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Agency for Healthcare Research Quality

Keynote Address

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.


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