title: The development and validation of a health-related quality of life questionnaire for pre-school children with a chronic heart disease.
abstract: OBJECTIVE
  Heart diseases are often associated with residual injuries, persisting functional restrictions, and long-term sequelae for psychosocial development. Currently, there are no disease-specific instruments to assess the health-related quality of life (HrQoL) of pre-school children. The aims of this study were to develop a parent proxy instrument to measure the HrQoL of children aged 3-7 years with a heart disease and to confirm its validity and reliability.
  
  
  METHODS
  Items from the Preschool Pediatric Cardiac Quality of Life Inventory (P-PCQLI) were generated through focus groups of caregivers. In a pilot study, comprehensibility and feasibility were tested. Five subdimensions were defined theoretically. Psychometric properties were analysed within a multicentre study with 167 parental caregivers.
  
  
  RESULTS
  The final 52-item instrument contains a total score covering five moderately inter-correlated dimensions. The total score of the questionnaire showed a very high internal consistency (Cronbachs' α = 0.95). Test-retest correlation was at r tt = 0.96. External validity was indicated by higher correlations (r = 0.24-0.68) with a generic paediatric quality of life questionnaire (KINDL) compared to the Strengths and Difficulties Questionnaire (r = 0.17 to 0.59). Low P-PCQLI total scores were significantly associated with inpatient as opposed to outpatient treatment (t = 6.04, p < .001), with at least moderate disease severity ((t = 5.05, p < .001) NYHA classification) and with poorer prognosis (t = 5.53, p < .001) as estimated by the physician.
  
  
  CONCLUSIONS
  The P-PCQLI is reliable and valid for pre-school children with a heart disease. It could be used as a screening instrument in routine care, and for evaluation of HrQoL outcomes in clinical trials and intervention research.
authors.affiliation: Department of Child and Adolescent Psychiatry/Psychotherapy, University Ulm Medical Centre, Steinhoevelstr. 1, 89075, Ulm, Germany, mandy.niemitz@uniklinik-ulm.de.
authors.forename: M
authors.initials: M
authors.lastname: Niemitz
authors.forename: D C M
authors.initials: DC
authors.lastname: Seitz
authors.forename: M
authors.initials: M
authors.lastname: Oebels
authors.forename: D
authors.initials: D
authors.lastname: Schranz
authors.forename: H
authors.initials: H
authors.lastname: Hövels-Gürich
authors.forename: M
authors.initials: M
authors.lastname: Hofbeck
authors.forename: R
authors.initials: R
authors.lastname: Kaulitz
authors.forename: C
authors.initials: C
authors.lastname: Galm
authors.forename: F
authors.initials: F
authors.lastname: Berger
authors.forename: N
authors.initials: N
authors.lastname: Nagdymann
authors.forename: B
authors.initials: B
authors.lastname: Stiller
authors.forename: T
authors.initials: T
authors.lastname: Borth-Bruhns
authors.forename: I
authors.initials: I
authors.lastname: Konzag
authors.forename: C
authors.initials: C
authors.lastname: Balmer
authors.forename: L
authors.initials: L
authors.lastname: Goldbeck
mesh_terms: D000328:Adult; D017028:Caregivers / Q000523:psychology; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D006305:Health Status Indicators; D006331:Heart Diseases / Q000503:physiopathology / Q000523:psychology*; D006801:Humans; D006814:Hungary; D008297:Male; D010290:Parents / Q000523:psychology*; D010372:Pediatrics; D019727:Proxy; D011594:Psychometrics / Q000295:instrumentation / Q000379:methods*; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D012574:Schools; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires / Q000592:standards*