Mendoza Tito R, Williams Loretta A, Shi Qiuling, Wang Xin Shelley, Bamidele Oluwatosin, Woodruff Jeanie F, Cleeland Charles S
Department of Symptom Research, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1450, Houston, TX, 77030, USA.
The University of Texas School of Public Health, Houston, TX, USA.
J Patient Rep Outcomes. 2020 Feb 19;4(1):15. doi: 10.1186/s41687-020-0180-8.
The validation of the Treatment-induced Neuropathy Assessment Scale (TNAS v2.0), a patient-reported outcome measure of symptoms associated with cancer treatment-induced peripheral neuropathy (TIPN), was previously reported. Further patient input (qualitative interviewing, cognitive debriefing) suggested that the measure should be modified to better reflect the TIPN experience. We report the performance of a revised version (TNAS v3.0) for assessing TIPN across cancer treatments. This TNAS version incorporates extensive patient input, in accordance with FDA guidance on the development of patient-reported outcomes measures. Patients with multiple myeloma, colorectal cancer, or gynecological cancer treated with bortezomib, oxaliplatin, or taxane-platinum combination therapy, respectively, completed the TNAS v3.0, European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy (EORTC-CIPN20), and a cognitive debriefing survey during a scheduled clinic visit. Patients also participated in in-depth qualitative interviews about their TIPN symptoms. The psychometric properties of the TNAS v3.0 were evaluated.
Cognitive debriefing survey results were summarized and showed that most patients found the items easy to complete, comprehensible, acceptable, and not redundant. A notable change from TNAS v2.0 was the separation of "numbness" from "tingling," although these 2 items remained the most severe, followed by a new "pain" item. The Cronbach coefficient alphas for the 9-item TNAS were 0.88 and 0.90 at the first and second administrations, respectively, indicating good reliability. The test-retest reliability of the TNAS was 0.97. The correlation coefficients for the 9-item TNAS and the EORTC-CIPN20 were 0.69 for the sensory subscale, 0.70 for the motor subscale, and 0.32 for the autonomic subscale, indicating good validity.
This psychometric evaluation showed that the TNAS v3.0 is valid and reliable. Further research is needed to determine clinically meaningful differences in TNAS v3.0 scores and demonstrate its responsiveness over time.
之前已报道了治疗引起的神经病变评估量表（TNAS v2.0）的验证情况，该量表是一种患者报告的与癌症治疗引起的周围神经病变（TIPN）相关症状的测评工具。进一步的患者反馈（定性访谈、认知详析）表明，该量表应进行修改，以更好地反映TIPN经历。我们报告了修订版（TNAS v3.0）在评估各种癌症治疗中的TIPN方面的表现。此TNAS版本根据美国食品药品监督管理局关于患者报告结局测评工具开发的指南，纳入了大量患者反馈。分别接受硼替佐米、奥沙利铂或紫杉烷 - 铂联合疗法治疗的多发性骨髓瘤、结直肠癌或妇科癌症患者，在预定的门诊就诊期间完成了TNAS v3.0、欧洲癌症研究与治疗组织化疗引起的周围神经病变量表（EORTC - CIPN20）以及一项认知详析调查。患者还参与了关于其TIPN症状的深入定性访谈。对TNAS v3.0的心理测量特性进行了评估。
认知详析调查结果汇总显示，大多数患者认为这些条目易于完成、易于理解、可以接受且不存在冗余。与TNAS v2.0的一个显著变化是将“麻木”与“刺痛”分开，尽管这两个条目仍然是最严重的，其次是一个新的“疼痛”条目。9项TNAS在首次和第二次施测时的克朗巴哈系数α分别为0.88和0.90，表明可靠性良好。TNAS的重测信度为0.97。9项TNAS与EORTC - CIPN20的相关系数在感觉子量表上为0.69，运动子量表上为0.70，自主子量表上为0.32，表明效度良好。
这项心理测量评估表明TNAS v3.0有效且可靠。需要进一步研究以确定TNAS v3.0分数在临床上有意义的差异，并证明其随时间的反应性。
