title: Danish 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).
abstract: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) to incorporate patient self-reporting of symptomatic adverse events.
  
  
  
  The aim of the study was to translate and linguistically validate a Danish language version of PRO-CTCAE.
  
  
  
  The U.S. English language PRO-CTCAE was translated into Danish using forward and backward procedures with reconciliation. The linguistic validity of the PRO-CTCAE Danish was examined in two successive rounds of semistructured cognitive interviews in a sample of 56 patients equally distributed by gender and cancer type (prostate, head and neck, lung, breast, gynecological, gastrointestinal, and hematological cancer), and who were currently undergoing cancer treatment.
  
  
  
  In the first round of linguistic validation (n = 42), the phrasing of five symptomatic toxicities was adjusted, and the refined phrasing was retested in a second round of interviews (n = 14). Agreement about phrasing that was both culturally acceptable and semantically comprehensible was achieved in the second round. Statements from participants describing the meaning of the PRO-CTCAE symptomatic toxicities support conceptual equivalence to the U.S. English language version.
  
  
  
  Availability of the NCI PRO-CTCAE in languages beyond English will support international congruence in self-reporting of side effects of cancer treatment. A rigorous methodology was used to develop the Danish language version of PRO-CTCAE. Results provide preliminary support for the use of PRO-CTCAE in cancer clinical trials that include Danish speakers.
authors.affiliation: Unit for Documentation & Quality, Danish Cancer Society, Copenhagen, Denmark; Department of Oncology, The Finsen Centre, Rigshospitalet, Copenhagen, Denmark. Electronic address: baeksted@cancer.dk.
authors.forename: Christina
authors.initials: C
authors.lastname: Bæksted
authors.affiliation: Unit for Documentation & Quality, Danish Cancer Society, Copenhagen, Denmark.
authors.forename: Aase
authors.initials: A
authors.lastname: Nissen
authors.affiliation: Department of Oncology, The Finsen Centre, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Helle
authors.initials: H
authors.lastname: Pappot
authors.affiliation: Unit of Survivorship, Danish Cancer Society, Copenhagen, Denmark.
authors.forename: Pernille Envold
authors.initials: PE
authors.lastname: Bidstrup
authors.affiliation: Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland, USA.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.affiliation: Cancer Outcomes Research Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
authors.affiliation: Unit of Survivorship, Danish Cancer Society, Copenhagen, Denmark.
authors.forename: Susanne Oksbjerg
authors.initials: SO
authors.lastname: Dalton
authors.affiliation: Unit of Survivorship, Danish Cancer Society, Copenhagen, Denmark; Department of Oncology, The Finsen Centre, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Christoffer
authors.initials: C
authors.lastname: Johansen
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000188:drug therapy*; D000071066:Patient Reported Outcome Measures; D012959:Socioeconomic Factors; D014175:Translating; D014481:United States
chemical_list: D000970:Antineoplastic Agents
keywords: PRO-CTCAE; Patient-reported outcomes; cancer clinical trials; linguistic validation; symptomatic toxicity; treatment adverse events