Table 3.
GERD-HRQL scores and change from baseline
| Measure | MSA | LF | ||
|---|---|---|---|---|
| Mean GERD-HRQL ± SD Median (Min, Max) |
Mean Change from Baseline ± SD Median (Min, Max) [95% CL] p value |
Mean GERD-HRQL ± SD Median (Min, Max) |
Mean Change from Baseline ± SD Median (Min, Max) [95% CL] p value |
|
| Baseline |
n = 457 22.0 ± 9.1 22.0 (0.0, 47.0) |
n = 163 23.6 ± 9.8 23.0 (3.0, 47.0) |
||
| Paired Baseline/Month 12 |
n = 414 21.9 ± 9.0 22.5 (0.0, 46.0) |
n = 152 23.4 ± 9.9 23.0 (3.0, 47.0) |
||
| Month 12 |
n = 418 5.2 ± 6.4 3.0 (0.0, 42.0) |
n = 414 − 16.7 ± 10.0 − 17.0 (− 41.0, 21.0) [− 17.6, − 15.7] < 0.001 |
n = 154 4.9 ± 7.2 3.0 (0.0, 48.0) |
n = 152 − 18.5 ± 11.5 − 19.5 (− 45.0, 20.0) [− 20.3, − 16.6] < 0.001 |
| Paired Baseline/Month 24 |
n = 296 21.6 ± 9.2 22.0 (0.0, 41.0) |
n = 103 23.9 ± 10.1 24.0 (3.0, 47.0) |
||
| Month 24 |
n = 300 4.9 ± 6.1 2.0 (0.0, 35.0) |
n = 296 − 16.7 ± 10.6 − 17.0 (− 39.0, 28.0) [− 17.9, − 15.5] < 0.001 |
n = 105 3.9 ± 4.4 3.0 (0.0, 19.0) |
n = 103 − 20.0 ± 10.0 − 20.0 (− 45.0, 0.0) [− 22.0, − 18.1] < 0.001 |
| Paired Baseline/Month 36 |
n = 278 21.3 ± 9.3 22.0 (0.0, 41.0) |
n = 80 22.5 ± 9.7 22.5 (3.0, 47.0) |
||
| Month 36 |
n = 283 4.6 ± 6.0 3.0 (0.0, 39.0) |
n = 278 − 16.6 ± 10.2 − 18.0 (− 41.0, 12.0) [− 17.8, − 15.4] < 0.001 |
n = 82 4.9 ± 7.1 3.0 (0.0, 45.0) |
n = 80 − 17.8 ± 10.6 − 18.0 (− 39.0, 17.0) [− 20.1, − 15.4] < 0.001 |
CL confidence limit, GERD gastroesophageal reflux disease, HRQL health-related quality of life, LF laparoscopic fundoplication, max maximum, min minimum, MSA magnetic sphincter augmentation, SD standard deviation