Why guideline-making requires reform.

GUIDELINES ARE A CONSTRUCTIVE RESPONSE TO THE reality that the practicing physician requires assistance to assimilate and apply the exponentially expanding, often contradictory, body of medical knowledge. Guidelines are widely perceived as evidence based, not authority based, and therefore as unbiased and valid. Because they are sponsored by organizations, staffed by experts, and conducted according to apparently formal processes, the products of the exercise— the guidelines—are generally assumed to have the same level of certainty and security as conclusions generated by the conventional scientific method. For many clinicians, guidelines have become the final arbiters of care. Guidelines have taken hold and multiplied. The National Guideline Clearinghouse has registered 2373 guidelines produced by 285 organizations. Indeed, any group of individuals can designate itself a guideline group and different guideline groups have reviewed the same disease and reached different conclusions. If the process is so secure, how is this possible? After all, replication is the distinguishing characteristic of scientific knowledge and an essential test of the validity of any scientific statement. Given the influence of guidelines on clinical practice and given the fact that the process has been, and remains, essentially unregulated, the guideline process deserves review. In this Commentary, we examine the sources of guideline authority; identify major limitations of the present process; briefly address the issue of conflict of interest, both for the individuals who staff the committees and the organizations that govern them; and provide suggestions for reform that may help improve the conduct of the process. Examples are principally selected from lipid guidelines because many clinicians are familiar with them and they illustrate issues that apply to many other guidelines.