Session Type: Abstract Submissions (ACR)
Background/Purpose: Patient reported outcomes (PRO) are important to understand, educate, manage and follow patients with systemic lupus erythematosus (SLE). Lupus Impact Tracker (LIT) is a ten-item tool developed to facilitate patient-physician communication. Herein, we present its responsiveness to physician and patient assessed changes in disease status from data obtained during routine SLE patient care visits.
Methods: Longitudinal data on LupusPRO, physician assessed disease activity assessment, and patient reported changes in SLE health status was collected during 182 SLE patient routine clinical care visits. LIT score was derived from PRO data. Disease activity assessments used as anchors for testing responsiveness were the SLEDAI physician global assessment (PGA), Total SELENA-SLEDAI score, SELENA-Flare Index (SFI), and Patient reported changes in SLE health status. Cut-offs used to determine change in disease activity were as follows: PGA (change of 0.3), Total SELENA-SLEDAI (change of 4), SFI (remitting, stable, and flaring) and Patient reported changed in SLE health status (-7 to 7). For patient reported change in SLE health status, we categorized -2 to 2 as unchanged, -3 to -7 as worsening and 3 to 7 as improvement. Mixed model regression analysis was used to compare changes in LIT against disease activity and patient reported changes in SLE health status anchors.
Results: There were 658 visit data available for 182 SLE patients. Consecutive visits were 2-5 months apart with a median number of visits per patient of 7. PGA was available for 630 visits; Total SLEDAI was available for 249 visits; SFI was available for 610 visits ; Patient reported change in SLE health status was available for 449 visits. Mean (SD) age and SELENA-SLEDAI were 43.5 (13.2) years and 6.4 (7.3), respectively. PGA changed significantly for 269 visit data (increased in 125, decreased in 144) while 361 visit data had unchanged PGA. Total SELENA-SLEDAI changed significantly among 66 visits (29 increased, 37 decreased) and remained stable among 183 visits. Significant changes in SFI were observed in 149 visit data (80 remitting, 69 flaring) while 461 visit data was unchanged. Patient reported change in SLE health status changed significantly for 221 (150 improved, 71 worsened) and remained stable for 228 visits. LIT scores responded significantly and in the appropriate direction for changes in PGA (p<0.05), Total SLEDAI (p=0.01), and SFI (p<0.05) and patient reported changes in SLE health status (p=0.001).
Conclusion: LIT is responsive to physician- and patient-assessed changes in disease status in SLE. In addition to being used in clinical trials, LIT is an effective tool that may be used by patients and physicians in facilitating communication and tracking disease impact in SLE.
J. A. Block,
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