Background Little is published on comparative responsiveness of generic and disease specific Patients reported outcomes (PRO) tool in systemic lupus erythematosus (SLE).
Objectives To determine and compare the responsiveness and minimally clinical important difference (MCID) of a generic and disease specific PRO measure in SLE.
Methods SLE patients from a French multicenter study were clinically assessed for activity (SELENA-SLEDAI) at baseline, MOS Short Form 36 (SF-36), LupusQoL, and an overall health status item at baseline (D0), 3 (M3) and 6 (M6) months. Self-reported overall health status item enquired about the impact of lupus on overall health since past visit. Its 7 response options were: -3 “much improved”, -2 “moderately improved”, -1 “minimally improved”, 0 “the same”, +1 “minimally worse”, +2 “moderately worse” and +3 “much worse”. Responsiveness and MCID for SF-36 and LupusQoL domains were determined against +1 or -1 change in overall health status (Anchor-based approach). Descriptives and standardized response mean (SRM) of variations in SF36 and LupusQoL domains were estimated and compared using mixed models methods.
Results We included 185 SLE patients. Mean (SD) age and SELENA-SLEDAI were 39.6 (10.6) years and 2.6 (3.5). We analyzed 3 time-point data (515 visits) and two consecutive time-point data (306 visits). LupusQoL “Body Image”, “Fatigue”, and “Burden to others” domains did not change significantly with “worsening” in overall health status; while LupusQoL “body image”, and SF-36 “General Health” and “Physical Functioning” domains did not change significantly with an “improvement” in overall health status. SRM in comparable domains of SF-36 and LupusQoL were similar, except for improvement in LupusQoL Physical Health. SRM ranged from small-moderate for all domains on both measures (table).
Conclusions Both SF-36 and LupusQoL show responsiveness in most domains with change in overall health status. LupusQoL is more responsive to improvement, while SF-36 is more responsive to worsening in overall health status.
Disclosure of Interest H. Devilliers Consultant for: GlaxoSmithKline, Z. Amoura Consultant for: Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Neovacs, Roche, Teva Pharmaceuticals, and UCB Pharma, S. Audia: None Declared, M. Jolly Consultant for: GSK, Medimmune, P. Bielefeld: None Declared, L. Arnaud Consultant for: Amgen, C. Binquet: None Declared, J.-F. Besancenot: None Declared