Shen Wei, Burge Russel, Naegeli April N, Shih Jeremy, Alam Jahangir, Gold Deborah T, Silverman Stuart
Eli Lilly and Company, Indianapolis, IN, USA.
BMC Musculoskelet Disord. 2014 Nov 17;15:374. doi: 10.1186/1471-2474-15-374.
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.
The 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.
This 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.
Most 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.
我们从患有骨质疏松症的绝经后女性群体中收集了一般、临床、人口统计学和基于偏好的数据，从可靠性、有效性和反应性方面探讨了骨质疏松症评估问卷2.0的心理测量特性。
雷洛昔芬评估研究的多项结果是一项随机、安慰剂对照、多国临床试验，评估雷洛昔芬的疗效和安全性。在基线和每年时使用骨质疏松症评估问卷2.0（一种一般生活质量测量工具（诺丁汉健康量表））和一种基于偏好的测量工具（健康效用指数）。通过标准统计技术评估骨质疏松症评估问卷2.0的14个领域的心理测量特性。
本研究纳入了雷洛昔芬评估研究人群中完成问卷的1477名女性的一个子集。平均（标准差）年龄为68.4（6.8）岁。70%（n = 1038）的女性存在椎体骨折。骨质疏松症评估问卷2.0的9个领域的内部一致性>0.7。对于相似的骨质疏松症评估问卷2.0领域得分、诺丁汉健康量表领域和健康效用指数得分，相关性为中等且显著。除2个领域外，骨质疏松症评估问卷2.0的所有领域都能区分有或无椎体骨折的患者，并随着椎体骨折数量的增加检测到病情恶化。与无新发椎体骨折的女性相比，有≥1次新发椎体骨折的女性从基线到研究终点时骨质疏松症评估问卷2.0得分（不包括社交活动以及家人和朋友的支持）的恶化程度通常更大。
骨质疏松症评估问卷2.0的大多数领域表现出稳健的心理测量特性；然而，几个未显示这些标准领域可能需要重新评估并去除，以形成一个可能更简短且经过验证的骨质疏松症评估问卷版本。
