PMID- 32044423
OWN - NLM
STAT- MEDLINE
DCOM- 20210623
LR  - 20210623
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Linking)
VI  - 59
IP  - 5
DP  - 2020 May
TI  - 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.
PG  - 1082-1088.e6
LID - S0885-3924(20)30067-1 [pii]
LID - 10.1016/j.jpainsymman.2020.01.015 [doi]
AB  - 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.
CI  - Copyright (c) 2020 American Academy of Hospice and Palliative Medicine. All rights 
      reserved.
FAU - Yoon, Junghee
AU  - Yoon J
AD  - Department of Digital Health, SAIHST, Sungkyunkwan University, Seoul, Korea; 
      Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan 
      University, School of Medicine, Seoul, Korea.
FAU - Sim, Sung Hoon
AU  - Sim SH
AD  - 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.
FAU - Kang, Danbee
AU  - Kang D
AD  - 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.
FAU - Han, Gayeon
AU  - Han G
AD  - Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan 
      University, School of Medicine, Seoul, Korea.
FAU - Kim, Youngha
AU  - Kim Y
AD  - Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan 
      University, School of Medicine, Seoul, Korea.
FAU - Ahn, Jinseok
AU  - Ahn J
AD  - Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, 
      Sungkyunkwan University School of Medicine, Seoul, Korea.
FAU - Oh, Dongryul
AU  - Oh D
AD  - Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University 
      School of Medicine, Seoul, Korea.
FAU - Lee, Eun Sook
AU  - Lee ES
AD  - 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.
FAU - Kong, Sun Young
AU  - Kong SY
AD  - 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.
FAU - Cho, Juhee
AU  - Cho J
AD  - 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.
FAU - Mitchell, Sandra A
AU  - Mitchell SA
AD  - Division of Cancer Control and Population Sciences, National Cancer Institute, 
      Rockville, Maryland, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200208
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Antineoplastic Agents/therapeutic use
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Language
MH  - Male
MH  - Middle Aged
MH  - National Cancer Institute (U.S.)
MH  - *Neoplasms/drug therapy/therapy
MH  - Patient Reported Outcome Measures
MH  - Quality of Life
MH  - Reproducibility of Results
MH  - Republic of Korea
MH  - Surveys and Questionnaires
MH  - United States
OTO - NOTNLM
OT  - PRO-CTCAE
OT  - eeliability
OT  - patient-reported outcomes
OT  - symptomatic adverse events
OT  - validity
EDAT- 2020/02/12 06:00
MHDA- 2021/06/24 06:00
CRDT- 2020/02/12 06:00
PHST- 2019/11/11 00:00 [received]
PHST- 2020/01/26 00:00 [revised]
PHST- 2020/01/27 00:00 [accepted]
PHST- 2020/02/12 06:00 [pubmed]
PHST- 2021/06/24 06:00 [medline]
PHST- 2020/02/12 06:00 [entrez]
AID - S0885-3924(20)30067-1 [pii]
AID - 10.1016/j.jpainsymman.2020.01.015 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2020 May;59(5):1082-1088.e6. doi: 
      10.1016/j.jpainsymman.2020.01.015. Epub 2020 Feb 8.