OBJECTIVES Patients with Systemic Lupus Erythematosus (SLE) have shown significantly improved survival rates, causing researchers and physicians alike to become increasingly interested in patients' health-related quality of life. A variety of questionnaires exist to assess this measure; however, the Lupus Quality of Life Questionnaire (LupusQoL) is the only disease-specific questionnaire. Since this questionnaire was only recently developed and psychometrically validated, it has yet to be linguistically validated for use across diverse cultures and languages. The objective of this study was to create and validate thirteen translations of the LupusQoL. METHODS To evaluate the linguistic validity of harmonized translations of the LupusQoL, bilingual (target language and English) interviewers cognitively debriefed subjects to assess their ability to paraphrase and understand the instructions, questions and responses within each translation. A total of thirteen translations were debriefed as part of this research [Chinese (Taiwan), Dutch (Belgium), English (US/Canada), French (Belgium/France, Canada), Greek (Greece), Hungarian (Hungary), Italian (Italy), Portuguese (Brazil), Spanish (Argentina/Chile, Mexico, US/Canada), Swedish (Sweden)]. The results of the debriefings were compared on the basis of comprehension and number of suggested changes. RESULTS Seventy-three subjects were interviewed, between 5 and 7 subjects for each of the 13 languages tested. Subjects ranged in age from 19-76 years, with a mean age of 44.2 years and were stratified by educational level, including participants both with and without a high school degree. The overall item comprehension rate for the LupusQoL was 99.5%. Intra-item and intra-language comprehension rates were also established. All items had a comprehension rate of greater than 91.8%, while most had 100%; all countries had at least a 98.1% rate. CONCLUSIONS The translations of the instrument in this study demonstrated a high level of overall linguistic validity. This research will facilitate inter-country comparisons of Systemic Lupus Erythematosus and the pooling of data in multi-country studies.