Knoerl Robert, Gray Evan, Stricker Carrie, Mitchell Sandra A, Kippe Kelsey, Smith Gloria, Dudley William N, Lavoie Smith Ellen M
University of Michigan School of Nursing, Ann Arbor, MI, 48109, USA.
School of Health and Human Sciences, Department of Health Education, University of North Carolina at Greensboro, Greensboro, NC, 27412, USA.
Support Care Cancer. 2017 Nov;25(11):3437-3446. doi: 10.1007/s00520-017-3764-y. Epub 2017 Jun 2.
The aim of this study is to examine and compare with the validated, paper/pencil European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20), the psychometric properties of three electronically administered patient reported outcome (PRO) measures of chemotherapy-induced peripheral neuropathy (CIPN): (1) the two neuropathy items from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), (2) the QLQ-CIPN20, and (3) the 0-10 Neuropathy Screening Question (NSQ).
We employed a descriptive, cross-sectional design and recruited 25 women with breast cancer who were receiving neurotoxic chemotherapy at an academic hospital. Participants completed the paper/pencil QLQ-CIPN20 and electronic versions of the QLQ-CIPN20, PRO-CTCAE, and NSQ. Internal consistency reliability, intraclass correlation, and concurrent and discriminant validity analyses were conducted.
The alpha coefficients for the electronic QLQ-CIPN20 sensory and motor subscales were 0.76 and 0.75. Comparison of the electronic and paper/pencil QLQ-CIPN20 subscales supported mode equivalence (intraclass correlation range >0.91). Participants who reported the presence of numbness/tingling via the single-item NSQ reported higher mean QLQ-CIPN20 sensory subscale scores (p < 0.001). PRO-CTCAE neuropathy severity and interference items correlated well with the QLQ-CIPN20 electronic and paper/pencil sensory (r = 0.76; r = 0.70) and motor (r = 0.55; r = 0.62) subscales, and with the NSQ (r = 0.72; r = 0.44).
These data support the validity of the electronically administered PRO-CTCAE neuropathy items, NSQ, and QLQ-CIPN20 for neuropathy screening in clinical practice. The electronic and paper/pencil versions of the QLQ-CIPN can be used interchangeably based on evidence of mode equivalence.
本研究旨在检验并比较三种电子化管理的化疗所致周围神经病变（CIPN）患者报告结局（PRO）测量工具与经过验证的纸质版欧洲癌症研究与治疗组织生活质量问卷-化疗所致周围神经病变量表（QLQ-CIPN20）的心理测量特性，这三种测量工具分别为：（1）美国国立癌症研究所不良事件通用术语标准患者报告结局版（PRO-CTCAE）中的两项神经病变条目；（2）QLQ-CIPN20；（3）0-10神经病变筛查问题（NSQ）。
我们采用描述性横断面设计，招募了25名在一家学术医院接受神经毒性化疗的乳腺癌女性患者。参与者完成了纸质版QLQ-CIPN20以及QLQ-CIPN20、PRO-CTCAE和NSQ的电子版。进行了内部一致性信度、组内相关以及同时效度和区分效度分析。
电子版QLQ-CIPN20感觉和运动子量表的α系数分别为0.76和0.75。电子版和纸质版QLQ-CIPN20子量表的比较支持方式等效性（组内相关范围>0.91）。通过单项NSQ报告存在麻木/刺痛的参与者报告的QLQ-CIPN20感觉子量表平均得分更高（p<0.001）。PRO-CTCAE神经病变严重程度和干扰条目与QLQ-CIPN20电子版和纸质版的感觉（r=0.76；r=0.70）和运动（r=0.55；r=0.62）子量表以及NSQ（r=0.72；r=0.44）相关性良好。
这些数据支持电子化管理的PRO-CTCAE神经病变条目、NSQ和QLQ-CIPN20在临床实践中用于神经病变筛查的有效性。基于方式等效性证据，QLQ-CIPN的电子版和纸质版可互换使用。
