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

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

Secondary prevention of stroke. A telehealth-delivered physical activity and diet pilot randomized trial (ENAbLE-pilot).

BACKGROUND: Improving physical activity levels and diet quality are important for secondary stroke prevention. AIM: To test the feasibility and safety of 6-month, co-designed telehealth-delivered interventions to increase physical activity and improve diet quality. METHODS: A 2 × 2 factorial trial (physical activity (PA); diet (DIET); PA + DIET; control) randomized, open-label, blinded endpoint trial. Primary outcomes were feasibility and safety. Secondary outcomes included stroke risk factors (blood pressure, self-report PA (International Physical Activity Questionnaire (IPAQ)) and diet quality (Australian Recommended Food Score (ARFS)), and quality of life. Between-group differences were analyzed using linear-mixed models. RESULTS: Over 23 months, 99 people were screened for participation and 40 (40%) randomized (3 months to 10 years post-stroke, mean age 59 (16) years). Six participants withdrew, and an additional five were lost to follow-up. Fifteen serious adverse events were reported, but none were deemed definitely or probably related to the intervention. Median attendance was 32 (of 36) PA sessions and 9 (of 10) DIET sessions. The proportion of missing primary outcome data (blood pressure) was 3% at 3 months, 11% at 6 months, and 14% at 12 months. Between-group 95% confidence intervals showed promising, clinically relevant differences in support of the interventions across the range of PA, diet quality, and blood pressure outcomes. CONCLUSION: Our telehealth PA and diet interventions were safe and feasible and may have led to significant behavior change. TRIAL REGISTRATION: ACTRN12620000189921.

Adapted motivational interviewing for brief healthcare consultations: A systematic review and meta-analysis of treatment fidelity in real-world evaluations of behaviour change counselling.

BACKGROUND: Behaviour change counselling (BCC) is an adaptation of motivational interviewing (MI) designed to maximize the effectiveness of time-limited health behaviour change consultations. To improve intervention quality and understanding of treatment effects, it is recommended that evaluations of health behaviour change interventions incorporate existing fidelity frameworks (e.g. The National Institutes of Health [NIH] Behaviour Change Consortium) and ensure that treatment fidelity is assessed and reported. PURPOSE: This systematic review was designed to examine (a) adherence to NIH fidelity recommendations, (b) provider fidelity to BCC and (c) impact of these variables on the real-world effectiveness of BCC for adult health behaviours and outcomes. METHODS AND RESULTS: Searches of 10 electronic databases yielded 110 eligible publications describing 58 unique studies examining BCC delivered within real-world healthcare settings by existing providers. Mean study adherence to NIH fidelity recommendations was 63.31% (Range 26.83%-96.23%). Pooled effect size (Hedges g) for short-term and long-term outcomes was .19 (95% CI [.11, .27]) and .09 (95% CI [.04, .13]), respectively. In separate, random-effects meta-regressions, neither short-term nor long-term effect sizes were significantly modified by adherence to NIH fidelity recommendations. For the subgroup of short-term alcohol studies (n = 10), a significant inverse relationship was detected (Coefficient = -.0114, 95% CI [-.0187, -.0041], p = .0021). Inadequate and inconsistent reporting within the included studies precluded planned meta-regression between provider fidelity and BCC effect size. CONCLUSIONS: Further evidence is needed to clarify whether adherence to fidelity recommendations modifies intervention effects. Efforts to promote transparent consideration, evaluation and reporting of fidelity are urgently needed. Research and clinical implications are discussed.

Optimising a multi-strategy implementation intervention to improve the delivery of a school physical activity policy at scale: findings from a randomised noninferiority trial.

BACKGROUND: To maximise their potential health benefits, school-based physical activity policies need to be implemented at scale. This paper describes the third in a sequence of trials that sought to optimise an effective strategy (PACE) to assist schools' implementation of a physical activity policy. Specifically, it aimed to determine the probability that a multi-strategy intervention adapted to reduce in-person contact (Adapted PACE) was "as good as" the original intervention (PACE) in increasing the weekly minutes of structured physical activity implemented by classroom teachers. METHODS: A noninferiority cluster randomised controlled trial was undertaken with 48 primary schools in New South Wales, Australia. Schools were randomised to receive PACE or a model with adaptations made to the delivery modes (Adapted PACE). Teachers' scheduled minutes of weekly physical activity was assessed at baseline (Oct 2018-Feb 2019) and 12-month follow-up (Oct-Dec 2019). The noninferiority margin was set at - 16.4 minutes based on previous data and decision panel consensus. A linear mixed model analysed within a Bayesian framework was used to explore noninferiority between the two PACE models. A cost minimisation analysis was conducted from the health service provider perspective, using the Australian dollar (AUD). RESULTS: The posterior estimate for the between group difference at follow-up was - 2.3 minutes (95% credible interval = - 18.02, 14.45 minutes). There was an estimated 96% probability of Adapted PACE being considered noninferior (only 4% of the posterior samples crossed the noninferiority margin of - 16.4 minutes). That is, the minutes of physical activity implemented by teachers at Adapted PACE schools was not meaningfully less than the minutes of physical activity implemented by teachers at PACE schools. The mean total cost was AUD$25,375 (95% uncertainty interval = $21,499, $29,106) for PACE and AUD$16,421 (95% uncertainty interval = $13,974, $19,656) for Adapted PACE; an estimated reduction of AUD$373 (95% uncertainty interval = $173, $560) per school. CONCLUSIONS: It is highly probable that Adapted PACE is noninferior to the original model. It is a cost-efficient alternative also likely to be a more suitable approach to supporting large scale implementation of school physical activity policies. TRIAL REGISTRATION: Retrospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619001229167).

Scale-up of the Physical Activity 4 Everyone (PA4E1) intervention in secondary schools: 24-month implementation and cost outcomes from a cluster randomised controlled trial.

BACKGROUND: Physical Activity 4 Everyone (PA4E1) is an evidence-based program effective at increasing adolescent physical activity (PA) and improving weight status. This study aimed to determine a) the effectiveness of an adapted implementation intervention to scale-up PA4E1 at 24-month follow-up, b) fidelity and reach, and c) the cost and cost-effectiveness of the implementation support intervention. METHODS: A cluster randomised controlled trial using a type III hybrid implementation-effectiveness design in 49 lower socio-economic secondary schools, randomised to a program (n = 24) or control group (n = 25). An adapted implementation intervention consisting of seven strategies was developed to support schools to implement PA4E1 over 24-months. The primary outcome was the proportion of schools implementing at least four of the 7 PA practices, assessed via computer assisted telephone interviews (CATI) with Head Physical Education Teachers. Secondary outcomes included the mean number of PA practices implemented, fidelity and reach, cost and cost-effectiveness. Logistic regression models assessed program effects. RESULTS: At baseline, no schools implemented four of the 7 PA practices. At 24-months, significantly more schools in the program group (16/23, 69.6%) implemented at least four of the 7 PA practices than the control group (0/25, 0%) (p < 0.001). At 24-months, program schools were implementing an average of 3.6 more practices than control schools (4.1 (1.7) vs. 0.5 (0.8), respectively) (P < 0.001). Fidelity and reach of the implementation intervention were high (> 75%). The total cost of the program was $415,112 AUD (2018) ($17,296 per school; $117.30 per student). CONCLUSIONS: The adapted implementation intervention provides policy makers and researchers with an effective and potentially cost-effective model for scaling-up the delivery of PA4E1 in secondary schools. Further assessment of sustainability is warranted. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 prospectively registered 12th May 2017.

Impact of fast-food outlet density on incidence of myocardial infarction in the Hunter region.

BACKGROUND: There is an established association between fast-food consumption and metabolic diseases. Some studies also suggest that calorie-dense food promotes a proinflammatory response, which is itself linked with myocardial infarction (MI). Whether increased fast-food availability is a risk factor for MI remains unknown. AIM: To investigate the role of fast-food outlet density (FFD) as a novel environmental risk factor for MI in the Hunter region, New South Wales (NSW). METHODS: We conducted a retrospective cohort study using a database of all MI events between 1996 and 2013, extracted from the Hunter Cardiac and Stroke Outcomes unit. FFD was calculated for each local government area (LGA) of the Hunter region, allowing for a comparative analysis. Stratification by fast-food outlet data and LGA resulted in a total of 3070 cases. Weighted linear regression was used to investigate the role of FFD on incidence of MI in regional and rural Australia. RESULTS: FFD was positively correlated with rates of MI, remaining consistent in both single and multivariate predictor models adjusting for age, obesity, hyperlipidaemia, hypertension, smoking status, diabetes and socioeconomic status (P < 0.001). An increase of one fast-food outlet corresponded with four additional cases of MI per 100 000 people per year (4.07, 95% confidence interval, 3.86-4.28). CONCLUSIONS: FFD was positively associated with incidence of MI in both rural and metropolitan areas of NSW. This relationship remained consistent after multivariate adjustment for standard cardiovascular risk factors, highlighting the importance of an individual's food environment as a potential contributor towards their health.

A Pilot Longitudinal Study of 3-Dimensional Head and Neck Kinematics During Functional Tasks in Individuals With Chronic Idiopathic Neck Pain Either Wait-Listed for or Receiving Chiropractic Spinal Manipulative Therapy With Exercise.

OBJECTIVE: The purpose of this study was to determine if there is a relationship between pain and movement kinematics during functional tasks, evaluated over time, in individuals with chronic idiopathic neck pain. METHODS: Ten participants with chronic idiopathic neck pain performed 2 functional tasks (overhead reach to the right and putting on a seatbelt) while evaluated using 8 Oqus 300+ cameras. Kinematic variables included joint angles and range of motion (ROM) (°), head segment relative to neck segment (head-neck [HN]); and head/neck segment relative to upper thoracic segment (head/neck-trunk), velocity (m/s), and time (% of movement phase). Pain was quantified using a 100-mm visual analog scale. Linear mixed effects regression models were used to analyze associations between pain and kinematic variables adjusting for treatment group. RESULTS: For overhead reach, higher pain was associated with less HN peak rotation at baseline (ß = -0.33; 95% CI -0.52 to -0.14, P = .003) and less HN total rotation ROM at 6 months (ß = -0.19; 95% CI -0.38 to -0.003, P = .048). For the seatbelt task, higher pain was associated with less HN peak rotation (ß = -0.52; 95% CI -0.74 to -0.30 to -0.74, P < .001) and less HN total rotation ROM at baseline (ß = -0.32; 95% CI -0.53 to -0.10, P = .006). No other movement variables demonstrated meaningful relationships with pain for the reach or seatbelt tasks. CONCLUSION: Higher pain is associated with less HN peak and total rotation during functional reaching tasks requiring head rotation. Recognizing altered functional kinematics in individuals with chronic neck pain may assist patient management.

Scale-up of the Physical Activity 4 Everyone (PA4E1) intervention in secondary schools: 12-month implementation outcomes from a cluster randomized controlled trial.

BACKGROUND: 'Physical Activity 4 Everyone' (PA4E1) was an efficacious multi-component school-based physical activity (PA) program targeting adolescents. PA4E1 has seven PA practices. It is essential to scale-up, evaluate effectiveness and assess implementation of such programs. Therefore, the aim is to assess the impact of implementation support on school practice uptake of the PA4E1 program at 12 and 24 months. METHODS: A cluster randomised controlled trial, utilising a type III hybrid implementation-effectiveness design, was conducted in 49 randomly selected disadvantaged Australian Government and Catholic secondary schools. A blinded statistician randomly allocated schools to a usual practice control (n = 25) or the PA4E1 program group (n = 24), with the latter receiving seven implementation support strategies to support school PA practice uptake of the seven practices retained from the efficacy trial. The primary outcome was the proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers and analysed using exact logistic regression modelling. This paper reports the 12-month outcomes. RESULTS: Schools were recruited from May to November 2017. At baseline, no schools implemented four of the seven practices. At 12 months significantly more schools in the program group had implemented four of the seven practices (16/24, 66.7%) than the control group (1/25, 4%) (OR = 33.0[4.15-1556.4], p < 0.001). The program group implemented on average 3.2 (2.5-3.9) more practices than the control group (p < 0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)). Fidelity and reach of the implementation support intervention were high (both > 80%). CONCLUSIONS: Through the application of multiple implementation support strategies, secondary schools were able to overcome commonly known barriers to implement evidence based school PA practices. As such practices have been shown to result in an increase in adolescent PA and improvements in weight status, policy makers and practitioners responsible for advocating PA in schools should consider this implementation approach more broadly when working with schools. Follow-up is required to determine whether practice implementation is sustained. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017.

PACE-IT study protocol: a stepped wedge cluster randomised controlled trial evaluating the implementation of telehealth visual assessment in emergency care for people living in residential aged-care facilities.

BACKGROUND: Transfer of residential aged-care facility (RACF) residents to Emergency Departments (ED) is common, risky and expensive. RACF residents who present to ED are more likely to have hospital readmissions, longer stays and face major risks related to hospital acquired complications. Aged Care Emergency services (ACE) is a nurse led, protocol- guided, telephone RACF/ED outreach model that has been shown to be effective in reducing hospitalisation and length of hospital stay for RACF residents in the Hunter New England Local Health District, New South Wales (NSW). The Partnerships in Aged-Care Emergency services using Interactive Telehealth (PACE-IT) project enhances ACE by incorporating interactive video assessment and consultation. The PACE-IT project's primary aim is to assess whether augmentation of ACE services through the addition of protocol-guided interactive Visual Telehealth Consultation (VTC) for clinical decision-making, plus telephone follow-up, reduces RACF resident transfers to ED. METHODS: A stepped-wedge cluster randomised controlled trial will be conducted. The intervention will be delivered sequentially to 8 clusters; each cluster comprises one ED and two RACFs in NSW, Australia. The 16 RACFs in the study will be selected for order of implementation using a computer-generated randomisation sequence. A 2-step randomisation process will be undertaken, randomising the hospital EDs first and then randomising the RACFs aligned with each hospital. The PACE-IT intervention comprises: an initial phone call by RACFs to the ACE service in the ED; the ACE service in ED responds with a protocol-guided VTC, a management plan agreed between all participants; an automated consultation summary letter to the General Practitioner and the RACF; a post VTC 24 h follow-up phone call to the RACF. DISCUSSION: If shown to be effective, the intervention has the potential to improve the clinical care and quality of life for residents. Findings will provide high level evidence that will inform sustainable change and broad translation into practice across NSW. It will show how the change has been achieved and highlight success factors for scalability and sustainability. It will inform review of processes, the development of policy and guidelines that will integrate PACE-IT into existing service models in NSW. TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trials Registry (Trial ID ACTR N12619001692123 ) 02/12/2020.).

A stepped wedge trial of efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities.

BACKGROUND: Medication errors are a leading cause of mortality and morbidity. Clinical pharmacy services provided in hospital can reduce medication errors and medication related harm. However, few rural or remote hospitals in Australia have a clinical pharmacy service. This study will evaluate a virtual clinical pharmacy service (VCPS) provided via telehealth to eight rural and remote hospitals in NSW, Australia. METHODS: A stepped wedge cluster randomised trial design will use routinely collected data from patients' electronic medical records (n = 2080) to evaluate the VCPS at eight facilities. The sequence of steps is randomised, allowing for control of potential confounding temporal trends. Primary outcomes are number of medication reconciliations completed on admission and discharge. Secondary outcomes are length of stay, falls and 28 day readmissions. A cost-effectiveness analysis (CEA) and cost-benefit analysis (CBA) will be conducted. The CEA will answer the question of whether the VCPS is more cost-effective compared to treatment as usual; the CBA will consider the rate of return on investing in the VCPS. A patient experience measure (n = 500) and medication adherence questionnaire (n = 100 pre and post) will also be used to identify patient responses to the virtual service. Focus groups will investigate implementation from hospital staff perspectives at each site. Analyses of routine data will comprise generalised linear mixed models. Descriptive statistical analysis will summarise patient experience responses. Differences in medication adherence will be compared using linear regression models. Thematic analysis of focus groups will identify barriers and facilitators to VCPS implementation. DISCUSSION: We aim to demonstrate the effectiveness of virtual pharmacy interventions for rural populations, and inform best practice for using virtual healthcare to improve access to pharmacy services. It is widely recognised that clinical pharmacists are best placed to reduce medication errors. However, pharmacy services are limited in rural and remote hospitals. This project will provide evidence about ways in which the benefits of hospital pharmacists can be maximised utilising telehealth technology. If successful, this project can provide a model for pharmacy delivery in rural and remote locations. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) -ACTRN12619001757101 Prospectively registered on 11 December 2019. Record available from: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378878&isReview=true.

Psychological treatment for methamphetamine use and associated psychiatric symptom outcomes: A systematic review.

BACKGROUND: Regular methamphetamine use is associated with increased rates of psychiatric symptoms. Although there has been a substantial body of research reporting on the effectiveness of psychological treatments for reducing methamphetamine use, there is a paucity of research examining the effects of these treatments on co-occurring psychiatric symptoms. We addressed this gap by undertaking a systematic review of the evidence of the effectiveness of psychological treatments for methamphetamine use on psychiatric symptom outcomes in randomized controlled trials. METHODS: A narrative synthesis of studies was conducted following the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement to inform methodology. Eight electronic peer-reviewed databases were searched. Ten eligible studies were assessed. RESULTS: Most studies found an overall reduction in levels of methamphetamine use and psychiatric symptoms among samples as a whole. Although brief interventions were effective, there is evidence that more intensive interventions have greater impact on methamphetamine use and/or psychiatric symptomatology. Intervention attendance was variable. CONCLUSIONS: The evidence suggests that a variety of psychological treatments are effective in reducing levels of methamphetamine use and improving psychiatric symptoms. Future research should consider how psychological treatments could maximize outcomes in the co-occurring domains of methamphetamine use and psychiatric symptoms, with increasing treatment attendance as a focus. PROSPERO registration number: CRD42016043657.

Aboriginal Wingadhan Birrang (woman's journey) of smoking cessation during pregnancy as they participate in the ICAN QUIT in pregnancy pilot step-wedge trial.

BACKGROUND: Addressing smoking cessation during pregnancy among Aboriginal women is a national priority under the Closing the Gap campaign. There is a need to measure and report interventions to support Aboriginal women during pregnancy. AIM: To quantitatively assess women's smoking experiences over a 12 week ICAN QUIT in Pregnancy program. METHODS: Aboriginal women and/or women expecting an Aboriginal baby reported their smoking experiences through repeated cross-sectional survey at baseline, four weeks, and 12 weeks. Self-reported nicotine dependence measures (heaviness of smoking index, strength of urges and frequency of urges to smoke), intentions to quit smoking, quit attempts, use of nicotine replacement therapy were gathered as well as a carbon-monoxide measure at each time point. RESULTS: Expectant mothers (n=22) of Aboriginal babies participated from six Aboriginal Community Controlled Health Services between November 2016 and July 2017. At 12 weeks women reported (n=17) low heaviness of smoking index 1.21 with high strength of urges 2.64 and frequency of urges 3.00; 12/13 (92%) reported likely/very likely to quit smoking, made a mean 1.67 number of quit attempts, three women (13.6%) quit smoking (validated); 5/16 (31%) reported using nicotine replacement therapy. DISCUSSION: Participating women made multiple quit attempts demonstrating motivation to quit smoking. Smoking cessation interventions should be tailored to address high strength and frequency of nicotine dependence despite low consumption. CONCLUSION: Prolonged smoking cessation support is recommended to address physical, behavioural and psychological aspect of smoking. Cessation support should address previous quitting experiences to assess smoking dependence and tailoring of support. TRIAL REGISTRATION: Australian and New Zealand Clinicial Trials Registry (Ref #ACTRN12616001603404).

Cluster randomised controlled trial of an online intervention to improve healthy food purchases from primary school canteens: a study protocol of the 'click & crunch' trial.

INTRODUCTION: School canteens are the most frequently accessed take-away food outlet by Australian children. The rapid development of online lunch ordering systems for school canteens presents new opportunities to deliver novel public health nutrition interventions to school-aged children. This study aims to assess the effectiveness and cost-effectiveness of a behavioural intervention in reducing the energy, saturated fat, sugar and sodium content of online canteen lunch orders for primary school children. METHODS AND ANALYSIS: The study will employ a cluster randomised controlled trial design. Twenty-six primary schools in New South Wales, Australia, that have an existing online canteen ordering system will be randomised to receive either a multi-strategy behavioural intervention or a control (the standard online canteen ordering system). The intervention will be integrated into the existing online canteen system and will seek to encourage the purchase of healthier food and drinks for school lunch orders (ie, items lower in energy, saturated fat, sugar and sodium). The behavioural intervention will use evidence-based choice architecture strategies to redesign the online menu and ordering system including: menu labelling, placement, prompting and provision of feedback and incentives. The primary trial outcomes will be the mean energy (kilojoules), saturated fat (grams), sugar (grams) and sodium (milligrams) content of lunch orders placed via the online system, and will be assessed 12 months after baseline data collection. ETHICS AND DISSEMINATION: The study was approved by the ethics committees of the University of Newcastle (H-2017-0402) and the New South Wales Department of Education and Communities (SERAP 2018065), and the Catholic Education Office Dioceses of Sydney, Parramatta, Lismore, Maitland-Newcastle, Bathurst, Canberra-Goulburn, Wollongong, Wagga Wagga and Wilcannia-Forbes. Study results will be disseminated through peer-reviewed publications, reports, presentations at relevant national and international conferences and via briefings to key stakeholders. Results will be used to inform future implementation of public health nutrition interventions through school canteens, and may be transferable to other food settings or online systems for ordering food. TRIAL REGISTRATION NUMBER: ACTRN12618000855224.

Cervical muscle volume in individuals with idiopathic neck pain compared to asymptomatic controls: A cross-sectional magnetic resonance imaging study.

BACKGROUND: Neck muscle compositional changes may represent potential biomarkers contributing towards chronic neck-related pain and disability. OBJECTIVES: To determine differences in muscle volume in the cervical muscles of individuals with chronic idiopathic neck pain compared with age- and sex-matched asymptomatic individuals, and to determine if these muscle variables relate to spinal level, side (left or right), age, sex, body mass index (BMI) or muscle strength. STUDY DESIGN: Cross-sectional magnetic resonance imaging (MRI) study. METHODS: Muscle volume of five muscle (groups) from cervical levels C3-T1 in 20 pain and 17 asymptomatic participants were quantified using MRI: levator scapulae, multifidus including semispinalis cervicis, semispinalis, splenius capitus including splenius cervicis, and sternocleidomastoid. Isometric extensor and flexor muscle strength were assessed with a dynamometer. Linear mixed modelling determined differences between groups in muscle volume accounting for participant characteristics. RESULTS: Individuals with pain had greater muscle volume (adjusted mean difference 71.2 mm3 (95% CI 14.2-128.2, p = .015) of the sternocleidomastoid, accounting for spinal level, side, muscle group (extensors vs flexor), sex, age, body mass index and strength. Modelling indicated muscle volume differed between spinal levels (p < .001); greater extensor muscle strength was associated with greater volume (p = .011); female sex (p < .001) and older age (p = .012) were associated with less volume. CONCLUSION: Between-group differences in cervical flexor muscle volume, and volume differences across spinal levels and muscles suggest the contribution of cervical muscles to chronic idiopathic neck pain is multifaceted and complex.

A cluster randomised trial of an intervention to increase the implementation of physical activity practices in secondary schools: study protocol for scaling up the Physical Activity 4 Everyone (PA4E1) program.

BACKGROUND: The implementation of interventions at-scale is required to maximise population health benefits. 'Physical Activity 4 Everyone (PA4E1)' was a multi-component school-based program targeting adolescents attending secondary schools in low socio-economic areas. An efficacy trial of the intervention demonstrated an increase in students' mean minutes of moderate-to-vigorous physical activity (MVPA) per day and lower weight gain at low incremental cost. This study aims to assess the effectiveness and cost effectiveness of a multi-component implementation support intervention to improve implementation, at-scale, of the evidence based school physical activity (PA) practices of the PA4E1 program. Impact on student PA levels and adiposity will also be assessed, in addition to the cost of implementation. METHODS: A cluster randomised controlled trial, utilising an effectiveness-implementation hybrid design, will be conducted in up to 76 secondary schools located in lower socio-economic areas across four health districts in New South Wales (NSW), Australia. Schools will be randomly allocated to a usual practice control arm or a multi-component implementation support intervention to embed the seven school PA practices of the PA4E1 program. The implementation support intervention incorporates seven strategies including executive support, in-School Champion, teacher training, resources, prompts, audit and feedback and access to an external Support Officer. The primary trial outcome will be the proportion of schools meeting at least four of the seven physical activity practices of the program, assessed via surveys with Head Physical Education teachers at 12 and 24-months. Secondary outcomes will be assessed via a nested evaluation of student PA and adiposity at 12-months (Grade 8 students) and 24 months (Grade 9 students) undertaken in 30 schools (15 per group). Resource use associated with the implementation intervention will be measured prospectively. Linear mixed effects regression models will assess program effects on the primary outcome at each follow-up period. DISCUSSION: This study is one of few evidence-based multi-component PA programs scaled-up to a large number of secondary schools and evaluated via randomised controlled trial. The use of implementation science theoretical frameworks to implement the evidence-based program and the rigorous evaluation design are strengths of the study. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017. Protocol Version 1.

Feasibility and acceptability of Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy multicomponent implementation intervention and study design for Australian Indigenous pregnant women: A pilot cluster randomised step-wedge trial.

BACKGROUND: Many health providers (HPs) lack knowledge, confidence, optimism and skills in addressing smoking with pregnant women. This study aimed to explore the feasibility and acceptability of a) a co-designed multi-component intervention for HPs at Aboriginal Medical Services (AMSs) in culturally-targeted pregnancy-specific smoking cessation care and b) the study design. METHODS: Using a randomised step-wedge cluster design, the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy Trial was evaluated across six AMSs in three Australian states. HPs were provided educational resource packages including live interactive webinars, treatment manuals, patient resources, carbon monoxide (CO) meters, and oral Nicotine Replacement Therapy (NRT). Feasibility was assessed through recruitment and retention rates of both pregnant women (12-weeks) and HPs (end of study) as well as the potential to improve women's quit rates. Qualitative interviews with staff post-trial explored acceptability of the intervention and study, based on capability, opportunity and motivation from the Behaviour Change Wheel. RESULTS: Pregnant women (n = 22; 47% (95% CI: 32%, 63%) eligible) and HPs (n = 50; 54% (95% CI: 44%, 64%) eligible) were recruited over 6 months with retention rates of 77% (95% CI: 57%, 90%) and 40% (95% CI: 28%, 54%) respectively. Self-reported 12-week 7-day point-prevalence abstinence was 13.6% (n = 3) and validated abstinent with CO readings ≤6 ppm. Staff interviewed regarding intervention implementation highlighted the importance of provision and use of resources, including training materials, patient resources, CO meters and oral NRT. Resources helped increase capability and opportunity, restructure the environment, and provided social comparison and modelling. Staff were motivated by greater engagement with pregnant women and seeing the women's reductions in CO readings. Having the intervention at the AMSs improved organisational capacity to engage with pregnant women. Staff reported changes to their routine practice that were potentially sustainable. Recommendations for improvement to the implementation of the intervention and research included reducing training length and the tasks related to conducting the study. CONCLUSION: ICAN QUIT in Pregnancy was a pilot study with the ability to enrol Indigenous women. It was feasible to implement and acceptable to most staff of the AMSs in three states, with modifications recommended. Smoking in pregnancy is a key challenge for Indigenous health. The intervention needs to be evaluated through a methodologically rigorous fully-powered study to determine the efficacy of outcomes for women. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12616001603404. Registered 21 November 2016 - retrospectively registered, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371778.

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03).

PURPOSE: Malnutrition in head and neck cancer (HNC) treatment is common and associated with poorer morbidity and mortality outcomes. This trial aimed to improve nutritional status during radiation therapy (RT) using a novel method of training dietitians to deliver psychological techniques to improve nutritional behaviors in patients with HNC. METHODS AND MATERIALS: This trial used a stepped-wedge, randomized controlled design to assess the efficacy of the Eating As Treatment (EAT) program. Based on motivational interviewing and cognitive behavioral therapy, EAT was designed to be delivered by oncology dietitians and integrated into their clinical practice. During control steps, dietitians provided treatment as usual, before being trained in EAT and moving into the intervention phase. The training was principles based and sought to improve behavior-change skills rather than provide specific scripts. Patients recruited to the trial (151 controls, 156 intervention) were assessed at 4 time points (the first and the final weeks of RT, and 4 and 12 weeks afterward). The primary outcome was nutritional status at the end of RT as measured by the Patient-Generated Subjective Global Assessment. RESULTS: Patients who received the EAT intervention had significantly better scores on the primary outcome of nutritional status at the critical end-of-treatment time point (ß = -1.53 [-2.93 to -.13], P = .03). Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life. Although results were not statistically significant, patients who received the intervention had fewer and shorter unplanned hospital admissions. CONCLUSIONS: This trial is the first of its kind to demonstrate the effectiveness of a psychological intervention to improve nutrition in patients with HNC who are receiving RT. The intervention provides a means to ameliorate malnutrition and the important related outcomes and consequently should be incorporated into standard care for patients receiving RT for HNC.

Short-term androgen suppression and radiotherapy versus intermediate-term androgen suppression and radiotherapy, with or without zoledronic acid, in men with locally advanced prostate cancer (TROG 03.04 RADAR): 10-year results from a randomised, phase 3, factorial trial.

BACKGROUND: The optimal duration of androgen suppression for men with locally advanced prostate cancer receiving radiotherapy with curative intent is yet to be defined. Zoledronic acid is effective in preventing androgen suppression-induced bone loss, but its role in preventing castration-sensitive bone metastases in locally advanced prostate cancer is unclear. The RADAR trial assessed whether the addition of 12 months of adjuvant androgen suppression, 18 months of zoledronic acid, or both, can improve outcomes in men with locally advanced prostate cancer who receive 6 months of androgen suppression and prostatic radiotherapy. This report presents 10-year outcomes from this trial. METHODS: For this randomised, phase 3, 2 × 2 factorial trial, eligible men were 18 years or older with locally advanced prostate cancer (either T2b-4, N0 M0 tumours or T2a, N0 M0 tumours provided Gleason score was ≥7 and baseline prostate-specific antigen [PSA] concentration was ≥10 µg/L). We randomly allocated participants in a 2 × 2 factorial design by computer-generated randomisation (using the minimisation technique, and stratified by centre, baseline PSA concentration, clinical tumour stage, Gleason score, and use of a brachytherapy boost) in a 1:1:1:1 ratio to four treatment groups. Patients in the control group received 6 months of neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) and radiotherapy alone (short-term androgen suppression [STAS]); this treatment was either followed by another 12 months of adjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly; intermediate-term androgen suppression [ITAS]), or accompanied by 18 months of zoledronic acid (4 mg every 3 months, intravenously) starting at randomisation (STAS plus zoledronic acid), or both (ITAS plus zoledronic acid). All patients received radiotherapy to the prostate and seminal vesicles, starting from the end of the fifth month of androgen suppression; dosing options were 66, 70, and 74 Gy in 2-Gy fractions per day, or 46 Gy in 2-Gy fractions followed by a high-dose-rate brachytherapy boost dose of 19·5 Gy in 6·5-Gy fractions. Treatment allocation was open label. The primary endpoint was prostate cancer-specific mortality and was analysed according to intention-to-treat using competing-risks methods. The trial is closed to follow-up and this is the final report of the main endpoints. This trial is registered with ClinicalTrials.gov, number NCT00193856. FINDINGS: Between Oct 20, 2003, and Aug 15, 2007, 1071 men were enrolled and randomly assigned to STAS (n=268), ITAS (n=268), STAS plus zoledronic acid (n=268), and ITAS plus zoledronic acid (n=267). Median follow-up was 10·4 years (IQR 7·9-11·7). At this 10-year follow-up, no interactions were observed between androgen suppression and zoledronic acid so the treatment groups were collapsed to compare treatments according to duration of androgen suppression: 6 months of androgen suppression plus radiotherapy (6AS+RT) versus 18 months of androgen suppression plus radiotherapy (18AS+RT) and to compare treatments according to whether or not patients received zoledronic acid. The total number of deaths was 375 (200 men receiving 6AS+RT and 175 men receiving 18AS+RT), of which 143 (38%) were attributable to prostate cancer (81 men receiving 6AS+RT and 62 men receiving 18AS+RT). When analysed by duration of androgen suppression, the adjusted cumulative incidence of prostate cancer-specific mortality was 13·3% (95% CI 10·3-16·0) for 6AS+RT versus 9·7% (7·3-12·0) for 18AS+RT, representing an absolute difference of 3·7% (95% CI 0·3-7·1; sub-hazard ratio [sHR] 0·70 [95% CI 0·50-0·98], adjusted p=0·035). The addition of zoledronic acid did not affect prostate cancer-specific mortality; the adjusted cumulative incidence of prostate cancer-specific mortality was 11·2% (95% CI 8·7-13·7) with zoledronic acid vs 11·7% (9·2-14·1) without, representing an absolute difference of -0·5% (95% CI -3·8 to 2·9; sHR 0·95 [95% CI 0·69-1·32], adjusted p=0·78). Although safety analysis was not prespecified for this 10-year analysis, one new serious adverse event (osteonecrosis of the mandible, in a patient who received 18 months of androgen suppression plus zoledronic acid) occurred since our previous report, bringing the total number of cases of this serious adverse event to three (<1% out of 530 patients who received zoledronic acid evaluated for safety) and the total number of drug-related serious adverse events to 12 (1% out of all 1065 patients evaluable for safety). No treatment-related deaths occurred during the study. INTERPRETATION: 18 months of androgen suppression plus radiotherapy is a more effective treatment option for locally advanced prostate cancer than 6 months of androgen suppression plus radiotherapy, but the addition of zoledronic acid to this treatment regimen is not beneficial. Evidence from the RADAR and French Canadian Prostate Cancer Study IV trials suggests that 18 months of androgen suppression with moderate radiation dose escalation is an effective but more tolerable option than longer durations of androgen suppression for men with locally advanced prostate cancer including intermediate and high risk elements. FUNDING: National Health and Medical Research Council of Australia, Novartis Pharmaceuticals Australia, AbbVie Pharmaceuticals Australia, New Zealand Health Research Council, New Zealand Cancer Society, Cancer Standards Institute New Zealand, University of Newcastle (Australia), Hunter Medical Research Institute, Calvary Mater Newcastle Radiation Oncology Fund, and Maitland Cancer Appeal.

A prolonged antibiotic protocol to treat persistent Chlamydophila pneumoniae infection improves the extracranial venous circulation in multiple sclerosis.

Objective Chronic cerebrospinal venous insufficiency (CCSVI) is a condition associated with multiple sclerosis (MS). One mechanism that has been proposed is that the venous obstructions found in MS are due to a chronic persistent venulitis caused by the intra-cellular bacterial parasite, Chlamydophila pneumoniae (Cpn). The objective of the current study is to determine the effect of a combined antibiotic protocol (CAP) on the venous flow in MS patients as measured by a quantitative duplex ultrasound examination (QDUS). Method A non-randomised before-after cohort study was conducted to investigate differences in blood flow volumes pre and 6-months post antibiotic treatment for Cpn infection. Flow volume data were measured by QDUS across affected and unaffected sides from multiple veins segments, including internal jugular vein (IJV) segments J2 and J3, and vertebral vein (VV), as well as global arterial blood flow (GABF). Results 91 patients were included in the study. 64 (70%) were found to have positive Cpn serology. There was a statistically significant post-treatment difference seen for the affected side of Cpn infected patients (mean difference = 56 mL/min, p = 0.02). There was a non-significant increase seen for the affected side of uninfected patients (mean difference = 23 mL/min, p = 0.2). The difference in these effects (34 mL/min) was not statistically significant ( p = 0.3). The mean flow rate decreased in the unaffected side for both infected (-27 mL/min, p = 0.5) and uninfected patients (-69 mL/min, p = 0.01). There was a statistically significant post-treatment increase in GABF for the infected patients (mean difference = 90 mL/min, p = 0.02) and a difference of 76 mL/min for non-infected patients ( p = 0.01). Conclusion A CAP appears to improve the extra-cranial circulation in patients diagnosed with MS. This effect is statistically significant in patients with positive Cpn serology, although patients with negative Cpn serology also show some benefit, betraying a lack of specificity of this effect.

The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Pilot Study protocol: a feasibility step-wedge cluster randomised trial to improve health providers' management of smoking during pregnancy.

INTRODUCTION: Indigenous women have the highest smoking prevalence during pregnancy (47%) in Australia. Health professionals report lack of knowledge, skills and confidence to effectively manage smoking among pregnant women in general. We developed a behaviour change intervention aimed to improve health professionals' management of smoking in Indigenous pregnant women-the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy. This intervention includes webinar training for health professionals, an educational resources package for health professionals and pregnant women, free oral nicotine replacement therapy (NRT) for pregnant women, and audit and feedback on health professionals' performance.The aim of this study is to test the feasibility and acceptability of the ICAN QUIT in Pregnancy intervention to improve health professionals' provision of evidence-based culturally responsive smoking cessation care to Australian Indigenous pregnant smokers. METHODS AND ANALYSIS: This protocol describes the design of a step-wedge cluster randomised pilot study. Six Aboriginal Medical Services (AMSs) are randomised into three clusters. Clusters receive the intervention staggered by 1 month. Health professionals report on their knowledge and skills pretraining and post-training and at the end of the study. Pregnant women are recruited and followed up for 3 months. The primary outcome is the recruitment rate of pregnant women. Secondary outcomes include feasibility of recruitment and follow-up of participating women, and webinar training of health professionals, measured using a designated log; and measures of effectiveness outcomes, including quit rates and NRT prescription rates. ETHICS AND DISSEMINATION: In accordance with the Aboriginal Health and Medical Research Council guidelines, this study has been developed in collaboration with a Stakeholder and Consumer Aboriginal Advisory Panel (SCAAP). The SCAAP provides cultural consultation, advice and direction to ensure that implementation is acceptable and respectful to the Aboriginal communities involved. Results will be disseminated to AMSs, Aboriginal communities and national Aboriginal bodies. REGISTRATION DETAILS: This protocol (version 4, 14 October 2016) is registered with the Australian and New Zealand Clinical Trials Registry (Ref #: ACTRN12616001603404).