Abstract: Objective: To develop a cartoon-based pediatric adverse reaction self-reporting application and evaluate its equivalence to the paper-based version, to help children self-report symptomatic adverse reactions to the greatest extent possible. Methods: Based on the principles of user-centered design and incorporating perspectives from both experts and children, a cartoon-based pediatric adverse reaction self-reporting application was developed. Subsequently, 100 pediatric cancer patients aged 7-12 years from a tertiary grade A specialist hospital in Shanghai were selected using a convenience sampling method from October 2024 to January 2025, and a randomized crossover controlled trial was conducted to compare with the paper-based version of the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events questionnaire in terms of outcome equivalence, data quality, and questionnaire completion time. Results: In terms of equivalence, the within-group Intraclass Correlation Coefficient (ICC) of the two groups were 0.852 and 0.850, and the between-group ICC was 0.824, indicating good equivalence between the cartoon-based and paper-based versions. Regarding data quality, the cartoon-based version had no missing values, whereas the paper-based version had a 4.0% missing value rate. In terms of questionnaire completion time, the total time to complete the cartoon-based questionnaire was 212.70±84.04s, significantly shorter than that of the paper-based version (261.56±93.63s, P<0.001). Regarding preference, 84.0% of the subjects preferred the cartoon-based questionnaire. Conclusion: This study successfully developed a cartoon-based pediatric adverse reaction self-reporting application, which can help further promote clinical decision-making and treatment outcome evaluation.

Key words: pediatric; Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; application; equivalence