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

Bushmakin, Andrew G. MS1; Abraham, Lucy CPsychol2; Pinkerton, JoAnn V. MD3; Cappelleri, Joseph C. PhD, MPH1; Mirkin, Sebastian MD4

doi: 10.1097/GME.0000000000000176
Original Articles

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.

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From the 1Pfizer Inc, Groton, CT; 2Pfizer Ltd, Tadworth, Surrey, UK; 3Division of Midlife Health, Department of Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, VA; and 4Pfizer Inc, Collegeville, PA.

Received August 20, 2013; revised and accepted October 29, 2013.

Funding/support: This study was sponsored by Pfizer. The SMART-2 trial was sponsored by Wyeth Research, which was acquired by Pfizer in October 2009. Medical writing support was provided by Katie McClendon, PhD, of MedErgy and Diane M. Sloan, PharmD, of Peloton Advantage and was funded by Pfizer.

Financial disclosure/conflicts of interest: A.G.B., J.C.C., and S.M. are employees of Pfizer Inc. L.A. is an employee of Pfizer Ltd. In the past 12 months, J.V.P. has served as consultant (fees to the University of Virginia) for Pfizer, Noven Pharmaceuticals, Shionogi, and DepoMed; has received grants/research support (fees to the University of Virginia) from DepoMed, Bionova, and Endoceutics; and has received travel funds from Pfizer, Noven Pharmaceuticals, Shionogi, and DepoMed.

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Address correspondence to: Lucy Abraham, CPsychol, IPC 5-2, Pfizer Ltd, Walton Oaks, Dorking Road, Walton on the Hill, Tadworth, Surrey KT20 7NS, UK. E-mail:

© 2014 by The North American Menopause Society.