Literature Review of Methods toTranslate 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 indi-cators ” matched with “translating, ” “translation issues,” “cross-cultural research, ” and “cross-cultural comparison.” Articles were included if they proposed, compared or criti-cized translation methods. Results: Forty-five articles met our inclusion criteria: 23 rep