 As you and the audience know, this is the highlight of our annual year, our programs for the year, and we so look forward to it. I'm going to turn over the podium to Dr. Dan Salmezzi, who's going to moderate the first session, which I'm looking forward to enormously. Dan? Good morning and welcome to the very few people who are here early. This is a session on end of life care, and we're going to have... I'm going to really try to ask my presenters to really keep to their 10 minutes, because we'll be set far behind if you don't. So I'll introduce each one sequentially. Our first presenter is Josh Hauser, who's an assistant professor in both the Department of Internal Medicine and the Bueller Center on Aging Health and Society at Northwestern University's Feinberg School of Medicine. His interests include inpatient care, as well as palliative care and hospice, and he's going to come to the podium now and talk to us about palliative care education at the VA. Thank you. Thank you, Dan. Thank you, Mark. This might be Mark's surgical roots starting so early, and welcome to everybody. I want to tell a little bit of a story about a project we've been working on around education and palliative care at the VA system. And I first want to thank a few people. The Department of Veterans Affairs supported this work, and Amos Bailey, who's a palliative care physician at the Birmingham VA, has been my co-chair in this work. You can see the rest of the team there, and I also want to thank there are at least two people associated with the McLean Center who were integral of this work as well. Art Dursey and Ellen Fox have also been involved in this project. So here's what I want to do in the next 10 minutes or so. I want to talk briefly about the history of the education in palliative and end-of-life care or EPIC program, talk about the current state of palliative care at the VA, and talk about the development of this project called EPIC for Veterans. First about the EPIC project. The EPIC project started about 10 years ago at the AMA and moved to Northwestern in 2001. It's a train-the-trainer project to teach core competencies in palliative care around symptom management, communication skills, and ethics. And we have about 2,000 trainers who have taken our course, and they in turn have trained about 200,000 end-learners. And we accomplished that through a pretty dedicated group of master facilitators who teach each year at our conferences. This is just a quick slide of the topics that we teach, and I'm going to return to this in a moment when I talk about the specific VA-centered topics that we've been working on. But you can see basic material in symptom management, communication skills, and ethics. Over the last several years, we have evolved from having a core product, content, to specialty-based curricula, oncology, emergency medicine, looking at the overlap of palliative care and those specialties. We have a project in pediatric palliative care that's currently underway. We have a curriculum that was sponsored by the Lance Armstrong Foundation for patients and their family caregivers that focuses on communication skills with your physician and other healthcare professionals. We have international projects specifically in India and Saudi Arabia. And then we have adaptations for specific populations, and the Veterans Project is an example of that. So let me talk about what's going on at the VA in palliative care, and then talk about our project. So it's a nice coincidence that I'm giving this talk the day after Veterans Day, which was yesterday, as everybody knows. About a quarter of all deaths in the United States are among Veterans. They aren't all within the VA system. In fact, a majority are outside of the VA system, but there are about 20,000 inpatient deaths in the VA system amongst Veterans. And you can see on this slide some of the data about those deaths. There are about a quarter in the ICU, and that is slowly decreasing, as you can see on this slide from 2006 to 2009. And more and more deaths are within hospice beds in the VA. About 60% of patients had a palliative care consultation before deaths in the VA, and 20,000 sounds like a large number. It is a large number to me, but it's dwarfed by the number of outpatient deaths that occur in the VA, about 136,000. So a big part of the VA effort in palliative care has been to link with outpatient hospice providers as well. The Comprehensive End-of-Life Care Initiative, or CELC, was started by Tom Eads and Scott Shrieve at the VA. And education is a part of this. You can see it highlighted in yellow, but there are many other parts of this. And as I said, people like Ellen Fox, for example, working in the Integrated Ethics Office, have also been a significant part of this. This is an example of how the VA has connected with other care providers and care systems. This is through NHPCO, or the National Hospice and Palliative Care Organization, a campaign called We Honor Veterans. And then in terms of training, our EPIC project is one of three projects. There's a palliative care nurses assistance project and a project for nurses called ELNEC. So a word about our process. We took our core EPIC and EPIC-O material and adapted modules to make them more specific to the needs of veterans. We created about five new modules, and we also filmed 10 new trigger videos, which are short clinical vignettes, in this case of veterans themselves, their family members, and their professional caregivers, talking about their experiences. We had almost 100 writers, editors, and reviewers, both within the VA as well as externally. And we ended up with 19 topics. We had five topics for our plenary sessions, and we had 12 re-enacted clinical scenarios from our original EPIC curriculum, as well as 10 new videos of veterans, their family members, and their professional caregivers. So I want to show you, Dan has given me the three-minute sign. So I'm going to show you about a minute and a half of a video that we filmed with one of our veterans. And then I'm going to tell you a little bit about who we've taught this curriculum to and some of our next steps. So again, this is a video that's designed as kind of a trigger tape to an educational session that's about the experiences of veterans in World War II. I'm glad I had the chance to jump. Clayton Burlow is a World War II Army veteran who served in Europe from 1940 to 1945. He had wanted to be a pilot, but his eyesight wasn't good enough and instead became a gunner. In 1944, Mr. Burlow was captured by the German Army and spent time as a prisoner of war in Austria. He is now cared for in the Palliative Care Program at the Total Wisconsin VA Medical Center after sustaining a large stroke that has left him unable to walk. The Germans couldn't go on in there. We weren't prisoners anymore. We were free to eat. It all didn't make any difference, but it was different at the end of the prison camp. It was a time sort of, but it was also a very good experience. I would reject comments such as, I was treated better in prisoner of war camps than I am now and it's his frustration with dealing with his everyday dependency. Mr. Burlow goes on in that video to talk about the experience of marching out of prisoner of war camp and now being in a wheelchair and what that's like 70 years later. So again, this is an example of an educational technique that we use at the beginning of a teaching module to elicit conversation and discussion. Let me talk for the last minute about our topics, the things that we teach and how we've implemented this over the past year. So our curriculum is divided into roughly three overall groups of topics, communication and goals of care and you can see examples of that. We have as is foundational the Palliative Care information about symptom management and you can see examples of that in this slide. And finally, more traditional ethics topics and you can see examples of that in this slide. We also for the VA developed some new material on issues specific to veterans and PTSD is clearly an issue that has a higher prevalence in veterans populations and in the general population and that's an example of material that we developed for this project. We developed materials about the experience of veterans from different war eras and as well about navigating the VA system of care. Let me end with where we are in this project. The development process was a two-year undertaking. It was punctuated in the middle of that by an issue that some of you are familiar with called the death panels and that delayed us a little bit but we overcame that through a lot of hard work with a lot of people. We have now spent the last year teaching two live conferences and trained 260 of our trainers, 126 of whom have taken an extra day of intensive teaching skills work and we've had 12 webinars in conjunction with both the VA and NHPCO and had over a thousand attendees of those webinars. We've posted our curriculum on our distance learning platform, the EPIC project and we have some next steps that we're now interested in doing. Again, our goal was to train all of the palliative care teams at all of the VA facilities which are about 150 in the United States as well as to have them train their colleagues. The next steps in doing that is tracking the people whom we've trained and what they've done. The VA itself has a content management system which is an electronic platform for education and we're posting our curriculum to that. And then finally we're developing kits to help with clinical change around family meetings and depression screening. That's where we are. It's a pleasure to be here. I thank you Mark and again I thank you Dan for facilitating. Thanks a lot, Josh, that was very illuminating. Our next speaker is Alexia Tork who's an assistant professor of medicine in geriatrics at the Regenstrife Institute where she's an investigator at the Indiana University School of Medicine. She's also on the faculty of the university's Center for Aging Research and the Fairbanks Center for Clinical Medical Ethics and Lexi will talk to us about family experiences of healthcare decision making for the hospitalized older adult. Lexi. Thanks Dan and thanks to Mark for the opportunity to be here today. I started with this general title since I submitted it a while back. I'm going to focus today specifically on communication issues within the hospital setting between surrogates and clinicians. I'd like to begin by acknowledging my co-investigators and research staff at IU and the Regenstrife Institute. So we know that hospitalized adults 65 and older face major medical decisions and over 50% of hospitalizations and yet other researchers have found that over 40% of hospitalized adults lack decision making capacity and require a surrogate. However surrogate decision making is really fraught with difficulty. One third to half of hospitalized families report problems are communication and decision making. And there's evidence for severe distress for many surrogates as measured by PTSD inventory such as the Horowitz scale. Traditional ethical models of surrogate decision making ask the surrogate to rely on advanced directives and to speak for the patient using the standard known as substituted judgment. But we know that surrogates face additional challenges. They have to form their own separate relationships with clinicians, cope with stress and other difficult emotions and make decisions that could not have been anticipated prior to the acute illness. We and others have proposed that these challenges affect the process and outcomes of decision making and that coping with these challenges depends on the nature of the relationship between the surrogate and the physician. A number of other researchers have interviewed surrogates at some point across the period of their decision making and have described some key tasks that the surrogate has to undergo in order to make a decision. For example, the surrogate has to understand information, come to terms with the patient illness and cope with their obligation to the patient. So the surrogate is coping with concrete decisions in the midst of a setting of a great deal of kind of psychological and cognitive and emotional tasks. One of these interview studies that I want to mention because it was done by one of the current McLean fellows, Lisa Vig, involved interviewing veterans about their decision making experience and she identified some key elements that either hinder or facilitate the making of good decisions. These include surrogate characteristics and life circumstances, surrogate social networks, the relationship between the surrogate and the patient, and then surrogate clinician and communication and relationships. I'm going to focus on the last of these, particularly in the hospital setting. So the present study was to identify important determinants of successful surrogate clinician communication in the hospital from the surrogates point of view. We went about this by developing a conceptual model of communication and decision making and then developing an interview guide based on the model and conducting our interviews. So I'm going to start with our conceptual model. Communication theorists have proposed that there are two fundamental aspects of interpersonal communication, a content dimension that we've called information processing and a relationship dimension that we've called relationship building. Our model proposes that these two dimensions influence the quality of medical decisions made by surrogates and clinicians and that these decisions impact outcomes for both patients and surrogates. For each of these major dimensions of the model, we've selected constructs that seem most relevant to surrogate decision making and that are potential candidates for a future intervention. So for information processing, we've identified the process of disclosure, sense making, and expectations on the part of the surrogate, and in relationship building, emotional support, trust, the management of consensus and conflict, and then the roles and the participation of both the clinician and the surrogate. For purposes of today's presentation, I'm going to focus on this left side of the model with the elements of communication that play into the surrogates' experience. So to do this study, we did this in the context of a prospective observational study of surrogate decision making in two Indianapolis hospitals for adults 65 and older. We identified our patients by doing a physician screen that asks whether the patient has faced any major decisions. To find is those adjusting life-sustaining therapy, surgeries, and nursing home placement, and then asked whether a surrogate was consulted. Then we conducted our surrogate interviews, which were during or as close as possible to the hospitalization in order to capture the surrogates' experiences in real-time, or two to four months later if the patient had died to allow for acute grief. These were analyzed using grounded theory. So we conducted 35 interviews. As you can see, the majority were female, half were African-American and half were white, and the majority of surrogates were daughters, not surprisingly. We identified seven primary themes, and I'm going to talk about these in a little more detail. So the first, the frame of reference. We defined the frame of reference as a set of expectations about the hospital experience that guide the surrogate's behavior. These are based on past experiences, such as hospital experiences, life experiences, and even the current hospital experience. So here's a woman describing how she and her nieces had to make decisions for her sister. The one thing that they kept pushing and adamantly pushing is that we had to make a decision about whether they were going to resuscitate or if anything happened. We just buried their mother on a recent date, and they had to make the same kind of decision for her. The three of us had not even had a time to get through a grieving process before we were faced again with having to make a decision for another family member. So this points out the context in which decision-making occurs. Is it often a surrogate who's under stress already, or has other competing family obligations? The frame of reference creates certain expectations about the hospital experience, including how patients and surrogates should be treated, the condition of the hospital, and the behavior of the staff. So here's one describing our county hospital. From my understanding, this is like a county hospital, so everybody comes here. So your length of the time in the emergency room can be lengthy, you know. But for my mom, it wasn't lengthy. They helped her write that in there. This also shows how expectations can be changed by novel experiences. Trust and mistrust were really demonstrated by our patients through stories rather than explicit statements. And these stories demonstrate the different levels of trust that the surrogates experience, and also different domains in which trust is experienced, such as trust that surrogate will be kept informed, or that the clinicians have the patient's best interest at heart. So here's a very mistrustful man describing care of his mother. They have the pain medicine here. It's just a shame that they're reluctant to give it to her because they didn't think they were going to get their money for it. So she had to lay here and suffer the whole time. Other participants gained trust by comparing what they were told with what they actually observed. So as this one said, you know, I seen what they were telling me and then it was accurate. Everything was getting better, and I was glad of that. Although we and others have framed surrogate clinician relationships as dyadic, our interviews reflect that there may be no identifiable clinician with whom to form a relationship. So here's an example. We usually take her in an emergency room, and there's a team of doctors that is caring for her while she's in emergency. Then it's out of their hands, and I think they told me because I'm talking to those teams of doctors when I'm there, and once they say she has to stay, then it goes to some other doctors. And the other doctors, the only thing I knew about those was after she called me, Dr. Baker called me, that I knew it was Dr. Baker caring for her. This is actually unique in that the surrogate can identify at least one clinician. But we found in many cases that the surrogate couldn't identify anyone, and they actually apologized for this, suggesting that it violated their own expectations for hospital relationships. This second quote also kind of is an example of this concept of the relationship with a team, and also the surrogate's need for frequent communication. But one thing that I will say is that the staff here with their having, I believe, three different teams for mom, they were in contact with me on almost like a daily basis. I was extremely impressed that I had gotten so many calls from a team member from W Hospital. So Lord knows who is calling, but at least it's somebody. Finally, the surrogates mentioned the importance of emotional support on a regular basis, such as taking the time out to really sit there with me to explain that to me. That meant a lot to me, because some doctors they will tell you and explain it to you, and then they move on. But she actually, I felt like she really cared about what was going on with my mom. And finally, many describe the acquisition of information as a struggle. And fortunately in this day and age, when doctors have pagers, blackberries, and cell phones, it's best they're non-communicative and at times unavailable. Information that was kind of shared haphazardly, mainly by the nurses who were saying there was some kind of discussion about some kind of procedure. So to go back to our model, our findings confirm the importance of several of the key concepts we originally identified, which include information disclosure, sense-making, emotional support. But our findings also deepen our understanding of trust. Although the patients may enter the hospital with a baseline level of trust, this can be enhanced or diminished by the hospital experience. Specifically, surrogates build trust by comparing their own observations of the patients' care to what they're told by clinicians, a process of sense-making. Additionally, trust is built through the act of sharing information and through expressions of emotional support. So really much more of a connection between the information processing and relationship-building sides of communication than we had originally thought. So in summary, in the hospital setting, surrogate-clinician relationships are often fragmented in brief. Surrogates highly value expressions of emotional support, information, and frequent communication. These decrease the surrogates' distress and increase their trust. And finally, an interdisciplinary approach is accepted by most surrogates. They were happy to be called by a variety of clinicians from the medical team. So in conclusion, we need to revise our understanding of relationships between surrogates and clinicians in the hospital setting. In other terms, such as the surrogate-physician transaction or Mark's term accommodation may fit better. But emotional support and trust are possible even within these fragmented relationships. And I think many of you may have experienced this as clinicians where you meet a patient, for example, for the first time on the ward or in the clinic setting and really can establish trust quickly with the right behavior. Surrogates identify elements of communication that are amenable to intervention. And I think this really shows a way forward as far as how we communicate with them in the hospital. However, improving communication with the surrogate will require an additional expenditure of resources, particularly clinician time. And as I go through the hospitals talking with the clinicians it seems to be the most scarce resource that they have. So as we consider intervening to improve the surrogates' experience we need to consider the nature and extent of our obligation to surrogates. Are we obliged to improve the surrogates' communication experience because it will help the patient, for example, by improving patient outcomes? There's preliminary evidence that this is actually possible, particularly in the ICU setting. Or do we have a separate obligation to family members, such as, for example, a public health obligation to improve the experience of the many family members who face life-threatening illness in somebody in their family? And these surrogates suffer high levels of distress that appear to be partly due to our failure to communicate effectively for them. So I think the question for the future is about the nature of this obligation and whether, as a healthcare system, we're prepared to fulfill it. Thank you. Thanks, Lexie, for that wonderful presentation and for staying on time. Our next presenter is Gretchen Swartz, an assistant professor in the division of vascular surgery at the University of Wisconsin. She currently runs the ethics curriculum for first, second, and third-year medical students at the University of Wisconsin. And her interests lie in clinical ethics and medical decision-making. And she will talk about the role of surgeon error in withdrawal of postoperative life support. Thanks so much. I'm just delighted to be invited. And I have to tell you that my entire research program started a few years ago at a McLean Fellows conference when, after I spoke about something completely different than what I'm talking about today, Rachelle Bernacki stood up and said, Gretchen, why is it that surgeons have such a hard time withdrawing life-supporting therapy on their patients? And that has really prompted a lot of my investigations over the last three years. And I'm going to follow up with some of the data that we have now on surgeons. So the first strategy I used to try and figure out the answer to this question, you know, Rachelle was concerned that surgeons were really worried about their outcomes, and that's why they weren't withdrawing life-supporting therapy. And I really felt instinctively that that was actually not the case. And we started just with a qualitative investigation looking at surgeons. And I'm going to present the quantitative data here today, but I want to just briefly talk a little bit about what we found in our qualitative investigation. And what we really found is that surgeons felt that primarily the reason they weren't withdrawing life-supporting therapy is because they had some sort of agreement that formed pre-operatively with the patients, which we described and called surgical buy-in. There was a layered interaction that came between the surgeon and the patient, formed pre-operatively before an operation where they established buy-in. There were some significant contributors to this arrangement, which I'm going to talk mostly about today. And then finally there were some significant consequences for the stakeholders, primarily this issue of not withdrawing support when asked by the surgeon. So today I just wanted to follow up on this third thing, the second thing that we found here, which were these contributors to surgical buy-in. And this is what surgeons told us and why they felt that they were not going to withdraw support. So the first issue was this issue of personal responsibility for bad outcomes. Like I made this decision to do it, I'm going to see it through to the end, and that makes it a little harder, at least in my conscience, to throw in the towel, so to speak. The second was an issue of agency where surgeons really felt that they were the intervention and that they felt that by withdrawing support it was showing that they had failed the patient and actually possibly killed the patient. So obviously you don't want to be the agent you know who kills somebody in the operating room. And that this was a very emotional thing for surgeons. You might feel terrible, you always feel terrible, but you might feel really terrible if it was a completely elective procedure. And then finally there was an element of sort of normative sensibility that success was expected because we've been educated to be champions and winners, we've never been educated to recognize the potential of an adverse event. So while I started with Rachelle's idea about why this is happening, I think Boss really has looked at this in the past and now I can follow up a little bit more from his investigation. Really this issue of error and responsibility I think has significant implications for our surgical patients. And Boss says it so well, when a patient of an insurance die, his colleagues ask what happened and when the patient of a surgeon's die, his colleagues ask what did you do. And I think that this is what we're confronting when we talk to surgeons post-operatively who are having such a hard time withdrawing life-supporting therapy. So I did a quantitative investigation, a national survey of physicians. We interviewed vascular cardiothoracic and neurosurgeons primarily because they were homogeneous in the fact that they performed many high-risk operations and we wanted to make sure that the people we sampled were having to face these decisions about withdrawing life-supporting therapy. It was an incentivized mail-based survey and we had 23 questions based on the results from our qualitative study. We did some cognitive interviewing and primarily the results I'm going to show you today are based on a vignette. And our hypothesis in the vignette was that surgeons are less likely to withdraw life-supporting therapy in the setting of an elective operation when the complication is clearly the result of a surgeon error. And the vignette is briefly as follows. A 75-year-old woman who has an operation and we tailored the operation to the specialty of the physician who received the questionnaire. The operation occurs and on post-operative day seven she has had a very severe hemiplegic stroke and she's been re-intubated twice for a post-operative pneumonia and we asked the surgeon and the patient has decision-making capacity she wants to withdraw life-supporting therapy and we asked the surgeon what would she do. And they get three non-possible options. One is to withdraw the patient's request. The second is to wait three days and see how things go and the third is to wait an additional seven days to see how the patient does. So we used a two-by-two factorial design where we experimentally manipulated the vignette in each survey. We had the elective setting. So some surgeons had an elective procedure where there was clearly a surgeon error. Some surgeons received an emergent operation where there was surgeon error and then we had not clearly surgeon error so we didn't specifically design the complication as a result of surgeon error and went with the elective and emergency cases. Here's our design. You can see the vascular surgeon's got an ascending aneurysm. In the emergent setting it was ruptured. The cardiac surgeon's got an ascending aneurysm and the neurosurgeon's got an intracranial aneurysm. So our results, we were fairly happy that we had 900 surgeons respond to our survey which ended up being an adjusted response rate of 55%. As you can see, our surgeons were primarily male but these are the respondents who withdrew life-supporting therapy and you can see at the patient's request that it's about 40% of surgeons who would honor that request to withdraw life-supporting therapy on post-operative day seven. And you can see that this is different depending on the surgeon's subspecialty. So the cardiac surgeons were actually much less likely than the vascular surgeons to withdraw support and the other thing is they really depended on our vignette. So that surgeons who were told that they had made an error in the operating room were much less likely to withdraw support than surgeons who were not told that the complication was result of the error. And also the same happened with elective versus an emergency operation and the emergence of the two clinical scenarios together actually produced fairly predictable results and you can see that surgeons who had an elective case and committed an error were much less likely than those surgeons who received an emergency operation and the error was not clearly defined as theirs. We asked about factors that might impact their decisions to withdraw life-supporting therapy and these factors came primarily out of our qualitative study and the factors that were really significant were the factors such as personal optimism about the patient's future quality of life, feelings about the morality of withdrawing life-supporting therapy and also sort of a very paternalistic attitude that the patient was unable to accurately predict the value of her future health state. We're also interested in this issue of performance measures and outcomes profiling but this did not have an impact on whether the surgeon was willing to withdraw life-supporting therapy and then finally the results for the most part held on our multivariate analysis where not surprisingly the vignette did have a significant impact on surgeon's willingness to withdraw so surgeons who had an emergency operation that was not clearly the complication was not clearly the result of surgeon error were twice as likely to withdraw life-supporting therapy than those in the elective setting. So in conclusion, surgeons are less likely to withdraw life-supporting therapy post-operatively in elective cases when the surgeon has made a technical error and that the decision to withdraw or not withdraw is associated with optimism about the patient's prognosis and concern that the patient cannot predict the value of her future health state. I think there's some significant ethical concerns here. One is the emotional strain for surgeons. I think that this emotional problem of error and responsibility for outcomes really does impact how we take care of our patients post-operatively. And I think that while this feeling of responsibility is very important, it clearly has some significant side effects. So if there is a way that we can simultaneously respect the fierce ethics of responsibility that surgeons have for their patients but also to be able to step back a little bit and respect patients' autonomy, particularly in the setting of a bad outcome, that this would be something that we could have an outcome that more closely reflects patient preferences. And then finally, there's just this question of what is the right operative mortality rate and the performance of an operation in order to prove quality of life or save a life is certainly valuable to patients and their families, but it should be valuable even if the patient doesn't survive. And I think that this is something that within the surgical community is something very hard to stomach but should be something that is valued and treated as an important part of surgical care. So I think thinking a little bit more about normative behavior in our culture, this would be a nice thing to be able to intervene on. Thank you very much. Thank you again for a very interesting presentation. Wonderful data. The next presentation will be by James Kirkpatrick, who's an assistant professor of medicine at the University of Pennsylvania and a member of the Cardiovascular Institute there. His research expertise is in cardiovascular medical ethics and conflicts of interest. He's also a volunteer physician at the Esperanza Health Clinic in Philadelphia and James is going to talk to us about a different way of going green, the reuse of pacemakers. So thank you to Mark and the McLean's and to Dan for the opportunity to present something that will be actually quite a bit different than what we've heard already. Here's my disclosures that have no relevant disclosures, no industry affiliations. Well, to set the context for this thing, it's important to understand as a cardiologist I can say we're number one. We are number one in deaths in the world. Our cardiovascular disease is basically, as you know, the number one killer in the western world, but it's fast approaching the number one status in the rest of the world as well. The cardiovascular disease burden in lower and middle income countries is going to increase by 137% over a 30 year period. And that means about 14 million cardiovascular deaths for you. You can see from this graph that the number of deaths is actually much greater from cardiovascular disease in the developing world than it is in the western world. That's only going to get worse. What I think is particularly bad is that cardiovascular disease strikes patients at a younger age in the developing world. And even if they don't die from it, they can very much be debilitated. This leads to really economic implications for patients' families and also for the society in general. Now, in addition to all of the diseases that we are actively exporting as we export cigarettes and unhealthy lifestyle to the rest of the world, the fact is that there are a number of diseases in developing world countries that affect the heart that are specific to those countries. Chagas disease being one of them, which is caused by this protozoa and transmitted by the reduvator kissing bug, so mentioned because it tends to bite people around the lips at night. This can cause heart electrical conduction block treated with pacemakers, lethal arrhythmias, which can be treated with defibrillators, and cardiomyopathy or failing heart, which can be treated with a special kind of pacemaker and a defibrillator. Sudden unexplained death syndrome is the number one cause of sudden death or death in general of young, healthy Southeast Asian males. There is a high risk of recurrence if you happen to survive the first lethal arrhythmia, and there actually was a randomized controlled trial published in 2003 demonstrating that defibrillators were better than a medicine called a beta blocker in preventing this recurrence. So, not surprisingly, there are disparities in implants of pacemakers, and I'd have to make one correction this size, not per year. There are 450 million pacemakers per million population in basically every western country, and the U.S. of course is number one in that, but compare this to the rest of the world. South Africa at 54 per million, Thailand 22, Peru, and in Bangladesh they only have four pacemakers per million population. Why is this? Obviously it's because of the cost. The pulse generator is that little thing that you feel underneath the skin, and that's the thing that houses the battery and the pulse generation that paces the heart, and that's a pretty expensive device. The leads which connect that pulse generator to the heart can also be expensive, and defibrillators are much more expensive than that, and when you compare to the fact that the average person in Bolivia makes between $50 and $100 a month, it's just not going to happen for them if they need one of these devices, especially because these countries appropriately want to focus their health care money on prevention, not on expensive devices. So there actually are ways to get a device if you are a poor person in a lower and middle income country. The companies that make these devices can only keep them on the shelf for about 12 to 18 months, and then both the sterility and the battery life can no longer be said to be equivalent to a new device. So they donate these expired devices and they are implanted overseas. In addition, we can get devices that have been used, and I want to talk specifically about getting post-mortem devices. They take a device out when you need to upgrade the device, say from a pacemaker to a defibrillator, but I want to focus on the latter point. There is a precedent for this. It turns out that in the early 1990s Sweden used 14% of reused devices and 14% of their primary implants. Now in 1996, they had incorporated into the European common market and had to follow those rules and so they stopped doing it, but many in Sweden felt that this was not actually. And it turns out that there are a number of charity organizations in the United States that have been doing this for a long time. They collect used devices and they send them overseas and implant them. And one of the reasons they can do this is that devices have to be removed prior to cremation. They will explode in the crematorium chamber and damage it. So all morticians know how to take these devices out, and because cremation rates are expected to reach 59% in the United States by 2025, it may as a potential for being a lot of devices that get taken out. These devices can be cleaned. This is actually sterilization protocol that was used in Sweden in some of their trials. And I would argue that because of all this there is a significant supply. Pacemaker patients in general tend not to survive that long and some of this is for comorbidity reasons, but sometimes it's because they're just plain old. Patients who in 80 make up 32% of the implants in the United States, so their longevity is not going to outlast the pacemaker in many cases. Even if you want to say that after you want to send the device back because it fails within four years and consider the warranty issues, that's still six years left on a pacemaker. It's not uncommon that this happens. The cartoon says his pacemaker is lasting longer than he did. This is a joke, but it's really true. This is what happens. And these devices actually have a fair amount of battery life left. There's an organization started the University of Michigan which collects used devices from funeral homes and they reported on 2,000 devices that were donated to them. They found that 10% had greater than 75% battery life left or it would last at least four years. And interestingly again, the average time since implant to when they received that having been taken out of a dead patient was only two years. So when we looked at this, we actually found when we asked morticians what they did with these devices that they took out we found that the highest percentage reported that they just threw them away. There were some that donated them for reuse overseas. This is how I first found out about it and then these other things that you can actually do including donating to veterinary hospitals for reuse and race horses and dogs. So when we actually asked patients whether they would be willing to donate devices of the patients who said they'd be willing to sign an advance directive that authorized reuse of their pacemakers afterwards. I'm sorry, this is our data on when we actually asked electrophysiologists what they did with the devices. We found a similar thing that very few of them actually donated devices for reuse overseas and most of them actually threw away greater than 10 devices per year. A lot of them, as you can see, just kept them around in the lab or the office. So here's actually where we asked the patients about that and of the patients who were willing to sign an advance directive saying what they wanted done after they died with their device that you can see the vast majority said they'd be just fine with donating them for reuse overseas. But we felt that there were still some ethical and legal and logistical problems that were still involved here and that we needed to actually address these and in particular these are the barriers we thought that were most important. You can see they really have to do with non-maleficence some legal issues and then these competing interest issues as well. So it turns out when we actually looked at the five trials that compared new devices and old devices, these were not randomized trials, that there really was no difference in infections that were reported. Now you can argue about the follow-up time and the detectability of infections but the reality was in the data that we have there was no difference in infections. And the malfunctions although there were some more malfunctions reported in these trials in the reuse devices that turned out when we looked at them carefully, the reported ones really had more to do with the implant technique than actual failure of the device itself. So here's actually the advanced directive that we published dealing with pacemaker and defibrillator reuse and allowing patients to actually authorize this after they died and the pacemaker was removed and specifically we give patients options what can be done with the device because that's the biggest problem. People don't know information about where to donate it and if they want to return it to the manufacturers, they can certainly do that appointment of a surrogate to decide and then deactivation of the end of life. There's another area of interest that people need to make plans for that as well. Now one of the big issues here ethically is a competing interest of post-marketing surveillance. There have been a number as you're probably aware of device recalls and problems in devices that were discovered upon analysis of these devices which will return to the company for quote unquote bench analysis to take device apart and find a problem with it and it could be in fact that devices that basically are taken out of patients after they die may have more errors than those that are returned after they get an upgrade of their device or change out for battery depletion and so the heart rhythm society and others have recommended that all devices be returned to the manufacturers after they're taken out of patients but I would argue that rather if devices with an adequate battery life are sent back to manufacturers and the ones with adequate battery life are sent overseas that still represents a lot of devices that they can analyze and if the public gets interested in this idea of returning them overseas you're actually going to increase the number of devices that go back to the manufacturers. So when we argue this issue also and saying that basically this issue of saying the best may not be the enemy of the good in this particular case we drew on a quote by Peter Singer in a famous article from 1972 Famine Affluence and Morality he said, suffering and death from lack of food, shelter and medical care are bad and if it's in our power to prevent something bad from happening without sacrificing anything of comparable moral importance we ought to do it and we would argue that this applies to the reuse of pacemakers suffering from lack of pacemaker is bad and it is within our power to do something about it and therefore we ought to do it. So in conclusion I think that there is a need there certainly is a supply I believe that there is an ethical pathway to this and next we need more safety data we would like the FDA which currently considers reuse of pacemakers at least in the United States to be a quote unquote morally objectionable practice to officially at least say it's okay to reuse these overseas and then it raises this issue of domestic reuse which is another talk so I want to recognize the other people who have worked at this from Penn University of Chicago and also the University of Michigan and thank you for your time. Thank you James wonderful and interesting our last presenter for the panel this morning is Lynn Jansen who is the Madeleine Brill Nelson chair in ethics education and associate professor of medicine at Oregon Health and Science University Center for Ethics and Health Care. She has extensive experience teaching medical students and health care professionals about ethical issues challenging today's practitioners. Lynn she's going to talk about the problems with optimism in clinical trials. Thanks Dan thanks Dr. Siegler for inviting me to present our research today. In the brief time that I have I'm just going to discuss very overview findings from a study that we completed and published in IRB in January and then I'm going to just end by saying a word or two about the ethical significance of our research. As many of you already know there's been really quite a lot of academic discussion about the so called therapeutic error in early phase oncology trials. The therapeutic error occurs when a research participant falsely believes that participating in a clinical trial will provide her with a direct therapeutic benefit. It's widely recognized that this therapeutic error has the potential to undermine the moral validity of consent to participate in research. However I think it's necessary to describe correctly the nature and cause of this error in order to appreciate how it actually impacts on informed consent that it does so at all. So in the main the existing research on this issue has focused on the ways in which misunderstandings about the nature or benefits of research can cause subjects to commit the therapeutic error. Yet interestingly studies have also shown that the therapeutic error persists even after these misunderstandings have been corrected. This is interesting because these findings actually strongly suggest that the cause of the therapeutic error include more than simple deficits in understanding. So with this in mind I and my research team pursued an alternative explanation for the therapeutic error. The central hypothesis of our study which was an R21 pilot study funded by the National Cancer Institute was that participants in early phase oncology trials exhibit unrealistic optimism in their assessment of their susceptibility to risks and benefits associated with participating in those trials. Now and actually this is a really important point to grasp. Unrealistic optimism is not simply a state of mind. So it's not the same thing as mere hopefulness or even excessive hopefulness. Rather it's a bias. It's a form of irrationality if you will. That leads a person to believe that she is less likely to experience negative outcomes and or more likely to experience positive outcomes than others who are similarly situated to her. And in fact research in social psychology has shown that unrealistic optimism is quite prevalent in human psychology and in motivating human behavior. It's been shown to influence judgments about risks and benefits in a wide range of different contexts from the belief that one won't get HIV from engaging in unprotected sex to the belief that one can dodge all of the health risks associated with smoking. However nobody actually explored whether unrealistic optimism might influence assessments of research related risks and benefits in the context of early phase oncology trials. So the principal objective of our study accordingly was to understand the prevalence and magnitude of unrealistic optimism among individuals who were enrolled in early phase oncology trials. And to pursue this objective we gather data on how patients enrolled in these trials comparatively assessed their susceptibility to specific research related risks and benefits. And we employed the comparative risk benefit assessment form in order to achieve this objective. And this is actually the standard instrument that's used for measuring unrealistic optimism and it was developed by the social psychologist Dr. Neal Weinstein who was also a member of our research team. So we asked 72 patient subjects in early phase oncology trials to complete this questionnaire. But because it's a comparative questionnaire we needed to give them a frame of reference for making an accurate comparison. So prior to asking them to respond to these questions we asked them to take in mind the following description of the average cancer patient who's enrolled in an early phase oncology trial. So we at least told them that an average cancer patient who enrolls in an early phase oncology trial is someone who's already tried at least one but perhaps several kinds of therapies and these therapies have failed to control his or her cancer. So with this reference in mind subjects were asked then to rate how they compared with other patients enrolled in the same early phase oncology trial in which they were enrolled to compare themselves with respect to all of these questions and rate themselves on the 7 point scale ranging from negative 3 much below average to 3 much above average with 0 being average. And as this slide indicates we actually found significant levels of unrealistic optimism with respect to 3 of the 5 research related questions. In particular our data revealed that patient subjects exhibit unrealistic optimism when asked about the possibility of their cancer being controlled by the drugs administered in the trial their possibility of experiencing health benefits from participating in the trial and not experiencing health problems from the drugs administered in the trial. Now before I go on to discuss the ethical implications of our study I need to just mention one further feature of the study and that is that in addition to asking the comparative risk benefit assessment questionnaire we asked patients to complete what we called a purpose question and this was just simply an open ended question where we asked the patient subject what is your understanding of the purpose of the trial in which you are enrolled. And the purpose question in responding to this purpose question we found actually no significant relationship between the patient subjects understanding of the purpose of the trial in which they're enrolled as measured by that question and their degree of unrealistic optimism as measured by the comparative risk benefit questionnaire. In fact nearly three fourths of the respondents indicated correctly that the purpose of the trial in which they were enrolled was to generate generalizable scientific knowledge that had the potential to benefit future patients. So this is an interesting finding I think because it suggests that unrealistic optimism is not a product of a misunderstanding or at least not a simple misunderstanding about the nature of clinical research. So it provides us with a further reason for thinking that unrealistic optimism is an independent explanation for the persistence of this therapeutic error something different going beyond the therapeutic misunderstanding that we spent the last 20 years studying. Now of course our findings are preliminary they need to be corroborated by further research looking at a more diverse population and it would also be good to look at patient subjects with a broader range of malignancies but assuming that the preliminary findings are confirmed it will become important to think about what the ethical significance of unrealistic optimism in cancer research might be and on this issue I actually have quite a lot to say but given the time constraints I'm going to be very brief. Recall that I said that unrealistic optimism is a bias and as such it can interfere with a rational processing of the information that's given to us but the way in which it interferes with the processing of information actually has interesting and largely unexplored implications for informed consent and here's how. Biases in general do not compromise the understanding element of informed consent. We sort of had the beginning of showing that with a purpose question but this has actually been demonstrated in other contexts but biases do in fact interfere with how information gets processed by the person and when you look outside of the context of clinical research researchers have found for example that smokers who are also unrealistically optimistic that they're not misunderstanding the relevant facts about the dangers of smoking not at all their mistake is in how they apply that information and those facts to themselves so taking that same information into the context of research we begin to think that if we want to combat unrealistic optimism among trial subjects what we're going to need to do is provide them with more than simply more information we're going to need to develop interventions that may help to improve their appreciation and processing of the information that we give them and let me just call attention to one further factor about the unrealistic optimism that hints at its ethical relevance and this is how biases actually operate. Typically biases operate behind our backs it is we're not aware that we are under the grip of a bias and because they operate behind our back and without our awareness they pose a threat to our autonomy. Interestingly the traditional model of informed consent that we use in research doesn't actually do very well in identifying threats to autonomy that aren't simply the product of coercion or misunderstanding. So if we start to think that these biases are in operation and as we learn more about the factors that distort our rational judgment factors like unrealistic optimism we may need in fact to revise and broaden the model of informed consent that we use in clinical research. Now many people will say that there's actually nothing wrong with optimism. They're going to say if cancer patients and oncology trials have hope then that's a good thing and well we should not take it away from them. And in general I think that's probably right but I think our research is important because it challenges researchers to think a little bit more deeply about optimism than we have been doing in the past. It suggests that in cancer patients optimism just shouldn't always be by default assigned with a hopeful state of mind. Optimism is actually a much more complex phenomenon. It certainly can be ethically benign but it also can be a bias that distorts rational decision making and when it does distort rational decision making it becomes ethically troubling. Thank you. Oh and these are the people on my study here. I'd invite the panelists up to the podium and the paper session is now open for questions and again I thank you for staying relatively on time that we actually have above the schedule 11 minutes for questions. Fascinating project. I mean it's such a practical impact if this thing can continue to develop. And I was thinking about one of pushing toward more devices being recovered and used in this way. Monsanto the Agra Giant has created a soybean that's used virtually everywhere now that you not only have to buy the seed from them but you're not allowed to use the seed that's developed when you grow the soybean. And I wonder if you might look into having insurance companies roll out a plan in which when people are going to get a device they pay a lower co-payment of some sort if they agree that the device belongs still to the insurance company after their death. And that it could be recovered and used in a kind of systematic or in a well developed way that could be recovered and turned around. Yeah that's a very interesting idea and that involves both the issues of who owns the device which I think pretty much we can assume is the patient. Interestingly in Sweden the Swedish government they own the device and so it went back to them every time and then they would reuse it. So you could make that argument even from a public health standpoint if we were going to reuse them. And I like this idea actually of allowing patients a reduction in co-pay to actually have their devices reused. The big barriers to this the first barrier is the FDA they really hate this idea they think it's awful and have really maintained this for a long time mostly concerns of infection transmission. The other is the device companies they're really not interested in the reuse of their devices at all. So but that's a very interesting idea and a way that perhaps the insurance companies at least would potentially get behind this seeing the cost savings. We do have some initial sort of calculation data assuming about $84 million could be saved each year if we reused approximately 10% of devices which is kind of similar to what the Swedes were doing. I work with cancer patients doing clinical trials. I'm in palliative care and so I've observed what you describe. But my question is I think that there's a way in which in our society we've sort of cultivated this where we've promulgated this idea that cultivating optimism is a strategy to have better outcomes. So patients have this belief and I think a lot of physicians and others in society share this belief that if the more optimistic I am the better my outcomes are likely to be and so actually cultivating optimism is almost a strategy for better outcomes. Now I don't know if there's any evidence to support that. I know that there is lots of belief in that or that's my impression. So do you think that to me that complicates the issue. I mean if there's evidence that in fact being optimistic and hopeful improves your outcomes then we certainly don't want to discourage that. If the evidence is contrary then it becomes an issue. Can you address that? Sure. That's right. So in fact it is the case that what psychologists refer to as dispositional optimism which is just the general happy rosy outlook on life is something we can cultivate and is something that has been shown to lead to improved outcomes in a lot of different healthcare situations. Faster recovery from coronary artery bypass surgery and so on and so on so you can actually find data to support that claim. But it's really important to distinguish dispositional optimism which is what would be I think what you're talking about from unrealistic optimism which is itself a situation specific bias. It's an event specific situation specific bias. So it's not something that even one can cultivate because one's not even aware that one has it and that actually that doesn't lead to better outcomes. In fact the examples that I was giving to you suggested that it leads people to engage in more riskier behavior all around the board. Take risks that would endanger their health and their safety. So the key there is to keep that distinction in focus and certainly we don't want to discourage somebody's dispositional optimism but we need to be mindful of the fact that unrealistic optimism is a real force that can undermine rational processing of information. Thank you. Ryan Nash from UAB. Thank you all for excellent presentations. I do have questions for all of you but if I can limit myself to two short ones. The first for Lynn the one of my favorite coffee mugs is says I hear you I just disagree and I wonder I agree with you but I wonder in this how much is trust related to this bias of unrealistic optimism in that I've heard it said by patients I know the oncologist said that this isn't curable but I just disagree with them. So how much do we know whether a trust in medicine is related to this unrealistic optimism? Yeah that's an interesting question. I know that I know for certain that there are certain factors that that evoke the bias and I know for certain that in our study we found for example the sense of control ability on the part of the respondent was correlated with the bias but what you're asking seems to be something different the relationship of trust that the person experiences with his or her physician is that going to have any relationship in evoking the bias and I don't know the answer to the question I mean it's possible that lots of things the optimistic bias works in tandem with the therapeutic misconception and different things like that are going on so I don't know the answer to the question I haven't studied it but it's an interesting question. Thank you. And Gretchen the in my experience I think one of the reasons that my surgeons at UAB at least the trainees were very uncomfortable with with compassionate extubation for example was that their experience was one of two things they either had seen an order written extubate patient and move to the next room and patient dies like a fish out of water or they had seen orders for massive doses of medication patient ever breathes as they come off the ventilator and I wonder if the lack of good experience I mean surgeons being experiential learners I mean they want to do and they want to see it done well I wonder how much the lack of experience of doing these things in training may bring reluctance that if they could see it done well that there is a tertium quid there is a third option between these two poles could bring greater acceptance yeah you know we didn't ask that specifically because we didn't find that in our qualitative study we really reliant on the things that we had found to validate in our quantitative piece you know but we did find a lot of issues of conflict with ICU providers with their nurses and ICU physicians and I think that suggests that the surgeon regardless of how they feel about extubation or palliative care actually just had a completely different idea about what the appropriate course of therapy was so that the surgeon has a different goal and the intensive care unit team who may be able to provide much better palliative therapy at that point had a different goal as well and so I don't think that that would necessarily get us to a better point with surgeons I think the issue is much more it's deeper inside the surgeon than that it's sort of I got them here and it's now my duty to get them out and because it's my responsibility I can't possibly abide by these wishes to change our goals of therapy I actually am not going to ask a question but I want to congratulate the panelists as a each of you for really extraordinary presentations it spoke to me about the range of the field of clinical ethics and also about its maturing I mean your ability to get up and talk ranging from end of life decisions affecting a quarter of a million people who have been trained to surrogate decision making which will emerge increasingly as an important method of decision making for an aging population and a sicker population the interventions that Gretchen talked about in surgical decision making so important James's points about helping to meet the needs of the poor either in this country or in the third world and Lynn's work on phase one research which is so important as we go forward with scientific developments I mean it speaks to this combination of the normative with the empiric and to the range that we're addressing I thought each of the presentations was absolutely superb and I want to thank you and Dan for moderating it really Preston please and identify yourself Preston Reynolds at University of Virginia and I also want to echo Mark's comments this is really a superb panel and compliments to all of you guys Alexia surrogate decision making I was just fascinated with the fact that there are a lot of people who don't have a good care provider is there any data you've collected that care providers physicians are often confused as to who the surrogate decision maker and so it's a sea of people that are in a room who is a surrogate decision maker and so therefore how is the relationship going to get constructed when there's confusion on both sides and I remember people are certainly not one sided you know I think honestly I think there are many physicians in practice who really advocate both for the naming of a single surrogate through healthcare durable powers of attorney or sometimes pressure a family to identify a single decision maker and I would say that this is successful in a majority of cases but there are times when it's not and I would advocate this is a little bit kind of off the map but I would advocate a family consensus whenever possible so I think kind of resorting to hierarchies is a last resort when you can get multiple family members in a room and come to agreement that's the ideal and when there's multiple children it's actually okay we've got to keep moving on the last two questions one from Shola one from Laney Shola Shola all a party from Chicago great presentation by everyone but my question is for Jim if those pacemakers are good and reusable developing settings where we're dealing with poor people what are the impediments to actually using them here because we're talking about the healthcare cost you know being unsustainable if they're good out there why can't they be used there can you highlight some of the local impediments to that yeah that's really kind of our another issue that we're trying to deal with paper in right now none of the cardiology journals seem to want that for some reason so the biggest thing really is the FDA the FDA feels that it's unsafe pacemakers could a single use device you can reprocess single use devices we do it all the time already dialysis catheters and other dialysis filters and all those many different types of catheters the problem is a lot of the data was old and it was done overseas so the FDA before they would even consider something to be reused in the United States would need modern data in the modern era randomized controlled trials and preferably done in the United States the problem is in order to do such a trial like that it would be very expensive unless the device companies actually donate their new devices for it which they're not going to do in this setting so I think that as the healthcare crisis healthcare financing gets worse and worse there will be more consideration of things like this going on but at the moment these are really big options and as Mark pointed out and as we've discussed with others too if we start reusing them locally does that mean that there will be fewer devices to use overseas and there's a huge ethical issue there are we stealing from the poor to give to the rich in a sense so I think we're going to have to work all of that out as we go forward but that's a very good point and there is a potential cost savings there Laney, last question Laney Ross University of Chicago thank you all for a great panel so I have a comment and then a question for Lexi so the first was when you suggested changing the word relationship to transaction I want to say just say no Jerome Groupman just had a lovely article about a month ago in the New England Journal where he bemoaned the fact that we've moved from physicians and patients to providers to clients and I think the word transaction fits in that same model we want it to be a relationship even if it's a temporary one the question is pediatrics we deal with two surrogates all the time it's called mom and dad and so what lessons can you guys learn from the pediatricians? I mean I think the primary problem the entire model of adult decision making has been so focused on an autonomous patient that we have yet to fully consider what decision making is like when the patient's autonomy is limited and so we have a lot to learn from the pediatricians about how to make decisions in that context and I think particularly and I may have spoken about this at other times and others have written on this the issue of trying so hard to use autonomy as our primary guiding principle for surrogate decision making is in many ways misguided and I think what we can learn from the pediatricians is that there are multiple competing concerns they include not only the child's wishes the child's best interest and even perhaps the wishes and needs of the other members of the family so I think we could move a bit more towards the model of pediatric decision making and that would moving away from autonomy a bit towards a balancing of competing interests would actually be a positive thing for adult decision making well let me conclude by echoing Mark's comments thanking the panelists I mean I think we all appreciate that this was five creative interesting and important projects done by five very smart and talented former McLean fellows so thank you all very much the next portion of our program is really the highlight of the program it's the awarding of a new prize that the McLean Center has developed just this year the award presentation will be made by Dean Kenneth Polanski who is a dear friend of 30 years who returned to the University of Chicago after 11 years at WashU as the chairman of medicine to take over the deanship at the University of Chicago in 2010 it's a delight and pleasure to introduce you to Dean Kenneth Polanski thank you Mark this has been a really wonderful occasion it's I was here yesterday I really enjoyed the session this morning and due to be congratulated with the outstanding program that you put on and I think Mark and I were colleagues and friends at the inception of the McLean Center and I don't think that anyone could have imagined the success that it has enjoyed over this 23 years so I think that that's really a fantastic accomplishment and it's really delightful that Barry and Mary Ann are here, Barry McLean and Mary Ann and I think they deserve an enormous amount of credit along with Dorothy Jean who is Barry's late mother who had the vision that this was going to be an important area of investigation and had a wonderful relationship with Mark and one can see the results so this is a milestone now because this is the first year that the McLean Center prize in clinical ethics and health outcomes will be awarded and it's a significant prize it comes with a $50,000 cash award and this is the biggest prize in medical ethics Barry and Mark worked this out and Barry was going to put up the money and one of his close friends and colleagues of all of us Jim Frank who's a member of the Medical Center University Board a colleague of Barry's on the board when he heard about this insisted on donating half of the funds towards the prize you continue to inspire people to get involved in medical ethics and I think this is a wonderful outcome so it's particularly pleasurable to be able to present this to John Wenberg and John as I think all of you know is the pioneer in fact developed the use of epidemiologic data to study patterns of healthcare delivery and health outcomes so this approach has really had an absolutely profound effect on our understanding of the healthcare system so he's the creator and founding editor of the Dartmouth Atlas of Healthcare and what the Atlas showed and I think again you're all aware of is that there were striking differences in the amount of healthcare in different parts of the country and even in geographically closely located areas of the country and what was really very surprising and counter-intuitive was that the outcomes which were then studied did not correlate with the amount of money that was spent or the amount of care that was delivered and in fact in many cases there was an inverse relationship so this has obviously had a profound effect on our thinking about healthcare delivery Dr. Wenberg is the Peggy Y. Thompson Professor Emeritus for the Evaluate of Clinical Sciences at Dartmouth Medical School. He received his PhD from McGill and a master public health from Johns Hopkins he founded the center for the Evaluate of Clinical Sciences in 1988 and that center has really been an enormous locus at which outstanding people have congregated under his mentorship, they've developed their careers there and I think the collective impact that they have had on our understanding of healthcare delivery system has been really profound. Dr. Wenberg has received many honors and recognitions he's a member of the Institute of Medicine of the National Academy of Sciences he's published hundreds of scholarly papers he's received numerous prestigious awards from the Institute of Medicine from the Joint Commission from the American Heart Association and healthcare affairs or health affairs chose him to be the most influential health policy researcher of the past quarter century so I think that's certainly I would agree with that analysis so it's my very great pleasure to ask him to come to the podium and to welcome him as the first recipient of this award he's going to deliver a lecture entitled the importance of patient preferences in shared decision making in American medicine. John. Let me start by saying how profoundly thankful I am for this honor and I accept it not just personally but in name of the people I've been working with for so many years over at Dartmouth because this is a contribution that no one could have done by themselves it's a huge team we've had and I'm extremely appreciative of that and I need to thank Barry and Mary Ann thank you so much for all your friendship over the years and for this very nice award Mark and Anna and all of you in the audience thank you I don't know what you do when you get paid so much to give a lecture you get nervous and that's one of the few times I've gotten nervous because this topic is I know it pretty well but so I wrote kind of wrote it out just in case but I'm not very good at reading so I'll have to make sure I get everything set but basically I wanted to start with the kind of historical analysis of what I think is happening to the doctor-patient relationship that would build on the conversation that Paul you had yesterday basically the way I saw the changes that are coming about was the major assault on the idea of agency was behind the neoclassical model in which it was deemed rational to delegate decision-making to physicians we all grew up that way and we still many of us live in that heritage but the idea that physicians understand the science of medicine and are able to diagnose patient preferences was sort of fundamental to the idea that it was rational to delegate and the assumption quite reasonably was that patients don't know that there's an asymmetry of information and so forth now the agency model was important not only for the patient but it was also important for society because society generally assumed that the rational agency model i.e. the interpretation of medical need, patient preferences from the physicians would be based on knowledge and would set a limit basically to demand because if services were provided at a rate that was above what was deemed to be necessary that utilization would drop models were set in place to patrol the market to make sure that deviant behavior didn't get in the way so we had utilization review but all the time we had the assumption that more was better because if it was demanded because it was demanded by physicians who knew the scientific basis of medicine and importantly could accurately diagnose patient preferences the practice variation phenomenon which i've been working on for so many years essentially challenged the notion that science was driving the utilization and the patient preferences were driving utilization because of the enormous differences that existed between communities to all intents and purposes looked identical you may remember some of the studies we did with Boston New Haven comparisons year in and year out New Haven or Boston exceeded the rates in New Haven by about 60% now mind you those rates differences those difference in utilization were toward a very specific subset of the population namely those with chronic illness and acute medical conditions so the variation that we've been looking at in terms of spending and in terms of between regions is explained almost entirely by the differences in the intensity with which chronically illness is managed surgical variability is very idiosyncratic and it's gotten to the point where what we basically have identified as surgical signatures a region will be high on one procedure low on another now it's in the area of discretionary surgery where I think the clearest evidence comes forward of the advantages of shared decision making not only as an ethical model but also as an economic model of the utilization rates and I want to go through today just briefly if I can describing the contribution to this debate that our group worked on so long in terms of trying to rationalize the practice variation phenomenon through outcomes research and ultimately through engagement of the patient in shared decision making was this sequence of research carried over about a 10 year period of time beginning in the mid 70s through actually 15 years through the 90s that led not only to the rationalization and understanding of why people were doing operations the theoretical reason and the practical reason for it but also to the establishment of the first evidence that engagement of the patients would actually get you close to understanding what the right rate was the rate of procedures that would happen when patients were informed and were encouraged to take choices that were based on understanding of their own preferences and this in turn led to the formation of the foundation for informed medical decision making which has become at least one strategy for codifying medical evidence presenting scenarios that would allow patients to engage themselves into shared decision making so let me start with the surgical issue and I say we use this phrase learning what works and what patients want and basically it's a story that is engaged not only researchers but also professional professional leaders and without Dan Hanley who was the editor of the main medical journal in the mid 70s and on through the early 80s this project would have never happened and I suspect I wouldn't be here today talking to you about shared decision making Dan was not only editor of the main medical journal he was also the leader of the profession in Maine he was the secretary of the main medical association college physician at Bowdoin College and a member of the U.S. Olympic Committee very well respected and Dan took it upon himself to publish our data in the main medical journal and this is the only real data shop well not quite but mostly I'm not going to be talking much about data but this is that classic problem of the surgical signature each one of those colored bars for example concentrate on on the purple one which is prostatectomy for benign prostatic hyperplasia enlarged prostate you'll see in Portland the rates were about 40% higher than the state average in Lewiston they were about 5% higher and in Augusta they were 23% below the state average and it was this clustering pattern that got the attention of the physicians in Maine and led over a 10 year period to both a project of outcomes research and then ultimately a project in which we as a result of that research it was the informing of patients about their treatment options so in the very beginning in the first article that we published we said that in some parts of Maine 15% of men were receiving prostate surgery by age 85 and others 70% were and this was basically the information that caught the attention of the profession and Dan Handley arranged to recruit specialists to come to Dartmouth's Meneri Center where we sat watching the beautiful looms scenery out there and after about 5 hours in which or 3 or 4 hours after which I was catching a lot of hell from these guys about what rates were and what are you really talking about suddenly they started arguing among themselves about why we're doing this and so we would have urologists from one community next to another discussing and what it turned out to be was that they had a conflict of opinion that said that some of the urologists believed that they were operating on men in order to make them live longer because if you don't take this growing prostate out you'll get bladder decompensation and renal failure and this was actually the majority of opinion at that point in time we called it the preventive theory of surgery and there's a lot of other procedures silent gallstones and so forth but others believed that they were doing in order to make the quality of life better they did not believe that the natural history of untreated BPH benign prosthetic hyperplasia was sufficient to warrant the inoculation so to speak of the population in order to take out everybody's prostate they did it in order to make people feel better or to pee better as we used to say now at the time that we started this this was a delegated decision in which the patient relied on the doctor's interpretation of medical evidence and the interpretation of the patient's preferences and it was made under the assumption that urine flow indicated need the irony of this time was it didn't really matter what your theory was whether you were a quality of life man what you all did was you basically figured out how much cc's of urine you could pee into a test tube in a minute and that was sort of your parameter for doing this it was a very reductionist kind of point of view now by the time we finished our studies 15 years later we had shown through a variety of different approaches using claims data using decision analysis using the actuarial data from the census that there was no way the preventive theory was really going to work every way you cut the data you never made up for the bad effects the mortality associated with the initial surgical procedure and any reasonable assumption about extension of life expectancy but by definition then if there was anything going on it was the quality of life theory that had to hold and in this case we conducted a prospective evaluation of all the people in Maine who were using urologists to that state and without a clinical trial we could show a slam bang effect on symptoms there's no doubt about the fact that this procedure was making people pee better from the point of view of their quality of life but however it was quite clear that there were trade-offs and those trade-offs were differences between symptom improvement and concern about impotence and incontinence so we had a real trade-off kind of situation and this was what then led us basically to declare I guess is right that the proper understanding of the theoretical reasons for doing this is that it it improves the quality of life but it does so by concentrating on the quality of urination at the expense of the quality of sexual performance so clearly that was a trade-off and it was very interesting once we framed it that way and until this day we haven't had a lot of debate among men about whether this is the right way to view this procedure so if popularity ever comes to action science this is a pretty good viewpoint but what were we going to do about it that was the real question we could see clearly that preferences can't be diagnosed based on medical history physical exam, laboratory test or urine flow in fact one of the most interesting studies at least I thought we did was when we finally got to the point where we understood what was going on in terms of summarizing symptoms we could show basically that there was no correlation between urine flow and symptoms which said wow how crazy was this whole idea that was initially out there so that was where we basically said shared decision making was the key to learning which rate is right because engagement of the patient in the decision was the only way to understand what demand was at the micro level and that's what led us basically to this whole idea of shared decision making and I want to show you just am I doing okay on time yeah I just want to show you briefly a five minute clip of the first decision aid that we developed which this was done in 1987-88 Dr. Margolis was the chair of the department of pathology and Tom Almy was the chair of the department of medicine and we recruited them to be our storytellers because we felt that if doctors could visibly disagree on what they wanted then patients would be empowered also to get engaged and that turned out I think to be a fairly realistic strategy but we went on we were very optimistic at that time that the federal investment in outcomes research through the agency of healthcare policy and research was going to fund the basic analyses that we had done as the patient outcomes research team and what was left was to design a strategy for assuring that the results of these assessments all of which were devoted most of which were devoted to surgery could be translated into patient results and that led us to form the foundation for informed medical decision making which to this day is still doing this role and so there is probably what was most important about this strategy was that we could codify the way of assessing the science in a reproducible way of decision analysis and using other forms of putting what few clinical trials were together and so forth so that we got the science right and today the foundation has a network throughout the country maybe some of you in the room here are associated with it doing the assessments and then the next part is creating the scenarios of choice which are the ways in a way I think this kind of research opens up all sorts of new avenues for health services research particularly in communication, framing effects other issues associated how does one make certain that patient preferences are served by this kind of work and that was one of the interesting things that we were able to find we were able to do one important study in group health in Seattle which the entire population of those two staff model HMOs who had BPH were shown the videos and that allowed us to look at the formal question about when patients are informed what is the demand for surgery in a defined population which was the intrinsic question that the practice variations were raising and here you'll see on the far side over there the blue dots are the national distribution of transurethral prostatectomy surgical procedures at the time we were doing this you can see the HMO rate prior to the introduction of shared decision making was in the bottom third by the time we had gotten all the patients informed the rate had dropped to the very bottom of the national distribution in terms of turf rates suggesting that in most parts of the country believing this benchmark that most parts of the country were providing more surgery than informed patients wanted and that raised the whole ethical question basically of operating on the wrong patient as opposed to the wrong leg we think operating on the wrong patient has an imperative in ethics it has yet to be fully expressed and I hope I can anyway but were the decisions better that's the real question what could show with a simple questionnaire was that people that were using the decision aids were much better informed about the natural history of untreated BPH and about the relevant treatment options and the outcomes as far as we could judge them so the knowledge part of this was superior quite simply by a few can be ascertained with a few questions the concordance between patient values and care received was another question and here we could show because we were able to measure the degree of botheredness by symptoms and we were able to measure the degree to which patients were concerned about impotence and other downside risks of this procedure we were able to show that patients who really were concerned about their symptoms and bothered by them and didn't care much about sex were much more likely to choose to have surgery than average five times more likely than people who were at the other end of the spectrum so we could see a concordance between patient values and care received that gave us confidence that we were dealing here not just with an interesting movie but with something which was making a huge difference potentially in the lives of patients so that kind of here are the other conditions that for which mostly in fact all on this list are the kinds of decisions through which patient preferences based and knowledgeable decision making is absolutely key to rational choice and they make up these here make up about 25% of Medicare spending yeah maybe a little less because I think there's a couple missing but anyway it gives you a sense it's a pretty big chunk of the action and here is where I believe we can create I sometimes use the word islands of rationality where through outcomes research and engagement of patients we actually can be somewhat certain that our ethical requirements of information choice and our economic concerns that we do not waste resources by operating on people who don't want something can be realized and I think that slowly and slowly there is a growing sense of that being a reality it actually entered into a few of the pieces of the Accountable Care Act and so forth but I really do believe that the political will to complete this transition from classic delegated decision making to informed patient choice is going to take more leadership and more academic medical centers need to really take seriously the fact that this is their responsibility now this thing gets limited I'm just going to go over here now there's significant limits to what outcomes research and shared decision making can be can accomplish and that's because of the the fact that most care is not as we say preference sensitive in the direct way that I've been talking about in terms of the surgical procedures but rather it's very sensitive to the supply of resources and a lot of it is subliminal behavior you don't know it's happening because you don't know there's no signals coming up from the market to tell you that and here's where the end of life care issue and the disequilibrium in the market become joined that theories are and everything I look at particularly in the supply sensitive side are always in equilibrium with the supply we always know why we should do something in order to use up what we've got that's just the truism in medicine and that basically creates a downward pressure on practice style now what do I mean by this well basically let's say that we're talking about the frequency with which cardiologists visit their patients you have twice as many cardiologists per capita in a market you are going to basically get twice as many visits to cardiologists in a market because cardiologists always work 45 hours a week or more or less they're pushed to it by their managers these days sometimes and basically they achieve this by having the interval between revisits it's not that they can generate more patients with cardiac disease although there's a little bit of that going on but mostly it's the frequency with which they next schedule and you can see why that would be the case because you always ask the nurse to schedule a patient and she'll schedule the patient that's sicker, quicker but there will always be a queue basically that's waiting for you and the same is true in character in analogy with the hospital beds and other forms of things and this has a huge impact on the rate of admission to hospital for medical admissions here I simply have looked at the acute care hospital bed supply on the horizontal axis and the discharge rates now I always put hip fractures up here because hip fractures do not are not budged by supply hip fractures are one of the few things in medicine which obey the classic paradigm that illness and patient physician consensus and what we should do drives utilization because patients with hip fractures always go to the doctor almost always gets diagnosed right almost always gets admitted to the hospital so therefore the hospitalization rate is in fact a surrogate for the incidence rate and that's what we're seeing here but not so for medical conditions and here's where the the issue gets down into the whole question about and a life care and what I've done here is I put the percent of deaths associated with an admission to ICU during among patients that are assigned by pattern of practice to selected academic medical centers so of all the patients that use UCLA medical center and have chronic illness 38% of them end up dying in association with intensive care unit we don't know if they died in it but we know they died in the hospital when they were in it and you go all the way down the scale to Dartmouth-Hitchcock which is only 17% and you see in between are all sorts of varieties of medical practice and remember this is where our whole end of life care emphasis in ethics is trying to basically get in here and change this pattern of practice I just thought you might be interested in the University of Chicago how they stand by the way the green dots here are all the academic medical centers that have medical schools associated with them I failed to say that and you see there's quite a bit of variation within Chicago but but here's the slide that I wanted to concentrate on basically the support study many I think most of you in this room are probably familiar with that study it was a very extensive effort to intervene in end of life care to rationalize the clinical pathways the words I like to use and it failed it failed basically because patients that had preferences to die in hospital ended up dying at home and vice versa and it was generally considered that all this effort to redesign the clinical pathways wasn't working in the way the patients wanted we reanalyzed this data to look at the correlation between the percent dying in hospital in the support trial and the general pattern of hospitalization in the region in which those hospitals were located and you can see the red dots basically say that what really matters in terms of your likely of dying in the hospital is not the rationalization of the clinical pathway at least in this study it's the capacity of the system in which you are living so that is then the background in which we need to go to see the union between our interest in shared city making and improving the patient experience and what do we do about the capacity of the system and that's sort of held in this little diagram I won't try to get into it in any way but what we've done is we've taken people in the end of life care phase and we followed them back for five years at these different regions these different hospitals and the intensity of care in the last six months of life correlates with the intensive care in all previous six month periods of life as far back as we've gone so this is a system level problem and it's a problem that if we're going to get at it and if we're going to deal with a cost containment issues we've got to somehow link our strategies for reform the doctor-patient relationship to strategies for reforming the intensity of investment that's going on in terms of overall population services and unfortunately the focus here has to be on efficiency and lack thereof of acute hospitals and I want to say that in sort of closing here this is the kind of goals of health reform that come out of the Dartmouth Atlas work and I've taken this from my new book that basically traces this kind of story I've been telling you about and basically we need to establish informed choices of standard of practice and this is another way another mask for shared decision making I sometimes prefer the term informed patient choice because it sounds like a legal principle as well as a mathematical principle and shared decision making there's more than one way perhaps of making good choices and not just shared decision making we need to improve the science of healthcare delivery we simply have to invest in the kinds of work that allow you to continually evaluate the new theories and convert them into information that patients can understand and policy makers can understand and doctors can understand and that's one of my great disappointments in my career has been all the work that went into the original patient outcomes research teams and the efforts we made with George Mitchell and David Dernberger and others to get the agency real care policy of research established suddenly it just disappeared and came in 1994 because orthopedic surgeons or actually it was neurosurgeons didn't like the results of our back surgery findings so this stuff is really weak and we need support we need efforts we need commitment I'm sure that if the academic medical centers at that time had stood up and said this is unreasonable we can't abandon this program it wouldn't have been but we had no support basically from the mainstream science at that time we need to promote organized care there's no question that empirically at least places like Mayo Clinic Hitchcock places that are large group practices generally do much better than other places do in terms of resource use even though I'm not quite sure I understand why that's the case and so academic medical centers that have gotten to the point where they at least have salary staff have a special opportunity I think to move towards organized care which means long term follow up of patients and other things but finally we need to constrain young discipline growth in capacity and spending and that means we have to figure out when is enough enough and how do we make it happen that that we don't basically bankrupt the system as we make it more efficient there's not much in the accountable care organization I'm sorry in the accountable what is it the ACA legislation that helps here the one possible thing is the accountable care organizations with shared savings which mean that if academic institutions for example high side and come to agreement that benchmarks from there are more efficient brethren are reasonable the costs or the loss of revenue associated with the decline in inpatient capacity can somehow offset offset the loss ultimately however I'm pretty sure that what we're all going to find if we keep going this way and if we keep finding greater and greater pressure on inpatient facilities that the bond market and the equity markets are going to collapse and we'll find ourselves rowing someplace else but my hope is that we still have time and I'm echoing some of the conversations that was made yesterday by Arthur that we still have time to take the steps and I do believe we have the information we need to do this we don't have to do more research we need to do more action and again let me thank you I really feel honored by this and it's such a great gathering here and it's been a great privilege for me to be able to come over here on occasion and thank you Oliver especially Mary Ann and thank you thank you I think you can all see that Dr. Wendberg was a spectacular choice to be the first recipient of this award there is time for some questions why don't we try and do that actually I have a question so you put up the on your slide there number two so improve the science so obviously I'm in favor of improving science but I just wondered whether you believe and you sort of implied maybe not that it's lack of science and maybe data that's the rate limiting step it seems that we do have an enormous amount of data what we probably don't have is enough data at the local level for each physician practice for even hospital so I just wondered what you think how you translate these ideas into policy changes and action changes like at the University of Chicago Medical Center I think that the science basically I'm talking about is delivery science how much services do we need to manage chronically ill patients and what is the optimal well I'm not going to use the word optimal but what is the satisfying best strategy for doing that and here for example I would point to the work of of Intermountain Healthcare and Brent James where they have spent a lot of effort rationalizing the relationships between primary care positions and specialists and shown remarkable results in terms of improvements in quality measures but also in some observational studies in some randomized trials of actual outcomes of care being better so that's what I'm talking about because our biomedical science is fine it's the translation into clinical practice that has been neglected so much and yet that's the point where all this cost and all the sparks and all the energy that's going to arise right now yeah Lynn Janssen OHSU your talk was very interesting you focused on the cases where informed choice actually led to some savings in healthcare dollars but I wondered if it might also be the case that establishing informed choice in the context where you give patients more options to choose from the more expensive options it might also lead to increased costs thereby putting goal one and goal four on the slide up there in some conflict the choice of discretionary surgery versus other options for the same condition sorts out people's attitudes toward risk pretty quickly and I think patients generally are more risk averse about invasive treatments than clinicians so we can expect that to happen the interesting thing is that once we clarified that the purposes of treatment X is to improve the quality of life and patients have different attitudes about whether they would like it or not there's really no strong ethical argument why we should provide the more expensive treatment without differential co-payments and if society doesn't like the distribution or the effect on spending of information about treatment options with no co-payments or a small one then you can always adjust preferences by getting a little more skin in the game as they say and I think that's one way of answering your challenge it will not work however in my opinion for the chronic and ill patients because it's really hard to have an incentive not to see your doctor when he told you to come back or not to be hospitalized when you're pretty sick and there's a bed there so I think that for the preference side of the equation we do have other tools that policy makers could use if we get in a situation where things get to be too expensive and by the way once you introduce that kind of modulation on demand the prices will go down for sure in the more expensive ones very likely anyway Hi I'm Lexie Torghi from Indiana I really appreciate sort of the story you tell of how for elective surgeries you started with a great degree of disparities in provision of care to better data and a shared decision making model that relied on decision tools and I wonder if you think the way forward for end of life care you identify sort of a similar pattern of kind of these great disparities in how care is provided and I'm struggling as a clinician to think about how I might apply the same strategies of shared decision making with patients who are facing the end of life in order to optimize care Yeah I really do believe that we can do that but I wanted to make sure that people understand that if we do it for patient X and Y but not for alpha and beta or whatever the guys that aren't getting it are probably going to end up with even greater exposure to the care intensity at during their life basically so it's a threshold effect that affects the entire patient population that has to be kept in mind and then there's the individual patient flow through the system for which they're usually making certainly will protect some of them or put this way should end up in choices that reflect their preferences I think I mean we know you can do that you can affect preferences by scenarios around end of life care whether you could implement those preferences both for them and also take advantage of the reduced in demand that's associated with that is another question Michael Masal University I was intrigued with your initial studies where you demonstrated almost that what we thought would be a reliable biomarker urine flow would correlate with disease severity and I was also impressed that when you chose the physicians to describe the scenarios you were looking at both context and giving permission and quality of life but the third rail in the American health system is disability and the patterns of care when we become more dependent and more disabled and most of us as a value would not send a pet orangutan to the average American nursing home and so therefore how could you comment on how this fits into that model and the fears that especially vulnerable populations have with respect to disability I'm not sure that I this may not work but what we're talking about in terms of this elective surgery is a different category of care than what you're talking about in the sense we would probably not want to operate on a nursing home patient that had a very short life expectancy even though they may have some overflow urinary incontinence or something like that but the disability issue isn't that a problem give me another example my reason was to your model of shared decision making in dealing with uncertainty depends on informed preferences context and choices and all I wanted to do is extend because aside from elective surgery you kind of suggested that in dealing with both chronic diseases and complex choices that there is value to conceptualize and extend the model that's why I brought the disability question I'm not sure that I can answer that other than to say that in the vast sea of uncertainty that we're talking about here in chronic illness failure to have rationalized even the relationships between and what the trajectory of care should be and be able to compare that to other places that are trying to do the same thing create such a vacuum of knowledge that we really don't know what to do in terms of specific interventions end of life care has the interesting part about it because you have hospice option at some point when death seems inevitable but I've been trying to say that even though we might make some people's final days correspond more to their preferences by shared decision making unless we can affect the overall intensity of care it's likely to be very unlikely it will not first of all save costs which is an issue but secondly since we never know when someone's going to die it's going to be very difficult to do that in any kind of a systematic way I think we probably should end now otherwise there'll be no time for the break so sorry maybe you can speak to Dr. Wienburg over some coffee thank you very much