Guideline challenge

Meanwhile, as researchers struggle to arrive at normalvalues, medical organizations feel compelled to promulgate guidelines as a wayto improve patient care and to ensure that medical treatments are appropriateand justified. “Over the last two or three years, there has been a huge push todevelop guidelines because there’s so much public concern about safety andquality of health care,” says Philipp Dahm, MD, MHSc, clinical researchdirector for the urology department at the University of Florida College ofMedicine in Gainesville.

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“Our country’s health-care budget is exploding, soeveryone wants to make sure that the things physicians do make sense or areactually effective.”Organizations use various systems to develop guidelines, andDr. Dahm questions the reliability of these processes. “How do they decide whatis good evidence? Just because something is published doesn’t mean it’s worththe paper it’s written on.”

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

Dr. Dahm sees a fix: The Grading of RecommendationsAssessment, Development and Evaluation (GRADE) Working Group, which was formedin 2000. “Basically the first step is to evaluate the quality of theevidence—how effective is something, how certain are we about itseffectiveness, how directly applicable is it to the patients we’re talkingabout–and the importance of the treatment’s outcomes,” Dr. Dahm explains.

The framework also addresses how the guideline processshould take place. Dr. Dahm says it is “a very transparent process forguideline development.” (Details aboutthe GRADE framework are available at


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