development, selection, and adoption of clinical research eligibility representation standards and...

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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

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Page 1: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

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

Page 2: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

• Some are slides not included

Page 3: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

Vojtech Huser

• Survey results

Page 4: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

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)

Page 5: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

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

Page 6: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

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

Page 7: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall
Page 8: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

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

Page 9: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

Example 2: Marshfield ClinicEditor

Execution Engine

Page 10: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

Patient self-referral example

http://clinicaltrials.coh.org

Page 11: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

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

Page 12: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

CTMSs

Page 13: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall
Page 14: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

Electronic research form within PHR

Page 15: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

Form setup example (Velos): Are you willing to undergo additional tests?

Data element creation:

Form creation: (XSLT+JavaScript; FieldID)

Page 16: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

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

Page 17: Development, Selection, and Adoption of Clinical Research Eligibility Representation Standards and Screening Methods: Current and Future Directions fall

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)