125 Determinants for side effects 4 RESULTS In this nationwide study, patients and their parents were recruited in the Princess Máxima Center for pediatric oncology in the Netherlands between May 17, 2018 and March 27, 2021. Of 163 eligible patients, 105 were included in our study (Figure 2). Non-responders did not differ significantly on baseline characteristics compared to included patients. Median age of the included patients was 5.4 years (range 3.0-18.8) and 61% were boys. All parents completed the SDQ at T1 and T2, the SDSC was missing in one case. The SDQ increased from median 5 points (IQR 3-10) to 16 points (IQR 11-20) (p<0.001). The SDSC score increased from median 37 points (IQR 32-46) to 48 points (IQR 38-59) (p<0.001) (Figure 3). Clinically relevant dexamethasone-induced neurobehavioral or sleep problems were reported by parents in 70 (67%) and 61 (59%) of the patients respectively. In 53 patients (50%) both problems were reported, whereas in 27 patients (26%) no clinically significant problems occurred (Figure 4). Baseline characteristics did not differ between groups (Table 1). Results from all questionnaires were low to moderately correlated to each other at T1 (Pearson correlation 0.3-0.7, Supplemental Table 1). Of the 105 included patients, 19 (18.1%) were ≥11 years and therefore offered the SDQ selfreport. Twelve patients (63%) completed the SDQ at both timepoints, four patients (21%) at one timepoint and three patients (16%) did not complete any SDQ. The T1 ICC was 0.40 (95%-CI -0.11-0.72). For T2, the ICC was 0.73 (95%-CI 0.34-0.91). The ICC of the delta SDQ score was 0.30 (95%-CI -0.24-0.72). Dexamethasone-induced neurobehavioral problems In univariable regression analyses, child age, SDQ T1 score, maternal age and nationality, paternal age and nationality, NOSI-K and DT-P delta and T2 scores (reflecting parenting stress during a dexamethasone course of the child) were associated with parent-reported clinically relevant dexamethasone-induced neurobehavioral problems (Supplemental Table 2). Dexamethasone levels (AUC estimated values) were assessed in 86 patients. We did not find an association between dexamethasone AUC and neurobehavioral problems, also after adjusting for concomitant asparaginase use, which may influence dexamethasone pharmacokinetics.21
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