Too much of a good thing

A groundbreaking new study is examining how the media globally report on the benefits and harms of tests for healthy people.

Dr Mary O’Keeffe, from the School of Public Health at the University of Sydney, writes below that the findings are likely to shed new light on the causes of overdiagnosis in healthy people.

This article is published as part of the TOO MUCH of a Good Thing series, which is investigating how to reduce overdiagnosis and overtreatment in Australia and globally, and is published as a collaboration between Wiser Healthcare and Croakey.

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Mary O’Keeffe writes:

Have you heard about the new Apple Watch device that promises to detect, and save you, from heart issues before you get them? How about the quick and simple blood test by the name of liquid biopsy to detect cancer 10 years in advance?

We hear a lot about the future role of artificial intelligence (AI) in our lives, but do you know there are now promises that AI will detect dementia — before symptoms appear — and hopefully inform prevention?

What is common across these tests is their focus, not on sick people, but on well people — people with no signs of a medical problem.

The promises of testing seem to be moving from targeting the sick to apparently healthy and well people to identify those at an increased risk of a disease or disorder.

Sounds appealing doesn’t it?

In fact, research shows that many of us overestimate the benefits of testing. But are there pitfalls to consider?

Media’s role

Mass media and social media are key drivers of the hype around new tests and treatments.

The news is saturated with headlines displaying the latest advances in medicine and how they eventually will help our lives. Click-bait headlines containing words like ‘cure’, ‘revolutionary’, and ‘holy grail’ will always grab attention (here, here and here).

Previous research (here and here) tracking media coverage of medical treatments has identified evidence of exaggeration, inaccurate reporting of published scientific papers, overstating of benefits of treatments, downplaying of harms, and failure to report important conflicts of interest of the experts cited in the story.

So, the media often gives us an overly positive view of new treatments.

But how do the media reports on tests, in particular those for healthy people?

We actually do not know, and researchers in Wiser Healthcare are currently doing a research study mapping how the global media report on the benefits and harms of five tests for healthy people.

Potential harms of testing the healthy

Researchers in Wiser Healthcare have concerns about the promotion of new tests.

While early detection makes intuitive sense, the quest for ever-earlier detection of disease and the medicalisation of prevention can lead to unnecessary classification of the healthy as sick: overdiagnosis.

Overdiagnosis occurs when people receive a diagnosis that they do not need, that does more harm than good.

Giving somebody an unnecessary diagnosis can lead to overtreatment, psychological distress, and health anxiety. What is worse is that only a small proportion of people are knowledgeable about overdiagnosis.

Let’s take a look at some of these tests and what they promise.

3D Mammography for the early detection of breast cancer

Screening with mammography (both 2D and 3D) uses X‐ray imaging to find breast cancer before a lump can be noticed. The goal is to treat cancer earlier, when a cure is more likely.

Any headlines portraying a new test that can achieve this goal will be attractive to readers.

However, there is large uncertainty surrounding the benefits of 3D mammograms. For example, we already know that overdiagnosis is a significant harm of 2D screening mammography.

Overdiagnosis of breast cancer can lead to unnecessary surgery, radiotherapy and endocrine therapies, as these are standard treatments for women with screen-detected cancers (here, here and here).

We simply do not know enough about the benefits and harms of the newer 3D mammography.

But do the media portray this uncertainty in their reporting about the new test?

Liquid biopsy for the early detection of cancer

A quick and cheap way of detecting cancer will always sound attractive.

Many companies are now promoting a blood test, called liquid biopsy, to detect cancers (often several cancers at the same time) many years in advance (here, here and here). This carries a similar rationale to other new tests: catch the disease early — and either prevent or cure it.

However, as well as a lack of research demonstrating the actual validity of these blood tests (do they perform what they claim to do), there are concerns that the detection of certain cells in healthy populations could lead to overdiagnosis.

Blood biomarker tests and artificial intelligence for the early detection of dementia

Dementia is a devastating condition and millions of families worldwide are coping with a person who has the diagnosis. Current treatments do not prevent or cure the condition and at best slow down the progression of symptoms for short periods.

A simple blood test or device that will eventually prevent or cure dementia is appealing in that it works even earlier in the process, maybe even before symptoms appear.

The blood tests claim to detect biomarkers in a person’s blood that are apparently indicative of the future development of dementia (here, here and here).

AI technology is stated to have similar advantages, detecting brain or functional abnormalities in individuals, long before a diagnosis becomes visible.

However, it is unclear that either of these tests are valid (can they perform the role they claim to do), and that these tests will actually improve clinical outcomes.

Concerns have been expressed (here, here, here and here) that these new tests are an open invitation to overdiagnosis and that this overdiagnosis will have serious psychological, social and legal harms.

Apple Watch series 4 ECG sensor for the early detection of atrial fibrillation

Atrial fibrillation (AFib) is an irregular beating of the heart’s two upper chambers, and is considered a cause of stroke.

Timely diagnosis of clinically important AFib may enable the initiation of effective therapies in some people, and help reduce strokes and death.

The new Apple watch ECG is designed to detect changes in heart rhythms that may be a sign of a person going on to develop AFib (here and here).

 

 

 

 

 

 

 

 

Similar to claims about the other new tests, the idea of early detection seems appealing.

However, AFib is not hugely common, and a 24/7 screening device could lead to harms in the form of false positives/alarms, overdiagnosis and overtreatment.

The lack of knowledge around the natural course of AFib, along with research examining the validity of the Apple Watch for this purpose, leaves us unclear on the potential benefits and harms for the worldwide population.

I wonder do the media display this uncertainty about the Apple Watch?

So, researchers at Wiser Healthcare are concerned about the validity of these tests, the lack of evidence of benefit for testing the healthy, and how the media report on these tests.

This is where the concept of overdiagnosis becomes important to understand.  

Stay tuned for the results of this large study examining worldwide media coverage of the benefits and harms of testing the healthy.

This will be the first study in the world to analyse the media coverage of the benefits and harms of tests that have the potential for overdiagnosis in healthy people.

• Dr Mary O’Keeffe is a Marie Skłodowska-Curie Postdoctoral Fellow at the Institute for Musculoskeletal Health, a division of the School of Public Health, University of Sydney. Mary’s fellowship involves two years at the University of Sydney, a three-month secondment to the European Pain Federation in Belgium, and nine months at the University of Limerick in Ireland. Mary completed her PhD in the University of Limerick, Ireland in 2017. It involved a clinical trial examining the effectiveness of a personalised exercise and education approach for people with chronic low back pain compared to a group exercise and education approach.

• O’Keeffe’s current research focuses on nudge-interventions to improve healthcare delivery, media coverage of new tests for healthy people, media coverage of The Lancet low back pain series, and the impact of diagnostic labels for low back pain on treatment choices. She is passionate about public engagement and communicating evidence-based information about low back pain through radio, newspapers and social media. She is a member of Europe’s Voice of Young Science Network and an invited member of a low back pain guideline development committee within the European Pain Federation (EFIC).

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This article is part of an ongoing series that is published as a collaboration between Wiser Healthcare and Croakey.org.

The series investigates how to reduce overdiagnosis and overtreatment in Australia and globally. The articles are also available for republication by public interest organisations, upon request.

Bookmark this link and follow #WiserHealthcare on Twitter.

One of the four areas of focus for development of the new National Preventive Health Strategy is “current and emerging opportunities in cancer and chronic disease population screening”, and Health Minister Greg Hunt has sought advice on whether a lung cancer screening program should be introduced.

It is timely to consider the complexities and dilemmas of screening programs, which often involve more risks than is widely appreciated.

Evidence-based medicine expert Professor Paul Glasziou cautions in the article below that patients, doctors and Health Ministers must understand the limitations of screening “if we are to avoid an epidemic of overdiagnosis”.

His article is published as part of an ongoing series, TOO MUCH of a Good Thing, that investigates how to reduce overdiagnosis and overtreatment in Australia and globally. It is published as a collaboration between Wiser Healthcare and Croakey.

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Paul Glasziou writes:

“Cancer” may be a single word, but it is not a single disease. Cancer’s behaviour varies vastly: from slow growing or even dormant clumps of abnormal cells to the very aggressive tumours that can spread and be fatal in a few months.

In the last few decades we’ve learned that the dormant and slow growing types are much more common than we thought. And that we don’t really know what to do about them.

Many prostate cancers fall into this slow growing category.

Consider Andrew’s story (as told here): at age 45 he had a PSA test that was a bit high, so he proceeded to have a prostate biopsy (a needle into the prostate to sample the tissue), which showed a low grade cancer. He was told it would be fatal without surgery.

But, against advice, he decided not to have any treatment.

Twenty-one years later (now aged 66) he has never had treatment, and is alive with no prostate symptoms.

He said: “It is time men became brave. If they have fallen into the trap of testing, then they must study the real statistics and realise that despite the word ‘cancer’, this disease is highly unlikely to kill you.”

But of course, there are aggressive prostate cancers also, and doctors and scientists can’t reliably distinguish between the slow growing (like Andrew’s) and the aggressive types.

That can mean many men being hurt by treatments for disease that doesn’t matter, to try to save very few men with aggressive disease.

Autopsy studies

From autopsy studies of men who have died from other causes (so, not prostate cancer but from heart attacks, accidents etc), we know many have dormant and undetected prostate “cancers” (we should probably use a different name for these abnormalities, such as “borderline epithelial neoplasm”) – around 50 percent of men by the age of 70 years (see figure below).

Those men were certainly better off not having their prostate cancer detected before they died of something else.

We recently tried to estimate how many Australian men are now being diagnosed with ‘prostate cancer’ when in fact they have a dormant or slow growing prostate tumour.

To do this, we made a comparison between 1982, when men weren’t being tested for prostate cancer, and 2012, when about half of Australian men over 65 were being tested.

How many men who were alive in 1982 would be diagnosed with prostate cancer in their lifetime? And in contrast, how many men alive in 2012 would be diagnosed with prostate cancer in their lifetime? (We adjusted for overall changes in life expectancy.)

Critically, the death rate from prostate cancer in 2012 is no worse than in 1982, so extra diagnoses in 2012 were likely to be cancers that would never have become symptomatic.

Thousands affected annually

We found that 41 percent of currently detected prostate cancers would never have become apparent in 1982 – they were “overdiagnosed”.

That means around 8,000 men per year in Australia are diagnosed and treated for something that never would have become a problem.

If they had lived in 1982, these 8000 men a year would not have been given a PSA test, and would have lived out their entire lives never knowing that they had ‘prostate cancer’, and never experiencing any symptoms.

The figure below sets out these numbers: over the lifetime of 100 men, over 50 will develop cell changes that will look like prostate cancer, but only 12 of those men would ever develop symptoms.

Of those 12 men, 3 will eventually die of prostate cancer and 9 others will develop symptoms that mean they are diagnosed with prostate cancer but do not die of it.

Of the other 38 men who develop cell changes that look like prostate cancer, PSA screening detects 8 extra men (in 2012) with dormant cancers that never would have caused a problem, while 30 more could have a ‘cancer’ detected at autopsy but never would have had symptoms.

Consequences of overdetection

As you might guess, this all creates a dilemma for screening.

Screening is no guarantee of saving the 3 in 100 – the large trials suggest repeated screening might save fewer than 1 of the 3 men who would otherwise die (but the evidence on this is uncertain), but we will also overdetect and treat men with surgery and/or radiation who never would have had a problem.

A few years ago we asked a community “jury” of men – who spent a weekend going over the pros and cons – whether Australia should have a prostate screening program.

They said “no”, but that we should better inform GPs so they can inform their male patients about these pros and cons, so the men can make up their own minds.

The problem of overdetection is not just for prostate cancer, but is the Achilles heel of many cancer screening programs.

Thyroid, lung, and breast cancer screening all have a similar problem – though perhaps to a lesser degree than prostate cancer.

This is why many professional bodies, such as the Royal Australian College of General Practitioners, are cautious about screening recommendations.

Their preventive guidelines require clear evidence of benefits that would outweigh any downsides such as overdiagnosis. That leaves only a handful of conditions that are routinely worth screening for.

Challenging common beliefs

Counter to media messages and commonly held belief, earlier is not necessarily better. Timely diagnosis is to be encouraged, but pushing for earlier diagnosis can open a Pandora’s box of “abnormalities” whose behaviour and consequences we don’t understand well enough.

But once detected – as with Andrew – patients are left with the dilemma of constant anxiety or potentially unnecessary surgery and other treatments with side effects worse than the condition itself.

“Early is not necessarily better” may be out of kilter with common beliefs, but patients, doctors, and Health Ministers must understand this evidence, and the limitations of screening if we are to avoid an epidemic of overdiagnosis.

• Wiser Healthcare is hosting the 7th international Preventing Overdiagnosis scientific conference in Sydney, 5-7 December 2019. The conference is co-sponsored by the World Health Organization, and brings world experts to our shores to grapple with this intractable problem. See here for more information and to register.

• Professor Paul Glasziou is director of the Institute for Evidence-Based Healthcare at Bond University.

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This article is part of an ongoing series that is published as a collaboration between Wiser Healthcare and Croakey.org.

The series investigates how to reduce overdiagnosis and overtreatment in Australia and globally. The articles are also available for republication by public interest organisations, upon request.

Bookmark this link and follow #WiserHealthcare on Twitter.

Today, we are launching a new series that investigates how to reduce overdiagnosis and overtreatment in Australia and globally.

It is being published as a collaboration between Wiser Healthcare and Croakey. To follow the TOO MUCH of a Good Thing series, bookmark this link, and follow #WiserHealthcare on Twitter.

Below, Professor Stacy Carter, director of the Australian Centre for Health Engagement, Evidence and Values at the University of Wollongong, explains why overdiagnosis matters, including because of concerns about quality and safety of healthcare, lost opportunity, inequity and squandering precious resources.

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Stacy Carter writes:

Do you care about the quality and safety of our healthcare system? Do news stories about healthcare breakthroughs ever make you raise an eyebrow? Have you ever wondered whether to sign up for a test or a treatment?

Lean in: our new blog, Too Much of A Good Thing, is for you.

At Wiser Healthcare, we are part of a growing international movement of organisations and people concerned about a counterintuitive health problem. Our research aims to understand this problem, and identify proven ways to fix it.

Based in Australia, we are funded competitively through the Australian National Health and Medical Research Council. We are academic and clinical researchers in public health, medicine and allied health, psychology, social science and ethics. We are based at The University of Sydney, Monash University, Bond University and Wollongong University.

So what’s the problem?

Increasingly in health care systems, we don’t know when enough is enough.

That sounds wrong, doesn’t it?

News stories are full of urgent health issues not being addressed, exciting breakthrough treatments that will transform people’s lives, and overloaded health services not providing sufficient care.

The implication is that if we just recognised the seriousness of ill health, invested in ground-breaking technology, and did more, everything would be OK.

What if we told you that this version of events misses an increasingly important issue: that many of us are getting too much healthcare, and this makes things worse instead of better.

Health systems have developed some bad habits. Instead of focusing resources on helping people who are suffering and clearly need care, health systems are:

• Testing healthy people, just in case something might be wrong with them
• Using increasingly sensitive testing technology, so that the slightest change, however inconsequential, will be detected
• Expanding the definition of diseases so that more and more people are diagnosed – often with no obvious benefit to them
• Prescribing drugs to minimise an already small risk of future disease, when those drugs can cause significant, immediate side effects
• Offering high-tech treatments before we know that they are safe and effective, and
• Favouring complex care when simpler approaches would do just as good a job.

These problems are collectively referred to as ‘Too Much Medicine’ , ‘Overdiagnosis and overtreatment’ or ‘Low Value Care’.

Notice that this is not about negligent rogue doctors, or mistakes, or incompetence.

It’s about health services habitually offering interventions that are unnecessary, or that are likely to do more harm than good. And these interventions don’t just cause harm (as serious as that is).

They also use up healthcare capacity that could be better spent on more effective care for people who really need it.

So overdiagnosis is also about lost opportunity, inequity and squandering precious resources.

How can being diagnosed cause me harm?

Isn’t it always better to know if something’s wrong, no matter how minor? Isn’t disease always better out than in? Shouldn’t we all get checked regularly, and treat anything that might possibly be a risk to our future health? Isn’t it better to be safe than sorry?

Not always.

Diseases don’t always get worse or cause symptoms: they can stay the same for decades, or go away by themselves.

Being at risk for a condition does not mean that you’ll definitely develop that condition in future.

And most treatments come with side effects, sometimes very serious side effects. This means that being diagnosed and treated can sometimes cause you more harm than good.

Here’s an example: papillary cancer of the thyroid, the gland that sits in front of your Adam’s apple. There has been a huge recent increase in thyroid cancer diagnoses: 10-fold in some countries. This is mostly due to tiny cancers (less than 2mm) being found via imaging tests like ultrasound or CT scans, often ‘incidentally’ while testing for something else.

There is good evidence that more than 70 percent of these tiny cancers are harmless (some disappear on their own), and that regular monitoring can safely identify those few that need treatment later on.

Despite this, many people are told they have life-threatening cancer (a traumatic experience), and pushed into immediate treatment.

Treatment includes surgery (risking infection, voice problems due to nerve damage, and calcium deficiency due to damage to other glands); some people have to take thyroid hormone tablets for the rest of their lives. These are downsides most people would be willing to tolerate to avoid cancer death.

But in fact most people treated for low-risk micro-papillary thyroid cancer had zero risk of dying from the condition, or even developing symptoms.

They were harmed by unnecessary diagnosis, and so would have been better off if they had not been diagnosed.

Why this series?

In this series, we will highlight research on overdiagnosis, and discuss what it means for the future of healthcare.

We are investigating the extent of overdiagnosis (and how to measure it—a challenge in itself), the causes of overdiagnosis, how overdiagnosis is understood by patients and clinicians, and potential solutions.

We have shown, for example, that:

• About 41 percent of Australian men who have been diagnosed with prostate cancer have been overdiagnosed – which means any treatment those men received was unnecessary treatment;
• If low-risk conditions are given a more ‘medical-sounding’ name, people are more likely to want invasive treatment like surgery (even if this might not be necessary), feel more anxious about the condition and perceive it to be more severe;
• Between a quarter and a third of people who go to a doctor or hospital with uncomplicated low back pain are referred for an X-ray, ultrasound, MRI, CT scan or other imaging, even though evidence shows this won’t help.

Members of Wiser Healthcare (there are almost 90 of us), with our national and international collaborators, are passionate about preventing overdiagnosis. So much so that we spearheaded a National Action Plan, underpinned by a call to action signed by leading Australian organisations like the Consumers Health Forum of Australia, the professional Colleges and Associations of General Practitioners, Physicians, Radiologists, Surgeons, Rheumatologists and Physiotherapists, and Cancer Council Australia.

We are hosting an international conference on Preventing Overdiagnosis in December 2019 at the University of Sydney, co-sponsored by the World Health Organisation, which includes a free pre-conference ‘Beginners Guide to Overdiagnosis’ seminar you can attend if you’d like to hear more.

Understanding and resisting overdiagnosis is one of the great health puzzles of our time, and an urgent priority.

Join the fight to prevent harm and ensure wiser healthcare: get in touch, come along, and subscribe!

• Professor Stacy Carter is director of the Australian Centre for Health Engagement, Evidence and Values at the University of Wollongong

Acknowledgements: Thanks to Chris Maher, Kirsten McCaffery, Ray Moynihan and Rachelle Buchbinder for their contributions.

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This article is part of an ongoing series that is published as a collaboration between Wiser Healthcare and Croakey.org.

The series investigates how to reduce overdiagnosis and overtreatment in Australia and globally. The articles are also available for republication by public interest organisations, upon request.

The series is published on the Wiser Healthcare and Croakey websites. Bookmark the links and follow #WiserHealthcare on Twitter.