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.
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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DOI：
10.1186/s41687-017-0022-5
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发表时间：
2017
影响因子：
2.7
通讯作者：
Yamaguchi T
中科院分区：
文献类型：
--
作者：
Kawaguchi T;Azuma K;Sano M;Kim S;Kawahara Y;Sano Y;Shimodaira T;Ishibashi K;Miyaji T;Basch E;Yamaguchi T
不良事件通用术语标准(PRO-CTCAE)的患者报告结果版本由美国国家癌症研究所开发，作为评估患者症状的不良事件评估系统，而癌症临床试验往往低估了患者的症状。这项研究的目的是评估日本版PRO-CTCAE的心理测量学特性以及临床医生和患者之间不良事件评估的不一致程度。共有187名接受系统治疗的癌症患者入选。评估PROCTCAE日文版的重复性、标准效度和反应性。使用EORTC QLQ-C30作为外部锚。使用CTCAE和PRO-CTCAE对临床医生和患者之间的不良事件评估的不一致性进行评估。共有187名参与者(标准效度187人，重复性80人，反应性100人)进行了分析(MAGE=262.4年)。所有患者至少对一项症状有反应(男性=1.16)。日本PROCTCAE总体重复性的平均(SD)类内相关系数为0.63(0.02)。EORTC QLQ-C30条目与日本PROCTCAE条目的相关系数较高(Pearson相关系数r=0.56~0.76)。对反应性的分析显示了显著的剂量-反应趋势(容克希尔-特普斯特拉试验，PS测试，0.001)。根据不良事件的不同，临床医生和患者之间的评估存在差异。这些结果表明，日本对不良事件的评估存在低估，日本版的PRO-CTCAE对常见和临床重要症状具有可接受的信度和效度。
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 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. 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.