Showing posts with label PSA. Show all posts
Showing posts with label PSA. Show all posts

Tuesday, May 19, 2015

Medical testing: is it about quality?

In her New York Times “Well” blog of April 13, 2015, physician Abigail Zuger comments upon “Quantifying Tests, Instead of Good Care”. She discusses a variety of factors that lead to physicians ordering more and more tests. In part, this is the simply the result of the advance of technology and thus the profusion of tests that can be done --  laboratory tests, imaging (like x-rays and their ever more complex cousins), and even parts of the physical examination (“Yes, little blood pressure cuff over there in the corner, that means you”) --  which sometimes can be seen as meaning they should be done. Other factors are about money. The tests cost money, a negative for patients and insurers, but they make money for the laboratories and imaging facilities and the hospitals which often own them, and frequently employ the physicians doing the ordering. Dr. Zuger notes that “Ordering tests, chasing down and interpreting results, and dealing with the endless cycle of repeat testing to confirm and clarify problems absorb pretty much all our time.”

Another impetus is our desire – patients and physicians alike – to find out what is wrong when there is something wrong. Or, when there is nothing really wrong, to perhaps prevent later disease by finding something hidden lurking inside. There are all these tests we can get! The patient may have had many of them before, ordered by another provider, or know people who have had them. They hope that something will give them an answer. The doctor may feel that there may be an answer out there that s/he might miss if a test is not ordered, or if s/he is a primary care physician that a specialist might order these tests so maybe we should do it first; after all, it sometimes seems as if one thing specialists do when we refer patients to them is order a bunch of tests that we could have. Or, and this is a big focus of Dr. Zuger, that their “quality ratings” may suffer if s/he doesn’t order these tests.

Quality ratings are measures of things that doctors should do (or, sometimes but more rarely, should not do) for patients with certain conditions or complaints; increasingly, insurers, employers, and third-party groups are assessing the quality of care that a physician delivers in this way. Are these recommendations not based on evidence? In many cases, they are. For prevention, the US Preventive Services Task Force assesses the degree to which tests may be indicated or not for different people, often based upon their age and sex. It gives them ratings: ‘A’ is strongly recommended based on good evidence, ‘B’ means there is some, but weaker, evidence to support doing it, ’C’ means there is conflicting evidence and patient preference should be taken into account, ‘D’ means not recommended (might even be harmful), and ‘I’ means insufficient evidence to assess. A smart phone app, ePSS, can be downloaded by anyone; put in age and sex and it tells you which preventive tests are recommended.

Of course, not all doctors do all the recommended screening tests, and frequently they do tests that are not recommended (e.g., PSA to screen for prostate cancer) or more frequently than recommended (Pap smears to screen for cervical cancer), or in people for whom the test is not recommended (mammograms in younger women). When it comes to diagnostic testing rather than screening, looking for the cause of something when the patient is actually ill, there is even less consensus, and often a prevailing attitude of “more (testing) is better”. One effort to combat this is the Choosing Wisely campaign begun by the American Board of Internal Medicine Foundation. This campaign asked specialty societies to identify 5 or more commonly-done tests or interventions in their specialty that should not be done. However, the same recommendations are not always endorsed by every relevant organization. For example, the American Academy of Family Physicians recommends “Don’t do imaging for low back pain within the first six weeks, unless red flags are present.” Great, but neither the American College of Radiology nor the American Academy of Orthopaedic Surgeons, arguably the groups that could make money from this, has such a recommendation.

And then there is the risk. Some of the tests receiving USPSTF ‘D’ recommendations are more than not helpful; they can lead to harm, and this is even more true of the many potential tests that can be done looking for disease. Discussing the work of a collaboration at the Dartmouth Medical School that looks at the utility of tests, Dr. Zuger notes that such iconic treatments as controlling blood pressure can lead to bad outcomes in many older people where the benefits (avoiding stroke and other complications) begin to be outweighed by the risks:  “One study found that nursing home residents taking two or more effective blood pressure drugs did remarkably badly, with death rates more than twice that of their peers. In another, dementia patients taking blood pressure medication with optimal results nonetheless deteriorated mentally considerably faster. Yet no quality control system that I know of gives a doctor an approving pat on the head for taking a fragile older patient off meds.”

This is just the tip of the iceberg. Tests cost money, and often show results that lead to more tests, and then maybe to procedures (biopsies, for example) that maybe show abnormalities that lead to bigger interventions. And, sometimes these interventions are life-saving, but not always. Or maybe, even, not often.  And they do often have side effects, some of which are not insignificant. The person in whom a series of tests identifies cancer and is then treated and then survives is almost always grateful for the testing and the treatment, although in many cases they would have survived just the same with no treatment, and without the costs both in dollars and in side effects. The classic example is prostate cancer, where the evidence of any treatment making a difference in survival is weak at best; it is either a devastating disease from which one dies, painfully, or more commonly a benign condition that one dies with but not from but which treatment seems to have little influence on. Except for the cost, and the non-trivial side effects of impotence, incontinence, and the effects of radiation on the rectum.

Increasingly, data is showing that much breast cancer is similar. As discussed in my December 2012 blog post “More on mammography: just because you don't like the results doesn't make research junk science”, a large study by Bleyer and Welch showed that, with new and more sensitive mammographic screening, many more women are being diagnosed with early-stage breast cancer. However, despite treatment, we are not seeing anything like that reduction in late-stage breast cancer, which means most of those early stage cancers would not have progressed at all. And yet every woman diagnosed and treated sees herself as a survivor who has been cured, even in those cases where progression would not have occurred. In his wonderful recent New Yorker article “Overkill” (May 11, 2015), Atul Gawande notes that we treat all “cancer” as if it were rabbits in a pen who have to be chased down before they escape, when in fact many cancers are “birds” that have flown away and are gone before we can do anything and many others are “turtles” who are not going anywhere whatever we do.

The goal of medical care is now to achieve the “Triple Aim” of high quality, patient satisfaction, and lower cost. As with many things that come in threes, it is not that hard to achieve two but very challenging to achieve all three. Patients satisfaction is important, but not at any cost. Cost control is good, but not if it seriously limits quality. One place to start, then, is with quality, and specifically not doing what is useless or even harmful as assertively as we do what is likely to be of value.


And, of course, to make sure that it is the disease or risk of disease that determines what tests are done, not people’s insurance or socioeconomic status, ethnicity, gender or personality.

Tuesday, March 15, 2011

Men’s Health? Women’s Health? Valid screening opportunities or “Hallmark Holidays”?

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This blog has previously discussed the use of PSA as a screening tool for prostate cancer (March 21, 2009: PSA Screening: What is the value?, and a guest column by Robert Ferrer, MD MPH in October 27, 2009: PSA Screening: “One of Medicine's Great Success Stories"? ), and indicated that it was not only a poor test, but a dangerous one, leading to unnecessary biopsies, diagnosis of disease that was unlikely to progress and treatment that would probably not change the outcome but would almost certainly lead to significant morbidity.

A new study by Vickers, et al., published in the Journal of the National Cancer Institute (An Empirical Evaluation of Guidelines on Prostate-specific Antigen Velocity in Prostate Cancer Detection, JNCI, doi: 10.1093/jnci/djr028, first published online: February 24, 2011), shows that the use of “PSA velocity” as a screening test for prostate cancer, is flawed and not a valid indicator. PSA velocity refers to the rate of change (presumably, increase) in the level of prostate-specific antigen (PSA) over time; the theory, which this study demonstrates to be invalid, is that the faster the rate of rise (velocity), the more likely someone is to not only have prostate cancer, but to have aggressive cancer needing intervention. In fact, the study shows that “Biopsying men with high PSA velocity but no other indication would lead to a large number of additional biopsies, with close to one in seven men being biopsied….We found no evidence to support the recommendation that men with high PSA velocity should be biopsied in the absence of other indications; this measure should not be included in practice guidelines.” And so another effort to find a way to use PSA to diagnose prostate cancer, like “highly sensitive PSA” before it, bites the dust.

Unfortunately, the issue of PSA screening will probably not die out, despite this study and the recent change in the recommendation of the US Preventive Services Task Force (USPSTF), downgrading PSA testing from an “I” recommendation (evidence is insufficient to recommend for or against testing), to a “D” – not recommended. The political pressure from physicians, hospitals, and others who are at best “true believers” (they know that eventually their faith will be proven correct) to, at worst, motivated by the fear of losing a major source of income, will continue. Indeed, the “PSA velocity” was never even seen as a way of confirming the veracity of a high single PSA value (which, for the true believers, was sufficient) but a way to identify men who had a normal PSA – but maybe slowly rising from one normal value to another – as a market who could be treated.

The USPSTF recommendation was in fact ready several months before it was released, as discussed by Kenny Lin, MD, on February 28, 2011 his blog Common Sense Family Doctor, PSA testing: will science finally trump politics?. Dr. Lin was, at the time, the staff member at the Agency for Health Research and Quality (AHRQ) that put together the evidence review upon which USPSTF based its recommendation, and then quit over political interference from the White House: “The USPSTF scheduled its "re-vote" on prostate cancer screening for its November 2010 meeting. As reported in the Wall Street Journal and on this blog, the Task Force was forced to cancel that meeting due to the unfortunate "scheduling conflict" with the critical midterm Congressional elections.” (Editorial note: postponing the recommendation didn’t help the President’s party in those elections!)

The attraction of PSA screening and prostate cancer goes beyond that single disease; it is the cornerstone of the ostensible discipline of “Men’s Health”. This is a conceit developed by astute marketers to compete, or more correctly, profit from the cachet associated with, the long-established “Women’s Health”. After all, if Women’s Health is a good and established (and profitable) area, why should men – and particularly, those who want to make money caring for men – be left out? Women’s Health (capitalized) has its own specialty, obstetrics and gynecology, but, because this is essentially a surgical discipline, has brought in also providers in family medicine, internal medicine and some of its subspecialties (especially endocrinology, because of the issue of bone loss and osteoporosis), nurse practitioners, and others. There are Women’s Health clinics, journals, and meetings all over the place; surely Men’s Health should be just as important?

The centerpiece from which Women’s Health derived is the classic “Well-Woman Exam”, an annual ritual for most adult women, so deeply enshrined in both the national culture and insurance reimbursement system that it is no danger of being overturned by a USPSTF recommendation, or probably anything else. The essential characteristic of the Well-Woman exam is the provision of preventive services because the woman is, well, Well. This is a critical concept – once someone has symptoms that are addressed by any examination (more history questions, physical exam, laboratory, imaging) or treatment, this is no longer “Well-woman”; these are problems, conceived of, addressed, and even billed separately. “Well-woman” means that the women has no symptoms and involves only screening. This screening has long been centered around the Pap smear for cervical cancer, and the internal examination (medical: bimanual = using two hands) that is so associated with the Pap that popular usage considers them together. In addition, breast health is addressed through some combination of provider exam of the breasts, teaching of self-breast exam, and referral for mammography. All of these have been re-evaluated by evidence-based studies and recommendations have changed, often for fewer tests.

Breast cancer screening has been a subject of intense controversy, with USPSTF recommending that not all women over 40 receive mammography screening, reversing a position that they took 8 years earlier, and which even at that time was not based on evidence (see October 30, 2010: Breast cancer screening: conflicting evidence? what are the important questions for health?). The political response from the “breast cancer” community – and it was a political and emotional, not evidence-based scientific response, was huge, and was likely a major reason for the White House pressure on USPSTF to not release its PSA recommendation. In addition, teaching self-breast exam was no longer recommended (this is not to argue against doing self breast exam, a major way women find lumps, but rather to acknowledge the evidence that routinely teaching it does not add benefit). Pap smears themselves, the single best cancer screening tests among a group that are mostly less effective than we would hope, are no longer recommended in women under 21 by the American College of Obstetricians and Gynecologists (ACOG), and do not need to be done annually if they have been normal. Bimanual exams never had any evidence to support their routine use in asymptomatic women, because they cannot screen for any disease. Osteoporosis treatment with bisphosphonate drugs can sometimes lead to serious fractures; recommendations are now to treat only frank osteoporosis, not the less severe osteopenia, and then only for a limited time. Even calcium supplementation has been found to have risks (August 2, 2010, Calcium, Heart Attack and Osteoporosis).

Does this mean that there is no valid place for Women’s Health as a concept or even a discipline? Not necessarily. Women do have risks for conditions that are different from those of men, including for a number of things that men are deeply involved in – contraception (not a risk if there are not men involved), sexual abuse, domestic violence. Asking about these issues is critical, with counseling about them necessary, even if this is not what “Well-Woman” exams usually pay for. And, to the extent that it increases the likelihood that these issues are addressed, Men’s Health may have a place. But in general, the examples above indicate the slippery slope of creating such a field, because there is a need to justify its existence. This means finding tests that can be done, expanding the use of these tests beyond those in whom they were originally found to be useful, and even implementing treatment for which there is no evidence, and which are often found to create net harm.

Prevention is a good thing, but if a test or intervention has not been shown to actually prevent something, doing it is useless and costly at best, and maybe dangerous at worst. Women and men should get the screening tests that are indicated, but not those that aren’t. These include Pap smears and mammography (in the appropriate women), colon cancer screening, blood pressure screening and treatment, counseling about tobacco and alcohol, contraception and investigation of risks of violence and abuse. There are others, particularly in certain sub-populations. But we need to be cautious about the creation of new disciplines and the motivation for their creation – is it increasing health or increasing revenue? Providers, doctors and hospitals, like to do things that make money and promote the fact that they do them; cancer prevention and care is particularly emphasized (January 16, 2010: Cancer Care and Hospital Advertising).

We have “Hallmark holidays” (and as a resident of Kansas City, home of Hallmark, I have to be cautious here), like Mother’s Day and Father’s Day, created and promoted to sell things, that have become very beloved by a large number of people. We don’t need “Hallmark medical care”, designed by marketers to fill a niche as an opportunity to make profit.
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Monday, February 28, 2011

Common Sense Family Doctor blog: Maybe PSA's time has finally come -- to an end!

I highly recommend reviewing Dr. Kenny Lin's blog post on "Common Sense Family Doctor" regarding PSA testing, http://commonsensemd.blogspot.com/2011/02/psa-testing-will-science-finally-trump.html
It reviews not only Dr. Lin's experience in helping write the guidelines but the political pressure to "trump" science.
Hopefully, now, the evidence on the non-utility of PSA testing is clear -- but read his piece for the details.

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