OBJECTIVES: Review the development and properties of PRO instruments used in clinical trials and observational studies of patients with SLE. METHODS: A structured search was conducted to identify published articles in 2005-2011 through key literature databases (EMBASE and MEDLINE/PUBMED). Conference abstracts from targeted rheumatology, outcomes research and quality-of-life (QOL) scientific meetings in 2009-2011 were included. SLE therapy clinical trials within the past five years were identified through the ClinicalTrials.gov database. RESULTS: Over 60 different PRO instruments were used in SLE-related research; 7 were lupus specific, 11 assessed general QoL and the rest assessed select (diverse) disease symptoms (e.g., fatigue, pain) or other patient attributes (e.g., satisfaction, adherence). The SF-36, LupusQoL, and LupusPRO were most frequently used in SLE research. These instruments have 36, 34, and 43 items, respectively.  All three instruments have a recall period of past four weeks; they demonstrated robust reliability and construct validity when used in SLE patient samples, but generally weak associations (r=0.12-0.29) with SLE disease-activity indices. Validated symptom-specific FACIT-Fatigue scale was also used in some studies to measure this important aspect of patient experience and it correlated with SLE disease-activity indices. Recently, 10 items from the LupusPRO were validated for use as ‘Lupus Impact Tracker’ (LIT) to retain the reliability and validity of the longer tool while decreasing questionnaire burden. Brief validated instruments used in rheumatic-diseases (e.g., RAPID3: 15 items) are also being studied in SLE. CONCLUSIONS: The SF-36, LupusQoL, and LupusPRO are the most widely used validated PRO instruments, but these have a varying degree of questionnaire burden and specificity to SLE symptoms. Shorter versions of validated PROs (e.g., SF-12, LIT) or instruments such as RAPID3 may minimize questionnaire burden. The practicality of these PRO instruments for use in daily practice to discriminate clinically meaningful changes in patient-reported SLE treatment outcomes deserves further investigation.