ArticleBMC cancer2021
Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events.
Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Hearing impairment following radiotherapy in patients with nasopharyngeal carcinoma (Review).Molecular and clinical oncology · 2026Review
- Development and validation of a customised PRO-CTCAE scale for adult-type diffuse gliomas (VERONICA): a multicentre, prospective, observational cohort study in China.EClinicalMedicine · 2026Article
- Preferences for electronic health information support concerning chemotherapy adverse reactions among young and middle-aged breast cancer patients based on the Kano model.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Comparison of radiation-induced temporal lobe injury after helical tomotherapy versus conventional intensity-modulated radiotherapy for nasopharyngeal carcinoma: a propensity score-matched cohort study.Radiation oncology (London, England) · 2026Article
- GSTP1 c.313A > G mutation is an independent risk factor for neutropenia hematotoxicity induced by anthracycline-/paclitaxel-based chemotherapy in breast cancer patients.World journal of surgical oncology · 2022Article
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10 authors.
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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.
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