探讨化疗引起的周围神经病的临床相关结局测量的可靠性和有效性。
Exploring the reliability and validity of clinically-relevant outcome measures for chemotherapy-induced peripheral neuropathy.
机构信息
University of Michigan School of Nursing, 400 North Ingalls St, Office 2350, Ann Arbor, MI, 48109, USA.
Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, 14642, USA.
出版信息
Support Care Cancer. 2024 Sep 19;32(10):675. doi: 10.1007/s00520-024-08878-5.
PURPOSE
To explore the reliability and validity of clinically-relevant outcome measures for balance (i.e., The Short Physical Performance Battery [SPPB] - Balance Subscale) and sensation (i.e., monofilament threshold testing) for use in clinical trials of chemotherapy-induced peripheral neuropathy (CIPN).
METHODS
Adult, post-treatment cancer survivors (N = 142) who had reported ≥ 4/10 CIPN symptom severity following neurotoxic chemotherapy were recruited from six National Cancer Institute Community Oncology Research Program (NCORP) sites associated with the University of Rochester Cancer Center NCORP Research Base. Participants completed the monofilament threshold test at the screening and baseline time points (i.e., one week apart), while the Quality of Life Questionnaire-CIPN20, Treatment-Induced Neuropathy Assessment Scale, and SPPB - Balance Subscale were completed at baseline. Test-retest reliability of the monofilament threshold testing scores was assessed using the Intraclass Correlation Coefficient (ICC). The convergent validity among monofilament threshold testing, SPPB - Balance Subscale, and CIPN patient-reported outcome (PRO) scores at baseline was assessed using Spearman's correlation.
RESULTS
Ceiling effects were observed for SPPB-Balance Subscale scores as 113 (79.6%) respondents reported the highest score. Agreement between the screening and baseline monofilament threshold testing scores was moderate (ICC = 0.65). Monofilament threshold testing (r Range: 0.14 - 0.21) and SPPB Balance Subscale scores (r Range: -0.36 - -0.22) showed largely low correlations with all PRO measures.
CONCLUSIONS
Monofilament threshold testing demonstrated moderate test-retest reliability, but low convergent validity with CIPN PROs, while the SPPB - Balance Subscale demonstrated low convergent validity with CIPN PROs and ceiling effects (i.e., highest possible score) among post-treatment cancer survivors with CIPN. Future research is needed to identify promising measures of balance and sensation loss for use in clinical trials that complement CIPN PROs to aid in the identification of clinically relevant treatments for CIPN.
TRIAL REGISTRATION
NCT04367490 [April 29, 2020].
目的
探索与临床相关的平衡评估指标（即短体适能测试[SPPB]-平衡分量表）和感觉评估指标（即单丝触觉检查）在化疗诱导性周围神经病（CIPN）临床试验中的可靠性和有效性，这些指标应适用于临床。
方法
本研究招募了 142 名在接受神经毒性化疗后报告 CIPN 症状严重程度≥4/10 的成年癌症幸存者，他们来自与罗切斯特大学癌症中心 NCORP 研究基地相关的六个国家癌症研究所社区肿瘤学研究计划（NCORP）站点。参与者在筛查和基线时间点（即相隔一周）完成单丝触觉检查，同时在基线时完成生活质量问卷-CIPN20、治疗诱导性神经病评估量表和 SPPB-平衡分量表。采用组内相关系数（ICC）评估单丝触觉检查评分的重测信度。使用 Spearman 相关分析评估基线时单丝触觉检查、SPPB-平衡分量表和 CIPN 患者报告结局（PRO）评分之间的相关性。
结果
SPPB-平衡分量表的得分存在天花板效应，因为 113 名（79.6%）受访者报告了最高得分。筛查和基线时单丝触觉检查得分之间的一致性为中度（ICC=0.65）。单丝触觉检查（r 范围：0.14-0.21）和 SPPB 平衡分量表（r 范围：-0.36-0.22）与所有 PRO 测量值的相关性均较低。
结论
单丝触觉检查显示出中度的重测信度，但与 CIPN PRO 的相关性较低，而 SPPB-平衡分量表显示出与 CIPN PRO 的低相关性，且在有 CIPN 的癌症幸存者中存在天花板效应（即最高可能得分）。需要进一步的研究来确定用于临床试验的平衡和感觉丧失的有前途的评估指标，以补充 CIPN PRO，帮助确定针对 CIPN 的临床相关治疗方法。
试验注册
NCT04367490[2020 年 4 月 29 日]。
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