SCCM Resource Library-Ethical Now, Unthinkable in the Future

Video Transcription

Good evening. Welcome to this session of the SCCM Clinical Congress entitled Ethical Now, Unthinkable in the Future.  This is a topic that I think is timely for two reasons, both of which I think are well known to the audience.  One, this is our anniversary presentation of our Critical Congress, and as such, we really wanted this to reflect not only where we've come in the past 50 years, but where  we think critical care medicine is going to be going in the next 50 years. And since ethics is such an ineradicable portion of what we do and something that all of us  as critical care providers have to grapple with every day, we think that this is a very timely topic for us at this particular time.  Also, certainly everyone is well aware of the COVID pandemic, which we're now just finishing our first year in and will likely go into the second year.  And while I do not believe that basic medical ethics change, and certainly we all ascribe  to the principles of beneficence and malificence and patient autonomy and justice and compassion,  and I don't think those are going to change, I do think that evolving circumstances make us have to contemplate ethical issues that we may not have wanted to or been comfortable  contemplating in the past. And thus, I felt that this session would be not only an excellent forum for our experts  to give their perspectives on various aspects of critical care in this forum, but I also think that we could have a lively, robust Q&A session afterwards where these ethical  issues can really be aired out and what I hope will give everybody guidance going forward into what's likely going to be a continuous difficult time.  And of course, as we all know, the next plague and the next issue in critical care is always just around the corner. Our sessions will be divided into four.  Our first session is entitled, How Could or How Couldn't You? How History Will Judge Us for Rationing or Overusing Critical Care. And those are issues we all struggle with.  But just as I'm sure our presenter will tell us, there's no escaping them. And very often, if you can do them intelligently, you at least avoid doing them by default and  getting a better outcome. Our second presentation is called, Failing First, Do No Harm, Will We Be Using the Same Therapeutic Options in the Future?  And this is a presentation in which we hope to discuss some of the future tools that we'll have in terms of AI, precision medicine, and so forth, and what implications those  would be for therapeutic approaches in the intensive care unit. We will hear about the lost and forgotten patients, future considerations in family  waiting and family participation in the intensive care unit. And it is very pleasing to me as someone who's been doing critical care for quite some time  and has always deeply thought about and struggled with what role the family plays in the care of our patients and how to best bring them along.  And also, candidly, having been a family member myself with a loved one in the critical care unit, I think this will be a good perspective for us, again, both looking in the future  and also in the context of our COVID-19 pandemic. Finally, we'll hear about the ethics of allowing surrogate consent for research, and the presentation  will touch on some of the research issues. Once again, this is very timely in that what the past year has shown us, and in any pandemic,  the necessity for rigorous, timely, but well-done research is, if anything, accentuated. And fortunately, we do have the mechanism and the mechanics and certainly the motivation,  the triple Ms, as you were, of good research in which we can truly say we develop and deliver the best care to our patients, and that we do so in the framework of an evidence-based  medicine, but always motivated by each individual patient and what we think will benefit them. So again, thank you very much for joining us.  I look forward to a very well-done and well-informed and very interesting presentation, and I'm looking forward to a lively question and answer session at the end.  Thank you very much. Hi, my name is Dipali Dixit. I have no conflicts to disclose, though I will disclose that I will not be presenting  any randomized control trial, as there is limited evidence to what I will be presenting today.  But without a question, remarkable progress is being made on the use of precision medicine and artificial intelligence to advance ICU practice over the next 30 years or so.  There has been a pressing need to improve quality of care tied to patient outcomes. Unfortunately, reports continue to identify medical errors as one of the leading cause  of death in the United States. Additionally, we continue to see medication errors occurring at a substantial rate, which  obviously have led to increased length of stay in a hospital and a huge economic burden on our healthcare system.  Naturally, this has led to the unprecedented interest in precision medicine and artificial intelligence.  As I was preparing for this talk, I came across several papers that were describing future of critical care, and these papers were actually written by prominent intensivists around  the country. So let's see what we have in store for us. Hospitals will likely be smaller, more specialized, and definitely more user-friendly.  And I think we will be able to accommodate family members much more easily and perhaps even spend the night.  There will be fewer hospital beds, owing to more focus on disease prevention and improved patient care outside.  Patients will definitely be continuously monitored using newer devices such as wearable sensors. They're also known as electronic tattoos, and they're actually very cool to look at.  And what this is going to help us is easily access pertinent patient data such as stroke volume, cardiac output, tissue perfusion, among other parameters, to help us predict  decompensation before it starts, coupled with therapeutic strategies. One example I would also provide is fluid challenges will actually be driven by cardiac  output combined with titration oppressors and inotropes. Patients will definitely be more present and visible, which means perhaps clinicians  will physically be less present in the unit. Additionally, telemedicine will be everywhere.  Interestingly enough, COVID pandemic accelerated the implementation of telemedicine and patient home as a point of care.  Now with the assistance of specialized robots, early mobilization indeed is going to be the standard of care.  At this point, I would like to define what is artificial intelligence so that we're all on the same page.  Artificial intelligence has been defined as a field of study and design of machine intelligence intended to emulate human intelligence.  Just to keep in mind, I will be referring to artificial intelligence as AI for the remainder of the presentation.  It is definitely expected that AI will influence application in the ICU in a big way, especially given the large amounts of data that is collected routinely.  Though we must keep in mind, this technology is still in its infancy, but growing number of publications definitely hold promise.  Now moving on to precision medicine, which is also referred to as personalized medicine, has also been increasingly used in oncology as well as other areas, and now in critical  care to develop targeted therapy to optimize benefits and minimize risk. Ongoing AI research is targeted around predicting clinical decompensation, such as in patients  experiencing sepsis, acute kidney injury, sedation responsiveness, ARDS, delirium, among several other areas.  Interestingly, I will add these devices that the patients will be wearing, they will also help us identify when they will be needing to turn, therefore reducing hospital-acquired  pressure injury. So what are some of the implications that we can expect for therapeutic approaches in the future?  Well, one thing we can all agree on is that one size fits approach leads to divergent results.  These novel approaches will hopefully help us personalize treatments by identifying different  physiological ways in which patients respond, and this is how we can tailor therapy accordingly.  An exciting area for pharmacists is going to be the impact of AI technology in transforming  medication management, and certainly it's going to help us improve with medication safety, which is always first and foremost for us pharmacists.  Additionally, we see pharmacists often face dilemmas dosing ICU patients that are not commonly represented in clinical trials.  So for example, patients with extreme weights, elderly, critically ill, especially when they're on devices such as continuous renal replacement therapy, ECMO, or other devices.  The good news is ongoing studies using AI algorithms show precise dosing is definitely going to be feasible.  An example I'd like to give is that AI models have shown that autonomous dose adjustments can be done automatically based on renal function.  AI can also offer clinical decision support, and this is going to help us standardize best treatments for our patients and will help reduce clinician variability.  Now response to biomarkers will increasingly be used in the future as well to guide duration of therapy.  An example would be duration of antibiotic use in our septic patients or when to start and stop continuous renal replacement therapy or determine ongoing fluid needs.  With these fancy devices, we will have targeted drug delivery only to the diseased part, which  is exciting for us because it will definitely indeed minimize side effects for our patients.  There's definitely promise for improving accuracy and reducing costs with medication-related tasks.  This we definitely have learned over the years can identify phenotypes in heterogeneous ICU patients, including those with ARDS and sepsis.  Preliminary investigation has shown genetic factors may also play a role in hemodynamic response variability.  The other thing we often face in clinical practice is differences in responsiveness to vasopressors.  Now what we have learned is finding from these two small studies, they suggest that genetic factors may indeed have potential implications for patients with septic shock, though we  must keep in mind all this research is in gestational phases of research. Various scores have been used to predict sepsis earlier on, yet sepsis is often unclear until later stages.  Our goal and hope is that artificial intelligence has the potential to develop model to predict sepsis as well.  A few different groups have actually looked into doing this where artificial intelligence model predicted sepsis 12 hours before onset, which is huge for our patient outcomes.  As mentioned previously, artificial intelligence can offer decision support, which will again standardize the way we decide to optimize treatment for each patient with sepsis.  For example, we see a lot of variation in practice among clinicians with the amount of fluids they give or the doses of vasopressors given to our patients, which then predispose  them to side effects and poor outcomes. The good news is Komoroske and colleagues actually explored applications of AI model  to determine dose for fluid and vasopressor in septic patients, and the studies actually showed very good outcomes.  Our hope is that newer technology will also help with improving sedation practices as we often see over and under sedation in our ICUs.  And we all know that it is definitely associated with poor outcomes, including delirium, which is associated with poor outcomes, as we all know.  We have gone from massive sedation using both continuous infusion of benzos and opiates in the past to a current strategy of anal-goat sedation, where we think less is more.  The future may hold further improved sedation practices in the ICU. Now, about 90% of patients receive these agents, and we know that they're associated with  morbidity, mortality, and prolonged immobilization, which we know is also associated with development of post-intensive care syndrome.  The good news again is, indeed, the need for sedation will definitely be greatly reduced  with increased use of non-invasive monitoring and interventions, including mechanical ventilation.  Artificial intelligence may enable more personalized sedation to reduce clinician variability. Another thing that we often focus on, and there's ongoing research, is delirium.  Delirium assessment tools, such as CAM-ICU, are often used, but the assessment remains unsatisfactory.  Our hope and goal is that the innovative technology also holds promise for predicting delirium. In fact, a recent study conducted by Davadi and colleagues, pilot SICU studies showed  that data from wearable sensors, audio and video recording of the environment, they could actually predict patients at risk for developing delirium and detect delirium at an earlier  stage. Wow, this sounds huge. In fact, I think it's going to be a game changer as to how we use antipsychotics, as well as other medications for the management of ICU delirium.  And I think, ultimately, our patients are definitely going to be having improvement in their sleep hygiene.  Delirium assessment tools, such as CAM-ICU, is often used, but assessment remains unsatisfactory. Our hope and goal is that innovative technology will also help predict delirium.  Davadi and colleagues, pilot SICU studies showed that data from wearable sensors, audio and video recording of the environment, they could actually predict patients at risk for  developing delirium and detect delirium at a much earlier stage. I believe this is going to be a game changer in the way we use antipsychotics, as well  as other medications for the management of ICU delirium. Lastly, another promising technology is target-controlled infusion, mainly known in the field of anesthesia,  especially in the Europe area. But recently, some papers have described its use in the intensive care unit.  Now, in contrast to manually controlled infusion, this technology allows clinicians to target a predefined drug concentration in specific body compartment.  This system constantly calculates how much drug is in the tissue and exactly how that influences the amount of drug required to achieve the target concentration using models  of pharmacokinetics of the drug and patient covariates. There are theoretical advantages to this technology, where we might be able to attain target  concentrations without overshooting. We may also definitely individualize treatment and dose adjustments are going to be continuous.  In conclusion, the emergence of artificial intelligence and personalized medicine is growing throughout the healthcare and has potential applications in the ICU.  These advances are certainly exciting and will likely have an impact on future therapeutic approaches, potentially improve patient outcomes, and minimize cost. Thank you.  Hi, I'm Sarah Manchar, the trauma program manager at Hackensack University Medical Center.  Today, I'm lecturing on the lost and forgotten patients as part of the ethical now unthinkable  in the future lecture, the lost and forgotten patients, future considerations in family wellness in the ICU. I do not have anything to disclose.  Oftentimes there is a lot of confusion and miscommunication between families of ICU patients and the clinical team.  This is multifactorial, including various communication techniques, very busy families, confusion, workload, and burnout.  Multidisciplinary teams are really good, but also can add to the confusion and make scheduling meetings and staying on the same page very challenging.  And of course, COVID-19 has changed the ICU family dynamic. There are many visitation restrictions and families can't be at the bedside.  More than 5 million patients are admitted annually to the intensive care units in the U.S. One-fifth of Americans die after receiving care in an ICU.  Many patients who survive have poor functional outcomes and quality of life. As many as 50% of family members report not understanding a diagnosis, prognosis, or treatment plan.  Most ICUs have visitation restrictions and surveys show very high patient family satisfaction scores in the ICU.  However, the lowest scores are in the inclusion with and support during decision-making process.  Common platforms for clinician family communication that currently exist are family-centered rounds, interdisciplinary family meetings, electronic patient portals, and daily family  updates. This study was done in 2016. The objectives were to examine perspectives of patients' family members and healthcare  providers on family participation in rounds in the surgical intensive care unit. Patient family members and surgical ICU care providers were recruited for interviews to  explore the stakeholders' perspectives on family participation in rounds. The results were that both patient family members and healthcare providers described  inconsistent practices surrounding family participation in ICU rounds, as well as barriers to and facilitators of family participation.  Understanding the barriers to and facilitators of family participation in the ICU rounds is key to encouraging adaptation of family-centered rounds.  For families that live far away or have competing demands, telemedical options may facilitate participation.  This study done in 2018 was a comparison of opinions of intensive care unit staff and family members of the treatment intensity received by patients admitted to an ICU.  Achieving shared decision-making in intensive care units is very challenging because the patient has a limited capacity, leading to the reliance on surrogate decision-makers.  Prior research shows that ICU staff members often perceive that patients receive inappropriate or futile treatments, while some surrogate decision-makers of families admitted to the  ICU report inadequate communication with physicians. Therefore, there's an ongoing perception of both the ICU staff and surrogate decision-makers  around wishes for ICU treatments, and it's an essential component to improve these situations.  The objectives of the study were to compare the perceptions of the staff with the surrogate decision-makers of the patient.  The conclusion is that family members did not share the same perceptions of treatment with the ICU staff.  This may result from difficulty in prognostication, challenges in conveying poor prognoses to surrogate decision-makers, and the accuracy of surrogate decision-maker reporting.  Another study done in 2019 on clinician-family communication about the patient's values and preferences in intensive care units.  Little is known about whether clinicians and surrogate decision-makers follow any sort  of recommended strategies for shared decision-making by incorporating intensive care unit patients' values and preferences into treatment decisions.  So, the objective of this study was to determine how often clinicians and surrogates exchange  information about patients' previously expressed values and preferences and deliberate and plan treatment based on these factors.  The conclusion of relevance was that most clinician-family conferences about prognosis  and goals of care for critically ill patients appear to lack important elements of communication about values and preferences, with robust deliberation being particularly deficient.  Comprehensive interventions may be needed to better prepare surrogates for these conversations and improve clinician communication skills for eliciting and incorporating patients'  values and preferences into treatment decisions. This study was done to develop a model of interprofessional shared clinical decision-making in an ICU setting.  The conclusion was that both qualitative and quantitative data corroborated that physicians  and nurses from all units were similarly and moderately satisfied with their level of collaboration and shared decision-making.  However, most ICU clinical decision-making continues to take place independently, where there is some sharing of information, but rarely are decisions made collectively.  Another study done was looking at the multicenter study of key stakeholders' perspectives on communicating with surrogates about prognosis in intensive care units.  Surrogates of critically ill patients often have inaccurate expectations about prognosis,  yet there is little research on how intensive care unit clinicians should discuss prognosis,  and existing expert opinion-based recommendations give only general guidance that has not been validated with surrogate decision-makers.  The objective of this study was to determine the perspectives of key stakeholders on how prognostic information should be conveyed.  Some of the things that they came up with are listed here, that help families to see  prognosis through education, pictures, radiographs, and bedside explanations, convey the possibility  of poor outcomes early, discuss prognosis regularly over the course of the ICU stay as the patient's course evolves, numeric estimates may be helpful to some families,  and engaging multiple clinical disciplines in coordinating prognostic communication. The conclusion is family members, clinicians, and experts identified specific communication  behaviors that clinicians should use to discuss prognosis in the critical care setting.  These findings extend existing opinion-based recommendations and should guide interventions to improve communication.  During the COVID-19 pandemic, there were some novel approaches to communication due to the inability to have families at the bedside.  Family medical communication teams were experienced physician volunteers who were not doing clinical work during this time, and they would engage with the ICU teams  and update the families daily.  iPads for family and patient communication were added to multiple units across the country. Communication bundles were created.  The bundles include communication education for providers, durable power of attorney surrogate decision maker, conversations, and obtaining advanced directive documents,  as well as a template documenting family communication and updating the code status.  Another approach during the COVID-19 was palliative care rounds on all ICU patients.  So future considerations.  SCCM has a family engagement collaborative. The Society of Critical Care Medicine offers intensive care units an opportunity  to participate in a learning and improvement collaborative. This began in 2019 and continues.  The family engagement collaborative focuses on implementing and enhancing programs to engage patients and their families that are likely to have a positive impact  on the patient's care and experiences during their ICU stay.  Studies have shown that having family involvement saves clinicians time later on when it comes to having family care conferences because families are more knowledgeable.  Apps and online resources are a great way to engage family members. The patient communicator app by SCCM is designed to improve communication between patients,  families, and caregivers. Communication with patients who are unable to speak is often challenging. Mechanical ventilation, hearing or speech limitations,  language barriers, and other hurdles stand in the way of providing optimal patient-centered care.  This app was developed by Intensivus and can help ease the stress of a hospital day.  Features include a new diary function that allows patients to track their daily progress during and after their hospital stay. There are translation capabilities  in 18 different languages on a variety of topics and a scale that allows patients to identify where on the body they feel sensations like pain, itching, nausea,  and express the intensity of these sensations. There are more than 30 translatable phrases that allow patients to express various needs related to their care.  There are multiple family care apps available, one by Push Interventions. Another one was developed at Beth Israel Deaconess Medical Center in Boston. It's called MyICU.  It serves as a communication tool to better engage the ICU patients and family members in decision.  The app can be accessed by a dedicated iPad that they keep in each ICU room or remotely from a smartphone or home computer using a secure login.  This online tool allows users to learn more about the patient's medical condition and to get to know members of the care team.  There's another app by Navion, a company that has a patient engagement platform that helps to support patients, those they love and care teams in navigating illness together.  Given that no single communication platform is able to achieve all the goals of clinician family communication, the best approach may be to strategically combine platforms  in a deliberate way to efficiently achieve the proposed communication goals.  Here's a model of how multiple platforms of communication can be integrated across the ICU stay.  The goals for communication build on each other. For example, when a patient is admitted, the family's often overwhelmed and they don't know the extent of the patient's illness  and the clinicians know very little about the person. Therefore, early goals focus on establishing a trusting relationship and allowing both clinicians  and families to gather the information they need. This can be achieved in update on the day of admission or on day one. Days two and three can focus on,  depending on the availability of the family, they can focus on including the family and family-centered rounds.  They can focus on primary goals like orienting the family, exchanging basic information and establishing trust.  By the third phase, when the goals of care have been solidified, clinical outcomes are more apparent, the family and clinical team can plan for some transition from the ICU.  For some patients, this may involve moving to a different level of care within the hospital. For others, it may entail transfer to a care setting outside the hospital,  such as long-term care or hospice. And finally, for some, it may progress towards the dying process.  This is a digital project product that is intended for a full range of ICU providers, doctors, nurses, social workers, and therapists,  and for families to enhance communication about personhood. This shows a physical appearance of the patient, a life story, social connections, values, and preferences,  all about the patient. You can either do this in a paper form or electronically. It helps the providers gain a deeper understanding of the individual behind the patient.  It also permits families to connect with  and reflect on over time, their loved one's personhood and deeply held values. The get to know me page.  Patient and family centered care is healthcare approach that engages patients and their families to make care and management decisions  in collaboration with healthcare professionals. One way to achieve this is through virtual family participation in daily rounds. Many places have already started doing this,  and really it's our Neonatal Intensive Care Unit colleagues that have paved the way for virtual family participation.  Using technology to deliver healthcare, health information, and education can enhance patient family centered care and nurture a positive collaborative partnership  with families and healthcare providers.  And most importantly is family self-care. There can be daily optional meetings for families with loved ones in the ICU to meet and practice mindfulness and emotional health.  While caring for a loved one can be very rewarding, it also involves many stressors. And since caregiving is often a long-term challenge,  the emotional impact can snowball over time. The importance of self-care has been proven. It's hard to break away even temporarily when people depend on you,  but it's unrealistic to be on the go for 24 seven when stress is already high.  Neglecting yourself puts you at risk for burnout, compassion fatigue, and secondary traumatic stress. This is what the patient's family is going through.  Family members need to think of their response as a marathon and not a sprint. The only way that they can get through it is to pace themselves.  And they need to look at their own needs as well as their loved ones. There's strong correlation between self-care and avoidance of burnout.  Having a space where families can decompress and socialize with each other, even just for a few minutes out of the day can really help with their self-care  and overall emotional wellbeing.  So to recap, the future considerations in family wellness in the ICU can include apps and electronic communication platforms, standardized scheduled family communication,  get to know me posters, digital or non-digital, virtual family participation and daily rounds, and family self-care.  The key is communication.  Thank you and stay safe.  Thank you very much to the Society of Critical Care Medicine for the invitation. My name is Fred Rincon. I am an Associate Professor of Neurology  and Critical Care Physician at Cooper and the Rowan School of Medicine in Camden, New Jersey. We'll be talking about ethics in research specifically related to healthcare proxies  and decision-making in participation in clinical trials  in populations that cannot give consent.  These are my disclosures pertinent to the talk. I don't have any disclosures and no off-label use reporting.  So this is our patient. He comes into the emergency department or the intensive care unit with a significant illness. He cannot give consent for clinical therapy  or for any research intervention, but you want to enroll the patient in a specific clinical trial that you're participating in that you believe has some scientific merit.  The principle of medical and surgical morality consists in never performing on a man an experiment or in this particular case, a therapeutic,  which might be harmful. This is a principle that physicians and providers in general sort of like follow in clinical practice as the principle of primum non nocere,  but it also applies to clinical experimentation. And though we didn't have formalized policies in terms of the ethics of research until the late 1960s,  we see that historically we have had promulgations and statements from prominent physicians that have commented on the morality and the ethics of performing experiments in humans.  It wasn't really until the unethical experimentation during World War II that we see the surfacing of experiments  or unethical experiments in humans without consent, without appropriate disclosure. And this became relevant for the trials at Nuremberg  that pretty much emphasize on the unethical practices of physicians and providers in Nazi Germany. And from these proceedings,  we received from the development of several statements,  the Nuremberg Code. The Nuremberg Code is a document that highlights the practices of ethical research. And the first statement of the Nuremberg Code  is that you need consent and it must be voluntary for human subjects that is gonna be subjected to experimentation. And beyond that, the Nuremberg Code has more statements  that are important for clinical, I'm sorry, for research nowadays. It also determines that the experiment should be helpful, not just for the subject, but also for society  and that you should have some sort of like a priori information about the harm risk-benefit ratio of the experiment and so forth. So this led to the Declaration of Helsinki  that pretty much sort of like summarizes the Nuremberg Code. And historically we have evolved, we have several documents that actually talk about ethics  and research in the United States. We had the Bellman Report in the late 1970s, but in general, throughout the world, we see these documents that highlight those principles  that were promulgated from the Nuremberg Code and the Declaration of Helsinki. In the United States, we had our own scandals in terms of research. Beecher published this paper  in the England Journal of Medicine in 1966, where he highlighted at least 20 experiments that were primarily unethical in his mind. This led to a reappraisal of the way  that we conduct the research in this country.  It led to also a federal movement that led to the promulgation or the publication of the Bellman Report that consists of several ethical principles  that guide the way that we do research. And those primarily are related to the subject's autonomy, respect for subject, and which impinges on that primary principle  from the Nuremberg Code that the patient has to give consent, has to give consent in a voluntary way to participate in research. Informed consent is a legal term,  and it implies the ability of an individual to decide what ought to be done to his body, either for clinical purposes or research, and it determines that the patient has to be  in full capacity in some way to give that consent. And in this sense, you know, when you think about research,  it's all like, depart from this principle of autonomy because, you know, in our populations, in the emergency department and particularly in the intensive care unit,  most of our patients have the decision capacity or rescinded because of critical illness. So in terms of research, it becomes a little bit problematic  because our patients are not really in the sound mind to give informed consent. So in clinical practice, we use surrogate or proxy decision-making based on different standards,  best interest standard,  the preponderance of evidence, et cetera, that can guide clinical research, I'm sorry, that can guide clinical therapy. But in that sense,  we think that there is a potential benefit to the subject. When we think about clinical interventions, right? We think about benefits, risk-benefit ratio,  and we also think about the desires of the patient, and that's how we make decisions. These wishes are usually known by patients and in the form of advanced directives  or power of attorneys. But when it comes to research, we are really, you know, lost. There is really no indication of what benefits are in a clinical trial  because we depart from very strong principles of equipoise to conduct research, as I will discuss later. And then finally, in terms of desires,  you know, when we cannot even get desires about clinical interventions, much less for research. So to this end, there is a ethical departure of how we approach decision-making  based on proxies and surrogates in clinical practice and in human experimentation.  Because the ethics of science incorporates a principle of equipoise, where you depart from a null hypothesis, where you think as a investigator, as a researcher,  that there is no difference between two potential interventions, then you can assume that, based on that principle of equipoise, there is really no either risk or benefit  for the potential intervention that you want to test on your cohort. So this is very important. And attorneys have litigated this very, very strongly.  For example, in this case of Jesse Geisinger, who suffered from ornithine transcarbolamase deficiency, and he was undergoing gene therapy,  the attorneys concluded that this patient died  during this experiment. And the attorneys concluded that the investigators did not disclose a risk-benefit ratio appropriately, that the consent was flawed based on that premise,  that there was some harm to animals performed in prior experimentation. And most importantly, they discovered also  strong conflicts of interest between the investigators and the sponsor. So this highlights the importance of ethics, not just at the time of deciding  if the subject is able to participate in clinical research, but also in the way that you conduct  your human experimentation. And these are also principles that were enumerated in the Nuremberg Code and in the Declaration of Helsinki.  It's not just the subjects' respect and autonomy to decide if they want to participate in clinical research. And also involves the way that you conduct ethics,  I mean, experiments in an ethical way. So it's very important to know that as a investigator, you have to depart from a principle of equipoise,  where you assume that there is no benefit or risk for the populations. The minimal risk standard is very important at the time of conducting clinical research  in patients that don't have a decision capacity. And courts and attorneys have looked at this, and it seems that the principle of participating  on a clinical intervention is a little bit different than participating in clinical research because that lack of knowledge about potential benefits.  However, we have to understand what minimal risk is in human experimentation, which is the probability and magnitude of harm or discomfort  from your research intervention that shouldn't be greater than that ordinarily encounter in daily life. So this is a very low standard that can be easily breached.  So the Belmont Report was revised recently, and it contains information about human experimentation without decision capacity in reference to that minimal risk.  When we are conducting clinical research, of course, consent is very important. Information should be transferred to the patient or the decision maker.  Comprehension has to be evaluated. And then finally, this decision has to be voluntary. As I said, the Belmont Report was revised  to give a recommendation and authorization for legal representatives to provide consent on behalf of a prospective research subject.  But there are some considerations that need to be applied. And because we're talking about critically ill populations, emergency interventions that are time-dependent,  the concept of minimal risk becomes very important because as I said, courts, attorneys have litigated about the ability of individuals to participate  in research that requires an informed consent and voluntary participation.  This will be problematic in our courts, in our population, because of the nature of the disease states. So the National Institute of Health, for example,  has determined that surrogates and proxies can give consent in this setting if the research provides minimal risk. If there is greater than minimal risk,  but there is a prospect for direct benefit to subjects. But as I said, ethically, when you're coming from a principle of equipoise or no hypothesis,  you have to assume there is no benefit or risk. You're just testing that hypothesis in your clinical trial. So this is problematic in the sense  that scientifically, right, it makes no sense that it could be a probable subject. Of course, as an investigator, you hope that that is the result of your study,  but that is a sort of bias. And then finally, it authorizes surrogates and decision makers to provide consent on behalf of a subject that doesn't have capacity  when greater than minimal risk is present and no prospect of direct benefit to the subject, but with the likelihood of getting important knowledge in science about the subject.  So this is, I think, where we have to base most of our background on,  or framework to conduct research in our populations, is that based on the principle of equipoise and our interest to advance science and understand the subject's critical illness  and how they behave with interventions,  this is the way that we can actually conduct research ethically. However, what are the attitudes out there? What do patients think about this? Well, 30% of people are not willing  to participate in research out there. 76% have said that they would do if they would help them. This is actually not in support of the principle of equipoise.  There isn't really no evidence at the time of conducting a clinical trial when you're departing of a principle of equipoise that that would help anyone.  It could harm, actually, somebody, and that has to be disclosed as well. For those that have presented the possibility  of no benefit whatsoever, but with minimal risk, half would say yes, and only 9% would say if it's more than minimal risk and there is no benefit, would actually participate.  This is a very small number in terms of people out there when you survey the general population. Empiric research has also determined  that 50% of the people making decisions for them don't know what the patient wants. 41% of patients would prefer the spouse. That's actually less than 50%.  Most people actually would like providers to make decisions for them. And then finally, it's a false positive rate. Well, 20% of people would say, why did you enroll me in research?  And then finally, there is really a two-third agreement between what proxies want and what individuals want in terms of clinical research.  So this is very important because at the time of the signing in participating in clinical research  in a high-risk intervention, such as in the critical illness or emergency setting, we need to have some sort of a priori understanding of who is gonna decide for the patient.  And fortunately, in 1996, the FDA gave some support  to what we call research with waiver of informed consent.  And we have been able to conduct at least 40 clinical trials over the last 20 years in emergency, critically ill populations that have shared a lot of information  in understanding critical illness and trying to advance scientifically the field vertically.  So based on this, we have some protections for research. As I said, the NIH, the FDA, the federal government in the United States in this particular jurisdiction  provide some recommendations about how to protect research subjects. The IRBs are important in this sense. Independent assessors for capacity,  not just investigated at the time of enrollment. The standard assessment of capacity, meaning tools that are validated to evaluate capacity at the time of clinical,  I'm sorry, at the time of clinical decision or enrollment in clinical trials. The consent process, perhaps performed by a different assessor, right?  And then finally, sort of like these interventions and re-evaluation of capacity where you wait and see there's time to reconsider research and consent in the particular experiment  that you're running. So other protections for subjects are there. The most important thing is to understand that the ethics of research depart  from principles of autonomy, respect, and justice. We need to respect our patients' autonomy as much as we do in clinical operations.  When it comes to research, we need their consent because there is a sense of benefit or also potential harm. Disclosure is extremely important  at the time of enrolling patients in clinical research. And finally, the principle of justice. We need to make sure that we advance our field vertically  and that patients benefit from clinical research. So it's our duty not only to follow all of these clinical and ethical principles, but also to conduct research in an ethical way  and to make sure that our patients are being enrolled in clinical studies where there is really no intervention proven to help them. This will help our scientific community,  our fields to advance vertically. And for those diseases where there is really no  interventions available, perhaps understand them better and determine if clinical interventions are possible. With this, I would like to thank you and I would like to thank  the Society of Critical Care Medicine for the invitation and please stay safe.  ♪♪

Video Summary

The video transcript discusses the topic of ethics in critical care medicine. The speaker highlights the importance of discussing and grappling with ethical issues in critical care, especially in light of current circumstances such as the COVID-19 pandemic. The video covers various aspects of ethics in critical care, including the rationing or overusing of critical care, future therapeutic options, family involvement and participation in the intensive care unit (ICU), and the ethics of surrogate consent for research.<br /><br />The first session discusses the ethical considerations of rationing or overusing critical care in the future. The speaker acknowledges the ethical dilemmas that arise when making decisions about the allocation of limited resources in critical care settings.<br /><br />The second session explores the potential for advancements in precision medicine and artificial intelligence (AI) in the ICU. The speaker explains how wearable sensors and AI can help predict patient decompensation and tailor therapeutic strategies. Additionally, AI can improve medication management, dosing, and decision support in critical care.<br /><br />The third session focuses on the importance of family involvement and participation in the ICU. The speaker discusses future considerations for family waiting and family participation, including the use of technology and telemedicine to improve communication and support.<br /><br />The fourth session addresses the ethics of surrogate consent for research. The speaker discusses the challenges of obtaining informed consent from patients who are unable to give consent themselves and the need for rigorous research in times of crisis, such as the COVID-19 pandemic.<br /><br />Overall, the video emphasizes the importance of ethical considerations in critical care medicine and provides insights into potential future developments in the field.

Asset Subtitle

Ethics End of Life, 2021

Asset Caption

The Society of Critical Care Medicine's Critical Care Congress features internationally renowned faculty and content sessions highlighting the most up-to-date, evidence-based developments in critical care medicine. This is a presentation from the 2021 Critical Care Congress held virtually from January 31-February 12, 2021.

Learning Objectives

Identify evolving ethical dilemmas that will influence decision-making in critical care over the next century
Describe therapeutic modalities that may be considered ethically unacceptable in the future
Discuss future models that integrate family wellness into patient care plans
Compare and contrast surrogate and individual consent to participation in critical care research

Failing First Do No Harm: Will We Be Using the Same Therapeutic Approaches in the Future?
Deepali Dixit

The Lost and Forgotten Patients: Future Considerations in Family Wellness in the ICU
Sarah Monchar

The Ethics of Allowing Surrogate Consent for Research
Fred Rincon

Meta Tag

Content Type Presentation

Knowledge Area Ethics End of Life

Knowledge Level Foundational

Knowledge Level Intermediate

Knowledge Level Advanced

Membership Level Select

Tag Communication

Tag Medical Legal Issues

Year 2021

Keywords

ethics

critical care medicine

COVID-19 pandemic

rationing

family involvement

surrogate consent

precision medicine

artificial intelligence

telemedicine

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