Making Comparative Effectiveness
More than a Dream
Carolyn M. Clancy, MD
Director
Agency for Healthcare Research and Quality
AcademyHealth’s 2008 National Health Policy Conference
Washington, DC – February 4, 2008
Comparative Effectiveness
 Excellence & Mediocrity
 Turning Evidence Into Action
 21st Century Health Care
Excellence & Mediocrity
“A society which scorns
excellence in plumbing
simply because it is
plumbing, but rewards
mediocre philosophy simply
because it is philosophy will
soon become a society in
which neither its pipes nor its
theories will hold water.”
John W. Gardner (1961)
Scope of the Opportunity
in Health Care
 Major challenges in 21st
Century health care include
evaluating all of the
innovations and
determining which:
– Represent added value
– Offer minimal enhancements
over existing choices
– Fail to reach their potential
– Work for some patients and
not for others
Improving Evidence about
Benefits and Risks
 Comparative effectiveness
research addresses issues
including:
– Relevancy
– Timeliness
– Impact on priority populations
– Disproportionate impact on subpopulations
– The ability to impact treatment decisions
AHRQ FY 2008 Priorities
Patient Safety
 Health IT
 Patient Safety
Ambulatory
Patient Safety
Organizations
 New Patient
 Safety & Quality Measures, Safety Grants
Drug Management and
Patient-Centered Care
 Patient Safety Improvement
Corps
Medical Expenditure
Panel Surveys
Effective Health
Care Program
 Comparative
Effectiveness Reviews
 Comparative Effectiveness
Research
 Clear Findings for
Multiple Audiences
Other Research &
Dissemination Activities
 Visit-Level Information on  Quality & Cost-Effectiveness, e.g.
Medical Expenditures
 Annual Quality &
Disparities Reports
Prevention and Pharmaceutical
Outcomes
 U.S. Preventive Services
Task Force
 MRSA/HAIs
AHRQ FY 2008 Funding

$334.6 million
–
–

FY 2008 Request – $329.6 million
FY 2007 Appropriation – $318.7 million
FY 2008 appropriation includes:
–
$30 million for comparative effectiveness research

–
$5 million for research and activities to reduce Methicillin Resistant
Staphylococcus aureus (MRSA) and related infections


Double the $15 million designated in FY 2007
The first such federal grant to AHRQ for MRSA/HAIs
Congress also encouraged AHRQ to:
–
–
Consider proposals to detect medical errors and preemptively
control injury via compact medical devices
Investigate the feasibility of an open-source, no-cost license
computer model capable of predicting the effects of health care
policy alternatives to improve quality and cost-effectiveness
AHRQ Comparative
Effectiveness Research
 The additional funding for comparative
effectiveness will help ARHQ generate
a wealth of new products and tools:
–
–
–
–
The number of comparative effectiveness
reviews and technical briefs will double
New research initiated will include studies
on surgery, prescription drugs, biologics
and vaccines for Medicare beneficiaries in
priority condition areas
A new series of technical reports will
establish a foundation for guiding the
evaluation of gene-based test performance
The number of products designed to help
patients and clinicians make informed
decisions will increase
Program Enhancements
 Two reports will be commissioned for
use by AHRQ to:
– Enhance the Effective Health Care
Program’s infrastructure and growth needs
– Begin assessing the Program’s impact
 Money from the initial funding will be
used for awards to develop and
enhance individual scientist research
and methodological capacities for
conducting future comparative
effectiveness research
The Promise of Genomics:
Recent Activities



AHRQ is funding a Randomized Control Trial to clarify the added
value of genetic testing to improve warfarin dosing.
AHRQ and CDC are co-funding a DEcIDE project to review
databases focusing on utilization and outcomes of gene-based
tests and therapies
EPC Reports:
– Genomic testing in ovarian cancer
(completed)
– CYP450 testing in depression
(completed)
– HNPCC testing in colorectal
patients (completed)
– Horizon scan on cancer genetic
tests for CMS (completed)
– BRCA testing in breast and
ovarian cancers (w/USPSTF
recommendation)
– HER-2-Neu testing in breast
cancer (ongoing)
– Expression profile tests in breast
cancer (completed)
– Family history in breast, ovarian,
colorectal and prostate cancers
(completed)
– Screening for hemochromatosis
(w/USPSTF recommendation)
Comparative Effectiveness:
Effective Health Care Program


Uses current, unbiased evidence in making
head-to-head comparisons to show which
health interventions:
–
Add Value
–
Offer minimal benefit above current choices
–
Fail to reach their potential
–
Work for some patients, but not others
Builds on years of experience gained through
AHRQ’s Evidence-Based Practice centers
Goal: To develop and disseminate better evidence
about benefits and risks of alternative choices
Effective Health Care Program
A. Evidence synthesis (EPC program)
–
–
Systematically reviewing, synthesizing, comparing existing
evidence on treatment effectiveness
Identifying relevant knowledge gaps
B. Evidence generation (DEcIDE, CERTs)
–
–
Development of new scientific knowledge to address
knowledge gaps.
Accelerate practical studies
C. Evidence communication/translation
(Eisenberg Center)
–
–
Translate evidence into improvements
Communication of scientific information in plain language
to policymakers, patients, and providers
21st Century Health Care
Improving quality by promoting a culture of safety
through Value-Driven Health Care
Information-rich, patientfocused enterprises
Evidence is
continually refined
as a by-product of
care delivery
21st Century
Health Care
Information and
evidence transform
interactions from
reactive to
proactive (benefits
and harms)
Actionable information available – to
clinicians AND patients – “just in time”
The Social Case: Potential lives
saved through quality improvement
Woolf and Johnson,
How Can We
Enhance Our Efforts?
The Evolution of Translational Research
Making Better Decisions
 Many decisions in healthcare require different
types of evidence
 The demand side is as important as the
production of evidence
 Wise and prudent use of resources and
opportunities to advance effective health care
is imperative
 AHRQ’s Effective Health Care Program is the
model for how this can be achieved
www.effectivehealthcare.ahrq.gov
“Comparative Effectiveness Research typically will focus
on realistic decisions confronting patients and their
clinicians in actual practice…. Because of this focus on
effectiveness as opposed to efficacy, these investigations
will likely rely on both prospective trials and observational
data to determine relative value in real-world settings.”
IOM Roundtable on Evidence-Based Medicine