Table 4

Patient-reported outcomes and experiences at 3 months

OutcomeResponse, nDescriptive outcomeEffect (regression DD vs. pre-DD)Non-inferior
Pre-DDDDPre-DDDDDifference, mean (95% CI)Significance, p value
Continuous data, mean (SD)
Satisfaction (VAS 0–100)1441538.13 (1.5)7.95 (1.7)−0.16 (−0.53 to 0.21)0.408Yes
Pain (VAS 0–100)1441531.40 (2.1)1.52 (1.9)0.078 (−0.37 to 0.53)0.727
Functional outcome14114877.4 (26.4)81.0 (21.9)3.98 (−1.56 to 9.37)0.166
 QuickDASH363310.5 (12.2)13.2 (14.8)4.15 (−2.00 to 10.50)0.231Yes
 LEFS497263.1 (16.4)64.0 (15.4)1.06 (−4.56 to 6.81)0.716Yes
 PROMIS UE413135.3 (14.7)38.7 (13.6)3.79 (−3.40 to 10.88)0.270NA
 PROMIS Mobility151244.0 (12.5)54.1 (7.4)10.79 (2.78 to 19.67)0.019Yes
Health-related QoL
 EQ-5D-5L index851050.839 (0.189)0.852 (0.139)0.014 (−0.032 to 0.062)0.553
 EQ-5D-5L VAS8510580.2 (16.7)80.3 (13.1)0.19 (−4.1 to 4.4)0.932
 EQ-5D-Youth index56430.874 (0.242)0.949 (0.148)0.076 (0.003 to 0.156)0.052
 EQ-5D-Youth VAS564392.3 (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)1441535 (3.5)11 (7.2)2.05 (0.69 to 6.09)0.197
Treatment preference DD14415357 (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.