Health-related quality of life in children with congenital heart disease aged 5 to 7 years: a multicentre controlled cross-sectional study

Abassi, Hamouda; Huguet, Hélèna; Picot, Marie‐Christine; Vincenti, Marie; Guillaumont, Sophie; Auer, Annie; Werner, Oscar; Villeon, Grégoire De La; Lavastre, Kathleen; Gavotto, Arthur; Auquier, Pascal; Amédro, Pascal

doi:10.1186/s12955-020-01615-6

Cited by 33 publications

(48 citation statements)

References 54 publications

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“…As classically observed in HRQoL studies in the pediatric population, our results highlighted the existing difference between self and parents reports, both in healthy and CHD children [ 24 , 28 ]. Usually, proxy reports provide lower scores than self-reports, and, in our experience, parents’ reports seem to better reflect the actual disease severity, especially mothers of children with CHD [ 15 , 25 , 29 ].…”

Section: Discussionsupporting

confidence: 84%

Psychometric validation of the French self and proxy versions of the PedsQL™ 4.0 generic health-related quality of life questionnaire for 8–12 year-old children

Amedro

Huguet

Macioce

et al. 2021

Health Qual Life Outcomes

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Background The Pediatric Quality of Life Inventory Version 4.0 (PedsQLTM4.0) is a generic health-related quality of life (HRQoL) questionnaire, widely used in pediatric clinical trials but not yet validated in France. We performed the psychometric validation of the self and proxy PedsQLTM4.0 generic questionnaires for French children aged 8–12 years old. Methods This bicentric cross-sectional study included 123 children and their parents with congenital heart disease (CHD) and 97 controls. The psychometric validation method was based on the consensus-based standards for the selection of health measurement instruments (COSMIN). The reliability was tested using the intraclass correlation coefficient (ICC). To evaluate the validity of this scale, content, face, criterion, and construct validity psychometric proprieties were tested. Acceptability was studied regarding questionnaires’ completion and the existence of a floor or a ceiling effect. Results Test–retest reliability intra-class correlation coefficients were mainly in good range (0.49–0.66). 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 acceptable 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 PedsQLTM4.0 generic self and proxy HRQoL 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), https://clinicaltrials.gov/ct2/show/NCT01202916.

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Section: Discussionsupporting

confidence: 84%

Psychometric validation of the French self and proxy versions of the PedsQL™ 4.0 generic health-related quality of life questionnaire for 8–12 year-old children

Amedro

Huguet

Macioce

et al. 2021

Health Qual Life Outcomes

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“…We recently performed the complete psychometric validation of the French self and proxy versions of the PedsQL generic questionnaire for 8 to 12 year-old children [25]. We also found a good sensitivity of the PedsQL in several controlled prospective HRQoL studies among healthy controls and children with various chronic diseases [26][27][28][29].…”

Section: Primary Outcomementioning

confidence: 85%

“…Parents and children will complete the QoL questionnaires during the routine paediatric cardiology consultation (inclusion visit). Children aged 8 years old and above will complete the PedsQL self-questionnaire under trained nurse supervision, as in our similar QoL studies [26][27][28][29].…”

Section: Primary Outcomementioning

confidence: 99%

“…The primary outcome is the difference in the selfreported QoL score with the PedsQL instrument between the children with inherited cardiac disorders and the control group. We used the results from our previous QoL cross-sectional studies in patients with CHD to calculate the sample size [4,21,[26][27][28][29]39]. In our experience, as well as in similar studies using patient related outcomes, a difference of less than 5 points is not clinically relevant, and a difference of more than 10 points is ideal, but rarely achieved [2,27,29].…”

Section: Sample Sizementioning

confidence: 99%

“…We used the results from our previous QoL cross-sectional studies in patients with CHD to calculate the sample size [4,21,[26][27][28][29]39]. In our experience, as well as in similar studies using patient related outcomes, a difference of less than 5 points is not clinically relevant, and a difference of more than 10 points is ideal, but rarely achieved [2,27,29]. Therefore, we hypothesized to observe a difference in the total QoL score of 7 ± 15 points (over 100).…”

Section: Sample Sizementioning

confidence: 99%

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Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods

Amedro

Werner

Abassi

et al. 2021

Health Qual Life Outcomes

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Background Advances in paediatric cardiology have improved the prognosis of children with inherited cardiac disorders. However, health-related quality of life (QoL) and physical activity have been scarcely analysed in children with inherited cardiac arrhythmia or inherited cardiomyopathy. Moreover, current guidelines on the eligibility of young athletes with inherited cardiac disorders for sports participation mainly rely on expert opinions and remain controversial. Methods The QUALIMYORYTHM trial is a multicentre observational controlled study. The main objective is to compare the QoL of children aged 6 to 17 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or arrhythmogenic right ventricular dysplasia), or inherited cardiomyopathy (hypertrophic, dilated, or restrictive cardiomyopathy), to that of age and gender-matched healthy subjects. The secondary objective is to assess their QoL according to the disease’s clinical and genetic characteristics, the level of physical activity and motivation for sports, the exercise capacity, and the socio-demographic data. Participants will wear a fitness tracker (ActiGraph GT3X accelerometer) for 2 weeks. A total of 214 children are required to observe a significant difference of 7 ± 15 points in the PedsQL, with a power of 90% and an alpha risk of 5%. Discussion After focusing on the survival in children with inherited cardiac disorders, current research is expanding to patient-reported outcomes and secondary prevention. The QUALIMYORYTHM trial intends to improve the level of evidence for future guidelines on sports eligibility in this population. Trial registration ClinicalTrials.gov Identifier: NCT04712136, registered on January 15th, 2021 (https://clinicaltrials.gov/ct2/show/NCT04712136).

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A systematic review and meta‐analysis of school and cognitive function domains of health‐related quality of life measures for children and young adults with congenital heart disease

Mamasoula,

Pennington,

Adesanya

et al. 2023

Birth Defects Research

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BackgroundResearch on cognitive and school functioning domains of health‐related quality of life (HRQOL) for children and adolescents with congenital heart disease (CHD) presents inconsistencies.ObjectivesTo summarize and synthesize data on school and cognitive function domains of HRQOL for children and young people (CYP) with CHD.MethodsFive electronic databases MEDLINE, Scopus, PsycINFO, EMBASE, ERI, and citations were systematically searched. We included original‐research articles reporting the cognitive and school function domains of HRQOL for children and young people with CHD (child and parent reports included). Both fixed and random‐effects meta‐analyses were performed to estimate pooled mean test scores for cognitive and school function. A total of 34 studies met our inclusion criteria and were synthesized narratively, 17 studies were included in formal meta‐analyses.ResultsSelf‐reported cognitive function was lower for children and young people with CHD than healthy controls (SMD −0.28 (−0.42, −0.15)). Parental reports demonstrated similar results to self‐reports (SMD −0.54 (−0.91, −0.18)). School function was lower in children and young people with CHD compared with healthy controls in self‐reported (SMD −0.30 (−0.48, −0.13)) and parent reported HRQOL (SMD −0.49 (0.64, −0.36)). Self‐reported school function domain scores were lower for young (<8 years) (SMD −0.65 (−1.32, 0.03)) and older children (8–18 years) (SMD −0.25 (−0.47, −0.03)) with CHD than their peers. Similarly, parents reported lower school function domain scores for young (<8 years) (SMD −0.68 (−1.29, −0.07)) and older (8–18 years) (SMD −0.46 (−068, −0.25)) children with CHD than typically developing peers.ConclusionChildren born with CHD may experience lower cognitive and school function HRQOL scores than healthy controls (self and proxy‐report). This is consistent with a subgroup meta‐analysis of young (<8 years) and older (8 years old or more) children with CHD reporting lower school function scores compared to controls.

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Health-related quality of life in children with congenital heart disease aged 5 to 7 years: a multicentre controlled cross-sectional study

Cited by 33 publications

References 54 publications

Psychometric validation of the French self and proxy versions of the PedsQL™ 4.0 generic health-related quality of life questionnaire for 8–12 year-old children

Psychometric validation of the French self and proxy versions of the PedsQL™ 4.0 generic health-related quality of life questionnaire for 8–12 year-old children

Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods

A systematic review and meta‐analysis of school and cognitive function domains of health‐related quality of life measures for children and young adults with congenital heart disease

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