BACKGROUND The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 was one of the first disease-specific questionnaires developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996 major changes in BC treatment have occurred, requiring an update of the EORTC BC module. This study presents the results of the phase I-III update of the QLQ-BR23 questionnaire. PATIENTS AND METHODS The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items. RESULTS The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale. CONCLUSION Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.

中文翻译：

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用于评估乳腺癌患者生活质量的 EORTC 问卷的国际更新：EORTC QLQ-BR45。

背景 欧洲癌症研究和治疗组织 (EORTC) QLQ-BR23 是 1996 年开发的首批疾病特异性问卷之一，用于评估乳腺癌 (BC) 患者的生活质量 (QoL)。然而，自 1996 年以来，BC 治疗发生了重大变化，需要更新 EORTC BC 模块。本研究介绍了 QLQ-BR23 问卷 I-III 期更新的结果。患者和方法 EORTC QLQ-BR23 模块的更新遵循标准 EORTC 指南。系统的文献回顾揭示了第一阶段和第二阶段的 83 个潜在的相关 QoL 问题。在缩短问题清单并与患者和医疗保健提供者进行访谈后，将 15 个相关问题转化为 27 个项目。初步模块在国际上进行了预测试，多中心 III 期研究，以识别和解决项目的措辞可理解性和可接受性方面的潜在问题。提供了描述性统计数据。分析是定性和定量的。我们提供项目的心理测量结构。结果 I 期和 II 期结果表明需要用与新治疗方案相关的附加项目来补充原始 QLQ-BR23。III 期研究共招募了 250 名患者（来自 12 个国家）。最终更新的 III 期模块共包含 45 个项目：23 个来自 QLQ-BR23 的项目和 22 个新项目。新项目包含两个多项目量表：目标症状量表和满意度量表。目标症状量表可分为三个子量表：内分泌治疗、内分泌性和皮肤/粘膜量表。结论 我们的工作促成了新的 EORTC QLQ-BR45 模块的开发，该模块可以更准确、更全面地评估新的和可扩展的治疗对患者生活质量的影响。EORTC QLQ-BR45 的最终版本目前可用于临床实践。最后的第四阶段研究正在进行中，以确认该模块的心理测量特性。