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Integrating Comparative Effectiveness Research into Everyday Practice

Webcast Transcript, October 12, 2010

>>DR. STEPHANIE CHANG: Good afternoon, everyone. Good morning to those who are on the west coast. Good evening to those calling in from other countries east of us. Thanks for standing by. Sorry for the short delay.

I'd like to welcome you to today's Web conference titled Integrating Comparative Effectiveness Research into Everyday Practice. This conference is sponsored by the Agency of Healthcare Research and Quality, also known as AHRQ, through the Effective Health Care Program. This event today is an example of how we hope to build on our commitment to creating and disseminating resources and information about comparative effectiveness research to commission to support everyday practice. Thank you for partnering with us in this effort. I'm Stephanie Chang. I direct the Agency's evidence-based practice center program, and I'll be facilitating today's event. Next slide, please.

Before we get started, I just want to review some information about the Web conference technology today so that you can interact and participate and ask us questions throughout. If you have any questions throughout the program, you can submit them electronically by accessing the "ask a question" button. That's located on the bottom of your screen on the righthand side. You can click on the button and a box will appear on your screen that will request your e-mail address and your question. Once you complete that information, you press the submit button. We'll be having three moderated question-and-answer sessions where the speakers will be responding to some of the questions. Submit them as soon as you think of them. Don't wait until the end.
Also, if you are experiencing any technical difficulties now or later, you can also hit that same button and submit your technical question or problem to the "ask a question" box, and someone will get back to you through your e-mail.

Biosketches of this conference are available. You can find these in the resource library that's located next to the "ask a question" button. If you click on that button, you'll find the slides and a document with the speaker biosketches. There's also a link to the AHRQ Effective Health Care Program Web page that we really would like you to visit after this event.

For those of you who need it or find it helpful, today's Web conference includes closed captioning. The captioning appears in the box below the slides. And for those of you who missed part of it, the presentation will be recorded and made available on the Effective Health Care Program Web site.

Next slide. There's an agenda up on your screen. And I'll just review it really quickly right now. During this Web conference, the presenters will highlight the ways that comparative effectiveness research has been used to improve health care delivery and describe the ways that the various organizations have partnered with AHRQ to improve the delivery of health care.

Dr. Carolyn Clancy will be the first speaker. She's the director of AHRQ. And she'll start by describing how you as clinicians and those involved in the health care field can really find comparative effectiveness research to improve decisionmaking. Immediately after the presentation, she will be answering questions, so please do submit the questions throughout her presentation, and don't wait until the end.

Following Dr. Clancy, Jean Slutsky, director of AHRQ's Center for Outcomes and Evidence, will discuss the Effective Health Care Program specifically and highlight clinician resources available, as well as findings from a couple of research studies funded by the Program. At the end of her program she'll also answer questions from the audience. Please submit those throughout her presentation, as well.

The last part of the Web conference will feature three presentations that will be done in a series. First, these three organizations are some examples of how they have implemented research findings and related materials from the Effective Health Care Program into the delivery of health care through their program or policy work.

Dr. Amir Qaseem will go first, from the American College of Physicians, ACP. And he'll describe how they used the comparative research findings to create evidence-based clinical guidelines.

Second up will be Mary Jo Goolsby from the AANP, the American Academy of Nurse Practitioners, who will describe how they've created modules based upon the Effective Health Care Program clinician guides.

And the last speaker will be Dr. Nilay Shah from the Mayo Clinic, who will talk about how they developed a patient decision aid using the findings from the Effective Health Care Program. After all three of these speakers have finished, we'll have another moderated question-answer session for questions for any of the three of them. Please do submit those any time throughout those three presentations.

We have an exciting lineup. And I don't want to delay this any further. As I mentioned, the full descriptive profiles can be found on the resource library at the bottom of the page. But otherwise, we will move on.

Next slide. I have the pleasure of introducing the first speaker, Dr. Clancy, who is, hopefully, on the line.

>>DR. CAROLYN CLANCY: Great. Thank you for the introduction. I really appreciate it. And I want to welcome everyone here this afternoon, as well. I am really thrilled that there are so many clinicians joining us today to learn more about a growing branch of patient-centered health research previously called comparative effectiveness research and how this work can help improve the quality of health care you deliver every day.

In fact, I would say very directly that in our view, the success of our investments in this research will actually be judged by how much help it gives to clinicians and patients as they are struggling to make decisions every day.

My last information is that we had close to 1,000 registrants for today's event, so I am really excited. Next slide.

Before getting into the details about comparative effectiveness or patient-centered outcomes research, I wanted to provide just a little bit of background about AHRQ. Very simply stated, our mission is to improve the quality, safety, efficiency and effectiveness of health care for all Americans. Next slide.

This next slide shows you, rather than an organizational chart of offices and centers—if anyone feels deprived, I would be happy to get you one — but the real engine of how we do our work, our portfolio, is shown on this slide. And you can see that the upper right-hand wedge of the pie is labeled comparative effectiveness research and that's what we're going to be talking about today. But I think it's also important to recognize that each of these portfolios has great potential to help transform the health care system of the 21st century into one that is information rich but also patient focused, which doesn't necessarily feel like health care today, at least every day.

So, in addition to the fact that we're talking about comparative effectiveness today, again, we think it's very important the intersections among these areas are also recognized.

At the end of the day, we provide support for independent research that is always informed by the needs of people using the research, that is designed to help people and organizations at all levels make a wide range of informed choices. Next slide.

The ultimate goal here is informed choices. We're not telling people what to do; this is not prescriptive. It is actually descriptive. But I think many of us on the phone today together would agree that as a nation, we don't make informed choices about health care often enough.

Whether you're a doctor, a pharmacist, a nurse, or anyone else who has to make health care decisions, you can benefit from patient-centered outcomes research. This research is designed to help you, the busy and way too frequently time-challenged clinician find out what the latest and best science says about treating various conditions. Next slide.

This slide just shows a clinician with I'll say a mature female patient. If you would imagine for a moment that this woman is seeking guidance from you and wants to know, how can I relieve my pain without suffering side effects? What's the best medicine? Next.

The next one shows a clinician with an older gentleman. If you could imagine having the conversation, as I would imagine a number of you have with friends and family members and colleagues and so forth, about his newly diagnosed prostate cancer. He really wants an honest appraisal of his options. Should I have surgery? Chemotherapy? Radiation? Hormones? Watchful waiting? What is the best choice for me? And what are the risks?

Now, obviously people don't necessarily articulate their questions in that very clean, organized way. But at the heart of many, many clinical conversations between clinicians and patients, those are the ultimate questions. Next.

As a practicing clinician, I know you wake up every day wanting to provide the best, safest, and most appropriate care to every patient that you see. And a big, big part of that, a big part of the currency of health care, is talking to patients, listening to their concerns, and answering their questions with information they can use to figure out what is the best decision for their treatment options?

We know today that many patients are getting more involved in their health care decisions. It feels like every 10 minutes I'm getting another e-mail about how many Americans go online to find out more about potential treatments and so forth. And I'm really glad to see that happening. The health care system is much better off for it, and it's a trend that should be encouraged. And we also recognize that every patient is different: different life circumstances, different medical histories, and different values and preferences. Patients need reliable and understandable information that's relevant and applicable to their circumstances, Information that allows them to be a partner with you to make the best possible health care decisions.

I think you're getting the drift that we believe that the role of the patients in this equation is extremely important and, therefore, my Agency is making a big investment to educate patients and their families about taking an active role in partnering with their doctor, pharmacist, nurse, or other health care professional.

So, that brings us to today's topic. Where do you get the information to work with patients to make these critical decisions? Next.

Comparative effectiveness, or patient-centered outcomes research, focuses on patient-centered outcomes. It focuses on providing unbiased and practical evidence-based information. And it ultimately compares drugs, devices, tests, surgeries and other approaches to health care in terms of benefits and harms. And also what is known and what is not known.

The work that we support is not done generally within a category of type of service. Usually, we are doing this under the framework of looking at particular conditions. Again, similar to prostate cancer. Should I have surgery? Should I do watchful waiting? Should I have chemotherapy? Should I do some combination? And what does it mean for me if I make one or another decision? At the end of the day, we believe that this research to be most helpful to you has to be descriptive rather than prescriptive. Next.

So, I think it's very important to recognize both the tremendous advantages that this research offers as well as, quite honestly, what research can't necessarily do. This research can actually help make decisions more consistent and transparent and so forth, and at an organizational level can sometimes help clarify the nature of disputes over practice and policy.

We believe that it is very, very tightly linked to efforts to improve the quality of care and it can help patients make decisions about their own care. Next.

Now, this past year and a half has been amazingly busy for us at AHRQ. We have been the lead federal agency for this kind of work up until 2009 when the American Recovery and Reinvestment Act was passed. Now, up till that time, over 5 years, we received a total of $129 million from Congress for this type of research. And then when the Recovery Act was passed, that included a total of $1.1 billion—that's billion with a —for comparative effectiveness research, including $300 million directly to AHRQ.

Now, we thought we had to make the very, very most of this opportunity and took it very, very seriously. It's been an exciting and exhausting year. And we're very excited about the work that's really just getting started. And we're excited about it because of what it can do for you.

Again, the guiding vision for our efforts is that this is translated as good information that's available when and where you need it for clinicians and patients when they're struggling with a lot of very, very important decisions.

In order to make the best possible use of these resources, my colleagues, led by Jean Slutsky, whom you will hear from in a moment, and including Stephanie, who is moderating today's discussion, thought it was incredibly important that we actually have a very clear framework for how we would make these assessments.

The process, all of our research, begins with stakeholder input and involvement. In other words, we do our best to articulate and support others to articulate what we think are important questions. But we also put those questions out for public comment so that we know and have much better confidence in the fact that we're supporting the best possible research.

Interestingly, many countries have tried—many developed countries, I should say—have tried to figure out what's coming online or over the horizon. The kind of thing you might hear about at a medical meeting, or for those of you who provide care in the hospital, in the cafeteria or overhear in conversations. So, this year we've been able to make an investment in developing a methodology for what we're calling horizon scanning.

A very important linchpin and foundation of our efforts is about synthesizing existing evidence. There are actually renowned researchers who believe that no clinical trial should ever be conducted until a very rigorous systematic review or synthesis of existing studies has been done so that we know with some precision what are the most important areas for future research.

Now, anytime you do a systematic review or synthesis of existing research, whether it's the kind of rigorous work that we support or even a kind of back-of-the-envelope, you immediately stumble onto unanswered questions. And, again, this past year, we thought it was incredibly important to be able to be as clear as possible about those evidence gaps, so we actually made some investments in a strategy to figure out how to make the identification of important research gaps as consistent as possible.

When we do identify important gaps then, of course, we need to turn to a variety of different approaches to generate new, important evidence. And throughout all this, we're very squarely focused on developing and nurturing a workforce of researchers, including clinicians, who will continue to do this work throughout their careers. And we're also focused on supporting the development of the tools that they will need. Next slide.

Now, some of you may have been wondering, "How does this relate to the Affordable Care Act?" Let me just say there is one very explicit section, very, very well written in the Affordable Care Act, Section 6301, which establishes a new Patient-Centered Outcomes Research Institute, which, of course, we have shortened to PCORI here in the nation's capital. Very importantly, this is an independent, nonprofit institute which will be funded by a combination of public- and private-sector funding. It will set priorities and coordinate with existing agencies, such as AHRQ and NIH, that support patient-centered outcomes research.

By law, the director of AHRQ and the director of the National Institutes of Health are on the board of this new institute. The board was just announced several weeks ago. So, it'll be some time before you hear very much about the interworkings of this institute.

It's also important to recognize that the bill was very clear in prohibiting the findings to be construed as mandates on practice guidelines or coverage decisions, and includes some important patient safeguards. This is a comment more on how research is used than on the research itself.

At the end of the day, we know that improving health care and getting to a place where no matter where you land for health care, you'll have full confidence that the care you're getting is superb quality, is by definition a team sport. We look forward to working with you to improve the quality of care as we find new and important ways to conduct and apply patient-centered outcomes research. And we appreciate your continuing interest in practicing evidence-based medicine.

I want to urge you to use this information and share it with your patients to help you work together as a team to make the best possible treatment choices for each individual patient. I can tell you quite directly that I use the consumer guides a lot with my friends, with my family members. And to a person, they have found the information very empowering.

For example, the consumer guide for men confronting decisions about what to do about localized prostate cancer actually has a list of questions that they can take with them when they go to see a cancer specialist. And I can tell you every one of my friends has been very, very excited about this.

Stephanie, I think you said that people could send in questions now?

>> CHANG: That's right. People can submit questions in the "ask a question" box. I think we're running a little behind. We'll just have 5 minutes for questions. Dr. Clancy, one of the questions is you talked about how the comparative effectiveness research is to be used for the individual patient. How does comparative effectiveness research fit with personalized medicine tailoring it to the individual?

>>CLANCY: My shorthand answer is hand in glove. Personalized medicine, although I'm not entirely clear what the complete definition is, does actually have the potential to bring online new kinds of treatments that really are customized for your disease. Now, today, if we were to have a breakthrough in research, what we'd see is that some people would benefit dramatically, but we wouldn't have a systematic way of identifying all of the people who could benefit so that we could make sure that all of those folks had the opportunity to benefit from this new breakthrough kind of treatments. And sometimes we might use it in patients who wouldn't experience such a great benefit.

We think that a big part of the infrastructure necessarily for this research—for example, patient registries—will help us identify which patients are likely to benefit so that all who are likely to benefit can be identified and given the opportunity to benefit and will also help us identify which patients are probably doing just as well on standard treatments.

>>CHANG: Thank you very much. We probably just have time for one more question. Can you tell us a little bit about how the research topics are chosen and how that is decided between AHRQ and PCORI and how those two institutions might interact?

>>CLANCY: First of all, I am so glad you asked that question. We have, at the Effective Health Care Web site, which is—if you land yourself on, you can find it very easily, as well—lots of opportunities to hear from you. And we very, very much want to. You can weigh in on research priorities. You can respond to explicit requests for comments on the key questions that have been posted. You can actually submit comments in response to draft reports.

Occasionally, these draft reports even generate their own news coverage in the trade press. And we think that is actually fantastic, because we believe that it's very important to support research that's both transparent, credible and that's ultimately trusted.

>>CHANG: Thank you, Dr. Clancy. One last question I think we can fit it in. Are you going to be encouraging other organizations around the country to also conduct effectiveness or comparative effectiveness studies?

>>CLANCY: Well, I'm pleased to say that as a result of all the research investments we've made this past year—we're still catching our breath a little bit—in patient-centered outcomes research, there are many, many organizations around the country now conducting some of this work. And those efforts range from efforts to improve care for individuals with multiple chronic conditions to support for registries, which are an important research tool, but also a vital tool to assess and improve quality of care. To say I'm excited about all of these investments is a profound understatement.

>>CHANG: Thank you, Dr. Clancy. I'm afraid we're out of time. I'm sorry for those we didn't get your questions. But, hopefully, if there's time in Jean's, some of them may be relevant there, as well.

>>CLANCY: I was honored to serve as the warm up act to Jean Slutsky, who has really been a fantastic leader for this Program. I'm happy to turn it over to her.

>>CHANG: Thank you, Dr. Clancy. Jean? I'll introduce her briefly. She's the Director for the Centers of Outcomes and Evidence and my boss. The Center oversees the Effective Health Care Program, which she'll review today and all the work that's going on there. Jean?

>>MS. JEAN SLUTSKY: Hi, good afternoon. As Stephanie said, I'm Jean Slutsky, and I direct the Center for Outcomes and Evidence at AHRQ and the agency's Effective Health Care Program. I would also like to thank all of you for joining us today. I know there's been some technical difficulty, so I just want to reassure you that this will be taped, so you will be able to see it with the slides after this program.

Dr. Clancy talked generally about comparative effectiveness or patient-centered outcomes research and the large investment that the Federal government has made in it to improve the health care quality of our patients.

I would like to provide a little bit more detail about the efforts that AHRQ has made in this area over the last several years, especially those things that may be useful to you with your care for your patients and ways that you can actually interact with us to make this program even more effective. Next slide, please.

Actually in 2005, AHRQ established the Effective Health Care Program. This program was initially authorized under the Medicare Modernization Act of 2003. And for the last 5 years, the Effective Health Care Program has been conducting comparative effectiveness research in order to help serve people who have to make decisions either because they’re patients or consumers, clinicians, policymakers, and to improve the quality effectiveness and efficiency of health care delivered. Initially, the program was intended to meet the needs of the Medicare population as well as the Medicaid and the State child health insurance programs, which are really cradle-to-grave programs. But obviously these issues are important to patients who are cared for under different programs and insurance in the United States.

Even though it has a new name, patient-centered outcomes research, the focus of the research doesn't change. It is always focused on clinical effectiveness and treatments and interventions and strategies for providing health care and their impact on patient-centered outcomes.

The research focuses primarily on what we know now and what are important research gaps that are critical to fill and how we can translate this information for users. Next slide, please.

This slide presents a framework for how AHRQ has made investments in comparative effectiveness research. And this framework is how we've built our program. And what you can see is, it really starts with horizon scanning or understanding what might be important things for which we need to make investments in comparative effectiveness research, as well as evidence synthesis, which is very good at letting us know what we know from previous investments in biomedical research, and then can very effectively identify research gaps. And those research gaps are important for both researchers to plan their research programs and for funders of research, as well as understanding which priorities we might want to set for new research.

And then we fund programs of evidence generation or new research on strategies to provide health care, different clinical interventions, and on conditions and populations.

And then one of the most important things is a translation and dissemination and implementation program. The legislation that actually authorized the Effective Health Care Program was very specific that research findings should be translated into usable and understandable products.

And, finally, we hope that this leads to an improvement in care and back to the horizon scanning. Underpinning this whole framework is actually a research platform which helps support the infrastructure to do research by both methods development and training of new researchers, as well as stakeholder input, getting the needs of people who have to make decisions in the health care arena. Next slide.

This program is actually focused around 14 priority conditions that were established by the Secretary of Health and Human Services. And as you can see, these are very, very important conditions that affect a large number of Americans. And these 14 priority conditions do guide the work that we do within the Program. Next slide, please.

Also, it's very important to understand that the Effective Health Care Program has a research focus on priority populations, which include low-income groups, minority groups, women, children, the elderly, and individuals with special health care needs, such as those with disabilities and those who need chronic care or end-of-life care, or those who live in intercity or rural areas. So, patient populations that may not be represented in traditional clinical studies are sometimes hard to study because of the complexity of their conditions. Next slide, please.

Since the inception of the Effective Health Care Program, AHRQ has funded and completed dozens of patient-centered comparative effectiveness research projects. These projects include comprehensive reviews of diagnostic or treatment options for breast and prostate cancers, atrial fibrillation, diabetes, osteoarthritis, depression and many other conditions. To date we completed over 25 research reviews, as well as 16 original research reports. Many, many more are in the pipeline.

We've also made great progress in the areas of methods research. We have completed and posted about 36 methods research reports, including guidance on methods for conducting comparative effectiveness reviews as well as designing, implementing a registry for evaluating patient outcomes, conducting diagnostic tests for improved health outcomes, heterogeneity of treatment effects, and many other research projects on quasi-experimental or observational studies. Next slide, please.

The Effective Health Care Program creates a variety of products that are based on research reviews and reports. And this is part of our mandate to actually translate our findings for a variety of different audiences. This includes executive summaries of systematic reviews, which are manuscript length. Plus, summary guides that are written for clinicians, specifically just the facts, consumers and patients and policymakers. In fact, the clinician guides are designed so that they can be used with the clinician and the patient or alone.

We have recently added to our portfolio a number of materials to support clinician education, including continuing education modules that can be used onsite or transposed to your own site, interactive case studies, and faculty slides sets. We'll soon be adding patient decision aids, as well. Next slide.

I would like to highlight more of our consumer guides that summarize evidence in plain language in easy-to-read formats. These guides are paired with our clinician guides to promote shared decisionmaking. Most of our consumer guides have also been translated into Spanish. And the consumer guides are also available in audio files. The consumer guides can be found online or are available in print. And we also have a mechanism where you can order them in bulk, as well.

Most importantly, in echoing Dr. Clancy's comments, we want to encourage you to get involved in the Effective Health Care Program. Your participation is mutually beneficial. There are multiple points of involvement in our program before, during, and after the research is completed. You can nominate topics for research on our Web site. That's very important to us to know what research questions are important to you.

You can also give input on draft key questions and reports. This kind of involvement helps you get the type of research that will really help answer those controversial questions or just nagging clinical questions. And it helps us by getting the research right. If it isn't relevant and applicable, then we can't expect to have an impact. If it doesn't meet your needs, you're not going to use it.

After the research is completed, you can help disseminate the information to your colleagues and patients. And you can implement the findings in your clinical decisions. This helps both you and us by creating opportunities for better and more informed decisionmaking and making an impact on the quality of health care. We also want you to give us feedback on how effective these documents and products were for you.

We also recognize the importance of information sharing among colleagues, friends, and family when it comes to health care decisionmaking. All of our materials are available for free on our Web site and can be shared by a variety of social media tools, buttons, and widgets. I say this thinking I'm not really sure what a widget is, but I know that those of you who are maybe younger than me or have teenagers are very familiar with widgets. We encourage you to share all of this information with your colleagues and patients and maybe even your teenagers. Next slide.

At this point, I'd like to shift gears a bit and focus on some of the actual comparative effectiveness research findings from AHRQ's Effective Health Care Program. These are still referred to as comparative effectiveness because the reports were published prior to the change in vernacular to patient-centered outcomes research, but these two terms can be used interchangeably. Next slide.

As you can see by the key questions identified here, this research review focused on a p