Improving the identification of bone-specific physical activity using wrist-worn accelerometry: A cross-sectional study in 11-12-year-old Australian children.

Physical activity (PA) during childhood and adolescence is important for the accrual of maximal peak bone mass. The precise dose that benefits bone remains unclear as methods commonly used to analyze PA data are unsuitable for measuring bone-relevant PA. Using improved accelerometry methods, this study identified the amount and intensity of PA most strongly associated with bone outcomes in 11-12-year-olds. Participants (n = 770; 382 boys) underwent tibial peripheral quantitative computed tomography to assess trabecular and cortical density, endosteal and periosteal circumference and polar stress-strain index. Seven-day wrist-worn raw acceleration data averaged over 1-s epochs was used to estimate time accumulated above incremental PA intensities (50 milli-gravitational unit (mg) increments from 200 to 3000 mg). Associations between time spent above each 50 mg increment and bone outcomes were assessed using multiple linear regression, adjusted for age, sex, height, weight, maturity, socioeconomic position, muscle cross-sectional area and PA below the intensity of interest. There was a gradual increase in mean R2 change across all bone-related outcomes as the intensity increased in 50 mg increments from >200 to >700 mg. All outcomes became significant at >700 mg (R2 change = 0.6%-1.3% and p = 0.001-0.02). Any further increases in intensity led to a reduction in mean R2 change and associations became non-significant for all outcomes >1500 mg. Using more appropriate accelerometry methods (1-s epochs; no a priori application of traditional cut-points) enabled us to identify that ∼10 min/day of PA >700 mg (equivalent to running ∼10 km/h) was positively associated with pQCT-derived measures of bone density, geometry and strength in 11-12-year-olds.

Injections in the back of the eye: The why, the what and when to worry.

BACKGROUND: Many Australians, particularly the elderly, suffer from eye diseases that require treatment with regular injections given into the eye. These injections can result in complications, some of which can be vision threatening. OBJECTIVE: To summarise some of the more common reasons for intraocular injection, as well as some common and/or more serious complications of intraocular injection that might present to general practitioners. DISCUSSION: Intraocular injection is an increasingly common means of treatment for a range of eye conditions. Serious complications, although rare, often require acute intervention to achieve the best outcomes, and timely referral of patients with worrying symptoms is important to achieve optimum patient care.

An innovative business model using established Medicare items for delivery of cardiac rehabilitation: A value proposition for primary care.

BACKGROUND: Approximately 70% of Australians do not attend cardiac rehabilitation (CR). A potential solution is integrating CR into primary care OBJECTIVE: To propose a business model for primary care providers to implement CR using current Medicare items. DISCUSSION: Using the chronic disease management plan, general practitioners (GPs) complete four clinical assessments at 1-2 weeks, 8-12 weeks, and 6 and 12 months after discharge. The net benefit of applying this model, compared with claiming the most used standard consultation Item 23, in Phase II CR is up to $505 per patient and $543 in Phase III CR. The number of rural GPs providing CR in partnership with the Country Access To Cardiac Health (CATCH) through the GP hybrid model has increased from 28 in 2021 to 32 in 2022. This increase might be attributed to this value proposition. The biggest limitation is access to allied health services in the rural areas.

Assessing numeracy and medication calculations within undergraduate nursing education: A qualitative study.

AIM: To explore how undergraduate nursing students are assessed on nursing numeracy and medication calculations from the perspective of Australian nurse education leaders. DESIGN: A qualitative study. METHODS: Semi-structured interviews were conducted with 17 nurse education leaders between November 2022 and January 2023. Braun and Clarke's six phases of thematic analysis were used to analyse the data. RESULTS: Five key themes were identified: (i) high expectations to keep the public safe, (ii) diverse assessment formats, (iii) different ways of managing assessment integrity, (iv) assessment conditions incongruent to the clinical setting and (v) supporting struggling students. CONCLUSION: Nurse education leaders set high standards requiring students to achieve 100% in numeracy and medication calculation assessments, thus maintaining the reputation of nursing and patient safety. However, students struggled to meet this expectation. Diverse assessment formats were implemented, with some examination conditions contrary to clinical practice. Currently, there is no benchmark or independent point of registration examination in Australia, hence the problem is each university had a different standard to judge students' competence. Gaining insight into how these assessments are conducted provides an opportunity to work towards an evidence-based model or benchmark for the assessment of numeracy. IMPLICATIONS FOR THE PROFESSION: Dosage errors in clinical practice threaten patient safety and the reputation of the nursing profession. The accuracy rate of calculations by undergraduate and registered nurses is deficient worldwide. This research highlights a major educational issue, that being the wide variation in how numeracy assessments are conducted with no clear pedagogical rationale for a standardised method. Such assessments would establish a national standard, contributing to quality assurance, the development of the nursing profession and improve patient safety.

Knowledge translation in Indigenous health research: voices from the field.

OBJECTIVES: To better understand what knowledge translation activities are effective and meaningful to Indigenous communities and what is required to advance knowledge translation in health research with, for, and by Indigenous communities. STUDY DESIGN: Workshop and collaborative yarning. SETTING: Lowitja Institute International Indigenous Health Conference, Cairns, June 2023. PARTICIPANTS: About 70 conference delegates, predominantly Indigenous people involved in research and Indigenous health researchers who shared their knowledge, experiences, and recommendations for knowledge translation through yarning and knowledge sharing. RESULTS: Four key themes were developed using thematic analysis: knowledge translation is fundamental to research and upholding community rights; knowledge translation approaches must be relevant to local community needs and ways of mobilising knowledge; researchers and research institutions must be accountable for ensuring knowledge translation is embedded, respected and implemented in ways that address community priorities; and knowledge translation must be planned and evaluated in ways that reflect Indigenous community measures of success. CONCLUSION: Knowledge translation is fundamental to making research matter, and critical to ethical research. It must be embedded in all stages of research practice. Effective knowledge translation approaches are Indigenous-led and move beyond Euro-Western academic metrics. Institutions, funding bodies, and academics should embed structures required to uphold Indigenous knowledge translation. We join calls for reimaging health and medical research to embed Indigenous knowledge translation as a prerequisite for generative knowledge production that makes research matter.

Icanbelimod (CBP-307), a next-generation Sphingosine-1-phosphate receptor modulator, in healthy men: pharmacokinetics, pharmacodynamics, safety, and tolerability in a randomized trial in Australia.

Background: Icanbelimod (formerly CBP-307) is a next-generation S1PR modulator, targeting S1PR1. In this first-in-human study, icanbelimod was investigated in healthy men in Australia. Methods: Participants were randomized 3:1, double-blind, to icanbelimod or placebo in four single-dose cohorts (0.1 mg, 0.25 mg, 0.5 mg [n=8 per cohort], 2.5 mg [n=4]) or for 28-days once-daily treatment in two cohorts (0.15 mg, 0.25 mg [n=8 per cohort]). Participants in the 0.25-mg cohort received 0.1 mg on Day 1. Treatments were administered orally after fasting; following one-week washout, icanbelimod was administered after breakfast in the 0.5-mg cohort. Results: Icanbelimod exposure increased rapidly and dose-dependently with single and multiple dosing (Tmax 4-7 hours). Lymphocyte counts decreased rapidly after single (-11%, 0.1 mg; -40%, 0.25 mg; -71%, 0.5 mg; -77%, 2.5 mg) and multiple doses (-49%, 0.15 mg; -75%, 0.25 mg), and recovered quickly, 7 days after dosing. After single-dose 0.5 mg, although a high-fat breakfast versus fasting did not affect maximal decrease, lymphocyte counts tended to be lower after breakfast across most timepoints up to 72 hours. Twenty-eight participants (63.6%) experienced mainly mild treatment-emergent adverse events (TEAEs). After single-dose icanbelimod, the most common TEAEs were headache (28.6%, n=6) and dizziness (19.0%, n=4). Three participants experienced transient bradycardia, with one serious, following single-dose 2.5 mg icanbelimod. After multiple-dose icanbelimod, the most common TEAEs were headache (50.0%, n=6) and lymphopenia (41.7%, n=5), and two participants withdrew due to non-serious TEAEs. Up-titration attenuated heart rate reductions. Conclusion: Icanbelimod was well-tolerated up to 0.5 mg and effectively reduced lymphocyte counts. Clinical trial registration: ClinicalTrials.gov, identifier NCT02280434.b.

Providing sexual health care for international students in Australia: a qualitative study of a general practice team approach.

Background Provision of culturally responsive sexual health care for international students is important, given the large numbers of international students in Australia and known lower levels of health literacy among this cohort. Team-based care in general practice has the potential to provide this care. Methods A qualitative study that developed and evaluated a team-based model of care for female, Mandarin-speaking, international students in a university-based general practice. The model involved patients attending a consultation with a Mandarin-speaking nurse with advanced skills in sexual health who provided education and preventive health advice, followed by a consultation with a GP. Evaluation of the model explored patient and healthcare worker experiences using a survey and a focus group of patients, and interviews with healthcare workers. Data were analysed using a general inductive approach. Results The consultation model was evaluated with 12 patients and seven GPs. Five patients participated in a focus group following the consultation. Survey results showed high levels of patient satisfaction with the model. This was confirmed via the focus group findings. Healthcare workers found the model useful for providing sexual health care for this cohort of patients and were satisfied with the team approach to patient care. Conclusions A team-based approach to providing sexual health care for international students was satisfactory to patients, GPs and the practice nurse. The challenge is providing this type of model in Australian general practice under the current funding model.

Cystic Fibrosis and the Law: The Ramifications of New Treatments.

Until the discovery of the gene for cystic fibrosis (CF) in 1989, diagnostic developments were limited, and treatment focused on symptom alleviation. However, following the genetic breakthrough, some 2,000 mutations of the gene have been identified. More recently CF transmembrane conductance regulator modulator triple therapy (CFTRm) has been introduced in the form of triple therapy with ivacaftor, lumacaftor and tezacaftor (ETI), in the United States from 2019, Europe from 2020 and then Australia from 2021. The new treatment option has revolutionised both the quality of life and life expectancy of many persons diagnosed with CF. This editorial reviews major developments in the clinical care that can now be provided to patients, and reflects on the legal and ethical ramifications of the improved situation for many patients in the contexts of medical negligence, damages assessment, family law and criminal law. It also considers the difficult issues of access and equity caused by the limited availability of the triple therapy in low- and middle-income countries.

Moving Genomics into the Clinic: Platforms for Implementing Clinical Genomic Data-Sharing in Ways That Address Ethical, Legal and Social Implications.

This section explores the challenges involved in translating genomic research into genomic medicine. A number of priorities have been identified in the Australian National Health Genomics Framework for addressing these challenges. Responsible collection, storage, use and management of genomic data is one of these priorities, and is the primary theme of this section. The recent release of Genomical, an Australian data-sharing platform, is used as a case study to illustrate the type of assistance that can be provided to the health care sector in addressing this priority. The section first describes the National Framework and other drivers involved in the move towards genomic medicine. The section then examines key ethical, legal and social factors at play in genomics, with particular focus on privacy and consent. Finally, the section examines how Genomical is being used to help ensure that the move towards genomic medicine is ethically, legally and socially sound and that it optimises advances in both genomic and information technology.

Media, Advertising and Inventing (Anna)rexia.

Too many Australians suffer from poor body image and eating disorders. The Israeli, French and Norwegian Governments have created body image legislation to try to address this: it responds to concerns that the countless images of thin women people see can contribute to poor body image. By contrast, Australia does not have a Body Image Law: it has a voluntary code that the advertising industry generally does not follow. This article argues that Australia should enact a Body Image Law that reflects health evidence that body image needs to be improved. The Body Image Law would require disclaimers on images that were not retouched, create a specialised government body to evaluate images and attract civil penalties for breaching it. The authors believe that this is the first Australian article to suggest an Australian Body Image Law of this kind.

Recent Australian Legislative Developments in the Regulation of Assisted Reproductive Technology.

This section considers the recent resurgence of regulatory interest in the field of assisted reproductive technology (ART) practices focusing on the new legislative framework in the Australian Capital Territory (ACT). It provides an overview of the Australian regulatory framework in this field and considers how the new legislation in the ACT sits alongside this framework. A detailed overview of the key provisions of the ACT legislation is provided, before considering whether the legislation goes far enough in addressing some of the more controversial issues in the field of ART.

Insight and the Capacity to Refuse Treatment with Electroconvulsive Therapy.

All Australian jurisdictions have statutory provisions governing the use of electroconvulsive therapy. Cases in which the patient lacks insight into their psychotic illness and need for treatment and refuses to have ECT are particularly poignant. In Re ICO [2023] QMHC 1, the Queensland Mental Health Court considered whether a patient with a treatment-resistant psychotic illness had decision-making capacity to refuse ECT. The Court also considered whether the patient had been provided with an adequate explanation of the proposed treatment including the expected benefits, risks and adverse effects of ECT. As well as deciding whether ECT was appropriate in the circumstances, the Court considered whether there were alternative treatments including another trial of the oral antipsychotic clozapine. This article reviews issues relating to lack of insight in persons with psychotic illness and relevant considerations for determining capacity to decline ECT.

Informed Consent and the Duty to Warn: More than the Mere Provision of Information.

Before providing any form of medical treatment, medical practitioners are generally required to discharge their duty to warn. It is argued in this article that the duty to warn, at least as it relates to frail and elderly patients, requires the principles of shared decision-making to be adopted. Doing so will ensure a comprehensive biopsychosocial understanding of the patient and assist in identifying material risks that may not be readily apparent. Such risks include risks that threaten the patient's values, preferences, treatment aims and long-term outcomes. Once such risks are identified, in discharging the duty to warn, they should be contextualised in a manner that makes clear how that risk will manifest in that particular patient. These risks should then also be synthesised within the context of their other medical issues and longer-term interests. Finally, it is suggested that the traditional consent process may need restructuring.

Virtual Labs and Designer Bugs - Generative AI, Synthetic Biology and National Security.

AI technologies can pose a major national security concern. AI programs could be used to develop chemical and biological agents which circumvent existing protective measures or medical treatments, or to design pathogens with capabilities they do not naturally possess (gain-of-function research). Although Australia has a strong legislative framework relating to research into genetically modified organisms, the framework requires the interaction of more than 10 different government departments, universities and funding agencies. Further, there are few guidelines about the responsible use of AI in biological research where existing laws and policies do not apply to research that is conducted "virtually", even where that research may have national security implications. This article explores these under-scrutinised concepts in Australia's biological security frameworks.

Challenging Pandemic Law: From Vaccine Mandates to Judicial Review of Vaccine Approvals.

Over recent years, dozens of legal challenges have been instituted in response to government action during the COVID-19 pandemic. While public health orders have been challenged on several grounds, few cases have succeeded. Fewer cases still have called into question decisions made by the Therapeutic Goods Administration (TGA) to approve the COVID-19 vaccines. This section provides a brief update on one recent, partially successful COVID-19 health directions case before examining two applications in the Federal Court of Australia seeking judicial review of the TGA's approval of the COVID-19 vaccines. The section argues that, while both TGA applications were dismissed for lack of standing, they illustrate how and why third parties will ordinarily not be entitled to challenge administrative decisions about therapeutic goods.

Safe Access Zone Legislation and Its Compliance with the Human Rights of Anti-Abortion Protesters in Australia.

Terminating a pregnancy is now lawful in all Australian jurisdictions, although on diverse bases. While abortions have not been subject to the same degree of heated debate in Australia as elsewhere, protests aimed at persuading women not to have a termination of their pregnancy have occurred outside abortion service providers in the past. Over the last decade, this has led to the introduction of laws setting out so-called safe access zones around provider premises. Anti-abortion protests are prohibited within a specific distance from abortion services and infringements attract criminal liability. As safe access zone laws prevent protesters from expressing their views in certain spaces, the question arises as to the laws' compliance with protesters' human rights. This article analyses this by considering the human rights compliance of the Queensland ban in light of Queensland human rights legislation. It concludes that the imposed prohibition of anti-abortion protests near abortion clinics is compatible with human rights.

Denial of Desire for Death in Dementia: Why Is Dementia Excluded from Australian Voluntary Assisted Dying Legislation?

Euthanasia in the form of Voluntary Assisted Dying (VAD) is legal in all Australian States, but current eligibility criteria preclude access to people with dementia. This article discusses Australian VAD eligibility criteria that are problematic for people with dementia: (1) time until death within 12 months, (2) decision-making capacity for VAD, and (3) determination of intolerable suffering. Legislation in the Netherlands allows VAD for people with dementia. The challenges and philosophical issues raised by such cases are explored. It is proposed that the unique nature of dementia in its various forms warrants the formulation of dementia-specific VAD eligibility criteria. A case could be brought to challenge the denial of access to VAD of people with dementia on the basis that their exclusion is discriminatory and an abuse of human rights. If such a challenge was successful, it could form a common law precedent to allow people with dementia access to VAD.