TABLE 3.
Quality of Life assessment data
| Variable | Change from pre‐surgery a , EMM (95% CI) | p‐value | |||
|---|---|---|---|---|---|
| n | No sleeve | n | Sleeve | ||
| FACT‐B at 12 months | 43 | 2.60 (−1.66, 6.85) | 46 | 3.44 (−0.67, 7.56) | 0.78 |
| TOI at 12 months | 46 | 0.83 (−2.25, 3.91) | 48 | −0.11 (−3.12, 2.91) | 0.67 |
| ARM at 12 months | 43 | −3.67 (−4.93, −2.40) | 43 | −4.04 (−5.30, −2.77) | 0.68 |
| FACT‐B at 18 months | 49 | −3.25 (−7.41, 0.92) | 47 | 1.88 (−2.37, 6.14) | 0.091 |
| TOI at 18 months | 51 | −3.09 (−6.18, 0.001) | 49 | −0.30 (−3.46, 2.85) | 0.21 |
| ARM at 18 months | 42 | −3.50 (−4.78, −2.21) | 45 | −3.33 (−4.57, −2.09) | 0.85 |
| FACT‐B at 24 months | 44 | −0.34 (−4.84, 4.16) | 39 | 4.80 (0.01, 9.58) | 0.12 |
| TOI at 24 months | 45 | −0.43 (−3.72, 2.86) | 41 | 1.14 (−2.30, 4.58) | 0.51 |
| ARM at 24 months | 38 | −1.73 (−3.21, −0.25) | 35 | −3.22 (−4.76, −1.68) | 0.17 |
Note: The clinically important difference in Trial Outcome Index (TOI) is 5 points.
Abbreviation: EMM, estimated marginal mean.
a
Calculated using an ANCOVA model with later time point as the dependent variable and pre‐surgery value and randomisation group as independent variable.