Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events
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 a...
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doaj-93d06c121cdc4e3bb42736a9e54625fd2021-08-01T11:33:13ZengBMCBMC Cancer1471-24072021-07-0121111110.1186/s12885-021-08610-0Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse eventsShan-Shan Yang0Lei Chen1Ying Liu2Hai-Jun Lu3Bo-Jie Huang4Ai-Hua Lin5Ying Sun6Jun Ma7Fang-Yun Xie8Yan-Ping Mao9Department 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 TherapyDepartment 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 TherapyNursing Department, Jinan Seventh People’s HospitalDepartment of Radiation Oncology, the Affiliated Hospital of Qingdao UniversityDepartment of Oncology, the First People’s Hospital of Tianmen in Hubei ProvinceDepartment of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen UniversityDepartment 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 TherapyDepartment 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 TherapyDepartment 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 TherapyDepartment 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 TherapyAbstract 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 < 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. Conclusion The simplified Chinese version of the PRO-CTCAE showed good reliability, validity, and responsiveness.https://doi.org/10.1186/s12885-021-08610-0Patient-reported outcomesPRO-CTCAEChineseValidityReliability |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Shan-Shan Yang Lei Chen Ying Liu Hai-Jun Lu Bo-Jie Huang Ai-Hua Lin Ying Sun Jun Ma Fang-Yun Xie Yan-Ping Mao |
spellingShingle |
Shan-Shan Yang Lei Chen Ying Liu Hai-Jun Lu Bo-Jie Huang Ai-Hua Lin Ying Sun Jun Ma Fang-Yun Xie Yan-Ping Mao Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events BMC Cancer Patient-reported outcomes PRO-CTCAE Chinese Validity Reliability |
author_facet |
Shan-Shan Yang Lei Chen Ying Liu Hai-Jun Lu Bo-Jie Huang Ai-Hua Lin Ying Sun Jun Ma Fang-Yun Xie Yan-Ping Mao |
author_sort |
Shan-Shan Yang |
title |
Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events |
title_short |
Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events |
title_full |
Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events |
title_fullStr |
Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events |
title_full_unstemmed |
Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events |
title_sort |
validity and reliability of the simplified chinese patient-reported outcomes version of the common terminology criteria for adverse events |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2021-07-01 |
description |
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 < 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. Conclusion The simplified Chinese version of the PRO-CTCAE showed good reliability, validity, and responsiveness. |
topic |
Patient-reported outcomes PRO-CTCAE Chinese Validity Reliability |
url |
https://doi.org/10.1186/s12885-021-08610-0 |
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