Table 2.
SF-36: responsiveness and ability to detect change in SLE: (within-group)
| Reference | SF-36 domain |
Anchor (change in disease status) |
Findings | ||
| Improved | Unchanged | Worsened | |||
| <3 change in SLEDAI-2K (n=208) ES; SRM; p |
≥3 change in SLEDAI-2K (n=25) ES; SRM; p |
||||
| Baba et al, 201820 | PF | Clinical worsening defined by a change ≥3 in the SLEDAI-2K. The difference within each first-year and second-year pair assessed by paired t-test | Not reported | −0.04; −0.05;0.53 | 0.04; 0.07; 0.71 |
| RP | 0.00; 0.00; 0.97 | 0.19; 0.27; 0.18 | |||
| BP | 0.15; 0.16;0.02 | −0.12; −0.11; 0.58 | |||
| GH | −0.04; −0.04; 0.58 | −0.06; −0.06;0.76 | |||
| VT | 0.10; 0.11; 0.11 | 0.12; 0.14; 0.49 | |||
| SF | 0.11; 0.11;0.11 | −0.31; −0.38; 0.07 | |||
| RE | 0.08; 0.08; 0.26 | −0.08; 0.07;0.74 | |||
| MH | 0.06; 0.07; 0.29 | 0.00; 0.00; 0.99 | |||
| PCS | 0.00; 0.00; 0.95 | 0.06; 0.10; 0.63 | |||
| MCS | 0.12; 0.12; 0.08 | −0.21; −0.20; 0.33 | |||
| 0 change in SDI (n=204) ES; SRM; p |
≥1 change in SDI (n=29) ES; SRM; p |
||||
| PF | Clinical worsening defined by a change ≥1 in the SDI. The difference within each first-year and second-year pair assessed by paired t-test | Not reported | −0.02; −0.03;0.72 | −0.08; −0.10; 0.61 | |
| RP | 0.05; 0.05; 0.45 | −0.09; −0.08; 0.65 | |||
| BP | 0.16; 0.18; 0.01 | −0.17; −0.13; 0.47 | |||
| GH | 0.01; 0.01; 0.88 | −0.40; −0.30; 0.12 | |||
| VT | 0.15; 0.17; 0.02 | −0.22; −0.21; 0.26 | |||
| SF | 0.11; 0.12; 0.19 | −0.28; −0.22; 0.24 | |||
| RE | 0.09; 0.09; 0.20 | −0.11; −0.11; 0.58 | |||
| MH | 0.08; 0.09; 0.20 | −0.09; −0.10; 0.60 | |||
| PCS | 0.03; 0.03; 0.65 | −0.11; −0.11; 0.54 | |||
| MCS | 0.15; 0.15; 0.03 | −0.28; −0.24; 0.21 | |||
| (2 to 7); mean (95% CI) | (−1 to 1); mean (95% CI) | (−7 to −2); mean (95% CI) | |||
| McElhone et al, 2016 23 |
PF | Patient completed Global Rating of Change, ranging from 7 (a very great deal better) to −7 (a very great deal worse) with 0 indicating no change | 5.6 (3.9 to 7.3) | 1.2 (0.3 to 2.2) | −3.0 (−4.3 to −1.6) |
| RP | 14.7 (9.9 to 19.5) | 1.4 (−1.3 to 4.0) | −9.9 (−15.3 to −4.5) | ||
| BP | 13.0 (10.6 to 15.4) | 2.8 (1.1 to 4.5) | −7.0 (−9.3 to −4.7) | ||
| GH | 3.4 (2.2 to 4.6) | 0.3 (−0.6 to 1.2) | −2.0 (−3.2 to −0.8) | ||
| VT | 11.2 (8.4 to 14.0) | 0.9 (20.8 to 2.6) | −4.6 (−6.3 to −2.8) | ||
| SF | 10.1 (7.0 to 13.2) | 1.6 (0.1 to 3.2) | −7.0 (−10.8 to −3.1) | ||
| RE | 11.3 (6.6 to 15.9) | 2.6 (−0.3 to 5.4) | −10.1 (−15.9 to −4.3) | ||
| MH | 7.6 (5.9 to 9.4) | −0.1 (−1.6 to 1.4) | −5.5 (−7.5 to −3.6) | ||
| SRM; mean variation; *p<0.05 |
(SRM; mean variation) *p<0.05 |
||||
| Devilliers et al, 2015 29 |
PF | Patient completed 7-point VAS of change in lupus-related health status over 3 months. A difference +0.5 SD or more was considered worsening; a VAS with a difference of −0.5 |
0.40; +5.3* | −0.59; −7.8* | |
| RP | 0.50; +16.9* | −0.34; −11.7* | |||
| BP | 0.57; +12.2* | −0.62; −13.2* | |||
| GH | 0.37; +4.9* | −0.72; −9.5* | |||
| VT | 0.32; +5.9* | −0.41; –7.6* | |||
| SF | 0.36; +8.1* | −0.27; −6.1 | |||
| RE | SD considered an improvement | 0.58; +20.9* | −0.14; –4.9 | ||
| MH | 0.32; +5.5* | −0.35; –5.9* | |||
| PCS | 0.44; +2.8* | -0.69; –4.4* | |||
| MCS | 0.43; +4.2* | −0.2; −1.9* | |||
| PF | Patient-completed 4-point Likert Symptom Scale ranging from 0 (no problems) to 3 (severe problems) | 0.21; 3.0 | −0.44; −6.2* | ||
| RP | 0.39; +13.2* | −0.51; −17.2* | |||
| BP | 0.58; +11.8* | −0.63; −13.0* | |||
| GH | 0.16; 2.2 | −0.43; −6.1* | |||
| VT | 0.28; +5.0* | −0.39; −6.9* | |||
| SF | 0.47; +10.6* | −0.34; −7.7* | |||
| RE | 0.36; +13.0* | −0.26;−9.3* | |||
| MH | 0.41; +7.0* | −0.31; −5.3* | |||
| PCS | 0.29; +1.9* | −0.61; −3.9* | |||
| MCS | 0.41; +3.9* | −0.25; −2.4* | |||
| Mean (SD) | Mean (SD) | Mean (SD) | |||
| Hanly et al, 2011 28 |
PCS | Physician neuropsychiatric event questionnaire* | 1.73 (SD=0.71) | 0 | −0.62 (SD=1.58) |
| MCS | 3.66 (SD=0.89) | 0 | −4.00 (SD=1.97) | ||
| Improved ES; SRM | Remission/unchanged ES; SRM/ES; SRM |
Flare ES; SRM | |||
| Touma et al, 2011 27 |
PF | 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, remission as SLEDAI-2K=0, and unchanged for the rest of the patient visits | 0.05; 0.23 | 0.03; 0.03/0.00; 0.00 | 0.07; 0.12 |
| RP | 0.16; 0.30 | 0.05; 0.10/0.04; 0.05 | 0.50; 0.64 | ||
| BP | 0.02; 0.06 | 0.02; 0.02/0.01; 0.02 | 0.03; 0.04 | ||
| GH | 0.10; 0.40 | 0.00; 0.00/0.00; 0.01 | 0.02; 0.08 | ||
| VT | 0.15; 0.30 | 0.02;0.02/0.00; 0.01 | 0.09; 0.18 | ||
| SF | 0.09; 0.24 | 0.04;0.05/0.00; 0.01 | 0.20; 0.42 | ||
| RE | 0.00; 0.00 | 0.02; 0.03/0.01; 0.02 | 0.16; 0.18 | ||
| MH | 0.20; 0.43 | 0.05; 0.09/0.01; 0.03 | 0.03; 0.04 | ||
| PCS | 0.04; 0.09 | 0.02; 0.03/0.00; 0.00 | 0.20; 0.30 | ||
| MCS | 0.14; 0.60 | 0.02; 0.03/0.05; 0.10 | 0.02; 0.03 | ||
*A physician-generated 7-point Likert scale for NP events comparing the change in NP status between the onset of the event and time of study assessment was available for each NP event (1=patient demise, 2=much worse, 3=worse, 4=no change, 5=improved, 6=much improved, 7=resolved).
†MCID 1 by Strand et al; MCID 2 by Devilliers et al; MCID 3 by McElhone et al.
BP, bodily pain; ES, effect size; GH, general health; MCID, minimal clinically important difference; MCS, Mental Component Subscale; MH, mental health; PCS, Physical Component Subscale; PF, physical function; RE, role emotional; RP, role physical; SDI, Systemic Lupus International Collaborating Clinics Damage Index; SF, social functioning; SF-36, 36 Item Health Survey-Short Form; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SRM, standardised response means; VAS, Visual Analogue Scale; VT, vitality.