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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)

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 l...

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Autores principales: Miyaji, Tempei, Iioka, Yukiko, Kuroda, Yujiro, Yamamoto, Daigo, Iwase, Satoru, Goto, Yasushi, Tsuboi, Masahiro, Odagiri, Hiroki, Tsubota, Yu, Kawaguchi, Takashi, Sakata, Naoko, Basch, Ethan, Yamaguchi, Takuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5934908/
https://www.ncbi.nlm.nih.gov/pubmed/29757296
http://dx.doi.org/10.1186/s41687-017-0012-7
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author Miyaji, Tempei
Iioka, Yukiko
Kuroda, Yujiro
Yamamoto, Daigo
Iwase, Satoru
Goto, Yasushi
Tsuboi, Masahiro
Odagiri, Hiroki
Tsubota, Yu
Kawaguchi, Takashi
Sakata, Naoko
Basch, Ethan
Yamaguchi, Takuhiro
author_facet Miyaji, Tempei
Iioka, Yukiko
Kuroda, Yujiro
Yamamoto, Daigo
Iwase, Satoru
Goto, Yasushi
Tsuboi, Masahiro
Odagiri, Hiroki
Tsubota, Yu
Kawaguchi, Takashi
Sakata, Naoko
Basch, Ethan
Yamaguchi, Takuhiro
author_sort Miyaji, Tempei
collection PubMed
description 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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spelling pubmed-59349082018-05-09 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, Tempei Iioka, Yukiko Kuroda, Yujiro Yamamoto, Daigo Iwase, Satoru Goto, Yasushi Tsuboi, Masahiro Odagiri, Hiroki Tsubota, Yu Kawaguchi, Takashi Sakata, Naoko Basch, Ethan Yamaguchi, Takuhiro J Patient Rep Outcomes Research 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. Springer International Publishing 2017-12-05 /pmc/articles/PMC5934908/ /pubmed/29757296 http://dx.doi.org/10.1186/s41687-017-0012-7 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Research
Miyaji, Tempei
Iioka, Yukiko
Kuroda, Yujiro
Yamamoto, Daigo
Iwase, Satoru
Goto, Yasushi
Tsuboi, Masahiro
Odagiri, Hiroki
Tsubota, Yu
Kawaguchi, Takashi
Sakata, Naoko
Basch, Ethan
Yamaguchi, Takuhiro
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5934908/
https://www.ncbi.nlm.nih.gov/pubmed/29757296
http://dx.doi.org/10.1186/s41687-017-0012-7
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