Language Translation Methods

  • Methods used to translate and linguistically validate PRO-CTCAE and Ped-PRO-CTCAE follow the Principles of Good Translation and Cultural Adaptation Practice as articulated by ISPOR in 2005.
  • These methods include:
    • development of item definitions;
    • dual forward translation with reconciliation, dual back translation, back translation review and harmonization;
    • review by a bilingual oncology clinician (physician or nurse) to verify terminology;
    • final proofing by another independent bilingual oncology clinician, including diacritics; and
    • cognitive testing with a diverse sample of cancer patients who are receiving active cancer treatment or who have recently completed active treatment.
  • This approach is designed to yield translated versions of PRO-CTCAE and Ped-PRO-CTCAE that are conceptually equivalent to the English version, and readily understood by the target population.
  • PRO-CTCAE is currently available in more than 30 languages. Additional translations are in development (including Arabic [USA, Saudi Arabia, Morocco], Bengali, Bulgarian, Cebuano, Croatian, Farsi, Gujarati, Hindi, Italian [for Switzerland], Punjabi, Serbian, Slovak, Slovenian, Tagalog, Urdu, Vietnamese, and Welsh) and will be posted upon completion.
  • Translations of Ped-PRO-CTCAE and Ped-PRO-CTCAE [Caregiver] into Simplified Chinese and Italian are in development and will be posted upon completion.
  • To assure standardized translations, users are not permitted to translate components of the PRO-CTCAE Measurement System without a prior written agreement with the National Cancer Institute
  • NCI does not recommend using translations that have not been evaluated through cognitive interviewing
  • To assure consistency, all translations should be obtained directly from NCI via Form Builder.
  • A list of the PRO-CTCAE translations and the countries in which they have been tested is available.
  • Each translated version includes certification of the procedures used to assure conceptual equivalence.
Last Updated: 16 Feb, 2021