Abstract
Background
IMPACT-III and IMPACT-III-P are Health-Related Quality of Life (HRQoL) questionnaires for pediatric Inflammatory Bowel Disease (p-IBD) patients and their parents/caregivers. They ...consist of 35 items answered with a 1-5 points Likert scale that evaluate six domains. Higher scores indicate better HRQoL. IMPACT-III has been translated into over 70 languages and validated in several countries. However, the existing IMPACT-III Spanish translation showed room for improvement and none of the tools had been validated in our population. We aimed to perform a transcultural adaptation and validation of the Spanish versions.
Methods
With permission from the questionnaires’ authors, we performed the translation and back-translation by professional translators, followed by evaluation by an expert committee and a small group of p-IBD families (n=12). Members of the SEGHNP (Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition) were invited to recruit p-IBD patients aged 10-18 and their families (February’21-November’22) to complete the questionnaires. Demographical and clinical data of the p-IBD participants were analyzed. Validation was performed with the Cronbach's alpha coefficient (considering 0.8-0.9 a good internal consistency) and a confirmatory factorial analysis with Varimax rotation (desirable values >0.5). The Kaiser Meyer Olkin (KMO) measure (>0.5 good correlation) and the Bartlett’s sphericity test (p<0.05) were calculated to confirm the adequacy of the factor analysis. The utility (method and completion time) was considered. The correlation coefficient between IMPACT-III and IMPACT-III-P was analyzed. Data were collected and analyzed with REDCap and Stata 16.
Results
We included 370 patients and 356 parents/guardians from 37 hospitals. Descriptive statistics of the participants are shown in table 1. The KMO measure (0.8998 and 0.9228, respectively) and the Bartlett's sphericity test (p-value <0.001 for both) confirmed the factor analysis’ adequacy. The factorial model with four factors, complying with Kaiser’s criterion, explained 89.19% and 88.87% of the variance in the model. Cronbach's alpha (0.9123 and 0.9383) indicated excellent internal consistency. The use of a Likert scoring system and the completion median time of 10 minutes for both tools was considered optimal. The correlation coefficient was 0.92, which was considered excellent.
Conclusion
The SEGHNP versions of the IMPACT-III and IMPACT-III-P are valid and reliable to use with Spanish p-IBD families. Our findings suggest a 4-factor scores in both questionnaires, although the optimal factor structure should be further examined. In our sample, parents/caregivers were good proxies for rating their p-IBD children overall HRQoL.
