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™)

Journal of Patient-Reported Outcomes

José S. A. Belderbos¹  Evalien Veldhuijzen¹  Iris Walraven²  Neil K. Aaronson³  Katherine J. Kim⁴  Sandra A. Mitchell⁵  Shawn M. McKown⁶  Matthew Lauritzen⁶  Elizabeth Yohe Moore⁶ 

[1] Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands;Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands;Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands;Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands;Genentech – a member of the Roche Group, South San Francisco, USA;Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, USA;RWS Life Sciences, East Hartford, USA;

关键词: PRO-CTCAE;    Patient-reported outcomes;    Symptomatic adverse events;    Translation;    Linguistic validation;    Cancer;   

DOI  :  10.1186/s41687-020-00249-y

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsAll 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.ResultsThree 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.ConclusionsThe 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.

【 授权许可】

CC BY