Sunday, November 4, 2012

To protect patients, practice guidelines must meet higher standards

Recent news stories have suggested that many of the ills of our health system could be prevented if more physicians followed guidelines on appropriate indications for tests and treatments. For example, a Wonkblog post by The Washington Post's Sarah Kliff noted that 43 percent of cardiac surgeries performed in Michigan were unnecessary, according to practice guidelines. Kliff attributed the disconnect between guidelines and physicians' behavior to two factors: 1) surgeons who perform more surgery earn more income for themselves and their institutions; and 2) the "oculostenotic reflex," which Kliff defined as "the 'irresistible temptation' on the part of interventional cardiologists to expand narrowed coronary arteries, despite ... guidelines suggesting the use of a different intervention, such as medication (which comes with fewer risks and at a lower cost)." Extended across other medical specialties that tend to provide too many aggressive (and profitable) interventions, another way to say this is that if you've got a hammer, everything looks like a nail.

But how can clinicians be sure that a practice guideline is any good? In an article published in American Family Physician a few years ago, family medicine professor David Slawson and I proposed several attributes that health professionals should use to identify good clinical practice guidelines. Here's our list, which became the basis for a lecture I gave in the spring and fall of this year at the Temple University Family Practice Review Course:

1. Comprehensive, systematic evidence search with end date noted
2. Evidence linked directly to recommendations via strength of recommendation grading system
3. Recommendations based on patient-oriented rather than disease-oriented outcomes
4. Transparent guideline development process
5. Potential conflicts of interest identified and addressed
6. Prospectively validated (i.e., guideline use has been shown to improve patient-oriented outcomes)
7. Recommendations offer flexibility in various clinical situations

In 2011, an Institute of Medicine panel published an important report titled Clinical Practice Guidelines We Can Trust. Despite not having consulted Dr. Slawson or me, they produced a longer list of standards for developing trustworthy clinical practice guidelines that was nonetheless very similar to ours. Later that year, the American Cancer Society announced that it would revise its methods for creating cancer screening guidelines to be consistent with the IOM's standards.

That's a positive step, especially for a group that has produced some poor-quality guidelines in the past, but are others doing the same? Unfortunately, no. A recent study in the Archives of Internal Medicine surveyed a random sample of 130 guidelines in AHRQ's National Guideline Clearinghouse for adherence to the IOM's standards. The findings were disappointing, to say the least: "Fewer than half of the guidelines surveyed met more than 50% of the IOM standards. Barely a third of the guidelines produced by subspecialty societies satisfied more than 50% of the IOM standards surveyed." In the straightforward words of an editorial that accompanied the study, "guidelines are still not following guidelines."

In a fee-for-service payment system, doctors already have few incentives to follow practice guidelines, resulting not only in unnecessary heart surgery, but other abuses of patients such as excessive rates of screening colonoscopy. And as the Archives study showed, even conscientious physicians who provide guideline-concordant care may in fact be relying on documents that are worth little more than the paper they are printed on, especially if they were written by specialists whose incomes depend on doing more consultations and procedures.

The bottom line is that all of us - patients, advocates, policymakers, and health professionals alike - must demand that guideline-producing organizations meet higher standards. Groups that continue to convene guideline panels with financial and other conflicts of interest; continue to value the opinions of specialists more than those of generalists; and continue to make strong recommendations based on disease-oriented evidence or, worse yet, no evidence at all; should be called out for what they are: a clear and present danger to the health and well-being of every person who seeks health care.

1 comment:

  1. Addendum: In a commentary in the November/December issue of the Annals of Family Medicine (, Dr. Richard Hoffman and colleagues identify the American Urological Association and National Comprehensive Cancer Network guidelines on PSA screening as examples of poor-quality guidelines:

    "Viewed narrowly, the 2 specialty guidelines appear to be well-meaning efforts that, although based on untested hypotheses rather than direct evidence, might marginally reduce prostate cancer morbidity and mortality. More broadly, however, to propose screening strategies without any direct evidence of benefit takes us in the wrong direction—away from what has been a generally rising standard of evidence—and toward accepting expert opinion as adequate grounds for recommending procedures that expose many to the risk of harms for the benefit of very few."

    I couldn't agree more!