Congenital heart disease (CHD) accounts for nearly a third of all major congenital anomalies. Advances in pediatric cardiology shifted attention from mortality to morbidity and health-related quality of life (HRQOL) of patients with CHD and impact on their families. The purposes of this study were to assess the validity and reliability of the Italian version of the Pediatric Quality of Life (PedsQL) Cardiac Module and to create normative data for the Italian population. This was an observational cross-sectional study of pediatric patients (aged 2–18 years) with congenital or acquired Heart Disease (HD) and their parents. Families were asked to complete the cardiac pediatric health-related quality of life questionnaire (the Italian PedsQL™ 3.0 Cardiac Module) and the generic pediatric health-related quality of life questionnaire (PedsQL™ 4.0 Generic Core Scales). The sequential validation procedure of the original United States version of the PedsQL™ 3.0 Cardiac Module was carried out under the instruction of the MAPI Research Institute. To assess construct validity, Pearson’s correlation coefficients were assessed between scores on the Cardiac Module scales and scores on the scales of the General Module. To determine agreement between patient self-report and parent proxy-report, we used intraclass correlation coefficients (ICCs). To evaluate Internal consistency of items, we used Cronbach’s alpha Coefficient. The study enrolled 400 patients. Construct validity is good between PedsQL Cardiac Module total scores and PedsQL total scores (p < 0.001). The recommended standard value of 0.7 was reached on the Cardiac and General Module core scales. Intercorrelations between PedsQL Cardiac module and PedsQL scores revealed medium to large correlations. In general, correlations between Patient self-reports are poorer than Parent-proxy ones. Cardiac PedsQL scores are valid and reliable for pediatric patients with congenital and acquired HD and may be useful for future research and clinical management.

中文翻译：

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意大利语版心脏病患儿心脏生活质量问卷 (PedsQLTM) 的效度和信度

先天性心脏病 (CHD) 占所有主要先天性异常的近三分之一。儿科心脏病学的进展将注意力从冠心病患者的死亡率转移到发病率和健康相关的生活质量 (HRQOL) 及其对家庭的影响。本研究的目的是评估意大利版儿科生活质量 (PedsQL) 心脏模块的有效性和可靠性，并为意大利人口创建规范数据。这是一项对患有先天性或后天性心脏病 (HD) 的儿科患者（2-18 岁）及其父母的观察性横断面研究。要求家庭完成与心脏儿科健康相关的生活质量问卷（意大利语 PedsQL™ 3.0 心脏模块）和通用的儿科健康相关生活质量问卷（PedsQL™ 4. 0 通用核心量表）。PedsQL™ 3.0 心脏模块原始美国版本的顺序验证程序是在 MAPI 研究所的指导下进行的。为了评估结构效度，对心脏模块量表的分数和一般模块量表的分数之间的 Pearson 相关系数进行了评估。为了确定患者自我报告和父母代理报告之间的一致性，我们使用了组内相关系数 (ICC)。为了评估项目的内部一致性，我们使用了 Cronbach 的 alpha 系数。该研究招募了 400 名患者。PedsQL 心脏模块总分和 PedsQL 总分之间的结构效度良好 (p < 0.001)。在心脏和一般模块核心量表上达到了推荐的标准值 0.7。PedsQL Cardiac 模块和 PedsQL 分数之间的相关性揭示了中到大的相关性。一般来说，患者自我报告之间的相关性比父母代理报告之间的相关性差。心脏 PedsQL 评分对先天性和获得性 HD 儿科患者有效且可靠，可能对未来的研究和临床管理有用。