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 14 languages: English, Spanish, German, Italian, Danish, Japanese, Korean, Czech, French (for Canada), French (for France, Belgium, Switzerland), Greek, Hungarian, Polish, and Russian. Additional translations are in development (including Chinese [Simplified and Traditional], Dutch-Flemish, Malay, Portuguese, Romanian, 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