Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.
Department of Neurology, Haaglanden Medical Center, The Hague, the Netherlands.
Neuro Oncol. 2021 Aug 2;23(8):1327-1336. doi: 10.1093/neuonc/noab037.
Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients.
Clinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (>0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence.
A total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and -4 to -14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and -4 to -16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10).
MIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials.
最小有意义差异（MID）可用于解释健康相关生活质量（HRQOL）结果的临床相关性。本研究旨在为所有欧洲癌症研究与治疗组织（EORTC）生活质量问卷核心 30 （QLQ-C30）量表估计 MID，以解释脑肿瘤患者的组级结果。
使用了三个神经胶质瘤试验的临床和 HRQOL 数据。根据相关性（>0.30）和关联的临床合理性，为每个 EORTC QLQ-C30 量表选择临床锚点。计算了 HRQOL 和锚点的变化，对于每个量表和时间段，患者被分为以下三个临床变化组之一：一个锚点类别恶化，无变化或一个锚点类别改善。均值变化法和线性回归分别用于估计解释组内变化和随时间变化的组间差异的 MID。基于分布的方法用于生成支持性证据。
共有 1687 名患者参加了三项试验。保留的锚点是表现状态和八个常见不良事件术语标准（CTCAE）量表。用于解释组内变化的 MID 范围为 4 至 12 点的改善和-4 至-14 点的恶化。组间变化差异的 MID 范围为 4 至 9 的改善和-4 至-16 的恶化。大多数基于锚点的 MID 最接近 0.3 SD 基于分布的估计值（范围：3-10）。
EORTC QLQ-C30 量表的 MID 通常在 4 到 11 点之间，用于组内均值变化和组间均值差异变化。这些结果可用于解释神经胶质瘤试验的 QLQ-C30 结果。
