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

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. We aimed to cross-cultural adapt the P-CIN into Chinese context, and assess its psychometric properties. Methodological and descriptive study. Shenzhen Children’s Hospital, Henan Cancer Hospital and Shanghai Children’s Medical Center in China. 313 pediatric oncology patients were conveniently sampled. 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. 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. 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. Clinicaltrial, NCT07053579. Registered 18/06/2025, retrospectively registered. • CIPN is a severe adverse effect experienced by pediatric oncology patients undergoing chemotherapy with neurotoxic agents, resulting in negative health outcomes. • The P-CIN is the only patient reported outcome developed to assess pediatric CIPN; however, it has not been culturally adapted and validated in Chinese pediatric oncology patients. • The translated P-CIN was the only valid and reliable patient-reported outcome measure for pediatric CIPN in the Chinese cultural context. • The optimal cut-off value of the translated P-CIN to identify significant symptom burden of CIPN was 9, with a two-factor model demonstrating a good fit.