Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017;1(1):8.
doi: 10.1186/s41687-017-0012-7. Epub 2017 Dec 5.

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)

Tempei Miyaji  1   2 , Yukiko Iioka  3   4 , Yujiro Kuroda  5 , Daigo Yamamoto  6 , Satoru Iwase  7 , Yasushi Goto  8 , Masahiro Tsuboi  9 , Hiroki Odagiri  10 , Yu Tsubota  11 , Takashi Kawaguchi  12 , Naoko Sakata  13 , Ethan Basch  14 , Takuhiro Yamaguchi  1   2   15
Affiliations

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)

Tempei Miyaji et al. J Patient Rep Outcomes. 2017.

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.

Keywords: Adverse events; Japanese translation; Linguistic validation; PRO-CTCAE; Patient-reported outcomes.

PubMed Disclaimer

Conflict of interest statement

The study was performed in accordance with the Helsinki Declaration and Japanese ethical guidelines for epidemiology research. The study protocol was approved by the institutional review boards of the Kansai Medical University Hirakata Hospital and the University of Tokyo Hospital. All patients gave written informed consent before participating. In order to safeguard the participants’ privacy, the interviews were performed one-on-one in private rooms.This research was supported by Grants-in-Aid for Scientific Research from the Japanese Ministry of Education, Culture, Sports, Science, and Technology (24590595). The authors declare that they have no competing interests. Informed consent was obtained from all individuals involved in the study.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. Basch E, Iasonos A, McDonough T, et al. Patient versus clinician symptom reporting using the National Cancer Institute common terminology criteria for adverse events: Results of a questionnaire-based study. The Lancet Oncol. 2006;7(11):903–909. doi: 10.1016/S1470-2045(06)70910-X. - DOI - PubMed
    1. Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010;362(10):865–869. doi: 10.1056/NEJMp0911494. - DOI - PMC - PubMed
    1. Basch E, Abernethy AP, Mullins CD, et al. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol. 2012;30(34):4249–4255. doi: 10.1200/JCO.2012.42.5967. - DOI - PubMed
    1. Bruner DW, Hanisch LJ, Reeve BB, et al. Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) Transl Behav Med. 2011;1(1):110–122. doi: 10.1007/s13142-011-0025-3. - DOI - PMC - PubMed
    1. Basch, E., Reeve. B. B., Mitchell, S. A., et al. (2014). Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst, 106(9). - PMC - PubMed

LinkOut - more resources