Parent and child perception of quality of life in a randomized controlled peanut oral immunotherapy trial

Background Improved quality of life (QoL) after oral immunotherapy (OIT) in peanut allergic children is often reported by their parents, while the child's perspective is less clear. Objective We aimed to explore whether 2 years of OIT improved QoL in children with peanut allergy and to identify factors influencing change in QoL. Methods In the open-labeled TAKE-AWAY peanut OIT trial including children with anaphylaxis to peanuts, 57 were randomized to OIT and 20 to observation. The Pediatric Quality of Life Inventory Version 4.0 was completed by parents and children at enrollment (Y-0), after 1 year (end of updosing; Y-1) and after 2 years (Y-2) of OIT. Minimally clinically important difference (MCID) is >= 5.3. Perceived treatment burden was recorded by visual analogue scales, including adverse events (AEs). An open food challenge (OFC) was performed at Y-2. Results At Y-2, 18 children had discontinued OIT and 2 of 39 OIT children refused OFC, while 35 of 37 were desensitized to 7500 mg peanut protein. From Y-0 to Y-2,Y- the mean change (95% confidence intervals) in QoL was 4.4 (0.5, 8.3) among child self-reports and twice as large among parental proxy reports (9.3 [4.3, 14.3]; both P < 0.0001), without significant improvement among the controls. The change in QoL was significantly different from the controls for the parental proxy reports only (P = 0.002). Neither treatment burden nor AEs significantly predicted changes in QoL. Conclusion Two years of OIT improved child-QoL as reported by parents, but not by the children, suggesting that parents may overestimate improvement in child-QoL by OIT.