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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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.

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Author and article information

Contributors

Takashi Kawaguchi: +81-42-676-1521 , tkawa@toyaku.ac.jp

Journal

Journal ID (nlm-ta): J Patient Rep Outcomes

Journal ID (iso-abbrev): J Patient Rep Outcomes

Title: Journal of Patient-Reported Outcomes

Publisher: Springer International Publishing (Cham )

ISSN (Electronic): 2509-8020

Publication date (Electronic): 5 January 2018

Publication date PMC-release: 5 January 2018

Publication date (Print): 2017

Volume: 2

Issue: 1

Electronic Location Identifier: 2

Affiliations

[1 ]ISNI 0000 0001 0659 6325, GRID grid.410785.f, Department of Practical Pharmacy, School of Pharmacy, , Tokyo University of Pharmacy and Life Sciences, ; 1432-1, Horinouchi, Hachioji, Tokyo, Japan

[2 ]ISNI 0000 0004 1775 2495, GRID grid.412781.9, Department of Pharmacy, , Tokyo Medical University Hospital, ; 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan

[3 ]ISNI 0000 0001 2216 2631, GRID grid.410802.f, Department of Pharmacy Services, Saitama Medical Center, , Saitama Medical University, ; 1981, Kamoda, Kawagoe-city, Saitama, Japan

[4 ]ISNI 0000 0004 1769 1784, GRID grid.482668.6, Department of Pharmacy, , Juntendo University Nerima Hospital, ; 3-1-10, Takanodai, Nerima-ku, Tokyo, Japan

[5 ]ISNI 0000 0004 1771 8000, GRID grid.417200.0, Department of Pharmacy, , Toshiba General Hospital, ; 6-3-22, Higashioi, Shinagawa-ku, Tokyo, Japan

[6 ]ISNI 0000 0001 2216 2631, GRID grid.410802.f, Department of Digestive Tract and General Surgery, Saitama Medical Center, , Saitama Medical University, 1981, ; Kamoda, Kawagoe-city, Saitama, Japan

[7 ]ISNI 0000 0001 2151 536X, GRID grid.26999.3d, Department of Clinical Trial Data Management, Graduate School of Medicine, , The University of Tokyo, ; 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

[8 ]ISNI 0000 0001 2168 5385, GRID grid.272242.3, Division of Health Care Research, QOL Research Group, Center for Public Health Sciences, , National Cancer Center, ; 5-1-1 Tsukiji, Tokyo, Japan

[9 ]ISNI 0000 0001 1034 1720, GRID grid.410711.2, Department of Medicine, , University of North Carolina, ; Chapel Hill, NC USA

[10 ]ISNI 0000 0001 2248 6943, GRID grid.69566.3a, Division of Biostatistics, , Tohoku University Graduate School of Medicine, ; 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi Japan

Article

Publisher ID: 22

DOI: 10.1186/s41687-017-0022-5

PMC ID: 5934922

PubMed ID: 29757309

SO-VID: f10733fd-f805-4b0e-ae2e-191f08f24264

License:

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.

History

Date received : 8 July 2017

Date accepted : 21 September 2017

Funding

Funded by: Japan Society for the Promotion of Science KAKENHI

Award ID: 24590595

Award Recipient : Takuhiro Yamaguchi

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