Menopause, mood and hormone replacement therapy: methodological issues

In this paper a number of methodological issues relating to research on the relationship between the menopause, mood and hormone replacement therapy (HRT) are discussed. These issues relate to problems of design 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 headings, namely, the assessment of menopausal status, statistical modelling and the design and analyses of clinical trials. Problems relating to concepts and measurement of dependent variables are the subject matter of the papers that follow. Within the three main headings more specific issues are detailed. The paper concludes with a list of recommendations on how research in this important area might be further advanced.