Abstract
BackgroundThe US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general.ResultsTwenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events.ConclusionsThe study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items.
Highlights
The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-Common Toxicity Criteria for Adverse Events (CTCAE)) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials
The US National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) is a longstanding grading system widely used for evaluating an array of adverse events in cancer treatment
The patient-reported outcome (PRO)-CTCAE item library contains 124 items reflecting 78 symptomatic adverse events drawn from the CTCAE version 4.0
Summary
The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The US National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) is a longstanding grading system widely used for evaluating an array of adverse events in cancer treatment. In order to improve the accuracy and efficiency of collecting and grading adverse event data, the NCI has established the PatientReported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system [4,5,6,7]. Cognitive interview-based validation was performed in an adolescents-with-cancer population [11] and a pediatric and prosy version of the PRO-CTCAE is being developed [12]. The purpose of the Japanese translation is to encourage the use of PRO-CTCAE among Japanese-speaking cancer patients living in the USA, as well as those in Japan [16]
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