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