Development and Validation of the Chemotherapy-induced Peripheral Neuropathy Integrated Assessment – Oxaliplatin Subscale: A Prospective Cohort Study

Abstract

Abstract Background Current assessment tools for chemotherapy-induced peripheral neuropathy (CIPN) have rarely provided substantive guidance for interventions in clinical applications. The aim of this study was to develop an assessment tool specifically for oxaliplatin-induced peripheral neuropathy (OIPN), and to improve the accuracy, sensitivity and practicability of clinical assessment. Methods This study screened 445 OIPN-related literatures for producing a symptom list, and developed the questionnaire module through expert supplement, item generation, content correlation analysis, pre-testing, and item improvement. The validation phase used a Chinese population-based prospective cohort study from June 2021 to July 2022. Patients were asked to complete both the tested questionnaire and QLQ-CIPN20, and to cooperate for CTCAE grading one day before chemotherapy from cycles 2–6. Cronbach’s α coefficient and intraclass correlation coefficient (ICC) were calculated for the internal consistency and stability analysis, respectively. Exploratory factor analysis was performed to investigate the construct validity. The correlations among the tested questionnaire, QLQ-CIPN20 and CTCAE were compared for the criterion validity analysis. Wilcoxon signed-rank sum test was used to compare the sensitivity between the tested questionnaire and QLQ-CIPN20. Result A 20-item CIPN assessment tool named chemotherapy-induced peripheral neuropathy integrated assessment – oxaliplatin subscale (CIPNIA-OS) was developed. The validation phase included 186 patients. Cronbach's α coefficient of CIPNIA-OS was 0.764 (> 0.7), and ICC was 0.997 (between 0.9 and 1). The structure of CIPNIA-OS containing seven factors was examined. The correlation coefficient between CIPNIA-OS and CTCAE was 0.661 (95%CI 0.623 to 0.695), which was significantly higher than that between QLQ-CIPN20 and CTCAE (0.417, 95%CI 0.363 to 0.469, p < 0.01). Besides, the total score of CIPNIA-OS was mostly higher than QLQ-CIPN20, with an average difference of 2.189 (CI 95% 2.056 to 2.322), and the difference gradually expanded with the increase of chemotherapy cycles. Conclusion This study developed an original CIPN questionnaire which was dedicated for OIPN assessment. It was a comprehensive tool that covered acute OIPN symptoms and integrated features from several proven CIPN assessment tools. The validation results supported that CIPNIA-OS had good reliability, stability, construct, criterion validity, and was more accuracy and sensitive than QLQ-CIPN20 in the evaluation of OIPN.