P Amedro1, M C Picot2, S Moniotte3, R Dorka4, H Bertet5, S Guillaumont6, C Barrea3, M Vincenti7, G De La Villeon6, C Bredy4, C Soulatges4, M Voisin4, S Matecki8, P Auquier9. 1. Pediatric and Congenital Cardiology Department, University Hospital, Montpellier, France; Physiology and Experimental Biology of Heart and Muscles Laboratory - PHYMEDEXP, UMR CNRS 9214 - INSERM U1046, University of Montpellier, Montpellier, France; Self-perceived Health Assessment Research Unit, EA3279, Public Health Department, Mediterranean Medical School, Marseille, France. Electronic address: p-amedro@chu-montpellier.fr. 2. Epidemiology and Clinical Research Department, University Hospital, Montpellier, France; Clinical Investigation Center, INSERM-CIC 1411, Montpellier, France. 3. Pediatric and Congenital Cardiology Department, St-Luc University Hospital, UCL, Brussels, Belgium. 4. Pediatric and Congenital Cardiology Department, University Hospital, Montpellier, France. 5. Pediatric and Congenital Cardiology Department, St-Luc University Hospital, UCL, Brussels, Belgium; Clinical Investigation Center, INSERM-CIC 1411, Montpellier, France. 6. Pediatric and Congenital Cardiology Department, University Hospital, Montpellier, France; Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France. 7. Pediatric and Congenital Cardiology Department, University Hospital, Montpellier, France; Physiology and Experimental Biology of Heart and Muscles Laboratory - PHYMEDEXP, UMR CNRS 9214 - INSERM U1046, University of Montpellier, Montpellier, France. 8. Physiology and Experimental Biology of Heart and Muscles Laboratory - PHYMEDEXP, UMR CNRS 9214 - INSERM U1046, University of Montpellier, Montpellier, France; Pediatric Functional Exploration Laboratory, Physiology Department, University Hospital, Montpellier, France. 9. Self-perceived Health Assessment Research Unit, EA3279, Public Health Department, Mediterranean Medical School, Marseille, France.
Abstract
BACKGROUND: Health-related quality of life (HR-QoL) stands as a determinant "patient-related outcome" and correlates with cardio-pulmonary exercise test (CPET) in adults with chronic heart failure or with a congenital heart disease (CHD). No such correlation has been established in pediatric cardiology. METHODS AND RESULTS: 202 CHD children aged 8 to 18 performed a CPET (treadmill n=96, cycle-ergometer n=106). CHD severity was stratified into 4 groups. All children and parents filled out the Kidscreen HR-QoL questionnaire. Peak VO2, anaerobic threshold (AT), and oxygen pulse followed a downward significant trend with increasing CHD severity and conversely for VE/VCO2 slope. Self-reported and parent-reported physical well-being HR-QoL scores correlated with peak VO2 (respectively r=0.27, p<0.0001 and r=0.43, p<0.0001), percentage of predicted peak VO2 (r=0.28, p=0.0001 and r=0.41, p<0.0001), and percentage of predicted VO2 at AT (r=0.22, p<0.01 and r=0.31, p<0.0001). Significant correlations were also observed between several HR-QoL dimensions and dead space to tidal volume ratio (VD/VT), oxygen uptake efficiency slope (OUES), oxygen pulse but never with VE/VCO2 slope. The strongest correlations were observed in the treadmill group, especially between peak VO2 and physical well-being for parents (r=0.57, p<0.0001) and self (r=0.40, p<0.0001) reported HR-QoL. CONCLUSIONS: Peak VO2 and AT are the two CPET variables that best correlated with HR-QoL in this large pediatric cohort, parents' reports being more accurate. If HR-QoL is involved as a "PRO" in a pediatric cardiology clinical trial, we suggest using parents related physical well-being HR-QoL scores. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (number NCT01202916).
BACKGROUND: Health-related quality of life (HR-QoL) stands as a determinant "patient-related outcome" and correlates with cardio-pulmonary exercise test (CPET) in adults with chronic heart failure or with a congenital heart disease (CHD). No such correlation has been established in pediatric cardiology. METHODS AND RESULTS: 202 CHD children aged 8 to 18 performed a CPET (treadmill n=96, cycle-ergometer n=106). CHD severity was stratified into 4 groups. All children and parents filled out the Kidscreen HR-QoL questionnaire. Peak VO2, anaerobic threshold (AT), and oxygen pulse followed a downward significant trend with increasing CHD severity and conversely for VE/VCO2 slope. Self-reported and parent-reported physical well-being HR-QoL scores correlated with peak VO2 (respectively r=0.27, p<0.0001 and r=0.43, p<0.0001), percentage of predicted peak VO2 (r=0.28, p=0.0001 and r=0.41, p<0.0001), and percentage of predicted VO2 at AT (r=0.22, p<0.01 and r=0.31, p<0.0001). Significant correlations were also observed between several HR-QoL dimensions and dead space to tidal volume ratio (VD/VT), oxygen uptake efficiency slope (OUES), oxygen pulse but never with VE/VCO2 slope. The strongest correlations were observed in the treadmill group, especially between peak VO2 and physical well-being for parents (r=0.57, p<0.0001) and self (r=0.40, p<0.0001) reported HR-QoL. CONCLUSIONS: Peak VO2 and AT are the two CPET variables that best correlated with HR-QoL in this large pediatric cohort, parents' reports being more accurate. If HR-QoL is involved as a "PRO" in a pediatric cardiology clinical trial, we suggest using parents related physical well-being HR-QoL scores. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (number NCT01202916).
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