PMID- 35583994
OWN - NLM
STAT- MEDLINE
DCOM- 20221202
LR  - 20230225
IS  - 1538-9804 (Electronic)
IS  - 0162-220X (Linking)
VI  - 46
IP  - 1
DP  - 2023 Jan-Feb 01
TI  - Translation Into Simplified Chinese and Cultural Validation of the Pediatric 
      Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse 
      Events Using Cognitive Interviewing.
PG  - E31-E40
LID - 10.1097/NCC.0000000000001090 [doi]
AB  - BACKGROUND: The original English Pediatric Patient-Reported Outcome version of 
      the Common Terminology Criteria for Adverse Events (PRO-CTCAE) captures 
      symptomatic adverse events (AEs) in cancer clinical trials from the perspective 
      of pediatric patients. A Chinese version was needed to encourage the use of the 
      Pediatric PRO-CTCAE among Chinese pediatric oncology patients. OBJECTIVE: This 
      study translated and linguistically validated a simplified Chinese version of the 
      Pediatric PRO-CTCAE for oncological patients aged 7 to 18 years. METHODS: 
      Following the Functional Assessment of Chronic Illness Therapy translation 
      methodology, 130 questions were translated into Chinese. Semistructured cognitive 
      interviews investigated the comprehensibility and clarity of terms for symptoms, 
      attributes, and response options. Two rounds of interviews were conducted with 48 
      native Chinese-speaking children aged 7 to 18 years who were undergoing 
      chemotherapy or radiotherapy treatment. RESULTS: Most items, response options, 
      and recall periods were well understood by children across the age range in round 
      1. Nineteen items posed comprehension difficulties for 9 participants and were 
      revised and retested without further difficulties. CONCLUSIONS: The Pediatric 
      PRO-CTCAE was successfully developed and linguistically validated among Chinese 
      oncology patients. The results indicated that the Chinese Pediatric PRO-CTCAE was 
      semantically and conceptually equivalent to the English version. IMPLICATIONS FOR 
      PRACTICE: The availability of the simplified Chinese Pediatric PRO-CTCAE will 
      facilitate the generation of patient-reported outcome data about symptomatic AEs 
      for children with cancer in China and thus improve our understanding of 
      children's experience of treatment-related symptoms.
CI  - Copyright (c) 2022 Wolters Kluwer Health, Inc. All rights reserved.
FAU - Shen, Nanping
AU  - Shen N
AD  - Author Affiliations: School of Nursing, The Second Military Medical University 
      (Ms Shen); School of Nursing, Shanghai Jiao Tong University, China (Ms Ruan and 
      Ms Li); Department of Nursing, Shanghai Children's Medical Center, Shanghai Jiao 
      Tong University School of Medicine (Ms Sun); Department of Hematology and 
      Oncology, Shanghai Children's Medical Center, Shanghai Jiao Tong University 
      School of Medicine (Ms He); and School of Nursing, Fudan University (Dr Yuan), 
      Shanghai, China; Center for Advancement of Nursing Education, Koo Foundation Sun 
      Yat-Sen Cancer Center, Taipei, Taiwan (China) (Dr Chang).
FAU - Ruan, Haishan
AU  - Ruan H
FAU - Sun, Jiwen
AU  - Sun J
FAU - Li, Yihan
AU  - Li Y
FAU - He, Mengxue
AU  - He M
FAU - Yuan, Changrong
AU  - Yuan C
FAU - Chang, Lilu
AU  - Chang L
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220518
PL  - United States
TA  - Cancer Nurs
JT  - Cancer nursing
JID - 7805358
SB  - IM
MH  - United States
MH  - Humans
MH  - Child
MH  - National Cancer Institute (U.S.)
MH  - Surveys and Questionnaires
MH  - *Patient Reported Outcome Measures
MH  - *Neoplasms/drug therapy/diagnosis
MH  - China
MH  - Cognition
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2022/05/19 06:00
MHDA- 2022/12/03 06:00
CRDT- 2022/05/18 12:43
PHST- 2022/05/19 06:00 [pubmed]
PHST- 2022/12/03 06:00 [medline]
PHST- 2022/05/18 12:43 [entrez]
AID - 00002820-990000000-00030 [pii]
AID - 10.1097/NCC.0000000000001090 [doi]
PST - ppublish
SO  - Cancer Nurs. 2023 Jan-Feb 01;46(1):E31-E40. doi: 10.1097/NCC.0000000000001090. 
      Epub 2022 May 18.