Table 1.
Demographics and clinical characteristics of participants with SLE in patient-reported outcome validation studies
| Measure | First author and year | Citation | Patients in the study (n) | Female, n (%) | Age in years, mean (SD) | SLE disease duration in years, mean (SD) | Disease activity, median (range) | Disease damage, median (range) |
| SF36 | Nantes 201812 | 9 | 78 | NS (90) | 39.2 (13.3) | 11.9 (7.6) | SLEDAI 9.7 (4.8)* | SDI 1.7 (1.6)* |
| Stoll 199713 | 10 | 150 | 143 (95) | 40 (11.0) | 10 (7) | BILAG 5 (3–7) | SLICC 1 (0–2) | |
| Thumboo 199914 | 11 | 118 | 112 (94.5) | NS | 3.61 (0.01–16.1) | BILAG 2 (0–15) | SLICC 0 (0–8) | |
| Fortin 199815 | 12 | 96 | NS (90) | 36 (28–46)† | 15 (10–19)† | SLEDAI 6.2 (6.4)* | SLICC 1.29 (1.62)* | |
| Saba 200316 | 13 | 219 | NS (94.4) | 45 (NS) | NS | m-SLAM 4 (0–17)‡ | NS | |
| Touma 201159 | 14 | 41 | 37 (NS) | 45.3 (13.2) | 14.8 (10.3) | SLEDAI 2.59 (2.41) | NS | |
| McElhone 201617 | 15 | 101 | 95 (94) | 40.9 (12.8) | 9.3 (8.1) | BILAG 16.4 (8.1)* | SLICC 0.56 (1.18)* | |
| Colangelo 200918 | 16 | 202 | NS (94) | 50 (14) | 10 (7.4) | SLEDAI 6.1 (4.7)* | SLICC 1.4 (1.7)* | |
| EQ5D | Aggarwal 200955 | 54 | 167 | 156 (93.5) | 42.5 (13.0) | 9.3 (8.8) | SLEDAI 6.2 (5.7)* | SLICC 2 (2) |
| FACIT-Fatigue | Lai 201154 | 52 | 254 | 232 (90.9) | 40.3 (11.9) | NS | NS | NS |
| PROMIS | Kasturi 201750 | 48 | 204 | NS (93) | 40.0 (13.2) | 12.2 (8.8) | SLEDAI 4.2 (3.5)* | SDI 1.2 (1.7)* |
| Kasturi 201851 | 49 | 204 | NS (93) | 40.0 (13.2) | 12.2 (8.8) | SLEDAI 4.2 (3.5)* | SDI 1.2 (1.7)* | |
| Katz 201749 | 47 | 240 | 219 (91) | 58 (13) | 22 (12) | SLAQ 108* | NS | |
| Lai 201753 | 51 | 333 | 305 (91.6) | 44.7 (12.5) | 12.3 (9.6) | NS | NS | |
| Mahieu 2016 | 50 | 123 | 116 (94.3) | 45.3 (10.8) | NS | SLEDAI 2.3 (2.8)* | SLICC 1.7 (2.2)* | |
| LupusQoL | McElhone 200758 | 57 | 160 | 152 (95) | 45.3 (13.9) | NS | NS | NS |
| McElhone 201061 | 60 | 322 | 257 (NS) | 45.0 (13.4) | 10.5 (8.6) | NS | SLICC 0.75 (1.25)* | |
| Nantes 201812 | 9 | 78 | NS (90) | 39.2 (13.3) | 11.9 (7.6) | SLEDAI 9.7 (4.8)* | SDI 1.7 (1.6)* | |
| Devilliers 201757 | 56 | 295 | NS (90) | 42 (17–75)‡ | NS | SLEDAI 4 (2–6) | NS | |
| Touma 201159 | 14 | 41 | 37 (NS) | 45.3 (13.2) | 14.8 (10.3) | SLEDAI 2.59 (2.41) | NS | |
| McElhone 201617 | 15 | 101 | 95 (94) | 40.9 (12.8) | 9.3 (8.1) | BILAG 16.4 (8.1)* | SLICC 0.56 (1.18)* | |
| Jolly 201060 | 59 | 186 | NS (94) | 42.5 (12.9) | NS | SLEDAI 6.2 (5.8)* | SLICC 2.0 (2.1)* | |
| LupusPRO | Jolly 201271 | 71 | 323 | NS (93) | 45.1 (12.3) | 9.3 (7.6) | SLEDAI 3.9 (3.8)* | SDI 0.7 (1.1)* |
| Azizoddin 201773 | 72 | 137 | 124 (90.5) | 40.4 (14.1) | 8.13 (6.84) | SLEDAI 4.89(4.43)* | SDI 0.61 (1.05)* | |
| Bourré-Tessier 201474 | 73 | 123 | NS (94) | 47.7 (14.8) | NS | SLEDAI 4.0 (6.0)† | SDI 1.0 (3.0)† | |
| LIT | Jolly 201484 | 83 | 308 | NS (93) | 43.3 (13.3) | NS | SLEDAI 3.9 (3.8)* | NS |
| Jolly 201683 | 82 | 325 | NS (90) | 41.9 (13) | NS | SLEDAI 4.28 (3.8)* | SLICC 2.17 (1.59)* | |
| Giangreco 201587 | 86 | 182 | 170 (93) | 43.5 (13.2) | NS | SLEDAI 6.4 (7.3)* | NS | |
| Antony 201785 | 84 | 73 | NS (90) | 41 (19–74)‡ | NS | SLEDAI 4 (0–16)‡ | SDI 1 (0–6)‡ | |
| Brandt 201786 | 85 | 860 | 807 (93.8) | 45.8 (13.4) | 13.4 (9.2) | SLAQ 17.2 (9.4)* | NS | |
| Devilliers 201757 | 56 | 295 | NS (90) | 42 (17–75)‡ | NS | SLEDAI 4 (2–6) | NS |
*mean (SD).
†median (IQR).
‡mean (range).
BILAG, British Isles Lupus Assessment Group Disease Activity Index; EQ5D, EuroQol-5D; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; LIT, Lupus Impact Tracker; LupusPRO, Lupus Patient Reported Outcomes; LupusQoL, Lupus Quality of Life questionnaire; mSLAM, modified Systemic Lupus Activity Measure; NS, not shown; PROMIS, Patient Reported Outcomes Measurement Information System item-bank; SDI, The Systemic Lupus International Collaborating Clinics/American College of Rheumatology (ACR) Damage Index; SF36, Medical Outcomes Study Short-Form 36; SLAQ, Systemic Lupus Activity Questionnaire; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SLICC, Systemic Lupus International Collaborating Clinics.