Estimated mean values of study variables during criteria-positive and criteria-negative observations for all patients (N = 1555).
| Variable | Criteria (+) Observations, mean (95% CI) | Criteria (−) Observations, mean (95% CI) | Difference, mean (95% CI) |
|---|---|---|---|
| Fibromyalgia severity (0–31) | 22.5 (22.3, 22.7) | 14.4 (14.1, 14.7) | 8.1 (7.8, 8.4) |
| Widespread Pain Index (0–17) | 13.5 (13.4, 13.7) | 7.5 (7.3, 7.8) | 6.0 (5.7, 6.3) |
| Patient global (0–10) | 5.7 (5.6, 5.8) | 4.9 (4.8, 5.0) | 0.8 (0.7, 0.9) |
| Pain (0–10) | 6.7 (6.6, 6.8) | 5.4 (5.2, 5.5) | 1.3 (1.2, 1.4) |
| Fatigue (0–10) | 7.5 (7.5, 7.6) | 5.7 (5.6, 5.9) | 1.8 (1.7, 1.9) |
| Sleep disturbance (0–10) | 6.6 (6.5, 6.7) | 5.5 (5.3, 5.6) | 1.1 (1.0, 1.2) |
| Symptom count (0–37) | 16.4 (16.1, 16.7) | 13.1 (12.8, 13.4) | 3.3 (3.0, 3.6) |
| Mood (0–10) | 4.3 (4.2, 4.4) | 3.8 (3.7, 3.9) | 0.5 (0.4, 0.6) |
| HAQ (0–3) | 1.4 (1.3, 1.4) | 1.2 (1.2, 1.3) | 0.1 (0.1, 0.2) |
| PCS (0–100) | 29.3 (28.9, 29.6) | 31.7 (31.2, 32.2) | −2.5 (−2.8, −2.1) |
| MCS (0–100) | 39.5 (39.0, 40.0) | 42.5 (41.8, 43.1) | −3.0 (−3.5, −2.5) |
| EQ-5D (0–1) | 0.56 (0.55, 0.57) | 0.66 (0.62, 0.64) | −0.07 (−0.08, −0.06) |
HAQ: Health Assessment Questionnaire disability index; PCS and MCS: physical and mental component scores from SF-36 (Short-form 36).