title: Practical considerations in genomic decision support: The eMERGE experience.
abstract: BACKGROUND
  Genomic medicine has the potential to improve care by tailoring treatments to the individual. There is consensus in the literature that pharmacogenomics (PGx) may be an ideal starting point for real-world implementation, due to the presence of well-characterized drug-gene interactions. Clinical Decision Support (CDS) is an ideal avenue by which to implement PGx at the bedside. Previous literature has established theoretical models for PGx CDS implementation and discussed a number of anticipated real-world challenges. However, work detailing actual PGx CDS implementation experiences has been limited. Anticipated challenges include data storage and management, system integration, physician acceptance, and more.
  
  
  METHODS
  In this study, we analyzed the experiences of ten members of the Electronic Medical Records and Genomics (eMERGE) Network, and one affiliate, in their attempts to implement PGx CDS. We examined the resulting PGx CDS system characteristics and conducted a survey to understand the unanticipated implementation challenges sites encountered.
  
  
  RESULTS
  Ten sites have successfully implemented at least one PGx CDS rule in the clinical setting. The majority of sites elected to create an Omic Ancillary System (OAS) to manage genetic and genomic data. All sites were able to adapt their existing CDS tools for PGx knowledge. The most common and impactful delays were not PGx-specific issues. Instead, they were general IT implementation problems, with top challenges including team coordination/communication and staffing. The challenges encountered caused a median total delay in system go-live of approximately two months.
  
  
  CONCLUSIONS
  These results suggest that barriers to PGx CDS implementations are generally surmountable. Moreover, PGx CDS implementation may not be any more difficult than other healthcare IT projects of similar scope, as the most significant delays encountered were not unique to genomic medicine. These are encouraging results for any institution considering implementing a PGx CDS tool, and for the advancement of genomic medicine.
authors.affiliation: Department of Preventive Medicine, Division of Health and Biomedical Informatics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
authors.forename: Timothy M
authors.initials: TM
authors.lastname: Herr
authors.affiliation: Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
authors.forename: Suzette J
authors.initials: SJ
authors.lastname: Bielinski
authors.affiliation: The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine, Mount Sinai, New York, USA.
authors.forename: Erwin
authors.initials: E
authors.lastname: Bottinger
authors.affiliation: Division of Genetics and Endocrinology, Cook Children's Medical Center, Fort Worth, Texas, USA.
authors.forename: Ariel
authors.initials: A
authors.lastname: Brautbar
authors.affiliation: Center for Human Genetics, Marshfield Clinic Research Foundation, Marshfield, Wisconsin, USA.
authors.forename: Murray
authors.initials: M
authors.lastname: Brilliant
authors.affiliation: Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Chute
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
authors.forename: Beth L
authors.initials: BL
authors.lastname: Cobb
authors.affiliation: Department of Biomedical Informatics, Vanderbilt University, Baltimore, MD, USA.
authors.forename: Joshua C
authors.initials: JC
authors.lastname: Denny
authors.affiliation: Department of Pediatrics, The Children's Hospital of Philadelphia, The Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
authors.forename: Hakon
authors.initials: H
authors.lastname: Hakonarson
authors.affiliation: Group Health Research Institute, Seattle, Washington, USA.
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Hartzler
authors.affiliation: Department of Biomedical Informatics, Columbia University Medical Center, New York, USA.
authors.forename: George
authors.initials: G
authors.lastname: Hripcsak
authors.affiliation: Icahn School of Medicine, Mount Sinai, New York, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Kannry
authors.affiliation: Center for Biomedical Informatics, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Isaac S
authors.initials: IS
authors.lastname: Kohane
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA.
authors.forename: Iftikhar J
authors.initials: IJ
authors.lastname: Kullo
authors.affiliation: Nationwide Children's Hospital, Columbus, Ohio, USA.
authors.forename: Simon
authors.initials: S
authors.lastname: Lin
authors.affiliation: Department of Pharmacy, Division of Genetics and Genomics, Boston Children's Hospital, Boston, Massachusetts, USA.
authors.forename: Shannon
authors.initials: S
authors.lastname: Manzi
authors.affiliation: Department of Pediatrics, University of Cincinnati College of Medicine, Division of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
authors.forename: Keith
authors.initials: K
authors.lastname: Marsolo
authors.affiliation: University of Maryland School of Medicine, Baltimore, Maryland, USA.
authors.forename: Casey Lynnette
authors.initials: CL
authors.lastname: Overby
authors.affiliation: Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
authors.forename: Jyotishman
authors.initials: J
authors.lastname: Pathak
authors.affiliation: Biomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, Wisconsin, USA.
authors.forename: Peggy
authors.initials: P
authors.lastname: Peissig
authors.affiliation: Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
authors.forename: Jill
authors.initials: J
authors.lastname: Pulley
authors.affiliation: Group Health Research Institute, Seattle, Washington, USA.
authors.forename: James
authors.initials: J
authors.lastname: Ralston
authors.affiliation: Department of Preventive Medicine, Division of Health and Biomedical Informatics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
authors.forename: Luke
authors.initials: L
authors.lastname: Rasmussen
authors.affiliation: Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
authors.forename: Dan M
authors.initials: DM
authors.lastname: Roden
authors.affiliation: Weis Center for Research, Geisinger Clinic, Danville, Pennsylvania, USA.
authors.forename: Gerard
authors.initials: G
authors.lastname: Tromp
authors.affiliation: Molecular Pathology, Mashfield Labs, Marshfield, Wisconsin, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Uphoff
authors.affiliation: Department of Biomedical Informatics, Columbia University, New York, USA.
authors.forename: Chunhua
authors.initials: C
authors.lastname: Weng
authors.affiliation: Department of Pediatrics, Harvard Medical School, Division of Genetics and Genomics, Boston Children's Hospital, Boston, Massachusetts, USA.
authors.forename: Wendy
authors.initials: W
authors.lastname: Wolf
authors.affiliation: Genomic Medicine Institute, Geisinger Health System, Danville, Pennsylvania, USA.
authors.forename: Marc S
authors.initials: MS
authors.lastname: Williams
authors.affiliation: Department of Preventive Medicine, Division of Health and Biomedical Informatics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
authors.forename: Justin
authors.initials: J
authors.lastname: Starren
keywords: Clinical decision support; genomic medicine; personalized health care; pharmacogenomics; precision medicine