In Search of a Gold Standard Patient-Reported Outcome Measure for Use in Chemotherapy- Induced Peripheral Neuropathy Clinical Trials

43Citations
Citations of this article
60Readers
Mendeley users who have this article in their library.

This article is free to access.

Abstract

Purpose: To test a reduced version—CIPN15—of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy scale (QLQ-CIPN20) to establish a possible gold-standard patient-reported outcome measure for chemotherapy-induced peripheral neuropathy (CIPN). Methods: Using a prospective, longitudinal, case–control design, patients (n = 121) receiving neurotoxic chemotherapy completed the CIPN15 at baseline and 12 weeks and underwent objective neurological assessment using the 5-item Total Neuropathy Score-Clinical (TNSc). Healthy controls (n = 30) completed the CIPN15 once. Structural validity was evaluated using factor analysis. Because a stable factor structure was not found, a sum score was used to evaluate measures of the CIPN15’s psychometric properties—reliability, validity, sensitivity, and responsiveness—as follows: internal consistency via Cronbach’s α and item–item correlations; test–retest reliability via correlation between 2 CIPN15 scores from each patient; concurrent validity via correlation between CIPN15 and 5-item TNSc scores; contrasting group validity via comparison of CIPN15 scores from patients and healthy controls; sensitivity via descriptive statistics (means, standard deviation, ranges); and responsiveness via Cohen’s d effect size. Results: Most patients received single agent oxaliplatin (33.7%), paclitaxel (21.2%), or more than 1 neurotoxic drug concurrently (29.8%). Factor analysis revealed no stable factor structure. Cronbach’s α for the CIPN15 sum score was 0.91 (confidence interval [CI] = 0.89-0.93). Test–retest reliability was demonstrated based on strong correlations between the 2 scores obtained at the 12-week time point (r = 0.86; CI = 0.80-0.90). The CIPN15 and 5-item TNSc items reflecting symptoms (not signs) were moderately correlated (r range 0.57-0.72): concurrent validity. Statistically significant differences were found between patient and healthy control CIPN15 mean scores (P

Cite

CITATION STYLE

APA

Smith, E. M. L., Knoerl, R., Yang, J. J., Kanzawa-Lee, G., Lee, D., & Bridges, C. M. (2018). In Search of a Gold Standard Patient-Reported Outcome Measure for Use in Chemotherapy- Induced Peripheral Neuropathy Clinical Trials. Cancer Control, 25(1). https://doi.org/10.1177/1073274818756608

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Save time finding and organizing research with Mendeley

Sign up for free