Transcripts For CSPAN2 Bipartisan Policy Center Hosts Discussion On Patient Treatment Options 20170418

23rd on book tv on cspan2. Up next, the conversation from the Bipartisan Policy Center about Patient Centered research. How to provide the most effective medical treatment. Well hear from doctors of the Veterans Affairs department, John Hopkins University and heartfelt patient. [inaudible] [inaudible] good morning. It is great to see olivia here today. Im the chief medical advisor and i want to welcome all of you to todays event. For those of you who are new to bbc. We want to come by the best ideas from both political ideas to promote health and security for all. Todays event is being streamed live online and on cspan2. A recording will be available later this week. We invite you to interact with us on twitter about todays event using the bpc live. Well be taking questions after the panel discussion. If you are watching online and have a question for our panelist or opening speaker you can use bpc live and we will try to get to those during the q a. Over the next 90 minutes will be discussing Patient Centered comparative Effective Research. Essentially what our topic will be focusing on today is identifying how best to provide optimal care for patients based on science and based on patient priorities. As a physician for many years i recall instances conversations with patients when there was evidence in support of a particular course of treatment over another. I als recall other instances whn theres a lack of evidence. It is important for Healthcare Providers and patients so they can make the best Treatment Choices together. We call this, shared decisionmaking area today swarm is the first of two Educational Forums bpc plans to host on this topic. This morning we hope to learn how and why this research is conducted, how the results are used by patients, Healthcare Providers and other stakeholders and how this process is currently funded. Our second form will go deeper into the future scope and direction of comparative Effectiveness Research and its role in improving outcomes and effects on how care spending. Im sure the panel will touch on this today. Were honored to be hosting a fantastic group of speakers and leaders from the public and private sectors. We are thrilled to have a patient joining us today to provide her thoughts on this very important topic. Let me start by introducing doctor jody siegel who will be our opening speaker. You have jodys bio in front of you. She is a professor of medicine at Johns Hopkins university. A National Expert on comparative Effective Research and she will help by providing an overview of our topic. This will be followed by a moderated discussion with our panel in a discussion with all of you. Thank you. [inaudible] [inaudible] [inaudible] [inaudible] [inaudible] thank you very much for the invitation to be here today to join you and teach about this important topic before we hear from the panel of experts. I aim it for you to understand the goals of comparative Effective Research. But we hope to accomplish with this research and what fits the Translational Research pathway. As is fitting for Patient Centered research, lets start with the patient. Some of you may have asked this question to your doctors, doctor, should i be taking aspirin to prevent a heart attack . I know that i have some worries and risk factors. Should i . Clearly as clinicians we all want to get the right treatment to the right patient at the right time. Comparative Effective Research it generates evidence to inform the decisions that we make as clinicians but are made as pairs and as patients make. I wanted to start verbatim with the definition of comparative Effectiveness Research from the institute of medicine in 2009. Comparative Effectiveness Research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor clinical condition or to improve the delivery of care. The purpose of cer is to assist all stakeholders, clinicians, purchasers, policymakers to make informed decisions. This is about making decisions that will improve healthcare at the individual and Patient Healthcare levels. What are these questions that we need to make decisions about . What do Patients Want to know . Should i take aspirin . Should i start mammography at age 40 . Should i have my cancerous prostate remover in my safe waiting a bit . Should i take one of the newer anticoagulants to treat my blood clot . What do doctors want to know certainly some of the same things, but also, should i use the robot in this hysterectomy or should i use the usual open procedure . Should i recommend to my patients a colonoscopy or the new dna based stool cards adequate . Are the new medicines for diabetes better than metformin which i was prescribed . What does medicare or other pairs want to know . Should we cover implantable defibrillators . Should we cover Home Care Services after hip replacement . How often should we cover jerry jerry nutrition for those in nursing homes. Lets take a look at where we are in the terms of the pathway. A lot of people look at translational pathway moving left to right, basic research. Research that understands the mechanism of disease, the chemistry, the biology, physiology, genetics of how disease occurs. Clinical research is often early testing in humans. Testing treatments and devices to see if its safe in humans. Publisher based research is often Testing Research that is at a certain level. Like access to food or exercise. And then the Healthcare Delivery system, what is the best way to deliver care. Even for the right on this picture i would put dissemination and implementation research. What is the best way to actually get evidence into the hands of the people who need to implement the evidence. What is the best way to get the information to doctors or to payers . I was put comparative Effective Research to the right of the transitional pathway. The population base, the clinical comparative research, the Health Services research, and certainly the dissemination and implementation research. I misys Research Important . Many important healthcare decisions have little scientific evidence. Sorry to say that it is improving for the past 30 years that we still make lots of clinical decisions based on Expert Opinion or tradition, or i just think this is what is best for my patient. Certainly the quality and value of the care we deliver is uncertain. There is variation in practice, regionally across the country. You have to assume that some of the care delivered is not benefiting patients. There are tremendous economic implications of rising healthcare costs, new and very expensive treatments and diagnostic tests. They very rapidly going to practice, perhaps before theres evidence to suggest its usual for the whole population. Their slow translation into evidencebased practices. Some things we know what to do but its hard to get that into practice. What should be study . The institute of medicine in 2009 was tasked with considering priorities for comparative Effective Research. The iom panel solicited input and prioritized 100 research questions. Here is an example of a few. One is compare the effectiveness of Management Strategy into earlystage breast cancer. Establish a registry to compare the effectiveness of treatment strategies for low back pain. You can imagine these answer questions that are very important to clinicians and patients. Among the hundred top priorities, half were about Healthcare Delivery system which was a little surprising to many people. But emphasizing that understanding the comparative Effective Research. Who funds this type of research . Many different funders have some part in comparative Effective Researched to varying degrees. I want to highlight to that do the bulk of funding and that would be the agency for Healthcare Research and quality since 1999. Its a federal agency with the sole purpose of producing evidence to make healthcare safer, higher quality, more accessible, equitable and affordable. There also committed to training the next generation of researchers including comparative Effectiveness Researchers. Patient centered outcomes Research Institute since 2010 Funds Research that will help patients choose Treatment Options that best meet their needs. For this research that advances the quality and relevance of evidence of how disease can be effectively diagnosed, treated, and monitored. This is not to say that others dont also fund this research. These agencies have these as the primary mission. Let me highlight some comparative Effectiveness Research. You can get the research and see its impact. This is a fairly wellknown example from doctor peter, my colleague at hopkins. So they invested in the comprehensive unit based Safety Initiatives in 2003. The dr. Asked, is there a better way to prevent central line infections than what we are currently doing . Central line to catheter in the to give fluids, food and medicine. This program in the first 18 months they do 1500 lives in nearly 200 million just in michigan. The intervention was a very systematized checklist of processes that should have happened before central line is placed and while it is place. A very lowtech intervention that was highly impactful. Now, more than 1100 hospitals in 1800 teams have participated in initiatives like this. They have now spread out to do other things besides prevent central line infections. The evidencebased Practice Centers funded by hr q have produced more than 500 comprehensive systematic literature reviews. These literature reviews are used as the evidence to support the u. S. Preventative Services Task force recommendations. To support professional cited guidelines like American College of physicians, used to inform the nih consensus conference and informed cms decisions. This is about treating symptoms of diabetic neuropathy. Decisions for cancer treatment. Treatment of muscle invasive bladder cancer. As i said, these comprehensive reviews are used as guidelines. This came out just this month. These were guidelines about noninvasive treatments for low back pain. These are the u. S. Preventative Services Task force for screening for colon cancer. This is about treatment and management of gout. Again, these are all based on the systematic reviews ended by hr q. Im a pause for a moment to talk about the key methodologies that we use. We talked about evidence synthesis. That is taking the evidence that exists in the literature and comprehensively synthesizing it so it is useful. Certainly we also do evidence generation. So making new evidence. Sometimes this uses experimental methods like trial. Sometimes it uses observational methods like data from the Patients Health record or data from the administrative claims, billing data from patients and applying very rigorous and sometimes complex message to glean evidence from this data. Stakeholder engagement methods are part of cr as the dissemination and implementation methods. Other examples of important results for medical practice includes a study for the virginia surgical improvement program. So, these researchers asked, his bariatric surgery, weight loss surgery more effective at preventing deaths than usual care which is no surgery in morbidly obese veterans . So, they identified 2500 veterans, mostly men who had bariatric surgery and compared them to similar patients have not had the surgery. As these lines the show, that they diverge. The surgical patients had a much lower rate of mortality over the 12 years of followup than the non surgically treated patients. Rigorously done informs suggesting perhaps bariatric surgery is appropriate for these patients. Another is funded by its about inter venous versus oral antibiotics for children with bone infections after hospital discharge. So they asked are all into biotics as good as intravenous antibiotics . Yes, children treated with antibiotics did not have more treatment failures and it was much more satisfying to the patients, the parents and had fewer trips to the emergency room for comp locations of the catheters. That was the trial. That was a pragmatic trial. It was conducted in the usual care settings of these patients. The Patient Centered outcomes Research Institute has made major advances in establishing networks for the conduct of pragmatic clinical trials. These are different than the trials conducted by perhaps tried companies that are tightly controlled and the patients all look alike and everybody gets tight followup. These are trials conducted in the patients usual care setting and cared for by their usual doctors or surgeons. So we have set up a cornet with Clinical Data Research Networks which are networks of Health Systems and patient powered networks which are driven by patients. For example, john hopkins is part of the past Clinical Network which is other Health Symptoms in pennsylvania and utah. So the first trial that theyre involved in is answering this question, what is the best dose of aspirin to prevent heart attacks and strokes. Its hard to believe this question has not been answered. Aspirin has been used since the 1990s for stroke prevention. Should patients get 81 milligrams or 325 milligrams of aspirin . This is a big trial embedded in the usual healthcare system. Should enroll 20000 patients across the six sites. What outcomes are important when we conduct cer . This is Patient Centered research. Therefore the outcomes that we look at should be important to patients. Clinical trials often dont measure outcomes that are important to patients. They may be important to the fda if they are approving a product and saying that its safe, but theyre not always that relevant to patients. So Patient Centered Outcome Measures are measures that assess the impact of the disease and treatment of patients for example, pain. A very patient relegated outcome. Patients do not want pain. Depression. Theres lots of different measures and scales that are validated to measure outcomes that are important to patients. Like the hamilton rating scale for depression. Others might be survival or even time to work so that researchers can access these tools. May find the evidence, i might go to the clearinghouse which is a store the prevention of cardiovascular disease. In fact that guideline was based on a review funded by hr q and 2015. In fact, that review became the u. S. Preventative Services Task force background for the recommendations. So for my man patient, i would say there is be level evidence, yes, i think you will benefit for the use of aspirin to prevent heart attack and stroke. For my older woman patient i would say the evidence is unclear. Not strong evidence, im not sure which way to go. I want to finish by saying this is not exactly new. Cer and cr Type Research has been described in literature since the 1950s comparing different medicines. In fact, pragmatic trials were first described in the late 1960s by french epidemiologist and did not gain focus until the past decade. The virginia has been doing Health Services Research Since the 1970s. The growing tension in the 1980s with appreciation for what is evidence in the rising healthcare cost, the establishment of arc in 1999 and more recently nearly has focused the funding on cer and has done a lot to advance the methodologies we use to do the research. I do think it is now recognized as an essential late part of the translational pathway to improve patient outcomes, hopefully in a sustainable healthcare system. Thank you for your attention. [applause] thank you for that excellent presentation in providing some level setting for the audience. I would like to invite our moderator and panelists to the stage. Our moderator for this morning is gail lewinsky, many of you know gail who is a senior fellow at project had been former administrator of the Health Care Financing administration. Gail is also serving as one of four cochairs along with former Senate Majority leaders tom daschle and bill fritsche. And also andy on a new Bipartisan Group of Health Policy experts to identify a path forward on health care reform. Gil, thank you for your leadership and i will let you take away from here. Thank you. It is a pleasure to be here today. This is a topic near and dear to my heart. It is something i started working on about a dozen years ago or more. Now theres other people who worked on it longer but it is one that increases in importance as the Technology Pipeline keeps putting out new frequently new and expensive technologies. Very interesting mix of people today. I will briefly introduce them. And then i ask people to make just a couple minutes of comments if you can try to keep it to three or four at the most. Then will ask questions. Although you may want to make questions on what jody couldve mentioned in her comments. The first panelists will be jen high. She is here in a perspective that too often does not get enough attention, although it does from corey. And that is the patients perspective. She is a heart valve and pastor for the American Heart Association. Her more interesting activity she tells me she is a poet. Her daytime job is a teacher at nyu, but i like poet better, that sounds more interesting. They will hear from joe, he is a physician who is been the executive director since it was established. Following joe will hear from carolyn clancy, physician this is not her fourth year somebody needs to come up with shorter titles at the be to bend the executive director for the first ten years finally but not least import my fellow colonists, mary ross is Vice President for the Kaiser Foundation and leave the institute for Health Policy. More portly, the executive director of when i was chairing it. So jen. Hello. Im grateful to have your ear today. I was born with a congenital heart defect and was diagnosed at birth. I do not have very much of a pulmonary valve and i had a hole at the bottom of my heart. My parents were advised that i have an open heart surgery, sometime early on they are told by doctors that i would forget the experience so i have these dreams of waking up from that surgery still. In 1988 i had my first open heart and i received a shunt where the valve would be, could be. At the time the research was about as old as me. But my parents were told she probably would not be very active, very athletic but i would lead a fairly active normal lifestyle. So i grew up with that experience and with that knowledge that i had been fixed in some way. I was a word that was given to me for my narrative. I moved to the world as a fixed person who is not athletic but i think was more because i was clumsy then not being able to play sports. In 2009 i had moved to Mainland China to teach english abroad. I applied to graduate school, was accepted to nyu to study poetry and when i came back to the states my mom advised that i get back on my Parents Health insurance and then i go see a cardiologist. It had been a number of years since id seen one. I had fallen out of care at the age of 18 or 19 thinking i was an adult living in new york city and as a sick person did not necessarily need to see a cardiologist anymore. Im grateful for my mom to push me to see a cardiologist. In 2009 i was diagnosed with pulmonary hypertension. I was told i would need to surgery relatively soon to repair the shunts in the valve. I did not have much of a valve in my heart and marched and i was six months shy of heart failure. I was in california when i received the news that i have pulmonary hypertension and was advised to see a surgeon and cardiologist in new york when i got back to school. In early 2010 the director of my writing program, wonderful woman gave me the name of a cardiologist at nyu. Hes an adult cardiologist. At the time there is no adult cardiologist so i shuffled back and forth between him, pediatric cardiologist and a pediatric surgeon. I was given three options for repair, mechanical valve and it would be a onetime operation, bovine heart valve which is the one my dr. Had recommended to me. Its a valve that will not last forever unlike the mechanical valve but because of my lifestyle im an active person, even if clumsy. The valve would last a long time and at some point i would need a followup procedure and they would have that procedure in place when i would need it. Since 2010 ive been a heart valve ambassador for the American Heart Association sharing my experience of patients who might be experiencing this for themselves for the first time and help in anyway i can by providing emotional support for helping them gain access. Joe, can you talk a little bit about given the perspective that you have as a result about how to make sure that comparative effectiveness remains Patient Centered . And then what can be done to actually make it as patient relevant as possible . As you remember, in 2,082,009 was a time when although a lot of people were enthused about the research and arquette are ready made some major steps and methods, there is also a lot of concern about the fact that cr was nothing more than an attempt to keep newark, better more Costly Services from widespread use. There is a lot of worry about that. We were named the Patient Centered outcomes Research Institute rather than the cer institute. I like to say whats in a name. It made all the difference. It focused our board and our staff on the notion that healthcare is about serving patients by march for the last 50 or 60 years weve made decisions about what the research, what to consider is outcomes and what to recommend, not so much on the basis of patients is on the basis of among other things scientific interest, convenience, one person at the institution called us the physician centric Delivery System. But i want to say that i think jens presence here today illustrates that patients face major decisions. People face major decisions. They come to those decisions with a distinct set of life experiences, goals, aspirations. And they are also wellequipped to be articulate, if not always poetic and the decisions about what is important to research. To your question gail, we sit on the notion that Patient Centered Outcomes Research means comparative Effective Research that studies comparisons that matter to patients. I hasten to add this doesnt mean youre sitting in a room and the patient raise the question. Patients arent always the only ones that have questions. A clinician may have raise the question. A pair may have raise the question. A policy maker may have raise the question. In the end we say does this question matter to patients once they been informed as to why the physician, payor policymaker. Does the question matter. The second important part is, this is Outcomes Research, are the outcomes we are studying the outcomes that patients need information on. Here we are asking about patients. We will study mortality, this valve procedure has a 2 mortality rate. The other one has a 4 mortality rate. Also, will i be able to be a clumsy athlete or will i be able to walk up a flight of stairs. Will i be able to continue the activities that i was doing . And also while will it cost me . Those are all thing real patients consider. Is the comparison right into the outcomes meet the needs of patients. Thats how we make it Patient Centered. I just want to say one less thing. That is, jody mentioned that comparative Effectiveness Research is the way we get the answers to Clinical Questions that patients and physicians have. The type of research that get new products on the market, leave us short of information about who it works for and how it works compared to yesterday. That is very important. She also pointed out that Systems Solutions are often the solutions to questions that matter the most to patients. So the iowa found a question that had to do a system. We have been told that system questions are not the ones that it was set up to answer. I think another number people have new technologies as the primary focus of cer. Theres a lot to be said about that. And then theres these old nagging practical questions about how much to take, how long to take it, would it be okay to stop taking this effective medicine after two years . Cer covers all of that and i think we have learned that over the last years. Caroline, both given your time as a major sponsor of comparative Effective Research and also now with your work at the virginia, do you think there is, remains a strong commitment, medium commitment toward comparative Effectiveness Research and these agencies and others with the federal government, or as sometimes happens there is waxing and waning as new, up . I think the interest remains strong even though that may not be the headline. Ill explain what i mean. Very happy to be here on behalf of virginia. The notion of knowing which treatments work for which patients and under what circumstances and importantly does the effect last. If i took a drug for six months or year for depression and i stopped in a year or two later im having some of the same symptoms should i be back in the same treatment is so forth . Really literature is pretty silent on those questions. Although they are pretty real to lots of patients. Many of you may be surprised to know how strong and comprehensive a portfolio the virginia has in research. I wanted to mention a couple of examples. One of the aspects of it that makes it very unique is more than 60 of our investigators provide direct care in our system. So trying to figure out which treatments work for which patients, its an organic part of what we do. And then getting that information out to clinicians and patients across our system. We are a large system with Electronic Health workers. Barcoding for medicines which was the brainchild of a nurse in our system undergoing chemotherapy and wondering in my getting the right medicines. Does that have my name on it, literature lee and figuratively. A lot of Great Success stories. We also have a large cooperative studies program which is clinical studies by any other name. In the past year to we have launched service studies. You know elaborate infrastructures built and when the study is over the people move on to other positions. The question is therefore collecting these data and patient care as a result of providing care can we use that for studies . Have a couple of those going on which drastically reduces the investment needed to answer important questions. We had to actually make Research Investments in figuring out what were the best treatments for veterans experiencing serious mental and Behavioral Health issues. We learned in a study of Women Veterans that prolonged exposure therapy was marx tram effective for veterans with ptsd. This is not a question someone came to us specifically, but it was an experience and diagnosis were seeing probably among the veterans returning. We work very closely with nadh. With our academic affiliates who have big studies going on within nih now. In addition to conducting and supporting research we offer a terrific resource for disseminating that. If we make great studies and they are not actually used to the benefit of patients we missed a huge opportunity. I think what well see in the future across these agencies is incorporating new information over half a million of our veterans have enrolled we have both the genomic data and their electronic clinical record data set this time we do not know which ones work for long cancer but wont be able to link that back to other profiles. Im excited about the future, the question is whether we keep it out there is a headline or whether we continue to do good work. Such an excited time to be alive but theres so many options when you have a problem that all of us deserve and want good information about what is three treatment for me. Somebody with a Delivery System and he spent a lot of time thinking about medicare as a major payer, but also the provider implications, how is the rise in interest in comparative effectiveness impact decisionmaking is easy. Or as you might envision it in terms of portions of medicare . This with the 11 Million People now were responsible to them one at a time a were responsible to them is 11 Million People. We have a unique setting and that we are system we have a budget to work with, it is natural for us to think about how to improve things from the systems perspective not just do things one at a time. No ones income in our organization depends on volume. The last point, we have evidence and data in our dna, we been doing this long before computers and joe could speak to pitchers on the wall and his former building. When you have the evidence for Large Population to look at things in sight why are some doing better than others whether its treatment doing better than others are some settings. We sort of live and breathe this stuff. Example i would give is the decision ten years ago to improve our performance on Colorectal Cancer screening. When i was a Gold Standard they were not hitting the target we had set for ourselves. What are the options there. You can remind people more frequently and allowed her voice theres a reason they do not particularly like that test. With the new availability of blood tested and later fecal chemical test we are able to shift how we did things to make it much more patient oriented to send a kit to people, send an email from their physician. I can speak from personal experience that if your person over 50 and you are not compliant your offer to kid at every opportunity and eventually you take care of it. The outcome was aaa. You had medical results, lower cost and happier patients. That was the power of thinking differently and outside of the box monitoring to see the results. Doing comparative Effective Research in the real world, so to speak. How can we make the information that comes out about comparative Effective Research that might be available more easily known and available, both to the clinicians and the patients . Joe and i have had this conversation. I am strongly interested in understanding what its been happening in this area. Yet, the struggle to find out, although i am getting much more adept at Google Searches that i used to be. It is not readily known or available, what can we do to change it. Maybe joe could take a couple of minutes and then murray is a provider payer from the virginia perspective. I just greeted our Board Committee on dissemination and implementation because that is a huge concern and has spent. How do you get the information out . We know the story about it sitting on the shelf for 17 years, one reason was because it was the wrong information. It wasnt useful. Assuming were providing useful information how to get it out . There doesnt seem to be one simple way. Some of the purveyors of information on the internet are very good. One obvious strategy would be to align yourselves with them. Among the others are making the Research Articles available. Many journals to not make the article available without paying 30 or 35. We have done everything we could including financing, making Journal Articles when they appear, publicly available for free. That is one thing. We also have a strict policy about posting the results within 30 days in an abstract form on our website. The final report from each Research Project and then posting a final report from the project on our website so you can be searched by organizations. Part of the dissemination is the building good, shared decisionmaking approaches so physicians and patients have tools to talk about it. Other social media, other strategies, depends on who the audience is in the type of information. You are so right that we had everybody have to do better at giving useful information out. How do we have the kind of impact that those of us are patient supporters compared to comparative Effective Research that dont seem readily around us . On the patient side its a tough question. None of us as patients, we dont know what we dont know. All of us has experience walking in my adult son than about eight years old was a candidate for surgery to fix an issue in his foot. We interviewed three surgeons about this, one who recommended continued physical therapy. One said wait five years until hes in adolescence and one was ready to schedule surgery. And as the patients are saying i dont know what each three option is. The fact that we interviewed three surgeons was on the leading edge. I dont how to address that but those are big challenges. On the provider side, our successes because of the links between the questions being raised by her physicians feeding into the Research Process either inhouse or going out to the journals or rollers feeding it back to them in term of clinical support. But its contained in the medical groups themselves. Theyre getting their information from their peers, people they trust, they know it has scientific. That chess pieces harder to do when youre being fed something because he found it through a Google Search or whatever. He found one study, does that represent all the literature . There something new . The volume of information at the big challenge out there. Im a tad more optimistic on the patient side. Part of the issues that we put information about her research very broadly ahead of for lucky the media picks it up. In general you will not have these questions is the patient you have a decision. That is not a huge majority of the population at any given point in time. I very excited about some of the work on decision aids. That required a lot of indepth work to make all of the concepts that doctor spiegel presented to us extremely relevant to people who do not think about these issues. I do think well see more and more, this a big thing at virginia, about patients as partners in the enterprise. Patients will be asking more questions on that drive some of this enterprise. Frankly i think well see more apps which is exciting. Long ago we did a study about how do you get a doctors attention. If you think about the context of a busy clinician, the response and final conclusion makes a lot of sense. Want to know right now what is the answer or two options. This is long before you could hyperlink. Then i want to know wheres the evidence. Can i check that this isnt just a statement as i think x approaches the best. I think well see more more that coming out of patient groups, particularly because of the investments. Last, social media is likely to have an impact. In which case the search and a price how to be thinking about cultivating journalists. What they read will get picked up on social media feeds. When youre being forced, not so much as the young child but as an adult to make some decisions, to feel like you could access the kind of information that would make you an informed Decision Maker . My attitude whenever i had to make a decision was that nobody could be more interested than me. Youve had more concerns because of your congenital defect. Did you find the Information Available . When you are someone who is encountering both the new diagnosis and the necessity to respond to a some immediacy, for me it was like being an amateur and learning a Foreign Language all over again. Also thinking about where to look and how to look. It has taken me seven years since my surgery to know how to look and read a journal article. Another summer published and to advocate for necessity for those articles to be available. For me was very helpful to have a position who really thought about our 121 relationship. He was treating me and giving me advice, thinking about what would be best for my life practically speaking. Keeping in mind the Technology Available and ultimately helping me make the decision on how i saw my life and what i wanted my life to be like. He advised that i pursue pursuee bovine procedure because he anticipated i might be more active. Of the time is 25 or 26 years old. So i did want to go experience more of the world. Not that you couldnt do that with the other options but he seemed to think my qualityoflife would not change. Having that professional years so important. For the sake of completeness i wanted to mention a couple of other things that are part of the dissemination enterprise. One of them is that clinicians need this information. Clinicians are probably connected more to the specialty groups. Through guidelines and standards that are promulgated, or at least have the endorsement specialty groups, physicians learn more about new research. One of our goals is to get them, those Research Funding through evidence and into the guidelines. That is probably one of the more important disseminations. The other thing to share some of the optimism, as we begin addressing more questions that have obvious relevance to patients and as we conduct more research, the culture can begin to change to one where before making a decision people ask about the evidence and ask about why were not doing research on it. You can envision a future where research is much more part of routine care. The pointofcare trials in the virginia are exactly what we need. We need to make them more familiar with the fact that we often dont have the answer yet. Research is the way we find it. These days people get stuff coming to them and in feeds, you can put things in a google feed her figure out whats happening in the headlines, can you imagine that you were getting fed information or even know about what is happening with the particular issues you had. What would you want to know to verify or assure yourself that this is good information . I would want the evidence to be credible. Id want to know how to question that. I would want guidelines that were clear to me. These are things you should keep in mind when youre looking at the different articles. I would also want to know, both a professional and a researchers opinion, but also as i think about by peter relationship, how others are perceived being the information can be helpful. When the researchers used in other countries, it is primarily directed for decisionmaking about whether to cover new pharmaceutical, thats most frequent use. Has some of you know ive been very frustrated at this limited focus on comparative Effective Research because the bulk of the healthcare spending the high pharmaceutical pricing can be its not pharmaceuticals. Its so much more with regard to other types of intervention surgery, do you think we have made progress in getting people to understand that this is not just about drug a versus drug be . Two new drugs, to old drugs, and their effectiveness. But looking at the broader issues of looking at clinical outcomes of surgical interventions versus medical interventions, versus therapeutic intervention involving a new drug that people understand that is fundamentally the question that needs to be addressed. Since fda primarily a is on efficacy of drugs and devices, but rarely surgical procedures, only the instruments perhaps there is in a natural way to have this occur. Have we gotten beyond that people understand this is the most serious issue . Or do people get distracted him a much easier air be drug . In any area cancer comes to mind where first of all they have better develops Patient Networks that i think many conditions. And when you start to speak with the dr. And they say you should have x, y, z. Often oncologists are quite good at telling you there other options. Some of that is timing. The relevance is quite apparent. A lot is generational. I think millennials and generation x ares are much more likely test questions, todays Medicare Beneficiaries i would say not so much. I dont know that the practice environment at large or routinely welcomes that makes room for that. Its a little bit of your homework and we might be able to use the paper. Back i would say that our legislation told us to focus on high burden conditions and that included burden to society in terms of cost. If you look at our Research Portfolio is concentrated predominantly on conditions that are prevalent and costly. I think its a testament to the fact that its not just the a versus b, president obama didnt get it quite right when he talks about the red pill in the green pill. There is some of that in the portfolio but the vast majority are about the role of procedures versus medical approaches come about systemlevel interventions to include the transitions of care, i think thats very consistent with the type of research that we need to do to avoid waste and save money in our healthcare system. Systems like the virginia, they naturally gravitate to those questions. Its totally obvious to them where the resources are going. So comparative Effectiveness Research applies much more than a versus it be. Especially when its new drugs they present special challenges. As you say if youre speaking to a lay audience the red pill, blue pill thing makes sense. If you look at the options for Prostate Cancer think theres seven options ranging from being watchful waiting with mixed evidence for at least six of them. To joes point, an integrated system has a birds eye view. You can look at people rather than the organ system and the conditions and consider the alternatives. If your surgeon you do surgery. Youre not not your job to be thinking about the other possibilities. To your other point in thinking about the cost, were very reluctant to talk about opportunity costs. Not talking about them doesnt make it go away. Its still there. To see the private payers clearly at the moment that has any sense to reduce costs in terms of reimbursement and has been explicitly further outcomes finding in terms of its the decisionmaking. Private payers could in principle i like that is guidance for reimbursement and coverage. I would rather stick with the fda rules for coverage. To see this as slipping into use or coming into use as too scary for most payers to want to touch . I think it is hard for people to get too far from the herd. Could answer. Joe mentioned to a challenge of new technologies. It is actually where comparative Effective Research is most typically used in other parts of the world is on the decision whether or not to cover a new drug. Usually a device, its because its in a group that has a global budget and therefore a fixed limit on the resources. If they cover this then they will not cover as much of something else. You were raising some hesitancy about the ability of cer to look at new technologies versus existing technologies. Do you think its in the market before you know . Were there other reasons . If you think about it, when the drug gets approved it has gotten approved on studies typically a drug versus a placebo. In most instances the we just want to know that the drug works and gets in the market. We dont how it compares to another drug. From the patients point of view they want to know about a range of outcomes. If you are to mount a study the day after drug got approved you would have your results in about five years. What should we do for the remaining five years. There may be some ways to take some evidence sitting around coming surely know how old drugs to and maybe there are internet comparisons. What we tended to do in this country a bit more lately is to do models with a lot of assumptions. Those assumptions, thats a word for lack of evidence. So well do something that is a good guess. That may be the best we can do. In terms of mounting the new cer studies, we have to face the fact that it takes a while. One thing that could be different as we could get the studies planned or underway earlier so that we do not doubt the day something gets approved. Weve been looking at this. When i say we come i mean payers, manufacturers, patients, looking together. And planning how this new treatment is coming into play in the near future, how it fits into the overall approach of patients. We could be more plentiful than we are. That is the best i can come up with. We do not coming quicker on the new drugs, and the answer is that we will be glad to do the studies but it will take a while. The second wrinkle and this is while we are waiting, private insurers are unwilling to pay for the drug, our legislation left hanging the question of who would pay for the drugs in the study. It is not the manufacturer is not always motivated to compare their new product with another. Payers have not seen it to this point in their interest to coverage with evidence the approach that medicare has as its disposal does not use that often. My oppression may not be correct, was her some debate about whether medicare actually had coverage with Evidence Development legislative authority . I dont know whether you know if that was ever clarified. I thought it was a terrific way to not say no or yes, but to gather evidence of what medicare has traditionally done with local carriers to cover or not cover. But that did not generate evidence. So you had differential use but no evidence. We will try to get that resolved after the fact. You have race that question and i think it is a very important one. Important study to launch, for example expanding the number of people who would benefit from an automatic defibrillator and working closely with the college of cardiology anothers to make sure that in fact as we were expanding the number of people who were likely to get that treatment, we would learn how they did. It just simply said we will not pay unless we get some information back. Making that practical, outside of the hospital i think its tricky. I do think it is doable. It would be interesting to know if it was solidified. Just very brief about the legs, our approvals are based on efficacy and they are very well defined homogeneous populations. When you get into comparative effectiveness youre changing things. Youre going out with more diverse populations. There is a lot to be learned even before you get to the comparative piece of it. We are out of time for our panel. We have time now to see whether the audience has questions and answers or questions from you. Hello. Two questions. One has to do with the focus of comparative Effective Research and funding, which sounds like it is 90 plus clinical. Things that informed the u. S. Preventative Services Task force. Is there any potential research that might inform Population Health . Things that would be used by the community guide, things like different ways to prevent a the city in a population are different types of incentive design and Health Benefits . So that is the first question. The other is the different methods used in comparative effectiveness. The emphasis is largely thawed randomized clinical trials. How much lenses given. We will try to answer those. The first one we take the word clinical in our name, and our mandate to do comparative Clinical Research very seriously. On the other hand, were heavily invested in obesity prevention of obesity management and childhood and adulthood. It has a clinical flavor of what is the role of primary care . We probably would not fund a study about programs or food deserts for example. The second question was,. About 70 of what we funded today to in comparative effectiveness has been randomized trials. That is because sometimes the differences are small and the chances of confusing results and observation studies are large. Ill say that i am surprised that we do not have more natural experiments. That is, to state Medicaid Programs approach the same problem with different strategies, which one works better . We would entertain and love more of those studies. We do not have a lot of them now. Its a great question. Okay researchers, you heard it here first. [laughter] no one. Im david, you give an example of a terrific way of getting the Patient Centered comparison Treatment Options. But for my sons chronic disease and looking at evidence clinicians are not always effective. The research on this, im wondering if the systems, the virginia systems have ways of routinely assessing and providing feedback to the clinician so they are more effective at shared decisionmaking when they take into account what the patients lifestyle preferences are. At the end of life or any other time. To have any other mechanisms for that. One is we have shared decisionmaking tools available on our website for members to use. But the other piece of it is naturally looking at Quality Improvement is when you see highperforming positions you look and say what are you doing and getting the better clinical outcomes and satisfaction scores. Its learning within the system. I cannot speak to the curricul curriculum. One example that we had is a group visits so veterans get to speak with other veterans. Of course if they come to a decision and that is totally their call, this is done in the context of the system in which they get care. Having tried to find similar work, i am not sure you could do a 10t other way. We do group visits for a lot of different things, particularly Mental Health. That is one area where we can look at how you use this information. So rather than just going to her parents and networks as a separate enterprise forgetting oneonone care, it might be more integrated. I was just wonder if you could fold into the nih and how it would shape the direction of this in the Field Research . I have no constraints, trying to answering that with some of the panelists like to answer that . Id be interested in what you had to say. [laughter] the issue about whether market can be or should be part of nih has been going on for the past 40 plus years. Ive been researchers at the agency of arc, better known as the National Health senators research for those with long memories. I am a little worried, but i think the major issue is whether or not therell be a separate center with their own budget. I heard the standalone agency, we spent a little on Health Service research and we spent a ton of money on healthcare utilization. It strikes me that this has always been an incredible imbalance. I hope that, and i will treat it kindly but i am worried. Microphone please. In terms of the effectiveness, looking at different populations, women versus men and hispanics and africanamericans, obviously that make things more complicated. Im wondering if the dosage can be different . How will you handle that . Do you know for a long time based on the tile done on women in a different result. Still a lot of gaps in terms of what we know and differences. Currently more on minority. You really nailed it. There are a lot of the questions that we have flown older rather than addressed and practiced with very limited evidence. You point out the challenges of trying to understand different dosages, trying to understand how it works in different subgroups of patients. The one obvious thing is it will take larger studies. Thats another reason that we invested in cornet which has hundred Million People in it including, a good part of the va which is a system that starts electronic Health Record data but leads to claims, but in regular community settings, not the va only but systems that we wish were more integrated. We want to be able to do them at an affordable price. That makes the study simpler, you dont a lot of bells and whistles and you dont add a bunch of ethereal markers and physiological tests. You ask the question that you need the answer to but in subgroups and it enables you to look at different dosages and theres a lot of questions like that are going to get to more personalized way of doing healthcare. Let me just say thank you. This is a problem that we are challenged and in seriously embracing at the va. Maybe we can talk more about that. We have some really terrific researchers focused on Womens Health and where are the interventions. Its not just clinical at all. Ill have to say again. If we had it been named Patient Center i dont know that we would hit upon this nearly is squarely as we have. Now its obvious that weve been under utilizing data from trials for a very long time. Weve not been getting notions about Predictive Analytics modeling of will do better with what. Its much more in the forefront and this is. This is the first level of distinction of socioeconomic or racial distinctions. Do you see in the not so distant future been able to get much closer to either a genotype or metabolic type that looks at characteristics of individuals that may respond differently, clinically rather than using as gross proxy racial or ethnic classifications at that that wont remain of interest to people, because it will. It does take a while. No, i think its true. There was a paper about it a couple of years ago about Precision Medicine is at the end of rachel constructs and races really a social, cultural contract and the availability of Genetic Information is going to bring that to pass. I think at the same time we need to understand that Precision Medicine isnt just about jeans. Its about the language you speak and how far you are from a clinic and whether you can afford transportation and copayments. Its those kinds of things. That are in the genes. Good morning and thank you for your time. In terms of touching earlier on the technology how is this role being played right now in this research and what trends are emerging and touching on. [inaudible] you touched on an interesting topic. Arc has been interested before court came along and everybody was interested in telehealth. It does seem to be a way to deliver care when reading about the challenges of rural hospitals in rural populations were very interested with core. Its up priority population and we have a fairly robust portfolio. I think it could also be a lot bigger. Things are being done in telehealth now that werent imagined five years ago. I think people are giving tpa from the look or stroke using telehealth methods. Theyre using it a van that goes to the farm or a person has had a stroke and with a neurologist back at the University Medical center deciding whether they should start the person on tpa when they bring them to the hospital. Its quite amazing. Technology in general, we are looking for technologies and comparative questions about them that matter to patients and certainly thats health is. [inaudible] we use telehealth a lot. We use are this huge integrated Delivery System. For Mental Health. As im speaking, psychiatrist in manhattan are providing counseling and services to veterans living in very small towns in oregon. As the veterans we serve are in pretty remote areas. Its a huge boon to us and Mental Health is not the area at all. I know in large systems, they been looking at the tele Stroke Initiative and i do believe there was a company that was founded by someone in gw. This is becoming a real and it gets rid of that aspect of zip code medicines. The issue is of the technology, right . If the delivery of that theory specific narrow time window. Thats whats really exciting about that. I think well see more of that. We use a lot of virtual care, whether its a secure messaging, i think to carolyns point, its the system behind the technology that. Se, matters here. One of the issues with the finances of healthcare is recognizing the different incentives you have at the va and theyre using telehealth as opposed to whether its an addon without an easy ability to capture savings as part of the service system. Thats not really something they can answer, you can can look at whether its clinically effective but under what circumstances the other issue is of course doesnt make sense to adopt it and then its hard to do it as part of the financial words. The question is, is it a new service or a change in modality of existence . And does it add to total cost . I just want to be clear. Corey and studying this does Research Utilization and it does affect the future visits and hospitalizations. Mac so you can sleep in the issues . Okay. Any survey questions . Im here. [inaudible] im curious in the a comparative Effectiveness Research how do you collaborate internationally with similar institutions and how is that information applied here in the us . Do you mean collaborated in in research or in talking with each other . As you indicate, there are entities and nothing exactly like somewhat like the corey that does evidence syntheses or in the case of the uk. Nice. This is the closest thing to corey. They find comparative Effectiveness Research and made take it turn it over to nice. We turn the over nation into 20 instances of nice in the United States. We do costeffectiveness as its called and we see ourselves as the provider of evidence to those who would do costeffectiveness or value. In terms of international research, we do nearly all our research on us populations. If the most generalizable. If youre supposed to do world ford theres nowhere in the world has the same kind of world settings as we do. Theres a couple instances where sample size, rare diseases, weve gone to collaborations that have both us and international contributors. So, particularly, rare diseases. Im going to ask into the panelist to make a short response to one final question which is what is the biggest question in your mind that compare the effectiveness for them to take on that is not getting taken on . Carolyn . I would say chronic pain. Which is a huge problem for this country and certainly for veterans. Research wise it brings and all kinds of complicated dimensions, the interactions with complement three modalities, the interaction between the intervention and individuals in context from pain. That would be very high on my list and Mental Health. Are these a series of studies as opposed to . Yes. For some of them, yes its a process. The notion of longitudinal bond followup we have the capacity to do that. Others like pcori are doing it. A major area that really needs to get back i dont think ill let you me into choosing one. Comparative effectiveness is simply a way of thinking about the care we deliver. From new technologies to lingering problems like back surgery, certainly, chronic pain and Mental Health we spend more on Behavioral Health than any other topic of area. We plan it with stakeholder budgets to these very simple everyday questions. I would hesitate to pull out one area because that would suggest it wasnt equally useful for those others. Okay. Hard to argue with Mental Health and then its not in need of a lot of work. I would go outside to see our paradigm and still get back to dissemination of implementation ps we can do all the research we want but if its not getting to where it needs to be then its not. In one or two, you wish we had done or what were doing ask or all of the strategies that need to be adapted. I think its all the strategies. As our patient representative, an area that we you wish was more research is going on. Sure. I wake up grateful that my care occurred where it did. I had a private Research Institute in manhattan and im alive because of it. I wish that kind of care occurred in rural hospitals in the United States across this you economic experience. Thank you. Our time is up. Let me turn it back. I want to first just offer a couple of the concluding remarks. To all of our speakers today. Thank you for the terrific opening duty. Thank you to jen in particular for sharing her personal story, its very important gail for your leadership and moderating the panel. I want to think all of you in the audience for your questions. Its terrific. I want to think that bbc t team in particular, haner martin for leading efforts to organize this event. As i mentioned earlier, at the onset, this, this is the first of two Educational Forums on this topic that ppc is organizing. We look forward to seeing you next summer when we take an even more forward leaning perspective on where comparative Effectiveness Research needs to go and how we get there together. Thanks everybody and i hope to see you soon. Thank you. [applause] tonight on book tv a look at lights in the white house. Next, an interview with Adrian Muller former assistant to president clinton about his book, the president kitchen cabinet. Then Richard Carty not his book link and sense of. Peggy grandy writes about her time working in the Reagan White House in the book, the president will see you now. And former president judge w bush talks about his paintings of military veterans compiled in the book, portraits of courage