Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Catherine AcquadroEuropean Regulatory Issues and Quality of Life Assessment (ERIQA) Group

Abstract

We conducted a literature review to respond to regulatory concerns about the quality of translated patient-reported outcome questionnaires. Our main objective was to answer two questions: What do the methods have in common (and how do they differ)? Is there evidence of the superiority of one method over another? We identified 891 references by searching MEDLINE, Embase, and the Mapi Research Trust's database with "quality-of-life,"questionnaires,"health status indicators" matched with "translating,"translation issues,"cross-cultural research," and "cross-cultural comparison." Articles were included if they proposed, compared or criticized translation methods. Forty-five articles met our inclusion criteria: 23 representing 17 sets of methods, and 22 reviews. Most articles recommend a multistep approach involving a centralized review process. Nevertheless, each group proposes its own sequence of translation events and weights each step differently. There is evidence demonstrating that a rigorous and a multistep procedure leads to better translations. Nevertheless, there is no empirical evidence in favor of one specific method. We need more empirical research on translation methodologies. Several points emerge from this review. Fi...Continue Reading

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