Abstract
Background. 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. Methods. We evaluated aspects of the randomization process in 619 surgical trials published
within 10 prestigious journals between January 1990 and December 1999. Results. 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. Conclusions. 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. (Surgery 2002;132:513-8.)
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Article info
Footnotes
*Reprint requests: Professor John C. Hall, University Department of Surgery, Royal Perth Hospital, Perth WA 6000, Australia.
Identification
Copyright
© 2002 Mosby, Inc. Published by Elsevier Inc. All rights reserved.
