A Comprehensive Review of the emerge Infobutton Project

Transcription

1 A Comprehensive Review of the emerge Infobutton Project Casey L. Overby 1,2, John J. Connolly 3, Luke V. Rasmussen 4 1 University of Maryland School of Medicine, 2 Geisinger Health System, 3 The Childrens Hospital of Philadelphia, 4 Northwestern University emerge Steering Committee Meeting Monday, June 29 th, 2015

2 emerge EHR Integration WG Charter (Leads: Justin Starren and Marc Williams) The emerge II consortium supports research by existing biorepositories with linked electronic health records to incorporate current genomic knowledge into clinical research and ongoing clinical care. The EHR Integration workgroup will develop emerge II consensus and concepts for: 1. EHR integration of genomic information 2. Delivery of genomic clinical decision support using the EHR

3 emerge Infobutton Project Aims Develop new information resources based on emerge II & PGx scenarios New and synthesized knowledge from emerge Optimize how content is organized Targeting compliance with the HL7 Infobutton standard required by Meaningful Use Stage 2 Implement infobuttons within EHRs at emerge institutions Aid in adoption of technology Gap analysis of current solutions Development/enhancement to improve solutions

4 Physicians used infobuttons for pharmacogenomic scenarios University of Washington Simulation Study 22 physicians (oncology and cardiology fellows) 3 prescribing scenarios for patients with genetic tests results Drug Order Entry Laboratory Review Task Context # of website visits MEDOE 74 LABVEV 98 (Cimino JJ et al. AMIA 2013) (Overby et al. JBI. 2015)

5 Physicians found websites useful University of Washington Simulation Study 22 physicians (oncology and cardiology fellows) 3 prescribing scenarios for patients with genetic tests results 4 types of content Lab Results Review (LABREV) Drug order entry (MEDOE) (Overby, Devine, et al. Making pharmacogenomic-based prescribing alerts more effective: A scenario-based pilot study with physicians. Journal of Biomedical Informatics. June 2015)

6 emerge sites are considering similar PGx scenarios Multi-site pilot of pharmacogenetic sequencing in clinical practice Site Mount Sinai, Northwestern, Vanderbilt Mayo Clinic Drug CYP2C19 - clopidogrel; CYP2C9 / VKORC1 - warfarin; SLCO1B1 - Simvastatin CYP2C19 - clopidogrel; CYP2C9 / VKORC1 - warfarin; SLCO1B1 - Simvastatin; CYP2D6 - Codeine, Tramadol, Tamoxifen Marshfield/Essentia CYP2C19 - clopidogrel; CYP2C9, VKORC1, and CYP4F2 - warfarin; SLCO1B1 - Simvastatin Group Health Geisinger Cincinnati Children s Boston Children s CHOP HLA B* Carbamazepine CYP2C19 - clopidogrel; CYP2C9 / VKORC1 - warfarin; SLCO1B1 - Simvastatin; IL28B - Interferon response CYP2D6 - Codeine CYP2C9/VKORC1 -Warfarin SLC02B1 - montelukast; ABCB1 / CYP2C19 - ranitidine + omeprazole; CYP2D6 / ABCB1 / OPRM1 / COMT / UGT2B7 - Morphine Many sites are already developing content to support these scenarios (Table borrowed from Marc Williams and Justin Starren)

7 Template Content Topics DISCERN-Genetics Question Themes (20) 1. Aims are clear 2. Aims achieved 3. Background of the condition 4. Treatment choices 5. Risk 6. Purpose of the test 7. Testing procedure 8. Test accuracy 9. After the test 10. Access to test results 11. Shared decision making 12. Discrimination 13. Psychosocial consequences 14. Consequences for others 15. Additional sources of information 16. Sources of information used 17. Date of the information 18. Balance and bias 19. Local information 20. Overall quality (Sheppard et al. Eur J Hum Genet 2006) Template Content Topics (13) 1. Clinical scenario/overview 2. Background and effects of the condition 3. Treatment and management choices for the condition 4. Risk of developing, carrying or passing on the condition 5. Types of tests available or being offered 6. Testing procedure 7. Test accuracy and reliability 8. Shared decision making 9. Potential risks (psychosocial consequences, implications of discrimination, potential consequences for others) 10. Local information 11. Additional sources of support and information 12. Content contributors 13. Date of the information (Overby, Rasmussen, Hartzler, Connolly et al. A template for authoring genomic medicine content in the emerge Infobutton project AMIA 2014)

8 Additional tailoring needed for PGx scenarios Hints and content sections didn t always appear directly relevant genetic condition implies a disease-causing genetic condition Assessed with a broad range of genetic conditions (Sheppard et al. Eur J Hum Genet 2006) Cystic fibrosis Down s syndrome Familial breast cancer Familial colon cancer Hemochromatosis Huntington s disease Sickle cell disease Thalassemia

9 Many resources have sections or sub-sections that map directly to the content topics (11 resource/drug-gene pairs) 100% 100% 100% 91% 100% 73% 64% 73% 73% 45% 45% 45% 45%

10 Practical Considerations for Genomic Medicine Resources How content is delivered Multiple modalities (EHRs, handouts, websites) Sites using multiple approaches Where content is hosted Majority only planning to use locally hosted Externally hosted as secondary links Opinion of content available There are good existing resources but need more Requires a mix of site-specific and generalizable content Takeaway Infrastructure to develop content, and allow local hosting (Rasmussen, Overby, Connolly et al., Practical considerations for implementing genomic information resources: experiences from emerge and CSER. In preparation)

11 Summary and Current Efforts Identified a need for a national effort to produce sharable genomic medicine content capable of being accessed from the EHR Guiding areas of focus for genomic medicine content development Developed provider content Conducting an end-user evaluation Guiding areas of focus for developing a content authoring environment Infobutton adoption Infobutton-enabled content authoring

12 MyResults.org

13 MyResults.org Content Originally Developed for Patients Adapted from DISCERN genetics templates Patients Goal: Help patients makes sense of PGx Results Background FAQs Risks Videos/multimedia Contact

14 MyResults.org Content Developed for Professionals Adapted from DISCERN genetics templates Goal: Facilitate Clinical Decision Support Guidelines Links to primary literature Patients FAQs Recommended resources Infobutton compatibility Providers

15 MyResults.org

16 MyResults.org

17 MyResults.org

18 MyResults.org Detailed Test Results

19 MyResults.org: For Professionals

20 User Flow Google Analytics Google Analytics, Options: Originating institution/city/state/country Path through site Page views/duration Drop-off points Etc.

21 End-user evaluation under way Goal: Gather end user perceptions of emerge-developed content on MyResults.org Survey instrument 2 prescribing scenarios: clopidogrel/cyp2c19 and warfarin/cyp2c9&vcorc1 Links to MyResults.org provider pages Includes items from the Health-IT Usability Evaluation Scale (Yen PY, Wantland D, Bakken S. AMIA 2010) Survey was distributed to emerge and collaborating institutions 18 completed surveys to date Responses from 8 institutions Others planned

22 Sample characteristics: 18 respondents 100% Attending Physicians Other: Med Peds, Pediatrics, Pediatric Hematology, Neurology clopidogrel/cyp2c19 scenario warfarin/cyp2c9&vcorc1 scenario

23 Delivery of Content Using Infobuttons (1) Generate infobutton links using the context of the EHR or patient portal (3) An infobutton manager then determines the relevant sites (2) Configure resources to access using the Librarian Infobutton Tailoring Environment (LITE) (4) Individual sites may perform simple or advanced searches for customized content UpToDate MyResults Medline Plus Internal Repository

24 Use of OpenInfobutton Led by University of Utah (Del Fiol) Includes multiple components Infobutton Manager Infobutton Responder Discovers and indexes existing content for infobutton requests Librarian Infobutton Tailoring Environment Library of resource profiles emerge contributions Early release testing Contributing to documentation Evangelism in emerge and CSER communities

25 Gap Analysis Can new content by optimized for an infobutton-capable environment? What is the optimal environment for generalizable yet customizable content? Write once, reuse multiple times Considerations for branding and attribution

26 Proposed Solution (emerge II/PGx) Allow authors to develop content using a rich authoring environment Leverage existing content management systems (CMS) Start with Joomla (MyResults.org) Annotate articles and parts of the text with context flags e.g. This article is about CYP2C19 and clopidogrel, but this section in the article is about poor metabolizers Compatible with HL7 infobutton standard Accessible to OpenInfobutton, EHRs, etc.

27 Infobutton-Enabled Content Authoring Annotation Provide context elements (per HL7 infobutton standard) to describe the purpose of different articles and sections. emerge Infobutton CMS Indexing Convert the inline annotations to a database for faster retrieval and discovery on requests. Searching Handle HL7 infobutton requests, and determine most relevant article(s) to display. Display Optimize the display of articles based on the context of the original request. Code currently available for collaboration on University of Maryland GitLab instance

28 Example - Clopidogrel

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33 {ib-article clopidogrel~ MEDOE medication order entry~ PROV informationrecipient Provider } {/ib-article} <a name="guidelines"></a> <p><b>guidelines, OVERVIEW</b> <br>in 2013, the Clinical Pharmacogenetics Implementation Consortium (CPIC) of the National Institutes of Health's Pharmacogenomics Research Network issued a series of guidelines related to the... {ib-section extensive metabolizer } <a name="extensive_metabolizers"></a> <h2 class="ibsectiontitle">extensive Metabolizers:</h2> <div class="ibsectioncontent">... {/ib-section}

34 Phase III Technical CDS-linking to MyResults.org Add CMS import capabilities Browser-plugin for personalized annotations MyResults.org integration Improving CMS annotation experience Expand to additional CMSs (as necessary) Evaluation Using emerge CMS to customize content MyResults.org Google analytics Content development More drug-gene pairs Developed: Azathioprine (+mercaptopurine, thioguanine), Clopidogrel, Warfarin Planned: Omeprazole, morphine, montelukast, simvastatin, more Continued revisions to existing content Disease-specific resources Review/update of existing content RoR materials (Iftikhar)

35 Potential collaborations OpenInfobutton Project (Guilherme Del Fiol) Information Responder LITE (Jim Cimino) CSER EHR WG Recent CSER/eMERGE collaboration to understand where and how genetic information should be displayed in the EHR (Brian Shirts) Defined genetic categories & proposed clinical use examples Disease defining/diagnostic, risk actionable, pharmacogenomics, etc. Future collaboration: designing sharable modules for genetic categories in the CMS ClinGen EHR WG ClinGen web resources on ClinicalGenome.org (Marc Williams) Integrating OpenInfobutton with genomic resources (Bret Heale) Future collaboration: MyResults.org as a web resource IGNITE Clinical Informatics Interest Group (Josh Peterson, Casey Overby)

36 Acknowledgments University of Washington/Group Health Andrea Hartzler, PhD James D. Ralston Gail P. Jarvik, MD, PhD Vanderbilt University Josh F. Peterson, MD, MPH Josh C. Denny, MD, MS Sarah Stallings, PhD Mayo Clinic Iftikar J. Kullo, MD Christopher G. Chute, MD, DrPH (JHU) Robert R. Freimuth, PhD Northwestern University Justin Starren, MD, PhD RoseMary E. Hedberg, MA Vivian Pan, MS, CGC Aniwaa Owusu Obeng,PharmD Cincinnati Children's Hospital/Boston s Children s Hospital Ingrid Holm, MD, MPH Beth Cobb, MBA Marshfield Clinic Peggy L. Peissig, PhD CSER Collaborators Brian H. Shirts, MD, PhD (Univ. of Washington) Peter Tarczy-Hornoch, MD (Univ of Washington) Guilherme Del Fiol, MD, PhD (University of Utah) James Cimino, MD (University of Alabama at Birmingham) Geisinger Health System/Univ of Maryland Marc S. Williams, MD Alan Shuldiner, MD Amber Beitelshees, PharmD, MPH Mount Sinai Hospital emerge EHRI WG members emerge CERC WG members

37 Questions?