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.
Many aspects of QALY measurement in children are not yet fully developed. This study is aimed at contextualizing the mapping methodology in a field not yet covered: paediatric asthma. The objective is to derive utility values from non-preference-based questionnaires, the estimated utility values will be useful for QALY assessment by means of: i) evaluation of a linear mapping between the generic preference-based EQ-5D-3L (self-and proxy-versions) and the condition-specific non-preference-based Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), respectively; ii) assessment of the capability of mapping to discriminate for disease severity. MethOds: Either PAQLQ or PACQLQ and EQ-5D-3L will be administrated to 170 asthma children (7-17 years of age) during a 24-month multicenter randomized placebo-controlled trial of allergen specific sublingual immunotherapy coded EudraCT No. 2012-005678-76/FARM94793N at baseline, month 12, and month 24 visits. Level of severity will be assessed using the Asthma Control Test (ACT) and the Childhood-ACT (C-ACT) questionnaires. The possibility of a linear mapping will be evaluated through a Tobit model, where either PAQLQ/PACQLQ will be tested as predictors of EQ-5D-3L answers. Capability of mapping to be sensible in changes of disease severity will be measured through a Pearson's correlation between changes in estimated EQ-5D-3L scores and changes in ACT and C-ACT answers. Results: Linear mapping, if feasible, applies the statistical relationship between either PAQLQ or PACQLQ and EQ-5D-3L, being PAQLQ/PACQLQ answers predictors of EQ-5D-3L score. EQ-5D-3L and PAQLQ/ PACQLQ, as well as EQ-5D-3L built on PAQLQ/PACQLQ answers by applying the linear mapping is expected to discriminate for both patients' level and changes in disease severity. cOnclusiOns: This study seeks to inform policy makers in their choice of the source of utility values and their discrimination across severity groups and responsiveness in asthma children. PRM54 estiMatinG Means fRoM Medians: a Case stUdy WitH tReatMents foR MetastatiC ColoReCtal CanCeR (MCRC)
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