Adjusted mean difference between arms in secondary outcomes at 26 weeks
| Control | RAFT | Adjusted mean difference* (95% CI) | P value | Effect size | |||
| n (%)† | Mean (SD) | n (%)† | Mean (SD) | ||||
| Fatigue | |||||||
| BRAF-NRS Severity (0–10) | 142 (89.9) | 6.13 (2.30) | 152 (86.9) | 5.91 (2.22) | −0.24 (−0.75 to 0.27) | 0.35 | |
| BRAF-NRS Coping (0-10)‡ | 142 (89.9) | 5.32 (2.42) | 152 (86.9) | 5.25 (2.33) | −0.15 (−0.69 to 0.39) | 0.58 | |
| BRAF-MDQ Impact Overall (0–70) | 142 (89.9) | 34.74 (16.41) | 152 (86.9) | 31.51 (16.02) | −3.42 (−6.44 to -0.39) | 0.03 | 0.27 |
| BRAF-MDQ Physical (0–22) | 142 (89.9) | 14.40 (5.23) | 152 (86.9) | 13.72 (4.91) | −0.68 (−1.78 to 0.42) | 0.23 | |
| BRAF-MDQ Emotional (0–12) | 142 (89.9) | 5.36 (3.79) | 152 (86.9) | 4.37 (3.51) | −0.91 (−1.58 to -0.23) | 0.01 | 0.28 |
| BRAF-MDQ Cognitive (0–15) | 142 (89.9) | 6.55 (4.16) | 152 (86.9) | 5.89 (4.35) | −0.66 (−1.45 to 0.13) | 0.10 | |
| BRAF-MDQ Living with (0–21) | 142 (89.9) | 8.43 (5.68) | 152 (86.9) | 7.53 (5.43) | −1.19 (−2.17 to -0.21) | 0.02 | 0.23 |
| Pain NRS (0–10) | 142 (89.9) | 5.24 (2.41) | 152 (86.9) | 5.47 (2.32) | 0.16 (−0.33 to 0.65) | 0.51 | |
| Disability MHAQ (0–3) | 142 (89.9) | 0.70 (0.51) | 151 (86.3) | 0.71 (0.54) | 0.02 (−0.06 to 0.10) | 0.67 | |
| Quality of Life AIMS VAS (0–100) | 141 (89.2) | 47.70 (23.04) | 152 (86.9) | 47.22 (23.46) | −0.33 (−5.13 to 4.65) | 0.90 | |
| Disease Activity: | |||||||
| Assessed—DAS28 (0.96+) | 145 (91.8) | 4.10 (1.31) | 147 (84.0) | 4.13 (1.38) | 0.02 (−0.21 to 0.24) | 0.88 | |
| Self-report—sPDAS2 (2.4–7.9) | 142 (89.9) | 4.33 (1.04) | 151 (86.3) | 4.44 (1.13) | 0.05 (−0.16 to 0.26) | 0.63 | |
| Anxiety HADS (0–21) | 142 (89.9) | 7.56 (4.48) | 151 (86.3) | 6.65 (4.36) | −0.33 (−0.95 to 0.29) | 0.30 | |
| Depression HADS (0–21) | 142 (89.9) | 6.42 (4.06) | 151 (86.3) | 6.22 (3.76) | −0.50 (−1.14 to 0.14) | 0.13 | |
| Valued Life Activities (0–3) | 142 (89.9) | 1.07 (0.62) | 151 (86.3) | 1.09 (0.67) | −0.05 (−0.15 to 0.05) | 0.34 | |
| Helplessness AHI (5-30) | 142 (89.9) | 17.47 (5.46) | 152 (86.9) | 16.92 (5.06) | −0.61 (−1.65 to 0.43) | 0.25 | |
| Self-efficacy RASE (28-140)‡ | 142 (89.9) | 104.67 (13.31) | 151 (86.3) | 106.26 (14.78) | 3.05 (0.43 to 5.66) | 0.02 | 0.27 |
| Sleep quality: | |||||||
| Very good§ | 9 (6.3%) | 17 (11.4%) | 0.75 (0.47 to 1.17)¶ | 0.21 | |||
| Fairly good§ | 65 (45.8%) | 64 (43.0%) | |||||
| Fairly bad§ | 51 (35.9%) | 51 (34.2%) | |||||
| Very bad§ | 17 (12.0%) | 17 (11.4%) | |||||
*Linear regression adjusted for baseline measure of outcome and centre.
†Percentage of total randomised (Control 158, RAFT 175).
‡Higher score=better outcome.
§Number of patients (% questionnaires returned).
¶OR from ordinal logistic regression.
AHI, Arthritis Helplessness Index; AIMS, Arthritis Impact Measurement Scale; BRAF-MDQ, Bristol RA Fatigue Multidimensional Questionnaire; BRAF-NRS, Bristol RA Fatigue Numerical Rating Scale; HADS, Hospital Anxiety and Depression Scale; MHAQ, Modified Health Assessment Questionnaire; RASE, RA Self-Efficacy.