多汗症生活质量指数 (HidroQoL)：应用于 III 期临床试验数据的经典测试理论和项目反应理论的进一步验证。
Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial.
机构信息
Institute of Social Medicine and Health Systems Research, Otto-von-Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.
University of Regensburg, Regensburg, Germany.
出版信息
J Patient Rep Outcomes. 2023 Jun 6;7(1):55. doi: 10.1186/s41687-023-00596-6.
BACKGROUND
The Hyperhidrosis Quality of Life Index (HidroQoL ©) is a well-developed and validated patient-reported outcome measure assessing the quality-of-life impacts in hyperhidrosis with 18 items. Our aim was to extend the already existing validity evidence for the HidroQoL, especially in relation to structural validity. Especially Rasch analysis has not been applied to the final 18-item HidroQoL before.
METHODS
Data from a phase III clinical trial were used. Confirmatory factor analysis was conducted to confirm the two a priori HidroQoL scales within classical test theory. Furthermore, the assumptions of the Rasch model (model fit, monotonicity, unidimensionality, local independence) and Differential Item Functioning (DIF) were assessed using item response theory.
RESULTS
The sample included 529 patients with severe primary axillary hyperhidrosis. The two-factor structure could be confirmed by the confirmatory factor analysis (SRMR = 0.058). The item characteristic curves showed mainly optimally functioning response categories, indicating monotonicity. The overall fit to the Rasch model was adequate and unidimensionality for the HidroQoL overall scale could be confirmed, since the first factor had an eigenvalue of 2.244 and accounted for 18.7%. Local independence was below assumed thresholds (residual correlations ≤ 0.26). DIF analysis, controlling for age or gender, was critical for four and three items, respectively. However, this DIF could be explained.
CONCLUSION
Using classical test theory and item response theory/Rasch analyses, this study provided further evidence for the structural validity of the HidroQoL. This study confirmed several specific (measurement) properties of the HidroQoL questionnaire in patients with physician-confirmed severe primary axillary hyperhidrosis: the HidroQoL is a unidimensional scale allowing the summation of scores to generate a single score, and simultaneously it has a dual structure, also allowing the calculation of separate domain scores for daily activities and psychosocial impacts. With this study, we provided new evidence of the structural validity of the HidroQoL in the context of a clinical trial. Trial registration The study was registered (ClinicalTrials.gov identifier: NCT03658616, 05 September 2018, https://clinicaltrials.gov/ct2/show/NCT03658616?term=NCT03658616&draw=2&rank=1 ).
背景
多汗症生活质量指数（HidroQoL©）是一种经过充分开发和验证的患者报告结局测量工具，可评估多汗症对生活质量的影响，包含 18 个项目。我们的目的是扩展 HidroQoL 现有的有效性证据，特别是在结构有效性方面。特别是 Rasch 分析之前尚未应用于最终的 18 项 HidroQoL。
方法
使用 III 期临床试验的数据。在经典测试理论中，进行验证性因子分析以确认 HidroQoL 的两个先验量表。此外，还使用项目反应理论评估了 Rasch 模型（模型拟合、单调性、单维性、局部独立性）和差异项目功能（DIF）的假设。
结果
样本包括 529 例严重原发性腋窝多汗症患者。验证性因子分析可确认双因素结构（SRMR=0.058）。项目特征曲线主要显示最佳功能反应类别，表明单调性。Rasch 模型的整体拟合度适中，HidroQoL 整体量表的单维性可以得到确认，因为第一个因子的特征值为 2.244，占 18.7%。局部独立性低于假设阈值（残差相关性≤0.26）。控制年龄或性别后，分别有 4 项和 3 项分析的差异项目功能分析（DIF）为临界值。然而，这种 DIF 是可以解释的。
结论
本研究采用经典测试理论和项目反应理论/Rasch 分析，进一步证明了 HidroQoL 的结构有效性。本研究在经医生确认的严重原发性腋窝多汗症患者中，对 HidroQoL 问卷的若干特定（测量）特性进行了验证：HidroQoL 是一个单维量表，允许对分数进行求和以生成一个单一分数，并且同时具有双重结构，也允许为日常活动和心理社会影响计算单独的域分数。通过这项研究，我们在临床试验背景下为 HidroQoL 的结构有效性提供了新的证据。试验注册 该研究已注册（ClinicalTrials.gov 标识符：NCT03658616，2018 年 9 月 5 日，https://clinicaltrials.gov/ct2/show/NCT03658616？term=NCT03658616&draw=2&rank=1）。
Zotero 插件