Abstract
BACKGROUND: With the consequences of inadequate dosing ranging from increased bleeding risk to excessive drug costs and undesirable administration regimens, the antihemophilic factors are uniquely suited to dose individualization. However, existing options for individualization are limited and exist outside the flow of care. We developed clinical decision support (CDS) software that is integrated with our electronic health record (EHR) and designed to streamline the process for our hematology providers. OBJECTIVES: The aim of this study is to develop and examine the usability of a CDS tool for antihemophilic factor dose individualization. METHODS: Our development strategy was based on the features associated with successful CDS tools and driven by a formal requirements analysis. The back-end code was based on algorithms developed for manual individualization and unit tested with 23,000 simulated patient profiles created from the range of patient-derived pharmacokinetic parameter estimates defined in children and adults. A 296-item heuristic checklist was used to guide design of the front-end user interface. Content experts and end-users were recruited to participate in traditional usability testing under an institutional review board approved protocol. RESULTS: CDS software was developed to systematically walk the point-of-care clinician through dose individualization after seamlessly importing the requisite patient data from the EHR. Classical and population pharmacokinetic approaches were incorporated with clearly displayed estimates of reliability and uncertainty. Users can perform simulations for prophylaxis and acute bleeds by providing two of four therapeutic targets. Testers were highly satisfied with our CDS and quickly became proficient with the tool. CONCLUSION: With early and broad stakeholder engagement, we developed a CDS tool for hematology provider that affords seamless transition from patient assessment, to pharmacokinetic modeling and simulation, and subsequent dose selection.