OBJECTIVE:To evaluate the impact of an Australian Virtual Care service on low-acuity patient presentations to emergency departments (EDs) across a local health district. DESIGN:This was a retrospective study using an interrupted time series analysis to compare outcomes before and after the introduction of Mid North Coast Virtual Care (MNCVC). The comparison of these periods aims to identify changes in the rate of semi-urgent (category 4) and non-urgent (category 5) ED presentations following the intervention. SETTING:This analysis covers the Mid North Coast Local Health District, a coastal region in New South Wales, Australia. It encompasses EDs in Port Macquarie, Coffs Harbour, Kempsey, Macksville, Dorrigo and Bellingen. MAIN OUTCOME MEASURE:Whether there was a reduction in low-acuity ED presentations (category 4 and 5) as a proportion of total ED presentations at Mid North Coast EDs following the commencement of MNCVC as an alternative to ED attendance. RESULTS:In the years prior to intervention, the proportion of total ED presentations that were low-acuity presentations averaged 54.58%. Following intervention from July 2022 onwards, there was an immediate non-significant 1.04% decrease in the proportion of category 4 and 5 presentations (95% CI -2.11 to 0.04, p=0.063), with a further significant 0.12% decrease each month thereafter (95% CI -0.17 to -0.06, p<0.001). By December 2024, the model estimated a cumulative 4.64% decrease in the proportion of low-acuity presentations since the introduction of the virtual care service. CONCLUSIONS:Following commencement of a virtual care service, a significant and sustained reduction in the proportion of low-acuity presentations was observed across the district EDs. Virtual care services may contribute to easing the burden of low-acuity presentations on EDs.

Current designs used to optimise implementation strategies (e.g., sequential cluster randomised controlled trials (cRCTs) and multi-arm cRCTs) are inefficient and resource intensive. Bayesian adaptive designs may offer a more efficient alternative. We conducted a virtual trial re-execution to assess the impact of using a Bayesian adaptive design for optimising an existing implementation strategy (Physically Active Children in education (PACE)) used to support the delivery of school-based physical activity. The two previous, sequential, two-arm cRCTs used to optimise PACE were combined into a single three-arm cRCT. We assessed the performance of a fixed version of this trial design compared to an adaptive version incorporating one, two, or three interim analyses in a virtual re-execution. Adaptions included arm dropping and early stopping for futility, noninferiority, or efficacy. All adaptive designs stopped early for noninferiority, declaring the lower cost treatment as the optimal arm at interim analysis one. This was the same conclusion obtained in the fixed version of the three-arm cRCT and the original sequential two-arm cRCTs. Using adaptive designs, the same conclusion was reached using 50–75

Uptake of lung cancer screening (LCS) in high-risk populations remains suboptimal internationally. Primary care practitioners play a critical role in identifying eligible patients and initiating referrals for LCS. Targeted implementation strategies are needed to address health care barriers to the uptake of LCS such as limited awareness, eligibility assessment, low engagement, and poor health system preparedness. Implementation trials are needed to determine optimal decision-making and participant knowledge gains to ultimately increase screening uptake. The Ready to Screen trial is a cluster randomized controlled implementation trial to compare participants’ intention to screen for lung cancer in the Australian National Lung Cancer Screening Program (hereafter ‘the Program’) between bundled (intervention: core + link to multilingual trial website + SMS and email reminders, clinical decision support prompts for general practitioners) and core (control (core): initial letter mail out with LCS brochure only) implementation strategies. Twenty-eight general practices recruited across Australia will be randomly allocated (1:1 ratio) to either control or intervention. Practices will generate eligible patient lists using medical records to issue participation invitations. Eligible patients are aged 50–70 years and currently smoke or have quit within the past 10 years or have an unknown quit date. The primary outcome is participant intention to screen from self-report survey at patient recruitment. Secondary outcomes will be evaluated using the RE-AIM framework—examining Reach, Effectiveness (including cost-effectiveness), Adoption, Implementation and Maintenance. The PRISM framework will guide assessment of multi-level contextual factors hypothesized to influence these outcomes. Data collection will include trial recruitment and practice records, participant and provider self-report surveys, and semi-structured interviews. This trial will generate timely evidence about the effectiveness and cost-effectiveness of the bundled implementation strategy to support delivery of the Program within primary care practices. Findings will provide insights into contextual factors shaping implementation success and inform the future scaling and sustainability of LCS in Australia and internationally. ACTRN12625000045415 registered on 20/01/2025.

Abstract INTRODUCTION Healthful dietary patterns may attenuate dementia risk by preserving cerebrovascular health. Prior work has focused on systemic arterial stiffness, but cerebrovascular measures may be more sensitive to neuroprotective effects of diet. We examined associations between Mediterranean diet adherence, prefrontal cortex (PFC) arterial elasticity, and cognition in older adults. METHODS Participants were 198 older adults (58% female; mean age 65.6 years) from the Newcastle ACTIVate cohort. Mediterranean Diet (MedDiet) scores were derived from the Australian Eating Survey food frequency questionnaire. Pulse Relaxation Function (PReFx), an index of PFC arterial elasticity, was measured using pulse Diffuse Optical Tomography. Cognition was assessed with CANTAB and a cued task-switching paradigm. RESULTS Higher MedDiet was associated with higher PFC arterial elasticity. MedDiet was not associated with cognition, and PReFx did not mediate diet-cognition associations. DISCUSSION Greater Mediterranean diet alignment was cross-sectionally associated with PFC arterial elasticity, suggesting a pathway through which diet may influence brain health in ageing.

Ageing is often associated with a decline in cardiovascular and cerebrovascular health. This study examines the relationship between cerebral arterial elasticity and measures of cardiovascular health, as well as longitudinal changes in cerebral arterial elasticity over a 1.5 year interval. The pulse relaxation function (PReFx) is a measure of regional cerebral arterial elasticity derived using diffuse optical tomography (pulse-DOT). PReFx was measured over the anterior brain, including the frontal lobes and anterior sections of temporal and parietal regions that are especially vulnerable to vascular and cognitive ageing. We examined relationships between PReFx and measures of four cardiovascular risk factors (CVRF; i.e., hypertension, cholesterol, diabetes, obesity), as well as CVRF burden (i.e., number of CVRFs) in the highly active and cognitively healthy ACTIVate cohort (60-70 years). We replicated the well-established relationship between PReFx and both age and cardiorespiratory fitness, and examined associations between PReFx, measures of cardiovascular health and CVRF burden. Higher CVRF burden was linearly associated with lower cerebral arterial elasticity. The relationship between age and cerebral arterial elasticity was partially mediated by pulse pressure, an index of hypertension. PReFx declined significantly in as little as 1.5 years, and the effect did not vary with baseline level of any of the four CVRFs. We conclude that PReFx shows promise as a putative biomarker for monitoring cerebrovascular ageing in healthy older adults.

BACKGROUND:Approximately 70% of patients in intensive care units (ICUs) experience untreated pain, often due to severe patient conditions and communication barriers. AIM:The aim of this study was to implement the Critical-Care Pain Observation Tool (CPOT) to improve pain assessment in patients unable to self-report pain in the ICU. METHOD:A stepped-wedge trial was conducted in six adult ICUs in Saudi Arabia between February and June 2022. The sequential transition of ICU clusters occurred in February 2022, from control to intervention, until all ICUs were exposed to the intervention. The primary outcome was the number of pain assessments, whereas the secondary outcomes were reassessments. Other outcomes were length of stay, mechanical ventilation duration, and administered doses of sedatives and analgesic agents. Statistical analyses were performed using the Statistical Analysis Software v9.4. RESULTS:A total of 725 patients unable to self-report pain were included; 65% (n = 469) were male with an average age of 55 years. Implementing CPOT showed a significant increase in the number of pain assessments (rate ratio: 1.77, 95% confidence interval: 1.45, 2.16, p < 0.001) and reassessments (rate ratio: 13.99, 95% confidence interval: 8.14, 24.02, p < 0.001) between intervention and control conditions. There was no significant effect on the ICU length of stay, mechanical ventilation duration, and the amount of sedation (midazolam, propofol, and ketamine) and analgesia (fentanyl) administered. CONCLUSION:The study indicates that the implementation of the CPOT increased the frequency of pain assessment and reassessment. However, the impact on patient outcomes remains inconclusive. Further investigations focussing on CPOT as the primary pain scale are necessary to determine its holistic impact on patient outcomes over the long term. TRIAL REGISTRATION:NCT05488834. CLINICAL TRIAL REGISTRATION NUMBER:This study was registered with the U.S. National Library of Medicine (ClinicalTrial.gov, NCT05488834).

AIM:Smoking is a chronic relapsing condition that is under-reported in oncology settings. People who report current smoking (CS) and those who report recently quitting smoking (RQ) should receive cessation support when they are diagnosed with cancer. The study aimed to identify whether differences exist in the smoking cessation support given to CS and RQ in oncology and what advice is given regarding the benefits of cessation. METHOD:A survey exploring smoking cessation practices was completed by oncology clinicians (medical, nursing, and allied health) at nine cancer centers in Australia. Data were analyzed using mixed-effects ordinal regression modeling. RESULTS:Across the 177 clinicians completing the survey, the reported provision of smoking cessation care was significantly higher for CS than for RQ in relation to asking about smoking status (odds ratio [OR] 3.03, p = 0.001), advice on the benefits of quitting (OR 2.86, p = 0.001), and advice to call the Quitline (OR 5.08, p < 0.001). Exploratory analyses indicated doctors and nurse specialists were four times more likely to report referring CS to a Quitline compared to RQ (OR 4.38, p = 0.001; OR 4.29, 95%, p = 0.005, respectively). The cessation benefits that clinicians most often cited to their patients was that quitting "can reduce the chance of developing treatment complications and side effects". CONCLUSION:The relative lack of smoking cessation care provided to RQ in oncology suggests that the high risk of smoking relapse is not well-recognized. Greater awareness and training are needed regarding advising RQ about the survival-specific benefits of continuing to not smoke, offering referrals, and offering follow-up support.

Background: Effective management of type 2 diabetes remain a challenge for health services in Australia. Rural and remote communities in particular are at a higher risk of diabetes-related complications due to reduced access to specialist services, making the role of general practices all the more important in the provision of diabetes care. Integrated care targeted around increasing capacity to rural general practices in the treatment of type 2 diabetes may reduce the disparity in health outcomes among rural and remote patients suffering from type-2 diabetes. This protocol aims to describe a causal approach for the evaluation of a specialist-led integrated model of care delivered to general practices using large administrative health data. Methods and analysis: This will be an observational cohort study using linked general practice and hospital data from the Lumos program. This protocol adopts the target trial framework approach described by Hernan et al and the estimands framework proposed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We describe the data structure and statistical analysis plan that would be required for causal inferences. The target causal estimand is the effect of the Diabetes Alliance Program Plus integrated care intervention, among general practice active-attending adult patients with current and new diagnoses of type 2 diabetes, on three-year hospitalisation rates wherein type 2 diabetes is the principal diagnosis. Causal effect estimates and the precision in these estimates will be quantified. Ethics and dissemination: The Diabetes Alliance Program Plus has ethics approval from the Hunter New England Human Research Ethics Committee (2024/ETH01649), with approval registered with the University of Newcastle (R-2024-0073). The Lumos data asset is also ethically approved by the Population Health Services Research Ethics Committee (PHSREC; 2019/ETH00660), and DAP+ has received approval by their Governance Committee for the evaluation in this protocol. The analysis and interpretation of the results will be contingent of the quality of the observational data. Findings will be disseminated to local stake holders and submitted to scientific peer-reviewed journals. Data statement: The data will not be made publicly available due to privacy, ethical, and data governance restrictions. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement The Diabetes Alliance Program Plus and this work is supported by a philanthropic gift from the Colonial Foundation, administered by the Hunter Medical Research Institute. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Diabetes Alliance Program Plus has ethics approval from the Hunter New England Human Research Ethics Committee (2024/ETH01649), with approval registered with the University of Newcastle (R-2024-0073). The Lumos data asset is also ethically approved by the Population Health Services Research Ethics Committee (PHSREC; 2019/ETH00660), and DAP+ has received approval by their Governance Committee for the evaluation in this protocol. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data will not be made publicly available due to privacy, ethical, and data governance restrictions.

Objectives: The aim of this study was to evaluate the effectiveness and safety of a novel subperception spinal cord stimulation (SCS) waveform paradigm designed to target the dorsal horn dendrites for treating chronic neuropathic low back pain (LBP). The fi nal 12-month results are reported here. Materials and Methods: Twenty-seven participants were implanted with a commercial SCS system. Devices were programmed to deliver the waveform (frequency 100 Hz, pulse width 1000 mu sec, T9-T10 disk bipole) at decreasing stimulation perception threshold amplitudes (80%, 60%, then 40%) over a 14-week period. Participants were blinded to the program settings. Participants then received their preferred program for further evaluation at 26 and 52 weeks after activation. Outcome measures included back pain score (visual analogue scale [VAS]), Brief Pain Inventory (BPI), EuroQol 5-Dimension 5-Level (EQ-5D-5L), 36-Item Short Form Health Survey (SF-36), treatment satisfaction, and clinician global impression of change (CGIC). Results: At 52 weeks (n = 24), the responder rate (>= 50% pain relief) was 65.6%, and the high-responder rate (>= 80% pain relief) was 56.5%. The mean change from baseline in pain VAS was - 43.94 mm (95% CI - 57.89, - 30.00; p < 0.001) and mean pain relief was 64.69%+/- 39.43%. BPI and SF-36 scores remained significantly improved (p <= 0.001). EQ-5D-5L index and EuroQoL-VAS further improved, and 87.0% of participants met the minimum clinically important difference for the EQ-5D-5L index. Treatment satisfaction was 83%, and 91% of participants had a CGIC rating of " much improved" or above. No serious study-related adverse events were reported. Conclusions: The 12-month trial results show sustained improvements in pain, quality of life, and health-related outcomes. This novel subperception dorsal horn dendrite SCS approach seems a safe and promising treatment option for patients with chronic neuropathic LBP. The open-source availability of this waveform on commercial SCS platforms allows widespread patient access. Further evaluation seems warranted.

Trials optimising implementation strategies are complex, assess multicomponent strategies, and cluster randomise. We define optimisation as identifying the best combination of components for multi-component implementation strategies. Multi-arm, fixed, cluster randomised control trials (cRCTs) can assess multiple implementation components but suffer from low power due to challenges of recruitment. Adaptive designs offer increased efficiency, when compared to "fixed trial" approaches. A simulation study was conducted to assess whether adaptive designs are feasible (acceptable operating characteristics and adaptive interim decisions) for implementation cRCTs with few clusters. A four-arm cRCT was simulated under varying trial properties. The trials were simulated using fixed design and adaptive design parameters (number of interim analyses, timing of interim analysis, actions at interim e.g. allowing for early stopping for futility, arm dropping) and modelled using Bayesian hierarchical models. The power and type 1 error were compared between the fixed and adaptive designs, and the number of correct interim decisions under the adaptive design were examined. When the intra-class correlation (ICC) was high, the proportion of trials that incorrectly dropped the most effective arm increased. There were small power gains for adaptive designs, without increasing type 1 error. Power gains attenuated when ICC was high and sample size was low. Type 1 error was lower comparable between adaptive and non-adaptive designs. Adaptive designs are feasible for cRCTs with few clusters. They are not as feasible when the ICC is high due to increased risk of incorrect adaptive interim decisions.

BACKGROUND:Vaporized nicotine products (VNPs) are more effective than nicotine replacement therapy (NRT) for smoking cessation in general populations, but their effectiveness among low socioeconomic groups is largely unknown. OBJECTIVE:To examine whether VNPs are more effective than NRT for smoking cessation among people experiencing social disadvantage. DESIGN:Two-group, open-label, randomized trial with blinded outcome ascertainment. (Australian New Zealand Clinical Trials Registry ACTRN12621000076875). SETTING:Australia, between March 2021 and December 2022. PARTICIPANTS:1045 adults who smoked daily, were willing to quit smoking, and were receiving a government pension/allowance (proxy for social disadvantage). INTERVENTION:Participants were randomly assigned (1:1) to either a free 8-week supply of NRT or VNPs, and all participants received text-message support. MEASUREMENTS:The primary outcome was 6-month continuous smoking abstinence verified using a carbon monoxide breath test at 7-month follow-up. Analysis included randomly assigned participants in accordance with Russell Standard criteria and the intention-to-treat principle. RESULTS:Among 1045 randomly assigned participants, 866 (82.9%) completed final follow-up. The verified 6-month continuous abstinence rate was 9.6% (50 of 523) in the NRT group and 28.4% (148 of 522) in the VNP group (posterior risk difference estimate, 18.7% [95% credible interval, 14.1% to 23.3%]; >99% posterior probability that VNP is superior). Self-reported adverse events occurred less frequently in the VNP group (355 events among 237 participants) compared with the NRT group (442 events among 278 participants; incident rate ratio, 0.75 [95% CI, 0.65 to 0.88]; P < 0.001). LIMITATIONS:Biochemical verification method tested short-term exposure to cigarette smoke. CONCLUSION:Findings indicate that VNPs were more effective than NRT for smoking cessation in this population. Given the challenges for cessation among these socially disadvantaged populations, VNPs present a promising treatment option for this priority group. PRIMARY FUNDING SOURCE:Australian National Health and Medical Research Council.

Trials that aim to optimise the implementation of an intervention are often complex, requiring multiple, combined strategies and requiring uptake on multiple levels. Previous implementation trials have optimised implementation strategies using multi-arm cluster randomised control trials (cRCTs) but can be inefficient and waste resources. Adaptive designs may potentially improve efficiency of these trials, but under what design features and trial properties is unknown. A simulation study was performed to assess under what conditions, if any, one or two interim adaptive designs offer increased efficiency compared to a 'fixed trial' approach for implementation cRCTs. A four-arm cRCT was simulated with varied trial properties, with a fixed design or an adaptive design (varying by number of interim analyses and timing of interim analyses) and modelled using Bayesian hierarchical models. The adaptive design allowed for stopping early for futility and dropping an arm for futility. The power, type 1 error rate, and adaptive design decisions were compared between the designs across trial properties. Both one and two interim adaptive designs offered power gains and a lower type 1 error rate compared to the fixed designs across most trial properties. A high intra-class correlation (ICC) of 0.2 led to adaptive trials dropping effective arms or incorrectly stopping for futility more frequently, with the incorrect decisions being compounded when two interim analyses were used. The rate of these incorrect decisions was reduced when the first interim analysis in the two interim designs was delayed. Adaptive designs can offer improved efficiency, more power, and reduce resource wastage for trials compared to fixed designs.

Optimisation is the iterative process to improve a health intervention or implementation strategy within resource constraints. This review aimed to identify which study designs are being used to evaluate the optimisation of health interventions and implementation strategies, and whether they differ by optimisation target. This review identifies possible strategies to improve future optimisation trials. A scoping review of the Medline, EMBASE, CINAHL, and ProQuest Nursing and Allied Health Source databases was undertaken. The International Clinical Trials Registry Platform and the Australian New Zealand Clinical Trials Registry were also searched for relevant trials. Data were extracted by one reviewer for 64

Vaporized nicotine products (VNPs) are more effective than nicotine replacement therapy (NRT) for smoking cessation in general populations, but their effectiveness among low socioeconomic groups is largely unknown. To examine whether VNPs are more effective than NRT for smoking cessation among people experiencing social disadvantage. Two-group, open-label, randomized trial with blinded outcome ascertainment. (Australian New Zealand Clinical Trials Registry ACTRN12621000076875). Australia, between March 2021 and December 2022. 1045 adults who smoked daily, were willing to quit smoking, and were receiving a government pension/allowance (proxy for social disadvantage). Participants were randomly assigned (1:1) to either a free 8-week supply of NRT or VNPs, and all participants received text-message support. The primary outcome was 6-month continuous smoking abstinence verified using a carbon monoxide breath test at 7-month follow-up. Analysis included randomly assigned participants in accordance with Russell Standard criteria and the intention-to-treat principle. Among 1045 randomly assigned participants, 866 (82.9%) completed final follow-up. The verified 6-month continuous abstinence rate was 9.6% (50 of 523) in the NRT group and 28.4% (148 of 522) in the VNP group (posterior risk difference estimate, 18.7% [95% credible interval, 14.1% to 23.3%]; >99% posterior probability that VNP is superior). Self-reported adverse events occurred less frequently in the VNP group (355 events among 237 participants) compared with the NRT group (442 events among 278 participants; incident rate ratio, 0.75 [95% CI, 0.65 to 0.88]; P < 0.001). Biochemical verification method tested short-term exposure to cigarette smoke. Findings indicate that VNPs were more effective than NRT for smoking cessation in this population. Given the challenges for cessation among these socially disadvantaged populations, VNPs present a promising treatment option for this priority group. Australian National Health and Medical Research Council.

BACKGROUND AND AIMS:Signficant inequalities in tobacco smoking exist, with higher smoking rates among people from low-socio-economic status (low-SES) populations. Tailored technology-based programs for low-SES smoking populations have the potential for high reach, but require effectiveness data from large-scale trials. This trial among Australians who smoke from a low-SES background will determine the effectiveness and cost-effectiveness of tailored text-message (TTM) support compared with standard Quitline (SQL) telephone support service. DESIGN, SETTING AND PARTICIPANTS:This is a two-arm, parallel group, randomized, non-inferiority trial with allocation concealment and blinded outcome assessment in an Australian population within the greater Sydney region in New South Wales. Participants are adults who smoke daily (n = 1246), are interested in quitting and currently receiving a government pension or allowance, and will be recruited via advertisements. INTERVENTION AND COMPARATOR:Participants will be randomized (1:1 ratio) to receive either 12 months of TTM quit support or enrolment in SQL telephone support. MEASUREMENTS:Assessments will be completed at baseline (telephone interview), within 1 month (check-in call), at 3 months (on-line questionnaire) and 12 months (telephone interview) post-randomization. The primary outcome will be 6-month continuous abstinence verified by carbon monoxide breath test at 12-month follow-up. The study will test whether TTM is non-inferior to SQL by a non-inferiority margin of 2%, i.e. the quit rate in the TTM group will be no worse than 2% less than the quit rate in the SQL group. Secondary outcomes will include self-reported continuous and point prevalence abstinence and acceptability and cost-effectiveness of TTM versus SQL. CONCLUSION:Should the tailored text-message support prove non-inferior and more cost-effective than Quitline for this population, this will provide an opportunity for the upscaling of an effective, inexpensive and tailored quit support service. The trial findings will inform cessation treatment policy for priority populations in Australia and globally.

Background:Telestroke networks aim to address variability in both quality and access to stroke care in rural areas, by providing remote access to expert stroke neurologists. Implementation of telestroke requires adaptation of workflow processes and education. We previously developed virtual reality (VR) workflow training and documented acceptability, utility and feasibility. The effects on acute stroke treatment metrics have not been previously described. Aims:The overall aim was to improve hyperacute stroke metrics and shorten the time-to-reperfusion therapy administration in rural settings. Methods:This study applies a natural experiment approach, collecting stroke metric data during transition from a pre-existing pilot to a statewide telestroke service at five rural hospitals. Pre- and post-intervention data included baseline patient demographics and assessment, diagnosis, and treatment delivery metrics. The primary study outcome was door-to-decision time (thrombolysis and endovascular thrombectomy). Secondary outcomes included door-to-computerized tomography time, door-to-thrombolysis time and proportion of patients receiving thrombolysis or thrombectomy treatment. Usage data relating to the VR stroke workflow training of interprofessional healthcare professionals was automatically captured via Wi-Fi. Statistical comparisons of clinical metrics between the pre- and post-intervention time periods, defined as the timeframes before and after VR deployment, were performed. Results:A total of 2,683 patients were included (April 2013-December 2022); 1910 pre- and 773 post-intervention. All acute stroke time metrics significantly improved post-intervention. The primary outcome, door-to-decision time, decreased from 80 min [56-118] to 54 min [40-76; P < 0.001]. Secondary outcomes also improved, including door-to-thrombolysis time (90 min [68-114] vs. 68.5 min [54-90]; P < 0.001) and proportion of patients thrombolysed (11 vs. 16%; P < 0.001). The proportion of patients transferred for thrombectomy was unchanged (6 vs. 7%; P = 0.69). Seventy VR sessions totaling 15 h 39 min of training time were logged. VR training usage varied across sites (3-31 sessions per site). Conclusions:Delivery of a multi-factorial intervention including infrastructure, funding, education and training (with VR workflow training) as part of a state-wide telestroke rollout was associated with improved acute stroke treatment metrics. Additional work is required to identify the contribution of each intervention component on clinical outcomes and to increase training uptake and sustainment.

Abstract Background Fluoropyrimidine (FP) chemotherapies are commonly prescribed for upper and lower gastrointestinal, breast and head and neck malignancies. Over 16,000 people with cancer require FP chemotherapies per annum in Australia. Between 10 and 40% patients experience grade 3–4 (≥ G3) toxicities that require hospital-based management ± intensive care admission. Approximately 1% of patients die secondary to FP toxicities. Prospective screening for DPYD gene variants (encoding the key enzyme for FP catabolism) can identify patients at risk of ≥ G3 toxicity and allow for dose adjustment prior to first FP exposure. Evidence supports this as a cost-effective method of improving patient safety and reducing healthcare burden internationally; however, no Australian data confirms its feasibility on a large scale. Method This investigator-led, single-arm study will determine large scale feasibility of prospective DPYD genotyping, confirming patient safety and cost-effectiveness within the Australian health care system. 5000 patients aged 18 years and older with solid organ cancers requiring FP chemotherapy will be consented and genotyped prior to commencing treatment, and early toxicity (within 60 days) post-FP exposure will be determined. Toxicity data for DPYD variant carriers who have dose adjustments will be compared to the wild-type cohort and historical cohorts of carriers who did not undergo genotyping prior to FP exposure, and prospective variant carriers who do not undergo dose-adjustment. Prevalence of the four standard DPYD gene variants will be confirmed in an Australian population. Additionally, health economic analysis, implementation research via semi-structured interviews of patients and clinicians, and feasibility of UGT1A1 genotyping will be conducted. Discussion This study will determine the prevalence of DPYD gene variant status in Australia and its impact on FP-induced toxicity among Australians with cancer. Feasibility and cost-effectiveness for Australian health care system will be estimated to support national roll-out of prospective DPYD genotyping prior to FP administration. Additionally, feasibility will be confirmed with the intention of including UGT1A1 in future pharmacogenomic panels to aid chemotherapy prescribing. Trial registration This trial was registered with the Australian and New Zealand Cancer Trials Registry on 13th Dec 2023, ACTRN12623001301651.

Executive dysfunction is common in individuals with substance use disorder (SUD) and presents a barrier to treatment engagement. The study aimed to investigate the effectiveness of cognitive remediation (CR) for improving executive functioning and treatment retention in patients with SUD, using a stepped-wedge cluster randomized controlled trial. The sample included 527 adults enrolled across ten residential SUD treatment providers in NSW, Australia. The intervention consisted of 12 hours of CR delivered over six weeks in a group format. The comparator was treatment-as-usual (TAU). Primary outcomes included self-reported executive functioning and proportion of treatment completed (PoTC), measured as the number of days in treatment divided by the planned treatment duration. Intention-to-treat analysis did not find significant differences for self-reported executive functioning (mean difference = -2.49, 95%CI [-5.07, 0.09], p = .059) or PoTC (adjusted mean ratio = 1.09, 95%CI [0.88, 1.36], p = .442). Due to high dropout from the intention-to-treat sample (56%) a post-hoc analysis was conducted using a per-protocol approach, in which CR was associated with improved self-reported executive functioning (mean difference = -3.33, 95%CI [-6.10, -0.57], p = .019) and improved likelihood of treatment graduation (adjusted odds ratio = 2.43, 95%CI [1.43, 4.11], p < .001). More research is required to develop a CR approach that results in service-wide treatment effectiveness.

Objective: Routine health data has the potential to identify changes in patient-related outcomes, in close to real time. This pilot project used routine data to explore and compare the impact of changes to cultural responsiveness on service use by Aboriginal and Torres Strait Islander (hereafter, Aboriginal) clients in Australia.Methods: The New South Wales Minimum Data Set (MDS) for alcohol and other drug use treatment services was provided for 11 services for a period of 30 months from March 2019 to September 2021 (four months prior to two years after the intervention; data were analysed between March 2022 to February 2023). Change in cultural responsiveness was assessed via practice audits of services at baseline and two years. The average change in audit rating was analysed using a linear mixed regression model. Generalised Linear Mixed Models were used to identify changes in service use by Aboriginal clients. Results: All 11 services showed increased audit scores at two years, with a statistically significant mean increase of 18.6 (out of 63 points; b = 18.32, 95% CI 12.42-24.22). No statistically significant pre-to post-changes were identified in: (1) the proportion of episodes delivered to Aboriginal versus non-Aboriginal clients (OR = 1.15, 95% CI = 0.94-1.40), (2) the number of episodes of care provided to Aboriginal clients per month (IRR = 1.01, 95% CI = 0.84-1.23), or (3) the proportion of episodes completed by Aboriginal clients (OR = 0.96, 95% CI = 0.82-1.13). Conclusions: The lack of statistically significant impact on service use outcomes using MDS contrasts to the improvements in cultural responsiveness, suggesting further work is needed to identify appropriate outcome measures. This may include patient-reported experience measures. This project showed that routine data has potential as an efficient method for measuring changes in patient-related outcomes in response to health services improvements.

Objective: People with mental health conditions have high rates of chronic physical diseases, partially attributable to lifestyle risks factors. This study examined risk prevalence among community mental health service clients, their readiness and confidence to change, and associations with participant characteristics.Methods: Cross-sectional survey of adult clients from 12 community mental health services across 3 local health districts in New South Wales, Australia, collected from 2021 to 2022. Participants (n = 486) completed a telephone interview determining five risk factors, and readiness and confidence to change these. Multiple binary logistic regression models determined associations between readiness and confidence (for each risk), and participant characteristics (demographics and diagnosis).Results: Participants most commonly reported a diagnosis of schizophrenia (36.7%) or depression (21.1%). Risk factors were prevalent: ranging from 26% (harmful alcohol use) to 97% (poor nutrition). High readiness was greatest for smoking (68%), weight (66%) and physical inactivity (63%), while confidence was highest for changing alcohol use (67%). Two significant associations were identified; females were more likely than males to have high readiness to change nutrition (odds ratio = 1.14, confidence interval = [1.13, 2.34], p = 0.0092), with males more likely to have high confidence to change physical activity (odds ratio = 0.91, confidence interval = [0.45, 0.99], p = 0.0109).Conclusions: Many participants were ready and confident to change risk factors. Gender influenced readiness to change nutrition and physical activity confidence. Training to upskill mental health clinicians in provision of preventive care that builds confidence and readiness levels may aid in supporting positive behaviour change.