The EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) are commonly used Patient-Reported Outcome Measures (PROMs) for breast cancer. This study assesses and compares the internal responsiveness of the EQ-5D-5L and EORTC QLQ-C30 in Dutch breast cancer patients during the first year post-surgery. Women diagnosed with breast cancer who completed the EQ-5D-5L and EORTC QLQ-C30 pre-operatively (T0), 6 months (T6), and 12 months post-surgery (T12) were included. Mean differences of the EQ-5D-5L and EORTC QLQ-C30 between baseline and 6 months (delta 1) and between baseline and 12 months post-surgery (delta 2) were calculated and compared against the respective minimal clinically important differences (MCIDs) of 0.08 and 5. Internal responsiveness was assessed using effect sizes (ES) and standardized response means (SRM) for both deltas. In total, 333 breast cancer patients were included. Delta 1 and delta 2 for the EQ-5D-5L index and most scales of the EORTC QLQ-C30 were below the MCID. The internal responsiveness for both PROMs was small (ES and SRM < 0.5), with greater internal responsiveness for delta 1 compared to delta 2. The EQ-5D-5L index showed greater internal responsiveness than the EORTC QLQ-C30 Global Quality of Life scale and summary score. These findings are valuable for the interpretation of both PROMs in Dutch breast cancer research and clinical care.
欧洲五维健康量表五级版本（EQ-5D-5L）与欧洲癌症研究与治疗组织生命质量核心量表30题（EORTC QLQ-C30）是乳腺癌领域常用的患者报告结局指标。本研究评估并比较了荷兰乳腺癌患者术后第一年内EQ-5D-5L与EORTC QLQ-C30的内部反应性。研究纳入术前（T0）、术后6个月（T6）及术后12个月（T12）完成EQ-5D-5L与EORTC QLQ-C30评估的乳腺癌确诊女性患者。计算并比较基线至术后6个月（差值1）及基线至术后12个月（差值2）的EQ-5D-5L与EORTC QLQ-C30平均差异，以0.08和5作为各自的最小临床重要差异阈值。通过效应量与标准化反应均值评估两组差值的内部反应性。共纳入333例乳腺癌患者。EQ-5D-5L指数及EORTC QLQ-C30多数维度的差值1与差值2均低于最小临床重要差异。两种患者报告结局指标的内部反应性均较弱（效应量与标准化反应均值<0.5），且差值1的内部反应性高于差值2。EQ-5D-5L指数较EORTC QLQ-C30总体生命质量维度及总分显示出更强的内部反应性。本研究结果对荷兰乳腺癌研究及临床实践中两种患者报告结局指标的解释具有重要参考价值。
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