Italian translation, cultural adaptation and validation of the PedsQL™ 3.0 Diabetes Module questionnaire in children with type 1 diabetes and their parents

Abstract

BackgroundThe PedsQL™3.0 Diabetes Module is a widely used instrument to measure the disease-specific health-related quality of life summary measures in children and adolescents with type 1 diabetes. After cultural adaptation, we confirmed reliability and validity of PedsQL™3.0 Diabetes Module in its Italian version.MethodsParticipants were 169 Italian children and adolescents with type 1 diabetes aged 5–18 years and 100 parents. Reliability was determined by internal consistency using Cronbach’s coefficient alpha, and test-retest reliability by intra-class correlation coefficient (ICC). Validity was assessed through factor validity examined by exploratory factor analysis, and discriminant validity examined through multitrait/multi-item scaling analysis. Discriminant validity with respect to dichotomous patients’ characteristics at baseline was also examined through a multivariate analysis on the summary measures using the Wilks’ Lambda test.ResultsData completeness was optimal. Item internal consistency was satisfied at 89% for the child self-report scales and at 100% for the parents’ proxy-report scales. Most diabetes module scales was acceptable for group comparisons. Discriminant validity was satisfied for 71% of children and adolescents and for 82% of parents. A ≥70% Cronbach’s α coefficient was found for the summary measures of both reports. For the test-retest reliability, the ICC coefficients ranged from 0.66 (i.e., the Worry scale) to 0.82 for the other scales of the child self-report. The ICC coefficients were ≥0.87 for all the parents’ proxy-report scales. Factor analysis showed that the PedsQL™3.0 Diabetes Module for child self-report could be summarized in 10 components, which explained the 62% of the variance. For the parent proxy-report the statistical analysis selected 9 factors, which explained about 68% of variance. The external discriminant validity of the PedsQL™3.0 Diabetes Module summary measures were compared across gender, age, time since diagnosis and HbA1c mean cut off values. Significant differences in the “Treatment adherence” scale and in the “Communication” scale were observed across age, and by time since diagnosis.ConclusionsThe results show the reliability and validity of the Italian translation of the PedsQL™3.0 Diabetes Module, supporting therefore its use as an outcome measure for diabetes cross-national clinical trials and research.

Health related quality of life and family impact of type 1 diabetes among adolescents in Saudi Arabia

“…The diabetic teens in Saudi Arabia reported lower individual and total scale scores compared to diabetic teens in several other countries (Table 4). The ''About my Diabetes'' subscale score, however, was found to be the lowest in these countries [9,29,[33][34][35], in contrast to the ''Worry'' subscale being the lowest for adolescents in our study.…”

“…This finding is also apparent in literature comparing HRQoL in adolescents with T1DM [9,[29][30][31][32]. The Peds QL TM Diabetes Module has been used in a number of studies among adolescents with T1DM conducted in the Middle East [22,29,30], Europe [31,[33][34][35], and the United States (US) [9]. Although these studies are not nationally representative of the population of adolescents with T1DM in each country, valuable insight into HRQol for adolescents with T1DM for each country can be gained.…”

“…Although these studies are not nationally representative of the population of adolescents with T1DM in each country, valuable insight into HRQol for adolescents with T1DM for each country can be gained. HRQoL has been reported to range between 59.2 and 73.8 in other countries, with the lowest overall scores found in Iran and Greece, and the highest scores in Sweden and Italy and the US [9,33,35]. The diabetic teens in Saudi Arabia reported lower individual and total scale scores compared to diabetic teens in several other countries (Table 4).…”

<p>Type 1 Diabetes Mellitus in Pediatric Patients and Its Impact on Relationships in the Family Environment</p>

“…16 The Spanish version of the Diabetes Quality of Life (DQOL), a validated tool in Spanish, 8 has led to its choice over other questionnaires such as the Pediatric Quality of Life (PedsQL) to prevent cultural biases linked to translation. 17 T1D has a direct impact on a child's or adolescent's daily life, as it affects their diet, physical activity, rest, academic performance and psychosocial environment; thus, health professionals play a key role in their care, support and health education. 18 Self-management of diabetes by the pediatric patient and their environment is crucial.…”

“… 16 The Spanish version of the Diabetes Quality of Life (DQOL), a validated tool in Spanish, 8 has led to its choice over other questionnaires such as the Pediatric Quality of Life (PedsQL) to prevent cultural biases linked to translation. 17 …”