Table 1

DDS and HFS

MeasureVisitN = 48Mean (SD)Median (IQR)Effect sizeP value
DDSTotal scoreBaseline442.62 (0.98)2.44 (0.97)
Day 75441.83 (0.72)1.62 (0.79)−0.80<0.0001
Day 365391.50 (0.51)1.35 (0.59)−1.22<0.0001
Day 730271.32 (0.32)1.29 (0.47)−1.33<0.0001
Emotional BurdenBaseline473.75 (1.31)3.80 (2.00)
Day 75452.59 (1.23)2.20 (1.20)−0.83<0.0001
Day 365411.84 (0.91)1.60 (0.80)−1.48<0.0001
Day 730291.43 (0.47)1.20 (0.80)−1.79<0.0001
Physician-Related DistressBaseline461.67 (1.02)1.13 (1.00)
Day 75451.19 (0.45)1.00 (0.00)−0.47<0.0001
Day 365411.06 (0.21)1.00 (0.00)−0.58<0.0001
Day 730311.10 (0.32)1.00 (0.00)−0.510.0013
Regimen-Related DistressBaseline452.66 (1.20)2.40 (1.60)
Day 75461.77 (0.86)1.60 (1.00)−0.78<0.0001
Day 365401.61 (0.65)1.40 (0.60)−0.94<0.0001
Day 730311.42 (0.43)1.20 (0.80)−1.05<0.0001
Interpersonal DistressBaseline472.19 (1.38)1.67 (2.00)
Day 75451.59 (0.94)1.00 (0.67)−0.420.0002
Day 365401.47 (0.84)1.00 (0.67)−0.55<0.0001
Day 730311.35 (0.69)1.00 (0.33)−0.70<0.0001
HFSTotal scoreBaseline392.36 (0.66)2.39 (1.09)
Day 75401.33 (0.88)1.24 (1.43)−1.51<0.0001
Day 365350.54 (0.66)0.26 (1.09)−2.59<0.0001
Day 730180.41 (0.62)0.13 (0.43)−2.85<0.0001
Hypoglycemic Avoidance BehaviorBaseline412.52 (0.54)2.60 (0.80)
Day 75401.47 (0.90)1.60 (1.60)−1.86<0.0001
Day 365350.64 (0.83)0.20 (1.30)−3.34<0.0001
Day 730220.67 (0.82)0.25 (1.20)−3.31<0.0001
Worry About HypoglycemiaBaseline442.20 (0.90)2.15 (1.23)
Day 75451.27 (1.01)1.00 (2.00)−1.13<0.0001
Day 365400.53 (0.79)0.08 (0.77)−1.79<0.0001
Day 730270.47 (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.