110 Chapter 3 DISCUSSION This paper describes the DexaDays-2 protocol: a randomized controlled trial set up to replicate the finding that addition of physiological doses of hydrocortisone to standard dexamethasone treatment reduces neurobehavioral side effects in pediatric ALL patients. Our previous study suggests that patients with clinically relevant neurobehavioral problems benefit from treatment with hydrocortisone.14 Currently no other satisfying options to treat dexamethasone-induced neurobehavioral problems are available.38 The results of this study may affect the management of future ALL patients with dexamethasone-induced side effects as it may improve HRQoL for those who suffer most from these problems. Our study could also be important for adult patients or children with other conditions who receive dexamethasone and experience the accompanying neurobehavioral side effects.38,39 Furthermore, by investigating possible risk factors that could influence the inter-patient variability, we might be able to identify patients at risk for dexamethasoneinduced neurobehavioral problems at an earlier stage, providing a possible intervention. Besides earlier recognition, the potential identification of risk factors for dexamethasoneinduced neurobehavioral problems might lead to new outcomes which could be targeted to deal with these problems. For example, parenting stress or received support could be established as risk factors, providing starting points for non-pharmacological interventions. Several strong points of this study can be discussed. First, every patient with ALL in the Netherlands can be screened on eligibility for this study, rendering a large and hopefully unbiased population. From this population, we select patients who might benefit from the intervention, following the results of our previous DexaDagen-1 study. Second, the design, a double-blind placebo controlled randomized controlled trial with cross-over, will minimize the risk of bias in our RCT. Third, we measure the effect of hydrocortisone in two subsequent dexamethasone courses. This is an addition to our previous study protocol, by which we want to mimic the normal situation of repetitive dexamethasone courses, and to investigate whether the possible effect of hydrocortisone is lasting. Some possible study limitations have to be taken into account as well. To begin with, some patients might already use hydrocortisone therapy because patients heard of positive results from participants in our previous DexaDays-1 study. We address this problem by communicating the importance of our current study with all treating pediatric oncologists and asking them to include these patients in the study. Furthermore, because patients are coming to the Princess Máxima Center from the whole country, one extra visit might be a barrier for patients living far away. We try to overcome this problem by offering reimbursement of travel expenses and making it possible to visit a patient at home if the extra visit is the only objection of parents to participate. Another potential limitation is
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