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A FOCUS ON COVID-19 Finding the silver lining in a pandemic Helping Australians survive blood cancer How useful are tracking apps in curbing COVID-19 infections?


FOREWORD I start with a heartfelt thank you to our members for your ongoing loyalty. It is clear that despite the financial challenges many of us face, the value of being part of the national voice is acknowledged and considered essential – and we couldn’t agree more.

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he past few months have demonstrated incredible resilience and talent a n d i m p o r t a n t l y, a s e n s e o f cohesiveness that perhaps is not always immediately obvious. Ensur ing he a lth a nd me dica l research, today and tomorrow, remains a significant national priority in the minds of our politicians, policy makers and broader public, remains core to what Research Australia does every day. To share our passion with such a powerful alliance of leaders all striving to improve the wellbeing of the nation is truly an honour and a privilege. We are also pleased to be welcoming new members into the network and look forward to their contribution to the work we all do. We have been focused on bringing to light the broad range of research that is and has been underway in Australia in response to COVID-19 and believe it is critical that the scale of this research is evident to the broader community. Indeed, we suspect that even some organisations involved in research are not aware of the scale and scope. Dedicating this issue of INSPIRE to this subject is another way we can continue to do this. While there is brand new research being undertaken in response to COVID-19, projects we wouldn’t be doing otherwise, it is important to note that this research is building on work that was already underway. It is drawing on capacity and expertise that we have developed over decades, and the investments in science that we have made over this period. This is why we advocate for the sector

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to remain a priority for government, funders and philanthropists. Research Australia has advocated for collaboration across research organisations, between academia, gove r nme nt re se arch age ncie s and departments, with healthcare services and the private sector. The urgency and scale of the COVID-19 pa nd e mic ha s ac c e le rate d the creation of partnerships; competitors have put aside their own commercial interests, including pharmaceutical companies to pool resources and make information, samples and resources widely available. While the pandemic has closed international b o r d e r s i t h a s n o t p r e v e n te d international collaboration, which is currently occurring on a scale that is unprecedented. An example is QIMR Berghofer’s article on the work Dr Smith and his team are doing to understand how the human immune system fights the disease. They have recruited more than 40 Queenslanders who have recovered from COVID-19 and have blood samples to examine how their immune systems responded to the virus, with the goal of developing a new T cell immunotherapy. The Join Us register, developed by The George Institute Australia and the University of NSW, is a brilliant initiative which will improve the country’s capacity to recruit research participants and aims to put us at the forefront of clinical and public health research on the global stage. The article from Macquarie University in this issue is a great example of the power of national and global collaboration in the development of the Global Partnership on Artificial

Intelligence (GPAI), with particular emphasis on pandemic planning. Represented by AIHI’s Professor Enrico Coiera, along with four other representatives from Australia and partners from around the world, the group will guide the use of AI in healthcare. As our members are aware, one of Research Australia’s key objectives is to ensure evidence-based research is embedded into the health system. If research is to benefit patients and society, it needs to be utilised in our community. It can provide the information we need to make o u r h e a l th sys te m s s afe r, a n d more effective. All this requires our researchers and innovators to engage with others: hospitals, pharmaceutical and biote chnolog y companie s, governments, local communities and international partners. I encourage you to read the ar ticle from the National Breast Cancer Foundation (NBCF) which is identifying gaps in services and treatment. Although breast cancer has one of the highest sur vival rates, thanks largely to research, 9% of those diagnosed still die from the disease within five years. Last but not least, The Last Word is by Research Australia Director and Executive Leader of the Bupa Health Foundation, Associate Professor Annette Schmiede. It is a thoughtprovoking approach for fundamental reform of Mental Health Care in Australia. Enjoy the read and stay well.

Nadia Levin CEO & Managing Director


AWARD CATEGORIES Peter Wills Medal Advocacy Award Griffith University Discovery Award Frontiers Award Sponsored by ANU Data Innovation Award Sponsored by Bupa Health Foundation Philanthropy Award Health Services Award Sponsored by the NSW Government

Thank you to our 2020 Award Sponsors


CONTENTS

Australian Health & Medical Research & Innovation

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Surgery during COVID-19: Using Evidence Against the Unknown

Sewage surveillance key to detecting silent COVID-19 infection

Join Us a new digital resource to boost Australia’s research capacity

UNIVERSITY OF ADELAIDE

AUSTRALIAN NATIONAL UNIVERSITY

THEGEORGE INSTITUTE

26 Rising to the telehealth challenge: Clinician experiences during COVID-19 LA TROBE UNIVERSITY

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Helping Australians survive blood cancer

What have we learnt from COVID-19?

LEUKAEMIA FOUNDATION

MACQUARIE UNIVERSITY

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Innovation in Data & Technology in HMR

QIMR BERGHOFER JOINS THE FIGHT AGAINST COVID-19

How useful are tracking apps in curbing COVID-19 infections?

NATIONAL BREAST CANCER FOUNDATION

QIMR BERGHOFER

SAX INSTITUTE

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Publisher Research Australia Ltd Art Direction Matthew Ware p +61 403 844 763 or e matt@objktive.com For Advertising enquiries please contact the Research Australia office on p 02 9295 8546 or e admin@researchaustralia.org researchaustralia.org

INSPIRE ONLINE issuu.com/researchaustralia

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20 eHealth solutions to drive better mental health outcomes UNIVERSITY OF NEWCASTLE

34 Families and researchers working together to find answers for COVID-19 MURDOCH CHILDREN’S RESEARCH INSTITUTE

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24 Finding the silver lining in a pandemic EDITH COWAN UNIVERSITY

38 Adapting to solve the coronavirus pandemic MONASH UNIVERSITY

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INSPIRE is a publication of Research Australia Ltd ABN 28 095 324 379 384 My Victoria Street CHRISTOPHE KEREBEL CHRISTOPHE Twitter : @chriskere KEREBEL Darlinghurst NSW 2010

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Who can submit articles? Any current member of Research Australia who would like to share a relevant story that affects their organisation including, philanthropic donations and their outcomes, research findings, and any other related health and medical research topic that affects the Australian population. Submission guidelines & deadlines For information regarding how to submit and publishing deadlines visit the Research Australia website. Disclaimer The opinions expressed in INSPIRE do not necessarily represent the views of Research Australia. Whilst every effort has been made to ensure accuracy, no responsibility can be accepted by Research Australia for omissions, typographical or inaccuracies that may have taken place after publication. All rights reserved. The editorial material published in INSPIRE is copyright. No part of the editorial contents may be reproduced or copied in any form without the prior permission from Research Australia. © Research Australia 2020.

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Testing for COVID-19 at the Point of Care

National Clinical Trials Governance Framework: What it means for you

An opportunity for fundamental reform of Mental Health Care in Australia

UNSW SYDNEY

ARCS AUSTRALIA

BUPA HEALTH FOUNDATION


RECENT FORUMS Philanthropy Roundtable Research Australia has been focused on ensuring Members of Parliament hear directly from the research community and the national and state briefings we’ve conducted over the last few months have involved researchers discussing their work with MPs. It’s a key part of our sector advocacy, reminding politicians how and why we have this incredible health and medical research (HMR) capacity and why we must stay focused on sustainable investment so we have both a history and a future of excellent research impact and outcomes! Given that no conversation about investment in HMR can be complete without talking about philanthropy, we also wanted to provide information from charities who focus on fundraising for HMR – it is after all, a significant amount for many organisations.

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On July 7, Research Australia gathered CEOs from our membership organisations and other key representatives to share their thoughts on the impact of COVID-19 on Philanthropy in HMR but also the innovative approaches they have taken to retain donors and supplement valuable fundraising revenue shortfalls due to the effect of the restrictions. We have also surveyed the members in our alliance who support research either through funding, fundraising or commissioning to capture the impact the pandemic on their operations today and into the future. The report is intended for Government, the wider sector and the public as part of awareness raising of health and medical research. We are looking forward to convening our member organisation to focus on this important element of health and medical research - funding through philanthropy.


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RECENT FORUMS COVID-19 Parliamentary Briefings As the national alliance for health and medical research, Research Australia has been working to ensure all the amazing research efforts of our members in the fight against COVID-19 are seen by key political and government stakeholders. Research Australia took its efforts online and held briefings across state and federal parliaments. The engagement we have seen with our members of parliament has been extraordinary. The spotlight is firmly on our sector with 150 MPs, staffers and Departmental officials now briefed by Research Australia on the incredible work of our members. Research Australia understands that it is not only about getting the message out but also ensuring that our members always have a seat at the table. That’s why we ensure our members join us in meetings with key political stakeholders. In doing so, more Australian politicians are making informed decisions, drawing on the massive breadth of research into COVID-19. The topics we covered included understanding the virus, vaccine development, therapies, testing and diagnostics, health system and workforce, and community impacts. Many of these research areas were a surprise to some as research might not be viewed through this broad lens. Accordingly, we explored some of the longer-term research focuses of allied health, such as recovery and the vital importance of health data in understanding the medium to long term health implications of COVID-19 in patients. We heard from various organisations working on COVID-19 vaccine development, including the University of Queensland, the CSIRO, CSL, GSK the Harry Perkins Institute, the Burnet Institute and others. At other stages of the research pipeline, we heard from the Doherty Institute – the first organisation in the world outside China to grow the COVID-19 vaccine in a lab and make it available to other research organisations internationally. In total, Research Australia has identified over 200 research projects into COVID-19 during this pandemic and we know that these projects are just the tip of the iceberg. Researchers around the world are progressing their 8  INSPIRE 017 | 2020

research at an unprecedented rate and as we understand the virus further, new research leads will invariably arise. With this in mind, the importance of keeping governments up to date with our members’ research is unwavering. This pandemic has demonstrated more than ever the critical nature of health and medical research as a critical national capability and this goes beyond the immediacy of the pandemic. Research is critical to our wellbeing and our future. Research Australia’s top priority is leveraging the momentum gained during this pandemic so we can continue meeting the advocacy goals for our members and the sector more broadly, during and beyond the pandemic. There is a very real possibility that the COVID-19 pandemic will not be the only pandemic we see in our lifetime. The


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COVID-19 Series: Report 1

research response to it will serve Australia both now and in the future. So, please reach out to us if your organisation is developing research that needs the attention of key political stakeholders. Research Australia is the only alliance that represents the entire health and medical research pipeline in Australia nationally – our briefings are unique in this respect and will ensure that the correct focus will be given to your organisation and its research. Research Australia will always connect our membership with key decision makers because the most informed decision provide the highest returns for our health and our economy. To enquire into presenting at one of our upcoming briefings, please contact Lucy Clynes, Research Australia’s General Manager and Head of Government Relations, at lucy.clynes@researchaustralia.org

COVID -19

How Australia’s health and medical research sec tor is responding

COVID-19 Series: Report 2

The impact of COVID-19 on health and medical researchers

5/8/20 9:40 pm

RA0032 COVID Report #2 D5.indd

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SURGERY DURING COVID-19: USING EVIDENCE AGAINST THE UNKNOWN

In the face of the unprecedented, the Adelaidebased Australian Safety and Efficacy Register of New Interventional Procedures–Surgical of Research, Audit and Academic Surgery (Royal Australasian College of Surgeons), harnessed evidence from the scientific literature to provide guidance for surgical care in Australia and New Zealand during the COVID-19 pandemic. 10  INSPIRE 017 | 2020


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he COVID-19 pandemic has tested the resilience and adaptability of surgical care worldwide. Sur gica l patients with the disea se have experienced poor postoperative outcomes,1 and there has been concern for the safety of operating theatre staff. The suspension of elective surgery has created a global backlog of operations that could take close to a year to resolve. 2 The effects of COVID-19 could reshape systems of surgical care even as the spread of the pandemic subsides. Australia’s first cases of COVID-19 were confirmed on 25 January 2020, with the first associated death occurring on 1 March. With a surge in confirmed cases and concerns regarding the supply of personal protective equipment (PPE ), the Australian Health Protection Principal Committee responded quickly to advise National Cabinet to temporarily suspend all non-urgent elective surgery on 24 March.3 Although COVID-19 reached New Zealand about a month after Australia, surgical systems were still similarly disrupted. Harnessing over two decades of experience as a world leader in the evidence-based improvement of surgical care,4 the Adelaide-based Australian Safety and Efficacy Register of New Interventional Procedures–Surgical (ASERNIP-S) led a venture from Research, Audit and Academic Surgery (RAAS) of the Royal Australasian College of Surgeons (RACS) to provide guidance for surgeons across Australia and New Zealand during the COVID-19 crisis. As the virus’ capability of aerosol transmission 5 and widespread biodistribution6 jeopardised the intraoperative safety of surgical staff, questions were raised regarding the appropriate use of PPE and preoperative triage; these were identified as areas of focus in late March 2020. In late April, when regulations around elective surgery began to relax, preoperative screening for COVID-19 was also explored. Reliability of evidence was prioritised amidst the constant evolution of the COVID-19 literature.7 Rapid reviews of the existing evidence base were streamlined for clinical implementation through the advice of experts. A working group was urgently convened in late March, combining researchers from the ASERNIP-S and RAAS of RACS with five senior surgeons. In the following ten weeks, six teleconferences were conducted, and input was obtained from numerous experts across surgery, medicine and healthcare management in Australia and New Zealand. Ongoing searches were then conducted at one to two-week intervals to identify updates within the literature. 2020 | INSPIRE 017  11


THE MAIN FINDINGS FROM THE FOUR REPORTS WERE AS FOLLOWS:

1. Laparoscopic versus open surger y 8 : During surgery, all bodily tissues and fluids should be treated as a potential source of COVID-19. There is no current evidence that laparoscopy presents a greater risk to the operating theatre staff than open surgery with respect to COVID-19 transmission. Given the risk of aerosol transmission of COVID-19, caution must be taken when using an energy source that produces surgical plumes, and an appropriate capture device should be used. Limiting the use of such devices or using lower energy devices is desirable. Similarly, desufflation of pneumoperitoneum during laparoscopic surgery must be performed using an appropriate suction irrigator system attached to a high-efficiency particulate air filter. 2. Personal protective equipment 9: Appropriate PPE is essential given the virus’ transmission capabilities. Surgical staff should wear full PPE, including a surgical P2/N95 respirator, eye and head protection, during operations on patients with confirmed COVID-19, in addition to surgical emergencies and aerosol-generating procedures where the patient has not been confirmed as COVID-19 negative. Staff must have formal training in the use of PPE and should be supervised by a colleague during donning and doffing. Patients with suspected or confirmed COVID-19 should wear a surgical mask during transfer to and from theatre. 3. Surgical triage10 : Urgent surgery should continue throughout the pandemic, and a staged return of elective surgery should align with a decrease in COVID-19 caseload. Preparation for a potential future surge in COVID-19 cases is crucial. A case-by-case assessment of the need for surgery should incorporate the patient’s health, risk of COVID-19, and the supply of hospital resources. Multidisciplinary care and initial assessments by senior consultants should be implemented wherever possible. 4. Preoperative screening11: Patient-history should be examined for potential exposure to COVID-19. Hyposmia and hypogeusia may present as early symptoms of the disease, and can potentially discriminate from other influenza-like illnesses. Reverse transcriptionpolymerase chain reaction (RT-PCR) is the gold standard diagnostic test, and in patients suspected of COVID-19, any operation that can be delayed for 24 hours or more without adverse effect should await results from RT-PCR testing prior to surgery. Computed tomography is the most useful thoracic imaging modality for characterising pulmonary involvement in patients who have COVID-19 diagnosed by RT-PCR. The possibility of future global health emergencies on the scale of COVID-19 cannot be excluded. For surgical care, the evidence-based philosophy that the RACS embodies provides a reliable method for safely proceeding when faced with the unknown.

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1. COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study. Lancet. 2020; 396:27-38. 2. COVIDSurg Collaborative. Elective surgery cancellations due to the COVID-19 pandemic: global predictive modelling to inform surgical recovery plans. Br J Surg. 2020; 10.1002/bjs.11746. 3. Australian Government. Australian Health Protection Principal Committee (AHPPC) advice to National Cabinet on 24 March 2020. Edition., [updated 25 March 2020; cited 19 July 2020]. Available from: https://www.health.gov.au/news/australianhealth-protection-principal-committee-ahppc-advice-tonational-cabinet-on-24-march-2020 4. Maddern GJ, Babidge WJ, Faulkner KW. ASERNIP-S: unusual acronym, outstanding results. ANZ J Surg. 2020; 90:670-4. 5. van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARSCoV-1. N Engl J Med. 2020; 382:1564-7.


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From left to right: Joshua Kovoor, Kristin Weidenbach, Ning Ma, Lorw ai Tan, David Tivey, Danielle Stringer, Helena Kopunic , Guy Maddern and Wendy Bab idge Not pictured: Penny Williamson , Magdalena Moshi, Joanna Dun can, and Nathan Procter

6. Wang W, Xu Y, Gao R, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020; 10.1001/ jama.2020.3786. 7. Maddern GJ. Evidence, not eminence, in coronavirus disease 2019. ANZ J Surg. Forthcoming 2020. 8. Tivey DR, Davis SS, Kovoor JG, et al. Safe surgery during the coronavirus disease 2019 crisis. ANZ J Surg. 2020; 10.1111/ ans.16089. 9. Tan L, Kovoor JG, Williamson P, et al. Personal Protective Equipment and Evidence-Based Advice for Surgical Departments during COVID-19. ANZ J Surg. 2020; 10.1111/ ans.16194. 10. Babidge WJ, Tivey DR, Kovoor JG, et al. Surgery Triage during the COVID-19 Pandemic. ANZ J Surg. 2020; 10.1111/ans.16196. 11. Kovoor JG, Tivey DR, Williamson P, et al. Screening and Testing for COVID-19 Before Surgery. ANZ J Surg. Forthcoming 2020.

Authors: Mr Joshua Kovoor is a Medical Student, University of Adelaide; Associate Professor Wendy Babidge is the General Manager of Research, Audit and Academic Surgery, Royal Australasian College of Surgeons; Professor Guy Maddern is the R.P. Jepson Professor of Surgery and Discipline Lead, University of Adelaide, and the Surgical Director of Research and Evaluation, Royal Australasian College of Surgeons.

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SEWA

SURVEIL KEY TO DETECTING SILENT COVID-19 INFECTION

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AGE

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LLANCE

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Dr Pawan Parajuli, ANU © Jamie Kidston, ANU

Sewage testing is being rolled out around Australia in a bid to identify emerging community infection before clinical presentations spiral out of control. Researchers from ANU are fine-tuning this ‘messy science’ and are confident it can be added to our arsenal of Sars-CoV-2 detection methodologies.

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eople are quick to mock academics as working in ‘Ivory Towers,’ but Dr Aparna Lal and Dr Pawan Parajuli from the Australian National University have rolled up their sleeves in a bid to combat COVID-19. Literally. While hundreds of thousands of throat and nasal swabs testing for COVID-19 infection have been conducted across the country, there is another way we can track the virus – through our sewage. “We know the virus is shed in the faeces of infected 16  INSPIRE 017 | 2020

people. By testing wastewater we can get a better understanding of COVID-19 infection in our community, and get a head-start on any new outbreaks,” says Dr Lal. Indeed we learnt from similar testing in the Netherlands that the virus was detected in sewage before they saw a rise in clinical cases. Testing wastewater isn’t a new concept, with authorities already using this technique to track antibiotic and opioid use, and other viruses including polio. It is, however, the first time that this methodology has been used in an ACTIVE disease outbreak as a tool for surveillance. Not just in Australia, but globally. And if you’re wondering how a respiratory virus can end up in your poo, you’re not alone. It’s just one more example of SARS-CoV-2 behaving strangely. Your gastrointestinal tract, like your lungs, is home to a molecule called Angiotensin Converting Enzyme 2 that the virus needs to infect cells. This is also what could be behind people presenting with symptoms like diarrhoea when infected with the disease. Back to the detective work – how do you test for COVID-19 in sewage? Surely it’s trickier, and far smellier, than looking for the age-old ‘needle in a haystack.’

THE ANSWER: GENETICS.

Every day Dr Parajuli has the unenviable task of sifting through raw sewage from Canberra’s wastewater treatment plant in the search of SARS-CoV-2 RNA. His first task is to concentrate the wastewater sample to a fraction of its original volume, then use polymerase chain


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Dr Aparna Lal, ANU © Lannon Harley, ANU

reaction to amplify any small amounts of RNA present. Next he adds a dye to the sample that will fluoresce in the presence of SARS-CoV-2 RNA. Canberra has been relatively COVID-19 free. So how do we know the test will pick up the virus if it starts to circulate in the community? “While we specifically search for SARS-CoV-2 RNA daily, we also undertake a full metagenomics analysis of samples on a regular basis,” says Dr Parajuli. This means that instead of simply targeting the SARSCoV-2 virus, researchers analyse all RNA found in the sample. These RNA are sequenced and compared to a library of genetic materials to determine exactly which organisms can be found swimming around in our wastewater. “We have found other plant and animal viruses present in the samples, so we know this methodology will pick up viral RNA. We are currently further validating the protocol by spiking the samples with other enteric viruses to assess the sampling sensitivity,” says Dr Parajuli. While this method of detection won’t pick up individual cases – the wastewater is relatively dilute by the time it reaches the plant – researchers expect that analysis sensitivity could be in the order of one active case per 10,000 in the community. Which means we need at least 40 people to be infected in Canberra to see any positive results – let’s hope that doesn’t happen.

When it comes to larger cities with multiple sewage treatment plants, however, analysing wastewater at each site could help identify localised outbreaks and activate response plans accordingly. At the smaller end of the spectrum, there is potential to sample at suburb, campus, or even building level, representing a convenient alternative that doesn’t require individual testing – this is yet to happen in Australia, however.

This environmental surveillance project complements patient testing and hospital reporting during an active outbreak,” says Dr Lal. “The environment constantly gives us clues, if we public health researchers listen, we can act early and hopefully save lives.” So it turns out health heroes don’t always wear capes: sometimes they wear sturdy PPE and analyse sewage. **This project is the result of collaboration between the Australian National University, Icon Water, and ACT Government.

Author: Liz Drummond, science communicator at the Research School of Population Health, the Australian National University.

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JOIN US A NEW DIGITAL RESOURCE TO BOOST AUSTRALIA’S RESEARCH CAPACITY Crucial to the speed and quality of health system responses - particularly during an acute crisis such as the COVID-19 pandemic - is the ability to rapidly engage with large numbers of people across the Australian community.

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ut while the majority of community members indicate a willingness to be involved in research relevant to their health1, relatively few are ever offered the opportunity.

Identifying, recruiting and following research participants still uses last-century technology which is onerous, inefficient, ineffective and no longer fit-for-purpose. In Australia only one in five trials meet deadlines for recruitment2 and our capacity to undertake research and attract investment is impacted. Our response to health emergencies and our broader ability to conduct efficient and cost-effective research in Australia is dependent upon us having the latest digital tools for research2,3. The Join Us register, developed by The George Institute Australia and the UNSW Sydney, will deliver a step change in the country’s capacity to recruit research participants and put us at the forefront of clinical and public health research on the global stage. With proof of concept achieved in overseas jurisdictions such as Scotland1 and locally in the case of specific diseases, this initiative will significantly upgrade Australia’s capacity to engage the wider community in clinical and public health research. The Join Us register is a health research technology platform that will engage a million Australian patients and community members in a new national effort to address the nation’s most pressing health problems. The Join Us model is a simple one and has two primary goals: 1. Pre-consent one million Australians willing to be contacted directly about future research opportunities of relevance to them; and 2. Obtain permission to use the de-identified routinely collected health data from those one million Australians to answer pressing medical research questions. The success of Join Us will depend on the capacity of the register to support research that addresses diverse aspects of health across a breadth of population groups. This will require recruitment from every state and territory, equal enrolment of women and men, and the participation of older and younger adults across the full breadth of socio-economic strata in urban and rural areas. There will also need to be significant representation of Aboriginal and Torres Strait Islander people as well as other Culturally and Linguistically Diverse groups. The Join Us register has been designed as a diseaseagnostic tool to service a breadth of research disciplines and to support collaborative research efforts. Researchers with their own ethics approval will be able to apply to the register to find participants matching their eligibility criteria or to access de-identified health data for analysis. The digital technology underpinning Join Us uses robust and secure systems that have been developed to enable large scale customer management as well as secure

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storage, management and analysis CHRISTOPHE KEREBEL of sensitive health data (UNSW Sydney’s E-Research Institutional Cloud Architecture, or ERICA).

Ultimately, the goal of this project is to achieve better health and wellbeing for the Australian community by more rapidly translating new interventions from research into practice. THE JOIN US REGISTER WILL HELP US DELIVER:

• More clinical and public health research in Australia through enhanced access to research participants; • More researchers with access to low-cost outcome assessments achieved through linked data; • New research capacity across diverse disciplines for which patient populations and data were previously hard to access; • More local and overseas industr y investment in studies done with Australian researchers in Australian populations; • Recruitment of diverse and broadly representative population groups (including Aboriginal and Torres Strait Islanders and other Culturally and Linguistically Diverse groups) who will be specifically targeted for recruitment into the Join Us register; and • Greater involvement of the community in research through formal participation in the register’s ongoing operation and governance structure. The George Institute and the UNSW Sydney have worked with an external Executive Group to establish the register and have collaborated with the Consumers Health Forum Australia to gather community perspectives on the register. Engagement strategies will continue to evolve as the register evolves. We welcome your contributions and hope you can be a part of this exciting initiative. The Join Us register will ‘go-live’ in the second half of 2020. Find out more by watching the video.

1. McKinstry B, Sullivan FM, Vasishta S, Armstrong R, Hanley J, Haughney J, Philip S, Smith BH, Wood A and Palmer CN. Cohort profile: the Scottish Research register SHARE. A register of people interested in research participation linked to NHS data sets. BMJ Open. 2017;7:e013351. 2. EY. Scoping and analysis of recruitment and retention in Australian clinical trials. Final Report. Department of Health, Australia. 2016. 3. Sully BG, Julious SA and Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166.

Author: Dr Clare Arnott, Senior Research Fellow at The George Institute for Global Health

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eHEALTH SOLUTIONS TO DRIVE BETTER MENTAL HEALTH OUTCOMES

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Professor Frances Kay-Lambkin and team have adapted eCliPSE, an online clinical portal designed to enable access to evidence-based eHealth treatments, to address the mental health consequences of COVID-19.

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rior to COVID-19, one in four Australians would experience a mental health problem severe enough to seek treatment. During the pandemic that number has risen sharply, with three in four Australians reporting that their mental health has been impacted. A continuing sense of uncertainty, financial pressure and the challenges of working and schooling from home have added an extra burden without the regular availability of the usual face-toface mental health support systems. During isolation and lock-downs access to clinicians has been restricted, and there has been a concurrent rise in depression, anxiety, and an increase in drug and alcohol use* with 70% of Australians drinking more alcohol than usual. The greatest mental health impacts will be felt by the most marginalised. For people with pre-existing mental health and substance use disorders, stress is a well-known risk factor in relapse vulnerability, and it has the potential to worsen pre-existing conditions. Therefore, access to high-quality, evidencebased treatment is imperative. In a 2019 draft report into mental health, the Australian Government Productivity Commission identified that ‘Australia’s mental health support system already falls well short of the benchmark’ of a well-functioning healthcare system. With the extra demand for mental health services due to COVID-19, this already overloaded system has had even more pressure applied. In response to the pandemic, the Australian Government introduced a temporary Medicare Benefit Scheme telehealth item into primary care and allied health services. As of April 2020, over three million Australians had received a telehealth intervention, with 50% of mental health service appointments occurring via telehealth 2020 | INSPIRE 017  21


in this period. When combined with the challenges of lock-downs and reduced mobility during the pandemic, leveraging technology is the best way to optimise the mental health services available to all. Our cross-institutional, collaborative team** developed the eCliPSE online portal, to deliver online support for people to help them manage the social isolation and other challenges they face with anxiety, depression and alcohol use disorders.

It offers access to engaging, evidence-based eHealth treatments for people with anxiety, depression and alcohol/other drug use concerns – delivered directly, no matter where they are based in Australia. In 2019 we received a NHMRC partnership grant, with Beyond Blue as key partners, to roll eCliPSE out in mental health and alcohol/other drug use services across New South Wales in the largest implementation trial of the tool to date. This trial is also the first to develop and test different models of engagement and implementation of eCliPSE within and outside of traditional clinical settings. The research embedded into the rollout of eCliPSE will determine the impact of the tool and address future mental health needs in times of future disasters or hardship. It has the opportunity to expand the nation’s eHealth capabilities and reshape the way that mental health services are provided in Australia. The project will provide the first evidence of the cost-effectiveness and sustainability of implementing digital interventions at scale to improve mental health outcomes for our communities. Among many other impacts, COVID-19 led to a suspension of many research trials that were being implemented within health services across Australia. This included the eCliPSE trial, which was suspended early in 2020. However, given the early signs that the impact of COVID-19 would be felt strongly by people with pre-existing mental health and substance use disorders, our team felt that the potential of eCliPSE to help mitigate some of these impacts was great. In response, the team worked rapidly with NSW Health to adapt and scale up access to eCliPSE to provide immediate support and attempt to mitigate the mental health consequences of the pandemic. To complement this platform, we integrated a social networking intervention, the Breathing Space app, to create a supportive connected community, moderated by clinicians, where people can share stories about coping with COVID-19 and seek support. This additional tool was drawn from a previous trial conducted by the team using virtual social support for young people with depression and binge drinking concerns***. Already we are seeing an impact of this work. In the period April-May 2020, the eCliPSE portal attracted almost twice as many first-time visitors as the in the months FebruaryMarch 2020; people visiting the site are spending 40% 22  INSPIRE 017 | 2020

more time engaging with the tool, and are viewing three times as many pages and content on the website. Importantly, the ethics, duty of care, and clinical and safety protocols necessary for completing our previous research trials meant that we were rapidly able to provide a model of care for mental health and substance use concerns that integrated and leveraged technology safely and securely. This was important as very few models exist to guide digital integration, or to provide clinicians and services with the advice and support they need to do so. With rates of depression, anxiety, and alcohol use disorders likely to rise even more sharply in the next 6 to twelve months, tools like eCliPSE are critical to increasing the capacity of care under COVID-19 and beyond.

Early intervention and different models of care are critical in our response to COVID-19 across all of health, with digital treatments affording the opportunity for services to be delivered at-scale, relatively low-cost and facilitate access and equity to all Australians. While the team is looking forward to resuming the research associated with the project, for now we are committed to using our evidence-based tools, developed during our clinical research trials in mental health and substance use disorders, to help our nation respond to our most pressing concerns.

* Preliminary evidence points towards an overall rise in symptoms of anxiety and coping responses to stress, including increased drug and alcohol use amongst the general population (Holmes, E. et al., (2020). Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science. The Lancet Psychiatry, 7(6), 547-56). ** The project leverages long-term collaborations across University of Newcastle, University of Sydney and UNSW. *** For more information about the Breathing Space app see: KayLambkin, F. J., Baker, A. L., Geddes, J., Hunt, S. A., Woodcock, K. L., Teesson, M., Oldmeadow, C., Lewin, T. J., Bewick, B. M., Brady, K., Spring, B., Deady, M., Barrett, E., & Thornton, L. (2015). The iTreAD project: a study protocol for a randomised controlled clinical trial of online treatment and social networking for binge drinking and depression in young people. BMC public health, 15, 1025. https://doi.org/10.1186/s12889-015-2365-2. The Breathing Space app can be found on the Apple app and google play stores by searching ‘breathing space community’.

Author: Professor Frances Kay-Lambkin is interim Pro Vice-Chancellor, Research and Innovation at the University of Newcastle and the current HMRI (Hunter Medical Research Institute) Researcher of the Year.


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Professor Frances Kay-Lambkin 2020 | INSPIRE 017  23


FINDING THE SILVER LINING IN A PANDEMIC As the COVID-19 pandemic continues to wreak havoc around the world, a research team from Edith Cowan University have found positives in how they’ve adapted to delivering clinical trials digitally.

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xercise is one of just four exceptions for many Australians to leave their homes during the COVID-19 restrictions, which have been in place around the country at some point this year. However, for vulnerable populations, such as older people, patients with cancer and other chronic conditions, attending an exercise clinic, gym or fitness centre during a global pandemic is unthinkable. But the benefits of exercising most, if not every day, are well established as essential for reducing the risk and progression of all chronic diseases while their benefits in enhancing the immune system and mental health are also well known. In a global pandemic, when

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health systems around the world are overwhelmed with COVID-19, that’s more important than ever.

MAKING THE DIGITAL SHIFT

Professor Rob Newton and his colleagues at the Exercise Medicine Research Institute (EMRI) at Edith Cowan University have rapidly pivoted their various support services and research projects to be delivered using digital platforms.

Our team is conducting numerous research trials funded by the NHMRC, Movember Foundation and Cancer Council WA and we have had to adapt rapidly to avoid these research programs collapsing,” he said. “That’s an enormous challenge at the best of times, but with the added complication of a global pandemic, it becomes even more difficult. Not to mention our patients are primarily older people with chronic disease who are generally not the most tech savvy cohort.” The Institute’s largest trial has been funded by the Movember Foundation for $10 million to determine if highly specific exercise medicine can extend survival in men with terminal prostate cancer. This is an international trial with 20 sites across Australia, Europe, Asia and North America and the research team are now providing the exercise intervention and many of the patient assessments fully online. Without this capability, this important trial would have to be disbanded.


“Patients receive their exercise prescription through an app on their smart device and they are monitored and suppor ted by our exercise professionals via videoconferencing,” Professor Newton said. CHRISTOPHE KEREBEL “Exercise technique is checked and any problems or questions are addressed through this online communication while physical activity and heart rate are monitored remotely using wearable technology, such as smart watches.”

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THE CHALLENGES OF WORKING DIGITALLY

These innovations are not unique to Professor Newton and the EMRI team as researchers around the world have had to innovate and adapt to keep projects running under challenging circumstances. Millions of people across the globe are coming up with new ways to work remotely, while dealing with children dropping in uninvited on Zoom meetings and innumerable technical issues. However, just like many other industries and fields, the pandemic has afforded researchers a unique opportunity to reassess how they work and come up with more efficient and effective ways of working. “The COVID-19 crisis has driven us to rapidly adapt our research and clinical practices to find new ways of doing things,” Professor Newton said. “The new knowledge we are gaining as well as the infrastructure and technology being implemented means that we will be able to continue to support people with chronic diseases beyond the current COVID-19 crisis and provide safe and effective exercise medicine directly to those that need it most. “While COVID-19 is devastating it is driving considerable innovation, which will ultimately benefit our health system as well as people around the world suffering from chronic conditions, being able to access safe and effective exercise medicine when and where the patient chooses.”

Author: Professor Rob Newton is Professor of Exercise Medicine in the School of Medical and Health Sciences at Edith Cowan University, ViceChancellor’s Professorial Research Fellow in the Exercise Medicine Research Institute. In 2019 he was the joint WA Scientist of the Year in the 2019 Premier’s Science Awards for his research and advocacy in the field of exercise medicine.

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RISING TO THE TELEHEALTH CHALLENGE: CLINICIAN EXPERIENCES DURING COVID-19 The COVID-19 pandemic led to a rapid transition to telehealth services with no time for planning or training. In the early weeks of Melbourne’s first stay at home orders, researchers at Eastern Health asked staff what they liked about telehealth, what had been challenging and what tips they would give to others. This is what they said.

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he COVID-19 pandemic has caused a huge disruption to health services. A key response has been to make services that are usually provided face to face available via telephone or online video platforms. Broadly known as telehealth, remote delivery of healthcare has been shown to be as effective as face to face care in many situations, but until recently it had been seen primarily as a tool for reaching patients in rural and remote areas. Introducing a telehealth service is usually something that would be implemented over many months, with planning for infrastructure, training and stakeholder consultation, all delivered in accordance with established principles for managing organisational change. The arrival of COVID-19 threw the usual play book out the window. At Eastern Health, a large metropolitan health network in Melbourne’s Eastern suburbs, clinicians were directed to stop face to face consultations in outpatient and

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community settings in line with the virus containment strategy. Clinicians, managers and administrative staff in medical clinics, rehabilitation services and community clinics found themselves on a rapid learning curve. Each individual was learning from their own experience, but the pace of change meant that there was little opportunity to share this information with others on the same journey. Seeing this flurry of independent activity occurring throughout the organisation, researchers at the Allied Health Clinical Research Office, a collaborative research partnership between La Trobe University and Eastern Health, saw a need to find out how clinicians were responding to this rapid change. Led by Dr Katherine Harding, the team aimed to collect, synthesise and rapidly share this information to enable people to learn from one another’s experiences. A brief, targeted online survey was distributed via email and staff newsletters, and any staff member in an outpatient or community setting who had recently begun using telephone or video consultations was invited to participate.

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The survey essentially asked participants to provide responses to three open ended questions: 1. Can you describe any positive experiences of using telehealth so far? 2. What has been the biggest challenge(s)? 3. What is one tip you would give others transitioning to telehealth? There were 133 respondents to the survey, including allied health professionals (50%), doctors and nurses (20% each), and managers and administrative staff (10%) from a wide variety of clinical settings including rehabilitation services, outpatient clinics, chronic disease services and mental health services.

TELEHEALTH POSITIVES

Many respondents found telehealth software to be surprisingly easy to use. Clinicians reported patients were appreciative of efforts to continue to provide services while protecting them from potential exposure to COVID-19. Many clinical services could be provided using telehealth, and for some patients there were unexpected advantages over usual care. For example, telehealth saved time, saved travel, and fewer patients missed their appointments. Telehealth appeared to be particularly good for selected patients who found it safer or more convenient to talk to a health professional from their home.

CHALLENGES OF TELEHEALTH

Telehealth also came with challenges. Clinicians found suitable technology was often lacking both within the health service and in the community. Some clinicians lacked skills or confidence, and identified some limitations in what could be achieved over telehealth. For example, providing ‘hands on therapy’ or assessing aspects of physical function. Gaps also became apparent in the processes and capacity of ancillary services, such as administrative support, interpreters, and electronic systems for providing scripts and referrals.

Authors: Dr Katherine Harding, Professor Nick Taylor, Dr Amy Dennett and Annie Lewis of the Allied Health Clinical Research Office, Eastern Health and La Trobe University.

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WHAT ADVICE WOULD THEY GIVE TO OTHERS?

Clinicians had a wide range of advice and tips for their colleagues, including: • Have a positive attitude. Be open to change. • M aximise effectiveness of available technology. Get the best set up you can, familiarise yourself with the systems, and share resources with others. • B e prepared: make sure the patient has clear instructions, replicate the structure and routine of a face to face appointment, expect some things to take a little longer initially and have a contingency plan (eg a phone number at hand) in case of technology hitches. • I dentify supports: Involve family members, find champions within your team, buddy with a colleague to practice, and involve administrative staff to adapt systems. Dr Harding states “the rapid transition to remote health care consultations in response to COVID-19 has been a major challenge, but this study demonstrates the resilience of our health workforce and willingness by many to embrace change and find benefits in new ways of doing things. Despite the frustrations, many staff reported that they were able to deliver appropriate and effective services and satisfy the needs and expectations of their patients.”

She points out that this study also serves as an important example of the way in which health services research can be used to benefit health services during a period of crisis. “This project was completed with a very rapid turnaround, consisting of a total of three weeks from conception to distribution of early findings within the health service” she says. “The process of collecting the data and sharing the results reinforced the message that staff were not alone in the challenges that they were facing”. Looking to the future, this study challenges the validity of telehealth eligibility being limited to people with physical access issues. There appears to be a much broader range of benefits that can be realised for patients and services by having telehealth available as an option for service delivery, regardless of whether a patient would be otherwise able to access the clinic. Organisational support is required to tackle infrastructure issues, facilitate sharing of resources and build adequate support systems to maximise the benefits of telehealth in a post-COVID world.


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HELPING AUSTRALIANS SURVIVE BLOOD CANCER The Leukaemia Foundation has proudly supported blood cancer research for over two decades, investing in medical research that drives rapid advancements in diagnosis and treatments for blood cancer.

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n doing so it encourages the careers of promising scientists and clinicians and gives Australians access to the latest therapies through clinical trials. The goal? To help cure and conquer blood cancer – for good. The Leukaemia Foundation has been funding research for over 20 years. In that time, we have supported over 500 researchers and clinicians to undertake over 300 PhDs, clinical trials, and multi-year strategic research projects across 60 research institutes here in Australia and overseas. Leukaemia Foundation General Manger – Blood Cancer Partnerships Tim Murphy said the main aim of the program was to fund high-impact research that had broad potential for all people living with blood cancer. “Blood Cancer can impact anyone, adults and children alike, and is now among the most fatal and most costly conditions affecting Australians today. Current treatments are intense and prolonged and for those who survive they often face a long trail or even a lifetime of late effects,” Mr Murphy said. More than 17,300 people in Australia (that is one person every 31 minutes) will be diagnosed with a blood cancer in 2020 and there has been a 40 per cent increase in incidence rates over the last 17 years. Source - Australian Institute of Health and Welfare (AIHW) More than 110,000 people are living with a blood cancer today and this is projected to increase to almost 275,000 people by 2035. Source - State of the Nation: Blood Cancer in Australia report 2019 30  INSPIRE 017 | 2020

“The blood cancer research landscape has changed remarkedly over the last 20 years,” Mr Murphy said. Since the identification of the Philadelphia chromosome in patients with chronic myeloid leukaemia in 2001 and the completed mapping of the genome in 2003, there has been a rapid progress in the understanding of blood cancers at a genetic level. “While we still don’t know what causes blood cancers we are beginning to have a much better understanding of the genetic events that drive the biology of specific blood cancers, the pathways that lead to resistance and relapse, and the mechanisms blood cancers use to evade the normal immune response. “This ever-evolving understanding provides opportunities for the development of new precision based targeted therapies. This area of research is and will continue to be a major priority for the Leukaemia Foundation.

Through our National Research Program we fund across all phases of research from early and pre-clinical through to translational and clinical trials. “We know that good research can take time and investments in fundamental research today are needed to ensure that we develop the new Venetoclax of tomorrow. “We invest in innovation, access and people. We fund research aimed at better understand the biology of blood cancers, developing new targeted therapies and the diagnostics tools to inform how best to use them.


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Mr Tim Murphy, General Manager – Blood Cancer Partnerships

“We support Australian investigator led clinical trials as well as bring international clinical trials to Australia through our Trials Enabling Program in collaboration with the ALLG (Australasian Leukaemia and Lymphoma Group) to provide Australians access to the latest therapies. “We support the careers of the best researchers and clinicians in blood cancer through our various scholarship and funding programs. “We support early career scientists and clinicians through our PhD scholarship program in collaboration with Haematology Society of Australia & New Zealand (HSANZ), mid-career researchers through the Cancer Australia Priority Driven, Collaborative Research Scheme (PdCCRS) and senior researchers and clinicians through our strategic multi-year grants in collaboration with national and international partners to help take their ideas from benchtop to bedside and into clinical practice. “Funding blood cancer research for over 20 years through our scholarship and grants programs has encouraged the early careers of many promising scientists and clinicians. “Many of these individuals are now running their own laboratories, leading their own centres of excellence or are on the frontline of the latest developments in genomics, targeted therapies, and immunotherapies, helping to make the prospect of a cure for blood cancer more real, every day. We are proud to say that many of Australia’s leading haematologists and senior scientists have been supported by the Leukaemia Foundation’s National Research Program at some stage in their careers” Mr Murphy said.

COVID-19 has had unprecedented impacts on global health systems, economies, communities, and individuals. The current COVID-19 crisis has reinforced how important research and international collaboration and clinical trials are for the rapid translation of research into clinical practice. “While COVID has highlighted the importance of research it has also resulted in delays in research and large cuts to research funding. Reduced funding opportunities in particular, will create significant challenges for the research workforce in the short to medium term, with junior and early-to-mid career researchers being among the most impacted. “This is why programs like the Leukaemia Foundation’s National Research Program are now more important than ever. We, like many other charities, have been greatly impacted by COVID-19 which means we will need to scale back and re-evaluate our funding strategy, but we remain committed to funding research” Mr Murphy said. September is Blood Cancer Awareness Month and the Leukaemia Foundation is proud to join the Blood Cancer Taskforce as it awaits the release of a National Strategic Action Plan for Blood Cancer. Find out more at www.leukaemia.org.au.

Authors: Gail Heritage, PR Specialist, Leukaemia Foundation. Co-authored by Gail Heritage and Peter Diamond, National Head of Research.

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WHAT HAVE WE LEARNT FROM COVID-19? While it is important to stay informed, many of us may feel at risk of drowning in COVID-19 information. Some estimates show there have been more than 23,000 COVID-19 related journal articles published worldwide since January, with this figure doubling every 20 days. As well, every mainstream media outlet is awash with ‘breaking news’, opinion pieces and graphs.

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esearchers at the Australian Institute of Health Innovation (AIHI), Macquarie University and the NHMRC Partnership Centre for Health System Sustainability have contributed evidence-based research on COVID-19 while also questioning how best to identify, distil and communicate high quality COVID-19 research.

We have also explored the ability of voice assistants such as SIRI from Apple and ALEXA from Amazon to assist in providing timely and accurate information to the public. The United States’ Centers for Disease Control and Prevention introduced the chatbot ‘Clara’ to be used as a symptom checker.

AI IN HEALTHCARE

After many years of limited uptake and research into more effective implementation strategies, telehealth, including video conferencing and phone consultations, has finally come into its own. During the height of the Australia-wide lockdown between mid-March and mid-May, more than 9 million telehealth services were provided. Uptake was fast and kept people connected with their health professional, GPs and specialists alike.

Australia, after lagging behind other countries in investing in artificial intelligence (AI) in healthcare, is now a founding member of the Global Partnership on Artificial Intelligence (GPAI), with particular emphasis on pandemic planning. Represented by AIHI’s Professor Enrico Coiera, along with four other representatives from Australia and partners from around the world, the group will guide the use of AI in healthcare. In addition, AIHI has led the development of the National COVID-19 Research Platform, to aggregate information about the many different COVID-19 algorithms and data sets available to the community, and provide a directory service that matches up skilled researchers with COVID-19 projects. For instance, using AI algorithms to predict the severity of progression of COVID-19 in individual patients has been identified as useful to managing care for patients and distribution of hospital resources, such as the allocation of intensive care beds. While it has become accepted that older male patients with hypertension or diabetes are at higher risk of worse outcomes, early indications are that this new scanning technology may provide more precise predictions for individuals. 32  INSPIRE 017 | 2020

TELEHEALTH

Telehealth is however not appropriate in every situation. AIHI researchers are currently looking at the safety and effectiveness of telehealth when used by surgeons. They warn that telehealth should not be seen as a direct replacement for face-to-face consultations, but rather its own unique form of consultation. For it to be of benefit to the patient and the doctor, new skills must be mastered including the use of the technology, having effective lighting and good camera angles as well as the less obvious skills of reading body language and appreciating the nuances of screen- or telephone-based conversations. They warn for instance that without the proper context around remote consultations, unspoken cries for help may be missed – or important diagnostic signs or symptoms overlooked.


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Professor Jeffrey Braithwaite, Macquarie University

ORDINARY HEALTHCARE

Not everyone however is taking advantage of telehealth services during the pandemic. Many have simply put their usual healthcare regime on hold. They are avoiding hospitals and GPs. According to Medical Benefits Schedule data, there has been a significant drop in GP visits for the management of chronic disease and pathology tests are down. AIHI is currently conducting a survey of people over the age of 55 years to assess the impact of COVID-19 on their wellbeing and ability to access health services in NSW. We are also finalising a long-term international study of people who have complex medical conditions and manage their care at home. We have followed them over two years and have recently contacted them again to ask how they have coped during COVID-19, particularly those who have limited access to the internet and therefore telehealth.

TESTING

While understanding the challenges on the health system from a systems point of view is important, there are also essential public health challenges to ensuring people receive accurate information during the pandemic. Since March, messages have been conflicting. For a long time, for instance, the general public was told by health authorities that masks were not effective nor necessary to stop the spread of coronavirus. Now it is accepted that properly constructed masks will be vital in limiting the spread of the virus and on 22 July 2020, the wearing of face masks became mandatory when leaving home in parts of Victoria.

We are also now testing more people for coronavirus whereas in the first quarter of the year, with a limited supply of testing kits, the messaging was very different. Only people who met a very strict criteria would be tested. Now anyone with even mild symptoms of respiratory infection is being told to get tested. Indeed, in a study to be published shortly of various national governments’ approaches to managing the pandemic, conducted by AIHI and partners in Europe, we found evidence that broad based testing along with stringent safety practices is the key to COVID-19 management.

WHERE TO NEXT

No one should doubt that we still have a long way to go with the COVID-19 pandemic. The development of a vaccination is still uncertain, immunity is unproven and the long-term adverse health implications for not only people who have had COVID-19 but also those who have experienced disruption to their usual healthcare regime is unfolding. One thing we have learnt for sure however is that our health system has been able to flex and adapt to the challenges presented by the pandemic. We have found evidence of resilience both personally and in the health system as a whole. That is good news for the future.

Author: Professor Jeffrey Braithwaite, Founding Director of the Australian Institute of Health Innovation, Macquarie University.

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FAMILIES AND RESEARCHERS WORKING TOGETHER TO FIND ANSWERS FOR COVID-19

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Two new Murdoch Children’s Research Institute studies put a human face to COVID-19 research and bring families into the research fold.

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bit.

mong the thousands of research efforts to tackle COVID-19 across the world, families and researchers in Melbourne are also doing their

A prime example is Leila and Tony and their three primary school aged children, who live in Melbourne’s inner northern suburbs. Before COVID-19 had really taken hold in Australia, Leila and Tony attended an interstate wedding without their children, aged 9, 7, and 5. After returning home, the parents developed a cough, congested nose, fever and headache. Concurrently, other wedding guests were confirmed to have COVID-19, one of whom had passed the virus on to both parents. Immediately the family of five were among the first volunteers recruited to a Murdoch Children’s Research Institute study examining immune responses to SARSCoV-2, the virus that causes COVID-19. Detailed investigations of immune responses during SARS-CoV-2 infection have been reported in adults, with exposure to SARS-CoV-2 causing specific T cell responses, without producing a concurrent antibody response. However, data on immune responses in children exposed to SARS-CoV-2 have been scarce, and was a question that MCRI’s Dr Shidan Tosif and Dr Melanie Neeland were keen to investigate. Dr Shidan Tosif is the clinician leading the study and has daily contact with families recruited into the study.

Tony and Leila have been really great. They were so excited to be able to contribute to the research, especially in what was the very early phase of the pandemic here in Australia,” he said. Mum Leila became ‘chief doctor’ in the household, collecting samples from every family member up to three times a week for several weeks. Samples included taking the tricky nasopharyngeal swabs, as well as saliva, blood pricks, urine and stools. Clinical nurse Kate Dohl would turn up to the family’s house in full personal protective equipment to take the samples back to the lab. “Our neighbours wondered what on earth was going on for a bit there, it must have been a bit worrying for them!” says Leila. Once back in the laboratory, the samples were assessed 2020 | INSPIRE 017  35


Leila and Tony and their children

for the presence of the virus, as measured by PCR, and the family’s antibody and immune cell responses measured. Lead laboratory researcher on the study, Dr Neeland says, “Investigating immune responses to SARS-CoV-2 across all age groups is going to be key to understanding disease susceptibility, severity determinants, and possibly which vaccine candidates will be most appropriate.” In SARS-CoV-2 infection, reduced respiratory epithelial expression of the ACE2 receptor and trained innate immunity in children have been proposed mechanisms as to why they don’t seem to have as severe symptoms as adults. Children have comparatively milder COVID-19 disease and up to one-third are asymptomatic.

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Dr Neeland says, “We are now performing a careful analysis of the various subsets of immune cells and antibody types from each family member at a number of time points, showing exactly which immune response the children mounted.” Dr Tosif said that while all family members fully recovered without requiring medical care, the team unfortunately could still not be certain how long, if at all, they would be protected from reinfection. As well as characterising this one family’s responses to the virus in minute detail, Dr Tosif has quantified the pandemic’s early effects on children in Melbourne. In the first 30 days since seeing their first patient, the number of children testing positive to COVID-19 at an


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hospital treatment for their children due to fears of contracting the virus. “We have seen many worried parents coming to the hospital when their child has a cough or fever, but of over 400 children tested, only four tested positive to COVID-19,” she said. “This study showed that Australia as a whole has responded extremely well to the threat. Hospitals are a safe place with a very low risk of being exposed to COVID-19, and community transmission over the course of the study period was also low.” But Dr Ibrahim said despite the initially low number of cases, the recent spike in Victoria, and continuing high infection rates overseas, data has shown that children can still become severely unwell with COVID-19 and there shouldn’t be complacency. The four-week study included 434 patients, aged 0–18 years, who presented with COVID-19 symptoms to the emergency department or the respiratory infection clinic of a major paediatric hospital. The study started after the first positive case was confirmed at the hospital on March 21. None of the four positive children were admitted, developed severe symptoms or had significant additional medical conditions. They all recovered within two weeks after experiencing mild upper respiratory symptoms like a sore throat. All were treated using a Hospital-in-the-Home program. Dr Tosif oversaw follow-up with tççhe families and said the data highlighted the success of outpatient management for COVID-19 positive patients.

Our patients were not admitted after having a clinical assessment, knowing that their COVID-19 test may later return a positive result,” he said. Australian tertiary paediatric hospital was low and none who contracted the virus required in-hospital treatment, according to a study led by Dr Tosif and Dr Laila Ibrahim and published in Emergency Medicine Australasia. The research from the Murdoch Children’s Research Institute (MCRI) was the first Australian study to examine the rate of COVID-19 in children and adolescents presenting to hospital. MCRI’s Dr Laila Ibrahim said the study was reassuring for parents with children presenting to hospital with the usual childhood acute respiratory illnesses such as asthma, croup and bronchiolitis, that it was still unlikely they have COVID-19. Dr Ibrahim said parents should also not delay seeking

“We were confident that treating children with COVID-19 in the home was the best option and has avoided unnecessary hospital observations.” With the current uptick in infections in Victoria, communities are being asked to see themselves as the frontline in the fight against the pandemic. For Leila and Tony, the opportunity to act as the frontline and also be involved in the research efforts was an invaluable experience. Author: Tom Keeble BSc PhD, Communications Manager Murdoch Children’s Research Institute

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ADAPTING TO SOLVE THE CORONAVIRUS PANDEMIC Innovative trial designs overcome many limitations of conventional randomised designs, providing answers sooner while mitigating against the risk of inconclusive results, resulting in quicker translation of trial findings into practice. At no time in recent history has this been more important.

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rial design is rapidly becoming more sophisticated as new methodological research is undertaken; enabled by advanced statistical modelling. Funding calls from both the Medical Research Future Fund (MRFF) and Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect) recognise the importance of novel trial design to health and medical research1-2

Currently, Australian researchers are largely reliant on international collaborators in the UK and the US to design and analyse such innovative trials. By building capacity locally we can ensure that Australia maintains its reputation as a world leader in clinical trials, and delivers better health outcomes. The newly formed Australian Trials Methodology Research Network (AusTriM) comprises leading clinician-researchers and biostatisticians across 10 sites, and provides a network for statisticians to develop the methodology and training required to enable local researchers to plan and conduct such studies. Our researchers are currently leading the design of three trials with innovative design features to address coronavirus both in Australia and internationally.

RANDOMIZED, EMBEDDED, MULTIFACTORIAL ADAPTIVE PLATFORM TRIAL FOR COMMUNITY-ACQUIRED PNEUMONIA (REMAP-CAP)

REMAP-CAP is an Australian-led ongoing international adaptive platform trial which aims to improve outcomes for critically ill patients admitted to the ICU with pneumonia. With the coronavirus pandemic, this platform has been adapted to find the best treatment strategies for COVID-19 patients receiving intensive care in hospitals worldwide. The scale and design of the trial allow it to assess the effectiveness of a range of treatments already routinely used in clinical practice, as well as the flexibility to quickly incorporate new treatments as they demonstrate promise. Principal Investigator and Senior ICU consultant and Professor Steve Webb explains how the trial is responding to the pandemic: “In early 2020 we incorporated two pre-existing treatment domains and applied them for patients with COVID-19 (corticosteroid treatment and duration of macrolide therapy), and added five new domains (antiviral therapy, immune modulation, anticoagulation, convalescent plasma, and vitamin C). 2020 | INSPIRE 017  39


In addition, we have five new domains at different stages of submission for regulatory approval (statins, antiplatelet therapy, mechanical ventilation strategy, inhibitors of ACE2 system, and additional immune modulators).”

By assessing multiple treatment combinations at once the trial is able to answer questions faster and also evaluate the impact of combinations of treatments. Using Bayesian statistics, this data is regularly analysed to assess which treatments are performing well and which are not.ˮ As the trial progresses, response-adaptive randomisation ensures a higher proportion of patients are randomised to the best-performing treatments; ensuring that trial participants have a better chance of good outcomes. Treatments found to be inferior are dropped from the platform. This “learn-as-you-go” approach means that clinicians and public health authorities can be informed more rapidly, 40  INSPIRE 017 | 2020

rather than waiting precious weeks or months for trial results to be published. For this reason, the trial has attracted international support from philanthropic organisations and The Chief Medical Officers in the UK have urged clinicians to enrol patients in this important study. Since January, the trial has expanded from 52 to 242 sites, across 4 continents. For more information visit remapcap.org.

AUSTRALASIAN COVID-19 TRIAL (ASCOT)

The ASCOT trial is assessing which existing treatments are most effective in patients hospitalised with COVID-19 in Australia and New Zealand, and whether they will prevent patients deteriorating to the point of needing a ventilator in the Intensive Care Unit. When the study was first developed, proposed treatments were standard care (no intervention), lopinavir / ritonavir and hydroxychloroquine. The ability of the trial to adapt became critically important when on the 17th of June, The World Health Organisation announced that there was sufficient evidence that these two interventions did not reduce mortality for hospitalised COVID-19 patients. The ASCOT trial steering committee made the decision to


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Tom Snelling is leading the design of two coronavirus trials - ASCOT and CLARITY

not stop too early (without enough evidence to provide a clear answer) or continue on for too long (continuing to randomise patients when an answer could have been obtained sooner).

Minderoo Foundation announce $2 million in support of REMAP-CAP at St John of God Hospital, Subiaco. Pictured (L-R): Dr Steve Burnell (Minderoo Foundation), Professor Steve Webb.

drop the lopinavir / ritonavir and hydroxychloroquine arms of the trial; without having to abandon the study altogether. New treatments being investigated by the study include the antiviral drug remdesivir and convalescent plasma. The trial reached a major milestone last week, enrolling the first patient at Royal Melbourne Hospital in Victoria.

CONTROLLED EVALUATION OF ANGIOTENSIN RECEPTOR BLOCKERS FOR COVID-19 RESPIRATORY DISEASE (CLARITY)

The MRFF-funded CLARITY study (led by Associate Professor Meg Jardine, The George Institute for Global Health) will randomise COVID-19 patients to receive an angiotension II receptor blocker (ARB) or standard care to determine its impact on patient outcomes after 28 days. “CLARITY will use Bayesian inference in a so-called “Goldilocks design3”, that is, with a sample size that is adaptive so as to optimise the number of participants required for a definitive result” says Professor Snelling. This approach to sample size ensures that the trial does

1. Medical Research Future Fund. Clinical Trial Activity: Rare Cancers and Rare Diseases and Unmet Needs. 2018. https://beta.health.gov.au/initiatives-andprograms/clinical-trial-activity-rare-cancers-and-rarediseases-and-unmet-needs 2. Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect). Report: Clinical Trials in Australia: the economic profile and competitive position of the sector. 2017. https://www.mtpconnect. org.au/clinicaltrials 3. Broglio KR, Connor JT, Berry SM. Not too big, not too small: a goldilocks approach to sample size selection. J Biopharm Stat. 2014;24(3):685-705. doi:1 0.1080/10543406.2014.888569 https://pubmed.ncbi. nlm.nih.gov/24697532/

Authors: Professor Rory Wolfe is a senior biostatistician at Monash University and Chief Investigator of AusTriM. Professor Steve Webb is a Senior Staff Specialist in Intensive Care Medicine at Royal Perth Hospital and a Professor of Critical Care Research at Monash University. Professor Tom Snelling is director of the Health and Clinical Analytics team in the School of Public Health at the University of Sydney, and an infectious diseases physician in the Sydney Children’s Hospital Network. Madeleine Enright is the coordinator of the AusTriM network.

2020 | INSPIRE 017  41


INNOVATION IN DATA & TECHNOLOGY IN HMR NBCF-funded researcher Professor David Roder: Developing a National Breast Cancer Database for Research and Service Delivery

Professor David Roder, Chair of Cancer Epidemiology and Population Health, University of South Australia 42  INSPIRE 017 | 2020


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lthough breast cancer has one of the highest survival rates, thanks largely to research, 9% of those diagnosed still die from the disease within five years. The National Breast Cancer Foundation (NBCF) has commissioned an Australianfirst research project to better understand and predict who makes up that 9%. Professor David Roder, Chair of Cancer Epidemiology and Population Health at the University of South Australia is undertaking a project that will provide valuable information to better identify the women diagnosed with breast cancer who will have worse health outcomes compared to others and the detailed reasons for the disparity. This information will allow for a targeted research investment strategy, while also directing health care and service delivery to the 9% of women who need it most.

IDENTIFYING GAPS IN SERVICES AND TREATMENT

Currently, breast cancer is the most commonly diagnosed cancer in Australia. 55 Australians are diagnosed with the disease every day, and more than 3,000 will lose their life to the disease this year. NBCF’s mission is to reach zero deaths from breast cancer by 2030. Since NBCF’s inception in 1994, the five-year survival rate for breast cancer has improved from 76% to 91%, indicating that an evidence-based strategy taken by NBCF and others of investing in world-class research is working. A key piece of work that will help get NBCF towards ‘zero deaths’ is the linked data set being developed by Professor David Roder. The data set will reveal critical information relevant for planning and evaluating breast cancer control, and will incorporate data from cancer registries, hospital-inpatient records, radiotherapy centres, breast screening services, breast surgery audits, and MBS/PBS claims. By linking all of these data sources, researchers will be able to examine every aspect of the breast cancer health care pathway right from diagnosis.

With breast cancer survival rates now at 91%, this data set will be critical to determining who is in the 9%, and what factors need to be addressed to get Australia to zero deaths from breast cancer.ˮ This wide population-based database will place Australia at the forefront of research into patterns of treatment and care globally. It will be a valuable tool for research, and health-service planning and evaluation (including

monitoring effectiveness and cost effectiveness and identifying gaps in service delivery). It will ensure that the health system has the information it needs to adjust and strengthen services to address gaps and ensure impact where it is most needed to get to zero deaths from breast cancer. The data linkage is occurring in phases: the first in South Australia to establish proof of concept, then in NSW, with phased extensions to other Australian jurisdictions. To date, the initial analyses of the linked data for South Australia (between 2000–2014) has focused on timeliness of care, as this is critical for achieving the best possible outcomes.

KEY FINDINGS FROM THE STUDY SO FAR:

• T he proportion of women treated with surgery in the same month as diagnosis or subsequent two months was 96%. • Longer durations were more common in younger (<40) or older (>69) age groups, and in women residing in more socioeconomically disadvantaged areas. • T here was no statistically significant difference in duration from diagnosis to surgery based on remoteness of residence. • There was a general trend for earlier medical intervention to be associated with higher survival. The next steps have been to do further analyses with regards to timeliness of care, sections of the population diagnosed with advanced disease, sections receiving less treatment, and long-term impact of treatments and comorbidities, as well as incorporating data for other states and territories. NBCF will use the information generated by this project to make data-driven decisions in setting priority areas for breast cancer research funding, to ensure its research investment is targeted towards projects that will lead to zero deaths from breast cancer. Further, this project will also provide the evidence for NBCF and the community to advocate for changes in health policy and service delivery that could stop deaths from breast cancer – getting us to our goal of zero deaths by 2030. “Through this partnership with NBCF, we hope to speed up the translation of research evidence into health practice to save and improve the lives of breast cancer patients in Australia,” said Professor David Roder.

Authors: Dr Christopher Pettigrew Director, Research Investment and Liz Tse Senior Brand and Communications Manager. National Breast Cancer Foundation

2020 | INSPIRE 017  43


QIMR BERGHOFER JOINS THE FIGHT AGAINST COVID-19 The COVID-19 global pandemic is a health emergency unprecedented for generations.

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IMR Berghofer Medical Research Institute was established 75 years ago to research the terrible infectious and tropical diseases that plagued Queensland at that time. Armed with this history and knowledge, the Institute has joined the quest to better understand and treat coronavirus. QIMR scientists are working to leverage the Institute’s expertise not only in infectious diseases, but also chronic diseases and cancer research to focus on developing much needed treatments and rapid diagnostic tools for COVID-19. Researcher Dr Corey Smith, head of QIMR Berghofer’s Translational and Human Immunology Group is pursuing one of the many research projects at QIMR Berghofer. Dr Smith and his team have recruited more than 40 Queenslanders who have recovered from COVID-19. The recovered COVID-19 participants provided a blood sample, enabling Dr Smith’s team to examine how those people’s immune systems responded to the virus, with the goal of developing a new T cell immunotherapy. These preliminary studies are important in understanding how the human immune system fights the disease, to 44  INSPIRE 017 | 2020

develop drug treatments to treat very sick patients. T cells play a critical role in fighting disease and infection; however, as we get older our T cells become less effective at fighting disease. Dr Smith believes that it’s likely that those patients who suffer mild illness from COVID-19 do so because their T cells respond well and fight this virus. ‘The next phase of the research will involve comparing blood samples from seriously unwell COVID-19 patients in hospital to understand how their T cells were responding to the virus.’ ‘Imagine if we could take T cells from donors who have recovered from COVID-19 and “turbo charge” those T cells in the laboratory to recognise and attack the virus. This approach could help the sickest of patients fight and survive a COVID-19 infection which otherwise could have been fatal.’ QIMR Berghofer Deputy Director Professor David Whiteman AM says the Institute has an obligation to take its place amongst others researching this highly infectious respiratory disease.


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Dr Corey Smith

‘We need to understand who is most susceptible to this disease, why some people are affected very seriously while others are not, find drugs that prevent people getting the disease and develop a vaccine and effective treatments for those who contract coronavirus. There is so much work to do.’

‘It’s easy to feel disheartened in these unprecedented times. That’s why it’s been so wonderful to receive messages of support from our donors and community groups who genuinely appreciate the efforts all staff are making to ensure our vital research continues,’ Professor Whiteman says.

Professor Whiteman explains why this research is so important.

The QIMR Berghofer COVID-19 appeal continues to raise funds for research such as Dr Smith’s critical immunology research. With so much still to learn about this disease, QIMR Berghofer will continue its work for better treatments.

With enough support, and if the research findings pan out, it is possible that an immunotherapy could be developed in roughly six months. It’s important to remember that even with the promise of a future vaccine people will still contract the virus, and we are in a strong position to use our research to help the sickest patients who would struggle to fight this virus.ˮ

Authors: Kate Beresford, Communications and Marketing Manager. Julia Little, Marketing Manager External Relations, QIMR Berghofer

2020 | INSPIRE 017  45


HOW USEFUL ARE TRACKING APPS IN CURBING COVID-19 INFECTIONS? Researchers from Sydney’s Sax Institute have built a model to project the impact of a fully functioning contact-tracing app on infection rates during a second wave of the COVID-19 virus.

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arlier this year the Australian government, in line with several other governments across the world, released a contact-tracing smartphone app to help in controlling the COVID-19 pandemic. The COVIDSafe app has, it’s fair to say, proven to be controversial, with some software experts unearthing potential technical flaws. While many of these issues have been resolved, the question of whether a properly functioning app can actually help cut infection rates remains. It’s a question that has become all the more pressing with the devastating resurgence of infections in Victoria, leading to a new lockdown in that state. Our modelling work at the Sax Institute, published in the peer-reviewed journal Public Health Research & Practice, suggests that an app can make a substantial difference when outbreaks occur. While social distancing and high rates of testing will always remain the best ways to limit the spread of COVID-19 in the absence of a vaccine, we found that new cases could be reduced by over 50% if enough people use the app, and if the app works as it should. The ‘baseline’ scenario of our model assumes a 50% monthly decline in social distancing and a 5% monthly drop in testing intensity going forward – this was our estimate of what was happening in May when we were writing the paper. Our model finds that if 61% of the population in this scenario downloaded the COVIDSafe app onto their phones, the number of new infections in

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a second wave would be 55% lower than if there were no app.

In contrast, the current app uptake level, which is around 27%, would have a much smaller effect, resulting in only 24% fewer cases.ˮ The study involved an extensive review of the epidemiology of COVID-19, case-finding practices and factors that could affect the uptake of the app, and the development of a robust system dynamics model based on the behaviour of the virus and its interaction with social, behavioural, and policy factors, using pandemic data from Australia and across the world. The model projects the number of people infected by the virus through to the end of the year. It’s a flexible model that can be adjusted for new and emerging scenarios to account for different rates of testing, intensity of social distancing and uptake of the tracking app. Maintaining large-scale testing and social distancing remain the two critical factors in managing infection rates.


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Dr Danielle Currie

Dr Michael Frommer AM

But what we’ve demonstrated in our work is that we simply can’t afford to write off the tracking app because of its early teething problems. The app can be an important adjunct to our efforts in curbing the spread of the virus, speeding up case-finding and identifying contacts that are not necessarily known to the infected person – for instance in the situation where the person may have travelled on public transport or visited a shopping mall. Even in the event that a vaccine becomes available, we think the app will continue to be an important add-on to efforts to stop the spread through extensive testing and social distancing. It is an insurance, not necessarily used much when infection rates are low, but ready to contribute to the time-consuming work of contact-tracing when there are flare ups, such as the one we are currently seeing in Melbourne. We think our model projections provide good evidence for state and federal governments to redouble their efforts in

promoting the app to the public as well as ensuring that any remaining technical issues are swiftly resolved. We’re delighted to see our research and its implications are being taken seriously at the highest levels of government, with the Australian Government’s Deputy Chief Medical Officer Dr Nick Coatsworth referencing our work in a recent media conference, along with mentions from several Federal ministers.

Authors: Dr Michael Frommer AM is a Senior Adviser at the Sax Institute. He is a public health physician with extensive experience in government, NGO and academic roles and is the former head of the University’s medical program. Dr Danielle Currie is a Senior Simulation Modeller at the Sax Institute. She holds a PhD in Public Health from the University of Queensland.

2020 | INSPIRE 017  47


TESTING FOR COVID-19 AT THE POINT OF CARE Harnessing technology to ensure remoteness is no barrier to COVID-19 testing for Aboriginal and Torres Strait Islander Australians

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or Aboriginal Australians living in rural and remote areas, the nearest laboratory able to conduct a COVID-19 test can be hundreds of kilometres away. This means there are significant delays receiving a test result. At a time when people are recommended to self-isolate, this can be very difficult in many remote communities. “We needed to bring the lab to the community,” says Lorraine Anderson. She is the Medical Director of the Kimberly Aboriginal Medical Service in Balgo, Western Australia, which services remote communities from Broome, through Fitzroy Crossing and up to Wyndham. “Our communities are vulnerable to this new pandemic due to high rates of chronic disease and overcrowding. Because of the remote areas they live in, getting test results to and from communities can take longer, and with an infection like COVID-19, we cannot afford to lose any time. Delaying a result for a day could quite quickly become a life or death matter.” Fortunately, a testing solution has been rapidly rolled out to more than 85 health centres, which are acting as testing hubs for 150 remote communities across Australia. It is called the Aboriginal and Torres Strait Islander COVID-19

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Point-of-Care Testing Program, and is funded by the Australian Government, and coordinated by the Kirby Institute at UNSW Sydney in partnership with the Flinders University International Centre for Point-of-Care Testing. With additional funding support from UNSW’s COVID-19 Rapid Response Research Initiative, evaluation of the clinical and public health impact and cost effectiveness of the program is also being undertaken. This innovative program facilitates equity of access for COVID-19 testing and provides a model for how to roll out COVID-19 point-of-care testing programs in other settings.

RESULTS IN 45 MINUTES

What makes this program possible is a relatively small, but incredibly sophisticated testing machine called the GeneXpert. “The testing device employs state-of-the-art reverse transcriptase nucleic acid amplification technology to detect COVID-19,” says Professor Rebecca Guy, who leads the program at UNSW’s Kirby Institute. “Point-ofcare operators, who are nurses and Aboriginal health practitioners, receive the swab in a tube, mix and stand and then pipette some of the liquid from the tube into a cartridge that is analysed by the GeneXpert device. The test has close to 100% sensitivity and specificity and enables us to detect COVID-19 within 45 minutes.” “This is why we call it point-of-care testing. Patients have their test and receive the result on the spot, and therefore public health action can occur immediately,” continues Professor Guy.


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“This is a game-changer for the management of COVID-19 in remote communities,” says Lorraine Anderson. “A negative result means we avoid unnecessary isolation or evacuation from the community, where the cost of an aero-evacuation is more than $20,000 per patient; while a positive result will lead to quick action to isolate and provide clinical care for the patient and to follow up their contacts.”

BUILDING ON A PROGRAM THAT ALREADY WORKS

The key to success for any health initiative in remote Australia is collaboration – strong relationships that build on existing networks and respond to local realities and knowledge. The program involves collaborations with state health departments and laboratories, Aboriginal Community Controlled Health Services, Government Health Services, industry, and other research centres.

The team was able to implement this initiative so quickly because it built on an existing program that was using the same GeneXpert technology to rapidly test and deliver results for sexually transmissible infections (STIs).” “As part of the STI testing framework, we’d already built a robust testing, training and quality management program, so we were able to adapt it for performing a SARSCoV-2 test on the same platform,” says Professor Mark Shephard, Director of Flinders University’s International Centre for Point-of-Care Testing.

“We have developed innovative ways for training operators to perform point-of-care testing on the GeneXpert, including the use of mobile phone platforms to observe the practical competency of operators during training and to ensure operator safety when conducting the test.”

THE IMPACT

This testing solution may sound like it should be used everywhere all the time; however, unfortunately it is not that straightforward. Internationally, there is a limited supply of test cartridges, and so there is a need to target this technology to settings where it is likely to have the greatest impact. Professor James Ward, from the University of Queensland Poche Centre for Indigenous Health says that a combination of factors makes this program critical for remote Aboriginal communities. “An uncontained outbreak in a remote Aboriginal community would spread rapidly. Delays in test results of even a few days could mean the virus spreads quickly due to overcrowded housing. Rapid response and contact tracing when the first case is detected is critical to contain an outbreak.” “Access to point-of-care testing in Aboriginal communities provided by this program is an essential component of the public health response to this pandemic in Australia. This is one part of a range of critical strategies to reduce transmission in our communities,” says Professor Ward.

Author: Professor Rebecca Guy is a Professor in Epidemiology at the Kirby Institute at UNSW Sydney and leads the point-of-care COVID-19 testing program at the Kirby Institute. Her research focuses on reducing the impact of infectious diseases in vulnerable populations.

2020 | INSPIRE 017  49


NATIONAL CLINICAL TRIALS GOVERNANCE FRAMEWORK: WHAT IT MEANS FOR YOU Clinical trials provide early access to innovative treatments and interventions for patients and improve the overall standard of medical care provided in Australian hospitals through the uptake of evidence into practice.

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n Australia, clinical trials are delivered by teams of clinical trial investigators and clinical and nonclinical staff working with clinical trial sponsors, regulators, trial participants, consumers, patients and carers. Clinical trials are conducted in public and private health service organisations and trial sites ranging from sole proprietorships to large statutory corporations and public companies. To support the delivery of high-quality clinical trial services the Australian Commission on Safety and Quality in Health Care (the Commission) has developed the National Clinical Trials Governance Framework (Governance Framework) on behalf of all jurisdictions/states and in collaboration with the Australian Government Department of Health. In November 2019 the Council of Australian Governments Health Council (CHC) endorsed the Draft Governance Framework and national pilot. Due to the impact 50  INSPIRE 017 | 2020

of the COVID-19 pandemic on health services, the pilot timeframe has been extended until the end of 2020. Insights gained from the pilot will inform the implementation of the Governance Framework in 2021. The Governance Framework builds on the National Model Clinical Governance Framework and the National Safety and Quality Health Service (NSQHS) Standards, providing: ● The roles and functions for identified positions relating to clinical trial service provision within a health service organisation ● Actions against which health service organisations with a clinical trial service will be assessed for accreditation ● Suggested strategies health services may implement to meet the actions within the NSQHS Standards ● Examples of evidence a health service organisation may provide that demonstrates they have met the actions within the NSQHS Standards for clinical trial service provision. The Governance Framework aims to strengthen governance arrangements for clinical trial services by providing clarity to those responsible for delivering clinical trials; it also aims to reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector. The project stems from recognition by all health ministers that, while states and territories have worked to improve the environment for clinical trials, issues of fragmentation and inefficiency remain that impact on Australia’s attractiveness as a preferred location for clinical trials. In a 2018 survey of Contract Research Organisations by ARCS Australia, the lack of a national unified governance


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Dr Shanny Dyer, CEO, ARCS Australia

WHY IS GOOD GOVERNANCE IMPORTANT? structure and HREC approvals (including navigating jurisdictional differences) were identified as significant constraints in conducting clinical trials in Australia. The Governance Framework does not specify how a health service organisation should develop or implement its clinical trials governance systems. The health service organisation is to develop its own strategies to meet the requirements based on local and/or state/jurisdictional requirements. Whilst the framework provides flexibility to health service organisation on how to meet the standards, it clearly outlines the requirement, set out in both national and international guidelines and regulations, for conducting clinical trials.

These national and international guidelines and regulations complement each other while still recognising the ethical, social and scientific challenges which exist in different types of clinical research in Australia.ˮ Clinical trials are conducted according to the requirements set out in Good Clinical Practice (GCP) guidelines. Clinical trials are undertaken to determine the efficacy of therapeutic goods. The International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), European Committee for Standardisation and the International Organisation for Standardisation (ISO) provide standards for the conduct of clinical trials (and clinical investigations) which are the basis for regulations world-wide. In addition to these international standards, Australian clinical trial stakeholders must comply with National, state-based and institutional policies and guidelines. These vary based on the nature of the research, but include (but are not limited to), the Australian clinical trial handbook, The National Statement on Ethical Conduct in Human Research, the Australian Code for the Responsible Conduct of Research & Safety monitoring and reporting in clinical trials involving therapeutic goods. Understanding and complying with these standards are important for all levels of an organisation conducting clinical research. Failure to comply may result in severe

Good Governance practises ensures that within an organisational structure, the best outcomes can be achieved. It provides the set of relationships and functions established by the health service organisation or trial service (between its state or territory department of health, governing body, executive, workforce, patient, consumers and other stakeholders) to ensure good clinical trial service provision. It ensures that everyone, including frontline trial investigators and members of governing bodies such as boards, is accountable to patients and the community for assuring the delivery of clinical trials is of high quality, integrated into clinical care and continuously improving. consequences for the organisation, the individual and potentially our patients and participants. It is therefore important for everyone to understand the governance requirements. Health service organisations will require support to implement the Governance Framework. This will be especially the case in larger institutions, where multiple departments are involved in conducting research, and a consistent approach to the adoption of the Governance Framework will be critical. Implementation should be supported by a comprehensive communications and education strategy. As a long-term educator for staff undertaking clinical trials, ARCS Australia has developed the ‘Building a culture in Clinical Trial governance’ curriculum that provides tailored and relevant materials for the institution to ensure that all stakeholders undertaking clinical trials, including governing bodies, managers, the clinical trial workforce, sponsors and consumers, understand the requirements and their role within the Governance Framework. For further information, please contact ARCS on 02 8905 0829 or email us at arcs@arcs.com.au. For further information about the Commission, the Governance Framework and the NSQHS Standards go to: https://www.safetyandquality.gov.au/standards/clinicaltrials

Author: Dr Shanny Dyer, CEO, ARCS Australia

2020 | INSPIRE 017  51


PAID ADVERTORIAL

PASSWORD SECURITY – TIME FOR A NEW APPROACH? Cyber-attacks on the health and research sector are becoming more sophisticated as the Australian Government calls for stronger protective measures.

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PAID ADVERTORIAL

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yber-attacks in the healthcare sector are consistently listed at the ver y top of the industry sectors in the Australian Notifiable Data Breaches reporting, with recent figures revealing the sector registered nearly as many criminal breaches as the Finance and Legal/Accounting industries combined.1

The sector has recently seen an active surge in Advanced Persistent Threat (APT) Actors with the Australian Cyber Security Centre (ACSC) issuing an “advisory” in May this year. According to the Advisory (2020-009)2, APT actors (organised entities and nation states): “…pose the most significant threat to Australia’s national security and economic prosperity” and have, “…been seen undertaking brute force attacks using a trial-and-error method to guess login credentials, and password spray attacks that attempt to access numerous accounts with a list of commonly-used passwords”. The numbers are escalating with recent allegations a state-based actor has been launching attacks on organisations involved in COVID-19 vaccine research with the aim of stealing information and intellectual property. Password complacency is the common key to virtually all attacks with over 80% of hacking breaches being facilitated by weak, stolen, or predictable passwords.3

PASSWORD EDUCATION IS NOT SOLVING THE PROBLEM OF WEAK PASSWORDS.

According to the Verizon DBIR 2020 Report4, using compromised credentials is still the easiest, and lowest cost avenue for attacks. While over 90% of Australians are aware that re-using passwords across multiple accounts is a major security risk, over two-thirds of us still recycle our passwords.5 The reality is that somewhere between 50% and 80% of passwords can be cracked easily and routinely, using tools available freely across the web. This is mainly due to weak and predictable passwords. Even more disturbing is that privileged accounts (those accounts providing access to high risk systems and information) are just as poorly maintained, meaning less effort is required by the attackers in gaining access to your core IP.6

PEN-TESTING IS NOT SOLVING THE PROBLEM OF WEAK PASSWORDS

Penetration-testing (Pen-testing) is a common practice to identify weak passwords. Pen-testing for weak passwords has more recently become a “tick the box” compliance process as the introduction of Privacy Laws (such as GDPR) has nullified the ability to enforce changes at the user-level. Passwords are now “private information” so any pentesting solution that reveals user passwords breaches privacy compliance.7 Additionally, twelve percent of breaches are listed as insider attacks8, increasing risk to users – especially since those users are likely to be reusing passwords in their personal security outside the organisation. Since the purpose of passwords is to prevent unauthorised access to sensitive data and resources, the presence of weak passwords represents a GDPR compliance risk that, in itself, can result in significant fines.9 Unable to enforce and review, organisations can only request stronger passwords from their users, but with no visibility of changes, user behaviour is proven to revert to another weak password variation.

ALTERNATIVE AUTHENTICATION SOLUTIONS ARE NOT SOLVING THE PROBLEM OF WEAK PASSWORDS

While alternative authentication solutions, including MultiFactor Authentication (MFA) and biometrics for example, add a layer of protection to weak passwords, they are, to some extent, plastering over the real issue - the weak passwords themselves. Additionally, these solutions are often incompatible with legacy systems, can take months to deploy, and become expensive to support.10 While alternative authentication solutions help in any defensive posture, they often provide a level of false confidence. Once penetrated, sophisticated attackers can easily work around these protections and weak passwords are quickly recovered and leveraged to gain deeper access.

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PAID ADVERTORIAL

PASSWORD POLICIES ARE NOT SOLVING THE PROBLEM OF WEAK PASSWORDS

The reason MFA and tokens have proven popular is that organisations have resigned themselves to the fact that they are unable to strengthen the passwords themselves…because, until now, true password resilience has been unachievable. As a result, many industry experts are moving away from their “passwordless” narrative as the realisation sets in that passwords are here to stay, at least for some time to come. Industry experts including Gartner11 are now advocating: “… risk management leaders responsible for IAM should invest in other compensating controls in line with business needs”

PASSWORD HYGIENE VS PASSWORD HEALTH

Realising the need to strengthen passwords, admin teams introduced password policies designed to harden passwords against attack. While the intent is right, this solution does not generally inhibit attackers, while again providing a false sense of security to the business. Table 1 demonstrates the difference in password strength scoring based on policy versus actual password resilience against a simulated attack:

Table 1: Password Hygiene vs Simulated Attack Strength This demonstrates a simple fact - attackers know about policies and simply apply “derivations” of simple passwords in their attacks. While “Password123!” meets most password policy guidelines, it is clearly a weak password against an actual attack. This also highlights the risk of using derivatives of the same password across multiple accounts and simply adjusting that same base password whenever asked to change (e.g. “myp@ssw0rd11” is changed to “myp@ssw0rd22”). With the proliferation of compromised (leaked) credentials across the dark web, attackers now have access to a multitude of credentials pulled from previous data breaches. These passwords may be strong and compliant with the strictest policies, but if users tend to use the same passwords across their work and personal accounts, attackers can easily leverage this to compromise their work accounts. 54  INSPIRE 017 | 2020

THE SOLUTION TO THE PROBLEM OF WEAK PASSWORDS PASSWORD QUALITY ASSURANCE USING ENTERPRISE PASSWORD ASSESSMENT SOLUTION (EPAS)

The easiest and fastest way to secure user authentication is to stay with passwords but im p l e m e nt qu a li t y a s su ra n c e m e a su re s by strengthening the actual passwords against attack methods. Detack, an independent provider of high-end IT security ser vices and solutions, has been conducting security audits and penetration testing for 20 years. Through their experience in that role, they have developed a unique, “automated” solution for password quality assurance, Enterprise Password Assessment Solution (EPAS). Based on patented technology, EPAS regularly audits passwords and passphrases across the enterprise, detecting weak and/or compromised passwords, and assigns a numeric value or “Strength Score” (out of 100) based on how “at risk” each password is to an actual attack. The password algorithms assess all passwords individually against known weaknesses including: • A Dictionary Wordlist- EPAS compares all passwords against a massive repository wordlist for commonality • A Dynamic Wordlist- a company-specific wordlist created for every instance of EPAS aimed at removing company/application specific password use. • Leaked Passwords- EPAS compares against all known compromised password lists (currently a 1.6TB repository) • S hared and Re-Used Passwords- EPAS checks for re-used and shared passwords across accounts and applications within the business and compares changed passwords against previous versions. • Derivations of all Wordlists- EPAS checks for all d3r1v4t10n$ of all lists above preventing users from making simple adjustments to previous passwords or to recognised dictionary words. • Easily Guessed or Derived Passwords- EPAS tests for structurally weak passwords including passwords that can be easily guessed. • Missing and Default Passwords- EPAS checks across attached devices and admin accounts to find accounts still set with the default passwords or any accounts with no set password. Each password strength score is compared against the minimum requirement, set by the administrator (by application), and reports are generated that explain the root cause behind the scores applied. Each assessment delivers a separate compliance report, measuring password quality KPIs, with detailed analysis


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Table 2: Example enforcement feedback to user at login for all management layers while multiple assessments can be conducted ad-hoc or set to run automatically at set intervals. Analytics and reporting help to guide teams through planning, implementing, and measuring remediation programs, as well as demonstrating the ongoing improvements in password strength. Passwords are never stored, just measured, then discarded, so remediation can be achieved without revealing the clear text passwords- maintaining GDPR compliance and reducing insider-threat risks. For the first time, the technology available to attackers is now available and permitted to be used by the good guys. The optional EPAS Enforcer add-on ensures password integrity is quickly attained and maintained across the business- an outcome not available through any other solution in the market. Following any audit of an application, any “Failed” passwords are quarantined so that when the user next signs in, they are forced to correct and strengthen their password before progressing to the application (see Table 2). Additionally, when users are prompted to update their passwords, or when they signin to an application for the first time, the module ensures they create a strong password at that point before they can progress to the application. The ability to enforce stronger passwords across the enterprise, without compromising the passwords themselves, is what stands EPAS apart from other solutions in the market today.12 Launched in 2013, EPAS is currently deployed across thousands of production systems, assessing millions of passwords on a regular, automated basis, with zero impact on system availability. Detack offers their proven and patented EPAS solution in a simplified, cost-effective, on-premise model. Deployable within 3 to 5 days, EPAS is largely automated and requires minimal resourcing to operate.

We are so confident in the solution we are offering a free of charge “Proof of Concept” to any organisation that mentions this advertorial. Our technicians will work with your team to deploy EPAS in your current environment and deliver a baseline report of your password quality. The results speak for themselves. If you would like to explore EPAS in more detail, please reach out to our ANZ representatives at www.whynotconsulting.tech or via email: hello@whynotconsulting.tech 1. https://www.oaic.gov.au/privacy/notifiable-data-breaches/ notifiable-data-breaches-statistics/notifiable-data-breachesreport-july-december-2019/#comparison-of-top-five-industrysectors 2. https://www.cyber.gov.au/threats/advisory-2020-009-advancedpersistent-threat-apt-actors-targeting-australian-health-sectororganisations-and-covid-19-essential-services 3. https://blog.lastpass.com/2019/05/passwords-still-problemaccording-2019-verizon-data-breach-investigations-report.html/ 4. https://enterprise.verizon.com/resources/reports/2020-databreach-investigations-report.pdf 5. https://australiancybersecuritymagazine.com.au/lastpasspsychology-of-passwords-report-reveals-90-of-australiansknow-password-reuse-is-insecure-yet-two-thirds-do-it-anyway/?utm_source=ActiveCampaign&utm_medium=email&utm_ content=Psychology+of+Passwords+l+Drones+prove+their+value+l+Threat+Report+plus+latest+news%2C+events%2C+podcasts+and+more&utm_campaign=Thursday+7+May 6. https://thycotic.com/resources/privileged-access-managementmaturity-report/?utm_medium=Internal-Email&utm_ source=Pardot&utm_campaign=Nurture-Engagement-Flow&utm_ content=Prospects&utm_term=Auto_Nurture-Engagement-Flow_ Prospects_Email2 7. Enzoic, GDPR Password Policy: Critical Components https:// www.enzoic.com/gdpr-password-policy-critical-components/ 8. Australian Government 2020, Notifiable Data Breaches Report, Office of the Australian Information Commissioner, viewed July 2020, https://www.oaic.gov.au/privacy/notifiable-data-breaches/ notifiable-data-breaches-statistics/notifiable-data-breaches-reportjuly-december-2019/Australian Government 2020, Information Security Manual, Australian Signals Directorate, viewed June 2020, https:// www.cyber.gov.au/acsc/view-all-content/ism ) 9. https://www.netsec.news/gdpr-password-policy/ 10. Gartner 2020, Gartner Research: Don’t Waste Time and Energy Tinkering With Password Policies; Invest in More Robust Authentication Methods or Other Compensating Controls, Gartner, Viewed July 2020, https://www.gartner.com/en/ documents/3773163/don-t-waste-time-and-energy-tinkering-withpassword-poli 11. Gartner 2020, Peer Insights Review, Gartner, Viewed July 2020, https://www.gartner.com/reviews/market/security-solutionsothers/vendor/detack/product/epas

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THE LAST WORD An opportunity for fundamental reform of Mental Health Care in Australia

I

n this new COVID world it seems no day passes without a statement by State and Federal political leaders expressing their concern for the mental health of individuals and announcing funding for more mental health support services to mitigate the impact of the pandemic. This funding, mainly from the Federal Government, has built on additional funding for mental health support services that was provided after the devastating bushfires earlier in the year. Building the case to support the mental health of Australians during this pandemic is well expressed in the UN Policy Brief – Covid 19 The Need for Action on Mental Health, May 2020 “Although the COVID -19 crisis is, in the first instance, a physical health crisis, it has the seeds of a major mental health crises as well, if action is not taken” This Policy Brief was written in May without knowledge of the trajectory the pandemic would take. What we are now experiencing in Australia as a second wave, particularly in Victoria, only supports the potential for psychological distress to become more widespread across not only vulnerable populations, but what would be considered more resilient people. The vulnerable now include frontline healthcare workers, children and adolescents, the elderly and isolated, those with existing mental health issues – the list goes on. Add to this anxiety the economic impact, yet to really materialize as government fiscal supports are still in place, and the word catastrophic seems more appropriate. There is no roadmap for what is occurring. Additional funding for mental health support services is being rolled out but the reality is Australia’s mental health system, if indeed we can call it a system, was already

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under pressure and will struggle to cope. The recently released “Re-thinking Mental Health in Australia” described the current experience, (ref) “There are services providing mental health care that is awful, even dangerous; there are many places providing care that is at best adequate and typically short-term; and there are isolated pockets off well-intentioned and/ or quality mental health care.” The Federal Government and the Prime Minister moved quickly to announce several initiatives and extra funding for mental health in response to COVID. The “Mental Health Pandemic Response Plan” and the #In this Together: Supporting our Mental Health during COVID 19 (National Mental Health Commission) are the two main schemes. An analysis of this funding shows it is spread across many initiatives and builds on funding that was provided during and after the bushfires. Telehealth is one area that has received a major boost which was widely welcomed and brought about changes in mental health practice that have been years in the planning. This quick shift to telehealth has filled gaps that have been well described. Telephone support and counselling services have also received additional funding to expand services and meet significant increased demand. Additional subsidised psychological therapy sessions will be permitted for people facing further restrictions. Private health insurers are funding telehealth services and have seen a substantial uptake particularly for mental health support The list of programs and projects being funded is commendable and is enabling a rapid response to widespread psychological distress. How effective they are will only be understood through a commitment to monitoring and evaluating the programs and outcomes.


CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

My Twitter : @chriskere CHRISTOPHE KEREBEL

The challenge we face for mental health care as we come out of this pandemic or adjust to a new reality is to develop an evidence base around these various interventions. It is reassuring to know the NMHC has a monitoring and data management responsibility for the many initiatives the government has announced for the pandemic. The Commission is also developing a national mental health research plan which will need to reflect the COVID impact. Mental health research has historically been underfunded compared to other areas of health research. This has been recognised to a certain extent through the MRRF Mission funding but one area that continues to be overlooked is mental health system research to support improved planning and service investment. The pandemic has provided a once in a generation opportunity for fundamental reform in mental health.

DO WE NEED FUNDAMENTAL REFORM?

Mental health services are particularly affected by the division of roles and responsibilities between commonwealth, state and territory governments and the non-government sector. For individuals who experience acute and severe mental illness, state and territory governments deliver episodes of care in public acute and psychiatric hospital settings, or in specialised community mental health care setting. However, for individuals who do not qualify for this care, but who still experience moderate to severe mental ill health and require a high-level of support, there is no publicly funded service equivalent. If you are lucky and suffer with a permanent and significant disability from your mental illness, you may be eligible

to enter the ‘disability’ sector and receive psycho-social support. Without access to a seamless care pathway, often the only option for people is to pay high out of pocket costs and receive one-on-one care in a community setting. For those with private health insurance the prevailing option is inpatient care. Historically, there hasn’t been any service option for this group that delivers flexible, multidisciplinary, community-based care. To navigate through this complex, fragmented system while living with a mental illness is a well-documented challenge. COVID 19 will only exacerbate the fault lines on which our mental health system is built. On a final note of optimism, we should use the current momentum and widespread focus on mental health that the pandemic has brought to accelerate mental health reforms. These reforms need to be supported by research priorities that reflect: the need for an improved evidence base, contemporary planning, service mapping and system modelling tools, reformed funding models and improved consumer driven quality and service standards.

Author: Associate Professor Annette Schmiede, Research Australia Director and Executive Leader Bupa Health Foundation

2020 | INSPIRE 017  57


The Bupa Health Foundation partners with health and medical researchers to address the health needs of the Australian community. Our approach to partnering includes investing in research that improves health through changes to policy practice and behaviour; collaborating with researchers across the academic, industry and healthcare sectors; advocating for those who are improving health and developing the capabilities, skills and networks of the health and medical research community. The Bupa Health Foundation is one of Australiaâ&#x20AC;&#x2122;s leading foundations dedicated to health, investing over $33 million since 2005.

Find out more at bupa.com.au/foundation

Profile for Research Australia

INSPIRE Issue 17 - Responding to COVID-19  

We are delighted to publish our special COVID-19 edition of INSPIRE featuring articles from the following Research Australia contributing me...

INSPIRE Issue 17 - Responding to COVID-19  

We are delighted to publish our special COVID-19 edition of INSPIRE featuring articles from the following Research Australia contributing me...

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