European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
Division of Epidemiology and Health Services Research University Medical Centre, Institute of Medical Biostatistics, Epidemiology and Informatics, Mainz, Germany.
Head Neck. 2020 Nov;42(11):3141-3152. doi: 10.1002/hed.26363. Epub 2020 Jul 6.
We aimed to estimate minimally important difference (MID) for interpreting group-level change over time for European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in head and neck cancer.
Data were derived retrospectively from two published EORTC trials. Clinical anchors were selected using correlation strength and clinical plausibility of the given anchor/QLQ-C30 scale pair. MIDs for within-group and between-group change were estimated via the mean change method and linear regression, respectively. Distribution-based MIDs were also examined. MIDs for two of the scales, dyspnea and nausea/vomiting, are more uncertain considering their low correlations with the anchors.
Anchor-based MIDs could be determined for deterioration in 7 of the 14 QLQ-C30 scales assessed, and in 3 scales for improvement. MIDs varied by scale, direction of change, and anchor. Absolute MID values ranged from 5 to 15 points for within-group change and 4 to 12 for between-group change. Most MIDs were within 4 to 10 points.
Our findings, if confirmed, will aid interpreting changes in selected QLQ-C30 scale scores over time and inform sample size calculations in future clinical trials in head and neck cancer.
我们旨在估计欧洲癌症研究与治疗组织生活质量问卷核心 30 项(EORTC QLQ-C30)评分在头颈部癌症中随时间进行组内变化的最小临床重要差异(MID)。
数据来自两项已发表的 EORTC 试验的回顾性分析。临床锚点是通过给定锚点/QLQ-C30 量表对的相关强度和临床合理性选择的。通过平均变化法和线性回归分别估计组内和组间变化的 MID。还检查了基于分布的 MID。考虑到与锚点的低相关性,两个量表(呼吸困难和恶心/呕吐)的 MID 更不确定。
可以确定 14 个 QLQ-C30 量表中 7 个评估指标恶化的锚定 MID,以及 3 个指标改善的锚定 MID。MID 因量表、变化方向和锚点而异。组内变化的绝对 MID 值范围为 5 至 15 分,组间变化的 MID 值范围为 4 至 12 分。大多数 MID 值在 4 到 10 分之间。
如果得到证实,我们的研究结果将有助于解释头颈部癌症中选定的 QLQ-C30 量表评分随时间的变化,并为未来的临床试验提供样本量计算的信息。