Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

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  • Miyaji, Tempei
    • Other Affiliation: Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo
  • Iioka, Yukiko
    • Other Affiliation: Adult Nursing, Chronic Illness and Conditions Nursing, St. Luke’s College of Nursing
  • Kuroda, Yujiro
    • Other Affiliation: Department of Public Health, Fukushima Medical University
  • Yamamoto, Daigo
    • Other Affiliation: Breast unit, Kansai Medical University Medical Center
  • Iwase, Satoru
    • Other Affiliation: Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo
  • Goto, Yasushi
    • Other Affiliation: Department of Thoracic Oncology, National Cancer Center Hospital
  • Tsuboi, Masahiro
    • Other Affiliation: Division of Thoracic Surgery, National Cancer Center East Hospital
  • Odagiri, Hiroki
    • Other Affiliation: Division of Breast Surgery, Hirosaki National Hospital
  • Tsubota, Yu
    • Other Affiliation: Department of Surgery, Kansai Medical University
  • Kawaguchi, Takashi
    • Other Affiliation: Department of Practical Pharmacy, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
  • Sakata, Naoko
    • Other Affiliation: Department of Palliative Medicine, The University of Tokyo Hospital
  • Basch, Ethan
    • Affiliation: School of Medicine, Department of Medicine
  • Yamaguchi, Takuhiro
    • Other Affiliation: Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo
Abstract
  • Background 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 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. Results Twenty-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. Conclusions The 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.
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  • Article
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  • In Copyright
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  • The Author(s)
Journal title
  • Journal of Patient-Reported Outcomes
Journal volume
  • 1
Journal issue
  • 1
Page start
  • 8
Language
  • English
Bibliographic citation
  • Journal of Patient-Reported Outcomes. 2017 Dec 05;1(1):8
Publisher
  • Springer International Publishing

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