Sección de Gastroenterología y Nutrición Pediátrica, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.
Servicio de Gastroenterología, Hepatología y Nutrición Pediátrica, Hospital Sant Joan de Déu, Barcelona, Spain.
Eur J Pediatr. 2024 Aug;183(8):3417-3430. doi: 10.1007/s00431-024-05575-7. Epub 2024 May 21.
IMPACT-III and IMPACT-III-P are health-related quality of life (HRQoL) questionnaires for patients with pediatric inflammatory bowel disease (p-IBD) and their parents/caregivers. We aimed to perform a transcultural adaptation and validation for the Spanish context. Translation, back-translation, and evaluation of the questionnaires were performed by an expert committee and 12 p-IBD families. We recruited p-IBD patients aged 10-17 and their parents/caregivers. Utility, content, and face validity were considered. Validation was performed with Cronbach's alpha coefficient and varimax rotation. We confirmed the adequacy of the factor analysis using Kaiser-Meyer-Olkin (KMO) and Bartlett's sphericity tests. A confirmatory factor analysis was performed using the following goodness indexes: chi-square, Normed Fit Index (NFI), Root Mean Square Error of Approximation index (RMSEA), Standardized Root Mean Square Residual (SRMR), and Comparative Fit Index (CFI). The correlation coefficient between IMPACT-III and IMPACT-III-P was analyzed. We included 370 patients and 356 parents/caregivers (37 hospitals). Both questionnaires had good content and face validity and were considered user-friendly. The KMO measure (0.8998 and 0.9228, respectively) and Bartlett's sphericity test (p-value < 0.001 for both) confirmed the adequacy of the factor analysis. The 4-factor model, complying with Kaiser's criterion, explained 89.19% and 88.87% of the variance. Cronbach's alpha (0.9123 and 0.9383) indicated excellent internal consistency. The CFA showed an adequate fit (NFI 0.941 and 0.918, RMSEA 0.048 and 0.053, SRMR 0.037 and 0.044, and CFI 0.879 and 0.913). The correlation coefficient was excellent (0.92).
The SEGHNP versions of IMPACT-III and IMPACT-III-P are valid and reliable instruments for Spanish p-IBD families.
• IMPACT-III and parent-proxy IMPACT-III (IMPACT-III-P) are useful questionnaires for assessing health-related quality of life (HRQoL) in pediatric inflammatory bowel disease (p-IBD) patients and their parents/caregivers and have been translated and validated in several countries. • To date, no transcultural adaptation and validation of these questionnaires have been published for Spanish patients with p-IBD and their families.
• This is the first transcultural adaptation and validation of IMPACT-III and IMPACT-III-P for Spanish p-IBD families. • These are valid and reliable instruments for assessing HRQoL in Spanish families of patients with p-IBD.
对影响 III 型和影响 III 型-P 进行西班牙文化适应性和验证，这是用于儿科炎症性肠病（p-IBD）患者及其父母/照顾者的健康相关生活质量（HRQoL）问卷。
通过专家委员会和 12 个 p-IBD 家庭进行问卷翻译、回译和评估。我们招募了 10-17 岁的 p-IBD 患者及其父母/照顾者。考虑了效用、内容和表面有效性。使用 Cronbach's alpha 系数和最大方差旋转进行验证。使用 Kaiser-Meyer-Olkin（KMO）和 Bartlett 的球形检验来确认因子分析的充分性。使用以下良好指数进行验证：卡方，标准化拟合指数（NFI），均方根误差逼近指数（RMSEA），标准化均方根残差（SRMR）和拟合指数（CFI）。分析了影响 III 型和影响 III 型-P 之间的相关系数。我们纳入了 370 名患者和 356 名父母/照顾者（37 家医院）。两个问卷都具有良好的内容和表面有效性，并且易于使用。KMO 测量值（分别为 0.8998 和 0.9228）和 Bartlett 的球形检验（两者的 p 值均小于 0.001）均确认了因子分析的充分性。符合 Kaiser 标准的 4 因素模型解释了 89.19％和 88.87％的方差。Cronbach's alpha（分别为 0.9123 和 0.9383）表明具有极好的内部一致性。CFI 显示出适当的拟合度（NFI 为 0.941 和 0.918，RMSEA 为 0.048 和 0.053，SRMR 为 0.037 和 0.044，CFI 为 0.879 和 0.913）。相关系数极好（0.92）。
SEGHNP 版本的影响 III 型和影响 III 型-P 是西班牙 p-IBD 家庭的有效且可靠的工具。
IMPACT-III 和家长代理的 IMPACT-III（IMPACT-III-P）是用于评估儿科炎症性肠病（p-IBD）患者及其父母/照顾者健康相关生活质量（HRQoL）的有用问卷，已在多个国家/地区进行了翻译和验证。
目前，尚无针对西班牙 p-IBD 患者及其家庭的这些问卷的跨文化适应性和验证。
这是影响 III 型和影响 III 型-P 首次用于西班牙 p-IBD 家庭的跨文化适应性和验证。
这些是评估西班牙 p-IBD 患者家庭 HRQoL 的有效且可靠的工具。
