BACKGROUND EuroQoL EQ-5D is a commonly used measure of health-related quality of life (HRQOL) in clinical trials given the use of its index score as a measure of health utilities. It is unclear whether EQ-5D is sensitive to changes in neurocognitive function and progression that occur following brain radiation. This study sought to evaluate the sensitivity of EQ-5D-5L in reflecting these changes. PATIENTS and METHODS A secondary analysis of NRG Oncology CC001 was performed. Mean EQ-5D-5L index and visual analog scale (VAS) score changes from baseline between groups of patients stratified by neurocognitive function and intracranial progression status were assessed. MD Anderson Symptom Inventory for brain tumor (MDASI-BT) symptom and interference items were also analyzed between groups. RESULTS EQ-5D-5L index and VAS score changes between patients who had cognitive failure and those that had preserved cognition showed no significant differences at any time point. In contrast, VAS changes at 4 (1.61 vs -5.13, P = .05) and 6 months (8.17 vs -0.14, P = .04) were significantly improved in the patients who survived without intracranial progression. MDASI-BT cognitive factor scores were significantly improved in the cohort of patients with preserved neurocognitive function at 2 (1.68 vs 2.08, P = .05) and 4 months (1.35 vs 1.83, P = .04). MDASI-BT symptom interference was significantly associated with intracranial progression at 4 months, but not with neurocognitive status. CONCLUSION EQ-5D-5L index and VAS scores were not sensitive to neurocognitive changes that patients experienced, but VAS scores were sensitive to progression. This study challenges the routine use of EQ-5D as a QoL metric in brain metastases clinical trials that are focused on preventing neurocognitive dysfunction. Trial Registration NCT# 02360215

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评估 EQ-5D-5L 在脑转移患者中的敏感性：NRG CC001 的二次分析

背景 EuroQoL EQ-5D 是临床试验中常用的健康相关生活质量 (HRQOL) 衡量标准，因为使用其指数评分作为健康效用的衡量标准。目前尚不清楚 EQ-5D 是否对脑辐射后发生的神经认知功能变化和进展敏感。本研究旨在评估 EQ-5D-5L 反映这些变化的敏感性。患者和方法 NRG Oncology CC001 进行了二次分析。评估了按神经认知功能和颅内进展状态分层的患者组之间的平均 EQ-5D-5L 指数和视觉模拟量表 (VAS) 评分相对于基线的变化。 MD安德森脑肿瘤症状量表（MDASI-BT）症状和干扰项目也在组间进行了分析。结果 认知失败患者和认知保留患者之间的 EQ-5D-5L 指数和 VAS 评分变化在任何时间点都没有显示出显着差异。相比之下，没有颅内进展而存活的患者在 4 个月（1.61 vs -5.13，P = .05）和 6 个月（8.17 vs -0.14，P = .04）时的 VAS 变化显着改善。在 2 个月（1.68 vs 2.08，P = .05）和 4 个月（1.35 vs 1.83，P = .04）时，神经认知功能保留的患者队列中的 MDASI-BT 认知因子评分显着改善。 MDASI-BT 症状干扰与 4 个月时的颅内进展显着相关，但与神经认知状态无关。结论 EQ-5D-5L 指数和 VAS 评分对患者经历的神经认知变化不敏感，但 VAS 评分对进展敏感。这项研究对在脑转移临床试验中常规使用 EQ-5D 作为生活质量指标提出了挑战，这些临床试验的重点是预防神经认知功能障碍。试用注册 NCT# 02360215