title: Reliability, validity, and responsiveness of the pediatric quality of life inventory (PedsQL) generic core scales and asthma symptoms scale in vulnerable children with asthma.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Division of Pulmonary Medicine and Center for Health Care Quality, Division of Health Policy and Clinical Effectiveness, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. michael.seid@cchmc.org
authors.forename: Michael
authors.initials: M
authors.lastname: Seid
authors.forename: Christine A
authors.initials: CA
authors.lastname: Limbers
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Driscoll
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Opipari-Arrigan
authors.forename: Leticia Reyes
authors.initials: LR
authors.lastname: Gelhard
authors.forename: James W
authors.initials: JW
authors.lastname: Varni
mesh_terms: D000293:Adolescent; D001249:Asthma / Q000175:diagnosis* / Q000523:psychology / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods; D004644:Emotions; D005260:Female; D006262:Health; D006630:Hispanic or Latino; D006801:Humans; D008297:Male; D008603:Mental Health / Q000706:statistics & numerical data; D010290:Parents / Q000193:education; D044382:Population Groups / Q000706:statistics & numerical data; D019727:Proxy; D011594:Psychometrics; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D012951:Socialization; D013334:Students / Q000523:psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome