Translation Into Simplified Chinese and Cultural Validation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Using Cognitive Interviewing.

Abstract

The original English Pediatric Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) captures symptomatic adverse events (AEs) in cancer clinical trials from the perspective of pediatric patients. A Chinese version was needed to encourage the use of the Pediatric PRO-CTCAE among Chinese pediatric oncology patients. This study translated and linguistically validated a simplified Chinese version of the Pediatric PRO-CTCAE for oncological patients aged 7 to 18 years. Following the Functional Assessment of Chronic Illness Therapy translation methodology, 130 questions were translated into Chinese. Semistructured cognitive interviews investigated the comprehensibility and clarity of terms for symptoms, attributes, and response options. Two rounds of interviews were conducted with 48 native Chinese-speaking children aged 7 to 18 years who were undergoing chemotherapy or radiotherapy treatment. Most items, response options, and recall periods were well understood by children across the age range in round 1. Nineteen items posed comprehension difficulties for 9 participants and were revised and retested without further difficulties. The Pediatric PRO-CTCAE was successfully developed and linguistically validated among Chinese oncology patients. The results indicated that the Chinese Pediatric PRO-CTCAE was semantically and conceptually equivalent to the English version. The availability of the simplified Chinese Pediatric PRO-CTCAE will facilitate the generation of patient-reported outcome data about symptomatic AEs for children with cancer in China and thus improve our understanding of children's experience of treatment-related symptoms.