Dr. Christy Cummings - The IPO Framework: A Prequel to Shared Decision-Making in Pediatrics

All right, good morning everyone. It is my distinct pleasure today to introduce Dr. Christy Cummings. Dr. Cummings is the physician scientist and attending the natologist in the Division of Newborn Medicine here at Boston Children's Hospital, an associate professor of pediatrics at Harvard Medical School, and really one of the only NICHD funded ethicists in the country. As an ethics associate, she's a long standing and well-regarded member of the Ethics Advisory Committee at Boston Children's Hospital. She's also the Director of Medical Ethics and Humanities for the Division of Newborn Medicine, an associate program director for the Harvard Neonatal Paranatal Fellowship. As a member of the Boston Children's IRB for seven years, she's also the Chair of the Fetal Therapy Board for the Maternal Fetal Care Center. I first met Dr. Cummings almost five years ago now when I was a fellow here in the Critical Care Department and count myself as one of her trainees. And while she was instrumental in my education for taking care of neonates, she was also instrumental in the way that I think about and approach the compassionate care of our most vulnerable patients. Dr. Cummings' research and scholarly activities focus broadly on medical ethics and humanism and pediatrics and neonatology and the intersection with medical education, counseling, and communication. Recent publications have appeared in pediatrics. The Journal of Pediatrics, AJOB, Hastings Center Report, the Journal of Parentatology and the Journal of Medical Ethics. Her work in her field is not just nationally recognized, but using practice by medical ethics boards around the country. And on top of all of that, Dr. Cummings is the mother of four children and enjoys time with her family, running swimming, reading, and playing a cello. Please help me to welcome Dr. Cummings. Wow, thank you so much. And I packed house, this is amazing. It's really an honor to be here today. I am getting over a cold like many of us, so excuse me if I am losing my voice a little bit. I was here, and it was actually 2018 or 19 when I was here last talking with you. And it was about hope, fostering hope, and compassion and counseling for families requesting long shot therapies and really had to navigate that in a shared decision making process. That's okay, is that you? Oh, you're logging in. Perfect. All right, perfect. We're all good. And so I thought, what else can I share today? So in the meantime, since that cost several years ago, I've done some work on the pre-cooled to share decision making. And so along with one of my amazing mentors and now colleagues, Dr. Mark McHury at Yale, we have come up with the IPO framework. And so hopefully this is something that can be helpful to you as you think about decision making. All right, so I have no conflicts of interest or disclosures. I am supported in part by NICHD for work not related to this talk. And again, I just wanted to acknowledge the incredible mentorship and support from Dr. Mark McHury over at Yale. He had been chief there for several years and still runs their program for biomedical ethics and he's been an amazing friend and mentor. He actually co-authored this piece with me. But there's so many others I need to thank and I will just start right up with acknowledgments and thank them, including Mark. So this take a moment and think, I decided to do away with interactive polls. But think about this. When would you offer to perform a particular surgery or intervention? How would you decide whether or not to offer this to a family? Right? So we're taking a step back from share decision making and thinking about even offering something to a family. And I've come up some examples that hopefully are relevant and thank you, Patrick and Aaron, for going through with me some of these to get more relevant examples out of NICU. So consider, would you offer a laparotomy for suspected abdominal compartment syndrome in a child with palliated single ventricle complex congenital heart disease also with multi organ system failure? Would you offer that laparotomy for this family? Would you offer surgery for a full-term infant with a postnatal diagnosis of EATF and features of Trisomy 21 on exam? Would you offer that? What if it was Trisomy 13 on exam? Would you offer ECMO for a three-day old full-term infant with mcconey-maspiration syndrome, severe PPHN, OY, definitely needs criteria and they also have severe HIE. So severe neurologic injury from hypoxic, eczema and cephalopathy. Would you offer ECMO in that instance? As you think about some of these, some of these you might think in a flash absolutely, of course, no question or conversely, no way, absolutely not. Others might say, well, I'm actually not sure what I do. I do need a little more context and yes, these little case spiny-its are not having a lot of detail included partly on purpose to get through the talk and make some points. But think about these. Would you offer palliative debulking surgery for an adolescent with terminal cancer? And is in severe pain? And would you offer that? I think it depends on where the debulking would be. Is it around a essential vessel, for example, that would make it particularly risky or not? Would you offer fetus, prenaturally do a family with a fetus with congenital cyphragmatic hernia? Would you offer ECPR for an arrest of unknown etiology in an adolescent undergoing chemotherapy for a metastatic cancer? Some of these you have more time to think how there's no. Would you offer a lung biopsy for a diagnostic purposes in a child after bone marrow transplant? Complicated with neutropenia, quagulopathy, breast fur failure, and now lung lesions of unclear etiology? Would you offer that lung biopsy to this family? Would you offer a lung transplant for six-month-old, 23-week infant, who's now? Course is complicated with severe bronchopelomer dysplasia, has a trache in T-tube, and yet is too unstable to go to a rehabilitation facility, really not able to leave the hospital. Would you consider an HD catheter an infant with acute renal failure, but has multiple comorbidities, potentially even a genetic diagnosis? So, that's really just to get started. So hopefully today what we'll do is we'll start at the end, right, the easy stuff, the shared decision making. We'll quickly review that, and then we're going to take a step back and talk about clinical decision making. We'll identify some limitations in clinical decision making, and then introduce this novel framework, the IPO framework, for critical decision making, which I liken to a prequel to shared decision making, right? How do you even think about what to offer before you get to shared decision making with families? And we'll try to apply that quickly to several cases that might be relevant, and I'm happy to take questions to throughout. So, we'll start at the end, shared decision making, ethics and principles. So shared decision making and pediatrics is pretty much well established and accepted and supported by multiple professional societies, but it wasn't always this way. You can see that we've started, you know, back in the 60s, 70s, especially in the United States, there's really more of an approach of a paternalistic approach. Moved more, the pendulum swung more towards autonomy, parental authority, often leaving families to make a decision without a lot of support from us. And now we've swung back towards the middle and have really centered on shared decision making. And the AP has put out several statements to the American Academy of Pediatrics, as well as other professional societies, supporting the use of shared decision making in pediatrics when there's more than one medically reasonable or ethically permissible option, giving parents wide latitude to decide what's best for their child with our support. And so you can see these other frameworks that have been implemented beforehand. You can see the informative role where we really are just experts and we're providing information in the interpreter role where physicians in the past were more active in the account for it. To the paternalistic, which we just mentioned. We often make decisions for families without actually including them in that decision making. And then really deliverable. And so the word of is more similar to the current shared decision making model. But again, here, paternalistic, I decide for you, formative. I just give you the facts on what you decide interpretive. I give you the facts to help clarify your preferences. And then deliver the initiative and tell you my preferences and recommendations. And so we've moved really into a shared decision making model when there is more than one medically reasonable option or ethically permissible option. This is another framework that's now several years old that can be really helpful. And after you decide that there are multiple options that are ethically permissible, how to embark on best practices for shared decision making. And you can clearly see what's not shown over here. You know, visually not one that's option, then you don't embark on shared decision making. You just make that decision, right? So shared decision making, there's been a lot of literature on this in pediatrics and how to best approach this. And there's been some consensus recommendations. And this does incorporate ethics. And so I will refresh your memory without four principles, which is really the foundation of medical ethics. So we have the respect for autonomy, which forms the basis for informed consent, beneficence, which is doing good, non-molefacence avoiding harm and justice. So treating like persons similarly or similar cases similarly, and then on a macro level or institutional level, thinking about resource allocation, for example, of scarce goods, and appropriate or just distribution of those. But there's so many other ethical frameworks that we can use and we should be aware of. And we'll not go into them for the purposes of this talk. They could be separate talks. But I also love to incorporate feminist ethics, narrative ethics, trauma-informed ethics, which are amazing synergistic frameworks that can be used in conjunction with the four principles. So what are the rights of those involved, of the stakeholders in these decisions? And I will summarize this again. So we can get to the meaty stuff. But the rights of the infant or child or adolescent in pediatrics includes the right to life, the right to beneficial and just treatment, the right to be free from suffering and pain, and that includes the right to mercy when a proposed treatment is actually not going to achieve the goals and might do more harm than good. We have the parents and they have the right to make decisions on behalf of their child, typically those of the surrogate decision-makers in pediatrics unless there's a guardian or other court appointed decision-maker for them. They have the right to make decisions, but in order to do so, they have the right to accurate information from us, from the clinicians. And they have the right to guide in to support along the way, along the journey of decision-making. And there are some limits to this parental rights and parental authority, right? They have to make decisions in the best interests of their child and below some thresholds, the harm thresholds, we might intervene if we think that might not be what's best for the child. And so the medical team, the clinical team, has the duty to the patient first and foremost, but in pediatrics, we also recognize that they're a part of a family. We have the right to, we must respect parental authority within limits, but it's also our duty to communicate information in a way that families can understand that there's a decision to be made and to understand their values, understand their perspectives, to help support them in this decision-making and provide recommendations along support and compassion. So I mentioned the best interest standard. This really is the ethical requirement that people who care for others, like parents or other surrogate decision-makers for children, will do so in good faith, placing their assessment of that person's best interests above their own, right? That's the fiduciary relationship we have as clinicians. Parents, we've all agreed in society that parents determine the highest problem and net are maximal benefit among the available options. And I love this scheme of hearing, because you can see that with certain decisions, that this is, there's a policing certain need out. Oh, it's all right, I'll start with you. That's okay, here you can see over here, that there's, this graph shows that there's increasing certainty for treatment that is in the child's best interests. But below there, the black box, there's really increasing certainty that the treatment is not in a child's best interest. And so there are these thresholds where we talk about the gray zone that falls in the middle of these, where it's actually really not clear what's in the child's best interest and there's multiple ethically permissible options. And that's where we need to engage and share decision making with families. And so the harm principle is, I think, a nice color alert to the best interest standard, where this focus is first on whether the child will be harmed. If the parents wishes were followed, not in what is optimal for the child, right? So we have this ideal here, which we think parents must adhere to. But usually there's a range. Even if we as clinicians might not think that's optimal choice, it's still within the range of permissible options. And so we realize that there's this morally significant gap between what's optimal and what's best. And then down there, like I mentioned before, what will cause harm, that's harm threshold. And so we accord appropriate moral weight to parents as decision makers, as long as they don't fall below that harm thresholds. Right? So we call the zone of parental discretion, right? Where we have the best interest standard, this optimal decision, giving parents wide latitude, though, to decide among ethically permissible options in a shared decision making model. But if they fall below that harm threshold, then we might intervene. We must intervene. And so the zone of parental discretion provides this really clear, practical approach to operate operationalizing the harm principle and to help guide ethical decision making when there might be disagreement between parents and clinicians about what's the best treatment for a child. Okay. So shared decision making, just to summarize, there's a lot of literature written about this. You should be familiar with it. Parents should have wide but not unlimited discretion to make decisions for their children when there are decisions. Parents should protect and promote the best interests of their child while balancing other interests. And clinicians should really collaborate in a shared decision making process. I'm skipping to number six to promote the child's best interests. Okay. So there's lots of algorithms to really put this into practice. How do we operationalize the shared decision making model? There's a couple of different frameworks that you can use and helpful language that can be used as well. So this is just one of them drawing on some work from Lantos and myself. And you can see that it's an iterative process when there's time to really understand parents' personal values, perspectives, goals if the child is a decision-making capacity. For example, I can add a lesson. They are able to participate in this decision-making process and move towards a shared decision. You know that some parents and families, however, vary with their preferences about the degree of involvement in the shared decision-making, right? So some parents actually just want us to make all of this decision and not be burdened by that decision. And that's okay. Other families really want to have a much more active role in the decision. They want the facts. They want us to be there, but they really want to be left to make that decision alone. And so, and then the majority of families, though, do want to have a more collaborative decision-making role. But we won't know which families fall outside of that bell curve and want to have either all or none of the decision-making burden unless we ask. And it's really important. We shouldn't assume that all parents want to engage in shared decision-making. And so we do actually need to do better job of asking families, how do you like to make your decisions? How can we best help you give some examples to know what's accepted and what's normal without having parents guessing? And so this is another example of this shared decision-making continuum, right? So on the top here, it's 100% patient or surrogate decision-maker driven, all the way down to position driven, right? When you're really kind of leaving the world of shared decision-making and with families consented and input, letting them know that you're going to be making the decision and that's what they prefer. And so really, if you back it up a step before shared decision-making, now we're talking about clinical decision-making, right? So I'm just going to briefly highlight some of those points. We know that this is now, we as clinicians have determined that the next-sex option is clear that there's really not more than one medically reasonable or ethically permissible option. So shared decision-making is not indicated. We're exiting this algorithm already. So what is clinical decision-making, right? So for most clinicians, this judgment is based on the understanding of the patient, the context, the physiology, the disease process. We learn this in medical school, in training, fellowship, and as faculty. And we have a lot of support systems in place to help us with this type of clinical decision-making, right? We have protocols, policies, algorithms. We have clinical decision support systems. We even have calculators, right? We can plug into calculators, for example, a billi-rubin tool, plug in some data, and say, all right, does this infant require phototherapy or not based on the best updated practice guidelines? It's quite helpful, right? And so we can use our clinical judgment, though, to adhere or to deviate from some of these policies, because we have, unlike AI, we have the capacity to really take into context the entire clinical picture. So we might decide there's sufficient justification or rationale to it either adhere or deviate from these protocols that we've set forth. So key elements of the clinical reasoning and decision-making, we have to understand the patient's story. We've got to know the data. We have to understand and come up with a hypothesis of what might be going on. That's where this illness script comes into play. We learn this in medical school, and we try to put things into categories or buckets, so we can help quickly identify a problem, come up with a differential, and then come up with potential treatments, right? So that coming up with a diagnosis or a suggested treatment or a therapy. And so you may have heard, you know, thinking fast, thinking slow, there's something called the dual process theory whenever we make a decision, okay? And so there's system one. This in terms of our prehistoric past tells us to either run the other way when we see, for example, danger, a saber-toothed tiger, and this is rapid. It's intuitive. It's unconscious. So sometimes that can use here a six that are mental shortcuts to get us through quickly. We recognize these patterns that we've learned in training, and we haven't illness script, like what we might expect, right? This allows us to make a rapid, quick decisions. System two is a more deliberate, slower analytical, rational type of decision-making. It's conscious, it's effortful. You have to slow down, think a little bit, think a little bit, realize that this pattern might be a bit atypical. You need to do a little bit more thinking here to not have premature closure on the diagnosis, the differential, and lead down the wrong path, for example, with your suggested treatments and therapies. And so experienced clinicians typically will use the system one thinking, right? We know this. You've got this. And you match the illness characteristics to those patterns that you've seen before, and those are reinforced through years of experience. But sometimes we take mental shortcuts and use system two that can lead to poor decisions when we're really, sorry, in use system one that can take shortcuts and when we really should have used system two. Okay. So here are the risks I mentioned this. So what is it? It's really just a mental shortcut that allows us to solve problems and make judgments quickly and efficiently. We do this all the time in surgery, in the ICU, and sometimes quick, efficient decisions are necessary, right? We have no time to deliberate. This can shorten our decision making time and allow us to function without constantly stopping to think about the next course of action and lose critical time. But there's limitations here, right? So we have biases. And so sometimes these can play into our quick decision making, right? Anchoring, biopsy, the availability bias, I'll just highlight on some of these, right? The availability bias is where you judge things because you've just recently encountered this. And so it's more recently available in your memory. You just saw a case like this. So this next case must be like this, right? So you're using that bias as a heristic mental shortcut to come up with the potential diagnosis because you've just seen it. That can get to another bias called premature disclosure, sorry, premature closure, which I just mentioned, where you, your decision making process, like process one is, is ends too soon. You diagnosis is confirmed and accepted before it's been fully verified and you haven't had time to really explore, maybe this is not the only script that I was thinking that I've gone down the wrong path. This is just a schema of the knowledge script that we rely on when we are thinking fast. And it can be really helpful in many cases, but again, can have some limitations. Another bias is the confirmation bias. So it's really not sticking out all the facts, all the data. It's really just supporting what you already believe and coming to support and uphold that conclusion. And so it ignores information that might challenge your beliefs, potentially maybe new data that you're not up to date on. And so this is a really important one that we're going to actually get back to later on. So it's important when you're making a decision, even if it needs to be quick, that you take a little bit of a diagnostic or therapeutic time out. And pause and say, all right, I'm using system one right now to have time to actually, and should I think about system two, because I'm recognizing this is a bit more of a complex decision to make, right? So again, we are embarking down clinical decision making and before we get to share decision making. So the question is, should I offer this therapy to this family? And I think with some of the vignettes that I mentioned right in the very beginning, you might have had a quick reaction, absolutely not, or absolutely, or maybe I'm not sure. And I think that these clinical vignettes hopefully cause you to think about why or why not. You might offer this to a family and what's the rationale behind this. Of course, with all of these more complex decisions, the reason why some of them are so hard is because of the uncertainty that goes into this. So as I mentioned, Dr. Mark McHurray always mentioned good ethics begins with good data. You have to know the data. You have to be current. You can't be referencing our understanding data that's either isolated to your own institution or like a decade old. So a tool, Guandese quote, medicines, ground status uncertainty and wisdom for both patients and doctors is defined by how one copes with it. So you might think that there's a couple of different options, but which ones do I present to the family to engage in shared decision making? Is this even appropriate for the family? So how do you decide which diagnostic treatments or therapies to even offer to patients and families? Do you have a structured approach? And I would suggest if not that could lead to variation from case to case and potentially be problematic. And so this is where we have introduced the IPO framework, the impermissible, permissible and obligatory framework to help with some of these critical decisions that occur before you get to the stage of shared decision making. Hopefully I've set the stage there. Are there any questions now? Okay. So I think that the biggest need for this came up when we realized that many of the ethical conundrums and conflicts that we see in pediatrics actually arise from a lack of clarity about whether parents have the ability or the authority to decide and meaning whether we should offer it and even engage in the shared decision making. And so really in thinking about these clinical decisions, justice and fairness can be really helped by having a clear and consistent approach. And so this is what this framework aims to do. I will say that there's a caveat with this framework, right? This is not a billy-rooven calculator or an early onset, stepsist calculator where you can plug in data and get an answer. I wish that were the case, but it's not just that easy. There is some ethical, left and hard work that you still need to do in order to use this framework. Okay. And so we'll go into that. At least to provide a clear and consistent approach to do so fairly and justly. All right. So the conceptual model. So every medical intervention, whether it's diagnostic or therapeutic, can be considered either ethically impermissible or obligatory. All right. And so this is the zone of ethical permissibility. So if it's ethically impermissible, right on this far side, then it really should not be offered. It should not be done, even if requested by informed parents. If on the other side on the far right, if it's ethically obligatory, then it should be provided by the clinical team, even if the parents reject or object to this. And that this is where it can be difficult if parents decline, then you may need to engage in further discussions and communication with them or even obtain court order to proceed if this is really in the child's best interest. So then this is the typical part that central zone where the decision or the proposed therapy or diagnostic treatment is ethically permissible, right? And so this is where it's it could be ethically permissible. There's a range of options and the proposed treatment, though within that could be a subset of we think it's permissible, but we might not advise it in this case due to XYZ factor. Or we think it's actually advisable given what we know about patients' unique clinical circumstances and preferences. Or we might be neutral about it. But regardless, this is ethically permissible. And now this is the zone where you've determined it's permissible. There might be more than one option and you need to engage in shared decision making. In this zone, I'll just add that parent physicians should give their recommendations and it's okay to give the recommendations, but should not restrict parental choice. Again, giving parents wide latitude to make that choice that aligns with their perspectives and goals. All right. So within this conceptual model in order to determine where in the spectrum of proposed treatment or surgical option might be, we think about several factors and those are prognosis, feasibility and relevant rights. And so we'll go through each of these briefly before applying them. So prognosis. So if the prognosis with the treatment is significantly better than without considering all the options, this suggests that the treatment should be seen as a obligatory. If the prognosis would be clearly worse, it should be impermissible. And so assessment of prognosis needs to take into consideration all of the potential benefits and harms to the child, including uncertainty about this proposed treatment, the likelihood of doing good and the clinical importance. So we have to know the medical facts and the data. Sometimes this means a deep dive into the literature. Sometimes this means consultation with other colleagues or even other institutions to get the medical facts. Some treatments would clearly benefit a patient, but then negative consequences of providing them are not sufficient enough to frame them as a obligatory or to justify overriding parental choice. Assessment of prognosis also includes consideration of both the short term and the long term benefits and risks. And again, requires a current understanding of the relevant current data. Let's see. It's important to note that valid ethical reasoning, right, using the right frameworks and principles, might actually lead to incorrect rationale or incorrect premises because of using incorrect or outdated data. Again, good ethics starts with good data. The obligation there is on us to seek the most and best current data, consider the weaknesses or limitations of the data. And as new data become available, a treatment can move on this spectrum, right? So this is a dynamic process. So we talk about emerging technologies or emerging innovations. So where on the spectrum is that new technology? It could start out as being impermissible. Really, there's not enough preclinical research or data to support its use in clinical practice, or it might be permissible only in the context of research, right, like potentially fetal, right, for CDH that could be ethically permissible in the context of a really well-designed clinical trial, or it might be obligatory, right? It's now become an accepted standard of care practice with sufficient data on outcomes, both short and long term. Okay. So if the proposed intervention has moved on this zone of ethical permissibility, it's important to recognize me, there's a paradigm shift going on. All right, the second factor to consider in determining where on this spectrum your proposed treatment might be is feasibility. And so we know that the ethical added ought implies can, rightly suggest that one cannot be obligated to do something that we're really just incapable of doing. So feasibility is the second factor here in locating where you are on this spectrum. Non-feasible options can't be obligatory. So if it can't be done, it can't work. We can't be obligated to provide it. And so thinking, would this achieve the desired benefit? And whose desired benefits, right, is it the clinical team, is that the parents, what are the goals? And so we really need to make sure that we remain objective and unbiased and neutral when thinking about this and placing the patient in the family in the forefront of desired goals. And I want to just take a moment as a side step talking about futility, right? Because when I say feasible, I do not mean futility. And this is really important in ethics. Many ethicists have sort of jettisoned the word futility from their vernacular. I think with good cause, there's been a lot of debate about this in the literature and selfs take a short pause to talk about that. So the word futile derives from the Latin, which means leaky. And there's the Greek myth from the 90s talking about the 50 daughters who killed their husbands on their wedding nights. And we're then condemned to hate these to fill these water jugs to fill a basin that had holes in it for forever. And so this was their punishment. And so this was sort of the myth of deniities that describes futility. And so hence, leaky vessel. And so we can see this term dating back to hypocrites as well. Whenever the illness is too strong for available remedies, the physician surely must not expect that it can be overcome by medicine to attempt futile treatment as to display ignorance that is allied to madness. So really here, it's really in-cute producing the desired effect, achieving nothing. And so when we talk about futility in medicine, we really need to talk strictly about its narrow definition, the physiologic definition of futility, where it's really not going to achieve the pure physiologic effects that we want. The best example I can give of this is CPR in a dying patient. CPR in a dying patient is physiologically futile. It will not reverse the dying process. However, over years, we clinicians have used or adopted this term to really describe a treatment that we think might be futile because we think it might be inappropriate or useless based on our own values and priorities. And so I'll quote here the notion of futility generally fails to provide an ethical coherent ground for eliminating life-sustaining treatment, except in circumstances in which narrowly defined physiologic futility can be plausibly invoked, right, CPR. Futility has been conceptualized as an objective and to the independent of the patient or surgeon's perspective, differences in values and the variable probabilities of clinical outcomes undermine its basis. Assertions of futility may camouflage judgments of comparative worth, their implicit endubits about the allocation of resources. In short, the problem with futility is that the promise of objectivity can rarely be fulfilled. The rapid advance of language of futility into the jargon of bioethics should be followed by an equally rapid retreat. And this was written decades ago. And so we've really replaced this now with the more recent, this actually over 10 years old, almost 10 years old. We've replaced futility with potentially inappropriate treatment. And this is the ATS response for ICU care. And it's helped revise and revamp many policies from ethics committees around institutions around the country and replacing futility with potentially inappropriate treatment to expand this notion. And so really one of the questions is, can the physiologic goals can be achieved with medical treatments? And if no, then that's physiologically futile and ethically impermissible, we should not offer or provide this. They offer in this ATS statement questions to help illuminate this, especially when these situations are time sensitive as they often are. And my certain request to treatment is outside the boundaries of accepted practice. Would I be willing to have my rationale publicly reviewed, for example? What are the consequences? And am I sure that there's not biases or other factors playing a role into my decision here, which I think is helpful to remember? So back to futility, sorry, back to feasibility and not futility. Again, is it going to achieve the desired benefit? Is this resource even available, for example? In this change during pandemic, this has changed now with subsequent shortages of resources, both medication as well as product you've probably noticed in the OR. We certainly have an ICU. Is it a scarce resource that must be reconciled with? And if there is an option, but not potentially available at your own institution for whatever reason, because of scarce resources or you're not a center of excellence, is it available at another institution? So if that's the case, is transfer feasible, is transfer possible? Is the patient clinically stable or not to consider transfer? If the patient would die on route, then that's not a feasible option and should not be offered to families. It's okay to discuss that and acknowledge that, but should be offered. We've already talked about principles and rights. And so we've already talked about the rights of the newborn and the family or adolescent in older pediatrics, as well as the rights of the community and society, particularly in the instance of limited resources. What are the obligations of the clinical team, right? The onus is on us to have most current data and information and resources to make these decisions. In some instances though, I will talk about how, and I mentioned this before, there could be a paradigm shift, right? And so though prognosis, feasibility, and relevant rights, and ethical principles should determine the location on the IP spectrum of your proposed intervention, and another potential determinant worthy of consideration are attitudes. And so we know that there can be shifting attitudes with time over certain technologies, societal values, perspectives on disability, and quality of life. And so we need to acknowledge those. For example, take into consideration EA repair or ECMO for newborns with respiratory failure for infants with trisomy 21. This certainly has shifted in decades. And I'll come to another case example a little bit later on that reflects that, right? And so this is really important to think has there been a paradigm shift, or have attitudes changed really? And that might be the case for potential therapy that you're considering. There are other biases that we need to think about, and particular attitudes about disability and perceived quality of life. And we're cautioned to make sure that we, as we figure out what we might make available to parents and what we might offer to them, it's not clouded by our own biases and judgments. And so again, referencing some of these biases that we could be running up against and important to acknowledge and mitigate them as able. Unconscious bias can lead to message framing, right? Like when we do talk to families, have you already determined what you think is best for this infant or child? It's the way that we counsel can affect decision making, right? So being careful when talking to families and not just talking about mortality statistics, but potentially survival statistics, not just talking about potential disability, but also talking about potential ability, right? Framing the strengths and negatives, framing the harms and the risks with the potential good. I think it's really important to make sure we have neutral counseling when there really is a choice to be made. And thinking about going to this, have you already decided? Do you already think you know the answer before really fully exploring the data as well as your own biases? So it's also important to recognize that this process is dynamic. So outcomes data, feasibility, prognosis can change. And this might be more difficult for some, more experienced clinicians. And they might have difficult in accepting a treatment movement along the spectrum. Perhaps one that has gone from being impermissible to now permissible and actually even to now obligatory. And so I think that's important to recognize this that there's cognitive dissonance potentially that could happen and that to accept a movement or shift along this line could suggest that in the past one is acted unethically, right? Like well, we never offered this before. I think about all those families who didn't get this potential benefit. But I really, you have to realize that, you know, to analyze that such would be detrimental to the decision making process and forward movement and forward discovery, right? So we need to recognize that without flexibility and willingness to adjust our own clinical practice that medical and moral progress are not possible. So we should give ourselves that grace and flexibility. I will say that in our original paper, which is now of many years old, we actually called this, this was Mark's term, moral arthritis. And whenever he gave this talk, that was fine. I mean, he's more senior than I am. I've given this talk several times. Whenever I have given this talk, one of the audience questions has always been a critique about the turmoil arthritis, which I think is actually fascinating about the biases that go into that. But I will say I actually have arthritis and, you know, I have not come up with that. And so there's so many layers of biases that we hold. But anyway, we've changed this to moral inflexibility. If you go back and read the original paper, you'll know that it has that outdated, probably less PC term. So apologies for that. So now, how do we apply this in practice? So I think you need to identify that a decision is needed before you get to share a decision making about whether to even offer this to a family or not. Is this appropriate? And this could be a therapy, a surgical therapy or diagnostic treatment. And really determine the prognosis within without the proposed intervention, determine again prognosis, feasibility, relevant rights, consider our clinical attitudes. And if there's been a paradigm shift that has caused potentially the treatment to shift on the spectrum and might there be biases involved, for example, and then to try to locate, again, the difficult work, locate the position on the spectrum. And if you think this is ethically permissible, right, then engage in shared decision making with families. If you think it's ethically impermissible or on the other end ethically obligatory, you just need to inform the family of the plan and have a really transparent discussion with them. And this actually gets into informed consent and permissibility. So we need to respect the patient or the parental rights and obligations within informed consent, again, needing to stay abreast of all emerging data. And if really there are more than one ethically permissible option, we do need to discuss those. Again, even if it's not available at our own institution, to make sure that they're aware that it might be available at other institutions if it's transfer is feasible. And then it's okay to actually make recommendations. Families do want our opinions. We have the expertise. And it's all right and ask families would you like to know what I think? Would it be all right if I offered my recommendation families? Welcome that. And again, ask them how much involvement they want with their decision from us. All right, so putting this into practice, just summarized there. And I've taken a couple of examples to quickly talk about. We have some time. And so I did mention this. This is more of a historical case. You might some of you recognize an infant with tri-somy 21 with suffigy letries, and whether repair is ethically permissible, impermissible or obligatory. There's a lot of other potential dilemmas here that we won't of course have time to get into all of them, but just to give you an example. I'm sure you have others and I'd love to talk about those. So surgery for an infant with suffigy letriesia and suspected tri-somy 21, right? This actually you might recognize this case goes back to the case of baby doe in the 1980s, who was born with Down syndrome. The obstetrician said there was only a 50% chance of survival at that time, even if the surgery were successful. And that the child would remain, quote, severely retarded face a lifetime of medical treatment, disability, and dependency. And the obstetrician advised the parents to withhold treatment and let the child die of the birth defect. However, two other doctors at the institution, the pediatrician and the family physician, disagreed with OB's assessment and called for immediate surgery. Parents ultimately decided they did not want it to pursue treatment. And then the hospital initiated legal proceedings to override the parental decision, maskable attorney, including one who was represented in the couple that was prepared to adopt this baby, went to court to have him declared a neglected child under Indiana's child in the U.S. Services Statute and have a court order medical surgery. The Indiana courts ruled that there was no violation of the statute and parents confronted with contradictory medical opinions at the time had the right to decide the fate of their child. And thus baby doe died at six days of life of dehydration and pneumonia complications of untreated EA before the U.S. Supreme Court could hear the case and appeal. The surgeon general at the time actually was Dr. Everett Toup, who has a amazing, I don't know if you're familiar with him probably us or have known him. He had an amazing career decades at CHOP as a pediatric surgeon and then later as surgeon general and contribute widely to public health in the United States. And in, you know, from smoking cessation to supporting rights of children, particularly those with disabilities into HIV and AIDS. And so his career was really remarkable. He at the time was surgeon general and argued that the infant was denied treatment due to disability. And this also like triggered a fierce controversy over the rights of infants with congenital birth defects, to medical treatment as well as over the right of government to intervene in the relationship between doctors and patients in decisions by parents and the future of their children. And so ultimately in the aftermath of this, there was a Department of Health and Human Services notice to healthcare providers, states receiving federal money for child abuse programs, must have procedures to respond for the report of medical neglect. And in this instance, including potentially disabled infants with life threatening conditions. So they set up a handicap taught line. I don't know if anyone was in training at this time, but these are the notices were posted in delivery rooms and required them to be posted in delivery rooms, maternity words, nurseries, and nicoes, and it authorized intervention for investigation of any possible breach. So this is what that looked like. There was a response to the surgeon general, Dr. Cooper, actually from residents at Cha, pediatric residents that really called a, that found wrongdoing in these regulations, and I will quote here. The issue in our experience has never involved the decisions as whether to support an otherwise stable handicap child, but rather the long thoughtful decisions made jointly by physicians, nurses, parents, and social workers, and clergy, of when not to prolong the life of a desperately child with little chance of leading anything close to normal life. We would welcome the formation of formal biothics committee, which proposed by the AAP would provide a more reason stepwise course and guidelines for the human resolution ofethically complex situations, which was done. And so these baby dough regulations are amendment. You'll still hear about today. And they don't apply, though, however, when the infant is deemed to be chronically irversically comatose, when this treatment would really just prolong the dying or otherwise be again, I'll say futile. This was back in 1980s. And so this case, I think is important for clinicians and particularly surgeons to know about because now, you know, this reflects the shifting societal values and perspectives. We place on those with disability, particularly tricellum 21. So many would argue right now that, you know, back then it was, it was okay to not pursue treatment at the time, but today that really that that would be impermissible in that the surgery now in this context would be obligatory. And I have to have to mention too, we're not really talking about long gap here, which is a separate, separate entity. But really, we have to consider clinician attitudes here and how those might have changed over time, right? Because back then, you know, coop was performing these surgeries back then with nearly 100% success rates. And so, you know, what has changed over time really has not been the surgical approach. What has changed is our attitudes in society towards infants with with underlying genetic conditions, including tricellum 21. So now I'm going to throw out there. Well, what about if it's expected tricellum 13? What about other genetic conditions? Right? And so we might say the same thing for ECMO, right? And so there's a lot of debate in the literature about patient selection for ECMO. Would you offer ECMO for a patient with suspected genetic syndrome? And this was co-authored by Macario and others back at Yale in 2009. Really looking at once patient criteria was met versus severity of illness, how clinicians thought about whether to offer ECMO or not based on other factors. And this took into account all their clinical factors, but then potentially other biases that we have about prognosis and and long and long-term outcomes and potential for disability. Right? And so you can see there was wide variation where their clinicians would offer ECMO to infants or children with these various conditions. And that variation suggested potentially some investigation is needed as to why there's such variation. More recent data suggests that outcomes and patients with tricellum 13 actually come, although complications are frequent in this one study, they noted that the mortality rate for these patients tricellum 13 and 18 remain within the reported range for general pediatric population. So that tricellum 13 and 18 shouldn't be viewed as an absolute contraindication, but rarely really considered during the entire evaluation for the potential candidacy of ECMO, which I thought was interesting. There's another more recent paper that's also come out unsuspected, new, and adult genetic diagnoses and ECMO and that, you know, while in some cases it may not be ethically permissible to offer in other cases, it might offer time for the family to achieve a genetic diagnosis. And then to withdraw the life-sustaining treatments and make a more informed decision and so it could be helpful as a bridge to diagnosis to allow that time. So something just to consider as our capabilities with genetic diagnoses and rapid diagnosis change, but also the timeframe with which we might need to make some of these decisions. So, you know, an infant with tricellum 13 who meets severity of illness criteria for ECMO, this might be ethically permissible. And again, these are short clinical vignettes and each one will be unique and need to be tailored for that decision. A couple of minutes, right? I'll do a couple more. What about lung transplant for an infant who's now several months old in our NICU born at 22 weeks with severe BPD, right? Should we offer a lung transplant in this case? This has come up fairly recently. And is the patient even a candidate? Are there outcomes good enough in the infant or neonatal population? What about wait times on wait list or mortality and wait list? Is there a hidden mortality there? You know, we couldn't remember a success for the past decade here. Is there a bias there? Are we even a center of excellence for this? If not, is transfer feasible? If we consult the transplant team for an evaluation that could potentially be viewable and open notes with the parents see that and then ask if they are a candidate? Are we obligated to offer this? Even if we don't agree is a clinical team? What are some of the longer term outcomes? Like these questions have all come up and were real? A year or so ago? If the candidate isn't sorry, if the patient turns up to not be a candidate, have we caused further harm by fostering false hope? And what are the parental perspectives here? And so here we needed to really take a time out and think, what are the data? Can we go back to apply this to our framework and actually get better data about out long and short term short term outcomes in this patient population? You know, looking at the registries, looking at more recent data, acknowledging some of the limitations in the data. This was more for older children. And the time of listing was 21 years, so not really relevant to our population, was there more relevant data that could be helpful? Did it matter if there was a center of excellence or not? And some of the literature suggested that yes, the effective center volume and expertise does matter and have an outcome and pediatric long transplant. Right, so taking our biases into account and some of the relevant data would it be okay to offer this into certain context? And you know, the answer might be yes, it might be permissible depending on the clinical context, but it shouldn't be a blanket. Oh, no, of course not. That outcomes are so poor. We shouldn't even offer this to this family. And so I think this was opening for our team a little while back. All right, what about laparadomy for suspected abdominal compartment syndrome in a child with palliative single ventricle with complex congenital heart disease. And now with multi system organ failure, right? So again, going through our framework, really trying to figure out what are the medical facts? What is the most current data? Is this even feasible? Right? Would the interoperative mortality rate be so high that this would not achieve the desired outcome? What are the outcomes here and trying to even propose this? And what are the relevant rights of the child? What about the right to mercy or dignity? So I think that would be all needed to be examined and again, case by case, I'm not saying that blanket statements for the use clinical vignettes. They should all be yes or no just to include more clinical details to help guide that decision making. Right? So maybe in one particular case, you might determine that the risk is too high and would not achieve the desired outcome. And that this should not be offered to a family. And another instance that might be deemed that would be ethically permissible, but potentially in advisable, right? We strongly recommend against, but if the parents really want to, if they're informed, we might do it. Right? So then now you're moved into the ethically permissible, but we advise against it, but we still are going to do it if they really do want it. So I think that with each clinical vignette we're able to, I think the easier ones to anchor are the ones that are really ethically obligatory. I'm just giving some examples here. The ones that might be ethically impermissible. And then the ones in the middle that need to embark and share decision making sometimes are the most difficult. And you can see there's some that cross categories depending on the clinical context, right? So for example, Fito might be permissible only in the setting of a well established clinical trial. So just to summarize, when considering a proposed surgical zero peer intervention, clinicians should consider the relevant facts, the most current data, as well as uncertainty that involves in this and be humble about that. In order to place the proposed therapy on the IPO spectrum, we need to recognize there might be a possible paradigm shift. We also need to remember that even though we think it might be ethically permissible, the treatment might not be available. There might be scarce resources or drug shortage, for example, that affects that or the transfer might not be feasible because of patient condition or stability. We need to keep in mind the ethical principles, the relevant rights and obligation of our patients, our parents, the surrogate decision makers, and the extended family, if relevant, as well as our clinical team. We should recognize that we do have unconscious biases and we need to acknowledge those and attempt to mitigate them. And really come to grips with the fact that the longer we've been practicing, we might experience a cognitive dissonance or even a moral and flexibility as some treatment shift on the spectrum, either becoming now obligatory that we're once impermissible or even the reverse, once now accepted practice actually is no longer the case. And so I think these decisions time allowing do shouldn't be made alone in a silo. These are complex and really use your resources, right? So discuss with your colleagues, discuss with consulting services, get a second opinion if time allows it in another hospital, and then really try to make use of our ethics advisory committee. We really are here for you in order to help make the best decisions possible and that includes potential therapies and went to offer them to families before we get to the stage of shared decision making. So thank you so much. Just to take a home, a takeaway point, how might your approach to clinical decision making change going forward after hearing this talk and think about your own practice? And I'm happy to take questions. Thank you. Well, Dr. Cummings, thank you so much for this informative talk and also I'd be remiss to not thank you for your involvement involving an important leadership institution as well as your national presence in helping us think through these really important essential, but challenging approaches. We are out of time, but I do want to see if there's one or two questions in. I think one of the things that I struggle with is that all of our interventions cause harm to one degree or another on one into the spectrum. It's just pain and on the other end of the spectrum, it is potentially hastening or even causing death. And so as an extreme example, I don't think that I could ever be obligated to kill someone and collect their organs in order to save somebody else. But there's this whole great area where all of our interventions cause harm. And so how do you fit into the framework? Our obligation to cause harm to help somebody else? Yeah, absolutely. That's a great question. And I think that if you think about the four principles, we're always balancing those and none of those come first right. The respect for autonomy or informed consent. Our obligation to beneficence doing good, but also non-molephicence avoiding harm. We know that all of our potential therapies will cause some type of harm and that just needs to be balanced by the potential, the real potential for causing good and whether that outweighs that. And so that definitely is going to be a difficult calculus, particularly in these discussions. But I think that talking with other colleagues about the potential benefit and potential harm, hopefully we'll be able to clarify where you are in that scale and whether that tips you in favor of proceeding with the offering that treatment. If you really think that there could be more net good than than harm. Thank you so much. So many questions and there's going to say that this is what I think keeps many of us up at night. This is the stuff that drew many of us, I think to pediatric surgery and so much of critical care and things like that, which I was on service more with you when I was in the NICU as a fellow. Because my question is actually about the teaching side of it. Like I think a lot of us learn this just by existing in medicine and observing other people doing this well. And how do you teach this? How do you recommend teaching this like sort of on the fly reality of clinical medicine? Yeah, this is a great question. So we often think in ethics that we need to take it down to relevance and apply the philosophical and ethical theory apply it to clinical practice. And so that was the goal of this framework to really then use this in clinical practice and to say, all right, for the team here, we actually did this with one case with potential lung transplant for the infant with severe bronchopulmonary dysplasia. And you know, one of my colleagues was like, absolutely no, we can't offer lung transplant to this family. And I said, well, why not? Let's take a look. And you know, you can get out the framework and say, let's talk about this as a team first. And so I think there can be short teaching moments where you can say, well, actually think about that. Is that a fact? What are the most recent facts about this case? Assigning a trainee, can you come back tomorrow and tell me what are the most recent outcomes in lung transplant for neonates for infants? Right. Do we have those data? What are those data? And it's a great teaching point to say, maybe that, maybe that statement is no longer true, right? Or, or maybe it is. And we just need to get the facts first and then see where we are in that spectrum. So I think, you know, it doesn't have to be an hour long lecture, but it can be short teaching moments, you know, talking about genetic diagnoses, for example, and potential for disability. You know, is that clouding our decision making, whether to offer this or not? And we need to check those. And so that's like another quick teaching moment. So I think being able to incorporate quick teaching moments into relevant cases in practice in ICU in the OR can be really helpful. Because we really appreciate the talk, very, very helpful. And I think that I think I've observed for the most part the shared decision making model being what we practice here consciously, unconsciously. And it's very difficult to think about this outside of the perspective of being a surgeon in our experiences. And so in that respect to piggyback a little bit off of a Patrick brought up, I wonder if you could comment on what happens when there's an impasse from the perspective of a surgeon, you can take the example of the single, single, ventral cardiac kid who's on death store, who they want you to do a laparotomy for everybody wants it done the parents, the cardiologist, the ICU team, but you make the calculation that you don't want to be the one to kill this patient. And do you have a right to refuse when you're outvoted what what what happens in those situations? That's a great question. I do think that that requires more team discussion. And yes, I think that you as a surgeon do have a right to say, I don't think that this is ethically permissible for these reasons and lay them out. There is potentially more harm than good. It's not going to achieve the desired effect. The potential for interoperability is extremely high or even likely. And that's that's not that's not the goal. And and to discuss with the clinical team, of course, first before discussing with families to make sure the clinical teams on the same page, but that's not easy. I don't know if anyone else has we have to wrap it up. Sorry, I am available to talk afterwards. Unfortunately, we do have to wrap it up. But I think what we're seeing is that an hour is not long enough for us to have this conversation. And this has really been spectacular for you to give us the sort of the framework intellectually, the academic component of it. But we should think about whether there's a forum where we could get together and have a much more interactive informal discussion where we can learn from your deep thought and experience in this. As we all, as the questions demonstrate, we all live this every day in our care. But we may not have all had the benefit of the wisdom of study that you have had it. And I think your availability to us in a less formal setting might really be of benefit to all of us because as Dr. Mary says, like, this is working just up at night. Right. I would do it right. And that's not always a right and wrong answer and things change over time. So thanks so much for your time and for all the leadership that you provided for us as well as the great care of our patients. Thanks so much. It was a pleasure.