乳腺癌是女性最常见的癌症之一。患者报告的结果测量用于评估临床乳腺癌研究中患者与健康相关的生活质量。本研究在一项以晚期/转移性乳腺癌 (aBC) 患者为对象的临床试验中评估了国家综合癌症网络 - 癌症治疗功能评估 - 乳腺癌症状指数 (NFBSI-16) 子量表的结构、有效性、可靠性和反应性，并估计 NFBSI-16 有意义的变化阈值。来自参加 II 期试验 (Xenera-1) 的 101 名 aBC 患者的数据被纳入 NFBSI-16 的心理测量评估中。通过评估项目间相关性、项目总相关性和内部一致性（第 2 轮和第 5 轮）来评估分量表结构。使用量表级收敛效度（第 2 和第 5 周期）和已知组（基线）评估效度。通过第 3-4 个周期的重测来分析可靠性，并在第 5、7 和 9 个周期评估对改善和恶化的响应性。在周期中使用基于锚的方法（由基于分布的方法支持）来估计有意义的变化阈值5、7 和 9.NFBSI-16 内部一致性是可以接受的，但项目总相关性表明其子量表和 GP5 项目（治疗副作用）评分可能优于总分。收敛和已知群体的证据支持 NFBSI-16 的有效性。总和 DRS-P（疾病相关症状：身体）量表的重测信度为良好至优秀，GP5 项目的重测信度为中等。通常证明了对恶化的反应性，但由于观察到的改善有限，无法证明对改善的反应性。针对 DRS-P 和总分估计了基于锚的有意义的变化阈值。本研究提供的证据表明 NFBSI-16 具有理想的心理测量特性，可用于 aBC 的临床研究。它还提供了对群体和个人层面有意义的变化阈值的估计，以促进未来 aBC 研究中的分数解释。© 2024。作者。

Breast cancer is one of the most common cancers in women. Patient-reported outcome measures are used to evaluate patients' health-related quality of life in clinical breast cancer studies. This study evaluated the structure, validity, reliability, and responsiveness of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) subscales in a clinical trial featuring patients with advanced/metastatic breast cancer (aBC), and estimated NFBSI-16 meaningful change thresholds.Data from 101 patients with aBC enrolled in a phase II trial (Xenera-1) were included for psychometric evaluation of the NFBSI-16. Subscale structure was evaluated by assessing inter-item correlations, item-total correlations, and internal consistency (cycles 2 and 5). Validity was assessed using scale-level convergent validity (cycles 2 and 5) and known-groups (Baseline). Reliability was analysed via test-retest at cycles 3-4, and responsiveness to improvement and worsening was evaluated at cycles 5, 7, and 9. Meaningful change thresholds were estimated using anchor-based methods (supported by distribution-based methods) at cycles 5, 7, and 9.NFBSI-16 internal consistency was acceptable, but item-total correlations suggested that its subscales and the GP5 item (side-effect of treatment) scores may be preferred over a total score. Convergent and known-groups evidence supported NFBSI-16 validity. Test-retest reliability was good to excellent for Total and DRS-P (disease-related symptoms: physical) scales, and moderate for the GP5 item. Responsiveness to worsening was generally demonstrated, but responsiveness to improvement could not be demonstrated due to limited observed improvement. Anchor-based meaningful change thresholds were estimated for DRS-P and Total scores.This study provides evidence that the NFBSI-16 has desirable psychometric properties for use in clinical studies in aBC. It also provides estimates of group- and individual-level meaningful change thresholds to facilitate score interpretation in future aBC research.© 2024. The Author(s).