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

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

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://ichgcp.net/clinical-trials-registry/NCT01202916 .

Keywords: Kidscreen; Patient-reported outcome; Pediatric cardiology; Pediatrics; Psychometric validation; Quality of life.

Conflict of interest statement

Authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Correspondence between dimensions of the PedsQL, Kidscreen-52 and Kidscreen-27 quality of life questionnaires
Fig. 2
Fig. 2
COSMIN taxonomy of relationships of measurement properties [34]. Abbreviations: COSMIN, COnsensus-based Standards for the selection of health Measrurement Instruments; HR-PRO, health-related patient reported outcome. Permission to reproduce this figure was obtained from Elsevier and Copyright Clearance Center for print and electronic format (License number: 4823570991456)

References

    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. doi: 10.1542/peds.2008-2572.
    1. Moons P. Patient-reported outcomes in congenital cardiac disease: are they as good as you think they are? Cardiol Young. 2010;20(Suppl 3):143–148. doi: 10.1017/S1047951110001216.
    1. 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. doi: 10.1016/j.farma.2009.07.002.
    1. 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;30:154–160. doi: 10.1007/s11096-007-9152-9.
    1. 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. doi: 10.1016/j.ijnurstu.2006.03.015.
    1. 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;102:734–745. doi: 10.1007/s00063-007-1092-6.
    1. 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. doi: 10.1186/1477-7525-2-66.
    1. 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;26:631–637. doi: 10.2337/diacare.26.3.631.
    1. 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;94:2090–2106. doi: 10.1002/cncr.10428.
    1. 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;46:714–725. doi: 10.1002/art.10095.
    1. 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. doi: 10.1186/1477-7525-9-64.
    1. 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. doi: 10.1542/peds.2006-3778.
    1. 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. doi: 10.1186/1477-7525-11-193.
    1. 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;30:863–868. doi: 10.1515/jpem-2017-0026.
    1. 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;111:180–188. doi: 10.1016/j.acvd.2017.05.013.
    1. 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;283:112–118. doi: 10.1016/j.ijcard.2018.12.050.
    1. 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;39:800–812. doi: 10.1097/00005650-200108000-00006.
    1. 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. doi: 10.1186/1477-7525-10-3.
    1. 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. doi: 10.1186/1477-7525-10-42.
    1. 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;25:828–833. doi: 10.1111/j.1471-6712.2011.00889.x.
    1. 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. doi: 10.1186/1477-7525-5-2.
    1. 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;3:341–350.
    1. 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;102:2223–2230. doi: 10.1016/j.pec.2019.06.023.
    1. 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. doi: 10.1186/s12955-020-01615-6.
    1. 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;113:811–820. doi: 10.1016/j.acvd.2020.05.022.
    1. Kobayashi K, Kamibeppu K. Measuring quality of life in Japanese children: development of the Japanese version of PedsQL. Pediatr Int. 2010;52:80–88. doi: 10.1111/j.1442-200X.2009.02889.x.
    1. 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. doi: 10.1186/1477-7525-4-61.
    1. 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;36:1588–1601. doi: 10.1007/s00246-015-1201-x.
    1. 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;203:1052–1060. doi: 10.1016/j.ijcard.2015.11.028.
    1. 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;11:645–658. doi: 10.1111/j.1524-4733.2007.00291.x.
    1. 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;16:1347–1356. doi: 10.1007/s11136-007-9240-2.
    1. 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. doi: 10.1007/s11136-013-0428-3.
    1. 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. doi: 10.1186/s12955-014-0176-2.
    1. 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. doi: 10.1186/1471-2288-10-22.
    1. Fermanian J. Validation of assessment scales in physical medicine and rehabilitation: how are psychometric properties determined? Ann Readapt Med Phys. 2005;48:281–287. doi: 10.1016/j.annrmp.2005.04.004.
    1. Polit DF, Beck CT. The content validity index: are you sure you know what’s being reported? Crit Recommendations Res Nurs Health. 2006;29:489–497. doi: 10.1002/nur.20147.
    1. 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. doi: 10.4103/1117-1936.173959.
    1. 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.
    1. 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. doi: 10.1186/1756-0500-5-39.
    1. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16:297–334. doi: 10.1007/BF02310555.
    1. 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. doi: 10.1186/s41687-018-0035-8.
    1. 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. doi: 10.1161/JAHA.116.005445.
    1. 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. doi: 10.1186/1477-7525-9-103.
    1. Varni JW, Burwinkle TM, Seid M. The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity. Qual Life Res. 2006;15:203–215. doi: 10.1007/s11136-005-1388-z.
    1. 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;104:1026–1036. doi: 10.1136/heartjnl-2017-312339.
    1. 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. doi: 10.1186/s12955-020-01601-y.
    1. 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;14:872–883. doi: 10.1016/j.jval.2011.03.004.

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