Psychometric Validation Of The French Self And Proxy Versions Of The PedsqlTM 4.0 Generic Health-Related Quality Of Life Questionnaire For 8 To 12 Year-Old Children.

Pascal Amedro (1, 2) , Helena Huguet (3, 2) , Valérie Macioce (2) , Raphael Dorka (2) , Annie Auer (4) , Sophie Guillaumont (2) , Pascal Auquier (5, 6) , Hamouda Abassi (2) , Marie-Christine Picot (2)

1 PhyMedExp - Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
2 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
3 Unité de biostatistiques
4 Paediatric Cardiology and Rehabilitation Centre, Institut-Saint-Pierre, Palavas-Les-Flots, France
5 Laboratoire de Santé Publique
6 AMU - Aix Marseille Université

Background : The Pediatric Quality of Life Inventory Version 4.0 (PedsQL TM 4.0) is a generic health-related quality of life (HR-QoL) questionnaire, widely used in pediatric clinical trials but not yet validated in France. We performed the psychometric validation of the self and proxy PedsQL TM 4.0 generic questionnaires for French children aged 8 to 12 years old. Methods : The multicenter prospective study included 123 children and their parents with congenital heart disease (CHD) and 97 controls. Results : Test–retest reliability intra-class correlation coefficients were mainly in good range (0.49-0.66) for both self and proxy reports. Face validity was very good among parents (0.85) and children (0.75). Content validity was good (0.70), despite misinterpretation of some items. In construct validity, each subscale had good internal consistency reliability (Cronbach's α >0.72 in self-reports, >0.69 in proxy-reports). In the confirmatory factor analysis, the goodness-of-fit statistics rejected the original structure with 4 factors. The exploratory factor analysis revealed an alternative two-factor structure corresponding to physical and psychological dimensions. Convergent validity was supported by moderate (>0.41) to high correlations (0.57) between PedsQL and Kidscreeen questionnaires for physical, emotion and school dimensions. The ability of the PedsQL to discriminate CHD severity was better with physical, social and total scores for both self-reports and proxy-reports. Conclusions : The PedsQL TM 4.0 generic self and proxy HR-QoL questionnaires found good psychometric properties, with regard to acceptability, responsiveness, validity, and reliability. This instrument appeared to be easy to use and comprehend within the target population of children aged 8 to 12 years old and their parents. Trial registration: This study was approved by the South-Mediterranean-IV Ethics Committee and registered on ClinicalTrials.gov (NCT01202916) on 16 Sepetmber 2020, https://clinicaltrials.gov/ct2/show/NCT01202916.

Domaines: Sciences du Vivant [q-bio]

Pascal Amedro, Helena Huguet, Valérie Macioce, Raphael Dorka, Annie Auer, et al.. Psychometric Validation Of The French Self And Proxy Versions Of The PedsqlTM 4.0 Generic Health-Related Quality Of Life Questionnaire For 8 To 12 Year-Old Children.. 2020. ⟨hal-02908215⟩