1. Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall AMIA 2009 panel (CRI WG sponsored) Joyce C. Niland, PhD, MS1, Gilan El Saadawi, MD, PhD2, Chunhua Weng, PhD3, Vojtech Huser, MD, PhD 4, Jason P. Jones, PhD5,6, Rachel Richesson, PhD7 1City of Hope National Medical Center, Duarte CA; 2University of Pittsburgh. Pittsburgh, PA; 3Columbia University, New York, NY; 4Biomedical Informatics Research Center, Marshfield Clinic Research Foundation, Marshfield, WI; 5Intermountain Healthcare, Salt Lake City, UT; 6University of Utah, Salt Lake City, UT, 6University of South Florida, Tampa, FL

2. Some are slides not included

3. Vojtech Huser Survey results

4. Survey Investigate current technologies Convenience sample of institutions Qualitative analysis (structured interviews) Example scenario (Hodgkin Lymphoma) –1. Number of HL patients in 2008 –2. Strategy to enroll HL patients in 2010 –3. Additional questions (additional tests, future plans) Related Standards and Initiatives (BRIDG, Arden Syntax, caGrid, i2b2, CCHIT)

5. Institutions Different types of institutions –university affiliated medical centers, integrated delivery network Range of other factors –home-grown EHR vs. vendor, CTSA site Institutions –Columbia U –U of Pittsburg –Marshfield Clinic –Intermountain Healthcare –City of Hope Medical Center

6. 1. Query How many Hodgkin Lymphoma patients in 2008? Mediated data warehouse request Non-mediated system Example: Intermountain Healthcare –Clinical Programs framework –Designated analyst with expert data warehouse knowledge for a given domain http://intermountainhealthcare.org/about/quality/Pages/ClinicalPrograms.aspx

8. 2. Screening How can you enroll new HL patients (2010)? Wide variation, active area of research Data source: EHR system vs. Data Warehouse Example1: Columbia university –Vigilance system –Standard: Arden Syntax Example2: Marshfield Clinic –FlowGuide system (pilot phase) –Standard: XML process definition language

9. Example 2: Marshfield Clinic Editor Execution Engine

10. Patient self-referral example http://clinicaltrials.coh.org

11. 3. Follow-up Are you willing to undergo additional tests? Are you planning to be pregnant? Paper based Case Report Forms (CRF) Size of the study (local, consortium, industry) Standards: role of BRIDG? Research features of EHR systems (CCHIT) Clinical Trial Management System (CTMS) capabilities

12. CTMSs

14. Electronic research form within PHR

15. Form setup example (Velos): Are you willing to undergo additional tests? Data element creation: Form creation: (XSLT+JavaScript; FieldID)

16. Survey conclusions Existing standards are not equally adopted by surveyed sites Limited ability of existing standards to represent and distribute a query, enrolment logic and follow-up questions Survey limitations

17. Future New initiatives –ERGO and OCRe –New Oct 2009 release of BRIDG (ver 3.0) –HL7: Clinical Research Filtered Query Service CTMS vendors –Standard adoption –Proprietary solutions Niland (2008), Sim (2008), Tu (2008), Wang (2009)