Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events

BMC Cancer

Ai-Hua Lin¹  Bo-Jie Huang²  Shan-Shan Yang³  Fang-Yun Xie³  Ying Sun³  Yan-Ping Mao³  Jun Ma³  Lei Chen³  Hai-Jun Lu⁴  Ying Liu⁵ 

[1]Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China

[2]Department of Oncology, the First People’s Hospital of Tianmen in Hubei Province, Tianmen, China

[3]Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 651 Dongfeng Road East, 510060, Guangzhou, People’s Republic of China

[4]Department of Radiation Oncology, the Affiliated Hospital of Qingdao University, Qingdao, China

[5]Nursing Department, Jinan Seventh People’s Hospital, Jinan, China

关键词: Patient-reported outcomes;    PRO-CTCAE;    Chinese;    Validity;    Reliability;   

DOI  :  10.1186/s12885-021-08610-0

来源: Springer

【 摘 要 】

BackgroundThe psychometric properties of the simplified Chinese version of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) have not been assessed. Therefore, we aimed to assess its validity, reliability, and responsiveness.Patients and methodsA Chinese version of the PRO-CTCAE and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) were distributed to 1580 patients from four cancer hospitals in China. Validity assessments included construct validity, measured by Pearson’s correlations and confirmatory factor analysis (CFA), and known-groups validity, measured by t-tests. The assessment of reliability included internal consistency, measured by Cronbach’s ɑ, and test-retest reliability, measured by the intraclass correlation (ICC). Responsiveness was assessed by standardized response means (SRMs).ResultsData from 1555 patients who completed the instruments were analyzed. The correlations were high between PRO-CTCAE items and parallel QLQ-C30 symptom scales (r > 0.60, p < 0.001), except for fatigue (severity: r = 0.49). Moreover, CFA showed the PRO-CTCAE structure was a good fit with the data (Root Mean Square Error of Approximation = 0.046). Known-groups validity was also confirmed. Cronbach’s ɑ of all item clusters were greater than 0.9 and the median test-retest reliability coefficients of the 38 items were 0.85 (range = 0.71–0.91). In addition, the SRMs of PRO-CTCAE items were greater than 0.8, indicating strong responsiveness.ConclusionThe simplified Chinese version of the PRO-CTCAE showed good reliability, validity, and responsiveness.

【 授权许可】

CC BY