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How Clinical Guidelines Can Fail Both Doctors and Patients

Any confusion over the recent news of cholesterol guidelines in the U.S. is perfectly understandable. On the one hand, the guidelines suggest that nearly half the population should use statins to stave off heart attacks and strokes. On the other, use of the drugs is not with potential side effects and, to many, will offer no substantive benefits. The controversy highlights a problem mired in an outdated way of thinking about health care and the doctor-patient relationship.

Guidelines came about after generations of physicians wanted to bring something more than “opinion and experience” to the patient’s bedside. In the late 1960s legislation for the U.S. Food and Drug Administration was amended to call for a demonstration of efficacy and an assessment of benefits and risk as prerequisite to the licensing of any pharmaceutical. Modern clinical science resulted, first slowly and now with an avalanche of clinical trials, each pouring forth outcome data galore.

The Burden of Clinical Data

Clinicians are expected to stay current with this wealth of information. The modern medical curriculum instructs all budding physicians on how to evaluate the quality and the clinical relevance of all such contributions to the body of clinical science. Because some (or perhaps many) find this exercise overwhelming, there are organizations—many academic and some without any discernible relationships with purveyors that could pose a conflict of interest—that attempt to bundle the information in a fashion that might be relevant to particular physicians or physicians in particular specialties. Some of this bundling is quite systematic, some quite helter-skelter.

Occasionally there is a contribution to the literature that offers an unequivocal advantage for a particular patient group. More often, the bundlers are faced with a heterogeneous literature that often demonstrates little, if any, efficacy. Faced with these circumstances, biostatistics has offered up many a method to impute more value to the literature than is apparent at first blush. The result is that all this bundling adds to an enormous and ever-expanding secondary literature.

What is the clinician to do?

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