1. Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events
- Author
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Fang-Yun Xie, Lei Chen, Haijun Lu, Jun Ma, Yan Ping Mao, Ying Liu, Bo-Jie Huang, Shan-Shan Yang, Aihua Lin, and Ying Sun
- Subjects
Adult ,Male ,China ,Cancer Research ,Adolescent ,Drug-Related Side Effects and Adverse Reactions ,Psychometrics ,Intraclass correlation ,Validity ,PRO-CTCAE ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Cronbach's alpha ,Neoplasms ,Surveys and Questionnaires ,Genetics ,Adverse Drug Reaction Reporting Systems ,Humans ,Patient Reported Outcome Measures ,030212 general & internal medicine ,RC254-282 ,Reliability (statistics) ,Aged ,Aged, 80 and over ,Patient-reported outcomes ,Chinese ,Research ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Reproducibility of Results ,Construct validity ,Common Terminology Criteria for Adverse Events ,Middle Aged ,Reliability ,Combined Modality Therapy ,Confirmatory factor analysis ,Oncology ,030220 oncology & carcinogenesis ,Female ,Psychology ,Clinical psychology - Abstract
Background The 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 methods A 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). Results Data 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 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. Conclusion The simplified Chinese version of the PRO-CTCAE showed good reliability, validity, and responsiveness.
- Published
- 2021