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.
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。