Should intermittent pneumatic compression devices be standard therapy for the prevention of venous thromboembolic events in major surgery? Protocol for a randomised clinical trial (IMPOSTERS).

INTRODUCTION: Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits. METHODS: This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%. ETHICS AND DISSEMINATION: This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals. TRIAL REGISTRATION NUMBER: ANZCTR12622001527752.

Optimal antiseptic skin preparation agents for minimizing surgical site infection following surgery: cost and cost-effectiveness analysis.

BACKGROUND: The application of antiseptic skin agents prior to incision minimizes the rate of surgical site infection. Despite their ubiquity, the optimal skin preparation agent remains uncertain. A retrospective economic analysis was conducted to complement the results from the NEWSkin Prep trial which prospectively compared three preparation agents. METHODS: A cost and cost-effectiveness analysis was performed from a healthcare service perspective to compare chlorhexidine with 70% ethanol, and aqueous povidone-iodine, against povidone-iodine with 70% ethanol. Resource use estimates accounted for hospital admissions, readmissions associated with surgical site infection, outpatient and general practitioner attendances, visits from community nurses and therapeutic consumables. The measure of effectiveness comprised the net difference in number of patients with surgical site infections per 1000 patients. Costs were compared using a two-sample Welch's t-test. Deterministic and probabilistic sensitivity analyses were performed to evaluate the incremental cost-effectiveness ratio. RESULTS: The null hypothesis that the mean costs for the trial arms were significantly different was not rejected (Welch's t-test P value: 0.771 for chlorhexidine with 70% ethanol against povidone-iodine with 70% ethanol; and 0.955 for aqueous povidone-iodine against povidone-iodine with 70% ethanol). Based on bootstrap averages, the chlorhexidine with 70% ethanol intervention generated 8.0 fewer surgical site infections per 1000 patients and net cost savings of €151,698 (Euros) per 1000 patients compared with povidone-iodine with 70% ethanol, and aqueous povidone-iodine produced a net cost saving of €37,494 per 1000 patients but generated an additional 11.6 surgical site infections per 1000 patients compared with povidone-iodine with 70% ethanol. The comparison of chlorhexidine with 70% ethanol to povidone-iodine with 70% ethanol was sensitive to the inclusion of cost outliers, while the comparison of aqueous povidone-iodine to povidone-iodine with 70% ethanol was sensitive to the estimated cost per surgical site infection. CONCLUSION: Based on the outcomes from the NEWSkin Prep study, this economic analysis found no definitive evidence in favour of any one of the study comparators. Future model-based economic analyses of alternative skin preparations should critically address the quality of evidence and integrate the results from the NEWSkin Prep study.

Supporting adolescents' participation in muscle-strengthening physical activity: protocol for the 'Resistance Training for Teens' (RT4T) hybrid type III implementation-effectiveness trial.

INTRODUCTION: In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the 'Resistance Training for Teens' (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear. OBJECTIVE: To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T. METHODS AND ANALYSIS: We will conduct a hybrid type III implementation-effectiveness trial involving grade 9 and 10 (aged 14-16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) 'low' (training and resources), (2) 'moderate' (training and resources+external support) or 'high' (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p<0.025 for the outcomes and cost comparisons of the moderate and high support arms against the low support arm. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers. TRIAL REGISTRATION NUMBER: ACTRN12622000861752.

A cluster randomised controlled trial to assess the effectiveness of a multi-strategy sustainability intervention on teachers' sustained implementation of classroom physical activity breaks (energisers): study protocol.

BACKGROUND: Governments internationally have invested hugely in the implementation and scale-up of school-based physical activity interventions, but have little evidence of how to best sustain these interventions once active implementation support ceases. This study will assess the effectiveness of a multi-strategy sustainability intervention on classroom teachers' sustainment of energisers (short 3-5 min physical activity breaks during class-time) scheduled across the school day from baseline to 12 and 24-month follow-up. METHODS: A cluster randomised controlled trial will be conducted in 50 primary schools within the Hunter New England, Illawarra Shoalhaven, Murrumbidgee and Northern New South Wales (NSW) Local Health Districts of NSW Australia. Schools will be randomly allocated to receive either usual support or the multi-strategy sustainability intervention that includes: centralised technical assistance from a trained project officer; formal commitment and mandated change obtained from school principals; training in-school champions; reminders for teachers; educational materials provided to teachers; capturing and sharing local knowledge; and engagement of parents, carers and the wider school community. The primary trial outcome will be measured via a teacher logbook to determine the between-group difference in the change in mean minutes of energisers scheduled across the school day at 12 and 24-month follow-up compared to baseline. Analyses will be performed using an intention to treat framework. Linear mixed models will be used to assess intervention effects on the primary outcome at both follow-up periods. DISCUSSION: This study will be one of the first randomised controlled trials to examine the impact of a multi-strategy sustainability intervention to support schools' sustainment of a physical activity intervention. The proposed research will generate new evidence needed for the partnering organisations to protect their considerable investments to date in physical activity promotion in this setting and will provide seminal evidence for the field globally. TRIAL REGISTRATION: ACTRN12620000372987 version 1 registered 17th March 2020. Version 3 (current version) updated 4th August 2023.

Evaluating the scaling up of an effective implementation intervention (PACE) to increase the delivery of a mandatory physical activity policy in primary schools.

BACKGROUND: Physically Active Children in Education (PACE) is an effective implementation intervention for increasing the number of minutes classroom teachers schedule physical activity each week. To date, evaluations of PACE have included a smaller number of schools from only one region in New South Wales Australia. If PACE is to have population-wide benefits we must be able to deliver this support to a larger number of schools across multiple regions. This study aimed to evaluate the scale-up of PACE. METHODS: An uncontrolled before and after study, with 100 schools from three regions was conducted. Participating schools received PACE for approximately 12 months. We assessed the following outcomes: delivery of the evidence-based intervention (EBI) (i.e. minutes of physical activity scheduled by classroom teachers per week); delivery of the implementation strategies (i.e. reach, dose delivered, adherence and indicators of sustainability); and key determinants of implementation (i.e. acceptability of strategies and cost). Data were collected via project officer records, and principal and teacher surveys. Linear mixed models were used to assess EBI delivery by evaluating the difference in the mean minutes teachers scheduled physical activity per week from baseline to follow-up. Descriptive data were used to assess delivery of the implementation strategies and their perceived acceptability (i.e. PACE). A prospective, trial-based economic evaluation was used to assess cost. RESULTS: Delivery of the EBI was successful: teachers increas their average minutes of total physical activity scheduled across the school week by 26.8 min (95% CI: 21.2, 32.4, p < 0.001) after receiving PACE. Indicators for delivery of implementation strategies were high: 90% of consenting schools received all strategies and components (reach); 100% of strategies were delivered by the provider (dose); >50% of schools adhered to the majority of strategies (11 of the 14 components); and acceptability was > 50% agreement for all strategies. The incremental cost per additional minute of physical activity scheduled per week was $27 per school (Uncertainty Interval $24, $31). CONCLUSIONS: PACE can be successfully delivered across multiple regions and to a large number of schools. Given the ongoing and scalable benefits of PACE, it is important that we continue to extend and improve this program while considering ways to reduce the associated cost.

A Scoping Review of Economic Evaluations to Inform the Reorientation of Preventive Health Services in Australia.

The Australian National Preventive Health Strategy 2021-2030 recommended the establishment of evidence-based frameworks to enable local public health services to identify strategies and interventions that deliver value for money. This study aimed to review the cost-effectiveness of preventive health strategies to inform the reorientation of local public health services towards preventive health interventions that are financially sustainable. Four electronic databases were searched for reviews published between 2005 and February 2022. Reviews that met the following criteria were included: population: human studies, any age or sex; concept 1: primary and/or secondary prevention interventions; concept 2: full economic evaluation; context: local public health services as the provider of concept 1. The search identified 472 articles; 26 were included. Focus health areas included mental health (n = 3 reviews), obesity (n = 1), type 2 diabetes (n = 3), dental caries (n = 2), public health (n = 4), chronic disease (n = 5), sexual health (n = 1), immunisation (n = 1), smoking cessation (n = 3), reducing alcohol (n = 1), and fractures (n = 2). Interventions that targeted obesity, type 2 diabetes, smoking cessation, and fractures were deemed cost-effective, however, more studies are needed, especially those that consider equity in priority populations.

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.

Study protocol for an economic evaluation and budget impact of implementation strategies to support routine provision of antenatal care for gestational weight gain: a stepped-wedge cluster trial.

BACKGROUND: Antenatal clinical practice guidelines recommend routine assessment of weight and provision of advice on recommended weight gain during pregnancy and referral to additional services when appropriate. However, there are barriers to clinicians adopting such best-practice guidelines. Effective, cost-effective, and affordable implementation strategies are needed to ensure the intended benefits of guidelines are realised. This paper describes the protocol for evaluating the efficiency and affordability of implementation strategies compared to the usual practice in public antenatal services. METHOD: The prospective trial-based economic evaluation will identify, measure, and value key resource and outcome impacts arising from the implementation strategies compared with usual practice. The evaluation will comprise of (i) costing, (ii) cost-consequence analyses, where a scorecard approach will be used to show the costs and benefits given the multiple primary outcomes included in the trial, and (iii) cost-effectiveness analysis, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for gestational weight gain consistent with the guideline recommendations. Affordability will be evaluated using (iv) budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fund-holders. DISCUSSION: Together with the findings from the effectiveness trial, the outcomes of this economic evaluation will inform future healthcare policy, investment allocation, and research regarding the implementation of antenatal care to support healthy gestational weight gain. TRIAL REGISTRATION: Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12621000054819 (22/01/2021) http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380680&isReview=true .

Effectiveness and cost-effectiveness of a digital health intervention to support patients with colorectal cancer prepare for and recover from surgery: study protocol of the RecoverEsupport randomised controlled trial.

INTRODUCTION: Surgery is the most common treatment for colorectal cancer (CRC) and can cause relative long average length of stay (LOS) and high risks of unplanned readmissions and complications. Enhanced Recovery After Surgery (ERAS) pathways can reduce the LOS and postsurgical complications. Digital health interventions provide a flexible and low-cost way of supporting patients to achieve this. This protocol describes a trial aiming to evaluate the effectiveness and cost-effectiveness of the RecoverEsupport digital health intervention in decreasing the hospital LOS in patients undergoing CRC surgery. METHODS AND ANALYSIS: The two-arm randomised controlled trial will assess the effectiveness and cost-effectiveness of the RecoverEsupport digital health intervention compared with usual care (control) in patients with CRC. The intervention consists of a website and a series of automatic prompts and alerts to support patients to adhere to the patient-led ERAS recommendations. The primary trial outcome is the length of hospital stay. Secondary outcomes include days alive and out of hospital; emergency department presentations; quality of life; patient knowledge and behaviours related to the ERAS recommendations; health service utilisation; and intervention acceptability and use. ETHICS AND DISSEMINATION: The trial has been approved by the Hunter New England Research Ethics Committee (2019/ETH00869) and the University of Newcastle Ethics Committee (H-2015-0364). Trial findings will be disseminated via peer-reviewed publications and conference presentations. If the intervention is effective, the research team will facilitate its adoption within the Local Health District for widespread adaptation and implementation. TRIAL REGISTRATION NUMBER: ACTRN12621001533886.

Efficacy of intermittent compression devices for thromboembolic prophylaxis in major abdominal surgery: a systematic review and meta-analysis.

BACKGROUND: The benefits of mechanical prophylaxis for the prevention of venous thromboembolism (VTE) in abdominal and pelvic surgery are uncertain, with different guidelines stating that graduated compression stockings (GCS) and intermittent pneumatic compression devices (IPCDs) can be used either alone or in combination. To review the efficacy of IPCDs in preventing VTE following abdominal and pelvic surgery. METHODS: A systematic review was conducted, identifying relevant literature reporting clinical trials conducted in abdominopelvic surgery, comparing the effect of IPCDs alone or in combination with no prophylaxis, GCS and chemical prophylaxis. The review identified studies reported from 1966 to 2022 in Medline, Embase, PubMed and Cochrane databases for randomized controlled trials. RESULTS: Thirteen RCTs involving 1914 participants were identified. IPCDs were superior to placebo (OR VTE 0.39; 95% CI 0.20-0.76) but not superior to other forms of prophylaxis (OR 0.83; 95% CI 0.30-2.27) or to GCS alone (OR 0.9; 95% CI 0.24-3.36). The addition of IPCDs to GCS compared with GCS alone was beneficial (OR 0.45; 95% CI 0.23-0.91) as was the addition of IPCDs to standard perioperative chemoprophylaxis (OR 0.25; 95% CI 0.09-0.74). The overall quality and reliability of trials were low, with high risk of bias. CONCLUSIONS: IPCDs are more effective than placebo in reducing VTE rates but are not more effective than other forms of thrombo-prophylaxis (chemical or mechanical) following abdominal and pelvic surgery. There is poor quality evidence to suggest that they might have a role as additional prophylaxis when combined with GCS and chemical prophylaxis.

Cluster randomised controlled trial to determine the impact of an activity enabling uniform on primary school student's fitness and physical activity: study protocol for the Active WeAR Everyday (AWARE) study.

IntroductionMulticomponent school-based physical activity (PA) interventions can improve students' cardiorespiratory fitness (CRF) and PA. Due to the complex nature of such interventions when delivered at scale their effect sizes markedly reduce. Modifying student school uniforms, so that they are more PA enabling, may be a simple intervention that could enhance student health. The primary aim of this trial is to assess the effectiveness of an activity enabling uniform intervention (shorts, polo shirt and sports shoes) in improving children's CRF. METHODS AND ANALYSIS: A cluster randomised controlled trial will be conducted in 24 primary schools in New South Wales (NSW), Australia. Schools will be randomly allocated to either intervention or usual practice following baseline data collection. Active WeAR Everyday intervention schools will allow students in grades 4-6 (aged approx. 9-12 years) to wear their existing sports uniform (shorts, polo shirt and sports shoes) every day. To avoid any financial cost to students they will be provided with two additional sports shirts and one pair of shorts. Study outcomes will be assessed at baseline and 9 months postbaseline. The primary outcome is students' CRF measured using the 20 m multistage fitness test. Secondary outcomes include students': mean daily steps and steps/minute measured via accelerometer, quality of life, mental well-being and perceived PA self-efficacy. The acceptability, feasibility and cost of the intervention will be assessed. Analyses will be performed using an intention-to-treat framework. Linear mixed effects regression models will be used to assess intervention effects on the primary outcome at follow-up. Planned exploratory analyses will examine effects by subgroups (eg, gender). ETHICS AND DISSEMINATION: This study has received approval from Hunter New England Local Health District Human Ethics Committee (2020/ETHO2602) the University of Newcastle, Human Research Ethics Committee (H-2021-0013), NSW Department of Education (SERAP: 2020387) and Catholic School Offices. TRIAL REGISTRATION NUMBER: ACTRN12621000201875.

Time-efficient physical activity intervention for older adolescents with disability: rationale and study protocol for the Burn 2 Learn adapted (B2La) cluster randomised controlled trial.

INTRODUCTION: Physical activity declines during adolescence, with the lowest levels of activity observed among those with disability. Schools are ideal settings to address this issue; however, few school-based interventions have been specifically designed for older adolescents with disability. Our aim is to investigate the effects of a school-based physical activity programme, involving high-intensity interval training (HIIT), on physical, mental and cognitive health in older adolescents with disability. METHODS AND ANALYSIS: We will evaluate the Burn 2 Learn adapted (B2La) intervention using a two-arm, parallel group, cluster randomised controlled trial with allocation occurring at the school level (treatment or waitlist control). Secondary schools will be recruited in two cohorts from New South Wales, Australia. We will aim to recruit 300 older adolescents (aged 15-19 years) with disability from 30 secondary schools (10 in cohort 1 and 20 in cohort 2). Schools allocated to the intervention group will deliver two HIIT sessions per week during scheduled specialist support classes. The sessions will include foundational aerobic and muscle strengthening exercises tailored to meet student needs. We will provide teachers with training, resources, and support to facilitate the delivery of the B2La programme. Study outcomes will be assessed at baseline, 6 months (primary endpoint), and 9 months. Our primary outcome is functional capacity assessed using the 6 min walk/push test. Secondary outcomes include physical activity, muscular fitness, body composition, cognitive function, quality of life, physical literacy, and on-task behaviour in the classroom. We will also conduct economic and process evaluations to determine cost-effectiveness, programme acceptability, implementation, adaptability, and sustainability in schools. ETHICS AND DISSEMINATION: This study has received approval from the University of Newcastle (H-2021-0262) and the New South Wales Department of Education (SERAP: 2021257) human research ethics committees. Findings will be published in peer-reviewed journals, and key stakeholders will be provided with a detailed report following the study. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry Number: ACTRN12621000884808.

Iterative delivery of an implementation support package to increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy: study protocol for a stepped-wedge cluster trial.

INTRODUCTION: Antenatal care addressing alcohol consumption during pregnancy is not routinely delivered in maternity services. Although a number of implementation trials have reported significant increases in such care, the majority of women still did not receive all recommended care elements, and improvements dissipated over time. This study aims to assess the effectiveness of an iteratively developed and delivered implementation support package in: (1) increasing the proportion of pregnant women who receive antenatal care addressing alcohol consumption and (2) sustaining the rate of care over time. METHODS AND ANALYSIS: A stepped-wedge cluster trial will be conducted as a second phase of a previous trial. All public maternity services within three sectors of a local health district in Australia will receive an implementation support package that was developed based on an assessment of outcomes and learnings following the initial trial. The package will consist of evidence-based strategies to support increases in care provision (remind clinicians; facilitation; conduct educational meetings) and sustainment (develop a formal implementation blueprint; purposely re-examine the implementation; conduct ongoing training). Measurement of outcomes will occur via surveys with women who attend antenatal appointments each week. Primary outcomes will be the proportion of women who report being asked about alcohol consumption at subsequent antenatal appointments; and receiving complete care (advice and referral) relative to alcohol risk at initial and subsequent antenatal appointments. Economic and process evaluation measures will also be reported. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Hunter New England (16/11/16/4.07, 16/10/19/5.15) and University of Newcastle Human Research Ethics Committees (H-2017-0032, H-2016-0422) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health service decision makers to inform the feasibility of conducting additional cycles to further improve antenatal care addressing alcohol consumption as well as at scientific conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN12622000295741).

Economic evaluation of a multi-strategy intervention that improves school-based physical activity policy implementation.

BACKGROUND: Internationally, government policies mandating schools to provide students with opportunities to participate in physical activity are poorly implemented. The multi-component Physically Active Children in Education (PACE) intervention effectively assists schools to implement one such policy. We evaluated the value of investment by health service providers tasked with intervention delivery, and explored where adaptations might be targeted to reduce program costs for scale-up. METHODS: A prospective trial-based economic evaluation of an implementation intervention in 61 primary schools in New South Wales (NSW), Australia. Schools were randomised to the PACE intervention or a wait-list control. PACE strategies included centralised technical assistance, ongoing consultation, principal's mandated change, identifying and preparing in-school champions, educational outreach visits, and provision of educational materials and equipment. Effectiveness was measured as the mean weekly minutes of physical activity implemented by classroom teachers, recorded in a daily log book at baseline and 12-month follow-up. Delivery costs (reported in $AUD, 2018) were evaluated from a public finance perspective. Cost data were used to calculate: total intervention cost, cost per strategy and incremental cost (overall across all schools and as an average per school). Incremental cost-effectiveness ratios (ICERs) were calculated as the incremental cost of delivering PACE divided by the estimated intervention effect. RESULTS: PACE cost the health service provider a total of $35,692 (95% uncertainty interval [UI] $32,411, $38,331) to deliver; an average cost per school of $1151 (95%UI $1046, $1236). Training in-school champions was the largest contributor: $19,437 total; $627 ($0 to $648) average per school. Educational outreach was the second largest contributor: $4992 total; $161 ($0 to $528) average per school. The ICER was $29 (95%UI $17, $64) for every additional minute of weekly physical activity implemented per school. CONCLUSION: PACE is a potentially cost-effective intervention for increasing schools implementation of a policy mandate. The investment required by the health service provider makes use of existing funding and infrastructure; the additional cost to assist schools to implement the policy is likely not that much. PACE strategies may be adapted to substantially improve delivery costs. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12617001265369; Prospectively registered 1st September 2017 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373520.

Practice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: a randomised stepped-wedge controlled trial.

BACKGROUND: Clinical guideline recommendations for addressing alcohol consumption during pregnancy are sub-optimally implemented and limited evidence exists to inform practice improvements. The aim of this study was to estimate the effectiveness of a practice change intervention in improving the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. METHODS: A randomised stepped-wedge controlled trial was undertaken with all public maternity services in three sectors (one urban, two regional/rural) of a single local health district in New South Wales, Australia. All antenatal care providers were subject to a seven-month multi-strategy intervention to support the introduction of a recommended model of care. For 35 months (July 2017 - May 2020) outcome data were collected from randomly selected women post an initial, 27-28 weeks and 35-36 weeks gestation antenatal visit. Logistic regression models assessed intervention effectiveness. RESULTS: Five thousand six hundred ninety-four interviews/online questionnaires were completed by pregnant women. The intervention was effective in increasing women's reported receipt of: assessment of alcohol consumption (OR: 2.63; 95% CI: 2.26-3.05; p < 0.001), advice not to consume alcohol during pregnancy and of potential risks (OR: 2.07; 95% CI: 1.78-2.41; p < 0.001), complete care relevant to alcohol risk level (advice and referral) (OR: 2.10; 95% CI: 1.80-2.44; p < 0.001) and all guideline elements relevant to alcohol risk level (assessment, advice and referral) (OR: 2.32; 95% CI: 1.94-2.76; p < 0.001). Greater intervention effects were found at the 27-28 and 35-36 weeks gestation visits compared with the initial antenatal visit. No differences by sector were found. Almost all women (98.8%) reported that the model of care was acceptable. CONCLUSIONS: The practice change intervention improved the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. Future research could explore the characteristics of pregnant women and maternity services associated with intervention effectiveness as well as the sustainment of care practices over time to inform the need for, and development of, further tailored practice change support. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (Registration number: ACTRN12617000882325; Registration date: 16/06/2017) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372985&isReview=true.

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.

A randomised controlled trial of an implementation strategy delivered at scale to increase outdoor free play opportunities in early childhood education and care (ECEC) services: a study protocol for the get outside get active (GOGA) trial.

BACKGROUND: Increased outdoor play time in young children is associated with many health and developmental benefits. This study aims to evaluate the impact of a multi-strategy implementation strategy delivered at scale, to increase opportunities for outdoor free play in Early Childhood Education and Care (ECEC) services. METHODS: The study will employ a parallel-group randomised controlled trial design. One hundred ECEC services in the Hunter New England region of New South Wales, Australia, will be recruited and randomised to receive either a 6-month implementation strategy or usual care. The trial will seek to increase the implementation of an indoor-outdoor routine (whereby children are allowed to move freely between indoor and outdoor spaces during periods of free play), to increase their opportunity to engage in outdoor free play. Development of the strategy was informed by the Behaviour Change Wheel to address determinants identified in the Theoretical Domains Framework. ECEC services allocated to the control group will receive 'usual' implementation support delivered as part of state-wide obesity prevention programs. The primary trial outcome is the mean minutes/day (calculated across 5 consecutive days) of outdoor free play opportunities provided in ECEC services measured at baseline, 6-months (primary end point) and 18-months post baseline. Analyses will be performed using an intention-to-treat approach with ECEC services as the unit of analysis, using a linear mixed effects regression model to assess between-group differences. A sensitivity analysis will be undertaken, adjusting for service characteristics that appear imbalanced between groups at baseline, and a subgroup analysis examining potential intervention effect among services with the lowest baseline outdoor free play opportunities. DISCUSSION: Identifying effective strategies to support the implementation of indoor-outdoor routines in the ECEC setting at scale is essential to improve child population health. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12621000987864 ). Prospectively registered 27th July 2021, ANZCTR - Registration.

The Effectiveness and Cost of an Intervention to Increase the Provision of Preventive Care in Community Mental Health Services: Protocol for a Cluster-Randomized Controlled Trial.

Preventive care to address chronic disease risk behaviours is infrequently provided by community mental health services. In this cluster-randomised controlled trial, 12 community mental health services in 3 Local Health Districts in New South Wales, Australia, will be randomised to either an intervention group (implementing a new model of providing preventive care) or a control group (usual care). The model of care comprises three components: (1) a dedicated 'healthy choices' consultation offered by a 'healthy choices' clinician; (2) embedding information regarding risk factors into clients' care plans; and (3) the continuation of preventive care by mental health clinicians in ongoing consultations. Evidence-based implementation strategies will support the model implementation, which will be tailored by being co-developed with service managers and clinicians. The primary outcomes are client-reported receipt of: (1) an assessment of chronic disease risks (tobacco smoking, inadequate fruit and vegetable consumption, harmful alcohol use and physical inactivity); (2) brief advice regarding relevant risk behaviours; and (3) referral to at least one behaviour change support. Resources to develop and implement the intervention will be captured to enable an assessment of cost effectiveness and affordability. The findings will inform the development of future service delivery initiatives to achieve guideline- and policy-concordant preventive care delivery.

Reduced cognitive function contributes to economic burden of multiple sclerosis.

BACKGROUND: Cognitive impairment is a common symptom of multiple sclerosis (MS). The effect of cognitive impairment in people with MS on employment, quality of life and mental health is known, however, few studies have investigated if cognitive deficits contribute to the economic burden of MS. OBJECTIVE: To investigate if cognitive impairment correlates with the economic burden of MS. METHODS: The client service receipt inventory was used to determine cost to the healthcare system, participant out of pocket cost, community cost and total societal cost. Quality of life was evaluated using the EuroQoL. Participants cognitive performance was assessed with the Audio Recorded Cognitive Screen and the symbol digit modalities test. Spearman's rank correlation coefficient (r) was used to gauge the strength of the correlation between domain scores and cost metrics. RESULTS: Memory, speed of writing and the symbol digit modalities test were all negatively correlated with all aspects of cost of care (r = 0.24-0.59, P < 0.5). This was found to be independent of other factors, such as EDSS or mental health indices. CONCLUSION: Cognitive deficits are independently correlated with the economic burden of MS and should be monitored as part of routine care.