Reliability, validity, and responsiveness of the pediatric quality of life inventory (PedsQL) generic core scales and asthma symptoms scale in vulnerable children with asthma

J Asthma. 2010 Mar;47(2):170-7. doi: 10.3109/02770900903533966.

Abstract

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.

Publication types

  • Evaluation Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Asthma / diagnosis*
  • Asthma / psychology
  • Asthma / therapy
  • Child
  • Child, Preschool
  • Clinical Trials as Topic / methods
  • Emotions
  • Female
  • Health
  • Hispanic Americans
  • Humans
  • Male
  • Mental Health / statistics & numerical data
  • Parents / education
  • Population Groups / statistics & numerical data
  • Proxy
  • Psychometrics
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Reproducibility of Results
  • Severity of Illness Index*
  • Socialization
  • Students / psychology
  • Surveys and Questionnaires*
  • Treatment Outcome