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1

Walters, Judi, Kate Light, and Nathan Robinson. "Using agricultural metadata: a novel investigation of trends in sowing date in on-farm research trials using the Online Farm Trials database." F1000Research 9 (May 26, 2021): 1305. http://dx.doi.org/10.12688/f1000research.26903.2.

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Background: A growing ability to collect data, together with the development and adoption of the FAIR guiding principles, has increased the amount of data available in many disciplines. This has given rise to an urgent need for robust metadata. Within the Australian grains industry, data from thousands of on-farm research trials (Trial Projects) have been made available via the Online Farm Trials (OFT) website. OFT Trial Project metadata were developed as filters to refine front-end database searches, but could also be used as a dataset to investigate trends in metadata elements. Australian grains crops are being sown earlier, but whether on-farm research trials reflect this change is currently unknown. Methods: We investigated whether OFT Trial Project metadata could be used to detect trends in sowing dates of on-farm crop research trials across Australia, testing the hypothesis that research trials are being sown earlier in line with local farming practices. The investigation included 15 autumn-sown, winter crop species listed in the database, with trial records from 1993 to 2019. Results: Our analyses showed that (i) OFT Trial Project metadata can be used as a dataset to detect trends in sowing date; and (ii) cropping research trials are being sown earlier in Victoria and Western Australia, but no trend exists within the other states. Discussion/Conclusion: Our findings show that OFT Trial Project metadata can be used to detect trends in crop sowing date, suggesting that metadata could also be used to detect trends in other elements such as harvest date. Because OFT is a national database of research trials, further assessment of metadata may uncover important agronomic, cultural or economic trends within or across the Australian cropping regions. New information could then be used to lead practice change and increase productivity within the Australian grains industry.
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Walters, Judi, Kate Light, and Nathan Robinson. "Using agricultural metadata: a novel investigation of trends in sowing date in on-farm research trials using the Online Farm Trials database." F1000Research 9 (November 6, 2020): 1305. http://dx.doi.org/10.12688/f1000research.26903.1.

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Background: A growing ability and interest in the collection of data, together with the development and adoption of the FAIR guiding principles, has increased the amount of data available in many disciplines. This has given rise to an urgent need for robust metadata. Within the Australian grains industry, data from over thousands of on-farm research trials (Trial Projects) have been made available via the Online Farm Trials (OFT) website. OFT Trial Project metadata were developed as filters to refine front-end database searches, but could also be used as a dataset to investigate trends in metadata elements. Australian grains crops are being sown earlier, but whether on-farm research trials reflect this change is currently unknown. Methods: We investigated whether OFT Trial Project metadata could be used to detect trends in sowing dates of on-farm crop research trials across Australia, testing the hypothesis that research trials are being sown earlier in line with local farming practices. The investigation included 15 autumn-sown, winter crop species listed in the database, with trial records from 1993 to 2019. Results: Our analyses showed that (i) OFT Trial Project metadata can be used as a dataset to detect trends in sowing date; and (ii) cropping research trials are being sown earlier in Victoria and Western Australia, but no trend exists within the other states. Discussion/Conclusion: Our findings show that OFT Trial Project metadata can be used to detect trends in crop sowing date, suggesting that metadata could also be used to detect trends in other metadata elements such as harvest date. Because OFT is a national database of research trials, further assessment of metadata may uncover important agronomic, cultural or economic trends within or across the Australian cropping regions. New information could then be used to lead practice change and increase productivity within the Australian grains industry.
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Goller, Jane L., Jacqueline Coombe, Meredith Temple-Smith, Helen Bittleston, Lena Sanci, Rebecca Guy, Christopher Fairley, et al. "Management of Chlamydia Cases in Australia (MoCCA): protocol for a non-randomised implementation and feasibility trial." BMJ Open 12, no. 12 (December 2022): e067488. http://dx.doi.org/10.1136/bmjopen-2022-067488.

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IntroductionThe sexually transmitted infection chlamydia can cause significant complications, particularly among people with female reproductive organs. Optimal management includes timely and appropriate treatment, notifying and treating sexual partners, timely retesting for reinfection and detecting complications including pelvic inflammatory disease (PID). In Australia, mainstream primary care (general practice) is where most chlamydia infections are diagnosed, making it a key setting for optimising chlamydia management. High reinfection and low retesting rates suggest partner notification and retesting are not uniformly provided. The Management of Chlamydia Cases in Australia (MoCCA) study seeks to address gaps in chlamydia management in Australian general practice through implementing interventions shown to improve chlamydia management in specialist services. MoCCA will focus on improving retesting, partner management (including patient-delivered partner therapy) and PID diagnosis.Methods and analysisMoCCA is a non-randomised implementation and feasibility trial aiming to determine how best to implement interventions to support general practice in delivering best practice chlamydia management. Our method is guided by the Consolidated Framework for Implementation Research and the Normalisation Process Theory. MoCCA interventions include a website, flow charts, fact sheets, mailed specimen kits and autofills to streamline chlamydia consultation documentation. We aim to recruit 20 general practices across three Australian states (Victoria, New South Wales, Queensland) through which we will implement the interventions over 12–18 months. Mixed methods involving qualitative and quantitative data collection and analyses (observation, interviews, surveys) from staff and patients will be undertaken to explore our intervention implementation, acceptability and uptake. Deidentified general practice and laboratory data will be used to measure pre-post chlamydia testing, retesting, reinfection and PID rates, and to estimate MoCCA intervention costs. Our findings will guide scale-up plans for Australian general practice.Ethics and disseminationEthics approval was obtained from The University of Melbourne Human Research Ethics Committee (Ethics ID: 22665). Findings will be disseminated via conference presentations, peer-reviewed publications and study reports.
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Tirimacco, Rosy, Briony Glastonbury, Caroline O. Laurence, Tanya K. Bubner, Mark D. Shephard, and Justin J. Beilby. "Development of an accreditation program for Point of Care Testing (PoCT) in general practice." Australian Health Review 35, no. 2 (2011): 230. http://dx.doi.org/10.1071/ah09792.

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Objectives. To describe the development and evaluation of an accreditation program for Point of Care Testing (PoCT) in general practice, which was part of the PoCT in general practice (GP) Trial conducted in 2005–07 and funded by the Australian Government. Setting and participants. Thirty general practices based in urban, rural and remote locations across South Australia, New South Wales and Victoria, which were in the intervention arm of the PoCT Trial were part of the accreditation program. A PoCT accreditation working party was established to develop an appropriate accreditation program for PoCT in GP. A multidisciplinary accreditation team was formed consisting of a medical scientist, a general practitioner or practice manager, and a trial team representative. Methodology and sequence of events. To enable practices to prepare for accreditation a checklist was developed describing details of the accreditation visit. A guide for surveyors was also developed to assist with accreditation visits. Descriptive analysis of the results of the accreditation process was undertaken. Outcomes. Evaluation of the accreditation model found that both the surveyors and practice staff found the process straightforward and clear. All practices (i.e. 100%) achieved second-round accreditation. Discussion and lessons learned. The accreditation process highlighted the importance of ongoing education and support for practices performing PoCT. What is known about the topic? Currently there is no rebate for Point of Care testing in Australia. Before the Australian Government can consider a rebate it has to be shown that PoCT is safe for patient care. Implementation of a quality framework and an accreditation model for PoCT is vital to ensure that clinical care is not compromised by use of this technology. What does this paper add? This paper provides a model for PoCT accreditation that meets requirements of both the GP and scientific community. It reports on the first government-funded PoCT in general practice trial and illustrates what needs to be considered if the Government decides to fund PoCT in general practice. What are the implications for practitioners? Description of a PoCT accreditation process highlights to practitioners what is entailed in following the interim standards for PoCT currently available. This study is an important piece of work as it shows that PoCT in general practice can be performed safely within a quality framework that meets scientific accreditation requirements.
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Corcoran, Tomás B., Paul S. Myles, Andrew B. Forbes, Ed O'Loughlin, Kate Leslie, David Story, Timothy G. Short, et al. "The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study." BMJ Open 9, no. 9 (September 2019): e030402. http://dx.doi.org/10.1136/bmjopen-2019-030402.

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IntroductionThe intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.Methods/analysisThis is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria.Ethics/disseminationThe PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020.Trial registration numberACTRN12614001226695.
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Sturgiss, Elizabeth, Nilakshi Gunatillaka, Lauren Ball, Tina Lam, Suzanne Nielsen, Renee O'Donnell, Chris Barton, et al. "Embedding brief interventions for alcohol in general practice: a study protocol for the REACH Project feasibility trial." BJGP Open 5, no. 4 (April 28, 2021): BJGPO.2021.0037. http://dx.doi.org/10.3399/bjgpo.2021.0037.

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BackgroundAlcohol is a major source of harm in Australia that disproportionately affects low-income communities. Alcohol brief interventions (ABIs) combine an assessment of a person’s alcohol use with advice to reduce health risks. Despite their effectiveness, ABIs are not routinely performed by clinicians. This article presents a protocol for a feasibility trial of pragmatic implementation strategies and a new set of resources to support clinicians to complete ABIs in Australian general practices.AimTo explore the facilitators and barriers to increasing the uptake of ABIs in primary care, including acceptability, reach, adoption, fidelity, and sustainability.Design & settingA mixed-methods evaluation of the uptake of ABIs in general practice clinics serving low-income communities in Melbourne, Australia. The approach is informed by the Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT).MethodThe implementation strategies and resources will be trialled in five general practices over 12 months. The primary outcome will be change in the proportion of adult patients with a complete alcohol history in their electronic medical records. Baseline data collection includes a practice survey to describe practice routines for ABIs and de-identified patient medical record data on completed alcohol histories (repeated at 3, 6, 9, and 12-months post-intervention). Survey and interview data will also be collected from clinicians, patients, and primary health network staff to assess acceptability and feasibility of the intervention.ConclusionThe study will explore how the implementation strategies and resources can improve alcohol screening and management among low-income patients in general practice.
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Pearson, Sallie-Anne, Clare L. Ringland, and Robyn L. Ward. "Trastuzumab and Metastatic Breast Cancer: Trastuzumab Use in Australia—Monitoring the Effect of an Expensive Medicine Access Program." Journal of Clinical Oncology 25, no. 24 (August 20, 2007): 3688–93. http://dx.doi.org/10.1200/jco.2007.11.2516.

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Purpose Data from clinical trials are used for drug registration; however, many cancer medicines are ultimately used off-label. This study examines the extent to which the clinical practice use of trastuzumab for the treatment of metastatic breast cancer differs from its use under trial conditions. Methods This study involved all women (N = 1,469) with metastatic breast cancer who received trastuzumab in Australia between December 2001 and March 2005. Given that Australia operates a universal health care system, administrative databases could be examined to determine the duration of therapy, rate of off-label use, compliance with cardiac monitoring, and the extent of drug wastage (volume and cost). Results A total of 433 enrollees (29.5%) received trastuzumab as monotherapy and 1,036 enrollees (70.5%) received the drug in combination with chemotherapy. A total of 321 women (22%) received off-label trastuzumab. The median duration of trastuzumab therapy was longer than that on trial: 5.6 v 3.1 months for enrollees receiving monotherapy and 12.5 v 6.9 months for concomitant chemotherapy. Only 47 (3%) of enrollees received cardiac monitoring before and during trastuzumab therapy. We estimated 24% of trastuzumab dispensed was discarded, at a cost of $21.1 million Australian. Alternative administration schedules and the addition of another vial size potentially reduce wastage to 6% of volume dispensed. Conclusion Debates about the use of expensive cancer medicines should consider postmarketing assessments as well as trial experience. The longer duration of trastuzumab use in clinical practice and the high rates of off-label use provide incentive for new clinical trials. Strategies to improve cardiac monitoring and to minimize drug wastage are issues that require immediate attention.
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Browne, Lois H., and Peter H. Graham. "Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle." Clinical Trials 11, no. 6 (July 14, 2014): 629–34. http://dx.doi.org/10.1177/1740774514542620.

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Background: It is assumed investigators and statisticians fully understand the importance of avoiding missing outcomes and the intention-to-treat principle during design and analysis phases of a randomised controlled trial in order to obtain the most valuable and reliable results. However, many personnel undertaking day-to-day trial conduct and data collection commonly rely exclusively for guidance on the widely implemented, indeed regulated, International Conference on Harmonisation–Good Clinical Practice document as the guideline and standard for trial conduct. Purpose: This article describes adverse consequences of omission of intention-to-treat principles from training for trial personnel and explores the need for training in addition to the International Conference on Harmonisation–Good Clinical Practice guideline document. Methods: Data from the Breast Boost Study were used to illustrate a comparison of actual results, where vigilant senior investigators re-enforced intention-to-treat requirements throughout all aspects of trial conduct with results that could easily have occurred if study personnel did not understand the importance of intention-to-treat principles. Experience as a co-ordinating centre for an international trial (Trans-Tasman Radiation Oncology Group 08.06 Breast STARS) acted as an audit of data-management culture regarding intention-to-treat in Australia and New Zealand. Results: Despite the Breast Boost Study exceeding planned accrual, it was demonstrated that the study, which found a statistically significant result, could have reported a negative or inconclusive result under the scenario of trial conduct personnel having lack of understanding of the importance of avoiding losses to follow-up. Trans-Tasman Radiation Oncology 08.06 co-ordination experience verified that data-management culture in Australia and New Zealand does not adequately recognise intention-to-treat principles, and this is reflected in trial conduct. Limitations: Trial data described are limited to two trials and in the Australian and New Zealand setting. Conclusion: To be both scientifically and ethically valid, guidelines for trial conduct should include and stress the importance of the intention-to-treat principle and in particular avoiding missing outcomes. Our discussion highlights the vitally important role played by personnel involved in day-to-day trial conduct. Inclusion of scientific principles in guideline documents and/or training which goes beyond International Conference on Harmonisation–Good Clinical Practice to include intention-to-treat is essential to achieve robust research results. Related aspects of randomised trial consent and ethics are discussed.
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Patterson, Elizabeth, Heidi Muenchberger, and Elizabeth Kendall. "The role of practice nurses in coordinated care of people with chronic and complex conditions." Australian Health Review 31, no. 2 (2007): 231. http://dx.doi.org/10.1071/ah070231.

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General practice in Australia must cope with growing numbers of individuals with chronic and complex needs. The Australian Government has recognised the need to reform the primary health care sector to address this issue, with recent initiatives, such as coordinated care. The overall goal of coordinated care at a national level is to facilitate integrated care for people with chronic and complex conditions, by enhancing collaborative partnerships among general practitioners, primary health care providers, community service providers and clients. Interestingly, practice nurses (PNs) have not been identified as key stakeholders in the coordinated care service delivery model in Australia. In contrast, an expanded role for PNs has been in place in the United Kingdom and New Zealand for some time. This paper is based on focus group discussions with Australian PNs who have had a range of experiences in coordinated care models. The study identifies an important role for PNs, suggesting trial of a variety of models of coordinated care that include PNs in chronic disease management process.
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Wood, Ellen, Paul Harpur, and Nancy Pachana. "Teaching an old dog new tricks: Using courthouse facility dogs in Australia." Alternative Law Journal 43, no. 2 (June 2018): 89–95. http://dx.doi.org/10.1177/1037969x18767694.

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Courthouse facility dogs are increasingly used to support child witnesses and complainants during testimony in courtrooms across the globe. Although already commonplace in the United States, this practice has been largely unexplored in the Australian context. This paper puts forward the case for courthouse facility dogs in Australia and offers some insight into striking the delicate balance between protecting defendants’ rights to a fair trial, and improving the efficiency and quality of the legal system for vulnerable witnesses and victims.
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Wolf, Rand, Swarbrick, Spehar, and Norris. "Reply to Crawford et al.: Why Trap-Neuter-Return (TNR) Is an Ethical Solution for Stray Cat Management." Animals 9, no. 9 (September 16, 2019): 689. http://dx.doi.org/10.3390/ani9090689.

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The recently published article, ‘A Case of Letting the Cat out of the Bag—Why Trap-Neuter-Return Is Not an Ethical Solution for Stray Cat (Felis catus) Management,’ by Crawford et al. warrants rebuttal. The case presented in the paper, opposing the initiation of TNR trials in Australia, ignores peer-reviewed evidence which substantiates the effectiveness of TNR at reducing unowned urban cat numbers. In addition, the paper’s authors offer a number of unrealistic recommendations, which are little more than a rebranding of the failed status quo. Urban stray cats have long been considered a problem across Australia. Current practice calls for the trapping and killing of thousands of healthy urban stray cats and kittens each year with no apparent effect on the total population. In contrast, the literature offers numerous examples, including two recent studies in Australia, of reductions in urban stray cat numbers where TNR has been implemented. TNR has also been associated with reduced feline intake and euthanasia at shelters, which improves both animal welfare and the well-being of shelter staff. A large-scale trial of TNR in an urban Australian context is scientifically justified and long overdue.
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Abeysuriya, Kumi, Dena Fam, and Cynthia Mitchell. "Trialling urine diversion in Australia: technical and social learnings." Water Science and Technology 68, no. 10 (October 24, 2013): 2186–94. http://dx.doi.org/10.2166/wst.2013.473.

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This paper discusses a urine diversion (UD) trial implemented within the institutional setting of the University of Technology Sydney that sought to identify key issues for public UD and reuse systems at scale in the Australian urban context. The trial was novel in its transdisciplinary action research approach, that included consideration of urine diverting toilets (UDTs) as socio-technical systems where interactions between users' practices and perceptions and the performance of the technology were explored. While the study explored a broad range of issues that included urine transport, reuse, and regulations, amongst others, the boundary of the work presented in this paper is the practicalities of UD practice within public urban buildings. Urine volume per urinal use, an important metric for sizing tanks for collecting urine from waterless urinal systems in commercial buildings, was also estimated. The project concluded that current UDTs are unsuitable to public/commercial spaces, but waterless urinals have a key role.
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Skoss, Rachel, Jane White, Mandy J. Stanley, Melanie Robinson, Sandra Thompson, Elizabeth Armstrong, and Judith M. Katzenellenbogen. "Study protocol for a prospective process evaluation of a culturally secure rehabilitation programme for Aboriginal Australians after brain injury: the Healing Right Way project." BMJ Open 11, no. 9 (September 2021): e046042. http://dx.doi.org/10.1136/bmjopen-2020-046042.

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IntroductionAboriginal and Torres Strait Islander (hereafter respectfully referred to as Aboriginal) people are Australia’s First Peoples, having the longest continuous culture in the world and deep spiritual connections with ancestral land. Improvements in their health and well-being is a major policy goal of Australian governments, as the legacy of colonisation and disruption of cultural practices contribute to major health challenges. Lack of culturally secure services impacts participation of Aboriginal people in health services. Aboriginal people with a brain injury typically experience poor access to rehabilitation and support following hospital discharge. ‘Healing Right Way’ (HRW) is a randomised control trial aiming to improve access to interdisciplinary and culturally secure rehabilitation services for Aboriginal people after brain injury in Western Australia, improve health outcomes and provide the first best practice model. This protocol is for the process evaluation of the HRW trial.Methods and analysisA prospective mixed methods process evaluation will use the Consolidated Framework for Implementation Research to evaluate implementation and intervention processes involved in HRW. Data collection includes qualitative and quantitative data from all sites during control and intervention phases, relating to three categories: (1) implementation of trial processes; (2) cultural security training; and (3) Aboriginal Brain Injury Coordinator role. Additional data elements collected from HRW will support the process evaluation regarding fidelity and intervention integrity. Iterative cross-sectional and longitudinal data synthesis will support the implementation of HRW, interpretation of findings and inform future development and implementation of culturally secure interventions for Aboriginal people.Ethics and disseminationThis process evaluation was reviewed by The University of Western Australia Human Research Ethics Committee (RA/4/20/4952). Evaluation findings will be disseminated via academic mechanisms, seminars at trial sites, regional Aboriginal health forums, peak bodies for Aboriginal health organisations and the Australian Indigenous HealthInfoNet (https://healthinfonet.ecu.edu.au/).Trial registration numberACTRN12618000139279.
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White, Edward, and Julie Winstanley. "A randomised controlled trial of clinical supervision: selected findings from a novel Australian attempt to establish the evidence base for causal relationships with quality of care and patient outcomes, as an informed contribution to mental health nursing practice development." Journal of Research in Nursing 15, no. 2 (January 20, 2010): 151–67. http://dx.doi.org/10.1177/1744987109357816.

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This paper reports on selected findings from a novel randomised controlled trial (RCT) conducted in mental health settings in Queensland, Australia. Several national and state reports recently revealed the sub-optimal state of Australian mental health service provision which have direct implications for mental health nursing, including the privately experienced cost of working and coping in these settings. Clinical supervision (CS), a structured staff support arrangement, has shown promise as a positive contribution to the clinical practice development agenda and is now found reflected in health policy themes elsewhere in the world. However, CS is underdeveloped in Australia and the empirical evidence base for the informed implementation of CS, per se, has remained elusive. Within the overall context of a RCT design, therefore, and supplemented by other data collection methods, this large and generously funded study attempted to make an incremental contribution to better understanding this demanding substantive domain. Whilst the substantive insights and theoretical propositions reported here were derived from, and may be limited by, a sub-specialty of nursing and a single geographic location, they were earthed in the personal self-reported experience of those directly involved with a clinical practice innovation. They may resonate with counterparts beyond mental health nursing and Queensland, Australia, respectively, therefore, and may assist in both conceptualising and operationalising CS research, education, management, policy and clinical practice development decision making in the future.
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Passey, Megan, Mahnaz Fanaian, David Lyle, and Mark F. Harris. "Assessment and management of lifestyle risk factors in rural and urban general practices in Australia." Australian Journal of Primary Health 16, no. 1 (2010): 81. http://dx.doi.org/10.1071/py09061.

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Prevention of cardiovascular disease is a major public health challenge. Many chronic health problems are amenable to lifestyle interventions, which can ameliorate progression of disease and contribute to primary prevention. Prior to a large randomised controlled trial we assessed preventive care in trial practices. General practitioners and practice nurses completed a preventive care questionnaire covering frequency of assessing and managing behavioural and physiological risk factors, which was developed from previously validated instruments. Factor analysis confirmed 10 scales. Scores for rural and urban respondents were contrasted using univariate statistics. Sixty-three general practitioners and practice nurses completed the questionnaire (27 urban and 36 rural). The clinicians reported high levels of assessment and advice for cardiovascular risk factors but less frequent referral. There were no differences between urban and rural practitioners in relation to assessment of risk or stage of change, referral or barriers to referral or management of high blood pressure. Rural practitioners had lower scores for frequency of advice, and management of obesity/overweight, pre-diabetes and high lipids. Although clinicians report frequently advising high risk patients to exercise more, there remain significant gaps in provision of dietary advice and referral. Greater attention to addressing these issues is required to maximise the potential benefits for cardiovascular disease prevention in general practice.
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Holland, Anne E., Tamera Corte, Daniel C. Chambers, Andrew J. Palmer, Magnus Per Ekström, Ian Glaspole, Nicole S. L. Goh, et al. "Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial." BMJ Open 10, no. 12 (December 2020): e040798. http://dx.doi.org/10.1136/bmjopen-2020-040798.

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IntroductionInterstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation.Methods and analysisA randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King’s Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken.Ethics and disseminationEthical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences.Trial registration numberClinicalTrials.gov Registry (NCT03737409).
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Dineen-Griffin, Sarah, Victoria Garcia-Cardenas, Kris Rogers, Kylie Williams, and Shalom Isaac Benrimoj. "Evaluation of a Collaborative Protocolized Approach by Community Pharmacists and General Medical Practitioners for an Australian Minor Ailments Scheme: Protocol for a Cluster Randomized Controlled Trial." JMIR Research Protocols 8, no. 8 (August 9, 2019): e13973. http://dx.doi.org/10.2196/13973.

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Background Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MASs) promote efficiencies within the health care system. The cost savings and health outcomes demonstrated in the United Kingdom and Canada open up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. Objective This trial aims to evaluate the clinical, economic, and humanistic impact of an Australian Minor Ailments Service (AMAS) compared with usual pharmacy care in a cluster randomized controlled trial (cRCT) in Western Sydney, Australia. Methods The cRCT design has an intervention group and a control group, comparing individuals receiving a structured intervention (AMAS) with those receiving usual care for specific health ailments. Participants will be community pharmacies, general practices, and patients located in Western Sydney Primary Health Network (WSPHN) region. A total of 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments: reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhea, or low back pain. Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The coprimary outcomes are rates of appropriate recommendation of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, health services resource utilization, and EuroQoL Visual Analogue Scale. Differences in primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost-utility and cost-effectiveness analysis compared with usual care. Results The study began in July 2018. Thirty community pharmacies were recruited. Pharmacists from the 15 intervention pharmacies were trained. A total of 27 general practices consented. Pharmacy patient recruitment began in August 2018 and was completed on March 31, 2019. Conclusions This study may demonstrate the efficacy of a protocolized intervention to manage minor ailments in the community and will assess the clinical, economic, and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and appropriate self-medication may contribute to greater efficiency of health care resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a national MAS service in Australia, using a robust framework for management and referral for common ailments. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000286246; http://www.anzctr.org.au/ACTRN12618000286246.aspx International Registered Report Identifier (IRRID) DERR1-10.2196/13973
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Lockwood, Anne, and Fiona Maguire. "General Practitioners and Nurses Collaborating in General Practice." Australian Journal of Primary Health 6, no. 2 (2000): 19. http://dx.doi.org/10.1071/py00015.

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In 1998 the Fremantle Regional Division of General Practice (FRDGP), Silver Chain and the Health Department of Western Australia (HDWA) initiated an eleven-month trial which aimed to increase clinical integration by establishing professional partnerships between GPs and nurses. The project placed nurse in four general practices where they consulted with patients and undertook other activities that helped clarify nurse and GP roles within these partnerships. In addition to exploring some of the processes underlying development of partnerships, the project reported direct benefits for all stakeholders. For patients these included improved access and better quality of care. At an organisational level Silver Chain and general practices reported increased service provision and efficiency, additional promotion and marketing opportunities, improved networks with other providers, and opportunities for new business developments in service provision. From the professional practitioner perspective, doctors and nurses reported improved knowledge about the other profession and that the trial was an opportunity to explore role developments in the general practice context. Implications for expansion and development of a nursing role in general practice were discussed. The results suggest that further development of effective nurse/GP partnerships requires collaborative planning, close monitoring, and ongoing support for the processes of improved teamwork.
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Walters, Julia A. E., Helen Courtney-Pratt, Helen Cameron-Tucker, Mark Nelson, Andrew Robinson, Jenn Scott, Paul Turner, E. Haydn Walters, and Richard Wood-Baker. "Engaging general practice nurses in chronic disease self-management support in Australia: insights from a controlled trial in chronic obstructive pulmonary disease." Australian Journal of Primary Health 18, no. 1 (2012): 74. http://dx.doi.org/10.1071/py10072.

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The growing burden of chronic disease will increase the role of primary care in supporting self-management and health behaviour change. This role could be undertaken to some extent by the increased practice nurse workforce that has occurred over recent years. Mixed methods were used to investigate the potential for general practice nurses to adopt this role during a 12-month randomised controlled study of telephone-delivered health mentoring in Tasmanian practices. Nurses (general practice and community health) were trained as health mentors to assist chronic obstructive pulmonary disease patients to identify and achieve personal health related goals through action plans. Of 21% of invited practices that responded, 19 were allocated to health mentoring; however, general practice nurses were unable to train as health mentors in 14 (74%), principally due to lack of financial compensation and/or workload pressure. For five general practice nurses trained as health mentors, their roles had previously included some chronic disease management, but training enhanced their understanding and skills of self-management approaches and increased the focus on patient partnership, prioritising patients’ choices and achievability. Difficulties that led to early withdrawal of health mentors were competing demands, insufficient time availability, phone calls having lower priority than face-to-face interactions and changing employment. Skills gained were rated as valuable, applicable to all clinical practice and transferable to other health care settings. Although these results suggest that training can enhance general practice nurses’ skills to deliver self-management support in chronic disease, there are significant system barriers that need to be addressed through funding models and organisational change.
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Roydhouse, Jessica A., Smita Shah, Brett G. Toelle, Susan M. Sawyer, Craig M. Mellis, Tim P. Usherwood, Peter Edwards, and Christine R. Jenkins. "A snapshot of general practitioner attitudes, levels of confidence and self-reported paediatric asthma management practice." Australian Journal of Primary Health 17, no. 3 (2011): 288. http://dx.doi.org/10.1071/py11009.

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The prevalence of asthma in Australia is high. Previous findings have suggested that asthma management, particularly in primary care, remains suboptimal and recent government initiatives to improve asthma management and encourage the use of written asthma action plans (WAAPs) in general practice have been implemented. We aimed to assess the attitudes, confidence and self-reported paediatric asthma management practices of a convenience sample of Australian general practitioners (GPs). A baseline questionnaire was administered to GPs as part of a randomised controlled trial. General practitioners (GPs) were recruited from two areas of greater metropolitan Sydney, NSW between 2006 and 2008. Invitations were sent to an estimated 1200 potentially eligible GPs. Of 150 (12.5%) GPs that enrolled, 122 (10.2%) completed the baseline questionnaire. Though 89% were aware of the Australian National Asthma Guidelines, less than 40% were familiar with guideline recommendations. While 85.2% had positive attitudes towards WAAPs, only 45.1% reported providing them frequently. For children with frequent symptoms, 90% agreed they should prescribe daily, inhaled corticosteroids (ICS), and 83% reported currently prescribing ICS to such patients. These findings indicate gaps between GP attitudes and behaviours and highlights opportunities for interventions to improve paediatric asthma management.
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Uritani, Daisuke, Penny K. Campbell, Ben Metcalf, and Thorlene Egerton. "A comparison of psychological characteristics in people with knee osteoarthritis from Japan and Australia: A cross-sectional study." PLOS ONE 17, no. 5 (May 5, 2022): e0267877. http://dx.doi.org/10.1371/journal.pone.0267877.

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The aim of this study was to investigate differences in psychological characteristics between people with knee osteoarthritis (OA) from Japan and Australia. Sixty-two adults from Japan and 168 adults from Australia aged over 50 years with knee pain were included. Japanese data were collected from patients with knee OA diagnosed by medical doctors. Australian data were baseline data from a randomized controlled trial. Participants were not exercising regularly or receiving physiotherapy at the time. Psychological characteristics evaluated were depressive symptoms, fear of movement, and pain catastrophizing. These psychological characteristics were compared between the Japanese and Australian cohorts by calculating 95% confidence intervals (CIs) for difference of the mean. To test for equivalence, an equivalence margin was set at 0.5 standard deviations (SD) of the mean, where these SDs were based on the Australian data. When the 95%CI for the difference of the mean value lay entirely within the range of equivalence margin (i.e. between -0.5 and 0.5 times the Australian SD), the outcome was considered equivalent. There were no differences between the groups from Japan and Australia for depressive symptoms and the two groups were considered equivalent. There was no difference between groups for fear of movement, however the criteria for equivalence was not met. People from Japan with knee OA had higher scores for pain catastrophizing than people from Australia. The findings should be confirmed in other samples of people with knee OA from Japan and Australia due to the limitations of the participant recruitment strategy in this study. However, our findings suggest there may be a greater need to consider pain catastrophizing and build pain self-efficacy when managing Japanese people with knee OA. Implementation of international clinical practice guidelines for OA management may require different strategies in different countries due to different psychological profiles.
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Ball, Sarah, and Brian W. Head. "Behavioural insights teams in practice: nudge missions and methods on trial." Policy & Politics 49, no. 1 (January 1, 2021): 105–20. http://dx.doi.org/10.1332/030557320x15840777045205.

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Behavioural and experimental projects have become increasingly popular with policymakers. Behavioural insights teams have used several policy design and implementation tools drawn from behavioural sciences, especially randomised controlled trials, to test the design of ‘nudge’ interventions. This approach has attained discursive legitimacy in government agencies seeking to use the best available evidence for behaviourally informed, evidence-based policy innovation. We examine the practices of governmental behavioural insights teams in Australia, drawing on two research projects that included interviews with key personnel. We find that teams make strong commitments to using and promoting randomised controlled trials in government policy innovation. Nevertheless, some members of these teams are beginning to appreciate the constraints of relying solely on randomised controlled trials in the development of behavioural public policy. We conclude that while an initial focus on rigorous trials helped behavioural insights teams establish themselves in policymaking, strict adherence may represent a risk to their long-term growth and relevance.
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Mulyadi, Lilik. "MENGGAGAS KONSEP DAN MODEL IDEAL PERLINDUNGAN HUKUM TERHADAP WHISTLEBLOWER DAN JUSTICE COLLABORATOR DALAM UPAYA PENANGGULANGAN ORGANIZED CRIME DI INDONESIA MASA MENDATANG." Jurnal Hukum dan Peradilan 3, no. 2 (July 31, 2014): 101. http://dx.doi.org/10.25216/jhp.3.2.2014.101-116.

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Practice of whistleblower and justice collaborator law protection especially in the effort to destroy the organized crime in Holland, germany and Australia to institution and the protect orientation is variatif and partial. Protection practice in Holland uses witness agreements, it is the agreement between the public prosecutor and witness to give the testimony with reward especially to organized crime. In Germany, trough Witness Protection Law In Process Criminal Investigation and Protection Against Victims (Zeugenschutzgesetz/ZschG). Essentially, Zeugenschutzgesetz/ZschG rules the dimention for the witnesses, both witnesses and not the victims. Besides, it is also ruled about rights issues witnesses before the trial and during the trial process. On the aspect of witness rights before the trial include the examination of witnesses in the policemen and prosecution, the secret of witness identity and the changes of witness identity. Then, the witness right in the trial are separated examination of the suspect and inspection with a camera recording. Then in Australia trough the National witness Protection Program with a secret identity, no responsibility in criminal and civil, the protection from the defamation, the protection from criminal acts of retaliation and conditionalprotection if their names are published to the media.Keywords: Law Protection, whistleblower, justice collaborator and organized crime
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Crossland, Lisa, Deborah Askew, Robert Ware, Peter Cranstoun, Paul Mitchell, Andrew Bryett, and Claire Jackson. "Diabetic Retinopathy Screening and Monitoring of Early Stage Disease in Australian General Practice: Tackling Preventable Blindness within a Chronic Care Model." Journal of Diabetes Research 2016 (2016): 1–7. http://dx.doi.org/10.1155/2016/8405395.

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Introduction. Diabetic retinopathy (DR) is the leading cause of preventable blindness in Australia. Up to 50% of people with proliferative DR who do not receive timely treatment will become legally blind within five years. Innovative and accessible screening, involving a variety of primary care providers, will become increasingly important if patients with diabetes are to receive optimal eye care. Method. An open controlled trial design was used. Five intervention practices in urban, regional, and rural Australia partnered with ophthalmologists via telehealth undertook DR screening and monitoring of type 2 diabetes patients and were compared with control practices undertaking usual care 2011–2014. Results. Recorded screening rates were 100% across intervention practices, compared with 22–53% in control practices. 31/577 (5%) of patients in the control practices were diagnosed with mild-moderate DR, of whom 9 (29%) had appropriate follow-up recorded. This was compared with 39/447 (9%) of patients in the intervention group, of whom 37 (95%) had appropriate follow-up recorded. Discussion and Conclusion. General practice-based DR screening via Annual Cycle of Care arrangements is effective across differing practice locations. It offers improved recording of screening outcomes for Australians with type 2 diabetes and better follow-up of those with screen abnormalities.
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Guy, Rebecca, James S. Ward, Kirsty S. Smith, Jiunn-Yih Su, Rae-Lin Huang, Annie Tangey, Steven Skov, et al. "The impact of sexually transmissible infection programs in remote Aboriginal communities in Australia: a systematic review." Sexual Health 9, no. 3 (2012): 205. http://dx.doi.org/10.1071/sh11074.

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Objective To systematically review evaluations of the impact of sexually transmissible infection (STI) programs delivered by primary health care services in remote Aboriginal communities. Methods: PubMed, Google Scholar, InfoNet, Cochrane Controlled Trials Register, Australian New Zealand Clinical Trial Registry, conference proceedings and bulletins were searched to April 2011 using variations of the terms ‘Aboriginal’, ‘programs’ and ‘STI’. The primary outcome of interest in the review was the change in bacterial STI infection prevalence in the target age group assessed through cross-sectional screening studies over a 5-year period or more. The characteristics of the primary health care service, STI programs and other clinical service outcomes were also described. Results: Twelve reports described four distinct STI programs in remote communities and their impact on STI prevalence. In the Anangu Pitjantjatjara Yankunytjatjara (APY) lands of northern South Australia, there was a reduction in the age-adjusted chlamydia and gonorrhoea prevalence by 58% and 67%, respectively (1996–2003). In the Tiwi Islands of Northern Territory (NT), chlamydia and gonorrhoea positivity decreased by 94% and 34%, respectively (2002–2005). In the Ngaanyatjarra Lands of Western Australia, crude chlamydia and gonorrhoea prevalence decreased by 36% and 48%, respectively (2001–2005), and in the central Australian region of NT, there was no sustained decline in crude prevalence (2001–2005). Conclusion: In three of the four programs, there was some evidence that clinical best practice and well coordinated sexual health programs can reduce STI prevalence in remote Aboriginal communities.
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Cho, Yeoungjee, Neil Boudville, Suetonia C. Palmer, Josephine S. F. Chow, Carmel M. Hawley, Matthew D. Jose, Rob MacGinley, et al. "Practice of Peritoneal Dialysis Catheter Flushing in Australia and New Zealand: Multi-Center Cross-Sectional Survey." Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis 38, no. 2 (March 1, 2017): 98–103. http://dx.doi.org/10.3747/pdi.2017.00108.

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Background Evidence of effective interventions to prevent peritoneal dialysis (PD) catheter malfunction before first use is presently insufficient to guide clinical care. Regular flushing of the PD catheter (e.g. before PD commencement) has been adopted by some practitioners in the belief that it will prevent catheter obstruction and/or malfunction. The aim of this study was to characterize and evaluate PD catheter flushing practices across Australian and New Zealand PD units. Methods An on-line survey was distributed to all 62 PD units in Australia (12 August 2016; n = 51) and New Zealand (2 February 2017; n = 11), with questions relating to PD catheter flushing practices, audit, and outcomes. Results Forty-nine units of variable size (< 16 to > 100 patients) completed the survey (79% response rate). All centers flushed PD catheters at some stage after insertion as routine unit practice. Forty-one units (84%) routinely flushed during periods of PD rest at varying intervals ranging from alternate daily to monthly. The type and volume of solution used to flush varied between units. Units that practised routine flushing of PD catheters were almost twice as likely to audit their catheter-related outcomes (66% vs 38%, p = 0.23) and more likely to have reported blocked catheters in the preceding 12 months (84% vs 0%, p = 0.01) compared with those units that did not routinely flush PD catheters. Thirty units (61%) regularly audited and monitored catheter-related outcomes. Conclusions This study identified a wide variation in center practices relating to PD catheter flushing. Drawing conclusions about any relationship between flushing practices and clinical outcomes was impeded by the relatively low uptake of regular auditing and monitoring of catheter-related outcomes across surveyed units. Evaluation of the benefits and harms of standardized PD catheter flushing practices on patient outcomes in a randomized trial is needed to guide practice.
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Saleem, Ahsan, Gemma Woodruff, Kathryn Steadman, and Adam La Caze. "Investigating the impact of patient-centred labels on comprehension of medication dosing: a randomised controlled trial." BMJ Open 11, no. 11 (November 2021): e053969. http://dx.doi.org/10.1136/bmjopen-2021-053969.

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ObjectiveThis study aims to implement a version of patient-centred labels (PCL) consistent with current labelling practice in Australia; assess the effectiveness of PCL in relation to the proportion of participants that correctly comprehend dosing instructions, and explore the proportion of correct comprehension of PCL in participants with both low and high health literacy.DesignRandomised controlled trial.SettingA large tertiary care hospital in Brisbane, Queensland, Australia.Participants121 participants with a majority born in Australia (65.3%), New Zealand (14.0%), the UK (6.6%) and Ireland (2.5%).InterventionParticipants were randomly assigned to either a panel of three PCL (n=61) or three standard labels (n=60) and asked to comprehend their assigned panel of labels.Outcome measuresDifference in the proportion of participants that correctly comprehend dosing instructions provided on PCL compared with standard labels. The two-proportion test was used to measure the impact of PCL on the proportion of participants correctly comprehending dosing instructions.ResultsA greater proportion of participants were able to accurately comprehend PCL compared with standard labels. The proportion of participants who were able to correctly comprehend dose instructions provided on all three labels was significantly higher in the group that received PCL; 23.3% standard vs 83.6% PCL, p<0.001. The effect was observed in both low and high health literacy participants. The proportion of participants with accurate label comprehension was higher in participants with low Newest Vital Signs scores (8.3% standard vs 85.7% PCL, p<0.001) and low Rapid Estimate of Adult Literacy in Medicine scores (10.5% standard vs 96.0% PCL, p<0.001) who received PCL.ConclusionThis study supports the use of PCL in Australian pharmacy practice. PCL provide simple, clear and explicit dosing instructions to patients. Implementing PCL may reduce the risk of misinterpreting dosing instructions by patients and improve quality use of medicines.Trial registration numberACTRN12621000083897; Results.
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Bakhit, Mina, Natalia Krzyzaniak, Joanne Hilder, Justin Clark, Anna Mae Scott, and Chris Del Mar. "Use of methenamine hippurate to prevent urinary tract infections in community adult women: a systematic review and meta-analysis." British Journal of General Practice 71, no. 708 (January 17, 2021): e528-e537. http://dx.doi.org/10.3399/bjgp.2020.0833.

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BackgroundUrinary tract infections (UTIs) are often treated with antibiotics and are a source of antibiotic overuse.AimTo systematically review randomised controlled trials (RCTs) of adult women in the community with a history of recurrent UTIs and who use methenamine hippurate prophylactically.Design and settingSystematic review of women in the UK, Australia, Norway, and US (aged ≥18 years) with recurrent UTIs receiving methenamine hippurate against placebo or no treatment, and antibiotics.MethodThe authors searched three databases, clinical trial registries, and performed forward–backward citation analysis on references of included studies.ResultsSix studies involving 557 participants were included (447 were analysed). Of the six studies, five were published and one was an unpublished trial record with results, three compared methenamine hippurate against placebo or control, and three compared methenamine hippurate with antibiotics. For the number of patients who remained asymptomatic, methenamine hippurate showed a non-statistically significant trend of benefit versus antibiotics over 12 months (risk ratio [RR] 0.65, 95% confidence interval [CI] = 0.40 to 1.07, I2 49%), versus control over 6 or 12 months (RR 0.56, 95% CI = 0.13 to 2.35, I2 93%), and a non-statistically significant trend versus any antibiotic for abacteruria (RR 0.80, 95% CI = 0.62 to 1.03, I2 23%). A similar non-statistically significant trend of benefits for methenamine hippurate for the number of UTI or bacteriuric episodes was found, and a non-statistically significant difference in the number of patients experiencing adverse events between methenamine hippurate and any comparator, with a trend towards benefit for the methenamine hippurate, was identified. Antibiotic use and resistance were not consistently reported.ConclusionThere is insufficient evidence to be certain of the benefits of methenamine hippurate to prevent UTI. Further research is needed to test the drug’s effectiveness in preventing UTIs and as an alternative for antibiotic treatment for UTI.
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Lewandowska, Milena, Richard De Abreu Lourenco, Marion Haas, Cathy J. Watson, Kirsten I. Black, Angela Taft, Jayne Lucke, et al. "Cost-effectiveness of a complex intervention in general practice to increase uptake of long-acting reversible contraceptives in Australia." Australian Health Review 45, no. 6 (2021): 728. http://dx.doi.org/10.1071/ah20282.

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ObjectiveThe aim of this study was to evaluate the cost-effectiveness of the Australian Contraceptive ChOice pRoject (ACCORd) intervention. MethodsAn economic evaluation compared the costs and outcomes of the ACCORd intervention with usual care (UC). Data from the ACCORd trial were used to estimate costs and efficacy in terms of contraceptive uptake and quality of life. Rates of contraceptive failure and pregnancy were sourced from the literature. Using a Markov model, within-trial results were extrapolated over 10 years and subjected to univariate sensitivity analyses. Model outputs were expressed as the cost per quality-adjusted life years (QALY) gained and cost per unintended pregnancy resulting in birth (UPB) avoided. ResultsOver 10 years, compared with UC, initiating contraception through the ACCORd intervention resulted in 0.02 fewer UPB and higher total costs (A$2505 vs A$1179) per woman. The incremental cost-effectiveness of the ACCORd intervention versus UC was A$1172 per QALY gained and A$7385 per UPB averted. If the start-up cost of the ACCORd intervention was removed, the incremental cost-effectiveness ratio was A$81 per QALY gained and A$511 per UPB averted. The results were most sensitive to the probability of contraceptive failure, the probability of pregnancy-related healthcare service utilisation or the inclusion of the costs of implementing the ACCORd intervention. ConclusionsFrom a health system perspective, if implemented appropriately in terms of uptake and reach, and assuming an implicit willingness to pay threshold of A$50 000 the ACCORd intervention is cost-effective. What is known about the topic?The uptake of long-active reversible contraceptives (LARC) in Australia is low. The ACCORd trial assessed the efficacy of providing structured training to general practitioners (GPs) on LARC counselling, together with access to rapid referral to insertion clinics. What does this paper add?This study is the first to assess the cost-effectiveness of a complex intervention in the general practice setting aimed at increasing the uptake of LARC in Australia. What are the implications for practitioners?The results show that implementing a complex intervention in general practice involving GP education and the availability of rapid referral to LARC insertion clinics is a cost-effective approach to increase LARC use and its attending efficacy. If the majority of Australian GPs were able to deliver effectiveness-based contraceptive counselling and either insert LARC or use a rapid referral process to a LARC insertion clinic, the additional cost associated with the purchase of LARC products and their insertion would be offset by reductions to health system costs as a result of fewer UPB and abortions. Moreover, the benefits to women’s physical and psychological health of avoiding such events is substantial.
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Bainbridge, Jason. "‘Rafferty's Rules’: Australian Legal Dramas and the Representation of Law." Media International Australia 118, no. 1 (February 2006): 136–49. http://dx.doi.org/10.1177/1329878x0611800116.

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This paper explores the problems involved in representing the Australian legal system on film and television, how these problems are addressed, and what commentary these texts are making about the practice of law in Australia. It is suggested that the formal and dress requirements of the Australian legal system make the trial process a ritual based around the reification of the lawyer and the stigmatisation of the accused — in short, a degradation ceremony — and that Australian legal dramas reflect this. But because of this lack of dynamism in the courtroom, Australian legal dramas must seek alternative sits of drama — often domestic, and invariably outside the courtroom. In this way, they present a more holistic view of the lawyer/judge's life, reinterpreting court proceedings (and the institution of law itself) as a repressed set-up by actively displacing dramatic tension outside the courtroom, thus denying the courtroom the centrality it occupies in American representations and, by extension, American culture.
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Ellerton, Kirrily, Harishan Tharmarajah, Rimma Medres, Lona Brown, David Ringelblum, Kateena Vogel, Amanda Dolphin, et al. "The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial." BMJ Open 10, no. 8 (August 2020): e038354. http://dx.doi.org/10.1136/bmjopen-2020-038354.

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IntroductionPain caused by routine immunisations is distressing to children, their parents and those administering injections. If poorly managed, it can lead to anxiety about future medical procedures, needle phobia and avoidance of future vaccinations and other medical treatment. Several strategies, such as distraction, are used to manage the distress associated with routine immunisations. Virtual reality (VR), a technology which transports users into an immersive ‘virtual world’, has been used to manage pain and distress in various settings such as burns dressing changes and dental treatments. In this study, we aim to compare the effectiveness of VR to standard care in a general practice setting as a distraction technique to reduce pain and distress in 4-year-old children receiving routine immunisations.Methods and analysisThe study is a randomised controlled clinical trial comparing VR with standard care in 100 children receiving routine 4-year-old vaccination. Children attending a single general practice in metropolitan Melbourne, Australia will be allocated using blocked randomisation to either VR or standard care. Children in the intervention group will receive VR intervention prior to vaccination in addition to standard care; the control group will receive standard care. The primary outcome is the difference in the child’s self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised. Secondary outcomes include another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100 mm visual analogue scales) and adverse effects.Ethics and disseminationEthics approval has been obtained in Australia from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC 18-010). Recruitment commenced in July 2019. We plan to submit study findings for publication in a peer-reviewed journal and presentation at relevant conferences.Trial registration numberACTRN12618001363279.
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Evangelista, Eloisa J., Jo James, and Elizabeth Deveny. "Implementing Anticipatory Care Plans in general practice: a practice approach to improving the health literacy of the community and reducing reliance on emergency services during after-hour periods." Australian Journal of Primary Health 22, no. 5 (2016): 428. http://dx.doi.org/10.1071/py15045.

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The objective of this study was to trial a general practice approach to improve the health literacy of patients at risk of utilising medical, emergency or ambulatory services during after-hour periods in Australia. It did so by introducing an anticipatory after-hours care component in all new and revised care plans, known as an Anticipatory Care Plan (AntCaP).The pilot was conducted over a 6-month period in 2013–14. Thirteen general practices were recruited via expressions of interest and were paid a financial grant. Key practice staff were required to attend three workshops conducted by a Medicare Local and to be involved in the evaluation process. A pragmatic qualitative and quantitative evaluation process was conducted during the pilot, and ceased 6 months after the final workshop. The results indicate that the integration of AntCaPs into general practice was generally well received by practice staff and their patients, with early indications that AntCaPs can influence patient behaviour in the after-hours period.
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Vonesh, Edward. "On Small Solute Clearance and Patient Outcomes: Evidential Practice or Observational Trepidation?" Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis 29, no. 6 (November 2009): 623–29. http://dx.doi.org/10.1177/089686080902900606.

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Recent guidelines on peritoneal dialysis adequacy set a minimum target for small solute clearance at Kt/V urea 1.70. While evidence from both observational studies and randomized controlled trials (RCTs) supports such a minimum target, there continues to be debate over what role small solute clearance plays in determining patient outcome. Current ANZDATA Registry results from Australia and New Zealand add fuel to this debate by demonstrating a significant nonlinear U-shaped relationship between peritoneal small solute clearance and patient survival. The ANZDATA results indicate that patients with too low or too high peritoneal Kt/V urea may be at significant risk of death compared to those with a peritoneal Kt/V urea between 1.70 and 2.00. As these results are somewhat at odds with results from published RCTs, we will examine the level of evidence from the observational setting that is the ANZDATA Registry and contrast it against the level of evidence from RCTs, particularly the ADEMEX trial. New results from the ADEMEX study are presented as a possible explanation for the paradoxical U-shaped results seen in the ANZDATA study.
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Coleman, Michael J., Brian M. Sindel, and Richard A. Stayner. "Effectiveness of best practice management guides for improving invasive species management: a review." Rangeland Journal 39, no. 1 (2017): 39. http://dx.doi.org/10.1071/rj16087.

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Best practice management (BPM) guides are a key component of invasive species extension in Australia, and are becoming a more important way of reaching land managers with comprehensive invasive species management strategies. However, little is known about the quantifiable benefits of these guides as a stand-alone extension approach, or in comparison with other approaches. We therefore reviewed the existing literature to determine when this form of extension was appropriate, what determines the success or failure of BPM guides in facilitating best practice invasive species management, how effective they had been in the Australian context, and what methods were available to evaluate BPM guide effectiveness. BPM guides are most appropriately used in support of other forms of extension and enforcement of invasive species regulations; as a cost-effective alternative to more labour-intensive extension techniques; or in bringing together disparate information in a single comprehensive source for land managers and extension practitioners. They appear to be most appropriately distributed at mid- and late-stages of the invasion curve. Limited quantitative evidence of the effectiveness of BPM guides for invasive species in Australia is available, although there is a consensus that these materials are popular among target audiences, despite a range of studies having shown face-to-face extension to be more effective. Unfortunately, many factors make successful evaluation of a BPM guide difficult, such that extension professionals are less likely to consider the possibility of evaluation. However, we argue that extension professionals need to consider evaluation of written BPM guides, where time and funding makes this possible. Ideally this will involve formative evaluation to improve the content and messages of the guide, as well as summative evaluation to determine its effectiveness among the target audience and for the target species. We also suggest a range of economic evaluation possibilities that warrant further exploration and trial.
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Marino, L. V., K. L. Bell, J. Woodgate, and A. Doolan. "An international survey of the nutrition management of chylothorax: a time for change." Cardiology in the Young 29, no. 09 (September 2019): 1127–36. http://dx.doi.org/10.1017/s1047951119001525.

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AbstractIntroduction:Although chylothorax is an uncommon complication following paediatric cardiothoracic surgery, it has significant associated morbidities and increased in-hospital mortality, as well as results in higher costs. A lack of prospective evidence or consensus guidelines for management of chylothorax further hinders optimal management. The aim of this survey was to characterise variations in practice in the management of chylothorax and to identify areas for future research.Materials and methods:A descriptive, observational survey investigating conservative management practices of chylothorax was distributed internationally to health-care professionals in paediatric intensive care and cardiology units. The survey investigated five domains: the first providing general information about health-care professionals and four domains focusing on clinical practice including diet composition and duration.Results:In total, sixty-four health-care professionals completed the survey, representing 38 organisations from 16 countries. The respondents were dietitians (80%), physicians (19%), and nurses (1%). In Australia and New Zealand, management was most commonly directed by physicians’ preference (67%) as compared to unit protocols in Europe (67%), United States of America (67%), and Other regions (55%). Dietitians in Australia/New Zealand, United Kingdom, and Ireland followed the most restrictive diet therapy recommending &lt;5 g long chain triglyceride fat per day (p &lt; 0.00001). The duration of diet therapy significantly varied between regions: Australia/New Zealand: 4 weeks (36%) and 6 weeks (43%); Europe: 4 weeks (25%) and 6 weeks (57%); and North America: 4 weeks (18%) and 6 weeks (75%) (p &lt; 0.00001).Conclusions:This survey highlights international variations in practice in the management of chylothorax, particularly with respect to treatment duration and dietary fat restriction. Future research should include a multi-centre randomised controlled trial to inform evidence-based practice and reduce morbidity, particularly poor growth.
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Carey, Mariko, Rob Sanson-Fisher, Nick Zwar, Danielle Mazza, Graham Meadows, Leon Piterman, Amy Waller, et al. "Improving depression outcomes among Australian primary care patients: protocol for a cluster randomised controlled trial." BMJ Open 10, no. 2 (February 2020): e032057. http://dx.doi.org/10.1136/bmjopen-2019-032057.

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IntroductionDepression is a common and debilitating condition. In Australia, general practitioners (GPs) are the key providers of depression care. However, available evidence suggests that case finding for depression in primary care is poor. This study will examine whether a systematic approach to screening for depression and assessing patient preferences for depression care improves depression outcomes among primary care patients.Methods and analysisA cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12). Patients who are aged 18 and older, presenting for general practice care, will be eligible to participate. Eighty-three participants will be recruited at each clinic. Participants will be asked to complete a baseline survey administered on a touch screen computer at their GP clinic, and then a follow-up survey at 3, 6 and 12 months. Those attending usual care practices will receive standard care. GPs at intervention practices will complete an online Clinical e-Audit, and will be provided with provider and patient-directed resources for depression care. Patients recruited at intervention practices who score 10 or above on the Patient Health Questionnaire-9 will have feedback regarding their depression screening results and preferences for care provided to their GP. The primary analysis will compare the number of cases of depression between the intervention and control groups.Ethics and disseminationThe study has been approved by the University of Newcastle Human Research Ethics Committee, and registered with Human Research Ethics Committees of the University of Wollongong, Monash University and University of New South Wales. Results will be disseminated through peer-reviewed journal publications and conference presentations.Trial registration numberACTRN12618001139268; Pre-results.
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Perez Chacon, Gladymar, Marie J. Estcourt, James Totterdell, Dianne E. Campbell, Kirsten P. Perrett, Julie A. Marsh, Peter C. Richmond, et al. "OPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule." BMJ Open 10, no. 12 (December 2020): e042838. http://dx.doi.org/10.1136/bmjopen-2020-042838.

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IntroductionCombination vaccines containing whole-cell pertussis antigens were phased out from the Australian national immunisation programme between 1997 and 1999 and replaced by the less reactogenic acellular pertussis (aP) antigens. In a large case–control study of Australian children born during the transition period, those with allergist diagnosed IgE-mediated food allergy were less likely to have received whole-cell vaccine in early infancy than matched population controls (OR: 0.77 (95% CI, 0.62 to 0.95)). We hypothesise that a single dose of whole-cell vaccine in early infancy is protective against IgE-mediated food allergy.Methods and analysisThis adaptive double-blind randomised controlled trial is investigating whether a mixed whole-cell/aP vaccine schedule prevents allergic disease in the first year of life. The primary outcome is IgE-mediated food allergy by 12 months of age. Secondary outcomes include new onset of atopic dermatitis by 6 or 12 months of age; sensitisation to at least one allergen by 12 months of age; seroconversion in anti-pertussis toxin IgG titres after vaccination with aP booster at 18 months of age; and solicited systemic and local adverse events following immunisation with pertussis-containing vaccines. Analyses will be performed using a Bayesian group sequential design.Ethics and disseminationThis study has been approved by the Child and Adolescent Health Service Human Research Ethics Committee, Perth, Western Australia (RGS 00019). The investigators will ensure that this trial is conducted in accordance with the principles of the Declaration of Helsinki and with the International Conference on Harmonisation Guidelines for Good Clinical Practice. Individual consent will be requested. Parents will be reimbursed reasonable travel and parking costs to attend the study visits. The dissemination of these research findings will follow the National Health and Medical Research Council of Australia Open Access Policy.Trial registration numberACTRN12617000065392p.
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Lim, Adrian C., Adrian C. See, and Stephen P. Shumack. "Progress in Australian teledermatology." Journal of Telemedicine and Telecare 7, no. 2_suppl (December 2001): 55–58. http://dx.doi.org/10.1258/1357633011937146.

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Because of their remoteness, the majority of rural towns in Australia are disadvantaged in terms of access to dermatological services. Telemedicine offers one solution. Since the mid-1990s, Australian dermatologists have experimented with tele-medicine as an adjunct to clinical practice. The technical viability of teledermatology was first demonstrated in 1997. In 1999, the accuracy and reliability of teledermatology were demonstrated in a real-life urban setting. In 2001, Broken Hill (in western New South Wales), a location remote from dermatology services, served as a trial site for the institution of tele-dermatology as the primary method of accessing dermatological services. High patient and general practitioner acceptability and positive medical outcomes were demonstrated, but the study also revealed unexpected barriers and pitfalls in the effective operation of rural teledermatology.
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Little, John D., Jo Mcfarlane, David Barton, and Shashjit L. Varma. "Australian and US Responses to Electroconvulsive Therapy Dosage Selection." Australian & New Zealand Journal of Psychiatry 36, no. 5 (October 2002): 629–32. http://dx.doi.org/10.1046/j.1440-1614.2002.01081.x.

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Objective: The practice of electroconvulsive therapy (ECT) varies considerably across sites with a lack of certainty as to what constitutes seizure adequacy. The aim of this study was to trial a method to explore decision making and to describe any differences between Australian and US practitioners. Method: Two hundred and thirty-six consultant psychiatrists from Australia and US were asked what dosage of electrical energy they would prescribe after reading a standardized clinical vignette in which an unremarked upon change in seizure tracings followed the first two treatments. Results: Considerable variability in the dosage was found with 17.3% decreasing, 46.8% maintaining and 30% increasing charge. Involvement in administration of ECT was unrelated to this decision. Conclusion: Standardized vignettes may be a useful method to assess clinicians’ responses in dosage selection.
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Harrison, Kristie H., KS Kylie Lee, Timothy Dobbins, Scott Wilson, Noel Hayman, Rowena Ivers, Paul S. Haber, et al. "Supporting Aboriginal Community Controlled Health Services to deliver alcohol care: protocol for a cluster randomised controlled trial." BMJ Open 9, no. 11 (November 2019): e030909. http://dx.doi.org/10.1136/bmjopen-2019-030909.

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IntroductionIndigenous peoples who have experienced colonisation or oppression can have a higher prevalence of alcohol-related harms. In Australia, Aboriginal Community Controlled Health Services (ACCHSs) offer culturally accessible care to Aboriginal and Torres Strait Islander (Indigenous) peoples. However there are many competing health, socioeconomic and cultural client needs.Methods and analysisA randomised cluster wait-control trial will test the effectiveness of a model of tailored and collaborative support for ACCHSs in increasing use of alcohol screening (with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)) and of treatment provision (brief intervention, counselling or relapse prevention medicines).SettingTwenty-two ACCHSs across Australia.RandomisationServices will be stratified by remoteness, then randomised into two groups. Half receive support soon after the trial starts (intervention or ‘early support’); half receive support 2 years later (wait-control or ‘late support’).The supportCore support elements will be tailored to local needs and include: support to nominate two staff as champions for increasing alcohol care; a national training workshop and bimonthly teleconferences for service champions to share knowledge; onsite training, and bimonthly feedback on routinely collected data on screening and treatment provision.Outcomes and analysisPrimary outcome is use of screening using AUDIT-C as routinely recorded on practice software. Secondary outcomes are recording of brief intervention, counselling, relapse prevention medicines; and blood pressure, gamma glutamyltransferase and HbA1c. Multi-level logistic regression will be used to test the effectiveness of support.Ethics and disseminationEthical approval has been obtained from eight ethics committees: the Aboriginal Health and Medical Research Council of New South Wales (1217/16); Central Australian Human Research Ethics Committee (CA-17-2842); Northern Territory Department of Health and Menzies School of Health Research (2017-2737); Central Queensland Hospital and Health Service (17/QCQ/9); Far North Queensland (17/QCH/45-1143); Aboriginal Health Research Ethics Committee, South Australia (04-16-694); St Vincent’s Hospital (Melbourne) Human Research Ethics Committee (LRR 036/17); and Western Australian Aboriginal Health Ethics Committee (779).Trial registration numberACTRN12618001892202; Pre-results.
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Barnes, Courtney, Sze Lin Yoong, Nicole Nathan, Luke Wolfenden, Taya Wedesweiler, Jayde Kerr, Dianne S. Ward, and Alice Grady. "Feasibility of a Web-Based Implementation Intervention to Improve Child Dietary Intake in Early Childhood Education and Care: Pilot Randomized Controlled Trial." Journal of Medical Internet Research 23, no. 12 (December 15, 2021): e25902. http://dx.doi.org/10.2196/25902.

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Background Internationally, the implementation of evidence-based healthy eating policies and practices within early childhood education and care (ECEC) settings that encourage children’s healthy diet is recommended. Despite the existence of evidence-based healthy eating practices, research indicates that current implementation rates are inadequate. Web-based approaches provide a potentially effective and less costly approach to support ECEC staff with implementing nutrition policies and practices. Objective The broad aim of this pilot randomized controlled trial is to assess the feasibility of assessing the impact of a web-based program together with health promotion officer (HPO) support on ECEC center implementation of healthy eating policies and practices. Specifically, we seek to describe the completion rate of study evaluation processes (participant consent and data collection rates); examine ECEC center uptake, acceptability, and appropriateness of the intervention and implementation strategies; understand the potential cost of delivering and receiving implementation support strategies; and describe the potential impact of the web-based intervention on the implementation of targeted healthy eating practices among centers in the intervention group. Methods A 6-month pilot implementation trial using a cluster-randomized controlled trial design was conducted in 22 ECEC centers within the Hunter New England region of New South Wales, Australia. Potentially eligible centers were distributed a recruitment package and telephoned by the research team to assess eligibility and obtain consent. Centers randomly allocated to the intervention group received access to a web-based program, together with HPO support (eg, educational outreach visit and local technical assistance) to implement 5 healthy eating practices. The web-based program incorporated audit with feedback, development of formal implementation blueprints, and educational materials to facilitate improvement in implementation. The centers allocated to the control group received the usual care. Results Of the 57 centers approached for the study, 22 (47%) provided consent to participate. Data collection components were completed by 100% (22/22) of the centers. High uptake for implementation strategies provided by HPOs (10/11, 91% to 11/11, 100%) and the web-based program (11/11, 100%) was observed. At follow-up, intervention centers had logged on to the program at an average of 5.18 (SD 2.52) times. The web-based program and implementation support strategies were highly acceptable (10/11, 91% to 11/11, 100%). Implementation of 4 healthy eating practices improved in the intervention group, ranging from 19% (2/11) to 64% (7/11). Conclusions This study provides promising pilot data to warrant the conduct of a fully powered implementation trial to assess the impact of the program on ECEC healthy eating practice implementation. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001158156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378099 International Registered Report Identifier (IRRID) RR2-10.1186/s40814-020-00707-w
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Tannous, Kathy W., Ajesh George, Moin Uddin Ahmed, Anthony Blinkhorn, Hannah G. Dahlen, John Skinner, Shilpi Ajwani, et al. "Economic evaluation of the Midwifery Initiated Oral Health-Dental Service programme in Australia." BMJ Open 11, no. 8 (August 2021): e047072. http://dx.doi.org/10.1136/bmjopen-2020-047072.

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ObjectivesTo critically evaluate the cost-effectiveness of the Midwifery Initiated Oral Health-Dental Service (MIOH-DS) designed to improve oral health of pregnant Australian women. Previous efficacy and process evaluations of MIOH-DS showed positive outcomes and improvements across various measures.Design and settingThe evaluation used a cost-utility model based on the initial study design of the MIOH-DS trial in Sydney, Australia from the perspective of public healthcare provider for a duration of 3 months to 4 years.ParticipantsData were sourced from pregnant women (n=638), midwives (n=17) and dentists (n=3) involved in the MIOH trial and long-term follow-up.Cost measuresData included in analysis were the cost of the time required by midwives and dentists to deliver the intervention and the cost of dental treatment provided. Costs were measured using data on utilisation and unit price of intervention components and obtained from a micro-costing approach.Outcome measuresUtility was measured as the number of Disability Adjusted Life Years (DALYs) from health-benefit components of the intervention. Three cost-effectiveness analyses were undertaken using different comparators, thresholds and time scenarios.ResultsCompared with current practice, midwives only intervention meets the Australian threshold (A$50 000) of being cost-effective. The midwives and accessible/affordable dentists joint intervention was only ‘cost-effective’ in 6 months or beyond scenarios. When the midwife only intervention is the comparator, the midwife/dentist programme was ‘cost-effective’ in all scenarios except at 3 months scenario.ConclusionsThe midwives’ only intervention providing oral health education, assessment and referral to existing dental services was cost-effective, and represents a low cost intervention. Midwives’ and dentists’ combined interventions were cost-effective when the benefits were considered over longer periods. The findings highlight short and long term economic benefits of the programme and support the need for policymakers to consider adding an oral health component into antenatal care Australia wide.Trial registration numberACTRN12612001271897; Post-results.
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Healy, Genevieve Nissa, Ana D. Goode, Alison Abbott, Jennifer Burzic, Bronwyn K. Clark, David W. Dunstan, Elizabeth G. Eakin, et al. "Supporting Workers to Sit Less and Move More Through the Web-Based BeUpstanding Program: Protocol for a Single-Arm, Repeated Measures Implementation Study." JMIR Research Protocols 9, no. 5 (May 4, 2020): e15756. http://dx.doi.org/10.2196/15756.

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Background The web-based BeUpstanding Champion Toolkit was developed to support work teams in addressing the emergent work health and safety issue of excessive sitting. It provides a step-by-step guide and associated resources that equip a workplace representative—the champion—to adopt and deliver the 8-week intervention program (BeUpstanding) to their work team. The evidence-informed program is designed to raise awareness of the benefits of sitting less and moving more, build a supportive culture for change, and encourage staff to take action to achieve this change. Work teams collectively choose the strategies they want to implement and promote to stand up, sit less, and move more, with this bespoke and participative approach ensuring the strategies are aligned with the team’s needs and existing culture. BeUpstanding has been iteratively developed and optimized through a multiphase process to ensure that it is fit for purpose for wide-scale implementation. Objective The study aimed to describe the current version of BeUpstanding, and the methods and protocol for a national implementation trial. Methods The trial will be conducted in collaboration with five Australian workplace health and safety policy and practice partners. Desk-based work teams from a variety of industries will be recruited from across Australia via partner-led referral pathways. Recruitment will target sectors (small business, rural or regional, call center, blue collar, and government) that are of priority to the policy and practice partners. A minimum of 50 work teams will be recruited per priority sector with a minimum of 10,000 employees exposed to the program. A single-arm, repeated-measures design will assess the short-term (end of program) and long-term (9 months postprogram) impacts. Data will be collected on the web via surveys and toolkit analytics and by the research team via telephone calls with champions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework will guide the evaluation, with assessment of the adoption/reach of the program (the number and characteristics of work teams and participating staff), program implementation (completion by the champion of core program components), effectiveness (on workplace sitting, standing, and moving), and maintenance (sustainability of changes). There will be an economic evaluation of the costs and outcomes of scaling up to national implementation, including intervention affordability and sustainability. Results The study received funding in June 2018 and the original protocol was approved by institutional review board on January 9, 2017, with national implementation trial consent and protocol amendment approved March 12, 2019. The trial started on June 12, 2019, with 48 teams recruited as of December 2019. Conclusions The implementation and multimethod evaluation of BeUpstanding will provide the practice-based evidence needed for informing the potential broader dissemination of the program. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12617000682347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372843&isReview=true. International Registered Report Identifier (IRRID) DERR1-10.2196/15756
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Whittingham, Koa, Jeanie Sheffield, Catherine Mak, Corrine Dickinson, and Roslyn N. Boyd. "Early Parenting Acceptance and Commitment Therapy ‘Early PACT’ for parents of infants with cerebral palsy: a study protocol of a randomised controlled trial." BMJ Open 10, no. 10 (October 2020): e037033. http://dx.doi.org/10.1136/bmjopen-2020-037033.

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IntroductionNew international clinical practice guidelines exist for identifying infants at high risk of cerebral palsy (CP) earlier: between 12 to 24 weeks corrected age, significantly earlier than previous diagnosis windows in Australia at 19 months. The earlier detection of infants at high risk of CP creates an opportunity for earlier intervention. The quality of the parent-infant relationship impacts various child outcomes, and is leveraged in other forms of intervention. This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP. We predict that participating in the Early PACT programme will be associated with improvements in the parent-infant relationship, in parent mental health and well-being as well as infant behaviour and quality of life.Methods and analysisThis study aims to recruit 60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP. Participants will be randomly allocated to one of two groups: Early PACT or waitlist control (1:1). Early PACT is an online parent support programme grounded in Acceptance and Commitment Therapy (ACT). It is delivered as a course on an open source course management system called edX. Early PACT is designed to support parental adjustment and parent-infant relationship around the time of early diagnosis. Assessments will be conducted at baseline, following completion of Early PACT and at 6-month follow-up (retention). The primary outcome will be the quality of parent-child interactions as measured by the Emotional Availability Scale. Standard analysis methods for randomised controlled trial will be used to make comparisons between the two groups (Early PACT and waitlist control). Retention of effects will be examined at 6-month follow-up.Ethics and disseminationThis study is approved through appropriate Australian and New Zealand ethics committees (see in text) with parents providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations.Trial registration detailsThis trial has been prospectively registered on 12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3 74 896
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Zuo, Yeqin, Bernie Mullen, Rachel Hayhurst, Karen Kaye, Renee Granger, and Jonathan Dartnell. "OP08 Using Real World Data To Support National Postmarketing Surveillance." International Journal of Technology Assessment in Health Care 34, S1 (2018): 3. http://dx.doi.org/10.1017/s0266462318000739.

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Introduction:While medicines and medical tests are developed in a controlled clinical trial environment, postmarketing surveillance in the real world can be challenging. MedicineInsight—a database of longitudinal patient-level clinical information from primary care practices in Australia—is a novel program that collects primary care data to improve postmarketing surveillance at a national level.Methods:MedicineInsight collects de-identified clinical information from primary care practice information systems using data extraction tools. MedicineInsight currently includes 3.6 million regular patients of 3,300 family physicians (general practitioners) from 650 primary care practices across Australia. MedicineInsight data include longitudinal clinical information on diagnosis and medicines (dose, strength, route of administration, medication switches over time, adverse events, and allergies), and pathology testing data. A series of observational studies was developed for postmarketing surveillance of management of a range of health priorities including type 2 diabetes mellitus (T2DM), chronic obstructive pulmonary disease (COPD), depression, and antibiotics use.Results:Forty-four percent of patients with T2DM in the MedicineInsight database did not have a recorded hemoglobin A1c result and thirty-one percent did not have a recorded blood pressure reading in the previous 6 months. While guidelines recommend a stepwise approach to the initiation of COPD therapy, forty-nine percent of patients with COPD (with or without asthma) were prescribed dual therapy at initiation and a small number (4.5 percent) were prescribed triple therapy. Between 2011 and 2015, the annual rate of antidepressant prescribing per 1,000 family physician encounters increased by eight percent. High volumes of antibiotics were prescribed for respiratory tract infections in Australian primary care, notwithstanding guideline recommendations that antibiotics are not recommended in most cases.Conclusions:Large scale, real-world clinical data from primary care practices can play an important role in postmarketing surveillance at a national level.
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Millard, Fiona B., R. Lee Kennedy, and Bernhard T. Baune. "Dementia: opportunities for risk reduction and early detection in general practice." Australian Journal of Primary Health 17, no. 1 (2011): 89. http://dx.doi.org/10.1071/py10037.

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This project aimed to measure general practitioner (GP), practice nurse and patient health literacy about memory problems, dementia and its risk factors. Data were collected from general practices across Australia and a smaller sample in England. Questionnaires explored sources and adequacy of dementia knowledge and a randomised controlled trial tested the intervention of a dementia risk reduction pamphlet on patient knowledge of dementia risk reduction strategies. Data were analysed using SPSS software. The results of 621 questionnaires from patients aged over 30 years showed 37% had memory concerns, 6% recalled having a memory test, 52% would like a memory test and 15% had heard about dementia from their GP. Patients receiving the intervention were significantly more likely to be aware of dementia risk reduction strategies (P ≤ 0.005). The results of 153 GP/nurse questionnaires indicated 64% thought a doctor should discuss dementia with patients despite only 21% assessing their dementia knowledge as adequate. There was no significant difference in responses between Australia and England (P ≥ 0.05). The frequency of documentation of Mini-Mental State Examination and dementia diagnosis in computerised medical records of patients over 75 years was less than 0.01. These results demonstrate that many adult patients attending GPs have memory concerns, associate dementia with memory loss, and are receptive to information about dementia risk reduction. Most general practitioners and their nurses rate their dementia knowledge as inadequate with few testing for memory problems or discussing dementia with their patients.
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Byrne, Christopher, Andrew Radley, Sarah Karen Inglis, Lewis J. Z. Beer, Nicki Palmer, Minh Duc Pham, Brendan Healy, Joseph S. Doyle, Peter Donnan, and John F. Dillon. "Reaching mEthadone users Attending Community pHarmacies with HCV: an international cluster randomised controlled trial protocol (REACH HCV)." BMJ Open 10, no. 8 (August 2020): e036501. http://dx.doi.org/10.1136/bmjopen-2019-036501.

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IntroductionHepatitis C virus (HCV) is a global public health threat, and novel models of care are required to treat those currently or previously at highest risk of infection, particularly persons who inject drugs (PWID; ever injected), as conventional healthcare models do not have the reach to deliver cure of HCV to disadvantaged, disproportionately affected communities. In Western Europe and Australasia, it is estimated that HCV affects between 0.4% and 1.0% of the regions’ populations, accordingly, it affects between 0.4% and 0.7% of the populations of countries in this study (Scotland, Wales and Australia). Reaching mEthadone users Attending Community pHarmacies with HCV (REACH HCV) will evaluate community pharmacy-based diagnostic outreach and HCV treatment against conventional HCV testing and treatment pathways for clients receiving opioid substitution therapy (OST) in community pharmacies.Methods and analysisREACH HCV is an international multicentre cluster randomised controlled trial with sites in Scotland, Wales and Australia. The sites are community pharmacies which are randomised equally to one of two pathways: the pharmacy intervention pathway or the education-only (control) pathway. Participants are recruited from OST clients in these pharmacies.In the pharmacy intervention pathway, participants receive a rapid point-of-care HCV PCR test in their pharmacy by a study outreach nurse. If positive, direct-acting antivirals (DAAs) are delivered to participants via their pharmacist in line with their OST schedule.In the education-only pathway, pharmacists counsel OST clients on HCV and refer them to the nearest nurse-led clinic or general practitioner offering HCV testing according to standard care protocols. If positive, DAAs are delivered as in the intervention pathway.The primary endpoint for both pathways is sustained viral response at 12 weeks post-treatment . Secondary outcomes are: cost-efficacy by pathway; participants tested by pathway; adherence to therapy by pathway and impact of blood test results on treatment decisions.A statistical analysis plan will be finalised prior to data lock. Analysis will be by intention to treat (ITT) to show superiority. Modified ITT analysis will also be undertaken to explore the steps in the pathways.Ethics and disseminationThe trial received ethical favourable opinion from the East of Scotland Research Ethics Committee 2 (19/ES/0025) for UK sites and approval from the Alfred Hospital Ethics Committee (148/19) for Australian sites and complies with principles of Good Clinical Practice. Final results will be presented in peer-reviewed journals and at relevant conferences.Trial registration numberClinicalTrials.gov Registry NCT03935906.Protocol versionV.4.0—19 March 2020.
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Hewitt, Lyndel, Carolyn Frohmuller, Li Ming Wen, and Anthony D. Okely. "Effect of a multicomponent intervention in postnatal mothers’ groups on meeting the Australian Physical Activity Guidelines for infants: protocol for a randomised controlled trial." BMJ Open 12, no. 4 (April 2022): e054183. http://dx.doi.org/10.1136/bmjopen-2021-054183.

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IntroductionGiven the importance of tummy time and the low levels of tummy time reported globally, there is a need for high-quality intervention strategies to promote tummy time. This study describes the protocol of a randomised controlled trial that aims to determine the effectiveness of a multicomponent intervention delivered in postnatal mothers’ groups in increasing infant tummy time.Methods and analysisA randomised controlled trial will be conducted. Eligible participants will be mothers and their infants attending postnatal mothers’ groups (New South Wales, Australia). Participants will be randomised to participate in either (1) infant tummy time intervention group (practice, education, WhatsApp) plus usual care; or (2) usual care group. Randomisation process and outcome assessors will be blinded. The intervention will comprise an online education and practice session (60 min) and 4 weeks of WhatsApp messaging (standardised, three times per week). Usual care will be attendance at a mothers group once per week for 3 weeks for information and support for ad hoc mother craft activities (standard practice provided by early childhood nurses for this local health district). The primary outcome will be the amount of infant tummy time using the GENEActiv accelerometer and a questionnaire (post intervention). The accelerometer will be worn on the right hip secured by an elastic belt around the waist. Wear and non-wear time will be classified using temperature and z-axis cut points as per previous research. This protocol paper presents the scientific background and proposed methods of the randomised controlled trial. Findings will inform the design of practically based strategies to inform clinicians, educators and parents about infant physical activity.Ethics and disseminationThe University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee approved the study (2020/ETH02970). Dissemination plan is publication, staff training and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry ACTRN12621000575831; Pre-results.
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Shah, Smita, Jessica K. Roydhouse, Brett G. Toelle, Craig M. Mellis, Christine R. Jenkins, Peter Edwards, and Susan M. Sawyer. "Recruiting and retaining general practitioners to a primary care asthma-intervention study in Australia." Australian Journal of Primary Health 20, no. 1 (2014): 98. http://dx.doi.org/10.1071/py12093.

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The need for more evidence-based interventions in primary care is clear. However, it is challenging to recruit general practitioners (GPs) for interventional research. This paper reports on the evaluation of three methods of recruitment that were sequentially used to recruit GPs for a randomised controlled trial of an asthma communication and education intervention in Australia. The recruitment methods (RMs) were: general practices were contacted by project staff from a Department of General Practice, University of Sydney (RM1); general practices were contacted by staff from an independent research organisation (RM2); and general practices were contacted by a medical peer (chief investigator) (RM3). A GP was defined as ‘recruited’ once they consented and were randomised to a group, and ‘retained’ if they provided baseline data and did not notify staff of their intention to withdraw at any time during the 12-month study. RM1 was used for the first 6 months, during which 34 (4%) GPs were recruited and 21 (62%) retained from a total of 953 invitations. RM2 was then used for the next 5 months, during which 32 (6%) GPs were recruited and 26 (81%) were retained. Finally over the next 7 months, RM3 recruited 84 (12%) GPs and retained 75 (89%) GPs. In conclusion, use of a medical peer as the first contact was associated with the highest recruitment and retention rate.
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Liang, Jenifer, Michael J. Abramson, Nicholas Zwar, Grant Russell, Anne E. Holland, Billie Bonevski, Ajay Mahal, et al. "Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: study protocol for a cluster randomised controlled trial." BMJ Open 7, no. 9 (September 2017): e016985. http://dx.doi.org/10.1136/bmjopen-2017-016985.

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IntroductionUp to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings.Methods and analysisA cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS — Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George’s Respiratory Questionnaire score of patients with COPD at 6 months from baseline.Ethics and disseminationThis project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 – 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time.Trial registration numberACTRN12614001155684; Pre-results.
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