Shaneyfelt and Centor on guidelines

25 Feb
2009

 

I have great joy today as the co-author of a JAMA editorial.  This link will only work for subscribers – Shaneyfelt T, Centor R "Reassessment of clinical practice guidelines: Go gently into that good night" JAMA 2009; 301: 868-869.

Two major medicine sites have included quotes from our editorial – Cardio Care Guidelines Backed by Weak Evidence and ACC/AHA Guidelines Largely Based on Weak Evidence and Expert Opinion.  Some quotes from those articles:

In an accompanying editorial, Terrence Shaneyfelt, M.D., M.P.H., and Robert Centor, M.D., of the University of Alabama School of Medicine in Birmingham, said that practice guidelines "are actually expert consensus reports."

They expressed concern about the influence potential bias could have on the writing of guidelines, both financial and organizational.

"Guidelines often have become marketing tools for device and pharmaceutical manufacturers," they said. "Financial ties between guideline panel members and industry are common. "Experts" on guideline panels are more likely to receive industry funding for research, consulting fees, and speakers’ honoraria."

They also criticized guidelines for focusing on single diseases, failing to address the complexity of most patients’ conditions. They pointed out that most guidelines become outdated after 5 years.

"Most guidelines have a one-size-fits-all mentality and do not build flexibility or contextualization into the recommendations," they said.

As a result of these problems, they said that "many clinicians do not use guidelines. An even greater concern, however, is that some of these consensus statements are being turned into performance measures and other tools to critique the quality of physician care."

They called for major changes in guideline writing, including centralizing all guideline writing under a single agency, for example, under the guidance of the Agency for Healthcare Research and Quality or a similar group. They also advocated reducing or eliminating all potential conflicts of interest, prioritizing guideline development for the most important issues, and adding flexibility to account for the complexities of individual patients.

They remained skeptical that such changes would occur, however, "because many guideline developers seem set in their ways."

"If all that can be produced are biased, minimally applicable consensus statements, perhaps guidelines should be avoided completely. Unless there is evidence of appropriate changes in the guideline process, clinicians and policymakers must reject calls for adherence to guidelines," they said.

and

In an editorial accompanying the published study [2], Drs Terrence Shaneyfelt and Robert Centor (University of Alabama School of Medicine, Birmingham) write that the "overreliance on expert opinion in guidelines is problematic," particularly since the guideline committees come to the table with implicit biases, values, and goals that aren’t typically disclosed. Moreover, too many current guidelines are marketing- and opinion-based pieces, "delivering directive rather than assistive statements," they add.

In addition, they argue that guidelines are not patient-specific enough to be useful and do not allow for individualization of care, instead adopting a one-size-fits-all mentality. Moreover, there are simply too many guidelines on the same topic. The editorialists write that if the guidelines continue to exist, they need to undergo major changes, including limiting committee members with financial ties to industry or other potential conflicts of interest. Guideline development should also be centralized under a governing body to reduce bias and redundancy, something that might be achieved by allowing the US Department of Health and Human Services to oversee their drafting.

"However, it seems unlikely that substantial change will occur because many guideline developers seem set in their ways," write Shaneyfelt and Centor. "If all that can be produced are biased, minimally applicable consensus statements, perhaps guidelines should be avoided completely. Unless there is evidence of appropriate changes in the guideline process, clinicians and policy makers must reject calls for adherence to guidelines."

Speaking with heartwire, Tricoci, rather than fault the guideline committees, said the findings represent a failure of the current research system. With clinical trials performed predominantly by industry, unaddressed clinical questions are overlooked, as these companies are interested primarily in bringing new products to market.

Excuse me if I have a grin plastered on my face all day.  Dr. Shaneyfelt (a frequent commenter on this blog) originally published the classic article criticizing the guideline process.  He and I have discussed this issue often over the past 5 years.  Those discussions led to this editorial.

We must also thank the blog readers.  This blog gives me the opportunity to explore ideas, some of which lead to articles and editorials.  Readers will recognize many concepts that I have explored here in the past.

Back to smiling.

 

Related posts:

  1. Dr. RW and the JAMA editorial
  2. Another performance measure challenged – BP goal
  3. Caution – guidelines have biases
  4. Can expert panels improve health care?
  5. Guidelines as goals

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12 Responses to Shaneyfelt and Centor on guidelines

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JPB

February 25th, 2009 at 10:18 am

Bravo! I have thought that “guideline medicine” is one of the biggest problems in medicine today. It’s nice to see someone who has the guts to go counter from the current dogma!!

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pcb

February 25th, 2009 at 11:03 am

Good job, DB.

Your critique reminds me of a study done on COPD patients in the community showing that 95% of those being treated/diagnosed with COPD wouldn’t have qualified for the clinical trials used to set the guidelines for COPD treatment. (disqualified for various “strategic” reasons in the trials). Clearly absurd.

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JPB

February 25th, 2009 at 11:16 am

One more word regarding guidelines. One must be very wary of guidelines whose _primary_ purpose is to

1. raise physician income;
2. sell drugs
3. protect against liability.

I know that will not be very popular with the vested interests but we all need to start speaking out if the medical profession is to be saved!

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Bohdan A. Oryshkevich, MD, MPH

February 25th, 2009 at 2:02 pm

Dear Friends:

There is also this.
Subscription required.
JAMA. 2009;301(4):429-431 (doi:10.1001/jama.2009.15)
Allan D. Sniderman; Curt D. Furberg
Why Guideline-Making Requires Reform

What percent of what we do can be submitted to double blind studies? So that it can provide us with first rate guidelines? The DCCT was terrific. But is it applicable to the inner city diabetes epidemic?

Do we not have to make very careful observations at the bedside and then make decisions with the best information that we have? Why not first make certain that we know the patient and then work from there. Every patient is different.

If you begin with the premise that the patient comes first and you are not lazy and are competent and well read, are you not capable of making decisions on your own? Are you not capable of being practical, sensible, etc? Are you not capable of looking it up?

I do not know where the idea that cognitive physicians are expendable came from and that doctors, if properly trained and motivated, cannot make decisions on their own.

I do not understand why all these guidelines came forth in the first place.

I remember asthma guidelines that encouraged the use of serevent. Now it is off the market. It should never have been on the market given its similarity to similar long acting fonoterol.

I think that the single biggest impediments to quality economical care are the absent of generalists, the over-indebtedness of medical students which leads to income generating behavior, and outside influences from industry (pharmaceuticals and devices) which influence the language and culture of medicine in this country.

We have over utilization of imaging technology causing unnecessary radiation exposure, yet we have all the guidelines in the world in English accessible online immediately.

If we spend thirty billion dollars on pharmaceutical marketing per year and something less than five billion dollars on medical education, how can we be so serious about guidelines?

Bohdan A. Oryshkevich, MD, MPH
New York City

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JPB

February 25th, 2009 at 4:10 pm

I have to say another “Bravo”! It is heartening to hear physicians talking about these problems. How do we go forward? It is a subject that we neglect at our own peril….

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DrRich

February 25th, 2009 at 4:52 pm

DB,

Congratulations on a well written and very timely editorial. While I admit to some trepidation in having the government centralize the guideline writing process, at least we all know where the bias will lie there. Currently, with various interest groups engaging in “guideline duels” to further their own special agendas, we have institutionalized chaos where the biases are (as you point out) hidden.

Well done.

Rich

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Jean Claude

February 25th, 2009 at 6:06 pm

Excellent!

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The Happy Hospitalist

February 25th, 2009 at 9:48 pm

I read it on the hard copy. Great job.

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cory

February 27th, 2009 at 6:09 am

Re: Guidelines protecting against liability

If you spend any significant amount of time working with lawyers, you realize that unlike in medicine where doctors tend to draw a specific conclusion from a piece of information, lawyers can and do interpret information in diametrically opposite fashion in many instances. Virtually any “fact” can be viewed with alternative interpretations. It can work for your case or against your case. Lawyers commonly hear a piece of information and ponder it’s meaning for a second figuring how it can help or hurt their advocacy.
Thus it is with medical guidelines – some in the medical community think that establishing them protects you from liability. Sometimes. When you follow them you usually have a good defense and a good defense is usually going to deter a lawsuit. Ah, but it can work the other way- what happens when you follow the guidelines in a case where the patient may not exactly fit whatever criterion the guidelines are for- and the outcome turns bad? Even more importantly, if guidelines have been established, how often are you “liable” if you don’t follow them, even if you pursued an eminently reasonable course? There is a segment of the legal community who may look at the failure to follow guidelines as a decent argument to file suit when things don’t go right, even if you acted appropriately.

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Ron Chusid

March 1st, 2009 at 3:29 am

The problem with pushing guidelines is often not that the articles which contain the guidelines are bad but that some try to use them beyond where it makes sense.

Articles with guidelines on treating a specific illness are often of value to read, especially if they do a good job of separating what works well from what does not. As you have already pointed out here many times, there are also limits to the application of guidelines, such as in patients with multiple problems. The DCCT was very helpful, but could not be used as a pure cookbook guide to treat every diabetic.

Articles with guidelines are fine as long as left to physicians to consider as one of many sources of information to guide intelligent decision making. They cannot be reliably used by third parties to attempt to dictate care or as sole criteria to judge whether a physician’s treatment is appropriate in any specific case.

Guidelines can even be of use (beyond the hypothetical benefit of protection from liability). I once had a Medicare audit which led to a demand that some payments be returned. This was basically because the medical director of the Medicare intermediary had some ideas which conflicted with published recommendations. I appealed used articles which were essentially practice guidelines to defend my charges and the ruling was in my favor.

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