1. Electronic Data Capture Healthcare perspective
C.Daniel 1, 2, N. El Fadly 1, C.Bousquet 2, N.Lucas2, P-Y. Lastic3, P.Degoulet1, 2, G.Chatellier2
1 INSERM, U872 team20, Paris Descartes University, France
2 AP-HP,Hôpital Georges Pompidou,Paris,France
3 Sanofi-aventis R&D and CDISC Board of Directors
INSERM (French National Institute for Health and Medical Research)
13,000 people (6000 researchers) units
85% housed within university hospital or cancer treatment centers
U872 – team 20 : Knowledge engineering in Public Health and Medical Informatics
Developing information systems and medical knowledge bases & approaches for the evaluation of such systems.
Terminology systems for EHR indexation & secondary use of clinical data (registries, clinical research)

2. Secondary use of clinical data
Can EHR replace the need for eCRF?
What is the impact on the investigator or monitor roles?
What is the impact on:
Physicians/Nurses roles
IT staff role
How should the interaction model change between clinical care and clinical research actors to accelerate usage of IT solutions? And secondary usage of clinical data?

3. Context : AP-HP Patient care
Most important French University Hospital Organization with
1,000,000 hospitalized patients
38 hospitals with round 23,000 beds day care and 850 home care capacity
90,000 employees including 19,000 physicians
Single HIS/EHR: CareByThales® (Thales©) (2009)
Clinical information
Nurse notes
Discharge summaries, DRGs
Flow sheets, Care plans
Medical order
Imaging reports
Lab results
Patient focus
(Point-of-Care)
This month AP-HP has just chosen its future single EHR which be provided by the french consortium Thales-Medasys. The name of the solution will be CareByThales. This is the application dedicated to patient care.
EHR
EHR

4. Context : AP-HP Medical research
Medical Research is carried out in
18 Research Institutes, 8 Clinical Investigation Centers
(phase I & IIa, PK/PD, etc.) and 10 Clinical Research Units
100 INSERM teams
eCRF provider : ClinWeb® (TelemedicineTechnologies©)
Population focus
(Retrospective)
In AP-HP Medical Research is carried out in
18 Research Institutes, 8 Clinical Investigation Centers (phase I & IIa, PK/PD, etc.) and 10 Clinical Research Units
100 INSERM teams
Until 2010, the ECRF solution chosen by AP-HP is ClinWeb from TM supposed to be largely used for clinical trials
Clinical Trials

5. Multiple applications Multiple data forms => Redundant data entry
Context and problems
Patient focus
(Point-of-Care)
Population focus
(Retrospective)
EHR
EHR
Multiple applications
Multiple data forms
=> Redundant data entry
Clinical Trials
Clinical Research
Patient Safety
One of the current issues in CDISC is to adresse the redundancy of data entry. A physicians have to deal with lmltiple applications and forms for both patient care and external agencies (clinical trials, clinical research, patient safety, etc)
Adapted from E.D.Helton (HL7 RCRIM Co-Chair) & L.Bain (CDISC Liaison to Healthcare)

6. Integrating Patient Care & Clinical Research at HEGP
Development and deployment of IT in CRU
With respects to standards (HL7, CDISC)
Secondary use of clinical data?
Collaboration
Clinical Research Unit (Pr G.Chatellier – Dr N.Lucas)
Hospital Informatics Department (Pr P.Degoulet – Dr C.Daniel)
INSERM UMRS 872 eq 20 (M-C.Jaulent)
THALES (middleware solutions)
2 persons
PhD student – THAKES
Engineer

7. Our strategy Understanding each other’s needs
Clinical Research needs
Patient Care needs
Understanding existing standards (HL7, CDISC, IHE RFD, etc)
Iterative and incremental integration process
Use case driven : use cases capture the functional requirements and define the contents of the iterations
Standard-based (HL7, CDISC)
Syntactic alignment (HL7/CDA to CDISC/ODM) avoids double data entry, based on XForms

8. Understanding “Clinical Research (CR)” needs Actors
Actors of Clinical Research
Sponsor
Clinical Research Coordinator (CRC)
Monitor
Principal investigator / Physician
Clinical trial technician
Data manager 
IT staff
Newly involved in secondary uses of clinical data
Feeding clinical data repositories, registries, datawarehouses

9. Understanding CR needs Use cases
Use cases of Clinical Research
Clinical trial coordination
Clinical trial design (including EDC solution design)
Patient recruitment
Data capture (patient care/clinical research)
Data monitoring
Safety monitoring
Databases and interfaces administration

10. Understanding CR needs Comparing workfows with/without EHR
Using eCRF (CleanWeb)
Integrating EHR (DxCare) & eCRF
Use cases of clinical trial coordination

11. Understanding CR needs Comparing workfows with/without EHR
Using eCRF (CleanWeb)
Integrating EHR (DxCare) & eCRF
Use cases : patient scheduling, data capture, etc

12. Understanding CR needs Interaction diagrams
Data capture during the visit

13. Understanding CR needs Interaction diagrams
Patient care/clinical research interface management

14. Understanding “Patient Care” needs
Integrating the eCRF to EHR
Providing a method for gathering data within a user’s application to meet the requirements of an external system
Data could be automatically extracted from the EHR database
The form (for the external system) is designated as a clinical trial form and saved as a document in the patient’s record.
EHR
The RFD …
Thanks to a clinician uses a single
In fact if a physician,Chris Clinician has to provide data to differeznt external agency (more than one clinical trials, pateint safety solution, etc) he STILL has to ..within his EHR he will have to fill the form for the patient considered as a patient for patient care AND then to open fill a new forms for his patient considered as a study subjects. If he is lucky some fields (at least the demographics) will be automatically prepopulated by EHR mapped data.

15. Understanding “Patient Care” needs
Patient focus
(Point-of-Care)
Population focus
(Retrospective)
EHR
EHR
Alerts
Decision Support system
Clinical Trials/Patient safety/ Governmental agencies
RFD is nice of course especially wonderfull for clinical research
But from the EHR point of view
Gathering data within a user’s application to meet the requirements of an external systems is definitively NOT ENOUGH
The purpose is not only to ease data capture for external systems BUT ALSO to be sure that among these data those that may be usefull , usefull faor patient care, are properly stored in the EHR and NOT AS DOCUMENT but in a structured computable format available for Alert and Decision support system within EHR
before being a subject study A PATIENT is a PATIENT
Chris clinician records an AE that Paul Patient has had an Adverse event
Samule Sponsor, Patricia Pharmacovigilant WILL KNOW that Paul Patient has had an Adverse event SINCE Carolyn clinician (chris collegue)won’t be aware of this.
Franck FBI WILL KNOW that Paul Patient has an anthrax or influenza due to AH5N1 SINCE Chris Clinician will not be aware of this.
Carolyn Clinician
Samuel Sponsor
Patricia Pharmacovigilant
Chris Clinician
Franck FBI
Chris Clinician

16. Understanding “Patient Care” needs
Providing methods for gathering data within a user’s application to meet the requirements of BOTH external systems AND EHR »
EHR is not only a « host application »
SHARING medical data for both patient care (EHR) and clinical research
WHAT WILL BE REALLY GREAT

17. Preliminary conclusions about needs
Patient Care & Clinical Research : 2 different complex and parallel organizations and workflows (Kahn 2007)
Redundancy
Completion of the main record of a patient visit and transcribing patient information in the corresponding CRF for the clinical trial
Patient safety
Overlap between reporting forms or system(s)
Avoiding reporting SAE to the sponsor before/instead of completing EHR
Understanding workflow is critical to the design of the right IT solutions and their ultimate adoption
Columbia University’s INterTrial project (as part of the NIH Roadmap initiative to reengineer the national clinical research enterprise)
Kahn S.A. A day in the life of a clinical research coordinator : observation from community practice settings. Medinfo 2007

18. Conclusion
Understanding workflows is critical to the design of the right IT solutions and their ultimate adoption
Integrating Patient Care and Clinical Research
“Integrating the Healthcare Enterprise” (IHE)
Forum : users, IT vendors, academia
Definition of needs and of integrated workflows
Best use of existing standards (HL7, CDISC) (IHE “Integration Profiles”)
Compliance needs to be ensured (IHE Connecthatons)
Specific IHE domain : Clinical Research