Guideline challenge

Meanwhile, as researchers struggle to arrive at normal values, medical organizations feel compelled to promulgate guidelines as a way to improve patient care and to ensure that medical treatments are appropriate and justified. “Over the last two or three years, there has been a huge push to develop guidelines because there's so much public concern about safety and quality of health care,” says Philipp Dahm, MD, MHSc, clinical research director for the urology department at the University of Florida College of Medicine in Gainesville.

“Our country's health-care budget is exploding, so everyone wants to make sure that the things physicians do make sense or are actually effective.” Organizations use various systems to develop guidelines, and Dr. Dahm questions the reliability of these processes. “How do they decide what is good evidence? Just because something is published doesn't mean it's worth the paper it's written on.”

Dr. Dahm believe researchers do a “pretty good” job of reporting how they search for and grade evidence. “But then it all goes into a black box,” he says. “You've got all these people sitting in a room, and then out come the recommendations. The process of what happens in that room and how the people in the room come to decisions about recommendations is completely undefined.”

Dr. Dahm sees a fix: The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group, which was formed in 2000. “Basically the first step is to evaluate the quality of the evidence—how effective is something, how certain are we about its effectiveness, how directly applicable is it to the patients we're talking about--and the importance of the treatment's outcomes,” Dr. Dahm explains.

The framework also addresses how the guideline process should take place. Dr. Dahm says it is “a very transparent process for guideline development.” (Details about the GRADE framework are available at www.gradeworkinggroup.org.)

 

Regardless of what process is used, guideline developers are limited in large part by the scientific evidence available at a given point in time. As illustrated with PSA testing for prostate cancer and the use of GFR to diagnose renal disease, that evidence can change as researchers gain new knowledge of human biochemistry and physiology.

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