The Journal of Bone and Joint Surgery, Vol 72, Issue 10 1451-1455, Copyright © 1990 by Journal of Bone and Joint Surgery, Inc
Prerandomization: an alternative to classic randomization. The effects on recruitment in a controlled trial of arthroscopy for osteoarthrosis of the knee
RW Chang, J Falconer, SD Stulberg, WJ Arnold and AR Dyer
Department of Medicine (Arthritis-Connective Tissue Diseases Section), Northwestern University Multipurpose Arthritis Center, Chicago, Illinois 60611.
Possibly the greatest threat to the success of a randomized clinical trial
is the inability to recruit an adequate number of subjects. Concern that
the randomized clinical trial will adversely affect the physician-patient
relationship is the most common reason for physicians' reluctance to enroll
patients in such trials. We report a modification of a prerandomized
design, first described by Zelen, which was implemented in a randomized
clinical trial of arthroscopy for patients who had osteoarthrosis of the
knee. The method was associated with a sixfold increase in the rate of
accrual of patients as compared with the use of a classic randomization
trial. We propose the design as a potential solution to the problem of
recruitment of subjects, particularly for clinical studies.
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