Medicine is increasingly complex, a reality created by the explosion of kno
wledge during the last 50 years. The cost of applying this knowledge create
s a daunting economic challenge. As a result, there has been a profusion of
guidelines intended to influence medical practice. This report explores th
e interrelated issues and concepts that impact the value and success of gui
delines. These include medical quality and error, compliance, and the impac
t on outcomes in an evidence-based medicine context. Lessons learned from p
revious guidelines must be understood in relation to human behavior. Legal
implications of the guidelines must be considered because both an increase
and a decrease in liability can be anticipated. Many products have been lab
eled "advocacy guidelines" with a negative context. They are believed to ex
press motivation rather than optimizing care. The ideal of professionalism
is challenged, and there is potential for the growing use of guidelines in
enforcing punitive actions. Constructive experience has emphasized the appr
opriate required elements for practice guidelines: a systematic review of t
he literature, an assessment of the volume and level of the evidence, and d
evelopment of a review process by an appropriate multidisciplinary group fo
r consistency, clinical impact, and resource implications leading to clearl
y stated and reasonable recommendations. The dissemination of guidelines, b
eyond conventional publication in a journal, will impact the success of the
intended outcomes. The exploitation of electronic avenues, including the I
nternet and the evolving interactive electronic medical record, seems to be
essential for future success in these endeavors. (C) 2001 American Associa
tion for Clinical Chemistry.