186 Chapter 6 Table 1. Difference in neurobehavioral side effects measured with the SDQ n = 51 median (IQR) Randomized Controlled Trial Δ score dexa only Average Δ 2 courses hydrocortisone Average Δ 2 courses placebo Hydrocortisone vs placebo estimated effect (95%CI) Total Difficulties 12.0 (8.0;15.0) 5.0 (2.0;9.0) 5.8 (3.0;9.0) -2.05 (-6.00;1.90) Emotional problems 4.0 (3.0;6.0) 1.5 (0.5;3.0) 2.0 (1.5;3.5) -0.94 (-2.49;0.60) Conduct problems 2.0 (1.0;3.0) 1.0 (0.5;2.0) 1.0 (0.0;2.0) -0.32 (-1.54;0.89) Hyperactivity 4.0 (2.0;5.0) 1.5 (0.0;3.0) 2.0 (1.0;4.0) -1.64 (-3.29;0.01) Peer problems 2.0 (1.0;3.0) 1.0 (0.0;2.0) 0.5 (0.0;1.5) 0.88 (-0.18;1.93) Prosocial -4.0 (-5.0;-2.0) -2.0 (-3.5;-0.5) -2.0 (-3.0;-1.0) -0.37 (-1.85;1.10) Delta scores are calculated for the SDQ Total difficulties score and all subscales by subtracting day 1 (start dexamethasone course) from day 5 (end of dexamethasone course) scores. Hydrocortisone and placebo were added during two subsequent courses, for these courses the average delta score was calculated. The estimated effect is corrected for age, sex, start group (hydrocortisone/placebo), week of maintenance treatment, concomitant asparaginase treatment (yes/no), whether mother or father completed the questionnaire and an interaction term between intervention and time. Italicized values are statistically significant. Abbreviations: 95%CI: 95% confidence interval, dexa: dexamethasone, IQR: interquartile range, SDQ: strengths and difficulties questionnaire Secondary outcomes In total, 75 actigraphy weeks of 39 children were available for analysis. The main reason for missing data was the child refusing to wear the Actigraph (n = 11). No statistically significant difference in any sleep outcome between hydrocortisone and placebo was observed (Supplemental Table 3). The median delta SDSC Total score (n= 42) was 11 points (IQR 6–18) in ‘dexamethasone only’ course, and 4 (IQR 1–10) and 3 (IQR 1–8) in the hydrocortisone and placebo courses, respectively. There was no significant difference between hydrocortisone and placebo (Figure 4a, Supplemental Table 4). Results did suggest that parents reported less sleep problems if their child was further in maintenance treatment (Supplemental Table 5). The median delta most extreme hunger score (n = 38) was 2 points during ‘dexamethasone only’ (IQR 2–4), 2 points during hydrocortisone (IQR 1–4) and 2 points during placebo (IQR 1–3). Results showed that hydrocortisone led to an increased average and fasting hunger score compared to placebo (Figure 4b, Supplemental Tables 4 and 6).
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