Abstract

BackgroundWe explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability, validity, and responsiveness with generic, clinical, demographic, and preference-based data collected from a population of postmenopausal women with osteoporosis.MethodsThe Multiple Outcomes of Raloxifene Evaluation study was a randomized, placebo-controlled, multinational clinical trial evaluating efficacy and safety of raloxifene. The Osteoporosis Assessment Questionnaire 2.0, a generic quality of life measure (Nottingham Health Profile), and a preference-based measure (Health Utilities Index) were administered at baseline and annually. Psychometric properties of the 14 Osteoporosis Assessment Questionnaire 2.0 domains were evaluated by standard statistical techniques.ResultsThis study included a subset of 1477 women from the Multiple Outcomes of Raloxifene Evaluation study population completing the questionnaires. Mean (standard deviation) age was 68.4 (6.8) years. Prevalent vertebral fractures were found in 70% (n =1038) of women. Internal consistency was >0.7 in 9 Osteoporosis Assessment Questionnaire 2.0 domains. Correlations were moderate and significant for similar Osteoporosis Assessment Questionnaire 2.0 domain scores, Nottingham Health Profile domains, and Health Utilities Index scores. All but 2 Osteoporosis Assessment Questionnaire 2.0 domains distinguished between patients with or without prevalent vertebral fractures and detected worsening with increased number of vertebral fractures. Women with ≥1 incident vertebral fracture generally had a greater worsening in Osteoporosis Assessment Questionnaire 2.0 scores (excluding social activity and support of family and friends) from baseline to study endpoint compared with women without incident vertebral fractures.ConclusionsMost domains in the Osteoporosis Assessment Questionnaire 2.0 demonstrated robust psychometric properties; however, several domains not showing these criteria may need to be reassessed and removed for a potentially shorter and validated version of the Osteoporosis Assessment Questionnaire.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2474-15-374) contains supplementary material, which is available to authorized users.

Highlights

  • We explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability, validity, and responsiveness with generic, clinical, demographic, and preference-based data collected from a population of postmenopausal women with osteoporosis

  • Osteoporosis is a chronic disease in which bone mineral density (BMD) is reduced and structural deterioration of the bone tissue occurs, which leads to bone weakness and an increased susceptibility to fractures [1,2]

  • Prevalent vertebral fractures were found in 70% (n =1038) of women; the mean number of prevalent vertebral fractures (40 days before baseline) was 1.32 (1.38)

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Summary

Introduction

We explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability, validity, and responsiveness with generic, clinical, demographic, and preference-based data collected from a population of postmenopausal women with osteoporosis. Osteoporosis can impact multiple dimensions of HRQoL, including: anxiety and depression, reduced self-image, limitations in the ability to work and enjoy leisure activities, acute or chronic pain, difficulties in performing the activities of daily life, loss of independence, and changes in relationships with family and friends [3,6]. The HRQoL among patients with osteoporosis—as measured by disease-targeted instruments such as the Osteoporosis Assessment Questionnaire (OPAQ)—decreases following incident clinical fracture [6]. The OPAQ is an 81-item, validated instrument that was developed with patients and healthcare professionals which shows adequate psychometric properties and appropriateness for use during clinical trials [9,10,11]. The questionnaire was 1 of 2 disease-targeted instruments administered to measure HRQoL in the Multiple Outcomes of Raloxifene Evaluation (MORE) study

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