Table 1.
DDS and HFS
| Measure | Visit | N = 48 | Mean (SD) | Median (IQR) | Effect size | P value | |
|---|---|---|---|---|---|---|---|
| DDS | Total score | Baseline | 44 | 2.62 (0.98) | 2.44 (0.97) | ||
| Day 75 | 44 | 1.83 (0.72) | 1.62 (0.79) | −0.80 | <0.0001 | ||
| Day 365 | 39 | 1.50 (0.51) | 1.35 (0.59) | −1.22 | <0.0001 | ||
| Day 730 | 27 | 1.32 (0.32) | 1.29 (0.47) | −1.33 | <0.0001 | ||
| Emotional Burden | Baseline | 47 | 3.75 (1.31) | 3.80 (2.00) | |||
| Day 75 | 45 | 2.59 (1.23) | 2.20 (1.20) | −0.83 | <0.0001 | ||
| Day 365 | 41 | 1.84 (0.91) | 1.60 (0.80) | −1.48 | <0.0001 | ||
| Day 730 | 29 | 1.43 (0.47) | 1.20 (0.80) | −1.79 | <0.0001 | ||
| Physician-Related Distress | Baseline | 46 | 1.67 (1.02) | 1.13 (1.00) | |||
| Day 75 | 45 | 1.19 (0.45) | 1.00 (0.00) | −0.47 | <0.0001 | ||
| Day 365 | 41 | 1.06 (0.21) | 1.00 (0.00) | −0.58 | <0.0001 | ||
| Day 730 | 31 | 1.10 (0.32) | 1.00 (0.00) | −0.51 | 0.0013 | ||
| Regimen-Related Distress | Baseline | 45 | 2.66 (1.20) | 2.40 (1.60) | |||
| Day 75 | 46 | 1.77 (0.86) | 1.60 (1.00) | −0.78 | <0.0001 | ||
| Day 365 | 40 | 1.61 (0.65) | 1.40 (0.60) | −0.94 | <0.0001 | ||
| Day 730 | 31 | 1.42 (0.43) | 1.20 (0.80) | −1.05 | <0.0001 | ||
| Interpersonal Distress | Baseline | 47 | 2.19 (1.38) | 1.67 (2.00) | |||
| Day 75 | 45 | 1.59 (0.94) | 1.00 (0.67) | −0.42 | 0.0002 | ||
| Day 365 | 40 | 1.47 (0.84) | 1.00 (0.67) | −0.55 | <0.0001 | ||
| Day 730 | 31 | 1.35 (0.69) | 1.00 (0.33) | −0.70 | <0.0001 | ||
| HFS | Total score | Baseline | 39 | 2.36 (0.66) | 2.39 (1.09) | ||
| Day 75 | 40 | 1.33 (0.88) | 1.24 (1.43) | −1.51 | <0.0001 | ||
| Day 365 | 35 | 0.54 (0.66) | 0.26 (1.09) | −2.59 | <0.0001 | ||
| Day 730 | 18 | 0.41 (0.62) | 0.13 (0.43) | −2.85 | <0.0001 | ||
| Hypoglycemic Avoidance Behavior | Baseline | 41 | 2.52 (0.54) | 2.60 (0.80) | |||
| Day 75 | 40 | 1.47 (0.90) | 1.60 (1.60) | −1.86 | <0.0001 | ||
| Day 365 | 35 | 0.64 (0.83) | 0.20 (1.30) | −3.34 | <0.0001 | ||
| Day 730 | 22 | 0.67 (0.82) | 0.25 (1.20) | −3.31 | <0.0001 | ||
| Worry About Hypoglycemia | Baseline | 44 | 2.20 (0.90) | 2.15 (1.23) | |||
| Day 75 | 45 | 1.27 (1.01) | 1.00 (2.00) | −1.13 | <0.0001 | ||
| Day 365 | 40 | 0.53 (0.79) | 0.08 (0.77) | −1.79 | <0.0001 | ||
| Day 730 | 27 | 0.47 (0.81) | 0.00 (0.77) | −1.88 | <0.0001 |
The total DDS score, the four DDS subscales, the total HFS score, and the two HFS subscales stratified by post–initial transplantation study visits. Effect sizes were calculated as the mean individual change from baseline divided by the baseline SD; a value of 0.5 (i.e., half an SD) was determined to be the MID. Smaller DDS and HFS values indicate better HRQOL. Tests for change from baseline were performed using the Wilcoxon signed rank test. IQR, interquartile range.