title: Design and Testing of an EHR-Integrated, Busulfan Pharmacokinetic Decision Support Tool for the Point-of-Care Clinician.
abstract: BACKGROUND
  Busulfan demonstrates a narrow therapeutic index for which clinicians routinely employ therapeutic drug monitoring (TDM). However, operationalizing TDM can be fraught with inefficiency. We developed and tested software encoding a clinical decision support tool (DST) that is embedded into our electronic health record (EHR) and designed to streamline the TDM process for our oncology partners.
  
  
  METHODS
  Our development strategy was modeled based on the features associated with successful DSTs. An initial Requirements Analysis was performed to characterize tasks, information flow, user needs, and system requirements to enable push/pull from the EHR. Back-end development was coded based on the algorithm used when manually performing busulfan TDM. The code was independently validated in MATLAB using 10,000 simulated patient profiles. A 296-item heuristic checklist was used to guide design of the front-end user interface. Content experts and end-users (n = 28) were recruited to participate in traditional usability testing under an IRB approved protocol.
  
  
  RESULTS
  Decision support software was developed to systematically walk the point-of-care clinician through the TDM process. The system is accessed through the EHR which transparently imports all of the requisite patient data. Data are visually inspected and then curve fit using a model-dependent approach. Quantitative goodness-of-fit are converted to single tachometer where "green" alerts the user that the model is strong, "yellow" signals caution and "red" indicates that there may be a problem with the fitting. Override features are embedded to permit application of a model-independent approach where appropriate. Simulations are performed to target a desired exposure or dose as entered by the clinician and the DST pushes the user approved recommendation back into the EHR. Usability testers were highly satisfied with our DST and quickly became proficient with the software.
  
  
  CONCLUSIONS
  With early and broad stake-holder engagement we developed a clinical DST for the non-pharmacologist. This tools affords our clinicians the ability to seamlessly transition from patient assessment, to pharmacokinetic modeling and simulation, and subsequent prescription order entry.
authors.affiliation: Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation, Children's Mercy HospitalKansas City, MO, USA; Department of Pediatrics, University of Missouri-Kansas City School of MedicineKansas City, MO, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Abdel-Rahman
authors.affiliation: Department of Information Systems, Children's Mercy Hospital Kansas City, MO, USA.
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Breitkreutz
authors.affiliation: Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation, Children's Mercy Hospital Kansas City, MO, USA.
authors.forename: Charlie
authors.initials: C
authors.lastname: Bi
authors.affiliation: Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation, Children's Mercy Hospital Kansas City, MO, USA.
authors.forename: Brett J
authors.initials: BJ
authors.lastname: Matzuka
authors.affiliation: Division of Hematology/Oncology, Rainbow Babies and Children's Hospital, Case Western Reserve University Cleveland, OH, USA.
authors.forename: Jignesh
authors.initials: J
authors.lastname: Dalal
authors.affiliation: Department of Pharmacy, Children's Mercy Hospital Kansas City, MO, USA.
authors.forename: K Leigh
authors.initials: KL
authors.lastname: Casey
authors.affiliation: Department of Pediatrics, University of Missouri-Kansas City School of MedicineKansas City, MO, USA; Department of Laboratory Medicine, Children's Mercy HospitalKansas City, MO, USA.
authors.forename: Uttam
authors.initials: U
authors.lastname: Garg
authors.affiliation: Department of Information Systems, Children's Mercy Hospital Kansas City, MO, USA.
authors.forename: Sara
authors.initials: S
authors.lastname: Winkle
authors.affiliation: Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation, Children's Mercy HospitalKansas City, MO, USA; Department of Pediatrics, University of Missouri-Kansas City School of MedicineKansas City, MO, USA.
authors.forename: J Steven
authors.initials: JS
authors.lastname: Leeder
authors.affiliation: Department of Information Systems, Children's Mercy Hospital Kansas City, MO, USA.
authors.forename: JeanAnn
authors.initials: J
authors.lastname: Breedlove
authors.affiliation: Department of Information Systems, Children's Mercy Hospital Kansas City, MO, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Rivera
keywords: bone marrow transplant; decision support; software design; therapeutic drug monitoring; usability testing