Perspectives

The disability burden of non-fatal disease is not reflected in allocation of grants

Stephen E Gilbert · Rachelle Buchbinder · Ian A Harris · Christopher G Maher

Investigator‐initiated trials run by clinical trial networks provide net economic benefits to health systems Delivery of optimal health care relies on evidence from randomised clinical trials, among other factors, to inform best practice. While the generation of such evidence requires resources, both national and international assessments of health and economic benefits resulting from medical research indicate large returns on investment.1,2,3 In Australia, during the decade 2006–2015, more than 10 000 clinical trials were conducted through Australian clinical trials networks (CTNs), including more than 5 million participants, ranking Australia in the top tier of clinical trial activity.4 Industry‐funded clinical trials accounted for an estimated $930 million of the total $1.1 billion spent annually on clinical trials, with National Health and Medical Research Council (NHMRC) funding accounting for about $164 million annually.4 While the proportion of funding for non‐industry‐sponsored investigator‐initiated clinical trials (IITs) is relatively small, these studies account for more than half of Australia’s clinical trial activity.4 This study funding balance is similar to what is reported elsewhere.5 In Australia, IITs conducted by Australasian CTNs have had a major impact on the improvement of health care quality and outcomes around the world.6,7 IITs are designed and conducted by independent clinicians and academic researchers to generate clinical evidence to improve health care. Benefits are multilayered and not restricted to the discovery of new therapies. Much of the benefit comes from identifying and addressing uncertainty in existing practices; evaluating a range of treatment options that address key unanswered questions free of commercial imperatives, identifying alternative and potentially more efficient diagnostic strategies; and identifying more effective models of care or expensive interventions that are no more active than the lower cost alternative. Australasia has large, geographically dispersed CTNs across multiple clinical areas,8 with many more having been launched since the original report (personal communication Australian Clinical Trials Alliance [ACTA]). Between one‐quarter and one‐third of all Australian Government‐funded NHMRC support for clinical trials between 2004 and 2014 was awarded to IITs conducted by an established CTN.8 CTNs ensure clinically important, high priority and relevant research questions are appropriately conducted and provide efficiency through established infrastructure. Within Australasia, CTNs are widely regarded as key drivers of innovation and represent good value for public investment.8 Although the Australian Government invests in IITs and the CTNs that coordinate them, their value has not been well characterised. Governments are increasingly looking to systematically integrate activities that generate high quality evidence (such as IITs) with other aspects of the health care system (such as measurement of health outcomes or development of safety and quality policies) to build self‐improving, sustainable systems (Box). Understanding the potential return on investment is therefore paramount. In 2015, ACTA and the NHMRC profiled 37 established CTNs in Australia.8 Subsequently, a cost–benefit analysis for the profiled networks was calculated for those that i) were operational for more than 10 years; ii) had conducted more than five high impact peer‐reviewed IITs where an influence (or potential influence) on clinical practice and/or policy were identified (maturity); iii) received a significant proportion of funding from Australian funders (local investment); and iv) were available to participate (feasibility) in this analysis.9 Three CTNs that had conducted a total of 25 IITs were included in the analysis: the Australasian Stroke Trials Network (ASTN), the Interdisciplinary Maternal Perinatal Australasian Collaborative Trials (IMPACT) Network, and the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG). Gross economic benefits across these CTNs were almost $2 billion, with the majority due to improvements in patient health outcomes ($1.4 billion), and 30% due to avoided health service costs — $453 million from the difference in outcomes and $127 million from differences in service costs. Gross costs, which included the cost of running the CTN, coordinating centre costs and the cost of running the entire IIT program in each CTN, were about $335 million, with most of those costs being for the IIT program itself (accounting for 73% of total costs). The benefit to cost ratio was 5.8:1 if findings from the 25 IITs were implemented in 65% of the eligible Australian population for one year.9 Similar findings have been reported internationally, with studies in the United States reporting a benefit to cost ratio of 4.2:1 over 10 years.3 In the United Kingdom, randomised clinical trials funded under the National Institute for Health Research health technology assessment program were expected to have a net benefit of £3 billion, with just 12% of this benefit required to cover the costs for all research undertaken.10 In the Australian analysis, funding provided to run a portfolio of IITs did not cover the total costs within either a CTN or at an individual IIT level, and in‐kind support was relied upon to make up the shortfall. The NHMRC funding received by all Australasian CTNs between 2004 and 2014 was represented by just 9% of the $2 billion gross benefit.9 The magnitude of avoided health care costs appears large, reflecting the size of health care expenditure. The Australian analysis highlighted the importance of in‐kind support within CTNs not only to sustain the viability of the CTNs but for their ability to conduct individual IITs.9 The total quantum of site level, in‐kind support could not be quantified accurately during the study. However, this support was described as being finite, at capacity in many instances, and at risk of exhaustion. From a sustainability perspective, the reliance on in‐kind support is concerning, and undermines the timeliness, volume and international competitiveness of clinical research in Australasia. Anecdotal evidence from interviews suggested that site level in‐kind support represents up to a 50% increase in trial funding. Late‐phase IITs conducted by CTNs deliver better health outcomes and health service value through a variety of mechanisms. Importantly, IITs play a critical role in addressing clinically significant questions, influencing guidelines, and identifying ways to improve safety and quality and opportunities for more efficient resource use. As stated in a scoping review, IITs “can also yield a substantial knowledge return on investment for hospitals and institutions that actively engage in trials, including the following: more skilled clinicians and increased research capacity, improved patient outcomes, and better health system performance. Also, the difference in cost of care for trial and non‐trial patients can be negligible”.11 Large increases in the benefit to cost ratio could be realised through relatively small increases in implementation rates. Research to identify the barriers and enablers of trial implementation should allow IITs to be translated more effectively into frontline health care delivery. But, intuitively, the conduct of potentially practice‐changing IITs through CTNs is likely to enhance implementation rates, as these virtual, nationwide consortia of clinicians are likely to involve a majority of the relevant clinical community. Hence, the reasonable assumption that clinicians who participate in IITs are more likely to implement trial results in their own practice and to translate new knowledge to their clinical colleagues. What we do not yet know is the extent to which IITs translate into routine practice. This is rarely measured or monitored in Australia. Measures of implementation should be incorporated routinely into IIT design, particularly for randomised clinical trials that are arguably more likely to result in clinically significant and potentially practice‐changing findings. Notwithstanding the clear economic benefit demonstrated for the 25 trials conducted by the selected group of three CTNs, it might be possible to reduce trial costs further. The overall cost of trials is a complex, multilayered issue, particularly as small pilot studies are often required to demonstrate the feasibility of recruitment. But combined with the push to answer key questions more quickly especially for the seriously or critically ill patients, such considerations have been drivers in implementing newer adaptive trial designs, which have flexible sample sizes that might reasonably be expected to reduce clinical trial costs.12 The analysis conducted of the three selected CTNs represents the first such analysis conducted of the role of CTNs in the Australian health sector. Despite the limitations of the analysis, it is clear further investment in existing CTNs, as well as therapeutic areas for which there are no CTNs at present, is warranted. This needs to be done in a manner that seeks operational efficiencies, including consolidation of infrastructure and the means to ensure engagement with geographically dispersed health services to improve patient access to trials across communities.11 In conclusion, there is potentially enormous, and arguably untapped, value in investing in IITs conducted by CTNs, as they provide net benefits to health care systems. However, the exact return on investment is contingent on the level of implementation. Further work in this regard is warranted. So, where to from here? High quality health systems are reliant on a strong clinical trials sector. In particular, the role of IITs run by CTNs is paramount in order to address clinically important questions, especially those that relate to health care variation. Clinical trial infrastructure needs to be strengthened, and we must endeavour to reduce reliance on in‐kind funding to ensure that the sector remains viable. Finally, we must strive to maximise implementation of trial findings to optimise current investment in the sector. Box – A self‐improving, sustainable health care system

The joint ACTA/ACSQHC Working Group

Rapid advances in AI in ophthalmology are a harbinger of things to come for other fields of medicine The autonomous detection and triage of eye disease, or even accurate estimations of gender, age, and blood pressure from a simple retinal photo, may sound like the realms of science fiction, but advances in artificial intelligence (AI) have already made this a reality.1 Ophthalmology is at the vanguard of the development and clinical application of AI. Advances in the field may provide useful insights into the application of this technology in health care more broadly. Artificial intelligence Once described as the capacity of intelligent machines to imitate human intelligence and behaviour, AI now describes many theories and practices used to achieve computer intelligence (Box 1).2 Machine learning is an application of AI that uses algorithms or statistical models to make decisions or predictions. Complex patterns and relationships are learned from data to generate an outcome.2 Machine learning traditionally relies on the extraction of features from the data by human operators which then serve as input variables to optimise algorithm performance. The performance of these systems is constrained by the features that are recognised as important by humans. In contrast, artificial neural networks are an advanced method of machine learning able to extract features without explicit programming.2 Deep learning is the construction of multiple layers of artificial neural networks which can identify features in data that are not recognisable by humans. Although deep learning systems may be powerful, they lack human‐crafted inputs, meaning that large quantities of data are typically required to train algorithms. Artificial intelligence in ophthalmology As a discipline, ophthalmology is at the forefront of AI system development and translation in clinical practice. Leading uses of the technology include detecting, classifying and triaging a range of diseases, such as diabetic retinopathy, age‐related macular degeneration (AMD), glaucoma, retinopathy of prematurity, and retinal vein occlusion, from clinical images.3 The increasing global burden of eye diseases, coupled with the development of new therapies for previously untreatable conditions, has served as a major driver for AI innovation in ophthalmology. As a case in point, there are presently over 430 million people living with diabetes, most of whom require annual or biennial screening for retinopathy using retinal photography. This vast demand for diabetic eye screening services has stimulated the development of AI algorithms to identify sight‐threatening disease. Several algorithms have achieved performance that meets or exceeds that of human experts.4,5 Accordingly, in 2018, the United States Food and Drug Administration approved an AI system to detect referable diabetic retinopathy from retinal photographs, the first autonomous diagnostic system to be approved in any field of medicine.6 Advances in deep learning have extended to other imaging modalities that are commonly used in ophthalmology. Ocular coherence tomography is an imaging technology that produces highly detailed, depth‐resolved images of the retina. A recent collaboration between researchers and clinicians at Google DeepMind, Moorfields Eye Hospital and University College London culminated in the development of a deep learning system capable of detecting and triaging more than 50 different retinal conditions at levels equivalent to a panel of experienced ophthalmologists.7 AI systems with the capacity to detect a wide range of diseases, such as this, are likely to be most useful in clinical practice. A highly anticipated innovation is the development of AI systems capable of accurate disease prediction. Such tools could assist in managing patient expectations, improve the quality of care and reduce treatment costs.3 In ophthalmology, prediction models have been trained to personalise re‐treatment intervals for patients with neovascular AMD,8 predict progression from early to late AMD,9 estimate the extent of future visual field defects in patients with glaucoma,10 and predict diabetic retinopathy progression.11 Although these models presently achieve only moderate levels of accuracy, their performance has been shown to be superior to humans in several studies.3,8 Future advances in the accuracy of prediction models will likely come from the use of large longitudinal datasets drawing on multiple data sources, together with the development of more advanced AI systems.3 Despite these significant advances, AI systems are not in widespread clinical use and in some cases real‐world performance has been inferior compared with in silico validation.2,3 Training and validation of deep learning algorithms with large, representative data (eg, data from people of different ethnicities) acquired using multiple devices (eg, different retinal camera models) and data collection protocols (eg, retinal photographs acquired with and without pupil dilation) are key to achieving clinical applicability.4,5 This approach was used in the development of deep learning systems for retinal photographic screening for diabetic retinopathy, AMD and glaucoma which are now being used in large scale screening programs in Singapore and China.4,5 In these programs, AI is used to identify images without evidence of disease, so that human graders can focus their efforts on the images of those with disease, enabling improved efficiency and cost savings.12 Challenges to the clinical adoption of artificial intelligence Several obstacles to the adoption of AI in health care remain. The training of deep learning systems requires access to large amounts of medical data which has significant implications relating to privacy and data protection. In the context of ophthalmology, this is particularly pertinent, as the retinal vasculature may be considered biometric data, making it impossible to completely anonymise retinal photographs.3 Furthermore, characteristics that are not visible to human examiners, such as age and sex, can now be accurately predicted from a single retinal photograph using deep learning.1 Several recent major breaches of data protection laws relating to AI system development have already come to light.13 While individual patient data used to train an algorithm do not remain within the system, incorrect handling and sharing of data may lead to patients withdrawing consent to the use of their data under General Data Protection Regulation laws. It is not certain how data withdrawal requests will be dealt with when an individual’s data have been used in the process of training a deep learning system. Accordingly, developments in AI need to be accompanied by advanced data protection and security measures. Another challenge to the acceptance of deep learning algorithms in medicine is the difficulty in determining the basis for clinical decisions made by these systems, informally described as the “black box” problem. Visualisation tools have been developed to assist clinicians by highlighting the salient image features that contribute to the AI system classification (Box 2).12 This has the potential to create trust in system‐generated decisions, particularly if the features correspond with those used by experienced clinicians for clinical decision making.14 Interpretability is particularly important when considering legal liability in the event of patient harm arising from the use of AI in medicine. In traditional malpractice cases, a physician may be asked to justify the basis for a particular clinical decision and this is then considered in light of conventional medical practice.15 In comparison, challenges in identifying the basis for a given decision made by AI might pose problems for clinicians whose actions were based on that decision. The extent to which the clinician, as opposed to the technology manufacturer, should be held accountable for harm arising from AI use is a subject of intense debate.15 Factors such as the manner in which these AI systems are used and their classification as either products or software are likely to have important bearings on how cases are litigated.15 Further challenges for existing regulatory frameworks come from algorithms that continue to learn and evolve over time.15 Understanding how a given system is trained, its accuracy, and its operational limits is of great importance. Oversampling of a particular population or disease severity during training has the potential to introduce bias.4 Therefore, consideration of performance thresholds will help to inform appropriate use of AI systems. The Australian Government, through the CSIRO and Data61;16 the Australian Council of Learned Academies;17 the Australian Academy of Health and Medical Sciences;18 and specialty groups, such as the Royal Australian and New Zealand College of Radiologists,19 have made significant efforts to develop frameworks and policies for the effective and ethical development of AI. These consultative works have highlighted key priorities, including building a specialist AI workforce, ensuring effective data governance and enabling trust in AI through transparency and appropriate safety standards. Through targeted investment in research and development, Australia is aiming to advance its AI competitiveness. These framework documents provide guidance for developers, clinicians and health care consumers to navigate this rapidly evolving field. Broad dissemination of these documents should form part of a wider public engagement and education campaign to ensure that AI is developed and used in a considered and careful manner in health care. Rapid advances in AI in ophthalmology are a harbinger of things to come for other fields of medicine. While these technologies may eventually lead to more efficient, cost‐effective and safer health care, they are not a panacea in isolation. The successful integration of AI into health systems will need to first consider patient needs, ethical challenges and the performance limits of individual systems. Box 1 – Relationship between artificial intelligence and its subtypes Box 2 – Original retinal photograph of right eye with macular degeneration (A). Heat map of image A showing visualisation of traditional features associated with macular degeneration, such as central scarring (B). Original retinal photograph of left eye with referable diabetic retinopathy (C). Heat map of image C showing visualisation of traditional features, such as micro‐aneurysms and haemorrhages (D)

Jane Scheetz · Mingguang He · Peter Wijngaarden

Is the current genetics and insurance moratorium an effective long term regulatory solution for Australia? Genetic discrimination in life insurance is a longstanding issue in Australia,1,2 and has been the subject of two government inquiries.3,4 The use of genetic test results in underwriting continues to be self‐regulated by the life insurance industry.5 In 2019, following Parliamentary Joint Committee recommendations,4 the industry voluntarily introduced a moratorium restricting the use of genetic test results in life insurance underwriting for polices worth up to AU$500 000. Although the moratorium is an important step, concerns remain around the financial limits, public awareness, lack of government oversight and compliance monitoring. The impact and effectiveness of the moratorium needs evaluation to inform the planned 2022 review. A new research project has been funded by the Australian Government’s Genomic Health Futures Mission to serve that important function. Genomic testing has the potential to improve disease prevention and public health. For example, predictive testing of BRCA1/2 genes can identify women at high risk of developing breast and ovarian cancer, where risk can be mitigated through preventive surgery and/or screening. As genomic testing becomes more widespread, patients, general practitioners and other health professionals will increasingly be required to address issues related to privacy, data security, genetic discrimination and insurance.2,6 Although health insurance is community‐rated in Australia and therefore not subject to genetic discrimination,1 the use of genetic test results in life insurance is allowed under the Disability Discrimination Act 1992 (Cth). This means that life insurance companies can legally refuse coverage or increase premiums based on genetic test results. A number of ethical, social and medical implications arise when genetic test results are permitted to be used in insurance underwriting, especially predictive testing in otherwise healthy people.1,7 Previous studies show that fear of insurance discrimination deters individuals from taking clinically indicated genetic tests and participating in genetic research.1 In a study where predictive genetic testing for Lynch syndrome (which causes an increased risk of colorectal and other cancers) was offered, the proportion of people who declined testing when informed of the insurance implications was more than double the proportion who declined without knowledge of insurance implications.8 There are different concerns from the insurance industry perspective, including the possible actuarial implications of adding genomic information to risk models. Genomic test results can not only reveal risk (positive results), but also indicate reduced risk (negative results), potentially changing the dynamics of actuarial calculations. The notion of adverse selection, whereby individuals at high genetic risk may be more likely to take out insurance policies, is also raised by insurers. It is critical for the optimisation of genomic medicine that individuals can make informed choices about genetic testing and research participation without fear of insurance implications. Further, moral implications regarding the use of genetic information for insurance underwriting extend beyond actuarial fairness to include consideration of public interests such as justice, beneficence, autonomy and public health.7 Several governments internationally have therefore banned or restricted the use of genetic test results in risk‐rated insurance, including Canada, the United Kingdom and Europe, using various legal mechanisms.9 The National Health Genomics Policy Framework and Implementation Plan 2018–20216 is a strategic policy of the Council of Australian Governments, which recognises the potential of genomics for public health while acknowledging the need for ethical mechanisms for its delivery. Developing a national approach to issues including genetic discrimination was listed as a strategic priority for action in the Framework and listed as the first short term national priority in the implementation plan,6 making it one of the most significant ethical, legal and social issues facing genomic medicine in Australia. However, debate remains regarding the most effective mechanism of regulation. Following previous examination of these issues by the Australian Law Reform Commission and Australian Health Ethics Committee,3 a recent inquiry of the Parliamentary Joint Committee on Corporations and Financial Services into the life insurance industry considered the use of genetic test results in life insurance.4 The report expressed strong concerns about insurer access to genetic information and recommended that: a moratorium be implemented to “prohibit any life insurers from using the outcomes of predictive genetic tests at least in the medium term … as a matter of some urgency and [in] a form similar to the United Kingdom’s Moratorium”;4 the Financial Services Council (FSC), together with the Australian Genetic Non‐Discrimination Working Group (of which the authors are members), assess the consumer impact of a moratorium; and the federal government monitor the implementation of, and adherence to, such a moratorium, and if needed, implement legislation on the issue. The Australian Government has not yet responded to the Parliamentary Joint Committee recommendations. However, the FSC, Australia’s peak national body for life insurers, introduced an industry‐led moratorium in July 2019. Under the moratorium, Australian consumers need no longer disclose their genetic test results when applying for policies up to $500 000 for death/total permanent disability, $200 000 for trauma/critical illness, and $4000/month for income protection cover.10 The moratorium applies to all genetic test results, including research results and results obtained from internet‐based direct‐to‐consumer tests, which are increasingly resulting in clinical referrals.11 Above these financial limits (which are cumulative across multiple policies), life insurers can still ask for, and use, any existing genetic test result, which can lead to refused or delayed cover, exclusions or increased premiums. However, insurers must not require applicants to undergo a genetic test. Applicants can choose to disclose a favourable genetic test result (showing that an individual with a family history of a genetic condition does not have the familial genetic variant) to offset the effects on underwriting of an adverse family history. The FSC moratorium is a self‐regulated industry standard which is not legally enforceable — insurance companies’ legal right to discriminate on the basis of genetic test results remains. By contrast, the UK moratorium (which commenced in 2001) is an agreement between the UK government and the Association of British Insurers. It applies to all life insurance policies without any financial limits, with only one exception for Huntington disease, a progressive, neurodegenerative genetic disorder. Predictive genetic test results for Huntington disease must be disclosed by individuals in the UK only when applying for cover worth over £500 000 (about AU$900 000).12 All other individuals can make informed decisions about whether to have genetic testing or participate in genomic research without concerns about insurance implications. The FSC moratorium is an important step towards consumer protection, but concerns remain around its financial limits, interpretation of its terms, and lack of compliance monitoring. The FSC moratorium has no government or independent regulatory oversight, and as recommended by the Parliamentary Joint Committee, there is a critical need to monitor its implementation and effectiveness. The FSC will review the moratorium and its terms in 2022, to consider amendment and/or extension beyond its current 2024 end date.10 Currently, there are no mechanisms in place to collect independent evidence from different stakeholder perspectives to inform this review and the Australian Government has not indicated any intention to do so directly. A new research project, funded by the first competitive round of the Genomic Health Futures Mission, part of the Australian Government’s Medical Research Future Fund,13 has now commenced to serve that critical function until 2023. The A‐GLIMMER (Australian Genetics and Life Insurance Moratorium: Monitoring the Effectiveness and Response) project brings together leading researchers, clinicians, patient groups, and policy experts in Australia to answer the question of whether the FSC moratorium is an adequate and effective long term regulatory solution for Australia. The project aims to address this question by collecting a range of quantitative and qualitative data after the implementation of the moratorium, from different stakeholders including consumers, health care professionals, researchers and the insurance industry. In some cases, the data collected will be directly comparable to similar data collected and published before the moratorium.14,15 The project has widespread support across the community. More than 20 project partners, including the FSC, and other supporting bodies have provided written support and pledged resources towards the study. The project is endorsed by the Victorian Department of Health and Human Services, the Human Genetics Society of Australasia and Australian Genomics, a collaborative national network of clinical, research, academic and community organisations dedicated to implementation of genomics for health and the development of appropriate genomics policy. The overarching aim of A-GLIMMER is to ensure sufficient evidence is collected in the coming years to inform government and the 2022 FSC review, to help determine the effectiveness of the FSC moratorium as a long term regulatory solution in Australia. See the Box for a summary of project aims. A‐GLIMMER is divided into four work streams, which will collect data from consumers, health professionals, research studies and the insurance industry. A final report will be compiled at the conclusion of the project, and will be provided to the federal government to assist with future policy decisions. Although the project will not conclude until 2023, its findings will help inform the proposed FSC review in 2022. Achieving an adequate policy solution to this issue in Australia is essential for ensuring optimal integration of genomics into Australian health care, engendering public trust and consumer participation in genomics, and paving the way to realise the many benefits of genomic medicine for Australia. Box – Aims of A‐GLIMMER (Australian Genetics and Life Insurance Moratorium: Monitoring the Effectiveness and Response) A‐GLIMMER will: assess dissemination and awareness of the Financial Services Council moratorium following its implementation describe the impact of the moratorium on consumers, health care, research and financial services evaluate the effectiveness of the self‐regulated Financial Services Council moratorium as a long term regulatory solution

Jane Tiller · Ingrid Winship · Margaret FA Otlowski · Paul A Lacaze

Although VTE risk in minor gynaecological procedures is low, a systematic approach to prophylaxis is necessary

Esther MC Johns · Alex Ades · Pavitra Nanayakkara

Current Good Clinical Practice guidelines are bureaucratic and should align with less burdensome examples of international trial policy

Tanya Symons · Steve Webb · John R Zalcberg

Australian services for people with dementia are fragmented, challenging to navigate and hard to access The coronavirus disease 2019 (COVID‐19) pandemic has led to reflections around reforming Australia’s health care system.1 In view of future reforms, this article is intended to provoke policy and clinical discussion regarding what an effective, efficient model of service delivery meeting the needs of people with dementia and their families may look like. The opinion presented here belongs to the members of the National Health and Medical Research Council (NHMRC) National Institute for Dementia Research Special Interest Group in Rehabilitation and Dementia. For the purposes of this article, we define a model of service delivery as the systemic framework through which services are organised, accessed, funded and delivered. Services in Australia for people with dementia are inadequate Dementia is the leading cause of disability, the second leading cause of death in Australians aged over 65 years, and the leading cause of death in women in Australia. In 2020, it is estimated that Australia will spend $8.1 billion on health care and $3.8 billion on social services for people with dementia, with a further $6.1 billion in lost productivity and earnings.2 Australian services for people with dementia are often fragmented, challenging to navigate and hard to access.3 It can be difficult for people with dementia to obtain a diagnosis, there are limited health and social services for early dementia, including post‐diagnostic support, and existing services are often poorly coordinated.3,4 Services face workforce shortages and gaps in worker knowledge and skills related to dementia.5 People with dementia and their care partners have called for support and information after diagnosis; flexibly delivered services that support their quality of life, including meaningful activity; and inclusion in decision making.6 A philosophical and societal shift in thinking is required: from provision of care to enablement, where people living with dementia are empowered to continue to direct their own lives.7 We are not meeting the human rights of people with dementia to health care Australia does not currently meet the human rights of people with dementia to timely and accessible health services of appropriate quality or to participation in health care decisions.4,6 The right to quality health care is affected by the variable delivery of best‐practice dementia care by memory clinics,8 acute hospitals,9 primary care,10 and community and residential aged care,11 perhaps because the role of each of these is unclear. Australia’s systems and context Australia has a long‐standing commitment to a universal health system and to long term care for older people. The health and aged care systems were developed largely in isolation from one another and have failed to resolve conflicts around medical and social models of care for older people. Health care systems are slowly adapting to this era of chronic disease and population ageing,12 but person‐centredness and integration within and across acute, primary, community and residential aged care systems remain a challenge.11 Principles underpinning models of service delivery for Australians with dementia Members of our group reviewed principles underpinning services such as the Department of Health Aged Care Sector and the Council of Australian Governments National Disability Insurance Scheme. 13,14 We reached a consensus that the following principles should apply to models of service delivery for dementia that: has an overarching objective to maintain positive health and wellbeing of people with dementia, their care partners and families; recognises dementia as a disability, consistent with the World Health Organization Convention on the Rights of Persons with Disabilities, and promotes autonomy, social participation and rehabilitation; takes into account the cognitive disability of people with dementia in accessing support and being a partner (along with their families) in planning care through supported decision making; is delivered by a multidisciplinary workforce who have knowledge and skills around dementia; is accessible for all people with dementia and care partners; is ongoing, cost‐effective and economically sustainable; is needs‐based, not capped according to central budgets; is integrated for seamless experience for people with dementia and care partners, within and across primary, acute and subacute health care, aged care and social services; and is evidence‐based. Review of possible models of service delivery for dementia We identified models of service delivery for dementia and other chronic conditions based on input from our broad authorship group and searching the peer‐reviewed and grey literature. These models are described in the and considered in terms of fit with the principles above. We included care pathways even though these are not a model because they are often used to improve service access and integration. In addition, we map the models of service delivery to our health and aged care funding systems, illustrating the limited integration across systems (Box). Learnings from these models: The self‐directed approach places the needs of the person with dementia centrally but may require processes to ensure supported decision making. Information is also needed regarding the risks and benefits of self‐management versus budget holding or service provider management, integration with health care, and consideration of costs. Case management improves outcomes for the person with dementia and could be flexible and needs‐based if sufficient workforce and integration across systems could be achieved. However, it would require a significant investment of resources. Strengths of the primary care chronic disease management model include equity and familiarity of access, and care coordination by a trusted health professional or practice team. Weaknesses include the limited amount of treatment (ie, current cap of five subsidised allied health consultations per year), limited dementia management skills in some general practitioners and practice nurses, and often poor integration with aged care. Shared and stepped care models may be able to be adapted to combine the strengths of the primary care chronic disease and specialist approaches, but integration of aged care services would be essential. Stepped care may not be the best fit for people diagnosed with dementia in other settings (eg, hospitals or residential care facilities). A specialist team approach with a skilled workforce is well equipped to provide evidence‐based care, although this is unlikely to be made universally accessible (eg, in regional areas) and may be cost‐prohibitive. Navigator and care pathway approaches may increase access to services, but do not improve the type or amount of supports or treatment available. None of the models of service delivery that we identified in Australia or overseas appear to sufficiently meet the principles above. There is no clear recognition that dementia is both a social and a medical issue. Australia has moved strongly in the direction of recognising the rights of people with disabilities including social participation but there is limited appreciation of this need in respect to most models for dementia. Recognition of dementia as a disability is only apparent in the self‐directed care model. The models also do not sufficiently consider the needs of the person with dementia and care partners together. Barriers to all the current models are the poor dementia knowledge and the tendency to stigmatise people with dementia by many health and aged care professionals.15 Next step: investment in model development We need to combine desirable elements in the primary care chronic disease management, case management, and specialist multidisciplinary care models. Having a system with a point of entry through primary care could maximise accessibility. Having a dementia and aged care specialist (eg, dementia nurse or case manager) working with GPs would bring the required skills and knowledge. A close partnership with a specialist multidisciplinary team (in person or using telehealth) would assist with diagnosis, ongoing support and management of complex cases, with possibly the most complex cases being managed by the specialist team. There needs to be investment to develop a model that is accessible, integrated and effective in meeting the needs of people with dementia. Our service delivery model needs to be co‐designed with people with dementia, their care partners, health, aged care, and state and federal government stakeholders, including treasury departments. Public health, social equity and human rights principles should underpin model design. Research is needed to explore proposed models and their elements with current recipients, service planners and providers. Methodologies may include service mapping; gap, risk and unintended consequence analysis; and economic modelling. Potential models will then need to be tested in a coordinated series of pilots and rigorous health system trials building towards national implementation. History has shown that piecemeal demonstration pilots and practice improvement projects will not bring about large‐scale change. Australia’s last National Framework for Action on Dementia 2015–2019 has just lapsed.16 Our new framework should include the development of a model of service delivery that considers accessible pathways to diagnosis and effective and seamless ongoing support of health and wellbeing throughout the course of dementia. Box – Current service funding structures and service models for Australians with dementia GPs = general practitioners; NDIS = National Disability Insurance Scheme; NGOs = non‐government organisations; PHNs = primary health networks.

NHMRC National Institute for Dementia Research Special Interest Group in Rehabilitation and Dementia

Current calls for primary care‐based screening and brief interventions for alcohol use should be reviewed Alcohol continues to contribute to significant morbidity and mortality in the Australian community. It is responsible for 4.5% of total disease burden,1 and 4186 deaths in 20172 and over 144 000 hospitalisations per year.3 While levels of alcohol consumption are slowly declining, alcohol continues to be a major preventable contributor to disease and death among Australians. Currently, over 25% of Australians report consuming alcohol at moderate or high risk levels.4 Over the past 20 years, there has been considerable research into the value of alcohol screening, brief intervention and referral for treatment (SBIRT) in primary health care as a public health measure to reduce alcohol consumption and related harms. The Alcohol Use Disorder Identification Test (AUDIT)5 was developed to assist with widespread standardised implementation of screening, and brief intervention for alcohol use disorder and has been extensively researched. More recently, the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)6 was developed to address a broad range of substances. There is good evidence based on numerous randomised controlled trials that brief interventions for alcohol use result in reductions in drinking which are at least sustained for 12 months.7 However, the actual size of the reduction in drinking has been revised down from 2007 when it was estimated that SBIRT would result in a reduction of alcohol intake by 57 g (nearly six standard drinks) per week,8 to 20 g (two standard drinks) per week.7 This reduction in effect size will inevitably affect estimates in cost‐effectiveness models. While overall average consumption has reduced, at least based on self‐report, SBIRT has been found to have little effect on frequency of binge drinking, numbers of drinking days per week, and intensity of drinking.7 It is therefore likely to have little effect on adverse events from intoxication, the major cause of harm for younger people. Despite strong evidence that SBIRT will result in self‐reported reduced drinking (albeit less reduction than previously thought), there have been problems with real‐world translation into practice, both on a large scale multi‐practice level9,10 and a national basis as demonstrated in Scotland.11 In terms of demonstrated effects on alcohol consumption at a population level, the most extensive program implemented so far has been Scotland’s Alcohol Strategy.11 This program aimed to deliver SBIRT across the entire primary care, emergency department and antenatal populations and was part of a suite of measures to address alcohol‐related harms in Scotland. Other measures included prohibition of multi‐buy discounting (eg, “buy five, get one free”), minimum unit pricing (unsuccessfully challenged by the Scottish Whisky Association in the Scottish Supreme Court and now being implemented), tightening of liquor licencing processes, and a tripling of investment in treatment and support services. Subsequent measures of alcohol consumption across Scotland, Wales and England have not demonstrated any significant differences in the trajectories of alcohol consumption between these countries. Consumption has decreased in all three countries.11 Although 43% of hazardous and harmful drinkers were screened in Scotland and received brief interventions, data on exactly who was screened were difficult to collect, and screening among women attending antenatal care was only partially implemented.11 Young people were difficult to access, probably due to lower health service attendance rates. Furthermore, a 2018 Cochrane review7 found that research into the effects of SBIRT on alcohol‐related harms, the end point of most importance, has been very limited, and was unable to reach a conclusion regarding the effect of SBIRT on alcohol‐related harms. The studies that have looked at this important issue found that there was no effect.7 In addition, recent research has cast doubt on the effectiveness of referral to treatment among the higher risk (mostly dependent) drinkers. Frost and colleagues12 reviewed the effects of brief interventions on rates of referral. They found that patients at high risk who had received a brief intervention actually had less contact with specialist addiction services in the year following the brief intervention compared with those who had not received the brief intervention. Despite these concerns regarding effectiveness in real‐world settings, SBIRT has been recommended over the past decade in Australia by the 2009 National Preventative Health Strategy,13 and by the National Alcohol Strategy in 2019.14 Significant investment in structurally supporting SBIRT in primary care or other settings has not been forthcoming from Commonwealth or state governments. Currently in Australia, we have a situation where the Australian National Alcohol Strategy advocates for the adoption of SBIRT. This is despite a lack of evidence that it is effective in reducing harms even in research settings, as well as a lack of evidence for its effect on reducing population levels of drinking, and evidence that it does not result in increased engagement in specialist treatment even in well resourced health systems which have identified this as a target area. However, despite the current evidence that population‐based screening does not seem to have an effect on overall alcohol consumption, there is no denying the clinical value of addressing unhealthy alcohol consumption when identified in primary care. The AUDIT and the ASSIST both explore relevant key areas such as frequency of use, harms and dependence, which are important for the clinician and the patient to understand and address. They enable the clinician and patient to determine the risks associated with the patient’s current drinking patterns, and to start a conversation which then enables an agreed response. They should still be promoted as tools to use when a patient has been identified as drinking excessively through normal clinical processes. Despite current levels of alcohol‐related morbidity, the general practice environment does not support general practitioners responding to the problem. Longer consultations are insufficiently remunerated, skills development has been suboptimal, and secondary and tertiary services are not readily available when and where required. SBIRT alone will not address the current levels of alcohol use in Australia and associated harms. There should be increased emphasis on development of the skills base of the medical workforce at student, general practice and other specialty training levels so that clinicians can respond to hazardous and harmful alcohol and substance use effectively. Tools such as the AUDIT and the ASSIST may well have a role here. Use of current GP Medicare items such as mental health care plans, chronic disease management plans and team care arrangements should be encouraged and facilitated to better support complex care for patients with problems relating to alcohol and substance use. In addition, addiction services should work with general practice to streamline access to advice and referrals and improve communication channels. At the same time, policy changes to reduce alcohol‐related harms should continue to be pursued. Medical bodies including the Australian Medical Association and the Australian colleges representing physicians, GPs, surgeons, psychiatrists and emergency physicians have advocated strongly for such changes regarding alcohol, but despite this advocacy, most of the Australian community has not felt the need for major change. In general, policy change will only occur in response to community concern. The 2019 National Drug Strategy Household Survey indicated that the Australian community continues to identify methamphetamine as the drug of most concern, above alcohol. In addition, support continues to decline for reducing trading hours for pubs and clubs and increasing the minimum drinking age, as well as for all other evidence‐based measures aimed at reducing the harms nominated in the survey.4 It appears that the Australian community currently least supports the harm reduction strategies with the strongest evidence, but on the other hand supports the strategies with the least evidence. If there were more community support, other policy changes could include reviews of pricing of alcohol and packaged liquor outlet density, further regulation of advertising of alcohol, and further changes to drink driving laws. These might include requiring a zero blood alcohol level for broader groups of drivers such as all younger drivers (ie, under 25 years of age) and drivers with previous drink driving convictions. There should be a renewed emphasis on alcohol as a significant driver of morbidity and mortality at three levels: on the clinical level, renewed emphasis on education and training for medical practitioners to enable clinicians to better respond to people drinking harmfully; on the health care structural level, changing remuneration arrangements to better support primary care treatment for people with alcohol‐related problems should be advocated for; and in parallel with these changes, increased advocacy for changes to policies that reduce drinking and related harms on a population level, with particular emphasis on high risk populations. Health professionals are generally not trained as advocates. Bringing about change, even when supported by sound evidence, is difficult and takes time. Vested interests have sophisticated advocacy skills and are well resourced. Opportunities for the development of advocacy skills at medical student and postgraduate levels should be developed and promoted. Australia remains a world leader in tobacco control. The health professions should join forces, building on the lessons from tobacco control, to change the way the Australian community views alcohol, and then lead changes in clinical practice and policy which will reduce alcohol‐related harms.

Chris B Holmwood

Recommendations to guide residential aged care facilities in preparing for and managing infectious disease outbreaks

Georgia E Aitken · Alice L Holmes · Joseph E Ibrahim

Peer support initiatives can help health professionals experiencing mental health and wellbeing challenges during the COVID-19 pandemic and beyond

Tahnee L Bridson · Kym Jenkins · Kieran G Allen · Brett M McDermott

Stage 3 lockdown measures in Victoria reduced COVID-19 transmission, but more was required to control the epidemic

Allan Saul · Nick Scott · Brendan S Crabb · Suman S Majumdar · Benjamin Coghlan · Margaret E Hellard

The dangers of modern football are often scrutinised, but has safety actually evolved over time?

Jacob L Jewson · Peter Brukner · Thomas J Gara · Lauren V Fortington

The MJA–Lancet Countdown on health and climate change was established in 2017, and produced its first Australian national assessment in 2018 and its first annual update in 2019. It examines indicators across five broad domains: climate change impacts, exposures and vulnerability; adaptation, planning and resilience for health; mitigation actions and health co‐benefits; economics and finance; and public and political engagement. In the wake of the unprecedented and catastrophic 2019–20 Australian bushfire season, in this special report we present the 2020 update, with a focus on the relationship between health, climate change and bushfires, highlighting indicators that explore these linkages. In an environment of continuing increases in summer maximum temperatures and heatwave intensity, substantial increases in both fire risk and population exposure to bushfires are having an impact on Australia’s health and economy. As a result of the “Black Summer” bushfires, the monthly airborne particulate matter less than 2.5 μm in diameter (PM2.5) concentrations in New South Wales and the Australian Capital Territory in December 2019 were the highest of any month in any state or territory over the period 2000–2019 at 26.0 μg/m3 and 71.6 μg/m3 respectively, and insured economic losses were $2.2 billion. We also found growing awareness of and engagement with the links between health and climate change, with a 50% increase in scientific publications and a doubling of newspaper articles on the topic in Australia in 2019 compared with 2018. However, despite clear and present need, Australia still lacks a nationwide adaptation plan for health. As Australia recovers from the compounded effects of the bushfires and the coronavirus disease 2019 (COVID‐19) pandemic, the health profession has a pivotal role to play. It is uniquely suited to integrate the response to these short term threats with the longer term public health implications of climate change, and to argue for the economic recovery from COVID‐19 to align with and strengthen Australia’s commitments under the Paris Agreement.

Ying Zhang · Paul J Beggs · Alice McGushin · Hilary Bambrick · Stefan Trueck · Ivan C Hanigan · Geoffrey G Morgan · Helen L Berry · Martina K Linnenluecke · Fay H Johnston · Anthony G Capon · Nick Watts

Rapid dissemination of information should not come at the expense of quality, ethical standards or oversight The coronavirus disease 2019 (COVID‐19) pandemic has resulted in wide‐ranging health, social and economic impacts. By October 2020, global cases exceeded 41 million, with 1.1 million deaths.1 Urgent requirements for information were met with data on epidemiology, clinical features and recommended management being circulated on social media and pre‐publication servers. While this has allowed timely sharing of data, it has also brought risk of misinformation, with consequent changes to medical practice and misdirection of scarce resources based on flawed evidence. Medical publishing uses peer review to provide independent and critical assessment to verify data integrity, validity of interpretations, and confidence in conclusions. This process can take many weeks; however, in a rapidly spreading pandemic, speed is a competing priority. We hypothesised that these considerations may have altered the nature of medical publication. Accordingly, we characterised various aspects of COVID‐19‐related articles published in the five leading general medical journals with the highest impact factors (Web of Science) compared with an equivalent period in the preceding year. Procedures for identifying, classifying and comparing publications were specified a priori. Research ethics approval was not required. Publications were identified in the United States National Library of Medicine PubMed database. All articles published between 1 January and 31 May (inclusive) in 2019 and 2020 in The New England Journal of Medicine, The Lancet, JAMA, The BMJ and Annals of Internal Medicine were included. The sampling timeframe was defined by the first public health notification of COVID‐19 in China on 31 December 2019, ending at the time of the conduct of the literature search (Box 1). Within the 2019 search results, 60 articles were randomly selected using a random number generator in Stata 15.1. Publications without abstracts were excluded. Journal websites for each study period were searched for retracted articles. Three reviewers independently abstracted the variables contained in Box 2 and Box 3. The h‐index (a measure of publication productivity and citation impact) of the first and last author was taken from Web of Science. A fourth investigator reviewed all data, harmonising interpretations and resolving any errors. Data were analysed using Stata 15.1. Skewed continuous data were described using medians with interquartile ranges (IQRs) and compared using the Wilcoxon–Mann–Whitney test. Categorical data were compared using the Fisher exact test or χ2 test as appropriate. Exact P values are reported and those less than 0.05 deemed significant. During January to May 2020, PubMed listed 4001 articles, of which 1120 (28%) were related to COVID‐19. There were 134 articles with PubMed‐coded abstracts which were included for full review (Box 4). One additional COVID‐19 article was identified in the search for retracted articles but excluded from quantitative comparisons because it lacked an abstract. During the same period in 2019, 54 articles were ultimately identified as eligible for comparison (Box 4). Compared with 2019, among the COVID‐19‐related publications in 2020, there were more case reports or case series, cohort studies, editorials and commentaries and fewer randomised controlled trials (7/134 [5.2%] v 19/54 [35.2%]) (Box 2). A similar proportion (37/52 [68.5%] non‐COVID‐19‐related articles v 74/134 [55.2%] COVID‐19‐related articles; P = 0.09) reported primary data. Of the 2019 articles, only two of 54 (3.7%) originated in China, whereas 32 of 134 (23.9%) of the COVID‐19 articles published in 2020 were from China. The proportion of COVID‐19 articles in 2020 for which a correction was published was higher than for non‐COVID‐19 articles published in 2019 (28/124 [20.9%] v 4/54 [7.4%] respectively; P = 0.03). Time to the first publication of a correction was no different (median, 6 days [IQR, 4–14] v 7.5 days [IQR, 5–18] respectively; P = 0.53). Three 2020 COVID‐19 articles,2,3,4 but none of the 2019 articles, were retracted after publication. Only one journal, JAMA, routinely reported when a manuscript was submitted. In this journal, the median time from submission to publication fell from 139 days (IQR, 130–144) in 2019 to 23 days (IQR, 12–30) in 2020 (P < 0.001). The median number of authors and their publication productivity and impact, as quantified by their median h‐indices, were similar. There was no statistically significant difference in the number of studies willing to share data under appropriate circumstances (P = 0.19), or those receiving commercial funding (P = 0.97). The measured characteristics of randomised trials related to COVID‐19 were not statistically different to studies of an equivalent type published in the preceding year; however, numerically fewer subjects (median, 199 [IQR, 127–397] v 424 [IQR, 225–1076]; P = 0.07) and centres (median, 10 [IQR, 1–55] v 30 [IQR, 4–168; P = 0.15) participated (Box 3). Similarly, the observational study sample size was significantly smaller (median, 152.5 [IQR, 15–3481] v 191 972.5 [IQR, 1407.5–756 444]; P < 0.001), and the number of participating centres was numerically lower in the 2020 COVID‐19 group (median, 1 [IQR, 1–7] v 26 [IQR, 1–49]; P = 0.07). While not significantly different between groups due to the low numbers, 11 (16.7%) observational studies among the COVID‐19 publications did not report oversight by an ethics committee or institutional review board, and only nine (56.3%) case reports and case series with ten patients or fewer stated that patient consent had been obtained or that an exemption from this requirement had been granted. In the first 5 months of the COVID‐19 pandemic, the five leading medical journals published a substantial number of articles that differed in many respects from their usual material. The journals examined were the clinically focused general medical journals with the top five Web of Science 2019 impact factors, ranging from 21.3 to 74.6, representing the medical literature with the greatest international influence on health policy and clinical practice. As reasonably expected, there was a seven‐fold reduction in the proportion of articles reporting randomised controlled trials, and a compensatory increase in small case series, opinions and editorials. While there were few (n = 2) articles in the random selection of 2019 papers that were published from China, nearly one‐quarter of the COVID‐19 publications came from this country, as anticipated given the location of the earliest cases. There was no difference in the median h‐indices of authors, suggesting experienced academics pivoted rapidly to COVID‐19 research. In circumstances which usually require consent, just under half of the COVID‐19 studies did not explicitly state consent was obtained, despite clear recommendations by the International Committee of Medical Journal Editors.5 The proportion of articles that referenced appropriate ethics committee or institutional review oversight was statistically unchanged; however, it is still a concern that 11 (16.7%) observational COVID‐19 studies lacked any statement to this effect. In addition, several other articles stated that they had been exempted from the requirement for ethical review due to the nature of the pandemic. Respect for personal autonomy and the value of independent oversight have always imposed additional workload on those seeking broader public health benefits. If COVID‐19 has created challenges in adhering to the usual practices of obtaining ethics approval and consent, consideration should be given to whether these processes could be amended to improve speed and accessibility, particularly during global health emergencies. There was a near three‐fold increase in the proportion of studies that published corrections, perhaps reflecting the observed reduction in time from submission to publication observed in the one journal for which these data were available. It is likely this figure is an underestimation, given that corrections and retractions would be expected to continue over time. Three COVID‐19 studies were retracted. The publication of one of these articles4 had important implications, resulting in the temporary cessation of the World Health Organization's trial of hydroxychloroquine.6 While the corrections and retractions may be an artefact of increased speed to publication, it is also possible that their higher number might be the effect of enhanced focus on research related to COVID‐19. Nonetheless, journals must retain the integrity of review processes if they are to offer value beyond alternative online means of information dissemination. This review has found similar results to bibliometric studies relating to the COVID‐19 pandemic, which have identified higher numbers of case series and reviews and fewer randomised clinical trials.7,8,9 We did not examine other articles from 2020 to understand the effect of COVID‐19 on contemporaneous publications, or to be able to comment on whether observed changes were specific to COVID‐19 or true of all 2020 articles. We note the convenience sampling of two similar periods may overestimate the magnitude of our findings. The cohort of 2019 studies for comparison was selected at random, rather than being matched by study type or size. When identifying h‐indices, we had difficulty identifying some Chinese authors, highlighting a bias against researchers without a name that can be distinctively rendered in the English language alphabet. Further implementation of unique author identifiers, such as the Open Research and Contributor ID (ORCID; www.orcid.org) or ResearcherID (Clarivate Analytics) would address this problem. We did not assess the quality of published studies or adherence to reporting guidelines. As part of their early response to the worldwide problem presented by the COVID‐19 pandemic, there was a significant change in the characteristics of articles published by leading medical journals, with some evidence of a tendency towards publishing articles prematurely and those with lower internal validity. While these unique circumstances no doubt warranted such a change, rapid dissemination of information should not need to come at the expense of quality, ethical standards or oversight. Others have suggested several solutions to this challenge, including a two‐track review process for pandemic and non‐pandemic research, rapid preliminary assessment of research methodology by skilled in‐house reviewers before deciding whether to send for peer review, sharing of peer‐reviews between reviewers and journals, and mentored peer reviewing by research trainees.10 As part of pandemic preparedness, planning to facilitate augmentation of resources available to medical publishers, allowing maintenance of standards of review, should occur. Box 1 – Search strategy ((“JAMA”[Journal]) or (“The New England Journal of Medicine”[Journal]) or (“Annals of Internal Medicine”[Journal]) or (“BMJ”[Journal]) or (“Lancet”[Journal])) and (2020/1/1:2020/5/31[Date — Entry]) or and (2019/1/1:2019/5/31[Date — Entry]) Articles related to COVID‐19 were identified by adding and ((“covid”[All fields]) or (“coronavirus”[MeSH Terms]) or (“coronavirus”[All fields]) or (“coronaviruses”[All fields])) Box 2 – Characteristics of publications 2019 non‐COVID‐19 2020 COVID‐19 P Total number of articles 54 134 Article type Systematic review/meta‐analysis/narrative review 8 (14.8%) 16 (11.9%) < 0.001 Randomised controlled trial 19 (35.2%) 7 (5.2%) Cohort study 11 (20.4%) 25 (18.7%) Cross‐sectional study 5 (9.3%) 8 (6.0%) Case–control study 1 (1.9%) 2 (1.5%) Case series 2 (3.7%) 30 (22.4%) Case report 0 (0.0%) 4 (3.0%) Diagnostic evaluation 0 (0.0%) 1 (0.7%) Opinion 7 (13.0%) 33 (24.6%) Other 1 (1.9%) 8 (6.0%) Reported primary data 37 (68.5%) 74 (55.2%) 0.09 Correction published 4 (7.4%) 28 (20.9%) 0.03 Days from publication to correction, median (IQR) 6 (4–14) 7.5 (5–18) 0.53 Retracted 0 (0.0%) 3 (2.2%) 0.56 h‐index of first author, median (IQR) 13.5 (3–36) 11.5 (6–30) 0.54 h‐index of last author, median (IQR) 26 (14–38) 21 (10–38) 0.14 Associated editorial of eligible articles 21 (38.9%) 44 (32.9%) 0.43 Number of masthead authors, median (IQR) 8 (5–19) 7 (4–18) 0.52 Number of total authors, median (IQR) 8 (5–23) 7 (4–19) 0.23 Region of origin China 2 (3.7%) 32 (23.9%) < 0.001 United States 24 (44.4%) 67 (50.0%) Europe 20 (37.0%) 24 (17.9%) Rest of world (high income countries) 3 (5.6%) 11 (8.2%) Rest of world (low income countries) 5 (9.3%) 0 (0.0%) COVID-19 = coronavirus disease 2019; IQR = interquartile range. Box 3 – Characteristics of studies reported table#t3 tbody td:nth-child(n+2) P. Pleft { text-align: center; } 2019 non‐COVID‐19 2020 COVID‐19 P Randomised controlled trials 19 7 Number of subjects, median (IQR) 424 (225–1076) 199 (127–397) 0.07 Participating centres, median (IQR) 30 (4–168) 10 (1–55) 0.15 Studies that received funding of any type from a commercial source 8 (42.1%) 3 (42.9%) 0.97 Studies in which a commercial entity had influence over any aspect of study conduct or reporting 7 (36.8%) 2 (28.6%) 0.69 Studies stating willingness to share data under appropriate circumstances 15 (78.9%) 7 (100.0%) 0.19 Studies stating individual patient consent or waiver was granted 19 (100.0%) 7 (100.0%) 1.0 Studies noting review by ethics committee 19 (100.0%) 7 (100.0%) 1.0 Observational studies* 19 66 Number of subjects, median (IQR) 191 972.5 (1407.5–756 444) 152.5 (15–3481) < 0.001 Participating centres, median (IQR) 26 (1–49) 1 (1–7) 0.07 Studies that received funding of any type from a commercial source 0 (0.0%) 4 (6.1%) 0.27 Studies in which a commercial entity had influence over any aspect of study conduct or reporting 0 (0.0%) 3 (4.5%) 0.34 Studies stating willingness to share data under appropriate circumstances 8 (42.1%) 15 (22.7%) 0.09 Studies not stating individual patient consent was obtained or a waiver was granted 3 (15.8%) 17 (25.8%) 0.37 Studies not noting review by ethics committee 0 (0.0%) 11 (16.7%) 0.06 Case reports/case series (≤ 10 patients) 1 16 Studies stating individual patient consent was obtained 1 (100.0%) 9 (56.3%) 0.40 COVID-19 = coronavirus disease 2019; IQR = interquartile range. * Observational studies included cross-sectional studies, case–control studies, cohort studies and case series reporting data from one patient or more. Box 4 – Publication identification flow diagram COVID‐19 = coronavirus disease 2019.

Kirsty A Whitmore · Kevin B Laupland · Clare M Vincent · Felicity A Edwards · Michael C Reade

Controlling the exit from work and accumulating multiple resources early predict adjustment to retirement The traditional approach to leaving a career in medicine has been informal. The fact that about 10% of medical practitioners in Australia are aged 65 years or over1 — a seemingly natural consequence of increased life expectancy, improved quality of life and fluctuations in financial markets — highlights the need for a more methodical process for leaving medicine. The final transition in a medical career is one that the profession has largely ignored, thereby risking unplanned departures that affect succession planning for practices, continuity of care for patients, and the wellbeing of the practitioner. The eventual introduction of proposed mandatory health checks for practitioners aged 70 years and over in Australia2 may hasten the retirement of some, which only increases the urgency of retirement planning becoming a routine task for all practitioners. The aim of this article is to describe a framework that examines how this transition may be achieved, so that practitioner wellbeing and adjustment to retirement are enhanced. For all the changes in medical culture that must occur — and to which the colleges, employers and other professional organisations must contribute — the individual practitioner ultimately remains responsible for their own welfare across the career cycle. While this article is aimed mainly at clinicians, its principles remain pertinent to other medical practitioners. Understanding the process of retirement Retirement is not a lone event. It is better understood as a longitudinal process that comprises three phases that may overlap.3 In the “pre‐retirement” phase, the practitioner continues to work but may anticipate and prepare for retirement. In the “transition” phase, decisions are made about how and when the practitioner should approach stopping work. The final phase of “adaptation” may involve some paid work but the practitioner is principally retired. Each phase is considered a critical turning point, in which action or neglect can influence the outcome of subsequent phases. Some practitioners may chart a non‐linear transition, moving in and out of work. Any approach to determining the optimal time to transition out of a career in medicine must consider individual motivation as well as other competing factors. The first is the right of all and the desire of some older practitioners to continue working versus the extrinsic demands of family expectations or life events, such as illness in a loved one. The second is the continued provision of clinical services by senior medical practitioners, usually within well established patient relationships, versus the right of patients to receive the highest level of care possible. In this regard, older practitioners are at increased risk of physical and cognitive changes that may potentially affect practice, such as poorer patient outcomes,4 and may lead to being the subject of a complaint to a regulatory authority.5 Why retirement planning may be hard When the transition away from work should start is an individual decision. Yet a cross‐sectional survey found that more than one‐third of older practitioners working in Australia had failed to even reach the pre‐retirement phase, as they reported no intention of retiring or were unsure about doing so.6 Moreover, not intending to retire was an occupational factor that predicted practitioners’ perceptions of ageing successfully.7 This suggests that even considering leaving work may be viewed as a sign of personal weakness. Financial factors related to inadequate superannuation funds, continuing debt, or other commitments have been found to prevent retirement planning.8 Several other reasons for continued practice and delayed retirement, however, reflect more intrinsic difficulties in detaching from medicine. These include a feeling of responsibility for patients, a lack of interests outside of medicine, and a fear of potential changes in their relationship with a spouse.8 These factors may be the result of a lifetime of work centrality whereby medicine takes precedence over other life roles.6 For many doctors, self‐identity is bound up in their work and the drive to further their careers. A study of academics suggested that work–life balance was more nebulous because outside interests, including family, were considered an inconvenient distraction.9 Conversely, emotional connections towards a workplace or institution may strengthen. Prioritising work limits social connections and creative pursuits, thereby perpetuating a reluctance to retire. A structured transition to retirement plan The purpose of adequate retirement planning is to enhance wellbeing after ceasing work. Pre‐retirement planning is a long term goal‐oriented behaviour that has been associated with retirement satisfaction.10 In addition, retirement adjustment is predicted by the conditions of exit — namely, control over how and when one leaves work11 — and resource acquisition in multiple domains.12 While the elements of planning should occur throughout the career cycle, we recognise that it is not a compelling consideration for many practitioners. We would still propose that all practitioners formally write an initial transition to retirement plan by the age of 55 at the latest, review it regularly, and the intervals between reviews should become more frequent with time (Box). The proposed introduction of the mandatory health check for practitioners aged 70 years or over should be an important incentive for self‐care. Traditional pre‐retirement planning has tended to consist only of financial advice such as wealth creation, tax optimisation, and estate planning. This is an essential task as people tend to underestimate how much money will be required in retirement, but should not be used as the sole criterion of fitness for retirement. The more pertinent questions are how time in retirement will be spent and how much it will cost to support, rather than a pre‐determined goal of wealth accumulation. Resource accumulation While adequate financial resources do contribute to retirement adjustment, so do adequate physical health, social engagement and emotional resources.12 This means a much broader spectrum of planning that uses advice from multiple professionals is required. Methods for optimising financial, physical and leisure resources are relatively easily sourced. What may be more difficult to manage, however, are the emotional resources needed to navigate the transition to retirement. In particular, the inevitable loss of self‐identity may lead to anticipatory grief and bereavement.13 That intending to retire is viewed as a mark of ageing less well by practitioners not only poses a considerable challenge for their retirement planning, but highlights the importance of understanding successful ageing in any discussion of transitioning away from full‐time work in medicine. Successful ageing is a concept that has evolved from a biomedical model, requiring an absence of physical disease and good physical functioning, to a more subjective notion that emphasises adaptation and autonomy.14 A sense of engagement, a prominent feature of self‐rated successful ageing, is inherent in the work of medical practitioners and is reflected in the pursuit of continued stimulation and learning, a sense of purpose and utility to society.15 Successful occupational ageing is based on insight into personal strengths, a dynamic process of goal setting, generativity (guiding and mentoring the next generation), and self‐care.14 There are a number of areas that are important for self‐reflection, such as the original motivations for training in medicine, the reasons for continuing to work, the anticipatory grief of the loss of identity and role, and the fear of ageing.14 Not every practitioner will be capable of self‐reflection, so that professional help may be required via a career development counsellor or vocational psychologist. While many practitioners will set a pre‐determined age or personal milestone at which to retire, others may continue to work indefinitely, thereby increasing the risk of practising with an impairment. This may be prevented by incorporating a professional advance care plan16 that outlines a set of premorbid views about ongoing practice in the event that capacity to practise is impaired. Permission would be given to one or more people, such as a spouse, friend or colleague, to monitor fitness to practise and to provide regular feedback. “Red flags” to stop working may include physical illness or concern from a trusted source about deterioration in cognition or procedural or clinical skills. Developing an encore career Developing an encore career is the final aspect of the transition plan that allows the use of skills and experience developed over a career, and helps maintain meaning and engagement. Giving consideration to the encore career while still working enables the practitioner to better position themselves to access greater opportunities. Up until this point, the practitioner may have found integrating different life roles challenging and pursuing outside interests unnecessary. An encore career can lead to feeling purposeful, provide goals to strive towards, and opportunities for intellectual and social pursuits. For example, a general practitioner keen to maintain patient contact but reduce caseload may want to specialise in an area of medicine (eg, mental health). Some may investigate governance roles with accrediting bodies, sit on guardianship or mental health review tribunals, or take up committee membership. Others may wish to provide leadership through directorships or management roles in hospitals or medical services. Others may wish to apply their lifetime of insights to teaching or research pursuits. Examples include teaching medical students, mentoring trainees, writing research grants and articles. It might be worthwhile revisiting those businesses or volunteering opportunities that were set aside before a medical career became the sole focus. Conclusion Retirement should not be viewed as a single endpoint but as an anticipatory process that involves the accumulation of social, emotional, financial and other resources. Active participation in retirement planning is essential to ease the transition, gain a better sense of control and enhance emotional adaptation. Encore careers provide the opportunity to capitalise on a lifetime of accumulated wisdom by integrating training, experience, interests and strengths. Given medicine’s long‐standing neglect of retirement planning, there is also a need for professional bodies to provide education about the transition process and for practitioners themselves to share stories of encore careers and inspire peers to explore avenues for transition. Box – My plan for transitioning to retirement I will accumulate the following resources: Physical resources ► What am I doing to take care of my health (diet, exercise, adherence with medications)? ► How often am I seeking independent health care, including consulting my general practitioner? Financial resources ► How do I optimise my finances (reduce debt, maintain income)? ► Who is my professional adviser? How often do I consult with them? Emotional resources ► Who are the people I can connect with for emotional support? Who do I support in return? ► Who do I know who has aged well and transitioned well? What can they share? ► What types of professional assistance do I need to support the transition? Social resources ► How do I maintain healthy relationships (spouse, children, family and friends)? ► Who can provide professional support to help me manage these relationships now and when I am not working? ► What relationships have lapsed that I want to re‐initiate? ► What interests can I develop or revisit? Cognitive resources ► What intellectual pursuits outside medicine can I follow? ► How do l want to learn, develop and grow? ► What creative pursuits do I want to develop? ► What courses or training might help to reposition me for an encore career? My professional advance care plan I will discuss the timing of transition and retirement with my peers and loved ones I will engage my junior colleagues in a discussion about succession planning I will reduce my hours, stop procedural work etc, at age X or if the following health or practice problems occur … I will stop working at age X or if the following health or practice problems occur … I will set up a peer mentoring system with close colleagues so that we can provide each other with feedback on professional issues and review skill levels. Encore career What are some professional aspirations I can pursue given greater time availability? How do I convert my passions and interests into pursuits? Do I want to focus on areas of expertise, governance, leadership or teaching and research? Was there a business opportunity I considered before my medical career that I want to revisit? What other career options have people who have successfully transitioned considered?

Chanaka Wijeratne · Joanne Earl

Artificial intelligence is being used in several different ways to curb the current pandemic while demonstrating its potential to be even more effective for the next one

Ian A Scott · Enrico W Coiera

Recent proposals to adopt tenecteplase as the recommended thrombolytic agent for stroke reperfusion will reduce its availability for patients with acute myocardial infarction

Mark Parsons · Leonid Churilov · Aletta E Schutte · Christopher Levi

Children may be more susceptible than originally thought and could play a role in community transmission

Zoë Hyde

Lifting lockdown when numbers are low but not zero means that superspreaders may remain, leading to a further wave of the epidemic

David Kault

The response to the largest institutional outbreak of COVID‐19 in health care workers in Australia to date needed to be multidimensional In many countries, high rates of health care workers with coronavirus disease 2019 (COVID‐19) have been associated with inadequate personal protective equipment (PPE), exposure to large numbers of patients with COVID‐19, worker fatigue, and limited access to diagnostic testing.1,2,3 In Australia, during the initial phase of the epidemic, infections in health care workers were largely attributable to international travel, corroborated by genomically distinct severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) lineages.4,5 At the Royal Melbourne Hospital, we observed a marked increase in staff infections during July and August 2020, concurrent with a statewide surge in COVID‐19 cases. To inform future responses in the Australian setting, we present a description of health care worker infections at our institution and the suite of interventions associated with outbreak control. Setting The Royal Melbourne Hospital City Campus is a 550‐bed university‐affiliated tertiary hospital with an additional 150 geriatric and rehabilitation beds at the Royal Park Campus, a large mental health service and four residential aged care facilities, employing about 10 000 staff. Throughout the pandemic, a rapid access COVID‐19 testing clinic was provided for symptomatic staff. To diagnose infection, deep nasal and throat swabs were sampled for nucleic acid testing (reverse transcriptase polymerase chain reaction [RT‐PCR] for SARS‐CoV2). SARS‐CoV‐2 RNA was detected using the Coronavirus Typing assay (AusDiagnostics).5 All positive COVID‐19 tests were notified to the Department of Health and Human Services, with staff members also being notified to the Royal Melbourne Hospital infection prevention services. Infected staff were interviewed by an infection prevention nurse consultant to identify any contacts and enquire about PPE use, work locations in the days before symptoms, nature of their work, characteristics of their patients, and any suspected acquisition events. Contacts with other staff outside work were also explored. Infected staff were required to isolate for 10 days or more after symptom onset and close contacts (≥ 15 minutes of face‐to‐face contact or ≥ 2 hours in a shared space in the 48 hours before symptom onset) were furloughed for 14 days and quarantined, according to state guidelines. Outbreaks (two or more epidemiologically and/or spatially linked staff and/or patients) were managed by a multidisciplinary incident management team. Data regarding health care worker infections were entered into a REDCap 10 (Research Electronic Data Capture) database, a secure web‐based platform, and were analysed using Stata 16. This study was approved by the Melbourne Health Human Research Ethics Committee (QA2020058). Overview Between 1 July and 31 August 2020, 262 cases of COVID‐19 were identified among Royal Melbourne Hospital staff (Box 1 and Box 2). Fifteen individuals (5.7%) required inpatient care and 13 (4.9%) received care by a hospital in the home service. Two were admitted to the intensive care unit (ICU), none requiring mechanical ventilation, with no deaths. Nurses were most commonly affected, followed by support staff (such as food and cleaning services) and doctors (17/21 of these being doctors‐in‐training) (Box 1). The trend in incidence of health care worker infections reflected the prevalence of inpatients with COVID‐19 (Box 3). The ICU had between zero and ten concurrent patients with COVID‐19 over the period (median, 7; interquartile range [IQR], 5.0–8.0), with four ICU staff acquiring COVID‐19. No operating theatre staff and no staff working in affiliated residential aged care facilities were infected. The median turnaround time for health care worker test results (from specimen collection to reporting) was 20.2 hours (IQR, 11.4–29.1 hours). Overt recognised PPE breaches were rarely reported. Contacts with known COVID‐19 cases outside the hospital were infrequent but did occur (eg, health care workers living together). Outbreak linked to geriatric and rehabilitation inpatient wards The Royal Park Campus had the highest number of staff with COVID‐19, making up 40.8% (n = 107) of health care worker infections at the Royal Melbourne Hospital, despite this campus constituting about 10% of the total staff workforce at the hospital (acknowledging that some staff move between sites). Between 12 and 18 July, the Royal Park Campus received a large number of patients from external residential aged care facilities, not affiliated with the Royal Melbourne Hospital, with COVID‐19 outbreaks. These residents were COVID‐19‐positive at admission and were managed with appropriate infection precautions throughout. COVID‐19 cases among staff rapidly escalated across all six wards at the campus after 16 July, peaking on 27 July. The peak number of patients with COVID‐19 at the Royal Park Campus was 60. At the Royal Park Campus there are a variety of buildings constructed from the 1970s to early 2000; most have central air conditioning plants, but one has a local split system. An engineering review of the wards revealed air exchanges met current requirements; however, a more detailed assessment of air movement suggested that some were not as well ventilated as others. Some patients were in single rooms, but many were in multibed spaces. Improved nurse to patient ratios were used to help manage patients. Despite this, because of large numbers of staff furloughs, the remaining staff experienced high workloads. A decision was made on 3 August to close four wards at the Royal Park Campus. Fifteen patients were moved to other health services, while the remaining 45 were moved to single rooms in wards with more modern infrastructure. Outbreaks linked to “hot wards” At the Royal Melbourne Hospital City Campus, most affected staff were working in wards with patients with suspected or confirmed COVID‐19 (“hot wards”) (Box 1). These staff were highly trained in PPE use, PPE was always readily available (ie, gowns, gloves, eye protection, and masks), and use was checked by a PPE “buddy” (usually a colleague) before patient room entry and at doffing. Staff noted that particular behaviour in infected patients appeared to be linked to transmission events (patients shouting, vigorous coughing). The peak combined prevalence of inpatients at the Royal Park and City campuses was 99 on 5 August 2020. As increasing numbers of staff infections were recognised, the density of patients on the COVID‐19 wards was reduced by closing beds in shared rooms and moving each patient to a single room where possible. On 21 July, use of N95 (or P2) masks by all staff at all times on COVID‐19 wards at both campuses was instituted. “Spotters” (supernumerary staff) were deployed to observe PPE donning and doffing, and senior staff ward walk‐arounds and additional cleaning with monitoring were implemented. Staff working on “hot wards” were offered weekly asymptomatic testing to detect any infections early. Outbreaks on “cold wards” On three occasions, clusters occurred outside the designated “hot wards”; that is, in wards not allocated to caring for patients with suspected or confirmed COVID‐19 infection. In some staff, having previously worked at the Royal Park Campus was identified as a potential risk factor. A management plan for these wards was deployed, including closure to new admissions, moving patients to separate rooms (where possible), managing the whole ward using increased precautions, deep cleaning, and voluntary testing of all patients and staff every 3–4 days. Hospital‐wide asymptomatic staff testing was instituted (> 600 staff tested) and whole hospital inpatient testing occurred as a point prevalence activity in late July, with no additional cases identified outside the affected wards. Institutional responses Responses were multifactorial and iterative, with daily review of emerging evidence that informed ongoing decisions. Importantly, a hierarchy of controls was used to manage these outbreaks (Box 4). A proactive approach was used to support infected and furloughed staff wellbeing, with dedicated nursing and medical staff monitoring physical and mental health as well as providing practical supports. This service managed over 680 staff during the outbreak period. Discussion We describe the largest institutional outbreak of SARS‐CoV‐2 health care worker infections reported in Australia to date. Our response was necessarily iterative and pragmatic and advice often pre‐dated formal state and federal recommendations. During these outbreaks, a number of key factors emerged that shaped our responses, extending well beyond a focus on PPE alone. First, the concept of a “critical burden” of infection framed our responses to patient movement and ward closures. Concurrent with large numbers of cases in the hospital and the community, the number of staff who acquired infection rose rapidly. Based on overseas experience,6,7 we hypothesised that large numbers of patients in confined spaces may have created a high density of droplets, aerosols and environmental contamination. This triggered a detailed assessment of ward physical layout, including the possible role of patient placement and air circulation. We elected to use single rooms wherever possible and to physically space infected patients by closing beds on the ward. The intensity of transmission in some wards led to a decision to close wards and move some patients to other health care services. Further, we adopted the use of N95 masks for staff working in areas with large numbers of patients with confirmed or suspected COVID‐19. While use of N95 masks for all COVID‐19 care was not recommended in state or federal guidelines at that time,8,9 this organisational decision was based on our local epidemiology and a need to trial any reasonably available strategy to contain health care worker infections. Second, the availability of rapid and accessible testing for staff was critical to informing real‐time outbreak management, highlighted by international studies.10,11 Rapid availability of data informed our daily incident management meetings and enabled prompt decision making using the best possible information. Finally, the importance of staff communication and wellbeing cannot be understated. Similar to other studies,3,12 many staff reported physical and mental fatigue and stress during these outbreaks. In addition, workforce shortages meant that staff were taking on extra shifts at short notice and working in unfamiliar roles. Accordingly, access to employee support programs was an important element of this response. Box 1 – Demographic characteristics of health care workers with coronavirus disease 2019 (COVID‐19), confirmed by polymerase chain reaction (PCR) testing, at the Royal Melbourne Hospital (1 July – 31 August 2020) Characteristic Number of confirmed cases
(%) Total number of confirmed cases 262 Sex Male 57 (21.8%) Female 205 (78.2%) Median age at diagnosis (IQR), years 32.7 (26.8–44.9) Employee type Nurse 179 (68.3%) Doctor 21 (8.0%) Allied health practitioner 9 (3.4%) Support staff (food services, environmental services) 38 (14.5%) Administrative staff 6 (2.3%) Student 4 (1.5%) Security staff 4 (1.5%) Laboratory staff 1 (0.4%) Location Royal Park Campus (rehabilitation, geriatric rehabilitation) 107 (40.8%) Hot wards* (COVID‐19 wards,† ED, ICU) 57 (21.8%) Cold wards‡ with recognised COVID‐19 outbreaks (3 wards) 20 (7.6%) Cold wards‡ with no outbreaks (1 or 2 unlinked cases; 6 wards) 7 (2.7%) Mental health ward§ 8 (3.1%) Not ward‐based (eg, non‐clinical) 31 (11.8%) Unknown (no campus/ward stated, includes both campuses) 32 (12.2%) ED = emergency department; ICU = intensive care unit; IQR = interquartile range. * Hot wards are wards dedicated to managing patients with confirmed or suspected COVID‐19. † COVID‐19 wards are wards where patients with confirmed or suspected COVID‐19 were managed. ‡ Cold wards are all other wards. § Mental health wards were situated at the City Campus and at other sites. Box 2 – Epidemic curve of health care worker infections at the Royal Melbourne Hospital (1 July – 31 August 2020) RPC = Royal Park Campus. * “Other” includes non‐clinical not ward‐based staff, staff working across several campuses, or ward not known. Mental health wards include off‐site facilities. Box 3 – Prevalence of inpatients with coronavirus disease 2019 (COVID‐19) at both the Royal Melbourne Hospital City Campus and the Royal Park Campus over time (13 July – 31 August 2020)* * Data start on 13 July 2020. Box 4 – Hierarchy of controls used to guide interventions to address health care worker infection with coronavirus disease 2019 (COVID‐19) at Royal Melbourne Hospital Elimination* Public health restrictions to reduce community incidence Testing availability in the community (and for staff) to identify and isolate cases early Rapid turnaround time for test results to identify and isolate cases early Frequent testing of staff and patients in wards with outbreaks for early recognition and management of cases Symptomatic staff furloughed until test results available Furlough asymptomatic staff who are contacts of COVID‐19 cases Work from home policies for staff Telehealth consultations rather than in‐person visits to hospital Visitor restrictions to hospitals (use of phone/iPad to liaise with family) Early discharge of patients not requiring inpatient care, use of hospital in the home services Use of remote meeting technology Engineering controls Attention to ventilation and air circulation in all clinical and non‐clinical areas Availability of negative pressure rooms Physical separation of patient groups (access to single rooms, wards with doors to separate from other wards) Equipment to improve turnaround times for microbiologic testing to enable rapid identification of cases Adequate space for staff to safely don and doff PPE Provision of break rooms with increased space enabling adequate physical separation Physical barriers for public facing non‐clinical staff (eg, perspex barriers) Appropriate cleaning (correct equipment to enable this) Administrative controls Existing policies, procedures and subcommittees (with appropriate governance) in place before the COVID‐19 pandemic regarding infection prevention, PPE, hand hygiene, transmission‐based precautions, cleaning, outbreak management, management of contact tracing, pandemic plan Appropriate governance (Emergency Operations Centre with multidisciplinary representation from all areas) during pandemic Use of national and state guidelines to inform development of hospital COVID‐19 guidelines Regular meetings of key stakeholders to discuss emerging issues Regular communications to staff via email, social media, and remote meetings by hospital executive and managers Policies to encourage physical distancing between staff (staggered breaks, start/stop times, roster redesign) Workflow changes to encourage distancing between staff and patients where possible Use of dedicated “COVID teams” in wards to minimise staff moving between wards Resourcing of staff in “COVID‐19 wards” to ensure manageable workload, improved nurse to patient ratios Bed allocation (avoidance of high density of COVID‐19-positive patients in wards, minimise use of shared rooms) Management of COVID‐19-positive patients in separate wards from COVID‐19‐negative patients Training (baseline and refreshers) and monitoring of PPE use (spotters) for all clinical and non‐clinical staff Increased resourcing of cleaning services and ongoing training in cleaning, using in‐house and not agency staff Monitoring of cleaning (eg, ongoing fluorescent marking programs, spotters) Hand hygiene training and auditing, including development of videos and posters specific to COVID‐19 PPE Universal pandemic precautions (surgical mask and face shields all staff all the time) Masks on patients where possible for source control Use of PPE appropriate to the circumstance (gowns, gloves, surgical masks, N95/P2 masks, eye protection) PPE = personal protective equipment. * Actions to remove or minimise the number of infected people on site.

Kirsty L Buising · Deborah Williamson · Benjamin C Cowie · Jennifer MacLachlan · Elizabeth Orr · Christopher MacIsaac · Eloise Williams · Katherine Bond · Stephen Muhi · James McCarthy · Andrea B Maier · Louis Irving · Denise Heinjus · Cate Kelly · Caroline Marshall

Lessons learnt from COVID-19 outreaks in residential aged care facilities could limit future impacts

Gwendolyn L Gilbert

There is more to female sexual function than circulating testosterone, and symptomatic women require a thorough clinical evaluation The 2019 global consensus position statement on the use of testosterone therapy for women1 aims to provide guidance for clinicians managing women with female sexual dysfunction. The recommendations, graded according to levels of evidence, have been developed by an international taskforce with representatives from a range of organisations and societies, headed by Australian endocrinologist Professor Susan Davis, the current President of the International Menopause Society. The position statement bases many of its recommendations on a systematic review and meta‐analysis of randomised controlled trials.2 The meta‐analysis includes data from 36 randomised controlled trials with 8480 participants and includes studies with a testosterone treatment duration of at least 12 weeks. The primary outcome indicates an improvement in satisfying sexual events, measured as a mean increase of one event over 4 weeks with the use of testosterone. There were also improvements in other parameters associated with sexual function, including sexual desire, arousal and self‐image. There were no cognitive, psychological, wellbeing or musculoskeletal (including bone mineral density) benefits. In doses that approximate physiological levels, the main adverse effects of testosterone therapy are significant increases in acne and hair growth but no difference in alopecia, clitoromegaly or voice change. The position statement provides recommendations covering the assessment of women with female sexual dysfunction, laboratory measurement of testosterone, indications for treatment, and ongoing monitoring once treatment is commenced. It emphasises that the only evidence‐based indication for the use of testosterone in women is the treatment of post‐menopausal women who have been diagnosed with hypoactive sexual dysfunction disorder (HSDD) after formal biopsychosocial assessment. Doses that approximate physiological testosterone concentrations in pre‐menopausal women are recommended. At these doses, testosterone therapy is not associated with serious adverse events. Notably there are no safety data for beyond 24 months of treatment. There are insufficient data regarding the use of testosterone therapy in pre‐menopausal women. The position statement does not comment regarding women with premature ovarian insufficiency and recommends caution in women with a breast cancer diagnosis, reflecting the lack of data.3,4 The classification of female sexual disorders has been a source of controversy and debate. In the Diagnostic and Statistical Manual of Mental Health Disorders, 5th Edition, HSDD and female sexual arousal disorder (FSAD) have been amalgamated and classified as a single entity: female sexual interest/arousal disorder. The writing group for the position statement regards HSDD and FSAD to be distinct conditions, a view shared by experts in the field.5,6 Diagnostic criteria for both conditions are outlined in Box 1.7 It is important to understand this clinical distinction as the position statement does not consider FSAD to be an indication for testosterone therapy. Serum testosterone levels decline during the reproductive years and are significantly reduced in women post‐oophorectomy.8 There was no reported correlation between androgen levels and reported sexual function in one study,9 and there is no serum testosterone cut‐off below which women are more likely to experience HSDD. The authors of the position statement comment that the relationship between endogenous androgen concentrations and sexual function remains uncertain because of issues related to androgen assays in some studies. Notwithstanding these factors, it is recommended that a baseline measurement of testosterone be taken to avoid overtreatment.1 Serum total testosterone rather than free testosterone is the recommended biomarker. The significance of free testosterone in the context of female sexual dysfunction has not been evaluated. Most commercial assays in Australia use immunoassays to measure testosterone, while free testosterone and free androgen index are calculated from total testosterone and sex hormone‐binding globulin. However, immunoassays are considered unreliable, particularly for low levels in the female reference range. Liquid and gas chromatography and mass spectrometry, while not yet in common use, are considered far more accurate and efforts are being made to increase availability.10 The position statement does not comment on whether menopausal hormone therapy should be used concurrently with testosterone therapy. However, a biopsychosocial model of treatment of female sexual dysfunction is recommended, which may include menopausal hormone therapy. Multiple studies have looked at the effect of oestrogen therapy alone, testosterone alone and a combination of the two on female sexual function, with variable outcomes. One of the main criticisms of studies demonstrating no improvement with oestrogen (alone or combined with testosterone) is that low therapeutic doses of oestrogen were used and circulating oestradiol levels were either not measured or were low and did not reach pre‐ovulatory levels consistent with those seen in pre‐menopausal women.11 Only one of eight studies included in the meta‐analysis did not include concomitant menopausal hormone therapy.2 Systemic oestrogen therapy is known to improve hot flushes, urogenital symptoms and mood disturbance, while topical vaginal oestrogen is effective in managing vulvovaginal atrophy.12 Both improve wellbeing in menopausal women and may enhance libido such that other therapies are not required,13 although an improvement in absolute terms has not been described. Our view is that menopausal hormone therapy with oestrogen with or without progestogen should be considered initially in all post‐menopausal women who present with low libido before the initiation of testosterone. A significant issue is the clinical meaningfulness of the finding of a mean increase of one satisfying sexual event per month. Many will argue that such an outcome does not justify the use of testosterone therapy in clinical practice. In context, however, the meaningfulness will depend on the individual woman. For example, for a woman experiencing no satisfying sexual events, an extra one per month would equate to twelve extra events per year and could represent a significant improvement in her quality of life. Consumer involvement in the development of the position statement may have provided insight into this question. In the meta‐analysis, testosterone therapy compared with placebo was found to reduce personal distress, a key component of HSDD, in all studies of post‐menopausal women. Perhaps more relevant to the discussion is whether a satisfying sexual event is adequate as the primary measure of efficacy for treatment. The authors address this in the final part of the position statement. Appropriately, recommendations are made for the design of future clinical trials, including the development of a validated instrument for the screening and diagnosis of HSDD that can also be used as a marker of efficacy of treatment. Australian perspective Sexual dysfunction is common among Australian women. The prevalence of low sexual desire and HSDD was 69.3% and 32.2%, respectively, among a sample of community‐based women aged 40–65 years in one study.14 In older women, the prevalence of HSDD was reported to be one in seven women in a population of women aged 65–79 years living in the community.15 The use of testosterone for therapeutic purposes in women has been controversial. Despite this, clinicians in many countries including Australia have been prescribing testosterone off‐label primarily for low sexual desire in women for several years.16 Various formulations have been used, including subcutaneous pellets, transdermal gels and intramuscular injections that are designed for men, with dosing then adjusted for the female population. In this setting, there is greater potential for treatment to result in supraphysiological testosterone levels. The position statement suggests that ‘‘where approved female preparations are unavailable, off‐label prescribing of an approved male formulation is reasonable”.1 Bio‐identical and compounded products are not recommended. In Australia, a 1% transdermal testosterone cream is available, designed specifically for women and indicated for symptoms caused by testosterone deficiency. Although the product is unlicensed in Australia, it has been available on prescription from pharmacies within Western Australia since 1999 due to an exemption under section 6 of the Therapeutic Goods Act 1989 (Cth). Women prescribed this treatment in other states are required to access it by mail order along with a prescription from their clinician. It was submitted for Therapeutic Goods Administration evaluation and inclusion on the Australian Register of Therapeutic Goods as a registered product in 2019 for the proposed indication of treatment of hypoactive sexual desire dysfunction in post‐menopausal women, and a response is expected by the end of 2020 (Michael Buckley, Medical Director, Lawley Pharmaceuticals, personal communications). Although limited by small sample sizes, pharmacokinetic and clinical studies of the recommended 5–10 mg daily dose of this cream demonstrated total and free testosterone levels within or above the pre‐menopausal range.17,18,19 Its availability in Australia overcomes the need to consider male preparations or compounded and bio‐identical products. The publication of the position statement will increase awareness of female sexual dysfunction in the medical community. Clinicians managing these patients will require education in practical terms about assessing such patients for HSDD and safely prescribing and monitoring testosterone therapy when indicated. Based on the authors’ expertise and experience, we propose an algorithm for the assessment of women presenting with female sexual dysfunction and use of testosterone (Box 2), with women initially undergoing a biopsychosocial assessment.6 We recommend information sheets for clinicians and patients written by local experts be made available on the websites of the Australasian Menopause Society, the Endocrine Society of Australia and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Conclusion The position statement is a timely addition to the literature regarding testosterone therapy for women. What is clear is that there is more to female sexual function than circulating testosterone and that symptomatic women require a thorough clinical evaluation, assessing for other factors which may be contributing to their presentation. Testosterone therapy is a small piece of the puzzle in the management of female sexual dysfunction. This position statement provides clarification regarding the indication, adverse effects and knowledge gaps. The availability in Australia of a transdermal testosterone preparation designed for women obviates the need to use male preparations, but further research regarding efficacy and safety is necessary. Future studies should address the safety of long term use of testosterone in women, particularly with respect to cardiovascular disease and breast cancer. Box 1 – Definition of hypoactive sexual desire disorder and female sexual arousal disorder7 Disorder Definition Hypoactive sexual desire disorder Any of the following for a minimum of 6 months: lack of motivation for sexual activity as manifest by reduced or absent spontaneous desire (sexual thoughts or fantasies); or reduced or absent responsive desire to erotic cues and stimulation or inability to maintain desire or interest through sexual activity loss of desire to initiate or participate in sexual activity, including behavioural responses such as avoidance of situations that could lead to sexual activity that is not secondary to sexual pain disorder AND is combined with clinically significant personal distress that includes frustration, grief, guilt, incompetence, loss, sadness, sorrow or worry Female sexual arousal disorder* Female cognitive arousal disorder Distressing difficulty or inability to attain or maintain adequate mental excitement associated with sexual activity as manifest by problems with feeling engaged, or mentally turned on or sexually aroused for a minimum of 6 months Female genital arousal disorder Distressing difficulty or inability to attain or maintain adequate genital response associated with sexual activity for a minimum of 6 months, including: vulvovaginal lubrication engorgement of the genitalia sensitivity of the genitalia associated with sexual activity Disorders related to: vascular injury or dysfunction, or neurological injury or dysfunction * Encompasses female cognitive arousal disorder and female genital arousal disorder Box 2 – Testosterone therapy for post‐menopausal women: proposed algorithm CNS = central nervous system; CVD = cardiovascular disease; HSDD = hypoactive sexual desire disorder; IMS = International Menopause Society; VTE = venous thromboembolism. * Simon et al.6 † Jane and Davis.20

Christina Jang · Jacqueline A Boyle · Amanda Vincent

The involvement of patient advocates should ensure that guidelines are rigorously patient‐focused The fundamental objective of clinical management guidelines for any disease entity is to ensure that the information required to provide evidence‐based management recommendations to patients is readily available to their treating clinicians. It is well established that familiarity with guidelines by clinicians and adherence to them increases the number of patients receiving best‐practice care and improves outcomes.1 However, although management guidelines are intended primarily for clinicians, they must also reflect the patient perspective.2 Patient representation on the Melanoma Guidelines Working Party After identifying the need to produce new Australian guidelines on the management of melanoma, a multidisciplinary working party — under the auspices of Cancer Council Australia and the Melanoma Institute Australia — was established in 2014 to critically assess new evidence and update the previous national guidelines. In addition to clinicians and researchers, two patient advocates (consumer representatives), representing patients with melanoma from around Australia through their affiliations with patient advocacy and support networks, were invited to join the working party. These patient advocates had personal experience of melanoma diagnosis and treatment and extensive prior involvement in melanoma advocacy. This meant that they were able to make important contributions based on their experience as well as providing feedback from the patient networks they represented. Electronic publication Whereas the two previous editions of Australian melanoma guidelines, published in 1999 and 2008 respectively, were printed documents, each taking more than 4 years to compile,3,4 the new guidelines were electronic and were made available on Cancer Council Australia's Wiki platform.5 This publication format allowed individual sections to be published as they were completed and permitted selective updating as new evidence became available. Electronic publication has also meant that the guidelines are more readily accessible to both doctors and patients. They can simply search on their computer, tablet or smartphone for “Australian melanoma guidelines” or go directly to the guidelines website (https://wiki.cancer.org.au/australia/Guidelines:Melanoma).5 The level of evidence supporting each guideline recommendation is clearly documented, informing doctors and assisting patients in their decision‐making process. Patients’ expectations from their treating clinician When patients who are concerned about the possibility of having a primary melanoma consult a general practitioner, dermatologist or surgeon, they are entitled to expect that evidence‐based guidelines will be followed and therefore that the steps below will take place: if there are any suspicious skin lesions, they will be carefully examined; if the doctor suspects that a lesion may be a melanoma, the recommended form of biopsy will be carried out (usually complete excision biopsy with a 2–3 mm margin); if melanoma is diagnosed, the recommended treatment and likely outcome will be clearly explained; the melanoma will be staged correctly, appropriately wide surgical excision will be recommended, and the option of sentinel node biopsy will be discussed for melanomas 1 mm or greater in Breslow thickness or 0.8–1.0 mm in thickness with higher risk pathological features, so that prognosis can be estimated accurately and the eligibility for adjuvant post‐operative systemic therapy can be determined;6,7 and the potential benefits and possible side effects of adjuvant therapy will be discussed. When patients are given a diagnosis of metastatic melanoma in regional lymph nodes, or at a systemic site and are referred to a surgeon, medical oncologist or radiation oncologist, again, they should be able to expect that the following will happen: appropriate surgery will be recommended, and surgery that may be unnecessary (eg, completion lymph node dissection for sentinel node positivity8,9) will not be undertaken without a full discussion of the advantages and disadvantages; and if surgery is not considered appropriate, therapeutic systemic therapy options will be discussed, again with a realistic description of the likely benefits and possible side effects.10 Use of the guidelines While different stakeholders will use guidelines in different ways, they are intended to be useful to both clinicians and patients: to GPs, particularly those who work in skin cancer clinics; to dermatologists, who see many patients when they first present with a primary melanoma but who rarely manage patients with metastatic melanoma; to surgeons who treat patients with both primary and metastatic melanoma; to medical and radiation oncologists who are involved in the care of patients with metastatic disease; and importantly, to patients by providing a reliable source of information. It is hoped that by having access to guidelines based on the best available evidence, both treating clinicians and patients will be better informed, treatment options will be better understood, and patients will receive the most appropriate care. The ongoing involvement of patient advocates in the process of developing and updating the Australian melanoma guidelines should ensure that they are useful and relevant to patients and that the health care outcomes most valued by them are considered, resulting in guidelines that are rigorously patient‐focused, as they should be.

Alison E Button‐Sloan · John F Thompson

A recently developed national transport and cryopreservation service improves equity of access to fertility care for young people across Australia Loss of fertility, which is a well recognised complication of cancer treatment, has a significant impact on quality of life and is ranked as one of the top survivorship concerns.1 Improvements in survival (> 88% for adolescents and young adults) and expansion of fertility preserving options have stimulated rapid evolution of the fertility preservation landscape, aiming to decrease this devastating impact of cancer therapy.2 In addition to the gonadotoxic burden of cancer treatment, societal trends of delayed fertility mean that there are many young people who have not yet completed or even commenced trying for a family when diagnosed with a life‐threatening illness. Fertility discussion, and provision of services to preserve gametes or tissue, is no longer seen as a distraction or a luxury but is acknowledged as a mandatory part of cancer management.3 However, barriers to provision of fertility preservation care remain. These include the lack of education of health care providers about both the long term fertility consequences of cancer treatment and the clinical value of available options. There is also often a lack of clarity about whose role it is to educate patients about these options. Importantly, there can be significant logistic, geographic and economic barriers for patients, especially outside the major centres, such that only 4–50% of young people take up fertility preservation in a timely fashion.4 Established strategies to preserve fertility for the future include medical therapies to protect the primordial follicle pool, vitrification of oocytes and embryos, and ovarian tissue cryopreservation for females. Mature sperm freezing is undertaken in post‐pubertal males, and testicular tissue cryopreservation, while providing the only opportunity for pre‐pubertal boys, is still considered experimental.3 Gonadal tissue cryopreservation Ovarian tissue cryopreservation is the only option for prepubertal girls and may be the only or best option for women at high risk of infertility from cancer treatment, particularly if there are time constraints or safety concerns with other options. Ovarian tissue cryopreservation is no longer considered experimental by peak bodies,3 and there have been over 140 births worldwide following ovarian tissue grafting, including several in young women whose ovarian tissue was cryopreserved as pre‐pubertal children.5 Testicular tissue cryopreservation provides an experimental option for fertility preservation in pre‐pubertal boys at significant risk of azoospermia from gonadotoxic treatments. As boys do not produce mature sperm that can be frozen, a treatment involving testicular biopsy and cryopreservation of spermatogonial stem cells, followed by transplantation into the testis after treatment, is proposed to allow restoration of fertility.6 Recent publications of in vitro sperm maturation and live birth success using the primate animal model provide optimism, such that the joint international consensus statement of peak fertility bodies in 2015 recommended that testicular tissue cryopreservation should be offered for pre‐pubertal boys,3 despite the currently experimental nature of future use, especially as there are no other options. Testicular biopsy can be safely performed and often coordinated concomitantly with other medically necessary procedures without delaying the start of treatment.7 While cryopreservation of eggs, sperm and embryos is a routine part of assisted reproductive laboratory activity, the technique for cryopreservation of ovarian and testicular tissue is biophysically different, and very few centres nationally and internationally have established tissue cryopreservation laboratories with validated, published protocols and clinical success after thawing.8 Due to distance challenges within Australia and lack of resources to meet the needs of these patients, particularly those who reside in rural and remote areas, ovarian and testicular tissue cryopreservation is not accessible to over 70% of people who would benefit from this opportunity.4 Establishment of the National Ovarian and Testicular Transport and Cryopreservation Service To provide equity of access to fertility care, the Fertility Preservation Service at the Royal Women's Hospital in Melbourne has developed the National Ovarian and Testicular Transport and Cryopreservation Service, allowing collaboration between local units and specialised centres, with professional and patient education as part of the program. There are several successful international models for collaborative care with published protocols and data to support transportation and storage of gonadal tissue or gametes in a specialised centre with expertise, health and safety regulations.9 The live birth rates with and without overnight transportation are comparable.9 The Fertility Preservation Service, a partnership between the Royal Women's Hospital and Melbourne IVF, was established 30 years ago. It is the largest service of its kind in Australia, with clinical expertise in counselling, cryopreservation, testing, storage and transport procedures. It sees about 300 patients per year, managed by a multidisciplinary team of fertility specialists, nurses, research scientists, research managers, laboratory staff, counsellors and administrators. There have been increasing referrals each year, reflecting the increased demand. Eighty percent of these are cancer related, with serious medical conditions and gender dysphoria forming the remainder. The Fertility Preservation Service has built extremely strong relationships with cancer centres, both in Victoria and nationally, and collaborates closely with other fertility preservation units, including the Fertility and Research Centre in NSW and the Royal Children's Hospital Melbourne. It supports data collection for the Australasian Oncofertility Registry.10 Based on a recent Fertility Society of Australia survey,11 we believe that Victoria, possibly because of both the dedicated fertility preservation centre and the well developed collaborative relationships, has the highest rate of patients referred for fertility consultation. The service stores gonadal tissue from over 1000 patients. Ovarian tissue grafting has been performed in 40 patients, with five children born and a live birth rate of 20% per embryo transferred. There are also mature eggs and embryos which have been cryopreserved from ovarian tissue stimulation. Testicular tissue has been cryopreserved for 163 patients. The establishment of a centralised national tissue retrieval and transport program allows gonadal tissue harvesting to take place in a local centre with subsequent transportation to the central laboratory for processing, cryopreservation and storage. Communication with the National Ovarian and Testicular Transport and Cryopreservation Service team occurs via a paging service which is checked daily by a dedicated nurse, with treating clinician and, when appropriate, patient follow‐up by teleconference. Subsequently, ovarian tissue grafting may be performed at the Royal Women's Hospital or the tissue can be transported back to the local centres. The service also provides follow‐up and psychological support for patients, and educational resources to assist with all aspects of fertility preservation, both for patients and health practitioners. Fertility preservation is a mandatory part of cancer care; the National Ovarian and Testicular Transport and Cryopreservation Service program will improve equity of access to fertility preservation for young women and men around Australia.

Genia Rozen · Stephanie Sii · Franca Agresta · Debra Gook · Catharyn Stern