Wednesday, December 14, 2011

Cancer group aims to boost trust in guidelines

In a field plagued by frequent controversy, the American Cancer Society has taken "a major step forward" with a new system for developing trustworthy screening recommendations.

Instead of having cancer specialists develop its guidelines, the ACS now leaves that to generalist health care professionals accompanied by a patient advocate.

The approach has previously drawn criticism for another prominent guideline-writing organization. The ACS argues, however, that it gets rid of an obvious conflict of interest, because oncologists might benefit financially from recommending new screening tests, which lead to more diagnoses and treatment.

Still, pulling the cancer experts, or subspecialists, was the toughest part of revamping the guideline process, said Dr. Tim Byers of the ACS, who led the new efforts.

"The conflict is that they know the most about it, but they also have the most self-interest in it," he told Reuters Health.

The ACS is the largest voluntary health organization in the U.S., and its guidelines are used by patients, doctors, insurance companies and policymakers alike. An article in today's Journal of the American Medical Association outlines its new system.

Most other groups that develop medical guidelines still have leading specialists at the helm. One exception is the government-backed U.S. Preventive Services Task Force, which consists of generalists such as family doctors and public health experts.

A few months ago, the panel caused an uproar among urologists when it issued a draft recommendation that healthy men not get screened for prostate cancer with the so-called PSA test.

And in 2009, it triggered a media storm after it recommended that doctors scale back routine mammograms for women in their 40s and 50s. Both recommendations are at odds with the ACS's guidelines.

While the U.S. Preventive Services Task Force does consult with subject experts before making its recommendations, it hasn't been explicit about it, which has fueled criticism of its guidelines.

BE CLEAR ABOUT THE HARMS

Subspecialists will still have an advisory role in the guideline development at the ACS, but they will no longer be able to vote and will not be writing the guidelines.

Byers said making recommendations always involves some degree of value judgment, and that the new ACS guidelines will be more transparent about that.

"We need to more explicitly describe potential harms along with benefits, and when we make recommendations to be clear about the balance between benefits and harms," he said.

While some screening tests -- say, mammography or colonoscopy -- have been shown to save lives, all have downsides.

For instance, there is the cost of looking for disease in healthy people, the anxiety and the potential for procedure complications. The tests may also sound a false alarm that can lead to unnecessary biopsies, which carry their own risks. And in some cases, early detection means doctors diagnose and treat cancers that would never have caused any harm if left alone -- a phenomenon known as overdiagnosis.

"Overdiagnosis is an inherent issue in any screening, even screening that is proven to be beneficial like mammography," said Byers.

BREAKING NEW GROUND

The ACS will also conduct systematic reviews of the medical evidence before making recommendations, to make sure as much as possible of its guidance is based on data instead of opinion.

Recent studies have shown that many guidelines rely more on expert opinions that real experiments, making them vulnerable to personal biases.

In an email to Reuters Health, Dr. Sheldon Greenfield of the University of California, Irvine, called the ACS's new system "a major step forward."

He added that a major challenge would be to make sure the public grasps the complexity of the science in the guidelines.

Greenfield recently chaired an Institute of Medicine committee that released standards for how to make clinical guidelines better and more trustworthy.

Earlier this year, he told Reuters Health that good guidelines need to be based on extensive reviews of the medical literature done by researchers with no financial conflicts of interest.

Greenfield also said the guideline panels have to represent all stakeholders, including doctors from other specialties and patients. Fulfilling all three requirements, he said, was "about as common as peace in the Middle East."

Dr. Michael LeFevre of the U.S. Preventive Services Task Force also applauded the ACS's efforts.

"This is the first time I have seen a major organization use the Institute of Medicine model," he told Reuters Health.

WILL CANCER SCREENING GUIDELINES EVER BE THE SAME?

LeFevre said he believes the new system might help align the advice from the two organizations.

"Many of the differences between Task Force recommendations and others have to do with the different processes by which those conclusions are reached," he said. "The process that was outlined certainly moves in the direction of the process that we use."

Byers was less convinced that the differences would disappear. Instead, his hope is "that we can be more explicit about what the reasons for those differences are."

The ACS is currently developing guidelines on lung cancer screening, a topic that sparked debate in the media earlier this year. According to Byers, the new system will be used "in spirit" to those guidelines, although it is too late to apply it full-out.

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