Cross-cultural adaptation and validation of the Pediatric Chemotherapy-Induced Neuropathy (P-CIN) using a patient-reported outcome measure for Chinese pediatric oncology patients

Abstract Background Chemotherapy induced peripheral neuropathy (CIPN) is a symptom commonly reported by pediatric oncology patients who receive neurotoxicity agents. Early identification is imperative for the intervention implementation. Currently, the Pediatric Chemotherapy-Induced Neuropathy (P-CIN) is an age-appropriate, patient-reported outcome (PRO) for pediatric CIPN. However, it has not been used in China, and importantly does not contain a cut-off value to guide healthcare professionals for clinical decision making. Objectives We aimed to cross-cultural adapt the P-CIN into Chinese context, and assess its psychometric properties. Design Methodological and descriptive study. Settings Shenzhen Children’s Hospital, Henan Cancer Hospital and Shanghai Children’s Medical Center in China. Participants 313 pediatric oncology patients were conveniently sampled. Methods The Chinese P-CIN version was cross-culturally adapted and validated according to the established methodological guidelines. Participants were asked to provide demographic and clinical information, complete the translated P-CIN, Wong-baker FACES Pain Rating scale, and Pediatric Quality of Life Inventory (PedsQL) Cancer Module, and nerve conduction study. Results The Chinese P-CIN version showed satisfactory internal consistency (Cronbach’s alpha coefficient: 0.771) and good test-retest reliability for 2-week interval (intraclass correlation coefficient: 0.810). Excellent content validity was demonstrated; the item content validity index (CVI) ranged from 0.90 to 1.00, the average-CVI was 0.98 and the universal-CVI was 0.85. The total score of the translated P-CIN was strongly correlated with the Wong-baker FACES Pain Rating scale (Spearman’s correlation coefficient (r): 0.909, p < 0.001) and PedsQL Cancer Module (r = -0.710, p < 0.001), presenting good convergent validity. Using the clinician diagnosis of pediatric CIPN as a reference criterion, the area under the curve was 0.894. The optimal cut-off value to identify significant symptom burden of CIPN was 9. Exploratory factor analysis yielded a two-factor model (Sensory symptoms and Functional Task Performance Ability). The confirmatory factor analysis results supported the good fit of the two-factor model. Known-group validity was supported by the significant differences in the translated P-CIN score between patients grouped by neurotoxic chemotherapy agents (p = 0.014, ηp²=0.019) and cancer diagnosis (p = 0.026, ηp²=0.016). Besides, 82% of the participants completed the translated P-CIN independently. Conclusions The Chinese P-CIN version was found to be a reliable and feasible PRO for pediatric CIPN. It shall be adopted as a routine tool for the detection of CIPN among Chinese pediatric oncology patients. Registration Clinicaltrial, NCT07053579. Registered 18/06/2025, retrospectively registered.