In this paper a number of methodological issues relating to research o
n the relationship between the menopause, mood and hormone replacement
therapy (HRT) are discussed. These issues relate to problems of desig
n and statistical analyses, problems which have prevented the reaching
of definite conclusions regarding the relationship between menopause,
mood and hormones. These problems are discussed under three main head
ings, namely, the assessment of menopausal status, statistical modelli
ng and the design and analyses of clinical trials. Problems relating t
o concepts and measurement of dependent variables are the subject matt
er of the papers that follow. Within the three main headings more spec
ific issues are detailed. The paper concludes with a list of recommend
ations on how research in this important area might be further advance
d. (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.