OBJECTIVES: Physicians treating systemic lupus erythematosus (SLE) use a variety of tools to monitor disease activity and organ damage however these do not capture the functional burden experienced by patients.  Studies suggest that communication between physicians and patients need to be optimized. The Lupus Impact Tracker (LIT), a brief, disease specific 10-item patient reported outcome tool, was developed to assess the impact of SLE on patients daily functioning and well-being. This study aims to evaluate the cross-cultural validity, acceptability and feasibility of the LIT in European clinical practice settings. Potential effect of LIT on communication during the consultation will also be assessed. METHODS: This is a prospective, observational, multicenter cross-sectional validation study of SLE patients on standard of care from hospital/clinical settings in five European countries (France, Germany, Italy, Spain and Sweden). 625 patients enrolled to obtain at least 500 evaluable cases irrespective of disease severity. Before the visit, patients will complete self-reported questionnaires: SF-36, Global Evaluation of Change (GEC), care satisfaction and LIT. During visits, physicians will record patient data, assess disease activity using the SELENA-SLEDAI and Physician Global Assessment (PGA), and disease damage using the SLICC/ACR damage index. After the visit patients and physicians complete LIT feedback questionnaires. Analyses will be performed using descriptive statistical methods with no specific hypothesis suggested. RESULTS: Psychometric evaluation of LIT in US clinical settings found the tool reliable and valid. Evaluation for use in European clinical practice settings is thus needed. Cross-cultural validity of LIT across countries will be analyzed using differential item functioning (DIF) analysis. Data from the Lupus Impact Tracker-(Patient and Physician) Feedback Questionnaires will be tabulated and summarized. CONCLUSIONS: We need improvement of the patient/physician interaction in lupus care. The LIT may be a valid and acceptable tool for use with SLE patients in European clinical practice settings.