Sunday, January 15, 2012

Get with the Guidelines!

Or not.

This slogan has been adopted by the American Heart Association for its campaigns aimed at getting practicing physicians to follow recommendations made by the AHA for evaluation and treatment of patients with heart attack, heart failure, and stroke.

Why are such campaigns needed? It seems the problem is that guidelines promulgated by medical organizations like the AHA are sometimes not followed by doctors in making decisions about how to care for their patients. And so the AHA has decided it is not enough just to develop and publish guidelines. It must also use marketing techniques to promote the guidelines and get doctors to follow them.

If you'll permit me a brief digression, I'd like to say I think the name for these efforts was ill-chosen. It is clearly akin to "Get with the program!" Nowadays, that command should, I think, be preceded by "Dude!" So what the slogan says to practicing physicians is, "Hey! We are the experts. We have published guidelines for patient care. Why aren't you following them? What is wrong with you?"

I'm going to go out on a limb, because my opinion is based on decades of anecdotal observations rather than systematic, scientific study, but I think doctors have egos a bit more inflated than those of folks in the general population, so this phrase may not be well-received.

More to the point, however, "Get with the Guidelines" is derived from "get with the program," which - according to the McGraw-Hill Dictionary of American Idiom and Phrasal Verbs - "implies that there is a clearly known method or 'program' that is usually followed."

How well or poorly do doctors follow guidelines? And do they generally have guidelines to follow?

Kumar and Nash, two physicians, last year published a book called Demand Better! Revive Our Broken Healthcare System. Fortunately for those of us who may not have the stamina to read the whole book, it was excerpted in an article in Scientific American last March. Two over-arching themes are noteworthy. First, there is a sound scientific basis for what doctors do only about 20% of the time. Second, when such a sound basis does exist, clinicians follow "evidence-based" guidelines only about half the time.

When I read the article in Scientific American, I found it disturbing. Not because it said doctors often don't follow guidelines, which I already knew. (In fact, I am among those physicians who sometimes don't follow guidelines, although I haven't tried to calculate the percentages.) And not because the article says we make a lot of decisions without having strong scientific evidence for guidance. Anyone who knows anything at all about modern medicine knows we have more questions than answers, and we are constantly doing research to find those answers.

No, I found it disturbing because it could easily lead the reader to the conclusion that doctors don't know what they're doing. Perhaps you agree with me that conclusion would require an unfair leap, because you have substantial confidence in modern medicine. But the article reports David Eddy, MD, PhD, a healthcare economist with Kaiser Permanente, expressed his opinion in just those words.

Now let me bring ego back into it, because it's hard for me not to be offended by that characterization. So I Googled Dr. Eddy and found that, at least according to what I could learn on the Web, after his residency training in surgery, Eddy was never a practicing clinician. That doesn't - in and of itself - mean he is wrong. It does, however, mean his pronouncements about the work of practicing doctors are made without that insight.

So what about following guidelines? Kumar and Nash cite a Rand Corporation study about how often doctors practice in a way consistent with 439 different "quality indicators." They found that physicians often failed to do things that were recommended (nearly half the time) and sometimes did things that were not recommended and considered potentially harmful (about ten percent of the time).

Apparently the folks at Rand believed the quality indicators they were examining were rooted in guidelines from professional organizations that were firmly based on scientific evidence. That raises an obvious question. Why are doctors not following these guidelines? Do they not know about them? Do they not believe in them? Are they waiting to see whether their colleagues are following them?

The answer is probably all of the above.

I like to think my own practice of medicine is rational and guided by scientific evidence. At the same time, I freely admit that I must make many decisions each day that are not guided by evidence because, to the best of my knowledge, relevant evidence does not exist. And so I am forced to fall back on what I have been taught, what has seemed to work in my experience, and what my colleagues do.

Now here is a key point: the existence of guidelines and the availability of compelling scientific evidence are not one and the same. What I mean is that professional organizations sometimes publish guidelines that are not accepted by some practicing doctors. This is true even when those organizations claim their guidelines are evidence-based. You see, some of us are naturally skeptical, and we want to evaluate the evidence for ourselves.

We have a few questions. First, do we agree with the conclusions reached by the "experts" who evaluated and rated the strength of the evidence? Second, do we agree with their decisions about what to recommend based on the evidence? Third, could their conclusions have been subject to any outside influence (for example, sources of funding)?

When an organization issues guidelines for the treatment of pneumonia, and the process of developing guidelines was partially funded by a company that makes an antibiotic for pneumonia, it raises questions. When another organization issues guidelines for the prevention of blood clot formation in hospitalized patients, and the development and promulgation of those guidelines was partially funded by a company that makes an anti-clotting drug, it raises questions.

As mentioned early in this essay, the American Heart Association issues guidelines for the treatment of stroke. There is a clot-busting drug that the AHA recommended for treatment of stroke not too long after the drug was approved for this by the FDA in the mid-90s. Many doctors were skeptical of this recommendation. Many remain skeptical. More recently, the AHA issued a new advisory that said some patients can be treated with this drug up to four and a half hours after the onset of the stroke instead of the previous guideline of three hours. Many doctors are skeptical, and the expanded "treatment window" has been catching on fairly slowly.

I have reviewed the evidence, and it is my opinion that the AHA is flat wrong. But we are not all scientists keenly interested in critical examinations of scientific evidence. Some of us are highly influenced by what we experience directly. Recently a patient at my hospital was treated with the clot buster beyond the original three-hour window. She experienced the most feared complication of use of this drug: bleeding into the area of the brain affected by the stroke. If I hadn't already been convinced by my own review of the science that treatment beyond three hours was a bad idea, how do you suppose my thinking would have been affected by this negative experience?

[It is important to remember the old maxim, "The plural of anecdote is not data." In other words, one's own clinical experience may not reflect scientific truth. If you flip a coin 1000 times, you will get pretty close to 500 each of heads and tails. If you flip it ten times, you could be way off from five and five, and you could be misled about probabilities if you don't keep in mind the effect of sample size.]

Finally, none of this takes into account the variables that must be considered when deciding whether and how to apply treatment guidelines to an individual patient. Treatment according to the guidelines may be inconsistent with the patient's preferences and values.

My point is that there are reasons - some very sound, some just a reflection of human nature - why doctors are slow to embrace guidelines. Anyone who says it's because they "don't know what they're doing" has a very incomplete understanding of the world.

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