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

OBJECTIVES: 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?
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: We need more empirical research on translation methodologies. Several points emerge from this review. First, producing high-quality translations is labor-intensive. Second, the availability of standardized guidelines and centralized review procedures improves the efficiency of the production of translations. Although we did not find evidence in favor of one method, we strongly advise researchers to adopt a multistep approach. In line with the recent Food and Drug Administration recommendations, we developed a checklist summarizing the steps used for translations, which can be used to evaluate the rigor of the applied methodologies.