Table 2. Analysis of the primary endpoints.
Change after one year*1 per group | Group comparison | ||||
Endpoint | Team-basedform of care | Standard care | Team-based − Standard | ||
Observedmean value (SD) | Observedmean value (SD) | Estimated difference[95% confidence interval] | p value | D | |
DAS28 | −0.14(1.07) | 0.04(1.15) | −0.19[−0.36; −0.02]*2 | < 0.001*4 | ↑ |
EQ-5D-5L | 0.02(0.21) | 0.01 (0.23) | 0.02[−0.02; 0.05]*3 | 0.285 | ↑ |
*1 final value – initial value
*2 estimated using a mixed linear model in der per protocol population with adjustment for patient sex,
baseline DAS28 score, type of rheumatoid disease, and center (random effect)
*3 estimated using a linear mixed model in intention-to-treat population with adjustment for patient age and sex,
EQ-5D-5L score at baseline, type of rheumatic disease, and center (random effect)
*4 p value from test for non-inferiority, p = 0.025 in test for superiority
DAS28, Disease Activity Score with 28 joints; EQ-5D-5L, EuroQol in 5 dimensions and 5 response levels; D, direction of the estimated difference;
SD, standard deviation; ↑ indicates advantage of team-based form of care.