Too much of a good thing
Too much of a good thing is a blog 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.
TOO MUCH of a good thing: should the Queen go for breast screening?
In the article below, University of Sydney Public Health Professor Alexandra Barratt explores the contention around the AgeX trial, the biggest randomised trial ever, which is considering how long should older women continue to be screened for breast cancer.
It 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.
To follow the series, bookmark this link, and follow #WiserHealthcare on Twitter.
Alexandra Barratt writes:
As you read over the Queen’s Birthday Honours list this weekend, and perhaps admire the longest reigning British monarch ever, might you wonder whether Her Majesty has regular mammograms for breast screening?
If you did, the answer is ‘probably not’ as the Queen is aged over 90 years and the United Kingdom National Health Service breast screening program offers standard screening to women between the ages of 50 and 70 years.
But what if she were in her 70s or even her 80s? Should she still have a screen? If something was found, would she live long enough to see the benefit of early detection, or would she just experience the more immediate traumas of surgery, radiotherapy and hormone therapy?
This is the question which the AgeX trial, the biggest randomised trial the world has ever seen, is trying to answer: How long should older women keep going for breast screening?
Originally planned to offer just one more screen to English women over 70 years of age, AgeX is now inviting women for up to 3 more screenings through to age 79. That’s five years longer than the current Australian breast screening program which invites women from 50 to 74 years of age.
With a planned sample size of “at least 6,000,000” (yes you read that right, at least SIX MILLION women) this cluster randomised trial “will assess reliably the risks or benefits” of extending screening past 70 years of age. The trial was set up in 2009-2010 to inform screening policy because of uncertainty about the advantages and disadvantages of screening beyond 70 years, amid growing interest in screening longer as life expectancy increased for English women.
A gift to women?
The AgeX trial is a rare and laudable example of rigorous policy testing. It stands in stark contrast to the 2013 Australian extension of the upper age of breast screening from 69 years to 74 years without setting up any comparable study to assess the impact of the policy change. AgeX should be a gift to women the world over by providing much needed evidence about screening in the modern world.
But the AgeX trial has been repeatedly criticised over its design, cost, potential harm to participants, and, most vehemently, over its ethics.
One of the key grounds for concern is the harm that breast screening causes older women through overdiagnosis and overtreatment. Overdiagnosis happens when indolent (i.e. inactive) cancers are detected by screening, but they wouldn’t have caused any harm within the woman’s remaining lifetime had they been left undetected and untreated.
The UK’s own independent review in 2012 found the risk of overdiagnosis and overtreatment was the major downside of screening.
Older women are less able to tolerate surgery and other cancer treatments than younger women, so overdiagnosis and overtreatment have a greater impact on their quality of life. Their higher risk of having, and dying from, other conditions means they’re also more likely to be overdiagnosed in the first place, as well as being less likely to live long enough to benefit from early cancer detection.
A question of consent
Yet, despite older women’s greater risk of being harmed by screening and lower chance of benefiting from it, AgeX is including women (and their medical data) in the trial without their informed consent.
Instead, women in the control arm simply stop receiving invitations after their 71st birthday, while women randomised to the extended screening arm continue to be sent invitations for up to 3 more screens (brief information about the trial is mailed out along with these invitations, but there is no consent process).
So it’s likely that many women are unaware of the risk of overdiagnosis and overtreatment they’re taking by continuing to be screened, and also unaware that they’re participating in a giant experiment. Critics argue that isn’t good enough when the trial itself was designed precisely because the advantages and disadvantages of screening women past 70 years of age are uncertain. More detailed information and an explicit informed consent process is needed, they say.
Complaints are also directed at the analysis. Although the information for women reads “This trial will assess the risks of screening in particular, the chances of being diagnosed and treated for a non-life-threatening cancer”, overdiagnosis isn’t mentioned in the protocol and estimating overdiagnosis isn’t part of the analysis plan.
The primary outcome is breast cancer mortality. All-cause mortality – the outcome that’s crucial for being certain that harms don’t outweigh the benefits of screening – will be reported, but the investigators warn there probably won’t be sufficient statistical power to detect a significant effect as most deaths will be from causes other than breast cancer.
So it’s anything but clear how AgeX is going to measure reliably the risks of screening past 70 years of age.
While the cost of AgeX isn’t given in the protocol documents, funding is being allocated by the Department of Health for the additional screenings. The ever-increasing demand for screening is putting the UK breast screening workforce into crisis: “The number and complexity of breast imaging examinations is rising and services cannot cope” says the Royal College of Radiologists.
The additional screenings have flow-on effects too – more women diagnosed with breast cancer means more surgeries, more radiotherapies and other cancer treatments. As well as extra costs, this has put extra load on surgical and oncology staff.
Coronavirus has changed all that, as breast screening – and AgeX – have been put on hold. This could mean that the results of AgeX – which had already been pushed back from the mid to late 2020s – could be delayed further.
No wonder this trial keeps on whipping up a storm. And it doesn’t look like there will be evidence-based information to guide older women, and possibly Her Majesty, in deciding when to stop screening anytime soon.
Alexandra Barratt (MBBS, MPH, PhD) is a Professor of Public Health in the School of Public Health, University of Sydney. She has a background in epidemiological research spanning clinical epidemiology and public health epidemiology. She is recognised internationally for her research to quantify the benefits and harms (including overdiagnosis) of cancer screening, particularly breast cancer screening. She is a lead investigator on Wiser Healthcare, an NHMRC funded research collaboration to reduce overdiagnosis and overtreatment in healthcare. Overdiagnosis is one of the biggest drivers of iatrogenic harm, waste and opportunity cost in healthcare and is a serious challenge for citizens, patients and healthcare services around the world.
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.
Too Much of Good Thing: Tackling medical excess remains a huge priority
In the article below, Dr Ray Moynihan explores some of the reasons why tackling the complex problem of too much medicine remains a big priority in the COVID era.
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.
To follow the series, bookmark this link, and follow #WiserHealthcare on Twitter.
Ray Moynihan writes:
A couple of weeks back, in the midst of the global pandemonium, there was one particularly surreal moment. A colleague had emailed me about a new opportunity to apply for research funding.
Nothing out of the ordinary there. As an academic researcher, those opportunities are my bread and butter, and they always generate great interest. This call for research proposals though turned out to be truly extraordinary.
While thousands were dying, health systems were flailing and economies folding, Britain’s biggest medical research funding body had released a new call for research titled “reducing overtreatment.”
More specifically the National Institutes for Health Research was calling for proposals to study “the evaluation of strategies and interventions to identify and de-intensify overtreatment.”
An initial reaction
As someone deeply engaged for a long time with the problem of too much medicine, my initial reaction was unexpected. The call for research on overtreatment somehow felt wrong. It seemed like a disrespectful distraction from the urgent need to respond to the pandemic.
Surely this was not the time to be worrying about medical excess. Perhaps anticipating reactions like mine, the funding body had a strong disclaimer up-front.
It stressed that COVID-19 research “should always be the priority” at this time. But then went on to explain that the new call was part of a wider plan “to keep the future research pipeline healthy.”
On further reflection there are of course very strong reasons to continue to investigate and tackle medical excess. Much has changed in recent months.
Yet as with the climate crisis, the facts about too much medicine remain the same. There are reliable estimates, from the United States and from the OECD, that around one in five dollars spent on healthcare is wasted, including on unnecessary tests, diagnoses and treatments.
The problem with overdiagnosis
A key driver of the problem of too much medicine is overdiagnosis, which happens when people receive an unnecessary diagnosis, defined as a diagnosis that will cause them more harm than good.
New Australian research from early 2020 estimates a whopping one in five major cancers may be overdiagnosed cancers.
In other words, those cancers would not have gone on to cause the person diagnosed any harm if they were left undetected. According to that paper – published in the Medical Journal of Australia – around 29 000 Australians may be overdiagnosed with these cancers every year.
Most of them will also be treated unnecessarily, so they will suffer untold harms from the anxiety of a frightening label, as well as the complications of invasive tests and treatments.
The epidemic of unnecessary care
Just last month, as the COVID lock downs took hold in many places, authors of an article in the New England Journal of Medicine reminded us of the epidemic of unnecessary care caused by screening healthy men for prostate cancer, using the PSA test.
“PSA screening represents a textbook case of overdiagnosis and overtreatment in medical care” they wrote.
As they explained, in recent decades in the United States, alongside the many men who have benefited from a screening test picking up a deadly cancer early, “more than a million men were diagnosed with a clinically insignificant ‘cancer’ and received treatment for pathologic findings not destined to cause symptoms or death.”
Alongside the incalculable harm to individuals there is also the massive costs of this problem to health systems. Yet to be calculated in Australia, one estimate from the United States suggested the overdiagnosis of breast cancer alone was costing that nation US$1.2 billion a year.
If you add in the costs from false positives from breast cancer screening, the figure is US $4 billion annually.
And apart from the harm to individuals and costs to health systems, too much medicine is also clearly contributing to excess greenhouse gases, helping to fuel the climate crisis.
Determining harms and costs
There are strong indications that overdiagnosis and overtreatment occurs across many conditions, way beyond cancers. One of the world’s oldest and most prestigious medical journals, The BMJ, is running an on-going campaign to tackle Too Much Medicine.
The campaign has a focus on raising awareness about the problem of overdiagnosis, across a wide range of conditions, from ADHD to gestational diabetes, from osteoporosis to polycystic ovary syndrome.
Often overdiagnosis occurs because definitions of disease have been expanded so much that many healthy people are labelled as sick.
Determining the extent of harms and costs from the overdiagnosis of cancer, and non-cancer conditions, remains a major research question, which will take years to properly answer.
Perhaps more importantly, we also need research to determine the best strategies to wind back all this harmful excess and try to redirect the wasted resources to genuine unmet need.
Thanks in large part to several research grants from the National Health and Medical Research Council, Australia is now at the forefront of research on overdiagnosis internationally.
It was Australia which initiated a new global scientific conference on overdiagnosis, which has become the key forum for discussing the science of the problem and its solutions.
The 8th Preventing Overdiagnosis conference is scheduled to go ahead at Oxford University in September this year, with a special theme on healthcare post-COVID.
A win-win situation
A lack of effective treatments is obviously a huge and on-going challenge in managing COVID-19 right now. But it’s already clear that medical excess is simultaneously a concern, when poorly evaluated, ineffective or dangerous treatments are widely promoted.
More profoundly, as the world seeks ways to fund the extraordinary costs of responding to the pandemic, tackling medical excess may offer a win-win-win situation.
Effectively reducing overdiagnosis and overuse can decrease harm to people, save money for health systems, and wind back healthcare’s contribution to the climate crisis.
Britain’s special call for research on how to reduce overtreatment is perhaps more relevant now than ever.
Dr Ray Moynihan is an Assistant Professor at Bond University’s Institute for Evidence-Based Healthcare, and an NHMRC Early Career Fellow researching overdiagnosis. As a journalist and author, he has published 4 books on the business of medicine.
‘Cancer’: what is really in a name?
We hear increasingly about the importance of tackling overtreatment, but less often about how overtreatment plays out in the lives of patients and their families.
In the article below, Brooke Nickel describes how the use of the word ‘cancer’ can lead to so many issues for people affected, and how it is time to re-think its use.
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.
To follow the series, bookmark this link, and follow #WiserHealthcare on Twitter.
Brooke Nickel writes:
No medical diagnosis has historically evoked such universal fear as ‘cancer’. For decades the word cancer has mostly been associated with intense illness and death. This has been further ingrained in society by public health messaging that cancer screening saves lives, coupled with images of cancer patients undergoing chemotherapy and stories of loved ones struggling with the disease. The clinical definition of cancer underpins this image by describing a disease that, if left untreated, will grow relentlessly and spread to other organs, killing the host. For some, this is the unfortunate reality. However, over the past few decades, our understanding and knowledge of cancer have progressed.
Now, the evidence indicates that some low risk cancers are non-growing or so slow growing that they will never cause harm if undetected and untreated. The strongest evidence for this has been shown in localised prostate cancer, low grade ductal carcinoma in situ (DCIS) of the breast, and low risk papillary thyroid cancer. Evidence has also begun to emerge in melanoma in situ, small lung cancer and certain small kidney cancers. Recent evidence estimates that 1 in 5 major cancers in Australia may have been overdiagnosed between 1982 and 2012. The consequence of overdiagnosing low risk cancer is that the diagnosis can cause more harm than good, through unnecessary stress and anxiety to individuals and their families, unnecessary side-effects associated with surgery or radiation and unnecessary medical costs.
Active surveillance as an option
Given the harms of overdiagnosis and overtreatment of these low risk cancers, active surveillance is now recognised as a safe and effective management option for some cancers. Active surveillance consists of closely monitoring the person affected and only providing treatment if there are changes in test results that show the cancer is getting worse. In localised prostate cancer, active surveillance has been a recommended management option for many years, and in low risk papillary thyroid cancer active surveillance has recently been recommended for very low risk tumours. Trials are currently being conducted across the world to assess active surveillance in low grade DCIS (here, here and here).
Although active surveillance and other more conservative treatments are recommended for the management of some cancers, people have a strong perception that aggressive immediate treatments are always required. It has been shown that the majority of men with localised prostate cancer still prefer radical prostatectomy or radiation therapy, rather than active surveillance to manage their diagnosis. Similarly, in DCIS it has been shown that women are increasingly opting for more aggressive treatments such as mastectomy and bilateral mastectomy rather than lumpectomy, even though these treatments do not improve breast cancer-specific survival.
Assumption that surgery is best
The label ‘cancer’ may make it harder for clinicians to recommend, and for patients to choose, active surveillance as a management option because of an overall strong fear of cancer and the longstanding assumption that aggressive surgery is the best treatment option. This has led to experts in the cancer community to question the label ‘cancer’. Otis W. Brawley, former chief medical officer of the American Cancer Society, has been quoted saying that: “We need a 21st-century definition of cancer instead of a 19th-century definition of cancer, which is what we’ve been using.” Furthermore, the World Health Organisation (WHO) currently states “there is an urgent need to integrate [new understanding of cancer] into cancer classifications internationally.”
Over the past five years our research group has tried to understand how the label ‘cancer’ may impact patients’ experience of diagnosis, psychological outcomes, and, importantly, treatment preferences in the context of the low risk cancers which may never cause harm. Our qualitative work has shown that some patients with very low risk papillary thyroid cancer describe being constantly worried after their diagnosis and treatment, and report continuously thinking that they are going to die. We have also found that patients report wide-ranging quality of life issues related to their diagnosis and treatment across physical, psychological and lifestyle domains. We have conducted a systematic review and two experimental studies (here and here) which demonstrated that use of the label ‘cancer’ in reporting a patients diagnosis (compare to a non-cancer label), significantly increased preferences for invasive surgery as treatment compared to active surveillance, and also significantly raised levels of anxiety, and willingness to accept more side-effects and harms from treatment.
Re-naming low risk cancers
We recently wrote an analysis article in The BMJ which collated some of the above evidence and proposed renaming and re-classifying low risk cancers for which there is evidence of overdiagnosis and calls from international experts to change the terminology and definition of cancer. Historically, there are some precedents for removing the label ‘cancer’ and re-classifying conditions where tumours have clearly been shown to be indolent and unlikely to cause harm. These include in 1998 in low risk bladder cancer, in 2001 in low grade cervical cancer cells, and more recently in 2016 for a variant of papillary thyroid cancer.
While a system-wide change for a number of other low risk cancers has and will create controversy, and will take time, we are now trying to understand what the community thinks of the idea of renaming and reclassifying low risk cancers by conducting community juries (a deliberative democratic method). We are also trying to work with pathologists to understand and consider re-calibrating diagnostic thresholds and/or alternative labels for low risk cancers.
There is no easy solution, so for now we should all be aware that for some the label ‘cancer’ may be doing more harm than good.
Dr Brooke Nickel is a Postdoctoral Research Fellow in The University of Sydney School of Public Health. Her research focuses on understanding the psychosocial impact of cancer diagnosis and treatment, and how to improve cancer communication and decision making.