Table 6.
Change in Quality of Life (QoL) and weight over time for the implant and systemic treatment arms during the initial 2 years of follow-up (as-randomized analysis).
| Sample Size* | Estimated Mean ‖(SE §) | Estimated Mean Change from Enrollment(SE) | Estimated Treatment Effect † (95% CI§) | P-value | |||
|---|---|---|---|---|---|---|---|
| Implant | Systemic | Implant | Systemic | Implant: Systemic | |||
| Vision-related QoL | |||||||
| VFQ-25 (Overall Composite Score) | N= | ||||||
| Enrollment | 255 | 60.6(2.4) | 64.9(2.5) | n/a | n/a | n/a | n/a |
| 6 months | 233 | 71.4(2.4) | 66.3(2.5) | 10.77(1.31) | 1.41(1.38) | 9.37 (5.64, 13.09) | <0.001 |
| 12 months | 235 | 72.7(2.5) | 69.7(2.5) | 12.13(1.60) | 4.86(13.8) | 7.27 (3.11, 11.42) | 0.001 |
| 24 months | 232 | 72.1(2.5) | 71.7(2.6) | 11.44(1.67) | 6.80(1.58) | 4.64(0.14, 9.15) | 0.043 |
| Generic health-related QoL | |||||||
| SF-36 (Mental Component Summary Score) | N= | ||||||
| Enrollment | 255 | 47.5(1.3) | 48.3(1.2) | n/a | n/a | n/a | n/a |
| 6 months | 236 | 51.1(1.12) | 45.5(1.4) | 3.58(1.12) | −2.75(1.14) | 6.33 (3.19, 9.47) | <0.001 |
| 12 months | 234 | 51.0(1.1) | 46.5(1.3) | 3.52(10.5) | −1.81(1.11) | 5.33 (2.33, 8.33) | 0.001 |
| 24 months | 232 | 50.0(L2) | 47.2(1.4) | 2.55(1.11) | −1.07(1.15) | 3.62(0.49, 6.76) | 0.023 |
| SF-36 (Physical Component Summary Score) | N= | ||||||
| Enrollment | 255 | 46.5(1.2) | 48.4(1.1} | n/a | n/a | n/a | n/a |
| 6 months | 236 | 46.4(1.2) | 46.6(1.1) | −0.07 (0.73) | −1.81 (0.67) | 1.73 (−0.21, 3.67) | 0.079 |
| 12 months | 234 | 47.5(1.2) | 46.6(1.1} | 1.02 (0.78) | −1.87 (0.87) | 2.89(0.60, 5.18) | 0.013 |
| 24 months | 232 | 47.6(1.2) | 46.6(1.1) | 1.15 (0.83) | −1.79 (0.90) | 2.95 (0.54, 5.36) | 0.016 |
| Health utility | |||||||
| EuroQol (Visual Analog Scale) | N= | ||||||
| Enrollment | 253 | 72.71.9) | 74.3(2.0) | n/a | n/a | n/a | n/a |
| 6 months | 233 | 75.0(2.1} | 72.5(2.0) | 2.34(1.61) | −1.85(1.90) | 4.19 (−0.69, 9.07) | 0.092 |
| 12 months | 234 | 77.31.9) | 71.3(2.2) | 4.66(1.36) | −3.00(1.78) | 7.65 (3.26, 12.05) | 0.001 |
| 24 months | 232 | 78.0(1.8) | 73.4(1.9) | 5.29(1.28) | −0.88(1.88) | 6.17 (1.87, 10.47) | 0.005 |
| EuroQol (EQ-5D HealthUtility Index) | N = | ||||||
| Enrollment | 254 | 0.81(0.02) | 0.83(0.02) | n/a | n/a | n/a | n/a |
| 6 months | 236 | 0.83(0.02) | 0.82(0.02) | 0.01(0.01) | −0.01(0.02) | 0.03(−0.02, 0.07) | 0.25 |
| 12 months | 235 | 0.83(0.02) | 0.80(0.02) | 0.02(0.02) | −0.03(0.02) | 0.05(0.00, 0.10) | 0.041 |
| 24 months | 232 | 0.84(0.02) | 0.81(0.02) | 0.02(0.02) | −0.02(0.02) | 0.04 (−0.01, 0.09) | 0.060 |
|
| |||||||
| Weight (kg) | N= | ||||||
| Enrollment | 255 | 87.8(26) | 86.0(27) | n/a | n/a | n/a | n/a |
| 6 months | 231 | 88.2(2.7) | 87.0(2.7) | 0.40(0.54) | 0.96(0.75) | −0.56 (−2.38, 1.26) | 0.54 |
| 12 months | 229 | 87.4(2.7) | 86.4(2.7) | −0.38(0.70) | 0.38 (0.81) | −0.76 (−2.87, 1.34) | 0.48 |