癌症患者化疗后进行纵向研究的功能评估/妇科肿瘤学组神经毒性量表（FACT/GOG-Ntx）子量表的心理计量学测试。
Psychometric testing of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale in a longitudinal study of cancer patients treated with chemotherapy.
机构信息
School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong SAR.
Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, Singapore.
出版信息
Health Qual Life Outcomes. 2020 Jul 23;18(1):246. doi: 10.1186/s12955-020-01493-y.
BACKGROUND
The aim of this study was to evaluate the psychometric properties of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale in a longitudinal study of cancer patients treated with chemotherapy.
METHODS
Patients were assessed with the FACT/GOG-Ntx subscale, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Scale 20 (EORTC QLQ-CIPN20), National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE), and light touch test using 10 g monofilament for up to ten assessment points from baseline (prior to initiation of first chemotherapy), after the end of each cycle (up to 6 cycles, 3 weeks per cycle), and at 6, 9, and 12 months after starting chemotherapy. Psychometric analyses included internal consistency reliability, convergent validity, factorial validity, sensitivity to change and responsiveness (minimal clinically important difference, MCID).
RESULTS
Cronbach's alpha coefficients of the FACT/GOG-Ntx subscale were 0.82-0.89 across assessment points. The subscale strongly correlated with the EORTC QLQ-CIPN20 (r = 0.79-0.93) but low-to-moderately correlated with the NCI-CTCAE sensory (r = 0.23-0.45) and motor items (r = 0.15-0.50) as well as the monofilament test (r = 0.23-0.47). The hypothesized 4-factor structure of the FACT/GOG-Ntx subscale was not confirmed at assessment points (χ2/df = 2.26-8.50; all P < 0.001). The subscale exhibited small-to-moderate sensitivity to change (r = 0.17-0.37). The MCIDs were between 1.38 and 3.68.
CONCLUSION
The FACT/GOG-Ntx subscale has satisfactory reliability, validity, sensitivity to change and responsiveness to evaluate CIPN in cancer patients. Future research is needed to explore the factorial structure of the FACT/GOG-Ntx subscale as the published four-factor structure was not supported in this study.
背景
本研究旨在评估功能性评估癌症治疗/妇科肿瘤组神经毒性（FACT/GOG-Ntx）量表在接受化疗的癌症患者纵向研究中的心理计量特性。
方法
患者使用 FACT/GOG-Ntx 量表、欧洲癌症研究与治疗组织生活质量问卷化疗诱导的周围神经病变量表 20 版（EORTC QLQ-CIPN20）、国家癌症研究所-常见不良事件术语标准（NCI-CTCAE）和 10g 单丝进行评估，评估时间多达十个时间点，从基线开始（在开始第一次化疗之前），每个周期结束后（最多 6 个周期，每个周期 3 周），以及开始化疗后 6、9 和 12 个月。心理计量学分析包括内部一致性可靠性、收敛有效性、因子有效性、变化敏感性和反应性（最小临床重要差异，MCID）。
结果
FACT/GOG-Ntx 量表的 Cronbach's alpha 系数在各评估点的范围为 0.82-0.89。该量表与 EORTC QLQ-CIPN20 呈强相关（r=0.79-0.93），但与 NCI-CTCAE 感觉（r=0.23-0.45）和运动项目（r=0.15-0.50）以及单丝测试（r=0.23-0.47）呈低至中度相关。在评估点上，FACT/GOG-Ntx 量表的假设 4 因子结构未得到证实（χ2/df=2.26-8.50；均 P<0.001）。该量表对变化具有小至中度敏感性（r=0.17-0.37）。MCID 介于 1.38 和 3.68 之间。
结论
FACT/GOG-Ntx 量表具有令人满意的可靠性、有效性、对变化的敏感性和对癌症患者 CIPN 的反应性。需要进一步研究来探索 FACT/GOG-Ntx 量表的因子结构，因为本研究不支持已发表的四因子结构。
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