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™)

Abstract

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.

Selecting a Subset Based on the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Patient-Reported Symptom Monitoring in Lung Cancer Treatment: Mixed Methods Study

“…This study was a single-center study, and multicenter verification is certainly needed. Nonetheless, the PRO-CTCAE item library has proven to be a valid and reliable questionnaire in previous studies, and it has only recently been linguistically validated in Dutch-speaking patients [ 19 , 20 ]. Moreover, the PRO-CTCAE subset with the additional items of body weight and temperature and a specification of coughing up blood is currently being tested in the trial SYMPRO-Lung (Symptom Monitoring With Patient-Reported Outcomes Using a Web Application Among Lung Cancer Patients in the Netherlands; Netherlands Trial Register: NL7897).…”

“…The PRO-CTCAE is developed through a consortium of patient-reported outcome (PRO) researchers, clinical investigators, trial sponsors, patient advocates, and the Food and Drug Administration (FDA), and it comprises 124 items, based on 78 CTCAE toxicities considered appropriate for patient reporting [ 18 ]. These items have been comprehensively validated in English-speaking patients [ 19 ] and have been translated and linguistically validated in a large number of languages, including Dutch [ 20 ].…”

SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial

“… 26 The PRO-CTCAE was comprehensively evaluated in English-speaking patients 27 and its translation into Dutch has recently been linguistically validated. 28 The subset of the PRO-CTCAE items for patients with lung cancer used in this study was created by a mixed method study based on the European Organization for Research and Treatment of Cancer (EORTC) phase 1 procedure for designing questionnaires. This procedure includes a literature review, patient interviews (n=25) and interviews with HCPs (n=22).…”

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

“…The original English PRO-CTCAE has been translated into different languages, such as Dutch, Chinese, Korean, and Japanese. [12][13][14][15] However, prior to this study, the original English-language Pediatric PRO-CTCAE had been translated only into Italian. The availability of a Chinese version of the Pediatric PRO-CTCAE would contribute to the identification of toxicity information in Chinese children and provide evidence for adjusting therapeutic protocol to improve tolerability, which is an indispensable part of highquality patient care.…”

“…The original English PRO-CTCAE has been translated into different languages, such as Dutch, Chinese, Korean, and Japanese 12–15 . However, prior to this study, the original English-language Pediatric PRO-CTCAE had been translated only into Italian.…”