By Carolyn M. Clancy, M.D., Director, Agency for Healthcare Research
and Quality
Bone Health Conference: Best Practices in Systems-Interventions to Reduce the Burden of Fractures
Washington,
DC, December 9, 2010
As we all know, the importance of bone health is far
greater than the amount of attention it gets. Just consider osteoporosis alone.
About 10 million Americans already have the disease. About 34 million others
are at risk, and estimates suggest that about half of all women older than 50—and
up to one in four men—will break a bone because of osteoporosis.
Bone health issues are not exclusive to older people.
They can impact men and women of every age and ethnic group. As the Baby Boomer
generation ages, the urgency for action to improve bone health is only
increasing, and I can't begin to tell you how timely it is for the Bone Health
Conference to be focusing on best practices in systems interventions to reduce
the burden of fractures.
I was reflecting this morning on a very good friend of
ours who had a compression fracture last year. She's 80 years old and what surprised
me about the situation—along with the fact that her husband doesn't know how to
cook anything except toast—was her experiences with prednisone. We took a lot
of field trips over there to bring food and other things, as did other friends.
This was not someone who was a stranger to medical care and she was clearly at
high risk, beyond being 80, Caucasian, and of relatively small build.
She had been treated for polymyalgia rheumatica and had
been struggling for the past few years to get off the 5 to 7 milligrams of
prednisone, but couldn't quite stop using it altogether. No one had talked to
her about this issue. I remember thinking that I didn't know if more
information at the outset might have enabled her to prevent this problem, but
it was sort of shocking to me that she was hearing it from me for the first
time. Thankfully, she's better; but we can do better than that.
We believe that comparative effectiveness research, or
patient-centered outcomes research, is the foundation of improving the quality
of care, including identifying and developing the evidence base for systems
interventions. When you shop for a new car, phone, or camera, you have lots of
information about your choices. But when it comes to choosing the right
medicine or the best health care treatment, clear and dependable
information currently can be very hard to find.
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 easy,
right? We put out all of the science, and we expect that it's going to
magically trickle down to the point of care perfectly and seamlessly. We have a
lot of evidence that it doesn't quite happen that way.
I was reflecting a bit earlier in the week about the
original vision that Ray Woolsey had for the Centers for Education and Research
on Therapeutics (CERTs). It brought to mind the story of a young woman with a
near fatal tachyarrhythmia who showed up at Suburban Hospital across the street
from the National Institutes of Health, where they determined that her
condition was attributable to an interaction between two of her medications. And
so that was taken off the market. For most of us, that would have been a home
run.
But not for Dr. Woolsey. Ray thought we should be able to
build in that kind of capability into the system. We should plan for it and not
have that kind of success contingent on a lucky coincidence of a fellow in pharmacology
being a moonlighter at Suburban Hospital on that particular evening.
So this very close connection between the scientific work
and its application and practice to improve health and health care was really
part of the original genesis of the CERTs, and it's one that we take very
seriously at AHRQ. Now there's a lot of talk and I think really serious
aspiration and passion, especially since Don Berwick became Administrator of
the Centers for Medicare & Medicaid Services (CMS), about keeping patients at the
center of care. Those of you who have had recent encounters with the health care
system, you have to think we have a little bit of work to do. My family and I
have had a lot of experience with this in the fall, when my dad was quite ill.
What struck me as we hung out in the waiting room—basically
took it over—outside of the intensive care unit, was how hard it is for people
who do not have a background in health or health care to navigate what we call
a system. It's not remotely friendly, not to mention issues such as health
literacy. And although we hear continuously that patients are reading and
looking and searching online, trying to figure out what they can do for various
symptoms and problems, it's really hard to answer that one important question
that all of us want the answer to.
I get calls and E-mails about this all the time from
people asking, "What should I do and where should I go to get it?" We've got
little pieces of the answer to that question scattered everywhere, and
we need to build a much more reliable system so that the answers are more self-evident
and we can be confident that we can deliver on them.
Obviously, the questions the clinicians want to know
about different interventions are very straight forward, although the
information evidence base that is necessary to answer those questions isn't
always readily available. That is the whole point of patient-centered outcomes
research. And we're very excited about the work in progress, to put it mildly. There
is a lot of incredibly important work underway to try and help us deliver with
more precision on the promise of all the advances in biomedical sciences.
We lead the world in biomedical science. That is
fantastic. And yet when a clinician and patient are sitting together trying to
figure out what the right treatment option for this individual's condition,
there is no good source of comparative information. They're making it up as
they go.
Those of you who still see patients know how much of what
we do is guess work. And when you start getting into comorbidities and so forth?
Total and complete guess work. So our aspiration is to close that information
gap, to be descriptive rather than prescriptive. There has obviously been a lot
of discussion—a lot of excitement and anxiety—about whether patient-centered
outcomes research is a good thing or a bad thing. That is completely
understandable, with regard to how it will be used. I get that. I think we all
get that. And frankly, how it's used ought to be just as transparent as the way
that we're doing this research.
We have had the benefit at AHRQ of engaging representatives
from across the spectrum, in and outside of health care, in this conversation and,
ultimately, our hope is that this work serves as a foundation to creating a
learning health care system; a system in which we will be able to be proactive
and identify people who need help before they have a compression fracture.
With all of the opportunities that were afforded AHRQ by
the Recovery Act, which became law in early 2009, we've had the privilege of
investing a total of $473 million from the $1.1 billion that was allocated for
patient-centered outcomes research. A quarter of the $1.1 billion supports
infrastructure. I think that amount is very important because it's a down
payment on the scientific infrastructure that we're going to need to identify
and implement effective systems-based interventions. It's the infrastructure
that we'll need to make the opportunity presented by the Affordable Care Act
sustainable.
The different Federal health care agencies worked very
hard to make sure that our use of the $1.1 billion was coordinated and focused.
This was not an easy challenge, given the breadth and depth of work that has to
be done. Some of you are aware of the challenges that are inherent in
conducting horizon scanning and synthesizing what we know and being very clear
about where the most important gaps exist in our knowledge base.
The focus on dissemination and translation is very strong,
and we have a lot of work to do to identify methods and opportunities for
expanding and enhancing translation and making sure that the information is
being delivered in the right places. There has been a lot of chatter about
social networking, twitter, and all that. I'm not clear yet on what might work
best. What I do know is, ultimately, if we're serious about a patient-centered
health care system, we need to figure out a way to get good information to
people where they are rather than figuring out how to drive them to our Web sites.
That type of strategy is not working well enough to generate
the kind of improvements that are necessary to transform the system. If you
have to get all your information when you're either going for health care or thinking
about it, it's not going to work. That's not actually how people use
information. We want to make sure that good information is impossible to avoid.
There are also specific challenges with making sound and
efficient investments in evidence generation, which includes strategies for
implementing scientific information into practice. And we're very excited about
the opportunity to make much more serious and substantial investments in
generation of evidence. Some of the infrastructure investments that were made
possible by the Recovery Act relate to patient registries and distributed data
networks, all of which will have important current and future impacts on our
capacity to do the research. I would also argue that these registries and data
networks represent sustainable infrastructure for the kinds of systems-based
interventions that you're going to need.
It is not possible to have true systems-based
interventions if you can't look back and determine who you missed. And yet, I
can think of only two examples in my entire career where we actually took
advantage of that kind of an opportunity. The first was in an emergency room
when I was an internal medicine resident. We had a weekly sit down with the
radiologists to go over all of the x-rays. They rarely came in at night, and
during the meetings they would give us guidance to help us read x-rays when
they weren't around. We learned a lot and the guidance was very timely.
The other time was in a physician-based homecare program
a little later in my career. The team I was working with created a database of
patient charts. Many of the patients we were working with had multiple chronic
illnesses and a huge array of additional medical issues and interventions. This
team also created a sit-down where we went through the charts to see if there
were ways to eliminate some of the "oops moments."
Any of you who have had the opportunity to review charts
have experienced these moments. And it's stunning to me how infrequently we do these
kinds of reviews in health care. The cultural ethos that guides what we do is
still one patient at a time, do the very best you can, and move on to do it all
over again. You want that passion, but you also need to have the capacity to
ask the question, "Where are we dropping the ball?"
Research can help us do so many things. For example, it
can help us:
- Make
more consistent decisions.
- Provide
clinicians and patients with important tools.
- Clarify
disputes over practice and policy.
Patient-centered outcomes research informs
health care decisions by providing evidence on the effectiveness, benefits, and
harms of different treatment options. The evidence is generated from research
studies that compare drugs, medical devices, tests, surgeries, or ways to
deliver health care. Our Effective Health Care Program (EHC) funds individual
researchers, research centers, and academic organizations to work together with
us to produce patient-centered outcomes research for clinicians, consumers, and
policymakers. The program was created as part of the Medicare Modernization Act
of 2003.
The authority in the Act related to the EHC program has
three parts. The first part basically says that researchers cannot set
priorities by themselves. They need to do it in collaboration with
stakeholders. In fact, for our program, the Secretary of Health and Human
Services has a very significant role in developing our research priorities. The
second part is all about conducting and supporting research, and the third part
talks about communicating our findings widely, to a variety of audiences.
We have a long way to go on part three. Just think about
the array of interventions that are possible with osteoporosis—the very
different profile of potential benefits and harms—and you suddenly start to
realize that you've got a cognitive task which exceeds the capacity of patient
pages in medical journals. These journals are not the right tools to help
individuals and their families think about this cognitively difficult task of
deciding on a treatment option. And there has been a strong focus, particularly
in the Recovery Act, on investments in priority populations, which are often underrepresented
in research.
One of the clinician guides developed by the EHC program
examines what the bottom line is for fracture prevention. We know that some
bisphosphonates and estrogen prevent hip and other nonvertebral fractures. We
know that drugs such as raloxifene and estrogen prevent vertebral fractures. And
we know that raloxifene, tamoxifen, and estrogen increase the risk of
thromboembolic events. What we don't know is how does exercise fit and how much
exercise is needed. The challenge comes when we have to deconstruct all of this
for a clinician-patient encounter, in terms of what's the right thing to do.
Having recently had a Dual
Energy X-ray Absorptiometry (DEXA) scan to measure my bone density, I
learned that I have vertebral osteopenia. This is a deep personal interest, yet
I know there is no dosing information. We don't really know if one class of
drugs is superior to another, and we don't know if the bisphosphonates are
superior to others or more effective for fracture prevention. There is a lot of
uncertainty and yet for American women—and women around the world—the clock is ticking.
So I think there is an urgent need to implement what we know and also to build
better information.
We have supported several projects that focused on adapting
consumer guides and other guides from the EHC program for use by different
audiences. One project at the University of Texas is actually translating the
guides for low-literacy patients. They're specifically targeting osteoporosis,
osteoarthritis, and rheumatoid arthritis, and they can be updated as we get
better information.
In the larger picture of quality of care, I'd like to
tell you that missed opportunities for prevention or potential treatment
identification of women and men at high risk for osteoporosis are our only
problem. Obviously, that's not the case. We have a very, very chaotic delivery
system, with an annual rate of improvement of about 2 percent, according to the
latest AHRQ National Healthcare Quality Report. We have a companion report, the
National Healthcare Disparities Report. Both are submitted to Congress each
year. One of the good pieces of new information from the Disparities Report is
that the number of women age 65 and older who are being screened has increased.
Under the Affordable Care Act, preventives services—including
the early identification of conditions like osteoporosis—will be much more
available through elimination of the copayments for evidence-based
interventions. The Act, which was signed into law last March, created the
Patient-Centered Outcomes Research Institute. This new entity will be based in
the private sector, funded by a combination of public and private funding.
The Institute's board of directors was announced in late
September. This is stakeholder governance at its best. There are 21 members. There
are experts representing consumers and patients, industry, physicians, and
other groups across health care. Dr. Francis Collins, Director of the National
Institutes of Health (NIH), and I are members. Of course, the Institute itself is
in the formative stages. One of the main questions we have to work out is what its
unique niche will be in a landscape that includes the CERTs. The language in
the Act says the Institute is encouraged to contract with AHRQ and NIH. Of
course, we're still working on what that will look like. Dr. Collins and I are
committed to working effectively with this new Institute.
The Affordable Care Act also includes a requirement for
developing a National Health Care Quality Strategy.
We're very excited about this first installment of the national
strategy, if you will. It has to be updated annually on a transitional path,
where the goal is to align all of the numerous efforts going on between the Federal
and State Governments, and between Government work and work being done in the private
sector.
A lot of people understand that there are problems with
our health care, even though it is one of the best—if not the best—system in
the world. They understand that we can do a better job. We have to do a whole
lot better and making quality improvement easy is going to have to be a part of
our shared aspirations.
The really good news for the work that is taking place
with respect to bone health is there are a lot of people who are interested in
it. There is a lot of momentum, with the Baby Boomers and the opportunities
that are currently being created to improve health care.
There are a lot of women and their families who are
interested, including the men in the family of my good friend who was treated
for polymyalgia rheumatica. I would imagine that they are big advocates for
this as well. There are many new advocates and the numbers grow every day.
Where there is pubic passion and commitment to making
things better, I don't think we can miss.
Current as of February 2011
Internet Citation:
Keynote Address: Bone Health Conference: Best Practices in Systems-Interventions to Reduce the Burden of Fractures. Speech by Carolyn Clancy, December 9, 2010. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/sp120910.htm
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