Randomization in surgical trials.

Abstract

There are concerns that use of the term "randomized" conveys a form of legitimacy to surgical trials that may sometimes be inappropriate. The objective of this study was to review the nature and use of randomization techniques in surgical trials. We evaluated aspects of the randomization process in 619 surgical trials published within 10 prestigious journals between January 1990 and December 1999. Only 33% of the published trials (202/619) adequately described a valid randomization process. Furthermore, 78% (484/619) did not declare the use or extent of a blinding technique and almost two-thirds of the published trials failed to state how they concealed the randomization process. Our study indicates that many published surgical trials ignore basic aspects of the randomization process. It is difficult for surgeons to have faith in trials that fail to demonstrate an unbiased allocation of patients and ignore the need to maintain some confidentiality about the allocation of patients into groups.