Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2021

Open Access 01-12-2021 | Research

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

Authors: Pascal Amedro, Helena Huguet, Valerie Macioce, Raphael Dorka, Annie Auer, Sophie Guillaumont, Pascal Auquier, Hamouda Abassi, Marie-Christine Picot

Published in: Health and Quality of Life Outcomes | Issue 1/2021

Login to get access

Abstract

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.
Appendix
Available only for authorised users
Literature
1.
Marino BS, Tomlinson RS, Drotar D, Claybon ES, Aguirre A, Ittenbach R, et al. Quality-of-life concerns differ among patients, parents, and medical providers in children and adolescents with congenital and acquired heart disease. Pediatrics. 2009;123:e708-715.PubMedCrossRef
2.
Moons P. Patient-reported outcomes in congenital cardiac disease: are they as good as you think they are? Cardiol Young. 2010;20(Suppl 3):143–8.PubMedCrossRef
3.
San Miguel R, del Villar V, Pérez C, de Frutos M, Mar J, Coma MJ. Role of health-related quality of life measurements in the design of drug clinical trials. Farm Hosp. 2010;34:16–22.PubMedCrossRef
4.
Miguel RS, López-González AM, Sanchez-Iriso E, Mar J, Cabasés JM. Measuring health-related quality of life in drug clinical trials: is it given due importance? Pharm World Sci. 2008;30:154–60.PubMedCrossRef
5.
Moons P, Budts W, De Geest S. Critique on the conceptualisation of quality of life: a review and evaluation of different conceptual approaches. Int J Nurs Stud. 2006;43:891–901.PubMedCrossRef
6.
Bullinger M, Schmidt S, Petersen C, Erhart M, Ravens-Sieberer U. Methodological challenges and potentials of health-related quality of life evaluation in children with chronic health conditions under medical health care. Med Klin (Munich). 2007;102:734–45.CrossRef
7.
Clarke S-A, Eiser C. The measurement of health-related quality of life (QOL) in paediatric clinical trials: a systematic review. Health Qual Life Outcomes. 2004;2:66.PubMedPubMedCentralCrossRef
8.
Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the pediatric quality of life inventory generic core scales and type 1 diabetes module. Diabetes Care. 2003;26:631–7.PubMedCrossRef
9.
Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the pediatric quality of life inventory generic core scales, multidimensional fatigue scale, and cancer module. Cancer. 2002;94:2090–106.PubMedCrossRef
10.
Varni JW, Seid M, Smith Knight T, Burwinkle T, Brown J, Szer IS. The PedsQL in pediatric rheumatology: reliability, validity, and responsiveness of the Pediatric Quality of Life Inventory Generic Core Scales and Rheumatology Module. Arthritis Rheum. 2002;46:714–25.PubMedCrossRef
11.
Feng L, Zhang Y, Chen R, Hao Y. The Chinese version of the Pediatric Quality of Life InventoryTM (PedsQLTM) 3.0 Asthma Module: reliability and validity. Health Qual Life Outcomes. 2011;9:64.PubMedPubMedCentralCrossRef
12.
Uzark K, Jones K, Slusher J, Limbers CA, Burwinkle TM, Varni JW. Quality of life in children with heart disease as perceived by children and parents. Pediatrics. 2008;121:e1060-1067.PubMedCrossRef
13.
Strullu M, Rakotonjanahary J, Tarral E, Savagner C, Thomas C, Méchinaud F, et al. Evaluation of health related quality of life in children with immune thrombocytopenia with the PedsQLTM 4.0 Generic Core Scales: a study on behalf of the pays de Loire pediatric hematology network. Health Qual Life Outcomes. 2013;11:193.PubMedPubMedCentralCrossRef
14.
Amedro P, Tahhan N, Bertet H, Jeandel C, Guillaumont S, Mura T, et al. Health-related quality of life among children with Turner syndrome: controlled cross-sectional study. J Pediatr Endocrinol Metab. 2017;30:863–8.PubMedCrossRef
15.
Amedro P, Bajolle F, Bertet H, Cheurfi R, Lasne D, Nogue E, et al. Quality of life in children participating in a non-selective INR self-monitoring VKA-education programme. Arch Cardiovasc Dis. 2018;111:180–8.PubMedCrossRef
16.
Amedro P, Gavotto A, Legendre A, Lavastre K, Bredy C, De La Villeon G, et al. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: the QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019;283:112–8.PubMedCrossRef
17.
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001;39:800–12.PubMedCrossRef
18.
Amiri P, Eslamian G, Mirmiran P, Shiva N, Jafarabadi MA, Azizi F. Validity and reliability of the Iranian version of the Pediatric Quality of Life InventoryTM 4.0 (PedsQLTM) Generic Core Scales in children. Health Qual Life Outcomes. 2012;10:3.PubMedPubMedCentralCrossRef
19.
Bendo CB, Paiva SM, Viegas CM, Vale MP, Varni JW. The PedsQLTM oral health scale: feasibility, reliability and validity of the Brazilian Portuguese version. Health Qual Life Outcomes. 2012;10:42.PubMedPubMedCentralCrossRef
20.
Arabiat D, Elliott B, Draper P, Al Jabery M. Cross-cultural validation of the Pediatric Quality of Life InventoryTM 40 (PedsQLTM) generic core scale into Arabic language. Scand J Caring Sci. 2011;25:828–33.PubMedCrossRef
21.
Varni JW, Limbers CA, Burwinkle TM. Parent proxy-report of their children’s health-related quality of life: an analysis of 13,878 parents’ reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007;5:2.PubMedPubMedCentralCrossRef
22.
Gheissari A, Farajzadegan Z, Heidary M, Salehi F, Masaeli A, Mazrooei A, et al. Validation of persian version of PedsQLTM 4.0TM generic core scales in toddlers and children. Int J Prev Med. 2012;3:341–50.PubMedPubMedCentral
23.
Werner O, Abassi H, Lavastre K, Guillaumont S, Picot M-C, Serrand C, et al. Factors influencing the participation of adolescents and young adults with a congenital heart disease in a transition education program: a prospective multicentre controlled study. Patient Educ Couns. 2019;102:2223–30.PubMedCrossRef
24.
Abassi H, Huguet H, Picot M-C, Vincenti M, Guillaumont S, Auer A, et al. Health-related quality of life in children with congenital heart disease aged 5 to 7 years: a multicentre controlled cross-sectional study. Health Qual Life Outcomes. 2020;18:366.PubMedPubMedCentralCrossRef
25.
Abassi H, Bajolle F, Werner O, Auer A, Marquina A, Mura T, et al. Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normalised Ratio self-monitoring. Arch Cardiovasc Dis. 2020;113:811–20.PubMedCrossRef
26.
Kobayashi K, Kamibeppu K. Measuring quality of life in Japanese children: development of the Japanese version of PedsQL. Pediatr Int. 2010;52:80–8.PubMedCrossRef
27.
Reinfjell T, Diseth TH, Veenstra M, Vikan A. Measuring health-related quality of life in young adolescents: reliability and validity in the Norwegian version of the Pediatric Quality of Life Inventory 4.0 (PedsQL) generic core scales. Health Qual Life Outcomes. 2006;4:61.PubMedPubMedCentralCrossRef
28.
Amedro P, Dorka R, Moniotte S, Guillaumont S, Fraisse A, Kreitmann B, et al. Quality of life of children with congenital heart diseases: a multicenter controlled cross-sectional study. Pediatr Cardiol. 2015;36:1588–601.PubMedCrossRef
29.
Amedro P, Picot MC, Moniotte S, Dorka R, Bertet H, Guillaumont S, et al. Correlation between cardio-pulmonary exercise test variables and health-related quality of life among children with congenital heart diseases. Int J Cardiol. 2016;203:1052–60.PubMedCrossRef
30.
Ravens-Sieberer U, Gosch A, Rajmil L, Erhart M, Bruil J, Power M, et al. The KIDSCREEN-52 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Value Health. 2008;11:645–58.PubMedCrossRef
31.
Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, et al. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007;16:1347–56.PubMedCrossRef
32.
Ravens-Sieberer U, Herdman M, Devine J, Otto C, Bullinger M, Rose M, et al. The European KIDSCREEN approach to measure quality of life and well-being in children: development, current application, and future advances. Qual Life Res. 2014;23:791–803.PubMedCrossRef
33.
Anthoine E, Moret L, Regnault A, Sébille V, Hardouin J-B. Sample size used to validate a scale: a review of publications on newly-developed patient reported outcomes measures. Health Qual Life Outcomes. 2014;12:176.PubMedCrossRef
34.
Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, et al. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol. 2010;10:22.PubMedPubMedCentralCrossRef
35.
Fermanian J. Validation of assessment scales in physical medicine and rehabilitation: how are psychometric properties determined? Ann Readapt Med Phys. 2005;48:281–7.PubMedCrossRef
36.
Polit DF, Beck CT. The content validity index: are you sure you know what’s being reported? Crit Recommendations Res Nurs Health. 2006;29:489–97.CrossRef
37.
Bolarinwa OA. Principles and methods of validity and reliability testing of questionnaires used in social and health science researches. Niger Postgrad Med J. 2015;22:195–201.PubMedCrossRef
38.
Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2:1–4.PubMed
39.
Bölenius K, Brulin C, Grankvist K, Lindkvist M, Söderberg J. A content validated questionnaire for assessment of self reported venous blood sampling practices. BMC Res Notes. 2012;5:39.PubMedPubMedCentralCrossRef
40.
Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16:297–334.CrossRef
41.
Acquadro C, Patrick DL, Eremenco S, Martin ML, Kuliś D, Correia H, et al. Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures. J Patient Rep Outcomes. 2017;2:8.PubMedCrossRef
42.
Chambers KD, Beausejour Ladouceur V, Alexander ME, Hylind RJ, Bevilacqua L, Mah DY, et al. Cardiac events during competitive, recreational, and daily activities in children and adolescents with long QT syndrome. J Am Heart Assoc. 2017;6:e005445.PubMedPubMedCentralCrossRef
43.
Ji Y, Chen S, Li K, Xiao N, Yang X, Zheng S, et al. Measuring health-related quality of life in children with cancer living in Mainland China: feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module. Health Qual Life Outcomes. 2011;9:103.PubMedPubMedCentralCrossRef
44.
Varni JW, Burwinkle TM, Seid M. The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity. Qual Life Res. 2006;15:203–15.PubMedCrossRef
45.
Amedro P, Gavotto A, Guillaumont S, Bertet H, Vincenti M, De La Villeon G, et al. Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart. 2018;104:1026–36.PubMedCrossRef
46.
Doostfatemeh M, Ayatollahi SMT, Jafari P. Assessing the effect of child’s gender on their father–mother perception of the PedsQLTM 4.0 questionnaire: an iterative hybrid ordinal logistic regression/item response theory approach with Monte Carlo simulation. Health Qual Life Outcomes. 2020;18:348.PubMedPubMedCentralCrossRef
47.
Huang I-C, Leite WL, Shearer P, Seid M, Revicki DA, Shenkman EA. Differential item functioning in quality of life measure between children with and without special health care needs. Value Health. 2011;14:872–83.PubMedPubMedCentralCrossRef
Metadata
Title
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
Authors
Pascal Amedro
Helena Huguet
Valerie Macioce
Raphael Dorka
Annie Auer
Sophie Guillaumont
Pascal Auquier
Hamouda Abassi
Marie-Christine Picot
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2021
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-021-01714-y

Other articles of this Issue 1/2021

Health and Quality of Life Outcomes 1/2021 Go to the issue

Research

Psycho-sexual influence of sterilization on women’s quality of life: a path model

Research

Determining the psychometric properties of a novel questionnaire to measure “preparedness for the future” (Prep FQ)

Research

Translation and validation of the Japanese version of the measure of moral distress for healthcare professionals

Research

Lifestyle-related behaviors and health-related quality of life among children and adolescents in China

Research

New resilience instrument for family caregivers in cancer: a multidimensional item response theory analysis

Research

Translation and validation of the Traditional Chinese version of the COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (Version 2)