Health-related quality of life in type 1 diabetes mellitus pediatric patients and their caregivers in Spain: an observational cross-sectional study.

Abstract

Objectives: This study assessed the health-related quality of life (HRQOL) of pediatric patients with type 1 diabetes mellitus (T1DM) and their caregivers.Methods: CHRYSTAL was an observational cross-sectional study conducted in Spain in 2014 on 275 patients under 18 years old diagnosed with T1DM. Patient/caregiver pairs were stratified by patients' HbA1c level (≥7.5% versus <7.5%), mean index scores were 0.94 and 0.95, andmean VAS scores were 82.8 and 89.2, respectively. Mean index scores were 0.91 for children with com-plications and/or comorbidities and 0.96 for children without. Mean VAS scores were 83.7 and 87.2,respectively. HRQOL per the PedsQL tool ranged from 68.1 (ages 2–4) to 73.1 (ages 13–18). EQ-5Dindex and VAS scores were significantly correlated (rho ¼ 0.29–0.43) with several age groups of thePedsQL. EQ-5D scales showed significant moderate correlation between EQ-5D-Y and EQ-5D-3L proxyVAS score (rho ¼ 0.45; p < .001).Conclusions: Patients with few complications and controlled HbA1c reported a relatively high HRQOL.The results suggest that parent-proxy EQ-5D ratings are valid for use as part of an overall health out-comes assessment in clinical studies of T1DM in pediatric patients