Medical Guidelines Often Not Evidence-Based

[Guest guest]

Plenty of Guidelines, but Where’s the Evidence?

By DARSHAK SANGHAVI, M.D

Published: December 8, 2008 NYTimes

Every year medical journals publish thousands of new research studies, and

few doctors have the time or expertise to read them all. To help them, a

patchwork of private and public organizations distill these studies into

up-to-date

clinical guidelines, which are recipes that doctors follow to treat everything

from ingrown toenails to heart attacks.

By creating national standards of care, these groups exert great influence

over medical practice. Yet the process for creating guidelines can be

idiosyncratic and error-prone, especially in regard to children’s health,

leading to

sudden shifts that confuse doctors and parents.

Over the last year, for example, the American Academy of Pediatrics abruptly

reversed its recommendation that healthy infants avoid peanuts and other

potential food allergens, without citing any new data. Weeks after the American

Heart Association widely publicized the need to perform cardiac testing in

children treated with drugs for attention problems, the academy issued a

contradictory guideline discouraging such testing.

Last summer, the academy issued a controversial policy statement calling on

doctors to check blood cholesterol levels in millions of young children and, in

some cases, prescribe chronic drugs to lower cholesterol.

Dr. Suchyta, the academy’s associate executive director, told me the

policy was reviewed by 14 committees and the board of directors before

publication. But he added that academy standards did not require any systematic

overview of the scientific literature before a policy was issued. The policies

may

thus rely greatly on some doctors’ personal views, not clear data.

In an oversight, the cholesterol policy was not assessed by the American

Heart Association or American College of Cardiology, which also issue

guidelines. “

Nobody thought to do that,†Dr. Suchyta said.

The committee that drafted the policy also had severe time constraints, said

one of its members, Dr. Jatinder Bhatia, a neonatologist in Georgia. The panel

must review its policies every five years, and this year it had to consider “

a whole bunch of reports,†he told me, including complex policies on infant

formula and vitamin supplementation — 1,178 pages in all, of which the

cholesterol policy was only 11 pages.

The committee also did not grade the quality of the evidence behind its

recommendations, like beginning cholesterol tests in many toddlers as young as 2

and treating children as young as 8 with cholesterol-lowering medications.

Clinical guidelines were first developed in the 1980s, when Medicare

officials asked experts to determine the appropriate use of pacemakers, which

were a

new, expensive technology. “From that effort, the whole concept of guideline

development took off,†said Dr. Elliott M. Antman, a past chairman of the

American Heart Association’s guideline development team, which wrote these

first

guidelines.

To produce its recent guidelines on heart attack treatment, he estimated, the

group spent hundreds of thousands of dollars to review and grade clinical

evidence and to assemble a team of dozens of experts. Few organizations invest

these resources into creating guidelines.

A report in The Journal of the American Medical Association found that only

about a third of clinical guidelines reviewed current medical evidence. Fewer

than half followed any kind of standard format.

Dr. Suchyta says the only group that finances comprehensive reviews of

pediatric health evidence is the federal Agency for Healthcare Research and

Quality.

So far, though, it has sponsored only about a dozen independent reviews,

which serve as the basis of reliable clinical guidelines.

Despite this evidence gap, the pediatrics academy has released hundreds of

care recommendations. The academy is a leading contributor to the National

Guideline Clearinghouse (www.guideline.gov), a public database created by the

American Medical Association that contains the consolidated wisdom of American

medicine in more than 2,200 guidelines. Among domestic contributors, the academy

is topped only by the Centers for Disease Control and Prevention and the

American College of Radiology.

Many of the academy’s recommendations — on topics as diverse as breast

feeding, circumcision and learning disabilities — may arouse controversy.

Moreover,

they may lead to jarring shifts over time, because the evidence is not

explicitly rated for quality.

By contrast, the United States Preventive Services Task Force clearly scores

its guidelines. Routinely checking blood pressure is a Grade A1 practice

(highly recommended, with good evidence), while routine mammography gets a B2

(less

strongly recommended, with fair evidence).

Evidence-based guidelines are critical to protecting public health from bad

medicine. In a notorious 2006 example, a group of cardiologists in Texas

published its own guideline promoting routine, and expensive, cardiac CT scans

in

healthy middle-aged people. The guideline, which lacked any evidence grading,

appeared in a supplement to The American Journal of Cardiology financed by

Pfizer, which makes the cholesterol-lowering drug Lipitor.

son, a health law professor at the University of Michigan who

investigated the rogue guideline, told me he “never got a straight answer as

to

whether it was submitted for peer review.†The guideline also failed to

disclose

any author conflicts of interest. Fortunately, because more trusted groups

like the heart association had more explicit evidence-based guidelines, the

rogue guideline failed to gain wide acceptance.

In contrast, because most pediatric guidelines lack evidence standards,

doctors have trouble knowing which ones are reliable. Last year, the

International

Society for Bipolar Disorders released a guideline to diagnose bipolar

disorder in children, and the lead author reported financial ties to seven

manufacturers of psychiatric medications. No clinical evidence was cited in the

guideline. Because the American Academy of Pediatrics lacks better

evidence-based

guidelines, this could become the standard of care.

Given the background noise from poor guidelines, some doctors ignore even

high-quality ones. For example, fewer than one in three pediatricians follow the

pediatrics academy’s guideline on ear infections, which discourages overuse of

antibiotics. That sensible recommendation arose from a comprehensive federal

review of evidence.

In standardizing care through pay-for-performance incentives, large insurers

like Medicare may increasingly reward doctors for following clinical

guidelines. Before that happens, though, it will be critical to establish better

standards for the standards — especially for children.

Darshak Sanghavi is a pediatric cardiologist at the University of

Massachusetts Medical School and the author of “A Map of the Child: A

Pediatrician’s

Tour of the Body.â€

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