ISW may limit medication-related comorbidities but intensive monitoring and unexpected rejection episodes may compromise HRQOL. We studied longitudinal HRQOL in pediatric LT recipients undergoing ISW in the iWITH (NCT101638559) trial.

METHODS: From 10/12 to 6/14, 88 subjects, mean age 10.4±3.4yrs (56% female; 58% biliary atresia; 35% living donor) initiated ISW. HRQOL was measured using parent proxy and self-reports of the PedsQL™4.0 Generic Core (GC) Scale, Multi-dimensional Fatigue (MF), and Transplant Modules (TM) at baseline (BL), 6 & 12 months after initiating ISW. Responses were analyzed using General Estimating Equations for trend over 12 months. Mean scores by rejection status at 12 months were compared by two-sided t-test with Bonferroni correction.

RESULTS: Response rate was 92%. Over 12 months, the Social Functioning subscale of the PedsQL™ 4.0 GC by parent-report and the Sleep/Rest Fatigue subscale of the PedsQL™ MF by self-report improved (both, p<0.03). Several parent-reported TM subscales showed improved trends, Total Score (p=0.05), Medication I (p=0.05), My Transplant &Others (p=0.003) and Treatment Anxiety (p=0.007). Parent and self-reported scores did not differ significantly by rejection status. Effect sizes (ES) were small for self-report data but moderate (≥0.50) or large (≥0.80) for parent-reported subscales with opposing trends from BL by rejection status

CONCLUSIONS: In this preliminary report, pediatric LT recipients undergoing ISW had modest longitudinal improvements in HRQOL over the first year. Trends in parent-reported scores suggest that rejection negatively impacts HRQOL. The durability of these outcomes requires extended follow-up.

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