Transcript AHRQ Slide Template 2004

Increasing the Value of Data: EMRs
and Disease Registries
Elise Berliner, PhD
Director, Technology Assessment Program
Center for Outcomes and Evidence
Outline
 AHRQ’s work on registries
 Examples of state initiatives
 Future collaboration opportunities
AHRQ Effective Healthcare
Program
 The Effective Health Care Program:
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Reviews and synthesizes published and unpublished
scientific evidence.
Generates new scientific evidence and analytic tools.
Compiles research findings that are synthesized and/or
generated and translates them into useful formats for
various audiences.
 Original research reports
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These reports are based on clinical research and studies
that use health-care databases and other scientific
resources and approaches to explore practical questions
about the effectiveness — or benefits and harms — of
treatments
www.effectivehealthcare.ahrq.gov
Online at effectivehealthcare.ahrq.gov
To order printed copy: email
[email protected]
AHRQ Publication No. 10-EHC049
Second Edition: Table of
Contents
1. Patient Registries
(Overview)
2. Planning a Registry
3. Registry Design
(includes Planning for
the End of a Patient
Registry)
4. Use of Registries in
Product Safety
Assessment
5. Data Elements for
Registries
6. Data Sources for
Registries
7. Linking Registry Data:
Technical and Legal
Considerations
8. Principles of Registry
Ethics, Data Ownership,
and Privacy
9. Recruiting and
Retaining Participants
in the Registry
10. Data Collection and
Quality Assurance
11. Interfacing Registries
With Electronic Health
Records
12. Adverse Event
Detection, Processing,
and Reporting
13. Analysis and
Interpretation of
Registry Data To
Evaluate Outcomes
14. Assessing Quality
Third Edition of the
Registries Handbook
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Development began in Fall 2010; expected completion
Fall 2013
11 new chapters
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Patient reported outcomes
Registries for rare diseases
Quality improvement registries
Device registries
Best practices in obtaining informed consent
Patient identify management
Protection of data from litigation/data protection concerns
(combined)
Public-private partnerships
Statistical techniques for analyzing combined data
Pregnancy registries
Registry transitions
Registry of Patient Registries
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Create a web based repository of information on
patient registries
Develop a framework and prototype syntax for
entering definitions of outcomes into online resources
such as the registry of patient registries
Develop a white paper on the feasibility of creating a
repository for expired registries that may be linked to
the registry of patient registries
Develop a white paper on possible strategies to create
a web based collaborative space for registries
development, a forum for methods, and a research
project workspace
www.effectivehealthcare.ahrq.gov
What is a Registry?
“A patient registry is an organized system
that uses observational study methods
to collect uniform data (clinical and
other) to evaluate specified outcomes for
a population defined by a particular
disease, condition or exposure, and that
serves one or more predetermined
scientific, clinical, or policy purposes”
Registry Goals
 Improve quality of care for individual patients
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Tracking and reminders for individual patients
 Improve quality of care across the health care system
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Tracking and reminders for processes in the health system
Tracking outcomes over time such as hospital readmission
rates
 Research
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Understanding disease progression
Postmarket studies of new drugs and devices
Comparative effectiveness of clinical and process
interventions
EHRs vs. Registries
 EHRs
 Registries
– Focused on
– Focused on
individuals
– Designed to collect,
share and use
information for the
benefit of the
patient
populations
– Designed to fulfill
specific purposes
defined before the
data are collected
and analyzed
Challenges to Research
using EMRs
 Requirements for informed consent
 Preserving patient privacy when sharing
data
 Types of information collected
 Completeness of information collected
 Variable vocabularies used
Privacy Laws
 Federal Level: HIPAA
 State Level: each state has it’s own
laws
– Example: ownership of medical records
 Alabama: medical practice owns medical
records
 New Hampshire: patient owns medical records
Source: Center for Medical Records Rights and
Privacy, Georgetown University
http://hpi.georgetown.edu/privacy/records.html
Provider Participation in
Registries
 Benefits
– Meet requirements for quality reporting
– Meet legal requirements
– Meet requirements for reimbursement
 Costs
– Cost of participation
Massachusetts/Cardiac
Procedures
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2000: legislation to “develop standards and criteria to be used by
the department of public health for the purpose of collecting,
monitoring and validating patient specific outcome data for all
hospitals in the commonwealth that perform open heart surgery
or angioplasty.”
2001: state legislature mandated Mass. Dept of Health to collect
patient specific outcome data and evaluate state programs
2002: regulations that data be collected through existing
professional society registries for ALL procedures in the state
Data sent to Mass Data Analysis Center (Mass DAC) at Harvard
Medical School
Source: Mass DAC website: www.massdac.org
Lessons Learned In Mass
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Surgeons and regulators may have different preferred
approaches but a common goal of assuring the highest quality
care
Implementation of the national professional society databases
better option than “home-grown” options
Choice of statistical techniques may vary from state to state
depending on the expertise of statistical consultants and the
preferences of local regulators and advisory boards
Cardiac surgeons prefer confidential QI initiatives but demand for
public accountability is growing
Need education of the media on the limitations of the analysis
Source: Shahian DM, Torchiana DF and Normand SLT
“Implementation of a Cardiac Surgery Report Card: Lessons
from the Massachusetts Experience” Ann Thorac Surg 2005;
80:1146-1150.
CDC Stroke Registry
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2001: Congress charged CDC
with implementing state based
stroke registries in efforts of
improving quality of care
2004: CDC grants to GA, IL,
MA, NC
2007: CDC new five year grants
to GA, MA, MI, MN, OH, NC
2007: Coordination between
CDC and AHA/ASA Get with
the Guidelines program to
develop standardized stroke
performance measures
Paul Coverdell National Acute
Registry States, 2009
Source: http://www.cdc.gov/dhdsp/programs/stroke_registry.htm
NJ Stroke Registry
 New Jersey
– 2004: “Stroke Center Act” to designate hospitals
that meet certain standards as “Primary” or
“Comprehensive” stroke centers
– 2006: NJ Department of Health and Senior
Service rules that designated stroke centers
maintain a database that supports outcomes
measurement and CQI.
– 2007: Launch of state registry with data elements
that closely match Coverdell registry
Source: http://www.nj.gov/health/healthcarequality/stroke/initiatives.shtml
http://www.nj.gov/health/healthcarequality/stroke/acute_registry.shtml
Washington State: Spinal
Procedure
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Wash State workers compensation did not cover spinal cord
stimulation (SCS) for back and leg pain after surgery
The Wash Department of Labor and Industries (WLI) agreed to
reimburse for SCS if patients agree to data collection to track
outcomes in patients receiving SCS
Study included a control group of patients not receiving SCS
Results
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Low rate of successful for all groups; similar between SCS and
control at 12 months and 19 months
Adverse events associated with SCS
Some subgroups (higher mental health scores) had better
outcomes
SOURCE: Turner JA, Hollingsworth W, Comstock BA and Deyo RA
Spinal cord stimulation for failed back surgery syndrome:
Outcomes in a workers’ compensation setting PAIN 148 (2010) 1425.
AHA Recommendations for the
Future of Registries
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AHA recommends that data quality reports from clinical registries should
be made public
AHA recommends that policy makers should promote the linkage of
clinical registries to supplemental data
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Key issue: interoperability among clinical registries, health information
technology systems and databases with administrative claims, lab data and
imaging data
AHA recommends that government entities and private payers should
financially support clinical registries as a means to promote efficient and
high quality care
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Key issue: Savings from standardized data collection rather than individual
data collection for pay-for-performance system
AHA recommends that these registries be leveraged for comparative
effectiveness research and for postmarket evaluation by device and
pharmaceutical companies
SOURCE; Bufalino VJ et al. The American Heart Association’s
Recommendations for Expanding the Applications of Existing and Future
Clinical Registries: A Policy Statement From the American Heart
Association. Circulation 2011, 123: 2167-2179.
Summary Points
 Registries are an important tool to
understand the outcomes of health
interventions
 State health initiatives provide important
incentives for participation in registries
 Coordination and interoperability are key
to leverage the investment in registries
for research on other important
questions
Opportunities for
Collaboration
 Coordination between states and
between state, federal and private
initiatives
– Harmonization of data elements and
definitions
– Leveraging national registries to meet state
needs
– Analysis and comparison of data across
different states
– Sharing lessons learned
Contact
Elise Berliner
[email protected]
301-427-1612