133 7 DELIRIUM | PART THREE meet its primary objective of demonstrating superiority of olanzapine over haloperidol. With a probability rate of 8.6% to achieve its primary objective, this was well below the threshold of 10% for futility. Consequently, the number of included patients is relatively small, and the power of the analyses performed to assess secondary endpoints is low. Finally, the use of rescue interventions to manage agitation (e.g., benzodiazepines and physical restraints) were not prospectively recorded. Because these interventions are known to be associated with delirium, this could have introduced bias. However, it should be noted that retrospective analysis of the medical records showed that only very few patients (<3%) received benzodiazepines, and none physical restraints. Conclusions Olanzapine and haloperidol are equally effective and safe for the management of delirium in a broad population of hospitalized patients with advanced cancer. The focus of future placebocontrolled RCT’s should change to individualized, multimodal intervention strategies for managing delirium. Acknowledgments This work was supported by ZonMW The Netherlands Organization for Health Research and Development (grant number 1151.0011). The funding source did not have a role in the design, analysis and interpretation of data; in the writing of the report; nor in the decision to submit the article for publication.
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