Abstract
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.
Highlights
The U.S National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAETM) is a library of items for assessing symptomatic adverse events by patient self-report in oncology trials
Extending the availability of National Cancer Institute (NCI) PRO-CTCAE in languages beyond English increases international consistency in the capture of Patient-Reported outcomes in patients participating in cancer clinical trials
The methodology used in this study consisted of forward-backward translation followed by cognitive debriefing, and is consistent with guidelines recommended by the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) guidelines for translation and cultural adaptation of PRO instruments [19]
Summary
The U.S National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAETM) 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. There is evidence that precision and reliability in capturing patient’s experiences of symptomatic AEs (e.g. pain, fatigue, and nausea) can be improved through the use of self-report data [1,2,3,4] This has led to the development of symptom reporting measures that rely on direct feedback from patients. These observations have led to a growing support for the development and use of PROMs for symptomatic AE reporting [7,8,9,10]
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