Language Translation: Methods and Certificates

  • Methods used to translate and linguistically validate 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 that are conceptually equivalent to the English version, and readily understood by the target population.
  • The PRO-CTCAE Instrument is currently available in 18 languages: English, Chinese (Traditional), Czech, Danish, Dutch (for Belgium and the Netherlands), French (for Canada), French (for France, Belgium, Switzerland), German, Greek, Hungarian, Italian, Japanese, Korean, Polish, Russian, and Spanish. Additional translations are in development (including Simplified Chinese, Malay, Portuguese, Romanian, and Turkish), and will be posted upon completion.
  • To assure standardized translations, users are not permitted to translate PRO-CTCAE 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.
  • 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.

Certificates of Translation