The Covert Rationing Blog

More Fun With Guidelines

May 27th, 2008 by DrRich

Lately DrRich has advanced the proposition that the “Guideline Movement” (the push to reduce all of medical practice to a set of fixed rules by which physician behavior can be controlled) is leading to guideline anarchy (whereby numerous interest groups, from the government to industry to professional societies, have begun a mad dash to create their own sets of guidelines in an attempt to get doctors to behave in ways that will further their own special agendas).

In the effort to give substance - and by extension, some level of legitimacy - to his theory, DrRich gave several examples of anarchical guidelines, and even proposed three different categories of them (i.e., Dueling Guidelines, Predatory Guidelines, and Industry-driven Guidelines).

DrRich is already beginning to see that, once you start looking for them, examples of guideline anarchy begin showing up all over the place. Consider a few of the more interesting ones DrRich has come across just over the couple of weeks:

Dueling Guidelines: Mammograms for women under 50.
DrRich was reminded of this obvious example by a reader. Whether women between 40 - 50 years of age should get routine mammograms has been a point of controversy for some years. Screening these younger women undoubtedly reveals cases of curable breast cancer that otherwise might have been missed. However, such screening also leads to many false positive mammograms, causing unnecessary invasive procedures (and unnecessary anxiety). Because the incidence of breast cancer is lower in younger women, it has been difficult to show objectively that the overall benefits outweigh the negatives of routine mammograms in this age group.

Still, the American Cancer Society, American College of Radiology, and the National Cancer Institute (groups that might benefit by more screening and by finding more cases of potential cancer that need to be evaluated) have long been persuaded that women over 40 should have routine screening. On the other hand, the American College of Physicians and the Canadian Task Force on the Periodic Health Examination (groups that traditionally have relied on overall population-based outcomes, and which are interested in cost savings) say that based on objective evidence, most women should wait until they are 50.

This example is interesting because it shows what happens to dueling guidelines over time. Due largely to vocal and effective lobbying from many groups in favor of screening, professional groups have tended to migrate from the “no” to the “yes” camp. The most recent converts have been the United States Preventive Services Task Force and the American Academy of Family Physicians, groups that traditionally have been in the “cost savings” camp. While the actual data has not changed appreciably, some guidelines have (apparently for non-data-based reasons).

Dueling Guidelines: Fancy anticoagulation for acute coronary syndrome.
A recent editorial appearing in The Lancet points with dismay to two sets of dueling guidelines, one from the American College of Cardiology (ACC) and American Heart Association (AHA), and the other from the European Society of Cardiology (ESC), on the use of two space-age anticoagulation medications in patients with acute coronary syndromes. While the details are fairly mind-numbing and can safely be left alone, the important point is that, after reviewing the same scientific evidence and using the same criteria for rating the evidence, the ACC/AHA essentially said, “yes, use the drugs;” while the ESC said, “no, not so much.” (We may be seeing a trend here, where professional organizations based in the U.S. seem to favor paying for fancy new drugs whose benefit may be considered by more cost-conscious organizations, like those in Europe, as marginal and not worth paying for.)

In any case, it is instructive to hear the lament of the Lancet’s editorialists, who complain,

“The committees reviewed the same research and used nearly identical criteria to rate the strength of the recommendations and to grade the quality of the evidence, but they interpreted the evidence for acute anticoagulant use differently and so reached different conclusions. Therefore, physicians who read recommendations from both the US and European societies might be confused.” (Eikelboom J, Guyatt G and Hirsh J. Guidelines for anticoagulant use in acute coronary syndromes. Lancet 2008; 371: 1559-1561.)

Yes, that’s dueling guidelines for you. If the editorialists would just become regular readers of this blog, they would not find their case so inexplicable.

Premature Guidelines: Beta blockers in noncardiac surgery.
This example requires defining a fourth category of guideline anarchy: Premature Guidelines are guidelines that are promulgated not so much before all the data is in (because all the data will never be in), but rather, before a reasonable amount of data is in. The reason organizations will find it advisable to jump the gun on guidelines is obvious - if you want to get doctors to act in a certain way, and if making guidelines is the best way to do that, the first ones to establish guidelines have a head start on controlling physician behavior.

Our example: Previous (but small) studies have shown that for patients at increased risk for heart disease who are having noncardiac surgery, treatment with beta blockers at the time of surgery reduces the incidence of heart attacks. So, the AHA and ACC (our recurrent friends and aggressive wielders of guidelines) have written formal guidelines that recommend the use of beta blockers in these patients. These particular guidelines, being attractively easy for bureaucrats to track by a simple review of medical records, have been very popular and quite widely adopted as quality measures, performance measures, items on P4P checklists, etc. Accordingly, lots and lots (and lots) of patients have received beta blockers during their noncardiac surgery because of these guidelines over the past several years.

But a very large and well-conducted study (the POISE study) now appearing in The Lancet shows that, while the incidence of heart attack is indeed reduced with the use of beta blockers, the incidence of stroke and of death are significantly increased. The net effect of using beta blockers turns out to be strongly negative. How embarrassing this will be for the AHA, ACC, and thousands of doctors and hospitals who have been dutifully following the guidelines so as to be good medical citizens!

The authors of the study have not played down the inflammatory implications of their new findings. According to theHeart.org, the lead author of the POISE study opines:

“If even only 10% of physicians followed these guidelines — which incidentally in the US are used in quality assessments, where you have people going around ranking hospitals in terms of whether or not they are giving perioperative beta blockers — and if the POISE data are true, then in the past decade 800,000 people would have died prematurely and 500,000 would have had a major stroke perioperatively because we gave beta blockers.”

Oops.

To be fair, an accompanying editorial, written by two physicians partially responsible for the existing guidelines, urges doctors not to panic, and suggests that there’s still a prominent place for beta blockers in these patients, and even suggests (vaguely) what that place might be. They are very reassuring. Unfortunately the data, at the moment, is not. All this will be straightened out over time, of course. But in the meantime we’ve got premature guidelines that remain in force, directing doctors to do something that - by all appearances - is harmful to patients.

(On his About.com heart disease site, DrRich discusses the POISE study, without the sarcasm, for patients who might need to interpret this new information. DB also addresses the implications of the POISE study, here.)

Way-premature Industry-driven Guidelines: Use of IVUS in stent placement.
In a presentation made earlier this month in Barcelona at the EuroPCR meetings, investigators urged that cardiologists use intravascular ultrasound (IVUS) whenever they place stents in coronary arteries. They urge this based on observational data suggesting that using IVUS (an invasive ultrasound technique for visualizing the interior of the artery) can lead to (marginally) improved clinical outcomes. This “suggestion” clearly does not amount to actual “guidelines,” but DrRich includes it here as an interesting view of the type of stuff that can quickly lead to guidelines.

The evidence currently supporting IVUS is not definitive, to say the least. It is based on relatively small observational studies and not on randomized clinical trials. But still, because IVUS is a highly specialized and expensive technique, it is bound to bring a very favorable level of reimbursement to cardiologists, if indeed it were a reimbursable technique. And a very important step to making it reimbursable would be to generate guidelines supporting (or preferably, demanding) its use. And to generate such guidelines, first one must create a groundswell of support among the cardiology thought leaders.

And that’s what was going on at EuroPCR. Indeed, the cardiologist/investigator who is the chief proponent of using IVUS (himself a major shareholder, consultant and speaker for the company that makes IVUS technology), urges that IVUS not be held to “unreasonable” standards such as those requiring randomized clinical trials, but instead that its advantages to patients are so patently obvious that it ought to be made a routine part of stent placement NOW.

Whether this particular example of way-premature industry-based guidelines will ever get anywhere, DrRich obviously cannot say. He offers this example simply as an illustration of the kind of “thinking” that, in the old days, used to lead to fancy dinners, $100 ink pens, trips to Honolulu, and even to compliant female companionship for influential (if geeky) medical thought leaders, all in an effort to increase sales; but that in the modern era leads to guidelines.

Posted in Guidelines, Abuse of

One Response to “More Fun With Guidelines”

1. Dr_Dredd wrote on 05/29/08 at 11:57 am :

   In the case of competing guidelines (such as the mammography example), it should be up to the patient to decide. I personally would rather undergo early screening and risk false positives, but I know not everyone feels this way.

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