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
Takashi KawaguchiTakuhiro Yamaguchi

Abstract

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. 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. 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 Japan...Continue Reading

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Citations

Feb 11, 2020·Strahlentherapie und Onkologie : Organ der Deutschen Röntgengesellschaft ... [et al]·Stratos VassisRoland Merten
Aug 7, 2020·Journal of Oral Rehabilitation·Maisa OmaraKatrin Bekes
Jun 22, 2020·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Lei LiuWeina Wang
Feb 20, 2021·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Mikiko KaizuArdith Z Doorenbos

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