Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Miyaji, Tempei; Iioka, Yukiko; Kuroda, Yujiro; Yamamoto, Daigo; Iwase, Satoru; Goto, Yasushi; Tsuboi, Masahiro; Odagiri, Hiroki; Tsubota, Yu; Kawaguchi, Takashi; Sakata, Naoko; Basch, Ethan; Yamaguchi, Takuhiro

doi:10.1186/s41687-017-0012-7

Cited by 49 publications

(31 citation statements)

References 20 publications

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“…Approximately 13% of study participants experienced some difficulty in interpreting the phrase´at its worst´. A similar issue was also reported in the cognitive interviewing study that was part of the development of the original U.S. English version of the PRO-CTCAE, and was also observed in the PRO-CTCAE-Japanese linguistic validation study [14,23]. Specifically, a minority of patients may focus on average severity of their symptoms rather than on the severity´at its worst´.…”

Section: Discussionsupporting

confidence: 57%

“…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: Discussionsupporting

confidence: 52%

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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: Discussionsupporting

confidence: 57%

Section: Discussionsupporting

confidence: 52%

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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“…Because outcome assessment by patients themselves has become more important, the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) has been developed, and its reliability and validity have been confirmed 41 42. The validity of the Japanese version of the PRO-CTCAE (PRO-CTCAE-J) has also been confirmed43 44 (table 1). PRO-CTCAE-J consists of 78 adverse event items, but it is possible to use adverse events partially as needed, and for this study, a relationship has been observed between physical activity in breast cancer survivors and ‘pain in joints (elbows, knees, shoulders)’, ‘numbness in limbs’, ‘swelling of arms’ and ‘feeling depressed no matter what’ 45…”

Section: Methods and Analysismentioning

confidence: 99%

Study protocol for a nationwide questionnaire survey of physical activity among breast cancer survivors in Japan

et al. 2020

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IntroductionA major concern is that few cancer survivors meet the guidelines for recommended levels of physical activity. No studies have investigated physical activity among breast cancer survivors nationwide in Japan. Therefore, the aims of this study are to identify the levels of physical activity among breast cancer survivors, to examine factors-related physical activity among breast cancer survivors and to identify breast cancer survivors’ preferences for and interest in exercise programmes in order to inform the future programme development.Methods and analysisWe will administer a cross-sectional survey using a self-report questionnaire to breast cancer survivors. At each of 50 facilities selected to include a variety of institutional backgrounds according to the population distribution of different regions throughout Japan, we will consecutively distribute the questionnaire to 30 outpatients who have completed initial treatments, except for hormone therapy. The target sample size is 1500 survivors. We will calculate descriptive statistics for each measurement item and perform univariate and multivariate analyses using outcome measures (eg, physical activity and quality of life) related to physical, psychological, social and environmental factors.DiscussionThis is the first nationwide survey of physical activity levels among breast cancer survivors in Japan. Identifying the factors associated with physical activity will help us to develop, disseminate and implement programmes that encourage more survivors to adhere to physical activity guidelines.Ethics and disseminationThe protocol was approved by the Institutional Review Board (IRB) of the National Cancer Center on 11 January 2019 (ID: 2018–295). In addition, many of the participating facilities required ethical approval from their local IRBs, while others did not. Accordingly, approval from the local IRBs of individual facilities was obtained when required. The findings will be disseminated through peer-reviewed publications and conference presentations.

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“…However, any adverse event during the study period will be recorded according to the Japanese version of patient-reported outcome common terminology criteria for adverse events (PRO-CTCAE). 18 Investigators will report to the president (chairman of the ethics committee) and the institutional data and safety monitoring board (I-DSMB) on all serious adverse events during the study period.…”

Section: Harmsmentioning

confidence: 99%

Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial

Hirose

Sakai

et al. 2020

BMJ Open

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IntroductionWhether medication optimisation improves clinical outcomes in elderly individuals remains unclear. The current study aims to evaluate the effect of multidisciplinary team-based medication optimisation on survival, rehospitalisation and unscheduled hospital visits in elderly patients.Methods and analysisWe report the protocol of a single-centre, open-label, randomised controlled trial. The enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications. The participants will be randomly assigned to receive either an intervention for medication optimisation or the usual care. The intervention will consist of a multidisciplinary team-based medication review, followed by a medication optimisation proposal based on the Screening Tool of Older Persons’ potentially inappropriate Prescriptions/Screening Tool to Alert doctors to the Right Treatment criteria and an implicit medication optimisation protocol. Medication optimisation summaries will be sent to primary care physicians and community pharmacists on discharge. The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation. Secondary outcomes will include each of the primary endpoints, the number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls. Participants will be followed up for 48 weeks with bimonthly telephone interviews to assess the primary and secondary outcomes. A log-rank test stratified by randomisation factors will be used to compare the incidence of the composite endpoint. The study was initiated in 2019 and a minimum of 500 patients will be enrolled.Ethics and disseminationThe study protocol has been approved by the Institutional Ethical Committee of St. Marianna University School of Medicine (No. 4129). The results of the current study will be submitted to a peer-reviewed journal.Trial registration numberUMIN000035265

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Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Cited by 49 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™)

Study protocol for a nationwide questionnaire survey of physical activity among breast cancer survivors in Japan

Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial

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