Table 4.
Model Based Estimates, Mean (SD) | Model Based Mean Change (95% CI) | P-Value | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Year 1 | Year 2 | Year 3 | Year 4 | Year 1 from Baseline |
Year 2 from Baseline |
Year 3 from Baseline |
Year 4 from Baseline |
Year 1 vs Baseline |
Year 2 vs Baseline |
Year 3 vs Baseline |
Year 4 vs Baseline |
|
SF-36 | |||||||||||||
Physical component summary | 35.1 (9.9) | 51.9 (6.5) | 51.2 (6.8) | 50.9 (6.7) | 47.2 (7.7) | 16.9 (12.9, 20.9) | 16.1 (11.9, 20.3) | 15.8 (11.8, 19.8) | 12.1 (7.8, 16.5) | <.001 | <.001 | <.001 | <.001 |
Mental component summary | 51.3 (9.4) | 48.0 (14.6) | 51.8 (10.2) | 51.5 (9.1) | 51.9 (7.4) | −3.3 (−9.7, 3.1) | 0.5 (−4.6, 5.6) | 0.1 (−4.4, 4.7) | 0.6 (−3.7, 4.9) | 0.511 | 0.998 | >0.99 | 0.992 |
Physical functioning | 37.0 (10.9) | 52.2 (5.2) | 52.5 (5.3) | 51.5 (7.3) | 51.5 (5.6) | 15.2 (10.3, 20.0) | 15.5 (10.6, 20.4) | 14.5 (9.4, 19.6) | 14.4 (9.5, 19.4) | <.001 | <.001 | <.001 | <.001 |
Role-physical | 39.5 (10.9) | 50.1 (10.0) | 52.8 (7.3) | 51.4 (8.2) | 47.3 (11.0) | 10.6 (5.1, 16.2) | 13.3 (8.2, 18.4) | 11.9 (6.8, 17.0) | 7.8 (1.7, 13.9) | <.001 | <.001 | <.001 | 0.008 |
Pain | 39.0 (9.6) | 47.7 (12.9) | 48.4 (10.5) | 48.3 (8.9) | 44.2 (9.0) | 8.7 (3.4, 13.9) | 9.3 (4.7, 14.0) | 9.2 (5.2, 13.3) | 5.2 (0.9, 9.5) | <.001 | <.001 | <.001 | 0.011 |
General health | 40.6 (10.4) | 54.0 (10.0) | 51.0 (9.1) | 52.0 (8.2) | 49.2 (8.2) | 13.4 (9.2, 17.6) | 10.4 (6.2, 14.5) | 11.4 (7.5, 15.2) | 8.6 (4.6, 12.6) | <.001 | <.001 | <.001 | <.001 |
Vitality | 40.4 (9.4) | 52.3 (10.0) | 51.6 (8.8) | 52.8 (7.3) | 50.5 (7.2) | 12.0 (7.0, 17.0) | 11.3 (6.4, 16.2) | 12.4 (8.2, 16.7) | 10.1 (5.7, 14.6) | <.001 | <.001 | <.001 | <.001 |
Social functioning | 45.3 (11.2) | 49.2 (13.0) | 52.2 (9.9) | 51.8 (9.5) | 51.1 (8.1) | 3.9 (−3.0, 10.9) | 6.9 (0.7, 13.1) | 6.5 (0.7, 12.3) | 5.8 (0.2, 11.5) | 0.416 | 0.025 | 0.024 | 0.042 |
Role-emotional | 49.6 (9.5) | 48.2 (11.7) | 53.4 (6.8) | 50.2 (9.9) | 51.3 (9.8) | −1.4 (−7.3, 4.6) | 3.8 (−0.9, 8.5) | 0.7 (−4.7, 6.0) | 1.7 (−3.9, 7.3) | 0.942 | 0.141 | 0.995 | 0.871 |
Mental health | 49.0 (8.1) | 48.3 (14.6) | 50.7 (9.9) | 51.2 (9.0) | 50.7 (6.5) | −0.8 (−6.6, 5.1) | 1.6 (−2.7, 6.0) | 2.1 (−1.7, 5.9) | 1.6 (−1.7, 5.0) | 0.993 | 0.778 | 0.456 | 0.587 |
IWQOL - Lite | |||||||||||||
Total IWQOL | 49.9 (20.0) | 91.7 (11.2) | 93.5 (11.2) | 91.7 (9.3) | 90.4 (11.2) | 41.8 (34.8, 48.9) | 43.6 (36.4, 50.8) | 41.8 (34.8, 48.9) | 40.5 (33.3, 47.7) | <.001 | <.001 | <.001 | <.001 |
Work | 65.5 (18.5) | 94.4 (11.4) | 96.4 (14.8) | 94.0 (10.1) | 93.1 (12.9) | 28.9 (21.5, 36.3) | 30.9 (22.8, 38.9) | 28.5 (21.3, 35.8) | 27.6 (19.7, 35.6) | <.001 | <.001 | <.001 | <.001 |
Physical function | 38.0 (21.1) | 92.0 (8.3) | 94.0 (8.0) | 90.1 (9.3) | 88.8 (11.2) | 54.0 (46.0, 62.0) | 56.0 (47.9, 64.1) | 52.0 (44.0, 60.0) | 50.7 (42.5, 59.0) | <.001 | <.001 | <.001 | <.001 |
Public distress | 56.1 (28.9) | 94.0 (14.1) | 96.6 (10.5) | 96.6 (6.8) | 95.2 (9.7) | 37.9 (28.1, 47.7) | 40.5 (30.4, 50.7) | 40.5 (29.9, 51.0) | 39.1 (28.9, 49.3) | <.001 | <.001 | <.001 | <.001 |
Sex life | 60.0 (37.1) | 93.7 (12.7) | 92.6 (17.6) | 92.7 (13.3) | 91.4 (15.0) | 33.7 (20.1, 47.2) | 32.5 (19.0, 46.1) | 32.7 (19.2, 46.2) | 31.4 (17.8, 45.0) | <.001 | <.001 | <.001 | <.001 |
Self-esteem | 49.3 (30.1) | 86.7 (19.2) | 89.7 (21.0) | 88.9 (15.1) | 87.3 (17.5) | 37.4 (26.5, 48.3) | 40.4 (29.0, 51.7) | 39.6 (28.8, 50.4) | 38.0 (26.9, 49.1) | <.001 | <.001 | <.001 | <.001 |
BIQOL | −0.3 (1.3) | 0.7 (1.4) | 0.8 (1.4) | 1.0 (1.3) | 0.7 (1.1) | 1.0 (0.3, 1.7) | 1.1 (0.4, 1.9) | 1.3 (0.6, 2.0) | 1.1 (0.4, 1.7) | 0.003 | <.001 | <.001 | <.001 |
BSQ | 85.4 (33.3) | 55.8 (20.7) | 57.5 (23.2) | 54.2 (21.1) | 54.6 (21.1) | −29.6 (−42.3, −17.0) | −28.0 (−40.9, −15.0) | −31.2 (−43.8, −18.6) | −30.8 (−43.9, −17.7) | <.001 | <.001 | <.001 | <.001 |
DAS | |||||||||||||
Overall | 109.8 (17.3) | 106.6 (21.2) | 106.6 (23.3) | 111.5 (18.8) | 108.2 (18.0) | −3.2 (−10.8, 4.4) | −3.2 (−11.5, 5.2) | 1.7 (−4.9, 8.3) | −1.6 (−8.4, 5.1) | 0.706 | 0.773 | 0.926 | 0.945 |
Consensus | 46.1 (6.4) | 45.0 (7.8) | 44.4 (10.5) | 47.5 (6.5) | 46.1 (6.4) | −1.1 (−4.5, 2.3) | −1.6 (−6.1, 2.8) | 1.4 (−1.5, 4.3) | 0.0 (−3.0, 3.1) | 0.853 | 0.795 | 0.598 | >0.99 |
Satisfaction | 38.1 (6.3) | 37.5 (7.1) | 36.1 (10.0) | 38.3 (7.0) | 37.4 (8.2) | −0.6 (−3.0, 1.8) | −2.0 (−5.5, 1.5) | 0.2 (−2.1, 2.5) | −0.7 (−3.6, 2.1) | 0.944 | 0.434 | 0.998 | 0.923 |
Cohesion | 15.5 (4.1) | 15.6 (4.5) | 15.5 (5.0) | 15.8 (5.4) | 14.1 (6.3) | 0.1 (−2.0, 2.1) | −0.1 (−2.4, 2.2) | 0.3 (−2.0, 2.6) | −1.5 (−4.3, 1.4) | >0.99 | >0.99 | 0.994 | 0.547 |
Affectional expression | 8.3 (2.5) | 8.4 (2.3) | 8.3 (2.4) | 8.7 (2.4) | 8.6 (2.3) | 0.1 (−1.2, 1.3) | −0.1 (−1.4, 1.2) | 0.3 (−0.9, 1.6) | 0.2 (−1.0, 1.4) | >0.99 | >0.99 | 0.902 | 0.983 |
BDI-I | 6.5 (5.9) | 4.1 (5.7) | 4.0 (7.1) | 2.1 (3.6) | 4.1 (5.1) | −2.4 (−5.1, 0.3) | −2.5 (−5.8, 0.9) | −4.4 (−6.9, −2.0) | −2.5 (−5.2, 0.3) | 0.103 | 0.203 | <.001 | 0.085 |