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

Abstract

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.

Association of age with health-related quality of life in a cohort of patients with systemic lupus erythematosus: the Georgians Organized Against Lupus study

“…Renal involvement in SLE was determined by whether renal ACR criteria28 were met in the diagnosis of SLE. Impact of SLE was assessed via the Lupus Impact Tracker (LIT)39 instrument, which has scores scaled to 0–100, with higher scores indicating greater impact of SLE. The presence of depressive symptoms was assessed via the nine-item Patient Health Questionnaire (PHQ-9) depression severity screener 40.…”

Prospective Validation of the Lupus Impact Tracker: A Patient‐Completed Tool for Clinical Practice to Evaluate the Impact of Systemic Lupus Erythematosus

“…Prior to the development of the Lupus Impact Tracker (LIT) (Supplementary Table 1, available on the Arthritis & Rheumatology web site at http://onlinelibrary.wiley.com/doi/10.1002/art.39601/abstract) , a brief, easy to administer patient‐reported outcome instrument that measures the impact of SLE on patients’ well‐being did not exist. Physician‐completed instruments used to assess SLE disease activity or organ damage focus primarily on clinical and/or laboratory findings in SLE, which may not necessarily reflect the extent to which the disease impacts the patient's life, are time‐consuming, and require training to complete.…”

“…In the item selection process for the LIT, psychometric methods, correspondence with clinical criteria, and qualitative studies involving patient feedback were used to select the 10 items from the LupusPRO that covered the concepts of cognition, lupus medications, physical health, pain/fatigue impact, emotional health, body image, and planning/desires/goals. The selected LIT items were evaluated in two different samples of patients and were shown to be reliable and valid . The purpose of the present study was to further investigate the reliability, validity, and responsiveness over time of the 10‐item LIT administered to SLE patients prospectively, in a clinical setting, without the context of the longer‐form LupusPRO, and to evaluate the acceptability and feasibility of administering and completing the LIT from a patient and physician perspective.…”

Perceived stress and reported cognitive symptoms among Georgia patients with systemic lupus erythematosus

“…Difficulty concentrating was assessed by the item “During the past 4 weeks, I experienced difficulty concentrating” (with possible responses of “none of the time,” “a little of the time,” “some of the time,” “most of the time,” and “all of the time”), from the Lupus Impact Tracker (LIT) (24). We dichotomized difficulty concentrating as all/most vs. some/little/none of the time.…”