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Appendix D
Comparative Effectiveness
Research Priorities:
FCCCER Recommendations (2009)
PRIORITY RECOMMENDATIONS FOR
OFFICE OF SECRETARY CER FUNDS1
Using the strategic framework for CER discussed in Section V, and tak-
ing into consideration the unique role that OS funds can play in addressing
high priority gaps, the Council developed a recommended high-level invest-
ment strategy for the use of the OS ARRA funds. The strategy has three
different levels of priority recommendations for OS fund investments in the
Core Activities and Cross-cutting Priority Themes in the CER framework
(Figure 3).
• Primary investment. This area of investment should represent a
large portion of the OS funds. It best fulfills the full range of pri-
oritization criteria and requires scaled investment in order to be
successful. The Council recommends that CER Data Infrastructure
be the primary investment.
• Secondary investments. These areas should also receive significant
investment. They are as critical to success in CER as the primary
focus, but individually may require a smaller amount of funding
to be successful. The Council recommends that Dissemination and
1 Passage from the Federal Coordinating Council for Comparative Effectiveness Research
Report to the President and Congress, June 0, 2009. Department of Health and Human
Services.
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2 LEARNING WHAT WORKS
Translation of CER, Priority Populations, and Priority Types of
Intervention be secondary investments.
• Supporting investments. These areas should not be the major focus
of OS funding as they do not fulfill the prioritization criteria as
well as primary and secondary investments, but some funding may
be necessary to support and enable investments in higher priority
areas and fill identified gaps. The Council recommends that Human
and Scientific Capital, Research, and Conditions receive supporting
investments. It is important to note that these recommendations
pertain only to OS funds; AHRQ, NIH, and VA have a history of
significant investments in Research, Human and Scientific Capital,
and Conditions.
The Council believes that this strategy and distribution of investments
will best position the Secretary to:
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APPENDIX D
• Respond to patient and physician demand for CER.
• Balance achieving near-term results with building longer-term
opportunities.
• Capture the distinctive value of the Secretary’s ARRA funds.
While it is the responsibility of the Office of the Secretary to opera-
tionalize this strategy, the Council’s rationale for these recommendations is
designed to help guide the Secretary in making specific investment decisions.
The Council based its rationale for each level of investment in the strategy
on the prioritization criteria described above, as well as representative
examples of investment in each area proposed through the public comment
process and by federal agencies.
Primary Investment
CER data infrastructure development is the most distinctive opportu-
nity for OS ARRA funding. It requires a large, up-front infusion of capital
to be successful that is unlikely to come from any source other than OS
ARRA funds, making it ideal for this funding mechanism. It has broad
potential impact, with the ability for resulting research to address condi-
tions and populations captured in the primary data. Given the absence of
comprehensive databases and data evaluation tools, there is significant
demand from the patient, clinical, and public health communities for new,
expanded data infrastructure and data access to support decision making.
Finally, investments in data infrastructure have the potential to generate
significant additional investments in two ways. First, some of these invest-
ments could take the form of public-private partnerships. Second, data
infrastructure is a tool that, once developed, will result in new research
conducted and/or funded by entities such as biomedical research organiza-
tions, payers, foundations, and health care providers.
The Council received proposals on a number of potentially promising
initiatives related to data infrastructure, including but not limited to:
• Building, expanding, and linking longitudinal administrative claims
databases.
• Linking administrative data with EHR-based or registry data.
• Expanding high-impact patient registries (e.g., collaborations with
specialty organizations, SEER).
• Distributed data networks populated by EHRs in practice and
provider settings.
• Expanding analysis of FDA and private sector data on drug and
device trials and safety.
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LEARNING WHAT WORKS
As the Office of the Secretary identifies specific opportunities in data
infrastructure, the Council recommends that it consider most carefully
those that:
• Expand access to existing resources, especially those currently man-
aged by Federal agencies.
• Create scaled platforms by leveraging existing data and capabilities
in the private sector.
• Capitalize on linkages between health IT investments and the
potential for CERinfrastructure to develop evidence to inform deci-
sion making.
• Ensure that infrastructure is responsive to needs of patients, provid-
ers, and other decision makers—and not driven by what is most
feasible.
The Council appreciates the relationship and need for coordination
between CER and health IT (e.g., through a distributed network of EHRs)
investments. As the Secretary develops HHS’s full portfolio of ARRA invest-
ments, it will be critical to consider both CER and health IT holistically,
not as policy silos, recognizing that success in CER is largely dependent on
success in health IT and vice versa. With all data infrastructure investments,
the government will need to ensure data security and privacy. Protecting
security and privacy is key to maintaining the public’s trust.
Secondary Investments
Secondary investments include a core area of investment—Dissemi-
nation and Translation of CER—and two cross-cutting themes—Priority
Populations and Types of Intervention.
Dissemination, translation and adoption of CER is about realizing the
benefits that comparative effectiveness research has to offer both patients
and providers. While the breadth and depth of the near-term impact depends
on what types of pilot programs the OS supports, the lessons and tools for
translation developed by those pilots will be relevant to all.
The lack of reliable success in disseminating findings from CER in
ways that translate into better health outcomes highlights the uncertainty
and difficulty of this enterprise. However, dissemination and translation is
essential to improving outcomes for patients and the link between evidence
production and how best to get this information to physicians and patients
in a way they understand is critical to capitalizing on the CER investment.
Despite important efforts by the federal government, especially AHRQ,
NIH, VA and DoD, the majority of current funding goes to building evi-
dence as opposed to ensuring that the existing evidence base is utilized in
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APPENDIX D
patient care and health systems management. This creates a unique role for
OS ARRA funding. Investments in dissemination and translation programs
also have the potential to generate additional investments, especially from
providers, if private institutions elect to implement similar efforts or partner
with the Federal Government on translation efforts.
There are a wide range of potential dissemination, translation and
adoption programs that the OS could support, including:
• Investing in dissemination and translation of CER findings through-
out the Federal delivery system.
• Dissemination and translation through partnerships with provider
and/or patient organizations.
• Decision support and shared decision-making tools to provide
information to clinicians and patients at the point of care.
• Developing standards for communication tools for patients and
providers, (e.g., a patient-friendly simple scoring system).
• Partnering with an existing consumer media channel (e.g., Internet
search engine or health information site) to expand patient access
to existing CER data.
• Creating a National Patient Library with a primary focus on pro-
viding evidence to patients in easy-to-use and understandable
formats.
The Council recommends that the Office of the Secretary consider the
following in making investments in dissemination and translation:
• Investing in better understanding the most effective methods to
disseminate and translate research findings to improve patient
outcomes.
• Identifying opportunities both to develop tools for translation and
to pilot implementation of these tools.
• Partnering with provider organizations in federal agencies, as well
as in states and the private sector.
• Accounting for potential surrogate decision makers (e.g., families)
and the context for decisions in patient-focused tools.
• Ensuring that programs address a specific need articulated by the
implementing organization or the partner to ensure success and the
sustainability ofdissemination activities.
• Focusing on developing standards for communication.
• Increasing understanding of the most effective methods to dis-
seminate findings to clinicians and patients to inform decision
making.
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LEARNING WHAT WORKS
From an operational perspective, investments in the cross-cutting
themes are somewhat distinct from investments in the core areas. Whereas
funding for a core area might go to a project or organization focused on a
specific activity, funding for a cross-cutting theme requires multiple coor-
dinated investments and activities to be successful. Investments in these
themes could cover some or all of the four core activities: research, data
infrastructure, human and scientific capital, and dissemination and transla-
tion. These investments could involve a coordinated investment across HHS
or the federal government, or they could be focused in academic centers,
integrated delivery system organizations, private industry, or other non-
governmental entities. Collaborative efforts to inform and transform care
will be essential to achieving meaningful impact across these cross-cutting
themes.
Investments in specific populations, meanwhile, will help ensure that
the benefits of CER are available to all. It can also focus CER efforts on
populations with existing health disparities and worse outcomes. CER has
the potential in some populations, such as racial and ethnic minorities, to
fill critical gaps that, historically, efficacy research has left unaddressed.
The Council identified several populations for whom the Secretary
should consider allocating CER funds:
• Racial and ethnic minorities
• Persons with disabilities
• Elderly
• Children
• Patients with multiple chronic conditions
Investment in specific types of interventions in a cross-cutting man-
ner also presents a unique opportunity for the nation’s health system. The
Council has identified six specific interventions for the Secretary to con-
sider that address large and varied populations, resulting in high potential
impact, are areas of high clinical uncertainty, and are not being adequately
addressed by other entities. They are:
• Medical and assistive devices (e.g., comparing rehabilitative
devices).
• Procedures and surgery (e.g., evaluating surgical options or surgery
versus medical management).
• Diagnostic testing (e.g., comparing imaging modalities for evaluat-
ing certain types of cancer).
• Behavioral change (e.g., developing and assessing smoking cessa-
tion programs).
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APPENDIX D
• Delivery system strategies (e.g., testing two different discharge pro-
cess care models on readmission rates or testing two different medi-
cal home models on preventing hospital admissions and improving
quality of life).
• Prevention (e.g., comparing two interventions to prevent or decrease
obesity, comparing strategies for reaching populations that do not
access the healthcare system with prevention efforts).
Furthermore, the Council recommends that the Office of the Secretary
consider the following in making investments in the cross-cutting themes
of priority populations and types of interventions:
• Focusing on immediate, specific patient needs that can generate
results.
• Concentrating on areas with cross-cutting gaps in research, data
infrastructure, scientific capital, and/or translation.
• Building on promising systems and practices already in place, both
within the government and in the private sector, and measuring
results when scaled up and disseminated.
• Strongly encouraging coordination across the government and with
entities outside of the government.
Supporting Investments
The Council recommends that the OS reserve some ARRA funding
for Research, Human & Scientific Capital, and the Conditions cross-cut-
ting theme. Because these investments and topics are the major foci of
CER activities at NIH and AHRQ, both of which will likely utilize ARRA
funds administered by those organizations for these purposes, they do not
represent distinctive investment for OS funds. However, there will likely
be targeted investments in these areas that could support other OS ARRA
efforts, such as training new researchers in CER methods or addressing gaps
not addressed elsewhere in the federal government.
In making these targeted investments, the Council recommends the
Office of the Secretary consider:
• Focusing on areas that maximize the value of the Secretary’s invest-
ments in other areas.
• Avoiding duplication of efforts with other agencies.
For all of the above investments, the Council recommends that the
Office of the Secretary consider the portfolio of investments and where
synergies exist to leverage one investment into multiple areas. For example,
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LEARNING WHAT WORKS
a data infrastructure investment that can also be used for a cross-cutting
priority theme would be of higher value than an investment that has more
limited applications. Doing so will help to ensure that the funds allocated
to the Office of the Secretary for CER will have a significant positive impact
on the quality of patient care in the near term, and lay the foundations for
continued improvements going forward.
