Clinical Research Informatics: Scope transformation of clinical exchange

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Clinical Research InformaticsScope
transformation of clinical exchange
Education
Research

• Alistair Erskine, MD (Chief Medical Information
  Officer)

Technology
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Benefits of Health IT

• Saving Cost
• 77B savings/year1
• CBO cost/benefits2

1 Hillestad et al. Can EMR systems transform
health care? potential health benefits, savings,
and costs. Health Aff (Millwood).
200524(5)1103-1117
2 Peter R. Orszag, Congressional Budget Office,
Evidence on the Costs and Benefits of Health
Information Technology, Testimony before
Congress 7/24/08
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Benefits of Health IT

• Saving Lives
• IOM reports1, CPOE with CDS2
• EMR Maturity correlates positive outcomes3
• Evidence from handful of health systems4

1 Institute of Medicine, Crossing the Quality
Chasm A New Health System for the 21st Century,
The National Academies Press, Washington, D.C.,
2005
2 Kaushal et al Effects of CPOE and CDSS on
Medication Safety A Systematic Review, Arch
Intern Med 163, no. 12 (2003) 14091416
3 Chaudhry et al. Systematic review Impact of
health IT on quality, efficiency, and costs of
medical care Ann Intern Med. 2006144(10)742-752
4 Amarasingham R et al. Clinical Information
Technologies and Inpatient Outcomes  Arch Intern
Med. 2009 169 (2) pp108-114
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e-Iatrogenesis1 ? Do no harm?
Adverse events2
Reduced efficiency3
Physicians reject system4
1 Weiner et al e-Iatrogenesis The Most
Critical Unintended Consequence of CPOE and other
HIT J Am Med Inform Assoc. 200714387388
2 Han et al. Unexpected increased mortality after
implementation of a commercially sold CPOE
system. Pediatrics. 2005116(6)1506-1512
3 Poissant et al The Impact of EHRs on Time
Efficiency of Physicians and Nurses A Systematic
Review J Am Med Inform Assoc. 200512505516
4 Ornstein C. Hospital heeds doctors, suspends
use of software Cedars-Sinai called it unsafe.
Los Angeles Times, January 22, 2003 B1
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Office of Clinical Transformation

• Better Clinical Input Architecture
• Focus on Process and Practice Transformation
• Drive Innovation and Optimization forever

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Informatics Transformation Cube
Analytics Intelligence
Education
Research
Finance
Technology
Patient
Information Exchange
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Categories of Clinical Research

• As defined by National Institute of Health
• Patient-oriented research. Research conducted
  with human subjects (or on material of human
  origin such as tissues, specimens and cognitive
  phenomena) for which an investigator directly
  interacts with human subjects.
• Epidemiologic and behavioral studies.
• Outcomes research and health services research.

NIH Director's Panel on Clinical Research
ReportBethesda, MD National Institutes of
Health 1997
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Components of Clinical Research
Embi PJ, Payne PR, Clinical Research Informatics
JAMIA. 200916316-327
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Data Standards in Clinical Research

• Gaps exist between clinical care and research,
  but there also exist significant overlaps in the
  types of data
• Harmonization of information models for clinical
  care/research ought to occur in tandem
• Data Standards remain the critical foundation

Richesson RL, Krischer J, Data Standards in
Clinical Research JAMIA. 200714687-696
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Healthcare Standards Development
Hammond WE, Jaffe C, Kush, RD, Healthcare
Standards Development, JAHIMA 80, No7 (July 2009)
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Health IT Standards Panel

• The Healthcare Information Technology Standards
  Panel (HITSP) is a cooperative partnership
  between the public and private sectors. The Panel
  was formed for the purpose of harmonizing and
  integrating standards that will meet clinical and
  business needs for sharing information among
  organizations and systems.

http//www.hitsp.org/default.aspx
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HITSP for Public Comment

• Clinical Research Requirements, Design and
  Standards Selection
• July 30, 2009 version 1.0
• RDSS 144 (Req Design and Stds Selection)
• http//www.hitsp.org/public_review.aspx until
  August 28th
• Document Use cases
• Protocol-driven sponsored research info exchange
• Registry Reporting scenario
• Research Network scenario

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Clinical Data Xchange Stds Consort.

• CDISC is a global, open, multidisciplinary,
  non-profit organization that has established
  standards to support the acquisition, exchange,
  submission and archive of clinical research data
  and metadata. The CDISC mission is to develop and
  support global, platform-independent data
  standards that enable information system
  interoperability to improve medical research and
  related areas of healthcare.

http//www.cdisc.org/
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CDSIC Data Models
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CDISC Interoperability
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Integrating the Healthcare Enterprise

• IHE is a global initiative that creates the
  framework for passing vital health information
  seamlessly from application to application,
  system to system, and setting to setting across
  multiple healthcare enterprises. IHE does not
  create new standards, but rather drives the
  adoption of standards to address specific
  clinical needs.

http//www.ihe.net/
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IHE - Process
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Health Level 7

• This Work Group supports the HL7 mission to
  create and promote HL7 standards by developing
  RCRIM standards to improve or enhance information
  management during clinical research and
  regulatory evaluation of the safety, efficacy and
  quality of therapeutic products and procedures
  worldwide.

http//www.hl7.org
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HL7 - RCRIM

• Standards Development Organization (SDO)
• Accredited by ANSI American National Standard
  Institute
• Gradual evolution since 2002 of an EHR-TC
  (Technical Committee) special interest
• Global EHR/CR Functional Profile began
  development in 2006 through collaboration of
  PhRMA/eSource Taskforce and eClinical Forum.

http//www.hl7.org/Special/committees/rcrim/index.
cfm
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EHR/CR (Clinical Research)
http//www.ehrcr.org/index.html
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Consortium for Health IT Progress

• First meeting April 17th 2009
• Catalyzed by Aneesh Chopra
• Representatives from 10 academic and academic
  medical centers
• Goal to collaborate on eminent NIST RFP for
  Research Center to
• Study healthcare delivery models
• Study the application of Health IT to enable
  better healthcare

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Consortium for Health IT Progress

• Rapidly emerging RFPs from the Recovery Act
  prompted the need for Program Manager
• Funding identified (300k from Commonwealth
  Technology Research Fund)
• Job description created, vetted and circulated
• UVA facilitated development of collaborative
  virtual space for members https//collab.itc.virg
  inia.edu