Development program for the Japanese version of the PRO-CTCAE

Background: The US National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) is a longstanding empirically developed grading system designed for use in cancer clinical trials to aid clinicians in detecting and documenting an array of adverse events (AEs) commonly encountered in oncology. There is growing awareness that collecting symptom data directly from patients using patient-reported outcome (PRO) tools can improve the accuracy and efficiency of symptomatic AE data collection. The purpose of the NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) project is to develop a patient-reported outcomes measurement system to allow patients to self-report the symptomatic adverse events listed in the CTCAE, thus improving the accuracy and precision of grading symptomatic AEs. The development of a translation of the NCI PRO-CTCAE into Japanese serves an important role by enabling collection of symptomatic AE information from Japanese speakers. A project team (the PRO-CTCAE-J Working Group) was formed to accomplish the translation and Japanese linguistic validation, and to explore the feasibility and acceptability of using the NCI PRO-CTCAE-J in the Japanese clinical trials context. A material transfer agreement was established between Japanese investigators and the US NCI in order to conduct this work. Methods and Results: Forward and back translations were performed and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee. We conducted cognitive interviews in a range of treatment settings among diverse groups of cancer patients. Participants were asked to self-complete the PRO-CTCAE and then were interviewed using semi-structured scripts and predetermined probes to determine whether any items were difficult to comprehend and/or not relevant to their symptoms. We are currently analyzing results of the interviews. PRO-CTCAE is being administered in an international randomized controlled trial (NCCTG0949/JCOG1018). Before JCOG1018 opened, we conducted a feasibility evaluation in 16 patients, to assure that patients were willing and able to report this information in a timely manner. There were no missing data and feasibility of the measurement was confirmed. The physicians' reports tended to underestimate than the patients' reports as previously published elsewhere. We are currently planning a validation study to examine the reliability and validity of the Japanese language translation of the PRO-CTCAE. Conclusion: We are continuing the development process under the provisions of a material transfer agreement with the US NCI and plan to have a translated and linguistically validated NCI PRO-CTCAE-J (Japanese language) available for use in Japanese clinical trials settings.