Problems in the "evidence" of "evidence-based medicine".

The proposed practice of "evidence-based medicine," which calls for careful clinical judgment in evaluating the "best available evidence," should be differentiated from the special collection of data regarded as suitable evidence. Although the proposed practice does not seem new, the new collection of "best available" information has major constraints for the care of individual patients. Derived almost exclusively from randomized trials and meta-analyses, the data do not include many types of treatments or patients seen in clinical practice; and the results show comparative efficacy of treatment for an "average" randomized patient, not for pertinent subgroups formed by such cogent clinical features as severity of symptoms, illness, co-morbidity, and other clinical nuances. The intention-to-treat analyses do not reflect important post-randomization events leading to altered treatment; and the results seldom provide suitable background data when therapy is given prophylactically rather than remedially, or when therapeutic advantages are equivocal. Randomized trial information is also seldom available for issues in etiology, diagnosis, and prognosis, and for clinical decisions that depend on pathophysiologic changes, psychosocial factors and support, personal preferences of patients, and strategies for giving comfort and reassurance. The laudable goal of making clinical decisions based on evidence can be impaired by the restricted quality and scope of what is collected as "best available evidence." The authoritative aura given to the collection, however, may lead to major abuses that produce inappropriate guidelines or doctrinaire dogmas for clinical practice.