Table 2.
All Patients: 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* | 314 | 14.2 | 1.4 | 314 | 8.5 | 1.2 | 5.7 | 1.8 | 2.1 | 9.3 | 0.0021 |
| Model fitted† | 14.7 | 1.3 | 9.0 | 1.3 | 5.7 | 1.7 | 2.5 | 9.0 | 0.0006 | ||
| Model fitted using MI‡ | 14.9 | 1.3 | 8.9 | 1.3 | 6.0 | 1.7 | 2.7 | 9.3 | 0.0003 | ||
| Baseline to 6 months: | |||||||||||
| Raw data* | 287 | 26.0 | 1.6 | 277 | 21.3 | 1.5 | 4.7 | 2.1 | 0.5 | 8.9 | 0.03 |
| Model fitted† | 26.5 | 1.3 | 21.5 | 1.3 | 5.1 | 1.7 | 1.7 | 8.4 | 0.0029 | ||
| Model fitted using MI‡ | 27.1 | 1.3 | 21.6 | 1.3 | 5.5 | 1.6 | 2.3 | 8.7 | 0.0008 | ||
| Baseline to 12 months: | |||||||||||
| Raw data* | 267 | 26.0 | 1.6 | 252 | 25.1 | 1.6 | 0.9 | 2.2 | −3.5 | 5.3 | 0.70 |
| Model fitted† | 26.8 | 1.3 | 25.3 | 1.4 | 1.5 | 1.7 | −1.8 | 4.8 | 0.38 | ||
| Model fitted using MI‡ | 27.2 | 1.3 | 25.7 | 1.3 | 1.5 | 1.7 | −1.8 | 4.7 | 0.37 | ||
| Baseline to 18 months: | |||||||||||
| Raw data* | 244 | 27.2 | 1.8 | 220 | 25.5 | 1.7 | 1.7 | 2.5 | −3.1 | 6.6 | 0.48 |
| Model fitted† | 27.4 | 1.3 | 24.7 | 1.3 | 2.7 | 1.7 | −0.6 | 5.9 | 0.11 | ||
| Model fitted using MI‡ | 28.1 | 1.3 | 25.3 | 1.3 | 2.7 | 1.6 | −0.5 | 5.9 | 0.10 | ||
| Baseline to 24 months: | |||||||||||
| Raw data* | 249 | 27.4 | 1.7 | 227 | 24.1 | 1.8 | 3.3 | 2.5 | −1.6 | 8.2 | 0.18 |
| Model fitted† | 28.1 | 1.5 | 24.2 | 1.5 | 3.9 | 1.9 | 0.1 | 7.6 | 0.04 | ||
| Model fitted using MI‡ | 28.9 | 1.6 | 25.0 | 1.5 | 3.9 | 2.0 | 0.1 | 7.8 | 0.04 | ||
| VEINES-Sym: | |||||||||||
| Baseline to 1 month: | |||||||||||
| Raw data* | 311 | 12.1 | 1.5 | 314 | 8.8 | 1.3 | 3.3 | 2.0 | −0.6 | 7.1 | 0.10 |
| Model fitted† | 12.9 | 1.5 | 9.6 | 1.5 | 3.3 | 2.1 | −0.8 | 7.4 | 0.11 | ||
| Model fitted using MI‡ | 13.1 | 1.5 | 9.3 | 1.5 | 3.8 | 2.1 | −0.4 | 8.0 | 0.08 | ||
| Baseline to 6 months: | |||||||||||
| Raw data* | 285 | 20.2 | 1.6 | 277 | 16.2 | 1.5 | 4.0 | 2.2 | −0.3 | 8.3 | 0.07 |
| Model fitted† | 21.1 | 1.5 | 16.8 | 1.5 | 4.3 | 2.1 | 0.1 | 8.4 | 0.05 | ||
| Model fitted using MI‡ | 21.5 | 1.5 | 16.8 | 1.5 | 4.7 | 2.2 | 0.4 | 9.1 | 0.03 | ||
| Baseline to 12 months: | |||||||||||
| Raw data* | 266 | 18.1 | 1.6 | 252 | 18.1 | 1.6 | 0.0 | 2.3 | −4.5 | 4.5 | 0.99 |
| Model fitted† | 19.1 | 1.5 | 18.2 | 1.5 | 0.9 | 2.1 | −3.3 | 5.1 | 0.68 | ||
| Model fitted using MI‡ | 19.2 | 1.5 | 18.4 | 1.5 | 0.8 | 2.2 | −3.5 | 5.1 | 0.72 | ||
| Baseline to 18 months: | |||||||||||
| Raw data* | 243 | 19.3 | 1.8 | 220 | 18.1 | 1.8 | 1.2 | 2.6 | −3.9 | 6.2 | 0.65 |
| Model fitted† | 20.2 | 1.5 | 18.2 | 1.5 | 2.0 | 2.1 | −2.2 | 6.1 | 0.35 | ||
| Model fitted using MI‡ | 20.6 | 1.5 | 18.7 | 1.5 | 2.0 | 2.1 | −2.1 | 6.1 | 0.34 | ||
| Baseline to 24 months: | |||||||||||
| Raw data* | 248 | 20.7 | 1.7 | 227 | 18.2 | 1.7 | 2.5 | 2.4 | −2.2 | 7.1 | 0.30 |
| Model fitted† | 21.2 | 1.6 | 18.2 | 1.7 | 3.0 | 2.3 | −1.5 | 7.6 | 0.19 | ||
| Model fitted using MI‡ | 22.1 | 1.7 | 18.9 | 1.6 | 3.2 | 2.3 | −1.3 | 7.7 | 0.16 | ||
| SF-36 PCS: | |||||||||||
| Baseline to 1 month: | |||||||||||
| Raw data* | 313 | 7.2 | 0.6 | 314 | 4.9 | 0.6 | 2.3 | 0.9 | 0.6 | 4.0 | 0.0077 |
| Model fitted† | 7.4 | 0.7 | 5.1 | 0.7 | 2.4 | 0.9 | 0.5 | 4.2 | 0.01 | ||
| Model fitted using MI‡ | 7.6 | 0.7 | 5.0 | 0.7 | 2.6 | 1.0 | 0.7 | 4.4 | 0.0072 | ||
| Baseline to 6 months: | |||||||||||
| Raw data* | 287 | 10.9 | 0.8 | 277 | 9.5 | 0.7 | 1.4 | 1.1 | −0.7 | 3.5 | 0.19 |
| Model fitted† | 11.5 | 0.7 | 9.7 | 0.7 | 1.8 | 0.9 | 0.0 | 3.6 | 0.05 | ||
| Model fitted using MI‡ | 11.8 | 0.7 | 9.6 | 0.7 | 2.2 | 1.0 | 0.3 | 4.1 | 0.02 | ||
| Baseline to 12 months: | |||||||||||
| Raw data* | 266 | 11.6 | 0.8 | 252 | 10.4 | 0.8 | 1.2 | 1.1 | −1.0 | 3.4 | 0.27 |
| Model fitted† | 11.5 | 0.7 | 10.0 | 0.7 | 1.5 | 0.9 | −0.3 | 3.4 | 0.10 | ||
| Model fitted using MI‡ | 11.8 | 0.7 | 10.0 | 0.7 | 1.8 | 0.9 | −0.1 | 3.6 | 0.06 | ||
| Baseline to 18 months: | |||||||||||
| Raw data* | 242 | 11.9 | 0.8 | 220 | 11.6 | 0.9 | 0.3 | 1.2 | −2.1 | 2.6 | 0.83 |
| Model fitted† | 11.6 | 0.7 | 10.3 | 0.7 | 1.3 | 1.0 | −0.7 | 3.3 | 0.21 | ||
| Model fitted using MI‡ | 11.9 | 0.7 | 10.5 | 0.7 | 1.3 | 1.0 | −0.6 | 3.3 | 0.18 | ||
| Baseline to 24 months: | |||||||||||
| Raw data* | 248 | 11.7 | 0.9 | 227 | 11.0 | 0.9 | 0.6 | 1.2 | −1.8 | 3.0 | 0.62 |
| Model fitted† | 11.7 | 0.8 | 10.7 | 0.8 | 1.0 | 1.1 | −1.2 | 3.3 | 0.37 | ||
| Model fitted using MI‡ | 11.9 | 0.8 | 11.0 | 0.8 | 0.9 | 1.1 | −1.3 | 3.1 | 0.42 | ||
| SF-36 MCS: | |||||||||||
| Baseline to 1 month: | |||||||||||
| Raw data* | 314 | −0.2 | 0.7 | 314 | −0.5 | 0.6 | 0.3 | 0.9 | −1.5 | 2.2 | 0.71 |
| Model fitted† | 0.3 | 0.1 | 0.4 | 0.1 | −0.1 | 0.1 | −0.3 | 0.1 | 0.42 | ||
| Model fitted using MI‡ | 0.3 | 0.1 | 0.5 | 0.1 | −0.2 | 0.1 | −0.4 | 0.0 | 0.11 | ||
| Baseline to 6 months: | |||||||||||
| Raw data* | 287 | 1.8 | 0.7 | 277 | 1.6 | 0.8 | 0.2 | 1.1 | −1.9 | 2.2 | 0.88 |
| Model fitted† | 1.8 | 0.5 | 2.4 | 0.5 | −0.6 | 0.7 | −1.9 | 0.8 | 0.42 | ||
| Model fitted using MI‡ | 1.8 | 0.5 | 2.9 | 0.5 | −1.1 | 0.7 | −2.4 | 0.3 | 0.11 | ||
| Baseline to 12 months: | |||||||||||
| Raw data* | 267 | 1.8 | 0.8 | 252 | 1.7 | 0.8 | 0.1 | 1.1 | −2.1 | 2.3 | 0.93 |
| Model fitted† | . | 2.2 | 0.4 | 2.8 | 0.5 | −0.6 | 0.6 | −1.7 | 0.5 | 0.30 | |
| Model fitted using MI‡ | . | 2.3 | 0.5 | 3.3 | 0.5 | −1.0 | 0.6 | −2.1 | 0.1 | 0.08 | |
| Baseline to 18 months: | |||||||||||
| Raw data* | 243 | 2.0 | 0.9 | 220 | 2.2 | 0.8 | −0.2 | 1.2 | −2.6 | 2.2 | 0.87 |
| Model fitted† | 2.5 | 0.5 | 3.2 | 0.5 | −0.6 | 0.6 | −1.8 | 0.5 | 0.29 | ||
| Model fitted using MI‡ | 2.7 | 0.5 | 3.6 | 0.5 | −1.0 | 0.6 | −2.2 | 0.2 | 0.11 | ||
| Baseline to 24 months: | |||||||||||
| Raw data* | 249 | 2.9 | 0.8 | 227 | 3.0 | 0.8 | −0.1 | 1.1 | −2.3 | 2.1 | 0.94 |
| Model fitted† | 2.9 | 0.6 | 3.6 | 0.6 | −0.7 | 0.7 | −2.1 | 0.8 | 0.36 | ||
| Model fitted using MI‡ | 3.1 | 0.6 | 4.0 | 0.6 | −0.9 | 0.7 | −2.4 | 0.6 | 0.22 | ||
*
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