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Opportunities for eConsent to enhance consumer engagement in clinical trials
Enhancing clinical trial recruitment through eConsent has potential but needs more evidence of use Consent for medical interventions or clinical research participation currently relies on the use of printed information combined with a conversation with a health care professional, which is largely undocumented. Studies have shown that few participants are truly informed at all using these traditional means, and have demonstrated that recall or comprehension of what was disclosed is poor.1,2,3 Attempts to develop standardised participant information and consent forms (PICFs) that meet ethical requirements have often resulted in longer and more complex documents. While consumers have been engaged to assist with these programs, the purpose of PICFs is still too heavily weighted toward satisfying regulatory requirements rather than patient information needs. Unsurprisingly, data show that, as PICFs get longer, they are less well understood,4,5 and there is evidence that this is one of the reasons why patients do not agree to participate in clinical research.6 eConsent is not simply a conversion of a paper PICF into an electronically delivered version. It also holds the promise of improving participant engagement in clinical trials through a variety of features that include: the use of multimedia tools to enhance comprehension; ready conversion into multiple languages; a means to track consent in a highly portable manner; and the opportunity to provide information in a more convenient way to persons with an inability to attend clinics. The use of eConsent does not replace the opportunity for participants to ask direct questions to their doctor or the investigators. Moreover, in most instances, participants will still be required to make a physical visit to a clinic to receive their treatment, whereupon they can ask questions and confirm their willingness to participate. There are relatively few studies using eConsent. In an early randomised controlled study, there was a preference for eConsent as well as improved comprehension and intention to participate in people assigned to use computer terminals rather than paper to receive information.7 In a more recent study involving people infected with human immunodeficiency virus,8 eConsent was found to be acceptable and had some advantages over paper information sheets. There were a majority of males included in the study (75%), and more than half were African American, with a mix of sexual orientation. Health literacy of participants was the only factor that emerged as having an impact on comprehension; however, the number of participants (n = 20) is too small to draw statistically sound conclusions. A 2013 study tested comprehension and satisfaction when using iPads to deliver information for a neuropathy in chemotherapy study.9 Importantly, the investigators presented the same information in both formats, but the iPad had an initial video outlining the main features of the study. They found that of the 55 patients who took part in the randomised study, there was a statistically significant association with increased comprehension in the group assigned to the iPad. The sample sizes were too small for definitive findings, but of interest was that use of the iPad did not increase likely participation rates (it was slightly lower). All participants advised that the information provided was still too complex regardless of the media used, and that simplified text, diagrams, animations and other ways to enhance comprehension are needed. A recent study reported on the TransCelerate eConsent Initiative, which employed a large survey of 3045 participants and a number of smaller stakeholder consultations.10 While there was general support by potential participants for the use of eConsent, the survey revealed that people living in the European Union had the greatest level of discomfort with it. In this survey, they also found that people were concerned that eConsent might eliminate site/participant discussion regarding participation, even though this is not the case where it has actually been used. In Australia, there has not been widespread use of eConsent to date. To better understand the Australian context, Clinical Trials: Impact and Quality (CT:IQ) — a cooperative funded by MTPConnect, an Australian Government Industry Growth Centres Initiative, using funds from the federal government's Medical Research Future Fund (MRFF) — set out to investigate stakeholder perceptions of eConsent and, therefore, to identify potential actionable insights. Chrysalis Advisory developed a survey that was sent via email to the members of CT:IQ for distribution to the wider clinical trial sector in the first quarter of 2019. A total of 179 participants completed the survey and as we used a snowball methodology, there is no denominator of persons polled. In addition, there were 19 semi‐structured interviews conducted drawn from the CT:IQ membership. The majority of respondents (68%) were women, 75% were aged 40 years or over, and 80% had more than 10 years of working in trials, demonstrating considerable experience in the sector. The full report is available on the website,11 with the questions presented on pages 58–59 of the report. The key findings are summarised in the Box. We specifically surveyed those deploying eConsent at this stage and not the end users because we wished to understand what the sector was already doing and what the perceived barriers and opportunities were. Although only 29.2% of respondents indicated that they had any direct experience with eConsent, our survey revealed that they were overall cautiously positive toward the use of eConsent. An important finding was that there was optimism that use of electronic formats would enable participants to drive the information‐seeking process in a way that best suited their needs. The physical infrastructure, particularly in some public hospitals, was widely held as not being adequate to support eConsent uptake. Wi‐Fi blind spots within hospitals were cited as a major reason for this, as well as difficulties achieving infrastructure updates within the public health system. Respondents recommended that approaches to eConsent should employ technologies that do not rely on expensive infrastructure delivered by health services. In addition, respondents indicated that, ideally, there should be a sector‐wide standard for site information technology infrastructure requirements combined with clear guidance for sponsors to standardise their approaches. A number of interviewees who had worked on trials with eConsent where sponsors had provided devices noted that the devices were clunky and prone to malfunction, which increased overall study time and burdened trial staff. Clinical trial sites often experienced sponsors insisting on their own standards, resulting in unnecessary duplication or incompatibility of instrumentation at sites. Many respondents cited that differences in the use of eConsent platforms and inconsistencies between organisations regarding eConsent compliance (eg, whether participants would be required to sign electronically, or would be able to consent by using technologies such as face recognition, fingerprint identification etc) made it difficult to adjust to the use of eConsent. Greater industry engagement and collaboration may mitigate this barrier by providing stakeholders with frameworks and support to implement eConsent. Furthermore, setting some national guidelines will facilitate the design, regulatory approval and implementation of strategies to adopt eConsent. While some stakeholders identified data security as a risk associated with eConsent, others did not believe security threats were any greater than similar threats to existing digital technologies in use throughout clinical trials and the medical field more broadly. They suggested that when appropriate security systems are in place and data governance risks are managed, stakeholders were not likely to be concerned about data governance risks for eConsent. Using eConsent does not automatically mean that participants will have the ability to provide consent offsite, simply that they have access to the information offsite. This is no different from participants providing wet ink signatures offsite in terms of risk and the fact that a person comes to a clinic and accepts the study treatments is a clear demonstration of consent. Two‐factor authentication processes enabled by eConsent may provide a more robust means to authenticate consent than current paper‐based processes. It was not surprising that eConsent was considered to add a cost burden over and above a paper‐based approach. However, few of the respondents considered the cost savings made through enabling prior reading of relevant documentation and, in particular, the major cost savings for the site and for the participants this could potentially deliver. A respondent from a large cancer centre articulated the potential benefits by outlining how participants from anywhere outside of a 50 km radius of the tertiary centre could avoid additional time needed in the clinic through being able to use eConsent. This centre is piloting a tele‐trial model to deliver trials in non‐tertiary settings and recognises that eConsent is pivotal to enabling this model, which promises to reduce the burden on patients through reducing their need to travel and to ensure that clinical trial participation is more available beyond metropolitan centres. It appears from our survey that Australia is willing but only partially ready to implement eConsent. The pathway forward will require proactive planning, leading and managing organisational change with the creation of practical demonstration cases of the development, delivery and use of eConsent in the clinical trial setting vital to support wider adoption. CT:IQ is now looking at a program to undertake these pilot projects as part of its initiatives to enhance clinical trial capability across Australia and in other jurisdictions. Box – Key findings of the eConsent survey Barrier Finding Problems with using paper‐based information sheets and consent forms 38% of respondents thought paper consent forms were not a problem, 71.5% thought they were too long, and 62% found them too complex 37.4% of respondents thought paper‐based consent impaired participant comprehension 67% of respondents believed eConsent would improve comprehension, although they did not believe that this would necessarily translate into greater recruitment 59.2% of respondents believed there was a significant issue with providing adequate information to people from culturally and linguistically diverse populations and saw eConsent as a solution to this Perception that regulators, HRECs and hospital governance offices will not accept eConsent 40.8% of respondents believed that ethics committees would not approve use of eConsent, 26.8% were unsure 90.5% of respondents found it necessary to have guidelines for use by both researchers and HRECs Patients will not be sufficiently proficient with technology or have access to suitable devices Certain demographics (eg, older people) were considered likely to struggle with eConsent eConsent was likely to be well received by younger generations Health services lack the infrastructure to deliver eConsent 82.7% of respondents identified a lack of IT infrastructure as a critical barrier to overcome 59.2% indicated that the current infrastructure was inadequate, particularly within hospital sites Difficulties with authentication of individuals and data security 46.3% of respondents believed there would be issues with data governance, security and privacy, but 29% of respondents disagreed with this 59.2% of respondents felt that they would lose the ability to ensure that the person signing the eConsent was actually the participant, the remainder were undecided or felt this was not a problem Lack of consistent practice across the sector 67% of respondents identified a lack of standardised guidelines as a significant barrier to success 49.2% of respondents indicated that staff were able to manage eConsent despite the lack of training and standardised guidance eConsent will be more expensive 60.3% of respondents believed that there would be a significant initial cost, which might be a barrier to uptake HRECs = human research ethics committees; IT = information technology.
Nikolajs Zeps · Nicholas Northcott · Leanne Weekes
Artificial intelligence in health care: preparing for the fifth Industrial Revolution
AI has arrived, with the potential for enormous change in the delivery of health care, but are we ready? Artificial intelligence (AI) is the trigger for the next great transformation of society: the fifth Industrial Revolution. AI has already arrived in health care, but are we ready for the kind of changes that it will introduce? In this article, we map out the current areas where AI has begun to permeate and make predictions about the kind of changes it will make to health care. Definition of AI AI comprises any digital system “that mimics human reasoning capabilities, including pattern recognition, abstract reasoning and planning”.1 It includes the concept of machine learning, where machines are able to learn from experience in ways that mimic human behaviour, but with the ability to assimilate much more data and with potential for greater accuracy and speed. Machine learning is a research field that has seen recent advances due to exponential increases in computing power (a phenomenon known as Moore's law), algorithmic coding that mimics the human cognitive process (deep learning), and access to large, linked sources of big data. The scope of AI can be specific, performing narrowly defined tasks (narrow AI) such as image interpretation, or more general, applying knowledge and skills in different contexts (general AI) such as making a diagnosis and predicting disease outcome. On the other hand, machine learning can also be designated “supervised”, in which a dataset is provided for the algorithm to evaluate its performance, or “unsupervised”, in which the machine is allowed to extract unknown potential features in developing an algorithm. The arrival of AI into current practice AI, machine learning, and deep neural network tools can assist medical decision making and management, and have already permeated into at least three different levels: AI‐assisted image interpretation; AI‐assisted diagnosis; and AI‐assisted prediction and prognostication. From diagnosing retinopathy to cardiac arrhythmias, from screening for skin cancer to breast cancer, from predicting outcome of stroke to self‐management of chronic diseases, AI and machine learning devices can replace many time‐consuming, labour‐intensive, repetitive and mundane tasks of clinicians and give possible suggestions of management plans (Box 1).2,3,4,5,6,7 While the advancement and new capabilities and opportunities are exciting, the responsibility and liability issues of AI‐assisted clinical diagnosis and management need much deliberation. AI‐assisted image interpretation One of the major advances in AI is pattern recognition enhancing image‐based diagnosis in radiology, pathology and endoscopy. AI‐assisted image analysis aids the detection of adenoma and polyps during colonoscopy. It can even provide optical biopsy to determine the nature of lesions with implications of treatment.8 Wireless capsule endoscopy is a groundbreaking advance in medical technology, allowing painless examination of the gut, reaching areas where conventional endoscopes cannot reach. However, reading thousands of images produced by the capsule is extremely time‐consuming. Deep neural network systems trained to read images of capsule endoscopy can scan thousands of pictures within minutes to reduce the burden of time and energy for gastroenterologists and also minimise the chance of missing significant lesions.9 Similarly, systems have been trained to read echocardiographic images to provide physiological measurements within seconds, and to read coronary computed tomography angiography images to determine coronary calcification, coronary stenosis severity, and functional haemodynamic effects of the stenosis. AI‐assisted diagnosis The diagnosis of many conditions (eg, acute or old myocardial infarction) and arrhythmias (eg, atrial fibrillation and ventricular tachycardia) can be made by experts reading electrocardiograms (ECGs) according to well established rules. Application of such rules in algorithms have allowed computers to make these diagnoses automatically in ECG machines for many years, but the diagnoses are subject to verification by physicians using the same rules. AI using machine learning and deep neural network can do the same from raw ECG data, but does not rely on the same rules, and thus can do much more than conventional ECG analysis. In the most basic AI formulation, diagnoses of important cardiac arrhythmias from a single lead rhythm strip or continuous single lead ECG recordings were made by machine learning using deep neural network algorithms with greater accuracy than an individual cardiologist and similar to a consensus panel of cardiologists.10 Where AI excels, however, is in discerning patterns not apparent to the experts, such that current or future paroxysmal atrial fibrillation can be diagnosed from an ECG in sinus rhythm,11 and asymptomatic left ventricular dysfunction can be diagnosed by a 12‐lead ECG.12 AI‐assisted prediction and prognostication AI may predict the occurrence of certain diagnoses and prognosticate clinical outcomes of patients based on clinical datasets, genomic information and medical images. Cardiologists have developed algorithms to assess the risk of cardiovascular disease and claimed that their prediction is superior to existing scoring systems. Gastroenterologists have also developed AI models to predict recurrence of bleeding and requirement of surgery in patients with gastrointestinal bleeding.13 Combining genomic, epigenetic and metagenomic data with biochemical and lifestyle information using machine learning will be a very powerful tool in medicine. However, mechanisms or reasons for reaching the machine decision may not be comprehensible to clinicians. The integration of various datasets in multilayer informatics could take prediction, prognostication and prevention of diseases to new levels that cannot be achieved by conventional statistical models. This capability, if validated in properly designed studies, will offer new dimensions to personalised medicine. Preparing for the future of AI Health disparities, excluded populations and data biases The quality of AI in health care is dependent on the quality of the data on which it is based. Algorithms are being developed and validated on data generated by health care systems where current practices may already be inequitable. A system built on poor quality, biased data will reflect those problems (“garbage in, garbage out”). If a health care system has excluded populations of patients, the structural inequalities of health care will be repeatedly reinforced by the AI. This is a not a new problem and we must do better science and be awake to the limits of data quality and evidence‐based medicine. Data sovereignty and stewardship AI is built on access to big data. Big data in health care is primarily generated by public health systems, funded by the public for the public. Increasingly, claims over the health data generated by these public systems are being contested.14 There was enormous public outcry over the use of British National Health System data by Google‐owned DeepMind, a company creating an AI‐based smartphone application for kidney disease. Many were angry about the private use of public data, when there was little public control over what would happen to the data or what benefit was being provided back to the National Health System.14 Issues of data sovereignty therefore threaten the existence of effective AI. Patient data should not be provided to technology giants without a good governance structure to protect data sovereignty. Changing standards of care An immediate issue for the use of AI is the question of how it will transform standards of care. Common law jurisdictions judge health professions, by and large, by measuring performance against competent professional practice as set by the professions themselves. If AI keeps its promise of benefit and it is integrated more into practice, standards of care must require AI use, and traditional forms of therapeutics will be forced to change. We will see a time when all medicine and allied health work as a team with AI. Those who refuse to partner with AI might be replaced by it. Legal responsibility for AI‐caused injury AI promises to massively reduce the occurrence of iatrogenic harms via increasing the quality of decision making, but the continued existence of AI‐related injury is easy to foresee. As machine algorithms improve themselves without human intervention, making the “black box” more opaque, regulatory agencies such as the Australian Therapeutic Goods Administration and the United States Food and Drug Administration need to refine their regulations. To the extent that AI continues to play a role in assisting clinical management, questions of responsibility for harm should be determined by ordinary rules of product liability. It is likely that courts will determine some of these liability questions by using analogies with vicarious liability — an employer is responsible for the negligence of the staff when the injury occurs in the course of the staff's employment. A doctor using AI should be responsible for AI decisions made in the course of treatment, especially if the doctor retains the power to make the final decision regarding treatment. But as AI takes on more autonomous decision making, it might be argued by some doctors that they should not be responsible for that which they cannot control. Similarly, it seems unfair for doctors to be held responsible for an AI decision when they are unable to deduce how and why that decision was made. Such matters are outside the scope of clinicians’ expertise and best dealt with legally as a product liability claim. A stepwise gradation model of shared responsibility between the human doctor and the machine in diagnosis and clinical management has been proposed15 (Box 2). Conclusions Before AI tools can be put into daily use in medicine, data quality and ownership, transparency in governance, trust‐building in black box medicine, and legal responsibility for mishaps are some of the hurdles that need to be resolved. Much effort is needed to translate algorithms into problem solving tools in clinical settings and demonstrate improvement in clinical outcomes with saving of resources. Box 1 – Examples of artificial intelligence (AI) permeation into clinical practices of different specialties Clinical management AI capability Diabetic retinopathy2 Detection of early changes in fundi of patients with diabetes Reading the retina and blood vessels to identify patients at risk of developing complicated diabetic retinal disease Breast cancer3 Diagnosis of early breast cancer based on mammography Reading mammographic pictures to detect early malignant transformation in breast cancer screening Skin cancer4 Diagnosis of skin cancer by its clinical morphology Identification of skin cancer by pictures and classification of types of skin neoplasia Cerebrovascular disease5 Predicting outcome after a cerebrovascular accident Predicting the outcome (mobility, morbidity and mortality) of stroke 90 days after the event Non‐communicable chronic diseases6 Monitoring of diabetes and heart failure in primary care setting Assisting patients monitoring of blood pressure and blood glucose at home and transmitting information to family medicine clinics Heart failure7 Predicting the clinical outcome of patients with heart failure Predicting in‐hospital mortality among patients with heart disease based on echocardiography Box 2 – Levels of artificial intelligence (AI)‐assisted decision in diagnosis and clinical management and possible share of responsibility between human doctor and machine
Joseph JY Sung · Cameron L Stewart · Ben Freedman
COVID‐19 and the Indo–Pacific: implications for resource‐limited emergency departments
Resource‐limited emergency departments responding to the COVID‐19 pandemic face many challenges — their strength lies in their unique solutions The coronavirus disease 2019 (COVID‐19) pandemic is stretching hospital resources around the world. Emergency departments (EDs) are on the frontline of care and have been impacted significantly by the surge of patients with both suspected and confirmed infection.1,2 Resource‐limited EDs in low and middle income countries are particularly vulnerable. Pre‐existing issues, including a limited workforce supply, have been exacerbated, and new threats, such as a lack of personal protective equipment (PPE) and oxygen, have emerged.1,2 This article explores the impacts of the COVID‐19 pandemic on resource‐limited EDs across the Indo–Pacific. It considers the unique challenges for the region and describes opportunities for building system resilience at a time of unprecedented demand for emergency care. Emergency departments and the COVID‐19 pandemic Emergency care systems are essential for universal health coverage.3 Effective emergency care improves health outcomes, and is critical to achieving the health‐related Sustainable Development Goal targets.4 EDs are the cornerstone of emergency care systems, enabling access to facility‐based care for patients with acute illness and injury. They provide an interface between community and hospital care, and address unmet needs for vulnerable patients. These roles are augmented during communicable disease outbreaks, when EDs fulfil surveillance, triage and clinical care functions.3,4 Since the World Health Organization (WHO) declared COVID‐19 a global pandemic in March 2020, most low and middle income countries across the Indo–Pacific have reported cases. About 20% of patients require hospital admission, and early recognition and resuscitation can help reduce mortality.1 EDs therefore have a key role to play in risk‐stratifying patients, providing initial therapy, establishing goals of care, and identifying patients who may benefit from advanced interventions. Pandemic preparedness The Indo–Pacific encompasses the eastern Indian Ocean and Western Pacific regions, connected through South‐East Asia. The region is characterised by cultural, geographical and economic diversity.5 The Global Health Security Index reflects a country's ability to detect, communicate and respond to a communicable disease outbreak.6 Most low and middle income countries across the Indo–Pacific score below the average preparedness level of 40.2 (on a scale of 0–100) and are among the least prepared countries.6 These findings reflect pre‐existing gaps in health care capacity that are likely to be exacerbated during a public health emergency.7 A historical lack of investment in emergency care systems across Indo–Pacific low and middle income countries means that many EDs have limited resilience in times of increased demand.3,4 Emergency care has not been a focus for international donors,4 and sequential reductions in the Australian Government's development assistance budget for health have further compromised capacity building efforts.8 Although these projections foreshadow a devastating impact on low and middle income countries across the region, the global experience of the COVID‐19 pandemic has illustrated the limitations of preparedness modelling. Several of the most prepared countries are now disease epicentres with overstretched health services, in part reflecting an initial reluctance to follow WHO advice regarding testing and contact tracing.9 Indo–Pacific nations may have strengths that protect against this trend, such as recent epidemic experience.10 Nimble and innovative responses may help build resilience, potentially providing globally relevant lessons that would typically be expected from high income countries. Challenges in public health response A major determinant of the pandemic's impact on EDs will be the success of broader public health interventions. Low and middle income countries, including those in the Indo–Pacific, will face unique challenges in disease containment.2 As demonstrated by several Pacific countries, island states have greater ability to shut their borders and limit inward passage of the virus. However, a freeze on international access will have a significant socio‐economic impact and is unlikely to be sustainable. It may also affect the supply of essential medical equipment, surveillance capacity (given that certain countries rely on foreign pathology services for COVID‐19 testing) and retrieval systems. An important mechanism to disrupt community transmission of COVID‐19 is physical distancing. This is antithetical to many sociocultural practices across the Indo–Pacific, where communal living is common and regular congregation at community meeting places is the norm. Modelling from a Papua New Guinean setting has demonstrated that physical distancing measures in that community were 60–70% less effective compared with Australia.11 Public health responses across the region have already been complicated by extreme weather events and humanitarian crises. Examples include Cyclone Harold, a category 5 cyclone that recently affected the South Pacific, and the climbing infection rate in the worlds’ largest refugee camp at Cox's Bazar in Bangladesh.12 Worsening climate change will further exacerbate the incidence and severity of natural disasters and disease outbreaks. Challenges for emergency departments As community transmission increases, demand for ED care will escalate. The impact may be more pronounced among Indo–Pacific communities as a result of high rates of non‐communicable disease.13 COVID‐19 appears to be more severe in patients with diabetes, hypertension and chronic pulmonary illness, all of which are prevalent across the region.13 Increasing demand is likely to expose pre‐existing deficiencies in ED systems and resources, including scarce critical care capacity.1,2 A survey of emergency care clinicians in the Pacific recently identified minimal integration of surge response with routine emergency care, and a lack of essential processes, such as triage and patient flow.7 Consistent with these data, Box 1 lists key challenges in systems, spaces, supplies and staff that have become evident to Indo–Pacific clinicians during COVID‐19 response planning.2 Emerging data suggest that frontline clinicians are at an increased risk of death from COVID‐19, in part due to suboptimal PPE.14 Limited access to PPE is a major threat and will place ED clinicians at increased risk of infection. Low and middle income countries face challenges in PPE procurement because of supply chain limitations as well as market‐based competition with high income countries.1,2 Illness among health care workers will stretch an already fragile health care workforce. In the event of a surge, EDs will require significant increases in staffing, and the challenge may be exacerbated by high rates of comorbidities, absenteeism and inadequate training.7,13 Additionally, many Indo–Pacific EDs rely on a sole medical leader for clinical and administrative decision making.15 The pandemic may place these clinicians at risk of burnout, illness and death, thereby exacerbating the mismatch between supply and demand for care. Unintended consequences To meet these challenges, EDs will need to make substantial changes to their processes. However, there is a risk that distraction from pre‐existing health priorities will worsen the overall impact. Patients with chronic disease have poor outcomes at times of increased health system stress, as occurred in West Africa during the 2014 Ebola epidemic when resources were diverted away from routine care.16 Lockdown measures will make it difficult for some patients to access emergency care, and fear of acquiring COVID‐19 in hospital may create a further barrier to ED attendance. Additionally, the socio‐economic consequences of public health interventions are likely to contribute to poor health outcomes in the longer term. There is also a risk that donor funding will target resource intensive equipment (such as ventilators) that may be unsuitable in a low and middle income country context. Many resource‐limited ED clinicians are accustomed to a low cost essential care approach.1 Rather than emphasising expensive and high risk interventions, a focus on simple measures such as rigorous infection control and oxygen therapy is likely to be advantageous.1 The pandemic has already had a gendered impact, exacerbating the “triple burden” of productive, reproductive and community work responsibilities imposed on women.17 This has been particularly evident in low and middle income countries, where women make up a larger proportion of frontline workers and are disproportionately expected to fulfil unpaid household duties.17 Addressing immediate needs Addressing these challenges requires urgent action. While high level guidelines such as the WHO Emergency and Disaster Risk Management Framework18 exist, these often neglect the practical challenges faced by EDs. COVID‐19 guidance for Indo–Pacific EDs must complement WHO recommendations, and be culturally appropriate, fiscally responsible and immediately actionable2 (Box 2). Indo–Pacific ED leaders are already implementing COVID‐19 response plans. Examples from across the region are profiled in Box 3. These early success stories highlight the capacity of local clinicians to lead disaster response activities and provide meaningful care in the face of escalating health care demand. The Australian Government has provided some support for this effort by contributing funds to the WHO response plan and deploying specialist advisors to selected Indo–Pacific countries.8 Opportunities An increasingly interconnected world, combined with climate change and mass migration, will result in more frequent communicable disease outbreaks. COVID‐19 provides an opportunity to build resilient EDs that are better prepared for this challenge. The pandemic is also a chance to enhance the sustainability of routine emergency care through system strengthening, facilitated by multisectoral collaboration between clinicians, governments, technical organisations and donors.3 This effort should be informed by existing guidance for the enhancement of human resources, infrastructure, governance and processes to improve regional emergency care capacity.7 Australian agencies, such as the Indo–Pacific Centre for Health Security, have a key role to play in resourcing this activity. The pandemic provides a unique opportunity for the Australian Government to advance its commitment to strengthening health care systems and deliver on the promise of its Pacific Step‐up.5,8 It also offers a chance to leverage Australia's expertise in emergency care for the benefit of the region.3 Conclusion Time will determine the full impact of COVID‐19 on the Indo–Pacific, but global trends suggest that ED capacity may be severely stretched. Responses should target the unique challenges for disease control and emergency care delivery across the region. Although local ED clinicians are already demonstrating leadership and adaptability in their surge planning, the pandemic provides an opportunity to build resilience in emergency care systems and enhance future capacity for both routine care and outbreak response. Australian clinicians, organisations and governments have a key role to play in supporting this effort. Box 1 – Challenges for COVID‐19 preparedness and response in emergency departments (EDs) Variable Challenge (and selected examples) Systems Disaster and surge plans Many EDs and hospitals do not have standard operating procedures for surge events and communicable disease outbreaks: “ED COVID‐19 operations need a focal point of command at hospital executive level so that ED preparatory activities can be prioritised and fast tracked” (Solomon Islands) Triage Some EDs have no formalised triage systems. Implementing a triage system, for the first time, during a pandemic is fraught with difficulty Patient flow Overcrowding, interdepartmental communication barriers and a lack of ward beds can delay care for both COVID and non‐COVID patients Space Isolation and resuscitation areas Many EDs lack the physical space and infrastructure to adequately provide safe and effective routine care. In the context of the pandemic, a lack of dedicated isolation and resuscitation areas will be a major challenge Storage capacity Attempts have been made stockpile essential resources; however, there is a lack of dedicated on‐site storage space at many hospitals Supplies Personal protective equipment (PPE) and cleaning agents PPE supply is a major and ongoing concern: “There is not a standby supply of PPE … in a normal working day. [There is no] process to ensure a consistent supply of PPE in the department” (Fiji) “Our hospital is not a central level hospital, [so] we [were not given] much supplies” (Myanmar) Laboratory testing There is often limited laboratory capacity, and staff have competing priorities beyond EDsMany testing facilities are offsite or overseas, resulting in delayed isolation, identification and treatment of patients with COVID‐19, placing staff and other patients at risk Oxygen There is a lack of portable oxygen cylinders and oxygen concentrators in many facilities. Relatively few facilities have capacity for intubation and ventilation Novel therapies There is uncertainty surrounding the therapeutic benefits of agents such as hydroxychloroquine, azithromycin and remdesivir. In some countries, these medications are difficult to source, and with international demand increasing, supply will become even more scarce. This will impact the availability of these medications for patients who require them for other indications Staff Critical care training There are few formally trained critical care staff in many EDs. Additionally, there are concerns about workforce shortages and the reliance on volunteers Some hospital staff do not appreciate the importance of early recognition and treatment: “[Some staff lack an] initial understanding of the role of ED in the approach to COVID‐19” (Fiji) Staff morale and safety concerns Many staff are concerned about the risk to themselves and their family members if they are required to care for patients with suspected COVID‐19 without adequate protection: “[There are] difficulties in commuting due to strict curfew/modified lock down and restrictions on inter district transport. [There is] COVID phobia created by the media” (Sri Lanka) “I don't want them to infect, I don't want them to exhaust, I don't want them to depress, I want to create safe and less stress environment” (Myanmar) Box 2 – Strategies for optimising emergency department (ED) preparedness and response* Systems Ensure ED processes are consistent with broader public health and hospital management strategies Utilise local case definitions to identify suspected cases Establish a clearly marked screening and triage process at the entrance to the hospital, and stream patients based on the acuity of their presentation. For example, low acuity patients might be redirected to a co‐located surge clinic Maintain infection prevention and control to the highest possible standards. Ensure patients and staff practice physical distancing, cough etiquette and hand hygiene Minimise the volume of patients in the ED and isolate symptomatic patients from others by establishing a respiratory zone Develop clear admission/discharge criteria and establish ceilings of care for the facility Space Establish a clearly marked screening and/or triage station at the entrance to the facility Ensure the ED and surge clinic (if established) have designated waiting areas for patients with respiratory symptoms Allocate separate areas in the ED for the management of symptomatic, medium and high acuity patients Supplies Anticipate equipment needs and stockpile to the extent that is possible, especially disposable items that will be in high demand (oxygen cylinders, antipyretics, personal protective equipment, etc) Follow World Health Organization guidelines on resource stewardship. For example, implement clear thresholds for providing supplemental oxygen, such as SpO2 < 90% on room air for stable patients, SpO2 < 92% on room air for pregnant women, and SpO2 < 94% on room air for patients with respiratory distress Avoid use of therapies that are likely to increase virus transmission (eg, nebulisers) Develop safe processes for cleaning and reusing equipment based on World Health Organization infection prevention and control advice Staff Make sure that all staff feel included, empowered, motivated and supported Update the staff contact list and plan for absenteeism Identify staff who are high risk for infection and reallocate them to other areas Train staff in the systems and processes that have been developed Remind staff that they should not work if they have acute respiratory symptoms Use ancillary staff and other community members for non‐technical tasks Remind others that COVID requires a whole‐of-government, whole‐of-health and whole‐of-hospital response; the ED cannot do it alone Ensure ED staff are involved in the post‐pandemic review process to promote ongoing systems improvement and sustainability * Adapted from Australasian College for Emergency Medicine. Managing COVID‐19 across the Indo‐Pacific: a guide for resource limited EDs. Melbourne: Australia, 2020. https://acem.org.au/getmedia/3930cc60-abb1-4517-b7af-36da918a3f7b/Managing-COVID-19-across-the-Indo-Pacific-(G763) (viewed Aug 2020). Box 3 – Examples of successful COVID‐19 preparedness and response strategies employed across Indo–Pacific emergency departments (EDs) Variable Strategy (and selected examples) Systems Leadership and coordination Many countries have developed national coordinating bodies that include ED clinicians as key stakeholders. This is a recognition of their pivotal role in crisis coordination: “Once there were initial reports of care in China, the Ministry of Health had formed a National Taskforce and … ED was invited to participate in it as stakeholders” (Fiji) Identification of key leaders at each stage of the patient journey has been essential: “The hospital formed its Taskforce and we had devised operating procedures and a flow chart with important contact persons at each stage” (Fiji) Triage, screening and patient flow There has been a rapid development of triage, screening and flow systems based on specific criteria: “For patients with respiratory symptoms and fever … the high acuity patients can be stabilised in the ED respiratory resus and transferred to ICU. Medium acuity patients to be stabilised in the step down area of the respiratory section of the ED. Ambulance will transport patients to the isolation wards and ICU” (Solomon Islands) Space Isolation and resuscitation areas Guided by experience from Africa during the Ebola outbreak, EDs in Solomon Islands, Fiji, Myanmar and Sri Lanka have undergone significant restructuring of limited spaces to facilitate separate areas for screening, isolation, resuscitation and storage Supplies Infection prevention and control, and personal protective equipment (PPE) Drawing on experience during the 2009 H1N1 pandemic, EDs have adapted guidelines for the judicious use of PPE, while emphasising that staff safety is a priority: “Within the storage area in ED of consumables, a cupboard is allocated to store PPE kits and this is tallied and replenished by the Hospital Infection Control team” (Fiji) “Health care worker exposure assessment protocol was designed” (Sri Lanka) “Luckily we have many people who want to donate what we need so we are still ok” (Myanmar) Resource utilisation Early decisions have been made about distribution of limited resources: “No CPR will be done on COVID‐19 high acuity patients who have (deteriorated) despite maximal non aerosol generating treatment” (Solomon Islands) “We decided to do respiratory team with only three people, because … when positive case came to our ED only these three need PPE” (Myanmar) Novel therapies These are not being used until there is proven evidence of benefit. Local guidelines have been developed: “Cautious use of fluids except in shock. Use of metered dose inhalers (rather than nebulisers) for asthma exacerbations” (Solomon Islands) Staff Critical care training Countries have begun re‐training staff in critical care and there has been redeployment and re‐training of staff from non‐essential areas to the ED. Non‐medical staff are also being utilised to assist with operational requirements such as cleaning and transportation Staff morale and safety There is a focus on open communication and staff wellbeing: “We did meeting every night with zoom and discussed the problems faced in their duty time … we asked their working capacity … and redrew duty roster” (Myanmar) “Special quarantine centres with all the facilities were designated for staff members who had problems in home isolation” (Sri Lanka) “Staff are undergoing medical checks. Staff with comorbidities will not be working in the respiratory section of the ED” (Solomon Islands)
Isobelle G Woodruff · Rob D Mitchell · Georgina Phillips · Deepak Sharma · Patrick Toito'ona · Krishantha Jayasekera · Khine Shwe Wah · Megan Cox · Gerard M O'Reilly
Teletrials: implementation of a new paradigm for clinical trials
Telehealth can be used to deliver clinical trials, improve access to novel therapies and develop clinical networks Australia is a vast country. Nearly 32% of Australians reside outside the major capital cities, while 95% of medical specialists practise in cities.1 People living in rural and regional areas consistently experience poorer health outcomes.2 Cancer is a considerable health issue, with 395 new cancer diagnoses per day.3 The regional mortality gap in cancer remains.4 Between 2000 and 2010, patients in regional and rural Australia had a 7% higher cancer mortality compared with those in metropolitan centres, equating to 9000 additional regional and rural cancer deaths.3,5 Barriers to better regional cancer care include travel requirements to metropolitan centres, limited access to expert diagnostics and therapeutics, and less access to clinical trials.6 As well as geographical issues, recruitment and retention of qualified health professionals in regional areas can be difficult, due to professional isolation and a perceived or actual lack of career opportunities.7 These issues relate not only to regional Australia but to many regional populations worldwide.4,8 In the past decade, there has been considerable investment by federal and state governments in the development of regional cancer centres, enabling increased research opportunities.9 Clinical trials remain a gateway to accessing cutting edge therapies and technology. Currently, less than 5% of regional cancer patients participate in any clinical trial; barriers include travel distance to a metropolitan site, a lack of trials available locally, and costs involved for patients and carers such as travel and accommodation and loss of earnings.10 While there are no set targets for participation rates, there has been a correlation between trial participation rates and improved cancer survival, such that a higher rate is desirable.11 In 2017, there were 432 actively recruiting cancer clinical trials in Victoria, totalling 1605 participants. Of these, 426 participants were living in a regional or rural area (27%); however, most participants were enrolled at a metropolitan site, with just 81 (5% of all trial participants) recruited to local clinical trials (personal communication, Christie Allan, Cancer Trials Management Scheme, Cancer Council Victoria, April 2019). Telehealth strategies Telehealth strategies have gained acceptance across many aspects of health care to enable delivery for patients closer to home, including anti‐cancer therapies.12 A logical extension is integration into clinical trial models. Such an approach has many benefits for patients, their families, regional health care, as well as potential economic savings by reducing the need to travel for care. Although this model is a change from usual care, patient safety and quality of care is maintained. The Victorian Comprehensive Cancer Centre (VCCC) is an alliance of ten leading research, clinical and academic institutions in Victoria. The VCCC established a teletrials program to build relationships between regional/rural Victoria and metropolitan centres, using telehealth to provide patients with the opportunity to access clinical trials closer to home. Teletrial framework development In developing a teletrial implementation framework, it was important to consider patient safety, ethical and regulatory requirements. In addition, so that the model would allow for differences across clinical trial requirements and capabilities at individual trial sites, we scoped potential barriers and enablers, to ensure its success. The Clinical Oncology Society of Australia model10 was used as a foundation template for the structure and relational concepts (Box). Importantly, the model recognises the potential for heterogeneity across trials and sites, rather than taking a one‐size‐fits‐all approach. Different sites may perform different roles in different trials; for example, taking blood samples, delivering chemotherapy or medication, trial documentation, or imaging. The model has been used in several teletrials enrolling across Australia.13 An important element was the development of standard operating procedures. Initially developed by Queensland Health, these were modified not only for use in Victoria but for consideration as the basis for national standard operating procedures for teletrials. In developing the teletrial framework, input and feedback were sought from stakeholders in cancer clinical trials. These included contract research organisations; the biopharmaceutical industry; principal investigators; Victorian regional sites through the Regional Trials Network; Human Research Ethics Committees (HRECs); local government through the Victorian Department of Health and Human Services; funding bodies; and consumers. Teletrial supervision plan The teletrial supervision plan (https://www.viccompcancerctr.org/what-we-do/clinical-trials-expansion/teletrials/resources/) contains detailed documentation regarding specific trial conduct and responsibilities, in particular the specific responsibilities of investigators at each site within the trial cluster, and which elements of the trial, imaging and drug delivery are performed at each site. Some trials may have all elements delivered at the local site, others may have most delivered locally but specialist services (eg, radionuclide therapy) at the central site. The supervision plan is site‐, trial‐ and time‐specific. It also includes standard operating procedures, Good Clinical Practice training, monitoring, HREC submissions and oversight, trial‐specific indemnity and contracts, plans for safety reporting, investigational product storage and delivery logistics, and details on joint consultations using telehealth, payments, data entry and document management. The supervision plan is generated in agreement with the principal investigators at the metropolitan and regional sites before the study, but with regular review and modifications as required to allow refinement as needed. Indemnity and legal coverage Teletrial indemnity and legal coverage for trial activities are frequently raised concerns. This can be documented in detail in the supervision plan but is no different for a teletrial over other models. The VCCC commissioned a draft clinical trial activity agreement for investigator‐initiated studies including a teletrial component (https://www.viccompcancerctr.org/what-we-do/clinical-trials-expansion/teletrials/resources/). Governance and ethics approval As with any clinical trial, ethics approval is required, usually through a human research ethics application. Local research governance office requirements will not vary, with local assessment of trial capability, including managing potential toxicities. The principal investigator remains responsible for ethics submissions and communication with HRECs. Each site will obtain local governance approval and be listed on the clinical trial notification form. The process for reporting on safety events remains as per standard of care. Proof of concept Using the framework described, a teletrial has commenced between a metropolitan site and two regional sites in Victoria. The first teletrial site patient was recruited in November 2018 and at 24 July 2020, 91 patients had been successfully recruited in regional centres, with all their trial activity delivered locally. Metropolitan and teletrial sites have successfully undergone study monitoring and further model evaluation is underway. Model evaluation Although the teletrial model is not an intervention in itself, merely a method of trial delivery, it is important to its widespread adoption at a new standard of care that there are benefits to all stakeholders. An ongoing health economic evaluation will evaluate costs associated with the teletrial (and potential savings), patient time and travel estimates, and qualitative assessment of patient and clinician participation in a teletrial to detail possible benefits. In addition, consumer and clinician perspectives studies are planned. A leading contract research organisation was commissioned to undertake an independent process review of the first teletrial to evaluate the model. No major protocol deviations were found in comparison to a conventional site in this pilot study. Potential benefits of a teletrial Teletrials provide a mechanism to enable disadvantaged patients to participate in clinical trials. They may also provide wider benefits14 beyond those experienced by individual participants, including: improved recruitment: as trials have a wider reach, they may recruit faster, translating new interventions to patients faster in a real‐world setting; improved retention: making trial access easier may improve participant retention, reduce missing data and accelerate trial objectives; increased diversity: teletrials may allow for easier access to the increasingly specific and rare subsets of cancer trial populations; professional development: partnerships developed from the trial network may translate into improved routine clinical care delivery and opportunities; and trial cost‐savings: while teletrial costs will be evaluated, the resources required to open a teletrial may be reduced, as much of the trial data will be retained at the primary site. Potential or perceived risks Some of the possible risks raised with the authors by stakeholders have been addressed above, including indemnity, legal and governance issues. Others may include: Clinical safety of new treatments in a regional setting: while a trial may involve a novel therapy, toxicities are often managed on a patient's return home to their regional site. Involving local clinicians in the trial may actually reduce this risk through better education regarding managing novel therapies. Clinical trial expertise: most regional sites already have extensive experience in clinical trials, and Good Clinical Practice training is standard. Trial monitoring challenges: with rapidly increased use of secure digital platforms, monitoring is increasingly becoming a remote activity, so location is not a barrier. We acknowledge that this model represents a change to usual process and therefore requires assessment, transparency and strong support and advocacy to overcome barriers to clinical trial participation.15 Teletrials do more than just meet trial metrics. They develop synchronous partnering between regional and metropolitan centres, allowing regional equity of access to cutting edge diagnostics and therapeutics while maintaining patients’ care delivery closer to home, thereby avoiding disruption to family, work and social interactions. Box – Teletrial model
Ian M Collins · Kate Burbury · Craig R Underhill
Navigating the complexities of voluntary assisted dying in palliative care
Voluntary assisted dying is not part of palliative care The Voluntary Assisted Dying Act 2017 (Vic)1 came into effect in Victoria on 19 June 2019. We present the case of an inpatient death under the voluntary assisted dying Act in our health service and describe a short case history followed by a discussion examining two relevant topics related to voluntary assisted dying and palliative care: conscientious objection and the complexity of palliative care involvement. Case report The patient was diagnosed with metastatic (axillary nodes) breast cancer in 2016 at the age of 53 years and declined completion staging and all conventional treatment options. She was referred to community palliative care services in 2019 with clinically progressive locoregional disease, manifesting as fungating malignant disease of the chest wall and axilla. She experienced symptoms of pain, nausea, anorexia, and weight loss. Pharmacological treatment options for her symptoms were refused due to her sensitivities to many medications. The patient lived alone but had support from friends and siblings. She had a history of chronic fatigue syndrome and mood disorder. She did not subscribe to a religion, but believed in the soul and an afterlife. She had been caring for her mother, who died from advanced breast cancer. Her mother's suffering at the end of her life was a significant reason for the patient's decision to pursue voluntary assisted dying. She commenced the voluntary assisted dying process in July 2019. Her initial intention was to self‐administer the voluntary assisted dying substances at her home on her birthday (early December). However, she was admitted to the palliative care unit (PCU) in late November for symptom management. During her admission, it became clear to the patient and her carer (who was also her voluntary assisted dying support person) that her deterioration would preclude her from returning home. She made a request to self‐administer the voluntary assisted dying substances in the PCU. The organisational voluntary assisted dying clinical practice guidelines stated that voluntary assisted dying could not occur in the PCU, in line with the Royal Australasian College of Physicians (RACP) statement on voluntary assisted dying, which recommended that “voluntary assisted dying must not be seen as part of palliative care”.2 The patient was informed of the organisational approach and the need to minimise misperceptions about the PCU. Both the patient and her support person understood and accepted our stance, and we commenced the search for another site within the service that could accommodate her wishes. Staff in the first venue of care option conscientiously objected to the admission. Despite her condition continuing to deteriorate and the imminence of her preferred date of administration, she remained understanding. Another venue of care within the service was found and she was transferred there 2 days before her birthday. She self‐administered the voluntary assisted dying substance on her birthday as originally intended. Conscientious objection Although not defined in the Act, conscientious objection has been outlined by the Victorian Department of Health and Human Services (DHHS) as an outcome of a conflict in beliefs or values.3 A similar conflict was recently discussed in relation to a growing concern about moral injury in health care, where moral injury was defined as “perpetrating, failing to prevent, bearing witness to, or learning about acts that transgress deeply held moral beliefs and expectations”.4 Health care professionals are subject to moral injury as a result of “being unable to provide high‐quality care and healing in the context of health care”.5 In this context, conscientious objection becomes integral to the psychological safety of the health care workforce as voluntary assisted dying is introduced into mainstream medicine. The DHHS in Victoria permitted each health service within its jurisdiction to decide on their extent of involvement in voluntary assisted dying.4 This was determined by “whether participation aligns with the values of the health service”.6 The Catholic Health and Aged Care Services, which are responsible for several health services across Victoria, were clear that they would not provide or facilitate voluntary assisted dying.7 Such health services are under no obligation to refer a patient who has requested voluntary assisted dying. However, there is a requirement to inform the patient as soon as practicable that they will not assist them and the services cannot actively inhibit the patient's access to treatment.3 All health services were obliged to nominate their level of participation, irrespective of the actual number of health care professionals in the organisation willing to be involved with voluntary assisted dying.3 These choices were: pathway A — single service (it has the necessary suite of services and staff with sufficient expertise to provide voluntary assisted dying within their existing health service); pathway B — partnership service (these services would require the assistance of other services to provide the full requirement of voluntary assisted dying); and pathway C — information and support service (it includes services electing not to provide voluntary assisted dying). The dilemma of this approach for health care services is the contentious nature of voluntary assisted dying. Organisations consist of people some of whose individual values and beliefs are unlikely to align neatly under the organisational approach when it comes to voluntary assisted dying. The Voluntary Assisted Dying Act (Part 1, Section 7) outlines scenarios where registered health care practitioners may conscientiously object to participation in the voluntary assisted dying process.1 It provides for health care staff to refuse to participate in, or be present for, the administration of the voluntary assisted dying substance. The DHHS has provided clear guidelines for individual health care practitioners with regards to conscientious objection.3 A health practitioner “has the right to refuse to assist or support the patient when the assistance is associated with voluntary assisted dying”. Health practitioners are expected to “provide routine and other care unrelated to a request for voluntary assisted dying”.3 Health practitioners also need to balance their own moral and ethical beliefs while respecting differences and ensuring the rights of the patient are upheld. Therefore, health services face the challenge of navigating between the principle of justice and equity in access to health care and the responsibilities to their employees. Health practitioners cannot conscientiously object to the routine care of a patient who has elected to undertake voluntary assisted dying. Palliative care The specialty of palliative care is in its infancy, having only received recognition in Australasia as a specialty in 1998. It aims to improve the quality of life of patients and caregivers, faced with life‐limiting illness, by addressing physical, psychosocial and spiritual challenges. There is mounting evidence that it is indeed effective in doing so.8 Nevertheless, population‐based studies demonstrate a public misperception associating palliative care with euthanasia.9 The International Association for Hospice and Palliative Care has stated that assisted dying in all its forms corrodes the work done by the specialty and risks patients refusing palliative care for fear that health practitioners may hasten their death.10 There is a continuing need to increase public awareness of palliative care and clarify misperceptions. Therefore, palliative care services need to maintain their differentiation from voluntary assisted dying. The RACP emphasises that voluntary assisted dying “must not be seen as part of palliative care” and that they need to be seen as “distinct practices”.2 Peak palliative care organisations, such as Palliative Care Australia and the Australia and New Zealand Society of Palliative Medicine, similarly emphasise that voluntary assisted dying is not part of palliative care practice.11,12 The International Association for Hospice and Palliative Care has recommended that assisted dying practices not take place in PCUs.10 The risk otherwise is further blurring of the public perception and an erosion of trust. The RACP has recommended that all patients seeking voluntary assisted dying should be made aware of palliative care and that a referral to palliative care is strongly recommended.2 The Victorian DHHS, in its voluntary assisted dying documentation, has also outlined a key role for palliative care. This includes “managing complex communication interactions with patients and families, and responding to complicated, multifaceted psychosocial and/or spiritual distress”.3 Furthermore, they describe the most “valuable [role] palliative care specialists play is supporting other healthcare teams and professionals through consultation, advice and support to provide end‐of‐life care for their patients”.3 The challenges for palliative care services are therefore clearly visible: how to maintain its distinction and separation from voluntary assisted dying and yet provide a necessary and expected service for patients at the end of life who have elected voluntary assisted dying. The RACP and the DHHS guidelines will necessitate palliative care involvement, not only for our patients and their families but also in support of medical practitioners. Palliative care services risk becoming the gatekeepers for voluntary assisted dying because of our expertise in managing complex communication and discussions around death and dying. In addition, there is the risk of further burdening already stretched palliative care services, with education, counselling and support of fellow health service staff, in matters relating to voluntary assisted dying. It is important to note that the voluntary assisted dying legislation does not provide extra resources to services to support their health care staff. Nevertheless, specialist palliative care services can help patients who elect voluntary assisted dying, as they are well placed to provide specialist support within clear boundaries of engagement. This can include optimal symptom management as well as psychosocial and spiritual support. The RACP, the Australia and New Zealand Society of Palliative Medicine and Palliative Care Australia have all emphasised the need for greater access and resourcing for specialist palliative care. Our concern echoes that of the Catholic Health and Aged Care Services that we cannot, at this time, be distracted by the diversion of limited palliative care resources to voluntary assisted dying and lose focus on the need to ensure adequate and timely access to palliative care across Victoria and Australia.7 The perception of specialist palliative care services in cases where voluntary assisted dying has been requested will remain problematic. Collaboration with families and treating teams is essential and should involve the recognition of specialist palliative care involvement separate from voluntary assisted dying. The challenge remains to educate the public and health care professionals about palliative care and how it differs from voluntary assisted dying, amidst a new background of mixed messages. Regardless of the end‐of‐life choice made, holistic care and good communication skills are not solely related to our specialty, these are skills that can be, and need to be, routine for all areas of medicine.
Eswaran Waran · Leeroy William
First Nations peoples leading the way in COVID‐19 pandemic planning, response and management
Engaging First Nations peoples in public health emergencies is critical to reducing health inequities
Kristy Crooks · Dawn Casey · James S Ward
The time for inclusive care for Aboriginal and Torres Strait Islander LGBTQ+ young people is now
Understanding the multiple identity groups of Aboriginal and Torres Strait Islander LGBTQ+ young people can assist in meeting their health care needs Where does a young, LGBTQ+ (lesbian, gay, bisexual, transgender, queer, and other non‐heteronormative or non‐binary sexual and gender identities, including asexual) Aboriginal and Torres Strait Islander person go for health care in Australia? Do they attend an Aboriginal community controlled health organisation in search of culturally sensitive care? Or do they visit an LGBTQ+‐friendly health service to access staff trained in sexual and gender diversity? Is there a space for them, and other LGBTQ+ Aboriginal and Torres Strait Islander young people, in the Australian health care landscape? These questions are being posed by Indigenous LGBTQ+ health advocates.1 Recent national policy documents outline the need for comprehensive health care for Aboriginal and Torres Strait Islander LGBTQ+ young people.2,3 Despite this identification in policy, limited information is available to health practitioners on working with Aboriginal and Torres Strait Islander LGBTQ+ young people (Box 1). Practitioners are limited by the absence of an integrated framework as well as a dearth of research into these young peoples’ health needs and service preferences. Intersectionality theory highlights that individuals can face multiple structural inequalities within each of the social groups that they occupy, which also affect their access to health, social and economic resources.4 We suggest intersectionality theory as a guiding principle for research and practice with Aboriginal and Torres Strait Islander LGBTQ+ young people. An intersectional approach means recognising that patients belong to multiple identity groups, such as sexual orientation and cultural groups, which are socially constructed and which affect their social positioning and subsequent treatment, such as discrimination, within health care systems.4 The health and wellbeing of Aboriginal and Torres Strait Islander LGBTQ+ young people Aboriginal and Torres Strait Islander LGBTQ+ young people occupy three intersecting identities, which, when considered separately, are each linked to risks for poor health. The risks for poor physical health and social emotional wellbeing among Aboriginal and Torres Strait Islander peoples are well documented.5 Within Australia, LGBTQ+ individuals experience heightened suicidality, serious assault, homelessness and psychological distress6,7 compared with their heterosexual, cisgender peers. These increased health risks do not indicate inherent vulnerability but rather are outcomes of discrimination, marginalisation, racism, transphobia and homophobia.15 Young people not only experience health risks associated with their development phase — for example, heightened risk of psychopathology, physical injury and emotional dysregulation9,10 — but are also often unaware of health services available to them or have fears around confidentiality.11 LGBTQ+ young people, in particular, report feeling isolated from health services.6 Health practitioners may therefore see Aboriginal and Torres Strait Islander LGBTQ+ young people in a variety of settings, including in suicidal crisis, seeking care after a serious assault or injury, or counselling for prolonged psychological distress. Although health care workers may be aware of the health risks associated with being Aboriginal and Torres Strait Islander, LGBTQ+ or young, the health outcomes for someone with these intersecting identities remain largely unknown. Emerging literature has begun to identify the health concerns of people who are both Aboriginal and Torres Strait Islander and LGBTQ+, although this work is thus far limited to adults.12,13,14 Consistent with research into these groups separately, findings suggest that suicidality, substance misuse and homelessness are primary health concerns for Aboriginal and Torres Strait Islander LGBTQ+ people. However, the evidence in adults also points to a set of health‐related concerns which are unique to being Aboriginal and Torres Islander and LGBTQ+. For example, some individuals move off Country in search of more accepting communities or to access gender‐affirming care.13,14 However, moving off Country can lead to feelings of dislocation due to loss of connection to Country, which can then precipitate illness. Arguably, Aboriginal and Torres Strait Islander LGBTQ+ young people find it harder to move off Country because of reduced financial and personal resources. Support and service in remote areas are also scarce.14 An inability to express gender or sexual identity is another health‐related concern for Aboriginal and Torres Strait Islander LGBTQ+ people. Some people report feeling pressure to suppress their sexual or gender identity when they are in Indigenous communities.12 Exclusion of gender diverse individuals from men's or women's business can negatively affect social and emotional wellbeing.13 Contemporary culture‐based wellbeing programs often continue this practice of providing support along binary gender lines. Some of the authors’ own experiences reiterate this unintentional bias; Indigenous health care providers use terms such as “sis”, “brother” or “sistergirl” when answering the phone, which can mean that people are misgendered. Although we acknowledge that these terms carry meaning to the Indigenous community, they can be problematical for trans and non‐gender‐conforming young people. There is therefore scope to develop a culturally sensitive way to bypass the use of these gendered terms until a young person's pronouns have been established. Intersectionality theory as a guiding framework International models8,15 provide a useful footing on which to consider intersectionality in the Australian health context. These models demonstrate how societal oppressions of racism and heterosexism within health care systems influence internal (eg, an individuals’ self‐concept) and external (eg, lack of LGBTQ+‐specific services, stigma toward multiple minority groups) risk factors. Importantly, the impact of these risk factors resulting from societal oppressions is not simply a multiplicative effect. Rather, individuals living within multiple minority groups face health disadvantage because of their unique social positioning. Common across these models is an emphasis on the social context of health outcomes because membership in multiple minority status groups can be associated with increased stresses and barriers impeding an individual's coping efforts. Further, when practitioners do not consider how a patient's gender, social class, ethnicity and sexual orientation influences their care needs, patients who experience multiple oppressions can become invisible by being left out of health research or ignored in policy and health promotion efforts, leading to delays in seeking care. Such invisibility in health care is a reported concern among Aboriginal and Torres Strait Islander LGBTQ+ people.12 Health care at the intersection: implications for health research and practice Adopting an intersectional approach to health care requires practitioners to consider the relationship between multiple structural inequalities faced by Aboriginal and Torres Strait Islander LGBTQ+ young people, and downstream consequences for this group's wellbeing. Doing so will likely require additional training and professional development. As Box 1 outlines, although not health providers per se, services and supports led by Aboriginal and Torres Strait Islander LGBTQ+ people have emerged in response to the multiple barriers presented by existing health services. These services provide a space for Aboriginal and Torres Strait Islander LGBTQ+ people to discuss intersecting identities. For example, the Gar'ban'djee'lum Network offers a space in which to celebrate sexual and cultural identity, and Black Rainbow partners with an online newspaper to publish content by Aboriginal and Torres Strait Islander LGBTQ+ authors, providing a platform for voices from people living at this intersection. Service providers can increase their awareness of the contemporary issues faced by Aboriginal and Torres Strait Islander LGBTQ+ young people by accessing online information from these organisations. Moreover, concrete steps which practitioners can follow can be guided by an awareness of intersecting categories, diversity of knowledges, power and multilevel analysis, reflexivity, time and space, and equity and social justice.8 Actions that practitioners can take which are consistent with these domains are outlined in Box 2. The increased focus on Aboriginal and Torres Strait Islander LGBTQ+ young people, led by and advocated for by Aboriginal and Torres Strait Islander LGBTQ+ community members and researchers, is a welcome step towards ensuring safe and effective health care for all Australians. However, there has been little guidance for practitioners on how best to work with this patient group. Health services wanting to support Aboriginal and Torres Strait Islander LGBTQ+ young people can: include an LGBTQ+ status question on intake forms; services can also use an open‐ended question format for young people to describe their gender, rather than tick‐boxes of “male”, “female” or “other”; provide visual displays of support in waiting rooms, such as displaying a rainbow pride flag and other pride flags alongside Aboriginal and Torres Strait Islander flags; and establish mechanisms for Aboriginal and Torres Strait Islander LGBTQ+ young people to provide service feedback (eg, asking patients from this group how the service can best meet their needs). Further, although there are increasing calls to apply an intersectional approach in health care — none more powerful than those of Aboriginal and Torres Strait Islander LGBTQ+ young people themselves — research has yet to systematically evaluate treatment outcomes for patients when such an approach is applied. Future research should measure treatment outcomes in services where staff apply an intersectional lens. The omission of young people from previous research into the health and wellbeing of Aboriginal Torres Strait Islander and LGBTIQ+ people also remains a pressing concern. Further research with young people is needed if practitioners and services working with young people are to effectively and appropriately work within an intersectional framework. Box 1 – Current services available for Aboriginal and Torres Strait Islander LGBTQ+ people* Organisation name Description Website Black Rainbow Advocacy for Aboriginal and Torres Strait Islander LGBTQ+ suicide prevention Support for homelessness, domestic violence, and people involved in the justice system http://www.blackrainbow.org.au/ Tekwabi Giz Provides support to the National LGBTI Health Alliance for Aboriginal and Torres Strait Islander LGBTQ+ people, specialised knowledge, advocacy https://lgbtihealth.org.au/tekwabigiz/ IndigiLez Women's Leadership and Support Group Special focus on Indigenous lesbians and same sex‐attracted women Advocacy for Aboriginal and Torres Strait Islander LGBTQ+ people, cultural retreats, safe sex workshops, family days, workshops, social activities, self‐defence workshops https://www.facebook.com/IndigiLez/ Sisters and Brothers NT Social change, advocacy, support, consultation, resource creation, and research, and awareness for sistergirls, brotherboys, and Aboriginal and Torres Strait Islander LGBTQ+ people https://www.facebook.com/SistersBrothersNTCelebratingDiversity/ First Nations Rainbow Acceptance, celebration, raising community awareness, improving wellbeing, and reducing stigma and discrimination https://www.firstnationsrainbow.org.au/ Yarns Heal Suicide prevention among Indigenous peoples, including sistergirls, brotherboys and LGBTQ+ individuals https://www.yarnsheal.com.au/ Gar'ban'djee'lum Network Support, advocacy, information on healthy lifestyles, social events, fundraising, and celebration of sexual and cultural identity https://www.afao.org.au/article/us-mob-garbandjeelum-network/ Blaq Aboriginal Corporation Celebration, representation and increased visibility of Aboriginal and Torres Strait Islander LGBTQ+ community members https://www.blaq.org.au/about-about * This list of organisations in not exhaustive but provides a starting point for practitioners wanting to learn more about Aboriginal and Torres Strait Islander LGBTQ+ health. Information in the table is taken from the organisations’ websites. None of the organisations listed are young people‐specific, although some make note of the importance of young people. Box 2 – Next steps in health care provision for Aboriginal and Torres Strait Islander LGBTQ+ young people Domain8 Next steps for research and practice Intersecting categories: health professionals should consider that patients likely occupy multiple social positions, not just the identity which appears most dominant Develop LGBTQ+ health information guides that are culturally sensitive to Aboriginal and Torres Strait Islander patients and easily accessible to young people Display the Aboriginal and Torres Strait Islander flags alongside the pride flags at health services Including LGBTQ+ status options on patient intake forms Because experiences of discrimination based on sexual and gender diversity among Aboriginal and Torres Strait Islander people can occur within the context of pre‐existing trauma,12 consider applying trauma‐informed care models when working with this patient group Specific health promotion efforts and programs targeted at Aboriginal and Torres Strait Islander LGBTQ+ young people Primary research into the social emotional wellbeing of Aboriginal and Torres Strait Islander LGBTQ+ young people Primary research into experiences and preferences of Aboriginal and Torres Strait Islander LGBTQ+ young people in the health system Diversity of knowledges: consider Indigenous and queer ways of knowing and being Seek Aboriginal and Torres Strait Islander LGBTQ+ young peoples’ perspectives on their health issues Assess whether Aboriginal and Torres Strait Islander LGBTQ+ young people have a culturally specific understanding of their health and wellbeing, which may differ from dominant, medicalised explanations Primary research into how Aboriginal and Torres Strait Islander LGBTQ+ young people conceptualise health and wellbeing Power and multilevel analysis: health professionals hold greater power than Aboriginal and Torres Strait Islander LGBTQ+ young people due to their positions in society; health issues for this patient group occur across multiple levels of society Reducing power differentials in the healing relationship by using less medicalised language with patients and asking them how to best cater to their specific needs Ensuring young people understand limits of confidentiality so that they can trust practitioners with disclosing their LGBTQ+ status Practitioners attend professional development opportunities that promote appropriate ways of working with Aboriginal and Torres Strait Islander LGBTQ+ young people (such training is currently provided by some organisations listed in Box 1). Primary research into the impact of various societal oppressions on Aboriginal and Torres Strait Islander LGBTQ+ young peoples’ wellbeing Primary research into enablers of effective service delivery in this patient group Reflexivity: consistent reflection on practice decisions and how they relate to patients’ social positioning Practitioners regularly reflect on assumptions they may hold about Aboriginal and Torres Strait Islander LGBTQ+ young people and the root cause of their health problems Discussions with LGBTQ+, Indigenous and mainstream health care providers around attitudes toward Aboriginal and Torres Strait Islander LGBTQ+ young people Time and space: patient needs and preferences are not static, and vary with social positioning Practitioners remain up to date on social trends which may affect this patient group (eg, recent legalisation of same sex marriage, release of the Uluru Statement from the Heart) Practitioners ask individual patients about their experience of living at this intersection, and not assume a universal experience Primary research into health care needs and preferences across the life course in this patient group Equity and social justice: advocating for increased inclusion of Aboriginal and Torres Strait Islander LGBTQ+ young people Health professionals can use their positions of social power to advocate for the needs of Aboriginal and Torres Strait Islander LGBTQ+ young people within their collegiate relations, workplaces and the broader health sector
Bep Uink · Shakara Liddelow‐Hunt · Kate Daglas · Dharma Ducasse
“Now we say Black Lives Matter but … the fact of the matter is, we just Black matter to them”1
If Black lives matter we need to be prepared to examine and address racial violence within the Australian health system My name is Kevin Yow Yeh and today I march for every Black death in custody but I especially march for my grandfather Kevin Yow Yeh Sr. At the age of 34 this man apparently had a heart attack at a Mackay watch house … This last month we've seen plenty of stats, 430 plus Black deaths in custody … and that's only since the Royal Commission, but what about all those deaths that led to that. My grandfather was one of them. Let's humanise these stories. When this man had a heart attack, he left his wife and he left five young children. My grandmother was still having his children when she had to put this man in the ground. That's why we march! Of course we stand in solidarity with our brothers in America. And, of course we stand in solidarity with our sisters in West Papua … but today we stand for our lives here, on stolen land.2 The statistical story of Indigenous health and death, despite how stark, fails to do justice to the violence of racialised health inequities that Aboriginal and Torres Strait Islander peoples continue to experience. This story has been reported on unremarkably in federal parliament for over a decade, as an annual account‐keeping exercise of policy failure and statistical targets not met.3 This story of failure and failing health has been told countless times in health and medical journal publications, and despite growing more frequent in number, these contributions to new knowledge never seem to translate to improved health outcomes. This story of failure does not do justice to the trauma and loss that Aboriginal and Torres Strait Islander communities experience. This story of failure does not do justice to the pain of never meeting the grandfather that you are named after. Tragically, despite the parlous state of Indigenous health, we have not been met here with the kind of urgency that the global Black Lives Matter movement has spurred elsewhere. What we have been presented with, aside from the Health Minister admonishing Black Lives Matter protestors for putting the health of the public at risk,4 has been the triumphal announcement of “research projects”,5 the release of a “landmark report”,6 and a drafting of “refreshed” and “historic targets”.7 All of these supposedly fresh responses were on track before the Black Lives Matter movement hit our shore. Rather than the “new normal” which the threat of coronavirus disease 2019 (COVID‐19) inspired, the Australian health system's Black Lives Matter moment is best characterised as indifferent; a “business as usual” approach that we know from experience betokens failure. When the threat of COVID‐19 loomed, action was swift and the Aboriginal and Torres Strait Islander leadership within and outside of the health system was even swifter in establishing taskforces, lobbying for additional resources for the community controlled sector, instituting special border control measures for remote Indigenous communities, and the development of emergency response plans to protect their communities.8,9 The effective response to the COVID‐19 pandemic sits in sharp contrast to the ongoing pandemic of racism that Indigenous peoples have been fighting since 1788 and which has taken far more Black lives in Australia. Sweet points out: “To date, there is very little sign that senior health policy makers, from the Chief Medical Officer to Health Minister Greg Hunt, will use their authority to name and address the system racism that contributes to poorer healthcare, as it does to overincarceration”.10 While broad attention is often focused on Black deaths in custody, the premature deaths of Indigenous peoples from supposed natural causes inside and outside of custody tell a consistent story of failure and violence that marks the Australian health system and society more broadly. Against the quietude of the Australian health system on racism are the powerful voices of Aboriginal and Torres Strait Islander peoples, on television screens, on public streets and in our spreadsheets, speaking the truth about how little Black lives seem to matter. Both Indigenous clients and clinicians have stories to tell of the violence of racism in the health system, of being cast in the category of less capable, less compliant, less deserving of care and less worthy of the category of human. This then brings us to the coronial inquiry, the endgame of not caring; of neglect. Here, never let us forget the mothers, the children, the cousins and the spouses weeping outside coroner's courts, bearing photos of their loved ones in their hands and on their clothing, simultaneously appealing for care and for justice.11 Moreover, let us not for a second dismiss the anguish of having to fight for the release of recorded footage of your loved one's final moments, to be replayed over and over, in which they too plead vainly, “I can't breathe”.12 So many grieving Indigenous families continue to appeal to the state for care and for justice via coronial inquiries in the hope that their tragedy will not befall another. But the awful truth is that the recommendations of coronial inquiries are not enforceable because the inquest is meant to discover what happened rather than determine responsibility. So again, regardless of the findings, the resulting outcome is business as usual. The coronial inquiry represents a theatre of power where, in the presence of an avoidable Indigenous death, the state declares its benevolence; duly recording the steps taken and policies and procedures adhered to or those requiring review, and the best efforts of police, medical officers or first responders, to deem the death another “unavoidable” tragedy. Gomeroi scholar Whittaker11 notes how the discourse of “natural causes” in coronial inquiries works to render Indigenous peoples as “fated to die” and beyond care because they were “already dead”. The coronial inquiry represents a moment of confluence of the health and legal systems and the state that seek to erase Indigenous existence and affirm the settler trope of a dying race. It represents the theatre of Indigenous health policy writ large. The story of Indigenous health failure, of persisting and alarming health statistics that are routinely attributed to a complex web of social, cultural and economic factors, sustains the notion of the inevitability of Indigenous ill health, of a race destined to die out, despite the best of efforts and intentions. How do we explain an unwavering commitment to a failed Indigenous health policy framework amid a global movement centred around the importance of Black lives, and a National Aboriginal and Torres Strait Islander Health Plan vision of a health system “free of racism” with no strategy for addressing systemic racism?13 How do we further explain the focus on the individual health behaviours or “choices” of Aboriginal and Torres Strait Islander peoples when we know “incessant racial health inequities across nearly every major health index reveal less about what patients have failed to feel and more about what systems have failed to do”.14 As Boyd and colleagues point out, “The solution to racial health inequities is to address racism and its attendant harms and erect a new health care infrastructure that no longer profits from the persistence of inequitable disease”.14 Earlier this year, the National Registration and Accreditation Scheme demonstrated the type of Black Lives Matter moment that the Closing the Gap refresh missed, by launching the Aboriginal and Torres Strait Islander Health and Cultural Safety Strategy 2020‐2025.15 The strategy sets clear directions for the Australian Health Practitioner Regulation Agency, the national boards and accreditation authorities, which regulate Australia's 740 000 registered health practitioners to ensure that patient safety for Aboriginal and Torres Strait Islander peoples is the norm. The landmark strategy embodies ambition and partnership to address racism and culturally safe care; shifting the blame of failure for good health from Black bodies and instead demanding structural and individual health reform of health practitioners and the systems that regulate them. It is this shift of focus that has been central to the calls from Aboriginal and Torres Strait Islander peoples. Black wounds have been laid bare, to reveal the violence of health and legal systems upon Aboriginal and Torres Strait Islander peoples in a desperate appeal for those same systems to care. At 34 years of age my grandfather died, where's his justice? … what about all the other families, what about all the other fathers, brothers, sisters, nephews and nieces …? What about all the other mob? Where's their justice? My name's Kevin Yow Yeh, f*** the system, if you're not with us you're against us! What is needed is an Australian health system that has a steadfast commitment to Black lives: not as in need of saving, but as deserving of care; one that matches the staunchness of grieving Black families marching the streets of our capital cities in the midst of a pandemic. Such a commitment demands that we abandon the failed Indigenous health policy of Closing the Gap16 in favour of a health justice framework,17 which would include, but not be limited to: A foregrounding of Indigenous sovereignty rendering visible the strength, capability and humanity of Aboriginal and Torres Strait Islander peoples, services and communities in all processes of health policy formation and implementation, not as partners but as architects. State and federal government commitment to the recommendations of the coronial inquiries into the deaths of Aboriginal and Torres Strait Islander peoples who have died of preventable or avoidable conditions in the health system, and the establishment of an Indigenous taskforce to oversee implementation. An explicit financial commitment from the National Health and Medical Research Council and the South Australian Health and Medical Research Institute (via the Indigenous Medical Research Future Fund) and the Australian Research Council for research that attends to the nature and function of race in producing the conditions that allow racialised health inequalities to persist, from birth to death, including the embodied consequences of racism. The establishment of awareness‐raising campaigns that make clear the various ways in which Aboriginal and Torres Strait Islander peoples may seek justice when experiencing discrimination within the health system, and commeasurable resourcing of legal services to support Indigenous peoples to take action. Introduction of publication guidelines for health and medical journals requiring research relating to racialised health disparities to foreground institutional racism in its analysis, rather than socio‐economic disadvantage and other social and cultural factors. Development of an interdisciplinary Indigenous health workforce agenda that centres the care of Indigenous people beyond capacity building to include attending to racial violence within workplaces across the Australian health system. We offer these strategies not as a solution, but as some small steps towards a radical reimagining of the Black body within the Australian health system; one which demonstrates a more genuine commitment to the cries of “Black Lives Matter” from Blackfullas in this place right now.
Chelsea J Bond · Lisa J Whop · David Singh · Helena Kajlich
Cancer survivorship care at the time of the COVID‐19 pandemic
During the pandemic, cancer survivors are lost in transition
Bogda Koczwara
Unemployment, suicide and COVID‐19: using the evidence to plan for prevention
COVID‐19‐related unemployment may significantly increase suicide rates; implementation of appropriate preventive measures is critical In response to the coronavirus disease 2019 (COVID‐19) pandemic, the imposition of social distancing policies and related labour market impacts have resulted in extensive job losses. Globally, the International Monetary Fund has predicted the steepest economic downturn since the Great Depression.1 In May 2020, 2.3 million Australians (one in five employed people) were either unemployed or had work hours reduced for economic reasons, resulting in the steepest rise in rates of unemployment on record — a change from 5.2% in March to 7.1%2 — with Treasury predicting a rate of 8% by September 2020. Unemployment alone is associated with a two‐ to threefold increased relative risk of death by suicide compared with being employed,3 and sudden spikes in unemployment are associated with corresponding surges in the population rates of suicide.4 The global financial crisis, which led to the deepest recession since the 1930s and the loss of 30 million jobs worldwide, is estimated to have resulted in at least 10 000 additional economic suicides between 2008 and 2010 in Europe and North America.5 Projections using historical data suggest suicide rates may increase by 3.3–8.4% over the 2020–2021 period in the United States6 and up to 27% in Canada.7 Of course, all this is speculative and although the links between economic recessions and suicide are well documented, what is less clear is how the relationship plays out in the context of larger sociocultural and health events such as COVID‐19. The 1918–1920 influenza pandemic caused around 39 million deaths worldwide and resulted in governments implementing quarantine, public hygiene and social distancing policies, but evidence regarding its impact on world economies and suicide is limited. The severe acute respiratory syndrome (SARS) epidemic of 2003 came at the height of the Asian financial crisis, so disentangling the two is difficult. However, during this period, suicide rates in a number of Asian nations increased in tandem with unemployment, reaching historical peaks in 2003.8 As the situation continues to change daily, an accurate estimate of likely unemployment resulting from the COVID‐19 pandemic is difficult. Even current estimates under‐represent the impact, as individuals who are still employed but at significantly reduced hours are discounted. This is of particular concern when considering the global financial crisis, which saw Australian unemployment take a comparatively minor increase from 4.0% to 5.8% and coincided with an increase in suicide rates of 22% and 12% for unemployed men and women respectively.9 As the present crisis may potentially double the current unemployment rate, one can extrapolate to alarming conclusions, with some (albeit unpublished) modelling reflecting this projection.10 Despite this grim speculative forecast, this is not the whole story. There are marked differences between the present crisis and those that have come before. For instance, the current recession is supply (rather than demand) driven, and the prospect of recovery, although slow, is conceivable and may bolter optimism. Although major industries will be severely affected, there is potential for increased local spending as the borders remain closed. In addition, some hope may be found in the resilience shown by civilians in times of global unrest — for instance, the often cited “Blitz spirit”11 — and the possibility that the shared experience of the pandemic might bring a sense of social cohesion, which may prove life‐preserving. Notwithstanding considerable evidence of the psychosocial impacts of mass unemployment, we argue that the impact of the COVID‐19 pandemic on suicide rates is far from predetermined, and that early and sustained action can prevent many suicides and other adverse mental health outcomes. During prior recessions, Austria, Sweden and Finland have each displayed resilience in the face of substantially increased unemployment.5 In fact, despite sizeable rises in unemployment rates in Sweden and Finland in the early 1990s, the rate of suicide decreased.4 We suggest that, based on the available literature, there are several factors that may moderate the impacts of widespread unemployment. These include both early prevention measures and crisis care: sustained welfare spending; labour market programs and protections; and adequate funding of, and access to, mental health services, including prevention programs and engaging new technologies in the reporting and care response. Firstly, countries with sustained welfare spending during recessions have less marked increases in suicide rates than those that cut spending on welfare and job search initiatives for the unemployed.12 Robust social policies to ensure adequate welfare benefits for people with low or sudden loss of income are thought to be central to offsetting the impact of the recession on suicide.13 Where governments expand public welfare spending in the wake of disasters, there is good evidence for a reduction in suicide. The federal government's introduction of the JobKeeper and JobSeeker payment schemes are likely to mitigate suicide risk while simultaneously stimulating the economy and require long term investment. Secondly, countries with active labour market programs, which assist the unemployed to find work or retrain, and those with labour market protections have lower rates of unemployment‐related suicide than countries that do not.12 It has been estimated that, during European recession periods in the past 50 years, each US$100 per capita of investment in active labour market programs reduced the association of unemployment with suicide by 0.4%.4 Thirdly, it is critical that investment is made immediately in mental health, not just in terms of treatment but also in evidence‐based prevention programs. Different approaches are required to reduce attempts, and deaths, involving both public health and clinical services. In terms of direct suicide prevention interventions, there is increasing evidence for multilevel systems approaches — using components ranging from individual‐level (eg, assertive aftercare, psychosocial interventions) to public health interventions (eg, general practitioner and gatekeeper training),14 in addition to indirect interventions (targeting risk factors). Critical to effectiveness is the degree of penetration of these services, based on early population modelling, and the types of factors likely to differentially affect communities, including indigenous communities. Improving quality, availability and access to programs and crisis support services is vital to preventing suicide,14 with the current crisis both creating new challenges and compounding pre‐existing systemic issues. While the mental health sector is rapidly mobilising to improve access and the government has been quick to revise the Medicare rebate in this regard, it is vital that resource allocation and innovation continues beyond the span of the physical distancing measures. While increasing telehealth services is critical, the health professionals available to support them are unlikely to increase to meet need, and blended services that include automatised digital components may be a more efficient solution. The additional $48.1 million in mental health funding announced in May 2020 is a positive step; however, further funding for evidence‐based prevention initiatives is more important than ever to alleviate demand on treatment services. In terms of suicide prevention, digital interventions may hold some utility for both at‐risk and actively suicidal individuals, especially where other health services are lacking.15 Of course, economies undergoing recessions by their very nature have significant financial constraints, and governments will inevitably have to review spending across all services. It is critical that these limited funds are directed toward the most viable and cost‐effective services. Importantly, not all groups are affected equally, and subgroup consideration is vital. In crisis periods, it can be the most disadvantaged groups that are disproportionately affected, and marginalised and at‐risk populations require specific attention. It is also important to consider that many of the adverse consequences of job loss, including house repossession, mounting debt, mental health problems and relationship strain, are delayed and, therefore, long term investment is required.16 Finally, engaging new technologies in the fight against suicide may present a valuable new tool. This includes information technology‐enabled coordinated care and the dynamic reporting of suicide risk using immediate and real‐time data so that developing hotspots can be identified and shut down and local services can be mobilised. Although this field of study is in its infancy, the potential for concepts such as integrated, geospatial mapping, hotspot surveillance, and real‐time reporting could lead to significant advancements in predicting and intervening in suicidal behaviour.17 Ultimately, the economic fallout resulting from the COVID‐19 pandemic represents a threat, requiring urgent mobilisation and planning. There are certain steps required to moderate the mental health impacts of widespread unemployment, including sustained welfare spending; labour market programs; adequate investment in, and access to, mental health treatment and prevention services; and the dynamic reporting of suicide risk to aid regional responses and means restriction. The current economic crisis presents an opportunity to implement policies that would not only mitigate the impact of the recession on suicide but may incidentally reduce the national health and economic burden presented by emotional distress in any economic cycle. In doing so, there may be the ability to emerge from the current crisis stronger and more resilient as a nation.
Mark Deady · Leona Tan · Nathasha Kugenthiran · Daniel Collins · Helen Christensen · Samuel B Harvey
E‐cigarette or vaping product use‐associated lung injury (EVALI): a cautionary tale
Tetrahydrocannabinol‐containing (THC) products with vitamin E additives are implicated in the pathogenesis of EVALI Electronic cigarettes, or e‐cigarettes, are battery‐powered devices that heat liquids containing nicotine and other chemicals in order to produce vapour.1 “Vaping” is the act of inhaling the vapour produced by an e‐cigarette.1 First marketed in 2005, e‐cigarette use is viewed by many as less harmful than traditional cigarette smoking, and championed as a strategy for smoking cessation.1,2,3 A detailed discussion of e‐cigarette use in smoking cessation is available in the United States Surgeon General's 2020 report, and is beyond the scope of this article; however, the report states that “there is presently inadequate evidence to conclude that e‐cigarettes, in general, increase smoking cessation”.2 Thus far, no e‐cigarette product for the therapeutic purpose of smoking cessation has been submitted to Australia's Therapeutic Goods Administration for safety evaluation or approval. Vaping in the US was initially associated with nicotine‐containing solutions. However, it is important to note that nicotine or nicotine salts may no longer be the only active ingredient in vaping solutions.1,4,5 In particular, unregulated vaping solutions or “home‐brew” products that contain tetrahydrocannabinol (THC) oil, or cannabinoids, can be obtained in the US.4,6 Vaping solutions come in a wide range of flavours, many designed to appeal to adolescents.1,2 Indeed, e‐cigarette manufacturers have used celebrity endorsements and social media‐based marketing campaigns to target adolescents, and these strategies appear to have been highly successful.1,2 There has been significant uptake of vaping among tobacco‐naive high school students, particularly in the US, where it is estimated that one in four high school students are current e‐cigarette users;7 moreover, in 2019, 14% of year 12 students reported vaping cannabis in the preceding 30 days.8 Between 2011 and 2018, e‐cigarette use increased among US high school students from 1.5% to 20.8%, even when traditional cigarette use declined from 15.8% to 8.1%.9 Consequently, from 2017 to 2018, overall use of tobacco products (traditional and e‐cigarettes combined) increased from 19.6% to 27.1%.9 In contrast, e‐cigarettes use among adults in the US has remained largely stable at 8.1 million e‐cigarette users (3.2%).10 It is possible that for young non‐smokers, e‐cigarettes may normalise smoking and serve as a gateway to nicotine dependency and traditional cigarette smoking, although this is strongly debated.1,9 In 2016, the Australian National Drug Strategy Household Survey reported that e‐cigarette use within the 12–17 and 18–29 years age brackets was about 7.1% and 16% respectively.11,12,13 The 2017 Australian secondary students’ alcohol and drug survey found that 13% of students had used an e‐cigarette at least once.14 Of the 2410 students who used an e‐cigarette, 48% reported that they had never smoked a traditional tobacco cigarette before using an e‐cigarette.14 E‐cigarettes may be perceived by young people as “a cool new gadget” and “safer than smoking”.1 Unfortunately, it has become abundantly clear that the use of illicitly sourced e‐cigarettes can be dangerous.10 In 2019, disturbing reports emerged of an acute and, for some, deadly outcome from vaping.15 Across the US, e‐cigarette users began to be admitted to hospitals with acute respiratory failure. In August 2019, the first fatality was documented in Illinois, while 200 other cases across 22 states were under investigation by the Centers for Disease Control and Prevention (CDC).15 This epidemic has spread very rapidly. There have been over 2800 hospitalised cases reported from every US state and territory and a total of 68 deaths.16 Patients were predominantly male (66%) and under 35 years of age (76%).6 [Correction added on 2 July 2020 after first online publication: Information has been updated on the second last sentence.] The CDC has termed this new disease “e‐cigarette or vaping product use‐associated lung injury” (EVALI)17 and has proposed four obligatory criteria for its diagnosis: use of an e‐cigarette (“vaping”) in the 90 days before symptom onset;18 pulmonary infiltrates or ground glass opacities on x‐ray or computed tomography scan; absence of pulmonary infection (defined by negative respiratory viral panel, negative influenza polymerase chain reaction, negative urinary pneumococcal antigen and sputum culture including Legionella, and bronchoalveolar lavage [BAL] culture); and no evidence of an alternative plausible diagnosis such as a cardiac disease or a neoplastic process.17,18 Patients with EVALI typically present with both respiratory (dyspnoea, cough, fever) and gastrointestinal (nausea, vomiting, diarrhoea, abdominal pain) symptoms.15,19 Usually, there is no prior history of respiratory disease. Diagnosis may be challenging, as EVALI can mimic infective pneumonia and gastrointestinal symptoms may sometimes precede respiratory symptoms.15 Respiratory failure may be severe enough to require invasive ventilation and intensive care support.15,19 Imaging findings include ground glass opacities on chest imaging,20 suggesting diffuse lung injury with bronchiolitis obliterans and cryptogenic organising pneumonia.19 Pathologically, limited lung biopsies have shown acute lung injury, acute fibrinous pneumonitis and diffuse alveolar damage.21 “Foamy” or lipid‐laden macrophages are often seen, suggestive of lipoid pneumonia.15 Aetiology and pathophysiology of EVALI: reasons for its recent emergence Careful epidemiological investigation has revealed two key findings explaining the recent emergence of EVALI after more than a decade of e‐cigarette use. Firstly, 80% of hospitalised patients with EVALI have admitted to using THC vaping products.6 Eighty‐four per cent of the reported THC products were acquired via informal channels and were probably manufactured outside of regulated facilities.15 The CDC identified “Dank Vapes” — a group of largely counterfeit THC‐containing products — as the most commonly reported THC brand across the US and used by 56% of patients with EVALI admitted to hospital.6 In contrast, only 13% of hospitalised patients with EVALI reported exclusive use of nicotine‐containing products; however, traces of THC were found in BAL samples.6,19 There may be unreliable self‐reporting and it is possible that the nicotine e‐cigarettes may have been contaminated by black‐market THC additives. Most patients reported using combination products containing either THC, cannabidiol or nicotine.6 Secondly, there is mounting evidence that a specific additive to vaping solutions — vitamin E acetate — played a major role in the 2019 EVALI outbreak.19,20 It is hypothesised that vaping the vitamin E acetate oil causes direct lung injury and lipoid pneumonia.21 Supporting this, BAL fluid from 51 patients from 16 states diagnosed with EVALI yielded vitamin E acetate in 94% (48/51) of the BAL samples.19 In an analysis of the THC‐containing e‐cigarette products used by 12 patients, vitamin E acetate was found in products from 11 patients.19 It is likely that this substance was added as a diluent or filler, and this practice appears to be a very recent development.19 The same chemical analysis performed on THC e‐cigarette products seized in 2018 did not find vitamin E acetate.19 Current evidence shows that THC‐containing products with vitamin E acetate additives are implicated in the pathogenesis of EVALI.21 Given the outbreak has only manifested in the past 18 months, it is likely that the addition of these substances into e‐cigarette solutions is a very recent occurrence. The CDC outlines three broad tenets for treating suspected EVALI: cover possible infective agents with empiric broad‐spectrum antibiotics; administer systemic steroids (optimal dose unknown); and provide best supportive care with oxygen therapy and close monitoring.15,17,20 In mild to moderate cases, the decision to start steroids can be delayed until culture results exclude or identify potential infectious pathogens.17 In severe cases, systemic corticosteroids should be given early due to the potential life‐threatening nature of EVALI.20 There have been reports of progressive ventilatory failure despite administration of high dose steroids (methylprednisolone 1 mg/kg), with patients requiring extracorporeal membrane oxygenation.20 So far, there are no confirmed reports of EVALI in Australia. Unlike in the US, nicotine‐containing liquids are illegal in Australia and can only be obtained on medical prescription for personal use.11 The sale of e‐cigarettes to people aged under 18 years is also illegal.11 In practice, however, a 2015 survey of Australian e‐cigarette use found that 90% of users purchased e‐cigarettes and liquids from unregulated online stores.11 Even legal nicotine‐free liquids sold in Australia have been found to contain traces of nicotine and other toxic substances, with no regulation of products.22 Most Australian e‐cigarette users are therefore vulnerable to the possibility of potentially dangerous substances being added to solutions, as has occurred in the US. Conclusion Vaping THC oil contaminated with vitamin E acetate is linked with severe lung injury and death. With more than 2800 cases of EVALI reported and 68 deaths, e‐cigarettes are definitely not risk‐free. Australian clinicians should maintain vigilance and ask every patient about e‐cigarette use. Adults using nicotine‐containing e‐cigarettes as an alternative to cigarette smoking should not revert to tobacco smoking.2 A reasonable and precautionary strategy is to advise patients that little is known about the long term effects of e‐cigarettes, and also to inform users that severe lung disease and death have occurred mainly with unregulated solutions. We recommend further research and ongoing field monitoring of e‐cigarette usage patterns in Australia.
Maitri Munsif · Mark Hew · Eli Dabscheck
COVID‐19: planning for the aftermath to manage the aftershocks
Australia has managed the crisis well so far but we should now also plan for future waves and the recovery phase Coronavirus disease 2019 (COVID‐19) pandemic management is focused on prevention, case finding and survival. Australia and New Zealand have done well and the numbers in our intensive care units (ICUs) are currently manageable. Our subacute sector is presently able to deal with patients requiring rehabilitation. However, rehabilitation needs following COVID‐19 are broad, complex and include cognitive, motor and respiratory sequelae to the infection, acute respiratory distress syndrome, and the thromboembolic response. Planning and anticipatory action has been Australia's strength so far. In the same vein, an active planning approach is now required for the post‐acute and rehabilitation response. This pandemic will inevitably have its waves, and will continue to threaten until a vaccine is rolled out. Not having a plan for possible surges is unconscionable, particularly when the consequences of the relaxation of restrictions are unknown. Currently, Australian numbers are at a trickle; however, the challenge has been front and centre in countries such as Italy,1 Spain, the United Kingdom and North America.2 In Wuhan, China, 36% of those with severe COVID‐19 had neurological complications such as stroke, critical care neuropathy, and the complications of prolonged bed rest (eg, venous thromboembolism, disseminated intravascular coagulation, acute kidney injury, delirium anxiety, post‐traumatic stress disorder).3 In Italy, rehabilitation physicians have been treating post‐extubation dysphagia, impaired mobility, critical care myopathy and neurocognitive losses,1 while the British Society of Rehabilitation Medicine has established a framework of partnership with acute services to improve patient flow, outcomes and access to ventilators.4 In the United States, hospitals have had to rapidly transition acute patients to rehabilitation hospitals. In New Orleans, a 1000 bed post‐acute hospital was dedicated to post‐COVID‐19 disability, with rehabilitation teams treating patients battling persistent hypoxia, stroke and mental illness.5 The majority of patients who are ventilated for more than 7 days suffer complications that require rehabilitation, 60% are unable to walk, and 17% die within a year.7 One‐third suffer neurological complications, many require inpatient rehabilitation for over 3 weeks, and some take over 150 days to regain their capacity to walk independently.8 Others with stroke or cardiac complications of COVID‐19 will require rehabilitation for up to 6 weeks, with some requiring lifelong support. Australia needs to plan now, not just for survivors in the initial post‐acute stage, but also to manage individuals affected in subsequent waves. Such patients may require rehabilitation, along with those, fearful of infection, who present to hospital late with non‐COVID‐19 conditions like stroke, and those with deteriorating chronic diseases who have not had access to hospital based services. That means not only estimating the patient population but also ensuring that subacute health workers have sufficient access to personal protective equipment, staffing and training. In the Australian Government's emergency response plan,9 the recovery phase devolves to the states, but there is no mention of the post‐acute phase. In April, the New South Wales Ministry of Health established a rehabilitation community of practice to advise it. This follows international experience, as the International Society of Physical and Rehabilitation Medicine's disaster committee lead, Australia's Fary Khan states: “early rehabilitation reduces disability and improves clinical outcomes”.10 Currently, many rehabilitation units are not prepared. Inpatient rehabilitation units (public and private) are almost always working to capacity. COVID‐19 patients will be expect to be accommodated in addition to usual patients (eg, strokes, spinal injuries, amputations). The NSW Rehabilitation Community of Practice has developed a staged COVID‐19 escalation plan,11 but the plans turn on one integral point — contagion. When COVID‐19 survivors come to rehabilitation wards will they no longer be infected? While a national statement exists,12 local de‐isolation protocols are yet to be implemented or updated in many hospitals and local health districts. Many people with severe COVID‐19 have positive nasal swabs for up to 37 days13 but are not considered infectious once 10 days have elapsed from after first symptoms. Attention to this timetable is critical should we need to make ICU beds readily available by shifting patients to rehabilitation. In some US rehabilitation hospitals, patients are assumed to always be infectious, which has a significant impact on personal protective equipment usage. To ensure de‐isolation, moderate and severe COVID‐19 patients transferring to rehabilitation must have negative swabs on 2 consecutive days, be symptom‐free for 2–3 days and be at least 10 days from symptom onset. In NSW, these criteria are currently being put in place and such a protocol will require discussion, review of the evidence, and leadership to execute. Once we have a de‐isolation protocol, we can confidently activate a staged escalation plan. While our ICUs are coping with current numbers, our subacute sector has been managing with innovative models of care, such as mobile rehabilitation teams.14 The NSW Rehabilitation Community of Practice's COVID‐19 response principles11 refer to mobile rehabilitation teams, variously called ART (acute care rehabilitation team) or SMART (specialist management with acute rehabilitation treatment) teams. They provide rehabilitation and discharge planning services to patients in the acute hospitals. It is a parallel care model in partnership with acute care that has been successful in decreasing length of stay and facilitating early discharge or transfer to inpatient rehabilitation facilities. These teams have discharged almost 50% of their patients directly home, avoiding inpatient rehabilitation admissions, and have been active in many NSW hospitals since 2009. Once home, tele‐rehabilitation physician consultations, supported by community‐based allied health practitioners, can be delivered, although additional resources are still being sought. Similar models exist or are under development in other jurisdictions as well. In the event that our acute hospitals start to face challenges in accommodating those needing COVID‐19 or ICU beds, the subacute sector will need to escalate to the next stage to create access. Options include decanting non‐COVID‐19 patients to the private sector, increasing resources to acute or mobile rehabilitation teams, scaled up tele‐rehabilitation services, and preparation for public hospital rehabilitation inpatient units to manage COVID‐19 patients. However, in order to decant to the private sector we need completed agreements with private hospitals, as flagged on 31 March by the Minister of Health.15 Many private hospitals have facilities that are well suited for rehabilitation patients. This would require delineating private hospitals as COVID‐19‐free facilities and would be dependent on appropriate triage and testing facilities. Managing the logistics will be a challenge in the subacute sector, particularly if planning is left as an afterthought. The efficient flow of disabled COVID‐19 patients from acute to rehabilitation care will likely produce better patient outcomes and improve safety. Egress from acute hospitals means access to intensive care and ventilation for the community. If Australia and New Zealand's success at flattening the curve continues, our existing subacute sector will manage. If not, mobile rehabilitation teams will need to be expanded, systems for patient flow to the private sector will need to be operational, and enhanced tele‐rehabilitation services will need to be working. This will require the same vision and leadership that made our acute COVID‐19 response world leading, collaborative and publicly supported. In the UK and the US, we see the brutality of this pandemic, with mass burials and the tragic toll on health care workers. Australia and New Zealand have avoided this so far, but it is because we have planned well. We now need to prepare for the recovery phase because surviving may not be the same as living.
Steven G Faux · Kathy Eagar · Ian D Cameron · Christopher J Poulos
The risks of medical complacency towards poliomyelitis
Australia needs to improve vigilance in the global endeavour to eradicate poliomyelitis In 1988, there were over 350 000 cases of paralytic poliomyelitis globally.1 In 2018, there were 29 cases and in 2019 there were 112 cases2 — all in the only two remaining countries in the world where wild poliovirus (WPV) is endemic (Afghanistan and Pakistan). We are tantalisingly close to global eradication. What is poliomyelitis? Poliovirus is an enterovirus and exists as three serotypes: WPV types 1, 2 and 3. Spread via the faecal–oral route, poliomyelitis results in subclinical or self‐limited infection in most patients, but causes acute flaccid paralysis (AFP) due to anterior horn cell damage in about one in 200 cases.3 Ubiquitous distribution of polioviruses and epidemics of paralysis caused widespread panic throughout the world in the early 20th century. With an ambitious and unprecedented level of international public and private collaboration and funding, the Global Polio Eradication Initiative (GPEI) was launched in 1988.2 In recent years, significant achievements have been recorded (Box 1), but the target of global eradication is yet to be reached. The GPEI currently faces two main global issues. Firstly, addressing the eradication of WPV1 in Afghanistan and Pakistan, and secondly, dealing with the growing issue of vaccine‐derived poliovirus (VDPV).1 Vaccine strain virus can slowly accumulate mutations over time, which eventually result in reversion to neurovirulence — these strains are known as VDPV. Although extremely uncommon, this phenomenon becomes increasingly prominent in areas where there are long term low vaccination rates, allowing continued circulation of the attenuated poliovirus contained in the Sabin vaccine. Ironically, the modern prominence of VDPVs is a consequence of the GPEI's successful endeavours to reduce WPV. Poliomyelitis close to home VDPVs are appearing in areas with low immunisation rates in Africa, and recent emergence in closer neighbours puts poliomyelitis back on our doorstep. In 2018, there was an outbreak in Papua New Guinea involving 26 VDPV type 1 AFP cases, including a death.4 In late 2019, the Philippines reported 15 VDPV cases, and Malaysia reported three cases in 2019 and one in 2020.5 These countries had previously been declared poliomyelitis‐free.6 Between 2012–13 and 2017–18, the median number of annual arrivals for Philippine citizens to Australia was 141 813, with 8% of these arrivals being children younger than 15 years.7 Screening individuals at our borders is not an economically viable option to prevent poliomyelitis, thus highlighting the importance of optimal immunisation and high quality surveillance. Australia's commitment to World Health Organization targets Australia and all other Western Pacific region countries were certified as poliomyelitis‐free on 29 October 2000.6 As a signatory to the World Health Organization's International Health Regulations (2005),8 Australia reports annually on its compliance, with obligations to prevent and respond to acute public health risks of international consequence. This includes observing temporary recommendations issued when the WHO declared the risk of international spread of poliovirus a public health emergency of international concern in 2014, poliovirus containment activities, and reporting to the WHO Regional Certification Commission providing evidence that Australia's poliomyelitis‐free status has been maintained. This evidence requires Australia to meet WHO‐specified surveillance standards. The Australian National Enterovirus Reference Laboratory plays an important role in providing enterovirus testing and environmental surveillance for Australia and the Western Pacific region to meet these requirements. Environmental surveillance for polioviruses is costly and labour‐intensive and involves sampling sewage for detection and then characterisation of enteroviruses. There is currently inadequate capacity to routinely conduct environmental surveillance throughout Australia. Therefore, this capacity is currently directed at monitoring during high risk episodes; for example, when there is a cluster of AFP cases or after the importation of a confirmed case. The detection of any poliovirus in Australia is considered a likely importation event, as Australia stopped the use of the oral polio vaccine in 2005. Adequate clinical surveillance is based on two key WHO indicators. Firstly, achieving an AFP detection rate of at least one case per 100 000 children younger than 15 years. Secondly, the WHO requires enterovirus culture on two stool samples collected at least 24 hours apart, both within 14 days of onset of paralysis, for at least 80% of reported AFP cases.9 Submission of two samples ensures adequate sensitivity, required due to intermittent viral shedding.10 Meeting these targets provides national and international reassurance that there is timely investigation that excludes poliomyelitis as the cause of AFP. However, for Australian clinicians, awareness of this surveillance and its purpose is often not well understood. An overview of the AFP surveillance structure is provided in Box 2. Importantly, AFP cases need to be notified and investigated even if another diagnosis (eg, Guillain–Barré syndrome) is likely. Australia's performance in meeting World Health Organization targets While Australia has met the surveillance target for AFP notification for the past 11 years, we consistently fail to reach the WHO benchmark for stool submissions (Box 3).11 This is in marked contrast to many of our closest neighbours. Only New Zealand, the small Pacific Island countries and Papua New Guinea have a similarly low performance over recent years. In 2018, adequate stool collection was achieved in only 44% of Australian AFP cases and 2019 results are currently at 65%.12 The most populous states of New South Wales and Victoria consistently underperform, with rates of 33% and 42% respectively for 2018 (Bruce Thorley, Head of Victorian Infectious Diseases Reference Laboratory, Australia, personal communication, September 2019). In 2018, three cases of AFP and anterior horn cell abnormality on magnetic resonance imaging in young children were reported to WHO by Australia as “poliomyelitis compatible” because of a lack of adequate clinical information and appropriate stool sample collection (David Isaacs, Chair of Polio Expert Panel, Australia, personal communication, September 2019). In addition to providing robust public health surveillance, ensuring adequate investigation of AFP can produce relevant diagnostic information for an individual. A 3‐year‐old child with permanent significant disability following AFP in 2018 had the neuropathic enterovirus D68 (EV‐D68) in faeces sent for AFP surveillance purposes.13,14 The converse may also apply. Detection of a non‐polio enterovirus by polymerase chain reaction (PCR) in a clinical sample does not preclude the possibility of dual infection with poliovirus. Co‐infection and subsequent recombination of species C non‐polio enteroviruses with Sabin‐like poliovirus is an important precursor event in the development of VDPVs.15 Barriers to improvement A number of logistical issues affect successful stool sample collection; for example, late presentation of patients, discharge before sample collection, and constipation may all have an impact on stool collection rates.16 In some instances, pre‐examination by microbiology laboratories using enterovirus reverse transcriptase PCR (RT‐PCR) may occur. This does not exclude poliovirus infection and testing at the WHO reference laboratory is still required. Due to the extended viral shedding in the gastrointestinal tract, stool samples are the specimen type most likely to facilitate enterovirus identification. The collection of rectal or throat swabs is discouraged by WHO due to reduced sensitivity compared with faeces samples. Pragmatism may dictate that the former may be preferable to no testing at all in a particular child if barriers to faeces collection exist. Recognising poliomyelitis in a low prevalence community Cases of poliomyelitis present as acute and often painful weakness in affected limbs. The weakness is often asymmetrical, affecting lower limbs more frequently than upper limbs, with rapid onset and usually no further progression after 48 hours. Sometimes patients may present atypically, reinforcing the need for any AFP to be reported and investigated. Alternative presentations may include dyspnoea or dysphagia due to weakness of bulbar or respiratory muscles. Cerebrospinal fluid findings are suggestive of viral meningitis. There are usually no systemic symptoms, although a recent history of a mild upper respiratory tract infection with or without headache may be elicited.3 A history of exposure to a high risk area (eg, Central Africa, Pakistan, Papua New Guinea or Afghanistan) and/or lack of previous immunisation is important. A history of distant past immunisation will not exclude the diagnosis, particularly if this was received overseas.10 Call to action There appears to be a level of complacency among physicians due to the rarity of clinical poliomyelitis in Australia. In addition, there is a lack of awareness in the diagnostic chain regarding the importance of laboratory surveillance. In 2020, a comprehensive action plan was implemented by the Paediatric Active Enhanced Disease Surveillance (PAEDS) network to improve faeces collections across the country. Clinicians should not fear that they are being alarmist in notifying AFP cases that they believe have negligible risk of poliomyelitis. The emphasis on detection and investigation of AFP cases despite an alternative diagnosis may seem pointless for an individual case, but at a national level, it allows confidence in the integrity of surveillance and, ultimately, achievement of poliomyelitis eradication. Conclusion The recent VDPV outbreaks in Papua New Guinea and the Philippines and the ongoing WPV1 circulation in Pakistan and Afghanistan emphasise the possibility of poliomyelitis re‐introduction into Australia. Clinical acumen is unlikely to provide a timely diagnosis. Clinicians are reminded that poliomyelitis as a diagnosis should be excluded in all cases of AFP; faeces collection from all AFP cases independent of age should be viewed as a priority to ensure the country remains poliomyelitis‐free and as an opportunity to maintain surveillance, even when another diagnosis is confirmed or highly likely. Box 1 – Selected achievements relevant for Australia in the history of the Global Polio Eradication Initiative2 Year Milestone 2000 Australia declared poliomyelitis‐free 2005 Inactivated polio vaccine replaces oral polio vaccine in Australia 2014 South‐East Asia declared poliomyelitis‐free 2015 Wild poliovirus type 2 declared eradicated 2017 99% of poliomyelitis eradicated globally 2019 Wild poliovirus type 3 declared eradicated Box 2 – Schematic overview of acute flaccid paralysis surveillance structure in Australia APSU = Australian Paediatric Surveillance Unit (www.apsu.org.au); PEP = Polio Expert Panel; PAEDS = Paediatric Active Enhanced Disease Surveillance Network (www.paeds.org.au); VIDRL = Victorian Infectious Disease Reference Laboratory (https://www/vidrl.org.au/surveillance/afp-surveillance1); WHO = World Health Organization. Box 3 – Percentage of acute flaccid paralysis notification with adequate stool sample collection, Australia, 1995–2018* WHO = World Health Organization. * Data reproduced, with permission, from Roberts et al.11
Meryta May · David Durrheim · Jason A Roberts · Rhonda Owen
Australia's national COVID‐19 primary care response
A rigorous and well supported primary care response to COVID‐19 is essential to protect the most vulnerable people in Australia In late December 2019, a pneumonia caused by a novel coronavirus (severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2]) was reported to the World Health Organization following identification in Wuhan, China. The outbreak was declared a public health emergency of international concern on 30 January 2020 and a pandemic on 11 March 2020. The respiratory disease complex was officially renamed coronavirus disease 2019 (COVID‐19) on 11 February 2020. On 27 February 2020, the Prime Minister of Australia announced the activation of the Australian Health Sector Emergency Response Plan for Novel Coronavirus (COVID‐19).1 Australia has a strong system of primary care provided by doctors, nurses and other health care workers, including allied health professionals, midwives, community pharmacists, dentists, and Aboriginal health workers. Comprehensive primary care services are available to all members of the community through general practice and Aboriginal community‐controlled health services, provided by general practitioners, primary care nurses, allied health and other health care professionals working at the forefront of the health system. Many of the nation's most vulnerable people also access services through aged care, home care and disability care services. Australia's primary care response to COVID‐19 acknowledges the need to protect vulnerable populations,2 to continue the provision of regular primary care services to the whole community for acute and chronic conditions, preventive care and mental health concerns,3 and the need to support and protect health care workers in community settings4,5 as well as in the nation's hospitals.6 In early March 2020, a targeted action plan was initiated by the Australian Government Department of Health to develop and refine the national COVID‐19 primary care response (Box 1). This action plan acknowledged the essential, first‐contact role of general practice in the nation's pandemic response,7 and was informed by lessons from previous epidemics and pandemics where primary care had limited involvement in both planning and response8,9 and by focused consultation with primary care stakeholder organisations. Consultation included a Primary Care COVID‐19 Preparedness Forum, led by Australia's Chief Medical Officer and held on 6 March 2020 with representatives from general practice and other medical specialties, nursing, allied health, pathology, pharmacy, practice management, rural workforce, Aboriginal and Torres Strait Islander health, the disability sector, Primary Health Networks, and federal, state and territory governments. The Australian Government also established the National Aboriginal and Torres Strait Islander Advisory Group on COVID‐19, co‐chaired by the Department of Health and the National Aboriginal Community Controlled Health Organisation (NACCHO). Issues considered in the framing of the primary care response included measures required to protect both the public and the primary care workforce from infection, the management of people presenting to general practice with fever and/or respiratory symptoms, the continued health care management of vulnerable people at increased risk of COVID‐19, concerns about seasonal influenza in winter, arrangements for pathology testing in the community, and the impacts on business continuity for community‐based health services. The primary care response was supported by a funding package of $2.4 billion announced by the Australian Government on 11 March 2020, which included $1.1 billion specifically allocated to support the COVID‐19 response in primary care.10 Key components of the primary care response included: funding of a whole of population model of telehealth (using telephone or video consultations); establishment of call centres to triage people with fever or respiratory symptoms, provide advice and direct them to the most appropriate health services; establishment of a nationwide network of respiratory clinics based in the community to complement state‐ and territory‐run fever clinics; development and delivery of online infection prevention and control training for all care workers; measures to safeguard the health of the members of remote Aboriginal and Torres Strait Islander communities across the continent; and ensuring consistent messaging to members of the nation's primary care workforce. Telehealth New funding provided through Australia's Medicare Benefits Schedule (MBS) enabled a shift to the use of telehealth modalities for all appropriate consultations between patients and their health care providers. Telehealth initiatives were rolled out in a rapid, staged approach: beginning with support for the use of telehealth for members of the nation's most vulnerable populations; followed by items specific to obstetrics and midwifery, nurse practitioner care, and mental health care provision; then measures to enable vulnerable health care providers to continue providing care through telehealth; and then moving to whole of population telehealth consultations for all patients by all health care providers funded under the MBS (Box 2). On 30 March 2020, bulk‐billing incentives for people with concession cards and children aged under 16 years being seen in general practice were doubled to ensure there were no barriers for the population needing to access health care services and advice, and additional payments were introduced to support the ongoing viability of the nation's general practices.11 At the time of writing (2 June 2020), over 11 million telehealth services had been delivered to the people of Australia. National call centre People with fever or respiratory symptoms, or with concerns about possible exposure to COVID‐19, were encouraged to call Healthdirect — the Australian Government‐funded national call centre that provides free health information and advice. Healthdirect activity peaked at around 37 000 calls from members of the public per week in mid‐March 2020. The Healthdirect website also provided an online COVID‐19 symptom checker, which can be downloaded as an application for mobile phones and other devices (www.healthdirect.gov.au). Since 25 March 2020, up to 370 000 people per day have used the symptom checker. General practice‐led respiratory clinics Evidence from prior epidemics has demonstrated that neglect of usual care can be an unintended consequence of prioritising the emergency response, resulting in increased morbidity and mortality related to other causes.3,12 The establishment of a network of more than 120 general practice‐led respiratory clinics has redirected people with fever and/or respiratory presentations away from general practices and emergency departments. Primary Health Networks have had a crucial role in supporting general practices and Aboriginal community‐controlled health services, working with their local hospital networks to identify and help establish respiratory clinics. In addition to protecting other patients and health care staff from potential infection, the respiratory clinics allowed other general practices across the country to continue providing regular essential primary care services to their patients. Online infection prevention and control training A series of online education modules was created to provide consistent, evidence‐based information to health care workers and others working in community settings with vulnerable people. This series included eight modules targeting residential aged care workers and a 30‐minute online course, targeting all care workers, including those working in hospitals, primary care, aged care and disability care.13 It provided education on aspects of infection prevention and control for COVID‐19 and has been completed by over 800 000 health care workers at the time of writing. Protection of remote Aboriginal and Torres Strait Islander communities The primary care response recognised that Aboriginal and Torres Strait Islander people, as well as other people living in remote communities, are at increased risk of COVID‐19, due to pre‐existing health issues, difficulties with service access and high population mobility. Building on the strength of Aboriginal and Torres Strait Islander leadership and on measures initiated by many communities themselves, on 26 March 2020, the Australian Government enacted biosecurity restrictions on entry and travel to remote communities. Grants were provided to support remote communities in self‐determining appropriate planning and preparedness activities, adapting national plans and protocols for local use to enable early retrieval and evacuation of suspected cases, and establishing the mechanisms to support responses to any outbreak, including the deployment of appropriate health care workers. Communication with members of the primary care workforce Regular webinars with primary care doctors, nurses, mental health and allied health professionals were initiated, along with regular teleconferences with the representatives of national primary care professional organisations, with the aim of providing consistent and ongoing two‐way communication with the nation's primary care workforce.14 Since 19 March 2020, there have been over 100 000 live views of online webinars and over 130 000 accesses of online newsletters, along with use of the content by medical media outlets and reproduction by national professional organisations in their own newsletters and emails to their membership. The primary care response was supported by a series of government fact sheets and other COVID‐19‐specific resources developed to assist the primary care workforce in knowing how to protect their patients and themselves from COVID‐19. These have been made publicly available at www.health.gov.au. Primary Health Networks supported these initiatives through the provision of updates about the management of people with suspected or diagnosed COVID‐19. Conclusion Lessons from previous epidemics and pandemics have emphasised the critical importance of engaging early and effectively with primary care4 and the need for a single source of trusted information from health authorities for both clinicians and members of the public.5,15 Australia's primary care response has sought to achieve this, through early collaborative planning and ongoing two‐way communication with the nation's primary care workers. The Australian Government's investment in primary care during the COVID‐19 pandemic is an investment in essential elements of the nation's health system, enabling optimal frontline care while mitigating spread and protecting the ongoing health of the nation's most vulnerable citizens. Box 1 – Aligning Australia's coronavirus disease 2019 (COVID‐19) response with existing knowledge The known: Lessons learnt from previous epidemics and pandemics emphasise the frontline role of primary care and the need for strong, consistent communication with the primary care workforce and the wider community The new: Australia's primary care response to COVID‐19 has seen rapid implementation of initiatives to protect the nation's most vulnerable citizens, preserve existing health system function, support and treat people with COVID‐19, and optimise workforce capacity The implications: Australia's investment in the primary care response to COVID‐19 is enabling effective frontline care while mitigating spread, and protecting the ongoing health of the nation's most vulnerable people Box 2 – Staged introduction of Australia's coronavirus disease 2019 (COVID‐19) telehealth response Stage/date Description Stage 1 (13 March 2020) General practitioner consultations using telehealth for patients aged at least 70 years, Indigenous people aged at least 50 years, pregnant women, parents of children under 12 months of age, and those who are immunocompromised or have a chronic medical condition resulting in increased risk from coronavirus infection Stage 2 (16 March 2020) Supporting telehealth consultations by obstetricians, midwives, nurse practitioners, and some mental health providers Stage 3 (23 March 2020) Enabling vulnerable GPs and other medical specialists (in the same categories as in Stage 1) and providers authorised to use telehealth item numbers to provide care for their patients using telehealth Stage 4 (30 March 2020) Extending existing telehealth items to all Australians. This included a substantial investment in mental health support, with specific commitments to children and young people, older Australians, and health care workers Stage 5 (6–20 April 2020) Supporting expanded telehealth for many specialist medical services and allied health services, including consultant physicians, psychiatrists, geriatricians, public health physicians, neurosurgery, chronic disease management by nurses and Indigenous health workers, and group psychotherapy
Jane Desborough · Sally Hall Dykgraaf · Lucas Toca · Stephanie Davis · Leslee Roberts · Catherine Kelaher · Michael Kidd
Location and primary health care reform
A fresh examination of potentially preventable hospitalisation rates gives new insights and strategic direction Australia lies at a critical juncture for health reform. In August 2019, the Minister for Health, the Honourable Greg Hunt MP, released Australia's Long Term National Health Plan,1 a 24‐page document anticipating the imminent initiation of a 10‐year Primary Health Care Plan. In October 2019, the Minister announced experts to provide independent advice for this purpose.2 With their counsel, this 10‐year Primary Health Care Plan will set a path to guide future primary health care reform. This undertaking behoves laser‐like focus on population‐based system‐level indicators. Potentially preventable hospitalisations (PPHs) comprise a nationally agreed set of 22 specific conditions selected through precise rationale.3 Hospitalisation for any one of those diagnoses is potentially prevented through effective community‐based primary health care.3 Total PPHs reflect a holistic system‐level indicator calculated by combining hospital admissions for all 22 agreed conditions from routinely collected data. As national coding requirements ensure consistency across jurisdictions, age‐standardised PPH rates per 100 000 people permit comparisons over time and place. While it is tempting to focus on one or several individual conditions, it is the total age‐standardised PPH rate that best reflects the integrated functioning of primary health care in that location.4 We accessed 2017–2018 age‐standardised total PPH rates for all 331 Statistical Areas Level 3 (SA3).5 As geographical footprints, SA3s provide a regional breakdown of Australia. Each SA3 has a population between 30 000 and 130 000 people and often closely aligns with the local government area.6 Total PPH rates are inequitably distributed in Australia, with the highest rates clearly visible in SA3s in remote and very remote regions (Box 1). We note the national median PPH rate is 2742 per 100 000, but PPH rates by SA3 are highly skewed (Box 2). The ten SA3s demonstrating the worst PPH rates each feature rates more than double the national median. Indeed, the highest PPH rate (26 661 per 100 000 population in Barkly, Northern Territory) is more than 16 times the lowest (1662 per 100 000 population in Stonnington East, Victoria). We then ranked PPH rates by deciles, noting the first decile comprises the 10% of SA3s across Australia with the best (lowest) PPH rates, while the tenth decile comprises the 10% with the worst (highest) rates. This distribution is also inequitable, exhibiting marked variation between states and territories (Box 3). Median PPH values for Queensland and the NT fall in the eighth and tenth worst deciles respectively (Box 3). Given that 75% of the SA3s in the Australian Capital Territory rank in the best two deciles for SA3s nationally, bureaucrats residing in the nation's capital may have limited awareness of the daily reality of system‐level health inequity elsewhere. Unabated continuation of inequities in the performance of primary health care compromises the health and wellbeing of Australians living every day in these locations. High total PPH rates also place relentless pressure on hospitals already showing strain. In response, recapitalisation of comprehensive primary health care as the foundation of the Australian health care system requires serious, proportionate and long term resource reallocation within health budgets across Commonwealth, state and territory governments. A fair and functional frontline primary health care system was assumed as a viable platform for the nation's coronavirus disease 2019 (COVID‐19) response.7 PPH rates provide much‐needed insight into geographic health inequity and emphasise the importance of strategic focus. A meaningful national mandate to reduce the size of the gap in age‐standardised total PPH rates between the lowest and highest SA3 deciles should be implemented through the 10‐year Primary Health Care Plan. It is also important to identify mechanisms to shift skew and median values by jurisdiction towards the best attainable rate. In addition, an explicit goal could be set in every SA3 to deliver a specific time‐based trajectory for total PPH rates. These strategic imperatives are the Minister's to set. Health care reform requires political leadership. In the Plan, there should be arrangements for continuous public monitoring of significant quantitative improvement in total PPH rates. At the very least, substantial new funding for local rejuvenation of primary health care in all SA3s in the worst decile should be prioritised. If not, we fail Australians living in these locations yet again. Box 1 – Distribution of potentially preventable hospitalisation (PPH) rates by Statistical Area Level 3 (SA3) in Australia Box 2 – National distribution of age‐standardised potentially preventable hospitalisation (PPH) rates per 100 000 population by Statistical Area Level 3 (SA3) Box 3 – Distribution by decile of age‐standardised total potentially preventable hospitalisation rates at Statistical Area Level 3 (SA3) by state and territory Decile (%) Total SA3s Jurisdiction 1 2 3 4 5 6 7 8 9 10 ACT 3 (38%) 3* (38%) 1 (12%) 1 (12%) 0 0 0 0 0 0 8 (100%) NSW 15 (17%) 15 (17%) 10 (11%) 10* (11%) 6 (7%) 8 (9%) 12 (13%) 5 (5%) 7 (9%) 1 (1%) 89 (100%) WA 4 (12%) 4 (12%) 5 (15%) 6* (18%) 4 (12%) 4 (12%) 2 (5%) 0 2 (5%) 3 (9%) 34 (100%) Tas 3 (20%) 1 (7%) 0 4* (27%) 4 (27%) 1 (7%) 0 2 (5%) 0 0 15 (100%) SA 2 (7%) 3 (11%) 5 (18%) 2 (7%) 7* (25%) 1 (3%) 4 (15%) 1 (3%) 0 3 (11%) 28 (100%) Vic 4 (6%) 6 (9%) 8 (12%) 6 (9%) 8 (12%) 13* (20%) 10 (15%) 7 (11%) 3 (4%) 1 (2%) 66 (100%) Qld 2 (3%) 1 (1%) 3 (4%) 4 (5%) 5 (6%) 6 (7%) 5 (6%) 18* (22%) 20 (24%) 18 (22%) 82 (100%) NT 0 0 1 (11%) 0 0 0 0 0 1 (11%) 7* (78%) 9 (100%) Total number of SA3s in each decile 33 33 33 33 34 33 33 33 33 33 ACT = Australian Capital Territory; NSW = New South Wales; NT = Northern Territory; Qld = Queensland; SA = South Australia; Tas = Tasmania; Vic = Victoria; WA = Western Australia. * Indicates the decile in which the jurisdiction's median potentially preventable hospitalisation rate lies.
Gemma C Ma · Jeanette E Ward
Is Australia over‐reliant on residential aged care to support our older population?
OECD data indicate that Australia is a comparatively high user of residential aged care The Royal Commission into Aged Care Quality and Safety interim report highlighted many concerns about aged care in Australia.1 These include that “the system designed to care for older Australians is woefully inadequate”, and that “aged care services … have simply not been seen as a priority by successive Australian Governments”. To inform the Royal Commission, we undertook a review of international approaches to the provision of aged care.2 As a component of our review, we examined data reported to the Organisation for Economic Co‐operation and Development from 13 countries.3 The list of countries included in the review was developed in consultation with experts and with input from representatives from the Royal Commission. Countries were selected based on the availability of information, applicability to the Australian aged care system, and to ensure a diverse range of countries were represented. Long term care is the provision of services for medical needs, personal care and assistance in living independently for people with long term dependencies due to their health care needs. Long term care can be provided in institutions (eg, nursing homes or residential aged care facilities) or by providing services to assist people to remain living in their own homes, including community services such as respite care. The OECD defines long term care institutions as specifically designed nursing and residential care facilities that provide accommodation and care as a package, with the predominant service being care. Institutional long term care recipients are those receiving formal long term care in institutions other than hospitals. We compared numbers of older long term care recipients in institutional care (12 countries) and estimates of long term care expenditure for older people (12 countries) (Box). Australia provides institutional long term care for almost 20% of the population aged ≥ 80 years, and 6% of those aged ≥ 65 years. This places Australia as the nation with the highest proportion of older people living in institutional care compared with 11 other nations (Box). The relative use of institutional care, as opposed to home or community care, was also highest for Australia, with 52.5% of long term care recipients aged ≥ 65 years and 58.6% of long term care recipients aged ≥ 80 years in institutional care. This is in comparison to a range of 21.6% in Japan to 34.6% in the Netherlands for recipients aged ≥ 65 years, and 23.1% in Japan to 41.8% in Canada for those aged ≥ 80 years (Poland is an exception, with institutional care provided for 94.1% of long term care recipients aged ≥ 65 years, and 100% aged ≥ 80 years, based on 2006 data; however, long term care is highly limited, with only 1.6% of the population aged ≥ 80 years receiving care). Our estimates of gross domestic product (GDP) expenditure on long term care for older people comprise the health component of government/compulsory long term care expenditure (not age‐specific) plus social expenditure on old age benefits in kind, as reported to the OECD. This approach best captures Australia's long term care expenditure on older people. Benefits in kind are services such as the home care packages program. However, this estimate does not capture cash benefits such as the carer allowance in Australia or direct cash payments that are a component of aged care benefits in some other nations (eg, Germany, England, Poland). In the OECD database, these payments cannot be separated from non‐care related cash provisions for older people, such as the age pension. The expenditure estimates indicate that many other nations spend a much greater proportion of their GDP on long term care for older people (Box). Different approaches to funding are used in other countries, including the provision of universal social care insurance, some of which includes compulsory contribution schemes such as in Japan and Germany.5 Limitations in these international comparisons include possible differences between nations in reporting or definitions of institutions, lack of data on the dependency levels of care recipients, and comparisons being limited to OECD nations reporting institutional care use. Nevertheless, the data indicate that in Australia a comparatively high proportion of older people live in institutions, with a relatively low financial investment in the whole aged care sector. While many countries have wait lists for home care services, the wait times of over 12 months for home care packages at the approved level (for level 2 and above; ie, beyond basic care needs, providing low to high level care) may lead to premature admission to institutional care for some people.6,7,8 In November 2019, the Australian government announced funding of an additional 10 000 home care packages at a cost of $496 million.9 However, in September 2019, there were about 63 000 people waiting for an approved home care package, and an additional 49 000 people were offered, while waiting, a package at a level lower than that approved.6 Some countries focus on keeping older people at home, with greater emphasis on preventive and rehabilitation approaches.10,11 In Denmark, for example, legislation obliges local municipalities to assess all older people applying for home care for their suitability for reablement: short term home‐based training programs aiming to increase people's independence.11 To reduce the number and proportion of older Australians living in residential aged care, there needs to be an increase in investment across the sector, particularly in home‐ and community‐based care. Box – Estimates derived from OECD data2 on proportion of older population receiving long term care (LTC) in institutions (A), and LTC estimates for expenditure on older people as a proportion of gross domestic product (GDP) (B) Notes: Data refer to 2015 or nearest year. A: Data not available for UK; it is unclear whether or not older people living in skilled nursing facilities are counted in US data. B: Data not available for New Zealand. Old age benefits in kind were not reported for Canada or Poland; Germany reports zero expenditure as benefits in kind. US expenditure may only include institutional care.4 Data extracted on 6 May 2019 (A) and 15 September 2019 (B) from https://stats.oecd.org/index.aspx?DataSetCode=HEALTH_STAT.3
Suzanne M Dyer · Madeline Valeri · Nimita Arora · Dominic Tilden · Maria Crotty
Challenges of diabetes management during the COVID‐19 pandemic
How to deal with diabetes and COVID‐19 — do we just dial in? The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the subsequent announcement by the World Health Organization of a global pandemic, has altered health care across the public and private sectors. Clearly, coronavirus disease 2019 (COVID‐19) is having a huge impact on general practitioners, emergency physicians, respiratory physicians, intensivists and related staff, and is also impacting the day‐to‐day delivery of chronic health care. Conditions such as type 1 and type 2 diabetes require regular, usually face‐to‐face contact with GPs, endocrinologists, diabetes educators, dieticians and podiatrists to optimise glycaemic control. However, with recommendations regarding social isolation to minimise spread of COVID‐19,1 the delivery of such health care is increasingly being delivered using telehealth. This has been greatly facilitated in Australia with the announcement of temporary Medical Benefits Schedule telehealth (videoconference and telephone) item numbers during the COVID‐19 pandemic.2 The eligibility criteria for bulk‐billing include individuals who are immunosuppressed or with chronic health conditions, which include diabetes mellitus. Significantly, the eligibility criteria also include pregnancy. At a time when individuals are being asked to socially isolate to minimise exposure to SARS‐CoV‐2, many who greatly need ongoing health care are avoiding these appointments out of fear of infection from those also attending the clinic and perhaps from clinicians, who are recognised to be at high risk of infection. It is therefore crucial that telehealth care services are offered (and if not available, fast tracked). This may be via videoconference, or a phone call for those who are less able to use newer technologies or if videoconferencing services are not available. Services traditionally offered in a group setting, such as group education for those with gestational diabetes or type 2 diabetes, may also be delivered via this technology. The use of diabetes management technology can benefit health care and telehealth consultation. Continuous or flash glucose monitoring can be used with both type 1 and 2 diabetes with therapeutic benefit. Many of these devices upload automatically to cloud‐based software. Other devices such as insulin pumps and blood glucose meters can be uploaded by the user before the consultation, which places a greater burden on the individual. Involvement of parents, carers and diabetes educators before the appointment may be of benefit. This may lead to improvements in individual diabetes self‐management. The electronic medical record is vital in updating changes to medications, results and scheduled appointments. Many pathology providers facilitate electronic access to test results, but anecdotally some patients may avoid having pathology tests taken in order to minimise travel and exposure to others. The individuals who are at greatest risk of complications from COVID‐19 are still being determined. It seems clear that those with diabetes and other chronic comorbidities are at increased risk of morbidity. A number of small observational studies have analysed comorbidities in individuals with severe SARS‐CoV‐2 infection from China. Rates of diabetes (type unspecified, but most likely to be type 2 diabetes given the low incidence of type 1 diabetes in China3) are reported between 7.4% in confirmed cases infection,4 and up to 17% in cases with severe pneumonia.5 A recent meta‐analysis of six studies (including 1527 people) analysed the prevalence of comorbidities among individuals with severe and non‐severe COVID‐19.6 Diabetes complicated 11.7% of severe cases compared with 4% of cases of non‐severe COVID‐19. This did not reach statistical significance; however, this is clearly limited by a lack of statistical power and further analyses are required. Retrospective analysis of survivors and non‐survivors of the 2002–2003 SARS coronavirus outbreak suggested that diabetes was a predictor for mortality.7 This association seemed to be driven by glycaemic control, with an independent association with elevated fasting plasma glucose. This further highlights the need to maintain ongoing medical care to optimise glucose control throughout the current COVID‐19 pandemic. All people who currently smoke should be advised to cease smoking. In addition, receiving the recently available influenza vaccine, which is usually recommended for people with diabetes, would be advisable, although patients should be aware that this will not protect against COVID‐19. Individuals with both type 1 and type 2 diabetes need to have clear action and sick day plans in the eventuality that they become unwell, and should be encouraged to seek face‐to‐face care for complications such as myocardial infarction or high risk foot ulcer. This should be emphasised even for individuals with long standing diabetes, whose initial diabetes education may have occurred years ago. Individuals with type 1 diabetes should have ketone monitoring strips available (preferably blood continuous subcutaneous insulin infusion ketone test strips), know when to test for ketones, and be aware of the need for additional insulin doses (via injection or continuous subcutaneous insulin infusion) during an intercurrent illness. Excellent sick day management resources are available on the websites of the Australian Diabetes Educators Association (https://www.adea.com.au) and National Diabetes Services Scheme (https://www.ndss.com.au). Individuals using hybrid closed loop insulin pumps should be educated that during illness the wearer may need to exit automatic mode to enable more rapid correction of hyperglycaemia with manual correction boluses of insulin and a temporary increased basal rate.8 The algorithm within the hybrid closed pump may otherwise not adapt quickly enough to manage hyperglycaemia during acute illness. With the increased use of sodium–glucose cotransporter type 2 (SGLT2) inhibitors in Australia and internationally, all individuals treated with SGLT2 inhibitors should be educated on the need to withhold these drugs during illness to minimise the risk of ketoacidosis.9 This should be reiterated to GPs and emergency physicians to screen for SGLT2 inhibitor use in patients presenting with COVID‐19 or any illness. There have been mixed anecdotal reports as to whether non‐steroidal anti‐inflammatory drugs (NSAIDs) may predispose patients to COVID‐19. There has been suggestion that NSAIDs may upregulate angiotensin‐converting enzyme 2 (ACE2),10 and therefore potentially predispose by a similar mechanism suggested for angiotensin receptor blockers (ARBs). Currently there are no guidelines to avoid the use of NSAIDs. In relation to COVID‐19, there is also increasing interest in the use of ACE inhibitors and ARBs in individuals with type 1 or type 2 diabetes and other chronic care conditions, such as diabetes. SARS‐CoV‐2 binds to ACE2, allowing entrance into the host cells.11 ACE inhibitors and ARBs can result in upregulation of ACE2 in some tissues in both human and animal models.10,12,13 However, not all investigators have found a link between these antihypertensives and upregulation of ACE2.14 It has been proposed that ACE inhibitors and ARBs may theoretically increase susceptibility to COVID‐19 by increasing ACE2 levels. However, there is currently no evidence to link the use of these agents to increased risk or severity of COVID‐19. Indeed, other research groups have hypothesised that the use of ARBs may be a potential therapeutic modality.15 Following SARS‐CoV‐2 binding to ACE2, there is downregulation of ACE2 with subsequent increased angiotensin levels and exacerbation of COVID‐19 related lung injury. It has been proposed that the downregulation of ACE2 by ARBs might protect against such injury.15 Other groups have suggested that ARBs may stabilise the binding of ACE2 to the type 1 angiotensin receptor and may therefore reduce available binding sites for SARS‐Cov‐2.16 Currently, there is no evidence to suggest changing antihypertensive therapy, and multiple national and international bodies including the Australian Diabetes Society, Australian and New Zealand Society of Cardiac and Thoracic Surgeons, and the American College of Cardiology and European Society of Hypertension have recommended that ACE inhibitors and ARBs should not be ceased.17 Trials are currently underway to assess the impact of these agents during COVID‐19 infection (https://clinicaltrials.gov). Patients should be encouraged to continue their ACE inhibitor or ARB drugs, and if not prepared to do so, be offered alternative drugs for blood pressure control. This is a time of great concern to all individuals, and perhaps more so to those who have been informed they are at greater risk of COVID‐19 and its complications. This may necessitate a greater state of preparedness. The current advice is that there will be no shortage of insulin supplies or consumables needed for insulin pump therapy or blood glucose monitoring equipment, yet anecdotally, local pharmacy shortages of insulins, ketone strips and oral hypoglycaemic drugs have been reported and are being addressed by government prescription limits. Should patients be unable to obtain their usual prescriptions, suitable alternatives can be recommended to them by their diabetes care clinicians. It is critical that individuals with diabetes and other chronic conditions do not hoard these medical supplies and inadvertently create a critical supply shortage. Continuation of health care to at‐risk individuals is crucial throughout the pandemic. Telehealth is the key for the delivery of such care. It is important that people with diabetes are educated regarding the management of their condition during acute illness, including medication changes. It is also critical that there is no deterioration in the medical management of glycaemia and other complications of diabetes, which, if neglected, may result in increased morbidity and mortality independent of COVID‐19.
Emma S Scott · Alicia J Jenkins · Gregory R Fulcher
COVID‐19 acute respiratory distress syndrome (ARDS): clinical features and differences from typical pre‐COVID‐19 ARDS
COVID‐19 ARDS is a predictable serious complication of COVID‐19 that requires early recognition and comprehensive management “This disease is still too strange to us, and there are too many doubts”, says Dr Ling Qin (LQ), after reviewing more than 400 patients with coronavirus disease 2019 (COVID‐19) pneumonia in Wuhan Union Hospital, China. COVID‐19 is a novel disease. We are familiar with acute respiratory distress syndrome (ARDS); however, when it occurs as part of COVID‐19, it has different features and there remain unanswered questions. So if someone has COVID‐19 ARDS, how does it compare and contrast with ARDS from other causes? To answer this question we provide a summary of the published literature (based on a PubMed search using the terms “COVID‐19” and “ARDS”, 17 April 2020) and current clinical experience from managing patients with COVID‐19 ARDS in Singapore (SHP) and Wuhan (LQ). Severe COVID‐19 represents viral pneumonia from severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection leading to ARDS. Its manifestations can be viewed as a combination of the two processes, namely viral pneumonia and ARDS. COVID‐19 is a novel disease recognised initially in Wuhan, China, in December 2019, and is now pandemic. It is likely caused by zoonotic spillover of a β‐coronavirus type 2b that is now transmitted between humans. Along with the other serious coronavirus infections of severe acute respiratory syndrome and Middle East respiratory syndrome, which also cause ARDS, COVID‐19 represents an ongoing global threat as this virus family has the potential to mutate and infect non‐immune populations. Australia's living guidelines provide the latest recommendations and evidence.1 Diagnosis SARS‐CoV‐2 infection can be confirmed by positive detection of viral RNA in nasopharyngeal secretions using a specific PCR test. COVID‐19 illness can be confirmed by a consistent clinical history, epidemiological contact, and a positive SARS‐CoV‐2 test. COVID‐19 ARDS is diagnosed when someone with confirmed COVID‐19 infection meets the Berlin 2012 ARDS diagnostic criteria2 of (i) acute hypoxaemic respiratory failure; (ii) presentation within 1 week of worsening respiratory symptoms; (iii) bilateral airspace disease on chest x‐ray, computed tomography (CT) or ultrasound that is not fully explained by effusions, lobar or lung collapse, or nodules; and (iv) cardiac failure is not the primary cause of acute hypoxaemic respiratory failure. ARDS is underdiagnosed in intensive care settings.3 ARDS develops in 42% of patients presenting with COVID‐19 pneumonia, and 61–81% of those requiring intensive care.4 COVID‐19 ARDS follows a predictable time course over days, with median time to intubation of 8.5 days after symptom onset in Singaporean patients.5 This is similar to previous reports where ARDS developed at day 8 or 9 after symptom onset. It is therefore important to monitor patients for the development of ARDS as their COVID‐19 infection progresses. Respiratory rate and SpO2 are two important parameters for judging patients’ clinical condition and allowing early recognition of ARDS. A patient who fits any one of the following conditions may have severe disease and require further evaluation: respiratory rate ≥ 30 breaths/min; SpO2 ≤ 92%; and PaO2/FiO2 ≤ 300 mmHg. Blood tests can also be helpful. In Singapore, it was noted that raised C‐reactive protein levels and blood neutrophil counts along with lymphopenia were more common in patients requiring invasive mechanical ventilation for COVID‐19 ARDS.5 Lung pathology ARDS causes diffuse alveolar damage in the lung. There is hyaline membrane formation in the alveoli in the acute stage, and this is followed by interstitial widening and by oedema and then fibroblast proliferation in the organising stage. COVID‐19 ARDS causes the typical ARDS pathological changes of diffuse alveolar damage in the lung.6,7 As patients move through the course of their illness, the longer term outcomes of ARDS are being reported, with lung fibrosis appearing as part of COVID‐19 ARDS.8,9 A study reported that 17% of patients had fibrous stripes in chest CT scans,9 and considered that the fibrous lesions may form during the healing of pulmonary chronic inflammation or proliferative diseases, with gradual replacement of cellular components by scar tissues. Thrombosis Pulmonary thrombosis is common in sepsis‐induced ARDS. Coagulation dysfunction appears to be common in COVID‐19, and is detected by elevated D‐dimer levels. In fatal cases there is diffuse microvascular thrombosis, suggesting a thrombotic microangiopathy, and most deaths from COVID‐19 ARDS have evidence of thrombotic disseminated intravascular coagulation.10 This may explain some of the atypical or unexpected manifestations seen in the lung, such as dilated pulmonary vessels on chest CT, and episodes of pleuritic pain. Vascular enlargement is rarely reported in typical ARDS, yet was seen in most cases of COVID‐19 ARDS.9 Mortality COVID‐19 ARDS appears to have worse outcomes than ARDS from other causes. The intensive care unit and hospital mortality from typical ARDS are 35.3% (95% CI, 33.3–37.2%) and 40.0% (95% CI, 38.1–42.1%), respectively.3 For COVID‐19 ARDS, mortality ranged between 26% and 61.5% if ever admitted into a critical care setting, and in patients who received mechanical ventilation, the mortality can range between 65.7% to 94%.4 Risk factors for poor outcomes include older age; presence of comorbidities such as hypertension, cardiovascular disease and diabetes mellitus; lower lymphocyte counts; kidney injury; and raised D‐dimer levels. Death from COVID‐19 ARDS is due to respiratory failure (53%), respiratory failure combined with cardiac failure (33%), myocardial damage and circulatory failure (7%), or death from an unknown cause.4 Radiology The radiology of ARDS is distinctive, yet COVID‐19 pneumonia appears to have unique features. This likely results from the co‐occurrence of viral pneumonia and ARDS, and allows radiologists to be fairly specific in diagnosing COVID‐19 pneumonia. The most discriminating features for COVID‐19 pneumonia in China compared with viral pneumonia in the United States included a peripheral distribution of opacification (80% v 57%; P < 0.001), frosted glass opacities (91% v 68%; P < 0.001), and vascular thickening or enlargement (58% v 22%; P < 0.001).11 These imaging features appear to be typical for COVID‐19 pneumonia and can be helpful in early screening of highly suspected cases and in evaluation of the severity and extent of disease. As COVID‐19 lung disease progresses, the lesions are more likely to be bilateral, lower lung predominant and multifocal. They often have the appearance of rounded opacities, termed “COVID balls”. With the development of ARDS, the extent of lung involvement increases, and there is a consolidative component.12 The opacities resolve with recovery from COVID‐19;13 however, with ARDS, the lesions increase in their extent and density, and evolve to fibrotic bands. Ventilation The strategy of breathing support is very important in treating COVID‐19 ARDS, as is the case with typical ARDS caused by other pathogens.14 The key elements are: use oxygen by nasal cannulae to achieve SpO2 > 92%; use of high flow nasal oxygen is controversial and highly dependent on the treatment location; avoid non‐invasive ventilation; prone ventilation appears to be beneficial; and consider extracorporeal membrane oxygenation for rescue. Because of concerns about viral transmission to other patients and health care workers,15 the use of high flow nasal oxygen and non‐invasive ventilation (such as bi‐level positive pressure ventilation) for COVID‐19 ARDS is highly dependent on the health care setting. Australian COVID‐19 guidelines1 strongly recommend against the use of high flow nasal oxygen in emergency departments, but provide a strong recommendation for its use in negative pressure single rooms. Non‐invasive ventilation may be used in negative pressure rooms with appropriate viral transmission precautions.1 Clinical experience has found inconsistent benefit from non‐invasive ventilation and there is concern about aerosol generation and increased risk of viral transmission. Prone ventilation appears to be beneficial for COVID‐19 ARDS.1 Placing a person in prone position promotes more homogenous aeration of the lung in ARDS and can improve oxygenation. While prone ventilation is used in only about 16% of patients with typical ARDS,3,16 in COVID‐19 it is being used successfully earlier in the course of ARDS, and suggested use is for > 12 hours per day.16 Venovenous extracorporeal membrane oxygenation can be used as rescue for mechanically ventilated adults with COVID‐19 and hypoxaemia that persists despite optimised ventilation, use of rescue therapies and prone ventilation. Among critically ill patients treated in Wuhan, prone ventilation and extracorporeal membrane oxygenation treatment were not found to be as effective as for ARDS caused by other pathogens. Possible reasons include: COVID‐19 pneumonia was still progressing and was not under control; lung lesions were not completely gravity‐dependent under ultrasound, so the effect of the prone position was limited; the patient's immune status was not restored, and a secondary hospital‐acquired infection worsened the condition; and when case numbers are high from the epidemic, the management mode and human resource arrangement of the isolation wards still need to be discussed and strengthened. Anecdotal observations in Singapore (SHP) and investigations in the Netherlands17 suggested that patients ventilated for COVID‐19 ARDS tended to have plateau pressures < 30 cmH20 and driving pressures < 15 cmH20 despite high oxygen requirements. The lung protective ventilation strategy used in typical ARDS involves a low tidal volume (6 mL/kg) and higher positive end expiratory pressure targets. For COVID‐19 ARDS, a change to more generous tidal volume targets allowing up to 8 mL/kg and lower positive end expiratory pressure levels is suggested to prevent patient self‐inflicted lung injury. Adjunct treatment In typical ARDS, continuous neuromuscular blocking agents, high dose corticosteroids and recruitment manoeuvers were the most frequently used adjunctive therapies. In COVID‐19 ARDS, the evidence for systemic steroids is still scarce and they are only recommended in patients with concomitant shock which has been unresponsive to vasopressors. There are concerns that steroids may increase viral shedding and possibly lead to a higher mortality rate. Antiviral therapy Many patients with COVID‐19 receive antiviral or immunosuppressive therapy. In Australia, the National COVID‐19 Clinical Evidence Taskforce1 recommends administering antiviral medications or other disease‐modifying treatments in the context of clinical trials. Singapore was using empiric lopinavir–ritonavir plus subcutaneous interferon‐β 1b initially, but is now randomising patients to receive remdesivir. In Wuhan, a broad range of antiviral and immune therapies are being used. All patients also received treatment with Chinese medicine. COVID‐19 ARDS is a predictable serious complication of COVID‐19 that requires early recognition and comprehensive management. Research programs such as the Medical Research Future Fund 2020 Respiratory Medicine Clinical Trials Research on COVID‐19 grant opportunity are required to answer the important questions that remain about therapies for COVID‐19 ARDS.
Peter G Gibson · Ling Qin · Ser Hon Puah
Reconsidering the immediate release of prisoners during COVID‐19 community restrictions
The current reduced capacity of post‐release services may compound offender vulnerabilities, increasing their risk of harm to themselves and others The coronavirus disease 2019 (COVID‐19) pandemic has affected many countries internationally and has been implicated in more than 445 000 deaths worldwide.1 The speed at which this infectious disease is transmitted has led to calls to immediately release prisoners from custody in some countries, including Australia, and has already led to the release of some prisoners in others. The reasons for these calls to action are intuitively rational. Custodial environments are susceptible to a COVID‐19 outbreak given the confined conditions and potential for overcrowding.2 Moreover, prison populations are often vulnerable, having poorer physical and mental health and other social challenges (eg, substance misuse, homelessness) compared with the general population.3 At the time of writing, Australian governments have yet to immediately release select prisoners into the community as part of efforts to mitigate the spread of COVID‐19, despite recent advocacy to do so. Experts across a number of sectors have recommended the early release of prisoners from vulnerable groups if possible, including Indigenous Australians, women, children, older prisoners, victims of domestic violence, and those with chronic health issues.4 However, the proposed early release strategy requires a nuanced assessment of its potential societal consequences and, most importantly, its immediate impact on the health and wellbeing of candidate prisoners for release. Victoria and New South Wales — Australia's most populous states — provide a useful case in point. Stage 3 restrictions — home confinement except for restricted essential activities5 — have been in effect for approximately 2 months. Some restrictions were eased in late May, although limits on public and private gatherings remain in place. Prisons in both Victoria and NSW have yet to record a single case of COVID‐19 within the inmate population. In Victoria, a number of safety mechanisms have been introduced by correctional centres to help manage the potential transmission of the virus.6 These include: temperature testing of all staff before entry to the facility; sending staff home who present with high temperatures and other flu‐like symptoms, and requiring them to undertake a COVID‐19 test before returning; isolating all new prison admissions for up to 14 days; isolating prisoners who display cold or flu‐like symptoms; adjusting programs to abide by physical distancing; and enabling prisoners to connect with family members via video calls on tablet devices (“video visits”) as an alternative to in‐prison visitation. Moreover, conventional medical, psychological and cultural support services continue to be available to prisoners. Similar precautions have been implemented in NSW correctional centres,7 which hold the largest proportion of prisoners in Australia. With no confirmed cases in both Victorian and NSW correctional centres and ongoing efforts to restrict the materialisation of COVID‐19 in custodial settings, the potential costs of releasing vulnerable prisoners into the community necessitates scrutiny. Any prisoners released under anti‐COVID‐19 preventive measures will return to a general community enduring social restrictions and society‐wide economic contraction. The post‐release community support services ordinarily available to released offenders are currently compromised or are experiencing significant delays.8,9,10,11 Moreover, government social security services (ie, Centrelink), which are heavily relied upon by individuals after release, are currently overwhelmed as they service thousands of newly unemployed clients.12 Mental health and crisis support services are also strained as they adjust to remote service delivery and contend with an elevated spike in community‐wide help seeking.13 The reduced capacity for intensive case management, monitoring and re‐entry assistance for released prisoners is a serious concern given their higher levels of complex mental and physical health needs, as well as histories of unemployment, addiction, social disadvantage and homelessness.3 Australian research points to high rates of mortality and self‐harm shortly after release from custody.14 Key predictors of post‐release mortality include mental disorder, suicide and substance misuse — concerns that transitional support programs and other post‐release interventions will be unable to optimally manage during the national lockdown. This scenario poses an increased health risk for released prisoners, compounding their vulnerability and increasing the likelihood of problem behaviour and recidivism. Without readily available coping strategies and assistance with pro‐social functioning, released prisoners with histories of violence, aggression, impulsivity and serious mental illness may put themselves and others (particularly cohabitants) at risk. Calls to release prisoners who are survivors of domestic violence must also consider the heightened risk of revictimisation after release. The social isolation, economic stress and reduced options for support during stage 3 restrictions may exacerbate unhealthy relationship dynamics, especially among those with complex needs. Moreover, physical distancing may not be adhered to by those whose behavioural and psychological needs are untreated. Proposals to immediately release vulnerable prisoners to avert the ostensible threat of COVID‐19 in Australian custodial environments warrant consideration. The potential for a COVID‐19 outbreak in custody is a genuine concern, notwithstanding proactive measures employed in Victorian and NSW correctional centres. However, this advocacy must consider the broader social context. A focus on early release cannot be uncoupled from the current compromised community environment prisoners will face after detainment. Community support services are increasingly strained at a time when released prisoners will have a greater need for them. As such, it is important to balance the relative health and safety trade‐offs of remaining in custody — in Victorian and NSW prisons, there are no confirmed cases of COVID‐19 and health supports remain available — with early release into a resource‐depleted community. The real prospect of harmful outcomes for immediately released vulnerable prisoners must be weighed heavily during this challenging period.
Stephane Shepherd · Benjamin L Spivak
Opening the lines of communication: towards shared decision making and improved end‐of‐life care in the Top End
Meeting the need for culturally appropriate discussions regarding patient values and preferences at end of life Advance care directives are pre‐emptive discussions that anticipate a future loss of ability to make or communicate decisions. There is no uniformity in advance care directives in Australia, with each state or territory having differing terminologies and requirements.1 The Northern Territory has the lowest population density but the highest proportion of Aboriginal people of any Australian jurisdiction.2 In the NT, an individual can make a common law or statutory advance care directive,3 referred to as an advance personal plan (APP).4 The NT APP enables documentation of legally binding directives in reference to resuscitation and life support, as well as the appointment of substitute decision maker(s).5 We have previously documented the utility of the NT APP for Aboriginal people but highlighted the need for a more culturally appropriate document.6 For patients with life‐limiting diagnoses reviewed at Top End Health Service (TEHS) hospitals, the APP could previously be used in conjunction with a not‐for‐resuscitation form. TEHS and community‐based clinicians noted clear patient care imperatives for a move away from decisions targeted solely towards cardiac arrest. Expanding capacity based on a more patient‐focused goals of care (GOC) framework also aligned with expanding evidence in the literature in support of such a focus.7 In the NT, there has been growing recognition of the need for improved discussions regarding patient values and preferences regarding end of life, informed specifically by cultural understandings.6,8 An important example of this includes determination of the site of death; for many Aboriginal people from rural and remote regions, the land holds particular spiritual and cultural significance.8 For such patients, the need to “finish up” (a culturally appropriate term for death and dying) “on country” (ancestral lands) may be paramount and may take precedence over life‐prolonging treatments in tertiary centres.8 Exploring cultural requirements The TEHS GOC committee was formed in March 2017. This group had wide stakeholder engagement across three TEHS hospitals and included medical, allied health, administrative, nursing, primary health care and Aboriginal practitioner representation. Through the committee, the NT Department of the Attorney‐General and Justice was enlisted to assist in updating the APP (governed under the Advance Personal Planning Act 2013 (NT)). Officers representing the Attorney‐General worked with the GOC committee to explore the core cultural values to be reflected in an updated APP. A Palliative Care Australia document was used as reference material for these discussions.9 The APP is a territory‐wide document (unlike the GOC) and the Attorney‐General's office additionally undertook consultation in Central Australia. An updated APP was released in June of 2018.4 New questions asked in the section concerning values and preferences (Section B) include: Where would you like to die/finish up? If nearing death, what is unacceptable to you? If nearing death, what are your goals/priorities? After death, what is important to you? People completing the APP are now able to specify cultural rituals such as ceremonial smoking, or to make a request for their body to be returned to their birth country. The capability to provide advance directives concerning cardiopulmonary resuscitation (CPR) if appropriate and other life‐sustaining treatments, as well as to nominate substitute decision makers, was retained. The ability to nominate a substitute decision maker in the event of future impairment of capacity is of utmost importance in the NT, as unlike other Australian jurisdictions, the NT does not recognise default decision makers (next of kin or responsible person in other states and territories).3 An educational video was produced with involvement of rural Aboriginal APP champions to illustrate the method and advantages of completing an APP. The new GOC form (Supporting Information) was progressively released throughout the TEHS in 2018. The trigger for commencing GOC discussions is if the treating clinician feels that their patient may be in their last year of life (the “surprise question”). This includes patients with advanced malignancy, end‐stage organ failure, dementia or other progressive neurodegenerative conditions. It also includes specific reference to GOC in neonatal and paediatric patients. Uptake of the form in this patient population remains small but important. The resuscitation component of the GOC form documents the appropriateness of rapid response/code blue calls as well as ceilings of care (possible options range from full intensive care unit care to supportive and palliative care). This allows staff caring for dying patients outside the hospice setting to obtain immediate clinical support as required, irrespective of whether CPR is to be performed. The GOC form also allows people to document their wish to remain in their regional hospital for end‐of‐life care. The implications of this and inherent ceilings of care require detailed discussion with patients and family. The TEHS GOC form also requires the documentation of barriers to understanding, cultural responsibility and patient wishes. For some Aboriginal people, in certain instances, the patient may not be the key decision maker (despite having decision‐making capacity). The appropriate clinical information — the “right story” — needs to be provided to the appropriate person, usually referred to as the “right person”.6 The GOC form provides structured assistance to the completing clinician, to consider the involvement of Aboriginal liaison officers, interpreters and the culturally defined right people. Finally, it requires the completing clinician to consider whether the patient wishes to finish up on country. The revised NT APP and the GOC form were significant steps towards improved and patient‐focused end‐of‐life care. The working group also recognised that improved documentation required a more comprehensive strategy informed by data collection and research, and enriched by communications training for clinicians in order to be robust and capable of developing over time. Data collection and research In February 2019, Royal Darwin Hospital participated in a Commonwealth‐funded national study, led by Advance Care Planning Australia, which captured the prevalence of advance care directives and other types of advance care planning documentation in Australian health and residential aged care facilities.10 These data were useful to Top End clinicians regarding the impact of the recently introduced GOC framework. Health records of people aged 65 years and older who had been admitted for 48 hours were reviewed for advance care directives and medical orders or clinical care plans. The GOC forms are non‐statutory (not based in legislation) and were classified as medical orders. The prevalence of medical orders in audited health records at Royal Darwin Hospital was 46%. By comparison, the average prevalence of medical orders across all participating hospitals was 49%. The majority of these reflected either some limitation of treatments or were aimed at symptom control. A small number of patients (eight out of 50) had both an APP and a GOC plan. Only one document showed an incongruence between the APP wishes and the GOC wishes. This was related to the documentation of CPR provision in a patient who had stated in their APP that they did not wish to have CPR. Despite being only a single example, this discrepancy is consistent with findings elsewhere indicating that clinicians have a tendency to provide more care or more interventions than patients would choose were their wishes specifically discussed and followed.11 Communications training As part of the strategy to enhance the concept of shared decision making, which underpins patient‐centred care, the TEHS provided the first set of communications training workshops in March 2019. The workshops were iValidate (developed and delivered by Barwon Health) and Paediatric SimCom training (developed by Deakin University). Over 40 clinicians including nurses, doctors, allied health workers, Aboriginal health practitioners from hospital and community as well as primary health care practitioners attended the training. Additional Aboriginal and non‐Aboriginal participants were trained “on the run” as actors and helped to develop scenarios alongside experienced iValidate simulation actors. This enhanced the cultural context and the clinical authenticity of the scenarios used. Further workshops were held in June and a workshop was held in a regional hospital in November 2019. Facilitator training has also commenced in parallel to the communications courses in order to develop a local facilitator faculty enhancing the sustainability of the program. Next steps The development of a GOC framework and a culture of shared decision making is an evolving process. The next step is specific research on the effectiveness of GOC frameworks from the patient's perspective and the development of communications training that is increasingly informed by the concept of shared decision making. Significant areas that remain to be addressed include an improvement of the end‐of‐life experience on wards outside of the hospice, bereavement services within the hospital, mortuary services, and services to those who wish to die in regional hospitals, at home or on country.
Emma Spencer · Eswaran Waran
Reducing stillbirth safely in Australia
Caution is needed so that population‐level reductions in the stillbirth rate are not offset by iatrogenic harm to healthy babies The federal Minister for Health the Honourable Greg Hunt MP recently launched the Safer Baby Bundle — a national stillbirth program that aims to reduce stillbirth in Australia by 20% by 2023.1 The program is one of the responses to recommendations arising from the federal Senate's Select Committee on Stillbirth Research and Education.2 It draws from similar bundles of care in the United Kingdom that have been associated with successful reductions in stillbirth.3,4 Undoubtedly, these whole‐of‐population level programs are important and effective. However, because late pregnancy stillbirth can be prevented simply by delivering all babies early, they have the potential for harm. There are five components of the Safer Baby Bundle: supporting women to stop smoking in pregnancy; improving awareness of a safe maternal sleeping position; improving decision making about timing of birth; improving the detection and management of fetal growth restriction (FGR); and raising awareness and improving care for women with decreased fetal movements (DFM). Of these five components, the latter two have the potential to increase early delivery. FGR is the strongest contributor to the burden of stillbirth. If detected and managed, the risk of stillbirth is 20‐fold lower than if FGR remains undetected.5 Improving the detection of FGR is central to any program aiming to reduce stillbirth. But increasing FGR detection may also cause harm. In a French population, half of the babies suspected of FGR antenatally had normal growth.6 In Victoria, a greater focus on improving the detection of FGR quadrupled the number of babies delivered early for suspected FGR, from 741 in 2000 to 2996 in 2017.5 The number and proportion of these babies with a birthweight in the 10th centile or greater increased from 307 (41%) to 1597 (53%).5 Striving to increase the sensitivity of FGR detection decreased specificity. This is a problem because unwarranted early delivery is harmful to both immediate perinatal5,6 and longer term developmental outcomes.7 Similar risks exist for increasing awareness of DFM. It has long been recognised that there is a relationship between DFM and stillbirth. Women who report DFM have a 2.4‐fold increased risk of stillbirth.8 However, translating this into an effective intervention has been challenging. Thirty years ago, it was shown that the use of formal fetal movement counting charts failed to reduce stillbirth.9 More recently, a large randomised controlled trial — the AFFIRM trial — assessed a care package for women presenting with DFM. In over 400 000 women attending 33 health services in the UK, increasing the awareness of DFM and standardising the care of those women presenting with DFM did not significantly reduce stillbirth.10 Moreover, there was evidence of harm to both mother and baby. Despite clear guidance for clinicians about what investigations to offer women with DFM and under what circumstances delivery was merited,11 there was an increase in the rates of induction of labour and caesarean delivery,10 with an additional 500 babies born between 32 and 34 weeks’ gestation and 5000 more born between 34 and 37 weeks’ gestation. The number of babies requiring admission to a neonatal unit also increased.10 The fact that most women with DFM will go on to give birth to a healthy baby suggests that the care package assessed by AFFIRM needs to be better targeted to women at risk. So what lessons can be drawn from these experiences for the Australian Safer Baby Bundle? Foremost, it is to be aware of the potential harm of any intervention and to look for this harm. This is possible with the use of balance performance measures12 —essentially, measures of unnecessary early delivery such as the proportion of babies delivered for suspected FGR but who were normally grown, or the number of neonatal unit admissions of term babies. Stillbirth programs elsewhere did not embed balance measures as part of their planned evaluation. Benefiting from the lessons learned by others, the Australian Safer Baby Bundle will include these measures to ensure that strategies designed to reduce stillbirth are targeted towards babies who are at most risk.1 The ultimate goal of balance measures is to reduce the unintended harm of our interventions. At present, no strategy has been shown to increase the sensitivity of FGR detection without causing harm. Neither is there a reliable tool to differentiate patterns of fetal movement that correspond to adverse outcome from those that are just a normal event. It is likely that more discriminatory screening tools reside in improved use of ultrasonography and biomarkers that assess fetoplacental function13 or in a better understanding of circadian patterns of fetal movements.14 Until then, caution is needed so that population‐level reductions in the stillbirth rate are not offset by iatrogenic harm to healthy babies. It is crucial that the potential for unintended harm is made explicit and that measures of unnecessary early delivery are used to monitor progress of the Safer Baby Bundle implementation in Australia.
Roshan Selvaratnam · Mary‐Ann Davey · Euan M Wallace
Tracking, tracing, trust: contemplating mitigating the impact of COVID‐19 through technological interventions
A false impression of technological panacea may see much needed interventions overlooked and may introduce unintended consequences and risks In the face of coronavirus disease 2019 (COVID‐19) limiting free movement, experts are scrambling to mitigate the profound impact that the disease is having on our lives. For many countries, this approach involves increased testing, isolation, and education about hygiene practices until a vaccine is found. To varying degrees, without much evidence as to their efficacy, countries are turning to technology to solve some of the current challenges.1 Increasingly, smartphone applications (apps) are being contemplated for tracking proximity of people to determine possible sources of transmission, with elements of technological solutionism. Such technical solutions require trust, and without honest and clear information about the possibilities and limitations of technologies, an app's benefits may be undermined by low adoption, or conversely a false impression of a technological panacea may see much needed interventions overlooked. For example, the Australian Government's target of a 40% uptake of the COVIDSafe app may or may not be effective in helping to control the disease, while 60% uptake is supported by independent modelling from the United Kingdom.2 Furthermore, such summary statistics do not clarify to the public the wide range of other factors and assumptions that must be considered in predicting the app's efficacy. Much is being written about the different technological models and whether they trace, track and comply with privacy and human rights frameworks, including whether this information can, in fact, ever be anonymised.3 Fully effective anonymisation is unlikely when collecting data as granular as regular interaction with others in addition to age, gender and postcode demographics, as has been demonstrated by previous attempts to de‐anonymise data.4 If these data are accidentally or deliberately linked with other datasets, such as births in hospitals or the public Myki public transport dataset,5 anonymity is virtually impossible to guarantee. Successful uptake of new technologies requires trust. When adoption is insufficient, collective benefits are not guaranteed. Civil society in the United Kingdom called for clear and comprehensive primary legislation to regulate data processing in symptom tracking and digital contact tracing applications, including with a strict purpose, access and time limitations.6 Such regulation may improve trust. Technology embeds values Even when people are told of the limitations of technology, they may have magical thinking about its capabilities.7,8 In early May 2020, the Australian Government furthered this magical thinking by direct messaging Australians that downloading the COVIDSafe app would help to keep people safe and ease restrictions, linking the two directly and potentially conflating the capability of COVIDSafe. Contact tracing apps may assist in manual tracing, in turn slowing the virus’ spread, but usage of an app does not render the individual protected from infection nor does it guarantee successful tracking without intensive manual efforts. Yet statements by those in authority have made strained assertions about COVIDSafe, likening the use of the app to the use of sunscreen9 or a digital vaccine: “You could think about contact tracing as a digital vaccine with our contact data being the virtual antibodies”.10 Such statements are incorrect representations of the app's capabilities.11 Even the technical details of the app are not immune from false messaging. For example, the app records all Bluetooth contacts, not just those that last 15 minutes or that are within 1.5 m. The filtering occurs after contacts are uploaded. Furthermore, there are some inaccurate statements on the official COVIDSafe website; for example, the frequently asked questions section states that “all information that is stored on the phone is digitally encrypted;” however, metadata, such as the device make and model for each contact, are stored unencrypted.12 Communication must be fact‐based, transparent and consultative, any short term gains in support from the use of emotive and persuasive messaging may be undone when they are ultimately demonstrated to be false. Centralised versus decentralised data collection The fundamental difference between centralised versus decentralised tracking is in who learns what. In the centralised approach, the central authority learns who an infected person has interacted with, whereas this does not occur in the decentralised system. Decentralised systems are no more challenging to implement but they better protect privacy. In a centralised approach (Box 1), such as TraceTogether (Singapore) or COVIDSafe (Australia): encrypted identifiers are issued by the central authority to each device; devices broadcast the encrypted identifiers via Bluetooth, and nearby devices listen for such broadcasts and record any that they receive; if a person tests positive, they report to the central authority all the identifiers they have received within a predetermined timeframe; and the central authority decrypts the identifiers and maps them to the individuals they were issued to and duly notifies them if they are deemed to be at risk. The above is a very high level description and there are many technical challenges in implementing such a system securely.13 In a decentralised approach (Box 2), as proposed by decentralised privacy‐preserving proximity tracing (DP‐3T), Covid Watch, Apple and Google: devices generate random identifiers that are not linked to an individual; identifiers are broadcast via Bluetooth and recorded by nearby devices; a person who tests positive publishes a list of the identifiers they have broadcast; and all apps on user devices download such lists and check if they received positive identifiers so as to identify likely contacts. While there are variations in the details, in the decentralised approach, the central authority does not map identifiers to individuals. Although the distinction between centralised versus decentralised tracking may seem small, from a privacy perspective, there is a significant difference. In the case of COVIDSafe, the identifiers are generated and provided to the phone individually rather than as a daily batch: the central authority can monitor whether the app is being used in at least 2‐hourly increments, and possibly as frequently as every 9 minutes, due to regular checks for new identifiers. Models reflect differing societal priorities. In Germany, where there are legal protections for both individual and group privacy, the decentralised app has been chosen. In fact, it has been suggested that a decentralised smartphone contact tracing system — as contemplated by DP‐3T, Apple, Google, and governments across Europe — would be likely to comply with human rights and data protection laws. In contrast, a centralised smartphone system would pose a greater risk to fundamental rights and would require significantly greater justification to be lawful.6 Even when consent for central data collection has been sought, it is unclear what users are consenting to in the absence of fully open code that includes server‐side code, a clear regulatory framework, and with omissions, such as the COVIDSafe's Privacy Impact Assessment and Privacy Policy failing to mention the collection of the devices’ make and model.14 In comparison, Singapore's TraceTogether is based on the same codebase and its frequently asked questions section notifies of such data collection.15 Efficacy and risks of using Bluetooth Bluetooth Low Energy (BLE) is designed to be a low power communication technology, it was not designed to facilitate range finding. Accurately measuring the distance between two devices based only on the received signal strength is a challenge, with error margins often in the metres.16 The signal strength is relative not absolute, and thus, the scale of the reported values differ by manufacturer. Furthermore, the signal strength is influenced by many external factors, including the angle at which the device is held, whether it is in a pocket or a bag and any objects around or between it and the other device. Whether BLE can deliver the necessary accuracy remains an open question. While the use of Bluetooth avoids direct location tracking, many other risks remain. There are vast networks of Bluetooth beacons distributed around cities, which facilitate location tracking. Security advice is to disable Bluetooth when not in use. While the public might be expected to compromise for the common good, legislation could also move to limit Bluetooth beacons during the crisis. However, the Privacy Amendment (Public Health Contact Information) Act 202017 passed on 14 May provides no such protections.18 It provides an exemption to those accidentally collecting COVIDSafe data as part of a wider collection of non‐COVIDSafe data. This appears to be aimed at protecting commercial tracking, rather than protecting privacy. Legal and social implications are as important as the technical ones Given the many risks of using technology, the contemplation of any technological solutions to alleviate the impacts of COVID‐19 needs to be not only technical but also legal and social. Making the code open for audit provides some technical guard rails, much as providing open and transparent proof of test results ensures that no risks are overseen. But beyond technical questions there are also legal questions, including with whom the data may be shared. A recently published article refers to the multiple legal regimes potentially applicable to the app in Australia, as experts scramble to review the legal protections for individuals using COVIDSafe.19 Enacting emergency measures in the face of catastrophes is easy. Rolling back changes to technology, habits and even culture is far more difficult. If they are to be used, technological tracking solutions must have sunset clauses to ensure that human rights are protected. But even with sunset clauses, the large quantity of data collected are effectively out in the world, where they can be accessed and misused. Protections and limits for these data and their providers need to be contemplated before use, not only to protect individuals but also for group privacy. Increasingly, there is a risk of data being accessed by overseas agencies, which could have an impact on national security. It is vital that the technical, legal and social challenges are addressed in coordination. Any new legislation must be written within the context of existing technological practices, particularly around Bluetooth tracking. Likewise, where technical compromises are made, they must be justified to the public with clear, concise explanations, in a manner that is transparent and open to scrutiny. While many liberties have been curtailed during COVID‐19, all modifications to existing rights are required, under law, to be legal, necessary and proportionate. These same standards apply to the use of technology. Legal protections need to be in place to ensure that rights are protected, including the right to privacy. Without sound legal protections and safeguards, tracing apps will not only fail but will embed values that may not be those that represent the society we wish to be. Box 1 – The centralised approach of contact tracing wherein the central server learns user contact details Box 2 – The decentralised approach to contact tracing wherein no central authority learns user contact details
Kobi Leins · Christopher Culnane · Benjamin IP Rubinstein
From SARS to COVID‐19: the Singapore journey
All countries must increase medical capabilities and adopt a concerted whole-of-government approach to combat COVID-19
Ray Junhao Lin · Tau Hong Lee · David CB Lye
Australia: an island in a sea of measles
Combatting the resurgence of measles requires vigilant clinicians and sustained, high level vaccination coverage At the beginning of 2020, Samoa was in a state of emergency due to a measles outbreak. It resulted in over 5700 cases and over 80 deaths, the majority being in children under 5 years of age.1 There were concurrent outbreaks regionally, in New Zealand, Tonga, American Samoa and Fiji. Globally, there has been a massive resurgence of measles with over 360 000 cases reported to the World Health Organization between 1 January and 31 July 2019 — almost three times the number reported over the same period for 2018. We have also seen the re‐establishment of endemic measles in some countries, such as the United Kingdom, where it was previously eliminated.2 In 2019, Australia had 285 confirmed measles cases, the highest number reported since 2014, the year that it was verified by the Regional Verification Commission for Measles Elimination in the Western Pacific to have eliminated measles.3 Most infections occurred in, or were secondary to, unimmunised or underimmunised individuals returning from countries where measles is endemic or that have active outbreaks.4 Australian doctors cannot afford to become complacent about measles, particularly while large outbreaks affect popular tourist and business destinations in the region. Why must we care about measles? Measles is the most highly communicable human virus known, and has a basic reproduction number (R0; the average number of secondary cases generated from a single case in a fully susceptible, freely mixing population) between 9 and 18 — double that of smallpox and quadruple that of Ebola virus.5 It can therefore result in devastating and explosive outbreaks where immunity gaps exist. It is transmitted by respiratory droplets, and aerosolised particles can remain airborne for up to 2 hours, making infection possible well after a patient has left an enclosed space such as a clinic waiting room. Cases are infectious from 24 hours before prodrome onset until 4 days after onset of rash. As the characteristic, maculopapular rash does not appear until 3–7 days into the illness (Box 1), each case may unwittingly expose hundreds of contacts by the time of diagnosis.5,6 Although the majority of patients recover from measles, up to one child in every thousand infected in wealthy countries will die, usually due to pneumonia or encephalitis.5 The immunosuppression caused by the measles infection may last months to years, and rare but devastating neurological complications include acute disseminated encephalomyelitis, measles inclusion body encephalitis and subacute sclerosing panencephalitis.5 The dramatic decrease in subacute sclerosing panencephalitis in Australia since 1990 is a testament to the impact of effective immunisation programs.7 There is no specific antiviral therapy for measles. Management remains supportive, with fluids, vitamin A, and antibiotic therapy if secondary bacterial infections arise.5 The importance of preventing measles through vaccination cannot be overstated. Breakthrough infection While most measles cases still occur in underimmunised individuals, some countries, including Australia, have seen a small but increasing proportion of cases occurring in adults reporting previous measles vaccination.5,8,9,10 At the time of elimination verification in Australia, the estimated efficacy of measles vaccine was 96.7% for one dose and 99.7% for two doses.11 Thus, about one in 300 fully vaccinated people who are exposed to measles are vulnerable to “breakthrough” infection, resulting from either an inadequate response at the time of vaccination or waning of immunity over time.8,9 The latter is particularly seen in post‐elimination settings where regular immune‐boosting from circulating wild strain virus is absent, and there is concern that this may become more common as the time since elimination increases.10,12 Measles should therefore be considered in all patients presenting with fever and rash, particularly if there is a history of travel, exposure to a confirmed case, or when measles is known to be circulating locally, even if the patient has received two doses of measles vaccine. Breakthrough infections often present as modified measles with a mild to moderate rash and less pronounced prodrome.8,9,10 Virus burden and transmissibility appear to be lower in modified cases than in a typical infection; however, onward transmission may still occur, making isolation of cases and public health responses still necessary.8,10 Attenuated symptoms, alongside often undetectable IgM antibody levels, make diagnosis considerably more challenging and definitive laboratory testing using polymerase chain reaction all the more relevant. Advances in laboratory testing Detection of measles IgM antibodies through serological testing is a commonly used diagnostic method but relies on optimally timed specimens. IgM is detectable in 75% of cases 3 days after rash onset, and in almost 100% after one week, but may not be present early in the illness or in the setting of waning immunity.4,8 Specificity varies from 60% to 97% and serology cannot distinguish wild‐type infection from recent vaccination.13 Nucleic acid testing of respiratory and urine specimens using polymerase chain reaction has revolutionised measles diagnosis. Sensitivity and specificity approach 100% from the first day of rash but decrease after 2 weeks, at which point serology remains useful.4,13 Preliminary results may be available within 4 hours of receipt by an accredited laboratory, and can distinguish between wild‐type virus and vaccine strain (genotype A).6 Nucleic acid testing is now the preferred method of diagnosis (often in conjunction with serology), and has the additional advantage that swabs are often easier to collect than blood in young children.4 Virus genotyping enables source and cluster identification, tracking of global transmission and detection of emerging strains, and provides supportive evidence to confirm elimination of endemic measles. For epidemiological purposes, breakthrough infections may be differentiated by avidity analysis of IgG antibodies in serum.8 Avidity is the strength with which antibodies bind to antigens. Low avidity suggests an inadequate immune response at the time of vaccination, while high avidity suggests an initially adequate response to vaccination followed by waning immunity.14 Public health management If measles is suspected, the patient should be isolated at home or under airborne precautions in a health care facility until the diagnosis is excluded by laboratory testing or the case is no longer infectious. A public health unit should be notified on clinical suspicion of measles before laboratory confirmation is received.4 Public health management includes vaccination of susceptible contacts within 72 hours following exposure, and passive immunisation of susceptible high risk contacts (immunocompromised patients, pregnant women and infants under 12 months of age) with intramuscular normal human immunoglobulin within 144 hours of exposure.4 With such a highly transmissible virus, any delay in notification and initiation of public health actions can result in large scale outbreaks. Vaccination importance and update Vaccination remains the key to control and prevention of measles cases and complications. A population immunity of 95% is required to eliminate ongoing measles transmission, and every year a new, susceptible cohort is born, mandating that high quality immunisation efforts be maintained.12,15 While childhood vaccination coverage in 2019 was above 90% for all Australian states and territories, few met the 95% target for measles (Box 2).16 Further, national and state/territory rates can conceal pockets of low vaccination coverage where the introduction of a single case can be the catalyst for an outbreak. As of April 2019, infants travelling to a high risk setting can be given measles vaccine from 6 months of age. They still require the further two doses routinely given at 12 months and 18 months of age as part of the current National Immunisation Program.4 Previously, measles vaccination was not recommended for infants aged under 12 months because of the presence of maternal antibodies, which provide protection in early life and render the vaccine less effective. This immunity now appears to wane earlier in infants born to vaccinated mothers in an elimination setting.5 In Australia, the second dose of measles vaccine was first recommended in 1993, initially for 10–16 year olds, and introduced into the National Immunisation Program for 4–5 year olds in 1998.15 Thus, adults born between 1966 and 1982 may be susceptible, being born after circulating measles began to decline but unlikely to have received two doses of vaccine. Measles vaccine should therefore be offered to anyone aged 12 months or older (or 6 months or older as detailed above), born after 1965, who does not have formal documentation of immunity or receipt of two doses of measles vaccine, particularly before travelling overseas. It is safe to give an additional dose if it is unclear whether two doses have been previously administered. Because it is a live attenuated vaccine, measles vaccine is contraindicated in pregnancy and in immunocompromised patients.4 Although vaccine hesitancy is a concern and receives substantial media attention, access to services and other practical factors remain important barriers to vaccination uptake.17 Conclusion Measles virus is the ultimate opportunist and will capitalise on any gaps in immunity. National programs are important, but measles control cannot be achieved without effective local prevention and control measures, including diligent vaccination and prompt diagnosis by alert clinicians. With outbreaks occurring regionally, concerted effort is required to maintain Australia's elimination of measles and continue progress towards the goal of global measles eradication. Box 1 – Typical measles rash Photograph showing skin rash on a patient's abdomen 3 days after the onset of measles infection. Image captured at New York Hospital–Cornell Medical Centre. Photograph courtesy of CDC/Heinz F. Eichenwald, MD from Centers for Disease Control and Prevention Public Health Image Library ID# 3168 (https://phil.cdc.gov/details.aspx?pid=3168). Box 2 – Australian state and territory immunisation coverage rates for 1‐year‐olds at 31 December 2019 Data source: Australian Immunisation Register. Infographic courtesy of Australian Government Department of Health.16
Kirsten M Williamson · Tony Merritt · David N Durrheim
The vitamin D testing rate is again rising, despite new MBS testing criteria
The number of tests for vitamin D deficiency in Australia rose steeply between 2000 and 2011, from 0.4 to 36.5 tests per 1000 population; the cost to Medicare increased from $1.1 million in 2000 to $95.6 million in 2010,1 and peaked at $151 million in 2012–13.2 Consequently, the Medical Benefits Schedule (MBS) items for testing (66608, 66609) were replaced in November 2014 by new items (66833–66837) with the aim of restricting testing to people at particular risk of vitamin D deficiency, including those with a history of osteomalacia or osteoporosis, elevated alkaline phosphatase levels, hyperparathyroidism, hypo‐ or hypercalcaemia, hypophosphataemia, malabsorption, chronic renal failure, deeply pigmented skin or chronic and severe lack of sun exposure, or a diagnosis of vitamin D deficiency, and people who used medications that reduce 25‐hydroxyvitamin D levels.3 The immediate effect of the new criteria was that the rate of vitamin D tests was 47% lower during 2014–16 than during 2013–14.4 However, the proportion of people tested who met none of the new MBS criteria increased from 71.3% to 76.5%, while the proportion with moderate to severe vitamin D deficiency increased only from 5.4% to 6.5%.4 Medicare data5 indicate that the testing rate has since increased, by 34% between 2015 and 2019, from 119 to 159 tests per 1000 population; the cost to Medicare rose 42%, from $73.7 million to $104.7 million (Box). The testing rate increased in all states; the rate for women increased by 30% (from 164 to 214 tests per 1000 population), and for men by 40% (from 74 to 105 tests per 1000 population) (Supporting Information, figures 1A,B). The most marked increases were for people aged 85 years or more, for whom the 2019 testing rate (women, 447 tests per 1000 population; men, 364 tests per 1000 population) exceeded the 2012 levels (women, 388 tests per 1000 population; men, 276 tests per 1000 population). Testing rates for people aged 0–25 years did not markedly change between 2015 and 2019 (Supporting Information, figures 1C,D). The Royal College of Pathologists of Australasia,6 like most medical authorities, does not recommend screening for vitamin D deficiency. The marked overall increase in testing since 2015 is not explained by changes in demographic or clinical factors, suggesting that at least some screening is unnecessary and that ordering doctors are either unaware of or do not support the new MBS vitamin D testing criteria. Evidence‐based guidelines6 and MBS policy, accompanied by education and audit activities, have failed to contain the level of vitamin D testing. Further, people who are socio‐economically disadvantaged or at particular risk of vitamin D deficiency, including Indigenous Australians, are still tested less frequently than other Australians.4 Finally, people at clear risk of vitamin D deficiency could be treated without testing, especially as the cost of supplementation ($2.25 per month) is only a fraction of that of a vitamin D test ($30.05). High quality research is needed to provide evidence for informing interventions that curb the use of low value tests in a health system that encourages a high volume of services, but not necessarily better value care. Box – Cost to Medicare of vitamin D testing (MBS items 66608 and 66609, 66833 to 66837), January 2000 – December 2019 MBS = Medical Benefits Schedule. Source: Medicare item reports.5 Our estimated rates for 2001 (2.3 per 1000 persons) and 2011 (140 per 1000 persons) differ from those estimated by Bilinski and Boyages1 using a different source of Medicare data. * The MBS items 66833 to 66837 were listed on 1 November 2014.
Louisa Gordon · Mary Waterhouse · Ian R Reid · Rachel E Neale