3

Proceedings
Day 2

February 26, 2013

WELCOME, BRIEF AGENDA OVERVIEW

Ms. Christine Bechtel

MS. BECHTEL: Welcome back. Hopefully, you have consumed enough coffee. A very exciting day that we have ahead of us. We have a really great lineup of topics and speakers and interesting points to engage with you guys. We are actually going to start the day focusing with this illustrious panel on patient and family engagement in what we have called knowledge generation for care improvement, a.k.a. research.

We are going to then move into a discussion led by John Santa, where we will talk about how we might change expectations around cost and quality for consumers. There has been a lot of discussion about that over the last couple of weeks. In particular, many of you probably saw Pauline Chen’s blog. I think it was yesterday or the day before in The Wall Street Journal. There are a lot of topics to be had in terms of how we move to version 2.0 of the consumer use of cost and quality data.

We are going to break for lunch at 1:00 and we are going to hear, as I mentioned yesterday, from David Goldhill, who is the CEO of the Game Show Network, about his experiences trying to care for his father in our health care system.

We are then actually going to go into a discussion around some crosscutting strategies that can advance patient and family engagement and partnership. One of the observations that a planning committee member made as we were putting these workshops together was about the fact that there is a common theme that does tend to underlie all of these three topical areas we have been focused on. Of course, we have talked about partnership. But the other common thread is this idea of decision making. Yesterday we talked about decision making in care. But today we are going to talk really about the decision to share your personalized clinical data for improving population health through research. And we are going to talk about the decision to choose a high-value health care provider, the decision to use tools that would help you identify high-value health care providers. We are going to have a great discussion around some crosscutting strategies that might support that kind of information dissemination and decision making, again, through that lens of partnership.

And then we are going to end with some reflections from a very diverse and very interesting set of our planning committee members on this pathway forward. If you recall, that is really what we are thinking about. How do we accelerate progress in these areas by building on what we already know? That is what our lineup looks like for the day. We will adjourn at 4:30. Lots of tearful goodbyes, hugs, things like that. And, again, I will just encourage you guys online as well as in the audience. We really do want to continue to have a robust and dynamic discussion like



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3 Proceedings Day 2 February 26, 2013 WELCOME, BRIEF AGENDA OVERVIEW Ms. Christine Bechtel MS. BECHTEL: Welcome back. Hopefully, you have consumed enough coffee. A very exciting day that we have ahead of us. We have a really great lineup of topics and speakers and interesting points to engage with you guys. We are actually going to start the day focusing with this illustrious panel on patient and family engagement in what we have called knowledge generation for care improvement, a.k.a. research. We are going to then move into a discussion led by John Santa, where we will talk about how we might change expectations around cost and quality for consumers. There has been a lot of discussion about that over the last couple of weeks. In particular, many of you probably saw Pauline Chen’s blog. I think it was yesterday or the day before in The Wall Street Journal. There are a lot of topics to be had in terms of how we move to version 2.0 of the consumer use of cost and quality data. We are going to break for lunch at 1:00 and we are going to hear, as I mentioned yesterday, from David Goldhill, who is the CEO of the Game Show Network, about his experiences trying to care for his father in our health care system. We are then actually going to go into a discussion around some crosscutting strategies that can advance patient and family engagement and partnership. One of the observations that a planning committee member made as we were putting these workshops together was about the fact that there is a common theme that does tend to underlie all of these three topical areas we have been focused on. Of course, we have talked about partnership. But the other common thread is this idea of decision making. Yesterday we talked about decision making in care. But today we are going to talk really about the decision to share your personalized clinical data for improving population health through research. And we are going to talk about the decision to choose a high- value health care provider, the decision to use tools that would help you identify high-value health care providers. We are going to have a great discussion around some crosscutting strategies that might support that kind of information dissemination and decision making, again, through that lens of partnership. And then we are going to end with some reflections from a very diverse and very interesting set of our planning committee members on this pathway forward. If you recall, that is really what we are thinking about. How do we accelerate progress in these areas by building on what we already know? That is what our lineup looks like for the day. We will adjourn at 4:30. Lots of tearful goodbyes, hugs, things like that. And, again, I will just encourage you guys online as well as in the audience. We really do want to continue to have a robust and dynamic discussion like 65

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we did yesterday. We have microphones. We have e-mail and online strategy. Please do avail yourselves of them. I am going to turn it over to Sue Brown Trinidad. She is a research scientist in the Department of Bioethics and Humanities at the University of Washington. She is going to moderate our panel. I will say that she focuses in her research on ethical, legal, and social implications of genomic research. She also is interested in studies, communication, and decision making, and health care settings, health equity, community-based participatory research, and more. She is a terrific thought leader and member of our planning committee for which we are grateful. I will turn it to you. Thank you, Sue. KNOWLEDGE GENERATION AND CARE IMPROVEMENT Dr. Susan Brown Trinidad (Moderator) DR. TRINIDAD: The first thing is always, I apologize if you cannot see me. But I also saw that girl fall down at the Oscars. It is a trade-off always. We have a lot of work to do this morning before 10:45. I know my panelists and thank you all for being here. On behalf of the Planning Committee, thank all of you for being here and all of you out there as well. I do want to point out there was a comment on the website last night saying, “Why aren’t there any patients up here?” I am pleased to say that today we will have patients participating as panelists. Knowledge generation and care improvement. The research world. I think there are a couple of big trends that are converging to bring us toward a direction that looks more like progress on a lot of the things that most of us in this room care about. Translational science and the research space. There is a lot of talk right now about how we move from the bench to the bedside. There has been less discussion of where patients fit in that translational process. I am hoping we will talk a little bit about that today. We will look at comparative effectiveness research, patient- centered outcomes. All of those things I think are beginning to grow in the direction of a critical mass to actually get patients involved in a way that is more reciprocal than what we have seen in the past. One way of framing what we will be thinking about and talking about this morning is, what do we know? The first question is, who are we? We have been in the research realm and historically a pretty limited set of people. There was some talk yesterday about culture and the important shaping that culture has that can sometimes be invisible to us because we are in it all the time. That definition of who we are when we are thinking about what we know is starting to get broader. And I think that is a really positive development and I think bringing patients into that definition of “we” is an important piece. The other issue is what we know, what do we know, how do we know that we know it, and what counts as knowledge. I come from the bioethics area. I have training in philosophy. All of these questions about epistemology, how do we know it is knowledge, what counts? Those are actually important issues from a policy standpoint. Whose input counts? I just came back from Bethel, Alaska. People in villages of fewer than a thousand people. Their ideas about what their health priorities are finally beginning to get some currency in the people who are providing services. That is important and that is an important change. 66

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We will address all of these issues. We will be shaping these around four directed questions. The first thing we will talk about is what the current state of play is. A lot is happening in the research world that is quite different from the way that things have traditionally been set up, with a bright line between the clinical realm and the research realm. That is getting blurry. And we have not yet caught up with what that means in terms of implementation or regulatory protections. Patient views about what is happening with research, research realities, and then the regulatory environment are all things that will fit under that section heading. We will also talk a little bit about public and patient opinions. In my own work, and my colleague Evette Ludman will talk a little bit about some of the work we have done together. People are supportive of improvement. We will hear a little bit about what they want from us in the research space. We have traditionally thought of people participating in research. It turns out there are some things they like in return. We need to think about that. Now, I would like to move on to introducing our distinguished panel. We have Dr. Nancy Kass who will start us off. She is the Phoebe R. Berman Professor of Bioethics and Public Health in the Department of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health and the Deputy Director for Public Health in the Berman Institute of Bioethics. Her current research projects examine ethics for a learning health care system, including quality improvement and comparative effectiveness, informed consent in randomized trials, ethics issues that arise in international health research, and ethics and public health preparedness. We will hear from Alice Leiter from the Center for Democracy and Technology about meaningful choice. She is Policy Counsel for the Center for Democracy and Technolog’s Health Privacy Project. Her work focuses on developing policies for the advancement, adoption, and implementation of health information technology and electronic health information exchange to improve health care. Ken Mandl will speak to us about the infrastructure we need for patient-engaged translational research. He is from Boston Children’s Hospital and is an associate professor at Harvard Medical School and the Louis Diamond Investigator at Children’s Hospital Boston, where he directs the Intelligent Health Laboratory within the Children’s Hospital Informatics Program. He has pioneered and published extensively in the areas of personal health records and biosurveillance. Under a major HHS initiative, he co-leads the SMART Platforms project, which seeks to create an apps store for health. We will close with a joint presentation from Peter Margolis and Jill Plevinsky from Cincinnati Children’s Hospital Medical Center. Dr. Margolis is a professor of pediatrics and director of research at the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s. His work encompasses the application and study of quality improvement methods and a broad range of areas, including primary and subspecialty care, communities, and public health settings to improve the health outcomes of children, families, and communities. Jill Plevinsky is currently a clinical research coordinator for the Inflammatory Bowel Disease Center at Boston Children’s Hospital and recently completed graduate work in child development at Tufts University. She was diagnosed with Crohn’s disease at age 7 and immediately became involved in awareness, education, and fundraising efforts through the Crohn’s and Colitis Foundation, for which she served as the Philadelphia Delaware Valley Chapter’s first youth ambassador and the founding chair of the National Youth Leadership Council. Thank you all very much. I will turn it over to Nancy. 67

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Ethical Challenges of a Changing Research Paradigm Dr. Nancy Kass DR. KASS: Thank you, Sue. Thank you for the organizers for inviting me. I apologize that I was unable to be here yesterday. It sounds like it was a really lively and terrific discussion and I apologize. I was saying to Sue that I always feel a little awkward and embarrassed coming in what feels like the middle of the discussion, but I was not here for the beginning. Correct me and bring things to my attention afterwards for things to which I should have paid attention. I want to start by acknowledging my partners in crime. Pieces of what I am going to be talking about today are drawn from a particular project on ethics in the learning health care system that I conducted with my fabulous and lovely colleagues. Here they are (Ruth Faden, Tom Beauchamp, Peter Pronovost, Steven Goodman, and Sean Tunis). Let me tell you what I want to do today. I was asked to talk about changing ethical paradigms. And what I want to do is introduce you to what I am going to call paradigm one, which you might call a historic paradigm, but I guess I would also argue is one that is alive and well today. There are some good reasons for that, but I also want to argue that I think there are some problems with it. Paradigm one is what I will also call the “distinctions paradigm.” I am going to tell you what the current ethical requirements of that paradigm are, and again, what I see as some of the problems. I am then going to say just a little bit about patient engagement. Probably not necessary to say very much for this audience, but I want to bring it in as a bridge to get to paradigm number two, which is what I am going to call the “ethics in learning health care system paradigm.” I will again then talk about what our ethical requirements are for paradigm number two. I will then suggest that some of what I see as the potential paradoxes that can come up in patient engagement are maybe not such a paradox at all. I want to start with paradigm one, which is where we are coming from, and again what I will call the distinctions paradigm. To rehearse a little bit of history, in the 1960s and 1970s, the American public became aware of research that our federal government had either funded or conducted that illustrated a variety of scandals or research abuses, often involving vulnerable populations who were often led to believe that they were being cared for as patients, when instead research was being done without their knowledge and in ways that was not helpful to them, provided no benefit, and often provided some abuse. This appropriately led to American outrage and Congressional action. Following this, in 1974, federal regulations were passed for the first time in this country to oversee human research. That led to a variety of ethics requirements, or I guess what I will call legal requirements, in the name of ethics. One that we are all familiar with is IRB review. All human research has to be looked at by an ethics committee before it can go into the field. Informed consent has to happen in most but not all cases of human research. Because the new regulations said research activities have to go through this oversight, and yet clinical care activities do not, an immediate first requirement was to define what these regulations apply to? That meant research had to be defined, and the regulations did that. Subsequently, a lot of academic scholarship also began to define what is research. Again, these distinctions and definitions became important because of the important practical application that things that were called research had to have a lot of ethical oversight, and things that were clinical care were not required to have any such oversight. 68

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I have a slide here with five things that my colleagues and I have said are categories of distinctions, the things that have been used in the literature and in regulatory definitions to distinguish research from practice. I have put under each of them what was implied, by contrast, about clinical care. The regulations say research is an activity that is intended from the get-go to produce generalizable knowledge, the assumption being that practice is intended to help the patient at hand exclusively. Research is where there is a systematic collection of data where there is an assumption that in clinical care (again, think back to the 1970s) there is no systematic data collection; we only collect data for the patient at hand and put it in his or her chart. There are then additional claims from the literature about what research is and how it differs from clinical practice. One such claim is that research poses risks. We have uncertainty about whether there is clinical benefit from the intervention we are giving to a patient, whereas the assumption in clinical care is that we only give treatments where we know that the benefits outweigh the risk. Another claim is that in research, there are burdens that arise from activities that are not necessary for clinical care. We ask patients to do things above and beyond what is necessary for their clinical care, extra questionnaires, extra tests. Again, the assumption is that in practice every single intervention or test, duplicated test, triplicate test, contributes to good care management. And then in research, the last piece of what we will call a distinguishing claim is that in clinical research there are protocols that dictate which treatment you or I receive as a patient, whereas in clinical care, it is physician autonomy or patient autonomy or the dyad autonomy that decided what care you get. Problems with this paradigm: We would argue that there are practical problems, conceptual problems, and moral problems with this approach. The practical problems are that there is complete confusion. One of the things we did in our work, and I do not have time to show it, is focus groups both with patients and with providers. There are some really stunning, and I would say amusing, quotes about the ways that people try to navigate this distinction when to them the activities look remarkably similar. There are conceptual problems. I am guessing that if I went back to this slide, each of you could point to some problems with this logic, and again some of it becomes almost comical. I was being a little tongue in cheek in talking about things like the duplicate and triplicate test, but it is actually no joke. There are multiple things done in clinical care where we do not know whether they work, and there are multiple additional burdens that are placed on us as patients for all sorts of reasons that have to do with the health care system not being properly integrated. This slide is pointing to some of those conceptual problems. A conceptual problem for people who do not live in our kind of academic wordsmithing context, is a problem where the words and claims are not working. For a good conceptual definition you could say, for example, the characteristics of a table are blah, blah, blah. All the things that have those characteristics are a table and things that do not have those characteristics are not a table. It is a way to provide a definition. We are saying that those words and claims of the conceptual definition of research are not working. The idea that producing generalizable knowledge happens in research but not in practice is conceptually problematic. We learn from ordinary medical care, and we learn from quality improvement activities and both types of learning are applied to future patients. Systematic data collection also is not unique to research. We collect data systematically in practice whether we want to or not. It is now required in so many ways. For your hospital to be accredited, systematic data collection on many outcomes is required. Again, for quality 69

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improvement, it is required. There are many ways in which clinical care data must be aggregated in the current American health care context. There are many errors and risks in ordinary clinical care. Nobody wants that to happen. It is not on purpose. People are working really hard to avoid it. But this idea that clinical care is absent of risks or will never impose an intervention that has more risks than benefits is erroneous. And at the same time, the flip side of the coin is that the research paradigm of the 1970s and 1980s, where clinical research was only about testing experimental treatments, also is false. There is so much research today that is comparing different treatments that have been FDA approved for decades to see which one is better, monitoring different treatments that have been used for 30 years to see how they really play out in different populations of patients, and in these types of studies it is hard to argue that the research poses any more risks than the regular clinical care patients would have experienced receiving those exact same treatments. And as I already said, practice will often include many unnecessary burdens. This leads to what people in my world of ethics call a moral problem, which is that there is overprotection. Again, remember that these ethics rules—and I will be the first to say I have taught these. There are so many pieces of these that I believe in. I have sat on many IRBs in my life. The whole foundational purpose of having these ethics rules is to protect patients or healthy volunteers from what they may not be aware of as significant and important risks done, if you will, at their expense for the sake of others. It is a very important concern that we always have to have for those of us who want to dedicate part of our professional lives to learning. At the same time, if the purpose of drawing a line between research and clinical care is to demarcate activities that need to be looked at to see if they pose too many risks to people or might be exploiting people, we may not be using the right set of criteria. The moral argument would be that there are some patients who are being overprotected and others who are being underprotected. In other words, tons of activities currently have to go to IRBs for review and oversight when the activities pose very little risk—certainly no more risk than daily clinical care; while a bunch of other activities that likely carry a lot of risks and chance for errors go forward with no oversight whatsoever. Let me move briefly to a couple of things about patient engagement. There is a lot of discussion, appropriately, currently about patient engagement, and of course this is much of the focus of today’s meeting. I imagine part of what you talked about yesterday was the need to have a lot more shared decision making in clinical care. And one of the articles that I read in preparing for this meeting, the Health Affairs article, which I loved, talked about shared decision making relying on three things, one of which being that doctors and patients be really open with each other about all of the evidence. There is this assumption that to have patient engagement you need good clinical evidence. Now, there is also this idea that in research, as a sign of respect, there has to be disclosure and discussion about what the research is about. There are two paradoxes in this space that I want to raise. One starts with the commitment that shared decision making relies on good evidence. It is sort of like a catch-22, because we have so little evidence available, that it is hard to be able to tell people the evidence related to their care or options. And then there is the paradox that one of the reasons we have so little good evidence is because of the hurdles and barriers that this large system of ethics oversight, and related concerns about privacy, have put in place. Paradox number two is that we believe ourselves to be very concerned about patients’ rights and our rights as citizens to know what it is going on, and thus demand to be told all details 70

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about all sorts of research activities, and yet because of this historical distinction between how we treat research versus clinical care, we basically say nothing to patients or communities about the extraordinary amount of data that is collected and aggregated every day in the health care system health departments and the CDC, and certainly all hospitals are routinely collecting data. This is why we know about obesity rates, cancer rates, what makes a difference in infections, in patient falls in hospitals, et cetera. I want to really briefly introduce what I will call paradigm number two, which is to introduce alternative ways to think about ethics and the learning health care system. The learning health care system. Again, I am going to make the assumption that a lot of you in the audience are really familiar with this. It draws on language from the Institute of Medicine. The learning health care system is where care and learning are deliberately integrated. It is not just that research is going on at the same time as care. There is a philosophical view that these must be and can be integrated. There is an assumption that high-quality care and learning depend on each other. There is a synergy there. Research with experimental drugs will still happen, but that is a little bit separate and not what I am talking about. When we can learn systematically from care, we ask questions like What are the outcomes of different treatment choices that are given all the time? What are the outcomes of different care approaches? This slide is the one slide that introduces some of the work that my colleagues and I have done that says a learning health care system is an ethical good. If we want evidence to give to patients for shared decision making, we have to have good evidence. And in order to ensure that such evidence is developed in an ethically acceptable way, there need to be seven foundational ethical commitments as you structure and run a learning health care system. Some will sound familiar and some maybe are a little bit less so. You always have to respect the rights and dignity of patients. You have to respect clinical judgments. You have to have a commitment to providing what you understand to be optimal clinical care to patients—it can never be compromised for the sake of learning. You must avoid imposing nonclinical burdens and risks. And certainly, talk to people about them if there will be any. And then some newer ones. We must address health inequalities. And really maybe not part of a traditional ethics guidelines, there must be some commitments on the part of clinicians and on the part of patients to participate in the learning process when it will not compromise your clinical care and when it will not pose unnecessary burdens. I think this is my last slide, which just says, so maybe this paradox is not quite so great. Patients are clamoring for better evidence and data. We have done some focus groups with patients ourselves, where it is often the people with the most significant chronic illnesses who are saying, Give us more data. Do not protect us so much that we cannot learn. There are so many more books, videos, websites today that are advocating for people to contribute their data for better treatments. Patients in trusting relationships are more willing to share their data. That gives us something we have to think about. And there are many possible strategies for engaging and disclosing and discussing this whole learning idea with patients in health care systems. It is important now to do the work to find out from patients how to do that. We were recently funded by PCORI to gather some preliminary data with patients about what their views are about disclosure, consent, and authorization in the context of a learning health care system. But I guess I will close by saying it seems that that is the way that honors what patient engagement is really designed to do and gather the data that patients need to have. Thank you. 71

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DR. TRINIDAD: Now, we will hear from Alice and we will hold questions until the end of the panel. Thank you. Meaningful Choice in a Learning Health Care System: The Relationship Between Privacy and Data Sharing for Research Ms. Alice Leiter MS. LEITER: Good morning. Thanks so much for the introduction and thank you so much for that presentation, Nancy. What I am going to talk about hopefully builds nicely upon it, because I have the great pleasure of talking to you all about the law or the system of obstacles and burdens as some of you may see it. Unfortunately, if we are going to talk about meaningful choice, if we are going to talk about privacy protections, and if we are going to talk about data sharing, you cannot really have an effective policy discussion about these issues until you first understand what is not possible legally. I will do my best despite some fairly dense slides to go not quickly in my speaking, but briefly at a high level through these first slides so that I can at least keep you somewhat awake. First, a little bit about the Health Privacy Project at the Center for Democracy and Technology. The project is premised upon the notion that I am sure we would all agree with, that health IT and the exchange of electronic health information are really the drivers and engines of health reform with the greatest potential to improve health. And certainly, in this new electronic health environment, some progress has been made to update and resolve some of the privacy and security challenges that arose when our system got turned on its head and became digitized. But as everyone is far too familiar with, a number of questions and challenges and implementation issues still exist, not withstanding some really solid and important and meaningful efforts on the part of HHS and CMS to update the HIPAA medical privacy rule and others to better fit this new environment. This last bullet is to hopefully toot our own horn a little bit and saying that the solutions that we advocate are really those that are practical. Too often, I think, privacy advocates are seen as hysterical. Consumer advocates are seen as hysterical. We really try to work with people like you who are like-minded to find workable solutions to not only keep privacy and security central and paramount, but to get data liquid and freely flowing, so that it can be leveraged for all of the purposes that it needs to be. I think these first couple of bullets about what a learning health care system is are written by people in this room. I certainly know this first one comes from Nancy. There are a lot of different ways to talk about a learning health care system and to define it. For my purposes in my work, the focus is really this need to safely and securely leverage clinical data for purposes that are beyond treatment and payment, and that a learning health care system is not going to be possible unless we find ways to do this. A little bit about HIPAA. Big question when it comes to research is, first of all, does HIPAA—again, this is the medical privacy law applied, the federal medical privacy law. These bullets are about the identifiability of the data, because if data is de-identified, HIPAA does not apply. There are numerous and technical ways to de-identify your data. There are legal standards. There are methodologies to do it. And limited data sets are familiar to all of you in the research community because they are a close cousin to de-identify data. They involve some removal of categories of information. They are permitted for research. Data holders are required 72

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to execute data use agreements to use limited data sets or information limited data sets, but individual consent is typically not required, which makes that quite attractive. Again, the reason that this is important is because, as many of you know, in order for information that is patient identifiable to be used for research purposes, you have to obtain patient authorization. Authorization is the legal term. Consent is more typically the policy term. We will talk a little bit about that. With a few exceptions, a privacy board waiver or an IRB waiver or some exceptions found in the law, this individual authorization is necessary. Now, that is not easy to obtain and often seen as incredibly onerous. It makes perfect sense that research on data that is qualified as de-identified is largely not regulated and therefore enormously attractive to those who are engaging in research. Unfortunately, it is not just HIPAA that we all have to worry about. I am not going to go through all of these, but there are numerous other state and local laws and regulations that can apply depending on the nature of the data, depending on the nature of the study, everything from the common rule—which I will talk about briefly on the next slide because it governs federally funded research to state laws—to health information exchange policies, to grant conditions and sometimes even international laws. The Common Rule, the big research rule for federally funded research unidentifiable data—it is not that it is not worth talking about it, but some of you may know about 18 months ago what is called Advance Notice of Proposed Rulemaking, kind of an early heads-up that we are going to do some regulating on this subject, was released that proposed some fairly significant changes. And the good news is that they all seemed to be designed to bring it in line with the HIPAA law. There are some gaps and there is some confusion. There are a number of headaches caused by the relationship between HIPAA and the Common Rule. We are hoping that once we get a little bit farther down the regulatory process with this rule, we will feel a little bit better. As we heard a little bit, and I will just say more specifically that there are some really common and legitimate criticisms of this legal framework that we have right now. As you could argue from my presentation, there is a disproportionate focus on whether or not the data is identifiable and whether or not patient consent is required. Having sort of laser beam focused on whether the data is stripped of these 18 or 16 or however many identifiers, and do we need to obtain patient authorization or consent, ignores a number of other valid and hugely important privacy protections that are available to us. Unsurprisingly, there is a real tendency to be conservative on the part of researchers and their interpretation of these rules and requirements for obvious reasons. You do not want to get in trouble and it is better to be safe than sorry. Unfortunately, that ends up causing or creating obstacles and barriers to research and to data sharing more broadly that may not actually exist or should not exist. What we would like instead? A comprehensive privacy and security framework is desperately needed, not just for medical information, but really for consumer individual information writ large. Until we have that, it is probably not going to be this open, safe, secure, facilitating of health IT and health information exchange that we would like. There should be less focus on consent and more focus on the rest of the so-called fair information practice principles. Sometimes they are FIPs. I have a slide about those in a couple of minutes or a couple of slides. The notion is that let’s broaden our focus and think about all the different tools in our arsenal and try to get away from this headache of consent. Central to this and fitting in with this broader theme of this whole meeting of consumer and patient engagement is that any privacy and security framework has to incorporate notions of consumer and patient expectations. This idea of context. When you are deciding which of the 73

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tools to pull out from your toolbox to protect privacy is important because in different contexts patients expect different things. And what you want is for no one to ever feel surprised or shocked or upset about a particular use of their health information. But you also do not want to assume that they are going to be—that a person is going to be shocked or upset or unwilling to share health information in a particular context. You do not know that until you have had full open transparency and engagement. If we can get all of these, you really have the basis for meaningful choice. Meaningful choice, and this does not just apply to research, but really consumer choice for use and exchange of health information in general, centers around a number of principles. The most important ones I have highlighted here. You have to be able to make the choice in advance. You have to be free to make the choice. You cannot feel like if you say no to something that something is going to be withheld from you, for example, medical treatment. And there needs to be absolutely full transparency and education about what that choice entails. Without that, it is not meaningful. This notion of opt in or opt out in the endless hours of discussion and debate that yours truly and many probably of you have sat in about what is going to be opt in or opt out should not matter as much if the choice, regardless of the system for giving it, is meaningful. These fair information practice principles—this list that I have given—was developed or articulated by the Markle Connecting for Health Initiative, but they can be found in a number of different articulations. The Federal Trade Commission, the Department of Health and Human Services, the Office of the National Coordinator for Health IT has its own set. But they have similar themes that are the most relevant. I will not read them all out for you, but you can see that this idea of choice is but one. The idea that you should be able to consent to the use and exchange of your health information is certainly important, but so too is openness and transparency, understanding the purpose, feeling that the very least of your data that is necessary is going to be used, that you have some ability to participate and control, that the data is accurate, that it is safe, and that there is some accountability and oversight for the use of your information. My next couple of slides are on ways to structure research networks to achieve this. Distributed networks versus centralized networks. I am running out of time and I think that that is maybe left best to more specific conversations later offline if you would like. I think ending on the fair information practices is most relevant to this presentation. I look forward to the discussion afterwards. Thank you. The Infrastructure Needed for Patient-Engaged Translational Research Dr. Kenneth Mandl DR. MANDL: Hello everybody. Good morning. Thank you for those excellent presentations that set up this idea of a learning health system and one in which there is progress and protection of patients. Now, I am going to focus on the plumbing. I am the IT talk here. And the plumbing is about how to hook patients. I do not mean this in a derogatory way because when I look at the whole idea of patient engagement, I am usually thinking about it as a patient or a father of a patient. It is very important to think about this learning health system, and that is the context in which we are discussing this today. There is an assumption that the care, the science, and the evidence are all in some way become much more aligned, interconnected, that there is a virtuous cycle, and that 74

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the patients are very much engaged in both contributing information as well as receiving back information, so that they can improve care and improve quality of life. Let’s just look at the way we do this. How do we hook patients into a system like this technically? In 1998, I wrote my first paper and it was extremely controversial. It was the idea that doctors and patients will actually e-mail each other and that this is something that could possibly be safe. There was a sense that, what if a patient e-mails that they are having a heart attack or doctors are just going to be overwhelmed by these unruly crowds that now have unlimited access to them 24 hours a day. We actually built the first doctor/patient e-mail system and tried it in 1998. It was for pediatrics. It has a cute giraffe on it. But since then, what we found is there have been very large-scale efforts. My HealtheVet, the Epic MyChart system, which is used across Kaiser and Group Health and many places. Millions and millions and millions of messages have gone back and forth. Most of the fears were never realized. Of course, this is one form of access and getting patients engaged. But this is mostly a free text thing, just a first step in the learning health system. Now, we have activated patients. Here are patients who come in. In the era of genomic medicine, patients plus Internet know a lot more than most of the doctors. I have here Dave, here in the second row. He has actually brilliantly formalized a whole conceptual structure around this idea of a technologically enabled and informed patient that he calls the e-Patient. Now, how do you then get information flowing back and forth between patients? There are these federal initiatives to try to do this. We have been screaming in the wilderness that patients need to have some access to their data. I am sure Alice can tell you better than I, but HIPAA was supposed to—the original HIPAA, 1976—was supposed to facilitate electronic access by patients to their data. But there was this little phrase that was in the regulation that said “if feasible.” For basically since then, since 1996, every single organization has decided that it is not feasible to give them electronic access to their data. And in fact, HIPAA was of course used as an excuse not to share the data with the patients most commonly. But then in HITECH there was language that once again promised data to the patients. That sort of did not quite work because the technological alignment was not perfect. You could get electronic access to data through, for example, a PDF file or something that really did not give you the opportunity to use your data in a Web 2.0 apps kind of way. We will talk about that a little more. But now there are projects that are quite formalized in the structure. One is called Blue Button. Blue Button is supposed to be a disruptive innovation. In the Department of Veterans Affairs, they can literally push a Blue Button, it looks like this, on their health record and get a copy of their data. The only problem is it comes out of no particular format and you cannot read it or understand anything that is in it. But it is there. You get your data. And then there is something called the Direct Project, which is about an e-mail system for health. The question is if there is going to be this kind of data liquidity, in other words, that data is now going to move out of systems toward patients so that we can begin to—one way to begin to engage them is we have seen these portals like Epic MyChart. The one is just I am going to show you the data. Here it is on a screen. But it is trapped. It is behind the screen. You cannot get it. You can knock on the screen or something, but it is there and there is nothing you can really do with it. Then there is this Blue Button, which is are we going to actually give you a copy of the data, hopefully, one day in a way that you can use it. And then under this thing called Meaningful Use, which is how we have described the properties of health information technology that make it useful and is the basis of certification and payments. There is this new thing called CCDA. Do not worry about it. But it is a standard for how the data comes out, 75

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I have argued with efforts to educate the public about the benefits to them of HIT and HIE that we don’t have much to show them. We’re asking them to enter into a social contract to give us their data and for us to use it, and we’re sort of promising that their care is going to get better. It’s very hard to demonstrate that. So, I think we have in sort of creating this priority list, we have to think about where can we really deliver, to use Ken’s word, the “hook”? Where can we really say to patients, we promise you this, and we’re going to deliver it next year to you, and you’re going to see the value of what we’re talking about. We need to demonstrate that a learning health care system and shared decision making, has real value for the public Lastly, the one thing I worried about, and I think somebody else has mentioned this, that we’re spending tens of billions of dollars on health information technology exchange. I don’t see very much attempt to integrate patients, families, and caregivers into the process, other than give them a portal and let them look at their lab values. I think we need to be thinking far differently about that. For one, they should be in at the ground floor. It’s a problem because vendors don’t even have clinicians in at the ground floor, which is one of the problems with the usefulness of their product. But we really need to have that community of patients, families, consumers, whatever we want to call them, caregivers, really engaged in this. And we have to design a system that meets their needs. And maybe patient portal and looking at lab values is good for some people. It might not be the priority of some other people. I don’t think we understand what is, as yet, but I worry that the horse will be out of the barn, we will have spent tens of billions of dollars on a system that doesn’t even begin to deal with the concerns that we’ve been talking about for the last day and a half. DR. ADIRIM: I’m Terry Adirim. I am from the Department of Health and Human Resources, the Health Resources and Services Administration. My agency serves the underserved by providing funding to health care entities to provide health care services. I had the great pleasure of being on this planning committee. I want to thank you so much for including me. I learned so much from my colleagues and I learned so much from all of you in the last day and a half. My remarks are very brief, and they’re centered around recapping what I heard from our workshop speakers were the barriers to achieving partnering with patients to drive shared decision making, and to summarize some of the approaches and solutions that came from our speakers. Health care has been transforming very quickly. An example includes a recent experience I had with the health care system. I got a mammogram, and received the results from the radiologist by e-mail before my doctor did, which I thought was kind of amusing. These changes give all of us the opportunity to impact the way medicine is practiced going forward. And I think listening to all the patients over the last day and a half really gives me a sense of urgency to do this and I really appreciated hearing everybody’s stories. So, what I heard over the last day and a half—that some of the barriers to achieving what we’re all trying to achieve, is that we’re still seeing within patients some passivity with regard to their health care, that there is a top-down authoritative culture within the medical profession, among both physicians and other practitioners. In fact, at this workshop someone told me about one of her experiences in the emergency department where a nurse authoritatively told her something, it wasn’t entirely accurate and gave her a look like who was she? I also heard articulated that there is a skills gap for both practitioners and patients with regard to how to practice shared decision making. There are also barriers with regard to access to 164

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information. And many of these gaps and challenges, as my colleagues have articulated, are due to technological challenges that I think we need to overcome. Part of the issue is that health care is not really a system because it is fragmented and siloed. It’s not really oriented to patients and patient needs. It’s really focused—and I’ll be the first to say as a physician—it’s really centered on the practitioners and our needs. So, until we change that culture it’s going to be very difficult to make the changes that we’re looking for. I think there are also real or perceived external pressures on us as practitioners. As everybody has talked about over the last day and a half, are the challenges within the payment structures. Fee-for-service payment leads to pressure to see more patients. And there are also regulatory and policy issues, including the way that we interpret these regulations and policies that are real barriers to being able to get where we want to go. With regard to solutions, what I’ve heard from all of you is that we really need a multi-prong, multidisciplinary approach. And what I took away from our keynote speaker is that we can learn a lot from people outside of medicine and people in other industries. Even though I didn’t agree with some of what he had to say, it is useful to include all views while determining strategies to improve health care. For example there is so much with regard to the manufacturing industry with regard to quality and other industries such as systems engineering to improve efficiency that we in medicine can learn from. So we need to bring other people to the table. Yesterday, in fact, a speaker mentioned that some of the issues could be ameliorated through a systems engineering approach. Some of us may agree and others may not but it would be useful to include some customer-focused strategies in our thinking about health care improvement. Even things on when and where patients get their treatment. Who said that you have to go to the doctor’s office to get your treatment? Who said that primary care must be available only on Monday through Friday 9 to 5? So, even just engineering the system so it’s more patient focused would be something to move toward. I heard a lot of physician and patient blaming language, and I caution people from blaming any people about this. Blaming does not help us to indentify the issues to address. It’s the process, not the people. So I think that we really need to spend a lot more time focusing on the process. We really need to address competency development, and training. We need to look at where we’re training our health care providers, how we’re training them. We are moving more toward team-based approaches, and I know at my agency a lot of the funding for health care is moving to interdisciplinary approaches care. So we’re moving in that direction, we need to keep promoting that. I think, too, listening today to our speakers, that we need a new research paradigm. Emerging is a more inclusive type of patient approach, and I think that’s really good, especially when it comes to governments’ opening up of data sources, use of data, and the giving back to patients who participate. And as we heard today that technology and social media are very important tools for reaching patients and facilitating communication between patients and their clinicians. Transparency too was a running theme over the last day and a half especially with regard to research. With regard to that there may need to be regulatory solutions. Transparency with regard to health care costs is important. And the Time article that came out recently made a huge impression with many of us with regard health care pricing. I think though we need to approach health economics with caution because health care is not a commodity like other commodities or like my iPad. Everybody will eventually enter the system and need health care and many of us 165

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believe that we’re entitled to it. So there may need to be different economic principles applied to health care. MS. SHERIDAN: Great, that’s a nice segue for me. It’s been fascinating for me to participate in this because I wear two hats. I am the Director of Patient Engagement at PCORI, Patient-Centered Outcomes Research Institute, but I also wear the hat of a mom. Like Cristin, I have a son who is a young man, who has cerebral palsy, multiple disabilities—we are frequent fliers in the health care system. And his condition was caused by newborn jaundice 17 years ago that was completely preventable. I also speak as a widow. I speak as a widow, where my husband Pat died 12 years ago of cancer. And it was a cancer that was diagnosed properly but the pathology got lost for 6 months and it was not communicated. So I listened the past 2 days through the patient lens, and also the research lens. And it’s a lovely combination. PCORI is about the perspective, the wisdom, and the outcomes of the patient population. When I say patients, it includes caregivers, family members, and advocates. Combining that with rigorous research I think that THAT is going to be the kind of science that drives change. And so what I walk away with today is hope. I am aware of barriers, I am aware of government challenges, I am aware of cost. But 10 years ago there would not have been patients in this room, and today we have patients in this room. And we have a lot of patients in this room. And I want to thank Dave and Kelly and Perry and Cristin and Greg and Ronny and Linda— all of you. We are here because of you. And you are our teachers, and we’re all teachers and learners. You gave us vision today, and this is important for us to focus on vision and hope. So, what I heard today—and I’m sorry if I don’t remember your names—I heard today to listen to what patients are clamoring for. I love that, because we are clamoring. And I heard that we want to be safe. We want to be informed, we want to be empowered. We want compassion. We want to survive. We want outcomes that we decide and we want quality of life amongst many other things. And I think addressing some of these challenges that we have, if we keep this paramount we can make a difference. So, Greg Biggers mentioned the “new we,” and I loved that. Thank you, Greg. And we’re talking about a new we. Sally talked about a patient-powered network which I think is really important to think about. Patients are powerful. Our data is powerful. Our experiences are powerful. So, something that was described earlier today—I suffered this when I was a patient advocate. We wanted change and we wanted it fast. So, we demanded solutions from The Joint Commission and from NIH and from CDC and from researchers who partnered with us. And they said hang on, good solution, but we need evidence. So, we backed up a little bit and we joined researchers and we developed the evidence and we gave it to CDC and we gave it to The Joint Commission and we gave it to those who regulate and create protocols for our country. And we saw change. It took us 8 years, but it happened. It happened in partnership. It happened in partnership with HHS, with researchers, with parents, and those parents drove that change. So, what I’m seeing regarding patient engagement is coming from the research world at PCORI. We are bringing patients in. And we are learning. We want you to help us. We’re trying to infuse patients at every step of research. And so we’re inviting patients to submit research questions. Tell us what’s missing. Tell us what you need us to research based on you and your life and your challenges and what information is missing. We’re bringing patients in and we’re training them. We have patients who are sitting at the table with scientists reviewing proposals and deciding what PCORI funds through their lens. 166

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We’re bringing patients in to help disseminate when we have research results. Traditionally, research goes into peer-reviewed journals; moms and dads and patients typically don’t read those. How do we find these creative pathways? We bring the patients in to help us do that. And then how do we evaluate ourselves? We want the patient population and caregivers and stakeholders, we want clinicians to tell us how are we doing and how can we do this better. So we’re creating an infrastructure right now, bringing people in as much as possible as we can. We’re going to be empaneling a patient engagement advisory panel in about 6 weeks to help guide us, help make sure that we are patient-centered and we are engaging patients every step of the way. So, what I am hearing and feeling over the past 12 years as a patient advocate or activist, whatever we call ourselves, we were pushing. We were calling for change, we were pushing. I’m seeing a shift now, where we are going to be pulling for change. We are going to be in front pulling along the system with us as partners. And that’s a difference. And I see that pull effect going on with these discussions. So, in conclusion, I think that we have an opportunity to make a difference in patient lives by really bringing in the patient points at every step of the way, whether it’s research, whether it’s as a patient themselves, if it’s in policy making, if it’s at the institutional level. Let’s look for every avenue where we can plug the patients in. Peter Margolis said, what if? Consider the what if. What if we did this? What if we had patient-powered networks and patients sitting on QIs and IRBs and in research? And that’s what I invite you to envision. I challenge you and I invite you. And I think that collectively we can make a difference. Thank you. MS. BECHTEL: So, I have three questions, one in each of the areas that we talked about. I probably have 500, but I’ve tried to narrow it down to three so that anyone who feels like taking a shot at it could. The first is in shared decision making. We heard from Gary Langer that more than 80 percent of patients would like to have shared decision making. We know from actually the research that Tresa talked about earlier that my organization asked them to do, we tested the idea of shared decision making in juxtaposition to some other health reforms like payment reform and IT and patient-centered medical home. And it wasn’t particularly compelling, because everybody said that’s just a fundamental right. So, I think we have a situation where there is a lot of openness and willingness to engage from patients. So I guess my question is what you guys sort of think the holdup is. Because I’m not sure it’s consumers on this. As we think about a pathway forward for shared decision making, where do we start? Audience Participation and Open Discussion MR. LEVIN: I have to do a disclaimer. I’m on the Board of The Foundation for Informed Medical Decisions, so I just want to make that clear. I think shared decision making is important. I think we’re talking about a democratic process. Sort of philosophically, I see this as democracy. In my more than 30 years of advocacy talking about the need for giving patients and families and caregivers the information they need to make informed choices before it was ever a foundation, I just saw that as basic democracy. And if you go back to when I started, we lived in a really closed world. There was one medical reporter, Larry Altman of The New York Times, who was an MD. There was no one else 167

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around. If you wanted to look at the PDR it wasn’t in Barnes & Noble, you only got it if you were a practitioner. You couldn’t get into a medical library. You could get into regional medical libraries like the library of medicine, but it was a nightmare to get through it. So it really was the control of information. That’s the opposite of a democratic state. So I always thought of it as a basic principle that in a democracy we needed to share information. There is also—and I have forgotten the name of the report although Michael may remember it— in 1982 there was a President’s Report commissioned on biomedical—long name. And there was one chapter of that, which is one book on self-autonomy in decision making. And this is going way back. So they probably did this study in the 1980s. And they asked people from various backgrounds, demographics, do you want information so that you can make a more informed choice? And the vast majority of people said yes. And this was in an era when there was no information. So I think that longing for information, that longing for participation, has been around for a long time. The other thing is if we really believe in informed consent as an ethical and medical imperative, how do you give informed consent if you don’t have any information? You’re just signing a piece of paper which is mostly what happens now. It’s a sham. People are not really giving informed consent to whatever it is they’re being asked to undergo. So I really think that shared decision making is a critical point. I think there are ways out there where people are experimenting. Washington State, for example. You can imagine mandating things. You can imagine payers saying we’re going to pay more or we’re not going to pay, unless there’s some documentation that’s reliable that there’s a shared decision making process. So I think that may be one of the priorities in the sense that we sort of understand it well, we have a lot of evidence about its effectiveness. And it’s probably doable. It’s not easy, but it’s probably doable. And we have a lot of examples throughout the country where people have done this successfully, either through mandates or on their own initiative or through grant programs. So it would be a good place to begin. MS. SHERIDAN: Something I think that in terms of shared decision making and participation, I was at the WHO for 7 years working with patients all over the world, and the WHO did a survey on outcomes and if patients wanted to participate in assuring their own outcomes. And we sent out a survey, got a response from 59 countries, and the overwhelming response was yes, we want to participate. It didn’t matter the culture, the country, the government, the economic status, yes. And then we said, what do you need to participate? And the answer was an invitation. And so have we, as a health care system, appropriately invited our patients and caregivers to participate in improving good outcomes? It was a simple response by the patient population, and the WHO honestly thought it was one of the sexiest pieces of surveys that they’ve ever done because it was so simple that it was overlooked prior to this. And so I ask, are our clinicians, are our hospitals, are our systems, is our government, are we extending that invitation to come participate with us? MS. BECHTEL: I think that is actually a good segue into a question about value. I thought the sessions today were really phenomenal. But they pointed to a real tension point for me. So on the one side we had—and Chuck Alston has a great slide on this, where he says value, VALU, is a four letter word for patients, for consumers. And we heard a lot about why that is today. And we heard Marge Ginsburg talk about the need for more public deliberation, and how do we shift expectations. In fact, that was the title of the session, changing expectations. On the other hand, we heard from Dave Debronkart, and this has been my experience as well 168

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and we’ve heard from a couple of other folks in the room, that when they were all ginned up to go get the cost information to find the high-value providers, because clearly they had either deliberated their way there or they had a high-deductible health plan, what we found was that the system was absolutely ill-equipped to give it to them. So, on the one hand, it feels to me like we want to invite patients to engage in this discussion about value and cost and quality. And on the other hand, when they accept the invitation, we say you go over there, we’re not ready for it. So I think Dave also used that four-part hierarchy of data, information, knowledge, and wisdom. So if we think about that, I don’t even know where on the spectrum we’re at with respect to cost information. We’re not at the knowledge part, we know that. AUDIENCE: Are we at the data part? MS. BECHTEL: That’s what I want to know, right. Are we even at the data part? How do we move forward? MR. GORMAN: I would say that we’re not at all. For most of the last year I’ve been branching out in my life as a patient advocate. I’ve spent a lot of time in Texas with my 92-year- old mother who is in good spirits, but has a lot of things going on. Last May, she was in hospital for a month. Part of that was necessary, but when the summary came from Medicare and I added up all the punitive charges, it was close to $500,000. What David was talking about before, there is virtually no honest pricing information available. So pricing has completely failed. It’s what Dr. Berwick is talking about as one of the problems. Pricing has completely failed to send signals that are meaningful to patients in any role as buyers, except we’re starting to get some and maybe more on high-deductible plans. But even there, I think people are going to end up in sort of one-off negotiations at the time of service and the point of service with the provider they’re talking to with an eye toward what is going to be the impact on the deductible. I mean it’s not going to be market-based decision making. MR. LEVIN: Excuse my ignorance on this, but I’d like to ask people at the table out there. Is there any evidence giving people cost with how it works right now makes any difference? Because if we’re all evidence based— DR. SOFAER: (Off mic response) MS. BECHTEL: For those of you who couldn’t hear because poor Shoshanna doesn’t have a mic, was that her work found that it actually could be dangerous to give consumers cost information. And I would say I think you mean in this context in particular, in this health care system. My sense is that—and I would love to know what you guys think, my sense is that what David Goldhill was really arguing was that if we open it up, actually forget giving them cost information, just make consumers responsible for burying the cost, the market will restructure itself. Now, I have to tell you, being at the age where a lot of people in this room are probably going to be on Medicare, certainly before I will, but before this David Goldhill system comes about, I don’t want to be caught in the middle. So I have to tell you. I mean, what do you guys think about this idea that let’s just put the burden on them because in some period of time the market will restructure? Will it work? MR. LEVIN: There is no question that people are more sensitive to what they have to pay if they have to actually pay it out-of-pocket. I think that’s a no-brainer. Is that the right way to deal with health? David was up there saying we’ll deal with catastrophic illness, we’ll deal with this, we will deal with that. One of the assurances of that, I was glad to hear he was in favor of National Health Program, very nice. 169

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But I think we really have to pilot that kind of idea to see what the risks are. We have a growing vulnerable population, not just by age, but by all kinds of disabilities and disease that require a lot of care. I know the 90-10 is an interesting artifact, and I think all the things we said are sort of fascinating challenges to the exceptionalism of health care. Whether the answer is to simply give all of us the $10,000 or the $15,000 to go out and buy our own care, I’m not sure. Because I don’t really know if we’re ready, if we can equip people with the information and the skill sets they need to make the right choices. I don’t think we’ve been very successful in doing that even without the challenge of, you’re going to pay for this out of your own pocket. So it isn’t really a marketplace, right? If I know what a copier is supposed to do—so when a company makes a bad copier, it means I go to the copier and I push the button and it jams or it doesn’t produce a copy. I’m not sure we know if I break my knee what the outcome necessarily should be. I want to be better, but I don’t know how much better it can be. It’s a very different world. I don’t think you can make just a transfer that this is like any other business, it’s like any other marketplace. It is in some respects, it isn’t in others. DR. ADIRIM: I agree with that because what happens is if you’re responsible for paying for something which could have a huge impact on whether or not you have a good quality of life or live or die, you have people in certain age groups who would forgo that care. It has been shown in certain studies that people of a certain age group, older, elderly, will give up whatever they have for younger generations. So that’s why social security was created, so that we could take care of elderly people. I don’t think health care runs by the same economics as other commodities. So I think you have to be very careful. That said, I think he had an interesting point because there is a difference between emergency type care, critical care, versus preventive care. So perhaps doing demonstrations or models where people would pay for routine care as opposed to more catastrophic, what’s now considered higher cost care, could be something to look at and then develop that evidence that you’re looking for, whether or not you can change people’s behavior with regard to use of health care. MS. SHERIDAN: Well, maybe this is a bit Pollyanna-ish but going back to patient engagement and having patients guiding change in research—and the reason that I say this is just the “what if,” Peter’s “what if.” If we did bring in patients at every level of research and solutions and systems and policy making, could we expedite change? And could we expedite better health care and better outcomes? And the reason why I think this is because, when I referenced what this mothers group in changing the standard of care for newborn jaundice, within 4 years of when we started with our researchers and the system, Brent James from Intermountain Health and Hospital Corporation of America implemented the solution even before there was evidence, and they reduced newborn readmissions by 30 percent. Somebody was saving money. And so I think the patient piece of driving change can be an expediter. Patients rarely give up, and honestly the researchers that we’ve worked with said the patients kept us on task and they kept us going when we were wearing out. But it was also the other way around. When the patients were getting worn out and frustrated, the researchers kept us going. And so can we use patients as a catalyst to expedite change that will help save us money? I know that’s not a short-term solution, it’s not the whole solution. But it’s part of the solution that I witnessed that I think it would be great to study. I know somebody who might be able to study that. 170

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MS. BECHTEL: Might have the funding for it, huh? A neurologist told me that when you hear a new idea, it fires the same receptors as pain in your brain. So I was feeling a little bit of pain in David’s presentation, but I don’t want to dismiss it because I get the point. All it takes is the one doc practice who everybody suddenly realizes they’ll see patients after hours, they post their prices on their website. We have little teeny examples here and there of people doing that. And I think it is really notable to point out what Tresa said, and what Chuck Alston also said in his public comment, that for the first time just in the last year or two, they’re really sensing a bigger or deeper anger and frustration with cost issues and that there may be kind of a change on the horizon. So, I’ll say before we wrap up, maybe we got the agenda order backwards. Maybe it has to be the research pathway first to set the stage and provide the evidence for shared decision making, which is how we’re going to get ultimately to value. So we’re going to wrap up and turn it back to our host Michael McGinnis here. But before we do that, any burning comments from our panel? MR. LEVIN: Just one comment I want to make. I think it’s important to keep in mind the rapidity of change right now; we’re in a world of rapid change. And a lot of what we have talked about is today, and not about tomorrow. And so by tomorrow, what we talked about today will be out of date. It’s a new paradigm of thinking that we really have to be thinking far down the road. We have to deal with today’s problems, but we have to deal with tomorrow’s problems even more. So we need to really always be doing that stretch. And as people have mentioned, we have a whole new generation coming up who doesn’t have a laptop like I do or a desktop, but really a device in their pocket. And it’s the way they get information. They go out to a restaurant, they don’t read a magazine; they look it up, get the rating. So, we just have to bear in mind the rapidity of changes is overwhelming. And we really have to sort of train ourselves to say whoops, we’re thinking in today’s world and we really need to think about what tomorrow’s world is going to look like. SUMMARY AND NEXT STEPS MS. BECHTEL: I want to say two thank yous. One is to the planning committee members, not just those up here on the stage, but those in the audience, if you want to stand and we can recognize everybody. And I also want to say thank you to our host, the Institute of Medicine and Michael McGinnis for his passion and commitment, and the staff for their support. We’re very grateful for your interest in the topic. Thank you. DR. MCGINNIS: Thank you, Christine, and thanks to all of you. This has been an extraordinarily rich and stimulating set of discussions, informed, directed, and inspired, as Susan said, by the patients who are here to help lead the discussion. In many ways, it has been a pioneering activity for the Institute of Medicine and the National Academies in focus, in scope, and in importance. This workshop embraces the central challenges that face the health care system today—better outcomes, lower costs, faster progress—and it has done so by seeking the Holy Grail of motivating and mobilizing the people who are served by health and health care in our nation as drivers for change—how can we democratize and grow the influence of people on care improvement, on lower costs, and on quicker progress? Not surprisingly, when pursuing a holy 171

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grail, the path can be elusive or, at least uncertain. That is clearly the case here. As Art just pointed out, we are looking into the future. We have to keep our eyes on the future very squarely, continuing to look as far beyond the horizon as we can, because things are changing very rapidly and we can’t be held back or held down by perspectives shaped in circumstances today that may not pertain tomorrow. We have heard a number of very interesting ideas, as well as a number of expressive take- home phrases. I have jotted down a few of them in each of our three categories: care decision strategies, value and quality, and knowledge generation. With respect to care decision strategies, we heard that a meaningful care experience is when someone goes out of their way. We heard “listen first, listen fully.” We heard “patient engagement is a skill, not a trait.” We heard “connectedness and connectivity count.” From one provider, we heard “decision aids save me time.” And we heard that “culture eats strategy for lunch every time.” We have heard that “real innovation is truly disruptive,” and, for us, truly disruptive would be the movement of care choice to the point of the individual. We heard about “the power of distributed leadership.” These concepts shape our thoughts about what we can do with respect to care decision strategies that will improve the future of health and health care. On the count of value and quality, we heard that “money is a proxy for quality in every industry but health care.” And, of course, that is true. However, we also heard that “wise use of resources resonates with people” and offers a foundation on which we can build. We were advised to let quality lead on value. We heard about the importance of the 3-second rule—“if it’s not engageable in 3 seconds, forget about it”—as a means of motivating change. We heard that absolute dollars register more than dollar signs when conveying information on outcomes and quality and cost. We heard the question, “Who is the trusted translator?” as a very important perspective to bear in mind. We heard that real incentives have feedback loops, and that “getting the dynamic of the feedback loop right is just as important as getting the initial message right.” In the area of knowledge generation, we heard that “patients represent untapped data streams.” We heard about the “paradox of protection.” In protecting patient privacy and prerogative, we have left patients unprotected with respect to the loss of evidence that otherwise could be generated. We heard that there is little hope of solving the long-term problem without integration of care and learning. We heard that data sharing will drive change, but “data sharing is not sharecropping.” This offers us an important admonition that “permission matters” when we are expanding our ability to mine clinical data. As a nod to the higher calling in knowledge generation, we heard that we owe it to ourselves, to our families, and to society to draw upon this resource for improving the public good in its most fundamental fashion. From these and many other take-home phrases throughout the course of this workshop, we’ve heard a number of suggestions about what needs to happen as we look to the future with respect to care processes, with respect to scientific insights, and with respect to price, cost, and value. In the care decision arena, we clearly need to focus on ways in which decision aids and decision information can be mobilized and delivered as efficiently as possible. To begin to work on the issues of trust, we need to work on the challenges affiliated with the multiple loci of information that is produced, and improve access to trusted information across the board. Of course, programs like Choosing Wisely are fundamentally important steps in that respect, and there is much more that we can do. We also can explore, it was suggested, possible approaches to shared decision making as a covered benefit. What are the strategies here to provide the economic incentives possible? If we’re really interested in care culture that changes both professional care culture and other elements of the culture that shape our future care delivery 172

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processes, we can make sure that we’re clearly future-oriented as we train health professionals. We can make it clear in our training processes that it’s not just team care, but that it is team care with the patient firmly embedded in the center of the process, and that the learning really draws from the patient. In the quality and value arena, possibilities include those just mentioned about marshaling information on quality, costs, and value in a more reliable fashion: building the science of transparency. To do that, we are going to have to better marry the processes of gathering cost information with those of gathering quality information, so that we have a more level playing field in sharing information with the public. We need to work on the graphic strategies for communicating information on quality, cost, and value. We should not despair of the fact that our current set of data points on cost and pricing is lacking at this point. We have a fundamental societal obligation to improve those data points. We can’t just ignore them. This may be our most fundamental challenge: doing everything we can to marshal honesty in our information on costs and prices. In the knowledge-generation arena, we have to develop a communication strategy to better make the case to the public that they can and should be advocates for using their information for care improvement. We need to develop practical, trusted approaches to privacy and consent as we deal with the imperative to draw on clinical data in a seamless fashion for scientific advances. And we need feedback approaches that will bring the utility of the information closer to home and to patients themselves; not just to society as a whole, but to patients themselves. Moving forward, we will review the transcript to identify common themes and strategies. We urge you to send in any other thoughts that you have, and we will send out an appeal for input on ways in which we can both refine the strategies that are most important, and again, as Art said, develop some priorities around ways in which we can all work together to move forward. I want to take this opportunity now to again thank Claudia and Julia for the great work that they did in putting this meeting together. I thank each of you, both presenters and participants in the effort, and again thank our Planning Committee who made this meeting possible: Terry Adirim, Leah Binder, Veronica Goff, Mark Gorman, Paul Grundy, Art Levin, Jim Mangia, Lyn Paget, Eric Racine, Susan Reinhard, Craig Robbins, John Santa, Susan Sheridan, Susan Trinidad, and last, but certainly not least, Christine Bechtel. Thank you all very much. REFERENCES Bernabeo, E., and E. S. Holmboe. 2013. Patients, providers and systems need to acquire a specific set of competencies to achieve truly patient-centered care. Health Affairs 32:250- 258. Braddock, C. H., K. A. Edwards, N. M. Hasenberg, T. L. Laidley, and W. Levinson. 1999. Informed decision making in outpatient practice: Time to get back to basics. JAMA 282(24):2313-2320. Forrest, C. B, W. V. Crandall, L. C. Bailey, P. Zhang, M. M. Joffe, R. B. Colletti, J. Adler, H. I. Baron, J. Berman, F. del Rosario, A. B. Grossman, E. J. Hoffenberg, E. J. Israel, S. C. Kim, J. R. Lightdale, P. A. Margolis, K. Marsolo, D. I. Mehta, D. E. Milov, A. S. Patel, J. Tung, M. D. Kappelman. 2013. Comparative effectiveness of anti-TNFα therapy for pediatric Crohn’s Disease. Under review. 173

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Henry, S. G., E. S. Holmboe, and R. M. Frankel. 2013. Evidence-based competencies for improving communication skills in graduate medical education: A review with suggestions for implementation. Medical Teacher 35(5):395-403. Towle, A., and W. Godolphin. 1999. Framework for teaching and learning informed shared decision making. BMJ 319:766-769. Wicks, P., M. Massagli, J. Frost, C. Brownstein, S. Okun, T. Vaughan, R. Bradley, and J. Heywood. 2010. Sharing health data for better outcomes on PatientsLikeMe. Journal of Medical Internet Research 2(2):e19. Wicks, P., D. L. Keininger, M. P. Massagli, C. de la Loge, C. Brownstein, J. Isojärvi, and J. Heywood. 2012. Perceived benefits of sharing health data between people with epilepsy on an online platform. Epilepsy & Behavior 23(1):16-23. 174