TABLE 4.
Effect of Sleeve application when Lymphoedema (RAVI > 10%) developed
| Variable | Change from pre‐surgery a , EMM (95% CI) | p‐value | |||
|---|---|---|---|---|---|
| n | No sleeve | n | Sleeve | ||
| FACT‐B at 12 months | 11 | 2.95 (−1.66, 7.56) | 14 | 11.80 (7.71, 15.88) | 0.007 |
| TOI at 12 months | 12 | 0.41 (−4.13, 4.95) | 14 | 6.84 (2.63, 11.04) | 0.042 |
| ARM at 12 months | 12 | −3.17 (−5.26, −1.08) | 13 | −3.92 (−5.93, −1.91) | 0.60 |
| FACT‐B at 18 months | 12 | −2.96 (−10.82, 4.89) | 14 | 4.69 (−2.58, 11.96) | 0.15 |
| TOI at 18 months | 13 | −3.82 (−9.84, 2.20) | 14 | 2.18 (−3.62, 7.98) | 0.15 |
| ARM at 18 months | 11 | −2.44 (−4.32, −0.55) | 14 | −3.58 (−5.26, −1.91) | 0.36 |
| FACT‐B at 24 months | 13 | 0.30 (−8.04, 8.63) | 13 | 4.71 (−3.63, 13.04) | 0.46 |
| TOI at 24 months | 13 | −0.38 (−6.19, 5.43) | 13 | 1.90 (−3.91, 7.71) | 0.58 |
| ARM at 24 months | 11 | −2.10 (−4.87, 0.68) | 12 | −4.41 (−7.07, −1.75) | 0.22 |
Note: In patients in either arm the use of a sleeve once lymphoedema occurred improved QoL with increased FACT‐B and TOI scores at 12 but not 18 months. Conventionally a 5‐point increase in scores is considered clinically relevant.
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 variables.