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Background: A growing body of evidence suggest an association between physical activity levels and students psychological well-being. A number of research studies have evaluated playground interventions that aim to increase physical activity levels, decrease conflict and bullying, and improve students behaviour. The HAPPY Study will evaluate the success of an intervention combining environmental modifications, teacher development, and peer support that can culminate in an easy to implement, low cost and effective model for increasing physical activity, and improving psychological well-being for children.Methods/design: Data will be collected at six New South Wales (NSW) primary schools, on physical activity levels, on-task time during classes, and social support for physical activity during a 12 month Cluster Controlled Trial (CT). Three quantitative data collection tools will be used to capture student's physical activity levels during lunch and recess breaks (the SOPARC tool), student's on-task behaviour during classes following recess and lunch breaks (the BOSS tool) and where students receive the most encouragement to be physically active from (the Physical Activity Social Support Scale survey). Baseline data will be analysed against follow-up data, collected after an intervention that is rolled out in all schools as part of a stepped wedge CT design.Discussion: A review of relevant Australian and New Zealand literature suggests that playground interventions can be successful at increasing physical activity levels, increasing social and conflict resolution skills in students, and decreasing incidences of bullying. This study will investigate any correlation between physical activity levels, and student behaviour during classes following breaks.Trial Registration: Australian and New Zealand Clinical Trials Register ACTRN12616000575437 , registered May 2016. [ABSTRACT FROM AUTHOR]

Background: Engagement and partnership with consumers and communities throughout research processes produces high quality research meeting community needs and promoting translation of research into improved policy and practice. Partnership is critical in research involving Aboriginal and/or Torres Strait Islander people (First Nations Peoples) to ensure cultural safety. We present lessons from the design, implementation and progress of the National Health and Medical Research Council funded INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on hemodialysis (INFERR) clinical trial. Main body: The trial was designed to understand the benefits and harms of iron therapy in First Nations Australians on haemodialysis with anaemia and hyperferritinaemia. The lack of evidence for treatment was discussed with patients who were potential participants. A key element ensuring safe conduct of the INFERR trial was the establishment of the Indigenous Reference Groups (IRGs) comprising of dialysis patients based in the Top End of Australia and Central Australia. Two IRGs were needed based on advice from First Nations communities and researchers/academics on the project regarding local cultural differences and approaches to trial conduct. The IRGs underpin culturally safe trial conduct by providing input into study materials and translating study findings into effective messages and policies for First Nations dialysis patients. Throughout the trial conduct, the IRGs' role has developed to provide key mechanisms for advice and guidance regarding research conduct both in this study and more broadly. Support provided to the IRGs by trial First Nations Research Officers and independent First Nations researchers/academics who simplify research concepts is critical. The IRGs have developed feedback documents and processes to participants, stakeholders, and the renal units. They guarantee culturally safe advice for embedding findings from the trial into clinical practice guidelines ensuring evidence-based approaches in managing anaemia in haemodialysis patients with hyperferritinaemia. Conclusion: Active consumer and community partnership is critical in research conduct to ensure research impact. Strong partnership with consumers in the INFERR clinical trial has demonstrated that First Nations Consumers will engage in research they understand, that addresses health priorities for them and where they feel respected, listened to, and empowered to achieve change. Plain English summary: In this paper, we present the importance of actively involving consumers in the planning, implementation and conduct of research using the example of a clinical trial among Aboriginal and/or Torres Strait Australians (First Nations Australians) who have kidney disease and are currently receiving haemodialysis. The study assesses how safe and effective it is for people on dialysis to receive iron given through the vein during dialysis when they have anaemia and high levels of a blood test called ferritin, a test used routinely to measure iron levels. Two consumer reference groups of First Nations patients on dialysis, one based in the Top End of Australia and the other based in Central Australia, are supported by First Nations Research Officers and Research Academics to make sure that the research is performed in a way that involves, respects and values First Nations participation, culture, and knowledge. Active consumer and community partnership in this study has supported robust research governance processes which we believe are crucial for knowledge translation to have a positive impact for patients. [ABSTRACT FROM AUTHOR]

Background: Mild cognitive impairment (MCI) is commonly defined as a transitional subclinical state between normal aging and dementia. A growing body of research indicates that health behaviors may play a protective role against cognitive decline and could potentially slow down the progression from MCI to dementia. The aim of this study is to conduct a bibliometric analysis of literature focusing on health behaviors and MCI to summarize the factors and evidence regarding the influence of health behaviors on MCI. Methods: The study performed a bibliometric analysis by retrieving publications from the Science Citation Index and Social Sciences Citation Index subdatabases within the Web of Science Core Collection. Utilizing VOSviewer and CiteSpace software, a total of 2,843 eligible articles underwent co-citation, cokeywords, and clustering analyses. This methodology aimed to investigate the current status, trends, major research questions, and potential future directions within the research domain. Results: The bibliometric analysis indicates that research on healthy behaviors in individuals with MCI originated in 2002 and experienced rapid growth in 2014, reflecting the increasing global interest in this area. The United States emerged as the primary contributor, accounting for more than one-third of the total scientific output with 982 articles. Journals that published the most articles on MCI-related health behaviors included "Journal of Alzheimer's Disease," "Neurobiology of Aging," "Frontiers in Aging Neuroscience," and other geriatricsrelated journals. High-impact papers identified by VOSviewer predominantly cover concepts related to MCI, such as diagnostic criteria, assessment, and multifactorial interventions. Co-occurrence keyword analysis highlights five research hotspots in health behavior associated with MCI: exercise, diet, risk factors and preventive measures for dementia, cognitive decline-related biomarkers, and clinical trials. Conclusion: This study provides a comprehensive review of literature on health behavior in individuals with MCI, emphasizing influential documents and journals. It outlines research trends and key focal points, offering valuable insights for researchers to comprehend significant contributions and steer future studies. [ABSTRACT FROM AUTHOR]

In 2018, the Australian Dementia Network (ADNeT) was established to bring together Australia's leading dementia researchers, people with living experience and clinicians to transform research and clinical care in the field. To address dementia diagnosis, treatment, and care, ADNeT has established three core initiatives: the Clinical Quality Registry (CQR), Memory Clinics, and Screening for Trials. Collectively, the initiatives have developed an integrated clinical and research community, driving practice excellence in this field, leading to novel innovations in diagnostics, clinical care, professional development, quality and harmonization of healthcare, clinical trials, and translation of research into practice. Australia now has a national Registry for Mild Cognitive Impairment and dementia with 55 participating clinical sites, an extensive map of memory clinic services, national Memory and Cognition Clinic Guidelines and specialized screening for trials sites in five states. This paper provides an overview of ADNeT's achievements to date and future directions. With the increase in dementia cases expected over coming decades, and with recent advances in plasma biomarkers and amyloid lowering therapies, the nationally coordinated initiatives and partnerships ADNeT has established are critical for increased national prevention efforts, co-ordinated implementation of emerging treatments for Alzheimer's disease, innovation of early and accurate diagnosis, driving continuous improvements in clinical care and patient outcome and access to post-diagnostic support and clinical trials. For a heterogenous disorder such as dementia, which is now the second leading cause of death in Australia following cardiovascular disease, the case for adequate investment into research and development has grown even more compelling. [ABSTRACT FROM AUTHOR]

Addressing respect, gender equity and gender-based violence in schools has a long history. Renewed government efforts to address gender-based violence in schools through a whole school approach have commenced under the umbrella 'respectful relationships education'. The research presented in this paper is nestled within a larger project aimed to evaluate the implementation and impact of a whole school approach to respectful relationships education across two Australian states (Our Watch, forthcoming). The purpose of this paper is to examine the effects of a six-month respectful relationships education program on the gender awareness and bias of early primary school students. Using a single group pre-post test research design, students from two primary schools in Australia completed a survey before (n = 202) and after (n = 217) completion of a respectful relationships education pilot program. A modified version of the Children's Occupation, Activities, and Traits-Attitudes Measure (COAT-AM; Liben and Bigler, 2002) and the Children's Occupation, Activities, and Traits-Personal Measure (COAT-PM; Liben and Bigler, 2002) were used to assess students' views about gender. After the pilot, boys and girls were significantly less likely to consider stereotypically masculine occupations and activities as only for boys and stereotypically feminine occupations and activities as only for girls. Results indicate that ongoing respectful relationships education could be an effective way to disrupt gender stereotyping in early primary school students. [ABSTRACT FROM AUTHOR]

Background: Despite Government investment, disparity in access to clinical trials continue between metropolitan and regional & rural sectors (RRR) in Australia and around the world. To improve trial access closer to home for RRR communities and rare cancer patients even in metro settings, the Australasian Teletrial Model (ATM) was developed by Clinical Oncology Society of Australia and implemented in four states. Aim of this paper is to describe the steps and processes involved in the development and implementation of ATM guided by implementation science frameworks. Method: Two implementation science frameworks namely iPARIHS and Strategic Implementation Framework were chosen to guide the project. Details of steps and processes were extracted from COSA final report. Results: ATM met the criteria for worthy innovation. For the development and implementation of the ATM, stakeholders were at national, statewide and clinical levels. A co-design with end-users and inclusion of key stakeholders in steering committees and advisory groups made the implementation smoother. Clinician levers including advocacy were useful to overcome system barriers. During the project, more patients, and clinicians at RRR participated in trials, more primary sites collaborated with RRR sites and more RRR sites gained trial capabilities. Conclusion: Pilot project achieved its objectives including improved access to patients locally, creation of linkages between metro and RRR sites and enhanced capabilities of and access to RRR sites. Implementation science frameworks were useful for identifying the necessary steps and processes at the outset. Ownership by governments and creation of streamlined regulatory systems would enable broader adoption. [ABSTRACT FROM AUTHOR]

Fatigue jeopardises soldiers' lives, and despite caffeine being the approved wakefulness aid in the Australian Defence Force (ADF), its efficacy equals a placebo with unwanted side effects. The US Military uses modafinil as an alternative, but no ADF studies on modafinil exist. This article argues for exploring alternatives, ensuring consent and conducting willingness-to-participate studies before conducting ADF modafinil trials. [ABSTRACT FROM AUTHOR]

The notion of a learning healthcare system (LHS) is gaining traction to advance the objectives of high-quality patient-centred care. Within such a system, real-world data analysis, clinical research and health service research are core activities of the health system. To support the transition to an LHS, the Australian Government is implementing the National Clinical Trials Governance Framework, which extends health service accreditation standards to the conduct of clinical trials. This initiative encourages the integration of clinical trials into clinical care and the fostering of a culture of continuous improvement. However, implementing this initiative may prove challenging if health system leaders, clinicians and patients fail to recognise the value of clinical trials as a core health system activity. In this article we describe the enduring value of clinical trials and how the COVID-19 pandemic has enhanced their value by addressing longstanding deficiencies in the way trials are conducted. We also summarise best-practice advice on the embedding of trials into routine health care to enable their integration into health system operations. What is known about this topic?: Many healthcare organisations seek to transition to a learning health system. In Australia, National Safety and Quality Health Service Standards, which support the embedding of clinical trials as a core health system activity, have been implemented to catalyse the move. What does this paper add?: Because there is little practical advice on how to embed clinical trials into health system operations, this paper summarises best practice. It also provides a rationale for embedding trials as a core health system activity, because the creation of a strong research culture is an important determinant of success. What are the implications for practitioners?: The successful transition to an LHS would significantly advance the goals of value-based care. [ABSTRACT FROM AUTHOR]

Background: Dysarthria after stroke is when speech intelligibility is impaired, and this occurs in half of all stroke survivors. Dysarthria often leads to social isolation, poor psychological well-being and can prevent return to work and social lives. Currently, a variety of outcome measures are used in clinical research and practice when monitoring recovery for people who have dysarthria. When research studies use different measures, it is impossible to compare results from trials and delays our understanding of effective clinical treatments. The aim of this study is to develop a core outcome set (COS) to agree what aspects of speech recovery should be measured for dysarthria after stroke (COS-Speech) in research and clinical practice. Methods: The COS-Speech study will include five steps: (1) development of a long list of possible outcome domains of speech that should be measured to guide the survey; (2) recruitment to the COS-Speech study of three key stakeholder groups in the UK and Australia: stroke survivors, communication researchers and speech and language therapists/pathologists; (3) two rounds of the Delphi survey process; (4) a consensus meeting to agree the speech outcomes to be measured and a follow-up consensus meeting to match existing instruments/measures (from parallel systematic review) to the agreed COS-Speech; (5) dissemination of COS-Speech. Discussion: There is currently no COS for dysarthria after stroke for research trials or clinical practice. The findings from this research study will be a minimum COS, for use in all dysarthria research studies and clinical practice looking at post-stroke recovery of speech. These findings will be widely disseminated using professional and patient networks, research and clinical forums as well as using a variety of academic papers, videos, accessible writing such as blogs and links on social media. Trial registration: COS-Speech is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, October 2021 https://www.comet-initiative.org/Studies/Details/1959. In addition, "A systematic review of the psychometric properties and clinical utility of instruments measuring dysarthria after stroke" will inform the consensus meeting to match measures to COS-Speech. The protocol for the systematic reviews registered with the International Prospective Register of Systematic Reviews. PROSPERO registration number: CRD42022302998. [ABSTRACT FROM AUTHOR]

Background: Formative online multiple‐choice tests are ubiquitous in higher education and potentially powerful learning tools. However, commonly used feedback approaches in online multiple‐choice tests can discourage meaningful engagement and enable strategies, such as trial‐and‐error, that circumvent intended learning outcomes. These strategies will not prepare graduates as self‐regulated learners, nor for the complexities of contemporary work settings. Objectives: To investigate whether providing only a score after formative online multiple‐choice test attempts (score‐only feedback) increases the likelihood of students to engage in self‐regulated learning compared with more directive feedback. Measurable outcomes included deeper learning, collaboration, information seeking, and satisfaction. Methods: Data in this mixed methods study were collected from nursing students through surveys, test results, focus groups, and student discussion board contributions. A quasi‐experimental design was used for quantitative data, and qualitative data were analysed thematically against domains of self‐regulated learning. Results and Conclusions: Students receiving score‐only feedback were more cognitively engaged with the content, collaborated constructively, and sought out richer sources of information. However, it was also associated with lower satisfaction. In this study, minimal feedback created states of uncertainty, which resulted in the activation of self‐regulatory actions. Implications for Practice: Providing overly directive feedback for formative online multiple‐choice tests is conducive to surface‐level learning strategies. By minimising feedback and allowing for extended states of uncertainty, students are more likely to regulate their learning through self‐assessment and problem‐solving strategies, all of which are required by graduates to meet the challenges of real‐world work settings. Lay Description: What is already known about this topic: Formative online multiple‐choice tests are widely used in higher education.Feedback is a critical element in the design of effective online multiple‐choice tests.Formative feedback should promote self‐regulated learning.Feedback types used in multiple‐choice tests facilitate strategies not conducive to self‐regulation. What this paper adds: Online multiple‐choice test feedback can influence how students self‐regulate their learning.Less feedback can result in greater self‐evaluation and performance in summative assessment.Less feedback can encourage richer help‐seeking strategies (collaboration and information seeking).However, less feedback can result in student dissatisfaction. Implications for practice and/or policy: Judicious use of feedback is required in the design of online multiple‐choice tests.Educators should consider providing less feedback to promote learner self‐regulation.Satisfaction with online multiple‐choice tests does not necessarily equate to greater learning. [ABSTRACT FROM AUTHOR]

Objective: To determine the effectiveness and safety of erenumab in patients with chronic migraine in the real‐world setting of 3 headache centers in Australia. Methods: Patients with migraine were prescribed erenumab (70 or 140 mg) in the setting of either a product familiarization program or paid access to the medication in 3 headache centers in Australia. We obtained baseline and monthly prospective data on monthly headache days, monthly migraine days, monthly triptan use days, monthly codeine use days, Headache Impact Test‐6 scores, and adverse reactions. In this paper, we present our data at 3 and 6 months in our subgroup of patients with chronic migraine with and without medication overuse. Results: A total of 170 patients with chronic migraine were prescribed erenumab in the 3 headache centers. At 3 months, 100/170 (58.8%) had 50% or greater reduction in monthly migraine days. At 6 months, 79/170 (46.5%) had 50% or greater reduction in monthly migraine days. At 6 months, there was a mean reduction in monthly headache days of 9.2 days, a mean reduction in monthly migraine days of 10.2 days. There were few adverse events reported. Conclusion: This is the first report from 3 Australian headache centers about erenumab in the real world. Our analysis has supported erenumab as an effective and well‐tolerated migraine preventative therapy for patients with chronic migraine who have failed many preventative therapies. [ABSTRACT FROM AUTHOR]

Background: Recruitment for randomised controlled trials in palliative care can be challenging; disease progression and terminal illness underpin high rates of attrition. Research into participant decision-making in medicinal cannabis randomised controlled trials (RCTs) is very limited. Nesting qualitative sub-studies within RCTs can identify further challenges to participation, informing revisions to study designs and recruitment practices. This paper reports on findings from a qualitative sub-study supporting RCTs of medicinal cannabis for symptom burden relief in patients with advanced cancer in one Australian city.Methods: Semi-structured qualitative interviews were conducted with 48 patients with advanced cancer, eligible to participate in a medicinal cannabis RCT (n=28 who consented to participate in an RCT; n=20 who declined). An iterative and abductive approach to thematic analysis and data collection fostered exploration of barriers and enablers to participation.Results: Key enablers included participants' enthusiasm and expectations of medicinal cannabis as beneficial (to themselves and future patients) for symptom management, especially after exhausting currently approved options, and a safer alternative to opioids. Some believed medicinal cannabis to have anti-cancer effects. Barriers to participation were the logistical challenges of participating (especially due to driving restrictions and fatigue), reluctance to interfere with an existing care plan, cost, and concerns about receiving the placebo and the uncertainty of the benefit. Some declined due to concerns about side-effects or a desire to continue accessing cannabis independent of the study.Conclusions: The findings support revisions to subsequent medicinal cannabis RCT study designs, namely, omitting a requirement that participants attend weekly hospital appointments. These findings highlight the value of embedding qualitative sub-studies into RCTs. While some challenges to RCT recruitment are universal, others are context (population, intervention, location) specific. A barrier to participation found in research conducted elsewhere-stigma-was not identified in the current study. Thus, findings have important implications for those undertaking RCTs in the rapidly developing context of medical cannabis. [ABSTRACT FROM AUTHOR]

This paper presents findings from the evaluation of an Australian trial of self‐managed home aged care. The self‐management model was codesigned by advocacy organisation COTA Australia, consumers and service providers. The primary aim of the evaluation was to examine whether self‐management improved consumers' perceptions of their choice, control, and wellbeing. The secondary aim was to examine whether provider prior experience with self‐managed packages significantly influenced consumers' perceptions of choice, control and wellbeing, thereby confounded trial effects. A pre‐test post‐test quasi‐experimental design and mixed‐methods design were used to collect data over nine months in 2018–2019. The pre‐trial methods and findings have been published. The post‐trial evaluation replicated the pre‐trial data collection method of an online survey (n = 60) and semi‐structured telephone interviews with consumers (n = 9), family carers (n = 13), and consumers and carers jointly (n = 2), totalling 24 interviews. Semi‐structured telephone interviews were also conducted with CEOs and senior managers from each of the seven providers (n = 14). Three providers had prior experience supporting self‐management. Parametric and non‐parametric tests examined the statistical data. Qualitative data were analysed thematically and framed according to self‐determination principles and ecological systems theory. Both datasets demonstrated that consumers reported greater choice and control at post‐trial than pre‐trial. This finding was not affected by providers' prior experience with self‐management; therefore, it was not a confounding factor. Participants reported improved wellbeing in interviews, however this was not reinforced statistically. Key desirable features of self‐management included greater autonomy and control over spending, recruiting support staff and paying lower administration fees. There was no evidence of increased risks or fraud. The research limitations included a small sample size, convenience sampling with providers recruiting interview participants, no control group and differences in trial implementation. The findings support the expansion of self‐management opportunities and more comprehensive evaluations that use mixed methods. [ABSTRACT FROM AUTHOR]

Purpose: This paper aims to examine student exercise physiologists (EPs) and student dietitians' confidence regarding working with people with severe mental illness (SMI) pre- and post-practicum in a mental health service. Design/methodology/approach: This single-arm, quality improvement project included students completing practicum within a lifestyle programme embedded in mental health services. Student EPs completed 100 h of practicum across 15 weeks as part requirement for their Bachelor of Exercise Physiology degree and student dietitians completed six weeks full-time (40 h/week) for the part requirement of their Master of Nutrition and Dietetics. Students completed the Dietetic Confidence Scale (terminology was adapted for student EPs) pre- and post-practicum. Findings: In total, 27 student EPs and 13 student dietitians completed placement and returned pre- and post-practicum questionnaires. Pre-practicum confidence scores were 90.8 ± 17.1 and 86.9 ± 18.9 out of a possible 140 points for student EPs and student dietitians, respectively. Confidence scores increased substantially post-practicum for both student EPs [mean difference (MD) = 29.3 ± 18.8, p < 0.001, d = 1.56] and dietitian students (MD = 26.1 ± 15.9, p = 0.002, d = 1.64). There were significant improvements in confidence across all domains of the confidence questionnaire for both EPs and dietitian students. Originality/value: There is a research gap in understanding the confidence levels of student EPs' and student dietitians' when working with people with mental illness and the impact that undertaking a practicum in a mental health setting may play. To the best of the authors' knowledge, this is the first study to explore student EP and student dietitian confidence in working with people with SMI pre- and post-practicum in a mental health setting. [ABSTRACT FROM AUTHOR]

Background: The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability.Methods: Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019.Results: Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map.Conclusions: The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.Trial Registration: This review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register. [ABSTRACT FROM AUTHOR]

There are good theoretical and empirical grounds to suggest that personal practices (PPs; e.g., self‐practice/self‐reflection [SP/SR] programmes, meditation programmes and personal therapy) can have a positive impact on therapist skills and client outcomes. However, to date, a weakness in many PP studies is the lack of cohort control groups. The two pilot studies reported in this paper examined SP/SR programmes integrated into postgraduate psychology training and are the first to include cohort control groups. Study 1 compared outcomes of students assigned to either SP/SR (n = 17) or a cognitive behaviour therapy (CBT) book study group (n = 13) during their first clinical placement. Study 2 compared outcomes of students who completed the SP/SR programme as part of CBT training (n = 12) with participants who completed the same CBT training in the previous year without an SP/SR programme (n = 17). Significant improvements in therapist confidence for the SP/SR groups were found in both studies. Study 2 also showed significantly higher therapist self‐awareness and lower burnout scores in the SP/SR group. These studies are limited by their small sample size and the lack of random allocation. Nevertheless, they provide preliminary empirical evidence demonstrating large effects of PP on trainees' personal and therapist selves and offer a basis for further research using randomized controlled designs with larger sample sizes. [ABSTRACT FROM AUTHOR]

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Many fields of medicine have benefitted from the formation of clinical trials networks, whereby researchers come together on a large scale to identify high-priority questions and implement coordinated clinical trials. Clinical trials networks in the field of mental health, however, have been rare and largely absent from the Australian context. Here, we present an overview of the newly formed Growing Minds Australia Clinical Trials Network, which represents the first comprehensive clinical trials network in child and youth mental health in Australia. The 60 principal members of the Growing Minds Australia Clinical Trials Network represent teams across 19 diverse areas related to specific forms of psychopathology (e.g. internalising, externalising, neurodevelopmental disorders, early psychosis, substance use), specific research methods and processes (e.g. health economics, eHealth, implementation science) and specialised areas of practice (e.g. school-based systems, parenting interventions, Indigenous mental health, refugee families). Core functions of the Growing Minds Australia Clinical Trials Network include collaborative trial protocol development; peer review, prioritisation and endorsement of proposed trials; training; development of clinical guidelines; and consumer representation. The research by the clinical trials network will encompass the populations typically accessing youth mental health services, while placing a key emphasis on the early periods of life, and the role of parents and caregivers as critical partners in the co-design of research and the delivery of intervention and prevention strategies. The structures and processes built into the network are designed to coordinate collaboration between diverse stakeholders and ensure that provisions for translation are integrated into research from the outset. In this paper, we examine the potential for a dedicated clinical trials network to initiate fundamental improvement in child and youth mental health systems, and discuss the unique and complex challenges associated with establishing such an initiative. [ABSTRACT FROM AUTHOR]

The Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network was formed to build capacity and infrastructure for high‐quality musculoskeletal clinical trials in our region. The purpose of this paper is to describe the steps taken in its formation to help others interested in establishing similar networks. In particular, we describe the steps taken to form the collaboration and our progress in achieving our vision and mission. Our aim is to focus on trials of highest importance and quality to provide definitive answers to the most pressing questions in our field. [ABSTRACT FROM AUTHOR]

Background: The paper examines the key issues experienced in recruiting and retaining practice involvement in a large complex intervention trial in Australian General Practice Methods: Reflective notes made by research staff and telephone interviews with staff from general practices which expressed interest, took part or withdrew from a trial of a complex general practice intervention. Results: Recruitment and retention difficulties were due to factors inherent in the demands and context of general practice, the degree of engagement of primary care organisations (Divisions of General Practice), perceived benefits by practices, the design of the trial and the timing and complexity of data collection, Conclusion: There needs to be clearer articulation to practices of the benefits of the research to participants and streamlining of the design and processes of data collection and intervention to fit in with their work practices. Ultimately deeper engagement may require additional funding and ongoing participation through practice research networks. [ABSTRACT FROM AUTHOR]

Background: In Australia, clinical trial drugs are conventionally dispensed through clinical trial pharmacies only, while community pharmacies dispense drugs approved by Australia's regulatory body. A large HIV pre-exposure prophylaxis study aimed to deliver clinical trial drug through community pharmacies to improve convenience and mimic real world prescribing. This paper describes the process of making community trials compliant with good clinical practice and reports outcomes of delivering clinical trial drug through community pharmacies. Methods: Eight community and four clinical trial pharmacies across three Australian states were approached to participate. A good clinical practice checklist was generated and pharmacies underwent a number of changes to meet clinical trial pharmacy requirements prior to study opening. Changes were made to community pharmacies to make them compliant with good clinical trial practice including; staff training, structural changes, and implementing monitoring of study drug and prescribing practices. Study drug was ordered through standard clinical trial processes and dispensed from study pharmacies by accredited pharmacists. Throughout the trial, record logs for training, prescriber signature and delegation, temperature, participant, and drug accountability were maintained at each pharmacy. The study team monitored each log and delivered on-site training to correct protocol variations. Results: Each pharmacy that was approached agreed to participate. All community pharmacies achieved good clinical practice compliance prior to dispensing study drug. Over the course of the study, 20,152 dispensations of study drug occurred, 83% of these occurred at community pharmacies. Only 2.0% of dispensations had an error, and errors were predominantly minor. On five occasions a pharmacist who was not accredited dispensed study drug. Conclusions: Community based pharmacies can undergo training and modifications to achieve good clinical practice compliance and dispense clinical trial study drug. Community based pharmacies recorded few variations from study protocol. Community based pharmacies offer a useful alternative to clinical trial pharmacies to increase convenience for study participants and expanded use of these pharmacies should be considered for large clinical trials, including HIV prevention trials. [ABSTRACT FROM AUTHOR]

Background: Outpatient chemotherapy is a core treatment for haematological malignancies; however, its toxicities frequently lead to distressing/potentially life-threatening side-effects (neutropenia/infection, nausea/vomiting, mucositis, constipation/diarrhoea, fatigue). Early detection/management of side-effects is vital to improve patient outcomes, decrease morbidity and limit lengthy/costly hospital admissions. The ability to capture patient-reported health data in real-time, is regarded as the 'gold-standard' to allow rapid clinical decision-making/intervention. This paper presents the protocol for a Phase 3 multi-site randomised controlled trial evaluating a novel nurse-led Telehealth intervention for remote monitoring/management of chemotherapy side-effects in Australian haematological cancer patients.Methods/design: Two hundred and twenty-two patients will be recruited from two hospitals. Eligibility criteria include: diagnosis of chronic lymphocytic leukaemia/Hodgkin's/non-Hodgkin's lymphoma; aged ≥ 18 years; receiving ≥ 2 cycles chemotherapy. Patients will be randomised 1:1 to either the control or intervention arm with stratification by diagnosis, chemotherapy toxicity (high versus low), receipt of previous chemotherapy and hospital. Patients allocated to the control arm will receive 'Usual Care' whilst those allocated to the intervention will receive the intervention in addition to 'Usual Care'. Intervention patients will be provided with a computer tablet and software prompting twice-daily completion of physical/emotional scales for up to four chemotherapy cycles. Should patient data exceed pre-determined limits an Email alert is delivered to the treatment team, prompting nurses to view patient data, and contact the patient to provide clinical intervention. In addition, six scheduled nursing interventions will be completed to educate/support patients in use of the software. Patient outcomes will be measured cyclically (midpoint and end of cycles) via pen-and-paper self-report alongside review of the patient medical record. The primary outcome is burden due to nausea, mucositis, constipation and fatigue. Secondary outcomes include: burden due to vomiting and diarrhoea; psychological distress; ability to self-manage health; level of cancer information/support needs and; utilisation of health services. Analyses will be intention-to-treat. A cost-effectiveness analysis is planned.Discussion: This trial is the first in the world to test a remote monitoring/management intervention for adult haematological cancer patients receiving chemotherapy. Future use of such interventions have the potential to improve patient outcomes/safety and decrease health care costs by enabling early detection/clinical intervention.Trial Registration: ACTRN12614000516684 . Date registered: 12 March 2014 (registered retrospectively). [ABSTRACT FROM AUTHOR]

Background: There is a need to increase the capacity and capability of musculoskeletal researchers to design, conduct, and report high-quality clinical trials. The objective of this study was to identify and prioritise clinical trial learning needs of musculoskeletal researchers in Australia and Aotearoa New Zealand. Findings will be used to inform development of an e-learning musculoskeletal clinical trials course. Methods: A two-round online modified Delphi study was conducted with an inter-disciplinary panel of musculoskeletal researchers from Australia and Aotearoa New Zealand, representing various career stages and roles, including clinician researchers and consumers with lived experience of musculoskeletal conditions. Round 1 involved panellists nominating 3–10 topics about musculoskeletal trial design and conduct that they believe would be important to include in an e-learning course about musculoskeletal clinical trials. Topics were synthesised and refined. Round 2 asked panellists to rate the importance of all topics (very important, important, not important), as well as select and rank their top 10 most important topics. A rank score was calculated whereby higher scores reflect higher rankings by panellists. Results: Round 1 was completed by 121 panellists and generated 555 individual topics describing their musculoskeletal trial learning needs. These statements were grouped into 37 unique topics for Round 2, which was completed by 104 panellists. The topics ranked as most important were: (1) defining a meaningful research question (rank score 560, 74% of panellists rated topic as very important); (2) choosing the most appropriate trial design (rank score 410, 73% rated as very important); (3) involving consumers in trial design through to dissemination (rank score 302, 62% rated as very important); (4) bias in musculoskeletal trials and how to minimise it (rank score 299, 70% rated as very important); and (5) choosing the most appropriate control/comparator group (rank score 265, 65% rated as very important). Conclusions: This modified Delphi study generated a ranked list of clinical trial learning needs of musculoskeletal researchers. Findings can inform training courses and professional development to improve researcher capabilities and enhance the quality and conduct of musculoskeletal clinical trials. [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]

Tobacco smoking leads to one in five deaths of Aboriginal Australians and accounts for 17% of the reversible health gap. One in two Aboriginal women are reported to smoke during pregnancy, with no effective strategies currently available for health practitioners to utilise for supporting Aboriginal women. Aboriginal community participation in primary health research is crucial to implementing ethical research, with a clear benefit to the people and communities involved. However, currently there is little evidence on how Aboriginal programs and interventions are being developed in partnership with Aboriginal people and communities. 'Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy' aims to address the prevalence of smoking during pregnancy by enhancing health providers' training in offering evidence-based smoking cessation care to Aboriginal mothers during pregnancy. This paper outlines the participatory research approach adopted for the developmental phase of the 'ICAN QUIT in Pregnancy' project developed in partnership with two Aboriginal Community-Controlled Health Services in NSW, and negotiation processes undertaken to implement a pilot intervention across NSW, SA and Qld. [ABSTRACT FROM AUTHOR]

Background: Hospital referral and admission in many- low and middle-income countries are not feasible for many young infants with sepsis/possible serious bacterial infection (PSBI). The effectiveness of simplified antibiotic regimens when referral to a hospital was not feasible has been shown before. We analysed the pooled data from the previous trials to compare the risk of poor clinical outcome for young infants with PSBI with the two regimens containing injectable procaine penicillin and gentamicin with the oral amoxicillin plus gentamicin regimen currently recommended by the World Health Organization (WHO) when referral is not feasible.Methods: Infant records from three individually randomised trials conducted in Africa and Asia were collated in a standard format. All trials enrolled young infants aged 0-59 days with any sign of PSBI (fever, hypothermia, stopped feeding well, movement only when stimulated, or severe chest indrawing). Eligible young infants whose caretakers refused hospital admission and consented were enrolled and randomised to a trial reference arm (arm A: procaine benzylpenicillin and gentamicin) or two experimental arms (arm B: oral amoxicillin and gentamicin or arm C: procaine benzylpenicillin and gentamicin initially, followed by oral amoxicillin). We compared the rate of poor clinical outcomes by day 15 (deaths till day 15, treatment failure by day 8, and relapse between day 9 and 15) in reference arm A with experimental arms and present risk differences with 95% confidence interval (CI), adjusted for trial.Results: A total of 7617 young infants, randomised to arm A, arm B, or arm C in the three trials, were included in this analysis. Most were 7-59 days old (71%) and predominately males (56%). Slightly over one-fifth of young infants had more than one sign of PSBI at the time of enrolment. Severe chest indrawing (45%), fever (43%), and feeding problems (25%) were the most common signs. Overall, those who received arm B had a lower risk of poor clinical outcome compared to arm A for both per-protocol (risk difference = -2.1%, 95% CI = -3.8%, -0.4%; P = 0.016) and intention-to-treat (risk difference = -1.8%, 95% CI = -3.5%, -0.2%; P = 0.031) analyses. Those who received arm C did not have an increased risk of poor clinical outcome compared to arm A for both per-protocol (risk difference = -1.1%, 95% CI = -2.8%, 0.6%) and intention-to-treat (risk difference = -0.8%, 95% CI = -2.5%, 0.9%) analyses. Overall, those who received arm B had a lower risk of poor clinical outcome compared to the combined arms A and C for both per-protocol (risk difference = -1.6%, 95% CI = -3.5%, -0.1%; P = 0.035) and intention-to-treat (risk difference = -1.4%, 95% CI = -2.8%, -0.1%; P = 0.049) analyses.Conclusions: Analysis of pooled individual patient-level data from three large trials in Africa and Asia showed that the WHO-recommended simplified antibiotic regimen B (oral amoxicillin and injection gentamicin) was superior to regimen A (injection procaine penicillin and injection gentamicin) and combined arms A and C (injection procaine penicillin and injection gentamicin, followed by oral amoxicillin) in terms of poor clinical outcome for the outpatient treatment of young infants with PSBI when inpatient treatment was not feasible.Registration: AFRINEST study [9] is registered with the Australian New Zealand Clinical Trials Registry: ACTRN12610000286044. SATT Bangladesh study [10] is registered with ClinicalTrials.gov: NCT00844337. SATT Pakistan study [11] is registered at ClinicalTrials.gov: NCT01027429. [ABSTRACT FROM AUTHOR]

Background and objective The Primary Care Collaborative Cancer Clinical Trials Group (PC4) is funded by Cancer Australia to support the development of new cancer in primary care research. We undertook a research prioritisation exercise to identify cancer research priorities in Australian general practice. Methods We adapted the nominal group technique, including a literature search and stakeholder survey. An expert group from the Primary Care Collaborative Cancer Clinical Trials Group consolidated and ranked priorities. A second stakeholder survey reviewing the top 50 priorities informed a final prioritisation workshop. Results Overall, 311 priorities were identified across the cancer continuum. Nearly one-third of priorities were related to cancer survivorship and included strategies to detect recurrence, behavioural interventions and tools to assess physical and psychosocial aspects of survivorship. Prevention/early detection comprised 43.4% of priorities. Palliative care produced the least priorities (9.6%). Cross-cutting research priorities (15.1%) included quality and models of care. Discussion This is the first study to identify cancer research priorities for general practice in Australia. It could be used to inform the development of targeted research and funding to improve the care and outcomes for Australians affected by cancer. [ABSTRACT FROM AUTHOR]

Purpose -- This paper outlines a pilot study that was undertaken in Australia in 2011 that combined social marketing with education. An intervention targeting 14-16 year olds to influence attitudes and behavioural intentions towards moderate drinking was developed and tested. Game On:Know alcohol (GO:KA) is a six-module intervention that is delivered to a year level cohort in an auditorium. GO:KA combines a series of online and offline experiential activities to engage (with) students. Design/methodology -- Following social marketing benchmark criteria, formative research and competitive analysis were undertaken to create, implement and evaluate an intervention. The intervention was delivered in one all boys' and one all girls' school in April and June 2011, respectively. A total of 223 Year 10 students participated in GO:KA with the majority completing both pre- and post-surveys. Paired samples Mests and descriptive analysis were used to assess attitudinal and behavioural intention change. Findings -- Attitudinal change was observed in both schools while behavioural intentions changed for girls and not boys according to paired samples t-testing. Post hoc testing indicated gender differences. Research limitations -- The lack of a control group is a key limitation of the current research that can be overcome in the 20 school main study to be conducted in 2013-2015. Originality/value -- The current study provides evidence to suggest that a combined social marketing and education intervention can change teenage attitudes towards moderate drinking whilst only changing behavioural intentions for female teenagers. Analysis of the intervention provides insight into gender differences and highlights the need for a segmented approach. [ABSTRACT FROM AUTHOR]

This paper investigates the recent public policy processes in Australia with regard to embryo research, including the work of the legislative review committee, parliamentary debates, and the production of the National Health and Medical Research Council guidelines for embryo research. We examine various mechanisms used during each of these policymaking stages to engage various publics, and the procedures for balancing conflicting values, which were particularly evident given the strong promotion of biotechnology investment by government side by side with vigorous opposition to certain technologies by segments of the Australian community. We explore the ethical and democratic challenges posed by developments in embryo research as well as various difficulties that arose in engaging the Australian public during these policymaking processes, whether these might prove to be impediments to the development of justifiable and legitimate life sciences research policy in Australia, and what the future prospects are for adequate public engagement in these contentious areas. [ABSTRACT FROM AUTHOR]

Research exploring the potential of psychedelic-assisted therapies to treat a range of mental illnesses is flourishing, after the problematic sociopolitical history of psychedelics led to the shutdown of clinical research for almost 40 years. Encouraged by positive results, clinicians and patients are now hopeful that further interruptions to research will be avoided, so that the early promise of these therapies might be fulfilled. At this early stage of renewed interest, researchers are understandably focusing more on clinical trials to investigate safety and efficacy, than on longer-term goals such as progression to community practice. Looking to identify and avoid potential pitfalls on the path to community clinics, the authors, a group of Australian clinicians and researchers, met to discuss possible obstacles. Five broad categories of challenge were identified: 1) inherent risks; 2) poor clinical practice; 3) inadequate infrastructure; 4) problematic perceptions; and 5) divisive relationships and fractionation of the field. Our analysis led us to propose some strategies, including public sector support of research and training to establish best practice and optimize translation, and funding to address issues of equitable access to treatment. Above all, we believe that strategic planning and professional cohesion will be crucial for success. Accordingly, our key recommendation is the establishment of a multidisciplinary advisory body, broadly endorsed and representing all major stakeholders, to guide policy and implementation of psychedelic-assisted therapies in Australia. Although these challenges and strategies are framed within the Australian context, we sense that they may generalize to other parts of the world. Wherever they apply, we believe that anticipation of potential difficulties, and creative responses to address them, will be important to avoid roadblocks in the future and keep the "psychedelic renaissance" on track. [ABSTRACT FROM AUTHOR]

Background: Clinical trials are necessary for the advancement of cancer treatment and care, however low rates of participation in such trials limit the generalisability of findings. The objective of this study was to examine the proportion of medical oncology outpatients in Australia who are invited and consent to participate in clinical trials and the factors associated with this.Methods: A sample of adult medical oncology patients was recruited from three Australian cancer treatment centres. Consenting patients completed two paper-and-pencil surveys; one at the time of consent and another approximately 1 month later. A multivariate logistic regression was conducted to explore factors associated with invitation and participation in a trial.Results: Thirty-eight percent (n = 146) of the 383 participants reported they had been invited to take part in a clinical trial. Of those invited, 93% reported consenting to participate in the trial, with the majority indicating that they did not regret their decision (89%). Treatment centre and time since diagnosis were significantly associated with being invited to take part in a clinical trial. None of the factors examined were associated with clinical trial consent rates.Conclusions: The main barrier to clinical trial participation is not being invited to do so, with the centre the patient attends being a modifiable determinant of whether or not they are invited. Increasing the resources available to treatment centres to ensure all patients are offered participation in trials they are eligible for may help to improve rates of trial participation. [ABSTRACT FROM AUTHOR]

Background: This paper describes the multi-institutional prospective phase II clinical trial, SPARK: Stereotactic Prostate Adaptive Radiotherapy utilizing Kilovoltage Intrafraction Monitoring (KIM). KIM is a real-time image guided radiotherapy technology being developed and clinically pioneered for prostate cancer treatment in Australia. It has potential for widespread use for target radiotherapy treatment of cancers of the pelvis, thorax and abdomen.Methods: In the SPARK trial we will measure the cancer targeting accuracy and patient outcomes for 48 prostate cancer patients who will be treated in five treatment sessions as opposed to the conventional 40 sessions. The reduced number of treatment sessions is enabled by the KIM's increased cancer targeting accuracy.Discussion: Real-time imaging in radiotherapy has the potential to decrease the time taken during cancer treatment and reduce the imaging dose required. With the imaging being acquired during the treatment, and the analysis being automated, there is potential for improved throughput. The SPARK trial will be conducted under the auspices of the Trans-Tasman Radiation Oncology Group (TROG).Trial Registration: This trial was registered on ClinicalTrials.gov on 09 March 2015. The identifier is: NCT02397317. [ABSTRACT FROM AUTHOR]

Aim This protocol paper describes a study that aims to determine if protected mealtimes implementation closes the energy deficit of 1900 kJ between estimated requirements and actual energy intake of hospitalized adults in the subacute setting. Background Protected mealtimes, a strategy developed to address the prevalence of malnourished hospitalized adults, aims to minimize unavoidable and unnecessary interruptions at mealtimes. It has been implemented widely with limited high-quality studies as to its effect. Design A pragmatic stepped wedge cluster trial. Primary outcomes are daily energy and protein intake. Methods Funding was awarded in October 2014. In this study, protected mealtimes implementation will occur across each cluster (ward) chosen at random. A waiver of consent has been endorsed, enabling all patients to receive the intervention. Patients excluded from outcome evaluation will be those receiving end of life care and patients who are nil by mouth. The selection of patients for outcome evaluation will also occur randomly. Sample size, randomization, statistical analysis and contamination issues consider the reporting guidelines of the CONSORT statement: extension to cluster randomized trials. Conclusions The methods selected will ensure that the research is of high quality with conclusions useful and relevant for translation into practice settings. The study does not aim to assess whether the intervention is sustainable beyond the study period, rather it will establish whether the removal of known barriers to intervention uptake enables high fidelity with the intervention. As a result we will have a greater understanding of the nutritional consequences of protected mealtimes in subacute care. [ABSTRACT FROM AUTHOR]

Background: Older people living in Residential Aged Care Facilities (RACF) are a vulnerable, frail and complex population. They are more likely than people who reside in the community to become acutely unwell, present to the Emergency Department (ED) and require admission to hospital. For many, hospitalisation carries with it risks. Importantly, evidence suggests that some admissions are avoidable. A new collaborative model of care, the Aged Care Emergency Service (ACE), was developed to provide clinical support to nurses in the RACFs, allowing residents to be managed in place and avoid transfer to the ED. This paper examines the effects of the ACE service on RACF residents' transfer to hospital using a controlled pre-post design.Methods: Four intervention RACFs were matched with eight control RACFs based on number of total beds, dementia specific beds, and ratio of high to low care beds in Newcastle, Australia, between March and November 2011. The intervention consisted of a clinical care manual to support care along with a nurse led telephone triage line, education, establishing goals of care prior to ED transfer, case management when in the ED, along with the development of collaborative relationships between stakeholders. Outcomes included ED presentations, length of stay, hospital admission and 28-day readmission pre- and post-intervention. Generalised estimating equations were used to estimate mean differences in outcomes between intervention and controls RACFs, pre- and post-intervention means, and their interaction, accounting for repeated measures and adjusting for matching factors.Results: Residents had a mean age of 86 years. ED presentations ranged between 16 and 211 visits/100 RACF beds/year across all RACFs. There was no overall reduction in ED presentations (OR = 1.17, p = 0.56) with the ACE intervention. However, when compared to the controls, the intervention group reduced their ED length of stay by 45 min (p = 0.0575), and was 40 % less likely to be admitted to hospital, . The latter was highly significant (p = 0.0012).Conclusions: Transfers to ED and admission to hospital are common for residents of RACFs. This study has demonstrated that a complex multi-strategy intervention led by nursing staff can successfully reduce hospital admissions for older people living in Residential Aged Care Facilities. By defining goals of care prior to transfer to the ED, clinicians have the opportunity to better deliver care that patients require. Integrated care requires accountability from multiple stakeholders.Trial Registration: The Australian New Zealand Clinical Trials Registration number is ACTRN12616000588493 It was registered on 6(th) May 2016. [ABSTRACT FROM AUTHOR]

Aim To discuss the methods of a study which will aim to determine the usability of a medical device not yet approved for use in a clinical trial. Background The Blood Loss Estimation and Evaluation of Drape (BLEED) pilot aims to determine the usability of a drape which measures blood loss during third stage labour. Third stage blood loss is usually estimated visually. This method has been found to be inaccurate. The drape has been tested in developing countries overseas and has been found to more accurately measure third stage blood loss when compared with visual methods. The usability of the drape has not yet been evaluated. Review methods Before starting the BLEED pilot study, the risks to the participants were evaluated and the drape was determined to pose minimal risk of harm for participants. The pilot study will involve recruitment of women and health professionals who will use the drape to measure third stage blood loss and then complete a survey about their opinion of the drape's usability. The data will be used to determine the suitability of using the drape in a clinical trial. Discussion The benefits of pursing this programme of research outweigh the challenges. The drape has been validated as more accurate than visual estimation for evaluating blood loss during third stage labour, yet the usability has not been established and a clinical trial is needed. This programme of research will determine if routine use of this drape in research and practice is justified. Conclusion This work will assist health professionals who are considering ways to improve clinical outcomes and will particularly inform researchers who are interested in piloting new devices in maternity care. While adherence to monitoring requirements and governance of clinical trials is essential, the system has become complicated for investigator-initiated research using devices. Despite these challenges, the authors of this paper believe that this research programme is justified. Implications for practice The complexity of navigating documentation and governance required for clinical trials may deter some healthcare professionals who plan to initiate research that involves the use of a medical device. While adherence to monitoring requirements and governance of clinical research is essential, research involving the evaluation of emerging medical technologies can be complicated, particularly for an investigator-initiated (clinician) researcher who does not have the support of a biotech company. These issues may deter clinician researchers from initiating trials and impede their ability to implement clinical research. Despite the challenges, the effectiveness and safety of technologies must be evaluated for their effectiveness in improving clinical outcomes for patients. [ABSTRACT FROM AUTHOR]

Aim: We examined key features of two outcome measures for social dysfunction and autism spectrum disorder traits, the Social Responsiveness Scale, Second Edition (SRS-2) and the Social Skills Improvement System - Rating Scales (SSIS-RS), in children with neurofibromatosis type 1 (NF1). The aim of the study was to provide objective evidence as to which behavioural endpoint should be used in clinical trials.Method: Cross-sectional behavioural and demographic data were pooled from four paediatric NF1 tertiary referral centres in Australia and the United States (N=122; 65 males, 57 females; mean age [SD] 9y 2mo [3y], range 3-15y).Results: Distributions of SRS-2 and SSIS-RS scores were unimodal and both yielded deficits, with a higher proportion of severely impaired scores on the SRS-2 (16.4%) compared to the SSIS-RS (8.2%). Pearson's product-moment correlations revealed that both questionnaires were highly related to each other (r=-0.72, p<0.001) and to measures of adaptive social functioning (both p<0.001). Both questionnaires were significantly related to attention-deficit/hyperactivity disorder symptoms, but only very weakly associated with intelligence.Interpretation: The SRS-2 and SSIS-RS capture social dysfunction associated with NF1, suggesting both may be suitable choices for assessing social outcomes in this population in a clinical trial. However, careful thought needs to be given to the nature of the intervention when selecting either as a primary endpoint.What This Paper Adds: The Social Responsiveness Scale, Second Edition yielded a large deficit relative to population norms. The Social Skills Improvement System - Rating Scales yielded a moderate deficit relative to population norms. Both scales were highly correlated, suggesting that they are measuring a unitary construct. [ABSTRACT FROM AUTHOR]

Background: To improve preventative health screening in regional Victoria, Australia, a collaborative student-led health prevention strategy was initiated. The aim of this study is to evaluate the impact of four health check clinics using a free 'pop-up' format within community settings. Methods: A mixed methods, explanatory sequential design was used to explore community health data and participant experiences in utilising the free health check clinics. The clinics were delivered over 6 months and located in three different communities within the regional government area. Descriptive statistics were used to analyse participant health data and a thematic analysis was utilised to determine themes from participant feedback and health outcomes. Results: The clinics were attended by 188 community members, largely impacted by government lockdowns during the coronavirus disease 2019 (COVID-19) pandemic. Health check results indicate the population is overweight and at high risk of diabetes. Participants enjoyed the free and convenient nature of the health check program and the location of the venues. Feedback from participants indicate the health education provided was useful and advocated for changes in current behaviours. Many embraced the new information and community connections and made changes to improve their future health. Others claimed to enjoy the clinic experience but reported no action from the recommendations. Conclusions: Evaluation of the health check clinics indicate they had a minor, yet positive impact on the local community in increasing engagement with preventative screening strategies. COVID-19 restrictions impacted participant numbers and thus more research is needed in a time where community movement is not limited. Access to preventative health care and screening is often challenging in regional areas. Free student-led pop-up health check clinics provide improved access and convenience, offering health education and early intervention strategies that aim to reduce future chronic health within the local population. This study demonstrates how community collaboration is able to provide screening services, support healthy behaviour change and strengthen the development of future health practitioners. [ABSTRACT FROM AUTHOR]

Background: Current estimates place just under one quarter of adolescents in Australia as overweight or obese. Adolescence has been identified as a critical period for the development of obesity, yet despite this recognition, there is limited systematic research into or evaluation of interventions for overweight adolescents. Reviews have concluded that there is a substantive evidence gap for effective intervention, but physical activity, lifestyle change and family involvement have been identified as promising foci for treatment. Methods: This paper reports on the development of a staggered-entry, waitlist controlled clinical trial to assess the impact of a multidisciplinary intervention aiming to change the poor health trajectory of overweight adolescents and help them avoid morbid obesity in adulthood--Curtin University's Activity, Food and Attitudes Program (CAFAP). 96 adolescents, aged 11-16 years, and parents, will attend twice weekly during an 8 week intensive multidisciplinary program with maintenance follow-up focussed on improving activity, food and attitude habits. Follow-up assessments will be conducted immediately after completing the intensive program, and at 3, 6 and 12 months post intensive program. Main outcomes will be objectively-measured physical activity, sedentary behaviour and activity behaviours; food intake (measured by 3 day diary) and food behaviours; body composition, fitness and physical function; mental and social well-being (quality of life, mood and attitudes), and family functioning. Discussion: This trial will provide important information to understand whether a community based multidisciplinary intervention can have short and medium term effects on activity and food habits, attitudes, and physical and mental health status of overweight adolescents. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12611001187932. [ABSTRACT FROM AUTHOR]

Background: Most skin cancers are preventable by encouraging consistent use of sun protective behaviour. In Australia, adolescents have high levels of knowledge and awareness of the risks of skin cancer but exhibit significantly lower sun protection behaviours than adults. There is limited research aimed at understanding why people do or do not engage in sun protective behaviour, and an associated absence of theory-based interventions to improve sun safe behaviour. This paper presents the study protocol for a school-based intervention which aims to improve the sun safe behaviour of adolescents. Methods/design: Approximately 400 adolescents (aged 12-17 years) will be recruited through Queensland, Australia public and private schools and randomized to the intervention (n = 200) or 'wait-list' control group (n = 200). The intervention focuses on encouraging supportive sun protective attitudes and beliefs, fostering perceptions of normative support for sun protection behaviour, and increasing perceptions of control/self-efficacy over using sun protection. It will be delivered during three x one hour sessions over a three week period from a trained facilitator during class time. Data will be collected one week pre-intervention (Time 1), and at one week (Time 2) and four weeks (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun protection behaviour. Secondary outcomes include attitudes toward performing sun protective behaviours (i.e., attitudes), perceptions of normative support to sun protect (i.e., subjective norms, group norms, and image norms), and perceived control over performing sun protective behaviours (i.e., perceived behavioural control). Discussion: The study will provide valuable information about the effectiveness of the intervention in improving the sun protective behaviour of adolescents. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology and associated processes to assist Australian guideline developers in considering a body of evidence and grading the resulting guideline recommendations. Methods: In recognition of the complexities of clinical guidelines and the multiple factors that influence choice in health care, a working group of experienced guideline consultants was formed under the auspices of the Australian National Health and Medical Research Council (NHMRC) to produce and pilot a framework to formulate and grade guideline recommendations. Consultation with national and international experts and extensive piloting informed the process. Results: The FORM framework consists of five components (evidence base, consistency, clinical impact, generalisability and applicability) which are used by guideline developers to structure their decisions on how to convey the strength of a recommendation through wording and grading via a considered judgement form. In parallel (but separate from the grading process) guideline developers are asked to consider implementation implications for each recommendation. Conclusions: The framework has now been widely adopted by Australian guideline developers who find it to be a logical and intuitive way to formulate and grade recommendations in clinical practice guidelines. [ABSTRACT FROM AUTHOR]

Background: Various models of intervention for caregivers of patients with dementia have been described. There has been little direct comparison of cultural differences between countries and the effect any differences may exert on the outcome of caregiver interventions. Aims: The aims of the three-country study (USA, Australia and the UK) were to assess whether caregiver interventions can still be successful when anti-dementia drugs are provided to patients, and whether a caregiver intervention can be successfully implemented using the same methods in three different English-speaking countries. In this paper, the cultural differences and similarities between the three countries are examined. Method: Randomised, controlled trial involving 158 patients and their caregivers (divided equally across three centres, New York, Sydney and Manchester) with all the patients receiving donepezil and the caregivers randomised to a caregiver intervention or treatment as usual. Results: There were few differences between countries in the main outcome measures, and no differences between the treatment-as-usual group and the intervention, but interesting cultural nuances were observed between groups. Despite these differences, the caregiver intervention was associated with positive results on caregiver depression across all the countries. Conclusions: This first multinational carer intervention study has emphasised the similarities between the three countries whilst highlighting crucial differences which may be important when planning cross-cultural studies in the future. The positive results achieved on caregiver depression were replicated across the three centres. Copyright © 2010 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

The aim of this paper is to link the history of the Multicentre Australian Study of Epidural Anaesthesia in high risk surgery, the MASTER Trial, the first National Health and Medical Research Council (NHMRC) funded multicentre randomised clinical trial in Australia led by anaesthetist researchers, and the decision of The Australian and New Zealand College of Anaesthetists (ANZCA) to establish a clinical trials network, in 2003, to the success of contemporary researchers in Australia and New Zealand in anaesthesia and perioperative medicine. [ABSTRACT FROM AUTHOR]

Background: The objective of this paper is to estimate the amount of cost-savings to the Australian health care system from implementing an evidence-based clinical protocol for diagnosing emergency patients with suspected pulmonary embolism (PE) at the Emergency department of a Victorian public hospital with 50,000 presentations in 2001-2002. Methods: A cost-minimisation study used the data collected in a controlled clinical trial of a clinical protocol for diagnosing patients with suspected PE. Thenumber and type of diagnostic tests in a historic cohort of 185 randomly selected patients, who presented to the emergency department with suspectedPE during an eight month period prior to the clinical trial (January 2002 -August 2002) were compared with the number and type of diagnostic tests in745 patients, who presented to the emergency department with suspected PE from November 2002 to August 2003. Current Medicare fees per test were usedas unit costs to calculate the mean aggregated cost of diagnostic investigation per patient in both study groups. A t-test was used to estimate the statistical significance of the difference in the cost of resources used for diagnosing PE in the control and in the intervention group. Results: The trial demonstrated that diagnosing PE using an evidence-based clinical protocol was as effective as the existing clinical practice. The clinical protocol offers the advantage of reducing the use of diagnostic imaging, resulting in an average cost savings of at least $59.30 per patient. Conclusion: Extrapolating the observed cost-savings of $59.30 per patient to the wholeof Australia could potentially result in annual savings between $3.1 million to $3.7 million. [ABSTRACT FROM AUTHOR]

Buprenorphine was registered in Australia as a maintenance and detoxification agent for the management of opioid dependence in November, 2000, and became widely available in August, 2001. This paper provides an overview of key developments in the introduction of buprenorphine treatment in Australia, with an emphasis upon the delivery of services in community-based (primary care) settings. A central study in this work was the Buprenorphine Implementation Trial (BIT), a randomized, controlled trial comparing buprenorphine and methadone maintenance treatment delivered under naturalistic conditions by specialist and community-based service providers (general practitioners and community pharmacists) in 139 subjects across nineteen treatment sites. In addition to conventional patient outcome measures (treatment retention, drug use, psychosocial functioning, and cost effectiveness), the BIT study also involved the development and evaluation of clinical guidelines, training programs for clinicians, and client literature, which are described here. Integration of treatment systems (methadone with buprenorphine, specialist and primarycare programs) and factors thought to be important in the uptake of buprenorphine treatment in Australia since registration are discussed. Am J Addict 2004;13[Suppl 1]:S29-S41) [ABSTRACT FROM AUTHOR]

Public health orders were introduced in many countries, including Australia, during the COVID-19 pandemic to reduce the spread of the virus. However, for many people this led to an exacerbation of mental health symptoms, particularly those living with severe or persistent mental illness (SPMI). Additionally, the conduct of clinical research was severely impacted during the pandemic, with many difficulties encountered in the conduct of clinical trials. This paper describes the COVID-related impacts experienced during the implementation of a randomised controlled trial (RCT) testing the effectiveness of a community pharmacist-led support service for people living with SPMI in Australia (the PharMIbridge RCT), and the strategies used to successfully implement the RCT. Australian public health orders led to interstate border closures, stay-at-home orders and work-from-home requirements, resulting in necessary changes to allow for the continuation of the RCT including; changes to trial regions, transferring some training materials online while delaying face-to-face (F2F) training components, delays in pharmacy and consumer recruitment, encouraging telehealth service delivery and extensions to timelines with existing funding. Having a solution-focussed and flexible approach, while still ensuring critical trial protocol elements were adhered to, such as providing opportunities for F2F skills-based training for pharmacists, as well as F2F site visits from researchers and mentors to support trial implementation, resulted in high pharmacy and consumer participant retention through to trial conclusion. Future planning for RCTs should consider possible pandemic-related risks and rapid responses from approval bodies to ensure researchers can be agile and adapt to ensure successful trial completion. [ABSTRACT FROM AUTHOR]

Introduction: Cancer clinical trials have traditionally occurred in‐person. However, the COVID‐19 pandemic has forced adaptions of all aspects of cancer care (including clinical trials) so they can be delivered remotely. We aimed to quantify and qualify current use of telehealth and how it can be further improved and routinely integrated into cancer clinical trials in Australia. Methods: We used a mixed‐method study design, involving surveys of 14 multi‐site Collaborative Cancer Clinical Trial Groups members across Australia (n = 98) and qualitative interviews with trial administrators and clinicians (n = 21). Results: The results of our study indicated a strong willingness to use telehealth for certain transactions of clinical trials because it was perceived as a way of increasing efficiency and reach of services. Hybrid models (including telehealth and in‐person methods), which considered transaction, cancer type, and patient preferences were most favorable. Additionally, telehealth allowed for greater equity to access and reduced trial burden but interestingly had little effect on increased diversity and recruitment. Factors influencing telehealth service implementation and uptake included communication among trial stakeholders, training, and learning from the experience of others in the clinical trials community. Conclusion: Many but not all aspects of clinical trial care are appropriate to be delivered via telehealth. A hybrid approach provides flexibility to trial delivery and may support greater equity of access to trials in the future. Our findings and actionable recommendations support the need for greater planning, training, and guidelines to enable telehealth to be better integrated into clinical trials. Opportunities exist to expand the use of remote patient monitoring to enable more objective data collection from trial participants in the future. [ABSTRACT FROM AUTHOR]

Background: Parents' Evaluation of Developmental Status, (PEDS), is a validated screening tool designed for primary health care clinicians to assess child development. Despite widespread use by local government child-nurse services, PEDS has not been tested in Australian general practice. We examined the effect of an intervention that aimed to use PEDS to improve documented assessment of child developmental status during routine general practice consultations. Methods: The study took place in a single general practice in Melbourne, Australia. The intervention included training of all general practice staff regarding PEDS processes and provision of PEDS questionnaires, scoring and interpretation forms. Mixed methods incorporated audits of clinical records of young children (1 to ≤ 5 years) before and after the intervention, and written questionnaires and a focus group (informed by the Theoretical Domains Framework and COM-B model) with receptionists, practice nurses and general practitioners. Results: Documented developmental status more than doubled after the intervention with almost one in three (30.4%) records documenting the PEDS tool. Overall, staff responses to questionnaires indicated that PEDS processes had been successfully implemented, half of the staff felt PEDS had developed their professional skills and clinicians expressed confidence using the tool (71%). Thematic analysis of the focus group transcript revealed divided reactions to PEDS screening with most barriers arising from general practitioners' motivation to use PEDS tools and perceptions of environmental constraints. Conclusions: A team-practice intervention that applied PEDS training and implementation, more than doubled documented rates of child developmental status during routine visits. Solutions to underlying barriers could be incorporated into a revised training module. Future studies need to test the tool in more methodologically robust studies that include analysis of the outcomes of developmental surveillance and long-term sustainability of PEDS use in practices. [ABSTRACT FROM AUTHOR]

This paper presents the results of five commercial-scale processing trials, designed to investigate the effect of dense 'Jumbo'-baling of burry Australian combing wools on their subsequent topmaking performance. From measurements of top properties and an analysis of product yields, it is concluded that, provided that the bales are adequately heated prior to being opened, the difference in processing performance between Jumbo-baled and conventionally baled wool is so small as to be commercially insignificant. [ABSTRACT FROM AUTHOR]

Purpose: This qualitative study aimed to understand the impact of the coronavirus disease 2019 pandemic from March to November 2020 on healthcare delivery and clinical trials for genitourinary (GU) cancers in Australia. Methods: Annually a pre‐conference workshop is hosted by the Australian New Zealand Urogenital and Prostate Cancer Trials Group for supportive care health professionals. In November 2020, those that selected to attend were invited to participate in a focus group. Workshop and focus group discussions were recorded and transcripts were analyzed thematically. Results: Seventy‐two individuals involved in GU cancer care and clinical trials took part. Participants described negative changes to GU cancer care and clinical trials from the pandemic due to reduced clinical services and increased wait times. Trial recruitment was paused temporarily during lockdowns, and standard treatment protocols were used to limit hospital visits. Trial process changes included electronic capture of informed consent, home delivery of oral medications, and delegations of assessments. These changes increased administrative activity for clinical trial teams and Human Research Ethics Committees. A transition to telehealth enabled continuity of service delivery and trials but reduced the opportunity for face‐to‐face patient consultations with increasing concern about the failure to detect supportive care needs. Conclusion: The pandemic has prompted a critical review of service delivery and clinical trials for people with GU cancers. [ABSTRACT FROM AUTHOR]