Ediebah Divine E, Reijneveld Jaap C, Taphoorn Martin J B, Coens Corneel, Zikos Efstathios, Aaronson Neil K, Heimans Jan J, Bottomley Andrew, Klein Martin
Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
Department of Neurology, VU University Medical Center, Amsterdam, The Netherlands.
Qual Life Res. 2017 Apr;26(4):869-880. doi: 10.1007/s11136-016-1426-z. Epub 2016 Oct 15.
Clinical trials in glioma patients with neurocognitive deficits face challenges due to lacking or unreliable patient self-reports on their health-related quality of life (HRQOL). Patient-proxy data could help solve this issue. We determined whether patient-proxy concordance levels were affected by patients' neurocognitive functioning.
Patient and patient-by-proxy HRQOL ratings were assessed via SF-36 and EORTC QLQ-BN20, respectively, in 246 patients. Data on neurocognitive functioning were collected on a subgroup of 195 patients. Patient-proxy agreement was measured using the Bland-Altman limit of agreement, the mean difference, the concordance correlation coefficient (CCC), and the percentage difference (PD, ±0, 5, or 10 points). We defined patients to be cognitively impaired (n = 66) or cognitively intact (n = 129) based on their neurocognitive performance.
Patients rated their physical function and general health to be better than their proxies did, while at the same time, patients reported more visual disorders, communication deficits, itchy skin, and problems with bladder control. The cognitively impaired subgroup reported poorer physical functioning, more visual disorders, headaches, itchy skin, and issues with bladder control. In the cognitively intact group, no statistical significant differences were observed between patients and proxies. Not surprisingly, Bland-Altman plots revealed a high agreement between the patient and patient-by-proxy rating in all HRQOL domains ranging from 95 to 99 %. The CCC was fairly high in all HRQOL domains (0.37-0.80), and the percentage of perfect agreement (PD ± 0) ranged from 8.5 to 76.8 %. In the cognitively impaired patients, the mean difference between patients and proxies was overall larger, and accordingly, agreement based on Bland-Altman plots was lower.
The level of agreement between patient and patient-by-proxy ratings of low-grade glioma patients' HRQOL is generally high. However, patient-proxy agreement is lower in patients with neurocognitive deficits than in patients without neurocognitive deficits.
由于神经认知功能缺损的胶质瘤患者缺乏或提供不可靠的与健康相关的生活质量（HRQOL）自我报告，针对此类患者的临床试验面临挑战。患者代理人数据可能有助于解决这一问题。我们确定了患者与代理人的一致性水平是否受患者神经认知功能的影响。
分别通过SF-36和欧洲癌症研究与治疗组织脑肿瘤生活质量问卷（EORTC QLQ-BN20）对246例患者的HRQOL进行患者自评和代理人评价。收集了195例患者亚组的神经认知功能数据。采用布兰德-奥特曼一致性界限、平均差异、一致性相关系数（CCC）和百分比差异（PD，±0、5或10分）来衡量患者与代理人的一致性。根据神经认知表现，将患者定义为认知受损（n = 66）或认知完好（n = 129）。
患者对自身身体功能和总体健康状况的评分高于代理人的评分，同时，患者报告有更多的视觉障碍、沟通缺陷、皮肤瘙痒和膀胱控制问题。认知受损亚组报告的身体功能较差、视觉障碍较多、头痛、皮肤瘙痒和膀胱控制问题较多。在认知完好组中，患者与代理人之间未观察到统计学显著差异。不出所料，布兰德-奥特曼图显示，在所有HRQOL领域中，患者自评与代理人评价之间的一致性较高，范围为95%至99%。所有HRQOL领域的CCC都相当高（0.37 - 0.80），完全一致的百分比（PD ± 0）范围为8.5%至76.8%。在认知受损患者中，患者与代理人之间的平均差异总体上更大，因此，基于布兰德-奥特曼图的一致性较低。
低级别胶质瘤患者HRQOL的患者自评与代理人评价之间的一致性水平总体较高。然而，神经认知功能缺损患者的患者与代理人一致性低于无神经认知功能缺损的患者。
