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

• Some are slides not included

Vojtech Huser

• Survey results

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)

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

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

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

Example 2: Marshfield ClinicEditor

Execution Engine

Patient self-referral example

http://clinicaltrials.coh.org

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

CTMSs

Electronic research form within PHR

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

Data element creation:

Form creation: (XSLT+JavaScript; FieldID)

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

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)