DEVELOPMENT OF THE LUPUS IMPACT TRACKER- A TOOL FOR PATIENTS AND PHYSICIANS TO ASSESS AND MONITOR THE IMPACT OF SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Author(s)
Jolly M1, Kosinski M2, Garris CP3, Jhingran PM3, Mikolaitis RA1, Dennis G4, Wallace DJ5, Clarke A6, Parke A7, Dooley MA8, Strand V9, Alarcón GS101Rush University, Chicago, IL, USA, 2QualityMetric Incorporated, Lincoln, RI, USA, 3GlaxoSmithKline R&D, Resea
OBJECTIVES: To derive a short form questionnaire from the LupusPRO©, for use in daily practice to assess the impact of SLE. METHODS: LupusPRO is a 44-item validated quality of life instrument. To identify the subset of items that would fit a unidimensional structure, one-factor confirmatory factor analysis (CFA) and item-to-factor loadings and goodness of fit statistics (Confirmatory Fit Index [CFI], Tucker-Lewis Index [TLI]) were conducted. Backward stepwise regression methods were used to eliminate items that showed the weakest relationship to clinical criterion measures of disease activity (SLEDAI total score, revised SELENA flare index) and patients' overall general health ratings (from LupusPRO). Four focus groups were conducted: patients were asked to rate each item of LupusPRO using a 4-point importance scale and to identify the “top 15” most important items. RESULTS: Based on CFA, 21 items fit a unidimensional structure. Both goodness of fit statistics (CFI,TLI) exceeded the recommended threshold of 0.9. All items showed high factor loadings ranging from 0.76 to 0.91. Backward stepwise regression analyses resulted in 12 items most highly related to patient and clinical criterion measures. Of focus group participants, 80% rated the top 15 items as “moderately” or “very” important (importance ratings ≥ 2.3). In total 7 items were selected across the 3 approaches (CFA, backward regression, focus groups). Another 14 were selected based on results from at least 2 approaches. Items measuring symptoms and procreation were excluded: symptom items did not fit with the intent of the tool; procreation items would not apply to all patients. Finally, changes in the item selection based on clinical consensus were made, without losing psychometric properties. CONCLUSIONS: Using quantitative and qualitative methods, 10 items were selected for inclusion in the Lupus Impact Tracker, a PRO intended for clinical practice use to monitor the impact of SLE on patients’ lives and well being.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PSY36
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Systemic Disorders/Conditions