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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)

  • Miyaji, Tempei1, 2
  • Iioka, Yukiko3, 4
  • Kuroda, Yujiro5
  • Yamamoto, Daigo6
  • Iwase, Satoru7
  • Goto, Yasushi8
  • Tsuboi, Masahiro9
  • Odagiri, Hiroki10
  • Tsubota, Yu11
  • Kawaguchi, Takashi12
  • Sakata, Naoko13
  • Basch, Ethan14
  • Yamaguchi, Takuhiro1, 2, 15
  • 1 The University of Tokyo, Department of Clinical Trial Data Management, Graduate School of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan , Tokyo (Japan)
  • 2 National Cancer Center, Division of Health Care Research, QOL Research Group, Center for Public Health Sciences, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan , Tokyo (Japan)
  • 3 Adult Nursing, Chronic Illness and Conditions Nursing, St. Luke’s College of Nursing, 10-1 Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan , Tokyo (Japan)
  • 4 Saitama Prefectural University, Graduate School of Health and Social Services, 820 San-Nomiya, Koshigaya-shi, Saitama, 343-8540, Japan , Saitama (Japan)
  • 5 Fukushima Medical University, Department of Public Health, 1 Hikariga-oka, Fukushima City, Fukushima, 960-1295, Japan , Fukushima City (Japan)
  • 6 Kansai Medical University Medical Center, Breast unit, 10-15 Fumizono-cho, Moriguchi-city, Osaka, 570-8507, Japan , Moriguchi-city (Japan)
  • 7 The University of Tokyo, Department of Palliative Medicine, The Institute of Medical Science, 4-6-1 Shirokanedai, Minato-ku, Tokyo, 108-8639, Japan , Tokyo (Japan)
  • 8 National Cancer Center Hospital, Department of Thoracic Oncology, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan , Tokyo (Japan)
  • 9 National Cancer Center East Hospital, Division of Thoracic Surgery, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan , Kashiwa (Japan)
  • 10 Hirosaki National Hospital, Division of Breast Surgery, 1 Tomino-cho, Hirosaki, Aomori, 036-8545, Japan , Aomori (Japan)
  • 11 Kansai Medical University, Department of Surgery, 10-15 Fumizonochō, Moriguchi-shi, Osaka, 570-0074, Japan , Osaka (Japan)
  • 12 Tokyo University of Pharmacy and Life Sciences, Department of Practical Pharmacy, School of Pharmacy, 1432-1, Horinouchi, Hachioji-city, Tokyo, 192-0392, Japan , Tokyo (Japan)
  • 13 The University of Tokyo Hospital, Department of Palliative Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan , Tokyo (Japan)
  • 14 University of North Carolina at Chapel Hill, Department of Medicine, 321 S Columbia St, Chapel Hill, NC, 27516, USA , Chapel Hill (United States)
  • 15 Tohoku University Graduate School of Medicine, Division of Biostatistics, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan , Sendai (Japan)
Published Article
Journal of Patient-Reported Outcomes
Springer International Publishing
Publication Date
Dec 05, 2017
DOI: 10.1186/s41687-017-0012-7
Springer Nature


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.

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