This article presents methods for sample size and power calculations for st
udies involving linear regression. These approaches are applicable to clini
cal trials designed to detect a regression slope of a given magnitude or to
studies that test whether the slopes or intercepts of two independent regr
ession lines differ by a given amount. The investigator may either specify
the values of the independent (x) variable(s) of the regression line(s) or
determine them observationally when the study is performed. In the latter c
ase, the investigator must estimate the standard deviation(s) of the indepe
ndent variable(s). This study gives examples using this method for both exp
erimental and observational study designs. Cohen's method of power calculat
ions for multiple linear regression models is also discussed and contrasted
with the methods of this study. We have posted a computer program to perfo
rm these and other sample size calculations on the Internet (see http: //ww
w.mc.vanderbilt.edu/prevmed/psintro.htm). This program can determine the sa
mple size needed to detect a specified alternative hypothesis with the requ
ired power, the power with which a specific alternative hypothesis can be d
etected with a given sample size, or the specific alternative hypotheses th
at can be detected with a given power and sample size. Context-specific hel
p messages available on request make the use of this software largely self-
explanatory. Controlled Clin Trials 1998;19:589-601 (C) Elsevier Science In
c. 1998.