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The Health Wrap: vaccine update, aged care, safety and quality, and dancing with squid cells

In The Health Wrap, Associate Professor Lesley Russell provides an update on coronavirus news and developments, reports on important safety and quality news for aged care and healthcare, and asks some probing questions about the role of “gut feelings” in diagnosis.

Also, who knew that you could play music through squid cells?


Lesley Russell writes:

Early last week there was a report of a case of coronavirus reinfection from Hong Kong — the first such confirmation of reinfection during the pandemic.

Since then there have been several other such reports. Two European patients, one in Belgium and one in the Netherlands, are also reported to have been reinfected with the virus and then a case from Nevada in the United States was reported in The Lancet.

Naturally, questions have been raised about what this means for the levels and longevity of protective immunity that is generated by infection – and perhaps by any vaccine.

In the cases from Hong Kong and Europe, the patients had only a mild illness with the second infection. That’s as expected; the immune system is able to mount a more robust response. But in the US case the patient, a young man, was much sicker with his second infection. The cause could lie in his immune system, the virus, or a combination of the two.


Progress towards safe, effective vaccines

The race for a coronavirus vaccine is heating up – driven in part by President Trump’s desire to be able to announce that the US has a vaccine ahead of the November 3 presidential elections (my bet is that he will make the announcement regardless of the facts – this article outlines how he could do it).

Still, the progress is quite remarkable. According to The New York Times Coronavirus Vaccine Tracker, nine vaccines are currently in Phase 3 trials. In two cases the vaccines are already approved –  China and Russia have approved vaccines without waiting for the results of Phase 3 trials.

In June, China approved CanSino’s vaccine for use in the military, a decision described as “political, and not scientific in nature”.

In early August President Putin announced that a Russian healthcare regulator had approved a vaccine, referred to as Sputnik V, before Phase 3 trials had begun. Russia later walked back the announcement, saying that the approval was a “conditional registration certificate”, which would depend on positive results from Phase 3 trials.

This rushed process is associated with serious risks– not just because the vaccines may not be safe or effective, but because an ineffective vaccine could increase vaccine hesitancy and might accelerate the rate of mutations in the virus.

Phase 3 trials are presenting challenges for vaccine-makers around the world, in particular with issues around recruiting enough participants and qualified health staff and establishing international liaisons with sound scientific supports.

Demonstrating that vaccines are safe, have no serious side effects, and provoke an immune response sufficient to  protect people from the virus requires data on between 20,000 and 40,000 people, who are split into control and test groups and then followed closely for several months or even years. This task is harder in those countries like China and Australia that have had success in controlling the pandemic as fewer people who are vaccinated will be exposed to the virus.

Chinese vaccine firms are reportedly finding it difficult to recruit patients in a crowded market and most Chinese Phase 3 studies are now being done overseas. Sinovac is doing Phase 3 studies in Brazil and Indonesia; Sinopharm will be testing its inactivated vaccines in Bahrain, Peru and Morocco; and CanSina will run its trials in Saudi Arabia and Pakistan although a trial in Canada has apparently run into political trouble.

In the US, where the virus still rages, Moderna and Pfizer, leading the race for a coronavirus vaccine, have reportedly enrolled more than half the people needed for their 30,000-person Phase 3 trials. But they are struggling to get enrolments from the Black and Hispanic communities who have been hit hardest by the virus.


No silver bullet

It’s likely that in the race to be the winner, the first vaccines will not be the best. In particular, some scientists are arguing that vaccines will need to generate both antibodies and T cells to be maximally effective.

If this is the case, then the vaccine being developed by Oxford University in conjunction with AstraZeneca and the University of Queensland might be one of the better candidates among those currently being tested.

This is the vaccine the Morrison Government is looking to purchase; it’s also the vaccine that some Catholic clergy are objecting to on the ground it is produced in a cell line that was generated from the kidney tissues of an aborted foetus in 1972 (On  related issues, don’t miss this article by Professor Julie Leask explaining why now is a critical period for public health communications about vaccination).

And then there is this article from Dr Bonny Parkinson at Macquarie University, who asks if a vaccine will really be the silver bullet that saves us from all our COVID-19 woes. She argues that around 67 percent of the population need to be immune to achieve herd immunity and reduce the incidence of infection (other experts place this figure higher). Whether this is achievable will depend on the vaccine efficacy and uptake.

I personally think that even if an effective vaccine is produced quickly and the anti-vaxxers have limited impact, it will still take some considerable time before most people are immunised.

So, in line with the article, I think social distancing, masks, increased hygiene efforts and testing and tracing will be with us for some time after the announcement of vaccine success – regardless of who makes it.


Effects of obesity and exercise on vaccine effectiveness

We know that obesity is a serious risk factor for death from COVID-19 – a recent report published in Obesity Reviews finds that it increases the risk of dying by 48 percent.

The authors of this report go further, stating that a standard vaccine dose may not be as effective in people with obesity.  This is based in work done with the flu vaccine in the US, where two-thirds of the adult population are overweight or obese.

This is an issue the developers of coronavirus vaccines will need to consider and factor into the trials.

On the other hand, exercise may boost the vaccine response. Two new studies of elite athletes found that working out amplifies the immune response to a flu shot.


Australia finally signs up to COVAX – but robs the aid budget

It was encouraging to see that Australia has finally signed up to COVAX and pledged $80 million to the global push to ensure any future coronavirus vaccine is distributed cheaply and fairly in developing countries in the Pacific and South East Asia.

But it was disheartening to see that the Morrison Government reallocated these funds from the existing aid budget.

The Pacific countries eligible for COVAX support will include Papua New Guinea, Solomon Islands, Vanuatu, Fiji, Samoa, Tonga, Tuvalu and Kiribati. Eligible countries in South East Asia will include Indonesia, Timor-Leste, Cambodia, Laos, Myanmar, The Philippines and Vietnam.

The United States has announced it won’t join COVAX, in a move described by Forbes as “the latest sign of the Trump administration withdrawing the country from the international health community’s response to the pandemic over political concerns”.


Also at Croakey on COVID

Please make time to read these additional Croakey articles:

Ben Veness: How many healthcare workers need to be infected before you will protect us, Premier?

Stephen Duckett and Will Mackey: Calling out a lack of pandemic policy action for prisoners and other vulnerable groups

Nicole MacKee: Calls for action to protect healthcare workers from COVID-19 risk

Sharon Friel: What do Australia’s COVID-19 policy responses REALLY mean for health?

Melissa Sweet: To govern for health, encourage the conversation

Nicole MacKee: For people with disability, the pandemic has brought hardship and neglect, Commission hears


Aged care

The dreadful saga continues regarding the failures in residential aged care, thrown into stark relief by the coronavirus pandemic.

As I write this, there have been 601 COVID-19 deaths in Australia and 401 of these have been in residents of aged care, with almost all (396) in for-profit, private sector facilities.

And sadly, about 40 percent of the healthcare workers infected in Victoria since July 1 work in aged care or the disability sector.

Source: Casey Briggs on Twitter, 25 August

The responsible Minister, Richard Colbeck, and the Morrison Government seem unable or unwilling to take responsibility and to begin the needed reform process (it’s not clear if they will even do so when the Royal Commission report finally comes down – but why wait until then?).

While the Government has announced a further $563.3 million to extend support for RACFs to respond to coronavirus. While this is very welcome, again it does nothing to reform the sector.

With such a government vacuum, it’s time for community stakeholders to step in and begin the needed work.

The is plenty of evidence and lots of worthwhile recommendations in the huge pile of submissions received by the Royal Commission.


Three important research papers recently released by the Royal Commission

1. Research Paper 8 – International and National Quality and Safety Indicators for Aged Care prepared by the South Australian Health and Medical Research Institute (SAHMRI)

This report suggests nine domains for routine monitoring of aged care quality and safety that can be implemented using existing administrative data collections and at no additional burden to aged care providers:

  • Medication-related quality of care, including antipsychotic medication use, sedatives and antibiotics
  • Falls and fractures
  • Hospital re-admissions
  • Hospitalisation for dementia / delirium in individuals with dementia
  • Pain (chronic opioid use)
  • Premature mortality
  • Pressure injury
  • Utilisation of care plans and medication reviews
  • Weight loss / malnutrition.

It also recommended that quality of life and other measures of wellbeing or consumer experience such as activities of daily living or physical restraints should be included as part of Australia’s routine monitoring in aged care.

2. Research Paper 9 – The Cost of Aged Care prepared by the University of Queensland

This report divided residential aged care facilities (RACFs) into three categories based on how they ranked on a number of indicators (use of high risk medicines; accreditation standards met; numbers of issues and complaints; customer experience rating).

It found that only 11 percent of RACFs were in the top category, with 11 percent in the lowest category and the majority (78 percent in the intermediate category.

Further analysis reveals the crucial details: there is a positive association between the quality of care delivered and the cost, and this varied by size of the facility – but really the differences were surprisingly small (see table)

Only 24 percent of public, 13 percent of not-for-profit and just 4 percent of for-profit RACFs are best quality. No RACF with fewer than 15 beds registered in the lowest quality tier.

But nursing homes with 200 or more beds accounted for 21 percent of all facilities in the worst performing tier. The best quality RACFs are small (less than 30 beds) and government-run (but still, only 41 percent are best quality).

If every RACF operated in 2018-19 without any cost inefficiency, the sector would have required $15.7 billion or $621million more than provided to perform at the top-quality level.

If the higher quality small-bed model was used, the additional funding needed in a single year is estimated to be $3.2 billion.

3. Research Paper 10 – Technical mapping between ACFI and AN-ACC prepared by the University of Wollongong.

This technical paper maps the Aged Care Funding Instrument (ACFI) to the Australian National Aged Care Classification (AN-ACC). The objective of this work was to enable the development of a casemix-adjusted indicator (“casemix index”) for residential aged care facilities that appropriately reflects the relative care needs of their residents.

It contributes to the work from the University of Queensland outlined above about how much residential aged care services should cost at different quality levels.


Staffing ratios in the spotlight

Staffing levels in RACFs have always been an issue. Now a recent article in The Medical Journal of Australia (unfortunately behind a paywall) from aged care expert Professor Joe Ibrahim finds that, when compared with international staffing benchmarks, Australia’s RACFs meet none of the minimum criteria for adequate staffing.

The report found:

more than half of all Australian aged care residents (57.6%) are in RACFs that have inadequate (one or two stars) staffing levels.

A little over a quarter (27.0%) are in RACFs that have three stars, 14.1% of residents are in RACFs with four stars, and 1.3% are in RACFs with five stars, which we consider best practice.”

For all residents to be receiving four-star level of care, staffing would need to increase by 37.2 percent.

Professor Ibrahim describes this as a “horrifying” assessment and has called for forensic accountants to be engaged to scrutinise just how the RACFs spend their money, in particular the government funds that are provided specifically for the healthcare workforce.


More money needed for aged care – but how much?

The papers outlined above show that, at a bare minimum, an extra $621 million per year (indexed from 2018-19) is needed to lift all RACFs up to ‘basic standards’.

It’s worth noting that the total Federal Government spend in 2018-19 was estimated in the Budget Papers to be $18 billion and the total public and private contributions to aged care have been estimated at about $27 billion.

In a consultation paper on financing aged care released in June, the Royal Commission looked at much bigger reforms and estimates that the total funding may need to rise by as much as 50 to 100 per cent; between $13 billion and $26 billion more from a range of sources.

That puts the Morrison Government’s recent announcement of additional funding of $171 million announced two weeks ago (and the $1.7 billion cut by the LNP Government from the Aged Care Funding Instrument in the 2015 MYEFO and the 2016-17 Budget) in perspective.

It turns out the Government had information that showed there would be a tripling of “losers” among RACFs as a result – almost 53 percent would lose funds. Those budget cuts had the effect of reducing funding for the highest levels of care, even as such needs are increasing

In fairness, the Commonwealth has now committed more than $1 billion for aged care support during the pandemic. But, as pointed out by Professor Ibrahim in an article for The Conversation, these funds are geared primarily towards dealing with the current coronavirus crisis and do little to begin the reform process or even better prepare the sector for further outbreaks .

Recently in Question Time, Prime Minister Morrison called aged care “pre-palliative care” which seems to indicate that he views RACFs as places where old Australians go to die, rather than homes where older, frail Australians live their last years. (The average stay in residential aged care is 2.6 years.) (Tweet above sent on 27 August).

Last week Opposition Leader Anthony Albanese gave a speech at the National Press Club where he outlined Labor’s approach to aged care, offering eight actions for improvement. You can read his speech here.

Meanwhile, former Prime Minister Tony Abbott (Federal Health and Ageing Minister from 2003-2007) has suggested the economic cost of lockdowns meant families should be allowed to consider letting elderly relatives with the coronavirus die by letting nature take its course.

Tweet by Jenny O’Connor, Mayor of Indigo Shire, 2 September


GP’s gut feelings on diagnosis – they matter

I read a very interesting paper recently – a systematic review and meta-analysis of the evidence about the role of GPs’ gut feelings in diagnosing cancer in primary care.

It found that these “gut feelings” were generally in response to patients’ symptoms and non-verbal cues and (not surprisingly) were reliant on continuity of care and clinical experience.

The point was made that because some specialists questioned the diagnostic value of these gut feelings, GPs often omitted them from referral letters, or chose investigations that did not require specialist approval.

In another paper from 2011, GPs’ diagnostic reasoning is seen as a complex task that combines analytical and non-analytical cognitive processes. Gut feelings emerge as a consequence of non-analytical processing of the available information and knowledge, either reassuring GPs or alerting them that something is wrong and action is required.

I discovered that there is quite a trove of publications on gut feelings in medicine – sometimes called “clinical intuition” – where medical practitioners form a hypothesis quickly and then verify it though more analytical means.

Over time, and with experience, clinical intuition is thought to become more accurate, and the analytical process occurs more quickly.

Some in the medical community think that quick decision-making is a problem, especially as lowering the rate of misdiagnoses—estimated to be at about 10 to 15 percent of all cases—is a widely held goal. You can read more on the issues here.


WHO Global Patient Safety Action Plan

The WHO has just released the first draft of its Global Patient Safety Action Plan 2021-2030: Towards Zero Patient Harm in Health Care.  It is open for feedback until 28 September 2020.

It finds:

  • The occurrence of adverse events due to unsafe care is likely one of the 10 leading causes of death and disability in the world.
  • In high-income countries, it is estimated that one in every 10 patients is harmed while receiving hospital care. The harm can be caused by a range of adverse events, with nearly 50 percent of them being preventable.
  • In OECD countries, 15 percent of total hospital activity and expenditure is a direct result of adverse events.

Australian patient safety issues

Australian-specific data on adverse events is confined to hospitals – see this report from the Australian Commission on Safety and Quality in Health Care (ACSQHC), The State of Patient Safety and Quality in Australian Hospitals 2019.

In 2013, between 12 percent and 16.5 percent of total hospital activity and expenditure was the direct result of adverse events.

In the financial year 2017–18, admissions associated with hospital-acquired complications were estimated) to cost the public sector $4.1 billion or 8.9 percent of total hospital expenditure. Sadly much of the data are out-dated (this is becoming a regular theme of my reporting!).

The report found the most burdensome adverse event types include healthcare-associated infections (HAIs), medication complications, delirium and cardiac complications.

Given that a significant proportion of healthcare is provided by primary care services, it is shocking that we know so little about the frequency, causes and consequences of errors and adverse events in this sector. The ACSQHC is working on this, but there are no reports from the commission to date.

There is an Evidence Check from the Sax Institute on Patient Safety in Primary Care, prepared in 2015. It found that:

Most of the research evidence that has been published in the primary healthcare patient safety literature continues to be conducted in the general practice setting.

Diagnostic errors were commonly associated with the potential for moderate to severe harm outcomes in primary healthcare settings.

There is insufficient evidence to estimate the frequency of harm, adverse events and diagnostic error in the primary healthcare setting.

In 2015 my colleague Dr Paresh Dawda and I also wrote about the need for more data and more action in this area, in an article published in The Medical Journal of Australia.

The NHS National Reporting and Learning System (NRLS) is apparently the only national incident reporting and analysis system found in the English language that is readily available for primary healthcare clinicians to use. It covers hospitals, general practice, community nursing, ambulance services, community pharmacy, dental and optometry services. Reporting is largely voluntary.

See a typical NRLS report here.

And follow @WePublicHealth this week, where the Australian Institute of Health Innovation is tweeting on #patientsafety.


Consultation paper for National Preventive Health Strategy

The Australian Government has released a consultation paper for the 10-year National Preventive Health Strategy. Comments are due by 28 September 2020.

Work on this strategy, first announced in June 2019, is lagging, with the coronavirus pandemic used as justification. You can track the consultations and round tables done to date and the composition of the Expert Steering Committee here. The website states that the strategy will now be developed by March 2021.

I’m hoping that the comments that come in and the Expert Steering Committee will put some real meat on the pretty slender bones outlined in the consultation paper.

It says that the strategy will ensure that:

  • Children get the best start in life
  • People live healthily for longer
  • Inequalities in health are addressed
  • Funding is rebalanced towards prevention.

But the focus seems to me to be too narrow to achieve these goals. There is a mention of the fact that “healthy environments are needed to support healthy living” – but there is no mention of climate change, access to clean water, housing, or – more generally – to the social determinants of health. I might add that although physical exercise and nutrition are seen as important, I could find no mention of the word “obesity”.

I think the issue is that, although the consultation paper does say “different sectors, including  across governments at all levels, will work together to address complex prevention challenges”, in fact the focus is only on what can be delivered through the healthcare system/s.


The best of Croakey

The Aboriginal Community Controlled Health Organisations (ACCHO) sector has a wealth of expertise in addressing the social and cultural determinants of health, responsive service development, and providing culturally safe care.

These are some of the findings from the work of The Centre of Research Excellence in Aboriginal Chronic Disease Knowledge Translation and Exchange (CREATE), a collaborative enterprise between the National Aboriginal Community Controlled Health Organisation (NACCHO), Wardliparingga Aboriginal Research Unit, at the South Australian Health and Medical Research Institute (SAHMRI), and the University of Adelaide’s School of Public Health.

In this article, Professor Alex Brown, a Chief Investigator, and Eddie Mulholland, CEO of Miwatj Health Aboriginal Corporation in East Arnhem and long-term member of the CREATE Leadership Group, explain why the wider health sector needs to gain a deeper understanding of the contributions of the ACCHO sector.


The good news story

This section often has a heavy emphasis on music – no apologies for that.

So this week how could I not totally recommend to you the latest musical effort from the ED Musos – a virtual choir and orchestra composed of Emergency Department doctors, nurses and colleagues who make music together for healthcare worker wellbeing and fun. You can follow them at @EDMusos.

Their latest, with contributions from family and pets, is “A Whole New World” – a guaranteed endorphin booster. Listen here.

And to add to your music pleasure, this: Playing music through squid cells.


Croakey thanks and acknowledges Dr Lesley Russell for providing this column as a probono service to our readers. Follow her on Twitter at @LRussellWolpe.

Previous editions of The Health Wrap can be read here.

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