124 Chapter 4 ALL‐11 MR patients n=277 Eligible patients n=163 Informed Consent n=105 Enrolled patients n=105 Neurobehavioral problems Yes: n=70 (67%) No: n=35 (33%) Exclusion n=114 (41%) ‐ Age (<3 or >18): n=17 ‐ Language barrier: n=14 ‐ No/less dexamethasone: n=17 ‐ Participation in related study: n=12 ‐ Mental retardation: n=9 ‐ Hydrocortisone use: n=18 ‐ Risperidone use: n=4 ‐ Other*: n=23 Refusal n=58 (35%) ‐ Burden/effort: n=17 ‐ No time: n=10 ‐ Few side effects: n=10 ‐ Child refuses: n=5 ‐ Too many studies: n=3 ‐ Not interested: n=5 ‐ Other: n=5 ‐ Unknown: n=3 ‐ Dropouts: 0 ALL patients n=388 Exclusion n=111 (29%) ‐ SR group: n=69 ‐ HR group: n=25 ‐ Not ALL‐11: n=17 Missing data on ‐ Neurobehavioral problems: 0 ‐ Sleep problems: 1 *Other reasons for exclusion: ‐ Still on doxorubicin: n=3 ‐ Deceased: n=2 ‐ Rarely in the Máxima: n=7 ‐ No permission oncologist: n=5 ‐ Other: n=6 Sleep problems Yes: n=61 (59%) No: n=43 (41%) Figure 2. CONSORT diagram Eligible acute lymphoblastic leukemia patients were approached for inclusion after approval of the treating pediatric oncologist. Reasons for refusal were stated by parents or patients. Patients with a rise of five points on the SDQ or seven points on the SDSC after 5 days of dexamethasone treatment were classified as having clinically relevant dexamethasone-induced neurobehavioral or sleep problems, respectively. Abbreviations: ALL: acute lymphoblastic leukemia, HRG: high risk group, MR: medium risk, SDQ: Strengths and difficulties questionnaire, SDSC: sleep disturbance scale for children, SRG: standard risk group.
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