Randomized clinical trials in the evaluation of surgical innovation.

Randomized clinical trials are widely accepted as the standard for evaluation of therapeutic innovation in many fields of medicine. The three basic components of such trials (concurrent comparison, random allocation, and objective observation) are designed to control four forms of bias (chronology bias, susceptibility bias, compliance bias, and observation bias) that may interfere with the interpretation of the results of a study. Only 2% of the articles evaluating therapeutic maneuvers published in the Journal of Neurosurgery have attempted to use concurrent controls. Only one of 863 such articles met the criteria for a randomized clinical trial. Reasons for underutilization of such trials in neurosurgery are discussed and suggestions for their wider use are offered.