Table 3. Analysis of the secondary endpoints.
|
Change after one year*1
per group |
Group comparison | |||
| Endpoint |
Team-based
form of care |
Standard
care |
Team based − Standard | |
|
Observed
mean value (SD) |
Observed
mean value (SD) |
Estimated difference
[95% confidence interval]*2 |
Direction | |
| CRP (mg/L)*3 | 0.0(−1.1–1.2) | 0.0(−1.5–1.4) | 0.0[−0.1; 0.2] | ↓ |
| Disease activity (NRS) | −0.2 (2.2) | −0.1 (2.5) | −0.1 [−0.5; 0.2] | ↑ |
| Pain intensity (NRS) | −0.1 (2.4) | 0.1 (2.2) | −0.2 [−0.6; 0.1] | ↑ |
| Fatigue(NRS) | −0.2 (2.3) | 0.0 (2.5) | −0.2 [−0.5; 0.2] | ↑ |
| Sleep disturbances (NRS) | −0.2 (2.6) | −0.0 (2.8) | −0.3 [−0.7; 0.1] | ↑ |
| Duration of morning stiffness (minutes) | 2.6 (30.3) | 1.4 (29.1) | 0.5 [−4.1; 5.2] | ↓ |
| Depression(PHQ-2) | −0.1 (1.5) | 0.0 (1.5) | −0.1 [−0.3; 0.1] | ↑ |
| Functional capacity (FFbH) | −2.0 (15.9) | −1.7 (13.0) | −0.1 [−2.9; 2.8] | ↓ |
| Physical activity (PRISCUS-PAQ) | −0.2(11.4) | −1.2 (10.2) | 1.6 [−0.2; 3.4] | ↑ |
*1 final value- initial value
*2 estimated using a linear mixed models in the intention-to-treat population for each endpoint with adjustment for patient age and sex, respective baseline value, and respective center (random effect)
*3 given the skewness of the distribution, median and interquartile range (Q25–Q75) of the changes are presented, and the model is calculated with log CRP.
CRP, C-reactive protein; FFbH, Hanover Functional Status Questionnaire (0–100); NRS, numeric rating scale (0–10);
PAQ, Physical Activity Questionnaire (≥ 168 MET hour/week [MET, metabolic equivalent]); PHQ-2, Patient Health Questionnaire 2 Items (0–6);
↑ indicates advantage of the team-based model of care, ↓ indicates advantage of standard care