TRANSLATING THE EXACT- ENSURING CONCEPTUAL EQUIVALENCE ACROSS MULTIPLE CULTURES
Author(s)
Arnold BJ1, Murray L2, Herzberg T1, Roberts L2, Leidy N21FACIT.org Translations, Elmhurst, IL, USA, 2United BioSource Corporation, Bethesda, MD, USA
OBJECTIVES: Translation and linguistic validation of patient reported outcomes (PRO) measures is an essential component of research methodology in preparation for multinational clinical trials. The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) was designed to evaluate frequency, severity, and duration of acute exacerbations of chronic obstructive pulmonary disease (COPD), including chronic bronchitis. The EXACT is 14-item daily diary designed to be administered on an electronic handheld device (e.g. personal digital assistant (PDA)). The objective of this work was to translate and linguistically validate the EXACT for use in 17 countries: Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Hungary, Japan, Korea, Netherlands, Peru, Philippines, Poland, Romania, South Africa, Taiwan and United Kingdom. METHODS: The EXACT was translated according to industry standard methodology, including detailed item definitions based on qualitative work conducted during instrument development. Five patients per country completed the respective translated questionnaire and participated in a cognitive interview. Interviews were conducted using a standardized guide to assess the understandability, cultural relevance, and appropriateness of wording of the translations. Qualitative analyses were performed to ensure that the content validity of the EXACT was maintained and equivalent across language versions. RESULTS: The study sample consisted of 90 patients with COPD (57.7% male). Mean age was 63 years. The sample consisted of patients who speak 14 languages collectively. All EXACT translations were well understood and proved relevant to the patients in this sample. Of interest, terms such as, “chest feel tight”, and “short of breath” were understood and described similarly by participants across countries. CONCLUSIONS: The results indicate the EXACT translations were conceptually equivalent to the English source version and easily understood by the target population for all 17 countries. We consider these translations acceptable for PRO assessment in international research and clinical trials, bringing the total number of validated EXACT translations to 25.
Conference/Value in Health Info
2010-05, ISPOR 2010, Atlanta, GA, USA
Value in Health, Vol. 13, No. 3 (May 2010)
Code
PRS33
Disease
Respiratory-Related Disorders