The ABCs of Guidelines

The ABCs of Guidelines

George W. Sledge, MD, FASCO

Nov 06, 2011

The ABC1 conference has been going on in Lisbon, Portugal, for the past three days. ABC stands for Advanced Breast Cancer, and the conference has been a mix of didactic lectures (on all things metastatic) and guideline development. It’s the latter I wish to discuss.

There are several types of guidelines. ASCO takes the Marianas Trench approach—seven miles deep but not very wide. Others (such as NCCN) tend to be broad but shallow, like the Platte River in August. Guidelines can be created in closed rooms, or (as with the ABC1 guidelines, which will eventually be published in The Breast under the auspices of the European School of Oncology) hashed out in public.

The Guideline panel I sat on today was a rapid-fire take on metastatic breast cancer, with the panel voting on dozens of questions following relatively brief (three-minute average) discussions. We had access to the questions prior to the meeting, and some prior Internet chatter, but the decisions were by majority vote in quick succession. As often happens when you fill a panel with talented and opinionated physicians, disagreements occur. Sometimes these were disagreements over style points, and sometimes disagreements about the meaning of the data.

In many cases the data are soft. Whenever you see the words “expert opinion” in a set of published guidelines, beware: expert opinion and a buck will get you a ride on a bus. A majority opinion is not always superior to a minority opinion. I know this because I was in the minority on more than one occasion, and I consider myself wise and prescient as to the outcome of Phase III trials that have yet to be performed. But, as Churchill famously said, democracy is the worst form of government, except for all the others.

And there is a certain wisdom to committees, as every ASCO volunteer knows. When Thomas Jefferson penned the immortal Declaration of Independence in 1776, he did so as part of a committee assigned to the task. He thought that the committee (which included, among others, John Adams and Ben Franklin—try and top that!) butchered his lovely child, and left us his version to compare with the one eventually accepted. Virtually every historian views the revised version as the superior one: sorry, TJ, but collective wordsmithing often improves even the best first draft.

Guideline committees have concerns that go beyond the science of oncology. What is the cost of a particular approach, both in terms of economics and toxicity, and should the financial cost be a determinant of what recommendations the committee makes? What effect will guidelines have on physician efficiency? Can the guidelines be carried out in resource-impaired low- and middle-income countries? What do you do when a new agent has had a positive Phase III trial but has not yet had a peer-reviewed publication or regulatory approval? What do you do when no Phase III trial has been performed and likely never will be? How far down in the weeds do you get when detailing optimum treatment approaches? What role should patient preferences play in the determination of appropriate therapy? These are all value judgments, and our values are not all the same.

Like most sausage making, the picture of a guidelines committee in action is not always a pretty one. This morning, the audience would occasionally clap and cheer after a particular vote was taken, as if their team had won. I know, comparing 2011 to 1995, that advances in technology and verdicts delivered by clinical trials can render the old verities irrelevant or just plain wrong. I suspect, because the same forces remain at work, that this guideline will at best be a rough draft of advanced breast cancer care. But that is fine: we don’t always get it right the first time, things change, and guidelines should as well.

ASCO faces its own challenges going forward, as we attempt to integrate our guidelines, and those of sister societies, into a Rapid Learning System. Will we be primarily a creator of guidelines, or will we vet those of others? How will our guidelines relate to and enrich our quality initiatives? How can we use our guidelines to provide decision support to practicing oncologists and their patients? These questions have real implications for our society, and for cancer care.

I mentioned Thomas Jefferson and the Declaration of Independence, and his disdain for committee wordsmithing. Yet when Jefferson died, the epitaph engraved on his tombstone didn’t mention the fact that he had been President of the United States, Vice-President, Secretary of State or Governor of Virginia. At the end of his long life he considered those accomplishments unimportant. Instead the gravestone reads:

“Here was buried
Thomas Jefferson
Author of the Declaration of American Independence
of the Statute of Virginia for religious freedom
& Father of the University of Virginia”

That guideline committee worked out OK, apparently. His other committee work wasn’t too shabby, either.


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