262 Chapter 8 Embargo phase Effective intervention for dexamethasone-induced neurobehavioral problems Hydrocortisone and placebo Brainstorm with ALL chair & international placebo expert Presentation and input ALL experts Ethical deliberation Input stakeholders Client council Pharmacy Patients’ representative organization Medical Director QoL Legal office Implementation advice First conclusions and implications Effect of hydrocortisone and placebo Possible nocebo effect dexamethasone Ethical responsibility for implementation First implementation advice 1. Offer children with dexamethasone-induced neurobehavioral problems the intervention (hydrocortisone or placebo) 2. Adjust information regarding dexamethasone side effects Implementation advice for children with ALL 1. Hydrocortisone or open-label placebo to reduce clinically relevant dexamethasoneinduced neurobehavioral problems 2. Cross-over to other intervention if first intervention ineffective 3. Adjust information regarding dexamethasone side effects to reduce nocebo effect Board of Directors Princess Máxima Center Evaluation Standard of Care Figure 1. Flow-chart illustrating our advisory and implementation process. The results were kept under embargo until a final decision regarding implementation was reached. Abbreviations: ALL: acute lymphoblastic leukemia, QoL: quality of life
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