Monthly Archives: September 2012
6 September 2012, 2.33pm AEST
Medical test results – why no news doesn’t mean good news
In health care, communication can be a matter of life or death. Take the case of an American woman diagnosed with a blood clot in her leg. She died suddenly of a pulmonary embolism the following day, while both a faxed and emailed report of her life-threatening condition sat unread in her doctor’s surgery…
Senior Research Fellow at the Centre for Health Systems and Safety Research, Institute of Health Innovation at University of New South Wales
Joanne Callen receives funding from the Australian Research Council (ARC) – ARC Discovery Project DP120100297 (‘Can technology make communication in complex systems safer and more efficient? evaluation of an electronic test management system in health-care’); ARC Linkage Grant (LP0989144) (‘Use of information and communication technologies to support effective work practice innovation in the health sector: a multi-site study’).
The Conversation provides independent analysis and commentary from academics and researchers.
We are funded by CSIRO, Melbourne, Monash, RMIT, UTS, UWA, Canberra, CDU, Deakin, Flinders, Griffith, La Trobe, Murdoch, QUT, Swinburne, UniSA, UTAS, UWS and VU.
Nph4dy9d-1348624306 A new review of international studies shows up to 62% of lab tests and 36% of radiology tests aren’t reviewed by doctors. It is believed the rate may be similar in Australia. Waiting room image from shutterstock.com
In health care, communication can be a matter of life or death. Take the case of an American woman diagnosed with a blood clot in her leg. She died suddenly of a pulmonary embolism the following day, while both a faxed and emailed report of her life-threatening condition sat unread in her doctor’s surgery.
A complex medical malpractice case, initiated in 2008 and still in the US courts, revealed that her frustrated radiologist hung up when he got the doctor’s answering service without leaving a message. An administrator at the medical practice received the emailed and faxed results and notified the doctor they were in – but not that they were urgent and that no one had read them.
Consequently, no potentially life-saving anti-coagulant treatment was initiated.
Much of the interest around the case lies in determining who is at fault and, especially, in any monetary damages which will eventually be awarded to the woman’s family. But what is so striking is just how ordinary the events were that led to such a catastrophic outcome, and how easily such vital chains of communication can break down.
So much so, that the failure to follow up test results is an increasingly serious patient safety issue around the world.
The results of our systematic review of the best evidence available internationally found up to 62% of laboratory tests and up to 36% of radiology tests for patients attending GP clinics and hospital outpatient departments are not reviewed by doctors. This includes tests that are returned positive for cancer cells.
The findings are published in the current edition of the Journal of General Internal Medicine.
The potential for harm if a critical diagnosis is overlooked is obvious. For every single patient admitted to hospital in Australia, for example, an average of 100 tests are performed.
Yet, there is not a single law or regulation requiring health care professionals to follow up results in Australia. Patients often rely on the assumption that “no news is good news” when, in fact, no news may mean the results are languishing in the email inbox or the in tray.
What might outcomes be, then, if the mysterious world of pathology and radiology was suddenly thrown open?
What if labs and radiology departments phoned or sent through test results in clear, simple to understand terms directly to the person who has the most at stake: the patient, or his or her immediate carer?
In many health systems, including Australia’s, this would be a big cultural change.
Many doctors don’t know who is ultimately responsible for patients not receiving test results. Doctor image from shutterstock.com
Our related recent research into the views of Australian emergency doctors at one major hospital found 21.2% believed they had missed a test result themselves over the past year, leading to a delay in treatment. And 47.4% believed a colleague had missed a test results. Half the emergency doctors didn’t know who was ultimately responsible if a result was overlooked, but only half would be comfortable if patients received their results directly.
The medical profession’s reluctance is based mainly on reasonable fears of triggering anxiety, panic or confusion among a public that is mostly unqualified to read lab and radiology reports. Certainly, the way results are presented would need to change and support services would have to be put in place.
It might, however, be as simple as a “your results require follow up” email, followed by a “what to do now” click-through link or directions to a phone information and counselling service.
Technology offers potential new solutions, such as the electronic tracking of results to ensure that they have not only been seen but that they have been “actioned”, with follow-up documented.
Patients, too, could simply be given direct access to their health records online, something which is increasingly feasible as people opt in to electronic health records systems around the world, and in Australia.
No single solution will protect all patients; health care systems and the communications chains they require are extremely complex. This means critical information can fall through the cracks despite the best efforts of individuals.
Medical tests cost about $1 billion a year. Flickr/drhenkenstein
But, there is a known danger in the status quo. Although our systematic review relied on data from the United States, where most research is being undertaken, it is fair to assume the risk of harm in Australia is much the same, given strong anecdotal evidence and the similarities of the health care systems.
In the US, all mammogram results have been reported directly to patients since national legislation was introduced in 1998. And increasingly, US radiology practices are voluntarily communicating results directly to patients with positive feedback. This suggests many people are, in fact, willing and able to take more responsibility for their own health.
In Australia, we need to consider every option. Given the huge and rising costs of medical testing and the consequences of delayed treatment in terms of both patient suffering and health care dollars, there is good reason to act urgently.
Australia has many excellent health-care providers with very good follow-up processes. Many test results are completely normal and so the failure to follow-up has no impact at all.
But just one record left unread is a potential personal tragedy if it means critical care is not delivered in time.
My Comment: Most of my patients have tests of one sort or the other, mostly of hormone levels. I request patients follow this up with a consultation, so that I can discuss them and make sure the correct treatment is given. Sometimes, I may order X-rays or ultrasounds, with requests for the X-ray clinic to return the tests results to me by email and/or Fax.
Sometimes this does not happen, or the results go astray. I will then be unaware that the tests had been done, and what is the result. The patient may assume I have received them, and you may not hear from me, assume all is well. That is why I ask patients to make sure I have received the results of all tests done. If you are booked in to see me for the results, then that wont be necessary of course. An email to confirm that I have seen the results is a very simple and satisfactory way of doing this.
Annabelle (6) stayed over (school holidays) When I put on my tie to go to work, she said” Granddad, you can’t wear a PINK tie!” When I asked why not, she said” Men don’t wear pink – that is for girlie-girls”
I posted yesterday’s story because I have first hand knowledge of how medical care can vary in medical practices and in hospitals. I have worked with some very incompetent doctors in my time, and have felt sorry for their patients. As I tell my family – don’t be afraid to ask questions. Get second opinions if necessary before making a major decision. Transparency is important, so ask to see what they have written about you, and what is on any letter to a 3rd party. My computer screen in my consulting room is tilted so my patients can see every word about them I write. That allows them to correct anything that is not absolutely correct. All doctors should do this. Mistakes happen, doctors get tired, staff get tired and an error gets compounded along the way. When my son was having an operation, I noticed that the medication he was on was twice the correct dose. The nurse had written 1/2 gm instead of 1/4 gm. The result was that he was getting a toxic dose that could have caused permanent ear damage. It was only my medical knowledge that alerted me to the fact of the overdose, and the fact that I checked everything the doctors and nurses did. Those without medical nous would have missed this, and the resulting damage may have been covered up by the people involved.
Message: Be vigilant. Check everything.
By MARTY MAKARY
When there is a plane crash in the U.S., even a minor one, it makes headlines. There is a thorough federal investigation, and the tragedy often yields important lessons for the aviation industry. Pilots and airlines thus learn how to do their jobs more safely.
The world of American medicine is far deadlier: Medical mistakes kill enough people each week to fill four jumbo jets. But these mistakes go largely unnoticed by the world at large, and the medical community rarely learns from them. The same preventable mistakes are made over and over again, and patients are left in the dark about which hospitals have significantly better (or worse) safety records than their peers.
As doctors, we swear to do no harm. But on the job we soon absorb another unspoken rule: to overlook the mistakes of our colleagues. The problem is vast. U.S. surgeons operate on the wrong body part as often as 40 times a week. Roughly a quarter of all hospitalized patients will be harmed by a medical error of some kind. If medical errors were a disease, they would be the sixth leading cause of death in America—just behind accidents and ahead of Alzheimer’s. The human toll aside, medical errors cost the U.S. health-care system tens of billions a year. Some 20% to 30% of all medications, tests and procedures are unnecessary, according to research done by medical specialists, surveying their own fields. What other industry misses the mark this often?
It does not have to be this way. A new generation of doctors and patients is trying to achieve greater transparency in the health-care system, and new technology makes it more achievable than ever before.
I encountered the disturbing closed-door culture of American medicine on my very first day as a student at one of Harvard Medical School’s prestigious affiliated teaching hospitals. Wearing a new white medical coat that was still creased from its packaging, I walked the halls marveling at the portraits of doctors past and present. On rounds that day, members of my resident team repeatedly referred to one well-known surgeon as “Dr. Hodad.” I hadn’t heard of a surgeon by that name. Finally, I inquired. “Hodad,” it turned out, was a nickname. A fellow student whispered: “It stands for Hands of Death and Destruction.”
Leonard Mccombe/Time Life Pictures/Getty Images; Photo Illustration/The Wall Street Journal‘Doctors absorb an unspoken rule: to overlook the mistakes of our colleagues.’
Stunned, I soon saw just how scary the works of his hands were. His operating skills were hasty and slipshod, and his patients frequently suffered complications. This was a man who simply should not have been allowed to touch patients. But his bedside manner was impeccable (in fact, I try to emulate it to this day). He was charming. Celebrities requested him for operations. His patients worshiped him. When faced with excessive surgery time and extended hospitalizations, they just chalked up their misfortunes to fate.
Dr. Hodad’s popularity was no aberration. As I rotated through other hospitals during my training, I learned that many hospitals have a “Dr. Hodad” somewhere on staff (sometimes more than one). In a business where reputation is everything, doctors who call out other doctors can be targeted. I’ve seen whistleblowing doctors suddenly assigned to more emergency calls, given fewer resources or simply badmouthed and discredited in retaliation. For me, I knew the ramifications if I sounded the alarm over Dr. Hodad: I’d be called into the hospital chairman’s office, a dread scenario if I ever wanted a job. So, as a rookie, I kept my mouth shut. Like the other trainees, I just told myself that my 120-hour weeks were about surviving to become a surgeon one day, not about fixing medicine’s culture.
Hospitals as a whole also tend to escape accountability, with excessive complication rates even at institutions that the public trusts as top-notch. Very few hospitals publish statistics on their performance, so how do patients pick one? As an informal exercise throughout my career, I’ve asked patients how they decided to come to the hospital where I was working (Georgetown, Johns Hopkins, D.C. General Hospital, Harvard and others). Among their answers: “Because you’re close to home”; “You guys treated my dad when he died”; “I figured it must be good because you have a helicopter.” You wouldn’t believe the number of patients who have told me that the deciding factor for them was parking.
There is no reason for patients to remain in the dark like this. Change can start with five relatively simple—but crucial—reforms.
Every hospital should have an online informational “dashboard” that includes its rates for infection, readmission (what we call “bounce back”), surgical complications and “never event” errors (mistakes that should never occur, like leaving a surgical sponge inside a patient). The dashboard should also list the hospital’s annual volume for each type of surgery that it performs (including the percentage done in a minimally invasive way) and patient satisfaction scores.
A survey of New Yorkers found that approximately 60% look up a restaurant’s “performance ratings” before going there. If you won’t sit down for a meal before checking Zagat’s or Yelp, why shouldn’t you be able to do the same thing when your life is at stake?
Nothing makes hospitals shape up more quickly than this kind of public reporting. In 1989, the first year that New York’s hospitals were required to report heart-surgery death rates, the death rate by hospital ranged from 1% to 18%—a huge gap. Consumers were finally armed with useful data. They could ask: “Why have a coronary artery bypass graft operation at a place where you have a 1-in-6 chance of dying compared with a hospital with a 1-in-100 chance of dying?”
Instantly, New York heart hospitals with high mortality rates scrambled to improve; death rates declined by 83% in six years. Management at these hospitals finally asked staff what they had to do to make care safer. At some hospitals, the surgeons said they needed anesthesiologists who specialized in heart surgery; at others, nurse practitioners were brought in. At one hospital, the staff reported that a particular surgeon simply wasn’t fit to be operating. His mortality rate was so high that it was skewing the hospital’s average. Administrators ordered him to stop doing heart surgery. Goodbye, Dr. Hodad.
Imagine that a surgeon is about to make an incision to remove fluid from a patient’s right lung. Suddenly, a nurse breaks the silence. “Wait. Are we doing the right or the left chest? Because it says here left, but that looks like the right side.” The surgery was, indeed, supposed to be on the left lung, but an intern had prepped the wrong side. I was that doctor, and that nurse saved us all from making a terrible error. It isn’t every hospital where that nurse would have felt confident speaking up—but it’s this sort of cultural factor that is so important to safety.
If anyone knows whether a hospital is safe, it’s the people who work there. So my colleagues and I at Johns Hopkins, led by J. Bryan Sexton, administered an anonymous survey of doctors, nurses, technicians and other employees at 60 U.S. hospitals. We found that at one-third of them, most employees believed the teamwork was bad. These aren’t hospitals where you or I want to receive care or see our family members receive care. At other hospitals, by contrast, an impressive 99% of the staff reported good teamwork.
It may come as a surprise to patients, but doctors aren’t very good at complying with well-established best practices in their fields. One New England Journal of Medicine study found that only half of all care follows evidence-based guidelines when applicable. Fortunately, there is a technology that could work wonders to improve compliance: cameras.
CorbisYou wouldn’t believe the number of patients who have told me their deciding factor in choosing a hospital was parking.
Cameras are already being used in health care, but usually no video is made. Reviewing tapes of cardiac catheterizations, arthroscopic surgery and other procedures could be used for peer-based quality improvement. Video would also serve as a more substantive record for future doctors. The notes in a patient’s chart are often short, and they can’t capture a procedure the way a video can.
Doug Rex of Indiana University—one of the most respected gastroenterologists in the world—decided to use video recording to check the thoroughness of colonoscopies being performed by doctors in his practice. A thorough colonoscopy requires meticulous scrutiny of every nook and cranny of the colon. Doctors tend to rush through them; as a result, many cancers and precancerous polyps are missed and manifest years later—at later stages.
Without telling his partners, Dr. Rex began reviewing videotapes of their procedures, measuring the time and assigning a quality score. After assessing 100 procedures, he announced to his partners that he would be timing and scoring the videos of their future procedures (even though he had already been doing this). Overnight, things changed radically. The average length of the procedures increased by 50%, and the quality scores by 30%. The doctors performed better when they knew someone was checking their work.
The same sort of intervention has been used for hand washing. A few years ago, Long Island’s North Shore University Hospital had a dismal compliance rate with hand washing—under 10%. After installing cameras at hand-washing stations, compliance rose to over 90% and stayed there.
Following Dr. Rex’s camera study, he did a follow-up, asking patients if they would like a copy of their procedure video. An overwhelming 81% said yes, and 64% were willing to pay for it. Patients are hungry for transparency.
Sue, a young accountant, came to my office complaining of abdominal pain. She wasn’t sure what was causing it. She offered various theories: “Could this be from my Bikram yoga?” “Did my late-night ice cream cause the pain?” “Does having unprotected sex have anything to do with it?” Throughout her visit, I took notes. When we were done, she looked down at them suspiciously.
She was concerned that I thought she was either nuts or an ice-cream addict. In the course of our conversation, I also learned that she wasn’t quite sure why I was recommending an ultrasound, though I thought I had told her.
I decided to start dictating my notes with the patient listening in at the end of his or her visit. “I also have high blood pressure,” was a correction one older patient blurted out. Another said, “My prior surgery was actually on the right, not the left side.” Another patient interrupted me and said, “No, I said I take 20 milligrams, not 25 milligrams, of Lipitor.” Being able to review your doctor’s notes in writing might be even better than my method, particularly if you could add your own comments, perhaps via the Web.
Harvard doctor-researchers Jan Walker and Tom Delbanco are using “open notes” at Harvard and Beth Israel Hospital in Boston, and my hometown hospital, Geisinger Medical Center in Pennsylvania, has begun giving patients online access to their doctors’ notes. So far, both patients and doctors love it.
Though there are many signs that health care is moving toward increased transparency, there is also some movement backward. Increasingly, patients checking in to see doctors are being asked to sign a gag order, promising never to say anything negative about their physician online or elsewhere. In addition, if you are the victim of a medical mistake, hospital lawyers will make never speaking publicly about your injury a condition of any settlement.
We need more open dialogue about medical mistakes, not less. It wouldn’t be going too far to suggest that these types of gag orders should be banned by law. They are utterly contrary to a patient’s right to know and to the concept of learning from our errors.
Political partisans can debate the role of government in fixing health care, but for either public or private approaches to work, transparency is the crucial prerequisite. To make transparency effective, government must play a role in making fair and accurate reports available to the public. In doing so, it will unleash the power of the free market as patients are better able to take charge of their own care. When hospitals have to compete on measures of safety, all of them will improve how they serve their patients.
Transparency can also help to restore the public’s trust. Many Americans feel that medicine has become an increasingly secretive, even arrogant, industry. With more transparency—and the accountability that it brings—we can address the cost crisis, deliver safer care and improve how we are seen by the communities we serve. To do no harm going forward, we must be able to learn from the harm we have already done.
—Dr. Makary, a surgeon at Johns Hopkins Hospital and a developer of the surgical checklists adopted by the World Health Organization, is the author of “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care,” published this month by Bloomsbury Press.A version of this article appeared September 22, 2012, on page C1 in the U.S. edition of The Wall Street Journal, with the headline: How to StopHospitals From Killing Us.
Understanding weight gain at menopause.
Women’s Health Research Program, Department of Epidemiology and Preventive Medicine, Monash University , Melbourne , Australia.
ABSTRACT Objective The aim of this review was to summarize the literature regarding the impact of the menopause transition on body weight and body composition. Methods We conducted a search of the literature using Medline (Ovid, 1946-present) and PubMed (1966-2012) for English-language studies that included the following search terms: ‘menopause’, ‘midlife’, ‘hormone therapy’ or ‘estrogen’ combined with ‘obesity’, ‘body weight’ or ‘body composition’. Results Whereas weight gain per se cannot be attributed to the menopause transition, the change in the hormonal milieu at menopause is associated with an increase in total body fat and an increase in abdominal fat. Weight excess at midlife is not only associated with a heightened risk of cardiovascular and metabolic disease, but also impacts adversely on health-related quality of life and sexual function. Animal and human studies indicate that this tendency towards central abdominal fat accumulation is ameliorated by estrogen therapy. Studies mostly indicate a reduction in overall fat mass with estrogen and estrogen-progestin therapy, improved insulin sensitivity and a lower rate of development of type 2 diabetes.
Conclusion The hormonal changes across the perimenopause substantially contribute to increased abdominal obesity which leads to additional physical and psychological morbidity. There is strong evidence that estrogen therapy may partly prevent this menopause-related change in body composition and the associated metabolic sequelae. However, further studies are required to identify the women most likely to gain metabolic benefit from menopausal hormone therapy in order to develop evidence-based clinical recommendations.
OVER-DIAGNOSIS EPIDEMIC – In the final instalment of our series, Paul Glasziou talks about the way forward. Over-diagnosis is a significant problem that’s already common in some areas of medicine, such as screening and some mental health conditions. It is a problem now but a bigger threat for the future…
OVER-DIAGNOSIS EPIDEMIC – In the final instalment of our series, Paul Glasziou talks about the way forward.
Over-diagnosis is a significant problem that’s already common in some areas of medicine, such as screening and some mental health conditions. It is a problem now but a bigger threat for the future: better imaging technologies, more biomarkers, more genetic tests and so on, will gradually expand the amount of over-diagnosis that’s possible.
There are several drivers for over-diagnosis. Of course there’s screening and new screening methods, but there are also areas that are not technology-driven. For instance, the diagnostic criteria in psychiatry where the changing definitions of mental illnesses have expanded the number of children and adults classed as having a mental illness.
A slippery slope
An interesting example of how over-diagnosis thrives was presented in a recent issue of the British Medical Journal (BMJ). Researchers did a study of magnetic resonance imaging (MRI) scans on people’s knees. Participants were middle-aged or elderly people. The study authors discovered that most people with knee symptoms had some sort of abnormality in their knee.
But then they also did a series of MRI scans on people with no symptoms at all, and discovered that about 85% of them had some sort of abnormality in their knee as well. So we can imagine a person with some minor symptoms getting an MRI scan done and discovering something that actually had nothing to do with their exact symptoms.
These new diagnostic technologies are one cause of the increasing rates of over-diagnosis. Our ability to detect earlier means that we’re going to detect disease in more people, some of whom would never have been disturbed by their apparent “disease”. A prime example of this dilemma is prostate cancer where if you looked carefully enough, you’d find around 70% of 70-year-olds have something a pathologist looking at under a microscope might call a prostate cancer. But most of those so-called cancers would never disturb the man in his lifetime.
Part of the problem is our ignorance about natural variation that were difficult to examine in live people. But technology such as MRI scans now makes that easier. But we discover things that surprise us, such as a large proportion of people have abnormalities. A lot of abnormalities are more normal than we expected. No one body is ideal – so someone many years ago said that “a normal person is someone who just hasn’t had sufficient tests”.
The first step to reducing the epidemic of over-diagnosis is raising awareness of the problem and its drivers (that’s partly what our conference next year is about). The next step will be to understand how the health care system develops these over-diagnoses and where they arise from, so we can try to improve the process by which that happens.
There isn’t a single simple solution to this complex problem. One piece of our work is to break down and sub-divide the problem of over-diagnosis – to understand the different causes and categories and how one might approach each.
The first article in this series discussed the three different categories of over-diagnosis. For screening, the best probable solution is that you develop cures for the diseases. We don’t screen for testicular cancer, because the cure rate is now so high that screening is not necessary. When we get to close to 100% cure rates for cancers, we won’t need to screen at all.
The second problem is changing disease definitions. Where we drop the diagnostic threshold, we get milder forms of disease – where people benefit less but still get an equal amount of harm from treatment and labelling. Eventually we get to such mild conditions that the likely adverse affects outweigh any benefits. For diseases defined by moveable thresholds we need to have an internationally agreed set of rules about when you change or lower thresholds.
At the moment, there isn’t a clearly laid out international agreement. Usually a steering committee gets together and decides that change a disease definition is appropriate but it does so without clear guiding principles. The groups that define what a disease is needs to have people with appropriate expertise involved, and we need to set some clear guidelines about the constituency of such committees. You need medical expertise but you also need other types of expertise that generally aren’t in these committees, for example, epidemiologists, consumer representatives, and perhaps sociologists. And you also need a minimal, or no, conflicts of interest in those groups.
The third category was the creation of new diseases. About four new diseases are being defined every week. In fact, most diseases were probably defined or described in the last century; we’re rapidly increasing the number of conditions we classify as disease. Most of these are legitimate but there are some that are probably less legitimately defined. We need to come to some agreement about what really constitutes a disease, and that’s particularly important for mental health conditions.
Over-diagnosis is consuming huge resources. It is shifting our attention from very ill people who really need the miracles of modern medical technology, and distracting us with conditions and interventions that provide marginal benefit, no benefit, or even net harm, as we move diagnosis towards milder forms of illness.
This series has been a great start for creating some awareness of the problem of over-diagnosis, but clearly it’s just a start. There needs to be a much wider awareness and attention given to this as a growing problem within medicine, because it has implications for the whole future and affordability of medicine.
This is final part of our series on over-diagnosis, click on the links below to read other articles:
OVERDIAGNOSIS EPIDEMIC – Today, Stacy Carter presents a philosophical view of over-diagnosis and what can be done to change how things stand. Recently a friend told me a story about her dad. Fit and well, he had a PSA test during a general medical check-up. The PSA test is controversial: many, including…
OVERDIAGNOSIS EPIDEMIC – Today, Stacy Carter presents a philosophical view of over-diagnosis and what can be done to change how things stand.
Recently a friend told me a story about her dad. Fit and well, he had a PSA test during a general medical check-up. The PSA test is controversial: many, including its inventor, say it should never be used to screen for cancer.
My friend’s dad’s PSA test started him on a path to prostate cancer diagnosis and surgery. The surgery made him incontinent. Humiliated by accidents, he couldn’t be far from a toilet so could no longer coach soccer or go on his daily long walk with friends. He became socially isolated and sedentary. He put on weight. And he developed diabetes.
Now his health is worse, but it’s not only his health that has been affected. Other aspects of his well-being – attachment to his friends and the ability to live the life he wants – have been undermined. His story is, sadly, not unusual, except for one thing.
The hospital where he was treated called him in to apologise for operating unnecessarily and harming him. Both he and his clinicians concede he was over-diagnosed (the disease would not have produced symptoms or shortened his life) and over-treated (he received treatment he didn’t need.)
The popularity of screening
In one British study, men described turning up to their GP determined to have a PSA test. In an Australian one, women worried that expert disagreement on PSA testing might discourage men from being screened. Most respondents to a US survey were enthusiastic about cancer screening, with 73% saying they’d rather have a full-body CT scan than $1,000 cash. Many thought it was irresponsible for healthy adults to avoid cancer screening.
We’re not just willing to go fishing for diseases. Some of us think it’s a moral obligation. And this is not surprising given two commonly accepted characteristics of contemporary Western society: we expect to be able to predict and control the future, and we tend to see health as an individual responsibility.
Benefits and harms
Moral obligation is the territory of ethics. So how should we think about the ethics of over-diagnosis in healthy people?
We need to start by weighing benefits against harms, but this is harder than it seems.
The benefits of tests and treatments are often overstated (so straight-talking interpretations like these are invaluable). Evidence is contested, uncertain and incomplete. Harms, in particular, are under-studied, and they’re not only physical.
If we are diagnosed (say, with cancer), we see ourselves differently. And a diagnosis can affect future generations. A cancer diagnosis in a parent can mean their child is declared “high risk” for developing cancer, potentially changing his or her medical care, insurance status, and self-concept for life.
Sometimes doctors or policymakers impose these harms on us, but not always. If patients demand tests or treatments, clinicians must trade-off possible harms against their duty to respect the choices and goals that matter to us. When decision-makers try to reduce harms by limiting services, they are often met with community outrage.
This passion is understandable. Unlike my friend’s dad, most over-diagnosed and over-treated people falsely believe they were saved from death by timely intervention. So it makes sense that they would altruistically defend others’ right to be saved.
We’re all in this mess together: trying to be good citizens, control the future, and wrestle with the uncertainty of science. It’s a difficult challenge, but it’s not impossible.
In 2007 in New Zealand, researchers gathered 11 women aged 40 to 49 together to consider the evidence on mammographic breast cancer screening in women their age. At the beginning, all 11 women supported screening. After two days of briefing and deliberation, ten out of 11 were against. We can’t replicate this process for everyone and every test, but it shows the power of good information and reasoned debate.
So what should we do? It depends on the disease and the treatment, and so on the evidence, however uncertain. But it also depends on our vision of a good society.
Over-diagnosis and over-treatment have arisen mostly from a high-tech chase after ever-more-finely-dissected risks in healthy individuals. There’s increasing concern that this chase is doing little for our health, and that the good it does is at the expense of people like my friend’s dad.
It’s not just these active harms we should worry about. We should also be concerned about the opportunity costs. We’ve known for decades that the best way to improve health is to improve the basics, like the food supply, the built environment, and the fairness of our social and economic systems. Changes like these are good for everyone’s health, and especially for the health of the least well off.
And such changes can only be achieved through collective effort. Perhaps the solution to over-diagnosis and over-treatment includes changing the way we think about ourselves: less as individual disease time-bombs, and more as members of a community, with a shared responsibility to work together to make it easier for everyone to be healthy.
OVER-DIAGNOSIS EPIDEMIC – We kick off the second week of this series with Jenny Doust looking at some drivers of over-diagnosis in general practice. It’s easy to dismiss general practice as being about minor illnesses requiring little clinical acumen. We see patients with the common symptoms of life…
We are funded by CSIRO, Melbourne, Monash, RMIT, UTS, UWA, Canberra, CDU, Deakin, Flinders, Griffith, La Trobe, Murdoch, QUT, Swinburne, UniSA, UTAS, UWS and VU.
OVER-DIAGNOSIS EPIDEMIC – We kick off the second week of this series with Jenny Doust looking at some drivers of over-diagnosis in general practice.
It’s easy to dismiss general practice as being about minor illnesses requiring little clinical acumen. We see patients with the common symptoms of life – coughs, fevers, backache and abdominal pain. Most of these are transitory and, for the large proportion, medical intervention makes little difference.
The diagnostic skills of a general practitioner, however, need to be as acute as those of House MD. Among all the children we general practitioners see with diarrhoea, we need to be able to pick the one with Crohn’s disease requiring urgent surgery. Among all the women who complain of feeling tired, we need to isolate the one who has life-threatening Addison’s disease. And among all the teenagers with flu-like symptoms, we need to find the one with a lymphoma in his chest.
These are all patients I have seen during my time as a general practitioner and they remind me constantly to take every person who walks through my door seriously.
The most common reason general practitioners are sued is because of missed diagnoses. Missed diagnoses also invoke a strong sense of professional failure. So how can general practitioners manage in this sea of uncertainty?
One way is to perform more tests. This is also popular with patients, who perceive that tests ensure nothing serious is missed. What is not well understood by patients (and sometimes also by clinicians) is the potential harm from testing.
The most obvious harm is the cost and resources required; we would quickly overwhelm the health system if we performed an MRI on every patient with back pain. A strong system of primary care results in a health-care system that’s both more efficient and less costly because primary-care physicians are skilled at filtering those with severe disease needing further tests, from those with self-limiting illnesses.
But even in Australia, with its highly trained general practice workforce, this skill is often under-appreciated.
Harms of testing
Less well understood are the harms due to the inherent inaccuracy of testing. By the laws of statistics, when the likelihood of a disease is very low, most positive test results will be false positives. We see this most clearly in screening programs, where most abnormal screening results will not have the disease on follow-up testing. This causes only minor harm if there is a follow-up test. But it is of much greater consequence if tests are assumed to be accurate and too much faith is put in the results.
The greatest harm from the increased use of testing, however, is not costs, resources or false positives. Rather, it’s the problem of over-diagnosis.
Clinicians and patients both believe that finding a disease earlier in its process means it will be more successfully treated. But there’s increasing evidence that finding disease early or at a milder stage has paradoxical harmful effects, even reducing survival and quality of life.
Wider availability of more sophisticated tests results in “incidentalomas”, incidental findings that would not have otherwise been diagnosed. The detection of thyroid cancers, for instance, has more than doubled in the past 30 years. But most of these diagnoses are incidental findings from imaging.
If the earlier detection of these cancers improved prognosis, you would expect to see a decline in the mortality rate from thyroid cancer. But the mortality rate has sadly been constant in this time.
Even more problematic is the widening of the definition of diseases and the lowering of disease thresholds. Examples of expanding definitions include chronic kidney disease, diabetes, and even the diagnosis of cancers, such as breast and bladder cancer.
We assume patients who are now included in the wider definition benefit from treatment as much as those using the old definition. In fact, we are likely to believe that they will benefit more as we have caught the disease early. But all medical treatments cause harm. And when patients with milder disease are treated, it becomes more likely that the potential harm of medical treatment will outweigh the benefits.
Wider disease definitions become self-reinforcing – we find more and so we test more. And because we have now included milder patients in our disease group, we are misled by the perceived improvement in patient survival and the reduction in disease complications in our new patient group.
Right now, we are in the midst of a perfect storm – a population that is increasingly anxious about health, doctors who don’t want to miss a diagnosis, a pharmaceutical industry that profits from widening the definitions of disease and a health system that rewards over-testing and fails to acknowledge the harms that can result from it.
We have set up a group to look for solutions to this problem, including a conference in 2013, but the answers are far from clear. Given the pervasive nature of over-diagnosis, solutions will need to involve all layers of the health-care system, including policy makers and key clinical opinion leaders.
As a general practice physician, I am hoping we will be able to spend less time labelling patients with an ever increasing number of “diseases” and to spend more time working with them on solving their health problems.
PSA screening and prostate cancer over-diagnosis
OVER-DIAGNOSIS EPIDEMIC – We finish our first week of this series with Robert Burton, Christopher Stevenson and Mark Frydenberg examining prostate cancer screening. Scientific oncology started with the creation of the modern microscope, which provided the basis for the modern pathologic study of cancer…
OVER-DIAGNOSIS EPIDEMIC – We finish our first week of this series with Robert Burton, Christopher Stevenson and Mark Frydenberg examining prostate cancer screening.
Scientific oncology started with the creation of the modern microscope, which provided the basis for the modern pathologic study of cancer in the late 19th century, and established the “fatal cancer” myth. As [one researcher] arguing (http://www.guardian.co.uk/commentisfree/2011/aug/02/breast-cancer-screening) against breast cancer screening put it, “since then, without pause for thought, the microscopic identification of cancer according to the classic criteria has been associated with the assumed prognosis of a fatal disease if left untreated.”
Earlier this week, an article in this series looked at the adverse effects of breast cancer screening. Today, we will examine the role of screening in the over-diagnosis of prostate cancer.
The fatal cancer myth began to unravel a century later. A 1993 study for instance, noted that prostate cancer was unique because “the frequency of histologically (pathologically) confirmed invasive cancer at autopsy greatly exceeds the prevalence of clinically significant carcinoma during life.”
The authors then affirmed that in no other malignancy was there such a vast reservoir of undetected cases that may never be clinically significant or cause death. They also noted that up to 40% of all men might be treated for prostate cancer but only 8% would ever have a cancer large enough to be diagnosed and only 3% would die of it.
Over-diagnosis of cancer is the detection of asymptomatic cancers that will not become clinically significant and cause disease or death in the patient’s lifetime. How many men have prostate cancer that might never come to light without screening and are therefore at risk of over-diagnosis?
A 2010 review of a 1996 study found that microscopic asymptomatic prostate cancers had been detected in 525 men of various ages killed in motor vehicle accidents in the United States (U.S). The findings indicated that this type of cancer could affect approximately a third of American men aged 30 to 39 years, increasing to about 70% at age 70 to 79 years.
Looking at these figures, together with similar autopsy studies, the authors of the review concluded prostate cancer was likely detectable in between 30 to 70% of men over 60 years old.
And a 2009 Australian study of prostate tissue, sampled from 133 cadavers referred for coronial autopsy, found invasive prostate cancer in about a quarter of the 70 men aged 50 or more years.
It seems over-diagnosis of prostate cancer was already inevitable by the time the Prostate Specific Antigen (PSA) blood test was introduced for prostate cancer screening in Australia in the late 1980s, because it could detect cancers that had previously gone undiagnosed.
Winds of change
In July 2012, the U.S. Preventive Services Task Force (USPSTF) found that “The mortality benefits of PSA-based prostate cancer screening through 11 years are, at best, small and potentially none, and the harms are moderate to substantial”. The task force recommended against PSA-based screening for prostate cancer, stating that the recommendation applied to men in the general U.S. population, regardless of age.
The recommendation was based on an analysis of the evidence from trials of PSA screening in the U.S. and Europe, but mainly on the 2009 report of the European randomised controlled trial (RCT), where 182,000 men aged 50 to 74 years from seven European countries were randomised to either PSA testing every two to seven years or to usual care.
This report was updated in 2012 with an average follow-up of 11 years. It found a statistically significant reduction (21%) in prostate cancer mortality in the population of men invited to screen and a 29% reduction in those who were actually screened.
But this reduction in mortality came at a cost. The authors reported that to prevent one death from prostate cancer at 11 years follow-up, 1,055 men would need to be invited for screening and 37 cancers would need to be detected. The USPSTF also noted that there was convincing evidence PSA-based screening led to substantial over-diagnosis of prostate tumours.
The amount of over-diagnosis of prostate cancer is an important concern because men with cancers that would remain asymptomatic for the remainder of their lives cannot benefit from screening or treatment.
Based on our analysis of trends in prostate cancer incidence (new cases per year) since PSA testing began in the late 1980s, over 75,000 Australian men who might never have known they had prostate cancer may have been turned into prostate cancer patients, possibly for only a small benefit.
At the same time, the men were exposed to the potential harms (incontinence, impotence) of unnecessary treatment. These harms can be avoided if the prostate biopsy shows that they have low-risk disease and are then managed by active surveillance, rather than immediate treatment of their cancer.
Deaths from prostate cancer have fallen by approximately 13,000 during that same time. Some men can be saved by early detection and treatment but others clearly do not benefit.
Performing PSA tests on everyone leads to substantial over-diagnosis. But not performing PSA tests at all would inevitably lead to under-diagnosis of some men who may have been cured by early detection and treatment. Before consenting to undergo PSA screening, men should understand that while there are possible, if modest, benefits to getting tested, they may be exposed to substantial harms from over-diagnosis and over-treatment.
2 September 2012, 6.23am AEST
The perils of pre-diseases: forgetfulness, mild cognitive impairment and pre-dementia
OVER-DIAGNOSIS EPIDEMIC – David Le Couteur discusses recent changes in the definition of dementia and their ramifications. The pattern of over-diagnosis is the same for many diseases: we screen healthy people and those with minimal symptoms; we use sophisticated technologies that detect early or minor…
OVER-DIAGNOSIS EPIDEMIC – David Le Couteur discusses recent changes in the definition of dementia and their ramifications.
The pattern of over-diagnosis is the same for many diseases: we screen healthy people and those with minimal symptoms; we use sophisticated technologies that detect early or minor abnormalities that may not progress; and we treat people with these abnormalities on the assumption that this will prevent significant illness and death.
The downside of all this medical intervention is that we’re exposing healthy people to the potential harms of diagnosis, investigation and treatment without any certainty about long-term benefits. Indeed, there’s a growing unease that this trend is being driven by the financial benefits of creating a larger market for drugs rather than genuine health gains.
I work in geriatric medicine and over the last few years, I have seen how the changing definitions of dementia and Alzheimer’s disease has insidiously been leading to over-diagnoses.
Screening the healthy
Let’s start with the schema of over-diagnosis: are we screening healthy people and those with minimal symptoms? Yes. In the past, we diagnosed older people complaining of minor memory impairment with “benign senescent forgetfulness”, and told them that it didn’t require any further action. It was, after all, benign.
But this terminology progressed to “mild cognitive impairment (MCI)” and now (more ominously), to pre-dementia and pre-clinical Alzheimer’s disease. We are also being encouraged to screen older people for any memory impairment because this has now been defined as a pre-disease or early disease.
The screening tools are usually simple questionnaires, such as the mini-mental state examination (MMSE). There’s variability in how well the assessments are performed, and forgetting the date or stumbling on a repetition task can lead to a diagnosis of mild cognitive impairment. But how many of these people actually progress to dementia?
Most studies show that only one in ten cases of mild cognitive impairment progress to dementia each year, and many improve. One study that followed outcomes for ten years concluded – “The majority of subjects with MCI do not progress to dementia at the long term.”
Yet all of these people will potentially be faced with the stigma of a dementia diagnosis and its consequences – paternalism, incapacity and loss of autonomy. And then there’s the fear of impending dementia, which can generate stress and despair.
Are we using sophisticated technologies to detect early or minor abnormalities? Yes. In attempt to improve the diagnosis of early dementia, we now have a range of investigations to detect the earliest cases before symptoms have developed. These include brain scans and measurement of biomarkers in the fluid that surrounds the brain.
The gold standard for such diagnoses is post-mortem brain pathology. Alzheimer’s disease is characterised by deposits of a protein called amyloid in plaques between brain cells and another protein called tau in tangles within the cells. But the relationship between amyloid plaques and the clinical features of dementia lessens as people age.
Many older people with the characteristic pathology of Alzheimer’s disease didn’t have any features of dementia at post mortem or memory problems when they were alive. On the other hand, the majority older people with dementia have multiple changes in their brains including those related to ageing and vascular disease. So the characteristic pathology of Alzheimer’s disease is not very useful in diagnosing dementia in the largest group of people with dementia, the elderly.
Are we treating these early abnormalities on the assumption that this will prevent the development of dementia? Yes, in some cases.
There are two groups of medicines available for the symptomatic treatment of Alzheimer’s disease (cholinesterase inhibitors and memantine). Although these drugs have not been proven to have any effect on influencing the progress of dementia, review articles in some medical journals promote the possibility of their “disease-modifying activity” and the need for early treatment with these medicines.
And it’s important to add that a trial of one of these medicines attempting to show a reduction in the conversion from mild cognitive impairment to dementia found that it actually increased the death rate.
The medicines are only funded by the Pharmaceutical Benefits Scheme (PBS) for moderately severe Alzheimer’s disease but undoubtedly some people will be using them (and probably a variety of alternative therapies as well) in the hope that they will delay dementia.
And there are other industries aiming to profit from the diagnosis of mild cognitive impairment (or early and pre-clinical dementia) by selling various brain fitness technologies ranging from video games to mobile phone apps.
Dementia is a tragic illness that places enormous burden and demands on patients, families and society. There’s no question of the value of increasing recognition of the care needs of people living with dementia, and for more research funding. These are essential because effective treatment and prevention of dementia will have a dramatic impact on the human race. But the growing emphasis on early diagnosis of dementia, mild cognitive impairment and preclinical dementia in everyday practice (with the subsequent risk of over-diagnosis and its consequences) seems to be giving the disease, not the patient, greater priority and importance.