Friday, July 20, 2018

Guideline vs physician: Which do you trust?

Hello and welcome. I am Dr George Lundberg and this is At Large at Medscape.

When I was working at the American Medical Association (AMA) in the 1980s, this notion that there should be medical guidelines to help physicians practice better medicine came forth. Guidelines were a well-intentioned academic effort to convert a burgeoning trove of data—which was being amassed under the rubric of evidence-based medicine—into actual practice by physicians far too busy to keep up on their own with the explosion of basic and clinical science.

In 1990, Field and Lohr defined clinical practice guidelines as: "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific circumstances." Thousands of clinical practice guidelines have been issued by country, by specialty field, and by payers. Many of these are available at

But back in the 1980s, what a fuss from so many AMA members who implored their elected leaders to protect them from "cookbook medicine." After all, don't we expect those decisions to be made by physicians who went to medical school to learn how? What about physician autonomy? Not to mention that insurance companies, government, even courts could judge physician behavior against the guidelines and refuse to pay. So the debate began, and it has not ended. The AMA politicians did some wordsmithing and substituted "Practice Parameters" for "Practice Guidelines." By 2007, the AMA's own Manual of Style had named these "Clinical Practice Guidelines," adding parenthetically, "(sometimes called practice parameters)."

Many physicians do endeavor to follow established and accepted guidelines. This is especially true in integrated multispecialty groups such as Kaiser Permanente. The US Veterans Health Administration (VA) and the Department of Defense have been leaders in this field.[4] The VA offers this caution: "This should not prevent providers from using their own clinical expertise in the care of an individual patient. Guideline recommendations are intended to support clinical decision-making and should never replace sound clinical judgment."

Conflicts of interest among the authors, the writing committees, even the sponsoring organizations, are a constant concern since so much money is involved. The Institute of Medicine saw fit to publish an entire book on this topic and included eight standards for how guidelines should be developed: standards (not guidelines) for guidelines.

Of course, Standards of Practice, Consensus Panels, Systematic Reviews, Task Force Reports, Care Pathways, Branching-logic Decision Trees, and Decision Tables are also related. Standards of care may describe the evolution of practices; "protocols" for care may rigidly dictate what must be followed.

Who should "own" clinical practice guidelines? Is it best that a specialty society with subject expertise develop guidelines, even when implementation of those guidelines takes place in the primary care setting? Or should primary care organizations, which live in the sometimes messy real world of patients with time and financial barriers, comorbidities, and other priorities, take ownership of developing guidelines for the care that they are expected to deliver?

Some examples: the American College of Cardiology/American Heart Association (AHA) hypertension guidelines released in November that the American Academy of Family Physicians has declined to endorse; or the just-released American College of Physicians type 2 diabetes guidelines[8] that take aim at the American Diabetes Association standard  that an HbA1c of 7% or below is the appropriate goal.

Or prostate cancer screening: The American Urological Association says screen; the US Preventive Services Task Force (USPSTF) says don't. Both say use shared decision-making, which sounds great but may be hard to accomplish.  PCPs are left in the middle, trying to explain to an anxious patient the pros and cons of a PSA test, including the downside potential of overdiagnosis, when it's a whole lot faster and easier to just order it!

The recent debacle with the stroke guideline, with AHA and the American Stroke Association rescinding huge chunks of their own guideline over the objection of the guideline panel, is a whole other issue. What a mess.

While truth may be ineluctable and eternal, humankind's search for truth is never ending. The basis for clinical practice guidelines must always be the best evidence. The individuals assembling the results of the best studies published in the best journals, and distilling those data into applicable prose, should be the best experts.

The sponsoring organizations should erect firewalls around those individuals and the committees, and between those individuals and the organization itself, and between both of those entities and the monetary impact of the resulting guidelines. Disclosure of conflicts of interest may not be enough to keep the results clean. Those experts with conflicts may need to recuse themselves or be barred from influencing guidelines. Always, follow the money.

I personally prefer government panels such as the USPSTF, which issues guidance informed by the best evidence and experts but formulated by mostly disinterested individuals. 

Science grinds slowly and issues once believed settled are reopened by new knowledge. Never forget that medical associations exist primarily to serve the best interests of their members. And then there are medical organizations that generate vast sums by creating and selling their guidelines, à la the National Comprehensive Cancer Network. Never mind the poor cancer patient; the organization coffers must come first.

Does all of this sturm und drang do any good?

The average life expectancy of an American lengthened from 75.46 years in 1985 to 78.74 in 2015—a good 9.5% growth, The percent of GDP expended on our medical and health care increased from 10.60% in 1985 to 17.9% in 2016, a whopping 60% increase.[14] Did the American people get their money's worth? I doubt it.

I'll take a competent, caring, professionally ethical, and personally moral physician over 10,000 guidelines every time.

The medical industrial complex (MIC) burgeoned. For-profit, money-driven medicine flourished. Towering shiny new temples dedicated to medical research, education, and care came to dominate many urban landscapes. Medical marketing seduced all. The rich became richer; the poor, poorer; and the once dominant, independent, and proud middle class lost net worth, and its mass "pain" of all sorts found increasing solace by tuning out with modern "opiums," commonly provided by key players in that same MIC who make money off that pain. I'll take a competent, caring, professionally ethical, and personally moral physician over 10,000 guidelines every time.

What now? We need key decisions to be shared by patients and physicians, informed by the best evidence, and taking cost (no matter who pays the bill) into consideration.[15] The timekeeping bean-counters be damned. Poor decisions forced by a rushed process often turn out to be penny wise and pound foolish.

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