Perspectives

Investment is urgently needed in repurposed drugs which could ease the burden of the COVID-19 pandemic

Jennifer H Martin · Nikola A Bowden

The existing system is failing to deliver the care that Australia expects Australia's aged care has changed considerably in recent decades. In response to consumer demand, old institutional‐style nursing homes have been progressively phased out in favour of better facilities. Home‐like furnishings and decor and single bedrooms personalised with residents’ own belongings have increasingly become the norm. In the process, they have become residential aged care facilities (RACFs), and there is no longer a distinction between low and high care.1 At the same time, older people want to stay in their own homes longer and have increasingly been able to do so because more community care is now available. Along with significant accommodation bonds and other charges, this has also served government objectives of reigning in the costs of Australia's ageing population.1 Contemporary residential care is no longer a lifestyle choice, it is now primarily for people who can no longer live at home. However, funding and staffing have not kept pace with this change.1 Aged care residents’ needs People living in RACFs now are typically very frail and have complex physical, cognitive and social care needs. During 2018, we independently assessed 5000 people living in RACFs.2 Only 15% of residents were independently mobile, one in two (50%) required mobility assistance, and over a third (35%) were not mobile. The bedridden group was at greatest risk of pressure injuries. People living in RACFs are vulnerable; the typical resident lacks energy and struggles with everyday activities. Most residents (> 80%) need help with activities such as showering, getting dressed or using the toilet. Moreover, many residents have memory, understanding and communication problems. Almost half of the residents find it difficult to interact with others and may become distressed when care staff try to assist them with personal hygiene, for example. Mental health problems are rife. Agitation is the most prevalent problem (43%), followed by depression (35%) and irritability (35%).3 There are about 180 000 residential care beds in Australia occupied on any one day by permanent residents.4 About 60 000 permanent residents die each year and about the same number take their place.5,6 The number of residents who die in their RACF is unclear. What is known is that many thousands are transferred to hospital due to staff not having the skills, confidence, capacity, resources or back‐up to provide the care they need.7 Neglect, the recently released interim report of the Royal Commission into Aged Care Quality and Safety, concluded that “substandard care is much more widespread and more serious than … anticipated”.7 Staffing in residential aged care facilities To inform its work, the Royal Commission requested a research study be carried out into residential care staffing.1 This involved a review of staffing standards internationally and an assessment of current Australian staffing levels against international and national standards. Australian staffing levels were calculated based on a time and motion study we conducted in 2018.3 Residents in Australia receive on average 188 minutes of care per day, which includes 36 minutes by registered nurses, 8 minutes by allied health professionals (mostly physiotherapists) and 144 minutes by personal care assistants.1 Anecdotally, registered nurses and allied health professionals are required to spend a disproportionate amount of time on paperwork for funding purposes, leaving even less time to spend on care. Adequate care time and staffing mix and levels So how can we tell if a RACF is providing adequate care time and has the right mix of staff? Our Royal Commission research considered these questions.1 The international literature consistently reports that staff time requirements are driven by resident function, cognition, behaviour and technical nursing requirements, and our 2018 research confirmed that these same drivers apply in Australia.3 The clear evidence in the international literature of a direct causal relationship between staff numbers and skill mix and resident safety and quality outcomes is equally applicable to Australia.8,9,10 Over 150 studies documented in systematic reviews, primarily from the United States, Canada, the United Kingdom and northern Europe, confirm a “strong positive impact of nurse staffing on both care process and outcome measures”.11 Organisational factors, such as professional staff mix (ratio of registered nurses to total staffing levels), staff turnover rates, use of agency staff, and consistency in staffing also have an impact on quality. We found that the five‐star rating system used in the US by the Centers for Medicare and Medicaid Services (CMS) is the most relevant system internationally for judging aged care in Australia. It has a strong evidence base and has been in widespread use for nearly 20 years.12 While it does not address allied health staffing levels, it could be developed to do so if such an approach were adopted in Australia. The CMS considers the amount of care time provided to residents by nursing and personal care staff and adjusts this according to the needs of residents in each home. The outcome is a rating of between one and five stars. The more stars the better. The five‐star threshold is the point at which there is no evidence of any additional quality improvements for residents (Box).12 As seen in the Box, Australian RACFs rate poorly compared with US RACFs. They also do badly compared with the standards in place in Germany and Canada and with the standards set down by the state governments of Victoria and Queensland.1 Research into the CMS system found that homes are more likely to “experience quality concerns” when staffing levels fall below a certain level.12 This threshold is equivalent to the minimum requirement for a three‐star rating (ie, 30 minutes of registered nurse time and 215 minutes of total time). Therefore, we determined that anything less than three stars is inadequate for Australian RACFs.1 Using these metrics, more than half of all Australian aged care residents (57.6%) are in RACFs that have inadequate (one or two stars) staffing levels. A little over a quarter (27.0%) are in RACFs that have three stars, 14.1% of residents are in RACFs with four stars, and 1.3% are in RACFs with five stars, which we consider best practice.1 Bringing all RACFs in Australia up to at least three stars would require an average staffing increase of 37.3% in those RACFs currently rated one or two stars, which would result in an overall increase of 20% in total care staffing across Australia. Achieving four stars would increase total staffing by 37.2% and five stars by 49.4%. Importantly, these increases are total numbers for the sector as a whole and need to be adjusted according to the mix of residents when applied to individual RACFs.1 The best international benchmark for allied health staff currently is from the Canadian province of British Columbia, which recommends a minimum of 22 minutes of allied health services per resident per day. Only 2% of Australian aged care residents currently receive this level of care. An additional 175% in allied health staffing is required to achieve this international standard.1 The evidence is clear Our research was requested by the Royal Commission against a background of numerous examples of poor quality care experienced by older people living in RACFs.1 A recurring theme has been the lack of staffing to meet the wide‐ranging and increasingly complex needs of residents — assertions that have been supported by the results of our research.1 It is clear from our research and from the evidence presented to the Royal Commission that there is a compelling case for additional resources in RACFs. This includes improving the staffing mix and increasing staffing levels to an acceptable standard. As the Royal Commission's interim report notes,7 the existing system has failed to ensure residents receive quality care. It is no longer acceptable to describe RACFs simply as a person's home or for advocates to argue that what is required is a social model of care delivered with a wellness philosophy.13,14,15 While on the surface it sounds attractive and in line with what consumers want, the evidence from the Royal Commission is that these arguments are now being used as a justification for inadequate care.7 Conclusion Residents in Australian RACFs have a right to be safe and to receive clinically competent and adequate care. This care needs to be provided within a non‐institutional environment that is respectful of individual choices and affords every resident the opportunity to be meaningfully engaged to the extent possible. There does not need to be a trade‐off between a social model of care and a clinically competent model. Aged care residents have a right to both and do not have the time to wait. Box – Star rating system for aged care facilities: comparison between Australia and the United States

Kathy Eagar · Anita Westera · Conrad Kobel

An integrated approach that includes a central role for pathology laboratories is necessary Mass casualty events (MCEs) are defined as events or other circumstances “where the normal major incident response of one or several health organisations must be augmented by extraordinary measures to maintain an efficient, suitable and sustainable response”.1 Haemorrhage is a leading cause of mortality in MCEs, accounting for almost 50% of deaths in the first 24 hours,2,3 and transfusion emergency preparedness is increasingly recognised as a critical element of an integrated approach to MCEs,4 with timely availability and appropriate delivery of blood components being an essential part of management. On 20 January 2017, an MCE occurred in Melbourne, Victoria, when a car struck pedestrians in the Bourke Street Mall in the central business district, killing six people and injuring more than 30. The injured were taken to various adult and paediatric hospitals around Melbourne, including designated trauma centres and non‐trauma hospitals, both public and private. A Code Brown was activated at some of these hospitals. This is a hospital alert activated internally when notification of an external incident is received, usually by emergency services or health departments, which requires mobilisation of additional capability and capacity within that facility to receive an influx of patients.5 In Victoria, the users of blood products, including public and private hospitals and pathology laboratories, are represented by the Victorian Blood User Group. The Blood User Group meets quarterly with Australian Red Cross Lifeblood (previously Australian Red Cross Blood Service) to discuss issues relevant to the use and supply of blood products. In February 2017, Blood User Group members highlighted concerns with communication during the Bourke Street incident. Poor communication from hospitals to their pathology laboratories was noted during activation of hospital Code Brown alerts. There was also uncertainty and lack of transparency surrounding supply of blood components from Lifeblood to hospitals in Victoria, not only to those involved in the incident but also those awaiting delivery of routine blood inventory. In response to these concerns, the Blood User Group held a forum in August 2017 to discuss these issues and to make recommendations to assist planning for future incidents. Blood User Group representatives and invited guests, including National Blood Authority representatives, heard presentations from the Victorian Department of Health and Human Services, Lifeblood and four hospitals that received patients, outlining issues and learnings from the incident, followed by further discussion. A summary of recommendations was circulated to forum attendees. This article highlights issues and recommendations pertinent to hospitals and associated pathology laboratories, in particular their haematology and transfusion laboratories. Recommendations Pathology staff must form part of hospital critical incident management teams In some hospitals, the associated pathology laboratory is not part of the critical incident management team, and when these hospitals were notified of the Bourke Street MCE by emergency services, this was only communicated to the pathology laboratory via public address systems or other informal means. Updates received by hospitals from emergency services throughout the event were similarly not always communicated in a planned way. Key pathology representatives in some hospitals also attended their emergency departments in person, which was invaluable for communication but occurred on an ad hoc basis rather than being part of a documented protocol. Without streamlined communication, pathology representatives can often only respond to blood component requests and transfusion specimens when they arrive, leading to potential delays in blood product provision. As transfusion support remains a core component of management in MCEs, a key recommendation is that pathology staff must form part of any hospital's critical incident management team. This should be documented in the critical incident protocol, and involves active pathology staff participation during critical incidents. Further formalised pathology roles, such as physical attendance at critical sites in the hospital (eg, emergency department) to streamline communication with the laboratory, are also encouraged. This ensures that pathology services receive adequate notification of critical events, and enables direct involvement in ongoing management of the incident in a systematic way with clear lines of communication. It also allows pre‐emptive action such as pre‐thawing of clinical plasma, and review and management of current inventory including appropriate use of emergency blood components. Implement safe, non‐sequential allocation of unit record numbers for consecutive emergency patients One hazard noted at the forum was a lack of specific labelling protocols for identifying patients presenting to some emergency departments, resulting in potentially dangerous patient identifiers being used; for example, consecutive unit record numbers for consecutive patients, or the same prefix on all patients. This may facilitate clerical errors and patient misidentification. It is recommended that institutions ensure that allocation of unit record numbers for consecutive unknown patients is performed in a safe way, which minimises the risk of patient misidentification. Ensure adequate levels of pathology staff familiar with critical event management Staffing levels were an issue at some sites during the Bourke Street MCE, owing to senior staff being on leave. Similarly, when critical incidents occur after‐hours, staffing is often limited and senior personnel may not be on site, resulting in less experienced staff enacting their critical incident management plans. Extra staff may be required and there may be difficulty of access to workplaces if the incident results in road closures. Working during the incident can be physically and emotionally tiring, and replacement staff will be required after the event.4,6 Therefore, it is recommended that all staff, irrespective of experience, should be familiar with their local critical incident management plan, and that consideration be given to how staffing levels are managed during and after a critical incident. Include pathology staff in practice disaster scenarios All hospitals should practise responses to disaster scenarios and involve pathology representatives. During the Bourke Street event, hospitals other than the major trauma centres received multiple casualties. “Walking wounded” may also present at nearby hospitals, irrespective of whether these have emergency departments. Performing practice scenarios is therefore important to familiarise staff with their critical incident plans. Limitations of these scenarios are recognised, as they often do not encompass the practical issues faced by pathology teams, such as time taken to run multiple pathology samples, perform multiple crossmatches and accept into inventory large numbers of blood products. Despite these limitations, it is recommended that hospitals perform practice disaster scenarios and involve pathology staff to highlight areas of potential weakness. Consider standby phase in Code Brown responses One hospital activated their Standby Code Brown during the Bourke Street MCE, when it was first notified by emergency services of the possible arrival of casualties, but before patient numbers or severity of injuries were known. This standby phase alerted the critical response areas of the hospital, including the emergency department and pathology services, to an external incident, allowing review of department response plans such as staffing levels and blood product inventory without activating a full Code Brown response. The standby code remained in place until the hospital was advised of further details of presenting patients. It is recommended that hospitals incorporate such a standby phase in their emergency response plan. This alerts relevant departments to plan and prepare for escalation of an event when a critical incident is first notified to the hospital, but before further details are known or casualties have presented, without activating the full series of Code Brown activities which can be disruptive. Discussion Effective communication during MCEs is critical. It is common for many more blood components to be requested than are eventually transfused, and the overall requirement for products in these events is often lower than expected.7,8 Most blood use in MCEs occurs within the first 24 hours, particularly in the first 4 hours as the majority of severe casualties arrive within this time frame.2,7 Therefore, the key to managing these chaotic and rapidly evolving events is early, accurate and ongoing updated communication between emergency services, state health departments, hospitals, pathology laboratories and Lifeblood to ensure that blood components are urgently allocated to appropriate patients while limiting unnecessary ordering and cross‐matching of products. Local communication between hospital departments and pathology laboratories can be improved by implementing the above recommendations, in particular by involving pathology laboratories in critical incident management. Hospitals may use existing communication channels including email, intranet and paging or other messaging services; however, the protocol for using these should be clearly documented in the critical incident management plan. Broader statewide communication via health departments and Lifeblood would also allow other health care services to respond appropriately; for example, by managing blood inventory conservatively until the extent and impact of the MCE is known. This requires effective communication between health departments and Lifeblood, and it is imperative that information circulated via state jurisdictions and Lifeblood is consistent to avoid confusion. Forum attendees recommended that the National Blood Authority enable Lifeblood to disseminate information to pathology services through a web‐based blood product ordering system, BloodNet, which is used by transfusion laboratories throughout Australia. Health departments should similarly ensure that existing channels for communicating emergency information to hospitals, such as hospital personnel contact details, are current. Any communication must also be effective outside standard business hours. Fax or email messages are unreliably received after‐hours, and phone contact with appropriate hospital personnel may be more effective. The Bourke Street Mall MCE highlighted the challenges involved in supplying blood components during such events. The recommendations are similar to those published in a previous review on transfusion preparedness for MCEs4 and recognise the requirement for an integrated approach that includes a central role for pathology laboratories. Incorporating the lessons learnt from this incident will allow for more organised responses and streamlined communications between all departments and institutions.

Linda Saravanan · Amanda Ormerod

During the COVID‐19 pandemic, people with heart disease are likely abandoning usual medical advice As the world watches the spread of the coronavirus disease 2019 (COVID‐19) pandemic, affecting the health of millions of people and the lives of everyone, common health conditions including heart disease, stroke, cancer and other chronic diseases continue. While there is no doubt that there are direct consequences for morbidity and mortality of COVID‐19, including its direct cardiovascular effects, it will be important to ensure that these are not matched by the indirect consequences. Countries are at different stages in the natural history of the pandemic, but there is a clear pattern. Overloaded health systems necessitate the hasty development of new protocols and pathways for common conditions that deviate from established guidelines and that may be caused by changes in community behaviour, either imposed or arising from fear. Unproven therapies are being tested in the field and, in the absence of evidence, there is the potential for theory to drive practice to an extent that is generally not seen in conditions with an established evidence base. During the COVID‐19 pandemic, emergency department (ED) attendances fell dramatically in England, with 89 584 attendances in the week after the lockdown (23–29 March 2020), down 25% compared with the 120 356 attendances during the previous week and almost 50% down on attendances in February 2020.1 This decrease in ED attendances has also been reported in Europe, Canada and Australia.2 ST elevated myocardial infarction (STEMI) rates fell by about 40% in reports from Austria3 and the United States.4 It is possible that COVID‐19 is associated with plaque stabilisation and lower rates of STEMI, but it seems more likely that people with heart disease are abandoning usual medical advice at a time when they may need it the most. In New York, US, a 50% decrease in ED visits for acute coronary syndromes has been reported at the same time as an eightfold increase in out‐of‐hospital cardiac arrest calls in the first week of April 2020.5 It is not clear how many of these calls are COVID‐19‐related, but there seems to be no doubt that people have a reluctance to attend hospital during the peak of the epidemic, which is having a significant cost in mortality. The angiotensin‐converting enzyme inhibitors and angiotensin II receptor blockers controversy In the midst of all this, a controversy has emerged about the safety and value of angiotensin‐converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) — commonly used for the treatment of hypertension and heart failure — in the context of the COVID‐19 pandemic. In ordinary times, these are considered to be among the safest, best tolerated and most effective drugs for the management of both hypertension and heart failure, with a strong evidence base showing a reduction in morbidity and mortality from these conditions.6,7 To date, there is insufficient clinical evidence that ACEIs, ARBs or other inhibitors of the renin angiotensin system are either harmful or beneficial in the acquisition of COVID‐19 or its subsequent clinical course in individual patients. A number of clinical trials of losartan and recombinant angiotensin‐converting enzyme 2 (ACE2) are underway, such as the Losartan for Patients with COVID‐19 Requiring Hospitalization trial (ClinicalTrials.gov, NCT04312009). The debate has arisen because of circumstantial arguments based on COVID‐19 pathophysiology and renin angiotensin system physiology.8,9 It is argued that ACEIs and ARBs may be harmful because: hypertension is overrepresented among people who develop the most severe complications of COVID‐19;10 severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) gains entry to a cell using ACE2 and type II transmembrane serine proteases;11 ACE2 is highly expressed in the cardiovascular system, gut, kidneys and lungs (in the cardiovascular system, ACE2 is expressed in cardiomyocytes, epicardial adipose tissue, cardiac fibroblasts, vascular smooth muscle and endothelial cells);11 ACEIs or ARBs upregulate ACE2 in heart cells in some experimental models;12 these factors in theory may lead to a greater viral load and more serious infection. Several important links in this logic chain are contested. Early reports of high rates of hypertension in people dying of COVID‐19 or presenting with severe COVID‐19 were not adjusted for age. However, it is clear that most of these patients have comorbidities, including hypertension, heart failure and diabetes, all of which are more common in an older population. The mortality rate in the intensive care unit in 72 regional hospitals in Lombardy, Italy, was 26%. Most patients were male (82%) and had extensive comorbidities, especially hypertension (49% overall and 62% of deaths).10 ACE2 and COVID‐19 pathophysiology The relationship between COVID‐19 and the renin angiotensin system has been reviewed extensively.11 Although there is no doubt that ACE2 is a receptor for COVID‐19 and that the gene is widely expressed in the body, there is mixed evidence on whether it is upregulated by ACEIs or ARBs in animal models, and there is no evidence that it is increased de novo in tissues that have low expression.13 COVID‐19 suppresses ACE2.11 If ACE2 expression is increased by ACEIs or ARBs, it does not necessarily imply that this enhances the ability of SARS‐CoV‐2 to infect cells. The affinity of the virus for ACE2 is very high, and it is not clear that a small increase in expression due to renin angiotensin inhibition would increase intracellular viral load. Another counterargument to this hypothesis is that an increase in ACE2 expression would provide a counter to the suppression due to SARS‐CoV‐2 and allow the beneficial effects of ACE2, including anti‐inflammatory activity, to manifest; that is, ACEIs or ARBs may be beneficial. Trial design to resolve the matter In considering the possibility of interactions between COVID‐19 and medications, it is important to take into account the different stages in the evolution of the disease in an individual. The earliest stages are characterised by mild or absent upper respiratory symptoms and lymphopenia. A minority of people infected with SARS‐CoV‐2 subsequently develop pneumonitis and pulmonary complications. Even fewer people develop the most severe complications with hyperinflammation — also called “cytokine storm” — often with myocarditis and other major organ failures. It is quite likely that the renin angiotensin system and, by implication, drugs that interact with it, such as ACEIs or ARBs, have different actions at various stages of the condition according to the tissues affected. For example, ACE2 is protective in acute lung injury, suggesting that, although it facilitates viral entry through the epithelium, the ACE2 and its product, the angiotensin (1‐7) axis, could be used to reduce tissue injury caused by SARS‐Cov‐2, a potential target for therapy.11 This will be an important consideration in the design and setting of clinical trials. What clinicians can do in the meantime There are highly circumstantial arguments for and against the use of ACEIs and ARBs in patients with COVID‐19 and there are many more in the literature — as preprints and on social media. In the absence of good epidemiological and clinical trial data, there is no immediate and definitive resolution to the debate. What is clear is that people with hypertension and heart failure benefit from ACEIs and ARBs where indicated, and withdrawing treatment is likely to have serious consequences in some people. We are thus left with a situation where stopping ACEIs or ARBs in some people has known and potentially serious sequelae, whereas continuing them in people with or vulnerable to COVID‐19 has unknown consequences that, depending on how the experimental evidence is interpreted, may be negative, neutral or even positive. International and national authorities on cardiovascular disease, including the High Blood Pressure Research Council of Australia, the World Health Organization, the American Heart Association and the European Society of Cardiology, have been united in their recommendation that treatments with ACEIs or ARBs should be continued during the present pandemic pending evidence from clinical studies to the contrary.14,15 In a number of patient groups, ACEIs or ARBs are first line choices; for example, in patients with hypertension and proteinuria or in people with heart failure. Given the clear benefits they have provided over several decades, a decision to withdraw first line therapies should only be based on reasons supported by a strong evidence base. In other groups, such as in patients with uncomplicated essential hypertension, there are alternatives, including calcium channel blockers or diuretics. However, changing medications in patients with well controlled blood pressure requires careful monitoring and there is a risk in the short term that blood pressure will fall outside the optimal range. This may prove challenging during a period when telemedicine is the norm and given that not all households have home blood pressure monitoring equipment and training. As the ACEIs and ARBs controversy has been wisely canvassed in the media, health professionals will need to have a conversation with patients about the benefits or otherwise of continuing their present therapies. It is important that people understand that no concerns have been raised about other medications they may be taking, such as statins, antithrombotic agents, or treatment for diabetes. In recommending continuation of ACEIs or ARBs, physicians can draw comfort that they are backed by almost every cardiovascular health authority in the world. Nevertheless, the clinical trial results of both administration or withdrawal of ACEIs or ARBs cannot come quickly enough, and in the best case, they will allow us to turn practice into the right theory.

Garry LR Jennings

Usual care must be rapidly adapted to isolate, assess and test large numbers of patients during the COVID‐19 pandemic Coronavirus disease 2019 (COVID‐19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), emerged in China in late 2019.1 COVID‐19 is an example of a high consequence infectious disease that may present to an Australian hospital. These infections are uncommon in Australia and, in most cases, were imported from overseas. Less frequently, there is onward local transmission, such as during the influenza A(H1N1)pdm09 pandemic in 2009. High consequence infectious diseases present unique challenges to Australian hospitals. Their rarity leads to unfamiliarity and loss of institutional knowledge between events. Many hospitals operate at near maximal capacity between outbreaks and have limited surge capacity.2 Protocols designed to manage single patients require adaptation to situations where larger numbers of patients require isolation, assessment and testing for infection. While every Australian hospital has a mass casualty or disaster protocol, these are developed for all hazards and may not address problems specific to high consequence infectious diseases, including: the need to rapidly identify and isolate potentially infectious patients to prevent nosocomial transmission; the complexity of rapid triage and assessment on frequently evolving epidemiological and clinical grounds; the difficulty of differentiating high consequence infectious diseases from more common but clinically similar conditions;3 the absence of rapid diagnostic tests to aid clinical decision making; and the potential for a prolonged surge for weeks to months during which time the workforce may be affected by both infection and absenteeism. Here we describe the strategic approach of the Royal Melbourne Hospital to triage and screen patients who have presented at risk (or concerned that they are at risk) during the early phases of COVID‐19. Our resources may be of value to other organisations refining their triage and clinical algorithms. The Royal Melbourne Hospital response The Royal Melbourne Hospital is an adult tertiary referral centre and the designated state‐wide provider for quarantinable diseases. The emergency department (ED) treats over 80 000 patients annually. From 6 January 2020, we instituted tools to identify at triage those patients with risk factors for COVID‐19 and rapidly isolate them. Initially, there was capacity to assess patients in one of three existing negative pressure rooms. On 25 January, the first patient with COVID‐19 in Australia, who had arrived in Melbourne on a flight from Guangzhou, was confirmed. The Victorian Department of Health and Human Services informed all passengers on the flight of their possible contact with the patient, leading to a significant surge in presentations to the Royal Melbourne Hospital. Box 1 presents an overview of the challenges in managing high consequence infectious diseases and details of our coordinated approach. Key components that can be used by other services are detailed below. Governance Unlike other major incident responses, which tend to be short‐lived, response to an outbreak requires a sustained response that will inevitably have an impact on other clinical services. A governance process that includes executive sponsors and senior clinical leaders is essential. The Royal Melbourne Hospital COVID‐19 response leveraged an existing code brown (external emergency) pandemic subplan and clinical code yellow (internal infectious disease emergency) plans as a governance framework. A governance group including medical and nursing executives and senior clinicians from the ED, infectious diseases, infection prevention services and microbiology meet regularly. A single standard operating procedure exists on our hospital intranet that provides all clinically relevant information for frontline health care workers (eg, personal protective equipment guidelines, current case definitions, patient assessment algorithms). It is updated frequently given the dynamic situation and, thus, functions as a living document for staff. This document provides 24/7 access to an authoritative source that supports junior and senior staff alike to feel confident in their practices and approach. Infrastructure Establishment of a fever clinic. A particular design feature that may be adopted by other facilities is the rapid establishment of an out‐of‐department fever clinic. In response to the first surge of patients, we rapidly repurposed the nearby hospital transit lounge, which was closed for the weekend, into a fever clinic (Box 2). The clinic received its first patient within 2 hours of notification from the Victorian Department of Health and Human Services of the first local case. In its first 7 days, we assessed 109 patients. We discharged over 90% of patients within 4 hours of arrival. We retain this model as patient numbers continue to increase. In this model of care, patients are physically segregated from the rest of the ED into a dedicated rapid assessment and treatment space from their arrival, limiting exposure to other patients. The main benefit of this approach is that cases yet to be identified can be an important contributor to nosocomial transmission; therefore, early separation and detection are vital.4,5 However, immediate recognition of cases is difficult due to unfamiliarity with the disease, overlap in clinical presentation with more common illnesses, and due to patient wait times. Our fever clinic model of care was based on the success of this model in Toronto and Taiwan during the severe acute respiratory syndrome (SARS) outbreak,6 where no transmission was reported in these facilities despite hospital exposure being implicated in the majority of cases in these regions (eg, it was the presumed source of exposure for 72% of patients in Toronto7,8). It has also been reported as an effective strategy for triaging patients in Wuhan for COVID‐19.9 Similar approaches appear to have been used in other countries, but detailed descriptions are not yet available in the literature. In Australia, segregation of major incident patients was exemplified by the Royal Darwin Hospital, which functioned as the forward receiving hospital for medically evacuated patients during the 2002 Bali bombings.4 The benefits of establishing a fever clinic include: protecting an existing environment for the maintenance of business continuity; facilitating protocolised interventions for spatially clustered groups of patients; providing a physical location to send additional disaster resources without cluttering areas of core business; and enhancing record‐keeping. Limitations of our approach include the additional staffing required, operational impact of loss of transit lounge, staff unfamiliarity with the location of resources (such as resuscitation trolleys), and a slightly further distance from resuscitation bays if patients deteriorate. Moreover, we were also concerned about the risk of stigmatisation of patients who are seen to be segregated from the main ED waiting room cohort. Implementation of electronic self‐registration and self‐screening. A surge related to an emerging infectious disease provided our clerks’ department with a confluence of unique administrative and logistical challenges. These included: a high proportion of patients came from a non‐English speaking background; contact tracing and follow‐up requires accurate registration and an extended suite of contact details, but usual disaster response medical records protocols generate only anonymised patient registrations; non‐clinical staff (ward clerks) unfamiliar with personal protective equipment would be required to extensively interview patients to confirm details at some point; patients came in bursts, producing delays in registration; manual screening paperwork and registration papers provide a potential fomite for disease transmission; and our ED is paper‐free under usual circumstances. We developed a novel solution to this problem, leveraging the fact that over 91% of Australian citizens and over 96% of Chinese citizens own a smartphone5,10 and converted an initial paper‐based bilingual screening tool to an online one. This is hosted using the research electronic data capture (REDCap) tool (www.projectredcap.org).11 Patients are directed to a secure website optimised for use on a smartphone. The registration portal is free to use. They answer questions regarding their epidemiological risk (such as a detailed travel history, or being a health care worker), clinical risk factors (such as being immunocompromised) and symptoms. Results are immediately fed to remote clinical computers where ward clerks can register the patient without direct patient contact and clinicians can see screening information before their clinical encounter. While not yet tested under a pandemic scenario, we anticipate this method of self‐registration may be particularly useful in the event of a significant surge in patient numbers. Triage sieve and sort of patients can be rapidly undertaken by clinicians who are fed real‐time registration data. Compared with usual mass casualty principles, the inclusion of epidemiological data in the electronic tool is valuable for triage in this setting to screen out the relatively high proportion of patients with perceived, but not actual epidemiological risk factors. Our REDCap infrastructure is available in the Supporting Information for adaptation by other health services. Conclusion The importation of emerging infections into Australia is rare, and onward transmission is rarer still. As the Royal Melbourne Hospital received a surge in patients who required screening for COVID‐19 relatively early during the current outbreak, our recent observations may provide opportunities for other hospitals to enhance their preparedness and response plans. We prioritise prevention of nosocomial transmission (using a scalable, separated fever clinic) early planning for worsening surge (adopting scalable solutions) and clear clinical governance (providing malleable and accessible centralised resources). Box 1 – Elements of the Royal Melbourne Hospital clinical response Element of response Challenges Approach used Clinical governance Multiple clinical units involved, with tangible impacts on business as usual activity and frequent changes to the model of care and the expectations Where possible, we operated within existing plans and policies. Daily executive and head of unit level huddles were instituted initially, and then stepped down to weekly as needed, producing hospital agreement on messaging and expectations of all teams and sharing of information between executive, infectious diseases (ID), infection prevention services (IPS) and emergency medicine (EM). COVID‐19 multidisciplinary working groups were formed within the ED and ID clinical units Infrastructure A space was needed to accommodate the extra patients while maintaining infectious isolation among them, and between them and the rest of the ED census A graduated response used with existing ED negative pressure rooms used for small numbers, a cohort subwaiting area was created when several patients were present in the ED at once, and a separate fever clinic was created in the nearby transit lounge used for surge response Infection prevention and control practices Transmission dynamics are incompletely understood and there is a risk of nosocomial amplification (especially during aerosolising procedures) Education sessions, posters, and videos used to reinforce PPE training; nebulisers removed from dedicated treatment space; hand sanitiser stations; PPE stations and infectious waste bins deployed; and a SOP employed for aerosolising procedures (Supporting Information) Clinical care (including triage, assessment and testing) There is rapidly evolving understanding of clinical and epidemiological characteristics of the disease. Staff lack familiarity with the disease and with the roles performed (concierge nurse, fever clinic doctor), while the normal ED and hospital functions need to continue alongside Creation of a SOP including clinical algorithms for triage, assessment and biological sampling as a living document hosted on the hospital intranet, and updated as needed and used as a single source of truth for clinical staff. Gradual transition to algorithm‐driven assessment by junior medical staff to free up senior staff for unwell patients. Action cards with role descriptions were provided in the SOP for all fever clinic staff Communication with patients Initially, most patients were Mandarin‐speaking Bilingual signage (English and Mandarin) deployed in the fever clinic, and bilingual patient resources and screening questionnaire generated. Discharge information sheets specific to different tiers of risk were translated into Mandarin and provided to all patients discharged from the fever clinic Human resources Maintenance of staff competence and confidence essential for safety and prevention of absenteeism Regular education sessions to provide updated clinical information and epidemiology, train in PPE, and answer questions COVID‐19 = coronavirus disease 2019; ED = emergency department; PPE = personal protective equipment; SOP = standard operating procedure. Box 2 – Floor plan of the Royal Melbourne Hospital fever clinic and guiding principles for a fever clinic COVID‐19 = coronavirus disease 2019; PPE = personal protective equipment; SOP = standard operating procedure.

Amanda M Rojek · Martin Dutch · David Camilleri · Emma Gardiner · Emma Smith · Caroline Marshall · Kirsty L Buising · Nicola Walsham · Mark Putland

The maintenance of sustainable low cost physical distancing and enhanced hygiene may decrease the number and severity of cases It is estimated that about two‐thirds of cases of coronavirus disease 2019 (COVID‐19) exported from China between 1 and 13 January 2020 were undetected globally.1 Most of these exported cases were mild and were only detected after several hundred cases had accumulated and severe or fatal cases were recognised 5–8 weeks later, as likely occurred in the COVID‐19 outbreaks in Iran, South Korea, Italy and Seattle, United States.2 The spread of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) transmission globally has been very rapid. The basic reproduction number (R0) is estimated at between 2 and 3.3,4 The mode of transmission is thought to be droplet and contact infection, although opportunistic or close range airborne infection may be involved.4 The transmission dynamics of the early cases of COVID‐19 were significantly different to those during the severe acute respiratory syndrome (SARS) epidemic in 2003. In particular, the proportion of COVID‐19 cases from health care settings was low and the proportion with no known risk exposures was high.4 Another significant factor is that viral loads in nasopharyngeal and respiratory secretions are highest soon after symptom onset in patients with COVID‐195 compared with a peak of around 10 days in patients with SARS,6 making transmission before entering health care facilities and in the pre‐symptomatic phase more likely.7 Even though the understanding of transmission dynamics is at an early stage, they do suggest that the stepwise introduction of stringent measures will be necessary to control this epidemic and highlight the importance of early community control. Australia and other countries have experienced a first wave of disease and managed to effect a decline in cases.8 Quarantine; city lockdowns; complete childcare, school, university and workplace closures; and cancellation of mass gatherings and events have a significant social and economic impact and were not often implemented until significant transmission was confirmed — when they may be less effective. Countries are now challenged with identifying which of these various controls can be relaxed to allow some routine societal and economic activities to return. However, there are low cost, sustainable interventions that may be maintained over what may be many years of continued mitigation9 (Box 1). These low cost enhanced hygiene and physical distancing measures are applicable pre‐emptively before confirmation of local community transmission or where transmission of SARS‐CoV‐2 appears to be under control. The purpose of these interventions is to slow the transmission of disease and limit the impact on health services, particularly on hospitals and intensive care units, to ensure access to high level care when needed. The interventions are based on the following assumptions, which require further exploration: community‐wide SARS‐CoV‐2 transmission may be occurring undetected or may only be recognised after containment is no longer feasible; interventions implemented after community‐wide transmission is detected will be less effective; reduction of the force of infection, particularly early, will delay the epidemic peak, blunt the epidemic peak, spread cases over a longer time, and help limit the potential for critical care services to be overwhelmed, which may be lifesaving;12,13 low cost sustainable interventions will assist in the relaxation of more economically costly interventions, and enhanced hygiene and physical distancing interventions should: ▸decrease the total number of cases per week; and ▸decrease the severity of cases through reducing viral inocula. Box 2 illustrates the concept of limiting the peak in cases so that health services are less likely to be overwhelmed and there is less unmet health service need. Unmet need may include inability to admit patients to a hospital or to provide hospitalised patients in critical condition access to intensive care. Interventions to reduce infection lead to longer but less peaked epidemics. A slower evolution in the epidemic also allows time for health care staff to provide better care, for recovery of infected health care workers, for learning and adapting to the evolving situation by administrators, and for vaccines and treatments to be developed. This principle is validated in simulations for influenza14 and appears to be validated with the reduction in COVID‐19 cases in Australia and the relative lack of overburden on clinical services.8 Measures to decrease the number and severity of cases Pre‐emptive and ongoing maintenance of low cost interventions (such as enhanced hygiene and physical distancing measures) (Box 1) may not only decrease the total number of cases but may also decrease the severity of cases. The R0 is the average number of secondary cases of an infectious disease that arise from cases in a totally susceptible population and reflects the epidemic potential of a pathogen.15R0 is a function of the number of contacts an infectious person has, the risk of transmission per contact, and the duration of infectiousness. Physical distancing mostly acts on the first factor by reducing the number of contacts each person makes. Hygiene measures mostly act on the second factor, as they reduce the risk of transmission if a contact occurs. It is difficult to disentangle the effectiveness of the multiple control measures implemented in pandemic‐affected areas. The World Health Organization–China Joint Mission on COVID‐19 determined that widespread community transmission and outbreaks occurred in Wuhan before the implementation of comprehensive control measures.4 However, in other parts of China, community transmission has been limited and after public gatherings were cancelled and people were restricted to their homes, most transmission occurred in families. For example, among 344 clusters involving 1308 cases (out of a total 1836 cases reported) in Guangdong Province and Sichuan Province, 78–85% have occurred in families.4 Community‐wide interventions may decrease the average viral exposure dose encountered in the community. People exposed to a higher viral dose (inoculum) are more likely to become infected and have more severe disease. Animal models for other coronavirus infections demonstrate that increased viral inocula lead to more severe disease and higher viral loads in the lungs and other organs and fluids.16 The SARS outbreak in Amoy Gardens, Hong Kong, in 2003 provided evidence that patients with presumed higher exposure to the index case had higher nasopharyngeal viral loads and more severe illness.17 SARS‐CoV‐2 cases with more severe disease have been found to have around 60 times higher viral load than those with mild disease.18 Modelling of the 2009 influenza pandemic also supported a hypothesis that severe illness was due to a higher infectious dose of the virus mediated by the number of simultaneous infectious contacts.19 Viral loads in severe patients with Middle East respiratory syndrome (MERS) were higher than those in a mild group, and the patients in the severe group had more prolonged viral shedding in respiratory secretions, beyond 21 days after the onset of symptoms, whereas viral RNA was no longer detected by 21 days in the mild group.20 Therefore, it is proposed that early measures that lower the number of contacts, the likelihood of transmission, and average viral infective dose in an area of transmission may have a multiplier effect leading to fewer cases and fewer severe cases that are less infectious. Maintaining the early reduction of the R0 would result in fewer cases overall and have a significant negative multiplier effect on the overall impact of the epidemic, including the number of deaths (Box 3). The higher case fatality rate in Wuhan, compared with other provinces in China, may partially relate to health care resource availability and shortages in the face of overwhelming community transmission as well as greater severity of disease due to higher infection doses.12,17 These interventions will be particularly important for people over 60 years of age and those with underlying medical conditions. The costs of intervention The suite of low cost interventions, other than a working from home policy, is unlikely to affect work productivity and may provide the community with some reassurance that all is being done to prevent the epidemic and that maintenance of the low cost measures may allow earlier opening of some workplaces. WHO is supportive of pre‐emptive interventions to prevent COVID‐19 in workplaces.21 Some may see it as being overreaching, but thus far, communities seem to voluntarily adopt low cost interventions, and acceptance may be enhanced through consultation and trust building.22,23 Influenza co‐benefits For regions approaching their influenza season, optimal prevention and control of seasonal influenza, such as vaccination, in the face of potential COVID‐19 cocirculation is also crucial to minimise the double burden on health services. The measures discussed here (enhanced hygiene and physical distancing) are also effective against influenza, resulting in potential co‐benefits for both pathogens. Early indications from Flutracking.net (https://info.flutracking.net/reports-2/australia-reports) indicate that physical distancing and hygiene enhancements have markedly decreased influenza‐like illness in Australia. Limitations While physical distancing and enhanced hygiene interventions in Australia appear to be working, the evidence on the effectiveness of individual interventions in preventing COVID‐19 is not yet available. However, there is evidence from observational and simulation studies for the effectiveness of physical distancing measures in controlling seasonal influenza.13 Other measures, such as hand hygiene and cleaning surfaces, have a long history of use in infection prevention and control.24 Despite the lack of robust evidence of effectiveness for these measures, their relative low cost means that there is little harm and much potential benefit in maintaining and optimising them. We have made no recommendations in regard to masks. The use of masks outside of health settings is controversial and it is important that medical grade masks not be diverted from health care supplies. Nevertheless, surgical masks are protective of large droplet spread, have about half the effectiveness of N95 masks for small droplet transmission, and are suggested to be cost‐saving in some modelled pandemic influenza scenarios.25 The use of masks may have a role in the community setting if there are adequate supplies.10 There is evidence suggesting that community use of masks may have reduced the risk of contracting SARS.26 It is clear that masks should be used in households caring for patients with COVID‐19 at home. Policy development and scientific review of the literature on community use of masks is very dynamic at this time. The US Centers for Disease Control and Prevention has made a recent recommendation that cloth masks be used at the community level and many recent reviews have come to divergent conclusions about the usefulness and risks of community mask use.27,28,29,30 Coherent policy development in this space will rely on transparently articulating the scientific evidence on community mask use with a public conversation on the potential risks in implementation. The interventions discussed here should be tailored to individual settings and communities, in partnership with members of those communities. In particular, these interventions should be adapted to the unique circumstances of groups, such as Indigenous communities; vulnerable groups, including homeless populations; and culturally and linguistic diverse communities. Conclusion SARS‐CoV‐2 continues to disseminate globally and there are likely to be recurrent waves of infection into the foreseeable future. We would argue that these low cost interventions, although formulated at an earlier stage of the epidemic, have increasing relevance. They will protect against the emerging concern for pre‐symptomatic transmission and their optimisation will better enable the more restrictive and economically damaging constraints to be relaxed.7 Box 1 – Low cost hygiene and physical distancing interventions Settings Interventions Workplace No handshaking policy Promote cough and sneeze etiquette, but focus is on excluding ill staff Videoconferencing as default for meetings Defer large meetings Signage for all offices/meeting rooms advising of maximum occupancy based on 4 m2 per person and 2 m distancing Enforced sanitisation of hands at entrance Regular hand sanitation schedule reminders via email Avoid gathering in lunch and break rooms Gamifying hygiene rules, for example, to discourage touching face Ill* people should stay at home and ill workers immediately isolated Hold necessary meetings outside in open air if possible Staff with ill household contacts should stay at home† Disinfect high touch surfaces regularly and between users Work from home where possible and consider staggering of staff Consider opening windows and adjusting air conditioning to increase air flow and maintain warmer more humid environments‡ Limit food handling and sharing of food in the workplace Assess staff business travel risks§ Enhance hygiene and screening for illness among food preparation (canteen) staff and their close contacts Analyse the root cause of crowding events on site and prevent through rescheduling, staggering or cancelling Mark floor areas to indicate 2 m distancing points in areas where staff spontaneously gather to prompt distancing Minimise the number of employees in a work vehicle at any one time School Supervised sanitisation of hands at entrance and at regular intervals Defer activities that lead to mixing between classes and years Promote cough and sneeze etiquette, but focus on excluding ill persons Strict stay at home policy if ill Gamifying hygiene rules, for example, to discourage touching face Regular handwashing schedule Disinfect high touch surfaces regularly and between users Outdoor lessons where possible Consider opening windows and adjusting air conditioning Enhance hygiene and screening for illness among food preparation (canteen) staff and their close contacts Review after‐school care arrangements that lead to mixing of children from multiple classes and ages Commercial, entertainment and transport Sanitisation of hands at building entrance encouraged Tap and pay preferred to limit handling of money Disinfect high touch surfaces regularly Avoid crowding through booking and scheduling, online pre‐purchasing, limiting attendance numbers Enhance hygiene and screening for illness among food preparation staff and their close contacts Enhance airflow and adjust air conditioning to increase air flow and maintain warmer more humid environments Public transport workers, taxi and ride share drivers — vehicle windows opened where possible, increased air flow, high touch surfaces disinfected Household All households Enhanced hand sanitisation Gamifying hygiene rules, for example, to discourage touching face Disinfect high touch surfaces regularly “Welcome if you are well” signs on front door Increase ventilation rates in the home by opening windows or adjusting air conditioning Promote cough and sneeze etiquette Households with ill members Measures listed above Confirmed cases of COVID‐19 should be isolated away from susceptible household members if there are not completely separate bedroom, bathroom and kitchen facilities If care must be provided at home, ill household members are given their own room and only one person cares for them The door to the ill person's room is kept closed10 Wearing simple surgical or dust masks by both infected persons and other family members caring for the patient if needing to be in the same room Consider extra protection or alternative accommodation for household members aged over 65 years or with underlying illness COVID‐19 = coronavirus disease 2019. *Ill person refers to someone with symptoms of respiratory illness or fever, who is not yet under investigation for COVID‐19 but could be an unrecognised case. †This could be costly unless used judiciously while awaiting exclusion of COVID‐19 in the suspected case and should be introduced based on likelihood of local transmission. ‡Evidence that low temperature and low humidity in air‐conditioned environments may enhance the survival of coronaviruses such as severe acute respiratory syndrome (SARS).11 §When international travel restrictions are lifted, sites such as the Centers for Disease Control and Prevention travel risk assessment site may be useful (https://www.cdc.gov/coronavirus/2019-ncov/travelers/map-and-travel-notices.html). Box 2 – Intended impact of enhanced hygiene and physical distancing measures on the coronavirus disease 2019 (COVID‐19) pandemic* *Figure adapted from Fong et al.13 Box 3 – Conceptual model of how pre‐emptive interventions with a negative multiplier effect could affect an impending epidemic

Craig B Dalton · Stephen J Corbett · Anthea L Katelaris

Victorian legislation will help the health sector reduce emissions and adapt to climate change

Brett Sutton · Vanora Mulvenna · Daniel Voronoff · Tiernan Humphrys

The origins, scope and significance of the 2019–2020 Climate Health Western Australia Inquiry

Tarun S Weeramanthri · Sarah Joyce · Revle Bangor‐Jones

A lockdown can substantially reduce epidemic size and flatten the curve, ensuring that health system capacity is not exceeded and economic recovery occurs sooner than with a phased approach Exponential epidemic growth has been clearly demonstrated for coronavirus disease 2019 (COVID‐19) in every country it has touched, with ascertained cases growing from 25 at the start of March in Australia to over 6000 cases 6 weeks later. For every ascertained case, there may be anywhere up to nine infections that are not detected.1 This silent component of spread is likely driven by asymptomatic2 or mild infection, especially in younger people. In countries which restrict testing to symptomatic high risk people only, there will be silent growth of undetected infection until the epidemic is large enough to be felt in the health system.3 The epidemic in China was largely localised through January 2020, with small numbers of imported cases in other countries. Following a lockdown on 23 January, it peaked on 5 February4 and has declined since. However, as the cases decreased in China, COVID‐19 began surging in other countries by late February. Asian countries such as South Korea took an aggressive approach to testing and achieved control.5 In contrast, a more relaxed approach saw Europe becoming the new epicentre, followed by the United States,6 which had epidemic growth because of major testing failures. In Italy, Spain and parts of the US, health systems capacity has been exceeded, with resulting shortages of intensive care beds and ventilators. Case fatality rates (CFRs) have varied globally, from 0.85% in South Korea to over 10% in Italy.7 Whether the CFR is 0.85% or 10%, this is orders of magnitude higher than seasonal influenza8 or even the 2009 influenza pandemic.9 Two factors influence CFR — testing and capacity to ventilate. More widespread testing will result in identification of mild and asymptomatic cases, as in South Korea, and a lower apparent CFR. Given respiratory failure is the leading cause of death from COVID‐19, the inability to ventilate patients will drive the CFR up. In Germany, the number of intensive care unit (ICU) beds per head of population is 29.2 per 100 000 compared with 12.5 per 100 000 in Italy,10 so despite having a high number of cases, capacity has not been exceeded. In Italy and Spain, however, ICU capacity was exhausted. In contrast, in China, large hospitals were built in a matter of days to ensure that capacity to ventilate patients was not lost, keeping the CFR lower than in Italy. From this perspective, it is key that Australia flattens the curve to keep health system capacity available to ventilate every patient who needs it. We have 9.4 ICU beds per 100 000 population — less than Italy — although Australian capacity has been expanded as part of COVID‐19 preparedness.11 R0 and flattening the curve Central to flattening the epidemic curve is R0, the basic reproductive number. R0 is the number of secondary cases arising from one index case in a completely susceptible population. The epidemic threshold is defined mathematically as when R0 exceeds 1, which creates conditions for an epidemic, although an epidemic may not always occur. If R0 is less than 1, an epidemic cannot be sustained because one infectious case infects less than one other person on average, and infection will die out. The best estimates of R0 for COVID‐19 lie between 2 and 3.12 Public health disease control strategies such as vaccination, social distancing and travel bans aim to reduce the R value to below 1, thereby stopping the epidemic. The R modified by such measures is manifested as flattening of the curve, which is dampening of the natural trajectory of the epidemic that would otherwise occur. Herd immunity strategy — risks and no benefits Closely related to R0 is the concept of herd immunity. Herd immunity is a concept related largely to vaccination programs. It is the observation that when enough people are immune to an infection, even people who are non‐immune are protected because the number of non‐immune individuals is too small for infection to spread. Immunity can be gained by infection or by vaccination. Unless we can eradicate an infection, vaccination is the only way to control it long term. However, a range of non‐pharmaceutical measures will also control epidemics, and can be used in the short to medium term to reduce the size of the epidemic, manage demand in the health system, and save as many lives as possible. The required proportion of people in a population who need to be immune to induce herd immunity (H) is related to R0 and calculated by the formula H = 1 − (1/R0).13 If we assume R0 is 2.6, we need 61% of the Australian population to be immune to gain herd immunity for the remaining 39% of people. Therefore, any desire to “allow” some transmission (an idea floated by some experts in the United Kingdom and Australia) will only cause more disease and death without any benefit at infection rates < 60%.14 If > 60% of Australians were infected, we would have a worst‐case scenario, endanger our health workers, and rapidly exhaust our health system capacity. Further, allowing transmission of COVID‐19 would not get rid of the disease — it would cause recurrent, cycling epidemics of a mass scale, as seen with measles, mumps, rubella, smallpox and all other epidemic infectious diseases before vaccination. We would also see resulting high morbidity and mortality in older people, as 50% of the population is aged over 40 years. Younger people would also be affected. In the US, 36% of patients admitted to the ICU were aged 45–64 years and 12% were aged 20–44 years. Deaths in the US have been seen in all age groups above 18 years.6 Large studies also show that children can have severe disease or die — 50% had mild disease, 30% moderate disease and 6% critical illness.15 In one study, a child aged 10 months died.16 Young people and children tend to transmit respiratory infections most intensely in society because they have the highest contact rates.17 This means that mild or asymptomatic infection in young people could be a driver of epidemic growth. Many people live in multigenerational arrangements, so young people becoming infected could result in older people or people with chronic diseases becoming ill. The Australian response The Deputy Chief Medical Officer suggested, based on modelling, a worst case scenario of 15 million Australians infected and 150 000 deaths.18 We are a high income country of 26 million people, and it should be noted that in China, with nearly 1.4 billion people, even if true case numbers were 100 times greater than reported, less than 1% of their population was infected and 3298 people had died as of 23 March 2020.7 We may not be able to achieve China‐style lockdowns, but surely we can control the disease enough to spare our health system and minimise morbidity and mortality. Modelling for Australia suggests we could run out of ICU beds if the epidemic trajectory remains unaltered.19 The protection of the health workforce is also key to our response. The other impact of health system overload is the infection of health workers, who are already vulnerable because of the failure to stockpile adequate personal protective equipment (PPE), thus further compromising the ability to respond. Studies have shown that viable severe acute respiratory syndrome coronavirus 2 can be found widely on surfaces and in the air 3 hours after aerosolisation, highlighting the risk of airborne transmission.20 This is supported by the finding of the virus in air outlet fans in the hospital room of an infected patient.21 It is therefore likely that transmission is multimodal, including respiratory and contact. In the US, critical PPE shortages forced health workers to use plastic garbage bags as gowns, with some workers dying. The US Centers for Disease Control and Prevention initially recommended respirators for health workers treating COVID‐19, but as shortages worsened, downgraded this to surgical masks and even bandanas.22 We must flatten the curve to ensure that Australian health workers are not placed at risk by PPE shortages. Further, if hospital beds are full with COVID‐19 patients and a large proportion of health workers are infected, the ability to treat other serious conditions like cardiovascular disease will be reduced. Mass community palliative care Another consequence of health system overload will be the need for community palliative care for patients with COVID‐19 who are unable to access hospital care. While the potential for mass mortality is sometimes considered in major disaster plans, the issue of mass palliation is often neglected. In severe COVID‐19 pneumonia, where respiratory support is not available there is a progressive decline of the patient until ultimate demise associated with severe hypoxaemia, cardiac failure, acute respiratory failure and sepsis. In the days and hours before death, however, the patient will usually suffer from progressive dyspnoea, chest pain and delirium, and will become progressively moribund and immobile.23 Provision of equitable, compassionate, safe and dignified end‐of‐life care to people with COVID‐19 who are unable to be offered life‐saving critical care is fundamental to ensuring the integrity of the Australian social fabric, and the moral and mental welfare of potentially large swathes of the population. Up to 40% of older women and 22% of older men aged 80 years and over live alone (https://aifs.gov.au/publications/nature-living-alone-australia), complicating how to achieve what is necessary and right. Planning around the country for this worst case outcome is currently underway, but requires significant resources, personnel, government support and a national approach. Short, sharp lockdown versus phased approach The impact of interventions is generally seen one to two incubation periods from implementation. The flattening of the curve seen in Australia from 24 March probably reflects the impacts of rolling travel bans implemented from 5–10 March. However, New South Wales is the epicentre of infection in Australia, and the lapses in border control with the Ruby Princess and other cruise ships may have led to an increase in cases by mid‐April. In light of this, a comprehensive lockdown including school closure buys time to scale up testing for when restrictions are lifted. A slow trickle of phased interventions and a “wait and see” strategy will leave us dealing with COVID‐19 in the health system for longer. For doctors, it is no consolation to hear that “we are not like Italy, Spain or the US”. All are high income countries that used a restricted testing strategy, unlike our Asian neighbours. The UK is probably the country whose approach has been most similar to ours. They are facing a strain on the National Health Service and shortages of PPE, despite confident assertions by authorities only weeks ago. The UK, like Australia, used restricted testing and did not test asymptomatic close contacts and other high risk groups.24 To ensure that Australia continues to flatten the curve, social distancing is especially important because of asymptomatic transmitters of infection. Being unable to identify infectious cases makes disease control much harder. Until we have a vaccine, all we have available in the toolkit is social distancing and travel restrictions, along with isolation of sick people and quarantine of contacts and return travellers. The World Health Organization recommends school closure during a serious pandemic, and outlines the evidence showing that comprehensive, simultaneous social distancing measures and early school closure work better than phased or gradual measures.25 China has demonstrated the feasibility of a short lockdown followed by phased lifting of restrictions. The Chinese epidemic curve4 shows the success of the lockdown, implemented in Wuhan on 3 January, while the epidemic was in the exponential growth phase with thousands of new cases a day. Within one incubation period, cases started to fall. China began lifting restrictions on 9 February, just over one incubation period from the lockdown. They have continued to gradually lift restrictions, from a more manageable baseline position of far fewer cases to track and contain, all within 8 weeks. A lockdown is a temporary measure which can result in substantial reduction of epidemic size, more manageable case numbers and a flattening of the curve so that health system capacity is not exceeded and economic recovery can occur sooner. Lockdown can be relaxed safely in a phased manner, but must be accompanied by extensive testing, including of asymptomatic high risk people such as close contacts, evacuees and people in institutional outbreak settings. To ensure all community cases are detected, any doctor should be able to exercise clinical judgement and order a test for COVID‐19. Failure to test asymptomatic at‐risk people and allow wider community testing will result in undetected transmission in the community and a bounce‐back of the epidemic as lockdown restrictions are lifted. The only two countries to achieve sustained flattening of the curve to date are South Korea and China. South Korea has achieved this with more targeted, short lockdowns along with extensive testing.5 The risk of a phased and gradual approach is continued epidemic growth, potential failure of the health system, and a far longer road to recovery. We have examples of countries that have failed and succeeded, which can guide such a response. Epidemic control is time critical, because epidemics rise exponentially. There is no real choice available between jobs and lives — failing to save lives now will result in more net job losses and a longer recession. In addition to expanded testing, key strategies to accompany a lockdown must be a financial aid package that is accessible and leaves no person in need; a mental health and domestic violence package with outreach capability; aged care and disability support; and support for Aboriginal and Torres Strait Islander communities. Much of this is already being addressed by the government. Other needs may also become apparent, such as a communications and social engagement package; a physical fitness package; and identification of other vulnerable groups and required support to ensure the wellbeing of all Australians. The unedited version of this article was published as a preprint on mja.com.au on 1 April 2020.

C Raina MacIntyre · David J Heslop

Opportunities to recognise and invest in general practice research need to be realised General practice research is essential to quality general practice, building an evidence base for over 27 000 general practitioners working within the specialty who provide medical care to the majority of Australians.1 Over eight in ten Australians consult with their GP at least once per year, and two million people are seen each week in general practice.2,3 General practice, a medical specialty, is the first point of access to the health system, providing longitudinal care for all. It is essential for the delivery of efficient, equitable and effective health care services.4 General practice is unique, complex and continuing to evolve. A GP must have a good working knowledge of 167 problems to cover 85% of the conditions that they see most frequently,5 and management of multimorbidity has become the norm. The number of general practices appears to be declining, practices are becoming larger, and the proportion of GPs who are practice owners is decreasing.6 General practice research is key to optimising health care in this evolving context, but needs to be supported by the profession, funders and our professional colleges. Current challenges General practice has traditionally been seen as an applied discipline, rather than one with an academic underpinning, and research has therefore been undervalued. The undervaluing of general practice research is reflected in current research funding and a paucity of opportunities during specialty training. The proportion of National Health and Medical Research Council funding to primary care research has been consistently low,7 and this has continued in the current Medical Research Future Fund budget, with only $5 million of $392.5 million for the 2019–20 financial year specifically allocated to primary care,8 despite primary care being noted as a medical research and innovation priority for 2018–2020.9 The Medical Research Future Fund 2019 investigator grant opportunity for early to mid career researchers included primary care research as one of its 11 research priority areas, but it will not be known if general practice research specifically has been supported until the results of that round are released. In the context of this undervaluing, GPs who have completed PhDs have expressed concerns about insecure academic career pathways,10 and the current ageing GP research workforce may not be replaced.11 Additional barriers to general practice research include lack of funding for Australia and New Zealand's academic primary care peak body (the Australasian Association for Academic Primary Care), general practice research networks, and payments to adequately compensate practices for the time and resources required to participate in research. Recent achievements Despite the challenges, general practice has a long tradition of rigorous, detailed and credible scientific research. This work covers a broad range of research questions, utilising a range of methodologies and frameworks (Box). However, general practice research outcomes are often less visible as hospital admissions avoided, diseases prevented, complications averted and health services redirected are key outcomes.4 The generalist nature of primary care means that research must deal with heterogeneous populations, multimorbidity and complex health service delivery. What would health care look like without general practice research? Primary care is the most efficient, equitable and effective place to deliver health care for most of the population,4 and is underpinned by a growing scientific knowledge base as research in and about general practice has evolved and grown over the past 50 years.12 Research in this setting is required as never before, with an ageing population, increasing rates of multimorbidity, and management continuing to move out of the hospital and into the community setting.13 There is no other academic specialty that will focus on generalist care in the community, and general practice is integral to research translation. Without general practice, the health outcomes of the population will be poorer and less equitable, and associated with increased health costs.4 Contextual knowledge of primary care is essential for credible and relevant general practice research. It is hard to imagine research into cardiology, for example, without the involvement of cardiologists. However, it is not uncommon for research in health services and primary care to not involve GPs, or to involve them at a late stage in development. Without GP involvement, research outcomes are unlikely to be fit for the general practice environment or appropriate for patients attending primary care. Academic GPs play important roles in both research and teaching, including training academic GP registrars and supervision of primary care researchers and students more broadly. They contribute to shaping the policy and practice environment through representing general practice on guideline development groups and engaging with international colleagues to develop and implement research methodologies suitable for the primary care environment. Without support of general practice research and training, this expertise would be lost. GPs and practice staff work with academic GPs and play a critical role in the development and implementation of interventions, recruitment and data collection and interpretation. Without compensation for their time (participation in research often results in loss of income) and without the infrastructure of practice‐based research networks, this practice knowledge cannot be harnessed. Data collected from general practice that is not interpreted through a generalist lens with an understanding of the context in which general practice operates can result in conclusions that do not reflect practice. A lack of focus on general practice research and academic opportunities will have a flow‐on effect to the recruitment of new GPs. To build interest in general practice more broadly, attention needs to be paid to medical students who often believe there is little intellectual challenge in the profession and a lack of academic opportunities.14 The national General Practice Student Network, a network for medical students interested in general practice supported by General Practice Registrars Australia, provides an opportunity for academic GPs and the Royal Australian College of General Practitioners (RACGP) to link with medical students to showcase opportunities for GP research, teaching and academic training. Towards the future Vocational training will be transitioned to the RACGP and the Australian College of Rural and Remote Medicine from the federal Department of Health in January 2022. This presents a real opportunity for shaping the future of general practice training by acknowledging the importance of research to the discipline, expanding current academic registrar programs and encompassing key Australian Medical Council accreditation recommendations, including that appropriate candidates can enter research training during specialist medical training with opportunities to undertake intercalated research degrees.15 This would provide a foundation for a supported path in GP academia. The RACGP Expert Committee – Research is currently developing a research strategy that will address these issues. Advanced Health Research Translation Centres and Centres for Innovation in Regional Health exist around Australia, and are partnerships of hospitals, research institutes and universities developed to accelerate translation of research into clinical care. As these structures currently stand, primary care is often lost among the multitude of hospital partners and clinicians and researchers who have little experience of, or interaction with, general practice. The Centres work together as the Australian Health Research Alliance, which currently does not include primary care as one of its system level initiatives. A focus on primary care would provide a more meaningful option for engaging with community general practice and primary care, working collaboratively with properly funded and sustainable practice‐based research networks that have led to successful innovations in other parts of the world. The GP academic community would welcome closer collaboration with both the Medical Research Future Fund and the Australian Health Research Alliance. The promise of big data has huge implications for general practice, with many heralding this as the beginning of a new era, but big data without appropriate expert interpretation is likely to lead to misunderstanding. General practice has a long history of working with data, starting with Charles Bridges‐Webb developing the first general practice survey in 1961, laying the groundwork for the Bettering the Evaluation and Care of Health (BEACH) program.2 Large general practice datasets are now held by NPS MedicineInsight, Primary Health Networks, and departments of general practice (for example, the UNSW electronic Practice Based Research Network and the Data for Decisions program at the University of Melbourne). The ability to track the patient journey between primary care and hospitals is being realised through linked datasets. The National Primary Health Care Data Asset is now under development, and it is critical that this includes oversight and input of GP clinician‐scientists to ensure that data are not misinterpreted. General practice is an academic specialty based on an international body of literature and decades of research. However, in Australia we still have a way to go to understand why primary care works in our context, how to best implement change, and how to teach best practice to new clinicians. Recognising and investing in the value of general practice research will require a systems approach that includes medical student training, vocational training, and support of research infrastructure and GP clinician‐scientists to enable research and research training in general practice and translation into practice and policy. This investment in general practice research and infrastructure should reflect the size of general practice in Australia, the population it serves, and the proportion of the associated Medicare spend. Box – Examples of general practice research informing clinical practice and health service design Research Key findings and implications for general practice General practice research involvement ASPirin in Reducing Event in the Elderly (ASPREE)12 Higher all‐cause mortality was found in healthy older adults in Australia aged over 70 years of age who received daily aspirin. This suggests that aspirin may not be of benefit for primary prevention of cardiovascular disease in this age group Mark Nelson (principal investigator) and Nigel Stocks were authors on this randomised controlled trial. Australian GP Associate Investigators in clinical practice recruited 87% of the 19 114 patient participants What treatments are effective for common colds in adults and children? Decongestants alone, or with antihistamines or analgesics, can be helpful for adults with nasal symptoms, but other commonly recommended treatments such as echinacea, vapour rub and heated, humidified air have no evidence of effect Systematic review led by Mieke van Driel13 Comparing non‐sterile to sterile gloves for minor surgery: a prospective randomised controlled non‐inferiority trial14 Non‐sterile gloves are not inferior to sterile gloves in regard to wound infection for minor skin excisions in general practice Trial led by Clare Heal, conducted in a single private general practice in Mackay, Queensland How to increase uptake of long acting reversible contraception (LARC) through general practice15 Online GP training in effectiveness‐based contraceptive counselling, together with GP access to rapid referral to a LARC insertion clinic increases LARC uptake by women Cluster randomised controlled trial in 57 general practices in Melbourne led by Danielle Mazza Bettering the Evaluation and Care of Health (BEACH)2 The BEACH dataset, consisting of almost 1.8 million GP–patient encounters recorded between 1998 and 2016, has been used to inform general practice research, education and policy Each year, about 1000 GPs recorded data about 100 consecutive patient encounters, contributing to the development of the BEACH dataset. Graeme Miller was the Medical Director of BEACH Clinical outcomes of an integrated primary–secondary model of care for individuals with complex type 2 diabetes: a non‐inferiority randomised controlled trial16 GPs with special interests working with a Beacon model of integrated care for diabetes achieved clinical outcomes that were not inferior to hospital‐based specialist clinics, with greater patient satisfaction Claire Jackson co‐led the development and evaluation of the Beacon model, which has now also been adapted and utilised in Western Australia Composite Abuse Scale17 The Composite Abuse Scale was developed as a research tool to classify women according to type and severity of abuse. It has been translated into eight languages and is considered the standard for assessing women's self‐reported experiences of abuse The Composite Abuse Scale was developed by Kelsey Hegarty and used in a cluster randomised controlled trial to identify women who screened positive to intimate partner violence and who may benefit from brief counselling from their GP

Jo‐Anne E Manski‐Nankervis · Elizabeth A Sturgiss · Siaw‐Teng Liaw · Geoffrey K Spurling · Danielle Mazza

An objective measure could support GPs’ clinical judgement and aid discussions about the need for on‐road testing or driving cessation Assessing fitness to drive in older people is an increasingly important but challenging role for general practice. General practitioners are often the first port of call for concerned family or friends, and many Australian states and territories require older drivers to undergo regular assessment of their health and fitness to drive. Some GPs are uncomfortable in this role, citing concern to maintain relationships with older patients, concern about the impact of driving cessation, lack of familiarity with legal responsibilities and local resources, lack of training and clear guidance, lack of an objective measure, and poor access to on‐road driving assessments.1,2,3,4 Some GPs report sleepless nights having assessed an older person as fit to drive for another year.1 While the answer might be simple — that is, to speak to the older person and their family — this is not always straightforward. An objective measure of driving fitness could help. The number of older drivers in Australia is increasing, as is the number of seriously or fatally injured very old drivers (≥ 85 years of age).5 Older people are more vulnerable in road traffic accidents and are more likely to die or suffer severe injury.5,6 While road deaths in Australia have decreased overall in the past ten years (19%), road deaths in older people (≥ 75 years of age) have increased (23%).7 Driving is a complex task requiring sensory input (vision, hearing), cognitive function (attention, comprehension, memory, decision making, reaction time), and motor function (power, coordination).8 Ageing is associated with decline in sensory, cognitive and motor function. Accidents can happen to anyone, but road traffic accidents involving older drivers often receive widespread media attention. Recent examples include Prince Philip's driving accident at the age of 97 years, and the 86‐year‐old driver on the Sunshine Coast who reversed over and killed a 6‐year‐old girl.9 However, the loss of a driver's licence can be a devastating blow to independence and wellbeing.10 While many older drivers are safe and cautious drivers aware of their limitations, some are not. GPs play a key role in monitoring driver safety. GPs have two main responsibilities: to assess and make a recommendation on a driver's health and fitness to drive when requested, and to report to the relevant licensing authority any impairment adversely affecting a driver's ability to drive safely when impairment is known. The duty to report is discretionary in most Australian states, but in South Australia and the Northern Territory it is mandatory. Doctors who report in good faith are protected from civil and criminal liability for breaching patient confidentiality, except in the NT where there is no express legal protection.8 The requirements for medical assessment in older drivers of private vehicles vary across Australian states and territories (Box).8 In Queensland, the Australian Capital Territory and New South Wales, drivers are required to undergo an annual medical assessment from the age of 75 years; in Western Australia, drivers are required to have an annual assessment from 80 years of age; while in SA, the NT, Victoria and Tasmania, there is no specific age‐based requirement. Some states require on‐road testing from the age of 85 years for some licence classes. Each state licensing authority has developed its own medical assessment form, with substantial variation in the information collected. SA has the longest assessment form, with 73 tick‐boxes listing medical conditions. SA and WA also collect information about recent involvement in road traffic accidents. Most states require drivers to submit the completed form to the licensing authority themselves, but some states give GPs the ability to complete and submit the form online, preventing drivers discarding unfavourable assessments and doctor‐shopping. The GP role in assessment is to ensure that the health of older drivers meets medical standards and does not unduly increase their crash risk. Austroads and the National Transport Commission have produced an extensive document to guide GPs in assessment.8 While the Austroads document has much useful information, some GPs say its utility in the time‐pressured context of general practice is limited, and that the document lacks clear guidance on referral thresholds and use of screening tests.1,2 The document recommends that GPs assess functional ability across three domains — sensory, cognitive and motor function — and that the key question GPs should consider is: “Is there a likelihood the person will be unable to control the vehicle and act or react appropriately to the driving environment in a safe, consistent and timely manner?”.8 The document provides detailed guidance on the medical standards for driver licensing purposes for many medical conditions; however, it is less clear regarding the increasingly common grey zone where an older person may be mildly impaired across several domains, with multiple interacting conditions including mild cognitive impairment and multiple medications. The document recommends: “Professional judgement must determine what is acceptable decline … and what is irreversible, hazardous deterioration in driving‐related skills that requires reporting to the licensing authority”.8 If GPs are uncertain or concerned, the document recommends that they refer older drivers to a medical specialist or general occupational therapist for assessment, or to a driver assessor occupational therapist for on‐road testing.8 On‐road testing “remains the most accurate way of determining fitness to drive”.11 However, on‐road testing is likely an imperfect predictor of future crash risk,12 especially in the context of fluctuating health conditions, and in Australia can be difficult to access, especially in rural and remote areas, and costly.1,2 In practice, GPs often use the relevant state or territory medical assessment form to guide their assessment, and make their recommendation based on clinical judgement sometimes informed by a single cognitive screening test.1 The in‐office screening tools that GPs report using most often in Australia include the Montreal Cognitive Assessment, the Mini‐Mental State Examination, the clock‐drawing test, and the Trails Making Test.1,2,4 However, despite their widespread use in clinical practice, single screening tests do not reliably predict driving risk.13,14,15 A toolkit comprising a composite battery of tests correlates better than any single test with the on‐road driving assessment.13,14,15,16 A toolkit validated for use in general practice is needed. Such a toolkit would not replace the occupational therapist on‐road assessment, but could support GP clinical judgement in differentiating older drivers in need of on‐road testing or driving cessation, and could be used as a communication tool to support a recommendation for further assessment or driving cessation while preserving relationships (“the test says …”). A toolkit used regularly, say annually, might demonstrate change over time, which could guide discussions about the need to plan for eventual driving cessation. Several toolkits have been developed and tested internationally, but their uptake in general practice has been limited, sometimes by the need for special equipment or input from family members.11,14,17 To be feasible in the Australian general practice context, any toolkit would need to be easy and quick to administer and require no expensive equipment or special training. Ideally, a toolkit would assess across all three functional domains and have face validity with older drivers, as some older drivers may, for example, consider memory tests irrelevant to their driving ability. A toolkit developed and tested by a Belgian group looks promising.18 This toolkit comprises visual acuity using the Snellen chart, the Functional Reach Test,19 and a road signs recognition test (a component of the Stroke Drivers Screening Assessment20). These tests assess across all three functional domains and are potentially readily accessible in general practice. When tested in Belgian drivers aged ≥ 70 years, the three tests together correctly classified two‐thirds of drivers compared with the on‐road driving assessment.18 Preliminary use of the toolkit in three Australian GP practices (JM, GS) suggests that the toolkit is acceptable to both patients and practitioners, and that the tests can be completed in a timely fashion. No toolkit is likely to be perfectly sensitive and specific — there will always be a need for GPs to use clinical judgement. Nevertheless, an objective measure could support GPs’ clinical judgement and aid discussions about the need for on‐road testing or driving cessation. Work remains to validate and test a toolkit for use in Australian general practice. Box – Regulatory requirements for medical assessment of older drivers of private vehicles, and practitioner reporting duties, by Australian state or territory8 State or territory Medical assessment Patient declares crashes Duty to report Australian Capital Territory Annually from 75 years of age No Discretionary Not liable if report in good faith New South Wales Annually from 75 years of age No Discretionary Not liable if report in good faith Northern Territory Only when condition notified No Mandatory No express indemnity Queensland Annually from 75 years of age No Discretionary Not liable if report in good faith South Australia No prescribed period or age for licence class C, otherwise annually from 70 years of age Traffic crashes in past 5 years Mandatory Not liable if report in good faith Tasmania No prescribed period or age, but may occur if a condition or concern is declared or reported No Discretionary Not liable if report in good faith Victoria No prescribed period or age, but may occur if a condition or concern is declared or reported No Discretionary Not liable if report in good faith Western Australia Annually from 80 years of age, unless a medical condition requires earlier assessment Traffic offences and crashes Discretionary Not liable if report in good faith

Katharine A Wallis · James Matthews · Geoffrey K Spurling

Risk of SGLT2 inhibitor-associated diabetic ketoacidosis in type 2 diabetes: some answers, but more questions

Peter S Hamblin · Rosemary Wong · Leon A Bach

Timely diagnosis of cirrhosis and HCC surveillance using ultrasound may help improve patient outcomes

Gary P Jeffrey · Louisa Gordon · Grant Ramm

Gaps in availability of both meningococcal ACWY and B vaccines exist for high risk groups Invasive meningococcal disease (IMD) is a serious disease and an emotive public health issue in Australia. In the early 2000s, IMD case numbers declined nationally by about 80%, from 688 in 2002 to 149 in 2013,1 due to a drop in serogroup C and B disease. The decline in serogroup C disease followed the comprehensive childhood meningococcal C vaccination program — free vaccination was available up to age 19 years — introduced in 2003.2 Simultaneously, but without clear cause in the absence of vaccination, meningococcal B (MenB) disease declined slowly from 1.49 cases per 100 000 population in 2003 to 0.47 in 2015 (293 and 112 cases respectively).3 Overall, the IMD incidence rose again after 2014, driven mainly by the emergence of serogroup W and, to a lesser extent, serogroup Y.1,4 Most serogroup W strains are close variants of the virulent ST‐11 clone initially identified in the United Kingdom and South America in 2009, which was associated with more frequent atypical clinical presentations, greater severity and increased mortality.1 Although the emergence of serogroups W and Y was a game changer, serogroup B still accounted for about half of all IMD cases in Australia between 2016 and 2018.4 Compared with some other vaccine‐preventable diseases, IMD is relatively rare, affecting about one in every 100 000 Australians, equating to an average of 250 cases per year between 2014 and 2018.1,4 However, the case fatality rate is high, and around 10–30% of survivors experience long term sequelae.3,5 Although IMD can occur at any age, it is more common in children aged less than 2 years (especially those aged < 12 months) and older adolescents (Box 1). Aboriginal and Torres Strait Islander (hereafter respectfully referred to as Indigenous) children aged up to 14 years are also disproportionately affected compared with non‐Indigenous children (Box 2). For example, rates of serogroup W IMD in Indigenous children were more than 30‐fold higher compared with non‐Indigenous children of the same age during 2016–2018 (Box 2). People with certain medical conditions also have a high risk of IMD.6 These conditions include asplenia; complement deficiency, which in some types the risk is up to 10 000 times greater than in the general population;7 and use of eculizumab, which is a monoclonal antibody directed against complement and is used for treating paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome. Increased use of quadrivalent meningococcal conjugate vaccines Three brands of quadrivalent meningococcal conjugate (MenACWY) vaccines are available in Australia: Menactra (Sanofi), Menveo (GlaxoSmithKline) and Nimenrix (Pfizer). These quadrivalent vaccines include a capsular polysaccharide from each ACWY serogroup conjugated to a carrier protein, superseding the less immunogenic polysaccharide‐only vaccines previously used. The rapid rise of serogroups W and Y disease prompted all states and territories to fund MenACWY vaccination programs in 2017 and 2018 as an outbreak response.8 These programs varied but predominantly targeted adolescents aged 15–19 years, aiming to both directly prevent disease and to interrupt community transmission of meningococci through reduced acquisition of nasopharyngeal carriage, which is most prevalent in this age group.9,10 Some jurisdictions also implemented time‐limited vaccination programs covering select age groups, from infancy up to older adolescence, to control serogroup W outbreaks. The most notable of these outbreaks began in September 2017 in the Northern Territory and spread to nearby communities in central Australia, including regions in Western Australia, Queensland and South Australia. Indigenous children aged less than 10 years living in remote communities were primarily affected, with 19 cases within a few months.11 Meningococcal B vaccine use in Australia The modes of transmission, pathogenesis and treatment of serogroup B IMD are the same as for IMD caused by other serogroups, although the case fatality rate appears lower for serogroup B (6.9%) than for serogroups W, C and Y (12.8%, 12.0% and 10.8% respectively).12 However, the development of a vaccine against serogroup B disease was problematic for decades because serogroup B capsular polysaccharide is cross‐reactive with human tissues (an autoantigen) and thus poorly immunogenic.13 Two MenB vaccines, developed using novel recombinantly derived protein antigens common to many serogroup B strains, are now available in Australia: Bexsero (GlaxoSmithKline), since 2013, and Trumenba (Pfizer), since 2017. Trumenba is only registered for use from 10 years of age, whereas Bexsero can be used from 6 weeks of age. Both MenB vaccines have a high cost (around $100 per dose) and require multiple doses. Bexsero also causes higher rates of fever in young children than other vaccines included in the National Immunisation Program (NIP), necessitating the use of prophylactic paracetamol around the time of immunisation.6 Data on the benefits of MenB vaccine use are gradually accumulating, predominantly from the UK, which is the only country to have formally evaluated an ongoing funded population‐based program. Infants in the UK have been offered a three‐dose course of Bexsero (scheduled at ages 2, 4 and 12 months) since 2015. New data from the UK over 3 years estimate vaccine effectiveness against serogroup B IMD to be 52.7% (95% CI, −33.5 to 83.2) for a two‐dose primary schedule for infants, and 59.1% (95% CI, −31.1 to 87.2) for a two‐dose primary schedule followed by a booster dose at one year.14 However, Bexsero does not appear to have an impact on nasopharyngeal carriage of serogroup B,9 which implies that herd immunity (indirect protection in unvaccinated individuals) would be limited or absent despite population‐based vaccination.9 In addition, for both vaccines, protection against only around three‐quarters of all circulating MenB strains is predicted, based on in vitro assays.15 To date, the use of MenB vaccines in Australia has been limited in the absence of NIP funding. In October 2018, in the context of higher serogroup B IMD incidence rates compared with other parts of Australia, the South Australian government introduced the only state‐funded MenB vaccination program for young children, expanding to adolescents in February 2019.8 In 2020, a population‐level study of adolescent MenB vaccination in the Northern Territory will commence to explore its impact on gonorrhoea — a high incidence sexually transmitted disease caused by the related organism Neisseria gonorrhoea — as well as on serogroup B IMD (Helen Marshall, Professor in Vaccinology and National Health and Medical Research Council Practitioner Fellow, Robinson Research Institute, University of Adelaide, Australia, personal communication, January 2020). Assessment and introduction of meningococcal vaccines to Australia's National Immunisation Program Both equity and cost‐effectiveness are important considerations when approaching decision making regarding vaccine incorporation into immunisation programs. To be added to the Australian NIP, vaccines require a comprehensive assessment and must be recommended as cost‐effective by the Pharmaceutical Benefits Advisory Committee (PBAC); this is based on economic modelling, typically undertaken by the vaccine manufacturer.16 With a low IMD incidence (one per 100 000), relatively small numbers of deaths, and trends in serogroup incidence being difficult to predict, the accurate assessment of the cost‐effectiveness of both types of meningococcal vaccines (MenACWY and MenB) has been challenging. Low incidence rates have meant reliance on immunologic correlates of protection to predict vaccine impact (randomised placebo‐controlled efficacy studies are not feasible for such rare outcomes) and a limited number of post‐market vaccine effectiveness estimates. Other key uncertainties include the duration of protection and the magnitude of any herd protection effect, particularly for MenB vaccines, for which evidence is showing that there is no effect on nasopharyngeal meningococcal carriage.9 These uncertainties, together with the high cost of the MenB vaccines in particular, provide challenges for the value for money assessment necessary to underpin vaccine introduction into long term programs. In 2018, the MenACWY vaccine Nimenrix replaced the meningococcal serogroup C vaccine on the NIP at 12 months of age, and was also added to the NIP for use in a single birth cohort of adolescents aged 14–16 years from early 2019, replacing jurisdictionally funded programs.8 This is expected to provide direct protection to vaccinated individuals as well as some indirect protection to unvaccinated people over time.17 The potential to fund the MenACWY vaccine for certain high risk groups with underlying medical conditions through the NIP has also been flagged in a recent positive PBAC recommendation,18 which is under active consideration by the Australian Government. The Bexsero MenB vaccine was assessed by the PBAC on three occasions between 2013 and 2015, but was deemed as not being cost‐effective at the manufacturer's proposed price.19 In November 2019, following another manufacturer application, the PBAC recommended the NIP inclusion of Bexsero for Indigenous infants (with a catch‐up to 2 years of age) and for anyone with certain medical conditions (asplenia, complement deficiency, and eculizumab treatment). However, once again, the use of the vaccine in a broader population‐based program for infants and adolescents was not considered cost‐effective.20 The implementation of these recommendations is under active consideration by the Australian Government. Gaps in the prevention of meningococcal disease in Australia The Australian immunisation handbook recommends that any person who wants to protect themselves against invasive meningococcal disease can receive MenACWY and MenB vaccines from as early as 6 weeks of age.6 Box 3 shows groups particularly recommended for vaccination based on their higher risk of disease, compared with current and anticipated funded meningococcal vaccine programs. New proposed and existing funded programs are a substantial achievement and will provide protection to many individuals most at risk from vaccine‐preventable meningococcal strains. However, some equity gaps remain. It will take time to accrue the benefits of reduced MenACWY disease incidence and disease transmission across the population when vaccinating only at ages one and 15 years, especially without including all infants in the NIP‐funded program. It is possible that the disparity in IMD rates between Indigenous and non‐Indigenous children may persist for years, particularly for serogroup B disease, in the absence of herd immunity and of an adolescent program funded by the NIP. Assessing program impact on disease, particularly in jurisdictions where wider populations did, or continue to, receive state‐funded vaccines (against MenACWY or MenB disease), such as Western Australia, Tasmania and South Australia,8 is essential to evaluate evidence of benefit. The remaining access gaps are very challenging to address for high cost vaccines that are not offered at cost‐effective prices by the manufacturer. Other initiatives, such as ensuring that health services fund vaccination of persons living with human immunodeficiency virus and of at‐risk laboratory workers (two groups not included in the NIP), and addressing the social determinants of health that underpin high rates of meningococcal disease (and other vaccine‐preventable diseases), are also important.21 Conclusion Australia has progressively implemented funded vaccination programs for various high risk groups using MenACWY and MenB vaccines over the past 5 years. The anticipated expansion of NIP funding to include medical at‐risk groups for both vaccines and to include young Indigenous children for MenB vaccine, in addition to established MenACWY programs, should be effective over time to protect those most at risk of disease. Close monitoring of emerging data on the duration of vaccine protection from Australia and internationally is needed, particularly for individuals with underlying medical conditions whose risk is enduring. It remains challenging that for one disease, IMD, we must use two vaccines; while at least one pentavalent vaccine (MenABCWY) is under development, it is years away from use, and the assessment of cost‐effectiveness is equally uncertain. This rare but deadly disease will continue to challenge; clinicians should remain aware and discuss vaccination options against both MenB and MenACWY disease with their patients. Box 1 – Invasive meningococcal disease (IMD) notification rates by serogroup and age group (Australia, 2016–2018) The graph shows the rate of cases of IMD notified to the National Notifiable Diseases Surveillance System between 1 January 2016 and 31 December 2018. The total cases include all notified cases of IMD, including serogroups B, C, E, W, Y and unknown serogroup. There were no cases of serogroup A in this period. Box 2 – Average annual notification rates of invasive meningococcal disease (IMD) for Aboriginal and Torres Strait Islander people compared with non‐Indigenous people, by age group and serogroup (Australia, 2016–2018) RR = rate ratio. The graph shows the rate of cases of serogroup B and W IMD notified to the National Notifiable Diseases Surveillance System between 1 January 2016 and 31 December 2018. Box 3 – Australian recommendations for meningococcal vaccination and funded programs*† Recommendations Funded programs for MenB vaccines‡ Funded programs for MenACWY vaccines‡ Overall AIH recommendation Any person who wants to protect themselves against invasive meningococcal disease can receive MenACWY and MenB vaccines from as early as 6 weeks of age No funded programs that cover all age groups No funded programs that cover all age groups Specific AIH recommendations for high risk groups§ All individuals in particular age groups (6 weeks to 4 years and 15–19 years) State/territory: South Australia: 6 weeks to 12 months of age, with catch‐up to 4 years of age8 Northern Territory: to be provided for adolescents from early 2020 as part of an NHMRC‐funded research study¶ NIP: One dose at age 12 months One school‐based cohort (age ~ 15–16 years)8 State/territory: Various current and previous programs — for further detail refer to summary document8 or individual health department websites Aboriginal and Torres Strait Islander people (6 weeks to 19 years of age) NIP: Nil, but anticipated it will likely be included for infants, with catch‐up to 2 years of age20 NIP: One dose at age 12 months One school‐based cohort (age ~ 15–16 years)8 State/territory: South Australia: 6 weeks to 12 months of age, with catch‐up to 4 years of age8 Northern Territory: to be provided for adolescents from early 2020 as part of an NHMRC‐funded research study¶ State/territory: Various current and previous programs — for further detail refer to summary document8 and individual health department websites High risk due to medical condition (asplenia/hyposplenia, complement deficiency, eculizumab use, HIV, post‐HSCT; all people aged ≥ 6 weeks) NIP: Nil, but anticipated it will be included for individuals with asplenia/hyposplenia, complement deficiency, eculizumab use20 NIP: Nil, but anticipated it will be included for individuals with asplenia/hyposplenia, complement deficiency, eculizumab use20 Other: Some individual hospitals or local health services may fund the vaccine for patients with HIV or HSCT Other: Some individual hospitals or local health services may fund the vaccine for patients with HIV or HSCT Other risk factors (young adults aged 20–24 years who smoke or live in close quarters; eg, military barracks or university residential accommodation) Nil (self‐funded) Nil (self‐funded) Laboratory workers at risk Nil (may be employer‐funded) Nil (may be employer‐funded) Travellers to endemic areas Nil (self‐funded) Nil (self‐funded) AIH = Australian immunisation handbook; HIV = human immunodeficiency virus; HSCT = haematopoietic stem cell transplant; NHMRC = National Health and Medical Research Council; MenACWY = serogroups A, C, W and Y meningococci; MenB = serogroup B meningococcus; NIP = National Immunisation Program. * Adapted from the AIH6 and other referenced sources. † Note that the number of doses recommended varies by specific group — refer to the AIH for details. ‡ As of 17 January 2020. § Recommendations are for both MenACWY and MenB vaccines. ¶ Helen Marshall, Professor in Vaccinology and NHMRC Practitioner Fellow, Robinson Research Institute, University of Adelaide, Australia, personal communication, January 2020.

Cyra Patel · Clayton K Chiu · Frank H Beard · Nigel W Crawford · Kristine Macartney

We need informative citation metrics that will be less prone to misuse and gaming

John PA Ioannidis · Kevin W Boyack

Inclusion of the right to health in Queensland's Human Rights Act is historic but not without challenge In February 2019, the Queensland Parliament passed the Human Rights Act 2019, which took effect on 1 January 2020. Its introduction makes Queensland the third Australian jurisdiction to implement human rights legislation, after the Australian Capital Territory and Victoria in 2004 and 2006, respectively. While the Queensland Act is based on a model of rights legislation broadly consistent with the Victorian and ACT models, it differs in its inclusion of the right to health services (section 37): Every person has the right to access health services without discrimination. A person must not be refused emergency medical treatment that is immediately necessary to save the person's life or to prevent serious impairment to the person.1 The inclusion of section 37 is historic. The right to health is made subject to law on Australian shores and a state/territory government is finally accountable, by law, to protect and promote the enjoyment of the highest attainable standard of physical and mental health. Rights language is part of Australia's public health vernacular, evidenced by the Australian Charter of Healthcare Rights.2 However, unless such rights are expressed in domestic law, then right to health principles and policies are important words on paper without overt legal consequence for effective monitoring and accountability.3,4 As Australia lacks a legal tradition regarding the right to health, the introduction of section 37 creates interpretive challenges for the new Queensland Human Rights Commission (QHRC). The right to health has received limited robust attention in both Australian schools of public health and law, as well as in Australian public health‐related literature.5 The QHRC, and Queensland's courts and tribunals, will likely look to United Nations (UN) commentary on the right to health, and to overseas jurisprudence and scholarship for guidance on section 37's emergent framing.3,6 With the right to health found in over 100 national constitutions and the UN Special Rapporteur on the right to health issuing annual reports, guidance is available.7,8 Health service obligations and remedies under the new Act Queensland government departments and public employees will have a responsibility to protect and promote the human rights of Queensland individuals, and in their health service delivery and decision making, act in a way consistent with their obligations under the Act.1 Health agencies that fit the Act's “public entity” criteria are also bound to comply with the Act. If an individual alleges a section 37 violation, they should make a complaint to the government agency or public entity, which must respond within 45 business days.1,6 If an inadequate or no response is received, the individual — or two or more people jointly — can lodge a complaint with the QHRC.1 Given that the Act's regulatory model favours discussion, rights awareness raising and education, the QHRC will aim to pragmatically resolve section 37 disputes. Monetary damages will not be available.6 In the case of judicial review, a person might have the original decision quashed or referred back to the original decision maker for redetermination.6 In certain circumstances, pending legal advice, a section 37 complainant might have grounds to pursue a distinctly separate medical negligence cause of action if a health professional or service provider breaches their common law duty of care and the complainant has sustained pain and suffering, loss or injury.9 Some grievances against health service providers (notably private providers) can continue to be dealt with by the Health Ombudsman under Queensland's Health Ombudsman Act 2013, and the QHRC may indeed refer complaints to the Health Ombudsman (with the complainant's consent).1,10 However, potential complainants under either Act should be aware the objectives of both Acts markedly differ. The Health Ombudsman Act emphasises that the health and safety of the public are paramount, thereby framing health through a health security lens at the population level, whereas the Human Rights Act takes an individual level approach: the enjoyment of the highest attainable standard of physical and mental health of each and every person in Queensland is paramount (Box 1). Additionally, the Health Ombudsman Act does not recognise the special importance that human rights — and by extension, health and human rights and accessible, non‐discriminatory health service provision — has for Queensland's Aboriginal peoples and Torres Strait Islander peoples.1 On this point, there is no reason why the definition of health services in section 37(1) could not be interpreted to integrate a culturally responsive meaning for Queensland's Indigenous peoples, consistent with the UN Declaration on the Rights of Indigenous Peoples (Box 2).11 Interpreting section 37 and health rights protections found elsewhere in the Act The Act takes a narrow approach to interpreting the right to health Section 37 is modelled on the right to health in article 12 of the International Covenant on Economic, Social and Cultural Rights.12 The UN Committee responsible for the Covenant stated in General Comment No. 14 that article 12 contains two elements: the right to access health services; and the right to access the underlying determinants of health, or the underlying factors that promote conditions in which people can lead a healthy life.3 Regarding the first element of what accessible, non‐discriminatory health services might look like for section 37 achievement, General Comment No. 14 provides the QHRC with instruction (Supporting Information).3 The Queensland Parliament has clarified it will only adopt the first element of article 12 of the International Covenant, which protects right to health service access; section 37 will not extend to include Queenslanders’ right to the broader health determinants. By limiting section 37 to questions of access to emergency medical treatment and non‐discriminatory health service provision, Parliament cautiously chose not to conflate the parameters of section 37. For some right to health academic specialists, this measured approach is prudent.13 Although section 37 claims are not to incorporate the determinants of health, complainants may nevertheless lodge separate or concurrent claims that capture certain health determinants, such as the right to culture (sections 27 and 28). Public health practitioners are well aware that culture is a significant health determinant.14 Housing is also a major determinant of health, and a housing rights claim (that causally impacts a claimant's health and wellbeing) might be realised under section 24 (property rights). Claims that seek to protect and promote the rights of individuals and communities to access the determinants of health relating to food and water could be sought under the right to life (section 16). This is because, per the explanatory notes to the Human Rights Bill 2018 (Qld), this right reflects the positive obligation on states “to take positive steps to protect the lives of individuals through, for example … positive measures to address other threats to life such as malnutrition and infant mortality” (emphasis added).6 With this in mind, section 16 allegations that identify a compelling food or water security nexus that threatens the right to life could be made. However, the QHRC can refuse to deal with a complaint it considers “frivolous, trivial, vexatious, misconceived or lacking in substance”.1 The protection of other health rights elsewhere in the new Act As highlighted above, the content of section 37 claims will likely raise other rights contraventions. It is foreseeable, for example, that a section 25 right to privacy breach by a health service provider could directly or indirectly create a section 37 access to health service violation (and vice versa). Further, a section 37 contravention, or its ramifications, may be so egregious that the complainant could rationally argue that they have experienced a breach of their section 17(b) right not to be treated in a cruel, inhuman or degrading way by the health service. Section 17(c) also protects and promotes an individual's health and human right to “not be … subjected to medical or scientific experimentation or treatment without the person's full, free and informed consent”.1 Certainly, in some cases, a fine line will arise between informed consent to medical treatment and health service access under section 37. The Act also covers reproductive health and rights. Section 106 clarifies that the Act “does not affect laws about termination of pregnancy”, thereby referring to and upholding the Termination of Pregnancy Act 2018 (Qld). According to Queensland Health, that Act “ensures termination of pregnancy is treated as a health issue rather than a criminal issue” and “supports a woman's right to health, including reproductive health and autonomy”.15 Final comments Queensland Health already has antidiscrimination policies and protocols for its staff and for its patients and clients. Therefore, compliance with section 37 and the Act's wider provisions should not be onerous for government and many other public health service agencies bound by the new Act. However, if international right to health experience can teach Queensland anything, it is that government response to allegations of section 37 violations should not be reactive and visible at QHRC conciliation meetings alone.4 Advancing the right to health for all Queenslanders will not occur in legal silos but in complement with planned educational and promotional activities that help build a culture in the Queensland public sector and broader community that respects and promotes health and human rights, as well as promotes a dialogue about the nature, meaning and scope of health rights for Queensland's most important asset, its human capital.1,6 This will require the engagement of both government and non‐government stakeholders, as well as community members, beyond the health sector. Box 1 – Objectives and principles of the Human Rights Act 2019 (Qld) and Health Ombudsman Act 2013 (Qld) Human Rights Act 2019 Health Ombudsman Act 2013 Main objects: section 3* Main objects: section 3 † to protect and promote human rights; and to help build a culture in the Queensland public sector that respects and promotes human rights; and to help promote a dialogue about the nature, meaning and scope of human rights. to protect the health and safety of the public; and to promote— professional, safe and competent practice by health practitioners; and high standards of service delivery by health service organisations; and to maintain public confidence in the management of complaints and other matters relating to the provision of health services. Preamble* Paramount guiding principle: section 4 † In enacting this Act, the Parliament of Queensland recognises— The inherent dignity and worth of all human beings. The equal and inalienable human rights of all human beings. Human rights are essential in a democratic and inclusive society that respects the rule of law. Human rights must be exercised in a way that respects the human rights and dignity of others. Human rights should be limited only after careful consideration, and should only be limited in a way that can be justified in a free and democratic society based on human dignity, equality, freedom and the rule of law. Although human rights belong to all individuals, human rights have a special importance for the Aboriginal peoples and Torres Strait Islander peoples of Queensland, as Australia's first people, with their distinctive and diverse spiritual, material and economic relationship with the lands, territories, waters, coastal seas and other resources with which they have a connection under Aboriginal tradition and Ailan Kastom. Of particular significance to Aboriginal peoples and Torres Strait Islander peoples of Queensland is the right to self‐determination. The main principle for administering this Act is that the health and safety of the public are paramount. Without limiting subsection (1), the health and safety of the public is the main consideration for— the health ombudsman, when deciding what relevant action to take to deal with a complaint or other matter; and the director of proceedings, when deciding whether to refer a matter to QCAT; and QCAT, when deciding a matter referred to it under this Act. QCAT = Queensland Civil and Administrative Tribunal. * Reproduced from https://www.legislation.qld.gov.au/view/html/asmade/act-2019-005;8 † Reproduced from https://www.legislation.qld.gov.au/view/html/inforce/current/act-2013-036.10 Box 2 – The right to health: article 24 of the United Nations Declaration on the Rights of Indigenous Peoples* Indigenous peoples have the right to their traditional medicines and to maintain their health practices, including the conservation of their vital medicinal plants, animals and minerals. Indigenous individuals also have the right to access, without any discrimination, to all social and health services. Indigenous individuals have an equal right to the enjoyment of the highest attainable standard of physical and mental health. States shall take the necessary steps with a view to achieving progressively the full realization of this right. * Reproduced from https://www.un.org/development/desa/indigenouspeoples/wp-content/uploads/sites/19/2018/11/UNDRIP_E_web.pdf.11 Declarations are not ratified. Adopted by the UN General Assembly on 17 September 2007. Supported by the Australian Government on 3 April 2009.

Claire E Brolan

The use of defibrillators for ventricular arrhythmias may significantly reduce mortality when sudden cardiac death is the major contributor The 2018 guidelines from the National Heart Foundation and the Cardiac Society of Australia and New Zealand provide evidence‐based direction for the management of heart failure in Australia.1 A Perspective article published in the Journal in 20192 challenged the weak recommendation for the implantation of a defibrillator in the primary prevention of mortality in dilated cardiomyopathy (DCM) with a left ventricular ejection fraction (LVEF) of 35% or below.1 The authors of the MJA article2 questioned the differences between this recommendation1 and recent Canadian and American guidelines.3,4 We welcome this opportunity to clarify the basis for the Australian guidelines recommendation. To understand the heart failure disease process, it is fundamental to recognise the differences in mechanisms of death and prognosis in ischaemic cardiomyopathy (ICM) versus DCM. Sudden cardiac death is more frequently responsible for mortality in ICM compared with pump failure and death from non‐cardiac causes in DCM. As such, defibrillators that provide shocks for ventricular arrhythmias are expected to significantly reduce mortality when sudden cardiac death is the major contributor. Combined with recent clinical trial data, this is the foundation for the current guidelines in primary prevention, making a strong recommendation for a defibrillator in reducing mortality in ICM compared with a weak recommendation for DCM.1 The GRADE methodology (www.gradeworkinggroup.org) used in these guidelines ensures that the strength of a recommendation not only takes into account the quality of evidence but also the benefits and harms of an intervention, improvements in quality of life, longevity, patient preferences, and resource considerations. The contrasting prognoses of the two major underlying causes for systolic heart failure is demonstrated in the outcomes of clinical trials exploring the role of primary prevention defibrillators. The MADIT‐II trial found a significant reduction in mortality in ICM with an ejection fraction of 30% or below (P = 0.016).5 In contrast, there have been no randomised controlled trials demonstrating a significant reduction in total mortality with implantable cardioverter defibrillators (ICDs) in DCM. On the basis of the SCD‐HeFT trial,6 ICDs were recommended in patients with heart failure with reduced ejection fraction with an LVEF below 35% regardless of underlying coronary artery disease, despite the absence of statistical significance in DCM. The 2016 DANISH study randomly allocated 1116 patients with DCM and a LVEF below 35% to ICDs versus medical therapy, with no significant difference in total mortality.7 Importantly, there were higher rates of optimised medical therapy compared with earlier randomised ICD studies, and cardiac resynchronisation therapy was included in 58% of patients. The limitations of the DANISH trials suggested in the MJA article,2 such as the optimised medical treatment and low mortality, are strengths and more accurately reflect the expected outcomes in a contemporary DCM population who receive guideline‐directed medical therapy. Nonetheless, despite the absence of positive randomised controlled trials, recent meta‐analyses, with the inclusion of DANISH, continue to demonstrate a significant mortality reduction for primary prevention defibrillators in DCM.8 While meta‐analyses provide an analytical technique to pool results and inflate sample sizes to improve statistical power, there are important limitations. Biases related to study selection, publication bias, heterogeneity of study populations in relation to treatment, follow‐up, and study time points have an impact on the findings of meta‐analyses, despite attempts at statistical corrections. Early primary prevention ICD studies were stopped prematurely due to futility and, as such, contribute little to meta‐analyses.9 The inclusion of older studies in undertreated medical patients with the variable inclusion of cardiac resynchronisation therapy is an important limitation in the interpretation of meta‐analyses investigating primary prevention ICDs in DCM. Implanting physicians are cognisant of potential harm, with Australian data reporting ICD‐related complications requiring rehospitalisation or re‐operation in 10% of patients.10 Battery longevity and defibrillator lead durability are additional considerations. Careful patient selection is required to identify patients with DCM likely to benefit from ICD therapy. The 2018 Australian guidelines draw attention to the increased efficacy of ICD therapy in patients younger than 70 years identified as a pre‐specified endpoint in the DANISH study.11 Although the incidence of sudden cardiac death did not differ between age groups, the incidence of non‐sudden cardiac death becomes significantly higher in the older population. Our recommendation is supported by a recent clinical practice update from the Heart Failure Association of the European Society of Cardiology. Providing specific recommendations regarding subpopulations, such as patients with infiltrative or hypertrophic cardiomyopathy, was beyond the scope of the 2018 national guidelines. As we await better tools for risk stratification of patients with DCM, supportive data from randomised controlled trials and improvements in pharmacological and device‐based heart failure therapy, the weak recommendation for ICDs for the primary prevention of mortality1 provides the support for a considered decision between patient and physician, balancing the absence of randomised controlled trial data with the morbidity of an ICD implant. “It is precisely where evidence is lacking or is controversial that clinicians need the most guidance.”12

Peter M Kistler · John J Atherton · Garry Jennings

If we are committed to closing the gap, we should be committed to transforming relationships of power between Indigenous and non-Indigenous people

Chelsea J Bond · David Singh

Genetic research with Indigenous Australians is achievable with community engagement and appropriate governance mechanisms in place

Steven YC Tong · Heather D'Antoine · Melita McKinnon · Kyle Turner · Maui Hudson · Ngiare Brown · Jonathan R Carapetis · Dawn C Bessarab

Without specific investments in the health of adolescents, Australia will not redress health inequalities experienced by Aboriginal and Torres Strait Island peoples

Peter Azzopardi · Ngaree Blow · Tara Purcell · Ngiare Brown · Tirritpa Ritchie · Alex Brown

Living guidelines that incorporate new evidence as it becomes available have the potential to overcome some of the limitations inherent in static guidelines Diabetes is a complex chronic condition that affects about 1.7 million Australians and represents an estimated $15 billion per annum in direct and indirect costs to the Australian economy.1 Almost $215 million of subsidies were delivered during the 2015–16 financial year to the 1.32 million registrants of the National Diabetes Services Scheme, an Australian Government initiative that provides support to Australians living with diabetes. In 2019, an additional $100 million was announced for funding the Continuous Glucose Monitoring Initiative, which provides fully subsidised continuous glucose monitoring products to patients with diabetes who meet certain criteria.2 In 2017, almost 1.2 million hospitalisations and 11% of all deaths in Australia listed diabetes as the principal or associated cause.3 In addition to the costs associated with diabetes management and prevention, significant funding has been directed towards research into this key priority area, with the National Health and Medical Research Council (NHMRC) providing $375 million from 2013–2018 towards efforts to improve the prevention, diagnosis and management of diabetes.4 With the objective of strengthening diabetes policy and practice, the Australian Government developed the Australian National Diabetes Strategy 2016–2020, which outlines an integrated and coordinated approach for reducing the social, human and economic impact of diabetes.5 One of the key goals within this strategy involves strengthening prevention and care through the use of research, evidence and data. Indeed, developing a nationally endorsed set of diabetes guidelines, assessed against the clinical practice guidelines criteria, was a key recommendation of the Australian National Diabetes Strategy to improve complications and outcomes associated with the disease. Producing new clinical guidelines and implementing a system by which recommendations can be updated and adopted rapidly represents an important means by which this recommendation can be achieved. Clinical guidelines: is there a better way? High quality, evidence‐based clinical guidelines are integral to ensuring that health care decisions are based on the best available evidence. Unfortunately, evidence‐based clinical guideline development is an expensive and laborious undertaking in which several years can pass between inception and publication. In Australia, guidelines approved by the NHMRC are valid for 5 years from publication before they are considered outdated, following which they must be either updated or developed anew.6 These delays can result in several potential problems. First, new research is continually being generated throughout the development period, which may mean that a guideline is outdated before it is even published. Indeed, it has been demonstrated that one in five guideline recommendations are outdated within 3 years of guideline publication.7 Second, institutional memory of the decision‐making processes through which recommendations are derived can be lost, particularly if a significant period of time has transpired since the original guideline was developed. Third, changes in the policy and practice environment can shift priorities or raise new questions that were not considered when defining the original scope, resulting in the guideline failing to address some of the key current issues relating to the topic of interest (eg, the development of a new therapeutic or withdrawal of a technology from the Australian Register of Therapeutic Goods). Currently, all but one of the NHMRC‐approved diabetes clinical guidelines are outdated and have been rescinded. As a result, there is no up‐to‐date Australian guidance for clinicians caring for people with diabetes, potentially resulting in the suboptimal management and significant variation in care of this condition.8 Living guidelines Living guidelines represent an approach to guideline development in which individual recommendations are continually updated as new, relevant evidence becomes available. This is achieved through monthly searches of key databases to identify recently published research. Following analysis of the new data, an impact assessment is conducted to determine whether the evidence is of sufficient relevance, reliability and importance to justify revising recommendations.9 Updated recommendations are then published within a real‐time digital dissemination platform, providing stakeholders with access to the most up‐to‐date version of the guideline. Although the concept of living guidelines is not new, many of the processes employed in developing living guidelines have been generated through Project Transform, an innovative platform established by Cochrane to address the critical issue of evidence currency within clinical guidelines (https://community.cochrane.org/help/tools-and-software/project-transform/about-project-transform). These processes are supported by the development and refinement of machine learning algorithms (eg, randomised controlled trial classifiers), citizen science initiatives (eg, Cochrane Crowd), new methods for updating statistical analyses,10,11 and the development of online collaborative platforms for systematic review and clinical practice guideline production (eg, Covidence, MAGICApp). The application of these tools significantly reduces the workload of systematic review and guideline authors, and appears to result in the production of updated recommendations at a fraction of the resource and time costs otherwise required. In addition, the establishment of a living guideline development group improves the retention of institutional memory throughout the process of updating, and the feedback mechanisms built into the process provide a means by which the underlying scope can be adapted to changes in policy and practice in Australia (Box 1). Living evidence for diabetes Embracing the inherent potential in living guidelines, the Living Evidence for Diabetes Consortium is developing living guidelines that address key priorities relating to diabetes prevention, diagnosis and management (https://livingevidence.org.au/new-index-3#Living-Guidelines-for-Diabetes). Consisting of the Australian Diabetes Society, Diabetes Australia, the Australasian Paediatric Endocrine Group, the Australian Diabetes Educators Association and Cochrane Australia, with representation from the Royal Australian College of General Practitioners and the Australian Government Department of Health, the consortium has selected two proof‐of‐concept topics that fulfil the criteria for living guidelines (Box 2). Two systematic reviews are currently under development to underpin these guidelines, focused on the comparative safety and effectiveness of therapeutics for blood glucose control in adults with type 2 diabetes and the use of technologies (such as insulin pumps and continuous glucose monitors) for the management of type 1 diabetes in adult and paediatric populations. The need for clear guidance relating to these topics is demonstrated by the ongoing uncertainty regarding the most appropriate choice of second line therapies13 and the inception of do‐it‐yourself closed loop systems.14 Although the methods and processes required to produce living guidelines are still evolving, the development of living guidelines for diabetes represents a paradigm shift in the way recommendations are updated and shared with decision makers. Access to this resource should improve the likelihood that patients will consistently receive the best evidence‐based care available, and also provide an avenue through which guideline developers can respond to changes in policy and practice, resulting in guidelines that evolve to keep up with the current practice. Box 1 – Static guideline development (A) versus living guideline development (B) Box 2 – Requirements for converting traditional to living recommendations12 Not all recommendations are suitable for a living evidence approach. Three key requirements should be fulfilled to justify transitioning a static guideline into a living guideline: the guideline should focus on a priority topic for patient, clinical or policy decision‐making; uncertainty should exist regarding the strength and/or direction of recommendations; and there should be a high likelihood of new evidence becoming available in the near future which could increase certainty.

Heath White · Britta Tendal · Julian Elliott · Tari Turner · Sofianos Andrikopoulos · Sophia Zoungas

Information on COVID‐19 and its impact is being updated constantly and Australia must continue to be prepared at all levels of the health care system An outbreak of a novel coronavirus, formally named severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and causing coronavirus disease 2019 (COVID‐19), emerged in the city of Wuhan in Hubei province in central China in December 2019. The first cases were noted as a cluster of patients with pneumonia who were all linked to a live animal market, and testing found the presence of a previously unknown coronavirus. Coronaviruses are a group of viruses that affect both animals and humans, and several (OC43, 229E, HKU1 and NL63) are a cause of the common cold.1,2 However, two coronaviruses previously caused significant outbreaks associated with more severe disease: the SARS coronavirus in 2002–2003 and the Middle East respiratory syndrome coronavirus that emerged in 2012.1,2 In contrast to previous outbreaks, the rapid sharing of viral sequences enabled laboratories worldwide to develop diagnostic tests within weeks of discovery of the pathogen.3 An Australian laboratory subsequently isolated the virus from a clinical sample (the first to do so outside of China), and rapidly shared this virus with relevant global agencies, further aiding diagnostic, therapeutic and vaccine development efforts. Information on the new virus and its impact is being updated constantly. While ascertainment of the milder end of the disease spectrum varies between countries,4 the age‐specific severity profile appears to be relatively consistent.5 Age is clearly an important risk factor — there have been few severe cases reported in children, and a high case fatality risk in the elderly. However, it is not clear whether comorbidities reflect the age group affected or whether they are risk factors for severe disease.6,7 Early studies using data before the institution of public health interventions in China suggest that SARS‐CoV‐2 is as transmissible as SARS coronavirus and probably more transmissible than influenza viruses.8,9 Emerging data suggest that viral load is highest around the onset of illness in milder cases, and transmission may occur during this pre‐symptomatic period.10,11,12 Careful analysis of early data suggests that the mean incubation period is 6 days, with a range of up to 14 days.13 There have been a considerable number of large clusters associated with large events, including religious communities, weddings, business meetings, closed communities, dormitories and cruise ships.14,15,16,17 The importance of infection control is also reinforced by a report that 41% of cases in Wuhan were acquired nosocomially (including 40 health care workers and 17 patients).6 Since the World Health Organization was first notified of this new pathogen, more than 2 million cases and over 130 000 deaths have been reported globally. On 16 April 2020, there were 6462 confirmed cases of COVID‐19 in Australia, including 63 deaths. After early outbreaks in Asia, the hardest hit countries currently are the United States and in Europe. There is great concern about low and middle income countries with limited diagnostic and public health capacity. The public health, political and societal ramifications have been considerable, with disruptive interventions that would have been unthinkable even a few months ago. Ultimately, a vaccine will be required; at the time of writing, 60 vaccine candidates have been developed, including three entering human trials (https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/). For clinicians, the main considerations are the clinical management of patients with suspected COVID‐19 but also systems to facilitate the identification of potential cases and to permit safe assessment and referral as appropriate. The experience with SARS and Middle East respiratory syndrome also reinforces the need for health services (both internationally and within Australia) to promptly identify patients with suspected infection and implement effective infection control measures, including adequate protection of health care workers. Based on clinical features, it can be difficult to distinguish patients with COVID‐19 from those with other respiratory viral infections, including influenza. Although the original case series described fever in almost all patients,7 further experience has noted cases with only respiratory symptoms, and even a small proportion with gastrointestinal symptoms.6 This has resulted in constant changes to case definitions, initially limited to febrile respiratory infections in travellers, but now including the full spectrum of illness in patients with broader epidemiological risk factors. Clinicians should refer to current information to guide testing and management (Box 1). Nucleic acid assays for SARS‐CoV‐2 are available at all Australian reference laboratories and commercial tests are now available in diagnostic laboratories. Compared with other countries, Australia has now performed a proportionately large amount of testing per capita.18 However, the sheer scale of testing has placed extraordinary pressure on supply chains for essential components required for laboratory testing, both in Australia and globally. Current World Health Organization advice is to test patients who meet the case definition for COVID‐19, regardless of whether another respiratory virus is detected, as co‐infections may occur.19 In recent weeks, surveillance for COVID‐19 has expanded to include a much broader range of risk factors to ensure capture of community transmissions. The role of serological assays (particularly point‐of‐care testing) in the overall public health response to COVID‐19 has yet to be defined, although peak bodies such as the Royal College of Pathologists note that there is no role for point‐of‐care assays in the diagnosis of acute COVID‐19.20 Lessons of the past are instructive for Australia, particularly the experience in Canada with its similar federated government and comparable health care system. In 2003, an outbreak of SARS coronavirus in Toronto infected 438 people and caused 44 deaths, including many health care workers. Following this public health disaster, two important reviews were conducted: the National Advisory Committee on SARS and Public Health,21 and Ontario's SARS Commission.22 The former reinforced the need for a strong and adequately funded nationally coordinated public health and laboratory system and led to the establishment of the Public Health Agency of Canada. The SARS Commission made detailed recommendations, including endorsing the “importance of the precautionary principle that reasonable efforts to reduce risk need not await scientific proof [which] was demonstrated over and over during SARS”.22 It made recommendations regarding clear governance, preparing for the need for unexpected interventions (including the closure of three hospitals to control the outbreak), effective distribution of outbreak alerts and directives, the need for effective crisis communication, and the value of robust and timely surveillance. With the involvement of health care workers as cases, the Commission highlighted the need to listen to frontline workers and unions and ensure a robust safety culture and effective infection control. We have many more information (and misinformation) sharing tools than were available in 2003. It has been breathtaking to watch the scientific process unfold in almost real time. Rapid genomic sequencing and online databases are being used to generate and analyse primary data. Preprint servers and rapid review in traditional journals are quickly publishing research findings. Research centres and platforms are responding to rapidly collect data and evaluate interventions. Social media and traditional media platforms are disseminating public health messages and findings. However, the fundamental structure of our public health care system remains unchanged, with the same channels of formal communication and direction through jurisdictions and national networks. A future review should consider whether surveillance and response for all infectious disease threats could be better coordinated by a centralised national agency. There are still many major unresolved clinical and public health issues (Box 2). Clear communication to the public and to clinicians has been difficult, particularly with constantly changing epidemiology and evidence. Australia was not significantly challenged by the two previous zoonotic coronavirus outbreaks, but this global crisis has now significantly disrupted the lives of all Australians. With thousands of cases reported in Australia, public health authorities, governments at all levels, researchers and clinicians, laboratories and the community need to continue to work together in a timely and transparent manner to ensure an effective response. Box 1 – Useful sources of official information* Australian information Australian Government Department of Health: https://www.health.gov.au/health-topics/novel-coronavirus Smart Traveller: https://www.smartraveller.gov.au/ Jurisdictional health department sites: New South Wales: https://www.health.nsw.gov.au/Infectious/diseases/Pages/coronavirus.aspx; Victoria: https://www.dhhs.vic.gov.au/coronavirus; Australian Capital Territory: https://www.health.act.gov.au/health-professionals/chief-health-officer-alerts; Tasmania: https://www.coronavirus.tas.gov.au/; South Australia: https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/clinical+resources/clinical+topics/infectious+disease+control/novel+coronavirus+%282019-ncov%29+infection+for+health+professionals/novel+coronavirus+%282019-ncov%29+infection+information+for+health+professionals; Western Australia: https://ww2.health.wa.gov.au/Articles/A_E/Coronavirus; Northern Territory: https://coronavirus.nt.gov.au/; Queensland: https://www.qld.gov.au/health/conditions/health-alerts/coronavirus-covid-19 International situation reports and resources World Health Organization: https://www.who.int/csr/don/12-january-2020-novel-coronavirus-china/en/ United States Centers for Disease Control and Prevention: https://www.cdc.gov/coronavirus/2019-ncov/index.html European Centre for Disease Prevention and Control: https://www.ecdc.europa.eu/en/coronavirus * Websites viewed April 2020. Box 2 – Major unresolved clinical and public health issues Clinical Optimal samples for diagnostic testing (upper versus lower respiratory tract samples) Utility of existing and investigational antiviral agents and other treatments Host risk factors associated with poor clinical outcomes Public health and control The long term public health strategy for control to minimise morbidity and mortality, but taking into account broader impacts of health, the economy and society The optimal mix of case finding and isolation, contact tracing and quarantine, social distancing and personal hygiene Optimal, yet pragmatic, infection control measures to prevent infections in health care facilities and residential aged care facilities

Allen C Cheng · Deborah A Williamson

Misgendering negatively affects the mental and physical health of trans individuals

Irene J Dolan · Penelope Strauss · Sam Winter · Ashleigh Lin

More nuanced health advice is needed to protect populations and individuals from exposure to bushfire smoke

Sotiris Vardoulakis · Bin B Jalaludin · Geoffrey G Morgan · Ivan C Hanigan · Fay H Johnston

CYD-TDV (Dengvaxia) use in travellers should be considered on a case-by-case basis, with a detailed discussion of risks and benefits in light of its safety and efficacy profile

Irani Thevarajan · Joseph Torresi · Cameron Simmons