost analysis.

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 $34250 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.

A Benefit-Cost Analysis of BackTrack, a Multi-Component, Community-Based Intervention for High-Risk Young People in a Rural Australian Setting.

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.

Budget impact analysis of a multifaceted nurse-led intervention to reduce indwelling urinary catheter use in New South Wales Hospitals.

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.

SISTAQUIT: training health care providers to help pregnant Aboriginal and Torres Strait Islander women quit smoking. A cluster randomised controlled trial.

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

Effect of asthma management with exhaled nitric oxide versus usual care on perinatal outcomes.

INTRODUCTION: Asthma exacerbations in pregnancy are associated with adverse perinatal outcomes. We aimed to determine whether fractional exhaled nitric oxide (F ENO)-based asthma management improves perinatal outcomes compared to usual care. METHODS: The Breathing for Life Trial was a multicentre, parallel-group, randomised controlled trial conducted in six hospital antenatal clinics, which compared asthma management guided by F ENO (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). RESULTS: Pregnant 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). CONCLUSION: F ENO-guided asthma pharmacotherapy delivered by a nurse or midwife in the antenatal clinic setting did not improve perinatal outcomes.

Estimating the cost of an individualised music intervention for aged care residents with dementia.

BACKGROUND: 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. AIM: To determine the cost of implementing an individualised music intervention for older people with dementia in residential aged care in Australia. METHOD: 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. RESULTS: 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. CONCLUSION: 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.

Relational aspects of building capacity in economic evaluation in an Australian Primary Health Network using an embedded researcher approach.

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.

The effect of zinc supplementation on glucose homeostasis: a randomised double-blind placebo-controlled trial.

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.

Evaluation of an online intervention for improving stroke survivors' health-related quality of life: A randomised controlled trial.

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.

Cost, cost-consequence and cost-effectiveness evaluation of a practice change intervention to increase routine provision of antenatal care addressing maternal alcohol consumption.

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).

Treatment of opioid dependence with depot buprenorphine (CAM2038) in custodial settings.

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. DESIGN: Open-label, non-randomized trial. SETTING: Correctional centres in New South Wales, Australia. PARTICIPANTS: 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. MEASUREMENTS: 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 < 0.0001). CONCLUSIONS: This first study of depot buprenorphine in custodial settings showed treatment retention and outcomes comparable to those observed in community settings and for other opioid agonist treatment used in custodial settings, without increased risk of diversion.