LINGUISTIC VALIDATION OF THE NATIONAL EYE INSTITUTE – QUALITY OF LIFE QUESTIONNAIRE-42 (NEI-RQL-42) FOR PATIENTS WITH REFRACTIVE ERROR MODIFIED FOR SIMPLIFIED CHINESE IN MAINLAND CHINA AND HINDI IN INDIA

Author(s)

Zarzar K1, Tan R21Transperfect Translations, Research Triangle Park, NC, USA, 2Alcon Laboratories R&D International, Singapore, Singapore, Singapore

OBJECTIVES: The NEI-RQL-42 developed by RAND Corporation in US English is a reliable, valid, and sensitive   42 -item measure of the impact of refractive status on patients’ day-to-day life. No Simplified Chinese or Hindi versions existed previously. For an international study, the NEI-RQL-42 had to be translated and linguistically validated in Simplified Chinese for China and Hindi for India. METHODS: A standardized linguistic validation methodology was conducted by specialists for each target country: 1) concept definition; 2) dual forward translations by independent native-speaking linguists; 3) reconcili­ation of the forward translations; 4) back translation into English by a native speaking linguist; 5) resolution of the back translation; 6) international harmonization; 7) clinician (Ophthalmologist) review; 8) cognitive debriefing comprehension interviews on 5 Mandarin/Simplified Chinese and 5 Hindi native-speaking patients who are either pre- or post-cataract surgery and; 9) final proofreading. RESULTS: The main challenge on the conceptual level was the English original made extensive use of driving scenarios during the day and night in the US English source instrument to elicit responses. For Hindi and Simplified Chinese, driving scenarios were supplemented with walking and cycling, which were more relevant in the local context without compromising the conceptual intent of the source instrument. On the linguistic level, translating some of the frequency terms required discussion with the developer to identify a solution, as the gradation between the surrounding English response options was difficult to exactly match on a conceptual level in the target language due to linguistic limitations. CONCLUSIONS: According to the rigorous methodology used, with some minor adjustments, the Mandarin and Hindi versions of the NEI-RQl-42 were qualitatively concep­tually equivalent and culturally relevant. The Simplified Chinese and Hindi versions were successfully linguistically validated to measurement of the impact of refractive error on patients’ day-to-day lives and facilitate the comparison and pooling of data.

Conference/Value in Health Info

2010-09, ISPOR Asia Pacific 2010, Phuket, Thailand

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PSS13

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Sensory System Disorders

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