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过症生活质量指数 (HidroQoL):通过应用经典测试理论和物品反应理论,使用第三阶段临床试验数据进行进一步验证
Theresa Donhauser1,2, Christian Apfelbacher3, Gesina Kann1,2
1Institute of Social Medicine and Health Systems Research, Otto-von-Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.
Journal of patient-reported outcomes
|June 6, 2023
概括
过症生活质量指数 (HidroQoL) 证明了对评估过症影响的强有力的结构有效性. 拉什的分析证实了它的单维性和生命质量测量的双重结构.
科学领域:
- 医学研究 医学研究
- 心理测量 心理测量 心理测量
- 评估生活质量 评估生活质量
背景情况:
- 超症生活质量指数 (HidroQoL) 是一种18项患者报告的超症结局指标.
- 目前对HidroQoL的有效性证据需要扩展,特别是在结构有效性方面.
- 拉什分析以前没有被应用于最终的18项HidroQoL.
研究的目的:
- 扩展HidroQoL的有效性证据,专注于结构有效性.
- 首次将拉什分析应用于18项HidroQoL.
- 为了确认HidroQoL的测量特性,在患有严重的原发性下腺透症的患者中.
主要方法:
- 利用了来自III期临床试验的数据.
- 在经典测试理论中进行了确认因素分析 (CFA).
- 评估了使用项目响应理论的拉什模型假设 (适合性,单调性,单维性,局部独立性) 和差异性项目功能 (DIF).
主要成果:
- CFA证实了HidroQoL的两个因素结构 (SRMR=0.058).
- 拉什分析表明模型适合,证实了单维性 (第一因子自值=2.244),并显示了局部独立性.
- 对一些项目确定了DIF,但可以解释,响应类别通常运行得最好.
结论:
- 这项研究提供了进一步的证据,证明HidroQoL的结构有效性,使用经典测试理论和拉什分析.
- HidroQoL是一个有效的单维尺度,用于总和分数,以及对域分数 (日常活动,心理社会影响) 的双重结构尺度.
- 新证据支持HidroQoL在临床试验环境中的结构有效性,用于严重的原发性下.
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