PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：乳腺癌是女性最常见的癌症之一。在临床乳腺癌研究中，患者报告的结果指标用于评估患者与健康相关的生活质量。这项研究评估了结构，有效性，可靠性,在一项针对晚期/转移性乳腺癌（aBC）患者的临床试验中，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）分量表的反应性，并估计NFBSI-16有意义的变化阈值。
方法：纳入了一项II期试验（Xenera-1）的101例aBC患者的数据，用于NFBSI-16的心理评估。通过评估项目间相关性来评估子量表结构，项目总相关性，和内部一致性(周期2和5)。使用量表水平收敛有效性（第2和第5周期）和已知组（基线）评估有效性。在第3-4周期通过测试-再测试分析可靠性，在第5、7和9周期评估对改善和恶化的反应性。在周期5、7和9使用基于锚的方法(由基于分布的方法支持)估计有意义的变化阈值。
结果：NFBSI-16内部一致性是可以接受的，但项目-总相关性提示其分量表和GP5项目(治疗副作用)评分可能优于总评分.聚合和已知组证据支持NFBSI-16有效性。Total和DRS-P（疾病相关症状：身体）量表的重测可靠性良好至优异，GP5项目中等。对恶化的反应通常被证明，但是由于观察到的改善有限，因此无法证明对改善的反应性。估计DRS-P和总分的基于锚的有意义的变化阈值。
结论：这项研究提供了证据，证明NFBSI-16具有理想的心理测量特性，可用于aBC的临床研究。它还提供了组和个人水平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。
方法：纳入了一项II期试验（Xenera-1）的101例aBC患者的数据，用于NFBSI-16的心理评估。通过评估项目间相关性来评估子量表结构，项目总相关性，和内部一致性(周期2和5)。使用量表水平收敛有效性（第2和第5周期）和已知组（基线）评估有效性。在第3-4周期通过测试-再测试分析可靠性，在第5、7和9周期评估对改善和恶化的反应性。在周期5、7和9使用基于锚的方法(由基于分布的方法支持)估计有意义的变化阈值。
结果：NFBSI-16内部一致性是可以接受的，但项目-总相关性提示其分量表和GP5项目(治疗副作用)评分可能优于总评分.聚合和已知组证据支持NFBSI-16有效性。Total和DRS-P（疾病相关症状：身体）量表的重测可靠性良好至优异，GP5项目中等。对恶化的反应通常被证明，但是由于观察到的改善有限，因此无法证明对改善的反应性。估计DRS-P和总分的基于锚的有意义的变化阈值。
结论：这项研究提供了证据，证明NFBSI-16具有理想的心理测量特性，可用于aBC的临床研究。它还提供了组和个人水平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。
