Duke University Center for the Study of Aging and Human Development, Duke University Medical Center, Durham, NC 27710, USA.
Value Health. 2011 Dec;14(8):1109-16. doi: 10.1016/j.jval.2011.06.010. Epub 2011 Oct 1.
Existing questionnaires that assess preference and/or satisfaction with postmenopausal bone loss treatments were reviewed and determined to be inadequate for the assessment of an oral pill versus a subcutaneous injection. The Preference and Satisfaction Questionnaire (PSQ) was developed to assess preference, satisfaction, and bother with a weekly oral tablet versus a once every 6 months subcutaneous injection for treatment of postmenopausal bone loss.
Questions were developed based on literature review and expert input. Content validity of the PSQ in this patient population was assessed among current or previous bisphosphonate users in group interviews, and item comprehension and readability were also evaluated. Reliability, validity, and structure of the questionnaire were assessed in two phase 3 randomized clinical trials.
Twenty-four women participated in cognitive interviews and found the PSQ understandable and acceptable. Subsequently, 1583 trial participants took the PSQ. Interitem correlations, ranging from 0.50 to 0.97 for preference items, 0.85 to 0.94 for pill-satisfaction items, and 0.84 to 0.92 for injection-satisfaction items, and a well-fitting confirmatory factor analysis (root mean square error of approximation 0.04, nonnormed fit index 0.99, and root mean square residual 0.08) supported the structure of the instrument. Cronbach's alpha reliability values for pill satisfaction, injection satisfaction, pill bother, and injection bother were 0.93, 0.89, 0.82, and 0.61, respectively. Discriminative validity was indicated with better satisfaction and bother scores being related to adherence and the absence of adverse events.
The PSQ is a valid and reliable measure and may be a valuable tool to assess patient preference and satisfaction with a weekly oral tablet and 6-month subcutaneous injection for postmenopausal bone loss.
对评估绝经后骨质疏松症治疗的偏好和/或满意度的现有问卷进行了回顾，发现它们不足以评估口服片剂与皮下注射的差异。本研究开发了偏好和满意度问卷（PSQ），以评估每周口服片剂与每 6 个月皮下注射治疗绝经后骨质疏松症的偏好、满意度和困扰。
根据文献回顾和专家意见制定问题。在小组访谈中，评估了当前或以前使用双膦酸盐的患者人群中 PSQ 的内容效度，还评估了项目理解和可读性。在两项 3 期随机临床试验中评估了问卷的可靠性、有效性和结构。
24 名女性参加了认知访谈，发现 PSQ 易于理解且可以接受。随后，1583 名试验参与者完成了 PSQ。偏好项目的项间相关系数范围为 0.50 至 0.97，片剂满意度项目为 0.85 至 0.94，注射满意度项目为 0.84 至 0.92，拟合良好的验证性因子分析（均方根误差逼近值 0.04，非标准化拟合指数 0.99，均方根残差 0.08）支持该工具的结构。片剂满意度、注射满意度、片剂困扰和注射困扰的 Cronbach's alpha 可靠性值分别为 0.93、0.89、0.82 和 0.61。判别有效性表明，更好的满意度和困扰评分与依从性和无不良事件相关。
PSQ 是一种有效且可靠的测量工具，可用于评估绝经后骨质疏松症患者对每周口服片剂和 6 个月皮下注射的偏好和满意度。
