Background: Patient-reported outcomes such as health-related quality of life (HRQOL) are increasingly used as primary endpoints in clinical trials. The Pediatric Quality of Life Inventory (PedsQL) is widely used as a measure of HRQOL and may be a particularly suitable primary outcome in pediatric asthma clinical trials.
Objectives: To examine the reliability, validity, and responsiveness to clinical change of the PedsQL 4.0 Generic Core Scales and PedsQL Asthma Module Asthma Symptoms Scale in a sample of vulnerable children with persistent asthma recruited from Federally Qualified Health Centers.
Methods: Children (N = 252; ages 3 to 14 years) with persistent asthma (27% mild, 40.9% moderate, 32.1% severe) and their parents (93.7% mother, 83.3% Hispanic, 76.9% Spanish-speaking, 72.6% less than a high school diploma) enrolled in a clinical trial completed the PedsQL 4.0 Generic Core Scales, the PedsQL 3.0 Asthma Module Asthma Symptoms Scale, and a measure of asthma symptom frequency (used as an indicator of clinical change) at baseline and 3-month follow-up.
Results: The PedsQL demonstrated adequate internal consistency reliability and convergent and discriminative validity. Based on intra- and intersubject change, effect sizes, and standard errors of measurement, the PedsQL demonstrated responsiveness to clinical change. Conclusions. For both child self-report and parent proxy-report, the PedsQL Generic Core Scales Total Scale score and the PedsQL Asthma Symptoms Scale are suitable for use as primary asthma clinical trial outcomes.