title: A methodology for successfully producing global translations of patient reported outcome measures for use in multiple countries.
abstract: The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.
authors.affiliation: PharmaQuest Ltd, Jeffersons Business Centre, Banbury, Oxfordshire, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Two
authors.forename: Aneesa
authors.initials: A
authors.lastname: Verjee-Lorenz
authors.forename: Darren
authors.initials: D
authors.lastname: Clayson
authors.forename: Mehul
authors.initials: M
authors.lastname: Dalal
authors.forename: Kelly
authors.initials: K
authors.lastname: Grotzinger
authors.forename: Zobair M
authors.initials: ZM
authors.lastname: Younossi
mesh_terms: D002986:Clinical Trials as Topic; D003431:Cross-Cultural Comparison; D054521:Cultural Competency; D019698:Hepatitis C, Chronic / Q000523:psychology / Q000628:therapy; D006801:Humans; D007391:International Cooperation; D008107:Liver Diseases / Q000523:psychology / Q000628:therapy; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care / Q000379:methods; D011788:Quality of Life; D012015:Reference Standards; D015203:Reproducibility of Results; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D014177:Translations