Description of the 570 patients participating in the validation study, of the 50 patients participating in the reliability arm and of the 88 patients participating in the sensitivity to change arm of the study
| Characteristic | Baseline (N=570) | Reliability (N=50) | Sensitivity to change (N=88) |
|---|---|---|---|
| Female sex, N (%) | 440 (78.8) | 37 (74.0) | 73 (84.9) |
| Age, years | 56.0 (13.2) | 54.0 (13.1) | 51.8 (13.3) |
| Symptom duration, years | 12.5 (10.3) | 13.0 (12.8) | 10.5 (10.5) |
| Rheumatoid factor or anti-CCP positivity, N (%) | 415 (84.2) | 41 (88.0) | 75 (88.2) |
| Structural severity: Steinbrocker grade III or IV, N (%) | 154 (38.9) | 12 (30.8) | 27 (35.1) |
| DAS28–ESR | 4.1 (1.6) | 3.4 (1.4) | 5.3 (1.4) |
| HAQ | 1.15 (0.77) | 0.97 (0.64) | 1.52 (0.67) |
| Pain NRS over 1 week (0–10) | 4.7 (2.7) | 4.0 (2.5) | 6.7 (2.1) |
| Function NRS over 1 week (0–10) | 4.6 (2.7) | 3.9 (2.3) | 6.3 (2.3) |
| Fatigue NRS over 1 week (0–10) | 4.7 (2.8) | 4.5 (3.0) | 6.0 (2.2) |
| Sleep NRS over 1 week (0–10) | 3.8 (2.9) | 3.8 (2.8) | 5.1 (2.8) |
| Emotional wellbeing NRS over 1 week (0–10) | 3.9 (2.6) | 3.4 (2.6) | 5.3 (2.5) |
| Physical wellbeing NRS over 1 week (0–10) | 4.5 (2.5) | 3.7 (2.2) | 6.0 (2.2) |
| Coping NRS over 1 week (0–10) | 3.9 (2.6) | 3.1 (2.3) | 5.0 (2.2) |
| Morning stiffness duration, min | 62 (61) | 35 (37) | 106 (74) |
| SF-36 aggregated physical score | 35.7 (10.3) | 36.6 (10.0) | 32.5 (10.6) |
| SF-36 aggregated emotional score | 46.0 (12.1) | 48.5 (11.5) | 41.1 (11.9) |
| Current corticosteroid treatment, N (%) | 216 (38.2) | 14 (28.0) | 42 (47.7) |
| Current methotrexate treatment, N (%) | 380 (62.3) | 37 (74.0) | 47 (53.4) |
| Current biological treatment, N (%) | 304 (53.8) | 30 (60.0) | 35 (39.8) |
Results are presented as mean (SD) unless otherwise stated. Percentages are % of available data. Patients in the reliability and sensitivity to change studies are subgroups of the baseline population.
CCP, cyclic citrullinated peptide; DAS28, disease activity score; ESR, erythrocyte sedimentation rate; HAQ, health assessment questionnaire; NRS, numeric rating scale; SF-36, short form 36—generic quality of life scale; VAS, visual analogue scale.