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; Sung Hoon Sim; Danbee Kang; Gayeon Han; Youngha Kim; Jinseok Ahn; Dongryul Oh; Eun Sook Lee; Sun Young Kong; Juhee Cho; Sandra A Mitchell

doi:10.1016/j.jpainsymman.2020.01.015

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

J Pain Symptom Manage. 2020 May;59(5):1082-1088.e6. doi: 10.1016/j.jpainsymman.2020.01.015. Epub 2020 Feb 8.

Authors

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

Affiliations

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.

PMID: 32044423
DOI: 10.1016/j.jpainsymman.2020.01.015

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adverse Drug Reaction Reporting Systems
Antineoplastic Agents* / therapeutic use
Drug-Related Side Effects and Adverse Reactions*
Female
Humans
Language
Male
Middle Aged
National Cancer Institute (U.S.)
Neoplasms* / drug therapy
Neoplasms* / therapy
Patient Reported Outcome Measures
Quality of Life
Reproducibility of Results
Republic of Korea
Surveys and Questionnaires
United States

Substances

Antineoplastic Agents