Spillover effects from a type 2 diabetes integrated model of care in 22,706 Australians: an open cohort stepped wedge trial.

BACKGROUND: Many Australian adults are not receiving timely or effective diabetes management to prevent or delay the onset of diabetes related complications. Integrated care, a worldwide trend in healthcare reform, aims to reduce the fragmented delivery of health services and improve outcomes. This study aimed to test whether a specialist-led integrated model of care provided to a small subset of patients in general practices leads to spillover clinical improvements in all patients of the practice with type 2 diabetes. METHODS: Seventy-two general practice sites (clusters) in New South Wales, Australia received the Diabetes Alliance intervention, creating a non-randomised open cohort stepped wedge trial. The intervention comprised of case conferencing, delivered directly to a small proportion of adults with type 2 diabetes (n = 1,072) of the general practice sites; as well as practice feedback, education and training. Spillover clinical improvements were assessed on all adults with type 2 diabetes within the general practice sites (n = 22,706), using practice level data recorded in the MedicineInsight electronic database, compared before and after the intervention. Outcome measures included frequency of diabetes screening tests in line with the Annual Cycle of Care, and clinical results for weight, blood pressure, HbA1c, lipids, and kidney function. RESULTS: Compared to before Diabetes Alliance, the odds of all practice patients receiving screening tests at or above the recommended intervals were significantly higher for all recommended tests after Diabetes Alliance (odds ratio range 1.41-4.45, p < 0.0001). Significant improvements in clinical outcomes were observed for weight (absolute mean difference: -1.38 kg), blood pressure (systolic - 1.12 mmHg, diastolic - 1.18 mmHg), HbA1c (-0.03% at the mean), total cholesterol (-0.11 mmol/L), and triglycerides (-0.02 mmol/L) (p < 0.05). There were small but significant declines in kidney function. CONCLUSIONS: Integrated care delivered to a small subset of patients with type 2 diabetes across a large geographic region has spillover benefits that improve the process measures and clinical outcomes for all practice patients with type 2 diabetes. TRIAL REGISTRATION: ACTRN12622001438741; 10th November 2022, retrospectively registered: https://www.anzctr.org.au/ACTRN12622001438741.aspx .

Fasting vs no fasting prior to catheterisation laboratory procedures: the SCOFF trial.

BACKGROUND AND AIMS: Current guidelines recommend 6 hours of solid food and 2 hours of clear liquid fasting for patients undergoing cardiac procedures with conscious sedation. There are no data to support this practice, and previous single centre studies support the safety of removing fasting requirements. The objective of this study was to determine the non-inferiority of a no fasting strategy to fasting prior to cardiac catheterisation procedures which require conscious sedation. METHODS: This is a multicentre, investigator-initiated, non-inferiority randomised trial conduced in Australia with a prospective open label blinded endpoint design. Patients referred for coronary angiography, percutaneous coronary intervention or cardiac implantable electronic device (CIED) related procedures were enrolled. Patients were randomised 1:1 to fasting as normal (6 hours solid food and 2 hours clear liquid) or no fasting requirements (encouraged to have regular meals but not mandated to do so). Recruitment occurred from 2022 to 2023. The primary outcome was a composite of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia assessed with a Bayesian approach. Secondary outcomes included patient satisfaction score, new ventilation requirement (non-invasive and invasive), new intensive care unit admission, 30-day readmission, 30-day mortality, 30-day pneumonia. RESULTS: 716 patients were randomised with 358 in each group. Those in the fasting arm had significantly longer solid food fasting (13.2 versus 3.0 hours, Bayes factor >100 indicating extreme evidence of difference) and clear liquid fasting times (7.0 versus 2.4 hours, Bayes factor >100). The primary composite outcome occurred in 19.1% of patients in the fasting arm and 12.0% of patients in the no fasting arm. The estimate of the mean posterior difference in proportions in the primary composite outcome was -5.2% (95% CI -9.6 to -0.9, ) favouring no fasting. This result confirms non-inferiority (posterior probability >99.5%) and superiority (posterior probability 99.1%) of no fasting for the primary composite outcome. The no fasting arm had improved patient satisfaction scores with a posterior mean difference of 4.02 points (95% CI 3.36 to 4.67, Bayes factor >100). Secondary outcome events were similar. CONCLUSIONS: In patients undergoing cardiac catheterisation and CIED related procedures, no fasting was non-inferior and superior to fasting for the primary composite outcome of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia. Patient satisfaction scores were significantly better with no fasting. This supports removing fasting requirements for patients undergoing cardiac catheterisation laboratory procedures that require conscious sedation.

CCL2/CCR2 Expression in Locally Advanced Prostate Cancer and Patient Long-Term Outcome: 10-Year Results from the TROG 03.04 RADAR Trial.

This study investigated the prognostic value of the chemokine C-C motif ligand 2 (CCL2) and its receptor C-C motif chemokine receptor 2 (CCR2) expression in locally advanced prostate cancer treated with radiotherapy and androgen deprivation using the 10-year outcome data from the TROG 03.04 RADAR clinical trial. CCL2 and CCR2 protein expression in prostate cancer biopsies at the time of diagnosis were quantified by immunohistochemistry and digital quantification. CCR2 protein expression was detected in prostate cancer cells and was associated with prostate-specific antigen serum concentration (p = 0.045). However, neither CCL2 nor CCR2 tissue expression could predict prostate cancer progression, or other clinicopathological parameters including perineural invasion and patient outcome. In serum samples, CCL2 concentration at the time of diagnosis, as assayed by enzyme-linked immunosorbent assay, was significantly higher in patients with prostate cancer compared with benign prostatic hyperplasia (median difference 0.22 ng/mL, 95% CI, 0.17-0.30) (p < 0.0001) and normal controls (median difference 0.13 ng/mL, 95% CI, 0.13-0.17) (p < 0.0001). However, circulating CCL2 was not statistically significant as a predictor of disease progression and patient outcome. In conclusion, this study shows that although CCL2 and CCR2 are expressed in prostate cancer, with an increased level of CCL2 in the serum, neither CCL2 nor CCR2 expression has a clinical prognostic value in locally advanced prostate cancer.

Bone mineral density and body composition in Australians following plant-based diets vs. regular meat diets.

Background and aims: Bone mineral density (BMD) and body composition play an important role in maintaining metabolic health and physical functioning. Plant-based diets (PBDs) are known to be lower in protein and calcium, which can impact BMD and body composition. This study aimed to investigate the relationship between various PBDs compared to regular meat diet and whole-body BMD, body composition, and weight status. Methods: A cross-sectional study was conducted with adults (n = 240) aged 30-75 years, who habitually followed dietary patterns: vegan, lacto-vegetarian, pesco-vegetarian, semi-vegetarian, or regular meat eater (48 per group). Parameters were measured using dual-energy x-ray absorptiometry (DXA), and multivariable regression analyses were used to adjust for lifestyle confounders, socioeconomic factors, and BMI. Results: After adjustments, whole-body BMD and body composition were not significantly different between those following PBDs and regular meat diets, except for lacto-ovo vegetarians, who had significantly lower lean mass by -1.46 kg (CI: -2.78, -0.13). Moreover, lacto-ovo vegetarians had a significantly lower T-score by -0.41 SD (CI: -0.81, -0.01) compared to regular meat eaters. Waist circumference was significantly lower in individuals adhering to a PBD compared to a regular meat diet: vegans by -4.67 cm (CI: -8.10, -1.24), lacto-ovo vegetarians by -3.92 cm (CI: -6.60, -1.23), pesco-vegetarians by -3.24 cm (CI: -6.09, -0.39), and semi-vegetarians by -5.18 cm (CI: -7.79, -2.57). There were no significant differences in lean mass (%), fat mass (% and total), android/gynoid measures, body weight, or BMI across dietary patterns. All dietary patterns met the recommended dietary intake for calcium and protein, and 25-hydroxy-vitamin D status was comparable across groups. Conclusions: This cross-sectional study found that adhering to a PBD characterized by varying degrees of dairy and meat restriction is not associated with meaningful changes in BMD or body composition, provided that the dietary patterns are planned appropriately with adequate levels of calcium and protein.

Risk prevalence, readiness and confidence to change lifestyle risk factors among clients of community mental health services.

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.

Investigating the effect of an online enhanced care program on the emotional and physical wellbeing of patients discharged from hospital with acute decompensated heart failure: Study protocol for a randomised controlled trial: Enhanced care program for heart failure.

Objective: Depression is highly prevalent and associated with increased hospitalisations and mortality among patients with heart failure (HF). This study will evaluate the effectiveness and cost-effectiveness of an online wellbeing program for patients discharged from hospital with acute decompensated heart failure (ADHF) in (i) improving emotional and physical wellbeing, and (ii) decreasing healthcare utilisation. Methods: Two-arm randomised controlled trial. Eligible patients with ADHF will be recruited pre-discharge from two hospitals. Five hundred and seventy participants will be randomised to receive the intervention (online enhanced care program for HF: 'Enhanced HF Care') or usual care. Enhanced HF Care includes health education (11 micro-learning modules) and monitoring of depression and clinical outcomes via fortnightly/monthly surveys for 6 months, with participants offered tailored advice via video email and SMS. Cardiac nurses track real-time patient data from a dashboard and receive automated email alerts when patients report medium- or high-risk levels of depression or clinical symptoms, to action where needed. General practitioners also receive automated alerts if patients report medium- or high-risk survey responses and are encouraged to schedule a patient consultation. Results: Sixty-five participants enrolled to-date. Co-primary outcomes ('Minnesota Living with Heart Failure Questionnaire' Emotional and Physical subscales) and healthcare utilisation (secondary outcome) at 1- and 6-month post-recruitment will be compared between treatment arms using linear mixed effects regression models. Conclusions: This study has the potential to reduce the burden of depression for patients with HF by prioritising urgent mental health needs and clinical symptoms while simultaneously empowering patients with self-care knowledge. Trial registration: The trial was prospectively registered via the Australian New Zealand Clinical Trials Registry: ACTRN12622001289707. Issue date: 4 October 2022.

Cardiovascular Disease Risk in Individuals Following Plant-Based Dietary Patterns Compared to Regular Meat-Eaters.

Plant-based diets (PBDs) have been associated with a lower risk of cardiovascular disease (CVD). The aim was to investigate the predicted 5-year and 10-year risk of developing CVD in individuals following PBDs compared to regular meat-eating diets. This cross-sectional study included n = 240 middle-aged adults habitually consuming dietary patterns for ≥6 months: vegan, lacto-ovo vegetarian (LOV), pesco-vegetarian (PV), semi-vegetarian (SV) or regular meat-eater (RME) (n = 48 per group). Predicted 5-year and 10-year CVD risks were quantified using the Framingham Risk Equation and the Australian Absolute CVD risk calculator, respectively. Multivariable regression analysis was used to adjust for age, sex, smoking status, physical activity, alcohol use and BMI. Over three-quarters of the participants were women, mean age of 53.8 yrs. After adjustments for potential confounders, there was no difference in the predicted risk of CVD between regular-meat diets and PBDs, although crude analyses revealed that vegans had a lower 5-year and 10-year predicted risk of CVD compared to RMEs. SVs, PVs and LOVs had lower CVD risk scores, however, not significantly. Vegans had a favourable cardiometabolic risk profile including significantly lower serum lipid levels, fasting blood glucose and dietary fats and higher dietary fibre intake compared to RMEs. This was the first study to purposefully sample Australians habitually following PBDs. We found that PBDs do not independently influence the predicted risk of CVD, although PBDs tended to have lower risk and vegans had significantly lower cardiometabolic risk factors for CVD.

Metabolic Health, Overweight or Obesity, and Depressive Symptoms among Older Australian Adults.

BACKGROUND: The relationship between overweight or obesity and depressive symptoms in individuals with or without cardio-metabolic abnormalities is unclear. In a cross-sectional study we examined the odds of experiencing depressive symptoms in overweight or obese older adults with or without metabolic abnormalities. METHODS: The participants included 3318 older adults from the Hunter Community Study Cohort with a Body Mass Index (BMI) ≥ 18.5 kgm2, stratified by BMI and metabolic health risk. Obesity was defined as BMI ≥ 30 kgm2 and metabolically healthy as the absence of metabolic risk factors, according to International Diabetic Federation criteria for metabolic syndromes. Moderate to severe depressive symptoms were defined as a Centre for Epidemiological Studies Depression Scale (CES-D) score ≥ 16. RESULTS: Compared to the metabolically healthy normal weight (MHNW) group, the odds of experiencing moderate/severe depressive symptoms were higher in those classified as a metabolically unhealthy normal weight (MUNW) (odds ratio (OR) = 1.25, 95% Confidence Interval (CI): 0.76-2.06) or metabolically unhealthy obesity (MUO) (OR = 1.48, 95% CI: 1.00-2.19), but not in those classified as metabolically unhealthy overweight (MUOW) (OR = 0.96, 95% CI: 0.63-1.45), metabolically healthy overweight (MHOW) (OR = 0.80, 95% CI: 0.51-1.26), and metabolically healthy obesity (MHO) (OR = 1.03, 95% CI: 0.65-1.64). Compared with MHNW males, the odds of moderate/severe depressive symptoms were increased in all other BMI category-metabolic health groups for males and females. LIMITATIONS: Our relatively small sample size and cross-sectional design did not allow us to robustly establish causality. CONCLUSION: The odds of experiencing moderate/severe depressive symptoms were increased in metabolically unhealthy older adults regardless of normal weight or obesity, with the odds of having moderate/severe depressive symptoms being higher in females than in males.

Esophageal chemoradiotherapy with concurrent nivolumab: Pilot results in the palliative treatment of oligometastatic disease.

AIMS: Many patients diagnosed with esophageal cancer have dysphagia from their primary tumor and de novo metastatic disease. The purpose of this study was to test the safety and efficacy of nivolumab given concurrently with hypofractionated chemoradiotherapy to patients with oligometastatic and obstructing esophageal tumors. METHODS: Patients were enrolled in a planned single-arm, phase 2 clinical trial. Eligible participants had previously untreated oligometastatic (≤5 metastases on fludeoxyglucose-18 positron emission tomography scan outside the primary tumor radiotherapy field) esophageal or gastroesophageal carcinoma, dysphagia, and Eastern Cooperative Oncology Group performance status 0-1. Treatment was with 2 weeks of concurrent hypofractionated radiotherapy (30 Gy/10#) to the primary tumor, weekly carboplatin AUC2, weekly paclitaxel 50 mg/m2, and q2weekly nivolumab 240 mg, followed by nivolumab 480 mg continuing q4weekly until disease progression or 24 months total. A single metastasis was treated with stereotactic radiotherapy (SBRT) (24 Gy/3#) in week 7. RESULTS: Five patients were recruited before trial closure to new participants for logistical reasons. Existing participants continued treatment per protocol as a pilot study at one center. All five patients completed chemoradioimmunotherapy and SBRT. All patients derived an improvement in their dysphagia. Two patients completed 24 months of nivolumab without disease progression. Grade 3 adverse events (AEs) occurred in 3 patients, however, there were no grade 4 AEs, AEs due to SBRT, or AEs of special interest as defined by the protocol. CONCLUSION: Pilot results from five patients at one center found that treatment was well tolerated and effective for dysphagia relief. The efficacy of hypofractionated chemoradiotherapy with concurrent checkpoint inhibition should be tested in a multicentre study.

Lack of consensus in atypical congenital obstructive urethral lesions in children: Snapshot of the web-based ObsCUre (obstruction to the child urethra) study.

Background: Atypical Congenital Obstructive Urethral Lesions (ACOUL) are uncommon causes of urethral obstruction in children. They include Cobb's collar or Moorman's ring, Type III posterior urethral valve (PUV), congenital urethral narrowing and anterior urethral valves. This study is aimed to evaluate the knowledge and current practice amongst clinicians attending to ACOUL. An international online case based questionnaire was performed. Materials and methods: A survey was administered to members of international urological societies. It included 22 clinical questions on cases with ACOUL (14 questions suitable for statistical analysis) using cases of Type I PUV as controls. Two sets of paired questions evaluated change in opinion(s) after additional information was provided. Results: One hundred twenty-one participants responded with 71% reporting exposure of less than 5 cases per annum. In questions regarding diagnosis between 11.6% (14/121) and 21.5% (26/121) of participants identified the ACOUL as PUV. Among them, 66% of respondents agreed on ACOUL's causative role in urethral obstruction. Gini coefficient was consistently lower for ACOUL compared to PUV: diagnosis (mean 0.33 vs. 0.44) and prognosis (0.23 vs. 0.43). High intra-rater concordance (kappa 0.420.57) was observed for paired questions-a mean of 5.79% (7.44% and 4.13% for questions 10 and 12, 16 and 17, respectively) of participants changed their answers from an alternate diagnosis to the correct diagnosis of ACOUL after viewing endoscopic images. High variation in management of ACOUL was noted (Gini 0.51). Conclusions: This global snapshot survey identified substantial inconsistency among clinicians dealing with ACOUL. Although rarely encountered in clinical practice, better overall education of ACOUL is warranted.

Satisfaction with asynchronous e-learning: An exploratory factor analysis of the Learner Satisfaction with Asynchronous e-Learning (LSAeL) instrument.

AIM: To describe the development and psychometric testing of the Learner Satisfaction with Asynchronous e-Learning (LSAeL) instrument. BACKGROUND: Existing satisfaction with e-learning instruments may not accurately evaluate learner satisfaction with constructs associated with asynchronous e-learning. DESIGN: Methodological study. METHODS: Content, face and construct validity of the instrument were evaluated using a two-stage process. A five-member expert panel evaluated the instrument's content and face validity. A content validity index and a modified kappa co-efficient was used to calculate the content validity of individual test items and the global instrument and to adjust for chance agreement between raters. These data were then reviewed and individual items were removed, retained or refined accordingly. Using an empirically informed wholly asynchronous e-learning program 237 nursing students from a regional university in New South Wales, Australia completed the 35 item LSAeL instrument. An exploratory factor analysis (EFA) was then conducted to explore the dimensionality of the instrument. RESULTS: Exploratory factor analysis identified a seven-factor solution with 30 items, explaining an 86.1% of the total variance, was the best fit for the data. CONCLUSION: The study demonstrates that the construct validity of the LSAeL instrument is acceptable. Instrument development is an iterative process and further testing with other cohorts and in other settings is required.

Prevalence and Correlates of Cervical Cancer Prevention Knowledge Among High School Students in Ghana.

INTRODUCTION: Cervical cancer is a preventable yet highly prevalent disease in Africa. Despite female adolescents and young women being a target group for cervical cancer prevention strategies, little research has examined their knowledge of how to prevent the disease. The study aimed to describe: (a) knowledge about cervical cancer prevention and (b) sociodemographic, social, and systemic factors associated with and interacting with knowledge among female senior high school students in Ghana. METHODS: A cross-sectional survey assessed knowledge about (a) risk factors and (b) primary and secondary prevention of cervical cancer among 2,400 female students from 17 public senior high schools in the Ashanti region, Ghana. Descriptive statistics were used to describe knowledge. Linear mixed-effects regression models were used to examine factors associated with knowledge scores. RESULTS: Knowledge gaps were observed for at least two-thirds (>65%) of students. Most students (mean age = 17) did not know that early sexual debut (before 18 years) is a risk factor for cervical cancer (72%) and that a blood test cannot detect cervical cancer (71%). Students in later stages of senior high school education and those who received sexual health education from teachers and parents had significantly greater cervical cancer knowledge scores than their counterparts. Interactive effects showed that school-based sexual health education was associated with higher knowledge scores than home-based education among students. CONCLUSIONS: Most female senior high school students had gaps in knowledge about cervical cancer prevention. Finding new ways to strengthen the capacity of schools and parents to deliver accurate cervical cancer prevention information is warranted.

The association of exhaled nitric oxide with air pollutants in young infants of asthmatic mothers.

BACKGROUND: Exhaled nitric oxide is a marker of airway inflammation. Air pollution induces airway inflammation and oxidative stress. Little is known about the impact of air pollution on exhaled nitric oxide in young infants. METHODS: The Breathing for Life Trial recruited pregnant women with asthma into a randomised controlled trial comparing usual clinical care versus inflammometry-guided asthma management in pregnancy. Four hundred fifty-seven infants from the Breathing for Life Trial birth cohort were assessed at six weeks of age. Exhaled nitric oxide was measured in unsedated, sleeping infants. Its association with local mean 24-h and mean seven-day concentrations of ozone, nitric oxide, nitrogen dioxide, carbon monoxide, sulfur dioxide, ammonia, particulate matter less than 10 µm (PM10) and less than 2.5 µm (PM2.5) in diameter was investigated. The air pollutant data were sourced from local monitoring sites of the New South Wales Air Quality Monitoring Network. The association was assessed using a 'least absolute shrinkage and selection operator' (LASSO) approach, multivariable regression and Spearman's rank correlation. RESULTS: A seasonal variation was evident with higher median exhaled nitric oxide levels (13.6 ppb) in warmer months and lower median exhaled nitric oxide levels (11.0 ppb) in cooler months, P = 0.008. LASSO identified positive associations for exhaled nitric oxide with 24-h mean ammonia, seven-day mean ammonia, seven-day mean PM10, seven-day mean PM2.5, and seven-day mean ozone; and negative associations for eNO with seven-day mean carbon monoxide, 24-h mean nitric oxide and 24-h mean sulfur dioxide, with an R-square of 0.25 for the penalized coefficients. These coefficients selected by LASSO (and confounders) were entered in multivariable regression. The achieved R-square was 0.27. CONCLUSION: In this cohort of young infants of asthmatic mothers, exhaled nitric oxide showed seasonal variation and an association with local air pollution concentrations.

Implementation and evaluation of a nurse-led intervention to augment an existing residential aged care facility outreach service with a visual telehealth consultation: stepped-wedge cluster randomised controlled trial.

BACKGROUND: Up to 75% of residents from residential aged care facilities (RACF) are transferred to emergency departments (ED) annually to access assessment and care for unplanned or acute health events. Emergency department presentations of RACF residents can be both expensive and risky, and many are unnecessary and preventable. Processes or triage systems to assess residents with a health event, prior to transfer, may reduce unnecessary ED transfer. The Aged Care Emergency (ACE) service is a nurse-led ED outreach service that provides telephone support to RACF nurses regarding residents' health events. This service is available Monday to Friday, 8am to 4 pm (ED ACE hours). The primary objective of this study was to assess whether the augmentation of the phone-based ED ACE service with the addition of a visual telehealth consultation (VTC) would reduce RACF rate of ED presentations compared to usual care. The secondary objectives were to 1) monitor presentations to ED within 48 h post VTC to detect any adverse events and 2) measure RACF staff perceptions of VTC useability and acceptability. METHODS: This implementation study used a stepped wedge cluster randomised controlled trial design. Study settings were four public hospital EDs and 16 RACFs in two Local Health Districts. Each ED was linked to 4 RACFs with approximately 350 RACF beds, totalling 1435 beds across 16 participating RACFs. Facilities were randomised into eight clusters with each cluster comprising one ED and two RACFs. RESULTS: A negative binomial regression demonstrated a 29% post-implementation reduction in the rate of ED presentations (per 100 RACF beds), within ED ACE hours (IRR [95% CI]: 0.71 [0.46, 1. 09]; p = 0.122). A 29% reduction, whilst not statistically significant, is still clinically important and impactful for residents and EDs. A post-hoc logistic regression demonstrated a statistically significant 69% reduction in the probability that an episode of care resulted in an ED presentation within ED ACE hours post-implementation compared to pre-implementation (OR [95% CI]: 0.31 [0.11, 0.87]; p = 0.025). CONCLUSION: Findings have shown the positive impact of augmenting ACE with a VTC. Any reduction of resident presentations to a busy ED is beneficial to healthcare overall, but more so to the individual older person who can recover safely and comfortably in their own RACF. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ID ACTR N12619001692123) (02/12/2019) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378629andisReview=true.

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.

Outback Quit Pack: Feasibility trial of outreach smoking cessation for people in rural, regional, and remote Australia.

BACKGROUND: Tobacco smoking rates are higher in rural, regional, and remote (RRR) areas in Australia, and strategies to improve access to quit supports are required. This pilot study examined the feasibility of a smoking cessation intervention for people in RRR areas who smoke with the intention of using this data to design a powered effectiveness trial. METHODS: A randomised controlled trial (RCT) of the feasibility of a 12-week 'Outback Quit Pack' intervention consisting of mailout combination nicotine replacement therapy (NRT) and a proactive referral to Quitline, compared with a minimal support control (1-page smoking cessation support information mailout) was conducted between January and October 2021. Participants recruited via mailed invitation or Facebook advertising, were adults who smoked tobacco (≥10 cigarettes/day) and resided in RRR areas of New South Wales, Australia. Participants completed baseline and 12-week follow-up telephone surveys. Outcomes were feasibility of trial procedures (recruitment method; retention; biochemical verification) and acceptability of intervention (engagement with Quitline; uptake and use of NRT). RESULTS: Facebook advertising accounted for 97% of participant expressions of interest in the study (N = 100). Retention was similarly high among intervention (39/51) and control (36/49) participants. The intervention was highly acceptable: 80% of the intervention group had ≥1 completed call with Quitline, whilst Quitline made 3.7 outbound calls/participant (mean 14:05 mins duration). Most of the intervention group requested NRT refills (78%). No differences between groups in self-reported cessation outcomes. Biochemical verification using expired air breath testing was not feasible in this study. CONCLUSION: The Outback Quit Pack intervention was feasible and acceptable. Alternative methods for remote biochemical verification need further study. SO WHAT?: A powered RCT to test the effectiveness of the intervention to improve access to evidence-based smoking cessation support to people residing in RRR areas is warranted.

Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial).

Aims: Cardiac catheterization procedures are typically performed with local anaesthetic and proceduralist guided sedation. Various fasting regimens are routinely implemented prior to these procedures, noting the absence of prospective evidence, aiming to reduce aspiration risk. However, there are additional risks from fasting including patient discomfort, intravascular volume depletion, stimulus for neuro-cardiogenic syncope, glycaemic outcomes, and unnecessary fasting for delayed/cancelled procedures. Methods and results: This is an investigator-initiated, multicentre, randomized trial with a prospective, open-label, blinded endpoint (PROBE) assessment based in New South Wales, Australia. Patients will be randomized 1:1 to fasting (6 h solid food and 2 h clear liquids) or to no fasting requirements. The primary outcome will be a composite of hypotension, hyperglycaemia, hypoglycaemia, and aspiration pneumonia. Secondary outcomes will include patient satisfaction, contrast-induced nephropathy, new intensive care admission, new non-invasive or invasive ventilation requirement post procedure, and 30-day mortality and readmission. Conclusions: This is a pragmatic and clinically relevant randomised trial designed to compare fasting verse no fasting prior to cardiac catheterisation procedures. Routine fasting may not reduce peri-procedural adverse events in this setting.

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.

A systematic review of nonpharmacological interventions to reduce procedural anxiety among patients undergoing radiation therapy for cancer.

Procedural anxiety is a concern for a number of patients undergoing radiation therapy. While procedural anxiety is often treated pharmacologically, there is a clinical need for effective alternative strategies for patients who are contraindicated from medication use, and those who prefer not to take unnecessary medications. OBJECTIVES: The primary objective was to assess the efficacy of nonpharmacological interventions delivered to adults with cancer, in the radiation oncology department, just prior to, or during radiation therapy, in reducing levels of self-reported procedural anxiety. The secondary objectives were to assess the efficacy of these interventions in reducing physiological symptoms of procedural anxiety and anxiety-related treatment disruptions. DESIGN: Systematic review. DATA SOURCES: Electronic databases (MEDLINE, CINAHL, EMBASE, PsycINFO and Cochrane Central Register of Controlled Trials) were searched from inception up until February 2022. INCLUSION CRITERIA: Population: Adult patients with cancer undergoing external beam radiation therapy. INTERVENTION: Nonpharmacological interventions delivered within the radiation therapy department. Comparison: standard care controls, or standard care plus an alternative intervention. OUTCOMES: level of self-reported procedural anxiety (primary), physiological symptoms of anxiety (secondary) and measures of anxiety-related treatment disruptions (secondary). DATA EXTRACTION AND ANALYSIS: Two reviewers independently extracted data. A meta-analysis was originally planned but deemed not feasible as the studies could not be confidently pooled for meta-analysis, due to the variability in the interventions, study designs and the generally low number of studies. Therefore, a narrative synthesis is presented. RESULTS: Screening of 2363 records identified nine studies that met inclusion criteria: six studies of music interventions, two of video-based patient education and one of aromatherapy. Overall, three studies received a global rating of strong methodological quality and low risk of bias. Three studies reported a significant effect of the intervention on reducing the primary outcome of self-reported procedural anxiety: two music interventions (both strong methodological quality), and one video-based patient education (moderate methodological quality). One of the studies (a music intervention) also reported a significant reduction in the secondary outcome of physiological symptoms of procedural anxiety (systolic blood pressure). CONCLUSIONS: The evidence for nonpharmacological interventions delivered to adults with cancer just prior to, or during radiation therapy, in reducing levels of self-reported procedural anxiety is limited, with very few well-designed studies. There is a need for interventions for procedural anxiety during radiation therapy to be evaluated through rigorous randomised controlled trials.

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.