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Background: Observational studies have consistently found a link between low serum 25‐hydroxyvitamin D concentration and higher risk of cognitive impairment. Results from randomized controlled trials have been mixed, and few have been conducted in the general population. Methods: We recruited 21,315 community‐dwelling Australians aged between 60 and 84 years to participate in the D‐Health Trial, a randomized, double‐blind, placebo‐controlled trial. The intervention was monthly oral doses of 60,000 international units of vitamin D or placebo for 5 years. We assessed cognitive function in a randomly sampled group of participants aged ≥70 years using the Telephone Interview for Cognitive Status (TICS) at 2 and 5 years after randomization. The primary outcome for this analysis was TICS score; the secondary outcome was the proportion of people who had cognitive impairment (defined as TICS score ≤25). We analyzed data using mixed models (linear and logistic). Results: We interviewed 3887 participants at year 2 and 3614 participants at year 5. The mean TICS score at these time points was 32.3 and 32.2, respectively. Vitamin D supplementation did not affect cognitive function as measured by TICS score (mean difference between vitamin D and placebo groups 0.04; 95% CI −0.14 to 0.23), or alter risk of cognitive impairment (odds ratio 1.00; 95% CI 0.75 to 1.33). Conclusions: Monthly bolus doses of vitamin D supplementation neither enhanced nor hindered cognitive function among older adults. Population‐wide vitamin D supplementation of older adults that are largely vitamin D replete is unlikely to substantially benefit cognition. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to determine the efficacy of probiotic gargles compared with placebo gargles on reducing post-tonsillectomy morbidity in adults. Method: This was a triple-blind, randomised, controlled trial and feasibility study. Thirty adults underwent elective tonsillectomy and were randomly assigned to receive either probiotic or placebo gargles for 14 days after surgery. Daily pain scores and requirement of analgesia were measured for 14 days post-operatively. Secondary outcomes assessed probiotic safety and tolerability and the feasibility of the trial. Results: The probiotic group experienced less pain at rest on day 2. However, the amount of oxycodone (5 mg) tablets used was greater in the probiotic group compared with placebo. There were no statistically significant differences in the frequency of adverse effects between both groups. This trial was feasible. Conclusion: This pilot study suggested that probiotic gargles do not reduce post-tonsillectomy pain or bleeding, highlighting the importance of pilot and feasibility studies in clinical research. [ABSTRACT FROM AUTHOR]

Background: Physician burnout is a common problem, with onset frequently occurring during undergraduate education. Early intervention strategies that train medical students in psychological flexibility skills could support well-being and mitigate burnout risks associated with unmodifiable career stressors. There is a need for randomized controlled trials to assess effectiveness. As psychological flexibility varies contextually and among individuals, tailoring interventions may improve outcomes. Smartphone apps can facilitate individualization and accessibility, and the evaluation of this approach is an identified research priority. Objective: This study aimed to evaluate the effectiveness of a stand-alone app--delivered Acceptance and Commitment Training intervention for improving medical students' self-reported burnout, well-being, psychological flexibility, and psychological distress outcomes. We aimed to explore whether an individualized app would demonstrate benefits over a nonindividualized version. Methods: This parallel randomized controlled trial was conducted with a sample of medical students from 2 Australian universities (N=143). Participants were randomly allocated to 1 of 3 intervention arms (individualized, nonindividualized, and waitlist) using a 1:1:1 allocation ratio. Individualized and nonindividualized participants were blinded to group allocation. The 5-week intervention included an introductory module (stage 1) and on-demand access to short skill training activities (stage 2), which students accessed at their own pace. Stage 2 was either nonindividualized or individualized to meet students' identified psychological flexibility training needs. Results: The mean differences in change from baseline between the intervention groups and the waitlist group were not statistically significant for burnout outcomes: exhaustion (primary; individualized: -0.52, 95% CI -3.70 to 2.65, P=.75; nonindividualized: 1.60, 95% CI -1.84 to 5.03, P=.37), cynicism (individualized: -1.26, 95% CI -4.46 to 1.94, P=.44; nonindividualized: 1.00, 95% CI -2.45 to 4.46, P=.57), and academic efficacy (individualized: 0.94, 95% CI -0.90 to 2.79, P=.32; nonindividualized: 2.02, 95% CI 0.02-4.03, P=.05). Following the intervention, the individualized group demonstrated improved psychological flexibility (0.50, 95% CI 0.12-0.89; P=.01), reduced inflexibility (0.48, 95% CI -0.92 to -0.04; P=.04), and reduced stress (-6.89, 95% CI -12.01 to 5.99; P=.01), and the nonindividualized group demonstrated improved well-being (6.46, 95% CI 0.49-12.42; P=.04) and stress (-6.36, 95% CI -11.90 to -0.83; P=.03) compared with waitlist participants. Between-group differences for the individualized and nonindividualized arms were not statistically significant. High attrition (75/143, 52.4%) was observed. Conclusions: This trial provides early support for the potential benefits of Acceptance and Commitment Training for medical student well-being and psychological outcomes and demonstrates that psychological flexibility and inflexibility can be trained using a smartphone app. Although postintervention burnout outcomes were not statistically significant, improvements in secondary outcomes could indicate early risk mitigation. Replication studies with larger samples and longer-term follow-up are required, and future research should focus on improving implementation frameworks to increase engagement and optimize individualization methods. [ABSTRACT FROM AUTHOR]

Background: Involving patients and consumers in research design helps ensure relevance for those affected by the problem being investigated and can optimize recruitment to clinical trials. This is particularly important when conducting research involving pregnant women. Aims: We investigated women's motivations to participate in a hypothetical randomized control trial (RCT) of a third-trimester screening test for intrapartum fetal compromise (IFC) and adverse perinatal outcomes. Materials and methods: Women attending for routine antenatal care at a tertiary center were invited to complete a short, anonymized patient acceptability survey. The survey was developed with the assistance of the Perinatal Society of Australia and New Zealand's Consumer Advisory Panel and consisted of Likert scales and open-ended questions. It was designed to ascertain women's responses to research issues, particularly the acceptability of being randomized to a non-revealed arm of a screening test RCT. Results: 100 pregnant women took part; 40% indicated that they would agree/strongly agree to participate in a hypothetical RCT regardless of whether they were given the result of a screening test and 31% were unsure. Randomization to either an intervention or control group was acceptable to 47%, 30% were unsure and 23% were not willing to be randomized. Reasons to participate included the desire to contribute to research and to improve pregnancy care. Conclusions: Participation in an RCT of a screening test for IFC involving non-disclosure of the test result was acceptable to a large minority of pregnant women. This finding supports the feasibility of conducting a large-scale study of this design. [ABSTRACT FROM AUTHOR]

While there is a large body of evidence drawn from randomised controlled trials supporting the efficacy of SSGT in autistic adolescents, the control arms of these studies are almost exclusively treated either as usual or waitlist. Addressing this limitation, 90 verbal autistic adolescents (70% male) aged 12–17 years (M = 13.77, SD = 1.6) with IQ > 70 participated in this pragmatic two-armed randomised controlled trial design study evaluating the efficacy of sixteen 90-min sessions of SSGT KONTAKT® (n = 46) in comparison to a manualised interactive group cooking programme (n = 44) of equal dosage controlling for the potentially confounding effects of exposure to a social group context. The primary outcome was the adolescents' progress towards achieving their personally meaningful social goals at follow-up. Secondary outcomes were changes in autistic traits, quality of life, facial emotion recognition skills, social anxiety, and loneliness. Assessments were conducted at baseline, post intervention and 12-week follow-up. The interaction between time point and group allocation was investigated through a random-effects regression model (linear mixed model) to examine changes in the dependent outcomes. While intention-to-treat analysis (N = 90) demonstrated that both SSGT (ES = 1.36, p <.001) and active control (ES = 1.10, p <.001) groups made progress towards their personally meaningful social goals at follow-up, KONTAKT® participants demonstrated greater progress in social goal attainment than their peers in the active control group (ES = 0.35, p =.04). Findings suggest that KONTAKT® is efficacious in supporting autistic adolescents to achieve their personally meaningful social goals compared to other prosocial group activities. Trial registration: (1) Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12617001117303, registered 31 July 2017, anzctr.org.au; (2) ClinicalTrials.gov: NCT03294668 registered 22 September 2017, https://clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

High blood pressure (BP) is the leading preventable risk factor for death, but only one in three patients achieve target BP control. A key contributor to this problem is poor population awareness of high BP, as the majority of patients are asymptomatic. The Shop-To-Stop Hypertension study is a multicenter, cluster-randomized controlled trial to identify, refer and follow adults in need of hypertension care, whilst raising population-wide awareness. In participants with high BP measured by SiSU Health Stations located in major hardware chain stores across New South Wales, Australia, we will determine whether text message-based nudges will encourage repeat BP checks and visits to their doctor. Based on pilot data, we anticipate 65,340 participants will be screened over 12 months, of which 18% will have high BP. Thirty hardware stores will be randomized (1:1) to: (i) Intervention: participants detected with high BP (≥140/≥90 mmHg) will receive text message-based nudges to return for a repeat SiSU Health Station BP check and to visit their general practitioner (GP) to check and manage their BP; (ii) Control: participants with high BP will not receive text messages. The primary outcome is the difference in the proportion of participants with high BP having a repeat BP check at hardware Health Stations in the intervention vs. control group at 12 months. This novel setting for screening utilises a novel 'citizen science' approach inviting the general public to perform their own BP screening at health kiosks and foster behavioral change. This will allow screening in a low-stress environment. • Large, multicenter cluster-randomized trial with 12 months duration. • Identify, refer and follow adults in need of hypertension care, whilst raising population-wide awareness. • Primary outcome: difference in the proportion of participants having a repeat BP check at a health kiosk. • Combines screening with phone text message reminders to foster behavioral change to enter the care pathway. • Findings may increase hypertension diagnosis and health engagement with patients by facilitating a pathway to improved BP control. [ABSTRACT FROM AUTHOR]

Background: In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]-gum or lozenge) for smoking cessation.Methods: This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated.Discussion: Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021.  https://www.anzctr.org.au. [ABSTRACT FROM AUTHOR]

Background: Vitamin D supplementation may reduce the risk or severity of infection, but this has been investigated in few large population-based trials. We analyzed data from the D-Health Trial, using prescription of antibiotics as a surrogate for infection.Methods: The D-Health Trial is a randomized, double-blind, placebo-controlled trial in which 21 315 Australians aged 60-84 years were randomized to 60 000 IU of supplementary vitamin D3 or placebo monthly for 5 years. For this analysis, the primary outcome was the number of antibiotic prescription episodes; secondary outcomes were total number of prescriptions, repeat prescription episodes, and antibiotics for urinary tract infection. We estimated incidence rate ratios (IRRs) using negative binomial regression, and odds ratios using logistic regression.Results: Vitamin D supplementation slightly reduced the number of prescription episodes (IRR, 0.98; 95% confidence interval [CI], .95-1.01), total prescriptions (IRR, 0.97; 95% CI, .93-1.00), and repeat prescription episodes (IRR, 0.96; 95% CI, .93-1.00). There was stronger evidence of benefit in people predicted to have insufficient vitamin D at baseline (prescription episodes IRR, 0.93; 95% CI, .87-.99).Conclusions: Vitamin D may reduce the number of antibiotic prescriptions, particularly in people with low vitamin D status. This supports the hypothesis that vitamin D has a clinically relevant effect on the immune system.Clinical Trials Registration: Australian New Zealand Clinical Trials Registry: ACTRN12613000743763. https://www.anzctr.org.au/. [ABSTRACT FROM AUTHOR]

Background: High school canteens are an ideal setting for public health nutrition intervention, and choice architecture strategies that facilitate the purchase of healthier foods and beverages from school canteens are recommended by the World Health Organization. The rapid uptake of online lunch ordering within school canteens provides a unique opportunity to implement choice architecture strategies that support healthier food choices with high fidelity. Despite this, no trial has tested the efficacy of choice architecture strategies within an online lunch ordering system on improving the nutritional quality of high school student lunch purchases. The objective of this study was to assess the impact of embedding choice architecture strategies into an online lunch ordering system on the nutritional quality of the school canteen lunch purchases of high school students (aged 12–19 years). Methods: A cluster randomized controlled trial was conducted with nine high schools in one Australian state. Schools were randomized to receive either a 2-month choice architecture intervention (involving menu labelling, prompts, item positioning, and feedback), or usual online ordering. Nutrient quality of online canteen lunch purchases was assessed using routine data collected by the online ordering system. Primary outcomes were the proportion of 'Everyday', 'Occasional', and 'Should not be sold' items purchased, categorized using the state healthy canteen policy. Secondary outcomes were the mean energy, saturated fat, sugar, and sodium content of purchases and the mean weekly revenue from online lunch orders. Linear mixed models were analyzed to assess outcomes. Results: Analysis of the student cohort (Intervention: 4 schools, 656 students; Control: 5 schools, 675 students) showed significant between group differences over time for the intervention group for the mean percentage of online lunch items per student that were 'Everyday' (+ 5.5%; P < 0.001) and 'Should not be sold' (− 4.4%; P < 0.001). There were no between group differences over time in the mean percentage of online lunch items that were 'Occasional'; the average energy, saturated fat, sugar, or sodium content of lunch orders. There was also no difference in mean weekly revenue from high school student online lunch orders (P = 0.23). Conclusions: These findings suggest that a low intensity, choice architecture intervention embedded within an online ordering system can increase the purchase of healthier food items for high school students in one Australian state without any adverse impact on canteen revenue. Trial registration: This trial was prospectively registered on Open Science Framework on 23rd October 2020 as osf.io/h8zfr. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Higher cruciferous vegetable intake is associated with lower cardiovascular disease risk in observational studies. The pathways involved remain uncertain. We aimed to determine whether cruciferous vegetable intake (active) lowers 24-h brachial systolic blood pressure (SBP; primary outcome) compared to root and squash vegetables (control) in Australian adults with mildly elevated BP (SBP 120-160 mmHg inclusive)., Methods: In this randomized, controlled, crossover trial, participants completed two 2-week dietary interventions separated by a 2-week washout. Cruciferous vegetables were compared to root and squash vegetables (~ 300 g/day) consumed with lunch and dinner meals. Participants were blinded to which interventions were the active and control. Adherence was assessed using food diaries and biomarkers (S-methyl cysteine sulfoxide (SMCSO, active) and carotenoids (control)). Twenty-four-hour brachial ambulatory SBP and secondary outcomes were assessed pre- and post each intervention. Differences were tested using linear mixed effects regression., Results: Eighteen participants were recruited (median (IQR) age: 68 (66-70); female: n = 16/18; mean ± SD clinic SBP: 135.9 ± 10.0 mmHg). For both interventions, 72% participants had 100% adherence (IQR: 96.4-100%). SMCSO and carotenoids were significantly different between interventions (mean difference active vs. control SMCSO: 22.93 mg/mL, 95%CI 15.62, 30.23, P < 0.0001; carotenoids: - 0.974 mg/mL, 95%CI - 1.525, - 0.423, P = 0.001). Twenty-four-hour brachial SBP was significantly reduced following the active vs. control (mean difference - 2.5 mmHg, 95%CI - 4.2, - 0.9, P = 0.002; active pre: 126.8 ± 12.6 mmHg, post: 124.4 ± 11.8 mmHg; control pre: 125.5 ± 12.1 mmHg, post: 124.8 ± 13.1 mmHg, n = 17), driven by daytime SBP (mean difference - 3.6 mmHg, 95%CI - 5.4, - 1.7, P < 0.001). Serum triglycerides were significantly lower following the active vs. control (mean difference - 0.2 mmol/L, 95%CI - 0.4, - 0.0, P = 0.047)., Conclusions: Increased intake of cruciferous vegetables resulted in reduced SBP compared to root and squash vegetables. Future research is needed to determine whether targeted recommendations for increasing cruciferous vegetable intake benefits population health., Trial Registration: Clinical trial registry ACTRN12619001294145.  https://www.anzctr.org.au., (© 2024. The Author(s).)

Background: In an Australian randomized controlled trial (RCT), two techniques for intrapartum fetal surveillance were compared: ST analysis (STan) as an adjunct to cardiotocography (CTG), compared with CTG alone. The aim was to determine whether CTG + STan could reduce emergency cesarean birth rates while maintaining or improving neonatal outcomes. Secondary aims were to compare clinical, economic, and psychosocial outcomes. The purpose of this paper was to present psychosocial outcomes from one cohort enrolled in the trial., Methods: The study was conducted at one tertiary referral hospital. Participants who had taken part in the trial from the outset were invited to complete a questionnaire between March 2018 and January 2020, approximately 8 weeks after giving birth. Outcomes included depression, psychological distress, health-related quality of life, and infant feeding practices. Analysis was by intention to treat., Results: N = 207/527 participants completed the questionnaire (n = 113, STan; n = 94, CTG alone). Overall, no statistically significant or clinically meaningful differences were found in the two groups for symptoms of depression, psychological distress, quality of life, or infant feeding. A statistically significant difference was observed for the subscale of pain-discomfort, where scores were higher on average in the CTG alone arm relative to that in the CTG + STan arm., Conclusions: Although STan as an adjunct to CTG constitutes a different clinical technology from CTG alone, both monitoring types appeared to produce similar results in terms of postnatal psychosocial outcomes for women. Findings from this study provide service users and staff with a comprehensive assessment of STan that can be used to make evidence-informed decisions about monitoring options should STan become more widely available., (© 2024 The Authors. Birth published by Wiley Periodicals LLC.)

Background: Mental health problems are common among university students, yet many students do not seek professional help. Digital mental health interventions can increase students' access to support and have been shown to be effective in preventing and treating mental health problems. However, little is known about the extent to which students implement therapeutic skills from these programs in everyday life (ie, skill enactment) or about the impact of skill enactment on outcomes., Objective: This study aims to assess the effects of a low-intensity video-based intervention, Uni Virtual Clinic Lite (UVC-Lite), in improving skill enactment relative to an attention-control program (primary aim) and examine whether skill enactment influences symptoms of depression and anxiety (secondary aim). The study also qualitatively explored participants' experiences of, and motivations for, engaging with the therapeutic techniques., Methods: We analyzed data from a randomized controlled trial testing the effectiveness of UVC-Lite for symptoms of depression and anxiety among university students with mild to moderate levels of psychological distress. Participants were recruited from universities across Australia and randomly assigned to 6 weeks of self-guided use of UVC-Lite (243/487, 49.9%) or an attention-control program (244/487, 50.1%). Quantitative data on skill enactment, depression, and anxiety were collected through baseline, postintervention, and 3- and 6-month follow-up surveys. Qualitative data were obtained from 29 intervention-group participants through open-ended questions during postintervention surveys (n=17, 59%) and semistructured interviews (n=12, 41%) after the intervention period concluded., Results: Mixed model repeated measures ANOVA demonstrated that the intervention did not significantly improve skill enactment (F 3,215.36 =0.50; P=.68). Skill enactment was also not found to influence change in symptoms of depression (F 3,241.10 =1.69; P=.17) or anxiety (F 3,233.71 =1.11; P=.35). However, higher levels of skill enactment were associated with lower symptom levels among both intervention and control group participants across time points (depression: F 1,541.87 =134.61; P<.001; anxiety: F 1,535.11 =73.08; P<.001). Inductive content analysis confirmed low levels of skill enactment among intervention group participants. Participants were motivated to use techniques and skills that were perceived to be personally relevant, easily integrated into daily life, and that were novel or had worked for them in the past., Conclusions: The intervention did not improve skill enactment or mental health among students with mild to moderate psychological distress. Low adherence impacted our ability to draw robust conclusions regarding the intervention's impact on outcomes. Factors influencing skill enactment differed across individuals, suggesting that it may be necessary to tailor therapeutic skills and engagement strategies to the individual user. Theoretically informed research involving collaboration with end users is needed to understand the processes underlying skill enactment in digital mental health interventions., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000375853; https://tinyurl.com/7b9ar54r., (©Hayley M Jackson, Philip J Batterham, Alison L Calear, Jeneva L Ohan, Louise M Farrer. Originally published in JMIR Mental Health (https://mental.jmir.org), 21.08.2024.)

Introduction: Adolescent e-cigarette use, globally and within Australia, has increased in recent years. In response, public health agencies have called for the development of education and communication programmes targeting adolescents. Despite such recommendations, few rigorous evaluations of such interventions currently exist. The main objective of this study is to examine the potential effect of a text message intervention targeting parents and adolescents on adolescent susceptibility to e-cigarette use (eg, intentions towards using e-cigarettes). Secondary objectives are to (1): examine the effect of the intervention on adolescent e-cigarette and combustible tobacco use and (2) examine the acceptability of the intervention., Methods and Analysis: A randomised controlled trial employing a 2×2 factorial design will be conducted with parent-adolescent dyads (aged 12-15 years). Dyads will be randomly allocated to one of four arms: arm 1-a text message intervention delivered to adolescents only; arm 2-a text message intervention delivered to the parents of adolescents only; arm 3-a text message intervention delivered to both the parents and adolescents; and arm 4-an information only control, consisting of an e-cigarette factsheet provided to parents only. Participant recruitment commenced in March 2023 with the aim to recruit 120 parent-adolescent dyads. Data collection to assess study outcomes will occur at baseline, 6, 12 and 24 months post the commencement of the intervention. The primary endpoint will be 6-month follow-up. The primary outcome will be adolescent susceptibility to e-cigarette use, assessed using validated items. Analyses of trial outcomes will be undertaken under an intention-to-treat framework, with all participants included in the analysis in the group they were allocated., Ethics and Dissemination: Ethics approval has been obtained from the human research ethics committee of the University of Newcastle (H-2022-0340). Findings will be disseminated in peer-reviewed journals and at conferences., Trial Registration Number: The trial was registered prospectively with Australian New Zealand Clinical Trials Registry (ACTRN12623000079640)., Competing Interests: Competing interests: All authors declare that they have no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Numerous studies have demonstrated the effectiveness of digital interventions for improving the mental health of university students. However, low rates of engagement with these interventions are an ongoing challenge and can compromise effectiveness. Brief, transdiagnostic, web-based video interventions are capable of targeting key mental health and related issues affecting university students and may be more engaging and accessible for this population., Objective: This study used a 2-arm randomized controlled trial to evaluate the effectiveness of Uni Virtual Clinic-Lite (UVC-Lite), a fully automated, transdiagnostic, web-based video intervention, relative to an attention-control condition. The primary outcomes were symptoms of depression and generalized anxiety disorder. The secondary outcomes included psychological distress, social anxiety symptoms, body appreciation, quality of life, well-being, functioning, general self-efficacy, academic self-efficacy, and help seeking. Program use (intervention uptake and engagement) and satisfaction were also assessed., Methods: University students (n=487) with mild to moderate symptoms of distress were recruited from universities across Australia and randomly allocated to receive access to the UVC-Lite intervention or an attention-control condition targeting general health for a period of 6 weeks. UVC-Lite includes 12 modules, each comprising a brief animated video and an accompanying exercise. Of the 12 modules, 7 also included a brief symptom screening quiz. Outcomes were assessed at baseline, postintervention, and 3- and 6-months postintervention., Results: The primary and secondary outcomes were analyzed on an intention-to-treat basis using mixed models repeated measures ANOVA. The intervention was not found to be effective relative to the control condition on any of the primary or secondary outcomes. While 67.9% (114/168) of participants accessed at least 1 module of the intervention, module completion was extremely low. Subgroup analyses among those who engaged with the program (completed at least 1 video) and those with higher baseline distress (Distress Questionnaire-5 score ≥15) did not reveal any differences between the conditions over time. However, uptake (accessing at least 1 video) and engagement (completing at least 1 video) were higher among those with higher baseline symptoms. Satisfaction with the intervention was high., Conclusions: The UVC-Lite intervention was not effective relative to a control program, although it was associated with high satisfaction among students and was not associated with symptom deterioration. Given the challenges faced by universities in meeting demand for mental health services, flexible and accessible interventions such as UVC-Lite have the potential to assist students to manage symptoms of mental health problems. However, low uptake and engagement (particularly among students with lower levels of symptomatology) are significant challenges that require further attention. Future studies should examine the effectiveness of the intervention in a more highly symptomatic sample, as well as implementation pathways to optimize effective engagement with the intervention., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000375853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380146., (©Louise M Farrer, Hayley M Jackson, Amelia Gulliver, Alison L Calear, Liana Leach, Penelope Hasking, Natasha Katruss, Philip J Batterham. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 13.08.2024.)

Introduction: With the increasing use of oral anti-cancer medicines (OAMs), research demonstrating the magnitude of the medication non-adherence problem and its consequences on treatments' efficacy and toxicity is drawing more attention. Mobile phone interventions may be a practical solution to support patients taking OAMs at home, yet evidence to inform the efficacy of these interventions is lacking. The safety and adherence to medications and self-care advice in oncology (SAMSON) pilot randomised control trial (RCT) aims to evaluate the acceptability, feasibility and potential efficacy of a novel digital solution to improve medication adherence (MA) among people with cancer., Methods and Analysis: This is a two-arm, 12-week, pilot RCT aiming to enrol 50 adults with haematological, lung or melanoma cancers at an Australian metropolitan specialised oncology hospital, who are taking oral anti-cancer medicines. Participants will be randomised (1:1 allocation ratio) to either the intervention group (SAMSON solution) or the control group (usual care). The primary outcomes are the acceptability and feasibility of SAMSON. The secondary outcomes are MA, toxicity self-management, anxiety and depressive symptoms, health-related quality of life, and parameters relating to optimal intervention strategy. Quantitative data will be analysed on a modified intention-to-treat basis., Summary: While multicomponent interventions are increasingly introduced, SAMSON incorporates novel approaches to the solution. SAMSON provides a comprehensive, patient-centred, digital MA intervention solution with seamless integration of a mobile platform with clinical consultations that are evidence-based, theory-based, co-designed and rigorously tested. The pilot trial will determine whether this type of intervention is feasible and acceptable in oncology and will provide a foundation for a future full-scale RCT., Ethics and Dissemination: Primary ethics approvals were received from Peter MacCallum Cancer Centre and Swinburne University of Technology Human Research Ethics Committees (HREC/95332/PMCC and 20237273-15836). Results will be disseminated via peer-reviewed publications and presentations at international and national conferences., Trial Registration Number: The protocol has been prospectively registered on the Australian New Zealand Clinical Trials Registry with trial registration number (ACTRN12623000472673)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Rates of help-seeking for mental disorders and suicide are low among children and adolescents. Parents are viewed as gatekeepers for their care, yet they may lack the knowledge and skills to identify needs or facilitate service access. The primary aim is to test the effect of a new gatekeeper resource for parents and caregivers on their self-efficacy to recognise, respond and access support for mental health problems and suicide risk in their child., Methods and Analysis: A two-arm randomised controlled trial will compare an online mental health and suicide gatekeeper resource for parents and caregivers to a waitlist control. Australian parents of children aged 5-17 years recruited through social media and community advertising will participate in an online trial. Participants randomised to the intervention condition will be emailed the resource to work through at their own pace. The resource consists of three sections providing parents and caregivers with confidence, knowledge and skills to recognise and respond to mental health problems and suicide risk in their child, as well as support them in accessing professional help. The primary outcome measure is self-efficacy to recognise, respond and provide support for mental health problems and suicide risk, while secondary outcomes include perceived knowledge, stigma, literacy, help-seeking attitudes, intentions and barriers. Data will be collected at preintervention, postintervention (4 weeks after accessing the resource) and 12-week follow-up. Primary analyses will compare changes in self-efficacy in the intervention condition relative to the waitlist control using mixed-model repeated measures analyses., Ethics and Dissemination: The ethical aspects of the study were approved by the Australian National University Human Research Ethics Committee (Protocol 2023/195). If effective, the resource will fill an important gap in resources for parents, with the potential for dissemination through school groups, community organisations and clinical settings., Trial Registration Number: Australian New Zealand Clinical Trials Registry, ACTRN12623000933651., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Central venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion and thrombosis. While laboratory and clinical data are promising, tetra-EDTA (T-EDTA) has yet to be rigorously evaluated or introduced in cancer care as a catheter lock., Methods and Analysis: This is a protocol for a two-arm, superiority type 1 hybrid effectiveness-implementation randomised controlled trial conducted at seven hospitals across Australia and New Zealand. Randomisation will be in a 3:2 ratio between the saline (heparinised saline and normal saline) and T-EDTA groups, with randomly varied blocks of size 10 or 20 and stratification by (1) healthcare facility; (2) CVAD type and (3) duration of dwell since insertion. Within the saline group, there will be a random allocation between normal and heparin saline. Participants can be re-recruited and randomised on insertion of a new CVAD. Primary outcome for effectiveness will be a composite of CVAD-associated bloodstream infections (CABSI), CVAD-associated thrombosis or CVAD occlusion during CVAD dwell or at removal. Secondary outcomes will include CABSI, CVAD-associated-thrombosis, CVAD failure, incidental asymptomatic CVAD-associated-thrombosis, other adverse events, health-related quality of life, healthcare costs and mortality. To achieve 90% power (alpha=0.05) for the primary outcome, data from 720 recruitments are required. A mixed-methods approach will be employed to explore implementation contexts from the perspective of clinicians and healthcare purchasers., Ethics and Dissemination: Ethics approval has been provided by Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (HREC/22/QCHQ/81744) and the University of Queensland HREC (2022/HE000196) with subsequent governance approval at all sites. Informed consent is required from the substitute decision-maker or legal guardian prior to participation. In addition, consent may also be obtained from mature minors, depending on the legislative requirements of the study site. The primary trial and substudies will be written by the investigators and published in peer-reviewed journals. The findings will also be disseminated through local health and clinical trial networks by investigators and presented at conferences., Trial Registration Number: ACTRN12622000499785., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Mental health nurses are exposed frequently to occupational stress and can experience a range of negative impacts on their well‐being and intention to stay in the nursing workforce. Promoting Resilience in Nurses (PRiN) is a strength‐based resilience education programme that incorporates evidence‐based cognitive behavioural and interpersonal approaches with post‐traumatic growth theory. A partially clustered randomized controlled trial at a large public mental health service will be used to examine the effects of PRiN on mental health nurses' coping self‐efficacy, resilience, well‐being, mental health, emotional regulation, post‐traumatic growth, workplace belonging, and turnover intention as compared to controls. Process evaluations are increasingly used to help understand and interpret trial results for complex interventions. This paper describes the protocol for an embedded mixed methods process evaluation that aims to evaluate the PRiN programme implementation and identify factors that may explain variation in participant outcomes in the trial. Data collection includes a programme participant satisfaction survey; a follow‐up semi‐structured interview with selected programme participants; a unit/team manager survey on barriers and facilitators to staff recruitment and programme participation; and a fidelity checklist completed by programme facilitators. Normalisation Process Theory will be used to inform data analysis and integration. The findings will provide insights into factors that affect programme implementation, particularly in the context of the COVID‐19 pandemic and may help explain differences in participant outcomes. Findings will also inform post‐trial programme sustainability as well as potential future upscale and adaptation for implementation across healthcare settings. [ABSTRACT FROM AUTHOR]

Translation of findings from stroke trials into clinical practice remains low. Little is known about planned translation activities from the perspective of trialists who generate the evidence. This study aims to investigate perceptions of Australian stroke clinical trialists' about implementation of their findings into practice, and what translation activities they embedded into trial protocols. A descriptive cohort design and electronic survey was conducted. Three databases were searched to identify Australian stroke rehabilitation trials published between 2007 and 2017. Corresponding authors of the included trials were invited to complete an anonymous online survey about implementation of their trial intervention. Fifty-one trialists were invited to participate and 38 completed the survey (74% response rate). The majority (79%) considered their trial results to be clinically significant and 68% had pre-planned knowledge translation activities. The most common planned translation activities were publication (89%), conference presentation (87%), and feedback of results to target audiences (58%). Mixed opinions were evident regarding when and how to design knowledge translation activities for inclusion in trial protocols. Stroke rehabilitation trialists rely mostly on anecdotal reports about implementation of trial interventions, with few formally measuring uptake. The most common knowledge translation activities planned for by researchers are publication of findings in academic journals, and conference presentations. Mixed opinions exist regarding when and how to design for knowledge translation activities in trial protocols. Limited formal measurement of intervention uptake is completed. Further implementation research is required to support and measure effective translation efforts when embedded into trial protocols. [ABSTRACT FROM AUTHOR]

Summary: Background: Few randomized controlled trial (RCT) interventions targeted children's early risk behaviours using telephone or short message service (SMS) support. Objective: To evaluate the effectiveness of telephone or SMS early intervention focusing on mothers' behaviours starting from late pregnancy to improve BMI, and eating and screen time behaviours of children aged 2 years in comparison with the control group. Methods: A 3‐arm RCT was conducted in Australia, 2017–2019. Two arms involved the interventions using nurse‐led telephone or SMS support, delivered in nine stages from late pregnancy to age 2 years. The third arm was control. The primary outcome was children's objectively measured BMI and BMI z‐score at 2 years. Secondary outcomes included child eating and screen time behaviours as reported by parents at 2 years. Results: At 2 years, 797 mother–child dyads (69%) completed the telephone survey with 666 (58%) completing weight and height measurements. The study found no statistically significant difference in BMI between the groups. The mean BMI for telephone support was 16.93 (95% CI: 16.73 to 17.13), for SMS 16.92 (95% CI: 16.73 to 17.11) or for control 16.95 (95% CI: 16.73 to 17.16) with a difference of −0.02 (95% CI: −0.31 to 0.27, p = 0.907) in telephone versus control, and a difference of −0.03 (95% CI: −0.30 to 0.24, p = 0.816) in SMS versus control. Telephone support was associated with higher odds of no bottle at bedtime (adjusted odds ratio [AOR]: 2.99; 95% CI: 2.01 to 4.47), family meals (AOR: 2.05; 95% CI: 1.26 to 3.33), drinking from a cup (AOR: 1.89; 95% CI: 1.24 to 2.88), less screen time (<1 h/day) (AOR: 1.56; 95% CI: 1.10 to 2.23) and not eating dinner in front of the TV (AOR: 1.50; 95% CI: 1.09 to 2.06). SMS support was also associated with higher odds of no bottle at bedtime (AOR 2.30, 95% CI: 1.58 to 3.33) than the control. Conclusion: The telephone or SMS support intervention had no significant effects on BMI, but was effective in increasing no bottle use at bedtime. Telephone support showed more effects than SMS on reducing screen time and eating behaviours. [ABSTRACT FROM AUTHOR]

Rationale: Pleural effusion commonly complicates community-acquired pneumonia and is associated with intense pleural inflammation. Whether antiinflammatory treatment with corticosteroids improves outcomes is unknown. Objectives: To assess the effects of corticosteroids in an adult population with pneumonia-related pleural effusion. Methods: The STOPPE (Steroid Therapy and Outcome of Parapneumonic Pleural Effusions) trial was a pilot, multicenter, double-blinded, placebo-controlled, randomized trial involving six Australian centers. Patients with community-acquired pneumonia and pleural effusion were randomized (2:1) to intravenous dexamethasone (4 mg twice daily for 48 h) or placebo and followed for 30 days. Given the diverse effects of corticosteroids, a comprehensive range of clinical, serological, and imaging outcomes were assessed in this pilot trial (ACTRN12618000947202). Measurements and Main Results: Eighty patients were randomized (one withdrawn before treatment) and received dexamethasone (n = 51) or placebo (n = 28). This pilot trial found no preliminary evidence of benefits of dexamethasone in improving time to sustained (>12 h) normalization of vital signs (temperature, oxygen saturations, blood pressure, heart, and respiratory rates): median, 41.0 (95% confidence interval, 32.3-54.5) versus 27.8 (15.4-49.5) hours in the placebo arm (hazard ratio, 0.729 [95% confidence interval, 0.453-1.173]; P = 0.193). Similarly, no differences in C-reactive protein or leukocyte counts were observed, except for a higher leukocyte count in the dexamethasone group at Day 3. Pleural drainage procedures were performed in 49.0% of dexamethasone-treated and 42.9% of placebo-treated patients (P = 0.60). Radiographic pleural opacification decreased over time with no consistent intergroup differences. Mean duration of antibiotic therapy (22.4 [SD, 15.4] vs. 20.4 [SD, 13.8] d) and median hospitalization (6.0 [interquartile range, 5.0-10.0] vs. 5.5 [interquartile range, 5.0-8.0] d) were similar between the dexamethasone and placebo groups. Serious adverse events occurred in 25.5% of dexamethasone-treated and 21.4% of placebo-treated patients. Transient hyperglycemia more commonly affected the dexamethasone group (15.6% vs. 7.1%). Conclusions: Systemic corticosteroids showed no preliminary benefits in adults with parapneumonic effusions. Clinical trial registered with www.anzctr.org.au (ACTRN12618000947202). [ABSTRACT FROM AUTHOR]

Background: Globally, bronchiectasis (BE) unrelated to cystic fibrosis (CF) is recognized as a major cause of respiratory morbidity, mortality, and healthcare utilization. Children with BE regularly experience exacerbations of their condition resulting in frequent hospitalizations and decreased health-related quality of life (HR-QoL). Guidelines for the treatment and management of BE call for regular exercise as a means of improving aerobic fitness and HR-QoL. Moreover, research in adults with BE has shown that exercise can reduce the frequency of exacerbations, a potent predictor of future lung function decline and respiratory morbidity. Yet, to date, the health benefits resulting from therapeutic exercise have not been investigated in children with BE. The BREATH, Bronchiectasis - Exercise as Therapy, trial will test the efficacy of a novel 8-week, play-based therapeutic exercise program to reduce the frequency of acute exacerbations over 12 months in children with BE (aged ≥ 4 and < 13 years). Secondary aims are to determine the cost-effectiveness of the intervention and assess the program's impact on aerobic fitness, fundamental movement skill (FMS) proficiency, habitual physical activity, HR-QoL, and lung function.Methods: This multi-center, observer-blinded, parallel-group (1:1 allocation), randomized controlled trial (RCT) will be conducted at three sites. One hundred and seventy-four children ≥ 4 and < 13 years of age with BE will be randomized to a developmentally appropriate, play-based therapeutic exercise program (eight, 60-min weekly sessions, supplemented by a home-based program) or usual care. After completing the baseline assessments, the number of exacerbations and secondary outcomes will be assessed immediately post-intervention, after 6 months of follow-up, and after 12 months of follow-up. Monthly, parental contact and medical review will document acute respiratory exacerbations and parameters for cost-effectiveness outcomes.Discussion: The BREATH trial is the first fully powered RCT to test the effects of a therapeutic exercise on exacerbation frequency, fitness, movement competence, and HR-QoL in children with bronchiectasis. By implementing a developmentally appropriate, play-based exercise program tailored to the individual needs of children with bronchiectasis, the results have the potential for a major paradigm shift in the way in which therapeutic exercise is prescribed and implemented in children with chronic respiratory conditions. The exercise program can be readily translated. It does not require expensive equipment and can be delivered in a variety of settings, including the participant's home. The program has strong potential for translation to other pediatric patient groups with similar needs for exercise therapy, including those with obesity, childhood cancers, and neurological conditions such as cerebral palsy.Trial Registration: Australian and New Zealand Clinical Trials Register (ANZCTR) ACTRN12619001008112. [ABSTRACT FROM AUTHOR]

Background and Aims: Alcohol consumption is increasing among older adults. Rethink My Drink is a brief internet-delivered intervention to reduce alcohol consumption and related harms, adapted specifically for older adults. This protocol for a large-scale randomised controlled trial will evaluate whether Rethink My Drink is effective in reducing alcohol consumption and cognitive decline in a sample of older risky drinkers, compared with an active control. Design: 1:1 parallel group, randomised controlled trial. Setting: Online trial in Australia. Participants: Hazardous or harmful drinkers (defined as those scoring =5 on the Alcohol Use Disorders Identification Test [AUDIT]) age 60 to 75 years old (n = 842). Participants will be recruited from August 2021 to August 2022 through online social media advertisements and community networks. Intervention and Comparator: Participants will be randomly allocated to receive access to Rethink My Drink (intervention) or Alcohol: The Facts (comparator), an online patient information booklet provided by New South Wales (NSW) Health. Measurements: Primary outcomes include (i) average weekly standard drinks and (ii) rate of cognitive decline. Secondary outcomes include (i) typical quantity of drinks per drinking day; (ii) heavy episodic drinking; (iii) age-specific risky drinking; (iv) alcoholrelated harms; (v) subjective cognitive complaints; and (vi) quality of life. All primary and secondary outcomes will be assessed at baseline, post-intervention (4 weeks) and 12 months. Effectiveness will be evaluated using multilevel linear regression, adjusting for baseline demographic differences. Bonferroni adjustments will be used to control for multiple comparisons. Multiple imputation, regression weighting and sensitivity analyses will assess the effect of attrition. Comments: This will be the first large-scale trial, internationally, to examine whether a brief internet-delivered intervention is effective in reducing alcohol consumption and cognitive decline among older adults. If successful, the intervention will provide an accessible and highly scalable treatment to reduce risky alcohol consumption in older adulthood. [ABSTRACT FROM AUTHOR]

Volunteering has been identified as a potential mechanism for improving the psychosocial health of older adults. Utilizing a randomized controlled trial approach, the present study assessed the extent to which commencing volunteering can improve psychosocial health outcomes for older people. Fully retired Australian adults aged 60+ years (N= 445) were assessed at baseline and allocated to either the intervention or control arms of the trial. Those in the intervention condition were asked to participate in at least 60 min of formal volunteering per week for 6 months. Per-protocol analyses were conducted comparing psychosocial outcomes for those who complied with the intervention condition (n= 73) to outcomes for those who complied with the control condition (n= 112). Those who complied with the intervention condition demonstrated significant improvements in life satisfaction, purpose in life, and personal growth scores over a 12-month period relative to those in the control condition who did no volunteering. Findings provide evidence of a causal relationship between commencing volunteering and improvements in psychosocial health among older adults and indicate that encouraging participation in this activity could constitute an effective healthy aging intervention. [ABSTRACT FROM AUTHOR]

Background: Falls cause considerable morbidity and mortality in older people. It is unclear how vitamin D supplementation affects falls risk, particularly when taken at high doses. We sought to determine whether monthly high‐dose vitamin D supplementation reduces risk and incidence of falls. Methods: We used data from the randomized, double‐blind, placebo‐controlled D‐Health Trial conducted in Australia. Between February 2014 and May 2015, 21 315 participants aged 60–84 years were randomized (1:1) to monthly doses of either 60 000 IU of colecalciferol or placebo for a maximum of 5 years. People who reported a history of osteomalacia, sarcoidosis, hyperparathyroidism, hypercalcaemia or kidney stones or who were taking >500 IU/day supplementary vitamin D were ineligible. Each year, we collected blood samples from ~450 randomly sampled participants from each trial arm and measured 25‐hydroxyvitamin D [25(OH)D]. Falls, a prespecified tertiary outcome, were ascertained using annual surveys and, for a subset of participants, 3‐month falls diaries. The primary outcome for this analysis was any fall in the month before completing an annual survey. As part of our process to maintain blinding, we used random samples of participants (surveys, n = 16 000; diaries, n = 2400), with equal numbers per group. Participants with no outcome data were excluded. Following an intention‐to‐treat approach, we analysed outcomes using logistic, ordinal and negative binomial regression. Registration: Australian New Zealand Clinical Trials Registry (ACTRN12613000743763); registered 4 July 2013. Results: Mean treatment duration was 4.3 years (standard deviation [SD] = 1.4 years). Mean serum 25(OH)D concentrations during the trial were 114.8 (SD 30.3) nmol/L and 77.5 (SD 25.2) nmol/L in the vitamin D and placebo groups, respectively. Survey and diary analytic sets included 15 416 and 2200 participants, respectively; approximately half were randomized to vitamin D (surveys: 50.1%; diaries: 50.4%). Vitamin D had no effect on falling in the past month (odds ratio [OR] 1.02, 95% confidence interval [CI] 0.95–1.10). There was an interaction with body mass index (BMI) (P‐interaction = 0.001); vitamin D increased risk in participants with BMI < 25 kg/m2 (OR 1.25, 95% CI 1.09–1.43), but there was no effect in those with BMI ≥ 25 kg/m2 (OR 0.95, 95% CI 0.87–1.04). Analyses of diary data were consistent with these findings. The incidence of hypercalcaemia and kidney stones did not differ between groups. Conclusions: Monthly high‐dose vitamin D supplementation did not reduce risk of falling. A possible increased risk of falling with vitamin D supplementation in people with normal BMI warrants further investigation. [ABSTRACT FROM AUTHOR]

Background: Research suggests dyadic interventions can increase physical activity; such interventions are untested within postpartum parent couples. Methods: A three-armed pilot randomized trial addressed this gap and tested which type of dyadic intervention is most effective. Inactive postpartum mothers and a significant other were recruited in Australia (n = 143 assessed for eligibility) and randomised in a single-blinded fashion (i.e. participants were blinded) to 1 of 3 dyadic conditions involving a single face-to-face session with access to web-based group support: a minimal treatment control (n = 34), collaborative planning group (n = 38), or collaborative planning + need supportive communication group (n = 30). Participants were asked to wear their accelerometers for 8 days and completed self-report measures at baseline, end of intervention (week 4), and follow-up (week 12). We expected dyads in the collaborative planning + need supportive communication group would have the greatest increases in Physical Activity (PA), autonomous motivation, and partners' need supportive behaviours; and decreases in controlled motivation and controlling partner behaviours. Results: Results from 51 dyads using Bayesian actor-partner interdependence models provided some evidence for a small positive effect on total PA at follow-up for postpartum mothers in the collaborative planning group and for partners in the collaborative planning + need supportive communication group. Furthermore, partners in the collaborative planning + need supportive communication group were more likely to engage in some vigorous PA. At follow-up, postpartum mothers in the collaborative planning + need supportive communication group scored lower on personal autonomous reasons. Conclusions: The impact of prior specification mean intervention effects need to be interpreted with caution. Progression to a full trial is warranted. [ABSTRACT FROM AUTHOR]

Introduction: Gestational diabetes mellitus and overweight are associated with an increased likelihood of complications during birth and for the newborn baby. These complications lead to increased immediate and long-term healthcare costs as well as reduced health and well-being in women and infants. This protocol presents the health economic evaluation to investigate the cost-effectiveness of Bump2Baby and Me (B2B&Me), which is a health coaching intervention delivered via smartphone to women at risk of gestational diabetes., Methods and Analysis: Using data from the B2B&Me randomised controlled trial, this economic evaluation compares costs and health effects between the intervention and control group as an incremental cost-effectiveness ratio. Direct healthcare costs, costs of pharmaceuticals and intervention costs will be included in the analysis, body weight and quality-adjusted life-years for the mother will serve as the effect outcomes. To investigate the long-term cost-effectiveness of the trial, a Markov model will be employed. Deterministic and probabilistic sensitivity analysis will be employed., Ethics and Dissemination: The National Maternity Hospital Human Research and Ethics Committee was the primary approval site (EC18.2020) with approvals from University College Dublin HREC-Sciences (LS-E-20-150-OReilly), Junta de Andalucia CEIM/CEI Provincial de Granada (2087-M1-22), Monash Health HREC (RES-20-0000-892A) and National Health Service Health Research Authority and Health and Care Research Wales (HCRW) (21/WA/0022). The results from the analysis will be disseminated in scientific papers, through conference presentations and through different channels for communication within the project., Trial Registration Number: ACTRN12620001240932., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Multiple sclerosis (MS) causes a wide variety of symptoms. Loss of income due to sickness and early retirement comprise one-third of the total cost of MS in Australia. An intervention that maximises work productivity and keeps people with MS in the workforce for longer could provide a large societal cost saving and improve quality of life. The aim is to test the feasibility of delivering and evaluating a 10-week digitally delivered intervention called ' MS WorkSmart '. Findings will provide insights into participant profiles and address key methodological and procedural uncertainties (recruitment, retention, intervention adherence and engagement, and selection of primary outcome) in preparation for a subsequent definitive trial., Methods and Analysis: A parallel-arm randomised controlled feasibility study, comparing those randomised to receive the MS WorkSmart package plus usual care (n=20) to those receiving usual care only (n=20). Australians with MS, aged 18-60 years, who are employed, and self-report work instability will be recruited from the Australian MS Longitudinal Study. Online surveys, at baseline and 1-month postintervention, will include MS-related work productivity loss and risk of job loss, MS work behaviour self-efficacy, health-related quality of life, fatigue severity, MS symptom impact on work, intention to retire due to MS, MS-related work difficulties, and awareness and readiness for change at work. Qualitative feedback will be obtained via a semistructured survey following the intervention (for participants) and via interviews (coaches). Analyses will be primarily descriptive and focus on the feasibility and acceptability of the intervention and study procedures. Progression criteria will guide decisions around whether to progress to a full trial., Ethics and Dissemination: The study has been approved by the University of Tasmania Human Research Ethics Committee (H0024544). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and community presentations., Trial Registration Number: ACTRN12622000826741., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Postnatal depression affects up to one in six new mothers in Australia each year, with significant impacts on the woman and her family. Prevention strategies can be complicated by a woman's reluctance to seek professional help. Peer support is a promising but inadequately tested early intervention. Very few trials have reported on the efficacy of peer support in the perinatal period and no study has been undertaken in Australia. We will explore if proactive telephone-based peer (mother-to-mother) support, provided to women identified as being at high risk of postnatal depression, impacts on clinically significant depressive symptomatology at 6 months postpartum., Methods and Analysis: This is a protocol for a single-blinded, multi-centre, randomised controlled trial conducted in Melbourne, Australia. Eligible women will be recruited from either the postnatal units of two maternity hospitals, or around 4 weeks postpartum at maternal and child health centres within two metropolitan council areas. A total of 1060 (530/group) women will be recruited and randomly allocated (1:1 ratio) to either-usual care, to receive the standard community postpartum services available to them, or the intervention group, to receive proactive telephone-based support from a peer volunteer for 6 months, in addition to standard community services., Primary Outcome: clinically significant depressive symptomatology at 6 months postpartum as measured using the Edinburgh Postnatal Depression Scale., Secondary Outcomes: symptoms of anxiety and/or stress, health-related quality of life, loneliness, perception of partner support, self-rated parenting, child health and development, infant feeding and health service use. The cost-effectiveness of the intervention relative to standard care will also be assessed., Ethics and Dissemination: Ethics approval has been obtained from La Trobe University, St. Vincent's Hospital, the Royal Women's Hospital, Northern Health, Victorian Department of Health and Human Services and Victorian Department of Education and Training. Written informed consent will be obtained from all participants before randomisation. Trial results will be disseminated through peer-reviewed publications, conference presentations and a higher degree thesis., Trial Registration Number: ACTRN12619000684123; Australian New Zealand Clinical Trials Registry., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The aim of this work was to assess the cost-effectiveness of induction of labor with outpatient balloon catheter cervical priming versus inpatient prostaglandin vaginal gel or tape.Study Design: Economic evaluation alongside a multi-centre, randomized controlled trial at eight Australian maternity hospitals. The trial reported on 448 women with live singleton term pregnancies, undergoing induction of labor for low-risk indications between September 2015 and October 2018. An economic decision tree model was designed from a health services perspective from time of induction of labor to hospital discharge. Sensitivity and subgroup analyses were performed to test the robustness of model outcomes. We estimated resource use, collected data on health outcomes (using EQ-5D-3 L questionnaire) and reported cost (Australian Dollars) per quality-adjusted life year gained, incremental cost-effect ratio and net monetary benefit.Results: Deterministic analysis showed lower mean costs ($7294 versus $7585) in the outpatient-balloon (n = 205) compared to the inpatient-prostaglandin group (n = 243), with similar health outcomes (0.75 vs 0.74 quality-adjusted life years gained) and overall higher net monetary benefit ($30,054 vs $29,338). In probabilistic analyses outpatient-balloon induction of labor was cost-effective in 55.3 % of all simulations and 59.1 % for women with favourable cervix (modified Bishop score >3) and 64.5 % for nulliparous women.Conclusions: Outpatient-balloon induction of labor may be cost-saving compared to inpatient induction of labor with prostaglandin and is most likely to be cost-effective for nulliparous women, but more research is warranted in other settings to explore the generalisability of results. [ABSTRACT FROM AUTHOR]

Background and Aims: Recent meta‐analyses of motivational interviewing (MI) for reducing risky alcohol use in young people have reported modest effects. Few studies have targeted individual patient factors to increase MI effectiveness. This study determined if MI enhanced with individualised personality‐specific coping skills training (QuikFix) was more efficacious than standard MI or an assessment feedback/information (AF/I) control among young people with alcohol‐related injuries or illnesses. Design and Setting: Single‐centre, single‐blind, three‐group superiority randomized controlled trial with 1‐, 3‐, 6‐ and 12‐months follow‐ups. Telephone intervention, Brisbane, Australia. Participants: A total of 398 young people (16–25 years; M age = 20.30 years, SD = 2.12; 54% female) with alcohol‐related injuries and/or illnesses were recruited from an emergency department (ED) or rest/recovery service (RRS). Measures: The primary outcome was total standard (10 g ethanol) drinks in the past month (Timeline Follow back [TLFB]) at 12 months (primary time point). Secondary outcomes were total drinking days and standard drinks per drinking day (TLFB) in the past month and the frequency of alcohol‐related problems in the past 3 months (Rutgers Alcohol Problem Index). Interventions: Young people were randomized to two sessions of QuikFix enhanced with individualised personality‐specific coping skills training (n = 132), two sessions of MI (n = 136) or one session of AF/I (n = 130), all delivered by telehealth. Findings QuikFix resulted in greater reductions (all P < 0.0017) in the primary outcome of total standard drinks (M = 19.50, CI 99.75% = [11.31, 27.68]) than both MI (M = 32.61, CI 99.75% = [24.82, 40.40]; Cohen's D = 0.40) and AF/I (M = 34.12, CI 99.75% = [26.59, 41.65]; D = 0.45) at 12 months (retention n = 324/398, 81%). QuikFix had greater reductions on drinking days (M = 3.16, CI 99.75% = [2.37, 3.96]) than both MI (M = 4.53, CI 99.75% = [3.57, 5.48];D = 0.38) and AF/I (M = 4.69, CI 99.75% = [3.73, 5.65];D = 0.42) and fewer drinks per drinking day (M = 5.02, CI 99.75% = [3.71, 6.33]) than AF/I (M = 7.15, CI 99.75% = [5.93, 8.38;D = 0.47) at 12 months. Conclusions: Young people with alcohol‐related injuries and/or illnesses who attended ED and rest/recovery services and received an individualised personality‐specific coping skills training intervention (QuikFix) had greater reductions in the amount of alcohol consumed at 12 months compared with those who received motivational interviewing or an assessment feedback/information intervention. [ABSTRACT FROM AUTHOR]

Background: Survival rates for lymphoma are highest amongst hematological malignancies. In 2019, it was estimated that over 6400 Australians were diagnosed with lymphoma, a group of hematological malignancies with a high 5-year survival rate of ~ 76%. There is an increased focus on the promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care heavily rely on hospital-based specialist-led care. Maximizing the potential of general practitioners (GPs) in the ongoing management of cancer is consistent with the national health reform principles and the Cancer Council Australia's Optimal Care Pathways. GPs are well positioned to provide guideline-based follow-up care and are more likely to address comorbidities and psychosocial issues and promote healthy lifestyle behaviors. This study aims to test the feasibility of the GOSPEL I intervention for implementing an integrated, shared care model in which cancer center specialists and community-based GPs collaborate to provide survivorship care for patients with lymphoma.Methods: We describe a protocol for a phase II, randomized controlled trial with two parallel arms and a 1:1 allocation. Sixty patients with Hodgkin's and non-Hodgkin's lymphoma will be randomized to usual specialist-led follow-up care (as determined by the treating hematologists) or a shared follow-up care intervention (i.e., GOSPEL I). GOSPEL I is a nurse-enabled, pre-specified shared care pathway with follow-up responsibilities shared between cancer center specialists (i.e., hematologists and specialist cancer nurses) and GPs. Outcome measures assess feasibility as well as a range of patient-reported outcomes including health-related quality of life as measured by the Functional Assessment of Cancer Therapy-Lymphoma, patient experience of care, symptom distress, comorbidity burden, dietary intake, physical activity behaviors, financial distress/interference, and satisfaction of care. Safety indicators including hospital admission and unscheduled lymphoma clinic visits as well as process outcomes such as intervention fidelity and economic indicators will be analyzed.Discussion: This trial is designed to explore the feasibility and acceptability of a new model of shared care for lymphoma survivors. Patient-reported outcomes as well as potential barriers to implementation will be analyzed to inform a larger definitive clinical trial testing the effects and implementation of a shared care model on health-related quality of life of lymphoma survivors.Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12620000594921 . Registered on 22 May 2020. [ABSTRACT FROM AUTHOR]

Introduction: An important impediment to the large-scale adoption of evidence-based school nutrition interventions is the lack of evidence on effective strategies to implement them. This paper describes the protocol for a "Collaborative Network Trial" to support the simultaneous testing of different strategies undertaken by New South Wales Local Health Districts to facilitate the adoption of an effective school-based healthy lunchbox program ('SWAP IT'). The primary objective of this study is to assess the effectiveness of different implementation strategies to increase school adoption of the SWAP across New South Wales Local Health Districts., Methods: Within a Master Protocol framework, a collaborative network trial will be undertaken. Independent randomized controlled trials to test implementation strategies to increase school adoption of SWAP IT within primary schools in 10 different New South Wales Local Health Districts will occur. Schools will be randomly allocated to either the intervention or control condition. Schools allocated to the intervention group will receive a combination of implementation strategies. Across the 10 participating Local Health Districts, six broad strategies were developed and combinations of these strategies will be executed over a 6 month period. In six districts an active comparison group (containing one or more implementation strategies) was selected. The primary outcome of the trial will be adoption of SWAP IT, assessed via electronic registration records captured automatically following online school registration to the program. The primary outcome will be assessed using logistic regression analyses for each trial. Individual participant data component network meta-analysis, under a Bayesian framework, will be used to explore strategy-covariate interactions; to model additive main effects (separate effects for each component of an implementation strategy); two way interactions (synergistic/antagonistic effects of components), and full interactions., Discussion: The study will provide rigorous evidence of the effects of a variety of implementation strategies, employed in different contexts, on the adoption of a school-based healthy lunchbox program at scale. Importantly, it will also provide evidence as to whether health service-centered, collaborative research models can rapidly generate new knowledge and yield health service improvements., Clinical Trial Registration: This trial is registered prospectively with the Australian New Zealand Clinical Trials Registry (ACTRN12623000558628)., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Barnes, Jones, Wolfenden, Robertson, Seidler, Norman, Budgen, Mattingly, Piliskic, Moorhouse, Mozina, Plaskett, McDermott, Darney, Vuong, Douglass, McDonnell and Sutherland.)

Introduction: Androgen deprivation therapy (ADT) is commonly used to treat men with locally advanced or metastatic prostate cancer. Men receiving ADT experience numerous side effects and frequently report unmet supportive care needs. An essential part of quality cancer care is survivorship care. To date, an optimal effective approach to survivorship care for men with prostate cancer on ADT has not been described. This protocol describes a randomised trial of tele-based nurse-led survivorship that addresses this knowledge gap: (1) determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life (HR-QoL) in men with prostate cancer undergoing ADT and (2) evaluate PCEssentials implementation strategies and outcomes, including cost-effectiveness, compared with usual care., Methods and Analysis: This is an effectiveness-implementation hybrid (type 1) trial with participants randomised to one of two arms: (1) minimally enhanced usual care and (2) nurse-led prostate cancer survivorship essentials (PCEssentials) delivered over four tele-based sessions, with a booster session 5 months after session 1. Eligible participants are Australian men with prostate cancer commencing ADT and expected to be on ADT for a minimum of 12 months. Participants are followed up at 3, 6 and 12 months postrecruitment. Primary outcomes are HR-QoL and self-efficacy. Secondary outcomes are psychological distress, insomnia, fatigue and physical activity. A concurrent process evaluation with participants and study stakeholders will be undertaken to determine effectiveness of delivery of PCEssentials., Ethics and Dissemination: Ethics approval was obtained from the Metro South Health HREC (HREC/2021/QMS/79429). All participants are required to provide written informed consent. Outcomes of this trial will be published in peer-reviewed journals. The findings will be presented at conferences and meetings, local hospital departments, participating organisations/clinical services, and university seminars, and communicated at community and consumer-led forums., Trial Registration Number: ACTRN12622000025730., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: School canteens are a recommended setting to influence adolescent nutrition due to their scope to improve student food choices. Online lunch ordering systems ("online canteens") are increasingly used and represent attractive infrastructure to implement choice architecture interventions that nudge users toward healthier food choices. A recent cluster randomized controlled trial demonstrated the short-term effectiveness (2-month follow-up) of a choice architecture intervention to increase the healthiness of foods purchased by high school students from online canteens. However, there is little evidence regarding the long-term effectiveness of choice architecture interventions targeting adolescent food purchases, particularly those delivered online., Objective: This study aimed to determine the long-term effectiveness of a multi-strategy choice architecture intervention embedded within online canteen infrastructure in high schools at a 15-month follow-up., Methods: A cluster randomized controlled trial was undertaken with 1331 students (from 9 high schools) in New South Wales, Australia. Schools were randomized to receive the automated choice architecture intervention (including menu labeling, positioning, feedback, and prompting strategies) or the control (standard online ordering). The foods purchased were classified according to the New South Wales Healthy Canteen strategy as either "everyday," "occasional," or "should not be sold." Primary outcomes were the average proportion of "everyday," "occasional," and "should not be sold" items purchased per student. Secondary outcomes were the mean energy, saturated fat, sugar, and sodium content of purchases. Outcomes were assessed using routine data collected by the online canteen., Results: From baseline to 15-month follow-up, on average, students in the intervention group ordered significantly more "everyday" items (+11.5%, 95% CI 7.3% to 15.6%; P<.001), and significantly fewer "occasional" (-5.4%, 95% CI -9.4% to -1.5%; P=.007) and "should not be sold" items (-6%, 95% CI -9.1% to -2.9%; P<.001), relative to controls. There were no between-group differences over time in the mean energy, saturated fat, sugar, or sodium content of lunch orders., Conclusions: Given their longer-term effectiveness, choice architecture interventions delivered via online canteens may represent a promising option for policy makers to support healthy eating among high school students., Trial Registration: Australian Clinical Trials ACTRN12620001338954, https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380546 ; Open Science Framework osf.io/h8zfr, https://osf.io/h8zfr/., (©Tessa Delaney, Jacklyn Jackson, Christophe Lecathelinais, Tara Clinton-McHarg, Hannah Lamont, Sze Lin Yoong, Luke Wolfenden, Rachel Sutherland, Rebecca Wyse. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 19.03.2024.)

Background: Emotional symptoms are recognized as a key feature in individuals with major depressive disorder. Previously, emotional blunting has been described both as a side effect of antidepressant treatment and as a symptom of depression. Little is known about the change of emotional blunting during antidepressant treatment., Methods: The PREDDICT trial is a randomized, placebo-controlled, 6-week trial on the augmentation of vortioxetine with the anti-inflammatory agent celecoxib or placebo. Presently we report on exploratory secondary outcomes of changes in emotional blunting in depression assessed with the Oxford Depression Questionnaire (ODQ) total score and subscores from baseline to 8-week, 3-month, and 6-month follow-up assessments., Results: In the whole group, there was a significant improvement in the ODQ total score and all subscores after 8 weeks. After stratification of participants into the treatment groups, the ODQ total score as well as subscores related to emotional blunting as a symptom of depression (reduction in positive emotions, not caring) improved between baseline and all follow-up time points in both treatment groups. Changes in subscores considered as a side effect of antidepressants (general reduction in emotions, emotional detachment) were inconclusive in both treatment groups. Overall, the placebo-augmented group showed slightly better results in changes of emotional blunting scores than the celecoxib group as did those with elevated inflammation at screening, regardless of treatment group., Conclusions: This analysis suggests favorable effects of vortioxetine on emotional blunting in both short- and long-term course. The beneficial impact of vortioxetine on emotional blunting was weaker in celecoxib-augmented patients compared with placebo, possibly due to pharmacokinetic interactions. Clinical Trials Registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000527369p. Registered on 11 April 2017, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000527369p., (© The Author(s) 2024. Published by Oxford University Press on behalf of CINP.)

Objectives: Among patients with severe acute kidney injury (AKI) admitted to the ICU in high-income countries, regional practice variations for fluid balance (FB) management, timing, and choice of renal replacement therapy (RRT) modality may be significant., Design: Secondary post hoc analysis of the STandard vs. Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial (ClinicalTrials.gov number NCT02568722)., Setting: One hundred-fifty-three ICUs in 13 countries., Patients: Altogether 2693 critically ill patients with AKI, of whom 994 were North American, 1143 European, and 556 from Australia and New Zealand (ANZ)., Interventions: None., Measurements and Main Results: Total mean FB to a maximum of 14 days was +7199 mL in North America, +5641 mL in Europe, and +2211 mL in ANZ ( p < 0.001). The median time to RRT initiation among patients allocated to the standard strategy was longest in Europe compared with North America and ANZ ( p < 0.001; p < 0.001). Continuous RRT was the initial RRT modality in 60.8% of patients in North America and 56.8% of patients in Europe, compared with 96.4% of patients in ANZ ( p < 0.001). After adjustment for predefined baseline characteristics, compared with North American and European patients, those in ANZ were more likely to survive to ICU ( p < 0.001) and hospital discharge ( p < 0.001) and to 90 days (for ANZ vs. Europe: risk difference [RD], -11.3%; 95% CI, -17.7% to -4.8%; p < 0.001 and for ANZ vs. North America: RD, -10.3%; 95% CI, -17.5% to -3.1%; p = 0.007)., Conclusions: Among STARRT-AKI trial centers, significant regional practice variation exists regarding FB, timing of initiation of RRT, and initial use of continuous RRT. After adjustment, such practice variation was associated with lower ICU and hospital stay and 90-day mortality among ANZ patients compared with other regions., (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.)

Background: Training conversation partners of people with aphasia who use facilitative communication strategies is one method that can improve access to healthcare for people with aphasia. However, the efficacy of communication partner training (CPT) has been investigated almost exclusively in the context of face‐to‐face (F2F) delivery. Online training may offer more cost‐effective and accessible options to a wider range of conversation partners, including student healthcare professionals. Aims: To conduct a pilot randomized controlled trial with student healthcare professionals comparing (1) an online aphasia CPT program, (2) a F2F CPT program and (3) no program (control group) on outcomes relating to attitudes and knowledge of aphasia. Methods & Procedures: A 45‐min introductory aphasia CPT program was developed using the theories and techniques of Supported Conversations for Adults with Aphasia (SCA)™. A total of 30 first‐year undergraduates studying occupational therapy at The University of Sydney were randomly allocated to one of three conditions: online CPT delivery, F2F delivery or delayed training control (no program). Outcomes measures included pre‐post‐testing with the Aphasia Attitudes, Strategies and Knowledge (AASK) survey. Outcomes & Results: A significant difference existed for the AASK survey pre‐post‐change scores between the online, F2F and control groups (χ2(2) = 20.038, p = 0.000). Post‐hoc analysis revealed that, compared with the control (Ctrl) group, participants in both the online and F2F groups had significantly higher knowledge of aphasia (Online versus Ctrl: p = 0.000; F2F versus control: p = 0.002), knowledge of facilitative strategies (Online versus Ctrl: p = 0.000; F2F versus Ctrl: p = 0.002), and positive attitudes towards aphasia (Online versus Ctrl: p = 0.031; F2F versus Ctrl: p = 0.032). No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000). Conclusions and Implications: The results from this pilot randomized controlled trial indicate that online delivery of the 45‐min introductory CPT is equally as efficacious as F2F delivery, and thus may be a viable mode of delivery for future aphasia CPT programs. These pilot results pave the way for a larger study that will comprehensively evaluate the efficacy of an online aphasia CPT program for improving attitudes, knowledge and skills in a broad range of student healthcare professionals. What this paper addsWhat is already known on this subjectThe efficacy of F2F CPT for aphasia is well established. Online delivery of CPT programs may offer more cost‐effective and accessible services when compared with F2F approaches; however, there is a need to explore the efficacy of online programs.What this paper adds to existing knowledgeThe 45‐min online aphasia CPT program was found to be efficacious for improving student healthcare professionals' knowledge and attitudes towards aphasia and communication, and produced equally successful outcomes when compared with F2F delivery. This is the first study to report the efficacy of an online CPT program that is aligned with SCA for use with student healthcare professionals that also uses a self‐report outcome measure with validated psychometric properties.What are the potential or actual clinical implications of this work?Online CPT programs may be useful in both clinical and education contexts to support improved efficiency of services and to enhance communication environments for people with aphasia in healthcare contexts. [ABSTRACT FROM AUTHOR]

• We will monitor compliance with the intervention and adverse events. • Data will be analyzed following intention-to-treat principles. • A cost-effectiveness analysis will be performed. This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. This paper will provide a detailed description of the planned analyses for the TOPS trial. Australian New Zealand Clinical Trials Registry (ACTRN12615000939594). [ABSTRACT FROM AUTHOR]

Background To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to direct-acting antivirals (DAAs), especially among people who inject drugs (PWID). We aimed to determine the effectiveness of providing DAAs in primary care, compared with hospital-based specialist care. Methods We randomized PWID with HCV attending primary care sites in Australia or New Zealand to receive DAAs at their primary care site or local hospital (standard of care [SOC]). The primary outcome was to determine whether people treated in primary care had a noninferior rate of sustained virologic response at Week 12 (SVR12), compared to historical controls (consistent with DAA trials at the time of the study design); secondary outcomes included comparisons of treatment initiation, SVR12 rates, and the care cascade by study arm. Results We recruited 140 participants and randomized 136: 70 to the primary care arm and 66 to the SOC arm. The SVR12 rate (100%, 95% confidence interval [CI] 87.7–100) of people treated in primary care was noninferior when compared to historical controls (85% assumed). An intention-to-treat analysis revealed that the proportion of participants commencing treatment in the primary care arm (75%, 43/57) was significantly higher than in the SOC arm (34%, 18/53; P <.001; relative risk [RR] 2.48, 95% CI 1.54–3.95), and the proportion of participants with SVR12 was significantly higher in the primary care arm, compared to in the SOC arm (49% [28/57] and 30% [16/53], respectively; P =.043; RR 1.63, 95% CI 1.0–2.65). Conclusions Providing HCV treatment in primary care increases treatment uptake and cure rates. Approaches that increase treatment uptake among PWID will accelerate elimination strategies. Clinical Trials Registration NCT02555475. [ABSTRACT FROM AUTHOR]

Context: Chronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated.Objectives: Does oxycodone reduce chronic breathlessness compared with placebo?Methods: A multisite, randomized, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15 mg (5 mg, eight hourly) or placebo (ACTRN12609000806268 at www.anzctr.org.au). As-needed immediate-release morphine (2.5 mg per dose; six and less doses/day) was available for both arms as required by one ethics committee overseeing the trial. Recruitment occurred from 2010 to 2014 in 14 inpatient and outpatient respiratory, cardiology, and palliative care services across Australia. Participants were adults, with chronic breathlessness (modified Medical Research Council Scale 3 or 4), who were opioid naive. The primary end point was the proportion of people with greater than 15% reduction from baseline in the intensity of breathlessness now (0-100 mm visual analogue scale) comparing arms Days 5-7. Secondary end points were average and worst breathlessness, quality of life, function, and harms.Results: Of 157 participants randomized, 155 were included (74 oxycodone and 81 placebo), but the study did not reach target recruitment. There was difference in neither between groups for the primary outcome (P = 0.489) nor any of the prespecified secondary outcomes. Placebo participants used more as-needed morphine (mean 7.0 vs. 4.2 doses; P ≤ 0.001). Oxycodone participants reported more nausea (P < 0.001).Conclusion: There was no signal of benefit from oxycodone over placebo. Future research should focus on investigating the existence of an opioid class effect on the reduction of chronic breathlessness. [ABSTRACT FROM AUTHOR]

Background: Poorly managed acute coronary syndrome symptoms increase the risk of subsequent cardiovascular events. Purpose: The aim of this study was to evaluate the effectiveness of symptom management patient education on the knowledge of sublingual nitroglycerin for people with acute coronary syndrome. Methods: A randomized controlled trial was used to evaluate the 3-resource intervention. The study was conducted in a 448-bed Australian public hospital. The instrument used was the modified Sublingual Nitroglycerin Interview Schedule. Results: A total of 169 participants completed the study. The intervention group significantly improved their knowledge of sublingual nitroglycerin when compared with the control group (P = .002). Conclusion: This 3-resource symptom management patient education shows promise in improving sublingual nitroglycerin knowledge for people with acute coronary syndrome. [ABSTRACT FROM AUTHOR]

Background: Patients with kidney failure on hemodialysis (HD) experience considerable symptom burden and poor health-related quality of life (HRQoL). There is limited use of patient reported outcome measures (PROMs) in facility HD units to direct immediate care, with response rates in other studies between 36 to 70%. The aim of this pilot study was to evaluate feasibility of electronic PROMs (e-PROMs) in HD participants, with feedback 3-monthly to the participants' treating team, for severe or worsening symptoms as identified by the Integrated Palliative Outcome Scale (IPOS-Renal), with linkage to the Australian and New Zealand Dialysis and Transplant (ANZDATA) registry, compared with usual care., Methods: This is a registry-based cluster-randomized controlled pilot trial involving all adults receiving HD in 4 satellite units in Australia over a 6-month period. HD units were cluster randomized 1:1 to the control (HRQoL data collection only) or intervention arm (symptom monitoring with feedback to treating team every 3 months). Feasibility was assessed by participant response rate (percentage of eligible HD participants, including new incident participants, who completed the questionnaire at each time point); retention rate (percentage of participants who completed the baseline questionnaire and all subsequent measures); and completion time. HRQoL and symptom burden scores are described., Results: There were 226 unique participants who completed the e-PROMs (mean age 62 years, 69% males, 78% White-European, median dialysis vintage 1.62 years). At 6 months, response rate and retention rate for the intervention arm were 54% and 68%, respectively, and 89% and 97% in the control arm. Median time to complete IPOS-Renal was 6.6 min (5.3, 10.1) at 3 months, and when combined with the outcome measure (EQ-5D-5L), the median time was 9.4 min (6.9, 13.6) at 6 months., Conclusions: Electronic symptom monitoring among HD participants with feedback to clinicians is feasible. Variations in response and retention rates could be potentially explained by the lengthier questionnaire, and higher frequency of data collection time points for participants in the intervention arm. A definitive national RCT is underway., Trial Registration: ACTRN12618001976279 (07/12/2018)., (© 2023. The Author(s).)

Background: Hypothyroidism is common, and in iodine-sufficient areas, it is primarily caused by autoimmune destruction of the thyroid gland. Observational studies have consistently shown an inverse association between serum 25-hydroxyvitamin D concentration and autoimmune diseases; however, there is a lack of evidence from randomized controlled trials to support a benefit of vitamin D supplementation, particularly for autoimmune thyroid diseases. We, therefore, aimed to assess the effect of vitamin D supplementation on the incidence of hypothyroidism. Methods: We analyzed data from the D-Health Trial ( n  = 21,315), a randomized double-blind placebo-controlled trial of 60,000 international units per month of supplemental vitamin D 3 among Australians aged 60 years and over. Hypothyroidism, a tertiary outcome of the D-Health Trial, was defined by treatment with levothyroxine, ascertained through linkage with the Australian Pharmaceutical Benefits Scheme. The outcome was time to first prescription of levothyroxine. We began follow-up at 12 months after randomization; people who had died or who had been dispensed levothyroxine during the first year were excluded. Flexible parametric survival models were used to assess the effect of vitamin D supplementation on hypothyroidism, overall and within strata defined by age, sex, body mass index, and predicted baseline vitamin D status. Results: We included 17,851 participants in the main analysis (vitamin D  = 8939; placebo = 8912). During a median follow-up of 4.1 years (interquartile range 4.1-4.1), 293 participants developed hypothyroidism (vitamin D  = 138 [1.5%]; placebo = 155 [1.7%]). Vitamin D supplementation did not significantly reduce the incidence of hypothyroidism (overall hazard ratio [HR] 0.89; 95% confidence interval [CI] 0.71-1.12). There was some suggestion of an effect in females (overall HR 0.78; CI 0.58-1.06) but not in males (overall HR 1.06; CI 0.74-1.50; p interaction 0.20). Conclusions: Vitamin D supplementation did not reduce the incidence of hypothyroidism overall; however, the possible beneficial effect observed in females warrants further investigation. Clinical Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12613000743763.

Introduction: Improving physical activity (PA) and healthy eating is critical for primary and secondary prevention of cardiovascular disease (CVD). Behaviour change programmes delivered in sporting clubs can engage men in health behaviour change, but are rarely sustained or scaled-up post trial. Following the success of pilot studies of the Australian Fans in Training (Aussie-FIT) programme, a hybrid effectiveness-implementation trial protocol was developed. This protocol outlines methods to: (1) establish if Aussie-FIT is effective at supporting men with or at risk of CVD to sustain improvements in moderate-to-vigorous PA (primary outcome), diet and physical and psychological health and (2) examine the feasibility and utility of implementation strategies to support programme adoption, implementation and sustainment., Methods and Analysis: A pragmatic multistate/territory hybrid type 2 effectiveness-implementation parallel group randomised controlled trial with a 6-month wait list control arm in Australia. 320 men aged 35-75 years with or at risk of CVD will be recruited. Aussie-FIT involves 12 weekly face-to-face sessions including coach-led interactive education workshops and PA delivered in Australian Football League (Western Australia, Northern Territory) and rugby (Queensland) sports club settings. Follow-up measures will be at 3 and 6 months (both groups) and at 12 months to assess maintenance (intervention group only). Implementation outcomes will be reported using the Reach, Effectiveness, Adoption, Implementation, Maintenance framework., Ethics and Dissemination: This multisite study has been approved by the lead ethics committees in the lead site's jurisdiction, the South Metropolitan Health Service Human Research Ethics Committee (Reference RGS4254) and the West Australian Aboriginal Health Ethics Committee (HREC1221). Findings will be disseminated at academic conferences, peer-reviewed journals and via presentations and reports to stakeholders, including consumers. Findings will inform a blueprint to support the sustainment and scale-up of Aussie-FIT across diverse Australian settings and populations to benefit men's health., Trial Registration Number: This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To investigate whether use of ST analysis of the fetal electrocardiogram (STan) as an adjunct to continuous cardiotocography (CTG) reduces the rate of emergency Cesarean section (EmCS) compared with CTG alone., Methods: This was a randomized controlled trial of patients with a singleton fetus in cephalic presentation at ≥ 36 weeks' gestation, requiring continuous electronic fetal monitoring during labor at a tertiary maternity hospital in Adelaide, Australia, between January 2018 and July 2021. Participants were randomized to undergo CTG + STan or CTG alone. The calculated sample size was 1818 participants. The primary outcome was EmCS. Secondary outcomes included metabolic acidosis, a composite adverse perinatal outcome, and other maternal and neonatal morbidity and safety outcomes., Results: The present study enrolled 970 women, of whom 967 were included in the primary analysis. EmCS occurred in 107/482 (22.2%) deliveries in the CTG + STan arm and in 107/485 (22.1%) in the CTG arm (adjusted relative risk, 1.02 (95% CI, 0.81-1.27); P = 0.89). There was no difference in the rate of adverse maternal or neonatal outcomes between arms., Conclusions: The addition of STan as an adjunct to continuous CTG did not reduce the EmCS rate. The smaller-than-anticipated sample size meant that this study was underpowered to detect absolute differences of ≤ 5% and, therefore, this negative finding could be due to a Type-2 error. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology., (© 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.)

Background: The measurement and interpretation of patient experience is a distinct dimension of health care quality. The Midwives @ New Group practice Options (M@NGO) randomized control trial of caseload midwifery compared with standard care among women regardless of risk reported both clinical and cost benefits. This study reports participants' perceptions of the quality of antenatal care within caseload midwifery, compared with standard care for women of any risk within that trial. Methods: A trial conducted at two Australian tertiary hospitals randomly assigned participants (1:1) to caseload midwifery or standard care regardless of risk. Women were sent an 89‐question survey at 6 weeks postpartum that included 12 questions relating to pregnancy care. Ten survey questions (including 7‐point Likert scales) were analyzed by intention to treat and illustrated by participant quotes from two free‐text open‐response items. Results: From the 1748 women recruited to the trial, 58% (n = 1017) completed the 6‐week survey. Of those allocated to caseload midwifery, 66% (n = 573) responded, compared with 51% (n = 444) of those allocated to standard care. The survey found women allocated to caseload midwifery perceived a higher level of quality care across every antenatal measure. Notably, those women with identified risk factors reported higher levels of emotional support (aOR 2.52 [95% CI 1.87‐3.39]), quality care (2.94 [2.28‐3.79]), and feeling actively involved in decision‐making (3.21 [2.35‐4.37]). Conclusions: Results from the study show that in addition to the benefits to clinical care and cost demonstrated in the M@NGO trial, caseload midwifery outperforms standard care in perceived quality of pregnancy care regardless of risk. [ABSTRACT FROM AUTHOR]

Background: Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort.Methods: MYB aims to recruit 8,500 non-demented community dwelling 55 to 77 year olds from the Sax Institute's 45 and Up Study in New South Wales, Australia. Participants will be screened for risk factors related to four modules that comprise the MYB intervention: physical activity, nutrition, mental health, and cognitive training. Targeting risk factors will enable interventions to be personalized so that participants receive the most appropriate modules. MYB will run for three years and up to four modules will be delivered sequentially each quarter during year one. Upon completing a module, participants will continue to receive less frequent booster activities for their eligible modules (except for the mental health module) until the end of the trial.Discussion: MYB will be the largest internet-based trial to attempt to prevent cognitive decline and potentially dementia. If successful, MYB will provide a model for not just effective intervention among older adults, but an intervention that is scalable for broad use. [ABSTRACT FROM AUTHOR]

Introduction: This economic evaluation complements results of the randomised controlled trial that established non‐inferiority of the learning outcomes of a one‐week simulated clinical placement (SCP) in occupational therapy qualifying degrees in comparison to an equivalent traditional clinical placement (TCP). This companion study presents detailed cost analyses of two placement alternatives and a cost‐benefit study to assess the value for money of SCP. An economic evaluation of simulated versus traditional placements has not previously been conducted in Australia. Methods: Nine SCP/TCP rounds were conducted by six Australian universities. Costs were collected using study‐specific instruments. Public health sector costs were sourced from available literature. Willingness‐to‐pay for SCP/TCP was estimated using both a Discrete Choice Experiment and a Contingent Valuation method. These methods were employed to assess a comparative 'value' of SCP/TCP from the perspective of heads of occupational therapy departments (N = 28), who were asked to put a monetary value on the broader range of benefits associated with SCP/TCP. Results: From the universities' perspective the average cost per student ranged from AUD$460 to AUD$1511 for simulated and AUD$144 to AUD$1112 for traditional placement. From the health care sector perspective, the difference in costs favoured simulated placements for four implementations and traditional placements for five. In the Discrete Choice Experiment respondents preferred traditional rather than simulated placement and would pay additional AUD$533. The estimated monetary value of simulated placements from a contingent valuation ranged from AUD$200 to AUD$1600. Conclusions: For universities that procure TCPs predominately at public health care facilities and sustain high administrative overheads, the SCP program could be a cost‐saving alternative. From a broader value‐for‐money perspective, respondents favoured TCP over SCP, yet placed importance on placement availability and opportunity to demonstrate competence for students during the placement. Results should be interpreted with caution and further research with larger sample sizes is required. [ABSTRACT FROM AUTHOR]