Seyringer Simone, Pilz Micha J, Al-Naesan Imad, King Madeleine T, Bottomley Andrew, Norman Richard, Schlosser Lisa, Hell Tobias, Gamper Eva M
Department of Nuclear Medicine, Medical University of Innsbruck, 6020, Innsbruck, Austria.
University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria.
Sci Rep. 2025 Apr 28;15(1):14907. doi: 10.1038/s41598-024-83861-y.
The Quality of Life (QoL) Utility measure, QLU-C10D, is derived of the European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire, QLQ-C30. Based on the cancer-specific nature, the QLU-C10D is expected to be sensitive and responsive in lung cancer patients.This retrospective analysis used data from four international lung cancer multi-center trials (NCT00656136, NCT00949650, NCT01085136, NCT01523587). Clinical validity was assessed in comparison to a generic standard utility instrument, the EuroQoL Group´s EQ-5D-3L. Utilities of six country value sets (Australia, Canada, Italy, the Netherlands, Poland, UK) were calculated at baseline and end of treatment for both measures. Country value set pairs of both measures (k) were compared in terms of Relative Efficiency (RE) and difference in Effect Sizes (dES) in 1) sensitivity to detect differences between performance status groups and 2) responsiveness to changes at each trial sample. Analysis of the four trials (N1 = 496, N2 = 290, N3 = 202, N4 = 770) with the six country value sets of each utility measure showed ad 1) Sensitivity indices favored the QLU-C10D (k = 18, p ≤ 0.019; RE > 1.10; dES > 0.03), and ad 2) Responsiveness indices of changes within clinically known groups (k = 78), largely favored QLU-C10D (k = 74, p ≤ .024; RE > 1.01; dES > 0.02), in comparison with the generic utility instrument. In summary, 96% of the comparative indices favored the QLU-C10D. In summary, this study confirms the clinical validity of the QLU-C10D in lung cancer patients. The QLU-C10D produced homogenous results across six country value sets and detected differences/changes in alignment with clinical expectations. In most comparisons the QLU-C10D was more sensitive or responsive compared to the EQ-5D-3L.
生活质量（QoL）效用测量工具QLU - C10D源自欧洲癌症研究与治疗组织（EORTC）的生活质量问卷QLQ - C30。基于癌症的特异性，预计QLU - C10D对肺癌患者具有敏感性和反应性。这项回顾性分析使用了来自四项国际肺癌多中心试验（NCT00656136、NCT00949650、NCT01085136、NCT01523587）的数据。与通用标准效用工具欧洲生活质量小组的EQ - 5D - 3L相比，评估了临床有效性。计算了两种测量方法在基线和治疗结束时六个国家价值集（澳大利亚、加拿大、意大利、荷兰、波兰、英国）的效用值。比较了两种测量方法的国家价值集对（k）在以下方面的相对效率（RE）和效应大小差异（dES）：1）检测功能状态组之间差异的敏感性，以及2）每个试验样本中对变化的反应性。对四项试验（N1 = 496，N2 = 290，N3 = 202，N4 = 770）以及每种效用测量方法的六个国家价值集进行分析，结果显示：1）敏感性指数支持QLU - C10D（k = 18，p≤0.019；RE > 1.10；dES > 0.03），并且2）与通用效用工具相比，临床已知组内变化的反应性指数（k = 78）在很大程度上支持QLU - C10D（k = 74，p≤0.024；RE > 1.01；dES > 0.02）。总之，96%的比较指数支持QLU - C10D。总之，本研究证实了QLU - C10D在肺癌患者中的临床有效性。QLU - C10D在六个国家价值集上产生了一致的结果，并检测到与临床预期相符的差异/变化。在大多数比较中，QLU - C10D比EQ - 5D - 3L更敏感或更具反应性。
