Appl Clin Inform 2016; 07(04): 1088-1106
DOI: 10.4338/ACI-2016-05-RA-0081
Research Article
Schattauer GmbH

Iterative Development and Evaluation of a Pharmacogenomic-Guided Clinical Decision Support System for Warfarin Dosing

Brittany L. Melton
1  School of Pharmacy, University of Kansas, Lawrence, KS
,
Alan J. Zillich
2  College of Pharmacy, Purdue University, West Lafayette, IN
3  Center for Health Information and Communication, Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development
4  Regenstrief Institute, Inc
5  Indiana University Center for Health Services and Outcomes Research
,
Jason J. Saleem
6  Department of Industrial Engineering, University of Louisville, Louisville, KY
,
Alissa L. Russ
2  College of Pharmacy, Purdue University, West Lafayette, IN
3  Center for Health Information and Communication, Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development
4  Regenstrief Institute, Inc
5  Indiana University Center for Health Services and Outcomes Research
,
James E. Tisdale
2  College of Pharmacy, Purdue University, West Lafayette, IN
7  Indiana University School of Medicine, Indianapolis, IN
,
Brian R. Overholser
2  College of Pharmacy, Purdue University, West Lafayette, IN
7  Indiana University School of Medicine, Indianapolis, IN
› Author Affiliations
Funding: This work was supported by a Lilly seed grant to the Purdue University College of Pharmacy. Drs. Russ was supported in part by a VA HSR&D Research Career Development Award (CDA 11–214) and Dr. Overholser was supported in part by K08HL095655 (BRO) from the National Heart, Lung, and Blood Institute, National Institutes of Health (Bethesda, MD). Views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the U.S. government.
Further Information

Correspondence to:

Brian R. Overholser, PharmD, FCCP
Associate Professor
Purdue University College of Pharmacy
Research Institute 2: Room 402
950 W. Walnut St.
Indianapolis
IN 46202
Phone: (317) 278-4001   
Fax: (317) 880-0568   

Publication History

received: 26 May 2016

accepted: 30 September 2016

Publication Date:
18 December 2017 (online)

 

Summary

Objective Pharmacogenomic-guided dosing has the potential to improve patient outcomes but its implementation has been met with clinical challenges. Our objective was to develop and evaluate a clinical decision support system (CDSS) for pharmacogenomic-guided warfarin dosing designed for physicians and pharmacists.

Methods Twelve physicians and pharmacists completed 6 prescribing tasks using simulated patient scenarios in two iterations (development and validation phases) of a newly developed pharmacogenomic-driven CDSS prototype. For each scenario, usability was measured via efficiency, recorded as time to task completion, and participants’ perceived satisfaction which were compared using Kruskal-Wallis and Mann Whitney U tests, respectively. Debrief interviews were conducted and qualitatively analyzed. Usability findings from the first (i.e. development) iteration were incorporated into the CDSS design for the second (i.e. validation) iteration.

Results During the CDSS validation iteration, participants took more time to complete tasks with a median (IQR) of 183 (124–247) seconds versus 101 (73.5–197) seconds in the development iteration (p=0.01). This increase in time on task was due to the increase in time spent in the CDSS corresponding to several design changes. Efficiency differences that were observed between pharmacists and physicians in the development iteration were eliminated in the validation iteration. The increased use of the CDSS corresponded to a greater acceptance of CDSS recommended doses in the validation iteration (4% in the first iteration vs. 37.5% in the second iteration, p<0.001). Overall satisfaction did not change statistically between the iterations but the qualitative analysis revealed greater trust in the second prototype.

Conclusions A pharmacogenomic-guided CDSS has been developed using warfarin as the test drug. The final CDSS prototype was trusted by prescribers and significantly increased the time using the tool and acceptance of the recommended doses. This study is an important step toward incorporating pharmacogenomics into CDSS design for clinical testing.

Citation: Melton BL, Zillich AJ, Saleem JJ, Russ AL, Tisdale JE, Overholser BR. Iterative development and evaluation of a pharmacogenomic-guided clinical decision support system for warfarin dosing.


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Conflict of Interest

The authors declare that they have no conflicts of interest in the research.


Correspondence to:

Brian R. Overholser, PharmD, FCCP
Associate Professor
Purdue University College of Pharmacy
Research Institute 2: Room 402
950 W. Walnut St.
Indianapolis
IN 46202
Phone: (317) 278-4001   
Fax: (317) 880-0568