title: Development and psychometric evaluation of 2 age-stratified versions of the Pediatric GERD Symptom and Quality of Life Questionnaire.
abstract: OBJECTIVE
  The Pediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) represents 2 related age-stratified tools developed to assess pediatric gastroesophageal reflux disease (GERD). These include the PGSQ-Cp (for children ages 2 to 8 years, parent/caregiver report) and the PGSQ-A (for adolescents ages 9-17 years). The objective of the present study was to develop and evaluate PGSQ measurement properties.
  
  
  METHODS
  The PGSQ items were generated based on information from focus groups, expert clinician review, and cognitive debriefing interviews. The symptoms of pediatric GERD and the effect of these symptoms were addressed. The tools were evaluated in a 3-week psychometric evaluation with participants from 11 clinical sites in the United States. The study included other measures such as the Pediatric Quality of Life questionnaire (PedsQL) and clinician-rated GERD severity. After item reduction, internal consistency, reproducibility, construct validity, known-group validity, and responsiveness were assessed.
  
  
  RESULTS
  The 231 participants included 75 parents of children ages 2 to 8 years and 75 children ages 9 to 17 years with GERD and 41 parents of children and 40 children ages 9 to 17 years without GERD. Exploratory factor analysis demonstrated 4 symptom subscales for the PGSQ-Cp and 3 symptom subscales for the PGSQ-A. Both had subscales for total impact and school impact. High to moderate internal consistency was observed, ranging from 0.76 to 0.96 for the PGSQ-Cp and from 0.67 to 0.94 for the PGSQ-A. The PGSQ significantly differentiated between patients with GERD and controls (P < 0.0001, PGSQ-Cp; P < 0.0022-0.0001, PGSQ-A) and demonstrated responsiveness.
  
  
  CONCLUSIONS
  These results support the reliability, validity, and responsiveness of both versions of the PGSQ. The instruments should be useful for clinical studies.
authors.affiliation: United BioSource Corporation, Bethesda, MD 20814, USA. leah.kleinman@unitedbiosource.com
authors.forename: Leah
authors.initials: L
authors.lastname: Kleinman
authors.forename: Suzanne
authors.initials: S
authors.lastname: Nelson
authors.forename: Smita
authors.initials: S
authors.lastname: Kothari-Talwar
authors.forename: Laurie
authors.initials: L
authors.lastname: Roberts
authors.forename: Susan R
authors.initials: SR
authors.lastname: Orenstein
authors.forename: Reema R
authors.initials: RR
authors.lastname: Mody
authors.forename: Eric
authors.initials: E
authors.lastname: Hassall
authors.forename: Ben
authors.initials: B
authors.lastname: Gold
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: Omar
authors.initials: O
authors.lastname: Dabbous
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005764:Gastroesophageal Reflux / Q000150:complications; D006801:Humans; D010290:Parents; D010372:Pediatrics / Q000379:methods; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life; D015203:Reproducibility of Results; D012574:Schools; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires / Q000592:standards; D014481:United States