Junghee Yoon1, Sung Hoon Sim2, Danbee Kang3, Gayeon Han4, Youngha Kim4, Jinseok Ahn5, Dongryul Oh6, Eun Sook Lee7, Sun Young Kong8, Juhee Cho9, Sandra A Mitchell10. 1. Department of Digital Health, SAIHST, Sungkyunkwan University, Seoul, Korea; Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea. 2. Division of Hematology/Oncology, Department of Medicine, National Cancer Center, Goyang, Gyeonggi-do, Korea; Department of Laboratory Medicine, Hospital, National Cancer Center, Goyang, Gyeonggi-do, Korea. 3. Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea; Department of Clinical Research Design & Evaluation, SAIHST, Sungkyunkwan University, Seoul, Korea. 4. Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea. 5. Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. 6. Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. 7. Center for Breast Cancer, Hospital, National Cancer Center, Goyang, Gyeonggi-do, Korea; National Cancer Center Graduate School of Cancer Science and Policy, Goyang, Gyeonggi-do, Korea; Division of Translational Science, Research Institute, National Cancer Center, Goyang, Gyeonggi-do, Korea. 8. Division of Translational Science, Research Institute, National Cancer Center, Goyang, Gyeonggi-do, Korea; Department of Laboratory Medicine, Hospital, National Cancer Center, Goyang, Gyeonggi-do, Korea; Department of Cancer Biomedical Science, National Cancer Center Graduate School of Cancer Science and Policy, Goyang, Gyeonggi-do, Korea. 9. Department of Digital Health, SAIHST, Sungkyunkwan University, Seoul, Korea; Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea; Division of Hematology/Oncology, Department of Medicine, National Cancer Center, Goyang, Gyeonggi-do, Korea; Department of Health, Behavior and Society and Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. Electronic address: jcho@skku.edu. 10. Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland, USA.
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.
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.