Objective: To establish the psychometric properties of the Italian version
of two quality of life (QOL) questionnaires in menopausal women: the psycho
logical general well being index (PGWBI) and the women's health questionnai
re (WHQ). Method: These questionnaires were pop popd into Italian and then
self-administered to out-patient women a first time, 1 week later in stable
women to assess reproducibility, and 3 months later to evaluate responsive
ness over time. Baseline analyses included: factorial structure, multitrait
analysis, internal consistency reliability, and clinical validity. Results
: Questionnaires were returned by 155 women (median age: 54 years, median d
uration of amenorrhoea: 56 months, median Kupperman index 26). Principal co
mponent analysis (PCA) of the PGWBI showed an important general factor and
then, after rotation, three factors. The PCA of the WHQ showed ten factors.
Only five reproduced the dimensions postulated a priori quite well. The it
em convergent validity was confirmed for all items of the major dimension o
f the two questionnaires, and the item divergent validity, although accepta
ble, was less satisfying for the PGWBI than the WHQ. The internal reliabili
ty was good (Cronbach's alpha greater than or equal to 0.70) for the PGWBI
and for nine scales out of ten for the WHQ. The six dimensions of the PGWBI
and most of the dimensions of the WHQ were significantly correlated to the
Kupperman index, indicating the clinical validity of the instruments. The
responsiveness to change in clinical status at 3 months was better in the P
GWBI than in the WHQ with moderate effect size (around 0.5). Conclusion: Th
e Italian versions of the PGWBI and the WHQ are reliable and useful for HRT
clinical trials but the dimensional scores must be calculated bearing in m
ind the limitations in the structure. Other studies are needed to improve t
he factorial stability of certain WHQ dimensions. For the Italian version o
f the PGWBI, the validation process is to be completed by studies of mixed
populations suffering from other types of disease. (C) 2000 Published by El
sevier Science Ireland Ltd. All rights reserved.