Sprangers M A, Groenvold M, Arraras J I, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes H C, Hopwood P, Cull A, Aaronson N K
Netherlands Cancer Institute, Amsterdam, The Netherlands.
J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.
To construct a breast cancer-specific quality-of-life questionnaire (QLQ) module to be used in conjunction with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and to test its reliability and validity cross-culturally.
Module construction took place after the EORTC guidelines for module development. The module--the QLQ-BR23--consists of 23 items covering symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. This module was tested in 170 Dutch, 168 Spanish, and 158 American cancer patients at two points in time. The timing for the Dutch and Spanish patients was before and during treatment with radiotherapy or chemotherapy. For the American patients, the questionnaire was administered at admission at the breast clinic and 3 months after the first assessment.
Multitrait scaling analysis confirmed the hypothesized structure of four of the five scales. Cronbach's alpha coefficients were, in general, lowest in Spain (range; .46 to .94) and highest in the United States (range; .70 to .91). On the basis of known-groups comparisons, selective scales distinguished clearly between patients differing in disease stage, previous surgery, performance status, and treatment modality, according to expectation. Additionally, selective scales detected change over time as a function of changes in performance status and treatment-induced change.
These results lend support to the clinical and cross-cultural validity of the QLQ-BR23 as a supplementary questionnaire for assessing specific quality-of-life issues relevant to patients with breast cancer.
构建一个乳腺癌特异性生活质量问卷（QLQ）模块，以便与欧洲癌症研究与治疗组织（EORTC）的QLQ - C30联合使用，并跨文化测试其信度和效度。
模块构建遵循EORTC模块开发指南进行。该模块——QLQ - BR23——由23个条目组成，涵盖与不同治疗方式、身体形象、性功能及未来展望相关的症状和副作用。该模块在170名荷兰、168名西班牙和158名美国癌症患者中于两个时间点进行了测试。荷兰和西班牙患者的测试时间为放疗或化疗前及治疗期间。对于美国患者，问卷在乳腺门诊入院时及首次评估后3个月发放。
多特质量表分析证实了五个量表中四个量表的假设结构。总体而言，Cronbach's α系数在西班牙最低（范围：0.46至0.94），在美国最高（范围：0.70至0.91）。基于已知组比较，部分量表根据预期在疾病分期、既往手术、体能状态和治疗方式不同的患者之间有明显区分。此外，部分量表检测到随时间的变化是体能状态变化和治疗引起变化的函数。
这些结果支持了QLQ - BR23作为评估乳腺癌患者相关特定生活质量问题的补充问卷的临床及跨文化效度。
