Annelienke van Hulst

121 Determinants for side effects 4 Outcome measures Neurobehavioral problems We used the validated Dutch version of the parent-reported Strengths and Difficulties Questionnaire (SDQ) to assess neurobehavioral problems.23-27 This questionnaire measures psychological adjustment of children and adolescents using five subscales: emotional symptoms, conduct problems, hyperactivity-inattention, peer problems and prosocial behavior. The Total Difficulties score was calculated by adding the first four subscales; a higher score reflects more problems. Outcome measures were dichotomized: an increase of ≥5 points after five days of dexamethasone was considered as clinically relevant dexamethasone-induced neurobehavioral problems.11 The SDQ is also available as selfreport for children ≥11 years and was therefore offered to these patients.27 Sleep problems Sleep quality was assessed with the parent-reported Sleep Disturbance Scale for Children (SDSC).28,29 This validated questionnaire yields six subscales: disorders of initiating and maintaining sleep (DIMS), disorders of arousal (DA), sleep-wake transition disorders (SWTD), disorders of excessive somnolence (DES), and sleep hyperhidrosis (SHY). The sum provides a total sleep score; a higher score reflects more problems. An increase of ≥7 points on this total score, after five days of dexamethasone, was considered as clinically relevant sleep problems.11 The SDSC is not available as self-report. Determinants Patient and parent demographics, disease and treatment characteristics Patient, treatment and disease characteristics taken into account were age, sex, week in maintenance phase, ALL subtype (B-cell ALL or T-cell ALL), concurrent asparaginase use,21 and central nervous system (CNS) involvement. Both the SDQ Total Difficulties and the SDSC total score at T1 (i.e. pre-existing neurobehavioral or sleep problems) were evaluated as possible determinants. Family characteristics taken into account were number of siblings and parental factors such as age, nationality, highest level of education of both parents, and which parent completed the questionnaires. Support and parental coping We developed a short survey regarding received support (see Supplement). Questions concerned whether a child and/or parent received psychological or other support and why. Furthermore, since it is known from literature that coping with dexamethasone pulses in maintenance treatment can be extremely stressful,4 we asked parents to qualitatively describe how they cope with the dexamethasone treatment: how do they prepare their family and how do they manage during the treatment days. The qualitative responses were collected and pre-defined keywords were highlighted (e.g. ‘nothing/normal’ or

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