Basit Chaudhry, The National Coalition for Health Integration
On April 3, 2009, public testimony on comparative effectiveness
research was given at a meeting of the National Advisory Council
for Healthcare Research and Quality. The testimony represents
the views of the presenter and not necessarily those of the Agency
for Healthcare Research and Quality (AHRQ) or the Department
of Health and Human Services (HHS).
The Council provides advice and recommendations to the Director,
AHRQ, and to the Secretary, HHS, on priorities for a national
health services research agenda.
April 3, 2009
From:
The National Coalition for Health Integration
11755 Wilshire Blvd, Suite # 2000
Los Angeles, CA 90025
To:
National Advisory Council for Healthcare Research and Quality
Public Comment on the National Advisory Council's recommendations to the Director
of the Agency for Healthcare Research and Quality (AHRQ) and to the Secretary
of Health and Human
Services regarding comparative effectiveness research funding
Comparative effectiveness holds great promise to fundamentally change the
methodsthrough which healthcare is delivered by enhancing the integration
of scientific principles into clinical
practice. Current paradigms such as evidence based medicine and guidelines
based care have significantly enhanced normative decision making at the point
of care. However, even with
these innovations, clinicians are still often faced with complex decisions
which require reasoning under uncertainty. Clinical reasoning under uncertainty
can be due to the absence of relevant
research or to the limited external validity of efficacy oriented research
to the "real world"
context in which the vast majority of care delivery decisions are made. Comparative
effectiveness research has the potential to address both of these issues and
in turn to reduce the size of the problem space under which stakeholders need
to reason under uncertainty and to
make clinical decisions based on incomplete information.
We at the National Coalition for Health Integration (NCHI) support the strong
funding for comparative effectiveness research in the American Recovery
and Reinvestment Act. NCHI is a
non-profit coalition dedicated to supporting the transformation of healthcare
by enhancing the integration and portability of healthcare information through
the use of innovative open source
grid computing technologies as a national platform that will allow data integration
and analytics on a comprehensive scale.
While we fully support thenation's investment in comparative effectiveness
research, significant barriers to instituting this model exist. For example,
for the comparative effectiveness paradigm
to facilitate change, this research needs to be scalable, to make data available
in real time, to be low cost and to be feasible to implement in non-academic
research settings.
Critical to all of these endeavors is the efficient and scalable management
of healthcare data and information. Without this critical information infrastructure
engaging in robust comparative
effectiveness research will be significantly hampered. Methods such as pragmatic
head to head trials, large-scale observational studies and simulation modeling — all
core methods in
comparative effectiveness — are data intensive and require complex information
management. Without an efficient, robust health information management platform
such methods are unlikely
to be widely practicable.
For these reasons we urge the National Advisory Council for Healthcare Research
and Quality to recommend to the Director of AHRQ and to the Secretary of HHS
that funding for the
development of an information infrastructure to support comparative effectiveness
research be made a top priority.
Clearly, individual disease-specific studies are greatly needed. But at
this early stage, an open architecture, robust, scalable national data management
infrastructure platform allowing the
collection of information from disparate electronic health record systems is
critical. Such investments are likely to have a significant multiplier effects
by enhancing the feasibility of a
broad range of studies that would otherwise not be possible or could only be
conducted on considerably smaller scales.
AHRQ has shown critical leadership in the field of comparative effectiveness
research and as such is uniquely positioned to promote the development of
a robust infrastructure. Recently
Director Clancy wrote about the importance of a national information technology
infrastructure to support research in her paper published in the journal Health
Affairs entitled, "Investing In
Health Information Infrastructure: Can It Help Achieve Health Reform?" NCHI
supports many of the proposals for infrastructure discussed in that paper.
The IOM's Roundtable on Evidence Based Medicine has placed similar emphasis
on developing a comparative effectiveness information infrastructure. In their
workshop report, Learning What
Works: Infrastructure Required to Learn Which Care is Best the IOM Roundtable
identified important barriers to comparative effectiveness including research
fragmentation, "siloing" of
data and methods, short evidence life-cycles, and frayed transition points
in the research enterprise. To address these issues the Roundtable identified
core infrastructure that was
required to develop new forms of clinical evidence. The Roundtable emphasized
the need for investment in information technology to manage data and to facilitate
real-time learning. In
addition, the Round table identified the need to develop analytic tools that
would support end user activities in comparative effectiveness.
The NCHI feels that both the use of information technology and the development
of information tools should be at the forefront of infrastructure development.
But we also feel that it is
important to clearly specify what kinds of information technology and tools
are needed in the context of comparative effectiveness. Too often information
technology for research is equated
with the development of electronic health records, research databases, registries
or web sites to report results. All of these pieces are important. However,
even more important is the
development of a coherent network platform that will support the vertical and
horizontal information management activities required to engage in comparative
effectiveness research, a
complex endeavor which often involves multiple institutions, data sources,
research methods and investigators. More than specific pieces of technology,
what's needed is a scalable, modular
infrastructure based on open standards and an open architecture.
Project teams engaged in comparative effectiveness research can be conceptualized
as forming virtual organizations. Virtual organizations are collaborative
efforts between different entities
that come together to achieve a common purpose through the constrained sharing
of resources and dynamic relationships. For example, a comparative effectiveness
collaborative of
community-based hospitals may want to give investigators at each institution
real time access to small subsets of the clinical data they hold rather than
all the data they hold. After the research is
finished, such access may need to be stopped. Such dynamic, constrained sharing
of data resources is hall mark of a virtual organization. The information
management platform needed to
engage in robust comparative effectiveness needs to support the work of such
virtual organizations. Grid computing technologies, such as the National Science
Foundation supported
TeraGrid computing network, were specifically designed to develop platforms
to support the information management needs of such virtual organizations.
TeraGrid is based on open source
software, open architecture and open standards and has been widely used to
support research endeavors in many scientific disciplines.
One model that the NationalAdvisory Council could consider in making recommendations
on infrastructure to the Director of AHRQ and to the Secretary of HHS comes
from contemporary
particle physics research. Due to the cost of building accelerators, experiments
in particle physics now often involve several thousand experimental investigators
spread across the world
who need to manage petabytes of data in near real-time. Given this organizational
complexity, these investigators have had to develop robust information management
platforms based on
distributed computing paradigms. Such efforts led to the initial development
of the World Wide Web. More recently particle physics scientists have leveraged
grid technologies to support the
work of their virtual organization research project teams. CERN, the laboratory
with the world's largest particle accelerator, is currently implementing grid
computing technologies using the NSF
supported Globus Toolkit to link together investigators through and to manage
distributed data across their research networks.
Comparative effectivenessresearch represents a promising model to support
rational healthcare decision making and to in turn improve quality while enhancing
efficiency. Such disruptive
approaches require that the research enterprise be extended outside of the
traditional academic center in order to understand which interventions are
most effective under real world
circumstances. This model requires the linkage of investigators with varying
skill sets working at institutions which are likely to be geographically dispersed,
the integration of distributed data
sources, and the development of interoperable analytic tools that will work
across institutional barriers. At the same time these methods must be scalable
while minimizing complexity. Such
competing interests require a flexible, open information management and computing
platform. While ostensibly daunting, other disciplines such as particle physics
and climate science have
supported even more complex research endeavors through the use of open source
grid computing technologies.
NCHI appreciates the opportunity to provide this input and hopes that the
National Advisory Council will recommend to the Director of AHRQ and to the
Secretary of Health and Human
Services that funding for a comparative effectiveness research infrastructure
be made the highest priority possible. We hope that the National Advisory
Council will recommend that this
infrastructure be built on open source grid technology networks.
About The National Coalition for Health Integration
The National Coalition for Health Integration (NCHI) is a non-profit partnership
network dedicated to transforming healthcare delivery and research through
the establishment of a
national open source, open architecture health information management platform
that will support the patient centered, sharing of biomedical data across
the basic science— clinical care continuum.
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