This post is not news to faithful readers. I have ranted about flaws in guideline development for many years. I have a Grand Rounds that I give called Guidelines – a Skeptic’s View. I co-authored a JAMA editorial about guidelines last year.

The current NY Times article unfortunately is, in my opinion, a bit too superficial. I suspect that they do not really explain the details because it is a newspaper article. Diabetes case shows pitfalls of treatment rules

It sounds like a simple idea for improving health care: draw up guidelines on how best to treat a particular illness and then pay doctors to follow them. That strategy, which some insurers and health plans already employ, has been embraced during the health care debate by some lawmakers in Congress who want to extend it more broadly.

The goal is to improve treatment and, at the same time, save money. But setting guidelines that are good for every patient, it turns out, can get messy, with some experts warning that a big national plan of this sort poses risks. A recent case involving treatment for diabetes, one of the nation’s most pervasive illnesses, illustrates the difficulties.

Last year, a national guideline-setting group abruptly withdrew a controversial diabetes standard it adopted in 2006 that called for aggressive control of blood sugar, or glucose. The change came after a large federal study indicated that lowering glucose too quickly or too much in some patients could harm or even kill them.

In medical journal articles and elsewhere over the last year, some diabetes experts have lashed out at the group’s initial decision to approve the guideline, saying they warned back in 2006 that it was medically ill-advised for some patients.

“This was a case in which the advocates of a disease got caught up in their disease rather than the interests of patients,” said Dr. Rodney A. Hayward, a diabetes expert at the University of Michigan who had opposed the benchmark.

Critics like Dr. Hayward have also suggested that pharmaceutical companies influenced the guideline so they could sell more glucose-lowering drugs like insulin. The group that set the guideline, a Washington organization called the National Committee for Quality Assurance, received about $3 million, or 10 percent of its revenue, last year from drug and medical device makers.

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The main problem is that many guidelines are based not on rigorous studies like clinical trials but on weaker types of medical evidence. And critics like Dr. Groopman have argued that the guideline-setting process is often influenced by industry or by medical ideologues looking to advance their personal agendas.

“These guidelines often come out of specialty societies who tend to want to treat rather than not to treat,” said Arthur Levin, the executive director of the Center for Medical Consumers, a patient advocacy group. Mr. Levin also serves as an adviser to the National Committee for Quality Assurance and took part in the diabetes decision.

As I have written repeatedly, guidelines should adhere to the meaning of the word.

This scene from the Pirates of the Carribean makes the point

Barbossa: And how does a maid come to own a trinket such as that? Family heirloom, perhaps?
Elizabeth: I didn’t steal it, if that’s what you mean.
Barbossa: Very well, you hand it over and we’ll put your town to our rudder and ne’er return.
Elizabeth: [she hands it over] Our bargain?
[Barbossa walks away from her]
Bo’sun: Still the guns and stow ‘em, Signal the men, set the flags and make good to clear port.
Elizabeth: Wait! You have to take me to shore. According to the Code of the Order of the Brethren…
Barbossa: First, your return to shore was not part of our negotiations nor our agreement so I must do nothing. And secondly, you must be a pirate for the pirate’s code to apply and you’re not. And thirdly, the code is more what you’d call “guidelines” than actual rules. Welcome aboard the Black Pearl, Miss Turner .

Unfortunately in medicine guidelines too often become rules. The guideline “movement” started out as a well intentioned attempt to provide “guidance” for physicians in those situations for which excellent data provided a solid consensus. Unfortunately, subspecialty societies have hijacked the concept to advance their narrow beliefs about the diseases that they claim.

So sub-specialists write guidelines that we generalists should follow. They then do studies that “show” that sub-specialists adhere to guidelines better than generalists. Of course they only look at process, not outcomes.

The guideline writers likely ignored this post. Must read article on primary care In that post I focus on the paradox of primary care. I once again quote from the key article.

Thus, the paradox is that compared with specialty care or with systems dominated by specialty care, primary care is associated with the following: (1) apparently poorer quality care for individual diseases, yet (2) similar functional health status at lower cost for people with chronic disease, and (3) better quality, better health, greater equity, and lower cost for whole people and populations.

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The primary care paradox is the observation that primary care physicians provide poorer quality care of specific diseases than do specialists; yet primary care is associated with higher value health care at the level of the whole person, and better health, greater equity, lower costs, and better quality of care at the level of populations.

This paradox shows that current disease-specific scientific evidence is inadequate for conceptualizing, measuring, and paying for health care performance. Unraveling the paradox of primary care depends on understanding the added value of integrating, priori-tizing, contextualizing, and personalizing health care across acute and chronic illness, psychosocial issues and mental health, disease prevention, and optimization of health and meaning. This added value is hard to see in assessments at the level of diseases. The added value is readily apparent, however, at the level of whole people and populations.

This paradox highlights the problem. Patients rarely have single medical problems. Guidelines, even if perfectly written for single diseases, rarely adjust for patient complexity. Primary care physicians must be jugglers. They prioritize problem and treatments, knowing that sometimes too much treatment causes harm.

We should reform the guideline movement as my colleague Dr. Shaneyfelt and I proposed in the JAMA editorial – Shaneyfelt and Centor on guidelines. Admittedly I am obsessed with this issue, but my obsession comes from the harm that comes to patients when guidelines become rules and the rules are not appropriately tested. As in this article and several previous articles, guidelines can harm. Primum non nocere!

Related posts:

1. Must read article on primary care
2. Guidelines and performance measures need testing
3. Guidelines not rules
4. Why health care reform should focus on primary care
5. Improved performance – P4P or consistent primary care?

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