 I'm delighted to welcome you to today's meeting of these seminar series on ethical issues and organ transplantation. Our speaker today is Dr. Eliza Gordon from Northwestern University, where Eliza is a research associate professor in the Institute for Healthcare Studies and the Department of Surgery. Eliza earned her MD, I'm sorry, her PhD in medical anthropology at Case Western, did a year with us as an ethics fellow at the McLean Center, and then completed a master's degree at UIC in public health, where she specialized in community health. Eliza has published over 50 peer-reviewed publications, and her research interests include the Ethics of Organ Transplantation and Donation, Healthcare Access and Outcome Disparities, Research Ethics, and Chronic Illness Management. Currently Eliza serves on the Ethics Committee of UNOS, on the board of the American Society for Bioethics and Humanities, and as the director of CTECH. CTECH stands for the Chicago Transplant Ethics Consortium, a group that does research and writing on current topics in organ transplantation. It's a very active group, and they meet, I guess, weekly by telephone and computer. So I'm delighted that Eliza will be talking to us today about ethical challenges in informed consent for living donors. Welcome. Thank you, Mark. I really appreciate the invitation to come and speak to you and your colleagues here. It's a real honor to be a part of this transplant lecture series. So I've been doing some research in informed consent for living donation for the past several years, and this is kind of a nice synthesis of some of these ethical issues. So can you all hear me okay? Great. All right. So what I want to do is start off with providing the basic, you know, groundwork of the definition of informed consent and move into how informed consent pertains to transplantation and specifically living donation. I feel like I need a stepping stool because I want to see everyone over the screen. I also will go into some of the epidemiological context about living donation because that helps set the scene or give you a little bit of important background to understand what's going on in the minds of living donors. Then I'll move into some of the ethical issues in living donation and really zero in more on the ethical issues in informed consent. If there's time, I'll present some of the findings of one of my research studies and also then conclude with some future directions and interventions that may help to improve informed consent. So just to start off with, a basic definition of informed consent that can be described as an informed consent is an autonomous authorization by individuals of a medical intervention or of involvement in research that occurs if and only if a patient or subject with substantial understanding and in substantial absence of control by others intentionally authorizes a professional to do something. So there are several required elements of informed consent and informed consent is a process. It entails clinician and transplant candidate or patient or researcher communication and it's designed to assess in this case transplant candidates or living donor potential donors competency to make decisions. The disclosure of information regarding the risks, benefits, alternatives, the procedure and assurance of donor comprehension of disclosed information and informed consent involves and a voluntary decision and agreement to undergo the suggested procedure. So obtaining informed consent upholds the principle of self-determination and supports autonomous treatment decisions consistent with the candidates or potential donors life goals values and beliefs. So informed consent applies to any treatment procedure in the context of clinical research or treatment or research and informed consent for surgery is an ethical obligation a legal requirement and part of the patient's rights condition of Medicare participation for hospitals so Medicare has its own very specific requirements when it comes to informed consent in the transplant context. So in the context of transplantation these conditions of Medicare participation specify that each patient undergoes an extensive process of informed consent. It begins at referral and then ends with the written consent for surgery. And so CMS centers for Medicare and Medicaid services and the OPTN specify very particular information that should be disclosed to potential living donors and you can even go to the UNOS website and look at the revised policy that was revised just last month or two months ago. So with regard to living donors there are some specific required elements that need to be disclosed. The advisory committee on organ transplantation ACOT of the United States Department of Health and Human Services has established standards for informed consent for living donors and in particular they state that living donors must be informed about the risks benefits and alternatives to the donor and to the recipient. So in a way there are there's more than just the donor's life at stake there's also the recipient's life at stake and so it really requires balancing an extra set of perspectives when considering informed consent. The living kidney donor follow-up consensus conference stressed the need to inform living donors about the risks specific to themselves and I'll get into the rationale for why that's important in just a couple minutes but just keep that in mind so when I discuss some of my own research you'll remember that. And then respect for autonomy means that living donors have the right to determine how much risk they are willing to accept and that living donors as well as recipients have the right to refuse the donation so just because a potential donor wants to donate doesn't necessarily mean that the recipient will accept it. Okay and as I mentioned the OPTN has just revised their policy and updated their content that has to be disclosed. So in addition to the reason I just mentioned about why it's important to undergo informed consent there are a couple other things to keep in mind. One is that informed consent is important for ensuring patient safety especially in high risk clinical situations you want to make sure that donors in particular know what they're getting themselves into. As well there's been some really interesting research showing that being prepared for your surgical procedure in surgery more broadly and having realistic expectations are associated with better post-surgical patient health outcomes. So for example people have better functional health outcomes, perceived health, quality of life, greater engagement in their post-operative care, all those things. So being informed means or being prepared means it really relies on being informed so the two kind of go hand in hand. Okay so now I'd like to provide a little bit of epidemiological background about living donation. So living donation has been performed essentially to remedy the organ shortage. There's only so many deceased donations and living donations offer a nice supplement to address the shortage. So living kidney donation has been going on since 1954. Adult to adult living donor liver transplantation has been going on across throughout the world since 1989 but in the United States since 1998. There are over 95,000 patients waiting for a kidney transplant and in 2012, 16,000 received one and with regard to liver over 15,000 patients are waiting for a liver and only 6,000 received one. So there's a much different I guess magnitude of the need and difference between who is waiting and who's receiving one. And then about a third of all kidney transplants come from living donors and then about 4% of all liver transplants are from adult living donors. Just to continue a bit, so living donation rates have really declined over the last several years and you can see that the peak was in 2004 for kidneys. It was up to 6,600 but it's dropped more recently to 5,600 and the same goes for livers. It's dropped from 2001 to 2012. It's just been this ongoing trend and there have been a number of speculations as to why this has been going on but no firm definitive answer. There have been a couple ideas. The decline has been attributed to the less availability of living donors given that family members tend to donate but the recipients tend to be a little bit older. Economic factors having to get out, having to not be at work and then taking the paid leave or taking leave and not getting paid. That's been another key issue that people have suggested. Some programs may not encourage living donation, particularly some programs may not have living liver donor programs, very few in the country have those. And then a number of well-publicized living donor deaths, there are more than four but this is the four I was thinking of, have raised a lot of concerns about the safety of the donor procedure. So I'd like to turn to some of the ethical issues in living donation and the three key ones are the issues of non-maleficence, the categorical imperative and informed consent. So let's turn to issues of non-maleficence for a store of do no harm. A key issue of concern particularly for surgeons cutting into a potential donor is that it presents a lot of serious harms. You're cutting into someone who is otherwise a healthy living person and they don't need any kind of, they will not gain any kind of medical benefit through the process of undergoing surgery. So this really counters the whole imperative to do no harm. We can see here in this chart that there's magnitudes of difference between living donor, living liver donors and living kidney donors in terms of the complications and outcomes. So for kidney you see 0.03 percent chance of mortality whereas for liver it's 0.4 percent. And then with regard to the major complications for kidney three to six percent whereas clavian grade two refers to the moderate complications, grade three is like really severe. So 48 percent get moderate kinds of complications. And then with regard to mild complications 22 percent of kidney donors experience those whereas 42. So living liver donors have I would say magnitudes greater risk that they're undertaking. And what's interesting is that while a lot of the complications do get resolved say within months to a year there are some that emerge after a year. So Dr. Michael Abacassus who's the chair of our transplant program at Northwestern he and other members of the adult to adult live liver donor transplant consortium or A2 all they in a series of nine transplant centers doing adult to adult living donor transplant consolidate their data and found that a lot of living liver donors experienced complications after one year you know after one year after two years after three years four years five years six years post donation so that remains a problem. Another concern is the issue of the categorical imperative basically using people as a means to an end. I mean essentially living donors are undergoing the surgery to help another person they're not doing it for themselves so that is a concern. I posted up here actually you know what I want to do is pull this out. I'm going to show you the special issue of narrative in Korean bioethics. Okay. Daniel you know what I'm talking about. So there's this journal that Jim Dubois at St. Louis University. He is the editor of and we have a special issue on living donation and informed consent in this issue. So what is included in here is I have a brief intro but the bulk of that special issue pertinent I can pass this around if anyone's interested to take a look. But the bulk of the stories are the stories of actual living donors and what they went through and some were good and some were bad and some were in the middle or you know kind of a mix. So some of those contributors who are living donors said you know I am more than a live organ donor or I am not just a kidney source. In a way it's like these affirmative statements are kind of like well trying to really address this I'm asserting I'm not a means to an end in a way it's kind of like reaffirming that they are. And then there's this whole website living donors are people too you know all of this just suggests that people are the living donors are grappling with this issue. Okay and now I want to go into issues of informed consent for living donors. And I put voluntariness first as opposed to at the end which you know typically kind of comes later on when people give a voluntary consent because I think voluntariness or undue pressure sets the tone for living donors and what they are going through. So let me give you some more details to that. Okay so the living donors sense of undue pressure is framed largely by the available treatment options for the potential recipient. Okay so with kidneys you know kidney transplant candidates they have dialysis okay it's not the best transplantation is better and of course you know when their AV access is all used up then they really have no other choice but transplantation. But really dialysis is an alternative so there's less pressure on the potential donor to donate to a kidney transplant candidate whereas with liver transplant candidates there's no alternative but death okay so you know putting yourself in the shoes of the potential living liver donor what are you going to do I mean either see your loved one die or you know consider the idea of donating. So we're really working within the high stakes arena of life and death particularly for the liver donor candidates okay. So what kinds of pressures do people do potential donors feel okay there's been quite a number of studies that have documented undue pressure among potential donors kidney and liver donors whether it's internal feelings family pressures cultural expectations people feeling guilt financial pressures that they have to do it because the recipient is the bread winner and they got to support them their senses of obligation or duty some people will say I have no choice but to save the life of a loved one especially the case in pediatric patient. There's also a gender disparity issue that's been documented around the world where females donate more than do males do so females donating to their husbands is quite common and so you know how does that contribute to the sense of obligation and pressure. So there's been some great work by Miriam Valapur in Minnesota who found that 40 percent of living kidney donors reported some pressure to donate okay and what's interesting is that they found that significantly more pressure was found was felt among those donating to related recipients as opposed to unrelated so that those family ties that bind really do bind I guess and I had conducted a systematic review of living liver donors and found that undue pressure rates of undue pressure varied internationally with lowest rates in the United States moderate rates in Europe and the highest rates in Asian countries and I wanted to give you a quote here again from the narrative inquiry special issue by one of the donors and she said the psychologist explained to me that I could decline to donate and they would tell my brother that a medical issue came up during testing which disqualified me as a donor that plan may work for people who never have to see each other again but families are forever connected even with the feelings of entitlement the flawed relationships and disappointments permission to back out needed to come from my brother and my parents not from a psychologist that would never see me again I thought that that was really quite telling what's really going on in people's experiences okay now with regard to informed information disclosure this issue brings up a whole host of additional issues so potential living donors must obtain the necessary information to understand the procedure and its outcomes in order to effectively decide if donating coincides with their values and beliefs okay however as again from this special issue one person noted all I needed to know all I really needed to know I learned after my donation years later still learning so I'll describe for you in a little bit more detail now what some of these issues are so one is a lack of information to disclose there's relatively little known about the long term outcomes and transplant recipients particularly or recipients and donors excuse me particularly in the case of liver donors okay and then another issue is that there's always this issue of how much information do disclose we don't want to overburden people with too much information and cause overloads that they stop paying attention and zone out and you know some ethicists have commented about you can never really be fully informed but you can be relevantly informed to be able to appreciate what some of the data mean and opinions do vary within the transplant field about the amount and specificity of information that is needed by potential living donors as well as recipients another key problem is that there's a lot of variation across transplant centers and the types of information disclosed during living kidney donation informed consent processes so a couple studies demonstrate this an international study of a 221 transplant professionals found that US transplant centers were more likely to disclose potential travel expenses and loss of work income than non transplant non US transplant centers a study of consent processes for living kidney donors in 132 US programs found that 58 excuse me 57% of the programs presumed candidates consent to undergo evaluation as opposed to you know asking them and other transplant programs varied in the extent to which the informed consent elements were disclosed only 42% of those programs disclosed all of the elements of informed consent you know risks benefits alternatives all those things another international study found that 30% of 203 transplant professionals had discussed the long-term risks of premature cardiovascular disease or death with living kidney donor candidates in one of the studies I did I assessed consent forms across transplant centers and found that with regard to the readability they were written at a college reading level so they're at health literacy issues so information is inconsistently disclosed and within providers perhaps across providers across centers and a concern is that a lack of any kind of standardization of the consent process may result in under informing patients another key concern is that patients report being inadequately informed and having unmet information needs so a number of studies for both living liver donors and living kidney donors have documented you know precisely this that they're neither well informed or prepared they desired more information to prepare for the donation they had an unmet information needs they didn't feel that the information was really well explained they didn't understand the procedures for testing and surgical procedures furthermore with regard to a lack of understanding some had limited knowledge about the risks they found that living liver donors perceived unrealistically low risks they had a difficult time appreciating the risks in a way all of these sentences kind of blend together and you know capture a kind of a sense of this issue about people not really quite getting the risks okay and then here's an issue about expectations so donors experience greater morbidity than they expected more painful surgery and recovery than they expected they thought their explanations didn't match their experiences and and what was interesting there's only this one study that looked at associations among those who reported feeling less informed and found that those who are less informed were more likely to report that the donation was harmful to their health and that they were inadequately prepared for poor recipient outcomes so now I'd like to kind of switch gears a little bit and turn to you know the the relationship between disclosure and comprehension and the two kind of go hand in hand here so a key question is how much understanding is sufficient for valid consent and as I alluded to earlier the goal is not so much full understanding but substantial understanding you can't really give everyone every single detail but you can try to cover the key grounds that would be material to their decision-making so one of the questions that comes up is how should clinicians ensure patients understanding you know you certainly don't want to ask people did you understand that and you know people will nod their heads certainly the teach back to goal is an option but generally no formal assessment of comprehension is used by transplant centers that at least that I've documented and seen documented in the literature and this is a problem particularly given that CMS conditions for hospital participation specify that there needs to be an assessment conducted okay how's our time do we have like 15 great okay good all right so what I'd like to do is give you an example of some of the findings from my research that I've done on living liver donors okay so what I did was investigated prospecting living liver donors comprehension information needs and decision-making we so I conducted semi-structured interviews used like her scales and so all of the living liver donors who consecutively came into our transplant center and were evaluated participated were invited to participate in the study after they completed their final phase of evaluation so this is just two days before the actual surgery that might affect the findings so after they completed their final phase and informed consent and this was between 2009 and 2011 at Northwestern okay so I had interviewed 30 living liver donors and just to put this into perspective 30 is a large sample believe it or not but at Northwestern we do about you know 17 living adult-to-adult live liver donor transplants a year and Northwestern is one of you know nine leading transplant centers in the A2L consortium so that's among the high and in in the country so 30 is a nice size sample to help you understand this so okay so one of the things I wanted to point out was that there's a big fissure between being perceived as informed and perceiving that they understood the information so 90% rated on a Likert scale that they were informed about donation a great deal so like a five on the Likert scale that's the very end by contrast 66% reported that they understood the information about donation a great deal so there's something going on here there I would hope that they would match up on the high end and one of the things I was really interested in looking at is is their level of interest in learning about the risk information you know how much did they want it how much did they appreciate it or understand it and there seems to be some tensions about this some they wanted it but not quite or they had a difficult time understanding and so what I think is feeding into this tension is in part different expectations by providers and patients and the lack of long-term outcomes particularly for the liver donor context as and this tension is also compounded by a broader social context so I think that providers really expect to disclose what all these risks are whether or not the patient fully understands or appreciates it but you know here are the risks you got to know it but I'm not so sure that the donors totally get it and necessarily want it okay and the rest of my presentation will explain that and unpack it a little bit more in detail so you'll see what I mean and by social context a really interesting theme that came up in in the donor stories in the narrative inquiry special issue as one donor said the medical industry promotes only the happily ever after stories so a couple of the contributors to that special issue commented that there's kind of like the social pressure to not talk in any negative way about living donation because you don't want to threaten the you know the country's efforts to reduce the organ shortage you want to there's always this pressure to promote it and be the hero and speak positively but in fact some people have you know some bad outcomes and they experience pressure to not discuss it okay so a major finding was that while donors seem to acknowledge the information about the magnitude of donor risks they didn't seem to fully appreciate the potential impact of the risks on their lives so at Northwestern the liver surgeons and the independent donor advocate they routinely and directly reviewed the potential complications of donation and explicitly told donor candidates that they could die from donation I mean they they really pounded that into people's heads and in fact in the interviews with the donors they said that they liked that go figure but it really helped them recognize the serious the seriousness the severity of what they're about to go through and so when I had asked donors to identify the risks of donation to the donor living donors acknowledged that a list of risks was presented to them in their educational materials they remember having received it and they you know they were they were able to recall death by a leak and infection as the leading risks but there was no consensus on these identified risks and fewer than 60% of donors mentioned any given risk so you see here you know 60% of the 30 mentioned death and Diane a point Redo who is the medical director of the living donor program at Mount Sinai she had similarly found that only 70% of donors identified death from a list of risks so while so these findings are a little bit difficult to interpret so they may reflect reflect a lack of recall okay and that that's fair or it may recall it may reflect information overload that's fine or it could reflect that the risks were simply not of high significance for donors that they didn't care to remember it could be any of these things and so I found some further evidence of this last point you know that the risks may not necessarily be of importance and so specifically when I asked them how would you rate donation in terms of its risk to yourself 83% said that donation is not at all to somewhat so that's like on a Likert scale from one to five one two and three three being somewhat 83% the majority said it wasn't really risky to themselves liver donation go figure and then 50% verbally through their comments and statements downplayed the risks of living donation to themselves so they what I mean by that is that they dismissed the complications as par for the course something to deal with and get through okay and so you know importantly although transplant clinicians really want to inform the donors about the risks so that they know what they're getting themselves into and and can make an informed decision the donors reported that they didn't really utilize this risk information for decision making calculations so to me that was very surprising here are a couple of examples of how donors minimize the risks to themselves they place responsibility for managing the risk within the clinicians or trust in the hospital they believe that the risks are a normal and acceptable part of surgery and daily life they also believe the the likelihood of experiencing complications is low and that the relative impact of the complications on their health is minimal and manageable in comparison to the bigger picture of saving their loved ones life okay and the unlikely chances of death occurring remember what I told you about the voluntariness that that kind of provides the big picture of what these donors are going through here's some illustrative quotations to support this point of how living liver donors were minimizing the risks to themselves as one person said I think the chance for risk is so minimal that they're not important to me that's really striking another said I don't think risk is the right word it seems normal because like I said this is the biggest surgery you can have done so I imagine there's going to be some complications but it's reassuring knowing that none of them are life-threatening you know little thing here and there that's got to be normal in a type of surgery this big another said I have the list all the statistics and the minor minor ones I guess I think if the possibility of death was much much higher than what it is that would be the only thing right now that possibility is so minuscule that it's not even on the radar but that would be the only thing all other complications you can deal with so as these comments show downplaying the risks appears to have also served as a strategy motivating living donors to proceed with the donation process maybe it's rationalizing so that is donors were reassured by their own assessment that the risks were low so if we were to set aside the ethical excuse me like the legal requirements the hospital requirements for informed consent for protection for disclosure I think that these findings raise a question of what is the purpose of disclosing risk information and particularly if the risk information was downplayed and played a little role in decision-making by many donors so so here's just briefly the theoretical framework for informed consent informed decisions are really informed consent is really designed to help people make informed treatment choices right to make a decision to act here a couple quotes by fading and informed informed consent are acts of autonomous authorizing and in the case of refusals of declining so it's an action a decision okay um but in this case it wasn't so much used for decision-making as some of the respondents indicated rather it was used for preparation for donation not for decision-making and most donors had decided to donate before receiving much education from the transplant center to begin with and that that's a finding often found in in the literature so the information needs for decision-making were distinct from the information needs relating to feeling prepared for donation and a third of donors emphasized that information was vital for feeling prepared for donating and feeling secure in the decision that had already been made here's a couple more quotes about this the importance that they're placing on feeling prepared so I asked was there any other information that you really relied upon to help you with your decision-making and the respondents said not for the decision-making but most of the information I get was to prepare rather than to decide I mean this is people are just telling you directly there wasn't anything that they could have told me to change my mind if they had given me more information it wasn't that it would have changed my mind but it would have helped me feel prepared for the procedure and more aware of what to expect so just to wrap this up here I know we're running out of some time um providing risk information is generally touted as enabling patients researcher research participants and living donors to express their self determination for autonomous decision-making but although it's grounded in law this perspective really minimally explains the actual thought process is used by living liver donors rather an ethical analysis of the construct of informed consent should focus on identifying information that is material to their living liver donors preparedness rather than decision-making per se okay so disclosing the risk statistics may be insufficient for adequately preparing living donors to appreciate the impact of a complication on a donor's life so um so although they generally felt informed they insufficiently understood the donation process and downplayed the risks and decision-making so this raises questions about comprehension it illuminates the value of informed consent for preparation rather than decision-making um more comprehensible disclosure of information is needed in order to optimize the informed consent process and it's essential of course that prospective donors are adequately informed and that their information needs are addressed to ensure that they're well prepared um couple quick points here so how do we do this how can we ensure that patients are optimally informed and comprehend one suggestion and um uh some of my colleagues I don't know if um is Yolanda here and James out there so I'm really pleased so Yolanda and um James Chon um we collaborated on this paper it just got accepted it's impressed on shared decision-making and we propose how shared decision-making can help with informed consent process um and enhance um people's understanding um a couple other suggestions there's been a move in in transplantation I think jumping onto the bandwagon overall of utilizing you know the internet as a an inter a great intervention um to utilize interactive computer-based programs and so the the folks listed here a lot of these are surgeons not me but Schenker and Leclerc so within the world of surgery they're recognizing the value of using computer programs to facilitate the informed consent process others um Melul here from France they articulated an urgent need to produce website compliant with international standards for the quality of donor information so um there are a couple other interventions that are being done using the internet I've got an intervention I'm in the middle of doing so it's a promising one and it's promising because I think it serves to um standardize as well as personalize the information disclosure process and by doing so it can provide a delivery that is consistent across all all individuals it can prevent under informing or overwhelming people providing information at a level of detail that is preferred or desired um and enhances patient self-determination by ensuring that people are optimally informed and these kinds of web-based programs can also minimize the potential for fragmentation and education amongst various transplant clinicians or clinicians in general within a given center there's a little bit of a precedent for this in the in the VA system for informed consent and I thank you all for listening it was uh it was really interesting it's the first time seeing this phenomenon of a difference between the risk that's communicated and the risk that's under stood or expressed by uh patients in a clinical setting but you may be aware that there is a literature about this in the research informed consent setting um in which a distinction is made between frequency type probabilities which is a sort of fact about the world um and belief type probabilities which are beliefs people can have and recognizing that there's no necessary connect logical connection between the two so it's logically and chromatically okay for somebody to say I know that 20 percent of people you know are going to have x complication um but I'm sure I'm going I'm 100 sure I'm not going to be one of them now there are two reactions to that one has been that that's okay and people can have this kind of hope Christine Grady for instance has sort of talked about that then there's another school and Lynn you know Lynn Janssen's on this calling it unrealistic optimism which is a cognitive bias that people have so the people who smoke or unrealistically optimistic about their ability to avoid cancer etc and I wondered whether you looked at the transcripts or thought about um the responses in terms of that kind of a an interpretation is this unrealistic optimism is it hope the other possibility is just cognitive dissonance I've already decided to do this therefore um I you know none of these risks can pertain to me and I wondered if you had some sort of sort of psychological interpretation of it that way yeah really good point thank you um you know I thought a little bit about this you know what's going on you know hey wake up you know smell the roses this is a very serious situation so um you know I've tried to think about it from their standpoint you know it's a life and death situation and I think on the one hand you know there um I'm interviewing them two days before their donation so while you know they have all the way up to the point of getting you know anesthesia to back out I think they probably are quite resolved to proceed by that point some people do back out you know at the last minute but not many so in a way I think there is this you know I'm gung-ho I I need to just do it um you know there may be risks but I just have to save my my loved one's life and I think that when I had asked them so why are you donating I mean that was the vast majority of the reason is that you know I have to um I love my mom I love my dad or whoever and I have to save them um you know it may be that there is some cognitive dissonance I I am concerned because you know I work with surgeons and they're telling me they have to understand the risks but I'm not seeing that everyone necessarily does so I'm struggling it it's this so thank you very much very interesting presentation have you ever disqualified someone because you felt they truly had no concept of understanding especially if it's not to a loved one if they're just there to donate because they feel that they're calling um I am not a transplant clinician so I'm I'm not in that um in that position to to make that call but you can make the recommendation after your evaluation of them I'm not involved I was doing research oh okay so my other question is you talked about that four it's been well publicized that four living donors have died during uh the surgery for living donors for livers is that comparable to what goes on in kidneys in the same amount of time the four included kidney and liver but I think oh it included kidney and liver okay I think there might be more than that like five I have to it's really hard to get those news stories actually and some publications will list them but not all but I know for sure there are four I just wondered if that was a reason for people stepping away from living kidney donation you hear a lot about what happens if it's a liver but I just wanted that influence kidney donation at all um I don't have any direct data however you know the transplant center probably shuts down its program after that happens and you know that might have some reverberation you know it it it transforms from my understanding of talking with the surgeons when these things happen and they happen relatively recently that um there's kind of a um a sense of like let's um kind of a cold feet feeling cold feet let's let's quiet down our program let's be extra cautious and um you know not take marginal candidates who are potential donors let's kind of scale back our our efforts and and then build up again hi lisa tiolanda it's nice to meet you in person not over phone so thank you very much that was an excellent talk um just so I can't help but say but we do have to report this nationally to UNOS if there is a donor and you have to report it within 24 hours um otherwise UNOS the government will shut us down so it there is some safety net from the government but my question actually is um yeah have you queried or looked at what we as surgeons think we said and if there's any veracity to what we think we said versus what we really did say really thanks very much you made an important distinction between recall and recognition so I really do wonder what that table would have looked like had you provided the recipient or the donors a list of complications as opposed to ask them to recall it out of memory the the numbers that you gave for the recall is not that far out of line from other studies about research studies where patients in my arena cardiac are asked to recall what the risks are to prepare present participate in research study now that you've completed this study what are your further plans you have recommendations for how to handle a consent differently do you plan to do more studies what are you expecting yeah good always the tough question um so you know um I have this paper almost done as far as written up and in it I've proposed some of the ideas I've suggested here but better comprehensibility of the information provided another thing that I've been thinking about about is not just presenting the risks but talking about the risks in terms of the impact on their lives and I don't think that that's necessarily done so how does it affect me how does it affect my life what will what will my life be like um and and I think that that would help facilitate people's appreciation I mean that's really what it's not just understand I have a 10% chance of blah blah blah but how does that if I were to get blah blah blah how would that affect me and I think that would really help make the message sink in better Eliza I think one conclusion from your data might be that informed consent is working much better than you think it is or that you give it credit for I mean I'm struck by these numbers that you showed of the decline in adult living liver donors from 412 in a decade to 194 and so one one follow-up to the study that you did of 30 patients who were within two days of donating might be to interview 30 patients who had declined to donate and to find out what their recollection was of the risk factors that were given and and how they reached their decision as you pointed out correctly there are so many factors that that patients might invoke to account for their refusing to go forward with the procedure it might not be as clean a study as I envision that it should be but but it would be interesting to know just the difference and recall yeah between those who didn't do it compared to those who did do it okay thank you all right thank you uh so and I don't think we we are unique in the following way but given all the rules and regulations given um the intensity of the focus on ethics most programs that I know of that have at least existed for a while expend a lot of energy in making sure in a very layered way that donors are in fact informed and as a social worker and part of the living donor advocate team that is definitely one of the things that I focus on very intensively in a very lengthy interview that I have with donors it's a question that we ask at the point at which each of us sees the potential donor and the discussion um it's not just about who says what and who heard what but in fact the point you're making is very much the issue that is how does a donor talk about these concerns these issues and interpret those in the light of their own life so that means everything family work well-being psychological issues hopes fears future everything so I just wanted to say that to the best of my knowledge um on the part of myself and my colleagues this is happening so I think your um your presentation was really interesting but I did just want to make the point that I know of many instances certainly where it is more the rule than the exception and to let you know many people are involved in it not just the surgeon and you know the the nephrologist but all of us who play a role it's one of the reasons that the work up is in fact as intensive as it is so thank you sure yes thank you yep definitely it's a team effort as as required by uh cms that's a good thank you