Spotlight on guidelines

So much for a short week. So far we have seen three acquisitions, an FDA approval and one litigation settlement. But let’s start with guidelines.

Researchers published a study in JAMA that evaluated changes to Class 1 recommendations in American College of Cardiology/American Heart Association (ACC/AHA) guidelines between those published from 1998 to 2007 and revisions from 2006 to 2013. They determined that 20 percent were downgraded or omitted. Many of the revisions involved level of evidence below the standard of randomized clinical trials.

This generally has been interpreted as a bad thing, but that deserves to be challenged. Guidelines should not be static. Every day we see findings that shed light in one way or another on patient care. Sometimes the results illuminate some aspect so brightly that they stand on their own as game changers. Most are pin pricks that accumulatively put care in a new, although perhaps diffuse and less convincing, light.

Some changes reflect the knowledge gained over time. Other changes may result from guideline writers’ recognition that what was formerly expert opinion or recommendations based on less rigorous evidence didn’t pan out.

Some critics have found fault with the ACC/AHA authors for sticking with evidence from randomized clinical trials when they released controversial guidelines in November last year for the prevention of atherosclerotic disease. Trials typically use exclusion criteria in patient selection or sometimes fail to enroll sufficient numbers of diverse patient populations. As a consequence, the results may not apply to the broader patient population that physicians see in the clinical setting.

Recommendations based on expert opinion or below the gold standard of randomized clinical trials help them navigate rather than bush whack their way through this terrain.

There is always room for improvement, and the authors of the JAMA study make suggestions for future guidelines. Some of them, such as listing what’s new, already appear in newer documents. Others, such as clearly explaining the reasoning behind changes, may not yet.

The unofficial start of summer usually signals a slowdown. That has not been the case so far, and with conferences under way or set for June, there will be much more to come. We will keep you posted.

Candace Stuart

Cardiovascular Business, editor