184 Chapter 6 RESULTS Of 256 newly diagnosed ALL patients (17th May 2018 till 5th August 2020), 123 patients were eligible, of whom 79 gave informed consent to participate. The most common reported reason for refraining from participation was the burden and time-consuming nature of the study (38%). Of the 79 included patients, 52 (66%) experienced clinically relevant dexamethasone-induced side-effects and were therefore eligible for the RCT and subsequently randomized to start with hydrocortisone (n = 26) or placebo (n = 26) (Figure 2). Median age at the start of the RCT was 5.5 years (range 3.0–18.8) and 61.5% were boys. The randomized subgroups (hydrocortisone or placebo first) did not differ significantly with respect to baseline characteristics and baseline questionnaire measurements. The total group (n = 79), patients who refused to participate (n = 44), as well as the included patients who were not eligible for the RCT (n = 27), were not statistically different with regard to baseline characteristics either (Supplemental Table 1). There was no carry-over effect (p = 0.49), nor a period effect (p = 0.77) in our study, based on the primary outcome. Primary outcome: neurobehavioral problems The median increase in SDQ Total Difficulty score (delta SDQ) during ‘dexamethasone only’ was 12 points (interquartile range (IQR) 8–15). During hydrocortisone courses the median delta SDQ was 5 points (IQR 2–9) and during placebo courses 6 points (IQR 3–9) (Table 1). There was no statistically significant difference between hydrocortisone and placebo in reducing dexamethasone-induced neurobehavioral problems (p = 0.33). The mixed model analysis showed the same trend: estimated effect hydrocortisone compared to placebo −2.05 (95% CI −6.00 to 1.90) (Figure 3, Table 1, Supplemental Table 2). None of the covariates included in the model were associated with the primary outcome. The findings were consistent in the analyses of the SDQ subscores, however with smaller estimated effects (Table 1, Supplemental Table 2). At the end of the study period for each individual child, parents indicated whether they thought their child had started with placebo or hydrocortisone. Of 52 parents, 24 (46%) were correct, 24 (46%) were not, and four parents (8%) were unsure.
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