The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events

Abstract Background The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute as an adverse event assessment system to evaluate patients’ symptoms, which tend to be underestimated in cancer clinical trials....

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Main Authors:	Takashi Kawaguchi, Kanako Azuma, Motohiko Sano, Soan Kim, Yosuke Kawahara, Yoko Sano, Tomohide Shimodaira, Keiichiro Ishibashi, Tempei Miyaji, Ethan Basch, Takuhiro Yamaguchi
Format:	Article
Language:	English
Published:	SpringerOpen 2018-01-01
Series:	Journal of Patient-Reported Outcomes
Online Access:	http://link.springer.com/article/10.1186/s41687-017-0022-5

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spelling	doaj-401be9e809fb48358e5dbd7ca4732f2a2020-11-25T00:21:38ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202018-01-012111310.1186/s41687-017-0022-5The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse eventsTakashi Kawaguchi0Kanako Azuma1Motohiko Sano2Soan Kim3Yosuke Kawahara4Yoko Sano5Tomohide Shimodaira6Keiichiro Ishibashi7Tempei Miyaji8Ethan Basch9Takuhiro Yamaguchi10Department of Practical Pharmacy, School of Pharmacy, Tokyo University of Pharmacy and Life SciencesDepartment of Pharmacy, Tokyo Medical University HospitalDepartment of Pharmacy Services, Saitama Medical Center, Saitama Medical UniversityDepartment of Pharmacy, Juntendo University Nerima HospitalDepartment of Pharmacy, Toshiba General HospitalDepartment of Pharmacy, Tokyo Medical University HospitalDepartment of Pharmacy, Tokyo Medical University HospitalDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, 1981Department of Clinical Trial Data Management, Graduate School of Medicine, The University of TokyoDepartment of Medicine, University of North CarolinaDivision of Health Care Research, QOL Research Group, Center for Public Health Sciences, National Cancer CenterAbstract Background The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute as an adverse event assessment system to evaluate patients’ symptoms, which tend to be underestimated in cancer clinical trials. The aim of this study was to assess the psychometric properties of the Japanese version of the PRO-CTCAE and the degree of adverse event assessment discordance between clinicians and patients. Methods A total of 187 cancer patients receiving systemic therapy were enrolled. Reproducibility, criterion validity, and responsiveness of the Japanese version of PROCTCAE were assessed. The EORTC QLQ-C30 was used as an external anchor. Discordance of assessment of adverse events between clinician and patients were also assessed using the CTCAE and PRO-CTCAE. Results A total of 187 participants (187 for criterion validity, 80 for reproducibility, and 100 for responsiveness), were analyzed (Mage = 62.4 years). All patients responded to at least one symptom item (M = 16). The mean (SD) intra-class correlation coefficients of overall reproducibility for the Japanese PRO-CTCAE was 0.63 (0.02). The correlation coefficient for the corresponding items in the EORTC QLQ-C30 and the Japanese PRO-CTCAE was high (Pearson r = 0.56–0.76). The analysis of responsiveness revealed significant dose-response trends (Jonckheere-Terpstra test, ps < 0.001). Depending on the adverse events, a discrepancy was observed in evaluation between the clinician and patient. Conclusions These results revealed that there is underestimation in the assessment of adverse events in Japan, and that the Japanese version of the PRO-CTCAE had acceptable reliability and validity for common and clinically important symptoms.http://link.springer.com/article/10.1186/s41687-017-0022-5
collection	DOAJ
language	English
format	Article
sources	DOAJ
author	Takashi Kawaguchi Kanako Azuma Motohiko Sano Soan Kim Yosuke Kawahara Yoko Sano Tomohide Shimodaira Keiichiro Ishibashi Tempei Miyaji Ethan Basch Takuhiro Yamaguchi
spellingShingle	Takashi Kawaguchi Kanako Azuma Motohiko Sano Soan Kim Yosuke Kawahara Yoko Sano Tomohide Shimodaira Keiichiro Ishibashi Tempei Miyaji Ethan Basch Takuhiro Yamaguchi The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events Journal of Patient-Reported Outcomes
author_facet	Takashi Kawaguchi Kanako Azuma Motohiko Sano Soan Kim Yosuke Kawahara Yoko Sano Tomohide Shimodaira Keiichiro Ishibashi Tempei Miyaji Ethan Basch Takuhiro Yamaguchi
author_sort	Takashi Kawaguchi
title	The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events
title_short	The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events
title_full	The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events
title_fullStr	The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events
title_full_unstemmed	The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events
title_sort	japanese version of the national cancer institute’s patient-reported outcomes version of the common terminology criteria for adverse events (pro-ctcae): psychometric validation and discordance between clinician and patient assessments of adverse events
publisher	SpringerOpen
series	Journal of Patient-Reported Outcomes
issn	2509-8020
publishDate	2018-01-01
description	Abstract Background The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute as an adverse event assessment system to evaluate patients’ symptoms, which tend to be underestimated in cancer clinical trials. The aim of this study was to assess the psychometric properties of the Japanese version of the PRO-CTCAE and the degree of adverse event assessment discordance between clinicians and patients. Methods A total of 187 cancer patients receiving systemic therapy were enrolled. Reproducibility, criterion validity, and responsiveness of the Japanese version of PROCTCAE were assessed. The EORTC QLQ-C30 was used as an external anchor. Discordance of assessment of adverse events between clinician and patients were also assessed using the CTCAE and PRO-CTCAE. Results A total of 187 participants (187 for criterion validity, 80 for reproducibility, and 100 for responsiveness), were analyzed (Mage = 62.4 years). All patients responded to at least one symptom item (M = 16). The mean (SD) intra-class correlation coefficients of overall reproducibility for the Japanese PRO-CTCAE was 0.63 (0.02). The correlation coefficient for the corresponding items in the EORTC QLQ-C30 and the Japanese PRO-CTCAE was high (Pearson r = 0.56–0.76). The analysis of responsiveness revealed significant dose-response trends (Jonckheere-Terpstra test, ps < 0.001). Depending on the adverse events, a discrepancy was observed in evaluation between the clinician and patient. Conclusions These results revealed that there is underestimation in the assessment of adverse events in Japan, and that the Japanese version of the PRO-CTCAE had acceptable reliability and validity for common and clinically important symptoms.
url	http://link.springer.com/article/10.1186/s41687-017-0022-5
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The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events

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