Abstract
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.
Highlights
Reporting adverse events (AEs) is mandatory in clinical cancer trials to ensure the safety of patients and identify toxic characteristics of treatments
The correlations were high between PRO-CTCAE items and parallel Quality of Life Questionnaire (QLQ)-C30 symptom scales (r > 0.60, p < 0.001), except for fatigue
confirmatory factor analysis (CFA) showed the PRO-CTCAE structure was a good fit with the data (Root Mean Square Error of Approximation = 0.046)
Summary
Reporting adverse events (AEs) is mandatory in clinical cancer trials to ensure the safety of patients and identify toxic characteristics of treatments. The National Cancer Institute’s (NCI’s) Common Terminology Criteria for Adverse Events (NCI-CTCAE), which is commonly used in clinical settings, uses terminology consistent with the Medical Dictionary for Medical Affairs [1]. In light of the variability of AEs within and across trials, the PRO-CTCAE is a systematic measurement tool that can effectively capture the patient’s voice in reporting symptomatic AEs in cancer clinical trials. The psychometric properties of the simplified Chinese version of the PROCTCAE have not been assessed. 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. We aimed to assess its validity, reliability, and responsiveness
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