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6
Moving Forward
INTRODUCTION
Expanded capacity to develop and apply insights from comparative
effectiveness research (CER) is central to providing better information for
healthcare decisions of patients and their caregivers, understanding how to
appropriately tailor care of individual patients, and ensuring greater overall
value of health care delivered. The wide range of challenges and needs—
with respect to the work, information and data networks, and workforce
required for CER—discussed at the workshop helped identify some initial
priorities for immediate action. The pace of progress depends on aligning
incentives, encouraging needed culture change, and developing tools to bet-
ter support both the generation of insights from care through CER and the
seamless application of findings in clinical decision making.
Given the large scope and scale of transformation needed, moving
forward will require a long-term strategy that prioritizes and sequences
needs, engages all stakeholders, and builds sustained, cross-sector support.
The final session of the workshop featured discussion of key elements of
a roadmap, quick hits, and opportunities to build support. This chapter
includes a synthesis of this session’s discussion, as well as an overview of
the workshop’s common themes and possible follow-up actions to be con-
sidered for ongoing multistakeholder involvement through the Institute of
Medicine (IOM) Roundtable on Value & Science-Driven Health Care.
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LEARNING WHAT WORKS
THE ROADMAP—POLICIES, PRIORITIES,
STRATEGIES, AND SEQUENCING
Maximizing the returns on the considerable investment of time, human
resources, and money inherent to expanding CER capacity will require an
understanding of the broad range of policy needs, how existing resources
might be best deployed, and a sense for how quickly various elements can
be taken to the scale needed. Stuart Guterman, senior program director
for the Commonwealth Fund’s Program on Medicare’s Future, outlines
six broad policy areas in need of consideration: data, methods, workforce,
organization, translation, and financing. Guterman noted that a roadmap
for progress would identify clear end goals for each area, priority needs
within and between categories, and key actors or existing infrastructure
that could help initiate the activities needed. The following summarizes key
points from workshop discussions to provide a starting point.
ata. Capacity is needed to produce data relevant to healthcare
D
•
decision making by providers, patients, payers, and policy makers;
to ensure that the value of data is maximized by integrating these
data and establishing sustainable system linkages; and to develop
systems that make data and information available to appropriate
users when, where, and how they are needed. While these data
exist to some extent, attention needs to be focused on current gaps
and how emerging health information technologies (HITs) might
be applied to meet new data needs. As electronic health record
(EHR) capacity is adopted across the nation, the focus should be
on ensuring their usefulness—beyond billing and administration—
for research and decision support. For existing resources, work to
integrate and link disparate data sources and develop standards
will provide an important foundation for progress, but enhanced
data sharing among stakeholders will require attention to privacy
and data stewardship issues.
ethods. Research approaches are needed that meet the needs of
M
•
CER end users by providing timely information that is relevant to
real-world patients and decisions faced at the point of care. Prior-
ity needs include a better understanding of current methods most
useful for particular questions, the development of methodological
standards for these approaches, and investment to accelerate new
innovative methods that enable real-time analysis and learning.
Infrastructure to support methods development and to streamline
the conduct of clinical research will help accelerate this work.
ersonnel development. A cadre of professionals is needed—from
P
•
across healthcare sectors—dedicated to and trained in the use of
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MOVING FORWARD
tools and techniques for developing and applying comparative
effectiveness information. Current training and education programs
need to be reevaluated on how they might be best aligned with the
workforce needs of CER, and investment could be targeted to orga-
nizations and investigators that foster the type of multidisciplinary
and translational activities characteristic of CER. Clarification of
the scope and anticipated scale of research needs will help guide
resource use.
rganization. Prioritization and coordination across the many
O
•
organizations engaged in various aspects of evidence development—
primary research, synthesis, and translation—will enable more effi-
cient production of needed information. Assessment of capacities
that would most benefit from centralized coordination is para-
mount, as is the exploration of the governance and funding struc-
tures that might facilitate greater public–private collaboration
around issues of common concern.
ranslation. Additional focus is needed to ensure evidence is applied
T
•
in healthcare decision making. A focus on processes, tools, and
related capacities that ensures the broader application of evidence
in clinical decision making might begin with an immediate focus
on guidelines development processes. Also suggested are efforts to
bring research closer to the practice environment and enable learn-
ing in the postmarket environment.
inancing. Sufficient and sustained funding will be needed to estab-
F
•
lish and support CER and its application as an integral part of the
U.S. healthcare system. While funding mechanisms will depend in
part upon the nature of any entity charged with this work, imme-
diate attention can be focused on other funding mechanisms, such
as incentives and grants, that might be better structured to support
advances in the development and application of comparative effec-
tiveness information.
Comments by three respondents highlighted specific opportunities.
Elaine Collier, assistant director for clinical research at the National Cen-
ter for Research Resources, suggested that the National Institutes of Health
(NIH) Clinical and Translational Science Awards (CTSA) program could
play a role in expanded CER by virtue of its fundamental focus on infra-
structure development targeting a variety of areas: using informatics to
advance research; engaging physicians, patients, and other stakeholders
in developing a better understanding of how advances in health care are
made; training the next generation of investigators and supporting profes-
sional development; transforming processes and making them more effec-
tive across institutions; and emphasizing rigor and quality of studies in
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LEARNING WHAT WORKS
study design, biostatistics, and clinical research ethics. The CTSA program
could help foster the development of transformational strategies locally at
individual institutions as well as help disseminate these successful strategies
at a national level.
Jane Horvath, senior director for global public policy at Merck, sug-
gested giving attention to ensuring adequate support for the many infra-
structure needs identified. The development of a national electronic data
system for health care, for example, requires the development of a sound
business model and funding through private channels or consensus on such
a resource as a social good to be supported largely by public funds. Device
and pharmaceutical manufacturers can contribute to CER and help to fill
evidence gaps, but emphasis is also needed on supporting the innovation
these companies bring to the system. Changes in public policies, such as
patent law, licensure, and Stark regulations, might help to support CER by
stimulating premarket research and the generation of more data prior to a
product being licensed.
Bruce H. Hamory, executive vice president and chief medical officer
emeritus at Geisinger Health System, suggested that guidelines are needed
that better ensure that evidence development results in lowered costs and
better health care in the real world. Existing registries for cardiovascular
disease were cited as resources that truly inform patient decision making,
and Hamory emphasized the central importance of resolving data gover-
nance and privacy regulation issues to facilitate the development of similar
resources. Other priorities from his perspective included the development of
new models for information sharing, infrastructure for CER-related train-
ing, accelerated translation of studies into evidence, and models of financing
tied to patient benefits and cost reductions.
COMMON THEMES IN WORKSHOP DISCUSSIONS
Common themes reoccurring in the 2 days of discussion are summa-
rized in Box 6-1, and elaborated in the text that follows:
C
are that is effective and efficient stems from the integrity of the
•
infrastructure for learning. The number of medical diagnostics and
treatments available to patients and caregivers is increasing, but the
knowledge about their effectiveness—in particular, their compara-
tive effectiveness—is not keeping pace. This is in part a function of
the rate of change, but it is also a product of capacity that is both
underdeveloped and, as several participants noted, substantially
fragmented, which leads to gaps, inefficiencies, and inconsistencies
in the work. The accelerating rate of change in the interventions
requiring effectiveness assessment compels a substantial shoring up
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9
MOVING FORWARD
in the level of effort, the nature of the effort, and the coordination
of the effort in order to produce the necessary insights into the right
care for different people under different circumstances.
C
oordinating work and ensuring standards are key components of
•
the evidence infrastructure. Several presentations highlighted the
point that substantial activity is currently under way in effective-
ness research, including work on comparative effectiveness, but
the activities are fragmented and often redundant in both struc-
ture and function. The fact that the application of evidence lags
behind its production is in part a function of the disparate and
“siloed” approaches between and within organizations seeking
and developing information. The notions of infrastructure for evi-
dence development therefore also include the capacity for greater
coordination in the setting of study priorities; the development of
BOX 6-1
Infrastructure Required for Comparative Effectiveness
Research: Common Themes
• are that is effective and efficient stems from the integrity of the in-
C
frastructure for learning.
• oordinating work and ensuring standards are key components of the
C
evidence infrastructure.
• earning about effectiveness must continue beyond the transition from
L
testing to practice.
• imely and dynamic evidence of clinical effectiveness requires bridg-
T
ing research and practice.
• urrent infrastructure planning must build to future needs and
C
opportunities.
• eeping pace with technological innovation compels more than a
K
head-to-head and time-to-time focus.
• eal-time learning depends on health information technology
R
investment.
• eveloping and applying tools that foster real-time data analysis is an
D
important element.
• trained workforce is a vital link in the chain of evidence
A
stewardship.
• pproaches are needed that draw effectively on both public and pri-
A
vate capacities.
• fficiency and effectiveness compel globalizing evidence and local-
E
izing decisions.
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20 LEARNING WHAT WORKS
systematic decisions for the conduct of CER, systematic reviews,
and guideline development; and ensuring the consistent translation
of developed information. The identification of priority conditions,
evaluation, and evidence gaps is needed in order to target limited
resources, especially for high-cost or high-volume procedures and
interventions.
L
earning about effectiveness must continue beyond the transi-
•
tion from testing to practice. “The learning process cannot stop
when the label is approved,” one meeting participant pointed
out. Premarket testing for the safety and effectiveness of various
interventions cannot assess the results for all populations or the
circumstances of use and differences in practice patterns, so gath-
ering information as interventions are applied in practice settings
should represent a key focus in designing the infrastructure to learn
which care is best. Local coverage decisions and private insurer use
of coverage with evidence development approaches were cited as
opportunities to learn as a part of the care process.
T
imely and dynamic evidence of clinical effectiveness requires
•
bridging research and practice. The historical insulation of clinical
research from the regular delivery of healthcare services evolved to
facilitate data capture and control for confounding factors. With
the prospect of electronically enhanced data capture, and statisti-
cal approaches to improve analysis, as well as increasing demand
to keep pace with technologic innovation, this divide increasingly
limits the usefulness of research results. Efforts are under way to
better engage health delivery organization, practitioners, patients,
and the community in research prioritization, conduct and results
dissemination.
C
urrent infrastructure planning must build to future needs and
•
opportunities. Research is often driven more by the methods than
the questions. In fact, both are important, and infrastructure plan-
ning must account for both the key emerging healthcare ques-
tions and the key emerging CER opportunities. Emerging questions
include those related to the management of multiple co-occurring
chronic diseases of increasing prevalence in an aging population,
the improved insights into individual variation relevant to both
treatments and diagnostics, and the impact of innovation in short-
ening the lifecycle of any particular intervention. Emerging tools
include innovations in trial design, the development of new statisti-
cal approaches to data analysis, and the development of electronic
medical and personal health records.
K
eeping pace with technological innovation compels more than a
•
head-to-head and time-to-time focus. Much of the current discus-
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2
MOVING FORWARD
sion about CER has emphasized the need for more clinical trials and
more head-to-head studies. Although there are numerous examples
of diagnostic and treatment interventions for which such studies
are needed, the notion of a research process that essentially offers
periodic and static determinations is inherently limited. Especially
with the rapid pace of change in the nature of interventions and the
difficulty, expense, and time required to develop studies—and the
challenges of ensuring the generalizability of results in the face of
limitations of traditional approach to randomized controlled trials
(RCTs)—a first-order priority for effectiveness research is the estab-
lishment of infrastructure for a more dynamic, real-time approach
to learning. Leveraging new tools, such as HIT, should allow for a
more networked and distributed approach to information sharing
and evidence creation.
R
eal-time learning depends on HIT investment. It was noted that
•
collecting data is the most time-intensive part of trials and stud-
ies, and information technology (IT) is critical to streamlining this
work. Moreover, it is the key to accelerated learning from broader-
based clinical experience. We heard that “[t]he type of learning
needed cannot be paper based.” The increasing complexity of
the factors involved in understanding the effectiveness of clinical
options under different circumstances requires a blend of data-
base access and computing power that can only be provided from
broadly applied HIT. Although not in itself sufficient to produce
the information required for better medical care management, it is
a necessity for the continuous improvement expected of a learning
health system. A policy framework for privacy and security will be
necessary to build and maintain public trust that information will
be protected as it is shared.
D
eveloping and applying tools that foster real-time data analysis
•
is an important element. The scope and scale of evidence needs
suggests that innovation is needed across the range of research
methods, from making clinical trials faster and less expensive to
moving beyond RCTs to better address practical circumstances,
using registries, observational databases, and other emerging data
resources. If full advantage is to be taken of HIT, statistical tools
and analytic algorithms that can be embedded in databases to allow
real-time insights will be important. Similarly, tools are needed that
will allow findings to be drawn from databases built on different
vendor platforms, using semantic technology to integrate currently
disparate medical data, in order to develop the next generation
of statistical tools for the analysis of clinical data, including the
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22 LEARNING WHAT WORKS
building of models that allow insights to be generated by virtual
studies.
A
trained workforce is a vital link in the chain of evidence stew-
•
ardship. As in many other domains, progress in CER will relate
to the capacity to develop and maintain the broad and diversely
skilled workforce needed. Mention was often made of that factor
as a determining element as well for progress in development of
the learning health system. Given the pace of change in the num-
ber and variety of clinical interventions as well as in the tools and
approaches to assessing them, there is a need to ensure that these
developing opportunities are matched by the skills of the work-
force. This includes training and education in the methodologies
of research design, translating research, guideline development, and
maintaining and mining clinical records. But it also includes atten-
tion to reorienting the education of frontline caregivers around
their emerging responsibilities for access, interpretation, and dis-
cussion with patients of a dynamic evidence base, as well as help-
ing to ensure the availability and integrity of the clinical data that
shape conclusions on evidence.
A
pproaches are needed that draw effectively on both public and
•
private capacities. Several times in the course of the meeting it
was pointed out that although the total investment in CER in the
United States is substantial, it is inefficient because of the absence
of a vehicle for common priority setting and coordination of efforts
and because the work on effectiveness done by private companies
in product development and testing is usually not accessible to
the broader community. In aggregate, private investment often far
exceeds public investment in assessing a given intervention, but
even when available, studies associated with an enterprise with a
commercial stake may be viewed suspiciously. Several models are
in development to establish public–private collaborative efforts to
improve the efficiency and effectiveness of the work.
E
fficiency and effectiveness compel globalizing evidence and local-
•
izing decisions. Two presentations featured international work,
including the Cochrane Collaboration on evidence synthesis, and
efforts in Ontario, Canada, to develop and apply insights about
the comparative effectiveness of clinical interventions. Reference
was made throughout the meeting to work going on elsewhere
in the world and, in particular, to work at the National Institute
for Health and Clinical Excellence in the United Kingdom. This
brought clearly into play the need to ensure that, where possible,
common work to assess an intervention’s clinical effectiveness—or
collective work to assess the body of evidence—be collaborative
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MOVING FORWARD
and well coordinated across boundaries, while also being mindful
that different cultural and policy environments may lead to differ-
ent decisions at the local level.
KEY FACTORS AND NEEDS
Workshop speakers described a number of implications of the current
state of play for the development of an infrastructure for CER (Box 6-2).
These included the following:
everal elements are involved in infrastructure development .
S
•
Developing the infrastructure for CER has at least five dimen-
sions: putting in place the physical capacity (i.e., the hardware);
developing the analytic tools and methods; training the workforce;
establishing processes for efficient and effective operation; and
shaping the strategy for attention and phasing. Presentations at
the meeting described and discussed in qualitative terms the needs
and challenges in each of these dimensions and offered “opening
bid” quantitative estimates on the needs for the IT infrastructure,
as well as for investments in human capital. Refinements of these
first approximations will be needed, as will additional clarity on the
BOX 6-2
Key Factors and Needs for Expanded Comparative
Effectiveness Research Capacity
• Several elements are involved in infrastructure development:
o utting in place the physical capacity (i.e., the hardware),
p
o developing the analytic tools and methods,
o training the workforce needed,
o establishing processes for efficient and effective operation, and
o shaping the strategy for attention and phasing.
• S
trategies and priorities for infrastructure application include the
following:
o conduct of systematic reviews,
o conduct of primary research,
o clinical registry resources,
o introduction of health information technology throughout practice,
o fostering public and private collaboration, and
o keeping focus on the utility and impact of a networked world.
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2 LEARNING WHAT WORKS
analytic tools, processes, and strategies for a stronger infrastructure
for research into effective health care.
S
trategies and priorities for infrastructure application. The dimen-
•
sions noted above represent in certain ways the functional dimensions
of relevance to the infrastructure that is needed for effectiveness
research. There are phasing considerations as well, in part driven
by the ability and need to take actions even without additional
resources and in part driven by the time required to set in motion
the necessary activities. Suggestions for key strategies and priorities
for progress included the following:
o onduct of systematic reviews. There is an immediate need to
C
improve the conduct, coordination, and consistency of system-
atic reviews—a point that, in effect, echoed the recommenda-
tions of the 2008 IOM report Knowing What Works in Health
Care: A Roadmap for the Nation, presented by a member of that
committee.
o onduct of primary research. Similarly, the approach to pri-
C
mary research on effectiveness needs a more systematic means
of determining priorities, better tools and more streamlined
designs, and a deeper bench workforce to do the work.
o linical registry resources. In making the transition to a pat-
C
tern of real-time, continuous learning in health care—in effect,
creating a beta approach to clinical data systems that generate
learning—the technologies for clinical registries and in the field
of registry development, maintenance, and improvement will
need to be strengthened.
I
ntroduction of HIT throughout practice. In the area of IT
o
development, the issues include the need to install appropriate
hardware in virtually every clinical setting, the incorporation
into operating software of design elements that are pegged to
research activities and embedded analytic tools, the incorpora-
tion of design elements used in decision assistance, and training
of the required workforce to work with this technology.
oostering public and private collaboration. A longer-term devel-
F
opment needed to sustain the growth and improvement of the
infrastructure will include the design of approaches that foster
meaningful public and private collaboration in support of the
research activities.
o eeping focused on the usefulness and impact of a networked
K
world. Also important to guide strategy development for the
long term are approaches designed to take advantage of the
resources emerging in our increasingly networked world—the
opportunities for which hints are provided by recent develop-
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2
MOVING FORWARD
ments, such as the Patients Like Me Web site, the health main-
tenance organization research group, the registries of the Society
of Thoracic Surgeons, and even information made available by
such resources as Google and Wikipedia.
QUICK HITS—THINGS THAT CAN BE DONE NOW
Long-term support for CER will benefit from quick hits or actions that
can be taken now with near-term results that might help demonstrate the
benefit of CER. To open the session, W. David Helms, president and CEO
of AcademyHealth, noted several opportunities for collaborative efforts by
stakeholders to lay the groundwork for a national capacity for CER. These
efforts should target accelerating congressional action to establish a plat-
form for CER and increasing federal funding for CER; articulating the case
for CER (e.g., developing a database that better characterizes the volume
and costs of current CER work, drawing upon Health Services Research
Projects in Progress database, clinicaltrials.gov, the Cochrane Collaborative,
and others); examining models for national capacity (e.g., the Canadian
Health Services Research Foundation’s $100 million support for enhanced
knowledge transfer); and educating state policy representatives and Med-
icaid officials about the potential and needs for CER. Work can also begin
immediately to build up the needed workforce—through a reexamination
of funding and support streams, alignment of education and training pro-
grams around a broad array of research methods, and development of the
means for improved communication across disciplines (e.g., clarification of
terminology and methods). [Note: Subsequent to this meeting, Congress
increased the national capacity for CER with the establishment, in the
ACA of 2010, of Patient-Centered Outcomes Research Institute, previously
described.]
Two respondents also offered recommendations, and a summary of
these comments. Lynn Etheredge, a consultant with the rapid learning
project at George Washington University, suggested an immediate focus
on new technologies. While potentially offering new benefits to medical
care, collectively these products are also a primary driver of healthcare
cost increases. A national system to collect and analyze information
about these products in the postmarket environment would enhance
our understanding of safety and effectiveness is real-world populations.
Existing infrastructure that might be used to accelerate the development
of such a system includes the authority conferred to the Food and Drug
Administration for the Sentinel System, and the Centers for Medicare &
Medicaid Services (CMS) Coverage with Evidence Development policies.
A national research plan could guide requirements for reporting to a new
national data registry that would collect from the point at which a prod-
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2 LEARNING WHAT WORKS
uct or drug is first introduced into the market or is covered by Medicare.
Second, Etheredge noted the need to develop a national biobank initiative
to begin work to relate genetic information with clinical data collected
via EHRs. This will potentially improve diagnoses as well as our under-
standing of the heterogeneity of treatment responses. A national biobank
could be based in large part on data resources currently in place, includ-
ing the NIH compilation of genomewide association studies and genetic
data available from major healthcare providers. Similar resources could
be constructed for specific diseases, drawing on the considerable progress
already evident in the development of such resources as the Alzheimer’s
Disease Neuroimaging Network and the cancer Biomedical Informat-
ics Grid. Progress could also be accomplished in linking Medicaid data
on disabled and chronically ill patients nationally. Another potential
model is the Oregon Community Health Information Network, which is
engaged in bringing Electronic Privacy Information Center applications to
its safety-net clinics. Third, Etherege cited the huge potential in develop-
ing programs focused on Medicaid populations. Nationally, databases
and EHRs will cover most populations except the Medicaid, disabled, and
high-needs populations. Given the billions of dollars spent each year on
dual eligibles (Medicare and Medicaid users), a small initial investment in
better understanding the care of this population is needed. He suggested
that starting up research registries and databases using just some of the
states that could look in detail at the seriously disabled and chronically ill
populations would be a feasible project with immediate returns.
David Shulke, executive vice president of the American Health Qual-
ity Association, suggested that the existing national network of Medicare
Quality Improvement Organizations (QIOs) could be used to ensure the
translation and application of evidence into practice. Currently providers
and practitioners find it difficult to find, integrate, and use new data in clini-
cal practice. The QIOs are a national network of organizations or private
contractors that facilitate the adoption of evidence-based medicine and
could easily also be used to facilitate the use of comparative effectiveness
information. He urged that this be factored into the next Medicare contract
cycle, which starts in 2011.
Other suggestions during the open discussion included a demonstration
project on the use of personal health records to promote patient involve-
ment in the management of their own chronic disease and an exploration
of evidence available in other countries. The Independent Drug Information
System—a stakeholder partnership that engages providers, insurers, and
patients—and the Pragmatic Approach to Comparative Effectiveness group,
which is exploring the use of Bayesian techniques to streamline the efficient
generation of new knowledge, were both suggested as important new initia-
tives that might serve as models for various aspects of CER capacity.
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MOVING FORWARD
Issues for Possible Roundtable Follow-Up
Throughout the course of discussions, a number of items were identi-
fied as candidates for follow-up attention by the Roundtable on Value &
Science-Driven Health Care:
B
etter characterization of the elements of the infrastructure. Build-
•
ing on the work sponsored by the Roundtable on workforce needs
and IT infrastructure, continue to improve the initial estimates and
pursue similar assessments related to requirements for new analytic
tools and methods, establish processes for efficient and effective
operation of the fields of work, and shape the strategy for attention
and phasing. Include examples of effective work at the institutional
level.
C
larification of the nature of the “prework” needed for a more
•
systematic approach to the necessary RCTs. Even though a more
practical portfolio of research approaches is essential, the RCT
offers the key standard for the rigor required for certain circum-
stances. Their most effective deployment requires attention to
issues of the criteria indicating the need for an RCT, the issues and
priorities to be assessed, the best structure of the research ques-
tions, and improved approaches to trial design, conduct, and data
collection.
M
ore focus on the infrastructure needed for guideline develop-
•
ment, implementation, and evaluation. Several issues could be
productively engaged, including transparency and collaboration
across professional groups on improving consistency in the meth-
ods, standards, rules, and participants in guideline development
and approaches to implementation.
S
hare meeting discussions with organizational stakeholders in ele-
•
ments of the infrastructure. Examples given included the National
Quality Forum, the Association of American Medical Colleges, the
Association of Academic Health Centers, the Quality Improvement
Program, and CMS/Department of Health and Human Services in
the context of development of the 10th QIO statement of work,
the American Hospital Association Quality Forum, International
Society for Pharmacoeconomics and Outcomes Research, and pro-
vider groups.
evote additional attention to data stewardship issues. Because
D
•
the basic resource for effectiveness research is the clinical data
system, the Roundtable needs to catalyze more discussion on the
integrity of this resource, including issues of maintenance, privacy,
and data ownership.
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2 LEARNING WHAT WORKS
I
dentify possible incentives. Look at how subsidies and reimburse-
•
ment regulations can stimulate increased use of HIT in medical care,
increased use of HIT for application of evidence, and increased use
of HIT for the development of evidence.
E
xpand engagement of the business case and demand function
•
for infrastructure investment. Give additional attention to the eco-
nomic or business case for employers to appreciate the investment
and its necessity in improving value from health care, the case for
more attention by states, the case for the personal health record
deployment to drive more patient–provider interaction, and work
on the consequences of not investing.
M
ore focus on the issues of strategies and infrastructure for
•
implementing findings on effectiveness. Since evidence is virtually
useless if not applied, the Roundtable could give more attention
to understanding the infrastructure needs for effective guideline
implementation.
S
ponsor discussions on training and health professions education
•
reorientation. With greater appreciation for team-based, networked
information stewardship roles by caregivers, the health professions
groups should be recruited for collaborative consideration of the
training implications.
P
rovide information on the Roundtable’s Web site. The resources
•
of the workshop presentations and discussions should be posted on
the Web site—slides, links, and speaker contact information.
Building Support
Although an enhanced focus on CER will build upon the existing
infrastructure and activities, it still marks a significant shift in the nation’s
approach to clinical research and practice. Healthcare stakeholders gener-
ally view CER as an important tool for ensuring that healthcare decisions
are based on the best science; but additional work is needed to effectively
communicate between stakeholders and with the public and policy makers
about needed investments and potential returns from CER. Mary Woolley
from Research!America led an open discussion session on opportunities to
build support for the wide-ranging investments and developments articu-
lated throughout the workshop. Her comments along with suggestions
offered by three respondents are summarized below.
Four fundamental requirements for building support are important to
consider: (1) clarity about the ultimate goal, (2) understanding the target
audience, (3) ensuring all stakeholders are involved, and (4) understanding
the context. Using this framework, Woolley offered several suggestions on
key opportunities to build support for expanded development and use of
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MOVING FORWARD
CER. Much of the discussion about needs for infrastructure requires an
inside knowledge of the specific aspects of health care. However, a simply
stated goal, such as “By 2020 at least 90 percent of all clinical decisions
will be based on the best available evidence,” is fairly easy to understand
and might therefore serve as a better way to frame the many needs articu-
lated during this workshop to all stakeholders—including the public and
policy makers. Making the case will face challenges as CER is in some sense
a fundamental change in current and long-held practices in research and
health care. Developing support will therefore require broad consensus and
clarity about the fundamental CER value proposition and agreement about
core goals. Strategies for change must therefore factor in the need for value
acceptance and culture change.
Also necessary is clarity about the target audiences, as effective com-
munications need to be tailored to the interests and concerns of different
stakeholders. For each audience, there are various keys to building sup-
port: anticipating questions, but also listening carefully to questions posed
in order to better understand the needs of a particular audience; engaging
in clear communication and crisp, well-conceived messaging; and keeping
in mind that those not engaged in CER-related work, specifically includ-
ing the public and policy makers, are not as well versed as stakeholders in
the terminology and concepts of CER. Woolley offered an example from
personal experience: that health outcomes, while a commonly used term
within healthcare policy, was simply not understood well by the media and
other audiences. A simple language shift to “better health” was more read-
ily understood and perceived as speaking directly to the public’s interests.
Personal stories, effective metaphors, sound bites, and strong, crisp mes-
sages need to replace large reports laden with jargon.
Immediate wins, or quick hits, that help to illustrate the potential
of CER will also be essential to building support. Understanding public
opinion (which needs to be constantly gauged) and the context for com-
munications is also important. As of July 2008, research has demonstrated
that the American public continues to be concerned about the cost of health
care, and ranks it as the top long-term challenge facing the nation. How
might communications about healthcare reform and CER better reflect or
illustrate key opportunities to address these concerns?
Communication should not be unidirectional, but rather it should
be structured to fully engage all stakeholders involved in infrastructure
building. Such broad engagement will require the identification and strong
support of champions who can lead the effort as well as the commitment
of all interested stakeholders in taking action. Educating legislators about
the importance and relevance CER is one aspect of this work, but speaking
to other audiences—including those in our own social networks—will be
instrumental in developing the broad-based support needed. Fine-tuning
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0 LEARNING WHAT WORKS
communications strategies as lessons are learned about their effectiveness
will strengthen the overall effort.
Respondent Stephen Gorshow, from the Aetna coverage policy unit,
observed that individual participation in health plans inherently creates a
unique opportunity for the plan to follow members over the continuum of
health care. He suggested, however, that the fact that individuals obtain
care from multiple providers creates gaps in the quality of care, an issue
that calls for research to determine the extent and impact of this problem,
albeit with adherence to principles of patient privacy. Particularly in an
era of consumer-directed health plans, and toward a goal of encouraging
healthy practices among individuals, research is also needed to determine
the effects that changes in benefit design have on health-related behaviors.
Similarly, benefit issues need to be researched in ways that inform intelli-
gent decisions about what should and should not be covered. In addition,
research should be conducted to determine the optimal balance between
cost-sharing by health plan members and protection for the plan against
the high cost of the high-tech care available today for more serious ill-
nesses. Also advocated is a broader buy-in to available guidelines for wise
use of high-tech radiology as well as study of the driving forces behind the
need for private insurers to conduct programs to stem the overuse of such
technologies. These areas of needed research are directly relevant to how
patients experience health care, and they may therefore also be important
in improving communications with patients about the benefits of compara-
tive effectiveness.
A second respondent, David Longnecker, director of healthcare affairs
at the Association of American Medical Colleges, emphasized the impor-
tance of having clear, distinct goals as an important tool for building sup-
port for CER. Large, big-picture goals are necessary, but smaller interim
goals can also help drive rapid progress. In this respect, while it is important
to develop a research enterprise that can begin to narrow the many gaps in
evidence, streamlining and supporting the translation of research into prac-
tice might be an area where progress can be made quickly. An important
interim goal might therefore be to significantly improve the application of
known evidence; to that end, research is needed on how to best motivate
and support physicians and health professionals to implement evidence-
based care. In addition, Longnecker suggested some “quick hits” that might
be helpful in building support. The Department of Veterans Affairs EHRs,
National Consortium of Clinical Databases, and the Dartmouth Atlas
databases are existing data resources that could be mined now to expand
comparative effectiveness knowledge. Also, citing how the work of the
Leapfrog group in improving quality was greatly accelerated by CMS pay-
ment policies, Longnecker suggested that strategies are needed, particularly
financial rewards for practitioners, to help move CER forward.
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MOVING FORWARD
A third respondent, Eva Powell, director of the Health Information
Technology Project at the National Partnership for Women and Fami-
lies, observed that while consumer advocacy organizations are in favor
of moving CER forward, the issue of preserving and protecting patient
privacy rights remains of paramount importance. Indeed, she argued, the
fundamental validity of data is dependent on privacy being protected.
Powell advocated for reframing the conversation around patient privacy,
shifting it from a focus on barriers to participation in studies to a mindset
that underscores the essential importance, for the greater good, of study
participation. To ensure transparency in this realm, an agreed-on set of
standards and a policy framework that covers all participating entities is
required, as are changes in Health Insurancc Portability and Accountability
Act legislation.
Consumers do not have all the information or the simple tools needed
to become fully engaged in CER. Some work is already under way to
educate and communicate with the public and consumers, but additional
efforts are needed to ensure that the media is also educated. Because of their
work with local constituencies, QIOs are possible conduits to the public
and the media on health and health quality issues. In developing messages
about the benefits of CER in terms of its value to consumers, a value case
from the consumer perspective needs to be articulated and disseminated.
Important to understand in this regard is that making such a case on the
basis of improving efficiency or cost does not resonate with consumers, as
efficiency is often perceived by consumers as an attempt to deny them care
and, while recognizing that cost is important, consumers tend to be wary of
decision making based solely on cost. Value in health care, which includes
consideration of the benefits received by patients, is more likely to resonate
with consumers.
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