Summary estimates for secondary outcome measures over 12 months
| RLC | NLC | Difference | Effect size | |||||
| Baseline | Month 12 | Baseline | Month 12 | U | z | P value† | r | |
| Median (IQR)* | Median (IQR)* | |||||||
| FFbH (n)‡ | 77.78 (61.11–88.89) (111) | 80.56 (65.28–97.22) (101) | 75 (52.78–88.89) (109) | 83.33 (54.17–97.22) (97) | 4442.000 | −0.905 | 0.365 | |
| HADS-D (n)‡ | 6 (3–9) | 5 (2.0–9.50) (101) | 4 (2–8) (109) | 3 (1–6) (97) | 4781.000 | −0.169 | 0.866 | |
| HADS-A (n)‡ | 6 (3–9) | 6 (2–9) (102) | 6 (3–10) (109) | 6 (3–10) (97) | 4056.000 | −2.101 | 0.036 | 0.15 |
| RAID, pain (n)‡ | 6 (4–8) | 3 (1, 5) (105) | 6 (4, 8) (110) | 3 (2, 5) (97) | 4829.500 | −0.639 | 0.523 | |
| RAID, fatigue (n‡) | 5 (3, 7) | 3 (1, 6) (106) | 5 (3, 8) (110) | 3 (1, 5) (97) | 4939.000 | −0.488 | 0.626 | |
| ZAP trust (n)‡ | 4 (3, 4) | 4 (3, 4) (102) | 4 (4, 4) (110) | 4 (4, 4) (97) | 4856.500 | −0.285 | 0.775 | |
| ZAP quality (n)‡ | 2 (2, 3) (110) | 3 (2, 3) (102) | 3 (2, 3) (109) | 3 (3, 3) (97) | 4506.500 | −1.074 | 0.283 | |
| ZAP satisfaction (n)‡ | 2 (2, 3) (110) | 3 (2, 3) (102) | 3 (2, 3) (109) | 3 (3, 3) (97) | 4722.000 | −0.399 | 0.690 | |
*Medians of observed values (not change).
†P values based on non-inferiority testing of change scores (at corresponding standardised effect size margin of 0.4).
‡Numbers of available data were as per randomised allocation, that is, 112 for RLC and 111 for NLC unless otherwise stated in parentheses.
FFbH, Funktionsfragebogen Hannover; HADS-A, Hospital Anxiety and Depression Scale—Anxiety; HADS-D, Hospital Anxiety and Depression Scale—Depression; NLC, nurse-led care; r, effect size; RAID, Rheumatoid Arthritis Impact of Disease; RLC, rheumatologist-led care; U, Mann-Whitney U statistic; z, z-score; ZAP, 'Fragebogen zur Zufriedenheit in der ambulanten Versorgung', satisfaction about outpatient care.;