Development and Validation of the Lupus Impact Tracker: A Patient-Completed Tool for Clinical Practice to Assess and Monitor the Impact of Systemic Lupus Erythematosus MEENAKSHI JOLLY, 1 CINDY P. GARRIS, 2 RACHEL A. MIKOLAITIS, 1 PRITI M. JHINGRAN, 2 GREG DENNIS, 3 DANIEL J. WALLACE, 4 ANN CLARKE, 5 MARY ANNE DOOLEY, 6 ANN PARKE, 7 VIBEKE STRAND, 8 GRACIELA S. ALA ´ RCON, 9 AND MARK KOSINSKI 10 Objective. To derive and validate a brief patient-completed instrument, the Lupus Impact Tracker (LIT), to assess and monitor the impact of systemic lupus erythematosus (SLE). Methods. Items for the LIT were selected from the LupusPRO, a validated patient-reported outcomes measure, using 3 approaches: confirmatory factor analysis (CFA), stepwise regression, and patient focus groups. CFA was conducted to find items from the LupusPRO that fit a unidimensional structure to allow scoring as a single index. Stepwise regression methods identified items with the strongest relationship (convergent validity) with disease activity measures and patient health rating. Focus groups (n  26 patients) identified the most important items describing SLE impact. Selected items were evaluated for reliability and validity. Results. CFA found 21 items that fit a unidimensional structure. Stepwise regressions identified 15 of 21 items having good convergent validity with clinical measures. Patient focus groups identified 9 of 15 items as best capturing the impact of SLE. Overall, 7 items were selected across all 3 approaches (CFA, stepwise regression, and focus groups). Another 15 items were selected across 2 approaches. Through consensus with rheumatology clinician experts, a final set of 10 items was selected for the LIT. The LIT items showed good internal consistency (0.89) and test–retest reliabilities (0.87). Mean LIT scores differed significantly (P < 0.05) across criterion groups in the hypothesized direction, providing evidence of discriminant validity and responsiveness. Conclusion. The LIT is reliable and valid in SLE patients and offers a practical way for physicians and patients to assess and monitor the impact of SLE. INTRODUCTION Systemic lupus erythematosus (SLE) is a chronic autoim- mune disease of unknown etiology and can affect many organs, most often the skin, joints, lungs, kidneys, and nervous system. Currently, there is no cure for SLE, and the disease course is unpredictable, with periods of flares alternating with chronic activity or remission (1). The goals of treatment are to prevent flares and reduce disease activity and damage. Corticosteroids, antimalarials, immu- nosuppressants, and nonsteroidal antiinflammatory drugs are the core pharmacologic therapies. Supported by GlaxoSmithKline and Human Genome Sciences. 1 Meenakshi Jolly, MD, MS, Rachel A. Mikolaitis, MS: Rush University Medical Center, Chicago, Illinois; 2 Cindy P. Garris, MS, Priti M. Jhingran, PhD: GlaxoSmithKline R&D, Re- search Triangle Park, North Carolina; 3 Greg Dennis, MD: PPD, Rockville, Maryland; 4 Daniel J. Wallace, MD: Cedars- Sinai Medical Center and David Geffen School of Medicine at the University of California, Los Angeles; 5 Ann Clarke, MD, MSc: McGill University, Montreal, Quebec, Canada; 6 Mary Anne Dooley, MD, MPH: University of North Caro- lina, Chapel Hill; 7 Ann Parke, MBBS: University of Con- necticut at St. Francis Hospital and Medical Center, Hart- ford; 8 Vibeke Strand, MD: biopharmaceutical consultant, Portola Valley, California; 9 Graciela S. Ala ´ rcon, MD, MPH: University of Alabama at Birmingham; 10 Mark Kosinski, MA: Quality Metric, Lincoln, Rhode Island. Dr. Jolly has received consultancy fees, speaking fees, and/or honoraria (more than $10,000) from GlaxoSmith- Kline and holds patents for the Lupus Impact Tracker and LupusPRO and has received licensing fees from MedImmune and Eli Lilly. Ms Garris owns stock or stock options in GlaxoSmithKline. Dr. Jhingran owns stock or stock options in GlaxoSmithKline. Dr. Wallace has received consultancy fees, speaking fees, and/or honoraria (less than $10,000 each) from Bristol-Myers Squibb, GlaxoSmithKline, AbbVie, Pfizer, Sanofi, and Lilly. Dr. Clarke has received Arthritis Care & Research Vol. 66, No. 10, October 2014, pp 1542–1550 DOI 10.1002/acr.22349 © 2014, American College of Rheumatology ORIGINAL ARTICLE 1542