Language Translation Methods

  • Methods used to translate and linguistically validate PRO-CTCAE and the Ped-PRO-CTCAE module 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 (PRO-CTCAE), or with children and adolescents ages 7 to 17 years of age undergoing cancer treatment and their caregiver (Ped-PRO-CTCAE module).
  • This approach is designed to yield translated versions of PRO-CTCAE and the Ped-PRO-CTCAE module that are conceptually equivalent to the English version, and readily understood by the target population.
  • PRO-CTCAE has been validated in more than 50 languages. Additional translations are in development and testing and will be posted upon completion.
  • The Ped-PRO-CTCAE module is currently available in English, Simplified Chinese, and Italian. Additional language versions are in development.
  • 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 translations and the countries in which they have been tested is available for both PRO-CTCAE and the Ped-PRO-CTCAE module. Each translated version of PRO-CTCAE and the Ped-PRO-CTCAE module includes certification of the procedures used to assure conceptual equivalence.
Last Updated: 27 Jun, 2024