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Thursday
Aug112011

"guidelines are only as good as the evidence that underlies them"

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By ANaturalAdvocate

 

In the news lately has been an article entitled “Scientific Evidence Underlying the American College of Obstetricians and Gynecologists’ Practice Bulletins.” This article rates the evidence behind the obstetrical and gynecological recommendations made by ACOG as A (“good and consistent evidence”), B (“limited or inconsistent evidence”), or C (“consensus and opinion”) - levels used by the College itself. These recommendations “are meant to synthesize the best available data and make practical recommendations for clinicians” and are implemented “[t]o guide physicians in the implementation of best practice.” 

The article itself admits the limitations of these recommendations from professional organizations, which are often used as “benchmark[s] for quality,” especially where high-quality evidence may be lacking. Given that these recommendations - which come from practice bulletins on topics from Operative Vaginal Delivery to Shoulder Dystocia and Fetal Macrosomia - “strongly influence the practice of obstetrics and gynecology,” it is imperative that “clinicians must remain mindful of the limitations of guidelines.” The authors do state that these recommendations should not take the place of clinical judgment, however. 

“Among the obstetrics recommendations, level A evidence was noted for 24.6% of the diagnostic recommendations, 46.7% of the counseling recommendations, 20.9% of the guidelines for evaluation, 27.4% of the treatment recommendations, and 4.2% of the guidelines concerning mode of delivery. For gynecology, level A recommendations were found for 29.0% of the diagnostic guidelines, 35.0% of the counseling recommendations, 24.2% of evaluation guide- lines, and 38.1% of those recommendations that addressed treatment.”

While obviously the expertise and training of the physicians forming these recommendations must be taken into account in deciding the weight of “consensus and opinion,” it is clear that many recommendations do not have the evidentiary backing that many consumers assume is present.

A press release from the Big Push for Midwives illustrates the practical effects of these recommendations:

WASHINGTON, D.C. (August 15, 2011)—A study published this month in Obstetrics & Gynecology, the journal of the American College of Obstetricians and Gynecologists, found that barely one-third of the organization’s clinical guidelines for OB/GYN practice meet the Level A standard of “good and consistent scientific evidence.” The authors of the study found instead that the majority of ACOG recommendations for patient care rank at Levels B and C, based on research that relies on “limited or inconsistent evidence” and on “expert opinion,” both of which are known to be inadequate predictors of safety or efficacy.

“The fact that so few of the guidelines that govern routine OB/GYN care in this country are supported by solid scientific evidence—and worse, are far more likely to be based on anecdote and opinion—is a sobering reminder that our maternity care system is in urgent need of reform,” said Katherine Prown, PhD, Campaign Manager of The Big Push for Midwives. “As the authors of the study remind us, guidelines are only as good as the evidence that supports them.”

ACOG Practice Bulletin No. 22 on the management of fetal macrosomia—infants weighing roughly 8 ½ lbs or more at birth—illustrates the possible risks to mothers and babies of relying on unscientific clinical guidelines. The only Level A evidence-based recommendation on the delivery of large-sized babies the Bulletin makes is to caution providers that the methods for detection are imprecise and unreliable. Yet at the same time, the Bulletin makes a Level C opinion-based recommendation that, despite the lack of a reliable diagnosis, women with “suspected” large babies should be offered potentially unnecessary cesarean sections as a precaution, putting mothers at risk of surgical complications and babies at risk of being born too early.

“It’s no wonder that the cesarean rate is going through the roof and women are seeking alternatives to hospital-based OB/GYN care in unprecedented numbers,” said Susan M. Jenkins, Legal Counsel of The Big Push for Midwives. “ACOG’s very own recommendations give its members permission to follow opinion-based practice guidelines that have far more to do with avoiding litigation than with adhering to scientific, evidence-based principles about what’s best for mothers and babies.”

The Big Push for Midwives Campaign represents tens of thousands of grassroots advocates in the United States who support expanding access to Certified Professional Midwives and out-of-hospital maternity care. The mission of The Big Push for Midwives is to educate state and national policymakers and the general public about the reduced costs and improved outcomes associated with out-of-hospital maternity care and to advocate for expanding access to the services of Certified Professional Midwives, who are specially trained to provide it.

Media inquiries: Katherine Prown (414) 550-8025, katie@pushformidwives.org

 

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Reader Comments (26)

I'm happy to continue the discussion once you answer the question that I asked you this morning.

Please name the practices exclusive to midwifery (as opposed to practices discovered and studied by obstetricians) that meet the standard for Level A guidelines. Thus far, you haven't been able to name a single one.

August 16, 2011 | Unregistered CommenterAmy Tuteur, MD

Wow, you just went freaking bananas!

I see why you got screamy about the abstract. My intent was to show that even if a layperson without a subscription wanted to verify the source of the article mentioned in the press release, they could. I should have made that clearer. All caps, though? Really now?

We get pdf's galore every month of Green Journal articles over here, Amy. Probably best to not make accusations about not reading the actual article unless you have... well, evidence.

Levels well understood and when I researched my cesarean recommendation, the main reason for refusal was that their decision were based solely on Level C evidence. I weighed that and several other stats that I came across to weigh risk and benefits.

If you begin with the assumption that laypeople are stupid, ignorant and don't understand (or read) articles, you can build up the quackery narrative around it beautifully. We tend to start with the assumption that, given adequate information and data, consumers are capable of making decisions for themselves. Not every layperson is in grave danger of being duped.

Your bias is showing.

August 16, 2011 | Registered CommenterJill

But you were duped. The evidence is in the post.

The press release utterly misrepresents the study and you printed the press release verbatim without clarifying that it misrepresents the study.

Moreover, the entire premise of the post is disingenuous since there is nothing about homebirth midwifery that is based on Level A guidelines. If it is concerning that obstetrics recommendations are not all based on Level A guidelines, it ought to be a scandal that none of homebirth midwifery is based on Level A guidelines.

The article itself is graded III, the lowest form of evidence. So you are using an article based on the lowest form of evidence to claim that obstetrics isn't based on the highest form of evidence. Doesn't that strike you as hypocritical?

August 16, 2011 | Unregistered CommenterAmy Tuteur, MD

I did notice that the article was Level III and wondered if anyone thought it was ironic, too. It's very meta.

ANaturalAdvocate states that the press release illustrates the practical implications of the review and it does. The press release is one opinion. My opinion, as stated above, is that the 25.5% figure is much lower than I would have anticipated one would see in practice bulletins, but that it's not necessarily a negative. If you are consulting with a specialist, you usually want their opinion. Their opinion and subsequent recommendations would hopefully be based on their experience, the experience of their peers, their schooling and their training. Naturally, many other variables come into play (in any specialty), such as fear of litigation, economic incentives, expediency, policy (both formal and informal), cultural norms of the region and more. Add to that the preferences, finances, overall health, lifestyle, litigiousness and belief system of the patient and the decision making process is potentially very complicated.

The 25/75 breakdown, while surprising to me as a consumer, seems justifiable. Regarding the high number of guidelines with recommendations based on low-quality evidence and expert opinion, the author states "[t]his is particularly problematic as expert opinion is subject to bias, either implicit or subconscious." As a patient, I saw how powerful the fear of litigation is and how this bias has the potential to directly affect recommendations. Naturally, most care providers do not come right out and say, "I am recommending x because I am terrified of being sued again" and the recommendation is communicated to the patient as being based on the best evidence available rather than due to fear of litigation. Sometimes these overlap and everyone wins. Often, they don't.

August 18, 2011 | Registered CommenterJill

Did you see the June issue of the journal Birth?

Dr. Mark Kierse was publicly bewailing the fact that obstetricians follow the evidence from the Term Breech Trial (which showed that C-section is safer for breech babies) "merely" because it is the highest quality evidence.

"Clearly, the blame must rest fairly and squarely with what was heralded as a new paradigm, "evidence based medicine" ... [which] means a new scientific order in which there is no place anymore for the concepts of old. In the new evidence-based paradigm anything randomized became the gospel and anything else became either low evidence or lack of evidence."

So The Big Push sends out a mendacious press release insinuating that Level A guidelines should trump everything else, and Mark Kierse petulantly complains that when it comes to breech, Level A guidelines shouldn't trump everything else.

Which is it? Do obstetricians fail to follow best quality evidence or do they adhere too closely to best quality evidence? Seems like it doesn't matter; they'll be unfairly (and often mendaciously) pilloried regardless, since the real goal is simply to criticize and what's safest for patients has absolutely, positively nothing to do with it.

August 19, 2011 | Unregistered CommenterAmy Tuteur, MD

Late to the party because I missed this post, but with regard to THIS post (I will not get misdirected by people with their own agenda....)

I'm curious to know why such a small number of the ACOG guidelines are based on level A science. I can understand that there may be a lack of quality data, or that generating the appropriate data in a blinded, unbiased way is impossible. Although there are 3 levels of quality, are there any level C recommendations that are in contradiction to level A science? I.e. it's possible to make a quality recommendation based on the science, but ACOG guidelines run counter to the science?

And I haven't seen any comments on this shocking stat:
"level A evidence was noted for...4.2% of the guidelines concerning mode of delivery"
FOUR percent? Does this refer to vaginal vs c-section? Or are there other vagaries included in "mode of delivery"?

August 25, 2011 | Unregistered Commenterlarissa
This blog is all done!
Thanks for wanting to comment. This is an archive of a blog that once was. Take care! Jill