Patient-reported outcomes and experiences at 3 months
| Outcome | Response, n | Descriptive outcome | Effect (regression DD vs. pre-DD) | Non-inferior | |||
| Pre-DD | DD | Pre-DD | DD | Difference, mean (95% CI) | Significance, p value | ||
| Continuous data, mean (SD) | |||||||
| Satisfaction (VAS 0–100) | 144 | 153 | 8.13 (1.5) | 7.95 (1.7) | −0.16 (−0.53 to 0.21) | 0.408 | Yes |
| Pain (VAS 0–100) | 144 | 153 | 1.40 (2.1) | 1.52 (1.9) | 0.078 (−0.37 to 0.53) | 0.727 | – |
| Functional outcome | 141 | 148 | 77.4 (26.4) | 81.0 (21.9) | 3.98 (−1.56 to 9.37) | 0.166 | – |
| QuickDASH | 36 | 33 | 10.5 (12.2) | 13.2 (14.8) | 4.15 (−2.00 to 10.50) | 0.231 | Yes |
| LEFS | 49 | 72 | 63.1 (16.4) | 64.0 (15.4) | 1.06 (−4.56 to 6.81) | 0.716 | Yes |
| PROMIS UE | 41 | 31 | 35.3 (14.7) | 38.7 (13.6) | 3.79 (−3.40 to 10.88) | 0.270 | NA |
| PROMIS Mobility | 15 | 12 | 44.0 (12.5) | 54.1 (7.4) | 10.79 (2.78 to 19.67) | 0.019 | Yes |
| Health-related QoL | |||||||
| EQ-5D-5L index | 85 | 105 | 0.839 (0.189) | 0.852 (0.139) | 0.014 (−0.032 to 0.062) | 0.553 | – |
| EQ-5D-5L VAS | 85 | 105 | 80.2 (16.7) | 80.3 (13.1) | 0.19 (−4.1 to 4.4) | 0.932 | – |
| EQ-5D-Youth index | 56 | 43 | 0.874 (0.242) | 0.949 (0.148) | 0.076 (0.003 to 0.156) | 0.052 | – |
| EQ-5D-Youth VAS | 56 | 43 | 92.3 (9.6) | 94.7 (7.5) | 2.4 (−1.0 to 5.8) | 0.169 | – |
| Dichotomous data, n (%) | OR (95% CI) | ||||||
| Dissatisfied with treatment (Likert) | 144 | 153 | 5 (3.5) | 11 (7.2) | 2.05 (0.69 to 6.09) | 0.197 | – |
| Treatment preference DD | 144 | 153 | 57 (39.6) | 125 (81.7) | 6.72 (3.95 to 11.41) | <0.001 | – |
Propensity score-adjusted linear regression was performed to analyze continuous data with bootstrapping for non-normal distribution and binary logistic to analyze dichotomous data.
Non-inferiority margins: satisfaction −0.7; QuickDASH +15.91; LEFS −9.0; PROMIS Mobility −3.0.
A p value <0.05 was considered statistically significant.
DD, direct discharge; EQ-5D-5L, EuroQol-5-dimension 5-level questionnaire; LEFS, Lower Extremity Functional Scale; NA, not available; PROMIS, Patient-Reported Outcomes Measurement Information System; QoL, quality of life; QuickDASH, Shortened Version of the Disabilities of the Arm, Shoulder and Hand; UE, upper extremity; VAS, Visual Analog Scale.