Table 4.
LupusQoL: responsiveness and ability to detect change in SLE
| Reference | LupusQoL domain | Anchor (clinical severity measure) |
Findings | |
| Improved | Worsening | |||
| Devilliers et al, 201747 | SRI non-responders SRM; mean variation | SRI responders SRM; mean variation | ||
| PH | SRI responders were defined as ≥4-point reduction in SELENA-SLEDAI Scores from baseline | 0.42; 5.7 | 0.03; 0.5* | |
| PA | 0.65; 12.6 | 0.08; 1.6* | ||
| PL | 0.18; 3.5 | 0.07; 1.2 | ||
| IR | −0.06; −0.7 | 0.02; 0.4 | ||
| BU | 0.24; 6.0 | 0.18; 3.9 | ||
| EH | 0.38; 4.5 | 0.01; 0.3 | ||
| BI | 0.29; 4.7 | 0.13; 2.7 | ||
| FA | 0.26; 3.5 | 0.13; 2.5 | ||
| McElhone et al, 201623 | (GRC Score 2 to 7); mean (95% CI) | (GRC Score −7 to −2); mean (95% CI) | ||
| PH | Patient completed GRC, ranging from 7 (a very great deal better) to −7 (a very great deal worse) with 0 indicating no change | 5.6 (4.2 to 7.1) | −3.7 (−5.2 to −2.1) | |
| PA | 9.3 (7.1 to 11.5) | −6.5 (−8.9 to −4.1) | ||
| PL | 6.3 (3.9 to 8.8) | −4.6 (−7.0 to −2.2) | ||
| IR | 8.3 (4.3 to 12.4) | −7.7 (−14.7 to −0.6) | ||
| BU | 10.4 (7.7 to 13.1) | −4.6 (−6.9 to −2.3) | ||
| EH | 6.2 (4.7 to 7.8) | −4.4 (−6.0 to −2.7) | ||
| BI | 6.4 (3.6 to 9.2) | −2.5 (-4.2 to -0.8) | ||
| FA | 8.9 (6.8 to 11.0) | −4.6 (-6.5,–2.8)(81, 256) | ||
| SRM; Mean Variation | SRM; Mean Variation | |||
| PH | Patient completed a 100 mm VAS to rate their health during the last 3 months. A difference +0.5 SD or more was considered worsening; a VAS with a difference of −0.5 SD was considered an improvement | 0.47;+5.9* | −0.33; −4.1* | |
| PA | 0.43;+7.5* | −0.27; −4.8 | ||
| PL | 0.25;+4.4 | −0.52; −9.2* | ||
| IR | 0.16;+3.2 | −0.32; −6.7 | ||
| BU | 0.24;+4.9 | −0.01; −0.1 | ||
| EH | 0.37;+6.0* | −0.23; −3.7 | ||
| BI | 0.02;+0.3 | −0.07; −1.4 | ||
| FA | 0.67;+11.1* | −0.33; −5.4* | ||
| PH | Patient-completed 4-point Likert symptom scale ranging from 0 (no problems) to 3 (severe problems) | 0.42;+5.1* | −0.46; −5.6* | |
| PA | 0.47;+7.8* | −0.25; −4.2* | ||
| PL | 0.40;+6.7* | −0.55; −9.3* | ||
| IR | 0.28;+5.7* | −0.45; −9.3* | ||
| BU | 0.34;+6.9* | −0.15; −3.0 | ||
| EH | 0.35;+5.4* | −0.36; −5.5* | ||
| BI | 0.17;+3.1 | −0.10; −1.9 | ||
| FA | 0.32;+5.5* | −0.08; −1.4 | ||
| Touma et al, 201127 | ES; SRM | ES; SRM | ||
| PH | SLEDAI-2K 30 days, where improvement was defined as reduction in SLEDAI-2K≥4 from the previous visit, flare as an increase in SLEDAI-2K≥4 from the previous visit | 0.35;0.51 | 0.02; 0.03 | |
| PA | 0.41; 0.73 | 0.02; 0.04 | ||
| PL | 0.16; 0.36 | 0.06; 0.17 | ||
| IR | 0.00; 0.00 | 0.04; 0.14 | ||
| BU | 0.28; 0.37 | 0.24; 0.49 | ||
| EH | 0.30; 0.45 | 0.05;0.08 | ||
| BI | 0.27; 0.39 | 0.04; 0.07 | ||
| FA | 0.30; 0.53 | 0.21; 0.67 | ||
MCID 2 definition by Devilliers et al; MCID 3 definition by McElhone et al
*p<0.05.
BI, body image; BU, burden; EH, emotional health; FA, fatigue; GRC, Global Rating of Change; IR, intimate relationships; LupusQoL, Lupus Quality of Life; MCID, minimal clinically important difference; PA, pain; PH, physical health; PL, planning; SELENA, Safety of Estrogens in Lupus Erythematosus National Assessment; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SRI, SLE Responder Index; SRM, standardised response means; VAS, Visual Analogue Scale.