Have we entered a period where people are screening too much for disease? This question came up in two recent articles on mammogram screening and PSA tests for prostate cancer .The Wall Street Journal put the question to The Experts, an exclusive group of industry and thought leaders who engage in in-depth online discussions of topics related to articles in the Reports.
Also be sure to watch three of The Experts— David Foster, co-executive producer of the Fox television show "House"; Rita Redberg, a professor at University of California San Francisco Medical Center, and Elliott Fisher, a professor at Geisel School of Medicine at Dartmouth—answer this question and others on video in a Spreecast this Friday, Feb. 22 and 3 p.m. EST on WSJ.com/HealthReport.
David Foster: Screening Is Largely About Wishful Thinking
The "I had a slow growing cancer removed that never would have caused me any trouble but was found by a screening test and now I'm impotent and incontinent" lobby is not doing a very good job of getting their message out.
Wishful thinking is a powerful force and is shaping much of the interest in screening.
Dr. David Foster was a co-executive producer of Fox's medical drama, "House."
More in Big Issues: Health Care
Jeffrey Flier: With New Data, a Consensus Is Building
The use of screening tests to identify unrecognized disease is an increasingly important part of modern medical practice, capable of saving lives and reducing suffering when properly applied. But there are many factors that determine whether any specific test will achieve its goals, or ironically cause more harm than good to the patient. Like many aspects of medicine, it's complicated. Among the key factors that determine this critical balance are the accuracy of the diagnostic test (false positives and negative results), the frequency of the disease in the screened population, the efficacy and risks of procedures employed to validate a positive result and the efficacy and risks of available treatments. The more rare the disease, the more inaccurate and dangerous the test, and the less effective or riskier the treatment, the less likely it is that use of the screening test will be beneficial and the greater the likelihood that its use will cause more harm than good.
Ideally, decisions to employ a test should be based on informed consent by the patient and on data derived from randomized controlled studies of relevant populations. Of course, even with excellent data, individuals will differ in their willingness to be screened and patients—and I suspect many physicians as well—often have inadequate understandings of all of the relevant factors in rational decision-making in this area.
Economic factors external to medical science may play a role as well in how screening tests are actually applied. Financial incentives within the diagnostic and medical communities will often press for their greater use and concerns about costs of testing and care when recommendations for population screening are paid by insurance may stimulate resistance to such recommendations.
The use of mammography to screen for breast cancer and PSA measurements to screen for prostate cancer have been the subject of much discussion as new data on risks and benefits emerges and older data is reanalyzed and scrutinized. There remain legitimate disagreements between excellent physicians and epidemiologists on the details, but it seems safe to conclude that a consensus is building that we have been overusing these tests to some degree in recent years. As a result, many people who will never suffer from the disorders being screened for are caused to worry unnecessarily and many others receive treatments that are unnecessary and that cause their own treatment-induced morbidity. Yes, some people's lives are saved—the initial goal, which is, of course, extremely important—but many more have problems that would never had existed had the test not been performed. That is the conundrum—to find the right balance based on accurate data, a proper understanding of the risks and benefits and a recognition of the real differences between patients in their tolerance of such risks. We will be dealing with these issues for many years to come.
Dr. Jeffrey Flier (@JFlier) is the dean of Harvard Medical School.
Rita Redberg: The Harms of Screening Outweigh the Benefits
I think the pendulum has swung too far in favor of screening because there is a lot more harm than good from our current screening efforts. Screening by definition is looking for evidence of disease in persons who feel healthy and have no symptoms. Thus, these persons are already feeling perfectly well. The benefit of screening should be that we will find evidence of disease that may occur sometime in the future AND that we can act now to prevent or delay the onset of such disease and by doing so, live longer. Virtually none of our current screening programs provide such a benefit.
Mammography is one example of a highly contentious screening program. The U.S. Preventive Services Task Force recommendation that there was no evidence that women aged 40-49 benefit from routine screening in November 2009 was met with uproar and criticism from many quarters. The clear need for better public education about areas like screening is exactly what led JAMA Internal Medicine to launch the "Less is More" series to highlight areas of health care with no known benefit and definite harms in early 2010. The confusion greeting the new recommendation was understandable, after years of hearing that mammography was good, this more nuanced recommendation that mammography was not good for all women all the time, and actually could be harmful for some, was hard for many to understand. The actual story is even more complex, as although there is some evidence that mammography decreases deaths from breast cancer in women ages 50-75, there is no evidence that these women actually live any longer, because they die from other causes more or less at the same time as women who were not screened. Mammography starts with the uncomfortable and humiliating experience of having one's breast squished many different ways, progresses to a 50-50 chance of a false positive, and ultimately results in many unnecessary surgeries for lesions that would have never progressed to cancers. Although the vast majority of women receive no benefit from mammography, it still has ardent supporters.
Similarly, there is no evidence that PSA testing for prostate cancer leads to reduced mortality. The lack of evidence of benefits for many screening programs is cause enough for concern, but to make things worse, there is substantial evidence that many of these tests lead to harmful consequences. For example, we often diagnose "early cancers" that would never progress and never cause any problems. But we "treat" these cancers with a barrage of highly toxic and/or risky procedures—radiation, chemotherapy, and invasive surgery. Besides the harmful physical and psychological effects of such treatment, the increased radiation used in diagnosis and treatment itself can lead to increased cancers. For example, approximately 10% of all men treated surgically for prostate cancer will experience impotence or urinary incontinence.
There is no benefit to "early detection" unless the detection leads to an intervention that will either improve the quality of life or extend life. The vast majority of current screening programs does not meet these criteria, and in fact worsens quality of life and leads to serious harms. Our focus on early detection is well-intentioned, but it is time to reassess as the harms are outweighing the benefits.
Rita Redberg (@RFRedberg) is a Professor of Medicine and a cardiologist at the University of California San Francisco (UCSF) Medical Center.
Leah Binder: One Size Just Doesn't Fit All
My friend, whom I will call Betsy, went for her first routine mammogram at 42 on the eve of a long-anticipated vacation. As she rushed to finish packing, her doctor called with the bad news that her mammography results signaled strong suspicion of malignancy.
"Schedule an appointment with a surgeon right away," the doctor ordered.
Knowing that her seven-year-old would never forgive her for canceling his trip to Disney, Betsy headed on vacation anyway and scheduled the biopsy for the day of her return. While away, though, she couldn't focus on Mickey Mouse or the Magic Kingdom. She called the lawyer to update her will, planned with her husband on how he would manage financially as a widower, lost a lot of sleep, hugged her little boy and tried to accept the possibility—now less remote—that he would grow up motherless.
After the ruined vacation, she underwent the biopsy. The results: The surgeon said it came back with no trace of cancer. Although relieved, Betsy vowed not to have another mammogram until she was 50, if then.
"I'm just not going through that again," she said.
Cue the chorus of "tut-tuts." As my friend Jane said to Betsy, "You won't avoid breast cancer by avoiding a mammogram. But you may detect it early enough to need less treatment or it could save your life."
Yet mammograms carry risks and Betsy is right to be wary of them. False positives are common and the consequences go beyond ruined vacations and anxiety, which as Betsy will attest to are not minor. They can often lead to disfiguring biopsies, additional imaging that causes greater exposure to significant radiation and other follow-up diagnostic procedures that pose sometimes frightening risks.
On the other hand, as Jane points out, there are the potential benefits of finding cancer early enough to evade the necessity of the most aggressive treatment and to have the best chance of survival. But that analysis is not as straightforward as many of us might think. A Cochrane study—the gold standard for cold-eyed analysis of the science behind conventional wisdom—concluded that mammography has led to about 20% more mastectomies, not fewer, so mammography isn't going to help your odds of staying out of the operating room. And as H. Gilbert Welch, Lisa Schwartz and Steve Woloshin point out in the book, "Overdiagnosed: Making People Sick in the Pursuit of Health," for every 2,000 low-risk women in their 40s screened every year for a decade, one death may be avoided as a result of mammography.
The risk-benefit calculus was low enough that in a controversial decision the U.S. Preventive Services Task Force did not recommend mammography screening for low-risk women in their 40s, seeing more risk than benefit.
But for Jane and many other women, even a small chance of death makes mammography worth the risk.
So who is right, Jane or Betsy? They both are right—for their own lives. There is no one-size-fits-all approach to deeply personal questions like whether to have a mammogram when the science is not black and white and the risks are high.
Our willingness to assert our own agency as adults with our own risk-benefits calculations is important for preserving our own health, and on a broader scale important for our country's health. This is not as common as you might think; indeed a movement called shared decision making has emerged to better respect patient perspectives in calculating the risk-benefit equations for our own lives. This will not only improve the experience of individual patients, but will vastly improve the overall health system.
Leah Binder (@LeahBinder) is president and chief executive of Leapfrog Group, a national organization based in Washington, D.C., representing employer purchasers of health care and calling for improvements in the safety and quality of the nation's hospitals.
Murali Doraiswamy: Catch-22: We Want Early Diagnosis But Don't Want Imperfect Tests
This is a Catch-22 situation since there is no such thing as a perfect test. As a society we are eager to catch diseases early (preferably at the presymptomatic stage) but we don't want tests that perform imperfectly. This means that we will have to wait forever till a test is perfectly validated or if we introduce a test quickly we run the risk of having to withdraw it if it is misused. National health-care plans like those in the U.K. are slow to introduce screening tests that are not cost effective at a societal level but they pay a price in that many diseases are caught at later stages. Capitalistic societies like the U.S. take the latter approach but pay a price in the form of a huge volume of unnecessary testing and surgery to save a few lives. Most screening tests are not as well validated as we would like to have the public believe. Let's take even the basic annual physical exam which has been done for decades on the assumption that this is lifesaving. A recent pooled analysis of 183,000 people across 14 studies in the U.S. and Europe found that nine-year death rates were identical in those who underwent regular physical checkups and lifestyle counseling versus those who did not.
Dr. P. Murali Doraiswamy is professor of psychiatry and medicine at Duke University Medical Center where he also serves as a member of the Duke Institute of Brain Sciences and as a senior fellow at the Duke Center for the Study of Aging and Human Development.
H. Gilbert Welch: It Is Increasingly Easy to Find Something Wrong
I believe that screening mammograms should be presented to women as a choice—not a public health imperative. Since my argument on this appears elsewhere in this Journal Report, here I'll focus on the general issue of screening and how the current health-care system has systematically exaggerated its benefits and understated—or worse, ignored entirely—its harms.
A little background: Screening is the systematic search for abnormalities in those who have no symptoms of disease. Everyone understands that screening offers the possibility of helping some people, but few understand it invariably harms others. Let me explain.
First, to get people interested in screening in the first place you have to get people to worry about the disease you are screening for (the typical jargon is to "raise awareness"). You may not consider that a harm, but remember health is not simply a state of physical being—it's also a state of mind. It is certainly reasonable to ask to what extent the health-care system should be promoting a sense of vulnerability to disease in people who feel well.
Second, the math tends to work against screening: Many (often thousands) must be tested, to potentially help a few. Any harms of the testing process—false alarms, complications of diagnostic procedures, etc.—are multiplied since so many people are going through it.
Finally, whenever doctors screen for disease we end up treating a lot more people than we would otherwise. That's the problem of overdiagnosis. We look hard for early forms of disease, find more "disease" than will ever progress to cause problems, but because we can't distinguish which form is going to be important and which is not, we tend to treat everybody. That means we are treating people who can't benefit—because there was nothing to fix. But we take credit for having "cured" them anyway, while ignoring the harms of unneeded treatment.
That's what has happen to about a million American men from prostate cancer screening. And the harms there are very real: impotence and incontinence.
The truth is screening is a mixed bag. It makes more sense for some diseases than others and it makes more sense for some individuals than others. But it should always be an informed choice.
The fact is our diagnostic technologies are increasingly able to find something wrong—even in those who are well. That fact raises a general question for us to ponder: Is looking hard for things to be wrong a good thing for a health-care system to do?
Dr. H. Gilbert Welch is a general internist at the White River Junction VA and a professor of Medicine at the Dartmouth Institute for Health Policy and Clinical Research in the Geisel School of Medicine.
David Blumenthal: It All Depends on the Test
Screening tests are a complex topic. The U.S. Preventive Services Task Force (USPSTF) provides authoritative, scientific recommendations regarding the usefulness of screening tests. I support their policies. This would argue for less use of some screening tests (PSAs) but more use of others (screening for colon cancer) than we currently observe in the American population. So the issue is not too much or too little—but assuring that doctors and patients take note of and follow the best available evidence, which is nicely summarized by the USPSTF.
Dr. David Blumenthal (@DavidBlumenthal) is the president and CEO of the Commonwealth Fund, a national health care philanthropy based in New York City.
Fred Hassan: Figure Out What's Optimal as a Base Medical Benefit
I think there should be a healthy debate on what is optimal as a base medical benefit.
For those patients wanting more frequent or more extensive tests, they should make their own financial arrangements (including private insurance) to pay for them.
Fred Hassan is the chairman of Bausch & Lomb.
Elliott Fisher: We Screen Too Often and Should Focus on Other Ways to Prevent Disease
I have no doubt that we have overemphasized the benefits of screening, especially for breast and prostate cancer. The underlying problem is that the available tests detect many "cancers" that would never have caused any problems for the patient if they had not been found, which is also known as "overdiagnosis." A recent paper published in the New England Journal of Medicine concluded that 31% of all breast cancers diagnosed in the U.S.—affecting 70,000 women per year—represent overdiagnosis and that a relatively small number of women have their lives saved by screening. The authors concluded that most of the small reduction in breast cancer mortality rates seen in recent years is due to improved treatment, which should be very reassuring, and not earlier diagnosis through screening. One of the authors, Dr. H. Gilbert Welch, explains the findings here. (In the spirit of full disclosure, Dr. Welch is a close colleague with whom I've written about the problems of overdiagnosis and overtreatment before.)
As patients, we should therefore approach screening with eyes wide open, willing to acknowledge the small benefits and the substantial possibility of harm. We should also recognize that there are still many effective steps we can take to reduce our risk of cancer and other life-threatening conditions: avoiding smoking, maintaining a normal weight, and exercising regularly, for example.
Dr. Elliott Fisher is the James W. Squires professor of medicine and community and family medicine at Geisel School of Medicine at Dartmouth and director for population health and policy at the Dartmouth Institute for Health Policy and Clinical Practice.
Carol Cassella: Don't Forget the Individual In the Equation
My short answer is yes, but it's not a question that lends itself to a short answer. As we develop better tools to analyze screening tests over large populations and long periods it seems clear that we sometimes do more harm than good. But there are really two points of view to consider here. The first relates to what works best as public health policy, where meta-studies help clarify whether a global screening test is actually saving either lives or money. Annual mammograms, for example, are being questioned because they're picking up tumors so small many would never turn into invasive cancer. So annual mammograms needlessly expose many women to more tests, biopsies, surgical risks, and often more radiation—a known carcinogen. When you add all that up, the overall cost in both sick-days and dollars (not to mention worry) climbs for every patient that screening saves. But look at it from the individual's point of view. Are you willing to be the one who ends up with an aggressive tumor that might have been stopped earlier? Maybe you'd rather endure the biopsies and extra tests hoping any cancer discovered has a better chance of being cured. On the other hand, what if you knew you were doomed to develop a life-threatening infection after your biopsy? The meta-studies that generate these recommendations make good headlines but if you read the heated scientific debate that follows you realize how complicated the data is to interpret and apply on an individualized basis. The final decision, not be corny, needs to be made in a conversation between the patient and their doctor, not over the morning news.
Dr. Carol Cassella (@CarolCassella) is a practicing physician and author of the novels "Oxygen" and "Healer."
Charles Denham: Putting the Focus on the Doctor-Patient Conversation
Studies addressing screening for prostate cancer and for breast cancer have drawn some debate and the design of population studies are not squarely in my domain so I respectfully defer to others on the merits of them. However, overuse, underuse, and misuse of testing broadly is definitely a research area of ours especially in the area of imaging. Studies estimate that a primary care physician would have to spend 21.7 hours a day if they were to attend to ALL acute, chronic, and preventative care needs for a typical panel of 2,500 patients. So, we have a crisis—this can't be done.
Primary care doctors work an average of 8.6 hours per day and spend an average of 15 minutes of time with a patient and can't possibly take the time to undertake shared decision-making on screening or testing. They order tests to maintain their throughput and to save time. For instance, we will likely perform 80 million CT scans in America this year and more than 240 million world-wide. We likely overuse CT scans 20% to 30% of the time more likely due to convenience than for malpractice risk. We will soon publish that 88% of CT scans and high-tech studies are ordered not by specialists, but by primary care doctors. Yet on a per-doctor basis, they each order less than five of any high-tech studies a month. They can't possibly keep up on the indications for such tests.
The Choosing Wisely Campaign is a wonderful initiative that addresses such overuse of screening and diagnostic testing. It really deserves attention and it has made me proud to be a physician. In a few months Choosing Wisely will include at least 35 of our greatest medical societies that are providing new clear, practical and powerful guidelines to curb the overuse of testing, based on the best evidence.
These leading physician groups have now broken ranks with those who have said "we will give you more quality when you give us more money" and stepped up to own the problem. The campaign is a tremendous example of leadership and will have enormous impact on areas of screening and work up of the most common conditions. Primary care physicians, corporate benefit managers, and leaders of health-care systems should follow their lead and learn of this work. We covered it in our documentary "Surfing the Tsunami" and we will be covering it in future films. We are all patients and it is as important that we become informed of such programs so that we can engage in the crucial conversations with our primary care doctors who are on a faster and faster treadmill and need us all to do our part.
Dr. Charles Denham (@Charles_Denham) is the founder of the not-for-profit Texas Medical Institute of Technology, a medical research organization, and the for-profit HCC Corp., an innovation accelerator.
Harlan Krumholz: Patients Must Be Informed to Make Their Own Decisions
We should be asking at every opportunity whether screening is producing better results for patients. As a result of screening, we are identifying people who will carry a label of disease and perhaps undergo more testing and interventions. It is possible, though, that we are not producing a net benefit for patients.
This issue has garnered a lot of recent public dialogue with attention focusing particularly on mammography and PSA screening. These topics are highly charged and anyone wishing to discuss them needs to be aware of the hazards. Nevertheless, it is important to recognize that even for these mainstays there are questions about whether the screening is useful.
One particular article that influenced me showed the 10-year events for men being screened by PSA. Those who were screened had more biopsies, more diagnoses of prostate cancer and fewer prostate cancer deaths (1 fewer). But the screening will result in many more procedures, more cases of incontinence and more cases of impotence. For some people, that degree of risk reduction may not be worth what you have to go through.
In the end, patients should have the opportunity to understand the risks and benefits of screening—and the uncertainty—so that the decision is theirs to make. And they should realize that different doctors may have different views about screening—so they need estimates of risks and benefits that are supported by the science.
Dr. Harlan Krumholz (@HMKYale) is a cardiologist and the Harold H. Hines Jr. professor of medicine and epidemiology and public health at Yale University School of Medicine
John Sotos: In Absolute Terms, It's Impossible to Argue Either Way
Just to be sure we're all on the same page, "screening" means we are looking for a disease that already exists in a person, but has not advanced to the stage where it is causing symptoms. Usually, but not always, this means we are using some kind of machine or instrument to look for the disease. Regardless, all screening tests cost money in some way and all have potentials for both medical benefit and medical harm.
Those three qualities—financial cost, medical benefit, and medical harm—are the pillars for any discussion about screening.
If we remove cost from the equation—let's say our patient is wealthy and happy to pay for anything—questions of overscreening versus underscreening simply boil down to the patient's individual taste for balancing the benefit and harm potentials. Ideally, the physician communicates these potentials to the patient clearly and accurately, then lets the patient decide. Some decisions are easy, some are hard, as shown in Figure 1.
In this idealized, cost-ignoring scenario, overscreening and underscreening really do not exist. Some of us might question a patient's decision-making, but, ultimately, all of us walk in our own moccasins. In the real world, however, communicating benefits and harms is not easy and most patients do not want to make decisions completely on their own: They want guidance from a physician, who is accustomed to thinking about medical trade-offs and living with medical complications.
People who make policy about screening have a much more complicated chore, because they cannot ignore cost—it is added as a third dimension to Figure 1. And, just as different individual persons have different tastes for weighing benefit and harm, so, too, individual societies (or segments of societies) have different tastes for weighing reasonable costs versus excessive costs.
So, here again, it's really not possible, on an absolute scale, to say whether there is too much or too little screening.
Certainly, however, support for improving our preventive health capabilities is universal. PSA screening leaves much to be desired because it cannot distinguish between life-threatening prostatic cancers, and those that will ultimately prove harmless. Mammography would be better if it could more reliably distinguish benign from malignant lesions. Although knowledge of the patient's genome will someday improve the performance of these tests, better biochemical testing is more likely to move us closer to the Holy Grail.
Finally, it is also worth remembering how much screening has already brought us. Apart from the invention of antibiotics, the greatest public-health triumph of the 20th century was the reduction in death and disability from heart disease, which had reached epidemic proportions by the 1950s—a rate three-times its level today. No one innovation is responsible for this near-miracle, but the practice of taking blood pressure at every physician visit and the adoption of widespread cholesterol testing were big contributors. In fact, these screening techniques have been so successful that they have expanded the concept of "disease" to encompass what were once called "risk factors." Screening is now, and forever will be, a major part of medicine.
 The Foundation for Informed Medical Decision-Making has pioneered better ways to communicate the potentials for risk and benefit to patients.
 See figure 1 in: Nemetz PN, et al. "Recent trends in the prevalence of coronary disease: a population-based autopsy study of nonnatural deaths." Archives of Internal Medicine. 2008; 168(3): 264-170. Available online at: http://archinte.jamanetwork.com/article.aspx?articleid=413914
Dr. John Sotos was a medical technical adviser to the Fox television series "House" and is the author of several books, including "The Physical Lincoln."
Pamela Barnes: There Are Good Tests… And There Are Not-So-Good Tests
It depends on the screening test—the fact is that some are good tests and some aren't. Certain tests like the PSA for prostate cancer for example are not particularly good screening tests but are still widely used. This leads to results which can't be trusted, resulting in potentially unnecessary interventions (which also carry harmful risks). On the other hand, let's take cervical cancer screening for example.
Every year, 275,000 women die from cervical cancer and most of those deaths occur in developing countries where regular Pap tests or cervical cancer screening programs are not accessible. In the U.S., cervical cancer screening is excellent and the number of cases of cervical cancer and the number of deaths from it have dropped significantly in the past 40 years. So in this case, the cervical cancer screening test is a very good one and it literally can save lives. As head of EngenderHealth, a global women's health organization, I see this issue as one that boils down to access and quality of care. In many of the places we work, we are still seeing women missing out on lifesaving screening and treatment simply because they are poor or because of where they live. It's a health equity issue and we need to do more to close that gap.
Pamela Barnes is president and chief executive officer of EngenderHealth and was formerly president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation.
Atul Grover: Patient Preferences Are Key
The problem with recommendations for decreased screening is that they are made based on a population-health approach—which may make more sense from a societal perspective than from an individual patient's perspective. For example, while we may lack data on how to interpret tests such as PSAs, individual patients want all the information they can have about their health. Many patients are uncomfortable not looking for a cancer or not doing anything about a slow-growing cancer.
As a physician, I understand the difficulty in interpreting and acting on data that may not contribute to better health outcomes. I see that false positives or ambiguous test results can lead to care that is more harmful than good. As a patient, I am ambivalent about having a protracted conversation with my doctor if she orders a PSA as part of my routine health screening. On the other hand, my wife, who understands medical literature, still wants a mammogram even if the experts at the U.S. Preventive Services Task Force say women in their 40s may not benefit.
Health care is highly individualized, particularly in the U.S., and, as patients, we view more information as beneficial to our care. These questions will only loom larger as genetic testing becomes more widespread and our ability to assess current disease (or its likelihood) outpaces our ability to treat or cure it (e.g., Alzheimer's).
Dr. Atul Grover is the chief public policy officer of the Association of American Medical Colleges.
Susan DeVore: Emphasize Evidence in Making Screening Decisions
Our doctors and nurses are the world's best. There is often, however, competing evidence regarding what is the most effective and efficient care protocol. Prevention and early diagnosis are key to reducing long term costs of care. But without better industrywide standards built on sound evidence comparing the effectiveness of treatments and tools to reinforce these standards, variations in care are inevitable, increasing the possibility of overuse and harm.
A recent study examined, for example, blood use across 7.4 million de-identified discharges from 464 hospitals. It found that reduction in variation could yield a $165 million savings opportunity while maintaining positive patient outcomes.
Blood use, like so many other treatment protocols, is complex. Patient need and condition always play significant roles in variation and clinicians need to use their judgment when treating patients. But we need to identify the unjustified variations and work with professional societies to set better evidence-based standards that will improve quality and reduce costs. The same goes for imaging scans, PSAs and a multitude of other tests and procedures. This evidence, standards and continuing measurement against these standards will better assure appropriate and effective patient care.
Ultimately, we need to constantly improve the evidence while studying variation in care delivery, costs and outcomes. And in this technology-enabled world, this information needs to be available real time in the hands of caregivers so that evidence-based, data-driven decisions can be made.
Susan DeVore is president and CEO of the Premier health care alliance.
Peter Pronovost: Science and Evidence Are Key
The concept of screening for disease is, in principle, simple. Yet developing wise policies has proved devilishly difficult. Screening tests are effective when they identify disease at an earlier stage and when an effective therapy can be given that improves patient health. Yet screening tests are not perfect. Some patients who have the disease will not be identified (false negatives) and some without the disease will be labeled as having it (false positives). While the risks of being a false negative are obvious, the risks of being a false positive are often not recognized. For breast or prostate cancer, this may mean patients undergo additional tests or invasive procedures, including surgery. These unnecessary diagnostic tests and treatments pose risks for complications, inconvenience patients and their families, and add to medical costs. In addition, the psychological impact of incorrectly telling someone they might have cancer is profound. Screening patients at lower risk for a disease (such as younger women for breast cancer), means more false positives and more of these bad consequences. In addition, patients and policy makers may have different goals of a screening program. Patients may want to identify every last case (it could be them or a loved one), so they want to make false negatives zero, even if there are risks and costs. Policy makers need to balance the risks of being a false negative with risks of being a false positive, because health-care costs are skyrocketing and resources might be better spent on other health problems. For example, performing mammograms on women in their 20s and 30s, who have a low risk for cancer, would identify some women with cancers, yet would yield many more false positives and would harm more women than it saved.
Even if the disease is correctly recognized early (true positives), there is no guarantee that treating it will make a patient healthier. Sometimes the disease is diagnosed at such an early stage that it never would have caused a problem during the patient's lifetime. This is called overdiagnosis, and it is one of the toughest ideas for patients to understand. They ask, "How could it be a bad thing that my cancer was correctly diagnosed?" But sometimes the treatment is worse than the disease. The risks of serious harm from surgery and chemotherapy may be greater than the risks of the disease ever manifesting, especially if the disease progresses slowly. This issue makes it very difficult and expensive to figure out whether a screening program is truly effective. You can't just rely on the obvious—"We diagnosed more." You have to prove that it saves lives. Overdiagnosis will likely get worse as advances in medical technology enable us to detect more pre-disease that will never cause a problem.
Science should guide policy and recommendations for screening and should be based on evidence. The goals of these policies should be explicitly and transparently stated, the evidence made public, and basic assumptions about the risks of false negatives, false positives and overdiagnosis made clear. Patients who want additional screening should be able to get it, but at some out-of-pocket cost. Physicians who comply with the policy and appropriately do not screen should be protected from liability claims, even if for a particular patient whose disease was missed with tragic consequences. Without such provisions, health care has little hope of reducing the overuse of screening tests. At the same time, scientists should seek to develop better diagnostic tests. The rates of false positives and false negatives are a function of the test. With innovation, health care could develop new tests with better performance.
We must also tackle the tremendous problem of misdiagnosis. In a study published last year, my colleagues Dr. David Newman-Toker, Brad Winters and I found that there are more than 150,000 Americans annually who suffer permanent harm from misdiagnosis, including at least 40,000 to 80,000 deaths. That's more patients than die every year from breast and prostate cancer combined. Disease screening is important, but we need to focus more public attention and funding on eliminating diagnostic errors.
Dr. Peter Pronovost is a practicing anesthesiologist and critical care physician and a professor in the departments of Anesthesiology & Critical Care Medicine, Surgery and Health Policy and Management at Johns Hopkins.
J.D. Kleinke: Emotion is Driving a Health Care Holy War
No, screening everyone in the herd is often not worth it, we are now finding out across multiple disease prevention spheres. But America is unique as a culture in its view that the rights, wants, needs and anxieties of the individual are absolute and sacrosanct, and the fate of the herd be damned. The greatest illustration of this cultural compulsion is the absurdity of our medical malpractice system, which monetizes individual human travesty and bad outcomes far more than it seeks to root out legitimate negligence.
As with the perennial struggle over the horrors of medical malpractice, the question of whether or not to screen for cancer is one of those health-care Holy Wars that will never be resolved—merely shunted off into another who-pays economic grind-down—because where data ought to rule, emotion will always overrule.
Recall the collective angst over and instantaneous political reaction to U.S. Preventative Services Task Force's retrenchment in late 2009 on breast cancer screening. After decades of public service announcements, self-exam "buddy" reminders, and "racing for the cure" to raise breast cancer awareness, suddenly we find that all the effort and money dedicated to breast cancer screening for women under 50 actually saved "only" one life for every 1,904 women screened—while generating too many false positives, hundreds of unnecessary biopsies and excessive anxiety for healthy women.
For keepers of the public health, health-insurance bean-counters, stringently evidence-driven physicians and employers who pay directly or indirectly for their employees' medical care, the take-away was obvious—we're done. No more mammograms or ultrasounds for women under 50. For just about everybody else, it begged the obvious question: But what about that one woman saved? What if she is my sister? My wife? My daughter. Would I, reading that same study data over her open grave, countenance the inconvenience and cost for those other 1,903 women? For everyone I know who knows these issues well, the answer to that question is—unequivocal equivocation.
What is best for the group has nothing to do with what is best for my best friend, even though she is low-risk and 46 years old. Because in medicine, there is always another argument, a countervailing study, an exception. There is always me, and I am not a group, I am a study population of one, and my life is precious and therefore priceless.
In the case of cancer screening, the countervailing truth is that early detection is the single-most-important and durable factor in individual cancer survival. New findings about the epidemiology and economics of the group are not only irrelevant, but offensive to many—with the survivors in the discussion screaming the loudest. When it comes to any cancer, fear takes over, and rationality flies out the window. I am not justifying this perspective, merely explaining how it plays out in our current health-care system.
The instant political reaction to the USPSTF breast cancer finding was to ram a guarantee of coverage into President Obama's health-care-reform legislation, which was being drafted at that time. The women's health amendment did not specify age cutoffs—Congress wisely left that to doctors, contrary to critics' blanket claims that everything in Obamacare interferes with what doctors do—but it was intent on establishing, perhaps against future findings that no screenings are worth a damn, that women will be fully covered for breast cancer screening. As with everything else in Obamacare, the details about coverage by age will be sorted out in the grind of implementation.
Why this amendment? Because those in Washington who know how health coverage works knew that the findings would merely provide covering fire for insurers not to cover the screenings, at whatever minimal age someone else in Washington set. Insurers, of course, are following the new guidelines, and women under 50 are getting them anyway—by paying with their own money. This is how all the health-care Holy Wars ultimately play out. The technocracy, which is correct in this instance, says no, and the culture demands yes. Medical markets turn quickly from insurance coverage into cash markets (e.g. in vitro fertilization), often into gray markets (e.g. Internet pharmacies), and occasionally (e.g. abortion before Roe vs. Wade) into black markets.
With the advent of high-deductible insurance and ever-larger cost-sharing by patients, more and more medicine is going the way of retail anyway—and these "unnecessary" screenings are going with them. It is not the technically correct way to allocate resources, nor the best care for the herd, but it is how we choose as a society to care for ourselves.
J.D. Kleinke (@JDKonHealth) is a medical economist, author, health care business strategist and entrepreneur. In 2012, he was a resident fellow of the American Enterprise Institute. Prior to joining AEI, Mr. Kleinke was co-founder and CEO of Mount Tabor, a health-care information-technology development company.