Background and objectives
Conceptual framework and intended application
Identification of concept and domains to be measured
It was the concept to develop an instrument to measure health-related quality of life, specifically related to changes due to use of sex-steroid hormones in women. The concept for the development followed recommendations of the FDA for Patient-Reported Outcomes (PRO).
It was anticipated that several domains could be found learning from known pharmacological effects of sex-steroid hormones and reported short-term outcomes of treatment with such hormones: Effects of psychological nature, on sexual symptoms, (pre-) menstrual problems (hormones even used as treatment of “diseases”), and pharmacological hormone-related effects on certain organs such as breast, hair and skin.
A self-administrable scale was planned that is easy to apply, has a high acceptance in women, is easy to analyse, and can be applied in clinical trial as well in observational studies to describe a group, to compare results among groups (different locations or over time), and can be utilized as outcome measure.
The scale should be applicable to women irrespective of age, but with some preference for younger age. Ethnicity, social class, and health status or other factors should not play a role.