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. 2020 Oct 6;4(1):81.
doi: 10.1186/s41687-020-00249-y.

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™)

Evalien Veldhuijzen  1 , Iris Walraven  1   2 , Sandra A Mitchell  3 , Elizabeth Yohe Moore  4 , Shawn M McKown  4 , Matthew Lauritzen  4 , Katherine J Kim  5 , José S A Belderbos  1 , Neil K Aaronson  6
Affiliations

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™)

Evalien Veldhuijzen et al. J Patient Rep Outcomes. .

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.

Keywords: Cancer; Linguistic validation; PRO-CTCAE; Patient-reported outcomes; Symptomatic adverse events; Translation.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

References

    1. Atkinson TM, Li Y, Coffey CW, Sit L, Shaw M, Lavene D, et al. Reliability of adverse symptom event reporting by clinicians. Quality of Life Research. 2012;21:1159–1164. doi: 10.1007/s11136-011-0031-4. - DOI - PMC - PubMed
    1. Flores LT, Bennett AV, Law EB, Hajj C, Griffith MP, Goodman KA. Patient-reported outcomes vs. clinician symptom reporting during chemoradiation for rectal cancer. Gastrointestinal Cancer Research. 2012;5:119–124. - PMC - PubMed
    1. Basch E, Jia X, Heller G, Barz A, Sit L, Fruscione M, et al. Adverse symptom event reporting by patients vs clinicians: Relationships with clinical outcomes. Journal of the National Cancer Institute. 2009;101:1624–1632. doi: 10.1093/jnci/djp386. - DOI - PMC - PubMed
    1. Atkinson TM, Ryan SJ, Bennett AV, Stover AM, Saracino RM, Rogak LJ, et al. The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): A systematic review. Supportive Care in Cancer. 2016;24:3669–3676. doi: 10.1007/s00520-016-3297-9. - DOI - PMC - PubMed
    1. Denis F, Basch EM, Lethrosne C, Pourel N, Molinier O, Pointreau Y, et al. Randomized trial comparing a web-mediated follow-up via patient-reported outcomes (PRO) vs. routine surveillance in lung cancer patients: final results. Journal of Clinical Oncology. 2018;36:6500–6500. doi: 10.1200/JCO.2018.36.15_suppl.6500. - DOI

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