Prince of Wales Clinical School, University of New South Wales, Kensington, Australia.
Prince of Wales Clinical School, University of New South Wales, Kensington, Australia; Prince of Wales Hospital, Randwick, Australia.
J Pain Symptom Manage. 2019 Dec;58(6):1023-1032. doi: 10.1016/j.jpainsymman.2019.07.021. Epub 2019 Jul 30.
Efficient and accurate clinical screening for treatment-related toxicities is a critical component of optimal patient management. A number of alternate screening tools for chemotherapy-induced peripheral neuropathy (CIPN) have been proposed in response to demonstrated limitations with standard clinical screening, although their relative diagnostic value is unclear.
The aim of this study is to evaluate the relative construct validity and discriminant properties of available CIPN screening tools.
Patients treated with known potentially neurotoxic therapies underwent CIPN evaluation at one or multiple timepoints (N = 316 patients; age = 56 ± 13 years). At each testing session (N = 644 testing sessions), patients were evaluated using screening tools and comprehensive CIPN assessments. Comprehensive assessments were clinician-rated (Total Neuropathy Score, reduced) or patient-reported outcome (PRO; Functional Assessment of Cancer Therapy-Gynecologic Oncology Group/Neurotoxicity questionnaire). Similarly, screening tools were clinician-rated (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE]) or PRO (Patient Neurotoxicity Questionnaire, PRO-CTCAE).
Analyses revealed moderate-to-high correlations between screening tools and comprehensive assessments (0.55 ≤ rho ≤ 0.75; P < 0.001) and similar discriminant properties across screening tools (P > 0.01). Screening tool grading corresponding to clinically significant (grade 2/3) vs. low-grade (grade 0/1) CIPN would correspond to greater ratings of CIPN severity by more comprehensive assessments in a predicted 77%-91% of cases (c-statistic = 0.77-0.91; P < 0.01).
PRO screening tools provide adequate CIPN screening while avoiding potential biases demonstrated to limit currently used clinician-rated screening tools. Addition of a brief objective test did not add value to PRO screening. Up to 23% of patients would be misidentified through screening, providing quantitative evidence of the limitations of available screening tools. More extensive CIPN evaluations are critical in patients at risk of serious neurotoxicity.
高效准确的临床毒性筛查是优化患者管理的关键组成部分。针对标准临床筛查的局限性，已经提出了许多用于化疗诱导的周围神经病（CIPN）的替代筛查工具，尽管它们的相对诊断价值尚不清楚。
本研究旨在评估现有 CIPN 筛查工具的相对结构有效性和鉴别特性。
接受已知潜在神经毒性治疗的患者在一个或多个时间点接受 CIPN 评估（N=316 名患者；年龄=56±13 岁）。在每个测试会话（N=644 个测试会话）中，患者使用筛查工具和全面的 CIPN 评估进行评估。全面评估由临床医生进行评估（总神经病变评分，降低）或患者报告的结果（癌症治疗功能评估-妇科肿瘤学组/神经毒性问卷）。同样，筛查工具由临床医生进行评估（国家癌症研究所不良事件通用术语标准[NCI-CTCAE]）或患者报告的结果（患者神经毒性问卷，PRO-CTCAE）。
分析显示筛查工具与全面评估之间存在中度至高相关性（0.55≤rho≤0.75；P<0.001），并且在筛查工具之间具有相似的鉴别特性（P>0.01）。与临床显著（等级 2/3）相比，筛查工具分级对应于低等级（等级 0/1）的 CIPN ，在 77%-91%的情况下（C 统计量=0.77-0.91；P<0.01），与更全面的评估相比，将对应更大的 CIPN 严重程度评分。
PRO 筛查工具提供了充分的 CIPN 筛查，同时避免了当前使用的临床医生评定筛查工具所显示的潜在偏差。添加简短的客观测试对 PRO 筛查没有增加价值。多达 23%的患者可能会通过筛查被误诊，这提供了定量证据表明现有筛查工具的局限性。更广泛的 CIPN 评估对于有严重神经毒性风险的患者至关重要。
