Keynote Address by Carolyn M. Clancy, M.D., Director, Agency for Healthcare Research
and Quality (AHRQ)
China Outcomes Research & Evidence-Based
Medicine Summit
Shanghai, China (Via Videoconference), March 29, 2012
Good
morning, everybody! Greetings from the United States. It's 10 o'clock at night
here in Rockville, MD, about 20 miles from the Nation's capital. And I am very happy
to have the opportunity to speak with you during the opening of the China
Outcomes Research & Evidence-Based Medicine Summit in Shanghai.
I
would have loved nothing better than to join you there at the Shanghai
International Convention Center—to hear your thoughts and ideas about how we
can better apply the science to patient care.
Unfortunately,
that was not possible, and I appreciate your willingness to let me "beam in,"
so to speak, to talk about the direction of comparative effectiveness research—or
what we're calling patient-centered outcomes research—in the United States, as
well as my Agency's role in putting patients at the center of care.
But before
I begin, I want to say something about this Summit. As director of the first Federal
Agency in the United States with a legislative mandate to have a center for patient-centered
outcomes research, I must tell you, I think this is fantastic.
It's
very gratifying to see that you're looking to make the most of the growing
interest in patient-centered outcomes research in China. We're doing the same
thing here, and doing this is key to building the type of health care system
that uses all of the available tools to put patients first.
In reviewing
the literature for this event, we came across a list of trends in health care
that you have identified in China. According to your observations—
- Clinical experts are demanding more data on comparative
effectiveness studies and patient-reported outcomes studies.
- National and commercial health insurance organizations are
increasingly demanding evidence of medical pathways in the process of
reimbursement.
- The China Ministry of Health and State Food and Drug
Administration in China are strengthening postmarket safety monitoring of
medical products.
- Most health professionals in China have accepted the
concept of evidence-based medicine, and are demanding more data on the
effectiveness and safety of medical products used by Chinese patients.
These trends are the same or similar to those we are
seeing in the United States. For example—
- There is not enough credible, empirically based,
patient-centered outcomes research available to help patients, providers,
payers, and policymakers make informed treatment decisions.
- The Federal Government has provided us with the resources
to initiate the process of building a health care system in which the lag
between data acquisition and exploration can be measured in weeks or days, and
not months or years, as is currently often the case.
- And health professionals want more data that can help
them make better decisions.
I'm
the oldest of seven children. When we were growing up, and my brothers would
come up with a clever plan for something, they would call it "Management
Thinking." Actually they would say "MT" because that was their short-hand for
management thinking.
It's the
same way we think today about systems intervention. We've acted as if it's
something that's really easy.
We
put out all of the science, and we expect that it's magically going to trickle
down to the point of care perfectly and seamlessly. Of course, we have a lot of
evidence that it doesn't quite happen that way.
Also contributing to this phenomenon is the fact that health
care traditionally has been disease-centered, with physicians making almost all
treatment decisions based largely on clinical experience and data from various
medical tests.
In
the patient-centered model, patients are more active participants in their own
care, and interactions between diseases are important. They receive services
designed to focus on their individual needs and preferences, in addition to
advice and counsel from health professionals.
On
the practice side, successful uptake and integration of evidence into practice
requires an understanding of not only whether something works (clinical
efficacy), but also of what works where, when, and how (effectiveness), and for
which patients.
At
the Agency for Healthcare Research and Quality, or AHRQ, we have been studying
this second set of issues for many years, particularly through our
practice-based research mechanisms, which enable clinicians, provider
organizations, and health services researchers to collaborate on research involving
the translation of evidence into practice in diverse settings—from doctors'
offices and clinics to large, integrated health care systems.
My
predecessor, the late John Eisenberg, used to say that health services research
answers the enduring questions, such as—
- What works?
- Under what circumstances?
- For which condition?
- At what cost?
Patient-centered research adds "for which patients?"
Evidence-based medicine can't fix all of the problems.
For example, it can't fix controversies due to values or cost; overcome barriers
due to misaligned incentives, patient factors and system failures; and it can't
ensure or guarantee appropriate application to policy or practice. But it can reduce the chance of getting something wrong;
it can help make decisions more consistent, transparent, and rational and
reduce the extent of variations in health care that we see over time. Much of what we see in practice variations is a clear
indication of where we don't have good evidence.
Variation in care is a topic that is explored in the
National Healthcare Quality and National Healthcare Disparities Reports that my
Agency publishes every year. Overall, what we routinely see are modest improvements
in quality. In last year's report it was 2.3 percent overall. And the quality of care varies, not only by type of care,
but also across parts of the country—and with different types of preventive
services.
These variations were first revealed most dramatically in
a study by Dr. Jack Wennberg that was published about 45 years ago. Using a
$350,000 grant awarded by the Lyndon Johnson administration, Dr. Wennberg and
his colleague, Alan Gittelsohn, developed a method called Small Area Analysis. They analyzed Medicare data to determine how well
hospitals were doing. People generally anticipated that they would find service
lacking mainly in rural hospitals.
What the study found instead was tremendous variation in
virtually every aspect of health care delivery—including in
communities served by academic medical centers. The findings were completely
contradictory to the basic premise that medicine was driven by science and by
physicians who make clinical decisions based on well-established fact and
theory.
Jack's work pretty much provided the blue print for
creating AHRQ. And you can also draw a very direct line from this work to
patient-centered outcomes research.
Our mission at the Agency is to improve the quality, safety,
effectiveness, and efficiency of health care for all Americans. We do this by providing support for independent,
user-driven research that is designed to help people and organizations at the national,
state, and local levels make a wide range of informed choices.
Patient-centered outcomes research is a key element in my
Agency's safety and quality improvement efforts. And in many ways, AHRQ has
been at the forefront of much of the activity that has been generated around the
research.
Our mandate for conducting patient-centered outcomes
research was put forward in the form of our Effective Health Care Program that
was created as part of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, which expanded medication insurance coverage for the
elderly and disabled. The program became operational in 2005 and from then until
2009, it received $129 million from the Congress. We have since received
unprecedented investments in the research, through passage of the American Recovery
and Reinvestment Act of 2009 and the Patient Protection and Affordable Care Act
in 2010.
To provide some context: From 2005 to 2009, we developed
about 50 products. With increased resources from the two recent laws, we have
completed about 50 more products. And, over the next 2 years, we will be adding
about 75 more.
Products the Effective Health Care Program develops
include—
- Research
reviews, such as comparative
effectiveness and effectiveness reviews that outline the benefits and harms of
treatment options, and technical briefs that explain what is known—and what is
not known—about new and emerging health care tests or treatments.
- Original
research reports based on clinical
research and studies that explore the practical questions about the
effectiveness of treatments.
- Short
plain-language summaries that are tailored for use by clinicians,
consumers, or policymakers.
Many of the summaries for patients are currently
available in English and Spanish. And we would be happy to engage in
collaborations to make them available in Chinese. Several years ago (1997), we worked
with the National Asian Pacific Center on the Aging on two products. One was a smoking cessation pamphlet titled, You Can
Quit Smoking, which was published in Chinese, Tagalog, Korean, Laotian,
Vietnamese, and Cambodian. The other was the consumer summary, Prescription
Medicines and You. It was available in Chinese, Korean, Vietnamese, and
Cambodian.
Collaboration like this reminds me of my favorite African
proverb: If you want to travel fast, you
travel alone. If you want to travel far, travel with others.
Patient-centered outcomes research is about getting
beyond our own experiences. It expands our horizons beyond each transaction and
opens avenues to learning much, much more about what happens to patients over
time. And it is all about science that improves patient care. And while decisions and policies must be made locally,
evidence should be shared globally. Collaboration must also be global.
When we share, we become energized. We come up with lots
of new ideas about how we can help our patients, and together, we help to turn
local successes into strategies that can improve care everywhere. So it's incumbent on all of us to make sure we build in
the type of transparency that breeds trust. Trust in how the research is done
as well as in the results.
With the Effective Health Care Program, we engage stakeholders—including
patients—from the beginning. We partner with networks of researchers and
clinical teams across North America. We use input from stakeholders throughout the process of
patient-centered outcomes research, translation, dissemination, and
implementation of research findings. We have supported a Community Forum to improve and expand
public and stakeholder engagement in the research. This helps ensure that the
Program addresses issues that are relevant and important. It also improves the products, making them accessible,
user-friendly, and responsive to stakeholder information needs.
Stakeholders can also contribute by—
- Nominating topics for research.
- Commenting on draft research questions and reports.
- Advising on the distribution of patient-centered outcomes
research products and findings.
We also have a Recovery Act-funded Stakeholder Group.
Its activities include—
- Providing guidance on program implementation.
- Providing input on critical information gaps for practice
and policy, along with research methods to address them.
- Championing objectivity, accountability, and
transparency.
Health information technology, or health IT, is a very
important component in all of this. Another benefit of technology is that it has
also changed our mental model of how we're disseminating research. It used to be that practice and development of evidence
were very separate. Now, the boundaries between the conduct of research and the
applications of that research to patient care are becoming increasingly
blurred.
Health IT is providing a means to make this easier to do.
It's not the silver or magic bullet—the answer to our dreams—but it does give
patients access to more information from around the world. It also means doctors and hospitals and
policymakers have access to data that they couldn't see before. And these data
are a resource from which we all can benefit. This has been taking place in other countries, including
China, for years. A number of countries have done more to engage full-time
doctors in collecting data for research.
Health IT makes it easier, in much the same way that technology
is allowing me to join you today from across the world (6,500 miles away). Imagine the impact of this kind of regular, widespread, real-time
access to information in health care. Think about what the health care system's
capabilities would be if technology was as ubiquitous as it is in most other
industries.
Our bodies—our lives—are our most precious possessions.
How can it be that it's easier for us to buy gas, or do our banking, than it
can be to have our medical records transferred to a hospital in an emergency?
The Affordable Care Act authorized the creation of the
Patient-Centered Outcomes Research Institute. The nonprofit Institute—
- Sets priorities and coordinates with existing agencies
that support patient-centered outcomes research.
- Prohibits findings to be construed as mandates on
practice guidelines or coverage decision, and contains patient safeguards.
- Provides funding for AHRQ through its Trust Fund to
disseminate research findings, train researchers, and build capacity for patient-centered
outcomes research.
In late January, as is required by law, the first draft
of the Institute's National Priorities for Research and Research Agenda were released for public comment. The final versions of these documents will be
ready in May. They will be used to guide funding announcements for comparative
clinical effectiveness research. The comment period ended March 15, 2012. Once the
feedback is reviewed and the draft is revised accordingly, it will be brought
to the Board for consideration. The first funding announcements will be issued
in May of this year.
Applying the science to patient care. That's what it's
all about. That's where we start. And that's where we end. That's the goal.
To that end, another area of particular interest to AHRQ—and
one in which questions of effectiveness are especially complex—is in research
on promising delivery system interventions. And we have issued grants to
explore delivery system changes in areas including the patient-centered medical
home, public reporting on provider performance, and alternative approaches of
coordinating care across care settings.
We've also developed several projects that are designed
to expand the awareness and use of AHRQ's evidence-based products, tools, and
information. For example—
- The AHRQ Publicity Center is building a national
patient-centered outcomes research partnership network to make decision aids
and tools available in patient and professional communities.
- Our Academic Detailing program is working to
complete face-to-face educational visits to 1,300 primary care providers and
200 health system directors across the country.
- We have also established five Regional Offices (Atlanta, Chicago, Dallas, Denver, New York, and headquarters in Washington,
DC) to develop dissemination partnerships with local and regional health care
organizations, businesses, unions, supermarkets, consumers, and other
organizations.
We'll stop at nothing. Good information has to be
impossible to avoid.
We also continue to examine how best to spread
evidence-based practices as well as to undertake a wide variety of broad-based,
targeted dissemination approaches. One of our grant initiatives supports the spread of
patient-centered outcomes research findings through multistakeholder or multisite
networks that already exist. One such program is under way right now at Dartmouth
College, where a teen mental health screening, diagnosis, and support system is
being implemented in 15 rural primary care practices in Vermont and New
Hampshire. Among the practices that were in place by June of last
year, about 90 teenagers had screened negative. Another 19 were entered into
the registry with a positive finding.
Obviously, we are beyond excited about all of this
activity taking place in our own backyard, so to speak. But that is not why I'm
telling you about it. My goal in doing this has been to give you a sense of
the scale of this endeavor.
At the AHRQ Annual Meeting last September, someone asked
me how much the new health reform legislation and investments that followed are
changing our agenda. The serious and very real answer has two parts—not at all—and phenomenally.
We're not doing anything terribly different. We've been
building these paths step-by-step for a while. What's different is the scale. This is no longer a cottage industry. It cuts across
virtually every aspect of health care. And it is a once-in-a-lifetime chance to
make the kinds of transformational change in the system that all of us have
been talking and writing about for years. And a lot of it has to take place at the front lines of
care. We're not talking only about building a better library. This is all about leveraging evidence-based medicine at
the bedside more effectively, and making sure that patients understand what their
treatment options are so they can work with their health care teams to make the
best possible decision for them. But when it comes to figuring out what works, the only
thing that we know for sure, is that there is often no real way to know for sure.
With a lot of the patients that we treat, the preeminent
metric for whether we're doing more harm than good, especially for patients
with chronic illnesses, is how that patient is feeling. There are a growing number of short patient-reported
outcomes measures that can be used to see how patients are doing, but they
haven't become part of practice to the extent that they need to be. And in many instances, there is nothing complex or
magical about the steps that need to be taken to improve care. It could be something
as simple as implementing a hand-washing policy.
Lastly, I would again emphasize the need for improving quality
to be a team sport—even a global team sport. In a speech announcing the Department of Health and Human
Services' new Global Health Strategy in early January, Secretary Sebelius said, "Health is an issue which aligns the interests of the countries around the
world."
Health leaders everywhere are trying to solve the same
problems: including obesity, chronic disease, rising health care costs, a
shortage of primary care providers, and so forth.
Of course, each country has its own unique
characteristics, so what works in one may not work in another. But we can—and we
must—learn from each other. And right now, we have an enormous opportunity to pull
all of this together, so we can achieve the same precision that we're looking
to achieve in conducting the research, in actually applying the research to the
benefit of individual patients.
Thank you very much.
Current as of April 2012
Internet Citation:
Direction of Comparative Effectiveness Research in the United States and the Role of AHRQ. Keynote Address: China Outcomes Research & Evidence-Based Medicine Summit by Carolyn Clancy, March 29, 2010. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/sp032912.htm