RLC (n=113) | NLC (n=111) | Total (224) | |
Women, n (%) | 86 (76.8) | 80 (72.1) | 166 (74.4) |
Age (years), mean (SD) | 58.10 (11.54) | 58.81 (12.03) | 58.57 (11.88) |
RF-positive (n) | 105 | 101 | 206 |
ACPA-positve (n) | 96 | 96 | 192 |
Employed, n (%) (112, 110)* | 51 (45.5) | 54 (49.1) | 105 (47.3) |
Education (92, 94)* | |||
No secondary school, n (%) | 89 (96.7) | 83 (88.3) | 172 (77.10) |
Secondary school, n (%) | 3 (3.3) | 11 (11.7) | 14 (6.30) |
Professional training (111,109)* | |||
None, n (%) | 18 (16.2) | 16 (14.7) | 34 (15.2) |
Vocational, n (%) | 85 (76.6) | 79 (72.41) | 164 (73.5) |
University degree, n (%) | 8 (7.2) | 14 (12.8) | 22 (9.9) |
Therapy regimen | |||
New therapy, n (%) | 41 (36.6) | 28 (25.2) | 69 (30.9) |
Change of therapy, n (%) | 40 (35.7) | 49 (44.1) | 89 (39.9) |
Dose escalation, n (%) | 31 (27.7) | 34 (30.6) | 65 (29.1) |
Disease duration (years), median (IQR) (111, 109) | 5.83 (2.5–13) | 7.67 (2.63–18.79) | 6.24 (2.6–26.19) |
Baseline RA regimen, n (%) | |||
Glucocorticoids (103,104)* | 39 (37.8) | 39 (37.5) | 78 (37.7) |
Methotrexate (103, 105) | 35 (34.0) | 41 (39.0) | 76 (36.5) |
Leflunomide (103, 104)* | 14 (13.6) | 11 (10.6) | 25 (12.1) |
Sulfasalazine (103, 104)* | 4 (3.9) | 4 (3.8) | 8 (3.9) |
Hydroxychloroquine (103, 104)* | 4 (3.9) | 2 (1.9) | 6 (2.9) |
JAK inhibitors | 2 (1.8) | 0 (0) | 2 (0.9) |
Biological DMARD | 22 (21.4) | 27 (25.9) | 49 (21.97) |
Outcomes, median (IQR) | |||
DAS28-CRP (110, 111) | 4.41 (3.48–5.07) | 4.51 (3.42–5.18) | 4.42 (3.48–5.16) |
Tender joints | 6 (2–10) | 6 (2–12) | 6 (2–11) |
Swollen joints | 3 (1–6) | 3 (1–6) | 3 (1–6) |
Patient Global Health | 60 (43.5–74.75) | 60 (40–79) | 60 (42–75) |
FFbH (111, 109)* | 77.78 (61.11–88.89) | 75 (52.78–88.89) | 77.78 (56.25–88.89) |
RADAI (110, 110)* | 4.75 (3.14–5.82) | 4.70 (3.36–6.10) | 4.73 (3.23–5.99) |
RAID total (112,110)* | 5.30 (3.67–6.90) | 5.32 (2.84–7.21) | 5.30 (3.34–7.07) |
Pain (112, 110)* | 6 (4–8) | 6 (4–8) | 6 (4–8) |
Fatigue (112, 110)* | 5 (3–7) | 5 (3–8) | 5 (3–8) |
HADS (112, 109)* | |||
Depression | 6 (3–9) | 4 (2–8) | 5 (2–8) |
Anxiety | 6 (3–9) | 6 (3–10) | 6 (3–9) |
ZAP | |||
Trust (112, 110) | 4 (3–4) | 4 (4–4) | 4 (3–4) |
Quality (110, 109) | 2 (2–3) | 3 (2–3) | 3 (2–3) |
Satisfaction (110, 109) | 2 (2–3) | 3 (2–3) | 3 (2–3) |
*Numbers of available data were as per randomised allocation, that is, 113 for RLC and 111 for NLC unless otherwise stated in parentheses.
ACPA, anticitrullinated protein antibody; DAS28-CRP, Disease Activity Score in 28 Joints measured with C reactive protein; DMARD, disease-modifying antirheumatic drug; FFbH, Funktionsfragebogen Hannover; HADS, Hospital Anxiety and Depression Scale; NLC, nurse-led care; RA, rheumatoid arthritis; RADAI, Rheumatoid Arthritis Disease Activity Index; RAID, Rheumatoid Arthritis Impact of Disease; RF, rheumatoid factor; RLC, rheumatologist-led care; ZAP, 'Fragebogen zur Zufriedenheit in der ambulanten Versorgung', satisfaction about outpatient care.