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BIOLOGIC PRECISION DOSING IS NOW AVAILABLE AT THE BEDSIDE FOR CHILDREN AND ADULTS WITH INFLAMMATORY BOWEL DISEASE RECEIVING INFLIXIMAB


 
 
 There is significant variability in infliximab (IFX) pharmacokinetics (PK) in children and adults with multiple population PK models developed and several covariates identified to better predict drug clearance. Fortunately, therapeutic drug monitoring (TDM) is widely available and can be used to simplify model-informed precision dosing. However, empiric (“trial and error”) dose intensifications following TDM to achieve targeted levels can delay obtaining an optimal drug exposure and is a risk for super-therapeutic levels. In this study, we highlight the formal processes to create a clinical decision support tool (CDST) for IFX and assess the physician usability of the novel CDST.
 
 
 
 The development team included a PK software consultant, pharmacologists, pediatric gastroenterologists, nurses, software architects, and a human factor engineering firm (Pomiet, Dayton, OH). CDST development occurred in 4 distinct phases (sprints). Design sprints started with structured interviews with key stakeholders and finished with the creation of CDST wireframes (prototypes). Physician usability was assessed with the System Usability Scale (SUS)1 at 3 timepoints.
 
 
 
 CDST design sprints included in-person interviews with 11 unique health care providers (8 physicians) over 26 sessions. During Phase I, clinicians noted current practices and systems to dose optimize biologics are “cumbersome” and “not user-friendly” as key patient data to make informed decisions are in disparate locations within the electronic medical record (EMR). From Phase I to Phase IV, the design team used the wireframes for user feedback, made changes and developed the final CDST, RoadMABTM. Next, information services (IS) personnel integrated the CDST within the EMR. Patient data extraction occurs with a Fast Healthcare Interoperability Resources (FHIR) launch and produces an embedded browser within EMR. Additionally, our team created a standalone replica of the EMR CDST that is secured by Microsoft Azure and hosted by Amazon Web Services. Our precision dosing CDST is supported by PK software that incorporates past IFX administrations and laboratory results (covariates and drug concentrations), conducts Bayesian PK estimation using the selected population PK model and displays the past and predicted concentration-time profiles (Figure 1A). In order to simplify precision dosing during IFX induction, we also created the New Start Wizard within RoadMABTM. Finally, The SUS was administered at three timepoints with a minimum of 2 new physicians at each session. Physician clinical experience is presented in Table1. By the completion of RoadMABTM, the final mean (SD) SUS was 86.5/100 (15.2, Figure 1B).
 
 
 
 Our team has created a usable CDST for IFX that is now integrated within the EMR and available as a web portal for bedside (point-of-care) precision dosing.
