title: Translation and linguistic validation of the FACT-EGFRI-18 quality of life instrument from English into Dutch.
abstract: OBJECTIVE
  The Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRI-18) is a patient-reported outcomes questionnaire developed to assess the effect of EGFRI on patients. The FACT-EGFR-18 was translated into Dutch and evaluated in order to document that the translation adequately captures the concepts of the original English-language version of the questionnaire and is readily understood by subjects in the target population.
  
  
  METHODS
  Translation of the FACT-EGFRI-18 from English to Dutch was accomplished by employing the Functional Assessment of Chronic Illness Therapy (FACIT) multilingual translation methodology. Ten native-speaking residents of the target country who reported EGFRI associated dermatological adverse events (dAEs) were asked to review the translation of the harmonized FACT-EGFRI-18.
  
  
  RESULTS
  Participants generally found the Dutch FACT-EGFRI-18 easy to understand and complete. In addition, the translation retained the original meaning of the FACT-EGFRI-18 items and instructions. Based on the results of the cognitive debriefing interviews, no changes to improve clarity and comprehension of translations were identified.
  
  
  CONCLUSIONS
  The Dutch FACT-EGFRI-18 demonstrates content validity and linguistic validity, and was found conceptually equivalent to its English source, thus confirming linguistic validation. The results suggest that the Dutch FACT-EGFRI-18 can be applied to measure dAE related health related quality of life in Dutch-speaking patients undergoing EGFRI therapy. Formal validation of the Dutch FACT-EGFRI-18 is ongoing.
authors.affiliation: Department of Clinical Oncology, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, The Netherlands. Electronic address: C.B.Boers-Doets@lumc.nl.
authors.forename: Christine B
authors.initials: CB
authors.lastname: Boers-Doets
authors.forename: Hans
authors.initials: H
authors.lastname: Gelderblom
authors.forename: Mario E
authors.initials: ME
authors.lastname: Lacouture
authors.forename: Jason M
authors.initials: JM
authors.lastname: Bredle
authors.forename: Joel B
authors.initials: JB
authors.lastname: Epstein
authors.forename: Natascha A W P
authors.initials: NA
authors.lastname: Schrama
authors.forename: Helen
authors.initials: H
authors.lastname: Gall
authors.forename: Jan
authors.initials: J
authors.lastname: Ouwerkerk
authors.forename: Jan A C
authors.initials: JA
authors.lastname: Brakenhoff
authors.forename: Johan W R
authors.initials: JW
authors.lastname: Nortier
authors.forename: Ad A
authors.initials: AA
authors.lastname: Kaptein
mesh_terms: D000368:Aged; D032882:Comprehension; D003875:Drug Eruptions / Q000175:diagnosis / Q000209:etiology; D064420:Drug-Related Side Effects and Adverse Reactions; D004739:England; D004815:Epidermal Growth Factor / Q000009:adverse effects / Q000037:antagonists & inhibitors* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008037:Linguistics / Q000379:methods; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D009426:Netherlands; D011788:Quality of Life; D018570:Risk Assessment; D057566:Self Report; D011795:Surveys and Questionnaires; D014175:Translating; D016896:Treatment Outcome
chemical_list: D004815:Epidermal Growth Factor
keywords: Dermatological adverse event; Epidermal growth factor receptor inhibitor (EGFRI); FACT-EGFRI-18; Health related quality of life (HRQoL); Linguistic validation; Patient-reported outcome questionnaire