Design and conduct of antibiotic trials. A report of the Scientific Studies Committee of the Surgical Infection Society
J. S. Solomkin, E. P. Dellinger, N. V. Christou and A. D. Mason Jr
Several recent publications have identified important methodologic problems
in the design and conduct of antimicrobial trials in surgery. Developed by
consensus of the members of the Scientific Studies Committee of the
Surgical Infection Society, this report provides broad guidelines for the
construction of antimicrobial trials. The central issues identified include
pretrial definition of study purpose, entry criteria, assignment device,
and statistical analysis. These issues are fundamental in designing studies
with an acceptable likelihood of finding differences among those
antimicrobial regimens at least risk to the study subjects. The importance
of stratifying patients on the basis of background condition, disease, and
severity of illness is stressed. The inclusion in a study of variables that
enhance the statistical power and, therefore, the believability of this
study is stressed as an important means of clarifying substantial
differences between therapies.
