Last year the Institute of Medicine (IOM) published a report entitled “Clinical Practice Guidelines We Can Trust.” Clinical guidelines are what doctors use to diagnose and treat medical conditions. So is the IOM suggesting that there are clinical practice guidelines we can’t trust?
Well, perhaps not in so many words. But the IOM report does recommend that clinical practice guidelines be updated at pre-determined intervals. And accelerated whenever there is new data or information.
However, trusting these guidelines is going to require not just new data, but better understanding—of competing risks, the problems of false positives, and screenings and “biomarkers” that lead nowhere but a vicious circle.
For instance, some of these guidelines have become so overly narrow and specialized that they wind up causing more harm than good overall. The recommended screenings and treatment protocol may result in fewer complications from that particular problem. But many times, patients still suffer decreased quality of life—and even a higher risk of mortality. Which is like saying, “the operation was a success, but the patient died.”
One striking example of this problem appeared recently in the Archives of Internal Medicine. It involved a patient (referred to as Mr. R) who became an unfortunate victim of the clinical practice guidelines for abdominal aortic aneurysm (AAA). AAA is a bulge in the aorta that has the potential to rupture suddenly, which can be fatal.
The first research paper I ever published, as a medical student, was on surgical repair of AAA with the Chief of Surgery at the Graduate Hospital of the University of Pennsylvania, Dr. Paul Nemir, and I have followed this issue for 35 years now.
Today, clinical practice guidelines call for AAA screening for all men between the ages of 65 to 75 years who have ever smoked cigarettes. The problem is, while screening does lead to fewer deaths from AAA itself, it doesn’t result in any improvement in overall mortality. In fact, as the recent article in the Archives of Internal Medicine states, “If 1,000 people get screened, and 1,000 people do not, an estimated 110 will die after 4 years in each group. An identical risk of mortality despite the screening.”
But what about the quality of life in patients who do undergo screening—and subsequent treatment—for AAA? If Mr. R’s story is any indication, the prognosis is anything but good…
His doctor recommended screening for AAA because he fit the clinical practice guidelines. He was an overweight, former cigarette smoker who had previously suffered a heart attack. He also had high cholesterol and high blood pressure. Yet, despite these “risk factors,” Mr. R was still able to walk a mile. And only had to stop because of arthritis pain in his knee not heart or circulatory problems.
When his screening uncovered AAA, Mr. R agreed to the procedure his doctor recommended (again based on clinical practice guidelines). And within two weeks, he underwent surgery to have his aneurysm repaired with a stent.
But six months later, Mr. R’s left leg became completely numb. There was no pulse in it. As it turned out, the stent inserted to “repair” his AAA had become completely blocked. He had to undergo emergency surgery to try to save his leg. Followed by three more surgeries. And while he didn’t lose his leg, he’s now “a shell of his former self.” He can’t go two steps—let alone a mile—without the use of a walker.
Yet, Mr. R—and his doctors—did everything “right” according to the clinical practice guidelines for AAA.
Mr. R’s only regret is not asking for the statistics before undergoing screening in the first place. Knowing that the risk of mortality is exactly the same whether or not a person gets screened, he says he wouldn’t have bothered. “I thought it was a matter of life or death,” he said.
That’s certainly the way many clinical practice guidelines can make things seem. But as I’ve discussed before, both here in the Daily Dispatch as well as in my Insiders’ Cures newsletter, often times less medical care is better.
So when the IOM recommends taking a critical look at clinical practice guidelines, perhaps they should also add this insightful piece of advice from Mr. R’s story in the Archives of Internal Medicine: “The question before any intervention is not how poor the prognosis is without it, but how much better it is with it.”
Source:
“An unmeasured harm of screening,” Archives of Internal Medicine 2012; 172(19): 1,442-1,443