DEMONSTRATING CONCEPTUAL EQUIVALENCE- TRANSLATION OF THE CU-Q2OL FROM ITALIAN INTO ENGLISH

Author(s)

Arnold BJ1, Baiardini I2, Parks-Vernizzi E1, Zazzali JL31FACITtrans, Elmhurst, IL, USA, 2University of Genoa, Genoa, Italy, 3Genentech, Inc., South San Francisco, CA, USA

OBJECTIVES: Translation and linguistic validation of patient reported outcomes (PRO) measures is an essential component of research methodology in preparation for multinational research studies. The Chronic Urticaria Quality of Life questionnaire (CU-Q2oL) is a disease specific tool developed in Italian to assess chronic urticaria from the patient’s viewpoint. The objective of this work wasto translate and linguistically validate the CU-Q2oL from Italian to English for use in the US. METHODS: The CU-Q2oL was translated into English according to industry standard methodology. After the translation was completed, five patients completed the translated questionnaire and participated in a cognitive debriefing interview. Interviews were conducted using a standardized guide to assess the relevance, understandability, and appropriateness of the translations. Qualitative analyses were performed to ensure equivalence and that the content validity of the CU-Q2oL was maintained for the English version. RESULTS: The study sample consisted of 5 patients diagnosed with chronic idiopathic urticaria (80% male). Mean age of the patients was 39 years. The sample consisted of English speaking patients in the US.  All CU-Q2oL items were well understood and proved relevant to the patients in this sample. Of interest, terms such as, “hives”, and “swelling of the eyes” were clearly understood as intended. CONCLUSIONS: The results indicate that the English version of the CU-Q2oL translation is conceptually equivalent to the Italian source version and easily understood by the target population in the United States. We consider the translation to be acceptable for PRO assessment in research and clinical practice. Future research could include testing of the questionnaire with patients in other English-speaking countries to confirm its acceptability beyond the US.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PSS36

Disease

Sensory System Disorders

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