Evaluation of the measurement model and clinically important differences for menopause-specific quality of life associated with bazedoxifene/conjugated estrogens.

OBJECTIVE

This study aims to confirm the factor structure of the Menopause-Specific Quality of Life (MENQOL) questionnaire by using confirmatory factor analysis (CFA) and to determine whether improvements in menopause-specific health-related quality of life (HRQOL) observed with bazedoxifene (BZA)/conjugated estrogens (CE) relative to placebo are clinically meaningful.

METHODS

Postmenopausal women with seven or more moderate to severe hot flushes per day (or ≥50 per wk) received BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo for 12 weeks. HRQOL and treatment satisfaction were evaluated using the MENQOL questionnaire and the Menopause Symptoms Treatment Satisfaction Questionnaire, respectively. The structure of the MENQOL questionnaire was evaluated using CFA. To estimate clinically important differences (CIDs) in HRQOL, we used a repeated-measures model to estimate changes in MENQOL domain and total scores using Menopause Symptoms Treatment Satisfaction Questionnaire items as anchors.

RESULTS

The CFA model fits the MENQOL data (Bentler's comparative fit index >0.9). CID estimates ranged from 0.5 to 1.2 for the MENQOL domains and total score. Change from baseline in MENQOL vasomotor domain score for BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg compared with placebo was greater than the estimated CID, as were changes in MENQOL physical domain and total scores for BZA 20 mg/CE 0.625 mg compared with placebo.

CONCLUSIONS

CFA confirms the factor structure of the MENQOL questionnaire. Treatment with BZA/CE provides clinically meaningful improvements in HRQOL in a population of postmenopausal women with bothersome vasomotor symptoms.