title: Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea.
abstract: OBJECTIVE
  Following a 2009 US Food and Drug Administration guidance, a new patient-reported outcome (PRO) instrument was developed to support end points in multinational clinical trials assessing irritable bowel syndrome with diarrhea (IBS-D) symptom severity. Our objective was to assess the translatability of the IBS-D PRO instrument into ten languages, and subsequently perform a cultural adaptation/linguistic validation of the questionnaire into Japanese and US Spanish.
  
  
  METHODS
  Translatability assessments of the US English version of the IBS-D PRO were performed by experienced PRO translators who were native speakers of each target language and currently residing in target-language countries. Languages were Chinese (People's Republic of China), Dutch (the Netherlands), French (Belgium), German (Germany), Japanese (Japan), Polish (Poland), Portuguese (Brazil), Russian (Russia), Spanish (Mexico), and Spanish (US). The project team assessed the instrument to identify potential linguistic and/or cultural adaptation issues. After the issues identified were resolved, the instrument was translated into Spanish (US) and Japanese through a process of two forward translations, one reconciled translation, and one backward translation. The project team reviewed the translated versions before the instruments were evaluated by cognitive debriefing interviews with samples of five Spanish (US) and five Japanese IBS-D patients.
  
  
  RESULTS
  Linguistic and cultural adaptation concerns identified during the translatability assessment required minor revisions, mainly the presentation of dates/times and word structure. During the cognitive debriefing interviews, two of five Spanish respondents misunderstood the term "bowel movement" to mean only diarrhea in the Spanish version. Consequently, the term was changed from "movimiento intestinal" to "evacuaciones". None of the Japanese respondents identified issues with the Japanese version.
  
  
  CONCLUSIONS
  The translatability of the IBS-D PRO instrument into ten target languages was confirmed, with only minor changes made to the translations of the instrument. The translation and linguistic validation into Spanish (US) and Japanese provide evidence that this instrument can be used in multinational trials and clinical settings.
authors.affiliation: Astellas Pharma Global Development, Northbrook, IL.
authors.forename: Leticia
authors.initials: L
authors.lastname: Delgado-Herrera
authors.affiliation: Pharmerit International, Newton, MA, USA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Lasch
authors.affiliation: TransPerfect, Linguistic Validation Group, Boston, MA, USA.
authors.forename: Ana
authors.initials: A
authors.lastname: Popielnicki
authors.affiliation: Development Project Management, Astellas Pharma Inc, Tokyo, Japan.
authors.forename: Akito
authors.initials: A
authors.lastname: Nishida
authors.affiliation: Patient-Centered Outcomes Adelphi Values, Bollington, UK.
authors.forename: Rob
authors.initials: R
authors.lastname: Arbuckle
authors.affiliation: Patient-Centered Outcomes Adelphi Values, Boston, MA, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Banderas
authors.affiliation: Astellas Pharma Global Development, Northbrook, IL.
authors.forename: Susan
authors.initials: S
authors.lastname: Zentner
authors.affiliation: Astellas Pharma Global Development, Northbrook, IL.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Gagainis
authors.affiliation: Astellas Pharma Global Development, Northbrook, IL.
authors.forename: Bernhardt
authors.initials: B
authors.lastname: Zeiher
keywords: IBS-D PRO instrument; stool consistency; stool-form scale; translatability