IMPORTANCE OF THE CONCEPTUAL DEFINITION OF PRO MEASURES- A CASE STUDY WITH THE LINGUISTIC VALIDATION OF THE IRRITABLE BOWEL SYNDROME QUALITY OF LIFE (IBS-QOL) INSTRUMENT IN 17 ASIATIC LANGUAGES

Author(s)

Lambe J1, Patrick DL2, Toraubully N1, Skerritt B3, Acquadro C4
1Mapi, Lyon, France, 2University of Washington, Seattle, WA, USA, 3ICON, Dublin, Ireland, 4Mapi Research Trust, Lyon, France

OBJECTIVES: The Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) is a self-report measure developed to assess the impact of IBS and its treatment. The instrument contains 34 items, rated on a five-point scale. The IBS-QOL was translated into 17 Asiatic languages (Chinese for China, Hong Kong, Singapore and Taiwan, Korean, Bengali, Gujarati, Hindi, Kannada, Malayalam, Marathi, Punjabi, Telugu, Urdu, Tamil for India and Singapore, and Malay for Singapore). The objective of this study was to identify the main translation challenges, and which items needed the most references to conceptual definitions. METHODS: In each country, the linguistic validation was conducted with the author of the IBS-QOL, using either the standard forward/backward methodology or the adjusted process with reviews by the author, a clinician, and cognitive interviews with 12 patients. The basis for discussion was the list of concepts (LOC) elaborated with the author. For each country, the history grid of the translation process was analyzed. References/reminders of the LOC and author’s interventions were counted for each item across countries. RESULTS: Eleven items were found challenging (items 2,3,4,7,9,16,18,25,28,31,32). Four of them needed the most to refer to the LOC, i.e., item 3 “I am bothered by how much time I spend on the toilet” (100% of the countries); item 18 “I feel I get less done…” (53%); item 25 “I feel sluggish…” (76%); and item 31 “I worry about losing control of my bowels” (59%). For instance, the main difficulties with item 3 were conceptual (“on the toilet” not to be confused with “in the toilet”), and cultural (e.g., lack of toilets in India, or people squatting, not sitting). Examples of challenges will be provided. CONCLUSIONS: The development of the LOC with the author proved to be critical to the translation process and enabled the conceptual harmonization of the translations.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PRM119

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Gastrointestinal Disorders

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