| 제목 | Reliability and Validity of the Korean Language Version of the U.S. National Cancer Institute's Patient-Reported Outcomes Common Terminology Criteria for Adverse Events | ||
|---|---|---|---|
| 작성자 | 관리자 | 등록일 | 2022-04-13 |
내용
Reliability and Validity of the Korean Language Version of the U.S. National Cancer Institute's Patient-Reported Outcomes Common Terminology Criteria for Adverse Events
Junghee Yoon 1, Sung Hoon Sim 2, Danbee Kang 3, Gayeon Han 4, Youngha Kim 4, Jinseok Ahn 5, Dongryul Oh 6, Eun Sook Lee 7, Sun Young Kong 8, Juhee Cho 9, Sandra A Mitchell 10
Affiliations expand
- PMID: 32044423
- DOI: 10.1016/j.jpainsymman.2020.01.015
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Abstract
Context: To improve precision and accuracy in the capture of symptomatic adverse events (AEs) by self-report, the U.S. National Cancer Institute has developed a library of 124 patient-reported outcome (PRO) items reflecting 78 symptomatic AEs drawn from the Common Terminology Criteria for Adverse Events (CTCAE). The PRO-CTCAE™ item library has been translated and linguistically validated in the Korean language.
Objectives: The aim of this study was to examine the psychometric properties of PRO-CTCAE-Korean.
Methods: PRO-CTCAE-Korean and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (QLQ-C30) were administered to 1358 Korean-speaking individuals receiving treatment for cancer at two medical centers in Korea (mean age 55.1 years; SD ±11.9; 60% females; and 61% high school education or less). A subset of 82 study participants completed the same two measures on a second occasion approximately three days later.
Results: Correlations between PRO-CTCAE-Korean and conceptually relevant QLQ-C30 items were all greater than r = 0.30 except for headache severity. Most PRO-CTCAE-Korean items correlated at least moderately with QLQ-C30 summary scores. Monotonically decreasing total QLQ-C30 scores were observed across worsening levels of symptom frequency, severity, and interference (all P < 0.01), indicating that PRO-CTCAE-Korean response choices are well comprehended, and that PRO-CTCAE-Korean discriminates respondents with different levels of symptom burden. PRO-CTCAE-Korean also demonstrated generally acceptable to good reliability (88% of items intraclass correlation coefficient >0.50).
Conclusion: PRO-CTCAE-Korean is a reliable and valid instrument to capture symptomatic AEs by self-report in patients on cancer clinical trials.
Keywords: PRO-CTCAE; eeliability; patient-reported outcomes; symptomatic adverse events; validity.
