Environmental health

Objective: To assess long term survival and patient characteristics associated with survival following acute myocardial infarction (AMI) in Australia and New Zealand. Design: Cohort study. Setting, participants: All patients admitted with AMI (ICD‐10‐AM codes I21.0‒I21.4) to all public and most private hospitals in Australia and New Zealand during 2009‒2015. Main outcome measure: All‐cause mortality up to seven years after an AMI. Results: 239 402 initial admissions with AMI were identified; the mean age of the patients was 69.3 years (SD, 14.3 years), 154 287 were men (64.5%), and 64 335 had ST‐elevation myocardial infarction (STEMI; 26.9%). 7‐year survival after AMI was 62.3% (STEMI, 70.8%; non‐ST‐elevation myocardial infarction [NSTEMI], 59.2%); survival exceeded 85% for people under 65 years of age, but was 17.4% for those aged 85 years or more. 120 155 patients (50.2%) underwent revascularisation (STEMI, 72.2%; NSTEMI, 42.1%); 7‐year survival exceeded 80% for patients in each group who underwent revascularisation, and was lower than 45% for those who did not. Being older (85 years or older v 18–54 years: adjusted hazard ratio [aHR], 10.6; 95% CI, 10.1–11.1) or a woman (aHR, 1.15; 95% CI, 1.13–1.17) were each associated with greater long term mortality during the study period, as was prior heart failure (aHR, 1.79; 95% CI, 1.76‒1.83). Several non‐cardiac conditions and geriatric syndromes common in these patients were independently associated with lower long term survival, including major and metastatic cancer, cirrhosis and end‐stage liver disease, and dementia. Conclusion: AMI care in Australia and New Zealand is associated with high rates of long term survival; 7‐year rates exceed 80% for patients under 65 years of age and for those who undergo revascularisation. Efforts to further improve survival should target patients with NSTEMI, who are often older and have several comorbid conditions, for whom revascularisation rates are low and survival after AMI poor.

Bora Nadlacki · Dennis Horton · Sadia Hossain · Saranya Hariharaputhiran · Linh Ngo · Anna Ali · Bernadette Aliprandi‐Costa · Chris J Ellis · Robert JT Adams · Renuka Visvanathan · Isuru Ranasinghe

To the Editor: The article by Giuseppin,1 Chair of the Australian Medical Association Council of Rural Doctors, published in MJA InSight+, on ending geographic narcissism, overcoming metro‐based policy making, and instituting health self‐determination by rural practitioners and communities echoes the feedback we have received from health practitioners and consumers attending our workshops throughout northern Australia. The HOT NORTH (Improving Health Outcomes in the Tropical North) program (Box), funded by the National Health and Medical Research Council, aims to address inequitable health coverage across northern Australia through more widespread implementation of locally designed research and practice. Epidemiological and health service data indicate a higher disease burden and risk profile in northern Australia compared with the rest of the country, with health disparity increasing with age and remoteness and Indigenous Australians living in the north having worse health outcomes than the non‐Indigenous population.2 At 15 HOT NORTH forums held over the past 3 years, attended by over 1600 participants in locations from South Hedland to Thursday Island, we provided an opportunity for communities and local health staff to take control over the agenda, presentations and input to discussions. Participation increased, discussions became more interactive, and pride in the achievements of local health practitioners and researchers replaced the deficit data and focus of many previous presentations. The wider benefits of a consultative, locally designed and led health research and capacity‐building program are captured in the recent HOT NORTH impact report.3 While several initiatives have addressed regional and remote health care (eg, the Centre for Research Excellence in Rural and Remote Primary Healthcare, the Advanced Health Research and Translation Centre in Alice Springs, and Centres for Innovation in Regional Health in north Queensland and in regional New South Wales), we agree with Giuseppin that fundamental shifts in the rusted‐on core–periphery relationships are required to address the inequity of health coverage across Australia. However, in Australia (and its universities), this requires recognition of the pervasive dogma of “winner‐takes‐all” urbanism of “superstar cities”4 with their “creative class”,5 which arguably militates against an appetite and capacity for sustainably reshaping the service delivery and research landscape in response to the remoteness, cultures, power relations, social ties and other dynamics in rural and remote settings. Box – HOT NORTH capacity building, collaborations and regional engagement activities 2017–2019

Kevin Williams · Sean Rung · Bart J Currie

Screen‐detected breast cancer overdiagnosis occurs, but each woman has been diagnosed with cancer that cannot be ignored There are an increasing number of publications estimating the extent of cancer overdiagnosis, which for breast cancer is in the context of population cancer screening programs.1 Researchers investigating overdiagnosis point to a range of related harms, but it is important to view these in the context of screening benefits, such as reductions in risk of breast cancer death.2 Care needs to be taken not to conflate formal screening programs with informal or opportunistic approaches to early detection, such as prostate‐specific antigen (PSA) testing in prostate cancer. This article focuses on the risk of overdiagnosis in the context of population‐based breast screening programs, given that overdiagnosis is often at the heart of calls to cease mammographic breast cancer screening.3,4 Despite the emphasis often given to breast cancer screening in discussions of overdiagnosis, the concept should not be regarded as only applying to breast cancer screening, or to cancer screening more generally, but as an outcome that could apply, to varying degrees, to a wider range of screening and diagnostic practices. Defining overdiagnosis Overdiagnosis of a cancer is not a false positive or misdiagnosis; it is a diagnosis with histological verification of a cancer that would otherwise not have gone on to cause morbidity or death — although it cannot be determined at the time of diagnosis whether the cancer would have progressed to cause morbidity or death.5 An overdiagnosed cancer is in part a consequence of our capacity to diagnose cancers at increasingly earlier stages. It depends on competing causes of death; that is, a cancer will not cause morbidity or death in people who die beforehand from other causes, such as respiratory or cardiac diseases or trauma. The reality that a proportion of cancers will therefore be overdiagnosed is inherent in all screening programs, although the issue is not limited to screening. Major international reviews have concluded, after a careful evaluation of the balance between benefits and harms, that there is a net benefit from inviting women to receive breast screening (ie, benefits outweigh harms).2 The problem of overdiagnosis Concerns about overdiagnosis stem from the potential harms that may be experienced by a person receiving the overdiagnosis. Harms can range from the psychological stress of receiving a diagnosis through to the potential for complications and adverse effects of diagnostic procedures or treatments. However, the challenge is that for any individual, it is not possible at diagnosis to determine whether their cancer is overdiagnosed or not. The cancers that are overdiagnosed are indistinguishable from other cancers histologically. As this is a post mortem classification, cancers can only be classified as overdiagnosed when another cause of death supervenes. Estimating overdiagnosis and mortality benefits Estimates of overdiagnosis within breast cancer screening programs vary widely, and this is in part due to methodological as well as programmatic differences. Recent Australian modelling suggested that the rate of overdiagnosis across five cancers (breast, prostate, renal, thyroid and melanoma) was 18% in women and 24% in men.1 However, of these cancers, only breast cancer is part of population screening in Australia. Other studies of breast cancer overdiagnosis specifically point to much lower levels of overdiagnosis. Based on British and European reviews, Cancer Australia has estimated that for every 1000 Australian women screened for breast cancer every 2 years from age 50 to 74 years, around eight breast cancers (range, 2–21) may be found and treated which would not otherwise have been found in a woman’s lifetime.6 In addition, an equivalent number of breast cancer deaths would be avoided in these women.6 The European Screening Network (EUROSCREEN) Working Group calculated a summary estimate of overdiagnosis as about 6.5% of the expected number of diagnosed breast cancers (range, 1–10%) in screened women, based on data from studies in Europe.2 Overall, data from around the world indicate that breast screening confers an estimated reduction in breast cancer mortality of 23% in women invited for screening and 40% or more among those women who are screened.2 Cancer screening programs need to balance benefits and harms Decisions about whether to implement screening at a national level in any country should follow a comprehensive assessment of likely benefits at a population level (mortality reduction, delivery of more conservative therapy to people diagnosed with cancer via screening), harms (unnecessary treatments, psychological impacts) and costs (health service, individual out‐of‐pocket expenses, societal costs). In Australia, this principle is encapsulated in the Australian Population Based Screening Framework.7 It is well understood that some cancers are slower growing while others are more aggressive, but there are significant limits to our capacity to determine at diagnosis these characteristics at both an individual tumour and patient level. The concern, therefore, is that the potential to discourage women from breast screening through concerns of overdiagnosis would result in harms associated with later diagnosis, including deaths from breast cancer. Based on current international evidence, if left untreated, more than 90% of cancers found through routine screening would progress and become symptomatic and be potentially lethal, depending on modelling assumptions.2 Even drawing from the higher estimates of overdiagnosis, data would support that more than 70% of screen‐detected invasive cancers would progress to become symptomatic without treatment.8 These estimates are indicative of the scale of risk of developing a symptomatic breast cancer which could be detected earlier through screen detection. Screen‐detected cancers are found at an earlier stage and tend to be smaller; treatment guidelines advise less extensive surgery and reduced need for adjuvant treatments, as well as being associated with improved survival.9 Reducing the harms of overdiagnosed cancers The most readily recognised harm of overdiagnosis is overtreatment. However, overtreatment is distinct from overdiagnosis and the effects can be mitigated by promotion of evidence‐based clinical management guidelines. Significant advances have been made in tailoring treatment for breast cancer. These include advances in surgery and radiotherapy and using tumour characteristics such as oestrogen receptor, progesterone receptor, and HER2 status to tailor systemic therapies. Research is also being undertaken to investigate using active monitoring rather than surgery for ductal carcinoma in situ, as there is debate regarding the potential for this type of carcinoma, if left untreated, to progress to invasive cancer. Research is underway to determine if genomic or other molecular signals in tumours will provide clearer indications of which ductal carcinoma in situ and invasive cancers need treatment, including chemotherapy, and at what level of aggressiveness, irrespective of whether found through screening or other means.10 Advances from this research will better support women to make informed decisions about treatment. Population screening programs are offered within a policy framework that carefully considers the target population that stands to benefit from screening, including age criteria, and ongoing monitoring and reporting of sensitivity, specificity and interval cancers.7 There are also ongoing research efforts to improve the effectiveness of breast screening, including evaluation of new approaches to tailor screening to the individual woman’s risk profile to maximise benefit and minimise harms. Informed consent about breast screening needs to balance the potential harms with the demonstrated benefits of the current national screening program.

Vivienne Milch · Sanchia Aranda · Karen Canfell · Megan Varlow · David M Roder · David Currow · Cleola Anderiesz · Dorothy Keefe

During the coronavirus disease 2019 (COVID‐19) epidemic, the continued presence of viral RNA in the upper airways of infected people has been reported.1 Such persistence does not necessarily signify active infection or that the virus can be transmitted.2 In Queensland, repeat testing for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) in people with an initial positive test result was undertaken until June 2020, providing an opportunity to explore patterns of test positivity, apparent rates of clearance of viral RNA, and the extent to which each varied by the age and sex of the infected person. We analysed de‐identified data for people who underwent swab tests for SARS‐CoV‐2 processed in Queensland Health public laboratories between 10 January and 4 June 2020. SARS‐CoV‐2 RNA was detected by polymerase chain reaction (PCR). Testing was initially restricted to people with relevant symptoms who had visited high risk areas (Box 1); from April 2020, anyone with relevant symptoms could be tested. We analysed data on PCR test result, age and sex of the tested person, and postcode of the facility that requested the test; clinical information and reasons for testing were not available. People with positive results who subsequently received two consecutive negative test results at least 24 hours apart were defined as achieving “negative status”. Details of dataset structure, analysis and visualisation methods and code have been reported elsewhere.3,4 Our investigation was exempted from formal ethics review by the Gold Coast Health Human Research Ethics Committee (reference, LNR/2020/QGC/63045). We analysed data for 103 984 swabs from 97 476 people during the 146‐day study period. Time to negative status was examined by Kaplan–Meier analysis. Differences by age (under 65 years, 65 years or over) and sex, with adjustment for both, were calculated by Cox regression. Other associations between variables were quantified as unadjusted odds ratios. The timing of sample collection, particularly of repeat swabs, was not standardised, reflecting the exploratory nature of SARS‐CoV‐2 testing early in the pandemic. The median age of tested people was 41 years (interquartile range [IQR], 27–57 years; range, under one to 105 years); 55 708 (57%) were female. Nine hundred and fifty‐eight people (0.98%) were positive for SARS‐CoV‐2; their median age was 45 years (IQR, 29–61 years; range, under one to 88 years), and 496 were female (52%). Compared with people under 16 years of age, the odds of a positive result were higher for people aged 17–64 years (odds ratio [OR], 5.2; 95% confidence interval [CI], 3.4–8.1) and for those aged 65 years or more (OR, 6.0; 95% CI, 4.0–9.5); the odds of a positive test were lower for females than for males (OR, 0.80; 95% CI, 0.70–0.91). The numbers of people tested and of those positive for SARS‐CoV‐2 both peaked in the second half of March 2020, after which testing rates declined until late April before climbing again, while positivity rates remained low (Box 1). Of the 958 people with positive test results, 317 (33.1%) had repeat tests. Of the 243 people with initial positive results and at least two repeat tests, 147 (60.5%) achieved negative status. The median age of those who achieved negative status was 45 years (IQR, 30–59 years; range 20–84 years); 94 were women, 53 men (OR, 1.7; 95% CI, 1.0–2.9). Of the 243 people who underwent two or more repeat tests, 224 (92.2%) had positive results beyond 10 days and up to 72 days after their initial tests (Box 2). Seven of 147 people who achieved negative status (5%) subsequently had positive test results, including six men. For the 147 positive patients who achieved negative status, median time to clearance was 31 days (IQR, 18–47 days), and was unaffected by sex (women, 30 days; IQR 16–45 days; men: 31 days; IQR 20–49 days; hazard ratio [HR], 0.93; 95% CI, 0.66–1.3). Clearance was more rapid in people under 65 years of age (median, 29 days; IQR, 17–45 days) than in people aged 65 years or more (median, 43 days; IQR, 25–62 days; HR, 1.82; 95% CI, 1.17–2.93) (Box 3). We found that positive PCR test results often persisted for ten or more days after an initial positive result, in one case for 72 days. Such persistence does not indicate continued viral replication.2,5 From 21 March 2020, patients in Queensland, other than workers at high risk, were released from isolation on the basis of their symptoms and illness duration (ie, without further testing), and local transmission declined to zero (Box 1). Our finding of lower infection rates in younger people is consistent with previous reports,6 as is our finding that infection rates were higher for males than females.7 After adjusting for age, the viral clearance rate was similar for males and females. Clearance was greater for people under 65 years of age than for those aged 65 or more, as noted previously.8 This effect may have clinical significance; rates of hospitalisation, admission to intensive care, and death from COVID‐19 are higher among older people. Box 1 – Numbers of SARS‐CoV‐2 tests processed by Queensland Health public laboratories and of people with positive results, 10 January – 4 June 2020, with trend lines and indications for testing* * Repeat tests after first positive result are not included. Test trend line based on a generalised additive model for “all tests”; positive result trend line based on local polynomial regression fitting. Box 2 – Categorical heat map of SARS‐CoV‐2 tests for people with initial positive results who had at least two subsequent tests Box 3 – Kaplan–Meier analyses of virus clearance in 958 people who were initially positive for SARS‐CoV‐2, by age and sex* * Confidence bands generated by Cox proportional hazards regression, with Efron approximation (coxph function in R 3.6.3).

Paulina Stehlik · Kylie Alcorn · Anna Jones · Sanmarie Schlebusch · Andre Wattiaux · David A Henry

Australia has a once-in-a-lifetime opportunity to create a healthy, sustainable, equitable and prosperous future by taking bold action to build back better, fairer and greener after the coronavirus pandemic

Sandro Demaio

Coronavirus disease 2019 (COVID‐19) and subsequent containment measures affected consumer behaviour in Australia, including the stockpiling of essential items. Increased demand for prescription medications caused concern about potential medication shortages, and a range of policies were implemented in March 2020 to protect supplies.1 We used interrupted time series modelling to quantify the impact of the COVID‐19 pandemic on medication dispensing. The Pharmaceutical Benefits Scheme (PBS) subsidises public medication costs in Australia. We analysed Section 85 date of supply data2 to model dispensing during January 2016 – December 2019, by month, separately for all PBS prescriptions, the ten medications most frequently dispensed during the 2018–19 financial year, hydroxychloroquine, and dexamethasone. These models, which accounted for long term trends and seasonal changes, were used to predict expected dispensing during January – June 2020 (with 95% confidence intervals [CIs]), which we compared with actual dispensing rates during this period (online Supporting Information). Ethics approval was not required for our analysis of publicly available data. The number of prescriptions dispensed during March 2020 was significantly higher than predicted (4.80 million more prescriptions, +18.5%; 95% CI, +14.0% to +23.3%), but significantly lower in April (2.28 million fewer prescriptions, –9.2%; 95% CI, –5.3% to –12.8%) and May (2.08 million fewer prescriptions; –8.1%; 95% CI, –4.3% to –11.5%); there was no significant difference in June 2020 (988 778 fewer prescriptions, –3.8%; 95% CI, –7.5% to +0.1%) (Box). A similar pattern applied to the ten most dispensed medications; the increase in the number of hydroxychloroquine prescriptions dispensed in March was particularly large (24 286 more prescriptions, +95.5%; 95% CI, +89.1 to +102%) (Supporting Information). Increased dispensing of prescription medications in March 2020 was consistent with the general panic buying reported early in the COVID‐19 pandemic.3 Pharmacies also received increased requests for prescription and over‐the‐counter medications at this time, in some cases causing local shortfalls1 and concern that continued high dispensing might interrupt medication supply at the national level. This applied in particular to drugs considered early in the pandemic as potential treatments for COVID‐19, such as hydroxychloroquine. In response to increased dispensing in March, the Australian government rapidly implemented a range of policies for protecting medication supplies. Dispensing limits of one month’s supply were applied to medications if shortages would have serious health consequences.1 These policies reduced the total number of medications dispensed in April and May 2020, followed by the return to normal levels of prescription dispensing in June. Other factors likely to have been important were stockpiles amassed by people during March, public adjustment to the pandemic, and the early suppression of COVID‐19 in Australia. Restrictions on prescription dispensing were balanced by services to assist susceptible patients to isolate themselves; for example, the COVID‐19 home medicines service funded home delivery of prescription medications by community pharmacies and Australia Post,4 and funding for telehealth was increased to facilitate remote prescribing.5 Our findings indicate that medication supply can be safeguarded from panic dispensing by a range of regulatory policies combined with medication services for vulnerable people. This may be particularly important for ensuring equitable access to medications for treating COVID‐19. The risk of further COVID‐19 outbreaks underscores the importance of maintaining these policies and services. Box – Total number of prescriptions dispensed in Australia, January 2016 – June 2020, and numbers of COVID‐19 diagnoses in Australia, January 2020 – June 2020 CI = confidence interval. * Source: Australian Department of Health.2

Mustafa Mian · Subhashaan Sreedharan · Sarah Giles

To the Editor: We thank the MJA for highlighting the fit testing of N95 or P2 respirators in Australian health care workers. Regli and colleagues1 make a compelling case that mandatory fit testing should be implemented in Australian hospitals for frontline staff, in line with South Australian guidelines.2 We note that NSW Health has recently implemented mandatory fit testing in high risk areas.3 We commend these efforts, but they may have important implications that would need planning and consideration in implementation. First, it is clear that anatomical variation of the nasal and malar regions means that some health care workers will only pass the fit tests with particular N95 or P2 respirators.4 This means that along with the implementation of a fit testing program, inventory management systems are also required to facilitate hospital tracking of stocks of particular respirator types and to ensure that sufficient stock is available in high risk areas for individual health care workers. At the Southern Adelaide Local Health Network, we have implemented such a system, which tracks stock levels of all available respirators within the hospital so that key workers who can use only specific types of N95 or P2 respirators will have access to the right type of mask when needed. Second, the coronavirus disease 2019 (COVID‐19) pandemic has disrupted global supply chains, affecting the availability of N95 and P2 respirators. Moreover, fit testing is not a one‐off process, but must be conducted as a rolling program to ensure that all workers have access to appropriately fitting N95 or P2 respirators. Finally, even with an efficient fit testing program, due to anatomical variations, there will always be a proportion of health care workers for whom no masks will be suitable. Along with fit testing, health departments should prioritise health care worker redeployment policies and the development of new technologies to address the needs of the proportion of the workforce with ongoing fit test failure.

Anand Ganesan · Jane Parker · Darius Chapman

To the Editor: In an article on the Human Rights Act 2019 passed by the Parliament of Queensland, Brolan1 noted the Act was “historic but not without challenge”. This challenge is manifest in the case of prisoners. In 2007, the Queensland Coroner recommended prisoners have access to clean injecting equipment.2 We described in 2009 the threat to prisoners’ health of ongoing breaches in infection control,3 which was later evident in the cluster of coronavirus disease 2019 (COVID‐19) cases in the Wacol Youth Detention Centre in Brisbane. In 2018, The Medical Journal of Australia documented the precarious state of harm minimisation in Australia’s prisons. With reference to Queensland, there was only mention to the elimination of hepatitis C infection from one prison and the fact that opiate replacement therapy was not available to all prisoners.4 Furthermore, despite some initial success to improve hepatitis C infection rates among Queensland prisoners,5 they have gone backwards, with reportedly high rates of post‐treatment reinfection in Queensland prisons. How is it possible that Queensland continues to stand out as a model of health service deprivation? Evidence that opiate replacement therapy can be life‐saving for prisoners is conclusive.6 Human rights are universal. The right to health provision and health protection cannot be, and in fact has not yet been, effectively negotiated for or by the community’s most disempowered individuals. Despite human rights protections since 2004, the Australian Capital Territory’s dismal experience7 challenges not just Queensland but all Australians.

Michael Levy · Daniel Mogg

To the Editor: In a recent letter published in the MJA, Muhi and colleagues1 reviewed the source of acquisition by 11 health care workers with coronavirus disease 2019 (COVID‐19) who presented for symptomatic screening at a single clinic. Travel and transmission outside the workplace were considered the likely source of infection for most of them. Data on COVID‐19 cases collected for public health purposes in Western Australia up to 1 June 2020 were reviewed to inform local public health strategies to protect health care workers. Fifty‐seven cases of COVID‐19 among health care workers or workers in health care settings with direct patient contact were identified. Fifty‐six cases were confirmed by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) polymerase chain reaction (PCR) test, and one case had positive SARS‐CoV‐2 IgG serology indicating past infection. Thirty‐one health care workers acquired their infection from a cruise ship or overseas, and 26 health care workers acquired COVID‐19 within Australia. The likely source of the 26 locally acquired cases is shown in the Box. Ten health care workers acquired the infection in the workplace. A further eight had no known contact with a COVID‐19 case but worked during their incubation period. These health care workers may have acquired the infection from an unidentified patient with COVID‐19, from another health care worker, or via fomite transmission at work. Extensive contact tracing did not reveal an alternate source in a setting of limited community transmission. Where possible, whole genome sequencing was used to substantiate epidemiological findings. Transmission of COVID‐19 occurred between health care workers, emphasising the need for staff to recognise not only the risk from patients but also from colleagues, where use of personal protective equipment and physical distancing may be relaxed. There were no cases among staff in COVID‐19 clinics, suggesting that the use of personal protective equipment does mitigate risk. Workplace fomite transmission was the putative source on three occasions, which reinforces the importance of regular environmental cleaning, rigorous cleaning of shared equipment, and good cough etiquette and hand hygiene practices within health care facilities. Our review describes a larger cohort of COVID‐19 cases among health care workers, encompassing metropolitan and regional settings. With international travel restrictions, an increasing proportion of locally acquired infections among health care workers may be expected. From this analysis and others,2 colleagues and fomites should be recognised as potential workplace sources of infection, in addition to direct patient contact. Box – Likely source of coronavirus disease 2019 (COVID‐19) infection for locally acquired cases by Western Australian health care workers (HCWs) Source of infection Cases Direct HCW to HCW transmission 7 Likely fomite transmission 3 Unknown, but worked during incubation period* 8 From a close contact outside of work 5 Contact not identified, but interstate travel 3 Total 26 * No alternate source of infection identified in the context of limited community transmission.

Rebecca J Hogan · Suzanne McEvoy

Managing patients with acute chest pain should include opportunistic discussion of strategies for preventing coronary artery disease

Johannes T Neumann · Andrew M Tonkin

To the Editor: We read with interest the analysis and comments by Shand and colleagues.1 The authors show a rise in the dispensing of intravenous iron agents in the period from 2013 to 2017 for women. They suggest that this may be an issue relating to the inappropriate use of this agent. However, we question whether the data can support this suggestion, and feel this should be viewed cautiously because of the study limitations. The study did not examine the reasons for the escalation in prescriptions. The rise in numbers is not surprising. Iron deficiency anaemia is common and undertreated.2 While dietary modifications and oral iron are the first line treatment, oral iron is limited by the high occurrence of side effects in up to 50% of users.3 The new intravenous agents allow a full treatment in one visit — often in primary care — which is safe and effective. The authors are rightly concerned about safety; however, it is reassuring that studies have demonstrated the relative safety of these agents.4 During the study period, ferric carboxymaltose became more widely available, with its listing on the Pharmaceutical Benefits Scheme easing a financial barrier to women who need treatment. A number of education programs and various patient blood management initiatives to detect and treat iron deficiency that occurred during the study period could influence the study findings. A noteworthy activity was the landmark Patient Blood Management Collaborative facilitated by the Australian Commission on Safety and Quality in Health Care.5 The assumption by the authors that the number of women receiving treatment is equivalent to the number of dispensing claims by pharmacy is likely incorrect, as there are situations when an individual can have multiple dispensing claims. The study is timely because it highlights a serious condition affecting a large proportion of Australian women that must be better managed. Despite the various endeavours to improve access to treatment for women, iron deficiency remains undertreated and under‐recognised.

Pradeep Jayasuriya · Toby Richards · Bernd Froessler

Putting in place the mechanisms to assess coverage in vulnerable groups is essential to drive optimal uptake and best practice Several targeted vaccine programs introduced to the Australian National Immunisation Program (NIP) in 2020 exposed the limitations of the Australian Immunisation Register (AIR), particularly, its inability to collect information on medical risk factors to monitor vaccine uptake in at‐risk groups. These program changes highlight the need to optimise AIR reporting to improve the accuracy of individual‐level vaccination data for the benefit of patients and treating clinicians as well as the ongoing surveillance of vaccine coverage for medically at‐risk groups. As of 1 July 2020, Bexsero (GSK), the meningococcal B vaccine, was funded by the NIP for all Aboriginal and Torres Strait Islander children aged under 2 years and for other populations with specific medical risk factors, including asplenia, hyposplenia, complement deficiency, and use of eculizumab therapy.1 Additional doses of the pneumococcal 13‐valent conjugate vaccine (Prevenar 13, Pfizer) and the 23‐valent pneumococcal polysaccharide vaccine (Pneumovax 23, MSD) are now funded for Aboriginal and Torres Strait Islander people and for individuals with certain medical risk factors (eg, asplenia, immunosuppressive conditions, specific respiratory disorders).2 While these NIP changes are welcomed, clinicians need access to data that include information on medical risk to optimise benefits to patients. Both patients and medical practitioners need capacity to track receipt, ensuring that the most vulnerable people receive the recommended vaccines, and avoid unnecessary repeat vaccinations. Assessing compliance with these policy changes will be difficult because medically at‐risk individuals are currently unable to be identified on the AIR. The functionality of the AIR needs to change to enable the collection of medical risk factors, including pregnancy, and strive for more complete reporting of vaccinations that will deliver benefits at both a population and individual level. Accurate coverage data are vital for clinicians to be able to offer evidence‐based care and ensure their most vulnerable patients are protected, and to inform strategies to improve vaccine uptake. Globally, the strongest predictor of influenza vaccine receipt in pregnant women and children with medical comorbidities is a health care provider recommendation.3,4,5 Facilitating health care provider recommendations and other effective strategies to improve uptake, such as reminders or prompts for clinicians or text messages from clinicians to patients, will not be optimal without accurate vaccination data. In this article, we aim to highlight the need for optimising reporting to the AIR and increasing its capacity to collect information on medical risk factors, ensuring maximum program reach of targeted programs, and propose potential solutions. Lower uptake of targeted vaccine programs Despite targeted vaccine programs aiming to improve coverage for vulnerable groups, they often have lower uptake than universal vaccine programs.3,4,6,7,8 With the exception of Aboriginal and Torres Strait Islander people, the AIR currently fails to recognise people who qualify as vulnerable because the AIR does not capture “at‐risk” status, rendering the eligible group (ie, denominator) not easy to identify. Before 2016, the Australian Childhood Immunisation Register only recorded childhood vaccines up to 7 years. With the expansion to the whole‐of‐life AIR in September 2016, it was hoped that adult vaccinations, including maternal influenza and pertussis vaccines for pregnant women and vaccines for medically at‐risk groups, would be captured. This is an ongoing priority because the uptake of maternal influenza vaccine remains suboptimal, estimated to be 39% in Victoria between 2015 and 2017,6 with variation nationally across years and jurisdictions — 31.7% (Northern Territory, 2016), 54% (New South Wales, 2016) and 76% (South Australia, 2017).8,9,10 Similarly, influenza vaccine uptake in medically at‐risk children also remains suboptimal (about 40% nationally for 2014–2015 and 2017).3,4 Lack of recording of at‐risk status At present, there is no capacity to link vaccine receipt on the AIR with a person’s at‐risk status, as the register lacks the functionality to do so. There is a need for the AIR to be able to more accurately track vaccine receipt nationally to identify strategies to improve coverage in at‐risk groups. The lack of pregnancy status capture in the AIR necessitates the use of other data sources, such as perinatal datasets in jurisdictions where maternal immunisation is collected, or population surveys to obtain coverage estimates, but these are of no use to clinicians at the individual level. This is also the case for children who are medically at‐risk, with no capacity to link medical risk factors with vaccine receipt for identification and tracking of these children. Parents are known to over‐report vaccination status, particularly for children with complex and ongoing medical conditions.11 Identification of at‐risk status would also enable more targeted estimates of vaccine effectiveness for at‐risk individuals, rather than extrapolating from population‐level data, enabling more comprehensive assessment of targeted vaccine programs. Aside from the few countries that link national or statewide immunisation registers to health data,12 evaluating the uptake of influenza vaccination in medically at‐risk groups is a global problem, with considerable gaps in monitoring coverage due to incomplete identification of these individuals. Requirement to report vaccines to the AIR Until recently, while strongly encouraged, there was no requirement to report vaccinations to the AIR except for pharmacists under legislation in NSW and the Australian Capital Territory.13 However, an amendment to the AIR Act has recently been legislated, making it mandatory for all vaccination providers to report to the AIR vaccines given under the NIP, through school‐based programs and privately, such as for seasonal influenza and vaccines required for travel purposes.14 Under the new legislation, coronavirus disease 2019 (COVID‐19) vaccines must be reported to the AIR. In addition, influenza vaccinations must be reported to the AIR from 1 March 2021 and all other NIP vaccinations must be reported from 1 July 2021.15 The requirement has ramifications, as the completeness of reporting is likely to be lower for vaccines recommended and funded as part of targeted programs on the NIP, previously limiting accurate coverage assessments. While no studies have examined completeness of reporting maternal vaccination to the AIR,6,7 this is exacerbated by incomplete adult vaccination data in the register, especially with the expansion of other vaccine providers, such as pharmacists and workplace programs.16 The COVID‐19 pandemic highlights the requirement for a more adaptable AIR. With more than 200 COVID‐19 vaccine candidates in development,17 the rollout of COVID‐19 vaccines will be complex due to expected availability and the delivery capacity of immunisation providers. With a need to protect the most vulnerable people first, Australia’s COVID‐19 vaccination program will prioritise border and quarantine staff, health care workers and medically at‐risk groups. These vaccination encounters will need to be recorded and tracked, both for coverage and vaccine safety, using active surveillance systems such as AusVaxSafety (www.ausvaxsafety.org.au). Potential solutions to improve vaccine uptake and tracking Improving vaccine uptake in targeted programs requires a multifaceted approach, such as education, reduction of access barriers, and key structural modifications that should focus on core capabilities of the AIR and reporting requirements. While recent NIP changes present a unique opportunity to redefine the core functions of the AIR, there are potential complexities and ethical considerations around reporting pregnancy and medical conditions to the register. One potential solution would be to consider the linkage of AIR data to other national datasets (eg, Medicare, the Pharmaceutical Benefits Scheme, hospitalisations, the Therapeutic Goods Administration adverse event database), as occurs in some other countries.12 This is relevant for the introduction of COVID‐19 vaccines, for which safety monitoring and coverage tracking will be critical. Another solution would be to include pregnancy and medical risk factor data fields in the AIR. This information could be entered directly by providers if reporting on the AIR secure website or reported in a semi‐automated manner via practice management software (PMS), which is how most reporting currently occurs. While pregnancy and medical risk factors are often recorded in PMS, ensuring this is done routinely and updated appropriately would require substantial provider education. To improve access and ensure better integration within immunisation provider settings, particularly in general practice, bidirectional capacity could be developed to enable the AIR to link with PMS to reconcile vaccination status and provide clinical decision support on catch‐up vaccination schedules. The stricter reporting requirements, such as mandated reporting of all vaccinations and linking NIP vaccines with reporting, as outlined in the recent Australian Immunisation Register Amendment (Reporting) Bill 2020,14 will be beneficial, although the implementation and ensuring compliance may be challenging. Under the new AIR Reporting Bill, in addition to education and support, non‐compliant providers may also be subject to financial penalties. However, an incentives approach to reporting, in addition to mandated reporting, could also be implemented. For example, general practitioners and other immunisation providers could receive administrative payments for reporting vaccinations to the AIR (similar to what is done with the NIP childhood vaccines), thus acknowledging the time it takes from their busy schedule. Despite the AIR being internationally recognised and celebrated within Australia, there is opportunity for improvement if the AIR is to fulfil its potential as a lifelong register. The most pressing challenges ahead are the need to continue to optimise reporting to the AIR and build capacity to identify special risk groups (particularly given the new targeted NIP programs), and the need to improve reporting of all non‐NIP vaccines. We welcome the recent AIR Reporting Bill 2020; however, there remains a particularly urgent need to have the ability to identify individuals with risk factors such as pregnancy or medically at‐risk status. This would not only use the full potential of the AIR and optimise vaccine coverage surveillance but would also offer benefits at the individual level. We appreciate that such changes to the AIR and provider practice may be cumbersome. However, we are seeking support from the broader medical community to raise awareness and advocate that these changes should be prioritised, not only to improve accuracy in recording of vaccinations and at‐risk status but also to facilitate providers’ ability to access AIR data for better patient care. NIP vaccine programs tailored to the increased risk experienced by population groups are important, such as those targeted to pregnant women or medically at‐risk individuals. We must ensure that we have the mechanisms to accurately assess coverage in these vulnerable groups, not just the routine childhood NIP‐funded groups, to drive optimal uptake and best practice.

Jane Tuckerman · Christopher C Blyth · Frank H Beard · Margie H Danchin

The large number of long term hydroxychloroquine users in Australia necessitates clear guidelines on hydroxychloroquine retinopathy screening Hydroxychloroquine retinopathy, which causes permanent visual loss, is a well documented adverse effect in long term users of both hydroxychloroquine and chloroquine. However, it can be difficult to detect as visual acuity is often well preserved until the disease is severe.1 Because of this, it was once thought to be a rare adverse effect, with only 0.5–2.0% of long term hydroxychloroquine users estimated to suffer from the condition.2 However, a 2014 epidemiological study of 2361 patients using hydroxychloroquine long term in the United States found that this was a large underestimation.2 The investigators found an overall prevalence of 7.5% in patients who had taken the drug for at least 5 years, but this risk increased with length of use and dosage.2 Owing to its efficacy in treating a variety of inflammatory and dermatological conditions (eg, systemic lupus erythematosus), cost‐effectiveness and relatively good safety profile, hydroxychloroquine is widely used by many Australians long term.3 In 2015, there were about 28 300 individuals (0.12% of all Australians) using the drug daily.4 Given this estimated number of users and the 7.5% prevalence rate,2 there could be more than 2000 potential cases of hydroxychloroquine retinopathy in Australia. However, there is no recommended consensus on screening for this condition in Australia, which may lead to inconsistent screening and missed cases.5 Existing screening guidelines Currently, two main guidelines on hydroxychloroquine retinopathy screening exist and are used by practitioners in Australia: the American Academy of Ophthalmology 2016 guidelines and the United Kingdom Royal College of Ophthalmologists 2020 guidelines.1,6 While both are very similar, small but significant differences exist between them. For example, both guidelines recommend that patients who fall within the high risk category should commence screening earlier than the general population, who are screened starting from 5 years of taking hydroxychloroquine.1,6 However, there is some disagreement on which risk factors warrant classification into the high risk category (Box 1). Recommendations also vary regarding the frequency of screening in high risk patients.1,6 There are also small differences in the investigations recommended by each set of guidelines. For example, the UK guidelines6 recommend fundus autofluorescence as an additional standard screening investigation (Box 2). The need for Australian guidelines There are currently no studies discussing the prevalence of hydroxychloroquine retinopathy in Australia, which makes it difficult to determine whether current screening practices are sufficient. However, the differences in the US and UK guidelines may have practical consequences for the consistency of hydroxychloroquine detection rates in the Australian population.5 As these guidelines were developed in non‐Australian settings, they may also need to be modified to better suit Australia’s unique context. For example, compared with the US and the UK, Australia has a significantly larger proportion of residents identifying as Asian in ancestry. In 2016, about 13% identified as having Asian ancestry,7 compared with 5.9% of Americans who identified as Asian in 2019.8 Due to the more peripheral pattern of damage from hydroxychloroquine sometimes seen in Asian populations, there are recommendations that a wider 24‐2 or 30‐2 visual field test should be performed for such patients, in addition to the recommended 10‐2 visual field test in the US and UK guidelines.9 Another factor to consider is whether Australia’s public health system can support ophthalmology screening at the frequency recommended by the US and UK guidelines. Already, waiting times for non‐urgent appointments for ophthalmologists in the public system can reach years. In South Australia, the median waiting time for an outpatient ophthalmologist appointment ranges from 4.8 to 17.6 months at metropolitan hospitals,10 which makes annual screening impossible for many patients without private care. The costs to the health system also warrant consideration. Under the current Medicare Benefits Schedule, a standard specialist consultation (item 104) and visual field test (item 11224) would cost $131.65, totalling more than $1.5 million to test 50% of the individuals taking hydroxychloroquine annually in the public setting.11 Australia‐specific screening guidelines could better account for these practical considerations, although further studies would be necessary to determine how successfully the system already supports hydroxychloroquine retinopathy screening based on existing guidelines. Conclusion Given its potential to cause permanent vision loss and the number of Australians taking hydroxychloroquine long term, developing Australian screening guidelines for hydroxychloroquine retinopathy would be beneficial in promoting consistent screening practices tailored to the Australian population. Before these can be established, however, more research needs to be conducted on the prevalence and current detection rates of hydroxychloroquine retinopathy in Australia. Box 1 – Risk factors and recommendations in the United States1 and United Kingdom6 hydroxychloroquine retinopathy screening guidelines Risk factor US UK Hydroxychloroquine dose > 5 mg/kg Yes Yes Renal disease Yes Yes Tamoxifen use Yes Yes Pre‐existing retinal and macular conditions Yes No Equivalent chloroquine dose > 2.3 mg/kg No Yes Box 2 – Screening investigations for hydroxychloroquine retinopathy recommended by the United States1 and United Kingdom6 guidelines Investigations US UK Baseline (for patients with no known pathology) Fundus evaluation of the macula Fundus evaluation of the macula Spectral domain optical coherence tomography Screening 10‐2 visual field test Spectral domain optical coherence tomography 10‐2 visual field test Spectral domain optical coherence tomography Fundus autofluorescence

Marisse T Sonido · Kristopher Rallah-Baker · Monisha Gupta

A multilayered action plan is needed for a substantial, timely and sustained investment in dementia prevention In 2012, the Australian Government declared dementia as the ninth National Health Priority Area. Eight years later, dementia is the greatest cause of disability in Australians aged over 65 years, the second leading cause of mortality, and the highest in women.1 Today, more than 459 000 Australians live with dementia, and this number is expected to exceed one million by 2056.2 The societal, economic and health care burden of dementia is unprecedented, with significant impacts on individuals, caregivers and families. In addition to therapeutic advances, improved and timely diagnosis and coordinated person‐centred care, dementia prevention and risk‐factor management are our best chance to make a difference.3 How do we tackle dementia prevention cost‐effectively in the post‐pandemic era? Between 40% and 48% of dementia risk is considered modifiable.4,5 In Australia, the population‐attributable risk of dementia risk factors, in descending order, are physical inactivity (17.9%), mid‐life obesity (17.0%), low educational attainment in early life (14.7%), mid‐life hypertension (13.7%), depression (8.0%), smoking (4.3%), and diabetes mellitus (2.4%).5 In addition, the 2020 Lancet Commission report on dementia prevention, intervention and care4 includes hearing loss, traumatic brain injury, alcohol use, social isolation, and air pollution as risk factors. Emerging research suggests that a suboptimal diet,6 cognitive inactivity7 and sleep–wake disturbance8 also influence the modifiable dementia risk. We urge substantial, timely, and sustained investment in dementia prevention via a multilayered action plan with eight recommendations (Box). 1. Create public health and clinical practice guidelines for dementia prevention across the lifespan for the Australian setting. In 2019, the World Health Organization released dementia risk‐reduction guidelines stating that “the existence of potentially modifiable risk factors means that prevention of dementia is possible through a public health approach”.9 These guidelines focus on “interventions that delay or slow cognitive decline or dementia,” with the strongest recommendations being applied to addressing physical inactivity, tobacco cessation, hypertension and diabetes mellitus.9 Yet, in Australia, we do not have dementia prevention guidelines, with the clinical practice guidelines for dementia from the National Health and Medical Research Council (NHMRC) and the Australian Cognitive Decline Partnership Centre (CDPC) focusing on diagnosis and management.10 Since then, Australia has made significant progress by including dementia prevention guidelines for general practitioners in the CDPC’s Care guide for general practice.11 We recommend extending guidelines beyond primary care, including secondary prevention in memory clinics, prioritising educational attainment in early life, and developing occupational and environmental policy to reduce hearing loss, traumatic brain injury, and air pollution. 2. Equip and resource primary care providers to be the clinical spearheads for dementia prevention throughout life. Primary care is the usual entry point and key coordinator of care within the health care system and is well positioned to spearhead dementia prevention throughout life. The Medicare Benefits Schedule should increase focus on dementia prevention, enabling primary care, specialists, and allied health professionals more time, resources and team care. This could be achieved through new Medicare Benefits Schedule item numbers and modification of existing items, such as the 45–49‐year‐old health check for individuals at risk of chronic conditions. Private health insurers could complement this by expanding the scope of preventive health services to target dementia risk factors and rewarding individuals who participate with lower insurance premiums or greater rebates for health services. 3. Support multidisciplinary memory clinics and specialists to implement secondary prevention programs for those at high risk. Memory clinics and specialists should focus on secondary prevention for people at higher risk, such as those with mild cognitive impairment.12 The Australian Dementia Network (ADNeT) aims to unite and build the network of memory clinics, establish practice guidelines, harmonise assessments, and implement dementia prevention tools and strategies. ADNeT will also facilitate access to clinical trials, improve diagnostic accuracy to aid secondary prevention approaches and introduce a Clinical Quality Registry. 4. Fund research for evidence‐based interventions for modifiable risk factors for dementia across the life cycle to reduce the evidence‐to‐practice gap. While there has been increasing funding for dementia prevention research and the establishment of the International Research Network on Dementia Prevention as part of the Australian Government’s commitment to the World Dementia Council,13 urgent funding is still required to address critical evidence‐to‐practice gaps. The current evidence base includes observational studies and intervention trials that have generally focused on cognitive outcomes, rather than dementia incidence, given the long time frames needed. We need to strengthen the evidence base on managing risk factors across different phases of the lifespan, such as the most effective doses and forms of interventions in large‐scale trials. Rigorously evaluated multidomain prevention trials that simultaneously target multiple risk factors may present the best value for money if shown to be effective and sustainable, particularly as they address risk factors that have an established evidence base for preventing other conditions. A number of these trials are already underway in Australia. 5. Implement findings from dementia risk reduction and implementation research through translation into health promotion programs. Implementation research will be key to translating the increasing evidence base for dementia risk reduction interventions into effective health promotion programs. The science of behaviour change will be critical given the evidence‐to‐practice gap. This emphasises the importance of co‐design to empower individuals to modify their risk. For health professionals, education and training on dementia risk factors and skills in motivational interviewing and behaviour change principles should be prioritised. 6. Strengthen dementia prevention public health campaigns embracing Australians’ diversity, particularly Aboriginal and Torres Strait Islander Australians. Australian‐specific dementia prevention guidelines that inform public health campaigns need to appeal to all Australians, embracing geographic, socio‐economic, cultural, linguistic, social, ethnic, age, gender, and sexual diversity. This is particularly important for Aboriginal and Torres Strait Islander people, for whom dementia prevalence is three to five times higher than the general population. These measures need to be equitable and not disadvantage vulnerable groups that may already have reduced access to resources. 7. Resource and coordinate a whole‐of-community approach including government, public and private health care, community services and education sectors to operationalise guidelines and multifaceted dementia prevention programs throughout life. Dementia prevention is everyone’s business. Successful public health and disease prevention campaigns have required a coordinated effort across all levels of the health sector, government, policy makers, non‐government organisations, research, education, industry and the community. Yet, many Australians do not believe that dementia risk can be reduced.14 Dementia prevention is complex due to stigma, literacy, and multifactor risks throughout life. The success of widely known public health campaigns in Australia (eg, Quit for Life and Slip, Slop, Slap) is attributable to their focus on behaviour change using a single behaviour or risk factor, informed by knowledge of barriers and enablers. The Dementia Australia Your Brain Matters campaign was targeted at raising public awareness for dementia, but this was not sustained beyond the funding period (2012–2015). The report from the Lancet Commission identifies educational attainment in early life as an impactful risk factor4 and this should be prioritised given its broader socio‐economic benefits. There are specific mid‐life (hearing loss, traumatic brain injury, hypertension, alcohol intake, obesity) and late‐life factors (smoking, depression, social isolation, physical inactivity, diabetes, air pollution) which offer opportunities for risk reduction across the lifespan.4 From a practical perspective, as many dementia risk factors are shared with other chronic conditions, particularly vascular risk factors, these may present the best opportunity for greatest impact. 8. Mobilise peak health advocacy bodies to promote and coordinate public health messaging on dementia risk factors that cut across chronic conditions. How do we ensure value for money and sustainability of dementia prevention public health campaigns? A unified approach with clear messaging communicated through media, community organisations, and health professionals promoting shared responsibility is crucial. An initial focus on risk factors with the highest population‐attributable risk (physical inactivity and midlife obesity) is recommended to improve wellbeing and reduce risk for multiple chronic conditions. They are also ideal for integrated programs given their overlap with vascular risk factors and successful campaigns (eg, smoking cessation). A key step is the coordination and pooling of resources between peak advocacy bodies such as Dementia Australia, Diabetes Australia, and the Heart Foundation, with clear messaging focusing on single risk factors that have multiple benefits. In clinical practice, this facilitates approaches that are tailored to an individual’s experiences and motivation. For example, motivation for increasing physical activity for one individual may arise from receiving a result of impaired glucose tolerance, while for another it may be the experience of having a family member living with heart disease or dementia. Australia has excellent health infrastructure and an international reputation for dementia prevention due to our depth of clinical, research, and knowledge translation expertise. If we are committed to achieving the ambitious targets of reduced dementia prevalence and incidence, we must shine a spotlight on dementia prevention across all levels of society. To achieve this, the National Health and Medical Research Council National Institute for Dementia Research (NNIDR) Dementia Prevention Special Interest Group proposes this Dementia Prevention Action Plan for Australia. It is time for a call to action in the fight against dementia: dementia prevention needs to be the next international public health area of focus, with Australia playing a leading role. Box – Dementia Prevention Action Plan

For the NHMRC National Institute for Dementia Research, Dementia Prevention Special Interest Group*

The current mechanism for setting air quality thresholds in Australia does not adequately protect community health The current air quality framework to mitigate against the health effects of exposure to air pollution within Australia relies on national environmental protection standards — set out under the National Environmental Protection (Ambient Air Quality) Measure (the ambient air quality NEPM) — and the jurisdictional requirements for monitoring and reporting exceedances.1,2 The ambient air quality NEPM sets reportable limits for key criteria air pollutants.1 Criteria air pollutants are those that are legislated internationally as measures of air quality and include particulate matter (PM), nitrogen dioxide (NO2), carbon monoxide, ozone, sulfur dioxide (SO2) and lead1 (Box). Air toxics are non‐criteria air pollutants that are considered to pose a hazard to human health.7 Air toxics are legislated under a separate NEPM which has the goal of generating baseline data for later development of standards for five compounds: benzene, benzo(a)pyrene, formaldehyde, toluene and xylenes.7 The air toxics standards, based on the gathered baseline data, were due to be set in 20127 but are yet to be reviewed. In 2011, the National Environment Protection Council published guidelines for setting air quality standards.8 These guidelines outline a method that balances risk assessment (health effects based on the exposure–response relationship) with the costs of abatement strategies to achieve the required targets. The process for updating the ambient air quality NEPM based on new evidence about the health effects of criteria air pollutants is slow. Since the publication of these guidelines,8 there has only been one formal change to the NEPM, which was approved in 2016.1 This variation focused on modifications to the measures related to PM10 and PM2.5 (PM ≤ 10 µm and ≤ 2.5 µm in aerodynamic diameter, respectively), as it was thought that the potential benefits to human health, and the available abatement strategies, were greater than those for other criteria pollutants.9 The variation included, among other measures, the introduction of an annual average for PM10 and progress towards the introduction of a PM2.5 standard. The national standards for gaseous pollutants are currently under review.10 Moreover, the catastrophic 2019–20 bushfires have highlighted the importance of air quality for many Australians. It is therefore timely to consider the current ambient air quality standards and whether they are fit for purpose. We focus on the criteria air pollutants as these are the only air pollutants currently covered by legislation that attempts to enforce maximum exposure limits. Criteria air pollutants — are there safe limits? Particulate pollutants Air pollution is composed of a complex mixture of solid, liquid and gaseous molecules. Airborne PM is comprised of solid and liquid particles suspended in the air that vary in size and chemical composition. PM is generated from a range of sources including combustion, plant materials, sea salt and earth‐derived inorganic compounds. PM10 is small enough to bypass the upper airways and lodge in the conducting airways, but is usually too large to reach the alveoli. Acute exposure to PM10 is associated with hospitalisations and mortality for cardiorespiratory conditions,11 while long term exposure is linked to chronic cardiorespiratory conditions and metabolic disorders.12 No safe threshold for PM10 exposure has been identified.5,6 PM2.5 can penetrate deeper into the lungs and is one of the leading causes of global mortality and morbidity.13 PM2.5 has been linked to cardiovascular disease, respiratory disease, pre‐term birth, metabolic disorders and neurological health problems.4 Like PM10, there is no evidence for a safe threshold for PM2.5 exposure. This has been highlighted in Australian studies, where PM2.5 is typically low, showing associations between exposure to PM2.5 and mortality.2 Consistent with this, there is evidence that the exposure–response relationship is steeper at lower PM2.5 concentrations.14 Gaseous pollutants Of the gaseous air pollutants, data are most extensive for NO2, a combustion by‐product. Studies on the health effects of low concentrations of NO2 have shown associations between NO2 and childhood pneumonia and otitis media15 and impaired lung function.16 While data on the exposure–response relationship suggest that there is an effect threshold,2 it is three to five times lower than the current NO2 standard (Box).1 Data on the magnitude of the health effects of SO2, a combustion product primarily related to sulfur‐containing fuels, are less extensive. While there is an established relationship between exposure to SO2 and cardiorespiratory mortality,3 data are not robust enough to determine whether there is a health effect threshold. Similarly, while carbon monoxide has a range of physiological effects on the body,17 the co‐existence of carbon monoxide with other criteria pollutants makes it difficult to disentangle the contribution of this pollutant to the health effects of pollution in general. Acute exposure to ozone, a by‐product of interactions between combustion emissions and sunlight, is strongly linked to respiratory hospitalisations; however, consensus regarding a threshold for these health effects is contentious.18 Lead pollutants The teratogenic and neurological health effects of lead are well established and there is no safe level of exposure.4 While overall community exposure to lead has decreased with the elimination of tetraethyl lead from fuels, there are still some communities in Australia exposed to anthropogenic sources of lead. Summary Collectively, there is sufficient evidence to conclude that there is no safe threshold for exposure to PM10, PM2.5 or lead. For NO2, there is a threshold, but the current NEPM standard is well above this level.1 On this basis, the current standards are not sufficient to adequately protect the health of the Australian community (Box). Principles for setting air quality guidelines in Australia In Australia, the background concentrations of air pollution in most areas are relatively low compared with other countries around the world.19 To a certain extent, it is likely that this observation influences current policies regarding ambient air quality standard setting, which aim to identify a threshold concentration where the health risks are balanced against the feasibility of achieving these thresholds. Unfortunately, this puts regulators in a position of balancing the costs of expanding infrastructure against the benefits to human health, as the existing monitoring network, which assesses adherence to the standards, does not have sufficient coverage to generate data with enough accuracy to monitor exceedances.20 The adverse health effects of the NEPM criteria pollutants are well established. For many (eg, PM2.5), there is sufficient evidence, both from our review and expert consensus, that it is not possible to set a threshold as health effects can be detected even at low exposure doses, whereas for others, the threshold is well below the current NEPM standard (eg, NO2). The current approach to regulation of air pollution implies a causal model that is inconsistent with the available evidence. It provides no incentive for reducing exposure and allows increases in exposure to harmful pollutants, as long as the levels remain below the thresholds. This provides only partial health protection and adversely impacts community perceptions by implying that the current standards represent a “safe” level of exposure. It also relies on an accurate and comprehensive network for monitoring exceedances, which is lacking in many Australian jurisdictions, and appropriate mechanisms to ensure implementation of the measures, including appropriate penalties if standards are not met. We believe this approach must be replaced by regulation focused on harm minimisation using the principle of continual improvement; similar to the approach recently adopted by the European Union where targets for PM2.5 are set for percentage reductions in levels within a given time frame.21 This would drive better practice in air quality management and encourage implementation of strategies that improve ambient air quality and health for all Australians by reducing existing levels of exposure and discouraging new increases in exposure, regardless of the current levels. The concept of “no safe limit” was raised in independent commissioned reports20,22 provided before the most recent NEPM variation23 to guide the decision‐making process. The concept of an exposure reduction framework was also raised at that time and included in the impact statement prepared for the National Environment Protection Council outlining the case for the NEPM variation.9 It was argued that the introduction of an exposure reduction framework was necessary because there was no evidence for a threshold for the health effects of exposure to PM and, in contrast to the existing NEPM approach, it would maximise the community level health benefits.20 Unfortunately, it seems that this approach was dismissed because of concerns regarding the ability to monitor overall reductions in PM, due to inadequate monitoring infrastructure across the country, and whether reductions could actually be achieved.23 This seems to ignore the intent of such a framework — it is not about setting targets, it is about driving behaviour and promoting best practice. Reassuringly, the most recent impact statement prepared for the National Environment Protection Council for the revision of the standards for gaseous pollutants24 recommends changing the NEPM to make reference to minimising the health effects of exposures and “incorporation of exposure–reduction targets”. We endorse this approach. However, the recommended measures for gaseous pollutants still seem to rely on specifying a standard in the future,25 albeit a lower one, as part of an exposure–reduction framework, rather than proposing goals for continual reduction. In the absence of a mechanism to promote continual improvement and best practice by regulators and industry, we are failing to adequately protect the Australian community from the health impacts of air pollution. Box – Current National Environmental Protection Measures (NEPMs) for criteria air pollutants,1 the current evidence for the dose threshold for detectable health effects in humans, and whether the NEPMs are above these thresholds Pollutant Average maximum concentration Measurement period Allowable exceedances Dose threshold for health effects NEPM above health effect threshold Carbon monoxide 9 ppm 8 hours 1 day/year Unknown NA Nitrogen dioxide 0.12 ppm 1 hour 1 day/year Unknown NA 0.03 ppm 1 year None ~ 6–11 ppb2 Yes Ozone 0.10 ppm 1 hour 1 day/year Unknown NA 0.08 ppm 4 hours 1 day/year Unknown NA Sulfur dioxide 0.20 ppm 1 hour 1 day/year 0.2–0.4 ppm3 No 0.08 ppm 1 day 1 day/year Unknown NA 0.02 ppm 1 year None Unknown NA Lead 0.5 µg/m3 1 year None None4 Yes PM10 50 µg/m3 1 day None None5,6 Yes 25 µg/m3 1 year None None5,6 Yes PM2.5 25 µg/m3 1 day None None2 Yes 8 µg/m3 1 year None None2 Yes NA = not applicable; PM10 and PM2.5 = particulate matter ≤ 10 µm and ≤ 2.5 µm in aerodynamic diameter, respectively.

Graeme R Zosky · Stephen Vander Hoorn · Michael J Abramson · Sophie Dwyer · Donna Green · Jane Heyworth · Bin B Jalaludin · Jennifer McCrindle-Fuchs · Rachel Tham · Guy B Marks

We must consider how we can support communities hosting vaccine efficacy trials

George S Heriot · Euzebiusz Jamrozik

Difficulty in achieving proper informed consent for a complex screening test and the varying phenotypic outcomes leaves pregnant women in a precarious situation when results are abnormal The combined first trimester screening test for Down syndrome, involving a nuchal translucency scan and biochemistry at 11–13 weeks, improved detection rates to 90% when compared with the sensitivity of screening by age‐related a priori risk of around 30% for a false positive rate of 5%.1 The advent of non‐invasive prenatal testing (NIPT) in 2010 as a screening test for the common trisomies was revolutionary, with sensitivity, specificity and detection rates unmatched by the combined first trimester screening programs. NIPT was found to achieve a detection rate for Down syndrome of 99.7%, with a false positive rate of 0.04%.2 However, some NIPT providers now additionally offer extended panels and low resolution whole genome sequencing (WGS) including sex chromosome aneuploidies, rare autosomal aneuploidies, and subchromosomal deletions, duplications and recurrent microdeletions. This comes at a cost of a higher false positive rate and lower positive predictive value.3 Moreover, the expanded panels and WGS NIPT raise issues of clinical utility and ethical concerns.4,5 Clinical utility Screening not diagnosis NIPT is based on the detection of cell‐free fetal DNA in the maternal circulation. The placental origin of cell‐free fetal DNA means that NIPT can only be a screening test and is not diagnostic.6 NIPT findings can be confounded by confined placental mosaicism, cell‐free fetal DNA from a demised co‐twin placenta, maternal chromosomal changes or malignancy.6,7 Moreover, a NIPT result will be issued even if the fetus is demised. The current NIPT tests available are for specific chromosomal aneuploidy, extended panels of targeted conditions and low resolution WGS. Targeted and low resolution WGS NIPT Targeted NIPTs (Box 1) interrogate specific chromosomes: standard (usually 13, 18, 21, X and Y) or extended (specific recurrent microdeletions associated with known syndromes, such as 22q11.2 microdeletion [DiGeorge syndrome]).8 Many abnormalities that can be detected by targeted NIPT have varying clinical outcomes (eg, sex chromosome abnormalities and DiGeorge syndrome). Each of these conditions has varying sensitivity, specificity and positive predictive value. Other NIPTs interrogate every chromosome (by low resolution WGS). These tests can potentially screen for aneuploidy of every chromosome (all 22 autosomes and the sex chromosomes), and for subchromosomal gains and losses on every chromosome. There is potential utility in detecting rare or novel large subchromosomal imbalances, as they are likely to be associated with abnormal clinical phenotype when present in the fetus, and may indicate a familial balanced rearrangement. The clinical utility of screening for rare autosomal aneuploidies is less certain. Most rare autosomal aneuploidies (95%) are confined to the placenta, and those which are present in the fetus as well as the placenta often result in early fetal demise.9 The resolution of WGS NIPT is likely to increase as deeper sequencing becomes viable and cost‐effective. Whereas prenatal microarray testing of amniotic fluid in Australia is primarily used in the context of a fetal structural abnormality, higher resolution NIPT could become a general screening test. This would, however, increase both the number of variants of uncertain significance and the likelihood that they are detected in an apparently phenotypically normal fetus.3,10 Ethical concerns Respect for maternal autonomy is an important ethical principle in clinical guidelines for prenatal screening. Recommendation 2 of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists guidelines states: “Screening or diagnostic testing for fetal chromosomal and genetic conditions is voluntary and should only be undertaken as an informed decision by the pregnant woman”.11 In light of the issues surrounding clinical utility and complexity of expanded panels and WGS NIPT, care needs to be taken to ensure that autonomy is respected. Moreover, consent alone cannot be expected to do the ethical heavy lifting, because of (i) the challenges in providing adequate information arising from complexity of the tests; (ii) the risk of power imbalances and “normalisation” of testing; (iii) anxiety resulting from complex and potentially unnecessary medical decisions; (iv) the problem of screening for “normality” and genetic reductionism; and (v) the doctor’s responsibility in determining which NIPT test is clinically indicated. Complexity endangers informed consent Respect for autonomy requires that informed consent is obtained. From a medico‐legal perspective, consent must be given voluntarily. The individual must also be sufficiently informed regarding a test or procedure, including the associated risks and benefits. The requisite extent of information provision is generally determined in accordance with what information a reasonable person, in that person’s circumstances, would expect to receive. From an ethical perspective, however, it is the understanding of information that is important, not merely that a person was given the legally required information. Given the complexity of extended panels and WGS NIPT, ensuring understanding means that significant time needs to be invested. Power imbalances and normalisation Two additional factors could ethically undermine consent for all NIPT options. First, the power imbalance between a doctor and patient, whereby a patient simply agrees because “doctor knows best” and, second, the impression that NIPT is a normal part of care that it would be foolish to reject.12 The anxiety caused by uncertain results It is tempting to respect autonomy by being non‐paternalistic and non‐directive in counselling by giving parents all the information from prenatal testing regardless of its nature. However, this shifts the burden of the uncertain results and the resultant anxiety to the parents. Qualitative and quantitative research shows higher levels of decisional regret among parents whose results identified variation of uncertain significance. At least some parents would not have consented to the test if they had known what this would entail. The lack of certainty by clinicians about what these results might actually mean for a future child increased parental distress.13 The meaning of screening and the danger of genetic reductionism According to the synthesis of screening criteria offered by Andermann and colleagues (Box 2), screening should be used to identify an individual who is high risk for a specific disease or need, thereby filling the perceived gap between standard screening and invasive diagnostics.14 Screening is then followed up with diagnostic tests and appropriate treatment. The availability of extended panels and WGS NIPT (Box 1) increases the tendency away from screening for diseases guided by public health screening principles. It is difficult to identify a recognised need or define the objectives of the screening beyond merely looking to see if there is anything abnormal. Even if these principles were met, one may be detecting placental pathology, or clinical conditions with highly variable outcomes for the fetus. As the resolution of WGS NIPT increases, so does the likelihood of detecting variants of uncertain significance. Provision of extended panels and WGS NIPT should be seen in light of the bigger question of how we see genetic information in our society.15 Research shows that many genetic tests are in effect screening for “normality”, which partly explains the anxiety when variants of uncertain significance are reported.13 This approach potentially changes the purpose of screening from screening for a specific disease to screening for normality by identifying any abnormality in the genome. The error in this thinking is that it assumes that genetic variation is abnormal. Just because a genetic anomaly can be identified does not necessarily mean that it would be phenotypically expressed. Similarly, detection of genes associated with adult onset disease does not necessarily equate to disease, and the possible future development of therapies for currently untreatable conditions cannot be ruled out. Consent is not sufficient to justify a procedure of questionable clinical utility Screening should be recommended or chosen only if there is likely to be a proportionate benefit, and there is no disproportionate burden. What is proportionate rests on a number of objective and subjective factors, but the aforementioned public health screening principles provide a good starting point. We agree with national guidelines that recommend against routine screening for recurrent microdeletions, and recommend provision of in‐depth counselling before screening for sex chromosome abnormalities.11 Recommendations The following recommendations may address the clinical and ethical concerns outlined above. Informed consent is required for all NIPT tests, especially in the context of extended panels and WGS NIPT. Clinicians must understand the different abnormalities targeted by extended NIPT panels and be able to assess and communicate the clinical utility of screening in accordance with a particular patient’s needs, desires and circumstances (Box 1). If ordering WGS NIPT, given that there may be significant uncertainty as to the actual phenotypic or functional manifestation of a genetic variation in a particular child, the consent process should include helping to contextualise limitations and risks in the broader context of the human experience of risk and uncertainty. Genuine shared decision‐making models can empower patient autonomy by helping them to understand the implications of their possible decisions in relation to their values.16 Moreover, decision tools and algorithms that align a variety of scenarios with personal values can facilitate a high quality informed consent process. Higher resolution WGS NIPT should only be used for research purposes until we have robust data regarding its clinical utility. Box 1 – Non‐invasive prenatal testing (NIPT) options: current availability and main advantages and disadvantages CPM = confined placental mosaicism; PPV = positive predictive value; WGS = whole genome sequencing. Box 2 – Synthesis of screening criteria12 The screening program should respond to a recognised need. The objectives of screening should be defined at the outset. There should be a defined target population. There should be scientific evidence of screening program effectiveness. The program should integrate education, testing, clinical services and program management. There should be quality assurance, with mechanisms to minimise potential risks of screening. The program should ensure informed choice, confidentiality and respect for autonomy. The program should promote equity and access to screening for the entire target population. Program evaluation should be planned from the outset. The overall benefits of screening should outweigh the harm.

Joseph Thomas · James Harraway · David Kirchhoffer

To the Editor: Elasticated straps — also known as “octopus” straps or bungee cords — are used to secure loads of various shapes and sizes. Unexpected release of the potential energy stored in these straps can cause catastrophic injuries. The Royal Victorian Eye and Ear Hospital (RVEEH) is the largest eye hospital in Australia and is well positioned to assess and treat a variety of ocular injuries. We explored trends in presentations to the RVEEH emergency department (ED) for such injuries between 2007 and 2018, using the ED triage database and information relating to total numbers of ocular trauma presentations. This study was approved by the RVEEH Ethics Committee (09/886H). Between 2007 and 2018, there were 169 presentations involving an elasticated strap‐related eye injury (145 male and 24 female; mean age, 43.4 years). While most patients had multiple injuries, the most common primary diagnosis was traumatic hyphaema, followed by corneal abrasion and open globe (full‐thickness wounds) injuries (Box). There were 23 admissions, of which 21 required surgical intervention, with vitrectomy, orbital wound exploration and closure, and lensectomy being the most common procedures. The final visual acuity measurements of the 17 patients who were admitted and able to be followed up were 6/36 or better for nine patients and 6/60 or worse for eight patients. While males presented more frequently than females, the absolute number of yearly presentations by gender was stable. Elasticated strap‐related injuries accounted for 0.23% of the total 72 663 ocular trauma presentations in the period. While it is problematic to compare incidence with previous studies, due to factors such as growth of the RVEEH ED, growth of other hospitals around Melbourne, and population growth, elasticated strap‐related eye injuries remain a significant contributor to presentations at the RVEEH. These straps were a known danger in the early to mid‐1990s1 and they remain dangerous more than 20 years later, causing severe ocular damage and requiring operative intervention in 12.4% of patients. Although the total number of elasticated strap‐related eye presentations does not appear to be dramatically rising, the continued presence of severe eye injuries necessitating admission for surgical intervention is cause for concern. Multiple steps can be taken to address the continued challenge of elasticated strap‐related injuries. Thorough assessment of the patient remains crucial to facilitate prompt treatment of vision‐threatening diagnoses. In addition, preventive measures should be undertaken to lessen the likelihood of visual loss caused by these devices. This includes patient education and encouraging the use of alternative devices that are functionally similar but pose no risks to eyesight, such as non‐elasticated straps that can be gradually tightened, braided metal locking straps, or even self‐contained soft roof rack and strap combinations. Regulators should also consider whether the convenience of elasticated straps justifies the danger they continue to pose to eyesight almost half a century after they were first introduced to Australia and the first eye‐related injury was reported.2 Box – Primary diagnoses of elasticated strap‐related eye injury sequelae table#t1 tbody td:nth-child(n+2) P. Pleft { text-align: center; } Primary diagnosis* Total cases Traumatic hyphaema 63 (3.3%) Corneal abrasion 42 (24.9%) Open globe injury 11 6.5%) Conjunctival/lid/canalicular laceration 7 (4.1%) Commotio retinae 8 (4.7%) Traumatic iritis/mydriasis/uveitis 7 (4.1%) Periorbital haematoma 3 (1.8%) Corneal foreign body 2 (1.2%) Subconjunctival haemorrhage 2 (1.2%) Traumatic glaucoma 2 (1.2%) Conjunctival abrasion 1 (0.6%) Vitreous haemorrhage 1 (0.6%) Posterior vitreous detachment 1 (0.6%) Retinal detachment 1 (0.6%) Lens dislocation 1 (0.6%) Other injury 5 (3.0%) No abnormality detected 7 (4.1%) Patient did not wait to be seen 5 (3.0%) Total 169

Philip Rothschild · Peter Meagher · Thomas G Campbell

To the Editor: In 1996, two articles showed that bowel cancer screening in subjects aged 45–741 and 45–752 years, recruited in the early 1980s, led to a significant reduction in mortality; since then, the age range in Australia’s screening program remains at 50–74 years. Between 1981 and 2015–2017, the mean life expectancy at birth for men and women in Australia rose by 9.3 and 6.3 years respectively.3 In 2016–2018, the mean life expectancy at 75 years was 12.3 and 14.3 years for men and women respectively, and even at 80 years, the mean life expectancy was 9.1 and 10.6 years respectively,3 suggesting a reduction in morbidity in the 75–79 years cohort over the 1981–2017 period. In 2015, the estimated bowel cancer incidence and mortality rates for Australians in the 75–79 years range were 28% and 82% higher than in the 70–74 years range.4 In the United States, in adults aged 65 years and older, the prevalence of screening was higher than 80% in nine states.5 In Australia, mean participation in the National Bowel Cancer Screening Program (NBCSP) increased with age cohort6 (Box). Although there is an increased risk of complications from colonoscopy with increasing age, a prospective observational study compared the risks in the 75–79 with the 70–74 years range and found no increase in perforation rates.7 A US study found that colorectal cancer screening was cost‐effective at ages 79 and 80 years even in persons with severe comorbid conditions.8 A recent Australian microsimulation study9 suggested that the cost‐effectiveness of screening the 50–79 and 50–74 year groups would be almost identical, although the advantage of a likely high participation in the 75–79 age range was not addressed. It found that the number of immunochemical faecal occult blood tests and colonoscopies would increase by 10–16% and 21–30% respectively if the screening cessation age were extended to 79 years, both of which should be welcomed. Facilities in Australia can cope with such an increase in colonoscopies. In view of the above, the NBCSP age range should be extended to 79 years. At a minimum, a pilot study of such an extension should be undertaken. Box – Australian National Bowel Cancer Screening Program participation Age (years) Participation rates (%) 2014–2015 2015–2016 2016–2017 2017–2018 Mean 50–54 28.5 28.1 29.8 31.9 29.6 55–59 36.8 35.5 35.5 37.3 36.3 60–64 43.2 42.7 43.1 43.7 43.2 65–69 43.5 44.2 47.5 49.6 46.2 70–74 52.5 52.5 52.6 53.1 52.7

Donald J Frommer

The consequences of removing some restrictions may not be apparent for more than two months

Nick Scott · Anna Palmer · Dominic Delport · Romesh Abeysuriya · Robyn M Stuart · Cliff C Kerr · Dina Mistry · Daniel J Klein · Rachel Sacks‐Davis · Katie Heath · Samuel W Hainsworth · Alisa Pedrana · Mark Stoove · David Wilson · Margaret E Hellard

To the Editor: Restrictions and concerns associated with coronavirus disease 2019 (COVID‐19) have led to decreased routine immunisation coverage in many countries, including the United Kingdom1 and the United States.2 Australian data showing the COVID‐19 pandemic’s impact on vaccination coverage are not yet available, but it has disrupted services provided by the National Immunisation Program, which funds vaccination for children, adolescents, adults and special risk groups. In the face of ongoing COVID‐19 risk and restrictions, maintaining a resilient routine vaccination program is crucial. The COVID‐19 pandemic has heightened barriers to vaccination. Lockdown restrictions have affected immunisation service accessibility. Specifically, some clinics reduced face‐to‐face appointments in favour of telehealth3 or closed due to insufficient space and increased staffing and other requirements.4 Patients may have rescheduled appointments to avoid COVID‐19 exposure in waiting rooms, while school‐based programs have been disrupted by closures. Reduced consultations limit not only opportunities to vaccinate but also opportunities for health care providers to address vaccine questions and concerns and reinforce trust. Employment changes related to COVID‐19 may also exacerbate cost barriers for people at risk of under‐immunisation, such as migrants, international students, asylum seekers and refugees.5 To improve access, some jurisdictions have successfully established drive‐through vaccine clinics, and pharmacists in some states have been granted expanded permission to vaccinate children against influenza. However, some families may have delayed vaccines due to the COVID‐19 pandemic, and governments may need to consider additional resources for catch‐up vaccination and extensions or grace periods for “No jab, no pay” and “No jab, no play” policies. School‐based vaccination programs should be re‐established as a priority when schools reopen. Publicly available vaccination coverage data will not reflect COVID‐19‐related impacts until as late as December 2020. We recommend early release of more timely data to ensure service providers gain feedback on program performance. We also recommend awareness campaigns promoting timely National Immunisation Program vaccination or catch‐up. Information should be culturally and linguistically appropriate and should be developed through consultation and engagement with diverse communities, including Aboriginal and Torres Strait Islander communities. Australia’s immunisation providers are dedicated and adaptable, but we must now respond quickly to the challenges of COVID‐19 and remain vigilant to maintain routine vaccination coverage across the lifespan.

the Collaboration on Social Science, Immunisation (COSSI) Working Group

Complementary medicines are used by more than half the people in Australia, incurring out‐of‐pocket health expenses of about $5.2 billion in 2019.1 Information about their use by older adults in Australia is more than a decade old.2 Given subsequent demographic changes and doubling in sales of vitamins and supplements,1 we should update our knowledge in this area. We analysed data from the ASPirin in Reducing Events in the Elderly (ASPREE) Longitudinal Study of Older Persons (ALSOP) to assess self‐reported use (every day, occasionally, never) of complementary medicines (fish oil, glucosamine, ginkgo, coenzyme Q10, calcium, zinc, vitamins B, C, D and E, multivitamins, Chinese or herbal) by healthy people over 70 years of age residing in metropolitan or regional Victoria, South Australia, Tasmania, the Australian Capital Territory or southern New South Wales, recruited through their usual general practitioners.3 We summarised data as descriptive statistics; we assessed differences between groups in χ2 tests (categorical variables). Analyses were conducted in SPSS Statistics 23 (IBM). ALSOP was approved by the Monash University Human Research Ethics Committee (reference, CF11/1100). During January 2012 – July 2015, 14 757 of 16 703 ASPREE participants returned ALSOP Baseline Medical Questionnaires3 with at least partial responses to the questions on complementary medicines (response rate, 88%); their mean age was 75.2 years (standard deviation, 4.3 years), and 8068 (55%) were women). A total of 10 961 respondents (74.3%) reported using them either daily or occasionally; fish oil (6563 of 14 757 respondents, 44.5%), vitamin D (4995, 33.8%), glucosamine (3940, 26.7%), and calcium supplements (3652, 24.7%) were the most frequently reported items (Supporting Information, table 1). Complementary medicines were used by larger proportions of women (6637 of 8068, 82.3%) than of men (4324 of 6689, 64.6%; P < 0.001), and of people with more than 12 years of education (4418 of 5838, 75.7%) than of people with less education (6542 of 8918, 73.3%; P = 0.001). The proportions of complementary medicine users who reported a history of depression (987 of 4053, 24.4%) or osteoarthritis (3060 of 5240, 58.4%) were larger than for non‐users (depression, 264 of 1347, 19.6%; P = 0.002; osteoarthritis, 705 of 1598, 44.1%; P < 0.001); self‐reported diabetes was more common among non‐users (363 of 3790, 9.6%) than among complementary medicine users (815 of 10 944, 7.4%; P < 0.001) (Box; Supporting Information, tables 2 and 3). Almost three‐quarters of people in our sample of community‐dwelling older adults in south‐eastern Australia used complementary medicines, with fish oil the most common product. While proprietary complementary medicines are generally regarded as safe, their widespread use by older people, who generally have a greater burden of disease, higher medical expenses, and low or fixed incomes, raises questions about their marketing and promotion.5 Our study population represents Australians over 70 who regularly visit general practitioners, and we included participants from geographically and socio‐economically diverse backgrounds.3 As we pre‐specified a limited number of products, our use estimates may be conservative. In our study, complementary medicine use was defined differently to some earlier studies; for example, the Australian Health Survey which asked about complementary medicine use in the previous 24‐hour period.6 This difference may account for our estimates being slightly higher. Our findings provide the most comprehensive information to date on complementary medicine use by Australians over 70 years of age. Box – Characteristics of respondents to survey of community‐dwelling Australians over 70 years of age on their use of complementary medicine

for the ALSOP Complementary Medicine Research Group*

To the Editor: Pandemic responses across the world have been highly reactive. However, there remain only three strategic options to managing coronavirus disease 2019 (COVID‐19): mitigation, suppression and elimination (Box).2 With the promise of efficacious new vaccines, mitigation is appropriately not considered as part of Australia’s national strategy. However, our stated goal of achieving “no community transmission” remains poorly defined and risks missing important distinctions between elimination and suppression.3 Effective elimination is dependent both on getting to zero local cases and then staying there, with any new transmission chains immediately halted. All jurisdictions of Australia have now achieved elimination over significant periods, even without articulating this as their strategy. By comparison to suppression, greater relaxation of restrictions may well be allowable under an elimination approach if vigilance is maintained, as New Zealand has demonstrated.4 Although the challenges of ensuring quarantine of returning travellers are well recognised, this is an essential aspect of maintaining elimination and increases in importance as distancing restrictions are eased. Australia’s current strategy appears to imply suppression, with some virus circulating but with case numbers at manageable levels. Whether suppression has been achieved can be monitored by maintaining an effective reproduction number of no greater than one, or equivalently by ensuring the epidemic curve of new community cases is not upsloping. Importantly, the reproduction number and the rate of new cases at any point in time are unrelated — we could have effective suppression and a reproduction number of one with daily case rates of five, ten or 50. Our definition of no community transmission appears to imply complete identification of transmission chains with no “mystery cases”, regardless of the number of new cases. These considerations are important in determining whether we have full visibility of the epidemic and effective contact tracing but do not determine the reproduction number. The rapid spread of the virus necessitates a public health strategy that is clear, robust and agile. Improved control combined with the increasingly clear seasonality of the virus5 suggest that control can be maintained throughout the summer. However, if vaccination has not been widely distributed before winter 2021 and we do not make clear choices, further major outbreaks remain likely. Box – Characteristics of coronavirus disease 2019 (COVID‐19) epidemic response strategies (Trauer et al) Elimination Suppression Mitigation Our definition No cases or transmission, except in quarantined arrivals Very low community case rates; limited transmission Higher case rates, but within health service capacity Key metric of success No locally acquired cases Effective reproduction number not exceeding one,* or a horizontal sloping epidemic curve of locally acquired cases Hospital and ICU occupancy within (expanded) capacity Accrual of significant population‐level immunity No No1 Yes, likely to take many months, with considerable morbidity and mortality Need for mobility restrictions and hygiene measures Mobility may return to near normal while cases and transmission remain at zero; vigilance essential; likely need for episodic restrictions if quarantine escape occurs Continuous need for high levels of restrictions; strong possibility of disruptive lockdowns given that community transmission persists Unpredictable Need for restrictions on international arrivals Extremely high, and increases as distancing restrictions are eased Moderate Less important Current appropriateness for Australian jurisdictions† Reasonable Reasonable Not under consideration ICU = intensive care unit. * The effective reproduction number becomes more difficult to quantify precisely as numbers fall. † Given an effective vaccine appears likely.

James M Trauer · Ben J Marais · Romain Ragonnet · Julian Savulescu · Emma S McBryde