Journal articles on the topic 'Medical ethics Australia'
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Doran, Evan, Jennifer Fleming, Christopher Jordens, Cameron L. Stewart, Julie Letts, and Ian H. Kerridge. "Managing ethical issues in patient care and the need for clinical ethics support." Australian Health Review 39, no. 1 (2015): 44. http://dx.doi.org/10.1071/ah14034.
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Objective To investigate the range, frequency and management of ethical issues encountered by clinicians working in hospitals in New South Wales (NSW), Australia. Methods A cross-sectional survey was conducted of a convenience sample of 104 medical, nursing and allied health professionals in two NSW hospitals. Results Some respondents did not provide data for some questions, therefore the denominator is less than 105 for some items. Sixty-two (62/104; 60%) respondents reported occasionally to often having ethical concerns. Forty-six (46/105; 44%) reported often to occasionally having legal concerns. The three most common responses to concerns were: talking to colleagues (96/105; 91%); raising the issue in a group forum (68/105; 65%); and consulting a relevant guideline (64/105; 61%). Most respondents were highly (65/99; 66%) or moderately (33/99; 33%) satisfied with the ethical environment of the hospital. Twenty-two (22/98; 22%) were highly satisfied with the ethical environment of their department and 74 (74/98; 76%) were moderately satisfied. Most (72/105; 69%) respondents indicated that additional support in dealing with ethical issues would be helpful. Conclusion Clinicians reported frequently experiencing ethical and legal uncertainty and concern. They usually managed this by talking with colleagues. Although this approach was considered adequate, and the ethics of their hospital was reported to be satisfactory, most respondents indicated that additional assistance with ethical and legal concerns would be helpful. Clinical ethics support should be a priority of public hospitals in NSW and elsewhere in Australia. What is known about the topic? Clinicians working in hospitals in the US, Canada and UK have access to ethics expertise to help them manage ethical issues that arise in patient care. How Australian clinicians currently manage the ethical issues they face has not been investigated. What does this paper add? This paper describes the types of ethical issues faced by Australian clinicians, how they manage these issues and whether they think ethics support would be helpful. What are the implications for practitioners? Clinicians frequently encounter ethically and legally difficult decisions and want additional ethics support. Helping clinicians to provide ethically sound patient care should be a priority of public hospitals in NSW and elsewhere in Australia.
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Wheatland, Fiona Tito. "Medical Indemnity Reform in Australia: “First Do No Harm”." Journal of Law, Medicine & Ethics 33, no. 3 (2005): 429–43. http://dx.doi.org/10.1111/j.1748-720x.2005.tb00510.x.
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Medical indemnity is not usually the stuff of high political and social drama in Australia. When the biggest medical defense organization went into voluntary liquidation in 2002, this all changed. Newspapers carried stories on an almost daily basis about the actual or possible negative impact of the “crisis” on doctors, hospitals, and communities. Doctors became increasingly vocal in their criticisms and expansive in their claims. Their political organization, the Australian Medical Association, lobbied powerfully and successfully for government intervention to address the problem of dramatically escalating premiums for some doctors. This, combined with a broader public relations campaign about public liability insurance, resulted in significant changes in the law at both the federal and state level - not just in the area of medical negligence but in relation to most personal injury litigation.The genesis of and reasons for current medical indemnity problems in Australia have been the subject of much speculation and little rigorous analysis.
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Waldby, Catherine, Tereza Hendl, Ian Kerridge, Wendy Lipworth, Tamra Lysaght, Megan Munsie, and Cameron Stewart. "The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients." Regenerative Medicine 15, no. 1 (January 2020): 1238–49. http://dx.doi.org/10.2217/rme-2019-0089.
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The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.
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Forster, Melanie. "Ethical position of medical practitioners who refuse to treat unvaccinated children." Journal of Medical Ethics 45, no. 8 (June 27, 2019): 552–55. http://dx.doi.org/10.1136/medethics-2019-105379.
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Recent reports in Australia have suggested that some medical practitioners are refusing to treat children who have not been vaccinated, a practice that has been observed in the USA and parts of Europe for some years. This behaviour, if it is indeed occurring in Australia, has not been supported by the Australian Medical Association, although there is broad support for medical practitioners in general having the right to conscientious objection. This paper examines the ethical underpinnings of conscientious objection and whether the right to conscientious objection can be applied to the refusal to treat unvaccinated children. The implications of such a decision will also be discussed, to assess whether refusal to treat unvaccinated children is ethically justifiable. The best interests of both existing and new patients are crucially important in a doctor’s practice, and the tension between these two groups of patients are contemplated in the arguments below. It is argued that on balance, the refusal to treat unvaccinated children constitutes unjustified discrimination.
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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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Canaway, Rachel, Khic-Houy Prang, Marie Bismark, David Dunt, and Margaret Kelaher. "Public disclosure of hospital clinicians' performance data: insights from medical directors." Australian Health Review 44, no. 2 (2020): 228. http://dx.doi.org/10.1071/ah18128.
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Objective This study gathered information from public hospital chief medical officers to better understand underlying mechanisms through which public reporting affects institutional behavioural change and decision making towards quality improvement. Methods This qualitative study used thematic analysis of 17 semistructured, in-depth interviews among a peak group of medical directors representing 26 health services in Victoria, Australia. Results The medical directors indicated a high level of in-principle support for public reporting of identifiable, individual clinician-level data. However, they also described varying conceptual understanding of what public reporting of performance data is. Overall, they considered public reporting of individual clinicians’ performance data a means to improve health care quality, increase transparency and inform consumer healthcare decision making. Most identified caveats that would need to be met before such data should be publicly released, in particular the need to resolve issues around data quality and timeliness, context and interpretation and ethics. Acknowledgement of the public’s right to access individual clinician-level data was at odds with some medical directors’ belief that such reporting may diminish trust between clinicians and their employers, thus eroding rather than motivating quality improvement. Conclusions Public reporting of identifiable individual healthcare clinicians’ performance data is an issue that merits robust research and debate given the effects such reporting may have on doctors and on hospital quality and safety. What is known about the topic? The public reporting of individual clinician-level data is a mechanism used in some countries, but not in Australia, for increasing health care transparency and quality. Clinician-level public reporting of doctors’ performance attracts contention and debate in Australia. What does this paper add? This paper informs debate around the public reporting of individual clinician-level performance data. Among a discrete cohort of senior hospital administrators in Victoria, Australia, there was strong in-principle support for such public reporting as a means to improve hospital quality and safety. What are the implications for practitioners? Before public reporting of individual clinician performance data could occur in Australia, resolution of issues would be required relating to legality and ethics, data context and interpretation, data quality and timeliness.
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Barth, Dylan D., Marianne J. Mullane, Claudia Sampson, Coco Chou, Janessa Pickering, Mark P. Nicol, Mark R. Davies, Jonathan Carapetis, and Asha C. Bowen. "Missing Piece Study protocol: prospective surveillance to determine the epidemiology of group A streptococcal pharyngitis and impetigo in remote Western Australia." BMJ Open 12, no. 4 (April 2022): e057296. http://dx.doi.org/10.1136/bmjopen-2021-057296.
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IntroductionGroup A β-haemolytic Streptococcus (GAS), a Gram-positive bacterium, causes skin, mucosal and systemic infections. Repeated GAS infections can lead to autoimmune diseases acute rheumatic fever (ARF) and rheumatic heart disease (RHD). Aboriginal and Torres Strait Islander peoples in Australia have the highest rates of ARF and RHD in the world. Despite this, the contemporaneous prevalence and incidence of GAS pharyngitis and impetigo in remote Australia remains unknown. To address this, we have designed a prospective surveillance study of GAS pharyngitis and impetigo to collect coincident contemporary evidence to inform and enhance primary prevention strategies for ARF.Methods and analysisThe Missing Piece Study aims to document the epidemiology of GAS pharyngitis and impetigo through collection of clinical, serological, microbiological and bacterial genomic data among remote-living Australian children. The study comprises two components: (1) screening of all children at school for GAS pharyngitis and impetigo up to three times a year and (2) weekly active surveillance visits to detect new cases of pharyngitis and impetigo. Environmental swabbing in remote schools will be included, to inform environmental health interventions. In addition, the application of new diagnostic technologies, microbiome analysis and bacterial genomic evaluations will enhance primary prevention strategies, having direct bearing on clinical care, vaccine development and surveillance for vaccine clinical trials.Ethics and disseminationEthical approval has been obtained from the Western Australian Aboriginal Health Ethics Committee (Ref: 892) and Human Research Ethics Committee of the University of Western Australia (Ref: RA/4/20/5101). Study findings will be shared with community members, teachers and children at participating schools, together with academic and medical services. Sharing findings in an appropriate manner is important and will be done in a suitable way which includes plain language summaries and presentations. Finally, findings and updates will also be disseminated to collaborators, researchers and health planners through peer-reviewed journal publications.
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Marshall, Helen S., Prabha H. Andraweera, James Ward, John Kaldor, Ross Andrews, Kristine Macartney, Peter Richmond, et al. "An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia—Study Protocol." Vaccines 10, no. 2 (February 16, 2022): 309. http://dx.doi.org/10.3390/vaccines10020309.
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Invasive meningococcal disease (IMD) causes significant morbidity and mortality worldwide with serogroup B being the predominant serogroup in Australia and other countries for the past few decades. The licensed 4CMenB vaccine is effective in preventing meningococcal B disease. Emerging evidence suggests that although 4CMenB impact on carriage is limited, it may be effective against gonorrhoea due to genetic similarities between Neisseria meningitidis and Neisseria gonorrhoeae. This study protocol describes an observational study that will assess the effect of the 4CMenB vaccine against meningococcal carriage, IMD and gonorrhoea among adolescents in the Northern Territory (NT). All 14–19-year-olds residing in the NT with no contraindication for 4CMenB vaccine will be eligible to participate in this cohort study. Following consent, two doses of 4CMenB vaccine will be administered two months apart. An oropharyngeal swab will be collected at baseline and 12 months to detect pharyngeal carriage of Neisseria meningitidis by PCR. The main methodological approaches to assess the effect of 4CMenB involve a nested case control analysis and screening method to assess vaccine effectiveness and an Interrupted Time Series regression analysis to assess vaccine impact. Research ethics approvals have been obtained from Menzies and Central Australian Human Research Ethics Committees and the Western Australian Aboriginal Health Ethics Committee. Results will be provided in culturally appropriate formats for NT remote and regional communities and published in international peer reviewed journals. ClinicalTrials.gov Identifier: NCT04398849.
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Boyle, Malcolm J., M. ClinEpi, Erin C. Smith, and Frank L. Archer. "Trauma Incidents Attended by Emergency Medical Services in Victoria, Australia." Prehospital and Disaster Medicine 23, no. 1 (February 2008): 20–28. http://dx.doi.org/10.1017/s1049023x00005501.
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AbstractIntroduction:International literature describing the profile of trauma patients attended by a statewide emergency medical services (EMS) system is lacking. Most literature is limited to descriptions of trauma responses for a single emergency medical service, or to patients transported to a specific Level-1 trauma hospital. There is no Victorian or Australian literature describing the type of trauma patients transported by a state emergency medical service.Purpose:The purpose of this study was to define a profile of all trauma incidents attended by statewide EMS.Methods:A retrospective cohort study of all patient care records (PCR) for trauma responses attended by Victorian Ambulance Services for 2002 was conducted. Criteria for trauma categories were defined previously, and data were extracted from the PCRs and entered into a secure data repository for descriptive analysis to determine the trauma profile. Ethics committee approval was obtained.Results:There were 53,039 trauma incidents attended by emergency ambulances during the 12-month period. Of these, 1,566 patients were in physiological distress, 11,086 had a significant pattern of injury, and a further 8,931 had an identifiable mechanism of injury. The profile includes minor trauma (n = 9,342), standing falls (n = 20,511), no patient transported (n = 3,687), and deceased patients (n = 459).Conclusions:This is a unique analysis of prehospital trauma. It provides a baseline dataset that may be utilized in future studies of prehospital trauma care. Additionally, this dataset identifies a ten-fold difference in major trauma between the prehospital and the hospital assessments.
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Sinclair, Justin, Susanne Armour, Jones Asafo Akowuah, Andrew Proudfoot, and Mike Armour. "“Should I Inhale?”—Perceptions, Barriers, and Drivers for Medicinal Cannabis Use amongst Australian Women with Primary Dysmenorrhoea: A Qualitative Study." International Journal of Environmental Research and Public Health 19, no. 3 (January 29, 2022): 1536. http://dx.doi.org/10.3390/ijerph19031536.
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Objective: This study sought to investigate the perceptions, barriers, and drivers associated with medicinal cannabis use among Australian women with primary dysmenorrhea. A qualitative study via virtual focus groups involving 26 women experiencing regular, moderate, or greater menstrual pain explored categories including cost, associated stigma, current drug driving laws, community and workplace ethics, and geographical isolation within the context of patient access under current Australian laws and regulations. Results: A qualitative descriptive analysis identified that dissatisfaction with current management strategies such as over-the-counter analgesic usage was the key driver for wanting to use medicinal cannabis. A number of significant barriers to use were identified including patient access to medical prescribers, medical practitioner bias, current drug driving laws, geographic location, and cost. Community and cultural factors such as the history of cannabis as an illicit drug and the resulting stigma, even when prescribed by a medical doctor, still existed and was of concern to our participants. Conclusion: Whilst medicinal cannabis is legal in all states and territories within Australia, several barriers to access exist that require government regulatory attention to assist in increasing patient adoption, including possible subsidisation of cost. The high cost of legal, medicinal cannabis was a key factor in women’s choice to use illicit cannabis. Overall, the concerns raised by our participants are consistent with the broader findings of a recent Australian Senate inquiry report into barriers to patient access to medicinal cannabis in Australia, suggesting many of the issues are systematic rather than disease-specific. Given the interest in use of medicinal cannabis amongst women with primary dysmenorrhea, clinical trials in this area are urgently needed.
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Kitic, Cecilia M., Steve Selig, Kade Davison, Tania L. B. Best, Belinda Parmenter, Kate Pumpa, Bonnie Furzer, et al. "Study protocol for a multicentre, controlled non-randomised trial: benefits of exercise physiology services for type 2 diabetes (BEST)." BMJ Open 9, no. 8 (August 2019): e027610. http://dx.doi.org/10.1136/bmjopen-2018-027610.
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IntroductionControlled trials support the efficacy of exercise as a treatment modality for chronic conditions, yet effectiveness of real-world Exercise Physiology services is yet to be determined. This study will investigate the efficacy and cost-effectiveness of services provided by Accredited Exercise Physiologists (AEPs) for clients with type 2 diabetes (T2D) in clinical practice.Methods and analysisA non-randomised, opportunistic control, longitudinal design trial will be conducted at ten Exercise Physiology Clinics. Participants will be individuals with T2D attending one of the Exercise Physiology Clinics for routine AEP services (exercise prescription and counselling) (intervention) or individuals with T2D not receiving AEP services (usual care) (control). The experimental period will be 6 months with measurements performed at baseline and at 6 months. Primary outcome measures will be glycosylated haemoglobin (HbA1c), resting brachial blood pressure (BP), body mass index, waist circumference, 6 min walk test, grip strength, 30 s sit to stand, Medical Outcomes Short-Form 36-Item Health Survey and Active Australia Questionnaire. Secondary outcomes will be medication usage, out-of-pocket expenses, incidental, billable and non-billable health professional encounters and work missed through ill health. Healthcare utilisation will be measured for 12 months prior to, during and 12 months after trial participation using linked data from Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data.Ethics and disseminationThe study is a multicentre trial comprising: University of Tasmania, University of New South Wales Lifestyle Clinic, University of Canberra, Baker Heart and Diabetes Institute (covered under the ethics approval of University of Tasmania Health and Medical Ethics Committee H0015266), Deakin University (Approval number: 2016–187), Australian Catholic University (2016–304R), Queensland University of Technology (1600000049), University of South Australia (0000035306), University of Western Australia (RA/4/1/8282) and Canberra Hospital (ETH.8.17.170). The findings of this clinical trial will be communicated via peer-reviewed journal articles, conference presentations, social media and broadcast media.Trial registration numberACTRN12616000264482.
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Clough, Alan R., Kristy Grant, Jan Robertson, Matthew Wrigley, Nina Nichols, and Tracey Fitzgibbon. "Interventions to encourage smoke-free homes in remote indigenous Australian communities: a study protocol to evaluate the effects of a community-inspired awareness-raising and motivational enhancement strategy." BMJ Open 8, no. 3 (March 2018): e018955. http://dx.doi.org/10.1136/bmjopen-2017-018955.
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IntroductionRates of secondhand smoke exposure are currently significantly higher among remote indigenous communities in the top end of Australia. By implementing a ‘smoke-free home’ rule, secondhand smoke exposure can be reduced. Smoke-free homes encourage quit attempts and improve the health of children. The prevalence of indigenous smoking rates in remote, discrete communities in Australia is elevated compared with their non-indigenous counterparts. The primary aim of this project is to examine the feasibility of conducting a health-driven intervention to encourage community members to make their homes a smoke-free zone.Methods and analysisThis study uses mixed-methods exploratory evaluation design to obtain data from key informants and community householders to assess their willingness to implement a ‘smoke-free’ rule in their homes. Initial focus groups will provide guidance on intervention content and deliver evaluation procedures and community requirements. A rapid survey will be conducted to ascertain interest from community members in having the project team visit to discuss study objectives further and to have a particle meter (with consent) placed in the house. Focus groups recordings will be transcribed and analysed thematically. Rapid surveys will be analysed using frequency distributions and tabulations of responses.Ethics and disseminationThe National Health and Medical Research Council guidelines on ethical research approaches to indigenous studies will be adhered to. The James Cook University Human Research Ethics Committee has provided ethics approval.
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Emmerich, Nathan, and Christine Phillips. "Should professional interpreters be able to conscientiously object in healthcare settings?" Journal of Medical Ethics 46, no. 10 (December 3, 2019): 700–704. http://dx.doi.org/10.1136/medethics-2019-105767.
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In a globalised world, healthcare professionals will inevitably find themselves caring for patients whose first language differs from their own. Drawing on experiences in Australia, this paper examines a specific problem that can arise in medical consultations using professional interpreters: whether the moral objections of interpreters should be accommodated as conscientious objections if and when their services are required in contexts where healthcare professionals have such entitlements, most notably in relation to consultations concerning termination of pregnancy and voluntary assisted dying. We argue that existing statements of professional ethics suggest that interpreters should not be accorded such rights. The social organisation of healthcare and interpreting services in Australia may mean those who have serious objections to particular medical practices could provide their services in restricted healthcare contexts. Nevertheless, as a general rule, interpreters who have such objections should avoid working within healthcare.
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Usher, Kim, Navjot Bhullar, David Sibbritt, Suruchi Sue Anubha Amarasena, Wenbo Peng, Joanne Durkin, Reakeeta Smallwood, et al. "Influence of COVID-19 on the preventive health behaviours of indigenous peoples of Australia residing in New South Wales: a mixed-method study protocol." BMJ Open 11, no. 9 (September 2021): e047404. http://dx.doi.org/10.1136/bmjopen-2020-047404.
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IntroductionChronic conditions impact indigenous peoples of Australia at a much higher rate than non-indigenous Australians. Attendance at the Medicare Benefits Scheme (MBS) supported indigenous health checks are crucial to improve prevention and management of chronic health conditions. However, in conjunction with lifestyle and environmental factors, attendance rates at primary healthcare services for screening and treatment have fallen in Australia during the COVID-19 pandemic. This study aims to explore the influence of the COVID-19 pandemic on preventive health behaviours of indigenous Australians and the associated barriers to, and enablers of, engagement with health services to formulate a targeted intervention strategy.Methods and analysisA concurrent mixed-methods study (comprising quantitative and qualitative data collection methods) will be employed. Descriptive analysis of MBS data about the characteristics of indigenous peoples of Australia claiming health assessment services will be performed. Generalised estimating equation regression models will be used to examine the use of health assessment services over time. Qualitative interviews informed by indigenous research methods will be conducted. Interviews will investigate barriers to, and enablers of, engagement with health services. Thematic approach guided by the principles of indigenist praxis, storytelling and collaborative research will be used to analyse the interview data. The project commenced in July 2020 and will be completed by July 2022.Ethics and disseminationThe project received ethics approval from the Aboriginal Health and Medical Research Council of New South Wales and the University of New England Human Research Ethics Committee. Findings will be disseminated via peer-reviewed journal articles, conferences, government and relevant stakeholder reports, and infographics.
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McGrath, Pam, Saras Henderson, Hamish A. Holewa, David Henderson, and John Tamargo. "International medical graduates' reflections on facilitators and barriers to undertaking the Australian Medical Council examination." Australian Health Review 36, no. 3 (2012): 296. http://dx.doi.org/10.1071/ah11082.
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Objective. In Australia, 25% of international medical graduates (IMGs) make up the medical workforce. Concern is expressed in the literature about the lack of awareness and knowledge of issues that impinge on IMGs’ education. Although there is literature alluding to difficulties IMGs face with undertaking the Australian Medical Council (AMC) examination, there is little research detailing this experience. We therefore explored IMGs’ reflections on facilitators and barriers in undertaking the AMC examination. Methods. After ethics approval, in-depth telephone interviews were conducted with 30 IMGs selected from a hospital in Queensland. Data were coded and analysed using thematic analysis principles. Results. Two facilitating themes were identified: ability to sit for the first part of the examination in country of origin; and having access to resources such as bridging courses and study groups. Three themes represented barriers: not understanding procedural steps; financial issues; and lack of information on examination content and standards. Conclusion. The themes provide new insights and add depth to existing literature that can be used to improve procedural processes and education for IMGs towards successful outcomes in the AMC examination. What is known about the topic? There is concern expressed in the literature about the lack of awareness and knowledge of issues that impinge on IMGs education. The Australian work that is available only depicts educational experience of fellowships or education and training strategies after IMGs have passed their AMC examination. What does this paper add? The findings indicate that the process of sitting for the AMC examination is perceived as one of the major difficulties associated with entering and integrating into the Australian health system. The findings indicate a range of practical, financial and resource problems faced by IMGs attempting to sit for the AMC examination. What are the implications for practitioners? The detailed accounts from IMGs about their experience with undertaking the AMC examination will provide up-skilling program coordinators with the information they need to better assist IMGs to prepare for the examination. The provision of appropriate medical training and educational support will contribute to more effective integration of IMGs into the healthcare system.
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Gilbert, Julia, and Jane Boag. "‘To die, to sleep’ – assisted dying legislation in Victoria: A case study." Nursing Ethics 26, no. 7-8 (November 19, 2018): 1976–82. http://dx.doi.org/10.1177/0969733018806339.
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Background: Assisted dying remains an emotive topic globally with a number of countries initiating legislation to allow individuals access to assisted dying measures. Victoria will become the first Australian state in over 13 years to pass Assisted Dying Legislation, set to come into effect in 2019. Objectives: This article sought to evaluate the impact of Victorian Assisted Dying Legislation via narrative view and case study presentation. Research design: Narrative review and case study. Participants and research context: case study. Ethical considerations: This legislation will provide eligible Victorian residents with the option to request access to assisted dying measures as a viable alternative to a potentially painful, protracted death. Findings: This legislation, while conservative and inclusive of many safeguards at present, will form the basis for further discussion and debate on assisted dying across Australia in time to come. Discussion: The passing of this legislation by the Victorian parliament was prolonged, emotive and divided not only the parliament but Australian society. Conclusion: Many advocates for this legislation proclaimed it was well overdue and will finally meet the needs of contemporary society. Protagonists claim that medical treatment should not provide a means of ending life, despite palliative care reportedly often failing to relieve the pain and suffering of individuals living with a terminal illness.
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Watson, Lyndsey F., Jo-Anne Rayner, and Judith M. Lumley. "Hospital ethics approval for a population-based case–control study of very preterm birth." Australian Health Review 31, no. 4 (2007): 514. http://dx.doi.org/10.1071/ah070514.
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Aim: To describe the process involved in obtaining ethics approval for a study aiming to recruit women from all maternity hospitals in Victoria, Australia. Design: Observational data of the application process involving 85 hospitals throughout Victoria in 2001. Results: Twenty-three of the 85 hospitals had a Human Research Ethics Committee (HREC) constituted in accordance with the National Health and Medical Council requirements; 27 agreed to accept decisions from other hospitals having HRECs and 27 relied on ethics advisory committees, hospital managers, clinical staff, quality assurance committees or lawyers for ethics decisions. Four of the latter did not approve the study. Eight hospitals no longer provided maternity services in the recruitment period. The process took 16 months, 26 000 sheets of paper, 258 copies of the application and the cost was about $30 000. Approval was eventually obtained for recruitment at 73 hospitals. Discussion: Difficulties exist in obtaining timely ethics approval for multicentre studies due to a complex uncoordinated system. All hospitals should have explicit protocols for dealing with research ethics applications so that they can be processed in a straightforward and timely manner. To facilitate this, those without properly constituted HRECs should be affiliated with one hospital that has an HREC.
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Burns, Kara, and Suzanne Belton. "Clinicians and their cameras: policy, ethics and practice in an Australian tertiary hospital." Australian Health Review 37, no. 4 (2013): 437. http://dx.doi.org/10.1071/ah12039.
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Medical photography illustrates what people would prefer to keep private, is practiced when people are vulnerable, and has the power to freeze a moment in time. Given it is a sensitive area of health, lawful and ethical practice is paramount. This paper recognises and seeks to clarify the possibility of widespread clinician-taken medical photography in a tertiary hospital in Australia, examining the legal and ethical implications of this practice. A framework of law, state Department of Health policy and human rights theory were used to argue the thesis. Clinicians from 13 purposively chosen wards were asked to participate in an anonymous survey and confidential in-depth interviews. Questions were generated from the literature and local knowledge on the topics of ‘occurrence’, ‘image use’, ‘quality of consent’, ‘cameras and technology’, ‘confidentiality’, ‘data storage and security’, ‘hospital policy and law’ and ‘cultural issues’. One hundred and seventy surveys and eight interviews were analysed using descriptive statistics and theme and content analysis, then triangulated for similarity, difference and unique responses. Forty-eight percent of clinicians surveyed take medical photographs, with the majority using hospital-owned cameras. However, one-fifth of clinicians reported photographing with personal mobile phones. Non-compliance with written consent requirements articulated in policy was endemic, with most clinicians surveyed obtaining only verbal consent. Labelling, storage, copyright and cultural issues were generally misunderstood, with a significant number of clinicians risking the security of patient information by storing images on personal devices. If this tertiary hospital does not develop a clinical photography action plan to address staff lack of knowledge, and non-compliance with policy and mobile phone use, patients’ data is at risk of being distributed into the public domain where unauthorised publication may cause psychological harm and have legal ramifications for the hospital, its patients, and staff. What is known about the topic? While professional medical photography has been widely used for recording patient condition, evidencing care and teaching, little is known about the use of digital photographs taken by clinicians in Australian hospitals. Our research demonstrates that the ubiquitous nature of personal camera phones is encouraging clinicians to practice medical photography on personal devices. Clinicians who take photographs of patients have practical, legal and ethical issues to negotiate. Without careful management of these images, especially on personal devices, accidental and deliberate misuse is possible. What does this paper add? This paper adds to knowledge of clinician-performed medical photography practice: no other study has reported on the subject across multiple wards in an Australian tertiary hospital. This paper defines key areas of inquiry relevant to the topic, documents poor knowledge and compliance with hospital policy and highlights areas of risk to patients, staff and hospital. What are the implications for practitioners? It is likely that the behaviours and knowledge of digital photography documented in our research site are similar to that in other hospitals. Practitioners, managers and policy makers need to be aware of the ethics and regulations regarding consent, use, storage, disposal and ownership of patients’ digital images to ensure the practice follows ethical and legislated guidelines.
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Rai, Sumeet, Rhonda Brown, Frank van Haren, Teresa Neeman, Arvind Rajamani, Krishnaswamy Sundararajan, and Imogen Mitchell. "Long-term follow-up for Psychological stRess in Intensive CarE (PRICE) survivors: study protocol for a multicentre, prospective observational cohort study in Australian intensive care units." BMJ Open 9, no. 1 (January 2019): e023310. http://dx.doi.org/10.1136/bmjopen-2018-023310.
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IntroductionThere are little published data on the long-term psychological outcomes in intensive care unit (ICU) survivors and their family members in Australian ICUs. In addition, there is scant literature evaluating the effects of psychological morbidity in intensive care survivors on their family members. The aims of this study are to describe and compare the long-term psychological outcomes of intubated and non-intubated ICU survivors and their family members in an Australian ICU setting.Methods and analysisThis will be a prospective observational cohort study across four ICUs in Australia. The study aims to recruit 150 (75 intubated and 75 non-intubated) adult ICU survivors and 150 family members of the survivors from 2015 to 2018. Long-term psychological outcomes and effects on health-related quality of life (HRQoL) will be evaluated at 3 and 12 months follow-up using validated and published screening tools. The primary objective is to compare the prevalence of affective symptoms in intubated and non-intubated survivors of intensive care and their families and its effects on HRQoL. The secondary objective is to explore dyadic relations of psychological outcomes in patients and their family members.Ethics and disseminationThe study has been approved by the relevant human research ethics committees (HREC) of Australian Capital Territory (ACT) Health (ETH.11.14.315), New South Wales (HREC/16/HNE/64), South Australia (HREC/15/RAH/346). The results of this study will be published in a peer-reviewed medical journal and presented to the local intensive care community and other stakeholders.Trial registration numberACTRN12615000880549; Pre-results.
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Whop, Lisa J., Tamara L. Butler, Julia M. L. Brotherton, Kate Anderson, Joan Cunningham, Allison Tong, and Gail Garvey. "Study protocol: Yarning about HPV Vaccination: a qualitative study of factors influencing HPV vaccination among Aboriginal and Torres Strait Islander adolescents in Australia." BMJ Open 11, no. 8 (August 2021): e047890. http://dx.doi.org/10.1136/bmjopen-2020-047890.
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IntroductionAboriginal and Torres Strait Islander women experience a higher burden of cervical cancer than non-Indigenous women in Australia. Cervical cancer is preventable partly through human papillomavirus (HPV) vaccination; in Australia, this is delivered through the national school-based immunisation programme. While HPV vaccination uptake is high among Australian adolescents, there remain gaps in uptake and completion among Aboriginal and Torres Strait Islander adolescents. This study aims to gain a comprehensive understanding of the barriers and facilitators to HPV vaccination uptake and completion among Aboriginal and Torres Strait Islander adolescents in Queensland, Australia.Methods and analysisThe study will be guided by an Indigenist research approach and an ecological model for health promotion. Yarning, a qualitative Indigenous research method, will be conducted in up to 10 schools. Participants will include Year 7 (12/13 years old) Aboriginal and Torres Strait Islander adolescents; parents/caregivers; and local key informants and immunisation programme partners involved in the delivery of school-based HPV immunisation programme. Participants will be recruited through school representatives and investigator networks using purposive and snowball sampling and samples of convenience. Field notes, HPV vaccination clinic observations and sequential diagramming of the HPV vaccination process will be conducted. Thematic analysis of data will be led by Aboriginal and Torres Strait Islander researchers. Synthesised sequential diagrams of the process of HPV vaccination and qualitative themes summarising key findings will be produced.Ethics and disseminationThe Aboriginal Health and Medical Research Council of New South Wales Ethics Committee (1646/20), the Australian National University Human Research Ethics Committee (HREC, 2020/478), the HREC of the Northern Territory Department of Health and Menzies School of Health Research (19-3484) and the Townsville Hospital and Health Service HREC (HREC/QTHS/73789) have approved the study. Dissemination will occur via conferences and peer-reviewed publications. Further dissemination will be determined in partnership with the Aboriginal and Torres Strait Islander Steering Committee, including Youth Representatives and Consultation Network.
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Botha, Willings, Natasha Donnolley, Marian Shanahan, and Georgina M. Chambers. "Assessment of the societal and individual preferences for fertility treatment in Australia: study protocol for stated preference discrete choice experiments." BMJ Open 8, no. 2 (February 2018): e020509. http://dx.doi.org/10.1136/bmjopen-2017-020509.
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IntroductionIn Australia, societal and individual preferences for funding fertility treatment remain largely unknown. This has resulted in a lack of evidence about willingness to pay (WTP) for fertility treatment by either the general population (the funders) or infertile individuals (who directly benefit). Using a stated preference discrete choice experiment (SPDCE) approach has been suggested as a more appropriate method to inform economic evaluations of fertility treatment. We outline the protocol for an ongoing study which aims to assess fertility treatment preferences of both the general population and infertile individuals, and indirectly estimate their WTP for fertility treatment.Methods and analysisTwo separate but related SPDCEs will be conducted for two population samples—the general population and infertile individuals—to elicit preferences for fertility treatment to indirectly estimate WTP. We describe the qualitative work to be undertaken to design the SPDCEs. We will use D-efficient fractional experimental designs informed by prior coefficients from the pilot surveys. The mode of administration for the SPDCE is also discussed. The final results will be analysed using mixed logit or latent class model.Ethics and disseminationThis study is being funded by the Australian National Health and Medical Research Council (NHMRC) project grant AP1104543 and has been approved by the University of New South Wales Human Research Ethics Committee (HEC 17255) and a fertility clinic’s ethics committee. Findings of the study will be disseminated in peer-reviewed journals and presented at various conferences. A lay summary of the results will be made publicly available on the University of New South Wales National Perinatal Epidemiology and Statistics Unit website. Our results will contribute to the development of an evidence-based policy framework for the provision of cost-effective and patient-centred fertility treatment in Australia.
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Strachan, Glenda. "Not Just a Labour of Love: industrial action by nurses in Australia." Nursing Ethics 4, no. 4 (July 1997): 294–302. http://dx.doi.org/10.1177/096973309700400405.
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Deciding to take industrial action or go on strike has been an issue of great concern for nurses. While it is typical for most groups of workers to undertake industrial action in the pursuit of better wages and working conditions or improved quality of services, historically, nurses have found this a difficult course to pursue. Frequently, nurses have been caught between acceptance of themselves as ordinary workers and a professional model, which has carried with it the implication that a profession does not engage in industrial action (although, in reality, professions, including medical practitioners, have undertaken industrial action). Nurses in Australia have gone on strike, although widespread industrial action was not undertaken until the 1980s, when lengthy industrial campaigns, including strikes, were used in an effort to achieve enhanced status for the profession, improved career paths and increased salaries. While debate remains about the efficacy of this course of action, large numbers of nurses have been involved in these campaigns. Significant changes in salaries and status were achieved in the 1980s.
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Luke, Carly R., Katherine Benfer, Leeann Mick-Ramsamy, Robert S. Ware, Natasha Reid, Arend F. Bos, Margot Bosanquet, and Roslyn N. Boyd. "Early detection of Australian Aboriginal and Torres Strait Islander infants at high risk of adverse neurodevelopmental outcomes at 12 months corrected age: LEAP-CP prospective cohort study protocol." BMJ Open 12, no. 1 (January 2022): e053646. http://dx.doi.org/10.1136/bmjopen-2021-053646.
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IntroductionNeurodevelopmental disorders (NDD), including cerebral palsy (CP), autism spectrum disorder (ASD) and foetal alcohol spectrum disorder (FASD), are characterised by impaired development of the early central nervous system, impacting cognitive and/or physical function. Early detection of NDD enables infants to be fast-tracked to early intervention services, optimising outcomes. Aboriginal and Torres Strait Islander infants may experience early life factors increasing their risk of neurodevelopmental vulnerability, which persist into later childhood, further compounding the health inequities experienced by First Nations peoples in Australia. The LEAP-CP prospective cohort study will investigate the efficacy of early screening programmes, implemented in Queensland, Australia to earlier identify Aboriginal and Torres Strait Islander infants who are ‘at risk’ of adverse neurodevelopmental outcomes (NDO) or NDD. Diagnostic accuracy and feasibility of early detection tools for identifying infants ‘at risk’ of a later diagnosis of adverse NDO or NDD will be determined.Methods and analysisAboriginal and/or Torres Strait Islander infants born in Queensland, Australia (birth years 2020–2022) will be invited to participate. Infants aged <9 months corrected age (CA) will undergo screening using the (1) General Movements Assessment (GMA); (2) Hammersmith Infant Neurological Examination (HINE); (3) Rapid Neurodevelopmental Assessment (RNDA) and (4) Ages and Stages Questionnaire-Aboriginal adaptation (ASQ-TRAK). Developmental outcomes at 12 months CA will be determined for: (1) neurological (HINE); (2) motor (Peabody Developmental Motor Scales 2); (3) cognitive and communication (Bayley Scales of Infant Development III); (4) functional capabilities (Paediatric Evaluation of Disability Inventory-Computer Adaptive Test) and (5) behaviour (Infant Toddler Social and Emotional Assessment). Infants will be classified as typically developing or ‘at risk’ of an adverse NDO and/or specific NDD based on symptomology using developmental and diagnostic outcomes for (1) CP (2) ASD and (3) FASD. The effects of perinatal, social and environmental factors, caregiver mental health and clinical neuroimaging on NDOs will be investigated.Ethics and disseminationEthics approval has been granted by appropriate Queensland ethics committees; Far North Queensland Health Research Ethics Committee (HREC/2019/QCH/50533 (Sep ver 2)-1370), the Townsville HHS Human Research Ethics Committee (HREC/QTHS/56008), the University of Queensland Medical Research Ethics Committee (2020000185/HREC/2019/QCH/50533) and the Children’s Health Queensland HHS Human Research Ethics Committee (HREC/20/QCHQ/63906) with governance and support from local First Nations communities. Findings from this study will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberACTRN12619000969167.
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Stapinski, Lexine, Kylie Routledge, Mieke Snijder, Michael Doyle, Katrina Champion, Cath Chapman, James Ward, et al. "A Web-Based Alcohol and Other Drug Prevention Program (Strong & Deadly Futures) for Aboriginal and Torres Strait Islander School Students: Protocol for a Cluster Randomized Controlled Trial." JMIR Research Protocols 11, no. 1 (January 7, 2022): e34530. http://dx.doi.org/10.2196/34530.
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Background There are no available school-based alcohol and drug prevention programs with evidence of effectiveness among Aboriginal and Torres Strait Islander youth. To address this, we codeveloped the Strong & Deadly Futures well-being and alcohol and drug prevention program in partnership with an Indigenous creative design agency and 4 Australian schools. Objective This paper presents the protocol to evaluate the effectiveness of Strong & Deadly Futures in reducing alcohol and other drug use and improving well-being among Aboriginal and Torres Strait Islander youth. Methods The target sample will be 960 year 7 and 8 students from 24 secondary schools in Australia, of which approximately 40% (384/960) will identify as Aboriginal or Torres Strait Islander. The study design is a 2-group, parallel cluster randomized controlled trial with allocation concealment. Recruited schools will be block randomized (ratio 1:1), stratified by geographical remoteness, by an independent statistician. Schools will be randomized to receive Strong & Deadly Futures, a web-based alcohol and drug prevention and social and emotional well-being program that delivers curriculum-aligned content over 6 lessons via an illustrated story, or health education as usual (control). Control schools will be supported to implement Strong & Deadly Futures following trial completion. Surveys will be administered at baseline, 6 weeks, 12 months, and 24 months (primary end point) post baseline. Primary outcomes are alcohol use (adapted from the National Drug Strategy Household Survey), tobacco use (Standard High School Youth Risk Behavior Survey), and psychological distress (Kessler-5 Psychological Distress Scale). Secondary outcomes are alcohol and drug knowledge and intentions, alcohol-related harms, binge drinking, cannabis use, well-being, empowerment, appreciation of cultural diversity, and truancy. Results The trial was funded by the National Health and Medical Research Council in January 2019, approved by the Human Research Ethics Committee of the University of Sydney (2020/039, April 2020), the Aboriginal Health and Medical Research Council of New South Wales (1620/19, February 2020), the Western Australian Aboriginal Health Ethics Committee (998, October 2021), and the ethics committees of each participating school, including the New South Wales Department of Education (2020170, June 2020), Catholic Education Western Australia (RP2020/39, November 2020), and the Queensland Department of Education (550/27/2390, August 2021). Projected dates of data collection are 2022-2024, and we expect to publish the results in 2025. A total of 24 schools have been recruited as of submission of the manuscript. Conclusions This will be the first cluster randomized controlled trial of a culturally inclusive, school-based alcohol and drug prevention program for Aboriginal and Torres Strait Islander youth; therefore, it has significant potential to address alcohol and other drug harms among Aboriginal and Torres Strait Islander youth. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12620001038987; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380038&isReview=true International Registered Report Identifier (IRRID) PRR1-10.2196/34530
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Smith, Justine R., Alexandra L. Farrall, Janet L. Davis, Joke H. de Boer, Anthony J. Hall, Manabu Mochizuki, H. Nida Sen, et al. "The International Vitreoretinal B-Cell Lymphoma Registry: a protocol paper." BMJ Open 12, no. 7 (July 2022): e060701. http://dx.doi.org/10.1136/bmjopen-2021-060701.
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IntroductionVitreoretinal lymphoma is a rare ocular cancer with high morbidity and mortality despite treatment. Diagnosis by cytopathology is often delayed, and various molecular and image-based investigations have been developed. Diverse treatments are used, but there is a limited medical evidence to differentiate their effectiveness. We designed an international registry that would collect diagnostic, treatment and outcomes data, to establish new evidence for the management of this cancer.Methods and analysisThe International Vitreoretinal B-Cell Lymphoma Registry will accrue data retrospectively for individuals aged 18 years or older, diagnosed with new or recurrent vitreoretinal B-cell lymphoma on or after 1 January 2020. A steering committee of subspecialised ophthalmologists identified 20 key clinical data items that describe patient demographics, tissue involvements, diagnostic testing, ocular and systemic treatments and treatment complications, and visual acuity and survival outcomes. Customised software was designed to permit collection of these data across a single baseline and multiple follow-up forms. The platform collects data without identifiers and at 3 month reporting intervals. Outcomes of the project will include: (1) descriptions of clinical presentations, and diagnostic and therapeutic preferences; (2) associations between clinical presentations, and diagnostics and treatments, and between diagnostics and treatments (assessed by ORs with 95% CIs); and (3) estimations of rates of vision loss, and progression-free and overall survival (assessed by Kaplan-Meier estimates).Ethics and disseminationThe registry has received Australia-wide approval by a national human research ethics committee. Sites located outside Australia are required to seek local human research ethics review. Results generated through the registry will be disseminated primarily by peer-reviewed publications that are expected to inform clinical practice, as well as educational materials.
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Roberts, Shelley, Lauren T. Williams, Ishtar Sladdin, Heidi Neil, Zane Hopper, Julie Jenkins, Alan Spencer, and Andrea P. Marshall. "Improving Nutrition Care, Delivery, and Intakes Among Hospitalised Patients: A Mixed Methods, Integrated Knowledge Translation Study." Nutrients 11, no. 6 (June 24, 2019): 1417. http://dx.doi.org/10.3390/nu11061417.
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Malnutrition is a common and complex problem in hospitals. This study used an integrated knowledge translation approach to develop, implement, and evaluate a multifaceted, tailored intervention to improve nutrition care, delivery, and intake among acute medical inpatients. This observational, pre-post study was conducted in a medical ward at a public hospital in Australia. The intervention was co-developed with key stakeholders and targeted three levels: individuals (nutrition intake magnets at patient bedsides), the ward (multidisciplinary hospital staff training), and the organisation (foodservice system changes). Observational data were collected pre- and post-intervention on patient demographics, food intakes, and the mealtime environment. Data were entered into SPSS and analysed using descriptive and inferential statistics. Ethical approval was gained through the hospital and university ethics committees. A total of 207 patients were observed; 116 pre- and 91 post-intervention. After intervention implementation, patients’ mean energy and protein intakes (in proportion to their estimated requirements) were significantly higher and the number of patients eating adequately doubled (p < 0.05). In summary, a multifaceted, pragmatic intervention, tailored to the study context and developed and implemented alongside hospital staff and patients, seemed to be effective in improving nutrition practices and patient nutrition intakes on an acute medical ward.
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Byard, Roger W. "Deaths associated with wheelchairs." Medicine, Science and the Law 61, no. 3 (January 20, 2021): 193–97. http://dx.doi.org/10.1177/0025802420988224.
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As lethal events associated with wheelchair use are poorly reported in the literature, a search was undertaken of the Forensic Science South Australia (FSSA), Australia, autopsy database over a 20-year period for all cases where individuals who were wheelchair bound were found dead either in or beside their chairs. There were 16 cases, ranging in age from 30 to 92 years ( M = 58.6 years) and with a male-to-female ratio of 9:7. There were six accidents that involved burns, asphyxia, a fall and impact with a vehicle; three suicides that involved drowning and asphyxia; a single homicide involving drowning; a single undetermined case; and five cases due to medical conditions such as cerebral palsy with choking, ischaemic heart disease and pulmonary thromboembolism. Individuals who use wheelchairs may die from a wide variety of both unnatural and natural causes. Wheelchair users may be predisposed to specific types of accidents because of significant underlying physical impairment or serious diseases that may limit their ability either to move away from danger or to perform self-rescues. Morbidity and mortality associated with underlying medical conditions may be contributed to by the structure, stability and motility of wheelchairs.
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Mullane, Marianne J., Timothy C. Barnett, Jeffrey W. Cannon, Jonathan R. Carapetis, Ray Christophers, Juli Coffin, Mark A. Jones, et al. "SToP (See, Treat, Prevent) skin sores and scabies trial: study protocol for a cluster randomised, stepped-wedge trial for skin disease control in remote Western Australia." BMJ Open 9, no. 9 (September 2019): e030635. http://dx.doi.org/10.1136/bmjopen-2019-030635.
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IntroductionSkin is important in Australian Aboriginal culture informing kinship and identity. In many remote Aboriginal communities, scabies and impetigo are very common. Untreated skin infections are painful, itchy and frequently go untreated due to under-recognition and lack of awareness of their potential serious complications. We hypothesise that the skin infection burden in remote Aboriginal communities can be reduced by implementing streamlined training and treatment pathways integrated with environmental health and health promotion activities, tested in the See, Treat, Prevent (SToP skin sores and scabies) trial.Methods and analysisSToP will evaluate a skin control programme using a stepped-wedge, cluster randomised trial design with three intervention components (the ‘SToP activities’): (1) seeing skin infections (development of training resources implemented within a community dermatology model); (2) treating skin infections (employing the latest evidence for impetigo, and scabies treatment); and (3) preventing skin infections (embedded, culturally informed health promotion and environmental health activities). Four community clusters in the remote Kimberley region of Western Australia will participate. Following baseline data collection, two clusters will be randomly allocated to the SToP activities. At 12 months, the remaining two clusters will transition to the SToP activities. The primary outcome is the diagnosis of impetigo in children (5–9 years) at school-based surveillance. Secondary outcome measures include scabies diagnosis, other child health indicators, resistance to cotrimoxazole in circulating pathogenic bacteria, determining the economic burden of skin disease and evaluating the cost effectiveness of SToP activities.Ethics and disseminationThis study protocol was approved by the health ethics review committees at the Child and Adolescent Health Service (Approval number RGS0000000584), the Western Australian Aboriginal Health Ethics Committee (Reference number: 819) and the University of Western Australia (Reference RA/4/20/4123). Study findings will be shared with community members, academic and medical communities via publications and presentations, and in reports to funders. Authorship for all publications based on this study will be determined in line with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals published by the International Committee of Medical Journal Editors. Sharing results with organisations and communities who contributed to the study is paramount. The results of the SToP trial will be shared with participants in a suitable format, such as a single summary page provided to participants or presentations to communities, the Kimberly Aboriginal Health Planning Forum Research Subcommittee and other stakeholders as appropriate and as requested. Communication and dissemination will require ongoing consultation with Aboriginal communities to determine appropriate formats.Trial registration numberACTRN12618000520235.
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Kiel, Ida Almenning, Sofie Lionett, Evelyn Bridget Parr, Helen Jones, Maria Aurora Hernandez Røset, Øyvind Salvesen, Eszter Vanky, and Trine Moholdt. "Improving reproductive function in women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT): study protocol for a two-centre, three-armed randomised controlled trial." BMJ Open 10, no. 2 (February 2020): e034733. http://dx.doi.org/10.1136/bmjopen-2019-034733.
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IntroductionPolycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and the leading cause of anovulatory infertility. Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI). A healthy lifestyle is recommended to improve overall health and fertility in PCOS but there is limited evidence on the isolated effects of exercise, especially for reproductive outcomes. Previous findings indicate superior metabolic health benefits after vigorous compared with moderate-intensity exercise. Our primary aim is to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS.Methods and analysisThe study is a two-centre, randomised, controlled trial with three parallel groups. Women (n=64) from Trondheim (Norway) and Melbourne (Australia) with PCOS according to the Rotterdam criteria will be randomly allocated (1:1:1) to high-volume HIT, low-volume HIT or a control group with no exercise after stratifying for BMI < or ≥ 27 kg/m2and study centre. Measurements for study end points will be undertaken at baseline, after a 16 week exercise intervention and at 12 months following baseline assessments. The primary outcome measure is menstruation frequency, measured as the number of self-reported menstrual bleedings divided by the number of expected menstrual bleedings during a 12-month period. Secondary outcome measurements include markers of cardiovascular, metabolic and reproductive health, as well as quality of life and adherence to and enjoyment of exercise.Ethics and disseminationThe Regional Committee Medical Research Ethics, Norway, and The Australian Catholic University Human Research Ethics Committee, Australia, have approved the trial protocol. This trial will provide new insight regarding the impact of exercise on fertility in PCOS. We expect this trial to contribute to new therapeutic exercise strategies as part of clinical care for women with PCOS.Trial registration numberClinical trial govNCT02419482.
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Zion, Deborah, and Richard Matthews. "Can research ethics codes be a conduit for justice? An examination of Aboriginal and Torres Strait Islander guidelines in Australia." Research Ethics 18, no. 1 (October 25, 2021): 51–63. http://dx.doi.org/10.1177/17470161211053199.
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Aboriginal and Torres Strait Islander peoples in Australia, have historically experienced research as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, the risk of exploitation and oppression arising from research still raises challenging ethical questions. Since the 1990s the National Health and Medical Research Council in Australia has developed specific sets of guidelines that govern research with these populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead to research and research practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships.
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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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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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Neil, D. A., C. A. J. Coady, J. Thompson, and H. Kuhse. "End-of-life decisions in medical practice: a survey of doctors in Victoria (Australia)." Journal of Medical Ethics 33, no. 12 (December 1, 2007): 721–25. http://dx.doi.org/10.1136/jme.2006.017137.
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Windsor, Peter Andrew. "Role of Topical Anaesthesia in Pain Management of Farm Animals, a Changing Paradigm." Animals 12, no. 18 (September 17, 2022): 2459. http://dx.doi.org/10.3390/ani12182459.
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Field evidence indicates that livestock producers are motivated by access to products that readily deliver pain management during husbandry interventions and, more recently, viral epidermal infectious diseases, including FMD. There has been impressive adoption in Australia of a farmer-applied spray-on topical anaesthetic wound formulation (TAF; Tri-Solfen®, Medical Ethics, Australia), initially for managing pain of the breech modification ‘mulesing’ procedure that reduces susceptibility of sheep to flystrike. Over 120 million lambs have now received pain relief and cattle producers have commenced using the TAF for a range of husbandry procedures. This product has demonstrated efficacy for surgical castration and tail docking of lambs, surgical castration and dehorning of calves, surgical castration of piglets, debridement of lesions of the hoof for lame cattle and, importantly, treatment of clinical FMD lesions, including decubitus ulcerations occurring from prolonged recumbency. Multimodal use of an NSAID for improved pain management is advocated, particularly meloxicam, available by prescription from veterinarians for injection and as an oral formulation (Ilium Buccalgesic®, Troy Laboratories, Australia), with current work assessing the potential for prolonged delivery in molasses blocks. Increased use of TAF with NSAIDs significantly reduces pain and suffering in livestock, with enhanced healing of FMD lesions, reduced viral loads from Orf infections in lambs and diminished necessity of ‘antibiotic cover’, assisting antimicrobial-resistance (AMR) stewardship.
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Ray-Barruel, Gillian, Marie Cooke, Vineet Chopra, Marion Mitchell, and Claire M. Rickard. "The I-DECIDED clinical decision-making tool for peripheral intravenous catheter assessment and safe removal: a clinimetric evaluation." BMJ Open 10, no. 1 (January 2020): e035239. http://dx.doi.org/10.1136/bmjopen-2019-035239.
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ObjectiveTo describe the clinimetric validation of the I-DECIDED tool for peripheral intravenous catheter assessment and decision-making.Design and settingI-DECIDED is an eight-step tool derived from international vascular access guidelines into a structured mnemonic for device assessment and decision-making. The clinimetric evaluation process was conducted in three distinct phases.MethodsInitial face validity was confirmed with a vascular access working group. Next, content validity testing was conducted via online survey with vascular access experts and clinicians from Australia, the UK, the USA and Canada. Finally, inter-rater reliability was conducted between 34 pairs of assessors for a total of 68 peripheral intravenous catheter (PIVC) assessments. Assessments were timed to ensure feasibility, and the second rater was blinded to the first’s findings. Content validity index (CVI), mean item-level CVI (I-CVI), internal consistency, mean proportion of agreement, observed and expected inter-rater agreements, and prevalence-adjusted bias-adjusted kappas (PABAK) were calculated. Ethics approvals were obtained from university and hospital ethics committees.ResultsThe I-DECIDED tool demonstrated strong content validity among international vascular access experts (n=7; mean I-CVI=0.91; mean proportion of agreement=0.91) and clinicians (n=11; mean I-CVI=0.93; mean proportion of agreement=0.94), and high inter-rater reliability in seven adult medical-surgical wards of three Australian hospitals. Overall, inter-rater reliability was 87.13%, with PABAK for each principle ranging from 0.5882 (‘patient education’) to 1.0000 (‘document the decision’). Time to complete assessments averaged 2 min, and nurse-reported acceptability was high.ConclusionThis is the first comprehensive, evidence-based, valid and reliable PIVC assessment and decision tool. We recommend studies to evaluate the outcome of implementing this tool in clinical practice.Trial registration number12617000067370
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Sullivan, Elizabeth, Stephen Ward, Reem Zeki, Sarah Wayland, Juanita Sherwood, Alex Wang, Faye Worner, Sacha Kendall, James Brown, and Sungwon Chang. "Recidivism, health and social functioning following release to the community of NSW prisoners with problematic drug use: study protocol of the population-based retrospective cohort study on the evaluation of the Connections Program." BMJ Open 9, no. 7 (July 2019): e030546. http://dx.doi.org/10.1136/bmjopen-2019-030546.
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IntroductionThe rising rate of incarceration in Australia, driven by high reoffending, is a major public health problem. Problematic drug use is associated with increasing rates of reoffending and return to custody of individuals. Throughcare provides support to individuals during imprisonment through to post-release, improving both the transition to community and health outcomes post-incarceration. The aim of this study is to evaluate the Connections Programme (CP) that utilises a throughcare approach for release planning of people in prison with a history of problematic drug use. The study protocol is described.Methods and analysisPopulation-based retrospective cohort study. The study will use record linkage of the Connections dataset with 10 other New South Wales (NSW) population datasets on offending, health service utilisation, opioid substitution therapy, pregnancy, birth and mortality. The study includes all patients who were eligible to participate in the CP between January 2008 and December 2015 stratified by patients who were offered CP and eligible patients who were not offered the programme (non-CP (NCP)). Propensity-score matching will be used to appropriately adjust for the observable differences between CP and NCP. The differences between two groups will be examined using appropriate univariate and multivariate analyses. A generalised estimating equation approach, which can deal with repeat outcomes for individuals will be used to examine recidivism, mortality and other health outcomes, including perinatal and infant outcomes. Survival analysis techniques will be used to examine the effect of the CP by sex and Indigenous status on the ‘time-to’ health-related outcomes after adjusting for potential confounders.Ethics and disseminationEthical approval was received from the NSW Population and Health Services Research Ethics Committee, the Justice Health and Forensic Mental Health Network Human Research Ethics Committee, the Aboriginal Health and Medical Research Council Ethics Committee, the Corrective Services NSW Ethics Committee and the University of Technology Sydney Human Research Ethics Committee.
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Stevens, C. A., and R. Hassan. "Management of death, dying and euthanasia: attitudes and practices of medical practitioners in South Australia." Journal of Medical Ethics 20, no. 1 (March 1, 1994): 41–46. http://dx.doi.org/10.1136/jme.20.1.41.
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Hedrick, Kyli, and Rohan Borschmann. "Prevalence, methods and characteristics of self-harm among asylum seekers in Australia: protocol for a systematic review." BMJ Open 12, no. 3 (March 2022): e060234. http://dx.doi.org/10.1136/bmjopen-2021-060234.
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IntroductionAsylum seekers are at increased risk of self-harm compared with the general population, and the experience of detention may further exacerbate this risk. Despite this, evidence regarding the prevalence, methods and characteristics of self-harm among asylum seekers in Australia (including those detained in onshore and offshore immigration detention) has not been synthesised. Such information is necessary to inform evidence-based prevention initiatives, and effective clinical and governmental responses to self-harm. This review will synthesise findings from the literature regarding the prevalence, methods and characteristics of self-harm among asylum seekers in both detained and community-based settings in Australia.Methods and analysisWe searched key electronic health, psychology and medical databases (PsycINFO, Scopus, PubMed and MEDLINE) for studies published in English between 1 January 1992 and 31 December 2021. Our primary outcome is self-harm among asylum seekers held in onshore and/or offshore immigration detention, community detention and/or in community-based arrangements in Australia. We will include all study designs (except single case studies) that examine the prevalence of self-harm in asylum seekers. Studies published between 1992—the commencement of Australia’s policy of mandatory immigration detention—and 2021 will be included. We will not apply any age restrictions. The Methodological Standard for Epidemiological Research scale will be used to assess the quality of included studies. If there are sufficient studies, and homogeneity between them, we will conduct meta-analyses to calculate pooled estimates of self-harm rates and compare relevant subgroups. If studies report insufficient data, or there is substantial heterogeneity, findings will be provided in narrative form.Ethics and disseminationThis review is exempt from ethics approval as it will synthesise findings from published studies with pre-existing ethics approval. Our findings will be disseminated through a peer-reviewed journal article and conference presentations.PROSPERO registration numberCRD42020203444.
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Wagner, Bree, James P. Fitzpatrick, Trevor G. Mazzucchelli, Martyn Symons, Heather Carmichael Olson, Tracy Jirikowic, Donna Cross, et al. "Study protocol for a self-controlled cluster randomised trial of the Alert Program to improve self-regulation and executive function in Australian Aboriginal children with fetal alcohol spectrum disorder." BMJ Open 8, no. 3 (March 2018): e021462. http://dx.doi.org/10.1136/bmjopen-2017-021462.
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IntroductionWhile research highlights the benefits of early diagnosis and intervention for children with fetal alcohol spectrum disorders (FASD), there are limited data documenting effective interventions for Australian children living in remote communities.Methods and analysisThis self-controlled cluster randomised trial is evaluating the effectiveness of an 8-week Alert Program school curriculum for improving self-regulation and executive function in children living in remote Australian Aboriginal communities. Children in grades 1–6 attending any of the eight participating schools across the Fitzroy Valley in remote North-West Australia (N≈ 363) were invited to participate. Each school was assigned to one of four clusters with clusters randomly assigned to receive the intervention at one of four time points. Clusters two, three and four had extended control conditions where students received regular schooling before later receiving the intervention. Trained classroom teachers delivered the Alert Program to students in discrete, weekly, 1-hour lessons. Student outcomes were assessed at three time points. For the intervention condition, data collection occurred 2 weeks immediately before and after the intervention, with a follow-up 8 weeks later. For control conditions in clusters two to four, the control data collection matched that of the data collection for the intervention condition in the preceding cluster. The primary outcome is change in self-regulation. FASD diagnoses will be determined via medical record review after the completion of data collection. The results will be analysed using generalised linear mixed modelling and reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines.Ethics and disseminationEthical approval was obtained from the University of Western Australia (WA) (RA/4/1/7234), WA Aboriginal Health Ethics Committee (601) and WA Country Health Service (2015:04). The Kimberley Aboriginal Health Planning Forum Research Sub-Committee and WA Department of Education also provided approval. The results will be disseminated through peer-reviewed journals, conference presentations, the media and at forums.Trial registration numberACTRN12615000733572; Pre-results.
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Marschner, Simone, Edwina Wing-Lun, Clara Chow, Louise Maple-Brown, Sian Graham, Stephen J. Nicholls, Alex Brown, et al. "Randomised clinical trial using Coronary Artery Calcium Scoring in Australian Women with Novel Cardiovascular Risk Factors (CAC-WOMEN Trial): study protocol." BMJ Open 12, no. 12 (December 2022): e062685. http://dx.doi.org/10.1136/bmjopen-2022-062685.
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IntroductionCardiovascular disease (CVD) is the leading cause of death in women around the world. Aboriginal and Torres Strait Islander women (Australian Indigenous women) have a high burden of CVD, occurring on average 10–20 years earlier than non-Indigenous women. Traditional risk prediction tools (eg, Framingham) underpredict CVD risk in women and Indigenous people and do not consider female-specific ‘risk-enhancers’ such as hypertensive disorders of pregnancy (HDP), gestational diabetes mellitus (GDM) and premature menopause. A CT coronary artery calcium score (‘CT-calcium score’) can detect calcified atherosclerotic plaque well before the onset of symptoms, being the single best predictor for future cardiac events. A CT-calcium score may therefore help physicians intensify medical therapy in women with risk-enhancing factors.Methods and analysisThis multisite, single-blind randomised (1:1) controlled trial of 700 women will assess the effectiveness of a CT-calcium score-guided approach on cardiovascular risk factor control and healthy lifestyle adherence, compared with standard care. Women without CVD aged 40–65 (35–65 for Aboriginal and Torres Strait Islander women) at low-intermediate risk on standard risk calculators and with at least one risk-enhancing factor (eg, HDP, GDM, premature menopause) will be recruited. Aboriginal and Torres Strait Islander women will be actively recruited, aiming for ~10% of the sample size. The 6-month coprimary outcomes will be low-density lipoprotein cholesterol and systolic blood pressure. Barriers and enablers will be assessed, and a health economic analysis performed.Ethics and disseminationWestern Sydney Local Health District Research Ethics Committee (HREC 2021/ETH11250) provided ethics approval. Written informed consent will be obtained before randomisation. Consent will be sought for access to individual participant Medicare Benefits Schedule, Pharmaceutical Benefits Scheme claims usage through Medicare Australia and linked Admitted Patient Data Collection. Study results will be disseminated via peer-reviewed publications and presentations at national and international conferences.Trial registration numberACTRN12621001738819p.
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Dieng, Mbathio, Nikita Khanna, Mai Thi Hoang Nguyen, Robin Turner, Sarah J. Lord, Alexander M. Menzies, Jay Allen, et al. "Cost-effectiveness analysis of PET/CT surveillance imaging to detect systemic recurrence in resected stage III melanoma: study protocol." BMJ Open 10, no. 11 (November 2020): e037857. http://dx.doi.org/10.1136/bmjopen-2020-037857.
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IntroductionIn the new era of effective systemic therapies for advanced melanoma, early detection of lower volume recurrent disease using surveillance imaging can improve survival. However, intensive imaging follow-up strategies are likely to increase costs to health systems and may pose risks to patients. The objective of this study is to estimate from the Australian health system perspective the cost-effectiveness of four follow-up strategies in resected stage III melanoma over a 5-year period following surgical treatment with curative intent.Methods and analysisA decision-analytic model will be built to estimate the costs and benefits of (1) 12 monthly, (2) 6 monthly, (3) 3–4 monthly positron emission tomography/CT imaging for 5 years, compared with (4) no imaging follow-up. The model will be populated with probabilities of disease recurrence, test performance measures using data from >1000 consecutive resected stage III melanoma patients from Melanoma Institute Australia diagnosed between 2000 and 2017. Healthcare resource use, including surveillance imaging, doctor’s visits, subsequent tests and procedures to investigate suspicious findings, will be quantified from detailed patient records and valued using Australian reference pricing. Economic outcomes include cost per new distant melanoma recurrence detected and cost per diagnostic error avoided, for no imaging compared with the other strategies.Deterministic sensitivity analyses will examine the robustness of model results.Ethics and disseminationThis study was approved by the Sydney Local Health District, Sydney Local Health District Ethics Review Committee (RPAH Zone), AU/1/830638 and the Australian Institute of Health and Welfare (EO2019-1-454). The results of this study will be published in peer-reviewed medical and health economics journals and will inform melanoma management guidelines.
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Rapport, Frances, Patti Shih, Rebecca Mitchell, Armin Nikpour, Andrew Bleasel, Geoffrey Herkes, Sanjyot Vagholkar, and Virginia Mumford. "Better evidence for earlier assessment and surgical intervention for refractory epilepsy (The BEST study): a mixed methods study protocol." BMJ Open 7, no. 8 (August 2017): e017148. http://dx.doi.org/10.1136/bmjopen-2017-017148.
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IntroductionOne-third of patients with refractory epilepsy may be candidates for resective surgery, which can lead to positive clinical outcomes if efficiently managed. In Australia, there is currently between a 6-month and 2-year delay for patients who are candidates for respective epilepsy surgery from the point of referral for surgical assessment to the eventual surgical intervention. This is a major challenge for implementation of effective treatment for individuals who could potentially benefit from surgery. This study examines implications of delays following the point of eligibility for surgery, in the assessment and treatment of patients, and the factors causing treatment delays.Methods and analysisMixed methods design: Observations of qualitative consultations, patient and healthcare professional interviews, and health-related quality of life assessments for a group of 10 patients and six healthcare professionals (group 1); quantitative retrospective medical records’ reviews examining longitudinal outcomes for 50 patients assessed for, or undergoing, resective surgery between 2014 and 2016 (group 2); retrospective epidemiological study of all individuals hospitalised with a diagnosis of epilepsy in New South Wales (NSW) in the last 5 years (2012–2016; approximately 11 000 hospitalisations per year, total 55 000), examining health services’ use and treatment for individuals with epilepsy, including refractory surgery outcomes (group 3).Ethics and disseminationEthical approval has been granted by the North Sydney Local Health District Human Research Ethics Committee (HREC/17/HAWKE/22) and the NSW Population & Health Services Research Ethics Committee (HREC/16/CIPHS/1). Results will be disseminated through publications, reports and conference presentations to patients and families, health professionals and researchers.
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Humphrey, G. F. "Scientific Fraud: The McBride Case." Medicine, Science and the Law 32, no. 3 (July 1992): 199–203. http://dx.doi.org/10.1177/002580249203200303.
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Scientific fraud has occasionally been reported in Australia. The most recent case involved Dr William McBride, a prominent Sydney obstetrician who became well known in medical research for his part in drawing attention to the teratogenic effects of thalidomide. It is still not clear how much of McBride's later activities were fraud and how much poor quality research. The findings of the Inquiry into the matter (Gibbs et al., 1988) have considerable importance for the conduct of private research organizations, publication procedures of research journals, the role of assistants in research projects, collaboration between laboratories, and methods for inquiring into allegations of malpractice. The present paper is based on the Inquiry report.
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Chalmers, Don, and Robert Schwartz. "Malpractice Liability for the Failure to Adequately Educate Patients: The Australian Law of “Informed Consent” and Its Implications for American Ethics Committees." Cambridge Quarterly of Healthcare Ethics 2, no. 3 (1993): 371–79. http://dx.doi.org/10.1017/s0963180100004382.
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At first glance, the first informed consent case to be decided by the High Court of Australia appears to be little more than a clear and simple description of the substantive law accepted in most American jurisdictions - although that is no small accomplishment in and of itself. In Rogers v. Whitaker, the highest court in Australia succinctly and persuasively rejected informed consent as a species of battery law, accepted it as a form, of ordinary professional negligence law, and adopted the “American” patient-oriented standard (rather than the British doctor-oriented standard) for measuring the breach of a healthcare professional's duty to her or his patients. On second look, however, the opinion is an even more significant one because it reveals that the law of informed consent is now based on principles broad enough to create a duty on the part of healthcare providers to offer adequate health education to all of their patients. In Implicitly recognizing the physician's duty to educate her or his patients, the High Court's judgment is consistent with a view increasingly held In the medical and ethical communities that teaching patients about how to maintain their health is just as much a part of the doctor's function as diagnosing and treating disease. It may have taken 2,500 years for medicine to progress from, the Hippocratic notion that physicians should apply treatment to patients who are kept in blissful Ignorance of their condition and Its remedy, but there Is little doubt that medicine finally has entered a post-Hippocratic era.
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Karapetis, Christos Stelios, Rajiv Kumar, Quek Timothy, Shawgi Sukumaran, Ganessan Kichenadasse, Divyanshu Dua, Harminder Singh Takhar, et al. "What do patients with cancer think of the use of their tumor tissue for medical research?" Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 6541. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.6541.
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6541 Background: Research involving archival tumor tissue has become increasingly important in molecular oncology and has led to improved therapeutics. There are important ethical considerations for such research. We examined the attitudes of patients with cancer toward research that used their tumor tissue. Methods: From January to April 2012, consecutive patients with cancer attending the outpatient clinic of the Flinders Cancer Centre were asked to complete a 27-item investigator-developed questionnaire. The questionnaire included 4 sections: 1) demographics, 2) understanding of cancer research, 3) donation of tumor tissue and 4) ethical issues. Results: 118 patients completed the questionnaire, 53% male and mean age 61. 95% stated that they believed that research involving tumor tissue was beneficial to the public and to cancer patients in the future. 72% responded such research could have a direct benefit for them. 94% would allow their tissue to be used for future research. 86% stated that nothing would prevent them from allowing tissue research. Only14% believed that they needed to be informed about the research. Only 5% were of the opinion that the tissue still belonged to them after it had been removed from their body. 72% were not concerned where their tissue was sent for research, whilst 19% preferred that the research be conducted in Australia. When asked about the use of tissue for research after death, 10% stated that their prior approval was required, less than 1% wanted their family members to approve the research whilst 80% felt that ethics committee approval without individual consent was acceptable. Less than 1% stated that the tissue should be destroyed after death. 69% expressed a preference for the research findings to be available to everyone without commercialisation. Conclusions: The majority of patients permit the use of their tumor tissue for research with ethical approval but without the expectation of individual consent. After death, most patients did not want to have their tissue discarded and were accepting of research without the need for prior consent or family approval. We need to understand the preferences of the majority of patients in determining optimal policy for correlative tumor tissue research.
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Kosola, Silja, Evelyn Culnane, Hayley Loftus, Anna Tornivuori, Mira Kallio, Michelle Telfer, Päivi J. Miettinen, et al. "Bridge study protocol: an international, observational cohort study on the transition of healthcare for adolescents with chronic conditions." BMJ Open 11, no. 6 (June 2021): e048340. http://dx.doi.org/10.1136/bmjopen-2020-048340.
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IntroductionMore than 10% of adolescents live with a chronic disease or disability that requires regular medical follow-up as they mature into adulthood. During the first 2 years after adolescents with chronic conditions are transferred to adult hospitals, non-adherence rates approach 70% and emergency visits and hospitalisation rates significantly increase. The purpose of the Bridge study is to prospectively examine associations of transition readiness and care experiences with transition success: young patients’ health, health-related quality of life (HRQoL) and adherence to medical appointments as well as costs of care. In addition, we will track patients’ growing independence and educational and employment pathways during the transition process.Methods and analysisBridge is an international, prospective, observational cohort study. Study participants are adolescents with a chronic health condition or disability and their parents/guardians who attended the New Children’s Hospital in Helsinki, Finland, or the Royal Children’s Hospital (RCH) in Melbourne, Australia. Baseline assessment took place approximately 6 months prior to the transfer of care and follow-up data will be collected 1 year and 2 years after the transfer of care. Data will be collected from patients’ hospital records and from questionnaires completed by the patient and their parent/guardian at each time point. The primary outcomes of this study are adherence to medical appointments, clinical health status and HRQoL and costs of care. Secondary outcome measures are educational and employment outcomes.Ethics and disseminationThe Ethics Committee for Women’s and Children’s Health and Psychiatry at the Helsinki University Hospital (HUS/1547/2017) and the RCH Human Research Ethics Committee (38035) have approved the Bridge study protocol. Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study as well as patients and their parents/guardians.Trial registration numberNCT04631965.
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Sakzewski, Leanne, Yannick Bleyenheuft, Roslyn N. Boyd, Iona Novak, Catherine Elliott, Sarah Reedman, Cathy Morgan, et al. "Protocol for a multisite randomised trial of Hand–Arm Bimanual Intensive Training Including Lower Extremity training for children with bilateral cerebral palsy: HABIT-ILE Australia." BMJ Open 9, no. 9 (September 2019): e032194. http://dx.doi.org/10.1136/bmjopen-2019-032194.
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IntroductionChildren with bilateral cerebral palsy often experience difficulties with posture, gross motor function and manual ability, impacting independence in daily life activities, participation and quality of life (QOL). Hand–Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE) is a novel intensive motor intervention integrating upper and lower extremity training. This study aimed to compare HABIT-ILE to usual care in a large randomised controlled trial (RCT) in terms of gross motor function, manual ability, goal attainment, walking endurance, mobility, self-care and QOL. A within-trial cost–utility analysis will be conducted to synthesise costs and benefits of HABIT-ILE compared with usual care.Methods and analysis126 children with bilateral cerebral palsy aged 6–16 years will be recruited across three sites in Australia. Children will be stratified by site and Gross Motor Function Classification System and randomised using concealed allocation to either receiving HABIT-ILE immediately or being waitlisted for 26 weeks. HABIT-ILE will be delivered in groups of 8–12 children, for 6.5 hours per day for 10 days (total 65 hours, 2 weeks). Outcomes will be assessed at baseline, immediately following intervention, and then retention of effects will be tested at 26 weeks. Primary outcomes will be the Gross Motor Function Measure and ABILHAND-Kids. Secondary outcomes will be brain structural integrity, walking endurance, bimanual hand performance, self-care, mobility, performance and satisfaction with individualised goals, and QOL. Analyses will follow standard principles for RCTs using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Children’s Health Queensland Hospital and the Health Service Human Research Ethics Committee (HREC/17/QRCH/282) of The University of Queensland (2018000017/HREC/17/QRCH/2820), and The Cerebral Palsy Alliance Ethics Committee (2018_04_01/HREC/17/QRCH/282).Trial registration numberACTRN12618000164291.
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Cvejic, Erin, Gordon Parker, Samuel B. Harvey, Zachery Steel, Dusan Hadzi-Pavlovic, Claire L. Macnamara, and Uté Vollmer-Conna. "The health and well-being of Australia’s future medical doctors: protocol for a 5-year observational cohort study of medical trainees." BMJ Open 7, no. 9 (September 2017): e016837. http://dx.doi.org/10.1136/bmjopen-2017-016837.
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IntroductionClinical training in the undergraduate medical course places multiple stressors on trainees, which have been held to lead to heightened distress, depression, suicide, substance misuse/abuse and poor mental health outcomes. To date, evidence for morbidity in trainees is largely derived from cross-sectional survey-based research. This limits the accuracy of estimates and the extent to which predispositional vulnerabilities (biological and/or psychological), contextual triggers and longer-term consequences can be validly identified. Longitudinal clinical assessments embedded within a biopsychosocial framework are needed before effective preventative and treatment strategies can be put in place.Methods and analysisThis study is an observational longitudinal cohort study of 330 students enrolled in the undergraduate medicine course at the University of New South Wales (UNSW) Sydney, Australia. Students will be recruited in their fourth year of study and undergo annual assessments for 4 consecutive years as they progress through increasingly demanding clinical training, including internship. Assessments will include clinical interviews for psychiatric morbidity, and self-report questionnaires to obtain health, psychosocial, performance and functioning information. Objective measures of cognitive performance, sleep/activity patterns as well as autonomic and immune function (via peripheral blood samples) will be obtained. These data will be used to determine the prevalence, incidence and severity of mental disorder, elucidate contextual and biological triggers and mechanisms underpinning psychopathology and examine the impact of psychopathology on performance and professional functioning.Ethics and disseminationEthics approval has been granted by the UNSW human research ethics committee (reference HC16340). The findings will be disseminated through peer-reviewed publications and conference presentations, and distributed to key stakeholders within the medical education sector. The outcomes will also inform targeted preventative and treatment strategies to enhance stress resilience in trainee doctors.
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Tuckerman, Jane, Kelly Harper, Thomas R. Sullivan, Jennifer Fereday, Jennifer Couper, Nicholas Smith, Andrew Tai, et al. "Using provider–parent strategies to improve influenza vaccination in children and adolescents with special risk medical conditions: a randomised controlled trial protocol." BMJ Open 12, no. 2 (February 2022): e053838. http://dx.doi.org/10.1136/bmjopen-2021-053838.
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IntroductionInfluenza immunisation is a highly cost-effective public health intervention. Despite a comprehensive National Immunisation Program, influenza vaccination in children and adolescents with special risk medical conditions (SRMCs) is suboptimal. Flutext-4U is an innovative, multi-component strategy targeting paediatric hospitals, general practice and parents of children and adolescents with SRMC. The Flutext-4U study aims to assess the impact of Flutext-4U to increase influenza immunisation in children and adolescents with SRMC.Methods and analysisThis is a randomised controlled trial involving parents of children and adolescents (aged >6 months to <18 years) with SRMC receiving tertiary care at the Women’s and Children’s Hospital (WCH), Adelaide, South Australia, who are eligible for funded influenza immunisation with a hospital appointment between the start of the seasonal influenza vaccination season and 31 July 2021, their treating general practitioners (GPs), and WCH paediatric specialists.Parents (of children/adolescents with SRMC) are randomised (1:1 ratio) to standard care plus intervention (SMS reminder messages to parents; reminders (written correspondence) for their child’s GP from the hospital’s Paediatric Outpatients Department) or standard care (hospital vaccine availability, ease of access and reminders for WCH subspecialists) with randomisation stratified by age-group (<5, 5–14, >14 to <18 years).The primary outcome is influenza vaccination, as confirmed by the Australian Immunisation Register.The proportion vaccinated (primary outcome) will be compared between randomised groups using logistic regression, with adjustment made for age group at randomisation. The effect of treatment will be described using an OR with a 95% CI.Ethics and disseminationThe protocol and all study materials have been reviewed and approved by the Women’s and Children’s Health Network Human Research Ethics Committee (HREC/20/WCHN/5). Results will be disseminated via peer-reviewed publication and at scientific meetings, professional and public forums.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12621000463875).
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Duffield, Christine, Susan Chapman, Samantha Rowbotham, and Nicole Blay. "Nurse-Performed Endoscopy." Policy, Politics, & Nursing Practice 18, no. 1 (February 2017): 36–43. http://dx.doi.org/10.1177/1527154417700740.
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Increasing demands for health care globally often lead to discussions about expanding the involvement of nurses in a range of nontraditional roles. Several countries have introduced nurse endoscopists as a means of easing the burden of demand for a range of endoscopic procedures. A shortage of medical staff in Australia combined with increasing demand for endoscopy led to the implementation of nurse endoscopists as a pilot program in the state of Queensland, where a nurse practitioner model was implemented, and Victoria, where an advanced practice model was used. This article will discuss the implementation of and responses from the nursing, medical, and policy community to nurse-performed endoscopy in this country. Regarding health policy, access to cancer screening may be improved by providing nurses with advanced training to safely perform endoscopy procedures. Moreover, issues of nurse credentialing and payment need to be considered appropriate to each country’s health system model.