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. 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. 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. 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 .

中文翻译：

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针对8至12岁儿童的PedsQL™4.0通用健康相关生活质量问卷的法语自我版本和代理版本的心理计量学验证

儿科生活质量清单4.0（PedsQLTM4.0）是一种与健康相关的通用生活质量（HRQoL）问卷，已广泛​​用于儿科临床试验中，但尚未在法国进行验证。我们对8至12岁的法国儿童进行了自我和代理PedsQLTM4.0通用问卷的心理计量学验证。这项双中心横断面研究包括了123名先天性心脏病（CHD）患儿及其父母和97名对照。心理计量学验证方法基于选择健康测量仪器（COSMIN）的基于共识的标准。使用组内相关系数（ICC）测试了可靠性。为了评估该量表的有效性，测试了内容，面部，标准和构造效度的心理计量学适当性。研究者对问卷的完成情况以及存在底限或上限效应的可接受性进行了研究。重测信度组内相关系数主要在良好范围内（0.49–0.66）。父母（0.85）和儿童（0.75）的面部有效性非常好。尽管对某些项目有误解，但内容有效性良好（0.70）。在构造效度上，每个子量表均具有可接受的内部一致性信度（自我报告中的Cronbachα> 0.72，代理人报告中的> 0.69）。在验证性因素分析中，拟合优度统计数据拒绝了具有4个因素的原始结构。探索性因素分析显示了对应于生理和心理维度的替代性两因素结构。中度（> 0.41）到高相关性（0。57）在PedsQL和Kidscreeen问卷之间，以了解身体，情感和学校方面。在自我报告和代理报告的身体，社交和总分方面，PedsQL区分冠心病严重程度的能力更好。PedsQLTM4.0通用自我和代理HRQoL问卷发现在接受性，响应性，有效性和可靠性方面具有良好的心理计量学特性。在目标年龄为8至12岁的儿童及其父母的目标人群中，该工具似乎易于使用和理解。试验注册：该研究已获得南地中海IV伦理委员会的批准，并在ClinicalTrials.gov（NCT01202916），https：//clinicaltrials.gov/ct2/show/NCT01202916上进行了注册。在自我报告和代理报告的身体，社交和总分方面，PedsQL区分冠心病严重程度的能力更好。PedsQLTM4.0通用自我和代理HRQoL问卷发现在接受性，响应性，有效性和可靠性方面具有良好的心理计量学特性。在目标年龄为8至12岁的儿童及其父母的目标人群中，该工具似乎易于使用和理解。试验注册：该研究已获得南地中海IV伦理委员会的批准，并在ClinicalTrials.gov（NCT01202916），https：//clinicaltrials.gov/ct2/show/NCT01202916上进行了注册。在自我报告和代理报告的身体，社交和总分方面，PedsQL区分冠心病严重程度的能力更好。PedsQLTM4.0通用自我和代理HRQoL问卷发现在接受性，响应性，有效性和可靠性方面具有良好的心理计量学特性。在目标年龄为8至12岁的儿童及其父母的目标人群中，该工具似乎易于使用和理解。试验注册：该研究已获得南地中海IV伦理委员会的批准，并在ClinicalTrials.gov（NCT01202916），https：//clinicaltrials.gov/ct2/show/NCT01202916上进行了注册。关于可接受性，响应性，有效性和可靠性。在目标年龄为8至12岁的儿童及其父母的目标人群中，该工具似乎易于使用和理解。试验注册：该研究已获得南地中海IV伦理委员会的批准，并在ClinicalTrials.gov（NCT01202916），https：//clinicaltrials.gov/ct2/show/NCT01202916上进行了注册。关于可接受性，响应性，有效性和可靠性。在目标年龄为8至12岁的儿童及其父母的目标人群中，该工具似乎易于使用和理解。试验注册：该研究已获得南地中海IV伦理委员会的批准，并在ClinicalTrials.gov（NCT01202916），https：//clinicaltrials.gov/ct2/show/NCT01202916上进行了注册。