Linguistic Validation of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Korean

Cho, Juhee; Yoon, Junghee; Kim, Youngha; Oh, Dongryul; Kim, Seok Jin; Ahn, Jin‐Seok; Suh, Gee Young; Nam, Seok Jin; Mitchell, Sandra A.

doi:10.1200/jgo.18.00193

Cited by 15 publications

(13 citation statements)

References 20 publications

(23 reference statements)

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“…In this study we used a rigorous and well-established methodology [ 21 , 22 ] to generate a harmonized Dutch language version of the entire PRO-CTCAE item library for use in both the Netherlands and in Dutch-speaking Belgium. This methodology is line with both that used in the development of the original, English language version of the PRO-CTCAE and other PRO-CTCAE translation efforts that have been carried out in Danish, German, Spanish, Japanese and Korean [ 14 – 17 , 23 , 24 ]. More information about the PRO-CTCAE and permission to use this Dutch language version of the instrument can be obtained at http://healthcaredelivery.cancer.gov/pro-ctcae .…”

Section: Discussionmentioning

confidence: 54%

Dutch translation and linguistic validation of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)

Veldhuijzen

Walraven

Mitchell

et al. 2020

J Patient Rep Outcomes

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Background The U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) is a library of items for assessing symptomatic adverse events by patient self-report in oncology trials. The aim of this multi-site study was to generate and linguistically validate a Dutch language version of the U.S. PRO-CTCAE for use in the Netherlands and Dutch-speaking Belgium. Methods All 124 items in the PRO-CTCAE item library were translated into Dutch using established translation procedures, including dual forward translations, reconciliation, back-translation, reconciliation of the source with the back-translation, and expert reviews. Harmonization of the translation for use in both the Netherlands and Belgium was achieved via an iterative review process in which the translations were discussed and reconciled by consensus of PRO experts, clinicians and bilingual Dutch translators. The translated PRO-CTCAE™ items were completed by a geographically-diverse sample of Dutch speaking patients from the Netherlands (n = 40) and Belgium (n = 60), and who were currently receiving or who had recently completed cancer-directed therapy. Patients were diverse with respect to age, sex, educational attainment, and cancer diagnosis. Cognitive debriefing, using a semi-structured interview guide, probed for comprehension and clarity of PRO-CTCAE symptom terms, attributes (e.g. frequency, severity, interference), response choices, and understanding of ‘at its worst’ and ‘in the last 7 days’. Items for which the patient data indicated possible difficulties were considered for revision. Results Three items underwent minor phrasing revision and retesting was not deemed necessary. The symptom term for stretch marks was poorly understood by 12.5% of participants, and this item was revised to include parenthetical phrasing. It was retested with 10 participants from Belgium (n = 5) and the Netherlands (n = 5) and demonstrated acceptable comprehension. Conclusions The Dutch language version of PRO-CTCAE has been successfully developed and linguistically validated for use in oncology studies in the Netherlands and Dutch-speaking Belgium. Extending the availability of NCI PRO-CTCAE in languages beyond English increases international consistency in the capture of Patient-Reported outcomes in patients participating in cancer clinical trials.

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Section: Discussionmentioning

confidence: 54%

Dutch translation and linguistic validation of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)

Veldhuijzen

Walraven

Mitchell

et al. 2020

J Patient Rep Outcomes

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“…For cancer-specific symptom burden surveillance, we developed 10 subsets of the PRO-CTCAE-Korean (9 for specific cancers and 1 for general purpose). The PRO-CTCAE item library has been previously translated and validated in Korean [ 15 , 16 ]. The PRO-CTCAE-Korean instrument has been linguistically validated for use in Korean-speaking populations [ 15 ].…”

Section: Methodsmentioning

confidence: 99%

Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study

Kang¹,

Kim²,

Kim³

et al. 2023

JMIR Public Health Surveill

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Background Over 90% of patients with cancer experience 1 or more symptoms caused directly by cancer or its treatment. These symptoms negatively impact on the completion of planned treatment as well as patients’ health-related quality of life (HRQoL). It often results in serious complications and even life-threatening outcomes. Thus, it has been recommended that surveillance of symptom burden should be performed and managed during cancer treatment. However, differences in symptom profiles in various patients with cancer have not been fully elucidated for use in performing surveillance in the real world. Objective This study aims to evaluate the burden of symptoms in patients with various types of cancers during chemotherapy or radiation therapy using the PRO-CTCAE (Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events) and its impact on quality of life. Methods We performed a cross-sectional study of patients undergoing outpatient-based chemotherapy, radiation therapy, or both at the National Cancer Center at Goyang or at the Samsung Medical Center in Seoul, Korea between December 2017 and January 2018. To evaluate cancer-specific symptom burden, we developed 10 subsets for using the PRO-CTCAE-Korean. To measure HRQoL, we used the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Participants answered questions prior to their clinic appointments on tablets. Multivariable linear regression was used to analyze symptoms based on cancer type and to evaluate the association between the PRO-CTCAE items and the EORTC QLQ-C30 summary score. Results The mean age (SD) of the patients was 55.0 (11.9) years, and 39.94% (540/1352) were male. Overall, symptoms in the gastrointestinal category were the most dominant in all cancers. Fatigue (1034/1352, 76.48%), decreased appetite (884/1352, 65.38%), and numbness and tingling (778/1352, 57.54%) were the most frequently reported. Patients reported more local symptoms caused by a specific cancer. In terms of nonsite-specific symptoms, patients commonly reported concentration (587/1352, 43.42%), anxiety (647/1352, 47.86%), and general pain (605/1352, 44.75%). More than 50% of patients with colorectal (69/127, 54.3%), gynecologic (63/112, 56.3%), breast (252/411, 61.3%), and lung cancers (121/234, 51.7%) experienced decreased libido, whereas 67/112 (59.8%) patients with gynecologic cancer and lymphoma/myeloma reported pain during sexual intercourse. Patients with breast, gastric, and liver cancers were more likely to have the hand-foot syndrome. Worsening PRO-CTCAE scores were associated with poor HRQoL (eg, fatigue: coefficient –8.15; 95% CI –9.32 to –6.97), difficulty in achieving and maintaining erection (coefficient –8.07; 95% CI –14.52 to –1.61), poor concentration (coefficient –7.54; 95% CI –9.06 to –6.01), and dizziness (coefficient –7.24; 95% CI –8.92 to –5.55). Conclusions The frequency and severity of symptoms differed by cancer types. Higher symptom burden was associated with poor HRQoL, which suggests the importance of appropriate surveillance of PRO symptoms during cancer treatment. Considering patients had comprehensive symptoms, it is necessary to include a holistic approach in the symptom monitoring and management strategies based on comprehensive patient-reported outcome measurements.

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“…Adverse events and laboratory test assessments were based on the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 [19]. All medical events considered to be related to the procedure and the disease were recorded, including any symptoms or signs.…”

Section: Follow-up and Assessmentsmentioning

confidence: 99%

Comparison of Clinical Efficacy and Safety between 70–150 µm and 100–300 µm Doxorubicin Drug-Eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma

Hong

Kim

et al. 2022

Life

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Background: This study aimed to compare the efficacy and safety of 70–150 μm doxorubicin drug-eluting bead (DEB) transarterial chemoembolization (TACE) with those of 100–300 μm DEB-TACE as first-line treatment in patients with hepatocellular carcinoma (HCC). Methods: We retrospectively investigated 72 patients who underwent TACE with 70–150 μm DEBs (n = 40) or 100–300 μm DEBs (n = 32) for HCC in a tertiary center between March 2013 and May 2019. Initial treatment response and adverse events were assessed using the modified Response Evaluation Criteria in Solid Tumors and the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, respectively. Results: At the 2-month post-treatment assessment, the complete and objective response rates were 47.5% and 85.0%, respectively, for the 70–150 μm group and 34.4% and 81.3%, respectively, for the 100–300 μm group; however, the difference was not statistically significant (p > 0.05). In total, 65% patients in the 70–150 μm group and 59.4 % patients in the 100-300 μm group experienced at least one symptom of post-embolization syndrome after TACE; all symptoms were classified as grade 1 or 2. There was no significant difference between the two groups in terms of post-procedural laboratory changes such as changes in liver enzymes and bilirubin levels (p > 0.05). Laboratory toxicity of grade 3 occurred in three patients, all of which were transient elevation of liver enzyme levels. Hepatobiliary adverse events, such as bile duct injury, biloma, liver abscess, and hepatic infarction, were not observed in either treatment group. Conclusion: This study found no significant difference in tumor response between 70–150 μm and 100–300 μm DEB-TACE. Both groups showed favorable safety profiles, and the difference was not significant.

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Linguistic Validation of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Korean

Cited by 15 publications

References 20 publications

Dutch translation and linguistic validation of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)

Dutch translation and linguistic validation of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)

Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study

Comparison of Clinical Efficacy and Safety between 70–150 µm and 100–300 µm Doxorubicin Drug-Eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma

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