Table 4.
Femoral-popliteal DVT Subgroup: Change in Disease-specific and General QOL according to Treatment
| Outcome Measure | PCDT |
No PCDT |
PCDT – No PCDT Difference |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Mean | SE | n | Mean | SE | Est. | SE | 95% CI | p | ||
| VEINES-QOL: | |||||||||||
| Baseline to 1 month: | |||||||||||
| Raw data* | 134 | 12.4 | 2.2 | 145 | 12.3 | 1.6 | 0.1 | 2.7 | −5.2 | 5.4 | 0.97 |
| Model fitted† | 13.0 | 1.9 | 12.5 | 1.8 | 0.5 | 2.4 | −4.2 | 5.2 | 0.83 | ||
| Model fitted using MI‡ | 13.5 | 1.9 | 12.6 | 1.8 | 0.9 | 2.5 | −3.9 | 5.7 | 0.71 | ||
| Baseline to 6 months: | |||||||||||
| Raw data* | 119 | 24.4 | 2.4 | 133 | 24.3 | 2.0 | 0.0 | 3.1 | −6.1 | 6.1 | 0.75 |
| Model fitted† | 25.0 | 1.9 | 24.4 | 1.9 | 0.6 | 2.4 | −4.1 | 5.4 | 0.32 | ||
| Model fitted using MI‡ | 25.8 | 1.9 | 24.8 | 1.9 | 1.0 | 2.4 | −3.6 | 5.7 | 0.28 | ||
| Baseline to 12 months: | |||||||||||
| Raw data* | 114 | 24.9 | 2.4 | 119 | 25.9 | 2.1 | −1.0 | 3.2 | −7.3 | 5.3 | 0.83 |
| Model fitted† | 25.5 | 1.9 | 27.9 | 1.9 | −2.4 | 2.4 | −7.0 | 2.3 | 0.90 | ||
| Model fitted using MI‡ | 26.1 | 1.9 | 28.6 | 1.9 | −2.5 | 2.3 | −7.1 | 2.1 | 0.82 | ||
| Baseline to 18 months: | |||||||||||
| Raw data* | 105 | 25.8 | 2.7 | 98 | 25.0 | 2.5 | 0.8 | 3.7 | −6.5 | 8.1 | 0.99 |
| Model fitted† | 26.5 | 2.0 | 26.8 | 1.9 | −0.3 | 2.4 | −5.0 | 4.5 | 0.79 | ||
| Model fitted using MI‡ | 27.2 | 2.0 | 27.7 | 1.9 | −0.6 | 2.4 | −5.3 | 4.2 | 0.67 | ||
| Baseline to 24 months: | |||||||||||
| Raw data* | 108 | 26.3 | 2.6 | 99 | 25.2 | 2.3 | 1.1 | 3.5 | −5.8 | 8.1 | 0.75 |
| Model fitted† | 27.4 | 2.2 | 25.7 | 2.1 | 1.8 | 2.7 | −3.5 | 7.1 | 0.51 | ||
| Model fitted using MI‡ | 28.3 | 2.2 | 26.9 | 2.2 | 1.4 | 2.8 | −4.1 | 6.9 | 0.61 | ||
| VEINES-Sym: | |||||||||||
| Baseline to 1 month: | |||||||||||
| Raw data* | 134 | 11.2 | 2.3 | 145 | 12.5 | 1.8 | −1.3 | 2.9 | −6.9 | 4.4 | 0.66 |
| Model fitted† | 12.4 | 2.0 | 12.7 | 1.9 | −0.3 | 2.5 | −5.1 | 4.5 | 0.91 | ||
| Model fitted using MI‡ | 12.8 | 2.0 | 12.4 | 1.9 | 0.4 | 2.5 | −4.5 | 5.4 | 0.86 | ||
| Baseline to 6 months: | |||||||||||
| Raw data* | 119 | 20.3 | 2.4 | 133 | 19.1 | 2.2 | 1.2 | 3.3 | −5.2 | 7.7 | 0.70 |
| Model fitted† | 20.8 | 2.0 | 19.6 | 1.9 | 1.1 | 2.4 | −3.7 | 5.9 | 0.65 | ||
| Model fitted using MI‡ | 21.2 | 2.0 | 19.6 | 1.9 | 1.7 | 2.5 | −3.2 | 6.6 | 0.50 | ||
| Baseline to 12 months: | |||||||||||
| Raw data* | 114 | 18.0 | 2.4 | 119 | 19.2 | 2.3 | −1.2 | 3.3 | −7.6 | 5.3 | 0.72 |
| Model fitted† | 18.9 | 2.0 | 20.9 | 1.9 | −2.1 | 2.4 | −6.8 | 2.6 | 0.39 | ||
| Model fitted using MI‡ | 18.9 | 2.0 | 20.9 | 1.9 | −2.1 | 2.3 | −6.6 | 2.5 | 0.38 | ||
| Baseline to 18 months: | |||||||||||
| Raw data* | 105 | 18.0 | 2.8 | 98 | 17.9 | 2.7 | 0.1 | 3.8 | −7.5 | 7.7 | 0.97 |
| Model fitted† | 20.0 | 2.0 | 20.6 | 2.0 | −0.7 | 2.4 | −5.4 | 4.1 | 0.79 | ||
| Model fitted using MI‡ | 20.3 | 2.0 | 20.9 | 1.9 | −0.6 | 2.3 | −5.1 | 3.9 | 0.79 | ||
| Baseline to 24 months: | |||||||||||
| Raw data* | 108 | 20.4 | 2.7 | 99 | 19.5 | 2.1 | 0.9 | 3.5 | −5.9 | 7.7 | 0.78 |
| Model fitted† | 21.1 | 2.2 | 20.3 | 2.1 | 0.8 | 2.7 | −4.5 | 6.1 | 0.78 | ||
| Model fitted using MI‡ | 21.7 | 2.1 | 20.8 | 2.1 | 0.9 | 2.6 | −4.3 | 6.0 | 0.74 | ||
| SF-36 PCS: | |||||||||||
| Baseline to 1 month: | |||||||||||
| Raw data* | 133 | 5.9 | 1.0 | 145 | 6.4 | 0.8 | −0.5 | 1.2 | −2.9 | 2.0 | 0.70 |
| Model fitted† | 6.3 | 0.9 | 6.6 | 0.8 | −0.3 | 1.1 | −2.4 | 1.8 | 0.77 | ||
| Model fitted using MI‡ | 6.4 | 0.9 | 6.4 | 0.9 | 0.0 | 1.1 | −2.2 | 2.1 | 0.97 | ||
| Baseline to 6 months: | |||||||||||
| Raw data* | 119 | 10.7 | 1.2 | 133 | 11.0 | 1.0 | −0.3 | 1.5 | −3.3 | 2.7 | 0.86 |
| Model fitted† | 10.4 | 0.9 | 11.0 | 0.9 | −0.6 | 1.1 | −2.7 | 1.5 | 0.59 | ||
| Model fitted using MI‡ | 10.8 | 0.9 | 10.7 | 0.9 | 0.0 | 1.1 | −2.1 | 2.1 | 0.98 | ||
| Baseline to 12 months: | |||||||||||
| Raw data* | 113 | 12.0 | 1.1 | 119 | 10.5 | 1.0 | 1.5 | 1.5 | −1.4 | 4.5 | 0.31 |
| Model fitted† | 10.9 | 0.9 | 11.0 | 0.9 | −0.2 | 1.1 | −2.2 | 1.9 | 0.88 | ||
| Model fitted using MI‡ | 11.1 | 0.9 | 10.9 | 0.8 | 0.2 | 1.0 | −1.8 | 2.2 | 0.85 | ||
| Baseline to 18 months: | |||||||||||
| Raw data* | 104 | 12.4 | 1.2 | 98 | 11.2 | 1.2 | 1.2 | 1.7 | −2.2 | 4.5 | 0.50 |
| Model fitted† | 11.3 | 0.9 | 11.1 | 0.9 | 0.3 | 1.1 | −1.9 | 2.5 | 0.82 | ||
| Model fitted using MI‡ | 11.5 | 0.9 | 11.1 | 0.9 | 0.4 | 1.1 | −1.7 | 2.5 | 0.73 | ||
| Baseline to 24 months: | |||||||||||
| Raw data* | 107 | 12.3 | 1.2 | 99 | 10.9 | 1.2 | 1.4 | 1.7 | −2.0 | 4.8 | 0.41 |
| Model fitted† | 11.8 | 1.0 | 11.1 | 1.0 | 0.7 | 1.3 | −1.8 | 3.2 | 0.59 | ||
| Model fitted using MI‡ | 11.8 | 1.0 | 11.3 | 1.0 | 0.5 | 1.2 | −1.9 | 2.9 | 0.66 | ||
| SF-36 MCS: | |||||||||||
| Baseline to 1 month: | |||||||||||
| Raw data* | 134 | −0.6 | 1.0 | 145 | −1.4 | 0.8 | 0.8 | 1.3 | −1.7 | 3.4 | 0.53 |
| Model fitted† | 0.3 | 0.1 | 0.4 | 0.1 | −0.1 | 0.1 | −0.3 | 0.2 | 0.56 | ||
| Model fitted using MI‡ | 0.3 | 0.1 | 0.5 | 0.1 | −0.2 | 0.1 | −0.4 | 0.1 | 0.21 | ||
| Baseline to 6 months: | |||||||||||
| Raw data* | 119 | 1.5 | 1.1 | 133 | 0.0 | 1.0 | 1.5 | 1.5 | −1.5 | 4.6 | 0.33 |
| Model fitted† | 1.8 | 0.6 | 2.2 | 0.6 | −0.5 | 0.8 | −2.0 | 1.1 | 0.56 | ||
| Model fitted using MI‡ | 1.8 | 0.6 | 2.8 | 0.6 | −0.9 | 0.8 | −2.4 | 0.5 | 0.21 | ||
| Baseline to 12 months: | |||||||||||
| Raw data* | 114 | 1.6 | 1.3 | 119 | −0.2 | 1.0 | 1.9 | 1.6 | −1.3 | 5.1 | 0.26 |
| Model fitted† | 2.1 | 0.5 | 2.6 | 0.5 | −0.5 | 0.7 | −1.9 | 0.8 | 0.41 | ||
| Model fitted using MI‡ | 2.2 | 0.5 | 3.2 | 0.5 | −0.9 | 0.6 | −2.2 | 0.3 | 0.15 | ||
| Baseline to 18 months: | |||||||||||
| Raw data* | 105 | 2.6 | 1.2 | 98 | 0.7 | 1.1 | 1.9 | 1.7 | −1.4 | 5.2 | 0.26 |
| Model fitted† | 2.4 | 0.5 | 3.1 | 0.5 | −0.6 | 0.6 | −1.9 | 0.6 | 0.33 | ||
| Model fitted using MI‡ | 2.6 | 0.5 | 3.5 | 0.5 | −0.9 | 0.6 | −2.2 | 0.3 | 0.16 | ||
| Baseline to 24 months: | |||||||||||
| Raw data* | 108 | 1.8 | 1.1 | 99 | 1.8 | 1.2 | 0.1 | 1.6 | −3.1 | 3.3 | 0.95 |
| Model fitted† | 2.8 | 0.6 | 3.5 | 0.6 | −0.7 | 0.7 | −2.2 | 0.7 | 0.32 | ||
| Model fitted using MI‡ | 3.0 | 0.6 | 3.9 | 0.6 | −0.9 | 0.7 | −2.4 | 0.6 | 0.23 | ||
statistical comparison using an unpaired t-test (based on the raw data)
statistical comparison using a Wald test using a growth curve model with piece-wise linear regression over time adjusted for stratification factors: extent of DVT (iliofemoral vs. femoral-popliteal) and center, and baseline covariates: age, sex, BMI, Villalta score.
VEINES-QOL score (0–100 range) – higher is better; SF-36 major scales (0–100 range): physical component score (PCS) and mental component score (MCS) – higher is better; a 4-point difference is considered to be clinically meaningful
Auxiliary variables used in multiple imputation (MI): for SF-36 (MCS and PCS), age (continuous), sex, race, BMI (continuous) and all available SF-36 scores from previous visits; for VEINES-QOL, age (continuous), sex, BMI, extent of index DVT and all available VEINES scores from previous visits
SE, standard error; Est, estimate; 95% CI, 95% confidence interval